Puregon

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



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1. NAME OF THE MEDICINAL PRODUCT

Puregon 50 IU/0.5 mL solution for injection
Puregon 75 IU/0.5 mL solution for injection
Puregon 100 IU/0.5 mL solution for injection
Puregon 150 IU/0.5 mL solution for injection
Puregon 200 IU/0.5 mL solution for injection
Puregon 225 IU/0.5 mL solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Puregon 50 IU/0.5 mL solution for injection
One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. 
This corresponds to a strength of 100 IU/mL. One vial contains 5 microgram of protein (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection 
contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster 
ovary (CHO) cell line.

Puregon 75 IU/0.5 mL solution for injection
One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. 
This corresponds to a strength of 150 IU/mL. One vial contains 7.5 microgram of protein (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection 
contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster 
ovary (CHO) cell line.

Puregon 100 IU/0.5 mL solution for injection
One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. 
This corresponds to a strength of 200 IU/mL. One vial contains 10 microgram of protein (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection 
contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster 
ovary (CHO) cell line.

Puregon 150 IU/0.5 mL solution for injection
One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. 
This corresponds to a strength of 300 IU/mL. One vial contains 15 microgram of protein (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection 
contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster 
ovary (CHO) cell line.

Puregon 200 IU/0.5 mL solution for injection
One vial contains 200 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. 
This corresponds to a strength of 400 IU/mL. One vial contains 20 microgram of protein (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection 
contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster 
ovary (CHO) cell line.

Puregon 225 IU/0.5 mL solution for injection
One vial contains 225 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. 
This corresponds to a strength of 450 IU/mL. One vial contains 22.5 microgram of protein (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein). The solution for injection 
contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster 
ovary (CHO) cell line.

For the full list of excipients, see section 6.1.

 



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3. PHARMACEUTICAL FORM

Solution for injection (injection).
Clear and colourless solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

In adult females:
Puregon is indicated for the treatment of female infertility in the following clinical situations:
 Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been 

unresponsive to treatment with clomifene citrate.
 Controlled ovarian hyperstimulation to induce the development of multiple follicles in 

medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), 
gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].

In adult males:
 Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

4.2 Posology and method of administration

Treatment with Puregon should be initiated under the supervision of a physician experienced in the 
treatment of fertility problems.

The first injection with Puregon should be performed under direct medical supervision.

Posology

Dosage in the female
There are great inter- and intra-individual variations in the response of the ovaries to exogenous 
gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, 
therefore, be adjusted individually depending on the ovarian response. This requires ultrasound 
assessment of follicular development. The concurrent determination of serum oestradiol levels may 
also be useful.
Based on the results of comparative clinical studies, it is considered appropriate to give a lower total 
dosage of Puregon over a shorter treatment period than generally used for urinary FSH, not only in 
order to optimise follicular development but also to reduce the risk of unwanted ovarian 
hyperstimulation (see section 5.1).

Clinical experience with Puregon is based on up to three treatment cycles in both indications. Overall 
experience with IVF indicates that in general the treatment success rate remains stable during the first 
four attempts and gradually declines thereafter.

 



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 Anovulation
A sequential treatment scheme is recommended starting with daily administration of 50 IU 
Puregon. The starting dose is maintained for at least seven days. If there is no ovarian response, 
the daily dose is then gradually increased until follicle growth and/or plasma oestradiol levels 
indicate an adequate pharmacodynamic response. A daily increase of oestradiol levels of 
40-100% is considered to be optimal. The daily dose is then maintained until pre-ovulatory 
conditions are reached. Pre-ovulatory conditions are reached when there is ultrasonographic 
evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol 
levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained. Usually, 7 to 14 days of 
treatment is sufficient to reach this state. The administration of Puregon is then discontinued and 
ovulation can be induced by administering human chorionic gonadotrophin (hCG).
If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e. 
more than a daily doubling for oestradiol for two or three consecutive days, the daily dose 
should be decreased.
Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles 
exceeding 14 mm carry the risk of multiple gestations. In that case hCG should be withheld and 
pregnancy should be avoided in order to prevent multiple gestations.

 Controlled ovarian hyperstimulation in medically assisted reproduction programs
Various stimulation protocols are applied. A starting dose of 100-225 IU is recommended for at 
least the first four days. Thereafter, the dose may be adjusted individually, based upon ovarian 
response. In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for 
six to twelve days are sufficient, although longer treatment may be necessary.
Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a 
GnRH agonist or antagonist. When using a GnRH agonist, a higher total treatment dose of 
Puregon may be required to achieve an adequate follicular response.
Ovarian response is monitored by ultrasound assessment. The concurrent determination of 
serum oestradiol levels may also be useful. When ultrasound assessment indicates the presence 
of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response 
(plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with a 
diameter greater than 18 mm), the final phase of maturation of the follicles is induced by 
administration of hCG. Oocyte retrieval is performed 34-35 hours later.

Dosage in the male
Puregon should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, 
concomitantly with hCG. Treatment with Puregon and hCG should be continued for at least 3 to 
4 months before any improvement in spermatogenesis can be expected. To assess the response, semen 
analysis is recommended 4 to 6 months after the beginning of treatment. If a patient has not responded 
after this period, the combination therapy may be continued; current clinical experience indicates that 
treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.

Paediatric population
There is no relevant use of Puregon in the paediatric population for the approved indication.

Method of administration

To prevent painful injections and minimise leakage from the injection site Puregon should be slowly 
administered intramuscularly or subcutaneously. The subcutaneous injection site should be alternated 
to prevent lipoatrophy. Any unused solution should be discarded.
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper 
instructions are given by the physician. Self-administration of Puregon should only be performed by 
patients who are well-motivated, adequately trained and with access to expert advice.

4.3 Contraindications

For males and females
 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
 Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.

 



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 Primary gonadal failure.

Additionally for females
 Undiagnosed vaginal bleeding.
 Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
 Malformations of the reproductive organs incompatible with pregnancy.
 Fibroid tumours of the uterus incompatible with pregnancy.

4.4 Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.

Antibiotic hypersensitivity reactions
 Puregon may contain traces of streptomycin and/or neomycin. These antibiotics may cause 

hypersensitivity reactions in susceptible persons.

Infertility evaluation before starting treatment
 Before starting treatment, the couple's infertility should be assessed as appropriate. In particular, 

patients should be evaluated for hypothyroidism, adrenocortical insufficiency, 
hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment 
given.

In females

Ovarian Hyperstimulation Syndrome (OHSS)
OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and 
symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate 
enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and 
symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, 
hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances, 
venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test 
abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy 
have also been reported in association with OHSS.

OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy 
(endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be 
associated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs more 
than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. 
Because of the risk of developing OHSS, patients should be monitored for at least two weeks after 
hCG administration.

Women with known risk factors for a high ovarian response may be especially prone to the 
development of OHSS during or following treatment with Puregon. For women having their first cycle 
of ovarian stimulation, for whom risk factors are only partially known, close observation for early 
signs and symptoms of OHSS is recommended.

Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive 
Technology (ART). Adherence to the recommended Puregon dose and treatment regimen and careful 
monitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS, 
ultrasonographic assessments of follicular development should be performed prior to treatment and at 
regular intervals during treatment; the concurrent determination of serum oestradiol levels may also be 
useful. In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in 
diameter. 

 



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If OHSS develops, standard and appropriate management of OHSS should be implemented and 
followed.

Multiple Pregnancy
Multiple pregnancies and births have been reported for all gonadotropin treatments, including 
Puregon. Multiple gestation, especially high order, carries an increased risk of adverse maternal 
(pregnancy and delivery complications) and perinatal (low birth weight) outcomes. For anovulatory 
women undergoing ovulation induction, monitoring follicular development with transvaginal 
ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the 
risk of multiple pregnancies. The concurrent determination of serum oestradiol levels may also be 
useful. The patients should be advised of the potential risks of multiple births before starting 
treatment.

In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple 
pregnancy is mainly related to the number of embryos transferred. When used for an ovulation 
induction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development.

Ectopic Pregnancy
Infertile women undergoing ART have an increased incidence of ectopic pregnancies. Early 
ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Spontaneous Abortion
Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the 
normal population.

Vascular Complications
Thromboembolic events, both in association with and separate from OHSS, have been reported 
following treatment with gonadotropins, including Puregon. Intravascular thrombosis, which may 
originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the 
extremities. In women with generally recognised risk factors for thromboembolic events, such as a 
personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including 
Puregon, may further increase this risk. In these women the benefits of gonadotropin administration,
including Puregon, need to be weighed against the risks. It should be noted, however, that pregnancy 
itself also carries an increased risk of thrombosis.

Congenital Malformations
The incidence of congenital malformations after ART may be slightly higher than after spontaneous 
conceptions. This is thought to be due to differences in parental characteristics (e.g., maternal age, 
sperm characteristics) and multiple gestations.

Ovarian Torsion
Ovarian torsion has been reported after treatment with gonadotropins, including Puregon. Ovarian 
torsion may be associated with other risk factors such as OHSS, pregnancy, previous abdominal 
surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. 
Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate 
detorsion.

Ovarian and Other Reproductive System Neoplasms
There have been reports of ovarian and other reproductive system neoplasms, both benign and 
malignant, in women who have undergone multiple treatment regimens for infertility treatment. It is 
not established whether or not treatment with gonadotrophins increases the risk of these tumours in 
infertile women.

Other Medical Conditions
Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment 
with Puregon.

 



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In males

Primary Testicular Failure
Elevated endogenous FSH levels in men are indicative of primary testicular failure. Such patients are 
unresponsive to Puregon/hCG therapy.

Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say 
essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of Puregon and clomifene citrate may enhance the follicular response. After pituitary 
desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an 
adequate follicular response.

4.6 Fertility, pregnancy and lactation

Fertility
Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian 
hyperstimulation in assisted reproduction programmes. In males Puregon is used in the treatment of 
deficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method of 
administration, see section 4.2.

Pregnancy
The use of Puregon during pregnancy is not indicated. In case of inadvertent exposure during 
pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH. 
However, to date, no particular malformative effect has been reported. No teratogenic effect has been 
observed in animal studies. 

Breast-feeding
There is no information available from clinical or animal studies on the excretion of follitropin beta in 
milk. It is unlikely that follitropin beta is excreted in human milk due to its high molecular weight. If 
follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of 
the child. Follitropin beta may affect milk production.

4.7 Effects on ability to drive and use machines

Puregon has no or negligible influence on the ability to drive and use machines. 

4.8 Undesirable effects

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the 
site of injection (3% of all patients treated). The majority of these local reactions are mild and transient 
in nature. Generalised hypersensitivity reactions been observed uncommonly (approximately 0.2% of 
all patients treated with follitropin beta).

Treatment of females:
In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms 
related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adverse 
reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or 
distension, breast complaints and ovarian enlargement.

The table below lists the adverse reactions with follitropin beta reported in clinical trials in females, 
according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to 
< 1/100).

 



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SOC Frequency Adverse reaction
Nervous system disorders Common Headache 
Gastrointestinal disorders Common Abdominal distension 

Abdominal pain
Uncommon Abdominal discomfort

Constipation
Diarrhoea
Nausea

Reproductive system and breast 
disorders

Common OHSS
Pelvic pain

Uncommon Breast complaints1

Metrorrhagia
Ovarian cyst
Ovarian enlargement
Ovarian torsion
Uterine enlargement
Vaginal haemorrhage 

General disorders and 
administration site conditions

Common Injection site reaction2

Uncommon Generalised hypersensitivity 
reaction3

1. Breast complaints include tenderness, pain and/or engorgement and nipple pain
2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching
3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus

In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are 
considered to be related to ART or subsequent pregnancy.

In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with 
other gonadotrophins. 

Treatment of males:
The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males 
(30 patients dosed), according to system organ class and frequency; common (≥ 1/100 to < 1/10).

SOC Frequency1 Adverse reaction
Nervous system disorders Common Headache
Skin and subcutaneous tissue 
disorders

Common Acne
Rash

Reproductive system and breast 
disorders

Common Epididymal cyst
Gynaecomastia

General disorders and 
administration site conditions

Common Injection site reaction2

1. Adverse reactions that are reported only once are listed as common because a single report raises the 
frequency above 1%.

2. Local reactions at the site of injection include induration and pain.

Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

No data on acute toxicity of Puregon in humans is available, but the acute toxicity of Puregon and of 
urinary gonadotrophin preparations in animal studies has been shown to be very low. Too high a 
dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).

 

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5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; 
ATC code: G03G A06.

Puregon contains a recombinant FSH. This is produced by recombinant DNA technology, using a 
Chinese hamster ovary cell line transfected with the human FSH subunit genes. The primary amino 
acid sequence is identical to that of natural human FSH. Small differences in the carbohydrate chain 
structure are known to exist.

Mechanism of Action
FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production. In 
the female the level of FSH is critical for the onset and duration of follicular development, and 
consequently for the timing and number of follicles reaching maturity. Puregon can thus be used to 
stimulate follicular development and steroid production in selected cases of disturbed gonadal 
function. Furthermore Puregon can be used to promote multiple follicular development in medically 
assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-
fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. Treatment with Puregon is 
generally followed by administration of hCG to induce the final phase of follicle maturation, 
resumption of meiosis and rupture of the follicle.

Clinical Efficacy and Safety
In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian 
stimulation in women participating in an Assisted Reproduction Technology (ART) program and for 
ovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms of 
a lower total dose and a shorter treatment period needed to trigger follicular maturation.

For controlled ovarian stimulation, Puregon resulted in a higher number of oocytes retrieved at a lower 
total dose and with a shorter treatment period, when compared to urinary FSH.

Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and 
efficacy of Puregon with urinary FSH in controlled ovarian stimulation).

Puregon
(n = 546)

u-FSH
(n = 361)

Mean no. of oocytes retrieved 10.84* 8.95

Mean total dose (no. of 75 IU ampoules) 28.5* 31.8

Mean duration of FSH stimulation (days) 10.7* 11.3

* Differences between the 2 groups were statistically significant (p0.05).

For ovulation induction, Puregon resulted in a lower median total dose and shorter median duration of 
treatment when compared to urinary FSH.

 



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Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and 
efficacy of Puregon with urinary FSH in ovulation induction).

Puregon
(n = 105)

u-FSH
(n = 66)

Mean no. of follicles ≥ 12 mm 3.6* 2.6

≥ 15 mm 2.0 1.7

≥ 18 mm 1.1 0.9

Median total dose (IU)
a 750* 1,035

Median duration of treatment (days)
a 10.0* 13.0

* Differences between the 2 groups were statistically significant (p0.05).
a

Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).

5.2 Pharmacokinetic properties

Absorption
After intramuscular or subcutaneous administration of Puregon, maximum concentrations of FSH are 
reached within about 12 hours. After intramuscular administration of Puregon, the maximum FSH 
concentrations are higher and reached earlier in men as compared to women. Due to the sustained 
release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 
70 hours), FSH levels remain increased for 24-48 hours. Due to the relatively long elimination 
half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are 
approximately 1.5-2.5 times higher than after single-dose administration. This increase enables 
therapeutic FSH concentrations to be reached.
There are no significant pharmacokinetic differences between intramuscular and subcutaneous 
administration of Puregon. Both have an absolute bioavailability of approximately 77%.

Distribution, biotransformation and elimination
Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, 
metabolised, and excreted in the same way.

5.3 Preclinical safety data

Single-dose administration of Puregon to rats induced no toxicologically significant effects. In 
repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human 
dose, Puregon induced no toxicologically significant effects. Puregon showed no mutagenic potential 
in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Puregon solution for injection contains: 
Sucrose
Sodium citrate
L-methionine
Polysorbate 20
Water for injections.
The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. 

 



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6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.

6.3 Shelf-life

3 years.

The contents of a vial should be used immediately after piercing of the rubber stopper.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).
Do not freeze. 
Keep the vial(s) in the outer carton.
For patient convenience, Puregon may be stored at or below 25ºC by the patient for a single period of 
not more than 3 months.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container 

0.5 mL of solution in 3 mL vial (type I glass) with stopper (chlorobutyl rubber).
Pack of 1, 5 or 10 vials.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Do not use if the solution contains particles or if the solution is not clear.
The contents of a vial should be used immediately after piercing of the rubber stopper.
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBERS

Puregon 50 IU/0.5 mL solution for injection
EU/1/96/008/017
EU/1/96/008/018
EU/1/96/008/019

Puregon 75 IU/0.5 mL solution for injection
EU/1/96/008/020
EU/1/96/008/021
EU/1/96/008/022

 



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Puregon 100 IU/0.5 mL solution for injection
EU/1/96/008/023
EU/1/96/008/024
EU/1/96/008/025

Puregon 150 IU/0.5 mL solution for injection
EU/1/96/008/026
EU/1/96/008/027
EU/1/96/008/028

Puregon 200 IU/0.5 mL solution for injection
EU/1/96/008/029
EU/1/96/008/030
EU/1/96/008/031

Puregon 225 IU/0.5 mL solution for injection
EU/1/96/008/032
EU/1/96/008/033
EU/1/96/008/034

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Date of first authorisation: 03 May 1996
Date of latest renewal: 29 May 2006

10. DATE OF REVISION OF THE TEXT

DD month YYYY

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 

http://www.ema.europa.eu/


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1. NAME OF THE MEDICINAL PRODUCT

Puregon 150 IU/0.18 mL solution for injection
Puregon 300 IU/0.36 mL solution for injection
Puregon 600 IU/0.72 mL solution for injection
Puregon 900 IU/1.08 mL solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Puregon 150 IU/0.18 mL solution for injection
One cartridge contains a net total dose of 150 IU recombinant follicle-stimulating hormone (FSH) in 
0.18 mL aqueous solution. The solution for injection contains the active substance follitropin beta, 
produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 
833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein / mL (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).

Puregon 300 IU/0.36 mL solution for injection
One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 
0.36 mL aqueous solution. The solution for injection contains the active substance follitropin beta, 
produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 
833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein / mL (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).

Puregon 600 IU/0.72 mL solution for injection
One cartridge contains a net total dose of 600 IU recombinant follicle-stimulating hormone (FSH) in 
0.72 mL aqueous solution. The solution for injection contains the active substance follitropin beta, 
produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 
833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein / mL (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).

Puregon 900 IU/1.08 mL solution for injection
One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in 
1.08 mL aqueous solution. The solution for injection contains the active substance follitropin beta, 
produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 
833 IU/mL aqueous solution. This strength corresponds to 83.3 microgram of protein / mL (specific 
in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).

Excipient(s) with known effect:
This medicinal product contains 10 mg of benzyl alcohol per mL.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection (injection). 
Clear and colourless solution.
In cartridges, designed to be used in conjunction with a pen injector.

 



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4. CLINICAL PARTICULARS

4.1 Therapeutic indications

In adult females:
Puregon is indicated for the treatment of female infertility in the following clinical situations:
 Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been 

unresponsive to treatment with clomifene citrate.
 Controlled ovarian hyperstimulation to induce the development of multiple follicles in 

medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), 
gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].

In adult males:
 Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

4.2 Posology and method of administration

Treatment with Puregon should be initiated under the supervision of a physician experienced in the 
treatment of fertility problems.

The first injection with Puregon should be performed under direct medical supervision.

Posology

Dosage in the female
There are great inter- and intra-individual variations in the response of the ovaries to exogenous 
gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, 
therefore, be adjusted individually depending on the ovarian response. This requires ultrasound 
assessment of follicular development. The concurrent determination of serum oestradiol levels may 
also be useful.
When using the pen-injector, it should be realised that the pen is a precision device which accurately 
delivers the dose to which it is set. It was shown that on average an 18% higher amount of FSH is 
given with the pen compared with a conventional syringe. This may be of particular relevance when 
switching between the pen-injector and a conventional syringe within one treatment cycle. Especially 
when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a 
dose being given.
Based on the results of comparative clinical studies, it is considered appropriate to give a lower total
dosage of Puregon over a shorter treatment period than generally used for urinary FSH, not only in 
order to optimise follicular development but also to reduce the risk of unwanted ovarian 
hyperstimulation (see section 5.1).
Clinical experience with Puregon is based on up to three treatment cycles in both indications. Overall 
experience with IVF indicates that in general the treatment success rate remains stable during the first 
four attempts and gradually declines thereafter.

 



15

 Anovulation
A sequential treatment scheme is recommended starting with daily administration of 50 IU 
Puregon. The starting dose is maintained for at least seven days. If there is no ovarian response, 
the daily dose is then gradually increased until follicle growth and/or plasma oestradiol levels 
indicate an adequate pharmacodynamic response. A daily increase of oestradiol levels of 
40-100% is considered to be optimal. The daily dose is then maintained until pre-ovulatory 
conditions are reached. Pre-ovulatory conditions are reached when there is ultrasonographic 
evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol 
levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained. Usually, 7 to 14 days of 
treatment is sufficient to reach this state. The administration of Puregon is then discontinued and 
ovulation can be induced by administering human chorionic gonadotrophin (hCG). 
If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e. 
more than a daily doubling for oestradiol for two or three consecutive days, the daily dose 
should be decreased. 
Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles 
exceeding 14 mm carry the risk of multiple gestations. In that case hCG should be withheld and 
pregnancy should be avoided to prevent multiple gestations.

 Controlled ovarian hyperstimulation in medically assisted reproduction programs
Various stimulation protocols are applied. A starting dose of 100-225 IU is recommended for at
least the first four days. Thereafter, the dose may be adjusted individually, based upon ovarian 
response. In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for 
six to twelve days are sufficient, although longer treatment may be necessary.
Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a 
GnRH agonist or antagonist. When using a GnRH agonist, a higher total treatment dose of 
Puregon may be required to achieve an adequate follicular response.
Ovarian response is monitored by ultrasound assessment. The concurrent determination of 
serum oestradiol levels may also be useful. When ultrasound assessment indicates the presence 
of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response 
(plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with a 
diameter greater than 18 mm), the final phase of maturation of the follicles is induced by 
administration of hCG. Oocyte retrieval is performed 34-35 hours later.

Dosage in the male
Puregon should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, 
concomitantly with hCG. Treatment with Puregon and hCG should be continued for at least 3 to 
4 months before any improvement in spermatogenesis can be expected. To assess the response, semen 
analysis is recommended 4 to 6 months after the beginning of treatment. If a patient has not responded 
after this period, the combination therapy may be continued; current clinical experience indicates that 
treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.

Paediatric population
There is no relevant use of Puregon in the paediatric population for the approved indication.

Method of administration

Puregon solution for injection in cartridges has been developed for use in the Puregon Pen and should 
be administered subcutaneously. The injection site should be alternated to prevent lipoatrophy.
Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions 
are given by the physician.

4.3 Contraindications

For males and females
 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
 Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
 Primary gonadal failure.

 



16

Additionally for females
 Undiagnosed vaginal bleeding.
 Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
 Malformations of the reproductive organs incompatible with pregnancy.
 Fibroid tumours of the uterus incompatible with pregnancy.

4.4 Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.

Antibiotic hypersensitivity reactions
 Puregon may contain traces of streptomycin and/or neomycin. These antibiotics may cause 

hypersensitivity reactions in susceptible persons.

Infertility evaluation before starting treatment
 Before starting treatment, the couple's infertility should be assessed as appropriate. In particular, 

patients should be evaluated for hypothyroidism, adrenocortical insufficiency, 
hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment 
given.

In females

Ovarian Hyperstimulation Syndrome (OHSS)
OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and 
symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate 
enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and 
symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, 
hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances, 
venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test 
abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy 
have also been reported in association with OHSS.

OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy 
(endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be 
associated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs more 
than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. 
Because of the risk of developing OHSS, patients should be monitored for at least two weeks after 
hCG administration.

Women with known risk factors for a high ovarian response may be especially prone to the 
development of OHSS during or following treatment with Puregon. For women having their first cycle 
of ovarian stimulation, for whom risk factors are only partially known, close observation for early 
signs and symptoms of OHSS is recommended.

Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive 
Technology (ART). Adherence to the recommended Puregon dose and treatment regimen and careful 
monitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS, 
ultrasonographic assessments of follicular development should be performed prior to treatment and at 
regular intervals during treatment; the concurrent determination of serum oestradiol levels may also be 
useful. In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in 
diameter. 

If OHSS develops, standard and appropriate management of OHSS should be implemented and 
followed.

 



17

Multiple Pregnancy
Multiple pregnancies and births have been reported for all gonadotropin treatments, including 
Puregon. Multiple gestation, especially high order, carries an increased risk of adverse maternal 
(pregnancy and delivery complications) and perinatal (low birth weight) outcomes. For anovulatory 
women undergoing ovulation induction, monitoring follicular development with transvaginal 
ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the 
risk of multiple pregnancies. The concurrent determination of serum oestradiol levels may also be 
useful. The patients should be advised of the potential risks of multiple births before starting 
treatment.

In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple 
pregnancy is mainly related to the number of embryos transferred. When used for an ovulation 
induction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development.

Ectopic Pregnancy
Infertile women undergoing ART have an increased incidence of ectopic pregnancies. Early 
ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Spontaneous Abortion
Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the 
normal population.

Vascular Complications
Thromboembolic events, both in association with and separate from OHSS, have been reported 
following treatment with gonadotropins, including Puregon. Intravascular thrombosis, which may 
originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the 
extremities. In women with generally recognised risk factors for thromboembolic events, such as a 
personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including 
Puregon, may further increase this risk. In these women the benefits of gonadotropin administration,
including Puregon, need to be weighed against the risks. It should be noted, however, that pregnancy 
itself also carries an increased risk of thrombosis.

Congenital Malformations
The incidence of congenital malformations after ART may be slightly higher than after spontaneous 
conceptions. This is thought to be due to differences in parental characteristics (e.g., maternal age, 
sperm characteristics) and multiple gestations.

Ovarian Torsion
Ovarian torsion has been reported after treatment with gonadotropins, including Puregon. Ovarian 
torsion may be associated with other risk factors such as OHSS, pregnancy, previous abdominal 
surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. 
Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate 
detorsion.

Ovarian and Other Reproductive System Neoplasms
There have been reports of ovarian and other reproductive system neoplasms, both benign and 
malignant, in women who have undergone multiple treatment regimens for infertility treatment. It is 
not established whether or not treatment with gonadotrophins increases the risk of these tumours in 
infertile women.

Other Medical Conditions
Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment 
with Puregon.

 



18

In males

Primary Testicular Failure
Elevated endogenous FSH levels in men are indicative of primary testicular failure. Such patients are 
unresponsive to Puregon/hCG therapy.

Benzyl alcohol
Benzyl alcohol may cause anaphylactoid reactions.
Large amounts of benzyl alcohol may cause metabolic acidosis. Special precautions should be taken 
when prescribing Puregon to pregnant or breast-feeding women and patients with liver or kidney 
disease. 

Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say 
essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of Puregon and clomifene citrate may enhance the follicular response. After pituitary 
desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an 
adequate follicular response.

4.6 Fertility, pregnancy and lactation

Fertility
Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian 
hyperstimulation in assisted reproduction programmes. In males Puregon is used in the treatment of 
deficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method of 
administration, see section 4.2.

Pregnancy
The use of Puregon during pregnancy is not indicated. In case of inadvertent exposure during 
pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH. 
However, to date, no particular malformative effect has been reported. No teratogenic effect has been 
observed in animal studies. 

Breast-feeding
There is no information available from clinical or animal studies on the excretion of follitropin beta in 
milk. It is unlikely that follitropin beta is excreted in human milk due to its high molecular weight. If 
follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of 
the child. Follitropin beta may affect milk production.

4.7 Effects on ability to drive and use machines

Puregon has no or negligible influence on the ability to drive and use machines. 

4.8 Undesirable effects

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the 
site of injection (3% of all patients treated). The majority of these local reactions are mild and transient 
in nature. Generalised hypersensitivity reactions have been observed uncommonly (approximately
0.2% of all patients treated with follitropin beta).

Treatment of females:
In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms 
related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adverse 

 



19

reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or 
distension, breast complaints and ovarian enlargement.

The table below lists the adverse reactions with follitropin beta reported in clinical trials in females, 
according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to 
< 1/100).

SOC Frequency Adverse reaction
Nervous system disorders Common Headache 
Gastrointestinal disorders Common Abdominal distension 

Abdominal pain
Uncommon Abdominal discomfort

Constipation
Diarrhoea
Nausea

Reproductive system and breast 
disorders

Common OHSS
Pelvic pain

Uncommon Breast complaints1

Metrorrhagia
Ovarian cyst
Ovarian enlargement
Ovarian torsion
Uterine enlargement
Vaginal haemorrhage 

General disorders and 
administration site conditions

Common Injection site reaction2

Uncommon Generalised hypersensitivity 
reaction3

1. Breast complaints include tenderness, pain and/or engorgement and nipple pain
2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching
3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus

In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are 
considered to be related to ART or subsequent pregnancy.

In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with 
other gonadotrophins.

Treatment of males:
The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males 
(30 patients dosed), according to system organ class and frequency; common (≥ 1/100 to < 1/10).

SOC Frequency1 Adverse reaction
Nervous system disorders Common Headache
Skin and subcutaneous tissue 
disorders

Common Acne
Rash

Reproductive system and breast 
disorders

Common Epididymal cyst
Gynaecomastia

General disorders and 
administration site conditions

Common Injection site reaction2

1. Adverse reactions that are reported only once are listed as common because a single report raises the 
frequency above 1%.

2. Local reactions at the site of injection include induration and pain.

Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


20

4.9 Overdose

No data on acute toxicity of Puregon in humans is available, but the acute toxicity of Puregon and of 
urinary gonadotrophin preparations in animal studies has been shown to be very low. Too high a 
dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; 
ATC code: G03G A06.

Puregon contains a recombinant FSH. This is produced by recombinant DNA technology, using a 
Chinese hamster ovary cell line transfected with the human FSH subunit genes. The primary amino 
acid sequence is identical to that of natural human FSH. Small differences in the carbohydrate chain 
structure are known to exist.

Mechanism of Action
FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production. In 
the female the level of FSH is critical for the onset and duration of follicular development, and 
consequently for the timing and number of follicles reaching maturity. Puregon can thus be used to 
stimulate follicular development and steroid production in selected cases of disturbed gonadal 
function. Furthermore Puregon can be used to promote multiple follicular development in medically 
assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-
fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. Treatment with Puregon is 
generally followed by administration of hCG to induce the final phase of follicle maturation, 
resumption of meiosis and rupture of the follicle.

Clinical Efficacy and Safety
In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian 
stimulation in women participating in an assisted reproduction technology (ART) program and for 
ovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms of 
a lower total dose and a shorter treatment period needed to trigger follicular maturation.

For controlled ovarian stimulation, Puregon resulted in a higher number of oocytes retrieved at a lower 
total dose and with a shorter treatment period, when compared to urinary FSH.

Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and 
efficacy of Puregon with urinary FSH in controlled ovarian stimulation).

Puregon
(n = 546)

u-FSH
(n = 361)

Mean no. of oocytes retrieved 10.84* 8.95

Mean total dose (no. of 75 IU ampoules) 28.5* 31.8

Mean duration of FSH stimulation (days) 10.7* 11.3

* Differences between the 2 groups were statistically significant (p0.05).

For ovulation induction, Puregon resulted in a lower median total dose and shorter median duration of 
treatment when compared to urinary FSH.

 



21

Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and 
efficacy of Puregon with urinary FSH in ovulation induction).

Puregon
(n = 105)

u-FSH
(n = 66)

Mean no. of follicles  12 mm 3.6* 2.6

 15 mm 2.0 1.7

 18 mm 1.1 0.9

Median total dose (IU)
a 750* 1,035

Median duration of treatment (days)
a 10.0* 13.0

* Differences between the 2 groups were statistically significant (p0.05).
a

Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).

5.2 Pharmacokinetic properties

Absorption
After subcutaneous administration of Puregon, maximum concentration of FSH is reached within 
about 12 hours. Due to the sustained release from the injection site and the elimination half-life of 
about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours. Due to the 
relatively long elimination half-life, repeated administration of the same dose will lead to plasma 
concentrations of FSH that are approximately 1.5-2.5 times higher than after single-dose 
administration. This increase enables therapeutic FSH concentrations to be reached.
The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.

Distribution, biotransformation and elimination
Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, 
metabolised, and excreted in the same way.

5.3 Preclinical safety data

Single-dose administration of Puregon to rats induced no toxicologically significant effects. In 
repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human 
dose, Puregon induced no toxicologically significant effects. Puregon showed no mutagenic potential 
in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Puregon solution for injection contains:
Sucrose
Sodium citrate
L-methionine
Polysorbate 20
Benzyl alcohol
Water for injections.
The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. 

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.

 



22

6.3 Shelf-life

3 years.

Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum 
of 28 days.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).
Do not freeze. 
Keep the cartridge in the outer carton.
For patient convenience, Puregon may be stored at or below 25ºC by the patient for a single period of 
not more than 3 months.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container 

Puregon 150 IU/0.18 mL solution for injection
0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium 
crimp-cap with a rubber inlay.
Pack of 1 cartridge and 3 needles to be used with the Puregon Pen. 
Cartridges contain a minimum of 225 IU FSH activity in 0.270 mL aqueous solution, which is 
sufficient for a net total dose of 150 IU.

Puregon 300 IU/0.36 mL solution for injection
0.36 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium 
crimp-cap with a rubber inlay.
Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.
Cartridges contain a minimum of 400 IU FSH activity in 0.480 mL aqueous solution, which is 
sufficient for a net total dose of 300 IU.

Puregon 600 IU/0.72 mL solution for injection
0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium 
crimp-cap with a rubber inlay.
Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.
Cartridges contain a minimum of 700 IU FSH activity in 0.840 mL aqueous solution, which is 
sufficient for a net total dose of 600 IU.

Puregon 900 IU/1.08 mL solution for injection
1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium 
crimp-cap with a rubber inlay.
Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.
Cartridges contain a minimum of 1,025 IU FSH activity in 1.230 mL aqueous solution, which is 
sufficient for a net total dose of 900 IU.

6.6 Special precautions for disposal and other handling

Do not use if the solution contains particles or if the solution is not clear.
Puregon solution for injection is designed for use in conjunction with the Puregon Pen. The 
instructions for using the pen must be followed carefully.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Empty cartridges must not be refilled.
Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
Discard used needles immediately after injection.
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

 



23

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER

Puregon 150 IU/0.18 mL solution for injection
EU/1/96/008/040

Puregon 300 IU/0.36 mL solution for injection
EU/1/96/008/038

Puregon 600 IU/0.72 mL solution for injection
EU/1/96/008/039

Puregon 900 IU/1.08 mL solution for injection
EU/1/96/008/041

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Date of first authorisation: 03 May 1996
Date of latest renewal: 29 May 2006

10. DATE OF REVISION OF THE TEXT

DD month YYYY

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

 

http://www.ema.europa.eu/


24

ANNEX II

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 
FOR BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT

 



25

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

N.V. Organon
Kloosterstraat 6, 5349 AB Oss
Veersemeer 4, 5347 JN Oss
The Netherlands

Name and address of the manufacturers responsible for batch release

N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2)

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached.

 



26

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



27

A. LABELLING

 



28

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 50 IU/0.5 mL 1, 5 or 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Puregon 50 IU/0.5 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 0.5 mL follitropin beta corresponding to:
50 IU (100 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; 
sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 vial containing 0.5 mL
5 vials each containing 0.5 mL
10 vials each containing 0.5 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) and subcutaneous (SC) use
The contents of the vial should be used immediately after piercing of the rubber stopper.
For single use only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



29

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the vial in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/017
EU/1/96/008/018
EU/1/96/008/019

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



30

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 
NN 

 



31

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL TEXT Puregon 50 IU/0.5 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 50 IU/0.5 mL injection
follitropin beta

IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



32

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 75 IU/0.5 mL 1, 5 or 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Puregon 75 IU/0.5 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 0.5 mL follitropin beta corresponding to:
75 IU (150 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; 
sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 vial containing 0.5 mL
5 vials each containing 0.5 mL
10 vials each containing 0.5 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) and subcutaneous (SC) use
The contents of the vial should be used immediately after piercing of the rubber stopper.
For single use only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



33

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the vial in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/020
EU/1/96/008/021
EU/1/96/008/022

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



34

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 
NN 

 



35

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL TEXT Puregon 75 IU/0.5 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 75 IU/0.5 mL injection
follitropin beta

IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



36

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 100 IU/0.5 mL 1, 5 or 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Puregon 100 IU/0.5 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 0.5 mL follitropin beta corresponding to:
100 IU (200 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; 
sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 vial containing 0.5 mL
5 vials each containing 0.5 mL
10 vials each containing 0.5 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) and subcutaneous (SC) use
The contents of the vial should be used immediately after piercing of the rubber stopper.
For single use only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



37

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the vial in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/023
EU/1/96/008/024
EU/1/96/008/025

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



38

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 
NN 

 



39

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL TEXT Puregon 100 IU/0.5 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 100 IU/0.5 mL injection
follitropin beta

IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



40

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 150 IU/0.5 mL 1, 5 or 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Puregon 150 IU/0.5 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 0.5 mL follitropin beta corresponding to:
150 IU (300 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; 
sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 vial containing 0.5 mL
5 vials each containing 0.5 mL
10 vials each containing 0.5 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) and subcutaneous (SC) use
The contents of the vial should be used immediately after piercing of the rubber stopper.
For single use only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



41

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the vial in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/026
EU/1/96/008/027
EU/1/96/008/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



42

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 
NN 

 



43

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL TEXT Puregon 150 IU/0.5 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 150 IU/0.5 mL injection
follitropin beta

IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



44

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 200 IU/0.5 mL 1, 5 or 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Puregon 200 IU/0.5 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 0.5 mL follitropin beta corresponding to:
200 IU (400 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; 
sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 vial containing 0.5 mL
5 vials each containing 0.5 mL
10 vials each containing 0.5 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) and subcutaneous (SC) use
The contents of the vial should be used immediately after piercing of the rubber stopper.
For single use only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



45

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the vial in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/029
EU/1/96/008/030
EU/1/96/008/031

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



46

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 
NN 

 



47

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL TEXT Puregon 200 IU/0.5 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 200 IU/0.5 mL injection
follitropin beta

IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



48

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 225 IU/0.5 mL 1, 5 or 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Puregon 225 IU/0.5 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial contains 0.5 mL follitropin beta corresponding to:
225 IU (450 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; 
sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 vial containing 0.5 mL
5 vials each containing 0.5 mL
10 vials each containing 0.5 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) and subcutaneous (SC) use
The contents of the vial should be used immediately after piercing of the rubber stopper.
For single use only.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

 



49

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the vial in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/032
EU/1/96/008/033
EU/1/96/008/034

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

 



50

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 
NN 

 



51

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL TEXT Puregon 225 IU/0.5 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 225 IU/0.5 mL injection
follitropin beta

IM/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



52

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 150 IU/0.18 mL 1 cartridge

1. NAME OF THE MEDICINAL PRODUCT

Puregon 150 IU/0.18 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

225 IU recombinant FSH activity/0.270 mL
Net content 150 IU

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water 
for injections; sodium hydroxide and/or hydrochloric acid as pH adjustment. 

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 cartridge 
1 pack with 3 pen needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous (SC) use
For use only with the Puregon Pen.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum 
of 28 days. 

 



53

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze. 
2. Store at or below 25°C for a single period of not more than 3 months. 
Keep the cartridge in the outer carton. 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/040

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 

 



54

NN 

 



55

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARTRIDGE TEXT Puregon 150 IU/0.18 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 150 IU/0.18 mL injection
follitropin beta

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.270 mL

6. OTHER

MSD

 



56

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 300 IU/0.36 mL 1 cartridge

1. NAME OF THE MEDICINAL PRODUCT

Puregon 300 IU/0.36 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

400 IU recombinant FSH activity/0.480 mL
Net content 300 IU

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water 
for injections; sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 cartridge 
2 packs with 3 pen needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous (SC) use
For use only with the Puregon Pen.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum 
of 28 days.

 



57

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the cartridge in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/038

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 

 



58

NN 

 



59

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARTRIDGE TEXT Puregon 300 IU/0.36 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 300 IU/0.36 mL injection
follitropin beta

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.480 mL

6. OTHER

MSD

 



60

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 600 IU/0.72 mL 1 cartridge

1. NAME OF THE MEDICINAL PRODUCT

Puregon 600 IU/0.72 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

700 IU recombinant FSH activity/0.840 mL
Net content 600 IU

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water 
for injections; sodium hydroxide and/or hydrochloric acid as pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 cartridge
2 packs with 3 pen needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous (SC) use
For use only with the Puregon Pen.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum 
of 28 days.

 



61

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the cartridge in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/039

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 

 



62

NN 

 



63

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARTRIDGE TEXT Puregon 600 IU/0.72 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 600 IU/0.72 mL injection
follitropin beta

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.840 mL

6. OTHER

MSD

 



64

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT Puregon 900 IU/1.08 mL 1 cartridge

1. NAME OF THE MEDICINAL PRODUCT

Puregon 900 IU/1.08 mL solution for injection
follitropin beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1025 IU recombinant FSH activity/1.230 mL
Net content 900 IU

3. LIST OF EXCIPIENTS

Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water 
for injections; sodium hydroxide and/or hydrochloric acid as pH adjustment. 

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 cartridge 
3 packs with 3 pen needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous (SC) use
For use only with the Puregon Pen.
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum 
of 28 days. 

 



65

9. SPECIAL STORAGE CONDITIONS

Storage by the pharmacist
Store at 2°C - 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25°C for a single period of not more than 3 months.
Keep the cartridge in the outer carton.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/96/008/041

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN 

 



66

NN 

 



67

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARTRIDGE TEXT Puregon 900 IU/1.08 mL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Puregon 900 IU/1.08 mL injection
follitropin beta

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1.230 mL

6. OTHER

MSD

 



68

B. PACKAGE LEAFLET

 



69

Package leaflet: Information for the user

Puregon 50 IU/0.5 mL solution for injection
Puregon 75 IU/0.5 mL solution for injection
Puregon 100 IU/0.5 mL solution for injection
Puregon 150 IU/0.5 mL solution for injection
Puregon 200 IU/0.5 mL solution for injection
Puregon 225 IU/0.5 mL solution for injection

follitropin beta

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Puregon is and what it is used for
2. What you need to know before you use Puregon
3. How to use Puregon
4. Possible side effects
5. How to store Puregon
6. Contents of the pack and other information

1. What Puregon is and what it is used for

Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating 
hormone (FSH).

FSH belongs to the group of gonadotrophins, which play an important role in human fertility and 
reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. 
Follicles are small round sacs that contain the egg cells. In men, FSH is needed for the production of 
sperm.

Puregon is used to treat infertility in any of the following situations:

Women
In women who do not ovulate and do not respond to treatment with clomifene citrate, Puregon can be 
used to cause ovulation.
In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other 
methods, Puregon can bring about the development of multiple follicles.

Men
In men who are infertile due to lowered hormone levels, Puregon can be used for the production of 
sperm.

 



70

2. What you need to know before you use Puregon

Do not use Puregon

If you:
 are allergic to follitropin beta or any of the other ingredients of Puregon (listed in section 6)
 have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)
 have heavy or irregular vaginal bleeding where the cause is unknown
 have ovaries that do not work because of a condition called primary ovarian failure
 have ovarian cysts or enlarged ovaries not caused by polycystic ovarian syndrome (PCOS)
 have malformations of the sexual organs which make a normal pregnancy impossible
 have fibroid tumours in the uterus which make a normal pregnancy impossible
 are a man and are infertile because of a condition called primary testicular failure.

Warnings and precautions

Talk to your doctor before using Puregon if you:
 have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
 have uncontrolled pituitary gland or hypothalamic problems
 have an underactive thyroid gland (hypothyroidism)
 have adrenal glands that are not working properly (adrenocortical insufficiency)
 have high prolactin levels in the blood (hyperprolactinemia)
 have any other medical conditions (for example, diabetes, heart disease, or any other long-term 

disease).

If you are a woman:

Ovarian hyperstimulation syndrome (OHSS)
Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of 
Puregon from day to day. You may regularly have ultrasound scans of the ovaries. Your doctor may 
also check blood hormone levels. This is very important since too high a dose of FSH may lead to rare 
but serious complications in which the ovaries are overly stimulated and the growing follicles become 
larger than normal. This serious medical condition is called ovarian hyperstimulation syndrome 
(OHSS). In rare cases, severe OHSS may be life-threatening. OHSS causes fluid to build-up suddenly 
in your stomach and chest areas and can cause blood clots to form. Call your doctor right away if you 
notice severe abdominal swelling, pain in the stomach area (abdomen), feeling sick (nausea), 
vomiting, sudden weight gain due to fluid build-up, diarrhoea, decreased urine output or trouble 
breathing (see also section 4 on Possible side effects).
 Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation. 
Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days 
after the last injection has been given.

Multiple pregnancy or birth defects
After treatment with gonadotrophin preparations, there is an increased chance of having multiple 
pregnancies, even when only one embryo is transferred into the uterus. Multiple pregnancies carry an 
increased health risk for both the mother and her babies around the time of birth. Furthermore, 
multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the 
female, sperm characteristics, genetic background of both parents) may be associated with an 
increased risk of birth defects. 

Pregnancy complications
There is a slightly increased risk of a pregnancy outside the uterus (an ectopic pregnancy). Therefore, 
your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy 
outside the uterus.
In women undergoing fertility treatment there may be a slightly higher chance of a miscarriage.

 



71

Blood clot (Thrombosis)
Treatment with Puregon, just as pregnancy itself, may increase the risk of having a blood clot 
(thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can lead to serious medical conditions, such as: 
 blockage in your lungs (pulmonary embolus)
 stroke
 heart attack
 blood vessel problems (thrombophlebitis)
 a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.

Please discuss this with your doctor, before starting treatment, especially:
 if you already know you have an increased chance of having thrombosis
 if you, or anyone in your immediate family, have ever had a thrombosis
 if you are severely overweight.

Ovarian torsion
Ovarian torsion has occurred after treatment with gonadotropins including Puregon. Ovarian torsion is 
the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary to be cut off. 

Before starting to use this medicine, tell your doctor if you:
 have ever had ovarian hyperstimulation syndrome OHSS
 are pregnant or think that you may be pregnant
 have ever had stomach (abdominal) surgery
 have ever had a twisting of an ovary
 have past or current cysts in your ovary or ovaries.

Ovarian and other reproductive system tumours
There have been reports of ovarian and other reproductive system tumours in women who have had 
infertility treatment. It is not known if treatment with fertility medicines increases the risk of these 
tumours in infertile women.

Other medical conditions
In addition, before starting to use this medicine, tell your doctor if you:
 have been told by a doctor that pregnancy would be dangerous for you. 

If you are a man:

Men with too much FSH in their blood
Increased FSH blood levels are a sign of damage to the testicles. Puregon is usually not effective in 
such cases. To check the effects of treatment, your doctor may ask you for a semen sample to be 
analysed, four to six months after the start of treatment.

Children and adolescents
There is no relevant use of Puregon in children and adolescents.

Other medicines and Puregon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

If Puregon is used in a combination with clomifene citrate, the effect of Puregon may be increased. If a 
GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of Puregon 
may be needed.

 



72

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Puregon if 
you are already pregnant, or think you might be pregnant.

Puregon may affect milk production. It is unlikely that Puregon is passed into breast milk. If you are 
breast-feeding, tell your doctor before using Puregon.

Driving and using machines

Puregon is unlikely to affect your ability to drive or use machines.

Puregon contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially 
‘sodium-free’.

3. How to use Puregon

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 

Dosage in women

Your doctor will decide on your starting dose. This dose may be adjusted during your treatment 
period. Further details on the treatment schedule are given below.
There are large differences between women in the response of the ovaries to FSH, which makes it 
impossible to set a dosage schedule which is suitable for all patients. To find the right dosage, your 
doctor will check your follicle growth by means of ultrasound scanning, and measurement of the 
amount of oestradiol (female sex hormone) in the blood.
* Women who are not ovulating

A starting dose is set by your doctor. This dose is continued for at least seven days. If there is no 
ovarian response, the daily dose will then be gradually increased until follicle growth and/or 
plasma oestradiol levels indicate a proper response. The daily dose is then maintained until a 
follicle of proper size is present. Usually, 7 to 14 days of treatment are sufficient. Puregon 
treatment is then stopped and ovulation will be induced by giving human chorionic 
gonadotrophin (hCG).

* Medically assisted reproduction programs, for instance IVF
A starting dose is set by your doctor. This dose is continued for at least the first four days. After 
this, your dose may be adjusted, based upon your ovarian response. When a sufficient number 
of follicles of proper size are present, the final phase of maturation of the follicles is induced by 
giving hCG. Retrieval of the egg(s) is performed 34-35 hours later.

Dosage in men

Puregon is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in 
combination with another hormone (hCG), for at least 3 to 4 months. The treatment period equals the 
development time of sperm and the time in which improvement can be expected. If your sperm 
production has not started after this period, your treatment may carry on for at least 18 months.

How are the injections given

The very first injection of Puregon should only be given in the presence of a doctor or nurse. 
Injections may be given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or 
under the skin (in the lower stomach, for example).
When given into a muscle the injection should be given by the doctor or nurse.

 



73

When given under the skin the injection may, in some cases, be given by yourself or your partner. 
Your doctor will tell you when and how to do this. If you inject yourself with Puregon, follow the 
instructions for use in the next section, to give Puregon properly and with minimal discomfort.

Instructions for use

Step 1 - Preparing the syringe 
You should use sterile disposable syringes and needles for the administration of Puregon. The volume 
of the syringe should be small enough so that the prescribed dose can be given with reasonable 
accuracy. 
Puregon solution for injection comes in a glass vial. Do not use the solution if it contains particles or is 
not clear. First, you should remove the flip-off cap of the vial. Place a needle on a syringe and pierce 
the needle through the rubber stopper of the vial (a). Draw the solution up into the syringe (b), and 
replace the needle with an injection needle (c). Finally hold the syringe with the needle pointing 
upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until 
all the air has been expelled, and only Puregon solution is left in the syringe (d). If necessary, the 
plunger may be squeezed further, to adjust the volume to be administered.

Step 2 - The injection site
The best site for an injection under the skin is in the lower stomach around the navel (e) where there is 
a lot of loose skin and layers of fatty tissue. You should vary the injection site a little with each 
injection. 
It is possible to inject in other areas. Your doctor or nurse will tell you where to inject.

Step 3 - Preparing the area
A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the 
needle goes in. Wash your hands and swab the injection site with disinfectant (for example 
chlorohexidine 0.5%) to remove any surface bacteria. Clean about two inches around the point where 
the needle will go in and let the disinfectant dry for at least one minute before you proceed.

Step 4 - Inserting the needle
Pinch the skin a little. With the other hand, insert the needle at an angle of 90 degrees into the skin’s 
surface, as shown in the picture (f).

Step 5 - Checking the correct needle position
If the needle position is correct the plunger should be quite difficult to draw back. Any blood sucked 
back into the syringe means that the needle tip has penetrated a vein or artery. If this happens pull out 
the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site 

 



74

will stop bleeding in a minute or two. Do not use this solution. Start again with Step 1 using a new 
syringe, new needles and a new vial of Puregon.

Step 6 - Injecting the solution
Depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are 
not damaged.

Step 7 - Removing the syringe
Pull the syringe out quickly and apply pressure to the injection site with a swab containing 
disinfectant. A gentle massage of the site - while still maintaining pressure - helps disperse the 
Puregon solution and relieve any discomfort.

Any remaining solution should be discarded.
Do not mix Puregon with any other medicines.

If you use more Puregon than you should

Tell your doctor immediately.
Too high a dose of Puregon may cause hyperstimulation of the ovaries (OHSS). This may be noticed 
as pain in the stomach. If you are troubled by stomach pains, tell your doctor immediately. See also 
section 4 on possible side effects.

If you forget to use Puregon

If you forget a dose do not use a double dose to make up for a missed dose.
 Contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

Serious side effects in women
A complication with FSH treatment is hyperstimulation of the ovaries. Ovarian overstimulation may 
develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be 
a serious medical problem. The risk can be reduced by careful monitoring of follicular development 
during treatment. Your doctor will do ultrasound scans of your ovaries to carefully monitor the 
number of maturing follicles. Your doctor may also check blood hormone levels. Pain in the stomach, 
feeling sick or diarrhoea are the first symptoms. In more severe cases symptoms may include 
enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest (which may cause 
sudden weight gain due to fluid buildup) and the occurrence of blood clots in the circulation. See 
warnings and precautions in section 2.
 Contact your doctor immediately if you are experiencing stomach pains, or any of the other 
symptoms of ovarian hyperstimulation, also if this occurs some days after the last injection.

If you are a woman:
Common side effects (may affect up to 1 in 10 people):
- Headache
- Injection site reactions (such as bruising, pain, redness, swelling and itching)
- Ovarian hyperstimulation syndrome (OHSS)
- Pelvic pain
- Stomach pain and/or bloating

Uncommon side effects (may affect up to 1 in 100 people):
- Breast complaints (including tenderness)

 



75

- Diarrhoea, constipation or stomach discomfort
- Enlargement of the uterus
- Feeling sick
- Hypersensitivity reactions (such as rash, redness, hives and itching)
- Ovarian cysts or enlargement of the ovaries
- Ovarian torsion (twisting of the ovaries)
- Vaginal bleeding

Rare side effects (may affect up to 1 in 1,000 people):
- Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see 

warnings and precautions in section 2)

Pregnancy outside the uterus (an ectopic pregnancy), miscarriage and multiple pregnancies have also 
been reported. These side effects are not considered to be related to the use of Puregon, but to Assisted 
Reproductive Technology (ART) or subsequent pregnancy.

If you are a man:
Common side effects (may affect up to 1 in 10 people):
- Acne
- Injection site reactions (such as hardening and pain)
- Headache
- Rash
- Some breast development
- Testicular cyst

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects, you can help provide more information on the safety 
of this medicine.

5. How to store Puregon

Keep this medicine out of the sight and reach of children.

Storage by the pharmacist
Store at 2°C – 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25ºC (at room temperature) for a single period of not more than 3 months. 
Make a note of when you start storing the product out of the refrigerator.

Keep the vial(s) in the outer carton.
The contents of a vial should be used immediately after piercing the rubber stopper.
Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'. The expiry 
date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


76

6. Contents of the pack and other information

What Puregon contains

The active substance is follitropin beta.

Puregon 50 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a 
hormone known as follicle-stimulating hormone (FSH), in a strength of 50 IU in 0.5 mL aqueous 
solution per vial.

Puregon 75 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a 
hormone known as follicle-stimulating hormone (FSH), in a strength of 75 IU in 0.5 mL aqueous 
solution per vial.

Puregon 100 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, 
a hormone known as follicle-stimulating hormone (FSH), in a strength of 100 IU in 0.5 mL aqueous 
solution per vial.

Puregon 150 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, 
a hormone known as follicle-stimulating hormone (FSH), in a strength of 150 IU in 0.5 mL aqueous 
solution per vial.

Puregon 200 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, 
a hormone known as follicle-stimulating hormone (FSH), in a strength of 200 IU in 0.5 mL aqueous 
solution per vial.

Puregon 225 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, 
a hormone known as follicle-stimulating hormone (FSH), in a strength of 225 IU in 0.5 mL aqueous 
solution per vial.

The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for 
injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

What Puregon looks like and contents of the pack

Puregon solution for injection (injection) is a clear, colourless liquid. It is supplied in a glass vial. It is 
available in packs of 1, 5 or 10 vials. 
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

 



77

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tel/Tél: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel: + 370 5 2780247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД
Teл.: + 359 2 819 37 37
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tel/Tél: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: + 36 1 888 5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 99 99 000 (+ 31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel: + 372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: + 47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: + 30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel.: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o. 
Tel.: +48 22 549 51 00
msdpolska@merck.com

France
MSD France
Tél + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: + 351 214 465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel: + 40 21 529 29 00
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
msd.slovenia@merck.com

 



78

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: + 421 2 58282010
dpoc_czechslovak@merck.com

Italia
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: + 358 (0)9 804650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673
        (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: + 46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67 364224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited 
Tel: + 44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in Month YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

 

http://www.ema.europa.eu/


79

Package leaflet: Information for the user

Puregon 150 IU/0.18 mL solution for injection
Puregon 300 IU/0.36 mL solution for injection
Puregon 600 IU/0.72 mL solution for injection
Puregon 900 IU/1.08 mL solution for injection

follitropin beta

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Puregon is and what it is used for
2. What you need to know before you use Puregon
3. How to use Puregon
4. Possible side effects
5. How to store Puregon
6. Contents of the pack and other information

1. What Puregon is and what it is used for

Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating 
hormone (FSH).

FSH belongs to the group of gonadotrophins, which play an important role in human fertility and 
reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. 
Follicles are small round sacs that contain the egg cells. In men, FSH is needed for the production of 
sperm. 

Puregon is used to treat infertility in any of the following situations:

Women
In women who do not ovulate and do not respond to treatment with clomifene citrate, Puregon can be 
used to cause ovulation. 
In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other 
methods, Puregon can bring about the development of multiple follicles. 

Men
In men who are infertile due to lowered hormone levels, Puregon can be used for the production of 
sperm. 

2. What you need to know before you use Puregon

Do not use Puregon

If you:
 are allergic to follitropin beta or any of the other ingredients of Puregon (listed in section 6)
 have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)

 



80

 have heavy or irregular vaginal bleeding where the cause is unknown
 have ovaries that do not work because of a condition called primary ovarian failure
 have ovarian cysts or enlarged ovaries not caused by polycystic ovarian syndrome (PCOS)
 have malformations of the sexual organs which make a normal pregnancy impossible
 have fibroid tumours in the uterus which make a normal pregnancy impossible
 are a man and are infertile because of a condition called primary testicular failure.

Warnings and precautions

Talk to your doctor before using Puregon if you:
 have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
 have uncontrolled pituitary gland or hypothalamic problems
 have an underactive thyroid gland (hypothyroidism)
 have adrenal glands that are not working properly (adrenocortical insufficiency)
 have high prolactin levels in the blood (hyperprolactinemia)
 have any other medical conditions (for example, diabetes, heart disease, or any other long-term 

disease).

If you are a woman:

Ovarian hyperstimulation syndrome (OHSS)
Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of 
Puregon from day to day. You may regularly have ultrasound scans of the ovaries. Your doctor may 
also check blood hormone levels. This is very important since too high a dose of FSH may lead to rare 
but serious complications in which the ovaries are overly stimulated and the growing follicles become 
larger than normal. This serious medical condition is called ovarian hyperstimulation syndrome 
(OHSS). In rare cases, severe OHSS may be life-threatening. OHSS causes fluid to build-up suddenly 
in your stomach and chest areas and can cause blood clots to form. Call your doctor right away if you 
notice severe abdominal swelling, pain in the stomach area (abdomen), feeling sick (nausea), 
vomiting, sudden weight gain due to fluid build-up, diarrhoea, decreased urine output or trouble 
breathing (see also section 4 on Possible side effects).
 Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation. 
Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days 
after the last injection has been given.

Multiple pregnancy or birth defects
After treatment with gonadotrophin preparations, there is an increased chance of having multiple 
pregnancies, even when only one embryo is transferred into the uterus. Multiple pregnancies carry an 
increased health risk for both the mother and her babies around the time of birth. Furthermore, 
multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the 
female, sperm characteristics, genetic background of both parents) may be associated with an 
increased risk of birth defects. 

Pregnancy complications
There is a slightly increased risk of a pregnancy outside the uterus (an ectopic pregnancy). Therefore, 
your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy 
outside the uterus.
In women undergoing fertility treatment there may be a slightly higher chance of a miscarriage.

Blood clot (Thrombosis)
Treatment with Puregon, just as pregnancy itself, may increase the risk of having a blood clot 
(thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can lead to serious medical conditions, such as: 
 blockage in your lungs (pulmonary embolus)
 stroke

 



81

 heart attack
 blood vessel problems (thrombophlebitis)
 a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.

Please discuss this with your doctor, before starting treatment, especially:
 if you already know you have an increased chance of having thrombosis
 if you, or anyone in your immediate family, have ever had a thrombosis
 if you are severely overweight.

Ovarian torsion
Ovarian torsion has occurred after treatment with gonadotropins including Puregon. Ovarian torsion is 
the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary to be cut off. 

Before starting to use this medicine, tell your doctor if you:
 have ever had ovarian hyperstimulation syndrome OHSS
 are pregnant or think that you may be pregnant
 have ever had stomach (abdominal) surgery
 have ever had a twisting of an ovary
 have past or current cysts in your ovary or ovaries.

Ovarian and other reproductive system tumours
There have been reports of ovarian and other reproductive system tumours in women who have had 
infertility treatment. It is not known if treatment with fertility medicines increases the risk of these 
tumours in infertile women.

Other medical conditions
In addition, before starting to use this medicine, tell your doctor if you:
 have been told by a doctor that pregnancy would be dangerous for you. 

If you are a man:

Men with too much FSH in their blood
Increased FSH blood levels are a sign of damage to the testicles. Puregon is usually not effective in 
such cases. To check the effects of treatment, your doctor may ask you for a semen sample to be 
analysed, four to six months after the start of treatment.

Children and adolescents 
There is no relevant use of Puregon in children and adolescents.

Other medicines and Puregon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

If Puregon is used in a combination with clomifene citrate, the effect of Puregon may be increased. If a 
GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of Puregon 
may be needed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Puregon if 
you are already pregnant, or think you might be pregnant.

Puregon may affect milk production. It is unlikely that Puregon is passed into breast milk. If you are 
breast-feeding, tell your doctor before using Puregon.

 



82

Driving and using machines

Puregon is unlikely to affect your ability to drive or use machines.

Puregon contains benzyl alcohol

This medicinal product contains 10 mg of benzyl alcohol per mL.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large 
amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic 
acidosis”).
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large 
amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic 
acidosis”).

Puregon contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially 
‘sodium-free’.

3. How to use Puregon

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 

Dosage in women

Your doctor will decide on your starting dose. This dose may be adjusted during your treatment 
period. Further details on the treatment schedule are given below. 
There are large differences between women in the response of the ovaries to FSH, which makes it 
impossible to set a dosage schedule which is suitable for all patients. To find the right dosage, your 
doctor will check your follicle growth by means of ultrasound scanning, and measurement of the 
amount of oestradiol (female sex hormone) in the blood.
* Women who are not ovulating

A starting dose is set by your doctor. This dose is continued for at least seven days. If there is no 
ovarian response, the daily dose will then be gradually increased until follicle growth and/or 
plasma oestradiol levels indicate a proper response. The daily dose is then maintained until a 
follicle of proper size is present. Usually, 7 to 14 days of treatment are sufficient. Puregon 
treatment is then stopped and ovulation will be induced by giving human chorionic 
gonadotrophin (hCG). 

* Medically assisted reproduction programs, for instance IVF
A starting dose is set by your doctor. This dose is continued for at least the first four days. After 
this, your dose may be adjusted, based upon your ovarian response. When a sufficient number of 
follicles of proper size are present, the final phase of maturation of the follicles is induced by 
giving hCG. Retrieval of the egg(s) is performed 34-35 hours later. 

Dosage in men

Puregon is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in 
combination with another hormone (hCG), for at least 3 to 4 months. The treatment period equals the 
development time of sperm and the time in which improvement can be expected. If your sperm 
production has not started after this period, your treatment may carry on for at least 18 months. 

 



83

How are the injections given

Puregon solution for injection in cartridges has been developed for use in the Puregon Pen. The 
separate instructions for using the pen must be followed carefully. Do not use the cartridge if the 
solution contains particles or if the solution is not clear. 
Using the pen, injections just under the skin (in the lower stomach, for example) can be given by 
yourself or your partner. Your doctor will tell you when and how to do this. If you inject yourself with 
Puregon, follow the instructions carefully to give Puregon properly and with minimal discomfort. 
The very first injection of Puregon should only be given in the presence of a doctor or nurse. 

If you use more Puregon than you should

Tell your doctor immediately.
Too high a dose of Puregon may cause hyperstimulation of the ovaries (OHSS). This may be noticed 
as pain in the stomach. If you are troubled by stomach pains, tell your doctor immediately. See also
section 4 on possible side effects. 

If you forget to use Puregon 

If you forget a dose do not use a double dose to make up for a missed dose. 
 Contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

Serious side effects in women
A complication with FSH treatment is hyperstimulation of the ovaries. Ovarian overstimulation may 
develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be 
a serious medical problem. The risk can be reduced by careful monitoring of follicular development 
during treatment. Your doctor will do ultrasound scans of your ovaries to carefully monitor the 
number of maturing follicles. Your doctor may also check blood hormone levels. Pain in the stomach, 
feeling sick or diarrhoea are the first symptoms. In more severe cases symptoms may include 
enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest (which may cause 
sudden weight gain due to fluid buildup) and the occurrence of blood clots in the circulation. See 
warnings and precautions in section 2.
 Contact your doctor immediately if you are experiencing stomach pains, or any of the other 
symptoms of ovarian hyperstimulation, also if this occurs some days after the last injection.

If you are a woman:
Common side effects (may affect up to 1 in 10 people):
- Headache
- Injection site reactions (such as bruising, pain, redness, swelling and itching)
- Ovarian hyperstimulation syndrome (OHSS)
- Pelvic pain
- Stomach pain and/or bloating

Uncommon side effects (may affect up to 1 in 100 people):
- Breast complaints (including tenderness)
- Diarrhoea, constipation or stomach discomfort
- Enlargement of the uterus
- Feeling sick
- Hypersensitivity reactions (such as rash, redness, hives and itching)
- Ovarian cysts or enlargement of the ovaries

 



84

- Ovarian torsion (twisting of the ovaries)
- Vaginal bleeding

Rare side effects (may affect up to 1 in 1,000 people):
- Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see 

warnings and precautions in section 2)

Pregnancy outside the uterus (an ectopic pregnancy), miscarriage and multiple pregnancies have also 
been reported. These side effects are not considered to be related to the use of Puregon, but to Assisted 
Reproductive Technology (ART) or subsequent pregnancy.

If you are a man:
Common side effects (may affect up to 1 in 10 people):
- Acne
- Injection site reactions (such as hardening and pain)
- Headache
- Rash
- Some breast development
- Testicular cyst

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects, you can help provide more information on the safety 
of this medicine.

5. How to store Puregon

Keep this medicine out of the sight and reach of children.

Storage by the pharmacist
Store at 2°C – 8°C (in a refrigerator). Do not freeze.

Storage by the patient
You have two options:
1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
2. Store at or below 25ºC (at room temperature) for a single period of not more than 3 months. 
Make a note of when you start storing the product out of the refrigerator.

Keep the cartridge in the outer carton. 

Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum 
of 28 days. 
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction 
Manual of the Puregon Pen. 
Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'. The expiry 
date refers to the last day of that month.

Discard used needles immediately after injection. 
Do not mix any other drug into the cartridges. Empty cartridges must not be refilled. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


85

6. Contents of the pack and other information

What Puregon contains

 Each cartridge contains the active substance follitropin beta, a hormone known as 
follicle-stimulating hormone (FSH) in a strength of 833 IU/mL aqueous solution.

 The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl 
alcohol in water for injections. The pH may have been adjusted with sodium hydroxide and/or 
hydrochloric acid.

What Puregon looks like and contents of the pack

Puregon solution for injection (injection) is a clear, colourless liquid. It is supplied in a glass cartridge. 
It is available in packs of 1 cartridge. 

Marketing Authorisation Holder
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tel/Tél: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel: + 370 5 2780247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД
Teл.: + 359 2 819 37 37
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tel/Tél: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: + 36 1 888 5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 99 99 000 (+ 31 23 5153153)
medicalinfo.nl@merck.com

 



86

Eesti
Merck Sharp & Dohme OÜ
Tel: + 372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: + 47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: + 30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel.: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o. 
Tel.: +48 22 549 51 00
msdpolska@merck.com

France
MSD France
Tél + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: + 351 214 465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel: + 40 21 529 29 00
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
msd.slovenia@merck.com

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: + 421 2 58282010
dpoc_czechslovak@merck.com

Italia
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: + 358 (0)9 804650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673
        (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: + 46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67 364224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited 
Tel: + 44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in Month YYYY

 



87

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET