natgillin/translations-raw huggingface dataset:
Udvalget for Humanmedicinske Lægemidler (CHMP) har besluttet, at Puregons gavnlige virkninger er større end de risici, der er forbundet med stoffet til behandling af anovulatoriske kvinder, kvinder, som skal have ægløsning før indsættelse af en fertilitetsbehandling, og til mænd med hypogonadotrop hypogonadisme.
The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon’ s benefits are greater than its risks for women who are anovulatory, woman who need to ovulate before fertility treatment, and in men who have hypogonadotrophic hypogonadism.
Udvalget anbefalede, at Puregon fik markedsføringstilladelse.
They recommended that Puregon be given marketing authorisation.
Øvrige oplysninger om Puregon:
Other information about Puregon:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Puregon til SN. V.
The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon to N. V.
Organon den 3. maj 1996.
Organon on 3 May 1996.
Markedsføringstilladelsen blev fornyet den 3. maj 2001.
The marketing authorisation was renewed on 3 May 2001.
Den komplette EPAR for Puregon kan ses her.
The full EPAR for Puregon is available here.
EU- nummer EU/ 1/ 96/ 008/ 001
EU/ 1/ 96/ 008/ 001
Særnavn Styrke Puregon 50 IE
50 IU
Indgivelsesvej Subkutan og intramuskulær anvendelse
Subcutaneous and intramuscular use
Emballage pulver: ampul (glas); solvens: ampul (glas)
powder: ampoule (glass); solvent: ampoule (glass)
50 IE; solvens:
50 IU; solvent:
1 ml (50 IE/ ml)
1 ml (50 IU/ ml)
Pakningsstørrelse 1 ampul + 1 ampul
1 ampoule + 1 ampoule
Puregon 50 IE
50 IU
pulver: ampul (glas); solvens: ampul (glas)
powder: ampoule (glass); solvent: ampoule (glass)
3 ampuller + 3 ampuller
3 ampoules + 3 ampoules
Puregon 75 IE
75 IU
pulver: hætteglas (glas); solvens: ampul (glas)
powder: vial (glass); solvent: ampoule (glass)
75 IE; solvens:
75 IU; solvent:
Puregon 75IE
Puregon
5 hætteglas + 5 ampuller
5 vials + 5 ampoules
1 ml (75 IE/ ml))
1 ml (75 IU/ ml)
100 IE; solvens:
100 IU; solvent:
1 ml (100 IE/ ml)
1 ml (100 IU/ ml)
EU/ 1/ 96/ 008/ 011 Puregon
1 EU/ 1/ 96/ 008/ 011
100 IE; solvens:
50 IU; solvent:
1 ml (100 IE/ ml)
1 ml (50 IU/ ml)
1 EU/ 1/ 96/ 008/ 012 Puregon
EU/ 1/ 96/ 008/ 012
150 IE; solvens:
150 IU; solvent:
150 IE; solvens:
50 IU; solvent:
1 ml (150 IE/ ml)
1 ml (50 IU/ ml)
50 IE/ 0, 5ml
50 IU/ 0.5 ml
hætteglas( glas)
vial (glass)
0, 5 ml (100 IE/ ml)
0.5 ml (100 IU/ ml)
0, 5 ml (100 IE/ ml))
0.5 ml (100 IU/ ml)
75 IE/ 0, 5ml
75 IU/ 0.5 ml
0, 5 ml (150 IE/ ml)
0.5 ml (150 IU/ ml)
0, 5 ml (150 IE/ ml))
0.5 ml (150 IU/ ml)
EU/ 1/ 96/ 008/ 022 Puregon
EU/ 1/ 96/ 008/ 022
100 IE/ 0, 5ml
100 IU/ 0.5 ml
0, 5 ml (200 IE/ ml)
0.5 ml (200 IU/ ml)
0, 5 ml (200 IE/ ml))
0.5 ml (200 IU/ ml)
150 IE/ 0, 5ml
150 IU/ 0.5 ml
0, 5 ml (300 IE/ ml)
0.5 ml (300 IU/ ml)
2 EU/ 1/ 96/ 008/ 027 Puregon
EU/ 1/ 96/ 008/ 027
0, 5 ml (300 IE/ ml))
0.5 ml (300 IU/ ml)
200 IE/ 0, 5ml
200 IU/ 0.5 ml
0, 5 ml (400 IE/ ml)
0.5 ml (400 IU/ ml)
0, 5 ml (400 IE/ ml))
0.5 ml (400 IU/ ml)
225 IE/ 0, 5ml
225 IU/ 0.5 ml
0, 5 ml (450 IE/ ml)
0.5 ml (450 IU/ ml)
0, 5 ml (450 IE/ ml))
0.5 ml (450 IU/ ml)
250 IE/ 0, 5ml
250 IU/ 0.5 ml
0, 5 ml (500 IE/ ml)
0.5 ml (500 IU/ ml)
0, 5 ml (500 IE/ ml))
0.5 ml (500 IU/ ml)
300 IE/ 0, 36 Injektionsvæske, ml opløsning
300 IU/ 0.36 ml
0, 480 ml (833 IE/ ml)
0.480 ml (833 IU/ ml)
1 cylinderampul + 2 pakker med 3 kanyler
1 cartridge + 2 packs with 3 pen needles
600 IE/ 0, 72 Injektionsvæske, ml opløsning
600 IU/ 0.72 ml
0, 840 ml (833 IE/ ml)
0.840 ml (833 IU/ ml)
150 IE/ 0, 18 Injektionsvæske, ml opløsning
150 IU/ 0.18 ml
0, 270 ml (833 IE/ ml)
0.270 ml (833 IU/ ml)
900 IE/ 1, 08 Injektionsvæske, ml opløsning
900 IU/ 1.08 ml
1, 230 ml (833 IE/ ml)
1.230 ml (833 IU/ ml)
1 cylinderampul + 3 pakker med 3 kanyler
1 cartridge + 3 packs with 3 pen needles
Puregon 50 IE pulver og solvens til injektionsvæske, opløsning
Puregon 50 IU powder and solvent for solution for injection
10000 IE FSH/ mg protein).
One ampoule contains 50 IU recombinant follicle-stimulating hormone (FSH) corresponding to 5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Pulver til injektionsvæske, opløsning indeholder det aktive stof, follitropin beta, som er fremstillet ved genetisk manipulation af ovarieceller fra kinesiske hamstere (CHO).
The powder for solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Efter rekonstituering indeholder opløsningen 50 IE follitropin beta per ml.
After reconstitution, the solution contains 50 IU of follitropin beta per ml.
Pulver og solvens til injektionsvæske, opløsning (pulver til injektionsvæske og solvens til parenteral brug).
Powder and solvent for solution for injection (powder for injection and solvent for parenteral use).
Hvid til råhvid kage eller pulver.
White to off-white cake or powder.
Solvens er en klar og farveløs opløsning.
The solvent is a clear and colourless solution.
Puregon kan anvendes til behandling af kvindelig infertilitet ved følgende indikationer: • Anovulation (inkl. polycystisk ovariesyndrom) hos kvinder, som ikke har responderet på behandling med clomifencitrat. • Kontrolleret ovariehyperstimulation med henblik på at inducere udvikling af multiple follikler ved medicinsk assisteret reproduktion (f. eks. in vitro fertilisation/ overførsel af embryoner (IVF/ ET), gamete intrafallopian transfer (GIFT) og intracytoplasmatisk sperm injektion (ICSI)).
Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian disease, PCOD) 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)].
Behandling med Puregon skal initieres under opsyn fra en læge, som har erfaring inden for behandling af fertilitetsproblemer
Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Dette gør det umuligt at opsætte et standard doseringsskema.
This makes it impossible to set a uniform dosage scheme.
Derfor bør dosis justeres individuelt afhængig af ovariernes respons.
The dosage should, therefore, be adjusted individually depending on the ovarian response.
Dette kræver ultrasonografi og måling af østradiol niveauerne.
This requires ultrasonography and monitoring of oestradiol levels.
På baggrund af resultater fra sammenlignende kliniske studier anbefales det at give en lavere dosis Puregon sammenlignet med den dosis urinderiveret FSH, der generelt bruges, ikke kun med henblik på at optimere udviklingen af follikler, men også for at minimere risikoen for uønsket ovariehyperstimulation.
Based on the results of comparative clinical studies, it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
Klinisk erfaring med Puregon er baseret på op til 3 behandlingscykli i begge indikationer.
Clinical experience with Puregon is based on up to three treatment cycles in both indications.
Generel erfaring med in vitro fertilisation har vist, at succesraten for behandlingen forbliver stabil under de 4 første forsøg og derefter falder gradvist.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
2 • Anovulation Generelt anbefales det at bruge et "step- up" behandlingsskema startende med en daglig administration på 50 IE Puregon.
2 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
Hvis antallet af responderende follikler er for højt, eller østradiol niveauerne stiger for hurtigt, dvs. mere end en daglig fordobling i 2 eller 3 på hinanden følgende dage, bør den daglige dosis sættes ned.
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.
I sidstnævnte tilfælde bør hCG behandlingen ikke igangsættes, og graviditet bør undgås for at udelukke flerfoldsgraviditeter. • Kontrolleret ovariehyperstimulation ved medicinsk assisteret reproduktion Forskellige stimulationsregimer kan benyttes.
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.
En startdosis på 100- 225 IE anbefales i mindst de 4 første dage af behandlingen.
A starting dose of 100-225 IU is recommended for at least the first four days.
Puregon kan gives enten alene eller med henblik på at forhindre præmatur luteinisering, i kombination med en GnRH agonist eller antagonist.
Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Når der anvendes GnRH agonist kan det være nødvendigt at give en højere total behandlingsdosis for at opnå tilstrækkelig follikelrespons.
When using a GnRH agonist, a higher total treatment dose of Puregon may be required to achieve an adequate follicular response.
Når ultrasonografi viser tilstedeværelsen af mindst 3 follikler målende 16- 20 mm, og der er opnået en god østradiol respons (plasma niveauer på ca.
Ovarian response is monitored by ultrasonography and measurement of plasma oestradiol levels.
Dosering for mænd Puregon bør gives i en dosis på 450 IE pr. uge, helst i 3 doser á 150 IE samtidig med hCG.
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.
Behandlingen bør vare i mindst 3 til 4 måneder før der kan forventes nogen forbedring af spermatogenesen.
The treatment should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Hvis patienten ikke har responderet efter denne periode, kan kombinationsbehandlingen fortsættes, idet almindelig udbredt klinisk erfaring tyder på at behandling i op til 18 måneder eller længere kan være nødvendig for at opnå spermatogenese.
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.
Der er ingen relevant indikation for brug af Puregon hos børn.
There is no relevant indication for use of Puregon in children.
Puregon skal opløses i den medfølgende solvens.
Puregon should be reconstituted with the solvent provided.
Opløsningen bør anvendes straks.
The reconstituted solution should be administered immediately.
For at undgå injektion af store mængder kan Puregon (3- 4 frysetørrede kugler) opblandes med 1 ml solvens.
In order to avoid injection of large volumes 3 to 4 lyospheres of Puregon may be dissolved in 1 ml of solvent.
Hvis kun 1- 2 frysetørrede kugler kræves, kan mængden af solvens reduceres til 0, 5 ml.
When only 1 or 2 lyospheres are required the volume may be reduced to 0.5 ml.
Efter opløsning af hver frysetørret kugle skal det kontrolleres, at al tørstoffet er fuldstændig opløst.
After reconstitution of each sphere, it should be checked visually whether all freeze- dried material has dissolved completely.
Opløsningen må ikke anvendes, hvis den indeholder partikler eller er uklar.
The reconstituted solution should not be used if it contains particles or is not clear.
For at forhindre smertefuld injektion og minimere udsivning fra injektionsstedet bør Puregon opløsningen indgives langsomt intramuskulært eller subkutant.
To prevent painful injections and minimise leakage from the injection site Puregon should be slowly administered intramuscularly or subcutaneously.
Ved subkutan injektion bør injektionsstedet ikke være det samme hver gang for at forhindre lipoatrofi.
The subcutaneous injection site should be alternated to prevent lipoatrophy.
Selvadministration af Puregon bør kun foretages af patienter, som er velmotiverede, har fået udførlige instruktioner og har adgang til ekspertråd.
Self administration of Puregon should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. • Tumorer i ovarierne, mammae, uterus, testikler, hypofysen eller hypothalamus. • Udiagnosticeret vaginalblødning. • Primær ovarieinsufficiens. • Ovariecyster eller forstørrede ovarier som ikke har relation til polycystisk ovariesyndrom. • Misdannelser af genitalia som gør graviditet umulig. • Leiomyomer i uterus, som er uforenelige med graviditet. • Primær testikellidelse.
3 • Hypersensitivity to the active substance or to any of the excipients. • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding. • Primary ovarian failure. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). • Malformations of the sexual organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Primary testicular failure.
Passende FSH dosis justering( er) burde forebygge udvikling af multiple follikler.
Appropriate FSH dose adjustment(s) should prevent multiple follicle development.
Patienterne bør informeres om den mulige risiko for flerfoldsfødsler før påbegyndelse af behandlingen. • Den første Puregon injektion bør gives under direkte medicinsk overvågning. • Eftersom infertile kvinder, som er i assisteret reproduktionsbehandling, og især i in vitro fertilisationsbehandling, ofte har abnormaliteter i æggelederne, kan forekomsten af ektopiske graviditeter være forøget.
The patients should be advised of the potential risks of multiple births before starting treatment. • The first injection of Puregon should be performed under direct medical supervision. • Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Det er derfor vigtigt ved hjælp af ultralyd tidligt at bestemme, at graviditeten er intrauterin. • Abortraten hos kvinder i assisteret reproduktionsbehandling er højere end i den normale population. • Forekomsten af medfødte misdannelser efter assisteret reproduktionsteknologi (ART) kan være en smule højere end efter spontan undfangelse.
Early ultrasound confirmation that a pregnancy is intrauterine is therefore important. • Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population. • The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conceptions.
Hvis denne uønskede hyperstimulation indtræder (dvs. ikke som en del af kontrolleret ovariehyperstimulation ved medicinsk assisteret reproduktion), bør administrationen af Puregon afbrydes.
If this unwanted ovarian hyperstimulation occurs (i. e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Puregon should be discontinued.
I dette tilfælde skal graviditet undgås, og der må ikke indgives hCG, fordi administration af hCG kan inducere ovariehyperstimulationssyndromet (OHSS), foruden multiple ovulationer.
In that case pregnancy should be avoided and hCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS).
De kliniske symptomer, som optræder ved mild ovariehyperstimulation, er abdominale smerter, kvalme, diaré, og mild til moderat forstørrelse af ovarierne og ovariecyster.
Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.
Forbigående abnormaliteter i leverfunktionstests som kan tyde på leverdysfunktion, eventuelt ledsaget af morfologiske ændringer af leverbiopsi, er blevet rapporteret i forbindelse med ovariehyperstimulationssyndrom.
Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome.
I sjældne tilfælde kan der opstå alvorligt ovariehyperstimulations- syndrom, som kan være livstruende.
In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening.
Dette er karakteriseret ved store ovariecyster (tilbøjelige til at sprænges), ascites, ofte hydrothorax og vægtøgning.
This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain.
I sjældne tilfælde kan venøs eller arteriel tromboemboli optræde i forbindelse med OHSS. • Der er rapporteret om både benigne og maligne neoplasmer i ovarier og andre forplantningsorganer hos kvinder som har gennemgået behandlinger med adskillige lægemidler i forbindelse med fertilitetsbehandling.
In rare instances, venous or arterial thromboembolism may occur in association with OHSS. • There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Det er endnu ikke fastslået om behandling med gonadotropiner forøger risikoen (baseline) for disse tumorer hos infertile kvinder. • Kvinder med almindeligt kendte risikofaktorer for trombose i anamnesen eller som er familiært disponeret, alvorlig overvægt (Body Mass Index > 30 kg/ m2) eller kendt trombofili, kan have en forhøjet risiko for venøse eller arterielle tromboemboliske hændelser under eller efter behandling med gonadotropiner.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women. • Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity (Body Mass Index > 30 kg/ m2) or thrombophilia, may have an increased risk of venous or arterial thrombo-embolic events, during or following treatment with gonadotrophins.
Hos disse kvinder skal fordelene ved IVF- behandling opvejes
In these women the benefits of IVF treatment need to be weighed against the risks.
Det skal dog bemærkes, at en graviditet i sig selv medfører en forhøjet risiko for trombose. • Puregon kan indeholde spor af streptomycin og/ eller neomycin.
4 • Puregon may contain traces of streptomycin and/ or neomycin.
Sådanne patienter reagerer ikke på Puregon/ hCG behandling. • Hos mænd anbefales sædanalyse 4- 6 måneder efter behandlingsstart for at for at vurdere respons.
Such patients are unresponsive to Puregon/ hCG therapy. • In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
Samtidig brug af Puregon og clomifencitrat kan forstærke follikelresponset.
Concomitant use of Puregon and clomifene citrate may enhance the follicular response.
Efter desensibilisering af hypofysen ved brug af GnRH agonist, kan det være nødvendigt at give en højere dosis Puregon for at fremkalde tilstrækkelig follikelrespons.
After pituitary desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an adequate follicular response.
Der findes ingen indikation for anvendelse af Puregon under graviditet.
There is no indication for use of Puregon during pregnancy.
Der er ikke rapporteret om teratogen risiko efter kontrolleret ovarie hyperstimulation under klinisk anvendelse af gonadotropiner.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotropins.
Der er ikke set nogen teratogen effekt i dyrestudier.
No teratogenic effect has been observed in animal studies.
Puregon bør ikke anvendes i ammeperioden.
Puregon should not be used during breast-feeding.
Puregon påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Puregon has no or negligible influence on the ability to drive and use machines.
Klinisk brug af Puregon via intramuskulær eller subkutan administration kan resultere i lokale reaktioner ved injektionsstedet: blå mærker, smerte, rødme, hævelse og kløe er hyppigt rapporteret (3% af alle behandlede patienter).
Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection: bruising, pain, redness, swelling and itching are commonly reported (3% of all patients treated).
Det er usædvanligt (0, 1% af alle patienter, der blev behandlet med Puregon), at der ses generaliserede allergiske reaktioner inklusive erytem, nældefeber, udslæt og kløe.
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Puregon).
4. 4).
In approximately 4% of the women treated with Puregon in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).
Øvrige mere generelle symptomer, der er blevet rapporteret, inkluderer hovedpine og kvalme (hos op til 1% af de kvinder, der er behandlet med Puregon).
Other more general symptoms that have been reported include headache and nausea (in up to 1% of the women treated with Puregon).
I sjældne tilfælde er tromboembolisme blevet forbundet med Puregon/ hCG behandling, ligesom ved behandling med andre gonadotropiner.
In rare instances, thromboembolism has been associated with Puregon/ hCG therapy as with other gonadotrophins.
Der kan lejlighedsvist forekomme gynækomasti og akne under Puregon/ hCG- behandling.
Gynaecomastia and acne may occur occasionally during Puregon/ hCG therapy.
Dette er kendte bivirkninger af hCG- behandling.
These are known effects of hCG treatment.
Der er ingen data tilgængelige på Puregons akutte toksicitet i mennesker, men Puregons og gonadotropin præparaters akutte toksicitet, undersøgt i dyreforsøg, har vist sig at være meget lav.
5 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.
Dette stof produceres ved hjælp af rekombinant DNA teknologi, idet der anvendes ovarieceller fra kinesiske hamstre, som er tilført de humane FSH subunit gener.
This is produced by recombinant DNA technology, using a Chinese hamster ovary cell line transfected with the human FSH subunit genes.
Små forskelle i kulhydratkædestrukturen vides at eksistere.
Small differences in the carbohydrate chain structure are known to exist.
Hos kvinder er koncentrationen af FSH kritisk for indtræden og varigheden af follikeludviklingen, og som følge heraf for tidspunktet for og antallet af follikler som modnes.
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.
Endvidere kan Puregon bruges til at fremme udviklingen af multiple follikler ved medicinsk assisteret reproduktion (f. eks. in vitro fertilisering/ overførsel af embryoner (IVF/ ET), gamete intrafallopian transfer (GIFT) og ved intracytoplasmatisk sperminjektion (ICSI).
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)].
Hos mænd med FSH- mangel bør Puregon anvendes samtidig med hCG i mindst fire måneder for at fremme spermatogenesen.
In men deficient in FSH, Puregon should be used concomitantly with hCG for at least four months to promote spermatogenesis.
12 timer.
After intramuscular or subcutaneous administration of Puregon, maximum concentrations of FSH are reached within about 12 hours.