qanastek/EMEA-V3 huggingface dataset:
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)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji (POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni / trasferiment tal- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (ICSI)].
16 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
16 stabbli fl- ewwel erba ’ darbiet u tibda tonqos bil- mod wara dan. • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
A daily increase of oestradiol levels of 40- 100% is considered to be optimal.
Żieda ta ’ kuljum fil- livelli ta ’ estradjol ta ’ 40- 100% hija kkonsidrata li hi l- aħjar.
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.
Jekk il- pazjent ma jkollux rispons wara dan il- perijodu, it- terapija kombinata tista ’ titkompla esperjenza klinika attwali tindika li trattament sa 18- il xahar jew aktar tista ’ tkun meħtieġa biex ikun hemm spermatoġenisi.
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
17 L- injezzjoni taħt il- ġilda b’ Puregon tista ’ ssir mill- pazjent innifsu jew mis- sieħeb/ sieħba, kemm- il darba l- istruzzjonijiet għall- użu jkunu ngħataw mit- tabib.
17 • 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.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi. • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
This is thought to be due to differences in parental characteristics (e. g., maternal age, sperm characteristics) and multiple gestations. • Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment.
Dan jista ’ jkun minħabba differenzi fil- karatteristiċi tal- ġenituri (eż. età ta ’ l- mara, karatteristiċi ta ’ l- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva ta ’ l- ovarji mhux mixtieqa: fil- kura ta ’ pazjenti nisa, stima ultrasonografika ta ’ l- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli ta ’ l- estradjol għandhom jiġu stabbiliti qabel il- kura u f’ intervalli regolari waqt il- kura.
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.
Testijiet dwar il- funzjoni tal- fwied jistgħu jkunu temporanjament abnormali li jindika problemi fil- fwied, li jistgħu jkunu akkumpanjati b’ bidliet morfoloġiċi fil- bijopsija tal - fwied, ġew irrapportati flimkien ma ’ sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji.
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.
F’ każijiet rari jistgħu jseħħu tromboemboliżmi tal - vini jew ta ’ l- arterji flimkien ma ’ OHSS. • Kien hemm rapporti ta ’ neoplażmi fl- ovarji u fis- sistema riproduttiva, kemm tat- tip beninni kif ukoll tat- tip malinni, f’ nisa li ħadu diversi regimeni ta ’ mediċini għall- kura ta ’ l- infertilità.
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.
18 Għadu mhux stabbilit jekk il- kura bil- gonadotrofini żżidx ir- riskju mir- referenza bażi ta ’ dawn it- tumuri f’ nisa infertili. • Nisa li għandhom fatturi magħrufa li jistgħu jpoġġuhom f’ riskju ta ’ trombożi, bħal ma huma passat mediku personali jew tal- familja, obesità serja, (Indiċi ta ’ Piż tal- ġisem > 30 kg/ m2) jew trombofilja, jista ’ jkollhom riskju ogħla ta ’ każijiet ta ’ tromboemboliżmi tal- vini jew ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
18 • Puregon may contain traces of streptomycin and/ or neomycin.
Madankollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
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).
L- użu kliniku ta ’ Puregon li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok tat- tilqima: tbenġil, uġigħ, ħmura, nefħa u ħakk, li huma rapportati b’ mod komuni (3% tal - pazjenti kollha ttrattati).
The majority of these local reactions are mild and transient in nature.
Il- maġġoranza ta ’ dawn ir- reazzjonijiet lokali huma ħfief u fiequ wara ftit.
Treatment of men:
19 Kura fl- irġiel:
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.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
This is produced by recombinant DNA technology, using a Chinese hamster ovary cell line transfected with the human FSH subunit genes.
Dan hu magħmul b ’ teknoloġija rikombinanti tad- DNA, permezz ta ’ razza ta ’ celloli mill- ovarji tal- ħamster Ċiniż li hi mgħobbija bil- ġeni sekondarji tal- FSH tal- bniedem.
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.
Ġeneralment, kura b’ Puregon tkun segwita b’ teħid ta ’ l- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikoli, it - tkomplija tal- mejożi u jinfaqa l- follikulu.
5.3 Preclinical safety data
5. 3 Tagħrif ta’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Puregon powder for solution for injection contains: sucrose sodium citrate polysorbate 20.
It- trab Puregon għal soluzzjoni għall- injezzjoni fih: sucrose, sodium citrate polysorbate 20.
20 The ampoule of solvent contains sodium chloride (4.5 mg) in water for injections (1.0 ml).
L- ampulla tas- solvent fiha sodium chloride (4. 5 mg) f' ilma għal injezzjonijiet (1. 0 ml).
Pack of 1, 3, 5 or 10.
Trab lijofilizzat sterili f’ forma sferika f' ampulla ta' 1 ml (ħġieġ tip I) u 1 ml ta 'solvent (salina 0. 45%) f' ampulla ta' 1 ml (ħġieġ tip I) Pakkett ta '1, 3, 5 jew 10.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop.
Since an opened ampoule cannot be resealed in such a way to further guarantee the sterility of the contents, the solution should be used immediately after reconstitution.
Peress li ampulla miftuħa ma tistax tiġi ssiġillata mill- ġdid b' mod u manjera li ma tistax tigarantixxi aktar l- isterilità tal- kontenut, is- soluzzjoni għandha tintuż minnufih wara r- rikostituzzjoni.
Puregon 150 IU powder and solvent for solution for injection
Puregon 150 IU trab u solvent għal soluzzjoni għall- injezzjoni
One ampoule contains 150 IU recombinant follicle-stimulating hormone (FSH) corresponding to 15 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Ampulla waħda fiha 150 IU ormon rikombinanti li jistimula l- follikoli, (FSH), li tikkorispondi għal 15- il mikrogramm ta 'proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
The powder for solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
It- trab għal soluzzjoni għall- injezzjoni fih is- sustanza attiva fillitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO).
After reconstitution, the solution contains 150 IU of follitropin beta per ml.
Wara r- rikostituzzjoni, is- soluzzjoni fiha 150 IU ta ’ follitropin beta għal kull ml.
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)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji (POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni/ trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (ICSI)]
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
L - esperjenza globali bl- IVF tagħti indikazzjoni li b’ mod ġenerali r- rata ta ’ suċċess għall- kura tibqa ’ stabbli fl- ewwel erba ’ darbiet u tibda tonqos bil- mod wara dan.
23 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
23 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
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 (1000-3000 pmol/ l) are attained.
Il- kondizzjonijiet ta ’ qabel l - ovulazzjoni jintlaħqu meta jkun hemm prova ultrasonografika ta ’ follikulu dominanti b’ dijametru ta ’ 18- il millimetru u/ jew meta l- livelli ta ’ l- estradjol fil- plażma jilħqu 300- 900 picogrammi/ ml (1000- 3000 pmol/ l).
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
24 darba l- istruzzjonijiet għall- użu jkunu ngħataw mit- tabib.
4.3 Contraindications 24 • 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.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi. • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
• The presence of uncontrolled non-gonadal endocrinopathies (e. g. thyroid, adrenal or pituitary disorders) should be excluded. • In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiple gestations.
• Il- preżenza ta ’ endokrinopatiji mhux gonadali li m’ humiex ikkontrollati (eż. disturbi marbuti mat- tirojde, l- adrenali jew il- pitwitarju) għandhom jiġu esklużi. • Fi tqala li tkun seħħet wara l- ovulazzjoni stimulata bil- preparazzjonijiet gonadotropiċi, hemm riskju ogħla ta ’ ġestazzjonijiet multipli.
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.
F’ każijiet rari jistgħu jseħħu tromboemboliżmi tal- vini jew ta ’ l- arterji flimkien ma ’ OHSS. • Kien hemm rapporti ta ’ neoplażmi fl- ovarji u fis- sistema riproduttiva, kemm tat- tip beninni kif ukoll tat- tip malinni, f’ nisa li ħadu diversi programmi ta ’ korsijiet ta ’ mediċini għall- kura ta ’ l - infertilità.
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.
25 ta ’ dawn it- tumuri f’ nisa infertili. • Nisa li għandhom fatturi magħrufa li jistgħu jpoġġuhom f’ riskju ta ’ trombożi, bħal ma huma passat mediku personali jew tal- familja, obesità serja, (Indiċi ta ’ Piż tal- ġisem > 30 kg/ m2) jew trombofilja, jista ’ jkollhom riskju ogħla ta ’ każijiet ta ’ tromboemboliżmi tal- vini jew ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
25 • Puregon may contain traces of streptomycin and/ or neomycin.
Madankollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
Treatment of men:
26 Kura fl- irġiel:
Puregon showed no mutagenic potential in the Ames test or in the in vitro chromosome aberration test with human lymphocytes.
Fit- test Ames, u fit- test ta ’ l- aberrazzjoni tal- kromosome magħmul in vitro biċ- ċelluli limfoċiti umani, Puregon ma wera l- ebda riskju fuq il- ġeni.
27 The ampoule of solvent contains sodium chloride (4.5 mg) in water for injections (1.0 ml).
L- ampulla tas- solvent fiha sodium chloride (4. 5 mg) f' ilma għal injezzjonijiet (1. 0 ml).
EU/ 1/ 96/ 008/ 013 EU/ 1/ 96/ 008/ 014 EU/ 1/ 96/ 008/ 015 EU/ 1/ 96/ 008/ 016
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 28 EU/ 1/ 96/ 008/ 013 EU/ 1/ 96/ 008/ 014 EU/ 1/ 96/ 008/ 015 EU/ 1/ 96/ 008/ 016
Puregon 50 IU/ 0.5 ml solution for injection
Puregon 50 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
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)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji, POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni / trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (ICSI).
30 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
30 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
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.
Jekk ma jkunx hemm rispons ta ’ l- ovarji, id - doża ta ’ kuljum għandha tiżdid b’ mod gradwali sakemm it- tkabbir tal - follikulu u/ jew il- livell ta ’ l- estradjol fil- plażma jindikaw rispons farmakodinamiku xieraq.
A daily increase of oestradiol levels of 40- 100% is considered to be optimal.
Żieda ta ’ kuljum fil- livelli ta ’ l- estradjol b’ 40– 100% hija kkonsidrata li hi l- aħjar.
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 (1000-3000 pmol/ l) are attained.
Il- kondizzjonijiet ta ’ qabel l- ovulazzjoni jintlaħqu meta jkun hemm prova ultrasonografika ta ’ follikulu dominanti b’ dijametru ta ’ 18- il millimetru u/ jew meta l- livelli ta ’ l- estradjol fil- plażma jilħqu 300- 900 picogrammi/ ml (1000– 3000 pmol/ l).
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.
Jekk in- numru ta ’ follikuli li jirrispondu jkun kbir wisq jew il- livelli ta ’ l- estradjol jiżdied b’ rata mgħaġġla ħafna i. e. b’ aktar mid- doppju f’ jum, għal jumejn jew tliet ijiem konsekuttivi, id- doża ta ’ kuljum għandha titnaqqas.
When using a GnRH agonist, a higher total treatment dose of Puregon may be required to achieve an adequate follicular response.
Meta jintuża agonista tal- GnRH, jista ’ jkun hemm bżonn doża totali ta ’ Puregon aktar għolja għall- kura, sabiex jintlaħaq ir- rispons follikulari xieraq.
To prevent painful injections and minimise leakage from the injection site Puregon should be slowly administered intramuscularly or subcutaneously.
Sabiex tevita l- uġigħ ta ’ l- injezzjonijiet u sabiex tnaqqas it- tnixxija mis- sit ta ’ l- injezzjoni, Puregon għandu jingħata bil- mod ġol- muskolu jew taħt il- ġilda.
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
L- injezzjoni taħt il- ġilda b’ Puregon tista ’ ssir mill- pazjent nnifsu jew mis- sieħeb/ sieħba, kemm- il darba l- istruzzjonijiet għall- użu jkunu ngħataw mit- tabib.
Self administration of Puregon should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
It- teħid jista ’ isir mill- persuna nnifisha biss jekk din tkun motivata sew, imrawma tajjeb u jkollha aċċess għal parir speċjalizzat.
31 • 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.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi 31 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha.. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli ma ’ tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
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.
Il- pazjenti għandhom jiġu mgħarrfa dwar ir- riskji potenzjali ta ’ twelidijiet multipli qabel il- bidu tal- kura. • L- ewwel injezzjoni ta ’ Puregon għandha tingħata taħt superviżjoni medika diretta. • Billi nisa infertili li jkunu qegħdin fuq programm ta ’ riproduzzjoni assistita, u partikolarment IVF, ta ’ spiss ikollhom anormalitajiet fit- tubi, l- inċidenza ta ’ tqalat ektopiċi tista ’ tiżdid Għalhekk huwa importanti li wieħed jikkonferma kmieni, permezz ta ’ l- ultrasound, li t- tqala qiegħda fil- ġuf. • Ir- rata ta ’ telf ta ’ tqala f’ nisa għaddejjin mit- teknika ta ’ riproduzzjoni assistita hija ogħla minn dik fil- popolazzjoni normali. • L- inċidenza ta ’ malformazzjonijiet konġenitali wara Technoloġiji ta ’ Riproduzzjoni Assistita (ART) tista ’ tkun ħarira ogħla milli f’ konċepiment spontanju.
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).
F’ dak il- każ it- tqala għandha tiġi evitata u l- hCG għandu jinżamm, għaliex barra l- ovulazzjoni multipla, jista ’ jikkaġuna s- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS).
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.
F’ każijiet rari jistgħu jseħħu tromboemboliżmi tal- vini jew ta ’ l - arterji flimkien ma ’ OHSS. • Kien hemm rapporti ta ’ neoplażmi fl- ovarji u fis- sistema riproduttiva, kemm tat- tip beninn, kif ukoll tat- tip malinn, f’ nisa li ħadu diversi programmi ta ’ korsijiet ta ’ mediċini għall- kura ta ’ l - infertilità.
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.
Għadu mhux stabbilit jekk il- kura bil- gonadotrofini żżidx ir- riskju mir- referenza bażi ta ’ dawn it- tumuri f’ nisa infertili. • Nisa li għandhom fatturi magħrufa li jistgħu jpoġġuhom f’ riskju ta ’ trombożi, bħal ma huma passat mediku personali jew tal- familja, obesità serja, (Indiċi ta ’ Piż tal- ġisem > 30 kg/ m2) jew trombofilja, jista ’ jkollhom riskju ogħla ta ’ każijiet ta ’ tromboemboliżmu tal- vini jew ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
In these women the benefits of IVF treatment need to be weighed against the risks.
F’ dawn in- nisa l- benefiċċji tal- kura bl- IVF iridu
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Puregon may contain traces of streptomycin and/ or neomycin.
Madanakollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
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.
Dawn il- pazjenti ma jirrispondux għat- terapija ta ’ Puregon/ hCG. • Fl- irġiel huwa rakkomandat, li ssir l- analiżi tas- semen għal 4 sa 6 xhur wara l- bidu tal- kura biex jiġi eżaminat ir- rispons.
32 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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).
L- użu kliniku ta ’ Puregon li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok ta ’ l- injezzjoni; tbenġil, uġigħ, ħmura, nefħa u ħakk, li huma rapportati b’ mod komuni (3% tal - pazjenti kollha ttrattati).
4.9 Overdose
33 4. 9 Doża eċċessiva
33 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
L- FSH huwa indispensabbli fit- tkabbir u l- maturazzjoni normali tal- follikuli u fil- produzzjoni ta’ l - isterojde tal- gonadi.
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.
Fil- mara l- livell ta ’ l- FSH huwa kritiku għall- bidu u għal matul l- iżvilupp tal - follikuli, u sussegwentement għan- numru ta ’ follikuli li jilħqu jimmaturaw u għat- tul ta ’ żmien li jieħdu biex jimmaturaw.
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.
Minħabba li l- half life ta ’ l- eliminazzjoni hija relattivament twila, l- għoti ripetut ta ’ l- istess doża jwassal għall- konċentrazzjonijiet ta ’ l- FSH fil - plażma ta ’ madwar 1. 5- 2. 5 drabi ogħla minn meta tittieħed doża waħda.
Puregon showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Fit- test Ames, u fit- test ta ’ l- aberrazzjoni tal- kromosome in vitro biċ- ċelluli limfoċiti umani, Puregon ma wera l- ebda riskju fuq il- ġeni.
6.1 List of excipients
34 6. 1 Lista ta ’ sustanzi mhux attivi
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
Puregon, soluzzjoni għall- injezzjoni fih sucrose, sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
34 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
For patient convenience, Puregon may be stored at or below 25 ºC by the patient for a single period of not more than 3 months.
Għall- konvenjenza tal- pazjent, Puregon jista ’ jinħażen f’ temperatura ta ’, jew anqas minn 25 ºC mill - pazjent għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u ghal immaniggar iehor
Date of first authorisation:
35 Data ta ’ l- ewwel awtorizzazzjoni:
Puregon 75 IU/ 0.5 ml solution for injection
Puregon 75 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
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)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji, POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni/ trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (ICSI).
36 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
37 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
L- injezzjoni taħt il- ġilda b’ Puregon tista ’ ssir mill- pazjent innifsu jew mis- sieħeb/ sieħba, kemm- il darba l- istruzzjonijiet għall- użu jkunu ngħataw mit- tabib.
• 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.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi.
37 • 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.
38 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
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.
Għalhekk huwa importanti li wieħed jikkonferma kmieni, permezz ta ’ l- ultrasound, li t- tqala qiegħda fil- ġuf. • Ir- rata ta ’ telf ta ’ tqala f’ nisa għaddejjin mit- teknika ta ’ riproduzzjoni assistita hija ogħla minn dik fil- popolazzjoni normali. • L- inċidenza ta ’ malformazzjonijiet konġenitali wara Technoloġiji ta ’ Riproduzzjoni Assistita (ART) tista ’ tkun ħarira ogħla milli f’ konċepiment spontanju.
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.
F’ każijiet rari jistgħu jseħħu tromboemboliżmi tal- vini jew ta ’ l- arterji flimkien ma ’ OHSS. • Kien hemm rapporti ta ’ neoplażmi fl- ovarji u fis- sistema riproduttiva, kemm tat- tip beninn, kif ukoll tat- tip malinn, f’ nisa li ħadu diversi programmi ta ’ korsijiet ta ’ mediċini għall- kura ta ’ l - infertilità.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Puregon may contain traces of streptomycin and/ or neomycin.
39 riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
38 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Puregon).
Reazzjonijiet ta ’ sensittività ġenerali li jinkludu eritema, urtikarja, raxx u ħakk ġew osservati mhux komunamen (madwar 0. 1% tal- pazjenti kollha trattati b’ Puregon.
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.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq 40 l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
39 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
The primary amino acid sequence is identical to that of natural human FSH.
Is - sekwenza primarja ta ’ l- aċidi aminiċi hija identika għal dik li tinstab fl- FSH naturali tal- bniedem.
Puregon showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Fit- test Ames, u fit- test ta ’ l- aberrazzjoni tal- kromosome magħmul in vitro biċ- ċelluli limfoċiti umani, Puregon ma wera l- ebda riskju fuq il- ġeni.
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
41 sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
40 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Pack of 1, 5 or 10.
Soluzzjoni ta ’ 0. 5 ml f’ kunjett ta ’ 3 ml (ħġieġ tip I) b’ tapp (lastku tal- chlorobutyl) Pakkett ta ’ 1, 5 jew 10.
Puregon 100 IU/ 0.5 ml solution for injection
Puregon 100 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
42 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
44 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
43 • 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.
45 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli ma ’ tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
This is thought to be due to differences in parental characteristics (e. g., maternal age, sperm characteristics) and multiple gestations. • Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment.
Dan jista ’ jkun minħabba differenzi fil- karatteristiċi tal- ġenituri (eż. età tal- mara, karatteristiċi ta ’ l- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva ta ’ l- ovarji mhix mixtieqa: fil- kura ta ’ pazjenti nisa, stima ultrasonografika ta ’ l- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli ta ’ l- estradjol għandhom jiġu stabbiliti qabel il- kura u f’ intervalli regolari waqt il- kura.
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.
F’ każijiet rari jistgħu jseħħu tromboemboliżmi tal - vini jew ta ’ l- arterji flimkien ma ’ OHSS. • Kien hemm rapporti ta ’ neoplażmi fl- ovarji u fis- sistema riproduttiva, kemm tat- tip beninn, kif ukoll tat- tip malinn, f’ nisa li ħadu diversi programmi ta ’ korsijiet ta ’ mediċini għall- kura ta ’ l - infertilità.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Puregon may contain traces of streptomycin and/ or neomycin.
46 riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
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.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq 47 l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
45 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
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.
Minħabba li l- half life ta ’ l- eliminazzjoni hija relattivament twila, l- għoti ripetut ta ’ l- istess doża jwassal għall- konċentrazzjonijiet ta ’ l- FSH fil - plażma ta ’ madwar 1. 5- 2. 5 drabi ogħla minn meta tittieħed doża waħda.
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
48 sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
46 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Puregon 150 IU/ 0.5 ml solution for injection
Puregon 150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
48 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
51 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
49 • 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.
52 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
50 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
Fil - każ ta ’ espożizzjoni waqt it- tqala, l- informazzjoni klinika m’ hiex biżżejjed sabiex teskludi effett teratoġeniku ta ’ FSH rikombinanti.
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.
54 M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
51 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
55 sucrose sodium citrate L- methionine polysorbate 20 ilma għall- injezzjonijiet.
52 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Puregon 200 IU/ 0.5 ml solution for injection
Puregon 200 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
54 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
58 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
A daily increase of oestradiol levels of 40- 100% is considered to be optimal.
Żieda ta ’ kuljum fil- livelli ta ’ l- estradjol b’ 40- 100% hija kkonsidrata li hi l- aħjar.
55 • 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.
59 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain.
Din hi karatterizzatab’ ċisti kbar ta ’ l- ovarji (suxxetibbli li jinfaqgħu), axxite, ta ’ spiss idrotoraċi u żjieda fil- piż.
56 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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).
L- użu kliniku ta ’ Puregon li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok ta ’ l- injezzjoni: tbenġil, uġigħ, ħmura, nefħa u ħakk li huma rapportati b’ mod komuni (3% tal - pazjenti kollha ttrattati).
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.
61 M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
57 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
62 sucrose, sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
58 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Puregon 225 IU/ 0.5 ml solution for injection
Puregon 225 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 225 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kunjett wieħed fih 225 IU ormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 5 ml ta ’ soluzzjoni akwea.
This corresponds to a strength of 450 IU/ ml.
Dan jikkorrispondi għal qawwa ta ’ 450 IU/ ml.
One vial contains 22.5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 22. 5 mikrogrammi ta ’ proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
For a full list of excipients, see section 6.1.
Għal- lista kompluta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
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)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji, POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni / trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (ICSI).
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.
Skont ir- risżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Puregon jingħata f’ dożaġġ aktar baxx minn dak li ġeneralment jintuża għal FSH urinarju, mhux biss biex jinkisbu l- aħjar kondizzjonijiet għall- iżvilupp follikulari imma wkoll biex jitnaqqas ir- riskju ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji mhux mixtieq.
60 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
65 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
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 (1000-3000 pmol/ l) are attained.
Il- kondizzjonijiet ta ’ qabel l- ovulazzjoni jintlaħqu meta jkun hemm prova ultrasonografika ta ’ follikulu dominanti b’ dijametru ta ’ 18- il millimetru u/ jew meta l- livelli ta ’ l- estradjol fil- plażma jilħqu 300- 900 picogrammi/ ml (1000- 3000 pmol/ l).
61 • 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.
66 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Puregon may contain traces of streptomycin and/ or neomycin.
67 riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
62 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq 68 l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
63 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC: