qanastek/EMEA-V3 huggingface dataset:
1 cartridge + 2 packs with 3 pen needles
Skarto + 2 pakketti bi 3 labar tal - pinna
EU/ 1/ 96/ 008/ 039
UE/ 1/ 96/ 008/ 039
600 IU/ 0.72 ml
600 IU/ 0. 7 2 ml
3 EU/ 1/ 96/ 008/ 040
UE/ 1/ 96/ 008/ 040
150 IU/ 0.18 ml
150 IU/ 0. 1 8 ml
1 cartridge + 1 pack with 3 pen needles
Skarto + pakkett bi 3 labar tal - pinna
EU/ 1/ 96/ 008/ 041
UE/ 1/ 96/ 008/ 041
900 IU/ 1.08 ml
900 IU/ 1. 0 8 ml
1 cartridge + 3 packs with 3 pen needles
Skarto + 3 pakketti bi 3 labar tal - pinna
4
3/ 3
Puregon 50 IU powder and solvent for solution for injection
Puregon 50 IU trab u solvent għal soluzzjoni għall- injezzjoni
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).
Ampulla waħda fiha 50 IU ormon rikombinanti li jistimula l- follikoli (FSH) li tikkorispondi għal 5 mikrogrammi 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 follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO).
After reconstitution, the solution contains 50 IU of follitropin beta per ml.
Wara r- rikostituzzjoni, is- soluzzjoni fiha 50 IU ta ’ follitropin beta għal kull ml.
Powder and solvent for solution for injection (powder for injection and solvent for parenteral use).
Trab u solvent għal soluzzjoni għall- injezzjoni (trab għall- injezzjoni u solvent għal użu parenterali).
White to off-white cake or powder.
Kejk jew trab bajdani jew off- white.
The solvent is a clear and colourless solution.
Is- solvent jikkonsisti minn soluzzjoni ċara u mingħajr kulur.
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)]
Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
It- kura b’ Puregon għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ problemi tal- fertilità.
Dosage in the female There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins.
Dożaġġ fil- mara Ir- rispons ta ’ l- ovarji għall- gonadotrofini eżoġeniċi ivarja ħafna kemm fl- istess individwu, kif ukoll bejn individwi differenti.
The dosage should, therefore, be adjusted individually depending on the ovarian response.
Id - dożaġġ għalhekk għandu jiġi aġġustat individwalment skont ir- rispons ta ’ l- ovarji.
This requires ultrasonography and monitoring of oestradiol levels.
Dan jeħtieġ ultrasonografija u monitoraġġ tal- livelli ta ’ l- estradjol.
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- riżultati 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.
Clinical experience with Puregon is based on up to three treatment cycles in both indications.
Esperjenza klinika speċifika b’ Puregon hi msejsa fuq tliet ċikli ta ’ kura fiż- żewġ indikazzjonijiet.
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 ’
2 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
2 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.
The starting dose is maintained for at least seven days.
Id - doża tal- bidu tinżamm għal ta ’ l- anqas sebat ijiem.
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 ’ estradjol ta ’ 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).
The administration of Puregon is then discontinued and ovulation can be induced by administering human chorionic gonadotrophin (hCG).
Imbagħad Puregon jitwaqqaf u l- ovulazzjoni tkun tista ’ tiġi stimulata bl- għoti ta ’ gonadotrofina korjonika umana (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.
Jekk in- numru ta ’ follikuli li jirrispondu ikun 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.
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.
F’ dak il- każ l- ormon hCG għandu jiġi miżmum u t- tqala għandha tiġi evitata sabiex jiġi evitat li jkun hemm ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva ta ’ l- ovarju kkontrollata fi programmi mediċi ta ’ riproduzzjoni assista Diversi protokolli ta ’ stimulazzjoni huma applikati.
A starting dose of 100-225 IU is recommended for at least the first four days.
Doża tal- bidu ta ’ 100- 225 IU hija rrakkomandata għal ta ’ l- anqas l- ewwel erbat ijiem.
Thereafter, the dose may be adjusted individually, based upon ovarian response.
Minn hemm ’ il quddiem, id- doża tista ’ tiġi aġġustata individwalment, skont ir- rispons ta ’ l- ovarju mogħti.
Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Puregon jista ’ jingħata waħdu, jew sabiex tiġi evitata sitwazzjoni ta ’ lutejnizzazzjoni prematura, flimkien ma ’ antagonista jew agonista tal- GnRH.
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.
Ovarian response is monitored by ultrasonography and measurement of plasma oestradiol levels.
Ir- rispons ta ’ l- ovarji huwa sorveljat bl- ultrasonografija u bil- kejl tal- livelli ta ’ l- estradjol fil - plażma.
When ultrasonographic evaluation 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 (1000-1300 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.
Meta l- evalwazzjoni ultrasonografika tindika l- preżenza ta ’ mill- anqas tliet follikuli ta ’ 16- 20 mm, u jkun hemm evidenza ta ’ rispons tajjeb ta ’ l- estradjol (livelli fil- plażma ta ’ madwar 300- 400 pikogramm/ ml (1000- 1300 pmol/ l) għal kull follikulu ta ’ dijametru akbar minn 18 mm), il- fażi finali ta ’ tkabbir tal- follikuli tiġi stimulata bit- teħid ta ’ l- 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.
Dożaġġ fir- raġel Puregon għandu jingħata f’ dożaġġ ta ’ 450 IU/ ġimgħa, preferibbilment maqsum fi tliet dożi ta ’ 150 IU, flimkien ma ’ hCG.
The treatment should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Il- kura għandha titkompla għal ta ’ l- anqas 3 sa 4 xhur qabel ma jista ’ jkun mistenni xi titjieb fl- ispermatoġenisi.
There is no relevant indication for use of Puregon in children.
M’ hemmx indikazzjoni relevanti ghall- użu ta ’ Puregon fit- tfal.
Puregon should be reconstituted with the solvent provided.
Puregon għandu jiġi rikostitwit bis- solvent ipprovdut.
The reconstituted solution should be administered immediately.
Is- soluzzjoni rikkostitwita għandha tiġi amministrata minnufih.
In order to avoid injection of large volumes 3 to 4 lyospheres of Puregon may be dissolved in 1 ml of solvent.
Sabiex tevita injezzjoni ta 'volumi kbar minn 3 sa 4 lijosferi ta' Puregon jistgħu jiġu maħlula f '1 ml ta' solvent.
When only 1 or 2 lyospheres are required the volume may be reduced to 0.5 ml.
Meta hemm bżonn biss ta '1 jew 2 lijosferi il- volum jista' jiġi mnaqqas għal 0. 5 ml.
After reconstitution of each sphere, it should be checked visually whether all freeze- dried material has dissolved completely.
Wara r- rikostituzzjoni ta 'kull sfera, għandu jiġi ċċekjat bl- għajnejn li l- materjal kollu mnixxef- ffriżat ikun inħall kollu.
The reconstituted solution should not be used if it contains particles or is not clear.
Is- soluzzjoni likwida rikostitwia m' għandhiex tintuża jekk ikun hemm il- preżenza ta ’ frak jew is- soluzzjoni ma tkunx ċara.
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.
The subcutaneous injection site should be alternated to prevent lipoatrophy.
Il- lok tat- teħid ta ’ l- injezzjoni ta ’ taħt il- ġilda għandu jinbidel sabiex tkun evitata l- lipotrofija.
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
3 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.
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 ’ jsir mill- persuna nnifisha biss jekk din tkun motivata sew, imrawma tajjeb u jkollha aċċess għal parir speċjaliżżat.
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.
• Sensittività eccessiva ghas- sustanza attiva jew ghal xi 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 ma ’ 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 marbuta 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.
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.
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.
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.
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 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.
Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e. g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values.
Barra l- iżvilupp ta ’ numru kbir ta ’ follikuli, il- livelli ta ’ l- estradjol jistgħu jiżdiedu malajr, eż. aktar mid- doppju kull jum għal jumejn jew tliet ijiem konsekuttivi u b’ possibiltà li jintlaħqu livelli għoljin ħafna.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination.
Id - dijanjosi ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji tista ’ tiġi kkonfermata b’ eżami ta ’ l- ultrasound.
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.
Jekk iseħħ din l- istimulazzjoni eċċessiva ta’ l- ovarji mhux mixtieqa (i. e. mhux bħala parti mill - istimulazzjoni eċċessiva kkontrollata fi programmi mediċi ta ’ riproduzzjoni assistita) it- teħid ta ’ Puregon għandu jitwaqqaf.
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- ovarju (OHSS).
Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.
Is- sintomi u s- sinjali kliniċi tas- sindromu ta ’ l- istimulazzjoni eċċessiva ta ’ l - ovarji ħafifa huma uġigħ fl- addome, dardir, dijarea u tkabbir minn żgħir sa moderat ta ’ l- ovarji u taċ- ċisti fl- ovarji.
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- ovarju.
In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening.
F’ każijiet rari, ikun hemm is- sindromu ta ’ l- istimulazzjoni eċċessiva serja ta ’ l- ovarji, li tista ’ tkun ta ’ periklu għall- ħajja.
This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain.
Din hi karatterizzata b’ ċisti kbar ta ’ l- ovarji (suxxetibbli li jinfaqgħu), axxite, ta ’ spiss idrotoraċi u żjieda fil- piż.
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 -
4 • Puregon may contain traces of streptomycin and/ or neomycin.
4 infertilità.
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- semene għal 4 sa 6 xhur wara l- bidu tal- kura biex jiġi eżaminat ir- rispons.
Concomitant use of Puregon and clomifene citrate may enhance the follicular response.
L- użu ta ’ Puregon flimkien ma ’ clomifene citrate jista ’ jsaħħaħ ir- rispons follikulari.
After pituitary desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an adequate follicular response.
Wara t- telf tas - sensittività tal- pitwitarju minħabba l- agonista GnRH, jista ’ jkun hemm bżonn ta ’ doża ogħla ta ’ Puregon sabiex jintlaħaq r- rispons follikulari xieraq.
There is no indication for use of Puregon during pregnancy.
4. 6 Tqala u treddigħ M’ hemm l- ebda indikazzjoni għall- użu ta ’ Puregon waqt it- tqala.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotropins.
L- ebda riskju teratoġeniku ma ġie rraportat, wara stimulazzjoni eċċessiva ta ’ l- ovarji kkontrollata, f’ użu kliniku tal- gonadotropini.
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’ hix biżżejjed sabiex teskludi effett teratoġeniku ta ’ FSH rikombinanti.
No teratogenic effect has been observed in animal studies.
Fil- provi fuq l- annimali ma ġie osservat l- ebda effett teratoġeniku.
Puregon should not be used during breast-feeding.
Mara li qed tredda ’ m’ għandhiex tieħu Puregon.
Puregon has no or negligible influence on the ability to drive and use machines.
Puregon m’ għandu l- ebda effett jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddem magni.
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).
The majority of these local reactions are mild and transient in nature.
Il- maġġoranza ta ’ dawn ir- reazzjonijiet lokali huma ħfief ujfiequ wara ftit.
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 komunament (madwar 0. 1% tal- pazjenti kollha trattati b’ Puregon).
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).
F’ madwar 4% tan- nisa kkurati b’ Puregon fil- provi kliniċi, ġew rapportati sinjali u sintomi relatati mas - sindromu ta ’ l- istimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) (Ara sezzjoni 4. 4).
These include pelvic pain and/ or congestion, abdominal pain and/ or distension, breast complaints (breast tenderness, pain and/ or engorgement), ovarian enlargement, and spontaneous abortion.
Dawn kienu jinkludu uġigħ fil- pelvis u/ jew konġestjoni, uġigħ u/ jew nefħa addominali, ilmenti dwar is- sider (l- irtubija tas- sider, uġigħ u/ jew konġestjoni), tkabbir ta ’ l- ovarji u abort spontaneju.
Other more general symptoms that have been reported include headache and nausea (in up to 1% of the women treated with Puregon).
Aktar sintomi ġenerali oħra li ġew rapportati jinkludu uġigħ ta ’ ras u dardir (f’ madwar 1% tan- nisa trattati b’ Puregon).
In rare instances, thromboembolism has been associated with Puregon/ hCG therapy as with other gonadotrophins.
F’ każijiet rari, it- tromboemboliżmu ġie assoċjat ma ’ terapija b ’ Puregon/ hCG kif ukoll ma ’ gonadotrofini oħra.
Treatment of men:
5 Kura fl- irġiel:
Gynaecomastia and acne may occur occasionally during Puregon/ hCG therapy.
Ginekomastija u akne jistgħu jseħħu kull tant żmien waqt il- kura b’ Puregon/ hCG.
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.
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.
Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
Doża għolja ħafna ta ’ FSH tista ’ twassal għal stimulazzjoni eċċessiva ta ’ l- ovarji (ara sezzjoni 4. 4).
Puregon contains a recombinant FSH.
Puregon fih FSH rikombinanti.
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.
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 - isterojdi 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 għal 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.
Puregon can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Għalhekk, Puregon jista ’ jintuża biex jistimula l- iżvilupp tal- follikuli u l - produzzjoni ta ’ l- isterojdi f’ każijiet selettivi ta ’ problemi fil- funzjoni tal- gonadi.
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)].
Barraminhekk, Puregon jista ’ jintuża biex jinkoraġġixxi l- iżvilupp ta ’ follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assista [eż. fertilizzazzjoni in vitro/ trasferiment ta ’ l- embriju (IVF/ ET), trasferiment ta ’ gamete fil- fallopjan (GIFT) u injezzjoni ta ’ l- isperma fiċ- ċitoplażma (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.
Ġeneralment, kura b’ Puregon tkun segwita b’ teħid ta ’ l- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikulu, it - tkomplija tal- mejożi u jinfaqa l- follikulu.
In men deficient in FSH, Puregon should be used concomitantly with hCG for at least four months to promote spermatogenesis.
Fl- irġiel li għandhom nuqqas ta ’ FSH, Puregon għandu jingħata flimkien ma ’ l- hCG għal ta ’ lanqas erba ’ xhur sabiex jinkoraġġixxi l- ispermatoġenisi.
After intramuscular or subcutaneous administration of Puregon, maximum concentrations of FSH are reached within about 12 hours.
Wara li Puregon jingħata ġol- muskolu jew taħt il- ġilda, il- konċentrazzjonijiet massimi ta ’ l- FSH jintlaħqu wara 12- il siegħa.
After intramuscular administration of Puregon, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Wara li jingħata ġol- muskolu, il- konċentrazzjonijiet massimi ta ’ l- FSH ikunu ogħla u jintlaħqu qabel fl- irġiel milli fin- nisa.
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.
Minħabba r- rilaxx sostenut mil- lok ta ’ l- injezzjoni u minħabba l- half- life ta ’ eliminazzjoni ta ’ madwar 40 siegħa (li tvarja minn 12 sa 70 siegħa), il- livelli ta ’ l- FSH jibqgħu mgħollija għal 24- 48 siegħa.
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 relettivament 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 meħuda.
This increase enables therapeutic FSH concentrations to be reached.
Iż- żjieda tippermetti li l- konċentrazzjonijiet ta ’ l- FSH terapewtiku jiġu milħuqa.
There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Puregon.
M’ hemm ebda differenzi farmakokinetiċi sinifikanti bejn it- teħid ta ’ Puregon ġol- muskolu u t- teħid minn taħt il- ġilda.
Single-dose administration of Puregon to rats induced no toxicologically significant effects.
L- għoti ta ’ doża waħda ta ’ Puregon lill- firien ma kkaġunax effetti tossikoloġiċi sinifikanti.
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.
F’ dożi ripetuti fil- firien (fuq ġimagħtejn) u fil- klieb (13- il ġimgħa) b’ doża sa 100 darba aktar minn dik li tingħata lill- bniedem, Puregon ma kkaġunax effetti tossikoloġiċi sinifikanti.
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 in vitro biċ- ċelluli limfoċiti umani, Puregon ma wera l- ebda riskju fuq il- ġeni.
Puregon powder for solution for injection contains: sucrose sodium citrate
It- trab Puregon għal soluzzjoni għall- injezzjoni fih: sucrose, sodium citrate polysorbate 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).
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.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
Do not store above 30 °C.
Taħżinx f' temperatura 'l fuq minn 30 ºC.
Keep the ampoules in the outer carton.
Żomm l- ampulli fil- kartuna ta 'barra.
Sterile lyophilised sphere in 1 ml ampoule (type I glass) and 1 ml of solvent (saline 0.45%) in 1 ml ampoule (type I glass).
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).
Pack of 1, 3, 5 or 10.
Pakkett ta '1, 3, 5 jew 10.
Puregon should be reconstituted with the solvent provided using a gentle, swirling motion.
Puregon għandu jiġi rikostitwit bis- solvent fornut u għandu jiġi maħlul f' azzjoni ta 'tidwir bil- mod.
Vigorous shaking should be avoided.
Għandu jiġi evitat ix- xengil qawwi.
Do not use if the solution contains particles or if the solution is not clear.
Tużax jekk is- soluzzjoni fiha xi frak jew jekk it- soluzzjoni mhix ċara.
When dissolving more than one sphere, it should be checked visually whether all freeze-dried material has dissolved completely before the solution is transferred to the next ampoule to be reconstituted.
Meta qed iddewweb aktar minn sfera waħda, għandu jiġi ċċekjat bl- għajn biex tara jekk il- materjal kollu mnixxef- iffriżat inħallx qabel is- soluzzjoni tiġi trasferita għal ampulla sabiex tiġi rikostitwita.
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 tintuża minnufih wara r- rikostituzzjoni.
EU/ 1/ 96/ 008/ 001 EU/ 1/ 96/ 008/ 002 EU/ 1/ 96/ 008/ 003 EU/ 1/ 96/ 008/ 004
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 7 EU/ 1/ 96/ 008/ 001 EU/ 1/ 96/ 008/ 002 EU/ 1/ 96/ 008/ 003 EU/ 1/ 96/ 008/ 004
3 May 1996 7 Date of last renewal:
3 ta ’ Mejju 1996 Data ta ’ l- aħħar reviżjoni:
3 May 2006
3 ta ’ Mejju 2006
Puregon 75 IU powder and solvent for solution for injection
Puregon 75 IU trab u solvent għal soluzzjoni għall- injezzjoni
One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) corresponding to 7,5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 75 IU ormon rikombinanti li jistimula l- follikoli( FSH), li jikkorispondi għal 7. 5 mikrogrammi ta ’ proteina (f’ bijoattività speċifika in vivo ugwali għal 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 follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli minn ovarji tal- ħemster Ċiniż (CHO).
After reconstitution, the solution contains 75 IU of follitropin beta per ml.
Wara r- rikostituzzjoni, is- soluzzjoni fiha 75 IU ta ’ follitropin beta għal kull ml.
Powder and solvent for solution for injection (powder for injection and solvent for parenteral use).
Trab u solvent għas- soluzzjoni għall- injezzjoni (trab għall- injezzjoni u solvent għal użu parenterali).
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)].
Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Il- kura b’ Puregon għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ problemi tal- fertilità.
Clinical experience with Puregon is based on up to three treatment cycles in both indications.
Esperjenza klinika b’ Puregon hi msejsa fuq tliet ċikli ta ’ kura fiż- żewġ indikazzjonijiet.
9 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
L- esperjenza globali bl- IVF tagħti indikazzjoni li b’ mod ġenerali r- rata ta ’ suċċess għall- kura tibqa ’ stabbli fl - 9 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 tal- livelli ta ’ l - estradjol b’ 40– 100% hija kkonsidrata li hi l- aħjar.
The daily dose is then maintained until pre-ovulatory conditions are reached.
Din id- doża ta ’ kuljum mbagħad tinżamm hekk sakemm jintlaħqu l- kondizzjonijiet xierqa ta ’ qabel l- ovulazzjoni.
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 ħafna 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.
A starting dose of 100-225 IU is recommended for at least the first four days.
Doża tal- bidu ta ’ 100- 225 IU hija rrakkomandata għal ta ’ lanqas l- ewwel erbat ijiem.
Thereafter, the dose may be adjusted individually, based upon ovarian response.
Minn hemm ’ il quddiem, id- doża tista ’ tiġi aġġustata individwalment, skont ir- rispons ta ’ l- ovarji.
The treatment should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Il- kura għandha titkompla għal ta ’ lanqas 3 sa 4 xhur qabel ma jista ’ jkun mistenni xi titjieb fl- ispermatoġenisi.
In order to avoid injection of large volumes 3 to 4 cakes of Puregon may be dissolved in 1 ml of solvent.
Sabiex tevita injezzjoni ta 'volumi kbar minn 3 sa 4 kejks ta' Puregon jistgħu jiġu maħlula f '1 ml ta' solvent.
When only 1 or 2 cakes are required the volume may be reduced to 0.5 ml.
Meta hemm bżonn biss ta '1 jew 2 kejks il- volum jista' jiġi mnaqqas għal 0. 5 ml.
After reconstitution of each cake, it should be checked visually whether all freeze-dried material has dissolved completely.
Wara rikostituzzjoni ta 'kull kejk, għandu jiġi ċċekjat bl- għajnejn li l- materjal kollu mnixxef- ffriżat ikun inħall kollu.
The reconstituted solution should not be used if it contains particles or is not clear.
Is- soluzzjoni rikostitwia m' għandhiex tintuża jekk ikun hemm frak fiha jew jekk ma tkunx ċara.
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 ġol- muskolu jew taħt il- ġilda.
The subcutaneous injection site should be alternated to prevent lipoatrophy.
Il- lok tat- teħid ta ’ l- injezzjoni ta ’ taħt il- ġilda għandu jinbidel sabiex tkun evitata l- lipoatrofija.
Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
10 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.
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 speċjaliżżat.
10 • 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 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 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.
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.
Jekk iseħħ din l- istimulazzjoni eċċessiva ta ’ l- ovarji mhux mixtieqa (i. e. mhux bħala parti mill - istimulazzjoni eċċessiva kkontrollata fi programmi mediċi ta ’ riproduzzjoni assistita) it- teħid ta ’ Puregon għandu jitwaqqaf.
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 ’ l- istimulazzjoni eċċessiva ta ’ l- ovarji (OHSS).
Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.
Is- sintomi u s- sinjali kliniċi tas- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l - ovarji ħafifa huma uġigħ fl- addome, dardir, dijarea u tkabbir minn żgħir sa moderat ta ’ l- ovarji u taċ- ċisti fl- ovarji.
11 • Puregon may contain traces of streptomycin and/ or neomycin.
11 infertilità.
There is no indication for use of Puregon during pregnancy.
M’ hemm l- ebda indikazzjoni għall- użu ta ’ Puregon waqt it- tqala.
In rare instances, thromboembolism has been associated with Puregon/ hCG therapy as with other gonadotrophins.
F’ każijiet rari, it- tromboemboliżmu ġie assoċjat ma ’ terapija b’ Puregon/ hCG kif ukoll ma ’ gonadotrofini oħra.
Treatment of men:
12 Kura fl- irġiel:
12 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 baxx 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 ’ ċelloli mill- ovarji tal- ħamster Ċiniż li hi mgħobbija bil- ġeni sekondarji tal- FSH tal- bniedem.
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 taż- żmien li jieħdu biex jimmaturaw.
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 hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikoli, it - tkomplija tal- mejożi u jinfaqa l- follikulu.
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.
Minħabba r- rilaxx sostenut mil- lok ta ’ l- injezzjoni u minħabba l- half- life ta ’ l- eliminazzjoni ta ’ madwar 40 siegħa (li tvarja minn 12 sa 70 siegħa), il - livelli ta ’ l- FSH jibqgħu għoljin għal 24- 48 siegħa.
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 relettivament twila, l- għoti ripetut ta ’ l- istess doża għandu jwassal għall- konċentrazzjonijiet ta ’ l- FSH fil- plażma ta ’ madwar 1. 5- 2. 5 drabi ogħla minn meta tittieħed doża waħda.
This increase enables therapeutic FSH concentrations to be reached.
Iż- żjieda tippermetti li l - konċentrazzjonijiet ta ’ l- FSH terapewtiku jiġu milħuqa.
There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Puregon.
M’ hemm l- ebda differenzi farmakokinetiċi sinifikanti bejn it- teħid ta ’ Puregon ġol- muskolu u t- teħid minn taħt il- ġilda.
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.
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat bis- sodium hydroxide u/ jew hydrochloric acid.
The ampoule of solvent contains sodium chloride (4.5 mg) in water for injections (1.0 ml).
L- ampulla tas- solvent tikkonsisti minn sodium chloride (4. 5 mg) f' ilma għal injezzjonijiet (1. 0 ml).
The content of a vial should be used immediately after reconstitution.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
Keep the vial(s) and ampoule(s) in the outer carton.
Żomm il- kunjetti u l- ampulli fil- kartuna ta 'barra.
Pack of 1, 3, 5 or 10.
Kejk lijofilizzat sterili f' kunjett 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 ghall- skop kummercjali.
When dissolving more than one cake, it should be checked visually whether all freeze-dried material has dissolved completely before the solution is transferred to the next vial to be reconstituted.
Meta qed iddewweb aktar minn kejk wieħed, għandu jiġi ċċekjat bl- għajn biex tara jekk il- materjal kollu mnixxef- iffriżat inħallx qabel is- soluzzjoni tiġi trasferita għal kunjett sabiex tiġi rikostitwita.
The content of a vial should be used immediately after reconstitution.
Il- kontenut ta 'kunjett għandu jiġi wżat minnufih wara r- rikostituzzjoni.
EU/ 1/ 96/ 008/ 005 EU/ 1/ 96/ 008/ 006 EU/ 1/ 96/ 008/ 007 EU/ 1/ 96/ 008/ 008
14 EU/ 1/ 96/ 008/ 005 EU/ 1/ 96/ 008/ 006 EU/ 1/ 96/ 008/ 007 EU/ 1/ 96/ 008/ 008
3 May 1996 Date of last renewal:
3 ta ’ Mejju 1996 Data ta ’ l- aħħar reviżjoni:
Puregon 100 IU powder and solvent for solution for injection
Puregon 100 IU trab u solvent għal soluzzjoni għall- injezzjoni
One ampoule contains 100 IU recombinant follicle-stimulating hormone (FSH) corresponding to 10 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Ampulla waħda fiha 100 IU ormon rikombinanti li jistimula l- follikoli, (FSH) li tikkorispondi għal 10 mikrogrammi proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
After reconstitution, the solution contains 100 IU of follitropin beta per ml.
Wara r- rikostituzzjoni, is- soluzzjoni fiha 100 IU ta ’ follitropin beta f’ kull ml.