qanastek/EMEA-V3 huggingface dataset:
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.
8 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
9 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Fertavid kuljum.
Subcutaneous injection of Fertavid may be carried out by patient or partner, provided that proper instructions are given by the physician.
L- injezzjoni taħt il- ġilda b’ Fertavid 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.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi.
9 • 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.
10 • Tumuri tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- pitwitarju jew tal- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju tal- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku tal- ovarji (PCOD). • Malformazzjonijiet tal- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi tal- 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.
Disturbi marbuta mat- tirojde, l- adrenali jew il- pitwitarju) għandhom jiġu esklużi. • Fit- 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 Fertavid 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 ’ Fertavid 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 tal- 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.
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 tal- arterji, waqt jew wara l- kura bil- gonadotrofini.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Fertavid may contain traces of streptomycin and/ or neomycin.
Madanakollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju
These antibiotics may cause hypersensitivity reactions in susceptible persons.
11 akbar ta ’ trombożi. • Fertavid jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
10 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Dawn l- antibijotiċi jistgħu jikkawżaw reazzjonijiet ta ’ sensittività eċċessiva f’ persuni suxxettibbli. • Livelli ta ’ FSH endoġeniċi għolja fl- irġiel huma sinjali ta ’ indeboliment primarju tat- testikoli.
Clinical use of Fertavid 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 ’ Fertavid li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok tal- injezzjoni: tbenġil, uġigħ, ħmura, nefħa u ħakk, li huma rapportati b’ mod komuni (3% tal - pazjenti kollha ttrattati).
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Fertavid).
Reazzjonijiet ta ’ sensittività ġenerali li jinkludu eritema, urtikarja, raxx u ħakk ġew osservati mhux komunamen (madwar 0. 1% tal- pazjenti kollha trattati b’ Fertavid.
No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Fertavid fil- bniedem, iżda fi studji fuq 12 l- annimali ntwera li t- tossiċità akuta ta ’ Fertavid u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
11 5 PHARMACOLOGICAL PROPERTIES
TAGĦRIF FARMAKOLOĠIKU
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 tal- ħamster Ċiniż li hi mgħobbija bil- ġeni sekondarji tal- FSH tal- bniedem.
The primary amino acid sequence is identical to that of natural human FSH.
Is - sekwenza primarja tal- aċidi aminiċi hija identika għal dik li tinstab fl- FSH naturali tal- bniedem.
Fertavid 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 tal- aberrazzjoni tal- kromosome magħmul in vitro biċ- ċelluli limfoċiti umani, Fertavid ma wera l- ebda riskju fuq il- ġeni.
Fertavid solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
Fertavid, soluzzjoni għall- injezzjoni fih: sucrose,
12 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat b’ sodium hydroxide u/ jew b’ hydrochloric acid.
Keep the vial(s) in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra.
0.5 ml of solution in 3 ml vial (type I glass) with stopper (chlorobutyl rubber).
Soluzzjoni ta ’ 0. 5 ml f’ kunjett ta ’ 3 ml (ħġieġ tip I) b’ tapp (lastku tal- chlorobutyl) Pakkett ta ’ 1, 5 jew 10.
The contents of a vial should be used immediately after piercing of the rubber stopper.
Il- kontenut tal- kunjett għandu jintuża minnufih wara li jittaqqab it- tapp tal- gomma.
13 1.
14 15 1.
Fertavid 100 IU/ 0.5 ml solution for injection
Fertavid 100 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kull kunjett fih 100 IU ormon rikombinati li jistimula l- follikoli (FSH), f’ 0. 5 ml ta ’ soluzzjoni akwea.
This corresponds to a strength of 200 IU/ ml.
Din tikkorrispondi għal qawwa ta ’ 200 IU/ ml.
One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 10 mikrogrammi ta ’ proteina (f’ bijoattività speċifika in vivo ugwali għal madwar 10, 000 IU FSH / mg proteina).
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Is- soluzzjoni għal injezzjoni fiha s- sustanza attiva follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli minn ovarji tal- ħemster Ċiniż (CHO).
14 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
16 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Fertavid kuljum.
Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations.
Peress li follikuli ta ’ aktar minn 14- il millimetru jistgħu jwasslu għat- tqala, follikuli multipli ta ’ qabel l- ovulazzjoni li jkunu akbar minn 14- il millimetru jikkawżaw riskju ta ’ ġestazzjonijiet multipli.
15 • 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.
17 • Tumuri tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- pitwitarju jew tal- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju tal- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku tal- ovarji (PCOD). • Malformazzjonijiet tal- organi sesswali li huma inkompattibli ma ’ tqala. • Tumuri fibrojdi tal- 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 tal- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva tal- ovarji mhix mixtieqa: fil- kura ta ’ pazjenti nisa, stima ultrasonografika tal- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli tal- 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 tal- ovarji.
These antibiotics may cause hypersensitivity reactions in susceptible persons.
18 akbar ta ’ trombożi. • Fertavid jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
16 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Dawn l- antibijotiċi jistgħu jikkawżaw reazzjonijiet ta ’ sensittività eċċessiva f’ persuni suxxettibbli. • Livelli ta ’ FSH endoġeniċi għolja fl- irġiel huma sinjali ta ’ indeboliment primarju tat- testikoli.
No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Fertavid fil- bniedem, iżda fi studji fuq 19 l- annimali ntwera li t- tossiċità akuta ta ’ Fertavid u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
G03G A06.
G03G A06
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 tal- 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 tal- 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.
Fertavid can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Għalhekk, Fertavid jista ’ jintuża biex jistimula l- iżvilupp tal- follikuli u l- produzzjoni tal- isterojdi f’ każijiet selettivi ta ’ problemi fil- funzjoni tal- gonadi.
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 tal- eliminazzjoni hija relattivament twila, l- għoti ripetut tal- istess doża jwassal għall- konċentrazzjonijiet tal- FSH fil- plażma ta ’ madwar 1. 5- 2. 5 drabi ogħla minn meta tittieħed doża waħda.
Fertavid solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
Fertavid, soluzzjoni għall- injezzjoni fih sucrose,
18 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat b’ sodium hydroxide u/ jew b’ hydrochloric acid.
Date of last renewal:
Data tal- aħħar reviżjoni:
Fertavid 150 IU/ 0.5 ml solution for injection
Fertavid 150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kunjett wieħed fih 150 IU ormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 5 ml ta ’ soluzzjoni akwea.
This corresponds to a strength of 300 IU/ ml.
Dan jikkorrispondi għal qawwa ta ’ 300 IU/ ml.
One vial contains 15 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 15- il mikrogramma ta ’ proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Is- soluzzjoni għall- injezzjoni fiha s- sustanza attiva fillitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO).
20 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
23 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Fertavid kuljum.
In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for six to twelve days are sufficient, although longer treatment may be necessary.
Fi studji kliniċi ntwera li dożaġġi ta ’ bejn 75375 IU għal bejn sitta sa tnax- il jum huma biżżejjed, għalkemm jista ’ jkun hemm bżonn kura aktar fit- tul.
21 • 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.
24 • Tumuri tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- pitwitarju jew tal- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju tal- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku tal- ovarji (PCOD). • Malformazzjonijiet tal- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi tal- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
Appropriate FSH dose adjustment(s) should prevent multiple follicle development.
Aġġustament xieraq tad- doża tal- FSH għandu jevita li jkun hemm żvilupp follikulari multiplu.
Multiple gestation, especially high order, carries an increased risk of adverse maternal and perinatal outcomes.
Ġestazzjoni multipla, speċjalment b’ numru kbir, iġġib magħha riskju ogħla ta ’ kondizzjonijiet avversi waqt it- tqala u waqt it- twelid.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination.
Id- dijanjosi ta ’ stimulazzjoni eċċessiva tal- ovarji tista ’ tiġi kkonfermata b’ eżami tal- ultrasound.
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 tal- 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 tal- infertilità.
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 jiġu
22 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Dawn l- antibijotiċi jistgħu jikkawżaw reazzjonijiet ta ’ sensittività eċċessiva f’ persuni suxxettibbli. • Livelli ta ’ FSH endoġeniċi għolja fl- irġiel huma sinjali ta ’ indeboliment primarju tat- testikoli.
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.
However, to date, no particular malformative effect has been reported.
Madankollu sa ’ llum, ma ġie rrapportat l- ebda effett ta ’ malformazzjoni partikolari.
No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
26 M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Fertavid fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Fertavid u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
Fertavid solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
Fertavid, soluzzjoni għall- injezzjoni fih:
24 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat b’ sodium hydroxide u/ jew b’ hydrochloric acid.
Store in a refrigerator (2 °C – 8 °C).
Aħżen fi friġġ( 2 ºC – 8 ºC).
Fertavid 200 IU/ 0.5 ml solution for injection
Fertavid 200 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 200 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kunjett wieħed fih 200 IU ormon rikombinanti li jistimula l- follikoli, (FSH) f’ 0. 5 ml ta ’ soluzzjoni akwea.
This corresponds to a strength of 400 IU/ ml.
Dan jikkorrispondi ma ’ qawwa ta ’ 400 IU/ ml.
One vial contains 20 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 20 mikrogramma ta ’ proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Is- soluzzjoni għall - injezzjoni fiha s- sustanza attiva follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO).
26 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
30 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Fertavid kuljum.
A daily increase of oestradiol levels of 40- 100% is considered to be optimal.
Żieda ta ’ kuljum fil- livelli tal- estradjol b’ 40- 100% hija kkonsidrata li hi l- aħjar.
27 • 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.
31 • Tumuri tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- pitwitarju jew tal- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju tal- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku tal- ovarji (PCOD). • Malformazzjonijiet tal- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi tal- 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 tal- ovarji (suxxetibbli li jinfaqgħu), axxite, ta ’ spiss idrotoraċi u żjieda fil- piż.
28 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Dawn l- antibijotiċi jistgħu jikkawżaw reazzjonijiet ta ’ sensittività eċċessiva f’ persuni suxxettibbli. • Livelli ta ’ FSH endoġeniċi għolja fl- irġiel huma sinjali ta ’ indeboliment primarju tat- testikoli.
Clinical use of Fertavid 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 ’ Fertavid li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok tal- injezzjoni: tbenġil, uġigħ, ħmura, nefħa u ħakk li huma rapportati b’ mod komuni (3% tal - pazjenti kollha ttrattati).
No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
33 M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Fertavid fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Fertavid 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 bit- teknoloġija rikombinanti tad- DNA, permezz ta ’ razza ta ’ celloli mill- ovarji tal- ħamster Ċiniż li hi mgħobbija bil- ġeni sekondarji tal- FSH tal- bniedem.
30 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat b’ sodium hydroxide u/ jew b’ hydrochloric acid.
Fertavid 150 IU/ 0.18 ml solution for injection
Fertavid 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni
One cartridge contains a net total dose of 150 IU recombinant follicle-stimulating hormone (FSH) in 0.18 ml aqueous solution.
Stoċċ wieħed fih doża netta totali ta '150 IU ormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 18 ml soluzzjoni akwea.
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/ ml aqueous solution.
Is- soluzzjoni għall- injezzjoni fiha s- sustanza attiva follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO) f’ konċentrazzjoni akweja ta '833 IU/ ml.
This strength corresponds to 83.3 microgram of protein / ml (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Il- qawwa tikkorispondi ma ’ 83. 3 mikrogrammi ta 'proteina / ml (bijoattività speċifika in vivo ugwali għal madwar 10, 000 IU FSH / mg proteina).
In cartridges, designed to be used in conjunction with a pen injector.
Fi stoċċijiet, magħmula biex jintużaw flimkien ma ’ pinna li tinjetta.
Fertavid 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)].
Fertavid huwa intiż għall- kura tal- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku tal- ovarji (POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata tal- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [e. ż. fertilizzazzjoni / trasferiment tal- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika tal - isperma (intracytoplasmic sperm injection ICSI)].
The dosage should, therefore, be adjusted individually depending on the ovarian response.
Id- dożaġġ għalhekk għandu jiġi aġġustat individwalment skont ir- rispons tal- ovarji.
When using the pen injector, it should be realised that the pen is a precision device which accurately delivers the dose to which it is set.
Meta tintuża l- pinna li tinjetta, wieħed għandu jżomm f’ moħħu li l- pinna hija tagħmir preċiż li tagħti d- doża li tkun ssettjata għalih.
It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
Intwera li meta tintuża l- pinna, tingħata doża ta ’ FSH li hija 18% aktar għolja minn dik mogħtija b’ siringa konvenzjonali.
This may be of particular relevance when switching between the pen injector and a conventional syringe within one treatment cycle.
Din tista 'tkun ta' relevanza partikolari meta taqleb mill- pinna li tinjetta għas- siringa konvenzjonali f' ċiklu wieħed ta 'kura.
Especially when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a dose being given.
Meta wieħed jeqleb minn siringa għal pinna, xi aġġustamenti żgħar għandhom mnejn ikollhom isiru sabiex jiġi evitat li tingħata doża għolja wisq.
32 Based on the results of comparative clinical studies, it is considered appropriate to give a lower dosage of Fertavid than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
37 Skond ir- riżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Fertavid jingħata f’ dożaġġ aktar baxx minn dak li jingħata ġeneralment għal FSH urinarju, mhux biss biex jinkisbu l- aħjar kondizzjonijiet għall- iżvilupp follikulari imma wkoll biex jitnaqqas ir- riskju ta ’ stimulazzjoni eċċessiva tal- ovarji mhux mixtieq.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter. • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
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. • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Fertavid 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 tal- ovarji, id - doża ta ’ kuljum għandha tiżdid b’ mod gradwali sakemm it- tkabbir tal - follikulu u/ jew tal - 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 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 hija mbagħad tinżamm 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 millimetru u/ jew meta l- livelli tal- estradjol fil- plażma jilħqu 300- 900 picogrammi/ ml (1000– 3000 pmol/ l).
The administration of Fertavid is then discontinued and ovulation can be induced by administering human chorionic gonadotrophin (hCG).
Imbagħad, Fertavid 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 tal- 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 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 tal- ovarju kkontrollata fi programmi mediċi ta ’ riproduzzjoni assista Diversi protokolli ta ’ stimulazzjoni huma applikati.
When using a GnRH agonist, a higher total treatment dose of Fertavid may be required to achieve an adequate follicular response.
Meta jintuża agonista tal- GnRH, jista ’ ikun hemm bżonn doża totali ta ’ Fertavid aktar għolja għall- kura sabiex jintlaħaq ir- rispons follikulari xieraq.
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 tal- 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 tal- hCG.
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 kombiata tista ’ titkompla; esperjenza klinika attwali tindika li trattament sa 18- il xahar jew aktar tista ’ tkun meħtieġa biex ikun hemm spermatoġenisi.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen and should be administered subcutaneously.
Fertavid, soluzzjoni għall- injezzjoni fl- istoċċijiet ġiet żviluppata biex tintuża f’ pinna li tinjetta msejħa Puregon Pen u għandha tingħata taħt il- ġilda.
The injection site should be alternated to prevent lipoatrophy.
Is- sit tat- tilqima għandu jinbidel sabiex tiġi evitata l - lipoatropija.
Using the pen injector, injection of Fertavid can be carried out by the patient, provided that proper instructions are given by the physician.
38 Bl- użu tal- pinna li tinjetta, l- injezzjoni ta 'Fertavid, tista ’ ssir mill- pazjent, imbasta jkunu ngħataw l - istruzzjonijiet xierqa mit- tabib.
4.3 Contraindications 33 • 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 tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- pitwitarju jew tal- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju tal- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku tal- ovarji (PCOD). • Malformazzjonijiet tal- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi tal- 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. • Fit- tqala li tkun seħħet wara l- ovulazzjoni stimulata bil- preparazzjonijiet gonadotropiċi, hemm riskju ogħla ta ’ ġestazzjonijiet multipli.
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- omm, karatteristiċi tal- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva tal- ovarji mhux mixtieqa: fit- kura ta ’ pazjenti nisa, stima ultrasonografika tal- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli tal- 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 ’ estradjol jistgħu jiżdiedu malajr, eż. aktar mid- doppju kull jum għal jumejn jew tliet ijiem konsekuttivi u b’ possibiltà li jintlaħqu livelli eċċessivi għoljin ħafna.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination.
Id- dijanjosi ta ’ stimulazzjoni eċċessiva tal- ovarji tista ’ tiġi kkonfermata b’ eżami tal - ultrasound.
If this unwanted ovarian hyperstimulation occurs (i. e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Fertavid should be discontinued.
Jekk iseħħ din l- istimulazzjoni eċċessiva tal- ovarji mhux mixtieqa (i. e. mhux bħala parti mill- istimulazzjoni eċċessiva kkontrollata fi programmi mediċi ta ’ riproduzzjoni assistita) it- teħid ta ’ Fertavid 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 tal- 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 tal- ovarji ħafifa huma uġigħ fl- addome, dardir, dijarea u tkabbir minn żgħir sa moderat tal- 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 tal- ovarju.
This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain.
Din hi karatterizzata b’ ċisti kbar fl- 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 tal- 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 tal -
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 ’ ikollhom riskju ogħla ta ’ każijiet ta ’ tromboemboliżmi tal- vini jew tal- arterji, waqt jew wara l- kura bil- gonadotrofini.
In these women the benefits of IVF treatment need to be weighed against the
F’ dawn in- nisa l- benefiċċji tal- kura bl- IVF iridu jiġu mwieżna mar- riskji.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Fertavid may contain traces of streptomycin and/ or neomycin.
Madankollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju akbar ta ’ trombożi. • Fertavid jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
These antibiotics may cause hypersensitivity reactions in susceptible persons. • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Dawn l- antibijotiċi jistgħu jikkawżaw reazzjonijiet ta ’ sensittività eċċessiva f’ persuni suxxettibbli. • Livelli ta ’ FSH endoġeniċi għolja fl- irġiel huma sinjali ta ’ indeboliment primarju tat- testikoli.
Such patients are unresponsive to Fertavid/ 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 ’ Fertavid/ hCG. • Fl- irġiel huwa rakkomandat, li ssir l- analiżi għal 4 sa 6 xhur wara l- bidu tal- kura biex jiġi eżaminat ir- rispons.
After pituitary desensitisation induced by a GnRH agonist, a higher dose of Fertavid may be necessary to achieve an adequate follicular response.
Wara t- telf tas - sensittività tal- pitwitarju minħabba l- agonista GnRH, jista ’ ikun hemm bżonn ta ’ doża ogħla ta ’ Fertavid sabiex jintlaħaq r- rispons follikulari xieraq.
Clinical use of Fertavid 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 ’ Fertavid li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok tal- injezzjoni bħalma huwa tbenġil, uġigħ, ħmura, nefħa u ħakk, li huma rapportati b’ mod komuni (3% tal- pazjenti kollha ttrattati).
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Fertavid).
Reazzjonijiet ta ’ sensittività ġenerali li jinkludu eritema, urtikarja, raxx, u ħakk ġew osservati mhux komunament (madwar 0. 1% tal- pazjenti kollha trattati b’ Fertavid).
Treatment of men:
40 Kura fl- irġiel:
35 No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Fertavid fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Fertavid 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 bit- 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- follikulu u fil- produzzjoni tal- isterojdi 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 tal- FSH huwa kritiku għall- bidu u għal matul l- iżvilupp tal - follikuli, u sussegwentement għan- numru ta ’ follikuli li jilħqu jimmaturaw u għal matul ta ’ żmien li jieħdu biex jimmaturaw.
Treatment with Fertavid is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Generalment, kura b’ Fertavid tkun segwita b’ teħid tal- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikoli, it - tkomplija tal- mejożi u jinfaqa ’ l- follikulu.
After subcutaneous administration of Fertavid, maximum concentration of FSH is reached within about 12 hours.
Wara li Fertavid jingħata taħt il- ġilda, il- konċentrazzjoni massima tal- FSH tintlaħaq wara 12- il siegħa.
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 tal- injezzjoni u minħabba l- half- life tal- eliminazzjoni ta ’ madwar 40 siegħa (li tvarja minn 12 sa 70 siegħa), il- livelli ta ’ 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 tal- eliminazzjoni hija relettivament twila, l- għoti ripetut tal- istess doża jwassal għall- konċentrazzjonijiet tal- 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 tal- FSH terapewtiku jiġu milħuqa.
The absolute bioavailability of subcutaneously administered Fertavid is approximately 77%.
Il- bijodisponibbilità assoluta ta ’ Fertavid li jingħata taħt il- ġilda hi ta ’ madwar 77%.
6.1 List of excipients
41 6. 1 Lista ta ’ sustanzi mhux attivi
Fertavid 150 IU/ 0.18 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20
Fertavid 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni fiha: sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol ilma għall- injezzjonijiet.
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista jiġi aġġustat permezz ta ’ sodium hydroxide u/ jew hydrochloric acid.
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
La darba l- gomma ta 'ġewwa tal- istoċċ tkun ġiet mtaqba b' labra, il- prodott jista 'jinħażen għal massimu ta' 28 jum.
Keep the cartridge in the outer carton.
Żomm l- istoċċ fil- kartuna ta ’ barra.
For patient convenience, Fertavid may be stored at or below 25 ºC by the patient for a single period of not more than 3 months.
Għal konvenjenza tal- pazjent, Fertavid jista ’ jinħażen f’ temperatura ta ’, jew anqas minn 25 ºC mill - pazjent għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
0.18 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
0. 18 ml ta 'soluzzjoni fl- istoċċ ta' 1. 5 ml (ħġieġ tip I) bil- pistun tal- lastiku griż u tapp tennej tal - aluminju b’ inforra tal- lastku.
Pack of 1 cartridge and 3 needles to be used with the Puregon Pen.
Pakkett jikkonsisti minn stoċċ wieħed u 3 labar li għandhom jiġu użati mal - Puregon Pen.
Cartridges contain a minimum of 225 IU FSH activity in 0.270 ml aqueous solution, which is sufficient for a net total dose of 150 IU.
L- istoċċijiet fihom minimu ta ’ 225 IU tal- attività FSH f’ 270 ml ta 'ilma, li hu biżżejjed għal doża totali netta ta' 150 IU.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniggar ieħor
Fertavid 150 IU/ 0.18 ml solution for injection is designed for use in conjunction with a pen injector called Puregon Pen.
Fertavid 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża ma ’ pinna li tinjetta msejħa Puregon Pen.
The instructions for using the pen must be followed carefully.
L- istruzzjonijiet għall- użu tal- pinna għandhom jiġu segwiti b' attenzjoni.
Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Bżieżaq tal- arja għandhom jitneħħew mill- istoċċ qabel l- injezzjoni (ara l- istruzzjonijiet ta 'kif tuża l- pinna).
Empty cartridges must not be refilled.
Stoċċijiet vojta m' għandhomx jiġu mimlija mill- ġdid.
Fertavid cartridges are not designed to allow any other drug to be mixed in the cartridges.
L- istoċċijiet Fertavid mhumiex magħmula sabiex jippermettu li xi mediċina oħra titħallat fl- istoċċ.
Discard used needles immediately after injection.
Armi l- labar użati wara l- injezzjoni.
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Fertavid 300 IU/ 0.36 ml solution for injection
Fertavid 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni
One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 0.36 ml aqueous solution.
Stoċċ wieħed fih doża netta totali ta '300 IU ormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 36 ml ilma.
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/ ml aqueous solution.
Is- soluzzjoni għall- injezzjoni fiha s- sustanza attiva follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO) f ’ konċentrazzjoni akwea ta '833 IU/ ml.