qanastek/EMEA-V3 huggingface dataset:
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 [eż. fertilizzazzjoni / trasferiment tal- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika tal - isperma (intracytoplasmic sperm injection ICSI)].
39 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.
44 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.
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.
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 200- 400 pikogramm/ ml (1000- 1300 pmol/ l) għal kull follikula ta ’ dijametru akbar minn 18 mm), il- fażi finali ta ’ tkabbir tal- follikuli tiġi stimulata bit- teħid tal- hCG.
Using the pen injector, injection of Fertavid can be carried out by the patient, provided that proper instructions are given by the physician.
45 Bl- użu tal- pinna li tinjetta, l- injezzjoni ta 'Fertavid tista ’ ssir mill- pazjent stess, imbasta jkunu ngħataw l- istruzzjonijiet xierqa mit- tabib.
4.3 Contraindications 40 • 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 ta ’ lipotalamu. • 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 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 mhix 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.
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.
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.
46 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.
Treatment of men:
47 Kura fl- irġiel:
42 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.
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- follikulu, it - tkomplija tal- mejożi u jinfaqa ’ l- follikulu.
6.1 List of excipients
48 6. 1 Lista ta ’ sustanzi mhux attivi
Fertavid 300 IU/ 0.36 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20
Fertavid 300 IU/ 0. 36 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.
0.36 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
0. 36 ml ta 'soluzzjoni fl- istoċċ ta' 1. 5 ml (ħġieġ tip I) bil- pistun tal- lastku griż u tapp tennej tal - aluminju b’ inforra tal- lastku.
Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.
Pakkett jikkonsisti minn stoċċ wieħed u 6 labar li għandhom jiġu użati mal - Puregon Pen.
Cartridges contain a minimum of 400 IU FSH activity in 0.480 ml aqueous solution, which is sufficient for a net total dose of 300 IU.
L- istoċċijiet fihom 400 IU tal- attività FSH f' 0. 480 ml ta 'ilma, li hu biżżejjed għal doża totali netta ta' 300 IU.
Fertavid 300 IU/ 0.36 ml solution for injection is designed for use in conjunction with a pen injector called Puregon Pen.
Fertavid 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża ma ’ pinna li tinjetta msejħa Puregon Pen.
MARKETING AUTHORISATION NUMBER
NUMRU TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Fertavid 600 IU/ 0.72 ml solution for injection
Fertavid 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni
One cartridge contains a net total dose of 600 IU recombinant follicle-stimulating hormone (FSH) in 0.72 ml aqueous solution.
Stoċċ wieħed fih doża netta totali ta '600 IU ormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 72 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 ’ ċelloli mill- ovarji tal - ħamster Ċiniż (CHO) f' konċentrazzjoni akwea ta '833 IU/ ml.
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 [eż. fertilizzazzjoni / trasferiment tal- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika tal - isperma (intracytoplasmic sperm injection ICSI)].
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% akar għolja minn dik mogħtija b’ siringa konvenzjonali.
46 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.
51 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.
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 follikula ta ’ dijametru akbar minn 18 mm), il- fażi finali ta ’ tkabbir tal- follikuli tiġi stimulata bit- teħid tal- hCG.
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 sabiex tintuża ma ’ 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.
52 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 47 • 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 ta ’ lipotalamu. • 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.
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.
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
Fertavid has no or negligible influence on the ability to drive and use machines.
Fertavid m’ għandu l- ebda effett jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddemmagni.
In rare instances, thromboembolism has been associated with Fertavid/ hCG therapy as with other gonadotrophins.
F’ każijiet rari, it- tromboemboliżmu ġie assoċjat ma ’ terapija b’ Fertavid/ hCG kif ukoll ma ’
49 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.
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.
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.
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- follikulu, it- tkomplija tal- mejożi u jinfaqa ’ l- follikulu.
Fertavid 600 IU/ 0.72 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20
Fertavid 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni fiha sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol ilma għall- injezzjonijiet.
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- lastku ta 'ġewwa tal- istoċċ ikun ġie mtaqqab b' labra, il- prodott jista 'jinħażen għal massimu ta' 28 jum.
Keep the cartridge in the outer carton.
Żomm l- istoċċ kontenitur fil- kartuna ta ’ barra.
6.5 Nature and contents of container
In- natura tal- kontenitur u ta ’ dak li hemm ġo fih 6. 5
0.72 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
0. 72 ml ta 'soluzzjoni fl- istoċċ ta' 1. 5 ml (ħġieġ tip I) bil- pistun tal- lasktu griż u tapp tennej tal - aluminju b’ inforra tal- lastku.
Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.
Pakkett jikkonsisti minn stoċċ wieħed u 6 labar li għandhom jiġu użati mal- Puregon Pen.
Cartridges contain a minimum of 700 IU FSH activity in 0.840 ml aqueous solution, which is sufficient for a net total dose of 600 IU.
L- istoċċijiet fihom minimu ta ’ 700 IU tal- attività FSH f’ 0. 840 ml ta 'ilma, li hu biżżejjed għal doża totali netta ta' 600 IU.
Fertavid 600 IU/ 0.72 ml solution for injection is designed for use in conjunction with a pen injector called Puregon Pen.
Fertavid 600 IU/ 0. 72 soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża ma ’ pinna li tinjetta msejħa Puregon Pen.
SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgium
56 SP Europe Rue de Stalle, 73 B- 1180 Bruxelles Il- Belġju
Fertavid 900 IU/ 1.08 ml solution for injection
Fertavid 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni
One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in 1.08 ml aqueous solution.
Stoċċ wieħed fih doża netta totali ta '900 IU f' ormon rikombinati li jistimula l- folliki, (FSH), f’ 1. 08 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.
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)].
53 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.
58 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.
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 tliettliet 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 ’ 100225 IU hija rrakkomandata għal tal- anqas l- ewwel erbat ijiem.
Using the pen injector, injection of Fertavid can be carried out by the patient, provided that proper instructions are given by the physician.
59 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 54 • 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.
56 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.
Fertavid 900 IU/ 1.08 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20
Fertavid 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni fiha: sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol il- ilma għall- injezzjonijiet.
1.08 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
1. 08 ml ta 'soluzzjoni fl- istoċċ ta' 1. 5 ml (ħġieġ tip I) bil- pistun tal- lastku griż u tapp tennej tal - aluminju b’ inforra tal- lastku.
Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.
Pakkett jikkonsisti minn stoċċ wieħed u 6 labar li għandhom jiġu użati mal- Puregon Pen.
Cartridges contain a minimum of 1025 IU FSH activity in 1.230 ml aqueous solution, which is sufficient for a net total dose of 900 IU.
L- istoċċijiet fihom minimu ta ’ 1025 IU tal- attività FSH f' 1. 230 ml ta 'ilma, li hu biżżejjed għal doża totali netta ta' 900 IU.
Fertavid 900 IU/ 1.08 ml solution for injection is designed for use in conjunction with a pen injector called Puregon Pen.
Fertavid 900 IU/ 1. 08 soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża ma ’ pinna li tinjetta msejħa Puregon Pen.
SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgium
63 SP Europe Rue de Stalle, 73 B- 1180 Bruxelles Il- Belġju
59 ANNEX II
64 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Box 20 5340 BH Oss The Netherlands
Box 20, 5340 BH Oss, L- Olanda.
Biosearch Ireland National Cell & Tissue Culture Centre Glasnevin Dublin 9 Ireland
Biosearch Ireland, National Cell & Tissue Culture Centre, Glasnevin, Dublin 9, L- Irlanda.
Fertavid solution for injection in vials 50 IU/ 0.5 ml, 75 IU/ 0.5 ml, 100 IU/ 0.5 ml, 150 IU/ 0.5 ml, 200 IU/ 0.5 ml:
Fertavid soluzzjoni għall- injezzjoni f’ kunjetti ta ’ 50 IU/ 0. 5 ml, 75 IU/ 0. 5 ml, 100 IU/ 0. 5 ml, 150 IU/ 0. 5 ml, 200 IU/ 0. 5 ml:
Organon Kloosterstraat 6 Postbus 20 5340 BH Oss The Netherlands
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, L- Olanda.
Dublin Ireland
Dublin, L- Irlanda.
Organon S. A., Usine Saint Charles 60590 Eragny sur Epte France.
Organon S. A., Usine Saint- Charles, 60590 Eragny- sur- Epte, Franza.
Fertavid solution for injection in cartridges 150 IU/ 0.18 ml, 300 IU/ 0.36 ml, 600 IU/ 0.72 ml, 900 IU/ 1.08 ml:
Fertavid soluzzjoni għall- injezzjoni fi stoċċijiet ta ’ 150 IU/ 0. 18 ml, 300 IU/ 0. 36 ml, 600 IU/ 0. 72 ml, 900 IU/ 1. 08 ml:
Organon Kloosterstraat 6 Postbus 20 5340 BH Oss The Netherlands
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, L- Olanda
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
66 • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product Characteristics, section 4.2.)
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni 4. 2).
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 1. 3, ippreżentata f’ Moduli 1. 8. 1 ta ’ l- Applikazzjoni dwar l- Awtorizzazjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed tiffunzjona qabel u waqt li l - prodott ikun fis- suq.
PSURs The PSUR cycle of Fertavid will correspond to the one attributed to the cross-referred product, Puregon, until otherwise specified.
PSURs Iċ- ċiklu tal- PSUR ta ’ Fertavid għandu jikkorispondi ma ’ dak attribwit għal prodott inkroċjat ta ’ riferiment, Puregon, sakemm jiġi speċifikat mod ieħor.
62 ANNEX III
67 ANNESS III
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
69 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 50 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 50 IU/ 0. 5 ml kunjett 1
Fertavid 50 IU/ 0.5 ml solution for injection follitropin beta
Fertavid 50 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
50 IU (100 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 50 IU (100 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH).
Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall- injezzjonijiet; sodium hydroxide u/ jew hydrochloric acid għall- aġġustament tal- pH.
Solution for injection 1 vial containing 0.5 ml
Soluzzjoni għall- injezzjoni Kunjett wieħed fih 0. 5 ml
Intramuscular and subcutaneous use The contents of the vial should be used immediately after piercing of the rubber stopper.
Użu għal ġol- muskoli u għal taħt il- ġilda Il- kontenut tal- kunjett għandu jintuża eżatt wara li jittaqqab il- lastku.
Read the package leaflet before use.
Biex jintuża darba biss Aqra l- fuljett ta ’ tagħrif qabel l- użu.
65 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
70 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
Keep the vial in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra.
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Il- Belġju
BN:
Lott
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 50 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 50 IU/ 0. 5 ml 5 kunjetti
Solution for injection 5 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 5 kunjetti li fihom 0. 5 ml kull wieħed
67 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
72 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
Keep the vials in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra.
MARKETING AUTHORISATION NUMBER
NUMRU TAL - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 50 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 50 IU/ 0. 5 ml 10 kunjetti
Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate, L- methionine u polysorbate 20 fl- ilma għall- injezzjonijiet; sodium hydroxide u/ jew hydrochloric acid għall- aġġustament tal- pH.
Solution for injection 10 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 10 kunjetti li fihom 0. 5 ml
69 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
74 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
Keep the vials in the outer carton.
Żomm il- kunjetti fil- kartuna ta ’ barra.
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Fertavid 50 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Fertavid 50 IU/ 0. 5 ml
Intramuscular and subcutaneous use
Użu għal ġol- muskoli u għal taħt il- ġilda
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKONT IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI.
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 75 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 75 IU/ 0. 5 ml kunjett 1
Fertavid 75 IU/ 0.5 ml solution for injection follitropin beta
Fertavid 75 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
75 IU (150 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 75 IU (150 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH).
Solution for injection 1 vial containing 0.5 ml
Soluzzjoni għall- injezzjoni Kunjett fih 0. 5 ml
72 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
77 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
OUTER CARTON TEXT Fertavid 75 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 75 IU/ 0. 5 ml 5 kunjetti
75 IU (150 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 75 IU (150 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH)
Solution for injection 5 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 5 kunjett ta’ 0. 5 ml kull wieħed
74 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
79 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 75 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 75 IU/ 0. 5 ml 10 kunjetti
Solution for injection 10 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 10 kunjetti ta ’ 0. 5 ml kull wieħed
76 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
81 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
77 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Fertavid 75 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Fertavid 75 IU/ 0. 5 ml
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 100 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 100 IU/ 0. 5 ml kunjett 1
Fertavid 100 IU/ 0.5 ml solution for injection follitropin beta
Fertavid 100 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
100 IU (200 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta’ 100 IU (200 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH).
79 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
84 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Il_ Belġju
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
85 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 100 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 100 IU/ 0. 5 ml 5 kunjetti
100 IU (200 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 100 IU (200 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH).
Solution for injection 5 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 5 kunjetti ta’ 0. 5 ml kull wieħed
81 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
86 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
SP Europe, Rue de Stalle 73 B- 1180 Bruxelles, Il- Belġju
OUTER CARTON TEXT Fertavid 100 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 100 IU/ 0. 5 ml 10 kunjetti
83 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
88 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
84 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Fertavid 100 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Fertavid 100 IU/ 0. 5 ml
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
90 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 150 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 150 IU/ 0. 5 ml kunjett 1
Fertavid 150 IU/ 0.5 ml solution for injection follitropin beta
Fertavid 150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
150 IU (300 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 150 IU (300 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH)
86 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
91 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 150 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 150 IU/ 0. 5 ml 5 kunjetti
150 IU (300 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 150 IU (300 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH).
88 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
93 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
89 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
94 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 150 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 150 IU/ 0. 5 ml 10 kunjetti
90 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
95 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
91 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
96 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Fertavid 150 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Fertavid 150 IU/ 0. 5 ml
92 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
97 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 200 IU/ 0.5 ml 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 200 IU/ 0. 5 ml kunjett 1
Fertavid 200 IU/ 0.5 ml solution for injection follitropin beta
Fertavid 200 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
200 IU (400 IU/ ml) recombinant follicle-stimulating hormone (FSH) activity.
Kunjett fih 0. 5 ml follitropin beta li jikkorispondi għal: attività ta ’ 200 IU (400 IU/ ml) tal- ormon rikombinanti li jistimula l- follikulu (FSH).
93 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
98 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
99 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 200 IU/ 0.5 ml 5 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 200 IU/ 0. 5 ml 5 kunjetti
95 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
100 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
96 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
101 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 200 IU/ 0.5 ml 10 vials
KITBA FUQ IL- KARTUNA TA 'BARRA Fertavid 200 IU/ 0. 5 ml 10 kunjetti
Solution for injection 10 vials each containing 0.5 ml
Soluzzjoni għall- injezzjoni 10 kunjetti li fihom 0. 5 ml kull wieħed
97 Store in a refrigerator.
Aħżen fi friġġ.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
102 Il- pazjent jista ’ jaħżen Fertavid f’ temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
98 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
103 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT Fertavid 200 IU/ 0.5 ml
KITBA FUQ IL- KUNJETT Fertavid 200 IU/ 0. 5 ml
99 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 150 IU/ 0.18 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Fertavid 150 IU/ 0. 18 ml stoċċ 1
Fertavid 150 IU/ 0.18 ml solution for injection follitropin beta
Fertavid 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni follitropin beta
225 IU recombinant FSH activity/ 0.270 ml Net content 150 IU
Attività ta ’ 225 IU ta 'FSH rikombinanti / 0. 270 ml Kontenut nett 150 IU
Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate, L- methionine u polysorbate 20 u benzyl alcohol fl- ilma għall - injezzjonijiet; sodium hydroxide u/ hydrochloric acid għall- aġġustament tal- pH.
Solution for injection 1 cartridge 1 pack with 3 needles
Soluzzjoni għall- injezzjoni Stoċċ 1 Pakkett 1 ta ’ 3 labar
Subcutaneous use For use only with a pen injector called Puregon Pen.
Użu għal taħt il- ġilda Sabiex jintużaw biss ma ’ pinna li tinjetta msejħa Puregon Pen.
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
JIS La darba l- lastku tal- inforra tal- istoċċ ġiet mtaqqba b 'labra, il- prodott jista' jinħażen sa massimu ta '28 jum.
The patient may store Fertavid at or below 25 °C for a single period of not more than 3 months.
Il- pazjent jista ’ jaħżen Fertavid fit- temperatura ta ’ 25 °C jew inqas għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
101 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Fertavid 150 IU/ 0.18 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Fertavid 150 IU/ 0. 18 ml
Fertavid 150 IU/ 0.18 ml solution for injection follitropin beta
Fertavid 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni Follitropin beta
Subcutaneous use
Użu għal taħt il- ġilda
0.270 ml
0. 270 ml
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 300 IU/ 0.36 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Fertavid 300 IU/ 0. 36 ml stoċċ 1
Fertavid 300 IU/ 0.36 ml solution for injection follitropin beta
Fertavid 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni follitropin beta
400 IU recombinant FSH activity/ 0.480 ml Net content 300 IU
Attività ta ’ 400 IU ta 'FSH rikombinanti / 0. 480 ml Kontenut nett 300 IU
Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate, L- methionine u polysorbate 20 u benzyl alcohol fl- ilma għall- injezzjonijiet; sodium hydroxide u/ hydrochloric acid għall- aġġustament tal- pH.
Solution for injection 1 cartridge 2 packs with 3 needles
Soluzzjoni għall- injezzjoni Stoċċ 1 2 pakketti bi 3 labar
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
SP Europe Rue de Stalle 73 B- 1180 Bruxelles, il- Belġju
104 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Fertavid 300 IU/ 0.36 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Fertavid 300 IU/ 0. 36 ml
0.480 ml
0. 480 ml
105 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 600 IU/ 0.72 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Fertavid 600 IU/ 0. 72 ml stoċċ 1
Fertavid 600 IU/ 0.72 ml solution for injection follitropin beta
Fertavid 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni follitropin beta
700 IU recombinant FSH activity/ 0.840 ml Net content 600 IU
Attività ta ’ 700 IU ta 'FSH rikombinanti / 0. 840 ml Kontenut nett 600 IU
Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol fl- ilma għall- injezzjonijiet; sodium hydroxide u/ jew hydrochloric acid għall- aġġustament tal- pH.
107 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
112 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Fertavid 600 IU/ 0.72 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Fertavid 600 IU/ 0. 72 ml
0.840 ml
0. 840 ml
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT Fertavid 900 IU/ 1.08 ml 1 cartridge
KITBA LI TIDHER FUQ IL- KARTUNA TA 'BARRA Fertavid 900 IU/ 1. 08 ml stoċċ 1
Fertavid 900 IU/ 1.08 ml solution for injection follitropin beta
Fertavid 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni follitropin beta
1025 IU recombinant FSH activity/ 1.230 ml Net content 900 IU
Attività ta ’ 1025 IU attività ta 'FSH rikombinanti/ 1. 230 ml Kontenut nett 900 IU
Solution for injection 1 cartridge 3 packs with 3 needles
Soluzzjoni għall- injezzjoni Stoċċ 1 3 pakketti bi 3 labar
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
JIS La darba l- lastku tal- inforra ta 'ġewwa l- istoċċ ġiet mtaqqba b' labra, il- prodott jista 'jinħażen sa massimu ta' 28 jum.
110 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
115 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARTRIDGE TEXT Fertavid 900 IU/ 1.08 ml
KITBA LI TIDHER FUQ L- ISTOĊĊ Fertavid 900 IU/ 1. 08 ml
1.230 ml
1. 230 ml
112 PACKAGE LEAFLET:
117 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Aqra sew dan- il fuljett kollu qabel tibda tuża din il- mediċina − Żomm dan il- fuljett.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa taqrah. − Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. − Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Fertavid is and what it is used for 2.
X’ inhu Fertavid u għal xiex jintuża 2.
Before you use Fertavid 3.
Qabel ma tuża Fertavid 3.
How to use Fertavid 4.
Kif għandek tuża Fertavid 4.
How to store Fertavid 6.
Kif taħżen Fertavid 6.
WHAT FERTAVID IS AND WHAT IT IS USED FOR
X’ INHU FERTAVID U GĦAL XIEX JINTUŻA
Fertavid solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Fertavid, soluzzjoni għall- injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula l - follikulu (FSH).
FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
FSH jappartjeni fil- kategoija ta ’ gonadotrofini, li għadhom rwol importanti fil- fertilità u fir - riproduzzjoni tal- bniedem.
FSH is needed in women for the growth and development of follicles in the ovaries.
FSH huwa meħtieġ fin- nisa għat- tkabbir u l- iżvilupp ta ’ follikuli fl- ovarji.