qanastek/EMEA-V3 huggingface dataset:
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
69 sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
64 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Puregon 250 IU/ 0.5 ml solution for injection
Puregon 250 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 250 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kunjett wieħed fih 250 IUormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 5 ml ta ’ soluzzjoni akwea.
This corresponds to a strength of 500 IU/ ml.
Dan jikkorispondi għal qawwa ta’ 500 IU/ ml.
One vial contains 25 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 25 mikrogramma ta ’ proteina (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).
66 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
72 • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Puregon kuljum.
67 • 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.
73 • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ l- ipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
This is thought to be due to differences in parental characteristics (e. g., maternal age, sperm characteristics) and multiple gestations. • Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment.
Dan jista ’ jkun minħabba differenzi fil- karatteristiċi tal- ġenituri (eż. età ta ’ l- omm, karatteristiċi ta ’ l- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva ta ’ l- ovarji mhix mixtieqa: fil- kura ta ’ pazjenti nisa, stima ultrasonografika ta ’ l- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli ta ’ l- estradjol għandhom jiġu stabbiliti qabel il- kura u f’ intervalli regolari waqt il- kura.
68 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection: bruising, pain, redness, swelling and itching are commonly reported (3% of all patients treated).
L- użu kliniku ta ’ Puregon li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok ta ’ l- injezzjoni bħalma huwa tbenġil, uġigħ, ħmura, nefħa u ħakk, li huma rapportati b’ mod komuni (3% tal- pazjenti kollha ttrattati).
No data on acute toxicity of Puregon in humans is available, but the acute toxicity of Puregon and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
75 M’ hemmx informazzjoni disponibbli dwar it- tossiċità akuta ta ’ Puregon fil- bniedem, iżda fi studji fuq l- annimali ntwera li t- tossiċità akuta ta ’ Puregon u ta ’ sustanzi gonadotrofiċi urinarji hija baxxa ħafna.
69 Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
Treatment with Puregon is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Ġeneralment, kura b’ Puregon tkun segwita b’ teħid ta ’ l- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikoli, it - tkomplija tal- mejożi u jinfaqa ’ l- follikulu.
Puregon solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
76 sucrose, sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
70 6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Puregon 150 IU/ 0.18 ml solution for injection
Puregon 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni
Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e. g. in vitro fertilisation/ embryo transfer (IVF/ ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji (POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [e. ż. fertilizzazzjoni / trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (intracytoplasmic sperm injection ICSI)].
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.
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.
72 Based on the results of comparative clinical studies, it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
79 Skont ir- riżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Puregon 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 ta ’ l- 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 Puregon.
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 Puregon kuljum.
If there is no ovarian response, the daily dose is then gradually increased until follicle growth and/ or plasma oestradiol levels indicate an adequate pharmacodynamic response.
Jekk ma jkunx hemm rispons ta ’ l- ovarji, id - doża ta ’ kuljum għandha tiżdid b’ mod gradwali sakemm it- tkabbir tal - follikulu u/ jew ta ’ l - estradjol fil- plażma jindikaw rispons farmakodinamiku xieraq.
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 ta ’ l- estradjol fil- plażma jilħqu 300- 900 picogrammi/ ml (1000– 3000 pmol/ l).
The administration of Puregon is then discontinued and ovulation can be induced by administering human chorionic gonadotrophin (hCG).
Imbagħad, Puregon jitwaqqaf u l- ovulazzjoni tkun tista ’ tiġi stimulata bl- għoti ta ’ gonadotrofina korjonika umana (hCG).
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 ta ’ l- 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 Puregon may be required to achieve an adequate follicular response.
Meta jintuża agonista tal- GnRH, jista ’ ikun hemm bżonn doża totali ta ’ Puregon 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 ta ’ l- estradjol (livelli fil- plażma ta ’ madwar 300- 400 pikogramm/ ml (1000_ 1300 pmol/ l) għal kull follikulu ta ’ dijametru akbar minn 18 mm), il- fażi finali ta ’ tkabbir tal- follikuli tiġi stimulata bit- teħid ta ’ l- hCG.
Puregon solution for injection in cartridges has been developed for use in the Puregon Pen and should be administered subcutaneously.
Puregon, soluzzjoni għall- injezzjoni, fl- istoċċijiet saret biex tintuża fil- Pinna Puregon u għandha tingħata taħt il- ġilda.
Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician.
Bl- użu tal- pinna, l- injezzjoni ta 'Puregon, tista ’ ssir mill- pazjent, imbasta jkunu ngħataw l - 80 istruzzjonijiet xierqa mit- tabib.
73 • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding. • Primary ovarian failure. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). • Malformations of the sexual organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Primary testicular failure.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi. • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ lipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
This is thought to be due to differences in parental characteristics (e. g., maternal age, sperm characteristics) and multiple gestations. • Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment.
Dan jista ’ jkun minħabba differenzi fil- karatteristiċi tal- ġenituri (eż. età ta ’ l- omm, karatteristiċi ta ’ l- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva ta ’ l- ovarji mhux mixtieqa: fit- kura ta ’ pazjenti nisa, stima ultrasonografika ta ’ l- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli ta ’ l- estradjol għandhom jiġu stabbiliti qabel il- kura u f’ intervalli regolari waqt il- kura.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination.
Id- dijanjosi ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji tista ’ tiġi kkonfermata b’ eżami ta ’ l - ultrasound.
If this unwanted ovarian hyperstimulation occurs (i. e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Puregon should be discontinued.
Jekk iseħħ din l- istimulazzjoni eċċessiva ta ’ l- ovarji mhux mixtieqa (i. e. mhux bħala parti mill- istimulazzjoni eċċessiva kkontrollata fi programmi mediċi ta ’ riproduzzjoni assistita) it- teħid ta ’ Puregon għandu jitwaqqaf.
Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.
Is- sintomi u s- sinjali kliniċi tas- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji ħafifa huma uġigħ fl- addome, dardir, dijarea u tkabbir minn żgħir sa moderat ta ’ l- ovarji u taċ- ċisti fl- ovarji.
Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome.
Testijiet dwar il- funzjoni tal- fwied jistgħu jkunu temporanjament abnormali li jindika problemi fil- fwied, li jistgħu jkunu akkumpanjati b’ bidliet morfoloġiċi fil- bijopsija tal- fwied, ġew irrapportati flimkien ma ’ sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarju.
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.
81 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 ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Puregon may contain traces of streptomycin and/ or neomycin.
Madankollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju akbar ta ’ trombożi. • Puregon jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
74 • 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 Puregon/ hCG therapy. • In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
Dawn il- pazjenti ma jirrispondux għat- terapija ta ’ Puregon/ hCG. • Fl- irġiel huwa rakkomandat, li ssir l- analiżi 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 Puregon 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 ’ Puregon sabiex jintlaħaq r- rispons follikulari xieraq.
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Puregon).
Reazzjonijiet ta ’ sensittività ġenerali li jinkludu eritema, urtikarja, raxx, u ħakk ġew osservati mhux komunament (madwar 0. 1% tal- pazjenti kollha trattati b’ Puregon).
Treatment of men:
82 Kura fl- irġiel:
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 ta ’ l - 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 ta ’ l- 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 Puregon 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’ Puregon tkun segwita b’ teħid ta ’ l- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikoli, it - tkomplija tal- mejożi u jinfaqa ’ l- follikulu.
After subcutaneous administration of Puregon, maximum concentration of FSH is reached within about 12 hours.
Wara li Puregon jingħata taħt il- ġilda, il- konċentrazzjoni massima ta ’ l- 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 ta ’ l- injezzjoni u minħabba l- half- life ta ’ l- eliminazzjoni ta ’ madwar 40 siegħa (li tvarja minn 12 sa 70 siegħa), il- livelli ta ’ FSH jibqgħu għoljin għal 24- 48 siegħa.
Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Minħabba li l- half- life ta ’ l- eliminazzjoni hija relettivament twila, l- għoti ripetut ta ’ l- istess doża jwassal għall- konċentrazzjonijiet ta ’ l- FSH fil- plażma ta ’ madwar 1. 5- 2. 5 drabi ogħla minn meta tittieħed doża waħda.
The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.
Il- bijodisponibbilità assoluta ta ’ Puregon li jingħata taħt il- ġilda hi ta ’ madwar 77%.
6.1 List of excipients
83 6. 1 Lista ta ’ sustanzi mhux attivi
Puregon 150 IU/ 0.18 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 benzyl alcohol water for injections.
Puregon 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni fiha: sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol ilma għall- injezzjonijiet.
76 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
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 ta' l- istoċċ tkun ġiet mtaqba b 'labra, il- prodott jista' jinħażen għal massimu ta '28 jum.
For patient convenience, Puregon may be stored at or below 25 ºC by the patient for a single period of not more than 3 months.
Għal konvenjenza tal- pazjent, Puregon jista ’ jinħażen f’ temperatura ta ’, jew anqas minn 25 ºC mill - pazjent għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
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 ta ’ l - 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- Pinna Puregon.
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 ta 'l- attività FSH f’ 270 ml ta' ilma, li hu biżżejjed għal doża totali netta ta '150 IU.
Puregon 150 IU/ 0.18 ml solution for injection is designed for use in conjunction with the Puregon Pen.
Puregon 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża mal- Pinna Puregon.
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 ta 'l- arja għandhom jitneħħew mill- istoċċ qabel l- injezzjoni (ara l- istruzzjonijiet ta' kif tuża l - pinna).
Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
L- istoċċijiet Puregon mhumiex magħmula sabiex jippermettu li xi mediċina oħra titħallat fl- istoċċ.
Puregon 300 IU/ 0.36 ml solution for injection
Puregon 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni
Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e. g. in vitro fertilisation/ embryo transfer (IVF/ ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji (POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni / trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (intracytoplasmic sperm injection ICSI)].
78 Based on the results of comparative clinical studies, it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
86 Skont ir- riżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Puregon 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 ta ’ l- 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 ta ’ l- 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 ta ’ l- hCG.
Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician.
Bl- użu tal- pinna, l- injezzjoni ta 'Puregon tista ’ ssir mill- pazjent stess, imbasta jkunu ngħataw l - 87 istruzzjonijiet xierqa mit- tabib.
79 • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding. • Primary ovarian failure. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). • Malformations of the sexual organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Primary testicular failure.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi. • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ lipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
This is thought to be due to differences in parental characteristics (e. g., maternal age, sperm characteristics) and multiple gestations. • Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment.
Dan jista ’ jkun minħabba differenzi fil- karatteristiċi tal- ġenituri (eż. età ta ’ l- omm, karatteristiċi ta ’ l- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva ta ’ l- ovarji mhix mixtieqa: fit- kura ta ’ pazjenti nisa, stima ultrasonografika ta ’ l- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli ta ’ l- estradjol għandhom jiġu stabbiliti qabel il- kura u f’ intervalli regolari waqt il- kura.
Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome.
Testijiet dwar il- funzjoni tal- fwied jistgħu jkunu temporanjament abnormali li jindika problemi fil- fwied, li jistgħu jkunu akkumpanjati b’ bidliet morfoloġiċi fil- bijopsija tal- fwied, ġew irrapportati flimkien ma ’ sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji.
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.
88 • 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 ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
80 • 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.
Gynaecomastia and acne may occur occasionally during Puregon/ hCG therapy.
89 Ginekomastija u akne jistgħu jseħħu kull tant żmien waqt il- kura b’ Puregon/ hCG.
Treatment with Puregon is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Generalment, kura b’ Puregon tkun segwita b’ teħid ta ’ l- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikulu, it - tkomplija tal- mejożi u jinfaqa ’ l- follikulu.
6.1 List of excipients
90 6. 1 Lista ta ’ sustanzi mhux attivi
Puregon 300 IU/ 0.36 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 benzyl alcohol water for injections.
Puregon 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni fiha: sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol ilma għall- injezzjonijiet.
82 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
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 użatiużati mal- Pinna Puregon.
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 ta 'l- attività FSH f' 0. 480 ml ta' ilma, li hu biżżejjed għal doża totali netta ta '300 IU.
Puregon 300 IU/ 0.36 ml solution for injection is designed for use in conjunction with the Puregon Pen.
Puregon 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża mal- Pinna Puregon.
Puregon 600 IU/ 0.72 ml solution for injection
Puregon 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni
Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e. g. in vitro fertilisation/ embryo transfer (IVF/ ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji, POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [eż. fertilizzazzjoni / trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (intracytoplasmic sperm injection ICSI)].
84 Based on the results of comparative clinical studies, it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
93 Skont ir- riżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Puregon 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 ta ’ l- 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 ta ’ l- 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 ta ’ l- hCG.
Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician.
Bl- użu tal- pinna, l- injezzjoni ta 'Puregon, tista' ssir mill- pazjent, imbasta jkunu ngħataw l - 94 istruzzjonijiet xierqa mit- tabib.
85 • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding. • Primary ovarian failure. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). • Malformations of the sexual organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Primary testicular failure.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi. • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ lipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
It 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.
95 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 ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
86 • 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.
Puregon has no or negligible influence on the ability to drive and use machines.
Puregon m’ għandu l- ebda effett jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddemmagni.
Treatment of men:
96 Kura fl- irġiel:
6.1 List of excipients
97 6. 1 Lista ta ’ sustanzi mhux attivi
Puregon 600 IU/ 0.72 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 benzyl alcohol water for injections.
Puregon 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni fiha sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol ilma għall- injezzjonijiet.
88 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
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 ta' l- istoċċ ikun ġie mtaqqab b 'labra, il- prodott jista' jinħażen għal massimu ta '28 jum.
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- Pinna Puregon.
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 700 IU ta 'l- attività FSH f’ 0. 840 ml ta' ilma, li hu biżżejjed għal doża totali netta ta '600 IU.
Puregon 600 IU/ 0.72 ml solution for injection is designed for use in conjunction with the Puregon Pen.
Puregon 600 IU/ 0. 72 soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża mal- Pinna Puregon.
Puregon 900 IU/ 1.08 ml solution for injection
Puregon 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni
Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e. g. in vitro fertilisation/ embryo transfer (IVF/ ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Puregon huwa intiż għall- kura ta ’ l- infertilità fin- nisa fis- sitwazzjonijiet kliniċi li ġejjin: • Meta ma jkunx hemm ovulazzjoni (inkluż fil- mard polċistiku ta ’ l- ovarji, POCD) f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • Stimulazzjoni eċċessiva kkontrollata ta ’ l- ovarji sabiex tistimula l- iżvilupp tal- follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assistita [e. ż. fertilizzazzjoni / trasferiment ta ’ l- embriju in vitro (IVF/ ET), trasferiment tal- gamete intra- fallopjan (GIFT) u injezzjoni intraċitoplażmika ta ’ l- isperma (intracytoplasmic sperm injection ICSI)].
90 Based on the results of comparative clinical studies, it is considered appropriate to give a lower dosage of Puregon than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
100 Skont ir- riżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Puregon 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 ta ’ l- 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 ta ’ l- 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 ta ’ l- anqas l- ewwel erbat ijiem.
Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician.
Bl- użu tal- pinna, l- injezzjoni ta 'Puregon tista' ssir mill- pazjent, imbasta jkunu ngħataw l - 101 istruzzjonijiet xierqa mit- tabib.
91 • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding. • Primary ovarian failure. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). • Malformations of the sexual organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Primary testicular failure.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi. • Tumuri ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- pitwitarju jew ta ’ lipotalamu. • Emorraġija vaġinali li ma nstabx x’ qed jikkawżha. • Indeboliment primarju ta ’ l- ovarji. • Ċisti fl- ovarji jew ovarji mkabbra, mhux relatati mal- mard poliċistiku ta ’ l- ovarji (PCOD). • Malformazzjonijiet ta ’ l- organi sesswali li huma inkompattibli mat- tqala. • Tumuri fibrojdi ta ’ l- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
It 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.
102 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 ta ’ l - arterji, waqt jew wara l- kura bil- gonadotrofini.
92 • 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.
Treatment of men:
103 Kura fl- irġiel:
6.1 List of excipients
104 6. 1 Lista ta ’ sustanzi mhux attivi
Puregon 900 IU/ 1.08 ml solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 benzyl alcohol water for injections.
Puregon 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni fiha: sucrose, sodium citrate, L- methionine, polysorbate 20 benzyl alcohol il- ilma għall- injezzjonijiet.
94 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.
Pakkett jikkonsisti minn stoċċ wieħed u 69labar li għandhom jiġu użati mal- Pinna Puregon.
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 1025 IU ta 'l- attività FSH f' 1. 230 ml ta' ilma, li hu biżżejjed għal doża totali netta ta '900 IU.
Puregon 900 IU/ 1.08 ml solution for injection is designed for use in conjunction with the Puregon Pen.
Puregon 900 IU/ 1. 08 soluzzjoni għall- injezzjoni hija ddisinjata biex tintuża mal- Pinna Puregon.
95 ANNEX II
106 ANNESS II
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.
Puregon powder and solvent for solution for injection 50 IU, 100 IU, 150 IU Puregon 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, 225 IU/ 0.5 ml, 250 IU/ 0.5 ml:
Puregon trab u solvent għal soluzzjoni għall- injezzjoni 50 IU, 100 IU, 150 IU Puregon 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, 225 IU/ 0. 5 ml, 250 IU/ 0. 5 ml:
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.
Puregon powder and solvent for solution for injection 75 IU:
Puregon trab u solvent għal soluzzjoni għall- injezzjoni 75 IU:
Box 20, 5340 BH Oss, The Netherlands.
Box 20, 5340 BH Oss, L- Olanda
Puregon 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:
Puregon 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:
97 Organon S. A., Usine Saint Charles, 60590 Eragny sur Epte France.
108 Organon S. A., Usine Saint Charles, 60590 Eragny sur Epte Franza
98 ANNEX III
109 ANNESS III
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU 1 ampoule
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU ampulla 1
Puregon 50 IU powder and solvent for solution for injection follitropin beta
Puregon 50 IU trab u solvent għal soluzzjoni għall- injezzjoni follitropin beta
1 ampoule of powder contains: follitropin beta corresponding to 50 IU recombinant follicle stimulating hormone (FSH) activity.
Ampulla 1 bi trab li fiha: follitropin beta li jikkorispondi għal attività ta ’ 50 IU ta 'l- ormon rikombinanti li jistimula l- follikulu (FSH)
Other ingredients: sucrose, sodium citrate and polysorbate 20; sodium hydroxide and/ or hydrochloric acid as pH adjustment.
Sustanzi oħra: sucrose, sodium citrate u polysorbate 20; sodium hydroxide u/ jew hydrochloric acid għall- aġġustament tal- pH.
1 ampoule of solvent contains:
Kull ampulla 1 ta 'solvent fiha:
1 ml sodium chloride solution (0.45%) in water for injections.
1 ml soluzzjoni ta 'sodium chloride (0. 45%) f’ ilma għal injezzjonijiet.
Powder and solvent for solution for injection 1 ampoule containing powder 1 ampoule containing 1 ml solvent
Trab u solvent għal soluzzjoni għal injezzjoni Ampulla 1 li fiha trab Ampulla 1 li fiha 1 ml ta ’ solvent
Intramuscular and subcutaneous use Reconstitute the powder with the solvent provided immediately prior to use.
Irrikostitwixxi t- trab bis- solvent provdut eżatt qabel tuża.
Keep the ampoules in the outer carton.
Żomm l- ampulla fil- kartuna ta 'barra.
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU 3 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU 3 ampulli
1 ampoule of powder contains: follitropin beta corresponding to 50 IU recombinant follicle stimulating hormone (FSH) activity.
Ampulla 1 bi trab fiha: follitropin beta li jikkorispondi għal attività ta’ 50 IU ta 'ormon rikombinanti li jistimula l- follikulu (FSH).
1 ampoule of solvent contains:
Kull ampulla ta 'solvent fiha:
1 ml sodium chloride solution (0.45%) in water for injections.
1 ml soluzzjoni ta 'sodium chloride (0. 45%) f’ ilma għall- injezzjonijiet.
Powder and solvent for solution for injection 3 ampoules each containing powder 3 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għal injezzjoni 3 ampulli kull wieħed minnhom bi trab 3 ampulli kull wieħed minnhom b’ 1ml solvent
Intramuscular and subcutaneous use Reconstitute the powder with the solvent provided immediately prior to use.
Użu għal ġol- muskoli u għal taħt il- ġilda Irrikostitwixxi t- trab bis- solvent provdut eżatt qabel tuża.
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU 5 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU 5 ampulli
1 ampoule of powder contains: follitropin beta corresponding to 50 IU recombinant follicle stimulating hormone (FSH) activity.
Ampulla 1 bi trab fiha: follitropin beta li jikkorispondi għal attività ta ’ 50 IU ta 'ormon rikombinanti li jistimula l- follikulu (FSH).
1 ml sodium chloride solution (0.45%) in water for injections.
1 ml soluzzjoni sodium chloride (0. 45%) f’ ilma għall- injezzjonijiet.
Powder and solvent for solution for injection 5 ampoules each containing powder 5 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għal injezzjoni 5 ampulli kull wieħed minnhom bi trab 5 ampulli kull wieħed minnhom b’ 1ml solvent
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 50 IU 10 ampoules
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 50 IU 10 ampulli
Powder and solvent for solution for injection 10 ampoules each containing powder 10 ampoules each containing 1 ml solvent
Trab u solvent għal soluzzjoni għal injezzjoni 10 ampulli kull wieħed minnhom bi trab 10 ampulli kull wieħed minnhom b’ 1ml solvent
AMPOULE TEXT Puregon 50 IU powder
KITBA FUQ L- AMPULLA Puregon 50 IU trab
Puregon 50 IU powder for injection follitropin beta
Puregon 50 IU trab għall- injezzjoni follitropin beta
Intramuscular and subcutaneous use
Użu għal gol- muskoli u għal taħt il- ġilda
109 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
120 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
AMPOULE TEXT Puregon 50 IU solvent
KITBA FUQ L- AMPULLA Puregon 50 IU solvent
Puregon 50 IU solvent for parenteral use
Puregon 50 IU solvent għal użu parenterali
110 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT Puregon 75 IU 1 vial
KITBA FUQ IL- KARTUNA TA 'BARRA Puregon 75 IU kunjett 1
Puregon 75 IU powder and solvent for solution for injection follitropin beta
Puregon 75 IU trab u solvent għal soluzzjoni għall- injezzjoni follitropin beta