qanastek/EMEA-V3 huggingface dataset:
Ask your doctor which
Għid lit- tabib tiegħek liema metodu huwa
Phone No: _______________________________
Telefown: _______________________________
method is best for you.
l- aħjar għalik.
If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Jekk tinqabad tqila meta qed tieħu Ferriprox, waqqaf din il- mediċna minnufih u għid lit- tabib tiegħek.
Do not use Ferriprox if you are a nursing mother.
M’ għandekx tuża Ferriprox jekk int omm li qed tredda ’.
Make sure you do the following:
((Fuq ġewwa 1)) MONITORAĠĠ TA ’ L- GĦADD TA ’ ĊELLOLI BOJOD TAD- DEMM B’ FERRIPROX
Have your blood monitored on a weekly basis.
((Fuq ġewwa 2)) Kun żgur li tagħmel dan li ġej 1.
Even though agranulocytosis is an uncommon side effect of the drug, it is important to monitor your blood on a regular basis.
Ikollok id- demm tiegħek monitorat fuq bażi ta ’ kull ġimgħa.
2.
Hemm ċans żgħir li inti tista ’ tiżviluppa agranuloċitosi (għadd baxx ħafna ta ’ ċelloli 2.
Contact your doctor immediately if you develop a fever, sore throat or flu-like symptoms
Tikkuntattja lit- tabib tiegħek minnufih jekk bojod tad- demm) waqt li qed tieħu Ferriprox, li tiżviluppa deni, griżmejn juġawk jew sintomi jista ’ jwassal għal infezzjoni serja.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TA ’ PUBBLIKU EWROPEW VALUTAZZJONI (EPAR)
What is Fertavid?
X’ inhu Fertavid?
Fertavid is a solution for injection that contains the active substance follitropin beta.
Fertavid hu soluzzjoni għall- injezzjoni li fiha s- sustanza attiva follitropina beta..
This medicine is the same as Puregon, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Puregon, li hija diġà awtorizzata fl- Unjoni Europea (UE).
The company that makes Puregon has agreed that its scientific data can be used for Fertavid.
Il - kumpanija li tagħmel Puregon qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Fertavid.
What is Fertavid used for?
Għal xiex jintuża Fertavid?
Fertavid is used to treat infertility in women in the following situations: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation); • women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
Fertavid huwa użat għat- trattament ta ’ nisa li mhumiex fertili fis- sitwazzjonijiet li ġejjin: • nisa li huma anovulatorji (ma jipproduċux ovuli) u ma jirrispondux għat- trattament ta ’ klomifen ċitrat (mediċina oħra li tistimula l- ovulazzjoni); • nisa li għaddejjin minn trattament ta ’ fertilità (tekniki ta ’ riproduzzjoni assistita, bħall - fertilizzazzjoni in vitro).
Fertavid is administered to stimulate the ovaries to produce more than one egg at a time.
Fertavid huwa amministrat sabiex jistimula l- ovarji sabiex jiġu prodotti aktar minn bajda waħda f’ ħin wieħed.
Fertavid can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Fertavid jista ’ jintuża wkoll sabiex jistimula l- produzzjoni tal- isperma fl- irġiel li għandhom l - ipogonadotrofija ipogonadiżmu (marda rari ta ’ defiċjenza ormonali).
Fertavid can only be obtained with a prescription.
Fertavid tista ’ tinkiseb biss b’ riċetta tat- tabib.
How is Fertavid used?
Kif jintuża Fertavid?
Treatment with Fertavid should be carried out by a doctor who has experience in the treatment of fertility problems.
It- trattament b’ Fertavid għandu jsir minn tabib li għandu esperjenza fit- trattament ta ’ problemi ta ’ fertilità.
Fertavid is given as a ‘ subcutaneous’ injection (under the skin) or into a muscle.
Fertavid jingħata permezz ta ’ injezzjoni ‘ subkutanja (taħt il- ġilda) jew f’ muskolu.
The patient or their partner may carry out the injections.
Il- pazjenti jew ir- raġel/ mara j/ tista ’ tagħti l- injezzjonijiet.
Fertavid should only be administered by people who have been trained by the doctor and have access to expert advice.
Fertavid għandu jiġi amministrat biss minn persuni li ġew imħarrġa mit- tabib u li għandhom aċċess għal pariri esperti.
The dose and frequency of administration of Fertavid depend on its use (see above) and the patient ’ s response to treatment.
Id- doża u l- frekwenza ta ’ amministrazzjoni ta ’ Fertavid tiddependi fuq l- użu tiegħu (ara hawn fuq) u r- rispons tal- pazjent għat - trattament.
For a full description of the doses, see the Package Leaflet.
Għal deskrizzjoni sħiħa tad- dożi, ara l- Fuljett ta ’ Tagħrif.
How does Fertavid work?
Kif jaħdem Fertavid?
The active substance in Fertavid, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Is- sustanza attiva f’ Fertavid, follitropina beta, hija kopja tal- ormon naturali li jistimula l- follikola li tistimula l- ormoni (FSH).
In the body, FSH regulates reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
L- FSH jirregola l- funzjoni riproduttiva fil- ġisem: fin- nisa, tistimula l - produzzjoni tal- ovuli u fl- irġiel tistimula l- produzzjoni tal- isperma mit- testikoli.
Previously, the FSH used as a medicine was extracted from urine.
Preċedentement, l - FSH użat bħala mediċina kien estratt mill- urina.
The follitropin beta in Fertavid is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Il- follitropina beta f’ Fertavid huwa magħmul permezz ta ’ metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: hija magħmula minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- FSH uman.
How has Fertavid been studied?
Kif ġie studjat Fertavid?
Fertavid’ s use in women undergoing fertility treatment has been studied in 981 patients.
L- użu ta ’ Fertavid fin- nisa li jgħaddu minn trattament ta ’ fertilità ġie studjat f’ 981 pazjent.
The number of eggs recovered and the ongoing pregnancy rate were the main measures of effectiveness.
In- numru ta ’ bajd miġbur u r- rata ta ’ tqala attwali kienu l- kejl prinċpali tal- effikaċja.
Fertavid was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Fertavid ġie studjat f’ 172 mara anavolutorja, bil- kejl ta ’ kemm ċikli ta ’ trattament kien meħtieġa għal dawn in- nisa sabiex jovulaw.
In men, Fertavid was studied to see its effect on sperm production in 49 patients.
Fl- irġiel, Fertavid ġie studjat sabiex jiġi ċċekkjat l- effett fuq il- produzzjoni tal- isperma f’ 49 pazjent.
In all of the studies, Fertavid was compared with the natural FSH hormone that was extracted from urine.
Fl- istudji kollha, Fertavid ġie mqabbel mal- ormon natural FSH li kien estratt mill- urina.
What benefit has Fertavid shown during the studies?
X’ benefiċċji wera Fertavid matul l- istudji mwettqa?
Fertavid was as effective as the comparator in all of the studies.
Fertavid kien effettiv daqs il- mediċini ta ’ tqabbil fit- tliet studji kollha.
Fertavid was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Fertavid kien effettiv bħala FSH urinarja bħal trattament ta ’ fertilità fil- produzzjoni ta ’ ovoluzzjoni u fil- produzzjoni tal- isperma.
What is the risk associated with Fertavid?
X’ inhu r- riskju assoċjat ma ’ Fertavid?
The most common side effects with Fertavid are a reaction and pain at the injection site.
L- effetti sekondarji l- aktar komuni b’ Fertavid huma reazzjoni u uġiegħ fil- post tal- injezzjoni.
In 4% of the women treated with Fertavid in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e. g. feeling sick, weight gain and diarrhoea) have been reported.
F’ 4% tan- nisa trattati b’ Fertavid fi studji kliniċi, ġew rappurtati sinjali u sintomi relatati mas- sindromu ta ’ iperstimulazzjoni tal- ovarji (eż. tħossok ma tiflaħx, żjieda fil- piż u dijarrea).
Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Is- sindromu ta ’ iperstimulazzjoni tal- ovarji jiġri meta l- ovarji jirrispondu aktar milli suppost għat- trattament.
Doctors and patients must be aware of this possibility.
Tobba u pazjenti għandhom ikunu konxji ta ’ din il- possibilità.
For a full list of all side effects reported with Fertavid, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati bi Fertavid, ara l- Fuljett ta ’ Tagħrif.
Fertavid should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Fertavid ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- follitropina beta jew għal xi ingredjenti oħra.
Fertavid must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Fertavid ma għandux jintuża f’ pazjenti b’ tumuri fl- ovarji, fis- sider, fil - ġuf, fit- testikoli, fil- glandola pitwitarja jew fl- ipotalama.
It must not be used in men with testicular failure.
Ma għandux jintuża f’ irġiel b’ testikoli li ma jiffunzjonawx tajjeb.
In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding.
F’ nisa ma għandhux jintuża meta l- ovarji ma jiffunzjonawx tajjeb, f’ ovarji kbar jew minfuħa jew fil- preżenza ta ’ ċesti li ma humiex ikkawżati minn marda tal- ovarji jew tnixxija ta ’ demm mill- vaġina.
Why has Fertavid been approved?
Għaliex ġie approvat Fertavid?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fertavid’ s benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Fertavid huma akbar mir- riskji tiegħu f’ nisa għat- trattament tal- infertilità, u li fl- irġiel għal defiċjenza ta ’ spermatoġenesi minħabba ipogonadotrofija ipogonadiżmu.
The Committee recommended that Fertavid be given marketing authorisation.
Il- Kumitat irrakkomanda li Fertavid jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Fertavid:
Tagħrif ieħor dwar Fertavid:
The European Commission granted a marketing authorisation valid throughout the EU for Fertavid to SP Europe on xx March/ April 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Fertavid lil SP Europe fil - 19 ta ’ Marzu 2009.
The full EPAR for Fertavid can be found here.
L- EPAR sħiħ għal Fertavid jista ’ jinstab hawnhekk.
50 IU/ 0.5 ml
50 IU/ 0. 5 ml
Solution for injection
Soluzzjoni għall- injezzjoni
Subcutaneous and intramuscular use
Użu taħt il- ġilda u ġol- muskoli
0.5 ml (100 IU/ ml)
0. 5 ml (100 IU/ ml)
5 vials
5 kunjetti
75 IU/ 0.5 ml
75 IU/ 0. 5 ml
0.5 ml (150 IU/ ml)
0. 5 ml (150 IU/ ml)
100 IU/ 0.5 ml
100 IU/ 0. 5 ml
0.5 ml (200 IU/ ml)
0. 5 ml (200 IU/ ml)
150 IU/ 0.5 ml
150 IU/ 0. 5 ml
0.5 ml (300 IU/ ml)
0. 5 ml (300 IU/ ml)
200 IU/ 0.5 ml
200 IU/ 0. 5 ml
0.5 ml (400 IU/ ml)
0. 5 ml (400 IU/ ml)
150 IU/ 0.18 ml
150 IU/ 0. 18 ml
Subcutaneous use
Użu taħt il- ġilda
cartridge (glass)
skartoċċ (ħġieġ)
0.270 ml (833 IU/ ml)
0. 270 ml (833 IU/ ml)
1 cartridge + 1 pack with 3 needles
Skartoċċ + pakkett bi 3 labar
300 IU/ 0.36 ml
300 IU/ 0. 36 ml
0.480 ml (833 IU/ ml)
0. 480 ml (833 IU/ ml)
1 cartridge + 2 packs with 3 needles
Skartoċċ + 2 pakketti bi 3 labar
600 IU/ 0.72 ml
600 IU/ 0. 72 ml
0.840 ml (833 IU/ ml)
0. 840 ml (833 IU/ ml)
EU/ 1/ 09/ 506/ 019
1/ 2 EU/ 1/ 09/ 506/ 019
900 IU/ 1.08 ml
900 IU/ 1. 08 ml
1.230 ml (833 IU/ ml)
1. 230 ml (833 IU/ ml)
1 cartridge + 3 packs with 3 needles
Skartoċċ + 3 pakketti bi 3 labar
Fertavid 50 IU/ 0.5 ml solution for injection
Fertavid 50 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kunjett wieħed fih 50 IU ormon rikombinanti li jistimula l- follikoli, (FSH), f’ 0. 5 ml ta ’ soluzzjoni.
This corresponds to a strength of 100 IU/ ml.
Din tikkorrispondi ma ’ 100 IU/ ml.
One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 5 mikrogrammi ta ’ proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Is- soluzzjoni għall- injezzjoni fiha s - sustanza attiva follitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal - ħemster Ċiniż (CHO).
Clear and colourless solution.
Soluzzjoni ċara u mingħajr kulur.
In the female:
Fil- mara:
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 (ICSI).
In the male: • Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Fir- raġel: • Nuqqas ta ’ spermatoġenesi minħabba ipogonadiżmu ipogonadotrofiku.
Treatment with Fertavid should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Il- kura b’ Fertavid għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ problemi tal- fertilità.
Dosage in the female There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins.
Dożaġġ fil- mara Ir- rispons tal- ovarji għall- gonadotrofini eżoġeniċi ivarja ħafna kemm fl- istess individwu, kif ukoll bejn individwi differenti.
This makes it impossible to set a uniform dosage scheme.
Dan jagħmilha impossibli sabiex ikun hemm skema ta ’ dożaġġ uniformi.
The dosage should, therefore, be adjusted individually depending on the ovarian response.
Id - dożaġġ għalhekk għandu jiġi aġġustat individwalment skont ir- rispons tal- ovarji.
This requires ultrasonography and monitoring of oestradiol levels.
Dan jeħtieġ ultrasonografija u monitoraġġ tal- livelli tal- estradjol.
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.
Skond ir- riżultati ta ’ studji kliniċi komparattivi huwa kkonsidrat xieraq li Fertavid jingħata f’ dożaġġ aktar baxx minn dak li ġeneralment jintuża għal FSH urinarju, mhux biss biex jinkisbu l- aħjar kondizzjonijiet għall- iżvilupp follikulari imma wkoll biex jitnaqqas ir- riskju ta ’ stimulazzjoni eċċessiva tal- ovarji mhux mixtieq.
Clinical experience with Fertavid is based on up to three treatment cycles in both indications.
Esperjenza klinika b’ Fertavid hi msejsa fuq tliet ċikli ta ’ kura fiż- żewġ indikazzjonijiet.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
L- esperjenza
2 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
2 globali bl- IVF tagħti indikazzjoni li b’ mod ġenerali r- rata ta ’ suċċess għall- kura tibqa ’ stabbli fl - ewwel erba ’ darbiet u tibda tonqos bil- mod wara dan. • Meta ma jkunx hemm ovulazzjoni Skema ta ’ kura sekwenzjali hija rakkomandata li tibda b’ doża ta ’ 50 IU Fertavid kuljum.
The starting dose is maintained for at least seven days.
Id - doża tal- bidu tinżamm għal ta ’ lanqas sebat ijiem.
If there is no ovarian response, the daily dose is then gradually increased until follicle growth and/ or plasma oestradiol levels indicate an adequate pharmacodynamic response.
Jekk ma jkunx hemm rispons tal- ovarji, id - doża ta ’ kuljum għandha tiżdid b’ mod gradwali sakemm it- tkabbir tal - follikulu u/ jew il- livell tal- estradjol fil- plażma jindikaw rispons farmakodinamiku xieraq.
A daily increase of oestradiol levels of 40- 100% is considered to be optimal.
Żieda ta ’ kuljum fil- livelli tal- estradjol b’ 40– 100% hija kkonsidrata li hi l- aħjar.
The daily dose is then maintained until pre-ovulatory conditions are reached.
Din id- doża ta ’ kuljum mbagħad tinżamm sakemm jintlaħqu l- kondizzjonijiet xierqa ta ’ qabel l- ovulazzjoni.
Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/ or when plasma oestradiol levels of 300-900 picograms/ ml (1000-3000 pmol/ l) are attained.
Il- kondizzjonijiet ta ’ qabel l - ovulazzjoni jintlaħqu meta jkun hemm prova ultrasonografika ta ’ follikulu dominanti b’ dijametru ta ’ 18- il millimetru u/ jew meta l- livelli tal- estradjol fil- plażma jilħqu 300- 900 picogrammi/ ml (1000– 3000 pmol/ l).
Usually, 7 to 14 days of treatment is sufficient to reach this state.
Ġeneralment, ikun hemm bżonn minn 7 sa 14- il jum ta ’ kura sabiex jintlaħaq dan l- istat.
The administration of Fertavid is then discontinued and ovulation can be induced by administering human chorionic gonadotrophin (hCG).
Imbagħad Fertavid jitwaqqaf u l- ovulazzjoni tkun tista ’ tiġi stimulata bl- għoti ta ’ gonadotrofina korjonika umana (hCG).
If the number of responding follicles is too high or oestradiol levels increase too rapidly, i. e. more than a daily doubling for oestradiol for two or three consecutive days, the daily dose should be decreased.
Jekk in- numru ta ’ follikuli li jirrispondu jkun kbir wisq jew il- livelli tal- estradjol jiżdied b’ rata mgħaġġla ħafna i. e. b’ aktar mid- doppju f’ jum, għal jumejn jew tliet ijiem konsekuttivi, id- doża ta ’ kuljum għandha titnaqqas.
Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations.
Peress li follikuli ta ’ aktar minn 14- il millimetru jistgħu jwasslu għal tqala, follikuli multipli ta ’ qabel l- ovulazzjoni li jkunu akbar minn 14- il millimetru jikkawżaw riskju ta ’ ġestazzjonijiet multipli.
In that case hCG should be withheld and pregnancy should be avoided in order to prevent multiple gestations. • Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied.
F’ dak il- każ l- ormon hCG għandu jiġi miżmum u t- tqala għandha tiġi evitata sabiex jiġi evitat li jkun hemm ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva tal- ovarju kkontrollata fi programmi mediċi ta ’ riproduzzjoni assista Diversi protokolli ta ’ stimulazzjoni huma applikati.
A starting dose of 100-225 IU is recommended for at least the first four days.
Doża tal- bidu ta ’ 100- 225 IU hija rrakkomandata għal tal- anqas l- ewwel erbat ijiem.
Thereafter, the dose may be adjusted individually, based upon ovarian response.
Minn hemm ’ il quddiem, id- doża tista ’ tiġi aġġustata individwalment, skont ir- rispons tal- ovarji.
In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for six to twelve days are sufficient, although longer treatment may be necessary.
Fi studji kliniċi ntwera li dożaġġi ta ’ bejn 75- 375 IU għal bejn sitta sa tnax- il jum huma biżżejjed, għalkemm jista ’ jkun hemm bżonn kura aktar fit- tul.
Fertavid can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Fertavid jista ’ jingħata waħdu, jew sabiex tiġi evitata sitwazzjoni ta ’ lutejnizzazzjoni prematura, flimkien ma ’ antagonista jew agonista tal- GnRH.
When using a GnRH agonist, a higher total treatment dose of Fertavid may be required to achieve an adequate follicular response.
Meta jintuża agonista tal- GnRH, jista ’ jkun hemm bżonn doża totali ta ’ Fertavid aktar għolja għall- kura, sabiex jintlaħaq ir- rispons follikulari xieraq.
Ovarian response is monitored by ultrasonography and measurement of plasma oestradiol levels.
Ir- rispons tal- ovarji huwa sorveljat bl- ultrasonografija u bil- kejl tal- livelli tal- estradjol fil - plażma.
When ultrasonographic evaluation indicates the presence of at least three follicles of 16- 20 mm, and there is evidence of a good oestradiol response (plasma levels of about 300-400 picograms/ ml (1000-1300 pmol/ l) for each follicle with a diameter greater than 18 mm), the final phase of maturation of the follicles is induced by administration of hCG.
Meta l- evalwazzjoni ultrasonografika tindika l- preżenza ta ’ mill- anqas tliet follikuli ta ’ 16- 20 mm, u jkun hemm evidenza ta ’ rispons tajjeb tal- estradjol (livelli fil- plażma ta ’ madwar 300- 400 pikogramm/ ml (1000- 1300 pmol/ l) għal kull follikulu ta ’ dijametru akbar minn 18 mm), il- fażi finali ta ’ tkabbir tal- follikuli tiġi stimulata bit- teħid tal- hCG.
Oocyte retrieval is performed 34-35 hours later.
L- irkupru ta ’ ooċit isir 34- 35 siegħa wara.
Dosage in the male Fertavid should be given at a dosage of 450 IU/ week, preferably divided in 3 dosages of 150 IU, concomitantly with hCG.
Dożaġġ fir- raġel Fertavid għandu jingħata f’ dożaġġ ta ’ 450 IU/ ġimgħa, preferibbilment maqsum fi tliet dożi ta ’ 150 IU, flimkien ma ’ hCG.
The treatment should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Il- kura għandha titkompla għal tal- anqas 3 sa 4 xhur qabel ma jista ’ jkun mistenni xi titjieb fl- ispermatoġenisi.
If a patient has not responded after this period, the combination therapy may be continued; current clinical experience indicates that treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.
Jekk il- pazjent ma jkollux rispons wara dan il- perijodu, it- terapija kombinata tista ’ titkompla; esperjenza klinika attwali tindika li trattament sa 18- il xahar jew aktar tista ’ tkun meħtieġa biex ikun hemm spermatoġenisi.
There is no relevant indication for use of Fertavid in children.
M’ hemmx indikazzjoni relevanti ghall- użu ta ’ Fertavid fit- tfal.
Method of administration
Kif għandu jingħata
To prevent painful injections and minimise leakage from the injection site Fertavid should be slowly administered intramuscularly or subcutaneously.
Sabiex tevita l- uġigħ tal- injezzjonijiet u sabiex tnaqqas it- tnixxija mis- sit tal- injezzjoni, Fertavid għandu jingħata bil- mod ġol- muskolu jew taħt il- ġilda.
The subcutaneous injection site should be alternated to prevent lipoatrophy.
Il- lok tat- teħid tal- injezzjoni ta ’ taħt il- ġilda għandu jinbidel sabiex tkun evitata l- lipoatrofija.
Any unused solution should be discarded.
Kull fdal tas- soluzzjoni li jibqa ’ għandu jintrema.
Subcutaneous injection of Fertavid may be carried out by patient or partner, provided that proper instructions are given by the physician.
L- injezzjoni taħt il- ġilda b’ Fertavid tista ’ ssir mill- pazjent nnifsu jew mis- sieħeb/ sieħba, kemm- il darba l- istruzzjonijiet għall- użu jkunu ngħataw mit- tabib.
Self administration of Fertavid should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
It- teħid jista ’ isir mill- persuna nnifisha biss jekk din tkun motivata sew, imrawma tajjeb u jkollha aċċess għal parir speċjalizzat.
4.3 Contraindications
3 4. 3 Kontraindikazzjonijiet
3 • 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 ma ’ tqala. • Tumuri fibrojdi tal- utru li huma inkompattibli mat- tqala. • Indeboliment primarju tat- testikoli.
• The presence of uncontrolled non-gonadal endocrinopathies (e. g. thyroid, adrenal or pituitary disorders) should be excluded. • In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiple gestations.
• Il- preżenza ta ’ endokrinopatiji mhux gonadali, li m’ humiex ikkontrollati (eż. disturbi marbuta mat- tirojde, l- adrenali jew il- pitwitarju) għandhom jiġu esklużi. • Fit- tqala, li tkun seħħet wara l- ovulazzjoni stimulata bil- preparazzjonijiet gonadotropiċi, hemm riskju ogħla ta ’ ġestazzjonijiet multipli.
Multiple gestation, especially high order, carries an increased risk of adverse maternal and perinatal outcomes.
Aġġustament xieraq tad- doża tal- FSH għandu jevita li jkun hemm żvilupp follikulari multiplu. Ġestazzjoni multipla, speċjalment b’ numru kbir, iġġib magħha riskju ogħla ta ’ kondizzjonijiet avversi waqt it- tqala u waqt it- twelid.
Early ultrasound confirmation that a pregnancy is intrauterine is therefore important. • Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population. • The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conceptions.
Il- pazjenti għandhom jiġu mgħarrfa dwar ir- riskji potenzjali ta ’ twelidijiet multipli qabel il- bidu tal- kura. • L- ewwel injezzjoni ta ’ Fertavid għandha tingħata taħt superviżjoni medika diretta. • Billi nisa infertili li jkunu qegħdin fuq programm ta ’ riproduzzjoni assistita, u partikolarment IVF, ta ’ spiss ikollhom anormalitajiet fit- tubi, l- inċidenza ta ’ tqalat ektopiċi tista ’ tiżdid 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.
This is thought to be due to differences in parental characteristics (e. g., maternal age, sperm characteristics) and multiple gestations. • Unwanted ovarian hyperstimulation: in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment.
Dan jista ’ jkun minħabba differenzi fil- karatteristiċi tal- ġenituri (eż. età tal- mara, karatteristiċi tal- isperma) u ġestazzjonijiet multipli. • Stimulazzjoni eċċessiva tal- ovarji mhux mixtieqa: fil- kura ta ’ pazjenti nisa, stima ultrasonografika tal- iżvilupp tal- follikolar, u d- determinazzjoni tal- livelli tal- estradjol għandhom jiġu stabbiliti qabel il- kura u f’ intervalli regolari waqt il- kura.
Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e. g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values.
Barra l- iżvilupp ta ’ numru kbir ta ’ follikuli, il- livelli tal- estradjol jistgħu jiżdiedu malajr, eż. aktar mid- doppju kull jum għal jumejn jew tliet ijiem konsekuttivi u b’ possibiltà li jintlaħqu livelli għoljin ħafna.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination.
Id - dijanjosi ta ’ stimulazzjoni eċċessiva tal- ovarji tista ’ tiġi kkonfermata b’ eżami tal- ultrasound.
If this unwanted ovarian hyperstimulation occurs (i. e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Fertavid should be discontinued.
Jekk iseħħ din l- istimulazzjoni eċċessiva tal- ovarji mhux mixtieqa (i. e. mhux bħala parti mill - istimulazzjoni eċċessiva kkontrollata fi programmi mediċi ta ’ riproduzzjoni assistita) it- teħid ta ’ Fertavid għandu jitwaqqaf.
In that case pregnancy should be avoided and hCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS).
F’ dak il- każ it- tqala għandha tiġi evitata u l- hCG għandu jinżamm, għaliex barra l- ovulazzjoni multipla, jista ’ jikkaġuna s- sindromu ta ’ stimulazzjoni eċċessiva tal - ovarji (OHSS).
Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.
Is- sintomi u s- sinjali kliniċi tas- sindromu ta ’ stimulazzjoni eċċessiva tal- ovarji ħafifa huma uġigħ fl- addome, dardir, dijarea u tkabbir minn żgħir sa moderat tal- ovarji u taċ - ċisti fl- ovarji.
Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome.
Testijiet dwar il- funzjoni tal- fwied jistgħu jkunu temporanjament abnormali li jindika problemi fil- fwied, li jistgħu jkunu akkumpanjati b’ bidliet morfoloġiċi fil- bijopsija tal - fwied, ġew irrapportati flimkien ma ’ sindromu ta ’ stimulazzjoni eċċessiva tal- ovarju.
In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening.
F’ każijiet rari, ikun hemm is- sindromu tal- istimulazzjoni eċċessiva serja tal- ovarji, li tista ’ tkun ta ’ periklu għall- ħajja.
This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain.
Din hi karatterizzata b’ ċisti kbar tal- ovarji (suxxetibbli li jinfaqgħu), axxite, ta ’ spiss idrotoraċi u żjieda fil- piż.
In rare instances, venous or arterial thromboembolism may occur in association with OHSS. • There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
F’ każijiet rari jistgħu jseħħu tromboemboliżmi tal- vini jew tal- arterji flimkien ma ’ OHSS. • Kien hemm rapporti ta ’ neoplażmi fl- ovarji u fis- sistema riproduttiva, kemm tat- tip beninn, kif ukoll tat- tip malinn, f’ nisa li ħadu diversi programmi ta ’ korsijiet ta ’ mediċini għall- kura tal - infertilità.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women. • Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity (Body Mass Index > 30 kg/ m2) or thrombophilia, may have an increased risk of venous or arterial thrombo-embolic events, during or following treatment with gonadotrophins.
4 passat mediku personali jew tal- familja, obesità serja, (Indiċi ta ’ Piż tal- ġisem > 30 kg/ m2) jew trombofilja, jista ’ jkollhom riskju ogħla ta ’ każijiet ta ’ tromboemboliżmu tal- vini jew tal- arterji, waqt jew wara l- kura bil- gonadotrofini.
In these women the benefits of IVF treatment need to be weighed against the risks.
F’ dawn in- nisa l- benefiċċji tal- kura bl- IVF iridu jiġu mwieżna mar- riskji.
These antibiotics may cause hypersensitivity reactions in susceptible persons.
Madanakollu, wieħed għandu jinnota li t- tqala minnha nnifisha ġġorr riskju akbar ta ’ trombożi. • Fertavid jista ’ jkollu traċċi ta ’ streptomycin u/ jew neomycin.
4 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Dawn l- antibijotiċi jistgħu jikkawżaw reazzjonijiet ta ’ sensittività eċċessiva f’ persuni suxxettibbli. • Livelli ta ’ FSH endoġeniċi għolja fl- irġiel huma sinjali ta ’ indeboliment primarju tat- testikoli.
Such patients are unresponsive to Fertavid/ hCG therapy. • In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
Dawn il- pazjenti ma jirrispondux għat- terapija ta ’ Fertavid/ hCG. • Fl- irġiel huwa rakkomandat, li ssir l- analiżi tas- semen għal 4 sa 6 xhur wara l- bidu tal- kura biex jiġi eżaminat ir- rispons.
Concomitant use of Fertavid and clomifene citrate may enhance the follicular response.
L- użu ta ’ Fertavid flimkien ma ’ clomifene citrate jista ’ jsaħħaħ ir- rispons follikulari.
After pituitary desensitisation induced by a GnRH agonist, a higher dose of Fertavid may be necessary to achieve an adequate follicular response.
Wara t- telf tas - sensittività tal- pitwitarju minħabba l- agonista GnRH, jista ’ jkun hemm bżonn ta ’ doża ogħla ta ’ Fertavid sabiex jintlaħaq r- rispons follikulari xieraq.
There is no indication for use of Fertavid during pregnancy.
M’ hemm l- ebda indikazzjoni għall- użu ta ’ Fertavid waqt it- tqala.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotropins.
L- ebda riskju teratoġeniku ma ġie rraportat, wara stimulazzjoni eċċessiva tal- ovarji kkontrollata, f’ użu kliniku tal- gonadotropini.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
Fil- każ ta ’ espożizzjoni waqt it- tqala, l- informazzjoni klinika m’ hix biżżejjed sabiex teskludi effett teratoġeniku ta ’ FSH rikombinanti.
However, to date, no particular malformative effect has been reported.
Madankollu sal- lum, ma ġie rrapportat l- ebda effett ta ’ malformazzjoni partikolari.
No teratogenic effect has been observed in animal studies.
Fil- provi fuq l- annimali, ma ġie osservat l- ebda effett teratoġeniku.
Fertavid should not be used during breast-feeding.
Mara li qed tredda ’ m’ għandhiex tieħu Fertavid.
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 tħaddem magni.
Clinical use of Fertavid by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection: bruising, pain, redness, swelling and itching are commonly reported (3% of all patients treated).
L- użu kliniku ta ’ Fertavid li jingħata ġol- muskoli jew minn taħt il- ġilda jista ’ jwassal għal reazzjonijiet fil- lok tal- injezzjoni; tbenġil, uġigħ, ħmura, nefħa u ħakk, li huma rapportati b’ mod komuni (3% tal - pazjenti kollha ttrattati).
The majority of these local reactions are mild and transient in nature.
Il- maġġoranza ta ’ dawn ir- reazzjonijiet lokali huma ħfief u jfiequ wara ftit.
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Fertavid).
Reazzjonijiet ta ’ sensittività ġenerali li jinkludu eritema, urtikarja, raxx u ħakk ġew osservati mhux komunament (madwar 0. 1% tal- pazjenti kollha trattati b’ Fertavid).
Treatment of women:
Kura fin- nisa:
In approximately 4% of the women treated with Fertavid in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).
F’ madwar 4% tan- nisa kkurati b’ Fertavid fil- provi kliniċi, ġew rapportati sinjali u sintomi relatati mas - sindromu tal- istimulazzjoni eċċessiva tal- ovarji (OHSS) (Ara sezzjoni 4. 4).
Other undesirable effects related to this syndrome were observed in clinical studies.
Effetti mhux mixtieqa oħra relatati mas- sindromu ġew osservati fl- istudji kliniċi.
These include pelvic pain and/ or congestion, abdominal pain and/ or distension, breast complaints (breast tenderness, pain and/ or engorgement), ovarian enlargement, and spontaneous abortion.
Dawn kienu jinkludu uġigħ fil- pelvis u/ jew konġestjoni, uġigħ u/ jew nefħa addominali, ilmenti dwar is- sider (l- irtubija tas- sider, uġigħ u/ jew konġestjoni), tkabbir tal- ovarji u abort spontaneju.
They were all reported at an incidence of approximately 1% (pelvic pain and abdominal distension) or less.
Dawn lkoll ġew rapportati f’ inċidenza ta ’ madwar 1% (uġigħ fil- pelvis u nefħa addominali) jew inqas.
A slightly increased risk of ectopic pregnancy and multiple gestations has been seen.
Ġie osservat riskju daqsxejn ogħla ta ’ tqala ektopika u ġestazzjonijiet multipli.
Other more general symptoms that have been reported include headache and nausea (in up to 1% of the women treated with Fertavid).
Aktar sintomi ġenerali oħra li ġew rapportati jinkludu uġigħ ta ’ ras u dardir (f’ madwar 1% tan- nisa trattati b’ Fertavid).
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 ’ gonadotrofini oħra.
Treatment of men:
Kura fl- irġiel:
Gynaecomastia and acne may occur occasionally during Fertavid/ hCG therapy.
Ginekomastija u akne jistgħu jseħħu kull tant żmien waqt il- kura b’ Fertavid/ hCG.
These are known effects of hCG treatment.
Dawn huma effetti magħrufa tal- kura ta ’ hCG.
In one subject an epididymal cyst was observed.
F’ pazjent wieħed ġiet osservata ċista epididimali.
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.
Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
Doża għolja ħafna ta ’ FSH tista ’ twassal għal stimulazzjoni eċċessiva tal- ovarji (ara sezzjoni 4. 4).
5 5 PHARMACOLOGICAL PROPERTIES
TAGĦRIF FARMAKOLOĠIKU
Pharmacotherapeutic group: gonadotrophins; ATC code:
Kategorija farmakoterapewtika: gonadotrofini; Kodiċi ATC:
Fertavid contains a recombinant FSH.
Fertavid fih FSH rikombinanti.
This is produced by recombinant DNA technology, using a Chinese hamster ovary cell line transfected with the human FSH subunit genes.
Dan hu magħmul b’ teknoloġija rikombinanti tad- DNA, permezz ta ’ razza ta ’ celloli mill- ovarji tal- ħamster Ċiniż li hi mgħobbija bil- ġeni sekondarji tal- FSH tal- bniedem.
The primary amino acid sequence is identical to that of natural human FSH.
Is- sekwenza primarja tal- aċidi aminiċi hija identika għal dik li tinstab fl- FSH naturali tal- bniedem.
Small differences in the carbohydrate chain structure are known to exist.
Hemm differenzi żgħar magħrufa li jeżistu fl- istruttura tal- katina tal- karboidrati.
FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
L- FSH huwa indispensabbli fit- tkabbir u l- maturazzjoni normali tal- follikuli u fil- produzzjoni tal - isterojde tal- gonadi.
In the female the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity.
Fil- mara l- livell tal- FSH huwa kritiku għall- bidu u għal matul l- iżvilupp tal - follikuli, u sussegwentement għan- numru ta ’ follikuli li jilħqu jimmaturaw u għat- tul ta ’ żmien li jieħdu biex jimmaturaw.
Fertavid can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Għalhekk, Fertavid jista ’ jintuża biex jistimula l- iżvilupp tal- follikuli u l - produzzjoni tal- isterojdi f’ każijiet selettivi ta ’ problemi fil- funzjoni tal- gonadi.
Furthermore Fertavid can be used to promote multiple follicular development in medically assisted reproduction programs [e. g. in vitro fertilisation/ embryo transfer (IVF/ ET), gamete intra- fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Barraminhekk, Fertavid jista ’ jintuża biex jinkoraġġixxi l- iżvilupp ta ’ follikuli multipli fi programmi mediċi ta ’ riproduzzjoni assista [eż. fertilizzazzjoni in vitro/ trasferiment tal- embriju (IVF/ ET), trasferiment ta ’ gamete fil- fallopjan (GIFT) u injezzjoni tal- isperma fiċ- ċitoplażma (ICSI)].
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.
Ġeneralment, kura b’ Fertavid tkun segwita b’ teħid tal- hCG sabiex jinduċi l- aħħar fażi tal- maturazzjoni tal- follikoli, it - tkomplija tal- mejożi u jinfaqa l- follikulu.
In men deficient in FSH, Fertavid should be used concomitantly with hCG for at least four months to promote spermatogenesis.
Fl- irġiel li għandhom nuqqas ta ’ FSH, Fertavid għandu jingħata flimkien mal- hCG għal ta ’ lanqas erba ’ xhur sabiex jinkoraġġixxi l- ispermatoġenisi.
After intramuscular or subcutaneous administration of Fertavid, maximum concentrations of FSH are reached within about 12 hours.
Wara li Fertavid jingħata ġol- muskolu jew taħt il- ġilda, il- konċentrazzjonijiet massimi tal- FSH jintlaħqu wara 12- il siegħa.
After intramuscular administration of Fertavid, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Wara li jingħata ġol- muskolu, il- konċentrazzjonijiet massimi tal- FSH ikunu ogħla u jintlaħqu qabel fl- irġiel milli fin- nisa.
Due to the sustained release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours.
Minħabba r- rilaxx sostenut mil- lok tal- injezzjoni u minħabba l- half- life tal- eliminazzjoni ta ’ madwar 40 siegħa (li tvarja minn 12 sa 70 siegħa), il- livelli tal- FSH jibqgħu għoljin għal 24- 48 siegħa.
Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Minħabba li l- half life tal- eliminazzjoni hija relattivament twila, l- għoti ripetut tal- istess doża jwassal għall- konċentrazzjonijiet tal- FSH fil- plażma ta ’ madwar 1. 5- 2. 5 drabi ogħla minn meta tittieħed doża waħda.
This increase enables therapeutic FSH concentrations to be reached.
Iż- żjieda tippermetti li l- konċentrazzjonijiet tal - FSH terapewtiku jiġu milħuqa.
There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Fertavid.
M’ hemm l- ebda differenzi farmakokinetiċi sinifikanti bejn it- teħid ta ’ Fertavid ġol- muskolu u t- teħid minn taħt il- ġilda.
Both have an absolute bioavailability of approximately 77%.
It- tnejn għandhom bijodisponibbilità assoluta ta ’ madwar 77%.
Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.
L- FSH rikombinanti jixbaħ ħafna bijokemikalment lill- FSH urinarju tal- bniedem u jiġi mqassam, metabolizzat, u eliminat mill- ġisem bl- istess mod.
Single-dose administration of Fertavid to rats induced no toxicologically significant effects.
L- għoti ta ’ doża waħda ta ’ Fertavid lill- firien ma kkaġunax effetti tossikoloġiċi sinifikanti.
In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Fertavid induced no toxicologically significant effects.
F’ dożi ripetuti fil- firien (fuq ġimagħtejn) u fil- klieb (13- il ġimgħa) b’ doża sa 100 darba aktar minn dik li tingħata lill- bniedem, Fertavid ma kkaġunax effetti tossikoloġiċi sinifikanti.
Fertavid showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Fit- test Ames, u fit- test tal- aberrazzjoni tal- kromosome in vitro biċ- ċelluli limfoċiti umani, Fertavid ma wera l- ebda riskju fuq il- ġeni.
6.1 List of excipients
6 6. 1 Lista ta ’ sustanzi mhux attivi
Fertavid solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
Fertavid, soluzzjoni għall- injezzjoni fih sucrose, sodium citrate, L- methionine polysorbate 20 ilma għall- injezzjonijiet.
6 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat b’ sodium hydroxide u/ jew b’ hydrochloric acid.
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.
The contents of a vial should be used immediately after piercing of the rubber stopper.
Il- kontenut tal- kunjett għandu jintuża minnufih wara li jittaqqab it- tapp tal- lastku.
Store in a refrigerator (2 °C – 8 °C).
Aħżen fi friġġ (2 ºC – 8 ºC).
Keep the vial(s) in the outer carton.
Żomm il- kunjett( i) fil- kartuna ta ’ barra.
For patient convenience, Fertavid may be stored at or below 25 ºC by the patient for a single period of not more than 3 months.
Għall- konvenjenza tal- pazjent, Fertavid jista ’ jinħażen f’ temperatura ta ’, jew anqas minn 25 ºC mill - pazjent għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
0.5 ml of solution in 3 ml vial (type I glass) with stopper (chlorobutyl rubber).
Soluzzjoni ta ’ 0. 5 ml f’ kunjett ta ’ 3 ml (ħġieġ tip I) b’ tapp (lastku tal- chlorobutyl).
Pack of 1, 5 or 10.
Pakkett ta ’ 1, 5 jew 10.
6.6 Special precautions for disposal and other handling
Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u ghal immaniggar iehor 6. 6
Do not use if the solution contains particles or if the solution is not clear.
Tużax jekk is- soluzzjoni fiha xi frak jew jekk is- soluzzjoni mhix ċara.
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MARKETING AUTHORISATION NUMBERS
NUMRI TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF AUTHORISATION
DATA TAL- EWWEL AWTORIZZAZZJONI/ TIĠDID TAL- AWTORIZZAZZJONI
Date of first authorisation:
7 Data ta ’ l- ewwel awtorizzazzjoni:
Date of last renewal:
Data ta ’ l- aħħar reviżjoni:
Fertavid 75 IU/ 0.5 ml solution for injection
Fertavid 75 IU/ 0. 5 ml soluzzjoni għall- injezzjoni
One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Kunjett wieħed fih 75 IUormon rikombinanti li jistimula l- follikoli, (FSH) f’ 0. 5 ml ta ’ soluzzjoni akwea.
This corresponds to a strength of 150 IU/ ml.
Dan jikkorrispondi ma ’ qawwa ta ’ 150 IU/ ml.
One vial contains 7,5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Kunjett wieħed fih 7. 5 mikrogrammi ta ’ proteina (f’ bijoattività speċifika in vivo ta ’ madwar 10, 000 IU FSH / mg proteina).
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Is- soluzzjoni għall - injezzjoni fiha s- sustanza attiva fillitropin beta li jiġi prodott b’ inġinerija ġenetika minn razza ta ’ ċelluli mill- ovarji tal- ħemster Ċiniż (CHO).
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 (ICSI).