natgillin/translations-raw huggingface dataset:
300- 400 picogram/ ml (1000 - 1300 pmol/ l) for hver follikel med en diameter større end 18 mm), induceres den sidste fase af follikelmodningen ved indgivelse af hCG.
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.
Ægudtagningen finder sted 34- 35 timer senere.
Oocyte retrieval is performed 34-35 hours later.
Dosering for mænd Fertavid bør gives i en dosis på 450 IE pr. uge, helst i 3 doser á 150 IE samtidig med hCG.
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.
Behandlingen bør vare i mindst 3 til 4 måneder, før der kan forventes nogen forbedring af spermatogenesen.
The treatment should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Der er ingen relevant indikation for brug af Fertavid hos børn.
There is no relevant indication for use of Fertavid in children.
Selvadministration af Fertavid bør kun foretages af patienter, som er velmotiverede, har fået udførlige instruktioner og oplæring, og som har adgang til ekspertbistand.
Self administration of Fertavid should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. • Tumorer i ovarierne, mammae, uterus, testis, hypofysen eller hypothalamus.
• Hypersensitivity to the active substance or to any of the excipients. • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Undiagnosed vaginal bleeding.
3 • Udiagnosticeret vaginalblødning. • Primær ovarieinsufficiens. • Ovariecyster eller forstørrede ovarier som ikke har relation til polycystisk ovariesyndrom (PCOS). • Misdannelser af genitalier som gør graviditet umulig. • Fibromer (leiomyomer) i uterus, som er uforenelige med graviditet • Primær testikellidelse.
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.
• Tilstedeværelsen af ukontrollerede non- gonadale endokrinopatier (f. eks. sygdomme i thyreoidea, binyrer eller hypofyse) bør udelukkes. • Efter ovulationsinduktion med gonadotropiner er der en øget risiko for flerfoldsgraviditeter.
• 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.
Passende FSH- dosisjustering( er) bør forebygge udvikling af multiple follikler.
Appropriate FSH dose adjustment(s) should prevent multiple follicle development.
Flerfoldsgraviditeter, specielt med mange fostre, indebærer en forøget risiko for uønskede udfald for både kvinden og fostrene.
Multiple gestation, especially high order, carries an increased risk of adverse maternal and perinatal outcomes.
Patienterne bør informeres om den mulige risiko for flerfoldsfødsler før påbegyndelse af behandlingen. • Den første Fertavid- injektion bør gives under direkte medicinsk overvågning. • Eftersom infertile kvinder, som er i assisteret reproduktionsbehandling, og især i in vitro - fertilisationsbehandling, ofte har abnormaliteter i æggelederne, er forekomsten af ektopiske graviditeter forøget.
The patients should be advised of the potential risks of multiple births before starting treatment. • The first injection of Fertavid should be performed under direct medical supervision. • Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Det er derfor vigtigt, at bestemme tidligt ved hjælp af ultralyd, om en eventuel graviditet er intrauterin. • Abortraten hos kvinder i assisteret reproduktionsbehandling er højere end i den normale population. • Forekomsten af medfødte misdannelser efter anvendelse af assisteret reproduktionsteknologi (ART) kan være en smule højere end efter spontan undfangelse.
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.
Ved behandling af kvindelige patienter bør der ved hjælp af ultrasonografi foretages målinger af follikeludviklingen og østradiol niveauerne bør måles før behandling og med regelmæssige intervaller under behandlingen.
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.
Bortset fra udviklingen af et højt antal follikler, kan østradiol niveauerne stige meget hurtigt, f. eks. mere end en daglig fordobling i 2 eller 3 på hinanden følgende dage, og muligvis nå usædvanlige høje værdier.
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.
Diagnosen på ovariehyperstimulation kan evt. bekræftes ved hjælp af ultralydsundersøgelse.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination.
Hvis en uønsket hyperstimulation indtræder (dvs. ikke som en del af kontrolleret ovariel hyperstimulation ved medicinsk assisteret reproduktion), bør administrationen af Fertavid afbrydes.
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.
I dette tilfælde skal graviditet undgås, og der må ikke indgives hCG, da administration af hCG kan inducere ovarielt hyperstimulationssyndrom (OHHS), foruden multiple ovulationer.
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).
De kliniske symptomer, som optræder ved mild ovariel hyperstimulation, er abdominale smerter, kvalme, diarré, og mild til moderat forstørrelse af ovarierne og ovariecyster.
Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts.
Der er i forbindelse med ovarielt hyperstimulationssyndrom set forbigående abnormaliteter i leverfunktionstests, som kan tyde på leverdysfunktion, eventuelt ledsaget af morfologiske ændringer af leverbiopsi.
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.
I sjældne tilfælde kan der opstå alvorligt ovarielt hyperstimulationssyndrom, som kan være livstruende.
In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening.
Dette er karakteriseret ved store ovariecyster, ascites, ofte hydrothorax og vægtøgning.
This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain.
I sjældne tilfælde kan venøs eller arteriel tromboemboli optræde i forbindelse med OHSS. • Der er rapporteret om både benigne og maligne neoplasmer i ovarier og andre forplantningsorganer hos kvinder, som har gennemgået behandlinger med adskillige lægemidler i forbindelse med fertilitetsbehandling.
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.
Det er endnu ikke fastslået, om behandling med gonadotropiner forøger risikoen (baseline) for disse tumorer hos infertile kvinder. • Kvinder med almindeligt kendte risikofaktorer for trombose i anamnesen så som personlig eller familiær disponering, alvorlig overvægt (Body Mass Index > 30 kg/ m2) eller kendt trombofili, kan have en forhøjet risiko for venøse eller arterielle tromboemboliske hændelser under eller efter behandling med gonadotropiner.
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.
Hos disse kvinder skal fordelene ved IVF- behandling opvejes mod risici.
In these women the benefits of IVF treatment need to be weighed against the risks.
Det skal dog bemærkes, at en graviditet i sig selv medfører en forhøjet risiko for trombose.
It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Fertavid may contain traces of streptomycin and/ or neomycin.
4 • Fertavid kan indeholde spor af streptomycin og/ eller neomycin.
These antibiotics may cause hypersensitivity reactions in susceptible persons.
Disse antibiotika kan forårsage overfølsomhedsreaktioner hos modtagelige personer. • Forhøjede endogene FSH- niveauer hos mænd indikerer primær testikellidelse.
4 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Sådanne patienter reagerer ikke på Fertavid/ hCG behandling. • Hos mænd anbefales sædanalyse 4- 6 måneder efter behandlingens start for at vurdere behandlingens respons.
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.
Efter desensibilisering af hypofysen ved brug af en GnRH- agonist, kan det være nødvendigt at give en højere dosis Fertavid for at fremkalde tilstrækkelig follikelrespons.
After pituitary desensitisation induced by a GnRH agonist, a higher dose of Fertavid may be necessary to achieve an adequate follicular response.
Der findes ingen indikation for anvendelse af Fertavid under graviditet.
There is no indication for use of Fertavid during pregnancy.
Der er ikke rapporteret om teratogen risiko efter kontrolleret ovariel hyperstimulation under klinisk anvendelse af gonadotropiner.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotropins.
Kliniske data er ikke tilstrækkelige til at udelukke en teratogen effekt af rekombinant FSH i tilfælde af eksponering under graviditet.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
Fertavid bør ikke anvendes i ammeperioden.
Fertavid should not be used during breast-feeding.
Fertavid påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Fertavid has no or negligible influence on the ability to drive and use machines.
Klinisk brug af Fertavid via intramuskulær eller subkutan administration kan resultere i lokale reaktioner ved injektionsstedet: blå mærker, smerte, rødme, hævelse og kløe er hyppigt rapporteret (3% af alle behandlede patienter).
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).
Generaliserede allergiske reaktioner inklusive erytem, nældefeber, udslæt og kløe er usædvanlige (0, 1% af alle patienter, der blev behandlet med Fertavid).
Generalised hypersensitivity reactions including erythema, urticaria, rash and pruritus have been observed uncommonly (approximately 0.1% of all patients treated with Fertavid).
Behandling af kvinder:
Treatment of women:
4. 4).
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).
Andre uønskede effekter med relation til dette syndrom er blevet observeret i kliniske studier.
Other undesirable effects related to this syndrome were observed in clinical studies.
Disse inkluderer bækkensmerter og/ eller forstoppelse, smerter i abdomen og/ eller distension, brystgener (brystspænding, smerte i brysterne og/ eller brystforstørrelse), forstørrelse af ovarierne og spontan abort.
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.
1% (bækkensmerter og udspilet underliv) eller mindre.
They were all reported at an incidence of approximately 1% (pelvic pain and abdominal distension) or less.
En let øget risiko for ektopisk graviditet og multiple svangerskaber er observeret.
A slightly increased risk of ectopic pregnancy and multiple gestations has been seen.
Øvrige mere generelle symptomer, der er blevet rapporteret, inkluderer hovedpine og kvalme (hos op til 1% af de kvinder, der er behandlet med Fertavid).
Other more general symptoms that have been reported include headache and nausea (in up to 1% of the women treated with Fertavid).
I sjældne tilfælde er tromboembolisme blevet forbundet med Fertavid/ hCG behandling, ligesom ved behandling med andre gonadotropiner.
In rare instances, thromboembolism has been associated with Fertavid/ hCG therapy as with other gonadotrophins.
Behandling af mænd:
Treatment of men:
Der kan lejlighedsvist forekomme gynækomasti og akne under Fertavid/ hCG- behandling.
Gynaecomastia and acne may occur occasionally during Fertavid/ hCG therapy.
Dette er kendte bivirkninger ved hCG- behandling.
These are known effects of hCG treatment.
Hos én patient er et tilfælde af en cyste i epididymis blevet observeret.
In one subject an epididymal cyst was observed.
5 Der er ingen tilgængelige data vedrørende akut toksicitet hos mennesker i behandling med Fertavid, men undersøgelser i dyreforsøg har vist en meget lav akut toksicitet for Fertavid og gonadotropinpræparaters.
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.
4. 4).
Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
FARMAKOLOGISKE EGENSKABER
5 5 PHARMACOLOGICAL PROPERTIES
Farmakoterapeutisk klassifikation: gonadotropiner; ATC - kode:
Pharmacotherapeutic group: gonadotrophins; ATC code:
Dette stof produceres ved hjælp af rekombinant DNA - teknologi, idet der anvendes ovarieceller fra kinesiske hamstere, som er tilført de humane gener for FSH- subunit.
This is produced by recombinant DNA technology, using a Chinese hamster ovary cell line transfected with the human FSH subunit genes.
Den primære aminosyre sekvens er identisk med det naturlige humane FSH.
The primary amino acid sequence is identical to that of natural human FSH.
FSH er uundværlig for den normale follikelvækst og - modning og den gonadale produktion af steroider.
FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
Endvidere kan Fertavid bruges til at fremme udviklingen af multiple follikler ved medicinsk assisteret reproduktionsbehandling [f. eks. in vitro- fertilisation/ embryo transfer (IVF/ ET), gamete intra- fallopian transfer (GIFT) og intracytoplasmisk sædcelleinjektion (ICSI)].
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)].
Hos mænd med FSH- mangel bør Fertavid anvendes samtidig med hCG i mindst fire måneder for at fremme spermatogenesen.
In men deficient in FSH, Fertavid should be used concomitantly with hCG for at least four months to promote spermatogenesis.
12 timer efter intramuskulær eller subkutan administration af Fertavid.
After intramuscular or subcutaneous administration of Fertavid, maximum concentrations of FSH are reached within about 12 hours.
Efter intramuskulær administration af Fertavid er de maksimale FSH - koncentrationer højere og opnås tidligere hos mænd end hos kvinder.
After intramuscular administration of Fertavid, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
40 timer (varierende fra 12 til 70 timer), forbliver FSH- koncentrationen forhøjet i 24- 48 timer.
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.
På grund af den relativt lange eliminationshalveringstid vil gentagen administration af den samme dosis medføre FSH - plasmakoncentrationer, som er næsten 1, 5- 2, 5 gange højere end efter administration af en enkelt dosis.
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.
Denne stigning medvirker til opnåelsen af terapeutiske FSH- koncentrationer.
This increase enables therapeutic FSH concentrations to be reached.
77%.
Both have an absolute bioavailability of approximately 77%.
Enkeltdosis- administration af Fertavid til rotter har ikke medført toksikologisk signifikante virkninger.
Single-dose administration of Fertavid to rats induced no toxicologically significant effects.
I gentagne dosisforsøg på rotter (2 uger) og hunde (13 uger), med doser op til 100 gange større end den maksimale humane dosis, har Fertavid ikke medført toksikologisk signifikante virkninger.
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.
Fertavid udviste intet mutagent potentiale i Ames ’ testen eller i in vitro- kromosom- afvigelsestesten med humane lymfocytter.
Fertavid showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Fertavid injektionsvæske, opløsning indeholder:
Fertavid solution for injection contains: sucrose sodium citrate L-methionine polysorbate 20 water for injections.
6 saccharose natriumcitrat L- methionin polysorbat 20 vand til injektionsvæsker. pH værdien kan være blevet justeret med natriumhydroxid og/ eller saltsyre.
6 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Hos patienten kan Fertavid dog opbevares ved højst 25 °C i en enkelt periode, der ikke overstiger 3 måneder.
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.
0, 5 ml opløsning i 3 ml hætteglas (type I- glas) med prop (chlorbutyl gummi).
0.5 ml of solution in 3 ml vial (type I glass) with stopper (chlorobutyl rubber).
Pakninger med 1, 5 eller 10.
Pack of 1, 5 or 10.
SP Europe Rue de Stalle, 73 B- 1180 Bruxelles Belgien
SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgium
Dato for seneste forlængelse af markedsføringstilladelsen:
Date of last renewal:
7 10.
10.
Fertavid 75 IE/ 0, 5 ml injektionsvæske, opløsning
Fertavid 75 IU/ 0.5 ml solution for injection
Et hætteglas indeholder 75 IE rekombinatnt follikelstimulerende hormon (FSH) i 0, 5 ml vandopløsning.
One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Dette svarer til en styrke på 150 IE/ ml.
This corresponds to a strength of 150 IU/ ml.
10. 000 IE FSH/ mg protein).
One vial contains 7,5 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
Injektionsvæske, opløsning indeholder det aktive stof follitropin beta, som er fremstillet ved genetisk manipulation af ovarieceller fra kinesiske hamstere (CHO).
The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
9 • Anovulation Generelt anbefales det at bruge et "step- up" - behandlingsskema startende med en daglig administration på 50 IE Fertavid.
8 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
10 • Udiagnosticeret vaginalblødning. • Primær ovarieinsufficiens. • Ovariecyster eller forstørrede ovarier som ikke har relation til polycystisk ovariesyndrom (PCOS). • Misdannelser af genitalier som gør graviditet umulig. • Fibromer (leiomyomer) i uterus, som er uforenelige med graviditet • Primær testikellidelse.
9 • Primary ovarian failure. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). • Malformations of the sexual organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Primary testicular failure.
11 • Fertavid kan indeholde spor af streptomycin og/ eller neomycin.
These antibiotics may cause hypersensitivity reactions in susceptible persons.
Disse antibiotika kan forårsage overfølsomhedsreaktioner hos modtagelige personer. • Forhøjede endogene FSH- niveauer hos mænd indikerer primær testikellidelse.
10 • Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
12 Der er ingen tilgængelige data vedrørende akut toksicitet hos mennesker i behandling med Fertavid, men undersøgelser i dyreforsøg har vist en meget lav akut toksicitet for Fertavid og gonadotropinpræparaters.
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.
FARMAKOLOGISKE EGENSKABER
11 5 PHARMACOLOGICAL PROPERTIES
13 saccharose natriumcitrat L- methionin polysorbat 20 vand til injektionsvæsker. pH værdien kan være blevet justeret med natriumhydroxid og/ eller saltsyre.
12 The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Hos patienten kan Fertavid dog opbevares ved højst 25 °C i en enkelt periode der ikke overstiger 3 måneder.
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.
0, 5 ml opløsning i 3 ml hætteglas (type I glas) med gummilukke (chlorbutyl gummi).
0.5 ml of solution in 3 ml vial (type I glass) with stopper (chlorobutyl rubber).
Fertavid 100 IE/ 0, 5 ml injektionsvæske, opløsning
Fertavid 100 IU/ 0.5 ml solution for injection
Et hætteglas indeholder 100 IE rekombinatnt follikelstimulerende hormon (FSH) i 0, 5 ml vandopløsning.
One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 ml aqueous solution.
Dette svarer til en styrke på 200 IE/ ml.
This corresponds to a strength of 200 IU/ ml.
10. 000 IE FSH/ mg protein).
One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10 000 IU FSH / mg protein).
16 • Anovulation Generelt anbefales det at bruge et "step- up" - behandlingsskema startende med en daglig administration på 50 IE Fertavid.
14 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.