natgillin/translations-raw huggingface dataset:
I høje doser (≥ 5 IE/ kg/ dag) forårsager follitropin alfa en mindskning af antallet af levedygtige fostre uden at være teratogent samt dystoci svarende til det, der er observeret ved urin- baseret hMG.
Given in high doses (≥ 5 IU/ kg/ day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary hMG.
Den tilberedte opløsningen er stabil i 28 dage.
The reconstituted solution is stable for 28 days.
GONAL- f bliver leveret som pulver og solvens injektionsvæske, opløsning.
GONAL-f is presented as a powder and solvent for injection.
Produktet leveres i en pakning med et hætteglas med pulver og en solvenssprøjte til opløsning, samt 4 engangssprøjter til injektion med en måleskala for FSH enheder.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 4 disposable syringes for administration graduated in FSH units.
6. 6 Særlige forholdsregler ved bortskaffelse
80 6.6 Special precautions for disposal
GONAL- f 300 IE/ 0, 50 ml (22 mikrogram/ 0, 50 ml) skal tilberedes med de 0, 75 ml medfølgende solvens før brug.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) must be reconstituted with the 0.75 ml solvent provided before use.
GONAL- f 300 IE/ 0, 50 ml (22 mikrogram/ 0, 50 ml) må ikke opløses sammen med nogen anden GONAL- f beholder.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) preparation must not be reconstituted with any other GONAL-f containers.
Et sæt af injektionssprøjter med en måleskala for FSH enheder forefindes i GONAL- f Multidosis æsken.
A set of administration syringes graduated in FSH units is supplied in the GONAL-f Multidose box.
81
Dose (IU) 75 150 225 300
Dosis (IE) 75 150 225 300
Volume to
Mængde, som skal injiceres (ml) 0, 13 0, 25 0, 38 0, 50
be injected (ml) 0.13 0.25 0.38 0.50
Enkelte tilberede hætteglas skal kun bruges til en patient.
Individual reconstituted vials should be for single patient use only.
Ikke anvendt lægemidler samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
Any unused product or waste material should be disposed of in accordance with local requirements.
82 1.
81 1.
GONAL- f 300 IE/ 0, 5 ml (22 mikrogram/ 0, 5 ml) injektionsvæske, opløsning i en fyldt pen.
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) solution for injection in a pre-filled pen.
Follitropin alfa *, 600 IE/ ml (svarende til 44 mikrogram/ ml).
Follitropin alfa*, 600 IU/ ml (equivalent to 44 micrograms/ ml).
Hver ampul giver 300 IE (svarende til 22 mikrogram) i 0, 5 ml. * Follitropin alfa er rekombinant humant follikel stimulerende hormon (FSH) produceret ved en rekombinant DNA teknologi i kinesiske hamster (CHO) celle række.
Each cartridge delivers 300 IU (equivalent 22 micrograms) in 0.5 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
30 mg saccharose, 0. 555 mg dinatriumphosphatdihydrat, 0. 225 mg natriumdihydrogenphosphatmonohydrat, 0. 05 mg methionin, 1. 5 mg m- cresol, 0. 05 mg poloxamer 188.
30 mg sucrose, 0.555 mg disodium phosphate dihydrate, 0.225 mg sodium dihydrogen phosphate monohydrate, 0.05 mg methionine, 1.5 mg m-cresol, 0.05 mg poloxamer 188.
Injektionsvæsken har en pH værdi på 6. 7- 7. 3.
The pH of the solution is 6.7 - 7.3.
Disse patienter er i kliniske studier blevet indentificeret med et endogen LH serum niveau < 1, 2 IE/ l.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
Den anbefalede dosis for GONAL- f er den samme som for urin- baseret FSH.
The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Kliniske vurderinger af GONAL- f indikerer, at dens daglige dosis, administrationsregimet og monitoreringsproceduren ikke skal være anderledes, end hvad der gælder for behandling med urin -
Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing
83 baserede FSH- præparater.
82 preparations.
Der er påvist bioækvivalens mellem ækvivalente doser fra enkeltdosisbeholdere og flerdosisbeholdere med GONAL- f.
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
Når et optimalt respons er opnået, gives en enkelt injektion på 250 mikrogram r- hCG eller 5000 IE hCG eller maksimalt 10. 000 IE hCG 24- 48 timer efter den sidste GONAL- f- injektion.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Den mest almindelige dosis for superovulation omfatter indgift af 150- 225 IE GONAL- f per dag med start på dag 2 eller 3 af cyklus.
A commonly used regimen for superovulation involves the administration of 150-225 IU of GONAL-f daily, commencing on days 2 or 3 of the cycle.
Der gives en enkelt injektion på 250 mikrogram r- hCG eller 5000 IU op til 10. 000 IE hCG 24- 28 timer efter sidste GONAL- f- injektion for at inducere follikelmodning.
A single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG is administered 24-48 hours after the last GONAL-f injection to induce final follicular maturation.
Nedregulering med en gonadotropin- frigivende hormon (GnRH) - agonist eller antagonist er nu almindeligt anvendt for at hæmme den endogene LH- stigning og for at kontrollere LH- niveauerne.
Down-regulation with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
2 uger efter begyndelsen af agonist behandlingen, og der fortsættes med begge lægemidler, til adækvat follikeludvikling er opnået.
In a commonly used protocol, GONAL-f is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
Man kan f. eks. efter to ugers behandling med agonist eller indgive 150- 225 IE GONAL- f de 7 første dage.
For example, following two weeks of treatment with an agonist, 150-225 IU GONAL-f are administered for the first 7 days.
GONAL- f skal gives
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the
84 som en daglig injektion sammen med lutropin alfa.
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
Anbefalet dosisregime begynder med 75 IE lutropin alfa dagligt sammen med 75- 150 IE FSH.
A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH.
Når optimal respons er opnået, gives en enkelt injektion af 250 mikrogram r- hCG eller 5000 IE op til 10. 000 IE hCG, 24- 48 timer efter sidste GONAL- f og lutropin alfa injektion.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f and lutropin alfa injections.
Patienten anbefales at have coitus på selve dagen og dagen efter hCG indgivelsen.
The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Gonal- f må ikke anvendes i tilfælde af: • overfølsomhed over for det aktive stof follitropin alfa, FSH eller over for et eller flere af hjælpestofferne • tumor i hypotalamus eller hypofyse
• Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • Tumours of the hypothalamus and pituitary gland
og hos kvinder: • ovarieforstørrelse eller cyste, som ikke er forårsaget af polycystisk ovariesyndrom • gynækologiske blødninger af ukendt ætiologi • ovarie -, uterus - eller mammakarcinom
In women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
Gonal- f bør ikke anvendes, når effektivt respons ikke kan opnås, som for eksempel:
Must not be used when an effective response cannot be obtained, such as:
Hos kvinder: • primær ovariesvigt • misdannelse af kønsorganerne, der er uforenelig med graviditet • fibrøse tumorer i uterus, der er uforenelige med graviditet.
In women: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
Behandling med gonadotropiner er tidskrævende for lægen og øvrigt personale og kræver desuden tilgang til særligt monitoreringsudstyr.
84 Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
Sikker og effektiv brug af GONAL- f hos kvinder kræver 85 overvågning af ovarierespons via ultralyd alene eller helst i kombination med regelmæssig måling af serum østradiol.
In women, safe and effective use of GONAL-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Selv- administration af GONAL- f bør kun udføres af patienter, som er motiverede, har modtaget tilstrækkelig instruktion, og som har mulighed for at konsultere eksperter.
Self-administration of GONAL-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Når patienter instrueres i selv- administration, skal der som et vigtigt punkt gives specifikke instruktioner i anvendelsen af den fyldte pen.
During training of the patient for self- administration, special attention should be given to specific instructions for the use of the prefilled pen.
For patienter, som gennemgår stimulation af follikeludvikling, enten som behandling for anovulatorisk infertilitet eller med ART procedure, øges risikoen for at udvikle ovarieforstørrelse eller hyperstimulering.
Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or for ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Overholdelse af den anbefalede Gonal- f dosis og administrationskur samt nøje overvågning af behandlingen vil reducere risikoen for disse bivirkninger.
Adherence to the recommended GONAL-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Bedømmelse af follikeludvikling og modning skal gøres af lægen med erfaring i dette.
For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
Historiske data tyder på at ovulationsraten opnået med GONAL- f/ LH er sammenlignelig den der opnås med hMG.
Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/ LH is similar to that obtained with hMG.
Forhøjet ovarierespons til gonadotropinbehandling fører sjælden til OHSS, hvis ikke hCG administreres for at starte ovulation.
85 Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
Det er derfor vigtigt ikke at give hCG i tilfælde af hyperstimulation og desuden fortælle patienten at afstå fra coitus eller bruge en sikker præventions -
Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days.
4. 8).
Adherence to recommended GONAL-f dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see sections 4.2 and 4.8).
Reproduktionssystemstumorer
86 Reproductive system neoplasms
Det er ikke fastslået om behandling med gonadotropiner øger risikoen for disse typer af tumorer hos infertile kvinder.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
87 Medfødte misdannelser
Congenital malformation
Hos disse kvinder bør fordele med gonadotropin behandling opvejes imod risikoen.
In these women, the benefits of gonadotrophin administration need to be weighed against the risks.
Der skal noteres at graviditet i sig selv øger risikoen for tromboembolisk sygdom.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
Sædanalyse er anbefalet 4- 6 måneder efter behandlingens start, som en del af vurderingen af effekten.
Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Brug af GONAL- f samtidig med andre ovulationsstimulerende midler (hCG, clomifen citrat) kan forstærke follikelresponset, mens samtidig GnRH- agonist eller antagonist induceret hypofysedesensibilisering kan øge den dosis af GONAL- f, der er nødvendig for at opnå et adækvat ovarierespons.
Concomitant use of GONAL-f with other agents used to stimulate ovulation (e. g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
Der foreligger ikke tilstrækkelig dokumentation for at udelukke teratogen effekt, hvis rekombinant h- FSH anvendes under graviditet.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant hFSH.
Hidtil er der imidlertidet ikke rapporteret om nogen speciel misdannende effekt.
However, to date, no particular malformative effect has been reported.
Under amning kan sekretion af prolaktin medføre en forværret prognose for ovariestimulation.
During lactation, the secretion of prolactin can entail a poor prognosis to ovarian stimulation.
4. 8 Bivirkninger
87 4.8 Undesirable effects
88 Behandling af kvinder Forstyrrelser i immunsystemet
Treatment in women Immune system disorders
4. 4.
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur (see section 4.4).
89 5.
88 5.
I kliniske studier blev patienter med alvorlig mangel på LH og FSH definieret ved et endogent serumniveau af LH < 1, 2 IE/ l målt i et centralt laboratorie.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/ l as measured in a central laboratory.
1 døgn.
Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Steady state fordelingsvolumen og samlet clearance er henholdsvis 10 liter og 0, 6 liter/ time.
The steady state volume of distribution and total clearance are 10 l and 0.6 l/ h, respectively.
En ottendedel af follitropin alfa- dosis udskilles i urinen.
One-eighth of the follitropin alfa dose is excreted in the urine.
Efter gentagen indgift akkumuleres follitropin alfa 3 gange, og steady state opnås inden for 3- 4 dage.
Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days.
Hos kvinder, hvis endogene gonadotropinsekretion er hæmmet, har det ikke desto mindre vist sig, at follitropin alfa effektivt stimulerer follikeludviklingen og steroidgenesen på trods af umålelige LH- værdier.
In women whose endogenous gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Non- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion ud over det der allerede er beskrevet i andre afsnit i dette produktresumé.
Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SPC.
Poloxamer 188 Saccharose Methionin Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatdihydrat m- Cresol
Poloxamer 188 Sucrose Methionine Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate m-Cresol Phosphoric acid, concentrated
90 Phosphorsyre, koncentreret Natriumhydroxid Vand til injektionsvæsker
89 Sodium hydroxide Water for Injections
Efter anbrud: kan produktet opbevares i op til 28 dage ved eller under 25oC.
2 years Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Opbevares ved 2°C – 8°C (i køleskab).
Store in a refrigerator (2°C - 8°C).
Indenfor holdbarhedstiden skal produktet opbevares ved eller under 25°C i op til 3 måneder uden at blive nedkølet igen og skal kasseres, hvis det ikke er anvendt inden 3 måneder.
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
Opbevares i den originale pakning for at beskytte præparatet imod lys.
Store in the original package in order to protect from light.
Opbevaring efter anbrud, se punkt 6. 3.
For in-use storage conditions, see section 6.3.
0, 5 ml injektionsvæske, opløsning i 3 ml ampul (type I glas), med en stempel prop (halobutyl gummi) og en aluminium beskyttelseshætte med sort gummi indlæg.
0.5 ml of solution for injection in 3 ml cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Produktet leveres i en pakning med 1 fyldt pen og 5 kanyler til anvendelse med pennen ved administration.
Pack of one pre-filled pen and 5 needles to be used with the pen for administration.
Opløsningen må ikke anvendes, hvis den indeholder partikler eller er uklar.
The solution should not be administered if it contains particles or is not clear.
Alt ubrugt opløsning skal kasseres inden 28 dage efter anbrud.
Any unused solution must be discarded not later than 28 days after first opening.
GONAL- f 300 IE/ 0, 5 ml (22 mikrogram/ 0, 5 ml) pen er ikke konstrueret til at ampullen kan fjernes.
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) is not designed to allow the cartridge to be removed.
Dato for fornyelse:
20 October 1995 Date of last renewal:
92 1.
90 1.
GONAL- f 450 IE/ 0, 75 ml (33 mikrogram/ 0, 75 ml) injektionsvæske, opløsning i en fyldt pen.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) solution for injection in a pre-filled pen.
Hver ampul giver 450 IE (svarende til 33 mikrogram) i 0, 75 ml. * Follitropin alfa er rekombinant humant follikel stimulerende hormon (FSH) produceret ved en rekombinant DNA teknologi i kinesiske hamster (CHO) celle række.
Each cartridge delivers 450 IU (equivalent 33 micrograms) in 0.75 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
45 mg saccharose, 0. 8325 mg dinatriumphosphatdihydrat, 0. 33755 mg natriumdihydrogenphosphatmonohydrat, 0. 075 mg methionin, 2. 25 mg m- cresol, 0. 075 mg poloxamer 188.
45 mg sucrose, 0.8325 mg disodium phosphate dihydrate, 0.3375 mg sodium dihydrogen phosphate monohydrate, 0.075 mg methionine, 2.25 mg m-cresol, 0.075 mg poloxamer 188.
Disse patienter er i kliniske studier blevet indentificeret med en endogen LH serum niveau < 1, 2 IE/ l.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
93 baserede FSH- præparater.
91 preparations.
Hos kvinder med mangel på LH og FSH (hypogonadotropisk hypogonadism), er foremålet med GONAL- f behandling i forbindelse med lutropin alfa at udvikle en enkelt Graafst follikel fra hvilken
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the
94 en oocyt kan frigives efter indgivelse af Humant choriongonadotropin (hCG).
92 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
95 Behandling med gonadotropiner er tidskrævende for lægen og øvrigt personale og kræver desuden tilgang til særligt monitoreringsudstyr.
93 Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
Sikker og effektiv brug af GONAL- f hos kvinder kræver overvågning af ovarierespons via ultralyd alene eller helst i kombination med regelmæssig måling af serum østradiol.
In women, safe and effective use of Gonal-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Selv- administration af GONAL- f bør kun udføres af patienter, som er motiverede, har modtaget tilstrækkelig instruktion, og som har mulighed for at konsultere eksperter.
Self-administration of Gonal-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Overholdelse af den anbefalede Gonal- f dosis og administrationskur samt nøje overvågning af behandlingen vil reducere risikoen for disse bivirkninger.
Adherence to the recommended Gonal-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Forhøjet ovarierespons til gonadotropinbehandling fører sjælden til OHSS, hvis ikke hCG administreres for at starte ovulation.
94 Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
96 hyperstimulation og desuden fortælle patienten at afstå fra coitus eller bruge en sikker præventions - metode i mindst 4 dage.
Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days.
Der er rapporteret tilfælde af ovarie og reproduktionssystemstumorer, både benigne og maligne, hos kvinder der har gennemgået adskillige behandlinger med lægemidler for infertilitet.
95 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.
97 Medfødte misdannelser
Congenital malformation
Der skal noteres at graviditet i sig øger risikoen for tromboembolisk sygedom.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
98 Behandling af kvinder Forstyrrelser i immunsystemet
96 Treatment in women Immune system disorders
Exacerbation eller forværring af astma
Exacerbation or worsening of asthma
Behandling af mænd Sygdomme i hud og subkutane væv
Treatment in men
Farmakoterapeutisk klassifikation: gonadotropiner, ATC- kode:
97 Pharmacotherapeutic group: gonadotrophins, ATC code:
I kliniske studier blev patienter med alvorlig mangel på LH og FSH definieret ved et endogent serumniveauet af LH < 1, 2 IE/ l målt i et centralt laboratorie.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/ l as measured in a central laboratory.
Man skal derfor tage hensyn til variationer af LH nivået målt i forskellige laboratorier.
However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
En ottendedel af en follitropin alfa- dosis udskilles i urinen.
One-eighth of the follitropin alfa dose is excreted in the urine.
I høje doser (≥ 5 IE/ kg/ dag) forårsager follitropin alfa en mindskning af antal levedygtige fostre uden at være teratogent samt dystoci svarende til det, der er observeret ved urin- baseret hMG.
Given in high doses (≥ 5 IU/ kg/ day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary hMG.