natgillin/translations-raw huggingface dataset:
37 Behandling af kvinder Forstyrrelser i immunsystemet
Treatment in women Immune system disorders
4. 4.
38 The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
Saccharose Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatdihydrat Methionin
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate
39 Polysorbat 20 Phosphorsyre, koncentreret Natriumhydroxid
39 Methionine Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide
Pulveret bliver leveret i et 3 ml hætteglas (type I glas) med brombutyl propper beskyttet med aluminiumsringe og ” flip- off ” hætter.
The powder is presented in 3 ml vials (Type I glass) with stopper (bromobutyl rubber) and aluminium flip-off cap.
Solvens til opløsning bliver leveret i 1 ml fyldte injektionssprøjter (type I glas) med gummipropper.
The solvent for reconstitution is presented in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Produktet bliver leveret i pakninger af 1 hætteglas med 1 fyldt injektionssprøjte.
The product is supplied in packs of 1 vial with 1 solvent pre-filled syringe.
GONAL- f 37, 5 IE (2, 8 mikrogram), pulver og solvens til injektionsvæske, opløsning.
GONAL-f 37.5 IU (2.8 micrograms) powder and solvent for solution for injection.
Et hætteglas indeholder 3 mikrogram follitropin alfa, rekombinant humant follikelstimulerende hormon (FSH) for at kunne give 2, 8 mikrogram, svarende til 37, 5 IE.
One vial contains 3 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 2.8 micrograms, equivalent to 37.5 IU.
Den tilberedte opløsning indeholder 37, 5 IE/ ml.
The reconstituted solution contains 37.5 IU/ ml.
• Stimulering af multipel follikeludvikling hos patienter, som gennemgår assisteret reproduktions teknologi (ART) såsom in vitro befrugtning (IVF), “ gamete intra- fallopian transfer ” (GIFT) og “ zygote intra- fallopian transfer ” (ZIFT).
• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). • GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Disse patienter er i kliniske studier blevet indentificeret med en endogen LH serum nivå < 1, 2 IE/ l.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
For at undgå injektion af store voluminer kan GONAL- f 37, 5 IE (2, 8 mikrogram) opløses i 1 ml væske og derefter kombineres med GONAL- f 75 IE (5, 5 mikrogram) og/ eller 150 IE (11 mikrogram).
In order to avoid the injection of large volumes, GONAL-f 37.5 IU (2.8 micrograms) may be dissolved in 1 ml of solvent and combined with GONAL-f 75 IU (5.5 micrograms) and/ or GONAL-f 150 IU (11 micrograms).
Op til 3 beholdere af produktet kan opløses i 1 ml solvens.
Up to three vials of product may be dissolved in 1 ml of solvent.
42 Den anbefalede dosis for GONAL- f er den der anvendes til brug af urin FSH.
42 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Når disse doser anvendes i et klinisk studie, hvor man sammenligner GONAL- f og urinderiveret FSH, er GONAL- f mere effektivt end urinderiveretFSH hvilket ses ved en lavere total dosis og en kortere behandlingsperiode, for at opnå præ- ovulatoriske forhold.
However, when these doses were used in a clinical study comparing GONAL-f and urinary FSH, GONAL-f was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
GONAL- f kan gives som dagligeinjektioner.
GONAL-f may be given as a course of daily injections.
43 Anovulatoriske kvinder grundet svær mangel af LH og FSH.
43 Women with anovulation resulting from severe LH and FSH deficiency:
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 en oocyt kan frigives efter indgivelse af humant choriongonadotropin (hCG).
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 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Hvis en øgning af FSH blir nødvendig, bør dosis ændring ske efter 7- 14 dages interval og helst med 37, 5- 75 IE ad gangen..
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments.
og hos kvinder: • ovarieforstørrelse eller cyste, som ikke er forårsaget af polycystisk ovariesyndrom • gynækologiske blødninger af ukendt ætiologi • ovarie -, uterus - eller mamacarcinom
GONAL-f must not be used in: • hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • case of tumours of the hypothalamus and pituitary gland and 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 effektiv respons ikke kan opnås, som for eksempel:
GONAL-f should not be used when an effective response cannot be obtained, such as:
44 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
44 4.4 Special warnings and precautions for use
Sikker og effektiv brug af GONAL- f hos kvinder kræver overvågning af ovarierespons via ultralyd alene eller helst i kombination med regelmæssig måling af serumøstradiol.
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.
En klinisk undersøgelse kan påvise hypovolemi, hæmokoncentration, elektrolyt ubalance ascites, hæmoperitoneum, pleuraekssudat, hydrothorax, akut pulmonær distress samt tromboemboliske komplikationer.
45 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
45 Forhøjet ovarierespons til gonadotropinbehandling fører sjælden til OHSS, hvis ikke hCG administreres for at starte ovulation.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
Reproduktionssystemstumorer
46 Reproductive system neoplasms
Det er ikke
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.
46 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 tumors in infertile women.
Der foreligger ikke tilstrækkelig dokumentation for at udelukke teratogen effekt, hvis rekombinant FSH anvendes under graviditet.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant hFSH.
Adækvat
During lactation, the secretion of prolactin can entail a poor prognosis to ovarian stimulation.
4. 8 Bivirkninger
47 4.8 Undesirable effects
47 Behandling af kvinder Forstyrrelser i immunsystemet
Treatment in women Immune system disorders
De 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.
Saccharose Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatdihydrat Methionin Polysorbat 20
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Methionine Polysorbate 20 Phosphoric acid, concentrated
49 Phosphorsyre, koncentreret Natriumhydroxid
49 Sodium hydroxide
Solvens til opløsning bliver leveret i 1 ml fyldte injektionssprøjter (type I glas) med gummipropper.
The powder is presented in 3 ml vials (Type I glass), with stopper (bromobutyl rubber) and aluminium flip-off cap.
Produktet bliver leveret i pakninger af 1 hætteglas med 1 fyldt injektionssprøjte.
The solvent for reconstitution is presented in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Serono Eurpoe Limited 56 Marsh Wall London E14 9TP Storbritannien
56 Marsh Wall London E14 9TP United Kingdom
GONAL- f 1050 IE/ 1, 75 ml (77 mikrogram/ 1, 75 ml) pulver og solvens til injektionsvæske, opløsning.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) powder and solvent for solution for injection.
Et multidosis hætteglas indeholder 87 mikrogram follitropin alfa, recombinant humant follikelstimulerende hormon (FSH) for at kunne give 77 mikrogram, svarende til 1050 IE.
One multidose vial contains 87 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 77 micrograms, equivalent to 1050 IU.
30 mg saccharose, 1. 11 mg dinatriumphosphatdihydrat, 0. 45 mg natriumdihydrogenphosphatmonohydrat.
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate
Pulver og solvens til injektionsvæske, opløsning i en på forhånd opfyldt sprøjte.
Powder and solvent for solution for injection in a pre-filled syringe.
Den tilberedte opløsning har en pH værdi på 6. 5- 7. 5.
The pH of the reconstituted solution is 6.5 – 7.5.
• Anovulation (inkl. polycystisk ovariesyndrom PCOS) hos kvinder, som ikke har reageret på behandling med clomifencitrat.
• Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.
• Stimulation af multipel follikeludvikling hos patienter, som gennemgår superovulation forud for assisteret reproduktionsteknologi (ART) såsom in vitro fertilisation (IVF), “ gamete intra- fallopian transfer ” (GIFT) og “ zygote intra- fallopian transfer ” (ZIFT).
• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
Behandling med GONAL- f skal administreres under opsyn fra en læge, som har erfaring inden for behandling af fertilitetsproblemer.
Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Pulveret skal opløses før den første brug med medfølgende solvens.
The powder should be reconstituted prior to the first use with the solvent provided.
GONAL- f 1050 IE/ 1, 75 ml (77 mikrogram/ 1, 75 ml) må ikke opløses sammen med en anden GONAL- f beholder.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) preparation must not be reconstituted with any other GONAL-f container.
52 Den anbefalede dosis for GONAL- f er den samme som for urin- baseret FSH.
52 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Kliniske vurderinger af GONAL- f indikerer, at dens daglige dosis, administrationskuren og monitoreringsproceduren ikke skal være anderledes, end hvad der gælder for behandling med urin - baserede FSH- præparater.
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 preparations.
I en klinisk undersøgelse, hvor man sammenlignede GONAL- f og urin - baseret FSH, var GONAL- f mere effektivt end urin- baseret FSH, idet der krævedes en lavere total dosis og en kortere behandlingsperiode for at opnå præ- ovulatoriske forhold.
However, when these doses were used in a clinical study comparing GONAL-f and urinary FSH, GONAL-f was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
Der er påvist bioækvivalens mellem ækvivalente doser i enkeltdosisbehandling og flerdosisbehandling med GONAL- f.
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
Hensigten med GONAL- f- behandling er udvikling af en enkelt moden Graafsk follikel, hvorfra ægget vil blive frigivet efter indgift af hCG.
The object of GONAL-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
Hos kvinder, der menstruerer, bør behandlingen påbegyndes inden for de første 7 dage af menstruationscyklus.
In menstruating patients treatment should commence within the first 7 days of the menstrual cycle.
Dette kan om nødvendigt øges, fortrinsvist med 37, 5 IE eller 75 IE med 7 dages eller fortrinsvist med 14 dages mellemrum, for at opnå et tilstrækkeligt, men ikke for kraftigt respons.
A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Den maksimale daglige dosis overstiger normalt ikke 225 IE FSH.
The maximal daily dose is usually not higher than 225 IU FSH.
Når et optimalt respons er opnået, gives en enkelt injektion på 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 5 000 IU, up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Patienten anbefales at have coitus på selve dagen og på dagen efter hCG- indgiften.
The patient is recommended to have coitus on the day of, and the day following, hCG administration.
4. 4).
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Behandling bør genoptages i den næste cyklus på en lavere dosis end den foregående cyklus.
Treatment should recommence in the next cycle at a dosage lower than that of the previous cycle.
Kvinder, som gennemgår ovariestimulation med henblik på multipel follikeludvikling i forbindelse med in vitro fertilisation eller anden assisteret reproduktionsteknologi:
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies:
Behandlingen fortsætter med en dosis tilpasset patientens respons sædvanligvis ikke højere end 450 IE/ dag, til tilstrækkelig follikeludvikling er opnået (vurderes ved kontrol af serumøstrogen og/ eller ultralydsundersøgelse).
Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/ or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Der gives en enkelt injektion på op til 10. 000 IE hCG 24- 28 timer efter sidste GONAL- f- injektion for at inducere follikelmodning.
A single injection of 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 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 is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
2 uger efter begyndelsen af agonistbehandlingen, og der fortsættes med begge lægemidler, til adekvat 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 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.
Erfaringer med IVF viser, at frekvensen for vellykket behandling sædvanligvis er stabil under de fire første forsøg, hvorefter den gradvist aftager.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
53 Anovulatoriske kvinder grundet svær mangel af LH og FSH.
53 Women with anovulation resulting from severe LH and FSH deficiency:
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 en oocyt kan frigives efter indgivelse af Humant choriongonadotropin (hCG).
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 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Hvis patienten efter denne periode ikke har udvist respons, kan kombinationsbehandling fortsættes; nuværende klinisk erfaring indikerer, at behandling i mindst 18 måneder kan være nødvendig for at opnå spermatogenese.
If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
GONAL- f må ikke anvendes i tilfælde af: • tidligere overfølsom over for det aktive stof follitropin alfa, FSH eller over for et eller flere af hjælpestofferne • tumor i hypotalamus eller hypofyse
GONAL-f must not be used in: • hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • case of 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
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
• primær ovariesvigt • malformation af gonaderne, uforenelig med graviditet • fibroide tumorer i uterus, uforenelige med graviditet
In women: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
Hos mænd: • Primær testikelinsufficiens
In men: • primary testicular insufficiency
54 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
54 4.4 Special warnings and precautions for use
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 with access to expert advice.
Når patienter instrueres i selv- administration, skal der som et vigtigt punkt gives specifikke instruktioner i anvendelsen af flerdosis pakningen.
During training of the patient for self- administration, special attention should be given to specific instructions for the use of the multidose presentation.
Da Gonal- f flerdosis pakning er beregnet til flere injektioner, bør patienten modtage en klar instruktion for at undgå forkert brug af flerdosis pakningen.
As GONAL-f multidose is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.
På grund af lokal reaktion på benzylalkohol, bør det samme injektions stedet ikke bruges på efterfølgende dage.
Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Før behandlingen begynder, bør det vurderes om parrets infertilitet er egnet for behandlingen, og mulige kontraindikationer for graviditet bør vurderes.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Specielt skal patienten undersøges for hypotyreoidisme, adrenokortikalt svigt, hyperprolaktinemi og tumorer i hypofyse eller hypotalamus, og adækvat behandling skal gives.
In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Hvis en øgning af FSH dosis bliver nødvendig, bør dosisøgning ske i 7- 14 dages intervaller og helst med 37, 5- 75 IE ad gangen.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
Der er ikke foretaget nogen direkte sammenligning mellem GONAL- f/ LH og humant menopausalt gonadotropin (hMG).
No direct comparison of GONAL-f/ LH versus human menopausal gonadotrophin (hMG) has been performed.
Historiske data tyder på at ovulations raten opnået med GONAL- f/ LH er sammenlignelig den der opnås ved behandling med hMG.
Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/ LH is similar to what can be obtained with hMG.
Ovarie Hyperstimulation Syndrom (OHSS)
55 Ovarian Hyperstimulation Syndrome (OHSS)
OHSS er en alvorlig medicinsk tilstand til forskel fra ukompliceret ovarie forstørrelse.
OHSS is a medical event distinct from uncomplicated ovarian enlargement.
55 Følgende symptomer kan ses ved alvorlige tilfælde af OHSS: smerter og udspiling af maven, alvorlig ovarie forstørrelse, vægtøgning, dyspnø, oligouri og gastrointestinale symptomer såsom kvalme, opkast og diarré.
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Forhøjet ovarierespons til gonadotropinbehandling fører sjælden til OHSS, hvis ikke hCG administreres for at starte ovulation.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
Patienter der genemgår ovulations induktion ved hjælp af GONAL- f løber en forhøjet risiko for flerfoldsgraviditet samlignet med normal befrugtning.
In patients undergoing ovulation induction with GONAL-f, the incidence of multiple pregnancies is increased as compared with natural conception.
Graviditetsbortfald
56 Pregnancy wastage
56 Ekstrauterin graviditet
Ectopic pregnancy
Årsagen til dette antages at være forældrenes kendetegn (dvs. moderens alder, spermkvalitet) og flerfoldsgraviditet.
This is thought to be due to differences in parental characteristics (e. g. maternal age, sperm characteristics) and multiple pregnancies.
Brug af GONAL- f samtidig med andre ovulationsstimulerende midler (hCG, clomifen citrat) kan forstærke follikelresponset, mens samtidig GnRH- agonistinduceret 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 to induce pituitary desensitisation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.