natgillin/translations-raw huggingface dataset:
Behandlingen bør tilpasses til den enkelte patients respons, vurderet ud fra måling af follikelstørrelse ved hjælp af ultralyd og/ eller østrogensekretion.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/ or oestrogen secretion.
Dette kan øges fortrinsvist med 37, 5 IE eller med 75 IE med 7 dage eller fortrinsvist med 14 dages mellemrum om nødvendigt, 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 IU, or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Hvis der ikke fremkommer et respons efter 4 ugers behandling, skal den cyklus opgives, og patienten skal påbegynde en behandling med en større startdosis end i den afbrudte cyklus.
If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should recommence treatment at a higher starting dose than in the abandoned cycle.
Når et optimalt respons er opnået, gives en injektion på 5000 IE hCG eller maximalt 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.
Hvis et for kraftigt ovarielt respons opnås, bør behandlingen stoppes og hCG injektionen undlades (se pkt.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Behandlingen fortsætter med en dosis tilpasset patientens respons sædvanligvis ikke højere end 450 IE/ dag, til tilstrækkelig follikeludvikling er opnået vurderet 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.
Nedregulering med en gonadotropin- releasing hormon (GnRH) - agonist er nu almindeligt anvendt for at suprimere 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.
Man kan f. eks. efter to ugers behandling med agonist, administrere 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.
Anovulatoriske kvinder grundet svær mangel af LH og FSH.
13 Women with anovulation resulting from severe LH and FSH deficiency:
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 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
13 som en daglig injektion sammen med lutropin alfa.
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
Det kan accepteres at forlænge stimulations tiden i en cyklus op til 5 uger.
It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
GONAL- f skal gives, samtidig med hCG, i doseringer på 150 IE 3 gange ugentligt i minimum 4 måneder.
GONAL-f should be given at a dosage of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
Hos mænd: • Primær testikel insufficiens
In men: • primary testicular insufficiency
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
14 4.4 Special warnings and precautions for use
Sikker og effektiv brug af GONAL- f hos kvinder, kræver
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
14 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.
Der kan forekomme en vis grad af variation i respons på FSH administration patienter imellem.
There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients.
Hos visse patienter ses dårligt respons på FSH. Den laveste dosis i relation til behandlingsårsagen skal bruges af både mænd og kvinder.
The lowest effective dose in relation to the treatment objective should be used in both men and women.
Før behandlingen begynder, bør det vurderes om parrets infertilitet er egnet for behandlingen og mulige kontraindikationer for graviditet vurderes.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
En klinisk undersøgelse kan påvise hypovolemi, hæmokoncentration, elektrolyt ubalance, ascites, hæmoperitoneum, pleuraekssudat, hydrothorax, akut pulmonær distress samt tromboemboliske komplikationer.
15 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
15 For at minimere risikoen for OHSS og flerfoldsgraviditet, anbefales ultralydsundersøgelse sammen med måling af serumøstradiol.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Hvis østradiol niveauet er > 5500 pg/ ml (20. 200 pmol/ L) og hvor der findes 40 eller flere follikler, kan det blive nødvendigt at tilbageholde hCG administrationen.
When the oestradiol level is > 5500 pg/ ml (20200 pmol/ l) and where there are 40 or more follicles in total, it may be necessary to withhold hCG administration.
Reproduktionssystemstumorer
16 Reproductive system neoplasms
16 Medfødte misdannelser
Congenital malformation
Ingen klinisk significante interaktioner med andre lægemidler er rapporteret for GONAL- f.
No other clinically significant drug interaction has been reported during GONAL-f therapy.
GONAL- f bør ikke blandes med andre lægemidler i samme injektionssprøjte undtagen lutropin alfa hvor studier har vist at samtidig administration ikke signifikant påvirker, aktivitet, stabilitet, farmakokinetik eller farmakokinetiske egenskaber af den aktive substans.
GONAL-f should not be administered as mixture with other medicinal products, in the same injection, except lutropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Ved amning
Use during lactation
4. 8 Bivirkninger
17 4.8 Undesirable effects
17 Behandling af kvinder Forstyrrelser i immunsystemet
Treatment in women Immune system disorders
Alvorlige tilfælde af allergiske reaktioner inklusiv anafylaktiske reaktioner er også rapporteret
Serious cases of allergic reactions, including anaphylactic reactions, have also been reported.
Usædvanlig (> 1/ 1. 000, < 1/ 100)
Uncommon (> 1/ 1,000 ,< 1/100) Rare (> 1/10 ,000, < 1/1,000)
Ovarietorsion, en komplikation af OHSS
Severe OHSS (see section 4.4) Ovarian torsion, a complication of OHSS
Almene lidelser og reaktioner på indgivelses stedet
General disorders and administration site conditions
Sygdomme i hud og subkutane væv
Treatment in men Skin and subcutaneous tissue disorders
Gynækomasti, Varicocele
Gynaecomastia Varicocele
4. 4 ”.
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.
1 døgn.
Following intravenous administration, GONAL-f 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.
I høje doser (≥ 5 IE/ kg/ dag.) forårsager follitropin alfa en mindskning af antallet af levedygtige fostre uden at være teratogent, og dystoci svarende til det, der er observeret ved urin- 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.
Solvens:
19 Solvent:
Produktet bliver leveret i pakninger af 1 eller 10 ampuller med det tilsvarende antal solvens ampuller.
The product is supplied in packs of 1, 10 ampoules with the corresponding number of solvent ampoules.
GONAL- f skal opløses i solvensen før brug
GONAL-f must be reconstituted with the solvent before use.
Oktober 1995 Dato for fornyelse:
Date of last renewal:
Oktober 2005.
19 October 2005.
GONAL- f 75 IE (5, 5 mikrogram), pulver og solvens til injektionsvæske, opløsning.
GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection.
Et hætteglas indeholder 6 mikrogram follitropin alfa, rekombinant humant follikelstimulerende hormon (FSH) for at kunne give 5, 5 mikrogram, svarende til 75 IE.
One vial contains 6 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 5.5 micrograms, equivalent to 75 IU.
Den tilberedte opløsning indeholder 75 IE/ ml.
The reconstituted solution contains 75 IU/ ml.
30 mg saccharose, 1. 11 mg dinatriumphosphatdihydrat, 0. 45 mg natriumdihydrogenphosphatmonohydrat, 0. 1 mg methionin, 0. 05 mg polysorbat 20.
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate, 0.1 mg methionine, 0.05 mg polysorbate 20.
For at undgå injektion af store voluminer kan op til 3 beholdere af produktet opløses i 1 ml solvens.
In order to avoid the injection of large volumes, up to 3 vials of product may be dissolved in 1 ml of solvent.
22 Kliniske vurderinger af GONAL- f indikerer, at dens daglige dosis, administrationskuren og monitoreringsproceduren ikke skal være anderledes end hvordan man behandler med urinderiverede FSH (u- 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.
Når disse doser anvendes i en klinisk studie, hvor man sammenligner GONAL- f med urinderiveret FSH, er GONAL- f mere effektivt end u- FSH 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.
Dette kan øges fortrinsvist med 37, 5 IE eller med 75 IE med 7 dage eller fortrinsvist med 14 dages mellemrum hvis nødvendigt, 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.
Anovulatoriske kvinder grundet svær mangel af LH og FSH.
23 Women with anovulation resulting from severe LH and FSH deficiency:
23 som en daglig injektion sammen med lutropin alfa.
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
Anbefalet doserin 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.
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.
Når optimal respons er opnået, gives en enkelt injektion af hCG 5000 IE til 10. 000 IE, 24- 48 timer efter sidste GONAL- f og lutropin alfa injektion.
When an optimal response is obtained, a single injection of 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f and lutropin alfa injections.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen GONAL- f er et potent gonadotropinprodukt som kan fremkalde milde til alvorlige bivirkninger, og bør derfor kun bruges af læger som er specialiseret på infertilitetsbehandling.
GONAL-f is a potent gonadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Behandling med gonadotropiner er tidskrævende for lægen og øvrigt personale og kræver desuden tilgang til særligt monitoreringsudstyr.
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
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.
Historiske data tyder på at ovulationsraten 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 what can be obtained with hMG.
En klinisk undersøgelse kan påvise hypovolemi, hæmokoncentration, elektrolyt ubalance, ascites, hæmoperitoneum, pleuraekssudat, hydrothorax, akut pulmonær distress samt tromboemboliske komplikationer.
25 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
25 For at minimere risikoen for OHSS og flerfoldsgraviditet, anbefales ultralydsundersøgelse sammen med måling af serumøstradiol.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Normalt forsvinder OHSS spontant i forbindelse med begyndelsen af menstruation.
Usually, OHSS resolves spontaneously with the onset of menses.
Reproduktionssystemstumorer
26 Reproductive system neoplasms
26 Tromboembolisk risiko
Thromboembolic events
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 Ingen klinisk signifikante interaktioner med andre lægemidler er rapporteret for GONAL- f.
No other clinically significant drug interaction has been reported during GONAL-f therapy.
Der er ikke rapporteret om risiko for teratogenicitet efter kontrolleret ovariel hyperstimulering ved klinisk brug af GONAL- f.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotrophins.
Der foreligger ikke tilstrækkelig dokumentation for at udelukke teratogen effekt, hvis rekombinant h- FSHanvendes under graviditet.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant hFSH.
Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil eller betjene maskiner.
No studies on the effects on ability to drive and use machines have been performed.
27 Behandling af kvinder Forstyrrelser i immunsystemet
27 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
28 5.
28 5.
De non- kliniskedata 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 Phosphorsyre, koncentreret Natriumhydroxid
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Methionine Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide
Solvens:
29 Solvent:
GONAL- f bliver leveret som pulver og solvens til injektionsvæske, opløsning.
GONAL-f is presented as a powder and solvent for injection.
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 enten 2 ml hætteglas (type I glas) med propper (teflonbelagt gummi) eller i 1 ml fyldte injektionssprøjter (type I glas) med gummipropper.
The solvent for reconstitution is presented in either 2 or 3 ml vials (Type I glass) with stopper (teflon-coated rubber) or in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Produktet bliver leveret i pakninger af 1 hætteglas med det tilsvarende antal hætteglass med solvens eller som fyldte injektionssprøjter.
The product is supplied in packs of 1 vials with the corresponding number of solvent vials or packs of 1, 5 or 10 vials with the corresponding number of solvent pre-filled syringes.
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i overenstemmelse med lokale krav.
Any unused product or waste material should be disposed of in accordance with local requirements.
Oktober 1995.
20 October 1995.
Dato for fornyelse af tilladelsen:
Date of last renewal:
GONAL- f 150 IE (11 mikrogram), pulver og solvens til injektionsvæske, opløsning.
GONAL-f 150 IU (11 micrograms) powder and solvent for solution for injection.
Et hætteglas indeholder 12 mikrogram follitropin alfa, recombinant humant follikelstimulerende hormon (FSH) for at kunne give 11 mikrogram, tilsvarende 150 IE.
One vial contains 12 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 11 micrograms, equivalent to 150 IU.
Den tilberedte opløsning indeholder 150 IE/ ml.
The reconstituted solution contains 150 IU/ ml.
32 Den anbefalede dosis for GONAL- f er den der anvendes til brug af urin FSH.
32 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 hvordan man behandler med urinderiverede FSH (u- 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.
Når disse doser anvendes i et klinisk studie, hvor man sammenligner GONAL- f og urinderiveret FSH, er GONAL- f mere effektivt end urinderiveret FSH 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.
Dette kan øges fortrinsvist med 37, 5 IE eller med 75 IE med 7 dage eller fortrinsvist med 14 dages mellemrum om nødvendigt, 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.
Nedregulering med en gonadotropin- releasing hormon (GnRH) agonist er nu almindeligt anvendt for at suprimere 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.
33 Anovulatoriske kvinder grundet svær mangel af LH og FSH.
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).
33 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).
Anbefalet dosering 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.
og hos kvinder: • ovarieforstørrelse eller cyste, som ikke er forårsaget af poly0ystisk ovariesyndrom • gynækologiske blødninger af ukendt ætiologi • ovarie -, uterus - eller mamacarcinom
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
Hos mænd: • Primær testikel insufficiens
34 In men: • primary testicular insufficiency
34 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen GONAL- f er et potent gonadotropinprodukt som kan fremkalde milde til alvorlige bivirkninger, og bør derfor kun bruges af læger som er specialiseret på infertilitetsbehandling.
GONAL-f is a potent gonadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Behandling af kvinder Før behandlingen begynder, bør det vurderes om parrets infertilitet er egnet for behandlingen og mulige kontraindikationer for graviditet vurderes.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
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.
35 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.
En klinisk undersøgelse kan påvise hypovolemi, hæmokoncentration, elektrolyt ubalance, ascites, hæmoperitoneum, pleuraekssudat, hydrothorax, akut pulmonær distress samt tromboemboliske komplikationer.
Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
35 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.
For at minimere risikoen for OHSS og flerfoldsgraviditet, anbefales ultralydsundersøgelse sammen med måling af serumøstradiol.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
For at mindske risikon for flerfoldsgraviditet, anbefales nøje overvågning af ovarie stimulationen.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Ekstrauterin graviditet
36 Ectopic pregnancy
36 Medfødte misdannelser
Congenital malformation
Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil eller betjene maskiner.
37 No studies on the effects on the ability to drive and use machines have been performed.