natgillin/translations-raw huggingface dataset:
GONAL- f var lige så effektivt til at stimulere æggestokkene under kunstig befrugtning som sammen - ligningsstoffet.
GONAL-f was as effective as the comparator to stimulate ovaries during assisted reproductive procedures.
Hos kvinder, der ikke kunne få ægløsning, fremkaldte GONAL- f ægløsning hos 84% af kvinderne, sammenholdt med 91% for sammenligningsstoffet.
In women who could not ovulate, GONAL-f produced ovulation in 84% of women compared with 91% for the Comparator.
Det var også effektivt til at fremkal - de ægløsning hos kvinder med svær mangel på LH/ FSH.
It was also effective in triggering egg development in women with severe LF/ FSH deficiency.
I undersøgelsen hos mænd var GONAL- f effektivt til at stimulere sædcelleproduktionen:
In the study in men GONAL-f was effective in stimulating sperm production:
63% af patienterne opnåede sædcelletal på over 1, 5 millioner/ ml.
63% of patients achieved sperm counts above 1.5 million/ ml.
Skønt der kun indgik få patienter i undersøgelserne hos kvinder med svær mangel på LH/ FSH og hos mænd med hypogonadotrop hypogonadisme, er disse undersøgelser blevet godtaget, fordi sygdomme - ne er sjældne.
The studies in women with severe LH/ FSH deficiency and in men with hypogonadotrophic hypogonadism had low numbers of patients but were acceptable because these are rare conditions.
Hvilken risiko er der forbundet med GONAL- f?
What is the risk associated with GONAL-f?
De hyppigste bivirkninger (der ses hos flere end 1 ud af 10 patienter) er ovariecyster, lokale reaktioner på injektionsstedet (smerte, rødme, blå mærker, hævelse og irritation) samt hovedpine.
The most common side effects (seen in more than 1 patient in 10) are ovarian cysts, local reactions at the site of the injection (pain, redness, bruising, swelling and/ or irritation), and headache.
En fuldstændig liste over de indberettede bivirkninger for GONAL- f fremgår af indlægssedlen.
For the full list of all side effects reported with GONAL-f, see the Package Leaflet.
Denne mulighed må både læger og patienter være opmærksomme på.
Sometimes, the ovaries can over-respond to treatment, especially when hCG has been used (ovarian hyperstimulation syndrome), and both doctors and patients must be aware of this possibility.
GONAL- f må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for follitropin alfa, FSH eller andre af indholdsstofferne, eller hos patienter med svulster i hypofyse, hypotalamus, bryster, livmoder eller æggestokke.
GONAL-f must not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients, or in patients with tumours of the pituitary gland, hypothalamus, breast, uterus, or ovary.
Det bør ikke anvendes, når det ikke har mulighed for at virke (som hos patienter med primær ovarie - eller testikelinsufficiens).
It should not be used when an effective response cannot be obtained (such as in patients with primary ovarian or testicular failure).
Det bør desuden ikke anvendes til kvinder med forstørrede æggestokke, cyster i æggestokkene af anden årsag end polycystisk ovariesyndrom, eller med vaginal blødning.
In women, it must not be used when there is ovarian enlargement or cyst not due to polycystic ovarian disease, or vaginal bleeding.
Den fuldstændige liste over begrænsningerne for anvendelsen fremgår af indlægssedlen.
For the full list of restrictions, see the Package Leaflet.
Hvorfor er GONAL- f blevet godkendt?
Why has GONAL-f been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved GONAL- f er større end risiciene ved behandling af kvinder, der er anovulatoriske, kvinder med behov for ægløsning forud for fertilitetsbehandling og, anvendt sammen med luteiniserende hormon, til stimulation af ægmod - ningen hos kvinder med svær mangel på LH og FSH samt ved behandling af mænd med hypogona - dotrop hypogonadisme.
The Committee for Medicinal products for Human Use (CHMP) decided that GONAL-f’ s benefits are greater than its risks for women who are anovulatory, women who need to ovulate before fertility treatment, with luteinising hormone for the stimulation of follicular development in women with severe LH and FSH deficiency, and in men who have hypogonadotrophic hypogonadism.
Udvalget anbefalede meddelelse af markedsføringstilladelse for GONAL- f.
They recommended that GONAL-f be given marketing authorisation.
Andre oplysninger om GONAL- f:
Other information about GONAL-f:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for GONAL- f til Serono Europe Limited den 20. oktober 1995.
The European Commission granted a marketing authorisation valid throughout the European Union, for GONAL-f to Serono Europe Limited on 20 October 1995.
Denne tilladelse blev fornyet den 20. oktober 2000 og den 20. oktober 2005.
The marketing authorisation was renewed on 20 October 2000 and 20 October 2005.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for GONAL- f kan ses i sin helhed her.
The full EPAR for GONAL-f is available here.
Pulver: ampul (glas) Solvens: ampul (glas)
powder: ampoule (glass); solvent: ampoule (glass)
75 IE Solvens:
75 IU; solvent:
1 ml (75 IE/ ml)
1 ml (75 IU/ ml)
1 ampul + 1 ampul
1 ampoule + 1 ampoule
5 ampuller + 5 ampuller
5 ampoules + 5 ampoules
10 ampuller + 10 ampuller
10 ampoules + 10 ampoules
75 IE (5, 5 mikrogram)
75 IU (5.5 micrograms)
5 µg Solvens:
5 µg; solvent:
150 IE
150 IU
150 IE Solvens:
150 IU; solvent:
1 ml (150 IE/ ml)
1 ml (150 IU/ ml)
1050 IE/ 1, 75 ml (77 mikrogram / 1, 75ml)
1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml)
Pulver: hætteglas (glas) Solvens: fyldt
powder: vial (glass); solvent: pre-filled syringe (glass)
80 µg Solvens:
80 µg; solvent:
1 hætteglas + 1 fyldt injektionssprøjte
1 vial + 1 pre-filled syringe + 15 disposable syringes
37, 5 IE (2, 8 mikrogram)
37.5 IU (2.8 micrograms)
2, 5 µg Solvens:
2.5 µg; solvent:
75 IE
75 IU (5.5 micrograms)
Pulver og solvens til
Powder and solvent for solution for injection
Pulver: hætteglas
powder: vial (glass); solvent: pre-filled syringe (glass)
5 µg
5 µg; solvent:
1 hætteglas +
1 ml (5 µg/ ml)
1/ 3 EU- nummer
1 vial + 1 pre-filled syringe
Lægemiddelform
1/ 2 EU Number
Indhold (Koncentration)
Pharmaceutical form
Paknings- størrelse
Route of administration
(5, 5 mikrogram)
Packaging
(glas) Solvens: fyldt injektionssprøjte (glas)
Content (concentration)
1 ml (5 µg/ ml)
Package size
5 hætteglas + 5 fyldte injektionssprøjter
5 vials + 5 pre-filled syringes
150 IE (11 mikrogram)
150 IU (11 micrograms)
10 µg Solvens:
10 µg; solvent:
450 IE/ 0, 75 ml (33 mikrogram/ 0, 75ml)
450 IU/ 0.75 ml (33 micrograms/ 0.75 ml)
40 µg Solvens:
40 µg; solvent:
1 hætteglas + 1 fyldt injektionssprøjte + 6 engangssprøjter
1 vial + 1 pre-filled syringe + 6 disposable syringes
300 IE/ 0, 5 ml
300 IU/ 0.5 ml (22 micrograms/ 0.5 ml)
450 IE
450 IU; solvent:
1 hætteglas +
1 vial + 1 pre-filled syringe + 4 disposable syringes
300 IE / (22
300 IU/ 0.5 ml (22 micrograms/ 0.5 ml)
Injektionsvæske, opløsning i en fyldt
Solution for injection in a pre-filled pen
Ampul (glas) i en fyldt 0, 5 ml pen
cartridge (glass) in pre-filled pen
1 fyldt pen + 5 kanyler
1 pre-filled pen + 5 needles
mikrogram/ 0, 5ml) EU/ 1/ 95/ 001/ 034
EU/ 1/ 95/ 001/ 034
450 IE/ 0, 75 ml (33 mikrogram/ 0, 75m
450 IU/ 0.75 ml (33 micrograms/ 0.75 ml)
pen
Subcutaneous use
Subkutan anvendelse Ampul (glas) i en fyldt 0, 75 ml pen
cartridge (glass) in pre-filled pen
1 fyldt pen + 7 kanyler
1 pre-filled pen + 7 needles
900 IE/ 1, 5 ml (66 mikrogram/ 1, 5 ml)
900 IU/ 1.5 ml (66 micrograms/ 1.5 ml)
Subkutan anvendelse Ampul (glas) i en fyldt 1, 5 ml pen
cartridge (glass) in pre-filled pen
1 fyldt pen + 14 kanyler
1 pre-filled pen + 14 needles
GONAL- f 75 IE, pulver og solvens til injektionsvæske, opløsning.
GONAL-f 75 IU powder and solvent for solution for injection.
En ampul indeholder 75 IE follitropin alfa, rekombinant humant follikelstimulerende hormon (FSH).
One ampoule contains 75 IU follitropin alfa, recombinant human follicle stimulating hormone (FSH).
Den tilberedte opløsning indeholder 75 IE / ml.
The reconstituted solution contains 75 IU/ ml.
Follitropin alfa produceres i genetisk modificerede ovarieceller fra kinesisk hamster (CHO celler).
Follitropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
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.
Pulverets udseende: hvidt frysetørret pulver.
Appearance of the powder: white lyophilised pellet.
Solvensens udseende: klar farveløs væske.
Appearance of the solvent: clear colourless solution.
Den tilberedte opløsning har en pH værdi på 6. 5- 7. 5.
The pH of the reconstituted solution is 6.5 - 7.5.
• Behandling af 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.
• 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 sammen med en luteiniserende hormon (LH) opløsning anbefales til stimulaton af follikeludvikling hos kvinder med svær mangel af LH og FSH.
• 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 kliniskestudier blevet indentifieret 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.
• GONAL- f anvendes i kombination med behandling med humant choriongonadotropin (hCG) til stimulation af spermatogenesen hos mænd, som har medfødt eller erhvervet hypogonadotrop hypogonadisme.
• GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
4. 2 Dosering og indgivelsemåde
4.2 Posology and method of administration
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.
GONAL- f er beregnet til subkutan anvendelse.
GONAL-f is intended for subcutaneous administration.
Efter opløsning i vedlagte solvens bør præparatet anvendes umiddelbart.
The powder should be reconstituted immediately prior to use with the solvent provided.
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 containers of product may be dissolved in 1 ml of solvent.
2 Den anbefalede dosis for GONAL- f er den der anvendes ved brug af urin FSH.
2 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Kliniske vurderinger af GONAL- f indikerer, at dens daglige dosis, administrations kuren 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 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.
PCOS)
Women with anovulation (including PCOD):
Hensigten med GONAL- f behandling er udvikling af en moden Graafsk follikel hvorfra ægget vil blive frigivet efter administration med 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.
GONAL- f kan gives som daglige injektioner.
GONAL-f may be given as a course of daily injections.
Hos kvinder med menstruation bør behandlingen påbegyndes indenfor de første 7 dage af menstruationscyklus.
In menstruating patients treatment should commence within the first 7 days of the menstrual cycle.
Behandlingen bør tilpasses til den enkelte patientens 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 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 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 en 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 en optimal respons er opnået, gives en injektion 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.
Patienten anbefales at have coitus på selve dagen og på dagen efter hCG indgivelsen.
The patient is recommended to have coitus on the day of, and the day following, hCG administration.
Hvis et for kraftigt ovarielt respons opnås, bør behandlingen stoppes og hCG injektionen seponeres (se pkt.
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 forrige 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:
Den mest almindelige dosering 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.
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.
Sædvanligvis opnås tilstrækkelig follikeludvikling i gennemsnit på den tiende behandlingsdag (interval 5- 20 dage).
In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
En enkelt injektion på op til 10. 000 IE hCG administreres 24- 28 timer efter sidste GONAL- f injektion for at inducere follikulær modning.
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- releasing hormon (GnRH) agonist er nu almindelig 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.
2 uger efter starten af agonistbehandlingen, 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, 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.
3 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
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).
GONAL- f skal gives som en daglig injektion sammen med lutropin alfa.
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
Idet disse patienter er amenoreiske og har lav endogen østrogen sekretion, kan behandling påbegyndes når som helst.
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Behandlingen bør tilpasses den enkelte patients respons, vurderet ud fra måling af follikelstørrelse ved hjælp af ultralyd og serumøstrogen.
Treatment should be tailored to the individual patient’ s response as assessed by measuring follicle size by ultrasound and oestrogen response.
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.
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 IU-75 IU increments.
Når optimal respons er opnået, gives en enkelt injektion af hCG 5000 IE til 10000 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.
Patienten anbefales at have coitus på selve dagen og på dagen efter hCG indgivelsen.
The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Alternativt, kan intrauterin insemination (IUI) foretages.
Alternatively, intrauterine insemination (IUI) may be performed.
Lutealfasestøtte bør overvejes idet mangel af substanser med luteotropisk aktivitet (LH/ hCG) efter ovulation kan føre til for tidlig svigt af corpus luteum.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/ hCG) after ovulation may lead to premature failure of the corpus luteum.
Hvis et for kraftigt ovarielt respons opnås, bør behandlingen stoppes og hCG injektionen seponeres.
If an excessive response is obtained, treatment should be stopped and hCG withheld.
Mænd med hypogonadotrop hypogonadisme
Men with hypogonadotrophic hypogonadism:
GONAL- f skal gives, sammen 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.
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
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 mamacarcinom
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 effektivt respons ikke kan opnås, som for eksempel:
GONAL-f should not be used when an effective response cannot be obtained, such as:
Hos kvinder: • 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 testikel insufficiens
In men: primary testicular insufficiency
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.
4 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 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.
Hos visse patienter ses dårligt respons på FSH.
There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients.
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.
Injektion af GONAL- f skal kun udføres af patienter som er motiveret, tilstrækkeligt instruerede 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.
Den første GONAL- f injektion skal udføres under medicinsk tilsyn.
The first injection of GONAL-f should be performed under direct medical supervision.
Patienter med porphyri eller med en familie historie med porphyri skal monitoreres nøje under behandlingen med Gonal- f.
Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f.
Forværring eller første tegn på denne tilstand må kræve ophør af behandlingen.
Deterioration or a first appearance of this condition may require cessation of treatment.
GONAL- f indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. er næsten "fri for natrium".
GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.