natgillin/translations-raw huggingface dataset:
Før behandlingen begynder, bør det vurderes om parrets infertilitet er egnet for behandling og mulige kontraindikationer for graviditet vurderes.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Specielt skal patienten undersøges for hypothyroidisme, adrenokortikalt svigt, hyperprolaktinæmi og tumorer i hypofyse eller hypothalamus og adækvat behandling gives.
In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
For patienter, som gennemgår stimulation af follikeludvikling, enten i forbindelse med ART eller behandling for anovulatorisk infertilitet, øges risikoen for at udvikle ovarieforstørrelse eller hyperstimulering.
Patients undergoing stimulation of follicular growth, whether in the frame of a treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Overholdelse af anbefalet Gonal- f dosis og administrationskur samt nøje overvågning af behandlingen vil reducere risikoen for disse bivirkninger.
Adherence to 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 en læge med erfaring i dette.
Acute interpretation of the indices of follicle development and maturation require a physician whom is experienced in the interpretation of the relevant tests.
I kliniske studier så man en øget følsomhed af ovarierne overfor GONAL- f når det blev indgivet sammen med lutropin alfa.
In clinical trials, an increase of the ovarian sensitivity to GONAL-f was shown when administered with lutropin alfa.
Hvis en øgning af FSH dosis bliver nødvendig, bør dosisøgningen 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 fortaget 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 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 what can be obtained with hMG.
Ovarie Hyperstimulation Syndrom (OHSS)
Ovarian Hyperstimulation Syndrome (OHSS)
OHSS er en medicinsk tilstand til forskel fra ukompliceret ovarie forstørrelse.
OHSS is a medical event distinct from uncomplicated ovarian enlargement.
OHSS er et syndrom som manifesteres i stigende grader af alvorlighed.
OHSS is a syndrome that can manifest itself with increasing degrees of severity.
Ved OHSS ses markant ovarie forstørrelse, forhøjet serumniveau af kønssteroider og en øget vaskulær permeabilitet hvilket kan resultere i en ophobning af væske i bugen, lungerne og meget sjældent, i cavitas pericardialis.
It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
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.
Clinical evaluation may reveal hypovolaemia,
En klinisk undersøgelse kan påvise hypovolemi, hæmokoncentration, elektrolyt ubalance, ascites, hæmoperitoneum, pleuraekssudat, hydrothorax, akut pulmonær distress samt tromboemboliske komplikationer.
5 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
Meget sjældent, kan alvorlig OHSS blive kompliceret af lungeemboli, iskæmisk slagtilfælde og hjerteinfarkt.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
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.
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 - 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.
Patienten skal derfor følges i mindst 2 uger efter hCG administration.
OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after hCG administration.
5 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.
Ved anovulation er risikoen for OHSS og flerfoldsgraviditet øget ved serum niveauer > 900 pg/ ml (3300 pmol/ L) og hvis der findes mere end 3 follikler på 14 mm i diameter eller større.
In anovulation the risk of OHSS and multiple pregnancy is increased by a serum oestradiol > 900 pg/ ml (3300 pmol/ l) and more than 3 follicles of 14 mm or more in diameter.
Ved ART er der en øget risiko for OHSS ved østradiol niveauer > 3000 pg/ ml (11. 000 pmol/ L), samt 20 eller flere follikler 12 mm i diameter eller større.
In ART there is an increased risk of OHSS with a serum oestradiol > 3000 pg/ ml (11000 pmol/ l) and 20 or more follicles of 12 mm or more in diameter.
Hvis østradiolniveauet 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.
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).
OHSS kan blive alvorligere og længerevarende hvis graviditet opstår.
OHSS may be more severe and more protracted if pregnancy occurs.
Ved de fleste tilfælde opstår OHSS først efter afsluttet hormonbehandling og når sit maksimum syv til ti dage senere.
Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Hvis alvorlig OHSS opstår, skal evt. igangværende gonadotropinbehandling stoppes og patienten indlægges på hospital og behandles for OHSS.
If severe OHSS occurs, gonadotrophin treatment should be stopped if still ongoing, the patient hospitalised and specific therapy for OHSS started.
Flerfoldsgraviditet, især i mangefold, medfører en øget risiko for skadelig udfald for moder og foster.
Multiple pregnancy, specially high order, carries an increase risk in adverse maternal and perinatal outcomes.
Patienter der genemgår ovalutions 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.
Størstedelen af flerfolds fødsler er tvillinger.
The majority of multiple conceptions are twins.
For at mindske risikoen for flerfoldsgraviditet, anbefales nøje overvågning af ovarie stimulationen.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Hos patienter der gennemgår ART er risikoen for flerfoldsgraviditet primært relateret til antallet embryo der bliver tilbagelagt, deres kvalitet og patientens alder.
In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Patienten bør informeres om risikoen for flerfoldsgraviditet før behandling påbegyndes.
The patients should be advised of the potential risk of multiple births before starting treatment.
Graviditetsbortfald
Pregnancy wastage
Hyppigheden af graviditetsbortfald i form af spontan abort er øget hos patienter der er i stimulationsbehandling for ovulations induktion eller ART sammenlignet med normal populationen.
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than in the normal population.
Ekstrauterin graviditet
6 Ectopic pregnancy
Hyppigheden af ekstrauterin graviditet efter IVF er 2 til 5% sammenlignet med 1 til 1, 5% hos den generelle befolkning.
The prevalence of ectopic pregnancy after IVF was reported to be 2 to 5%, as compared to 1 to 1.5% in the general population.
Der er rapporteret tilfælde af ovarie og reproduktionssystemstumorer, både benigne og maligne, hos kvinder der har gennemgået adskillige behandlinger med lægemidler for infertilitet.
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Det er 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 tumors in infertile women.
6 Medfødte misdannelser
Congenital malformation
Årsagen til dette antages at være forskellen i 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.
Tromboembolisk risiko
Thromboembolic events
For kvinder med kendt risiko for tromboemboliske tilstand, personlig eller familiehistorisk, kan behandling med gonadotropin øge risikoen.
In women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with gonadotrophins may further increase the risk.
Hos disse kvinder bør fordele med gonadotropin behandling vejes overfor 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 et tromboembolisk tilfælde.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
Forhøjede endogene FSH- niveauer er tegn på primært testikelsvigt.
Elevated endogenous FSH levels are indicative of primary testicular failure.
Hos sådanne patienter er der ingen respons på behandling med GONAL- f/ hCG.
Such patients are unresponsive to GONAL-f/ hCG therapy.
Sædanalyse er anbefalet 4- 6 måneder efter behandlingens start for at vurdere effekten.
Semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
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.
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.
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 graviditet
Use during pregnancy
Der er ingen indikation for GONAL- f under graviditet.
There is no indication for use of GONAL-f during pregnancy.
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 gonadotropins.
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 FSH.
Hidtil er der imidlertid ikke rapporteret om nogen særlig misdannende effekt.
However, to date, no particular malformative effect has been reported.
Ingen fosterskadelig effekt er set i dyrestudier.
No teratogenic effect has been observed in animal studies.
Ved amning
7 Use during lactation
GONAL- f er ikke indikeret ved amning.
GONAL-f is not indicated during lactation.
Under amning kan sekretion af prolaktin medføre en ringe prognose for ovariestimulation.
During lactation, the secretion of prolactin can entail a poor prognosis to ovarian stimulation.
4. 8 Bivirkninger Indenfor hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter hvor alvorlige bivirkningerne er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
7 Behandling af kvinder Forstyrrelser i immunsystemet
Treatment in women Immune system disorders
Meget sjælden (< 1/ 10. 000)
Very rare (< 1/ 10,000)
Mild systemisk allergisk reaktion (f. eks. milde former for erytem, udslæt, opsvulmen af ansigtet, urticaria, ødem, vejrtrækningsbesvær).
Mild systemic allergic reactions (e. g. mild forms of erythema, rash, facial swelling, urticaria, oedema, difficulty breathing).
Alvorlige tilfælde af allergiske reaktioner inklusiv anafylaktiske reaktioner er også rapporteret.
Serious cases of allergic reactions, including anaphylactic reactions, have also been reported.
Sygdomme i nervesystemet Karsygdomme
Nervous system disorders Vascular disorders
Meget almindelig (> 1/ 10) Meget sjælden (< 1/ 10. 000)
Very Common (> 1/ 10) Very rare (< 1/ 10,000)
Hovedpine Tromboembolisme, normalt forbundet med alvorlig OHSS
Headache Thromboembolism, usually associated with severe OHSS
Respiratoriske, thorakale og mediastinale lidelser
Respiratory, thoracic and mediastinal disorders
Exacerbationer eller forværring af astma
Exacerbation or worsening of asthma
Almindelig (> 1/ 100, < 1/ 10)
Common (> 1/ 100, < 1/ 10)
Mavesmerter og gastrointestinale symptomer såsom kvalme, opkast, diarré, kramper i maven og oppustethed
Abdominal pain and gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal cramps and bloating
Meget almindelig (> 1/ 10)
Very Common (> 1/ 10)
Ovarie cyster
Ovarian cysts
4. 4)
Mild to moderate OHSS (see section 4.4)
Usædvanlig (> 1/ 1. 000, < 1/ 100) Sjælden (> 1/ 10. 000, < 1/ 1. 000)
Uncommon (> 1/ 1,000 ,< 1/100) Rare (> 1/10 ,000, < 1/1,000)
4. 4) Ovarietorsion, en komplikation af OHSS
Severe OHSS (see section 4.4) Ovarian torsion, a complication of OHSS
Milde reaktioner på injektionsstedet (smerte, rødme, blåt mærke, hævelse og/ eller irritation på injektionsstedet)
Mild to severe injection site reaction (pain, redness, bruising, swelling and/ or irritation at the site of injection)
Sygdomme i hud og subkutane væv
8 Treatment in men Skin and subcutaneous tissue disorders
Lidelser i det reproduktivesystem og brystsygdomme
Reproductive system and breast 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.
Gonadotropiner, ATC kode:
Pharmacotherapeutic group: gonadotrophins, ATC code:
GONAL- f er humant follikelstimulerende hormon produceret i genetisk modificerede ovarieceller fra kinesisk hamster (CHO celler).
GONAL-f is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
I kliniske forsøg blev patienter med alvorlig mangel på FSH og LH definieret ved et endogent serumniveau af LH < 1, 2 IE/ l målt i et centralt laboratorium.
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.
Hos mænd, med mangelfuld FSH, vil samtidig indgift af GONAL- f og hCG i mindst 4 måneder inducere spermatogenesen.
In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
1 døgn.
Following intravenous administration, GONAL-f is distributed to the extra cellular 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 fordelingsrummet og den totale 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 en GONAL- f - dosis udskilles i urinen.
One- eighth of the GONAL-f dose is excreted in the urine.
70%.
Following subcutaneous administration, the absolute bioavailability is about 70%.
Efter gentagen administration akkumuleres GONAL- f 3 gange og steady state opnås indenfor 3- 4 dage.
Following repeated administration, GONAL-f accumulates 3-fold achieving a steady-state within 3-4 days.
Hos kvinder hvis endogene gonadotropin sekretion er undertrykt, har det ikke desto mindre vist sig, at GONAL- f effektivt stimulerer follikeludviklingen og steroidgenesen, på trods af umålelige LH- værdier.
In women whose endogenous gonadotrophin secretion is suppressed, GONAL-f has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
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.
Der er rapporteret om nedsat fertilitet hos rotter som blev exponeret for farmakologiske doser af follitropin alfa (≥ 40 IE/ kg/ dag.) gennem længere perioder, på grund af reduceret frugtbarhed.
Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/ kg/ day) for extended periods, through reduced fecundity.
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.
9 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.
Eftersom GONAL- f ikke er indikeret under graviditet, er disse data dog af begrænset klinisk relevans.
However, since GONAL-f is not indicated in pregnancy, these data are of limited clinical relevance.
Saccharose Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatdihydrat Phosphorsyre, koncentreret Natriumhydroxid
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
For umiddelbar engangsbrug efter åbning og tilberedning.
For immediate and single use following first opening and reconstitution.
Pulveret er pakket i 3 ml neutral farveløs glas (type I) ampuller.
The powder is packaged in 3 ml neutral colourless glass (type I) ampoules.
Solvensen er pakket i 3 ml neutral farveløs glas (type I) ampuller.
The solvent is packaged in 3 ml neutral colourless glass type I ampoules.
Produktet bliver leveret i pakninger af 1, 5 eller 10 ampuller med det tilsvarende antal solvens ampuller.
The product is supplied in packs of 1, 5, 10 ampoules with the corresponding number of solvent ampoules.
Er kun til engangsbrug.
For single use only.
GONAL- f skal opløses i solvensen før brug.
GONAL-f must be reconstituted with the solvent before use.
GONAL- f kan tilberedes sammen med lutropin alfa og indgives som en injektion.
GONAL-f may be co-reconstituted with lutropin alfa and co-administered as a single injection.
I dette tilfælde skal lutropin alfa opløses først og bruges til at opløse GONAL- f pulveret.
In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
Anvend ikke produktet, hvis du bemærker at opløsningen indeholder partikler eller er uklar.
The reconstituted solution should not be administered if it contains particles or is not clear.
Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overenstemmelse med lokale krav.
10 Any unused product or waste material should be disposed of in accordance with local requirements.
Serono Europe Limited 56 Marsh Wall London E14 9TP Storbritannien
56 Marsh Wall London E14 9TP United Kingdom
20.
20 October 1995.
Oktober 1995 Dato for fornyelse af tilladelsen:
Date of last renewal:
Oktober 2005
19 October 2005.
GONAL- f 150 IE, pulver og solvens til injektionsvæske, opløsning.
GONAL-f 150 IU powder and solvent for solution for injection.
En ampul indeholder 150 IE follitropin alfa, rekombinant humant follikelstimulerende hormon (FSH).
One ampoule contains 150 IU follitropin alfa, recombinant human follicle stimulating hormone (FSH).
Den tilberedte opløsning indeholder 150 IE / ml.
The reconstituted solution contains 150 IU/ ml.
Hvidt frysetørret pulver.
Appearance of the powder: white lyophilised pellet.
Klar farveløs væske.
Appearance of the solvent: clear colourless solution.
Den tilbredte opløsning har en pH værdi på 6. 5- 7. 5.
The pH of the reconstituted solution is 6.5 - 7.5.
Disse patienter er i kliniske studier 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.
Den anbefalede dosis for GONAL- f er den der anvendes til brug af urin FSH.
12 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
12 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 og 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.