FrancophonIA/ELRC3.0 huggingface dataset:
English: The concurrent determination of serum oestradiol levels may also be useful.
Danish: Samtidig bestemmelse af estradiol i serum kan også være nyttig.
English: If you do a pregnancy test during your infertility treatment with Elonva, the test might wrongly suggest that you are pregnant.
Danish: Hvis du tager en graviditetstest under din fertilitetsbehandling med Elonva, kan testen fejlagtigt vise, at du er gravid.
English: The GnRH antagonist is used to prevent premature Luteinising Hormone (LH) surges.
Danish: GnRH-antagonisten anvendes for at undgå præmatur stigning i luteiniserende hormon (LH).
English: After a single subcutaneous injection of Elonva, the maximum serum concentration of corifollitropin alfa is 4.24 ng/mL (2.49-7.21 ng/mL
Danish: Efter en enkelt subkutan Elonva-injektion er den maksimale serumkoncentration af corifollitropin alfa 4,24 ng/ml (2,49-7,21 ng/ml
English: If you forget to use Elonva
Danish: Hvis du har glemt at tage Elonva
English: *corifollitropin alfa is a glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: *corifollitropin alfa er et glykoprotein fremstillet ved rekombinant DNA teknologi i ovarieceller fra kinesiske hamstere (CHO).
English: Subcutaneous use (SC)
Danish: Til subkutan anvendelse (s.c.)
English: More than one injection of Elonva within one treatment cycle or too high a dose of Elonva and/or (rec)FSH may increase the risk of OHSS (see OHSS in section 4.4.
Danish: Mere end én injektion af Elonva i en behandlingscyklus eller for høj Elonva-dosis og/eller (rec)FSH kan øge risikoen for OHSS (se OHSS i pkt.
English: Reproduction toxicology studies in rats and rabbits indicated that corifollitropin alfa does not adversely affect fertility.
Danish: Studier af reproduktionstoksicitet hos rotter og kaniner indikerer, at corifollitropin alfa ikke har en ugunstig virkning på fertiliteten.
English: - Swab the injection site (the area just below your belly button) with a disinfectant (for example, alcohol) to remove any surface bacteria.
Danish: - Aftør indsprøjtningsstedet (området lige under din navle) med et desinfektionsmiddel (f.eks. sprit) for at fjerne eventuelle bakterier på huden.
English: o A previous COS cycle that resulted in more than 30 follicles  11 mm measured by ultrasound examination.
Danish: o Tidligere COS-cyklus som resulterede i mere end 30 follikler ≥ 11 mm set ved ultralydsundersøgelse.
English: Abortion spontaneous
Danish: Spontan abort
English: Elonva 150 µg recFSH 300 IU N=268 N=128 N=756 N=750 N=694 N=696
Danish: Elonva 150 µg recFSH 300 IE N=268 N=128 N=756 N=750 N=694 N=696
English: Corifollitropin alfa exposure after a single subcutaneous injection is 665 hours*ng/mL (AUC, 426-1,037 hours*ng/mL
Danish: Eksponering for corifollitropin alfa efter en enkelt subkutan injektion er 665 timer*ng/ml (AUC, 426-1.037 timer*ng/ml
English: Storage by the pharmacist Store in a refrigerator.
Danish: Opbevaring på apoteket Opbevares i køleskab.
English: Elonva is intended for single subcutaneous injection only.
Danish: Elonva er kun beregnet til en enkelt subkutan injektion.
English: One of these gonadotropic hormones is follicle-stimulating hormone (FSH), which is needed in women for the growth and development of follicles (small round sacs in your ovaries that contain the eggs).
Danish: Et af disse hormoner er det follikelstimulerende hormon (FSH), som er nødvendigt hos kvinder for at sikre vækst og udvikling af follikler (små runde sække i dine æggestokke, som indeholder æg).
English: In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter.
Danish: Der er en øget risiko for OHSS ved ART, hvis man observerer 18 eller flere follikler på 11 mm i diameter eller derover.
English: Elonva must be injected under the skin (subcutaneously) into a skin fold (that you pinch between your thumb and index finger), preferably just below the navel.
Danish: Elonva skal indsprøjtes under huden (subkutant) i en hudfold (som du klemmer sammen mellem din pege- og tommelfinger) helst lige under navlen.
English: 1) postdose.
Danish: 1) efter dosering.
English: Elonva may cause a false positive hCG pregnancy test if the test is administered during the ovarian stimulation portion of the ART cycle.
Danish: Elonva kan medføre en falsk positiv hCG graviditetstest, hvis testen administreres under ovariestimulationen i ART-cyklus.
English:  Primary ovarian failure.
Danish: • Primær ovarieinsufficiens.
English: Elonva contains the active ingredient corifollitropin alfa and belongs to the group of medicines called gonadotropic hormones.
Danish: Elonva indeholder det aktive stof corifollitropin alfa og tilhører en gruppe af lægemidler kaldet gonadotropiner (gonadotrope hormoner).
English: If you use more Elonva or (rec)FSH than you should If you think you have used more Elonva or (rec)FSH than you should, contact your doctor immediately.
Danish: Hvis du har taget for meget Elonva eller (rec)FSH Hvis du tror, du har taget for meget Elonva eller (rec)FSH, skal du straks kontakte lægen.
English: Adherence to the recommended Elonva dose and treatment regimen and careful monitoring of ovarian response is important to reduce the risk of OHSS.
Danish: Det er vigtigt at overholde den anbefalede Elonvadosis og behandlingsregime og nøje overvåge det ovarielle respons for at nedsætte risikoen for OHSS.
English: Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities.
Danish: Intravaskulær trombose, som kan opstå i vener eller arterier, kan give en nedsat blodgennemstrømning til vitale organer og ekstremiteter.
English: Multiple pregnancies and specific characteristics of couples with fertility problems (e.g., a woman's age, certain sperm problems, genetic background of both parents) may also be associated with an increased chance of birth defects.
Danish: Flerfoldsgraviditet og særlige karakteristika hos par, som behandles for barnløshed (f.eks. kvindens alder, visse problemer med mandens sædkvalitet og begge forældres genetiske baggrund), kan også være forbundet med en øget risiko for medfødte misdannelser.
English: There is an increased chance of having twins or even more than two babies, even when only one embryo is transferred into the uterus.
Danish: Der er en øget sandsynlighed for at få tvillinger eller flere børn, selv hvis der kun opsættes et befrugtet æg i livmoderen.
English: Predicted range for 90% of subjects.
Danish: Forventet interval for 90% af forsøgspersonerne.
English: Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation.
Danish: Tidlig OHSS opstår normalt indenfor 10 dage efter hCG administration og kan være forbundet med for højt ovarierespons på gonadotropin stimulation.
English: Infertile women undergoing ART have an increased incidence of ectopic pregnancies.
Danish: Infertile kvinder, der gennemgår ART, har en øget hyppighed af ektopiske graviditeter.
English: After absorption into the blood, corifollitropin alfa is distributed mainly to the ovaries and the kidneys.
Danish: Efter absorption distribueres corifollitropin alfa primært til ovarier og nyrer.
English: IVF involves collecting the eggs from the ovary, fertilising them in the laboratory, and transferring the embryos into the uterus a few days later.
Danish: IVF indbefatter udtagning af æg fra æggestokkene, befrugtning på laboratoriet og opsætning af befrugtede æg i livmoderen et par dage efter.
English: The number of oocytes retrieved was a key secondary efficacy endpoint.
Danish: Antal aspirerede oocytter var et centralt sekundært virkningsendepunkt.
English: It is not known if treatment with fertility medicines increases the risk of these tumours in infertile women.
Danish: Det vides ikke, om behandlingen med fertilitetslægemidler øger risikoen for disse tumorer hos ufrugtbare kvinder.
English: As soon as three follicles  17 mm are observed, a single injection of 5,000 up to 10,000 IU hCG is administered the same day or the day thereafter to induce final oocyte maturation.
Danish: Så snart der ses tre follikler ≥17 mm, administreres en enkelt injektion på 5.000 op til 10.000 IE hCG samme dag eller dagen efter for at inducere modning af oocytter.
English: Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS following treatment with Elonva.
Danish: Kvinder med kendte risikofaktorer for højt ovarierespons kan være særligt tilbøjelige til at udvikle OHSS efter behandling med Elonva.
English: Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles.
Danish: Din læge vil foretage en ultralydsscanning af dine æggestokke for omhyggeligt at overvåge antallet af follikler.
English: Talk to your doctor before using Elonva.
Danish: Kontakt lægen, før du tager Elonva.
English: There is no relevant use of Elonva within the approved indication in the paediatric population.
Danish: Der er ingen relevante indikationer for Elonva i den pædiatriske population.
English: Corifollitropin alfa does not display any intrinsic LH/hCG activity.
Danish: Corifollitropin alfa viser ingen LH/hCG aktivitet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Elonva in one or more subsets of the paediatric population in hypogonadotrophic hypogonadism (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur (EMA) har udsat kravet om fremlæggelse af resultaterne af studier med Elonva hos en eller flere undergrupper af den pædiatriske population ved hypogonadotrop hypogonadisme (se pkt.
English: Other medical conditions
Danish: Andre medicinske tilstande
English: Seven days after the injection of Elonva, your doctor may decide to continue your stimulation cycle with another gonadotropic hormone, like (rec)FSH.
Danish: 7 dage efter Elonva-indsprøjtningen kan din læge beslutte at fortsætte din stimulationscyklus med et andet gonadotropin hormon såsom (rec)FSH.
English: The long duration of FSH activity was achieved by adding the carboxy-terminal peptide of the β-subunit of human chorionic gonadotropin (hCG) to the β-chain of human FSH.
Danish: Den lange varighed af FSH aktiviteten er opnået ved at tilføje den carboxy-terminale peptid af ß-delen af humant choriongonadotropin (hCG) til ß-kæden af humant FSH.
English: Blood clot (Thrombosis)
Danish: Blodpropper (trombose)
English: Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.
Danish: Elonva er indiceret til kontrolleret ovariel stimulation (COS) i kombination med en gonadotropin releasing hormon (GnRH) antagonist med henblik på at udvikle multiple follikler hos kvinder i medicinsk assisteret reproduktionsbehandling (ART).
English: Hepatic metabolism contributes to a minor extent to the elimination of corifollitropin alfa.
Danish: Metabolisme i leveren bidrager i mindre grad til eliminationen af corifollitropin alfa.
English: Women should be advised that if they feel dizzy, they should not drive or use machines.
Danish: Kvinder skal oplyses om, at de ikke bør føre motorkøretøj eller betjene maskiner, hvis de føler sig svimle.
English: Treatment with (rec)FSH is then stopped and the eggs are matured by giving hCG (human Chorionic Gonadotropin).
Danish: Herefter stoppes behandlingen med (rec)FSH, og æggene modnes ved at give hCG (humant choriongonadotropin).
English: Procedural pain
Danish: Smerter i forbindelse med proceduren
English: Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.
Danish: Derfor skal din læge udføre en tidlig ultralydsscanning for at udelukke muligheden for graviditet udenfor livmoderen.
English: In women undergoing ART procedures the risk of multiple pregnancy is mainly related to the number of embryos transferred.
Danish: Risikoen for flerfoldsgraviditet hos kvinder, der er i ART, er hovedsageligt relateret til antallet af embryoner, der bliver lagt tilbage.
English: Do not throw away an empty or unused syringe via household waste.
Danish: En tom eller ubrugt sprøjte må ikke bortskaffes som almindeligt husholdningsaffald.
English: Vascular complications
Danish: Vaskulære komplikationer
English: Ovarian torsion may be related to other conditions, such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, and previous or current ovarian cysts.
Danish: Ovarietorsion kan være relateret til andre tilstande, som f.eks. OHSS, graviditet, tidligere operation i abdomen, ovarietorsion i anamnesen og tidligere eller nuværende ovariecyster.
English: Preparing the injection
Danish: Forberedelse af indsprøjtningen
English: Number of oocytes retrieved
Danish: Antal aspirerede oocytter
English: The primary efficacy endpoint in the ENGAGE study was ongoing pregnancy (assessed at least 10 weeks after embryo transfer).
Danish: Det primære virkningsendepunkt i ENGAGE-studiet var igangværende graviditet (vurderet mindst 10 uger efter embryo-oplægning).
English: If treatment with Elonva results in pregnancy, there is a higher chance of pregnancy outside the uterus (an ectopic pregnancy).
Danish: Hvis behandling med Elonva medfører graviditet, er der en højere risiko for graviditet uden for livmoderen (en ektopisk graviditet).
English: Elonva should be administered as a single subcutaneous injection, preferably in the abdominal wall, during the early follicular phase of the menstrual cycle.
Danish: Elonva skal gives som en enkelt subkutan injektion, fortrinsvis i maveskindet, i den tidlige follikulære fase i mentruationscyklussen.
English: This leaflet was last revised in Month YYYY.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Before starting to use this medicine, tell your doctor if you have ever had ovarian hyperstimulation syndrome (OHSS).
Danish: Før du starter med at tage denne medicin, skal du fortælle din læge hvis du nogensinde har haft ovarielt hyperstimulationssyndrom (OHSS).
English: For convenience, the patient is allowed to store the product at or below 25°C for a period of not more than 1 month.
Danish: For letheds skyld kan patienten opbevare lægemidlet ved eller under 25°C i højst 1 måned.
English: Pituitary suppression with a GnRH antagonist (ganirelix acetate injection at a daily dose of 0.25 mg) was used in each of the three clinical trials.
Danish: Hypofysehæmning ved hjælp af en GnRH-antagonist (injektion med ganirelixacetat i en daglig dosis på 0,25 mg) blev anvendt i alle tre kliniske studier.
English: Elonva 150 µg recFSH 300 IU n N % n N % n N % n N %
Danish: Elonva 150 µg recFSH 300 IE n N % n N % n N % n N %
English: Contact your doctor without delay if you have pain in the stomach (abdomen) or any of the other symptoms of ovarian hyperstimulation, even if they occur some days after the injection has been given.
Danish: Kontakt straks din læge, hvis du har mavesmerter eller andre af symptomerne på overstimulation af æggestokkene, selv om de opstår nogle dage efter indsprøjtningen.
English: Always use Elonva exactly as your doctor has told you.
Danish: Tag altid Elonva nøjagtigt efter lægens anvisning.
English: In the treatment of women of reproductive age, the dose of Elonva is based on weight and age.
Danish: Ved behandling af kvinder i den fertile alder er dosis af Elonva baseret på vægt og alder.
English: A step-by-step “instructions for use” is given at the end of this leaflet.
Danish: Der findes en trin-for-trin brugsanvisning i slutningen af denne indlægsseddel.
English: It is important to have early ultrasound confirmation that a pregnancy is intrauterine, and to exclude the possibility of extrauterine pregnancy.
Danish: Det er vigtigt tidligt i forløbet at bekræfte, at en graviditet er intrauterin ved hjælp af ultralyd, og at udelukke muligheden for ektrauterin graviditet.
English: You should not use Elonva if you are already pregnant, or think that you might be pregnant, or if you are breast-feeding.
Danish: Graviditet og amning Du må ikke tage Elonva, hvis du allerede er gravid, eller tror du er gravid, eller hvis du ammer.
English: Ovarian hyperstimulation syndrome (OHSS)
Danish: Ovarielt hyperstimulationssyndrom (OHSS)
English: During the first seven days after the injection with Elonva, you should not use (recombinant) Follicle Stimulating Hormone ((rec)FSH).
Danish: I løbet af de 7 første dage efter Elonva-indsprøjtningen skal du ikke bruge (rekombinant) follikelstimulerende hormon ((rec)FSH).
English: In animal studies reproductive toxicity has been observed (see preclinical safety data in section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet (se prækliniske sikkerhedsdata pkt.
English: The mean number of embryos transferred in the FTET cycles of ENGAGE was 1.7 in both treatment groups.
Danish: Det gennemsnitlige antal oplægninger af embryoner i FTET-cyklusserne i ENGAGE var 1,7 i begge behandlingsgrupper.
English: In addition, ectopic pregnancy and multiple gestations have been reported.
Danish: Der er desuden rapporteret ektopisk graviditet og flerfoldsgraviditeter.
English: Treatment with Elonva should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Danish: Behandling med Elonva bør initieres under supervision af en læge med erfaring inden for fertilitetsbehandling.
English: How Elonva is given
Danish: Sådan gives Elonva
English: Ovarian torsion, adnexa uteri pain, premature ovulation, breast pain
Danish: Ovarietorsion, smerter i adnexa uteri, præmatur ovulation, brystsmerter
English: A possible complication of treatment with gonadotropic hormones like Elonva is unwanted overstimulation of the ovaries.
Danish: En mulig komplikation ved behandling med gonadotropinhormoner som Elonva er uønsket overstimulation af æggestokkene.
English: The mean number of embryos transferred in the FTET cycles of PURSUE was 2.4 in both treatment groups.
Danish: Det gennemsnitlige antal oplægninger af embryoner i FTET-cyklusserne i PURSUE var 2,4 i begge behandlingsgrupper.
English: It is not established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Danish: Det er ikke fastslået, hvorvidt behandling med gonadotropiner øger risikoen for disse tumorer hos infertile kvinder.
English: 1) and is similar after administration of 100 micrograms corifollitropin alfa to women with a body weight less than or equal to 60 kilograms and of 150 micrograms corifollitropin alfa to women with a body weight greater than 60 kilograms.
Danish: 1), og er sammenlignelig efter administration af 100 mikrogram corifollitropin alfa til kvinder med en legemsvægt på 60 kg eller derunder og efter administration af 150 mikrogram corifollitropin alfa til kvinder med en legemsvægt større end 60 kg.
English: Since corifollitropin alfa is not a substrate of cytochrome P450 enzymes, no metabolic interactions with other medicinal products are anticipated.
Danish: Da corifollitropin alfa ikke er et CYP-enzymsubstrat, forventes ingen metaboliske interaktioner.
English: Therefore, the use of Elonva is not recommended in combination with a GnRH agonist (see also section 4.2).
Danish: Derfor anbefales brugen af Elonva ikke i kombination med en GnRH-agonist (se også pkt.
English: Elonva is supplied in pre-filled luerlock syringes of 1 mL (type I hydrolytic glass), closed with a bromobutyl elastomer plunger and a tip cap.
Danish: Elonva leveres i 1 ml fyldte luerlock injektionssprøjter (type I hydrolytisk glas), lukket med en bromobutyl elastomer prop og et vippelåg.
English: Multiple pregnancies and births have been reported for all gonadotropin treatments, including Elonva.
Danish: Der er set flerfoldsgraviditeter og -fødsler for alle gonadotropinbehandlinger, herunder Elonva.
English: OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form.
Danish: OHSS medfører, at der pludselig ophobes væske i din mave og brystkasse, og OHSS kan medføre, at der dannes blodpropper.
English: Body Weight
Danish: Legemsvægt
English:  Malformations of the reproductive organs incompatible with pregnancy.
Danish: • Misdannelser af genitalia som er uforenelige med graviditet.
English: After administration of Elonva, no additional FSH-containing product should be administered prior to stimulation day 8 (see also section 4.2).
Danish: Efter administration af Elonva må der ikke administreres andre præparater, der indeholder FSH, før stimulationsdag 8 (se også pkt.
English: Pregnancy, puerperium and perinatal conditions
Danish: Graviditet, puerperium og den perinale periode
English: 36 years or younger
Danish: 36 år eller derunder
English: (0.10-0.18 L/h
Danish: 0,13 l/time (0,10-0,18 l/time
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til pH justering) Saltsyre (til pH justering) Vand til injektionsvæsker
English: Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of Elonva may replace the first seven injections of any daily (rec)FSH preparation in a COS treatment cycle.
Danish: På grund af dets evne til at stimulere en vedvarende multipel follikulær vækstudvikling i en hel uge, kan en enkelt subkutan injektion af den anbefalede Elonva-dosis erstatte de første 7 injektioner af ethvert dagligt (rec)FSH præparat i en COS (kontrolleret ovariel stimulation) behandlingscyklus.
English: Seven days after the injection with Elonva on stimulation day 1, COS treatment may be continued with daily injections of (recombinant) Follicle Stimulating Hormone [(rec)FSH] until the criterion for triggering final oocyte maturation (3 follicles ≥ 17 mm) has been reached.
Danish: 7 dage efter injektionen af Elonva på stimulationsdag 1 kan COS-behandling med daglige injektioner af (rekombinant) follikelstimulerende hormon [(rec)FSH] fortsættes, indtil kriteriet for follikelmodning (3 follikler ≥ 17 mm) er nået.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. injektion, dvs. det praktisk taget er natriumfrit.
English: Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts.
Danish: De kliniske tegn og symptomer på mild eller moderat OHSS er abdominalsmerter, kvalme, diarre, mild til moderat forstørrelse af ovarierne og ovariecyster.
English: The recommended doses of Elonva have only been established in a treatment cycle with a GnRH antagonist that was administered from stimulation day 5 or day 6 onwards (see also sections 4.1, 4.4, and 5.1).
Danish: De anbefalede doser af Elonva er kun fastlagt i en behandlingscyklus med en GnRH-antagonist, som blev administreret fra stimulationsdag 5 eller 6 og videre frem (se også pkt.
English: In more severe cases this may lead to enlargement of the ovaries, collection of fluid in the abdomen and/or chest (which may cause sudden weight gain due to fluid buildup) or clots in the blood vessels.
Danish: I mere alvorlige tilfælde kan dette medføre forstørrelse af æggestokkene, ophobning af væske i maven og/eller brystet (som kan medføre en pludselig vægtstigning som følge af væskeophobningen) eller blodpropper i blodkarrene.
English: The follow-up FTET trial for PURSUE included women who had at least one embryo thawed for use within two years of the date of the last cryopreservation for this trial.
Danish: Det opfølgende FTET-studie for PURSUE inkluderede kvinder, som havde fået mindst 1 embryon optøet til brug inden for to år efter datoen for den sidste kryopræservering for dette studie.