FrancophonIA/ELRC3.0 huggingface dataset:
English: During this treatment, Elonva is used in combination with a medicine (so called GnRH-antagonist) to prevent your ovary from releasing an egg too early.
Danish: Under denne behandling bruges Elonva sammen med et lægemiddel (en såkaldt GnRH-antagonist), som forhindrer dine æggestokke i at frigive et æg for tidligt.
English: Please discuss this with your doctor, before starting treatment, especially if: - you know you already have an increased chance of having a thrombosis - you, or anyone in your immediate family, have ever had a thrombosis - you are severely overweight.
Danish: Diskuter dette med din læge, før behandlingen startes, især: - hvis du allerede ved, du har forøget risiko for at få en blodprop - hvis du eller et nært familiemedlem har haft en blodprop - hvis du er svært overvægtig.
English: The pregnancy results from the first two FTET cycles of ENGAGE and PURSUE are summarized in Table 3 below.
Danish: Graviditetsresultaterne fra de første to FTET-cyklusser i ENGAGE og PURSUE er opsummeret i tabel 3 nedenfor.
English: The use of Elonva during pregnancy is not indicated.
Danish: Elonva er ikke indiceret under graviditet.
English: Dose In the treatment of women of reproductive age, the dose of Elonva is based on weight and age.
Danish: Dosering Ved behandling af kvinder i den fødedygtige alder er dosis af Elonva baseret på vægt og alder.
English: Other medicines and Elonva
Danish: Brug af anden medicin sammen med Elonva
English: Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
Danish: der tyder på nedsat leverfunktion med eller uden morfologiske ændringer i leverbiopsien, er også rapporteret i forbindelse med OHSS.
English: Administration of corifollitropin alfa to rats and rabbits, prior to and directly after mating, and during early pregnancy, resulted in embryotoxicity.
Danish: Corifollitropin alfa resulterede i embryotoksicitet, når det blev givet til rotter og kaniner før og straks efter parring og under tidlig graviditet.
English: What Elonva contains - The active substance is corifollitropin alfa.
Danish: Elonva indeholder: - Aktivt stof: corifollitropin alfa.
English: Although data in hepatically impaired patients are not available, hepatic impairment is unlikely to affect the pharmacokinetic profile of corifollitropin alfa.
Danish: Til trods for at der ikke er data tilgængelige for patienter med nedsat leverfunktion, er det usandsynligt at nedsat leverfunktion påvirker den farmakokinetiske profil for corifollitropin alfa.
English: In rare instances, blood clots (thrombosis) that formed inside a blood vessel, broke off, and travelled inside the bloodstream to block another blood vessel (thromboembolism) have been associated with Elonva therapy as with other gonadotropins.
Danish: I sjældne tilfælde er blodpropper (tromboser), som opstod i et blodkar, rev sig løs og blev ført med blodstrømmen og tilstoppede et andet blodkar (tromboemboli), blevet forbundet med Elonvabehandling, som det også er forekommet med andre gonadotropiner.
English: The co-primary efficacy endpoints were ongoing pregnancy rate and number of oocytes retrieved.
Danish: De coprimære virkningsendepunkter var frekvensen af igangværende graviditeter og antallet af aspirerede oocytter.
English: In rare instances, venous or arterial thromboembolism may occur in association with OHSS.
Danish: I sjældne tilfælde kan der opstå venøs eller arteriel tromboemboli i forbindelse med OHSS.
English: This may be due to cross-reactivity of hCG pregnancy tests with the carboxy-terminal peptide of the beta subunit of Elonva.
Danish: Dette kan skyldes krydsreaktion mellem visse hCG graviditetstests og Elonvas carboxy-terminale peptid af ß-delen.
English: Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain.
Danish: Kliniske tegn og symptomer på svær OHSS er store ovariecyster, akutte abdominalsmerter, ascites, pleuraekssudat, hydrothorax, dyspnø, oliguri, hæmatologiske abnormaliteter og vægtøgning.
English: Ovarian torsion is the twisting of an ovary.
Danish: Ovarietorsion er vridning af en æggestok.
English: In particular, women should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Danish: Især skal kvinder evalueres for hypotyroidisme, nedsat binyrebarkfunktion, hyperprolaktæmi og tumor i hypofyse eller hypotalamus, og eventuel behandling skal iværksættes.
English: Since the rate of elimination of corifollitropin alfa may be reduced in patients with renal insufficiency, the use of Elonva in these women is not recommended (see sections 4.4 and 5.2).
Danish: Da eliminationshastigheden for corifollitropin alfa kan være nedsat hos patienter med nyreinsufficiens, anbefales brug af Elonva ikke til disse kvinder (se pkt.
English: The syringe is packed together with a sterile injection needle.
Danish: Injektionssprøjten er pakket sammen med en steril kanyle.
English: Preclinical data revealed no special hazard for humans based on conventional studies of single and repeated dose toxicity and safety pharmacology.
Danish: Dette er vurderet ud fra konventionelle toksicitetsstudier efter enkelte og gentagne doser samt sikkerhedsfarmakologi.
English: - The other ingredients are: sodium citrate, sucrose, polysorbate 20, methionine and water for injections.
Danish: - Øvrige indholdsstoffer: natriumcitrat, saccharose, polysorbat 20, methionin og vand til injektionsvæsker.
English: Pregnancy outside the uterus (an ectopic pregnancy) and multiple pregnancies have also been reported.
Danish: Der er også set graviditet udenfor livmoderen (en ektopisk graviditet) og flerfoldgraviditeter.
English: In all three studies, treatment with a single injection of Elonva, 100 or 150 micrograms, for the first seven days of COS, resulted in a higher number of oocytes retrieved compared with a daily dose of recFSH.
Danish: I alle tre studier resulterede behandling med en enkelt injektion af Elonva, 100 eller 150 mikrogram, i de første syv dage af COS i et højere antal aspirerede oocytter sammenlignet med behandling med en daglig dosis recFSH.
English: In rare instances, thromboembolism has been associated with Elonva therapy as with other gonadotropins.
Danish: I sjældne tilfælde er tromboemboli blevet associeret med Elonva-behandling, som det også er tilfældet med andre gonadotropiner.
English: This justifies replacement of the first seven injections of daily (rec)FSH with a single subcutaneous injection of Elonva in COS for the development of multiple follicles and pregnancy in an ART program (see section 4.2).
Danish: Dette erstatter de første 7 injektioner med dagligt (rec)FSH med en enkelt subkutan injektion med Elonva i COS til multipel follikulær udvikling og efterfølgende graviditet i ART behandling (se pkt.
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Danish: Hyppigheden for medfødte misdannelser efter ART kan være en anelse forøget i forhold til spontane befrugtninger.
English: Table 1: Mean Number of Oocytes Retrieved from ENSURE, ENGAGE, and PURSUE Intent-to-Treat Population (ITT)
Danish: Tabel 1: Gennemsnitligt antal aspirerede oocytter fra ENSURE, ENGAGE og PURSUE Intent-to-Treat Population (ITT)
English: The rates for congenital malformations (major and minor combined) reported for infants born after an FTET cycle in the PURSUE study follow-up (16.4%) were similar to those reported for infants born after fresh ART cycles in the ENSURE, ENGAGE and PURSUE studies combined
Danish: Frekvensen af rapporterede medfødte misdannelser (større og mindre kombineret) for spædbørn født efter en FTET-cyklus i PURSUE-studieopfølgningen (16,4%) var sammenlignelig med frekvensen, som blev rapporteret for spædbørn født efter ARTcyklusser med oplægning af friske embryoner i ENSURE-, ENGAGE- og PURSUE-studierne tilsammen (16,8%).
English:  Tumours of the ovary, breast, uterus, pituitary or hypothalamus.
Danish: • Tumorer i ovarier, mammae, uterus, hypofysen eller hypotalamus.
English: Treatment with gonadotropic hormones like Elonva may cause ovarian hyperstimulation syndrome (OHSS).
Danish: Behandling med gonadotropiner som Elonva kan forårsage ovarielt hyperstimulationssyndrom (OHSS).
English: Elonva is indicated for use in infertility (see section 4.1).
Danish: Elonva er indiceret til brug ved infertilitet (se pkt.
English: In three randomized, double-blind, clinical trials, treatment with a single subcutaneous injection of Elonva, 100 micrograms (ENSURE study) or 150 micrograms (ENGAGE and PURSUE study), for the first seven days of COS was compared to treatment with a daily dose of 150, 200, or 300 IU of recFSH, respectively.
Danish: I tre randomiserede, dobbeltblinde kliniske studier blev behandling med en enkelt subkutan injektion af Elonva, 100 mikrogram (ENSURE-studiet) eller 150 mikrogram (ENGAGE-studiet og PURSUEstudiet), i de første syv dage af COS sammenlignet med behandling med en daglig dosis på hhv. 150, 200 eller 300 IE recFSH.
English: The syringe is equipped with an automatic safety system to prevent needle stick injuries after use and is packed together with a sterile injection needle.
Danish: Injektionssprøjten er forsynet med et automatisk sikkerhedssystem som forhindrer nålestik skader efter brug og er pakket sammen med en steril kanyle.
English:  Fibroid tumours of the uterus incompatible with pregnancy.
Danish: • Leimyomer i uterus, som er uforenelige med graviditet.
English: DD month YYYY
Danish: DD måned ÅÅÅÅ
English: Pregnancy complications
Danish: Komplikationer under graviditeten
English: 150 micrograms 150 micrograms
Danish: 150 mikrogram 150 mikrogram
English: Do not use this medicine after the expiry date which is stated on the label and outer carton after “EXP” (expiry date).
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Common (may affect up to 1 in 10 women) - Ovarian hyperstimulation syndrome (OHSS) - Pelvic pain - Feeling sick (nausea) - Headache - Pelvic discomfort - Breast tenderness - Tiredness (fatigue)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 kvinder) - Ovarielt hyperstimulationssyndrom (OHSS) - Bækkensmerter - Kvalme - Hovedpine - Bækkengener - Brystømhed - Træthed
English: Elonva is available in two strengths: 100 micrograms and 150 micrograms solution for injection.
Danish: Elonva findes i to styrker: 100 mikrogram og 150 mikrogram injektionsvæske.
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Elonva.
Danish: Tromboemboliske hændelser, både med og uden forbindelse med OHSS, er rapporteret efter behandling med gonadotropiner, herunder Elonva.
English: - Release your thumb from the plunger - The needle will withdraw automatically into the syringe where it will be locked permanently.
Danish: - Kanylen vil automatisk blive trukket ind i sprøjten, hvor den låses permanent.
English: Pregnancy from the Frozen-Thawed Embryo Transfer (FTET) cycles of ENGAGE and PURSUE
Danish: Graviditet fra cyklusser med oplægning af nedfrosne/optøede embryoner (Frozen-Thawed Embryo Transfer (FTET)) i ENGAGE og PURSUE
English: Serious side effects
Danish: Alvorlige bivirkninger:
English: The pregnancy results from the fresh cycles of ENGAGE and PURSUE are summarized in Table 2 below.
Danish: Graviditetsresultaterne fra cyklusser i ENGAGE og PURSUE med oplægning af friske embryoner er opsummeret i tabel 2 nedenfor.
English: The use of Elonva in combination with a GnRH agonist (another medicine to prevent your ovary from releasing an egg too early) is not recommended.
Danish: Det anbefales ikke at anvende Elonva i kombination med en GnRH-agonist (anden medicin som forhindrer dine æggestokke i at frigive et æg for tidligt).
English: Uncommon ( may affect up to 1 in 100 women) - Twisting of an ovary (ovarian torsion) - Liver enzyme increases - Miscarriage - Pain after oocyte retrieval - Procedural pain - Releasing an egg too early (premature ovulation) - Abdominal distension - Vomiting - Diarrhoea - Constipation - Back pain - Breast pain - Bruising or pain at the injection site - Irritability - Mood swings - Dizziness - Hot flush
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 kvinder) - Rotation af æggestokkene (ovarietorsion) - Forhøjede leverenzymer - Spontan abort - Smerter efter udtagning af ægceller (oocytter) - Smerter i forbindelse med proceduren - For tidlig ægløsning (præmatur ovulation) - Oppustethed - Opkastning - Diarré - Forstoppelse - Rygsmerter - Brystsmerter - Blå mærker eller smerter på indsprøjtningsstedet - Irritabilitet
English: Elonva is supplied in pre-filled syringes that have an automatic safety system to help prevent needle stick injuries after use.
Danish: Elonva leveres i fyldte injektionssprøjter med et automatisk sikkerhedssystem, som forhindrer nålestiksskader efter brug.
English: Twisting of the ovary could cause the blood flow to the ovary to be cut off.
Danish: Vridning af en æggestok kan medføre, at blodgennemstrømningen til æggestokken blokeres.
English: o have previously had a treatment cycle of controlled stimulation of the ovaries that resulted in the growth of more than 30 follicles with a size of 11 mm or larger o have a basal antral follicle count (the number of small follicles present in your ovaries at the beginning of a menstrual cycle) higher than 20
Danish: ): o hvis du har polycystisk ovariesyndrom (PCOS) o hvis du har haft ovarielt hyperstimulationssyndrom (OHSS) o hvis du tidligere har været i en behandlingscyklus med kontrolleret stimulation af æggestokkene, som resulterede i vækst af mere end 30 follikler i størrelsen 11 mm eller større o hvis du har et basalt antralt follikeltal (antallet af små follikler i æggestokkene i begyndelsen af en menstruationscyklus), som er højere end 20.
English: 50 - 60 kg More than 60 kg
Danish: 50-60 kg
English: Elimination of corifollitropin alfa predominantly occurs via the kidneys, and the rate of elimination may be reduced in patients with renal insufficiency (see sections 4.2 and 4.4).
Danish: Eliminationen af corifollitropin alfa sker hovedsageligt via nyrerne, og eliminationshastigheden kan være nedsat hos patienter med nyreinsufficiens (se pkt.
English: Other ingredients: sodium citrate, sucrose, polysorbate 20, methionine, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Danish: Hjælpestoffer: natriumcitrat, saccharose, polysorbat 20, methionin, natriumhydroxid (til pH justering), saltsyre (til pH justering), vand til injektionsvæsker.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Elonva på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Treatment with Elonva should be supervised by a physician experienced in the treatment of fertility problems.
Danish: Behandling med Elonva skal overvåges af en fertilitetslæge med erfaring i fertilitetsbehandling.
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Danish: Overstimulation af æggestokkene kan føre til en tilstand kaldet ovarielt hyperstimulationssyndrom (OHSS), som kan være en livstruende komplikation.
English: In women with generally recognized risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins may further increase this risk.
Danish: Kvinder med almindeligt kendte risikofaktorer for trombose, såsom trombose i anamnesen, familiær disposition, svær overvægt eller kendt trombofili kan have en forhøjet risiko.
English: For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.
Danish: Tæt observation for tidlige tegn og symptomer på OHSS anbefales hos kvinder i den første ovariestimulationscyklus, for hvem risikofaktorer kun er delvist kendte.
English:  Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: The follow-up FTET trial for ENGAGE included women who had at least one embryo thawed for use up to at least one year after cryopreservation.
Danish: Det opfølgende FTET-studie for ENGAGE inkluderede kvinder, som havde fået mindst 1 embryon optøet til brug i op til mindst 1 år efter kryopræservering.
English: Elonva is used to help achieve pregnancy in women having infertility treatment, such as in vitro fertilisation (IVF).
Danish: Elonva bruges til at opnå graviditet hos kvinder i fertilitetsbehandling, så som in vitro-fertilisering (reagensglasbefrugtning) (IVF).
English: What you need to know before you use Elonva
Danish: Det skal du vide, før du begynder at tage Elonva
English: In patients with mild, moderate or severe renal insufficiency the rate of elimination of corifollitropin alfa may be reduced (see sections 4.2 and 5.2).
Danish: Hos patienter med let, moderat eller svær nyreinsufficiens kan eliminationshastigheden for corifollitropin alfa være nedsat (se pkt.
English: Abdominal distension, vomiting, diarrhoea, constipation
Danish: Udspilet abdomen, opkastning, diarre, forstoppelse
English: Multiple births or birth defects
Danish: Flerfoldsgraviditeter og medfødte misdannelser
English: - A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger.
Danish: - En enkelt dosis på 100 mikrogram anbefales til kvinder, som vejer 60 kilogram eller mindre, og som er 36 år eller derunder.
English: N.V. Organon Veersemeer 4, 5347 JN Oss The Netherlands
Danish: Organon Veersemeer 4 5347 JN Oss Holland
English: Treatment with gonadotropic hormones like Elonva may (just as pregnancy) increase the risk of having a blood clot (thrombosis).
Danish: Behandling med gonadotropiner som Elonva kan (ligesom graviditet) øge risikoen for blodpropper.
English: Elonva is available in pack sizes of 1 pre-filled syringe.
Danish: Elonva er tilgængelig i pakninger á 1 fyldt injektionssprøjte.
English: o A basal antral follicle count > 20.
Danish: o Basalt antralt follikelantal > 20. o Polycystisk ovariesyndrom (PCOS).
English: Following use of Elonva, 61 infants were born after an FTET cycle in the PURSUE study follow-up, and 607 infants were born after fresh ART cycles in the ENSURE, ENGAGE and PURSUE studies combined.
Danish: Medfødte misdannelser rapporteret hos spædbørn født efter en FTET-cyklus Efter brug af Elonva blev 61 spædbørn født efter en FTET-cyklus i PURSUE-studieopfølgningen, og 607 spædbørn blev født efter ART-cyklusser med oplægning af friske embryoner i ENSURE-, ENGAGE- og PURSUE-studierne tilsammen.
English: Elonva may cause dizziness.
Danish: Elonva kan forårsage svimmelhed.
English: The primary efficacy endpoint was number of oocytes retrieved.
Danish: Det primære virkningsendepunkt var antal aspirerede oocytter.
English: <Justification for not including Braille accepted>
Danish: <Fritaget fra krav om brailleskrift>
English: Body weight is a determinant of exposure to corifollitropin alfa.
Danish: Legemsvægten er afgørende for dosering af corifollitropin alfa.
English: Ovarian torsion has been reported after treatment with gonadotropins, including Elonva.
Danish: Ovarietorsion er set efter behandling med gonadotropiner, herunder Elonva.
English: The first symptoms of ovarian overstimulation may be noticed as pain in the stomach (abdomen), feeling sick or diarrhoea.
Danish: De første symptomer på overstimulation af æggestokkene kan være mavesmerter, kvalme eller diarré.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: FTET Cycle 1 Ongoing pregnancy Live birth FTET Cycle 2 Ongoing pregnancy Live birth n = number of subjects with the event; N = total number of subjects a
Danish: Levende fødte børn n = antal forsøgspersoner med hændelsen; N = samlet antal forsøgspersoner a
English: 1 pre-filled syringe with an automatic safety (needle injury prevention) system and a sterile injection needle.
Danish: 1 fyldt injektionssprøjte med automatisk sikkerhedssystem (forebygger nålestiksskader) og en steril kanyle.
English: Do not use Elonva if you: - are allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of this medicine (listed in section 6) - have cancer of the ovary, breast, uterus, or brain (pituitary gland or hypothalamus) - have recently had unexpected vaginal bleeding, other than menstrual, without a diagnosed cause - have ovaries that do not work because of a condition called primary ovarian failure - have ovarian cysts or enlarged ovaries - have malformations of the sexual organs which make a normal pregnancy impossible - have fibroid tumours in the uterus which make a normal pregnancy impossible - have risk factor of OHSS (OHSS is a serious medical problem that can happen when the ovaries are overly stimulated.
Danish: (angivet i punkt 6) - hvis du har kræft i æggestokkene, bryst, livmoderen eller hjernen (hypofysen eller hypotalamus) - hvis du har haft uventet blødning fra skeden, som ikke er relateret til menstruation, uden en konstateret årsag - hvis dine æggestokke ikke fungerer på grund af en lidelse, som kaldes primær ovarieinsufficiens - hvis du har cyster på æggestokkene eller forstørrede æggestokke- hvis du har misdannelse af kønsorganerne, som umuliggør en normal graviditet - hvis du har muskelknuder (fibromer) i livmoderen, som umuliggør en normal graviditet
English: Storage by the pharmacist Store in a refrigerator (2ºC-8°C).
Danish: Opbevaring på apoteket Opbevares i køleskab (2 °C - 8 °C).
English: 100 micrograms 150 micrograms
Danish: 100 mikrogram 100 mikrogram 150 mikrogram
English: Injection site haematoma, injection site pain, irritability
Danish: Hæmatom på injektionsstedet, smerter på injektionsstedet, irritabilitet
English: The median total duration of stimulation was 9 days for both groups, indicating that two days of recFSH were required to complete ovarian stimulation from stimulation day 8 onwards (recFSH was given on the day of hCG for this study).
Danish: Den mediane samlede stimulationsvarighed var 9 dage for begge grupper, hvilket tydede på, at der var behov for to dage med recFSH for at gennemføre ovariestimulation fra stimulationsdag 8 og videre frem (recFSH blev givet på dagen med hCG-injektion i dette studie).
English: The median total duration of stimulation was 9 days for both groups, indicating that one day of recFSH was required to complete ovarian stimulation from stimulation day 8 onwards (no recFSH was given on the day of hCG for this study).
Danish: Den gennemsnitlige samlede stimulationsvarighed var 9 dage for begge grupper, hvilket tydede på, at der var behov for en dag med recFSH for at gennemføre ovariestimulation fra stimulationsdag 8 og videre frem (der blev ikke givet recFSH på dagen med hCG-injektion i dette studie).
English: The most frequently reported adverse reactions during treatment with Elonva in clinical trials (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%, see also section 4.4), headache (4.0%), pelvic pain (2.9%), nausea (2.3%), fatigue (1.5%), and breast tenderness (1.3%).
Danish: De hyppigst rapporterede bivirkninger i kliniske studier med Elonva (N=2.397) er bækkengener (6,0%), OHSS (4,3% se også pkt.