FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Danish: Det er derfor vigtigt ikke at give hCG i tilfælde af hyperstimulation og at tilråde patienten at afstå fra coitus eller bruge en barriere-præventionsmetode i mindst 4 dage.
English: Follitropin delta leads to greater exposure than follitropin alfa.
Danish: Follitropin delta medfører højere eksponering end follitropin alfa.
English: The maximum daily dose is 24 micrograms.
Danish: Den maksimale daglige dosis er 24 mikrogram.
English: • Do not put the pen in water or any other liquid.
Danish: • Kom ikke pennen i vand eller anden væske.
English: • Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Danish: • Injektier ikke ind i et område som er ømt, mørkt, rødt, hårdt, arret eller hvor du har strækmærker.
English: Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.
Danish: Sidenumre henviser til den trykte bruger instruktionsbog og ikke den faktuelle side i dette dokument.
English: The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer.
Danish: AMH-koncentration skal udtrykkes i picomol/l og afrundes til nærmeste hele tal.
English: The apparent volume of distribution is about 25 L after subcutaneous administration and the volume of distribution at steady state is 9 L after intravenous administration.
Danish: Det tilsyneladende fordelingsvolumen er omkring 25 l efter subkutan administration, og fordelingsvolumenet ved steady state er 9 l efter intravenøs administration.
English: Step 11 and 12:
Danish: Trin 11 og 12:
English: REKOVELLE is not indicated during pregnancy.
Danish: REKOVELLE er ikke indiceret under graviditet.
English: The most important effect resulting from parenteral administration of FSH is the development of multiple mature follicles.
Danish: Virkningsmekanisme Den vigtigste virkning af parenteralt administreret FSH er udvikling af multiple modne follikler.
English: The incidence of anti-FSH antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in cycle 3.
Danish: Forekomsten af anti-FSHantistoffer efter behandling med REKOVELLE var 1,1% i cyklus 1, 0,8% i cyklus 2 og 1,1% i cyklus 3.
English: Follitropin delta is a recombinant human FSH.
Danish: Follitropin delta er et rekombinant humant FSH.
English: In ovulatory patients with polycystic ovaries, the incidence of early moderate/severe OHSS and/or preventive interventions for early OHSS was 7.7% with REKOVELLE and 26.7% with follitropin alfa.
Danish: Hos ovulatoriske patienter med polycystiske ovarier var forekomsten af tidlig moderat/svær OHSS og /eller forebyggende foranstaltninger for tidlig OHSS 7,7% med REKOVELLE og 26,7% med follitropin alfa.
English: Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a new pen.
Danish: Læs den komplette instruktion inden du bruger REKOVELLE fyldt pen og hver gang du får en ny pen.
English: Blood clotting problems (thromboembolic events)
Danish: Blodpropper (tromboemboliske hændelser)
English: Adherence to the REKOVELLE dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events.
Danish: Overholdelse af det anbefalede dosis- og administrationsregime for REKOVELLE samt nøje monitorering af behandlingen vil minimere forekomsten af disse bivirkninger.
English: • Keep pressing the injection button in and when you see the number ‘0' lined up with the dose indicator, wait for 5 seconds (slowly count to 5).
Danish: • Bliv ved med at trykke indsprøjtningsknappen ind og når du ser tallet ‘0' ud for dosisindikatoren, vent 5 sekunder (tæl langsomt til 5).
English: Paediatric population There is no relevant use of REKOVELLE in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende REKOVELLE hos den pædiatriske population.
English: Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to give your REKOVELLE injection.
Danish: Kontakt dit sundhedspersonale (læge, sygeplejerske eller farmaceut) hvis du har spørgsmål om hvordan du giver din REKOVELLE injektion.
English: There are no data from the inadvertent exposure to REKOVELLE in pregnant women.
Danish: Der foreligger ingen data for utilsigtet eksponering af REKOVELLE hos gravide kvinder.
English: • Call your healthcare provider if you have questions about how to calculate your split-dose.
Danish: • Kontakt dit sundhedspersonale hvis du har spørgsmål til hvordan du skal udregne din delt-dosis.
English: Treatment with REKOVELLE should be initiated day 2 or 3 after start of menstrual bleeding, and continue until adequate follicular development (≥3 follicles ≥17 mm) has been achieved, which on average is by the ninth day of treatment (range 5 to 20 days).
Danish: Behandling med REKOVELLE skal påbegyndes dag 2 eller 3 efter menstruationsstart og fortsættes, indtil en tilstrækkelig follikeludvikling (≥3 follikler ≥17 mm) er opnået, hvilket i gennemsnit er på niende behandlingsdag (interval 5 til 20 dage).
English: • If the injection button is not easy to push in, do not use force.
Danish: • Hvis indsprøjtningsknappen ikke er let at trykke ind brug ikke kraft.
English: • Holding the injection button for 5 seconds allows for the full dose to be injected and absorbed under your skin.
Danish: • At holde injektionsknappen inde i 5 sekunder tillader den hele dosis at blive injektieret og optaget under huden.
English: • Keep the pen cap on the pen when it is not in use.
Danish: • Behold penhætten på pennen når den ikke er i brug.
English: Before starting treatment with this medicine, a doctor should check you and your partner for possible causes of your fertility problems.
Danish: Før behandling med dette lægemiddel skal du og din partner undersøges af en læge for at finde ud af årsagerne til jeres fertilitetsproblemer.
English: In patients who developed OHSS or were at risk of OHSS in a previous cycle, the daily dose for the subsequent cycle is 33% lower than the dose used in the cycle where OHSS or risk of OHSS occurred.
Danish: Hos patienter, som udviklede OHSS eller var i risiko for OHSS i en tidligere cyklus, er den daglige dosis i den efterfølgende cyklus 33% lavere end den dosis, der blev anvendt i den cyklus, hvor OHSS eller risiko for OHSS indtraf.
English: Following repeated daily subcutaneous administrations, REKOVELLE reaches steady-state within 6 to 7 days with a threefold higher concentration compared with the concentration after the first dose.
Danish: Efter gentagen administration af en daglig subkutan injektion når REKOVELLE steady state inden for 6 til 7 dage med en tre gange højere koncentration i forhold til koncentrationen efter den første dosis.
English: Use of results obtained with other assays than the ELECSYS AMH Plus immunoassay from Roche for REKOVELLE dose determination is not recommended, as there currently is no standardisation of available AMH assays.
Danish: Brug af resultater fra andre analyser end ELECSYS AMH Plus fra Roche til at fastlægge REKOVELLE-dosis anbefales ikke, da der ikke foreligger standardisering mellem tilgængelige AMHanalyser.
English: The dose of REKOVELLE is individualised for each patient to obtain an ovarian response with favourable safety/efficacy profile.
Danish: REKOVELLE-dosis er individuel for hver patient, for at opnå et ovarielt respons med en favorabel sikkerheds-/virkningsprofil.
English: Your healthcare provider should show you how to prepare and inject REKOVELLE the right way before you inject it for the first time.
Danish: Sundhedspersonalet skal vise dig hvordan du klargør og indsprøjter REKOVELLE korrekt inden du selv tager indsprøjtningen første gang.
English: It is more commonly seen in patients with polycystic ovarian syndrome and usually regresses without treatment.
Danish: Det ses hyppigere hos patienter med polycystisk ovariesyndrom og aftager sædvanligvis uden behandling.
English: • The injection button is firmly pushed in all the way until it stops.
Danish: • Indsprøjtningsknappen er trykket hele vejen ind indtil den stopper.
English: • If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle
Danish: • Hvis ikke en dråbe kommer til syne efter 5 forsøg, fjern nålen (Se trin 13), påsæt en ny nål
English: For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight.
Danish: For kvinder med AMH <15 picomol/l er den daglige dosis 12 mikrogram uanset kropsvægt.
English: Although limited, data did not indicate a need for a different dosing regimen of REKOVELLE in this patient population (see section 4.4).
Danish: Selvom data er begrænsede, indikerer de ikke, at et andet dosisregime af REKOVELLE er nødvendigt for denne patientgruppe (se pkt.
English: Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant.
Danish: Blodpropper i blodårerne (vener eller arterier) forekommer oftere hos gravide kvinder.
English: Gonadotropins are involved in reproduction and fertility.
Danish: Gonadotropiner er involveret i frugtbarhed (fertilitet) og forplantning.
English: The ESTHER-1 trial was a randomised, assessor-blinded, controlled trial in 1,326 IVF/ICSI patients.
Danish: ESTHER 1-studiet var et randomiseret, assessor-blindet, kontrolleret studie hos 1.326 IVF/ICSIpatienter.
English: Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be at risk of developing OHSS.
Danish: Patienter, som gennemgår stimulation af follikeludvikling, kan få forstørrede ovarier og have risiko for at udvikle OHSS.
English: In patients with excessive follicular development (of ≥25 follicles ≥12 mm), treatment with REKOVELLE should be stopped and triggering of final follicular maturation with hCG should not be performed.
Danish: Hos patienter med overdreven follikeludvikling (af ≥25 follikler ≥12 mm) bør behandlingen med REKOVELLE stoppes, og aktivering af follikulær modning med hCG bør ikke udføres.
English: Because of the risk of developing OHSS patients should be followed for at least two weeks after triggering of final follicular maturation.
Danish: På grund af risikoen for udvikling af OHSS skal patienten følges i mindst to uger efter aktivering af follikelmodning.
English: EXP After first use: Use within 28 days.
Danish: EXP Efter ibrugtagning: Anvendes inden for 28 dage.
English: REKOVELLE contains sodium
Danish: REKOVELLE indeholder natrium
English: Patients must be educated on how to use the REKOVELLE injection pen and to perform injections.
Danish: Patienterne skal uddannes i, hvordan de bruger REKOVELLE injektionspen, og hvordan de foretager injektionerne.
English: Safe and effective use of REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with measurement of serum estradiol levels, on a regular basis.
Danish: Sikker og effektiv brug af REKOVELLE kræver regelmæssig monitorering af ovarierespons med ultralyd alene eller i kombination med måling af serum-estradiol.
English: • leak-resistant, and
Danish: • lækagebestandig, og
English: In particular, patients should be evaluated for hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given.
Danish: Specielt skal patienten undersøges for hypotyroidisme og hyperprolaktinæmi og adækvat behandling gives.
English: • Do not use a pen if it has been dropped or hit against hard surfaces.
Danish: • Brug ikke pennen hvis den har været tabt eller slået mod harde flader.
English: The two co-primary endpoints were ongoing pregnancy rate and ongoing implantation rate in the fresh cycle, defined as at least one intrauterine viable fetus 10-11 weeks after transfer and number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred, respectively.
Danish: De to primære virkningsendepunkter var raten af igangværende graviditeter og igangværende implantationer i frisk cyklus, defineret som henholdsvis mindst et intrauterint levende foster 10-11 uger efter overførslen og antallet af intrauterine levende fostre 10-11 uger efter overførslen divideret med antallet af overførte blastocyster.
English: • fibroid tumours of the uterus incompatible with pregnancy
Danish: • Fibroide tumorer i uterus, uforenelige med graviditet
English: • The dose scale of the pen is numbered from 0 to 20 micrograms.
Danish: • Pennens doseringsskala går fra 0 til 20 mikrogram.
English: The amino acid sequences of the two FSH subunits in follitropin delta are identical to the endogenous human FSH sequences.
Danish: Aminosyresekvenserne af de to FSH-subunits i follitropin delta er identiske med sekvenserne i det endogene humane FSH.
English: Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta.
Danish: Da follitropin delta er produceret i en human cellelinje PER.C6, er glykosyleringsprofilen forskellig fra follitropin alfa og follitropin beta.
English: The maximum daily dose for the first treatment cycle is 12 micrograms.
Danish: Den maksimale daglige dosis i første behandlingscyklus er 12 mikrogram.
English: In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
Danish: Til forskel fra ukompliceret ovarieforstørrelse er OHSS en tilstand, som kan optræde med tiltagende sværhedsgrad.
English: Circulating levels of follitropin delta are inversely related to the body weight, which supports individualised dosing based on body weight.
Danish: Niveauet af cirkulerende follitropin delta er omvendt relateret til kropsvægt, hvilket understøtter individuel dosering baseret på kropsvægt.
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Danish: Patienten bør informeres om risikoen for flerfoldsgraviditet, før behandlingen påbegyndes.
English: REKOVELLE pre-filled pens: • Throw away (dispose of) your used pens in accordance with local waste regulations.
Danish: REKOVELLE fyldte penne: Bortskaf dine brugte penne ifølge lokale affalds regler.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Danish: Behandling skal indledes under supervision af en læge, som har erfaring inden for behandling af infertilitet.
English: Multiple pregnancy carries an increased risk of adverse maternal and perinatal outcomes.
Danish: Flerfoldsgraviditet medfører en øget risiko for et ikke gunstigt maternelt og perinatalt udfald.
English: Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider.
Danish: Forsøg ikke at selv tage indsprøjtningen før du er blevet undervist i hvordan du tager indsprøjtninger af dit sundhedspersonale.
English: • Hold the pen so the dose display window is visible during injection.
Danish: • Hold pennen så doseringsvinduet er synlig under injektionen.
English: • Tilting the pen can cause the needle to bend or break off.
Danish: • At vippe pennen kan forårsage, at nålen bøjes eller knækker af.
English: Repeated treatment with REKOVELLE of patients with pre-existing or treatment-induced anti-FSH antibodies did not increase the antibody titre, was not associated with decreased ovarian response, and did not induce immune-related adverse events.
Danish: Gentagen behandling med REKOVELLE hos patienter med præ-eksisterende eller behandlingsinducerede antiFSH-antistoffer øgede ikke antistoftiter, var ikke forbundet med nedsat ovarielt respons og medførte ikke udvikling af immun-relaterede bivirkninger.
English: The effect of an overdose is unknown, nevertheless, there is a risk that OHSS may occur (see section 4.4).
Danish: Virkningen af en overdosis er ukendt, men der kan være en risiko for OHSS (se pkt.
English: Throw away (dispose of) the pen if it has not been used after 3 months.
Danish: Kassér (bortskaf) pennen hvis lægemidlet ikke er brugt op efter 3 måneder.
English: Step 3: • Pull off the protective foil from the needle.
Danish: Trin 3: • Træk det beskyttende folie af nålen.
English: The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH concentration.
Danish: Antallet af udtagne oocytter stiger med dosen af REKOVELLE og serum-AMH.
English: Put your used needles in a puncture-resistant container, such as a sharps disposal container right away after use.
Danish: Kom dine brugte nåle i en punktér-fri beholder, som en kanyle-bøtte straks efter brug.
English: • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
Danish: • kan lukkes med et tæt-sluttende, punkteringsbestandigt låg, hvor skarpe genstande ikke kan komme ud,
English: In all patients with anti-FSH antibodies, titres were undetectable or very low and without neutralising capacity.
Danish: Hos alle patienter med anti-FSH-antistoffer var titrene ikke-detekterbare eller meget lave og uden kapacitet til at neutralisere FSH.
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Danish: Hyppigheden af medfødte misdannelser efter ART kan være en anelse højere end efter spontan undfangelse.
English: The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with gonadotropins) in your blood and your body weight.
Danish: Dosis af REKOVELLE i din første behandlingscyklus vil blive beregnet af din læge på basis af niveauet af antimüllersk hormon (AMH, en markør for, hvordan dine æggestokke vil reagere på stimulering med gonadotropin) i dit blod samt din kropsvægt.
English: Split-dose diary
Danish: Delt-dosis dagbog
English: Occurrence of ovarian torsion has been reported for ART cycles.
Danish: Forekomst af ovarietorsion er blevet rapporteret for ART-cykli.
English: Follitropin delta had a negative effect on fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day which is above the recommended maximal dose in humans.
Danish: Follitropin delta havde en negativ indvirkning på fertilitet og tidlig fosterudvikling hos rotter, som fik doser ≥0,8 mikrogram/kg/dag, hvilket er over den anbefalede maksimale dosis hos mennesker.
English: • Column B shows an example of the dose that is left in the pen (this is equal to what you are able to dial).
Danish: • Kolonne B viser et eksempel på den dosis der er tilbage i pennen (dette er hvad der kan drejes frem til).
English: Do not throw away (dispose of) your used sharps disposal container in your household trash.
Danish: Smid ikke (bortskaf) din kanyle-bøtte i husholdningsaffald.
English: See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and record your split dose.
Danish: Se “Giv en delt-dosis af REKOVELLE“ på side 22 til 231 med eksempler på hvordan du udregner og nedskriver din delte dosis.
English: REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of hormones called gonadotropins.
Danish: REKOVELLE indeholder follitropin delta, et follikelstimulerende hormon, som tilhører en gruppe hormoner, der kaldes gonadotropiner.
English: Women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (body mass index >30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins.
Danish: Kvinder med nylig eller aktuel tromboembolisk sygdom og kvinder med generelle risikofaktorer for tromboemboliske hændelser, såsom personlig eller familiær anamnese, svær overvægt (Body Mass Index (BMI) >30 kg/m2) eller trombofili, kan have en øget risiko for venøse eller arterielle tromboemboliske hændelser under og efter behandling med gonadotropiner.
English: Using the pen incorrectly could result in receiving an incorrect dose of medicine.
Danish: Hvis pennen ikke bruges korrekt kan det medføre at der bliver givet en forkert dosis af lægemidlet.
English: • Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).
Danish: • Skru nålen af i retningen mod uret for at fjerne nålen fra pennen (B+C).
English: The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than 1 dose of REKOVELLE.
Danish: REKOVELLE fyldt pen er en engangs vælg-en-dosis pen som kan anvendes til at give mere end 1 dosis af REKOVELLE.
English: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
Danish: Når din kanyle-bøtte er næsten fyldt, skal du følge retningslinjer for bortskaffelse af farligt affald.
English: The REKOVELLE dose is stated in micrograms.
Danish: REKOVELLE-dosis angives i mikrogram.
English: These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies after treatment with follitropin alfa.
Danish: Disse rater svarede til forekomsten af allerede eksisterende anti-FSH-antistoffer før eksponering for REKOVELLE i cyklus 1 (1,4%), og var sammenlignelige med incidensen af antiFSH-antistoffer efter behandling med follitropin alfa.
English: (See Steps 3 to 6), and repeat priming (See Steps 7 to 9).
Danish: • (Se trin 3 til 6), og gentag klargøring (Se trin 7 til 9).
English: The overdose of follitropin delta resulted in pharmacological or exaggerated pharmacological actions.
Danish: Overdosis af follitropin delta resulterede i farmakologiske eller uhensigtsmæssigt kraftige farmakologiske virkninger.
English: • Do not press the injection button when dialing the dose to avoid loss of medicine.
Danish: • Tryk ikke på indsprøjtningsknappen når dosis indstilles for at undgå tab af lægemiddel.
English: For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration (Table 1).
Danish: For kvinder med AMH ≥15 picomol/l reduceres den daglige dosis fra 0,19 til 0,10 mikrogram/kg med stigende AMH-koncentration (tabel 1).
English: Step 6: • Pull off the inner needle cap and throw it away.
Danish: Trin 6: • Træk den indre nålehætte af og smid den væk.
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with REKOVELLE.
Danish: Kliniske tilstande, der kontraindicerer graviditet, bør også vurderes før behandling med REKOVELLE.
English: • When turning the dial to your dose, you will hear a click sound and feel resistance on the dial for each increment to help you dial the correct dose.
Danish: • Når du drejer på knappen, vil du høre en klick-lyd og føle modstand for hvert trin for at hjælpe dig vælge den rigtige dosis.
English: Following daily administration of equal IU doses of REKOVELLE and follitropin alfa as determined in the rat in vivo bioassay (Steelman-Pohley assay), higher ovarian response (i.e. estradiol, inhibin B and follicular volume) was observed in patients after administration of REKOVELLE compared to follitropin alfa.
Danish: Efter daglig administration af ækvivalente doser (IE) af REKOVELLE og follitropin alfa, bestemt ved in vivo bioassay (Steelman-Pohley assay) i rotter, blev der observeret et højere ovarierespons (dvs. estradiol, inhibin B og follikulær volumen) hos patienter efter administration af REKOVELLE sammenlignet med follitropin alfa.