FrancophonIA/ELRC3.0 huggingface dataset:
English: REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at or below 25 °C for up to 3 months including the period after first use.
Danish: REKOVELLE kan fjernes fra køleskabet, uden at blive nedkølet igen, og opbevares ved eller under temperaturer på 25 °C i op til 3 måneder inklusive perioden efter ibrugtagning.
English: If you are not able to dial the full prescribed dose in your pen, this means that there is not enough medicine left in the pen to give the full dose.
Danish: Hvis du ikke kan indstille den fulde ordinerede dosis på pennen, betyder det at der ikke er tilstrækkelig lægemiddel tilbage i pennen til at give en hel dosis.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Danish: Før behandling påbegyndes, bør det vurderes, om parrets infertilitet er egnet til behandling, og mulige kontraindikationer for graviditet skal vurderes.
English: How to use REKOVELLE
Danish: Sådan skal du bruge REKOVELLE
English: • Store the pen in a refrigerator at 2 °C to 8 °C.
Danish: • Opbevar pennen i køleskab ved 2 °C to 8 °C.
English: Vaginal haemorrhage Breast pain Breast tenderness
Danish: Vaginalblødning Brystsmerter Brystømhed
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med REKOVELLE Fortæl altid lægen, hvis du tager anden medicin, herunder medicin købt uden recept, eller har gjort det for nylig.
English: • Only use the single-use click-on needles supplied with the pen.
Danish: • Brug kun de engangs klik-på nåle som findes vedlagt pennen
English: Step 2: • Pull off the pen cap.
Danish: Trin 2: • Træk penhætten af.
English: In the overall trial population, the mean number of oocytes retrieved was 10.0 ± 5.6 with REKOVELLE (N=636) in the individualised dosing regimen and 10.4 ± 6.5 with follitropin alfa (N=643) at a starting dose of 150 IU followed by dose adjustments.
Danish: I den samlede studiepopulation var det gennemsnitlige antal aspirerede oocytter 10,0 ± 5,6 for REKOVELLE (N=636) med individuel dosis og 10,4 ± 6,5 for follitropin alfa (N=643) med en startdosis på 150 IE fulgt af dosisjusteringer.
English: You will need to give a split-dose injection or throw away (dispose of) your current pen and use a new pen for your injection.
Danish: Du må i givet fald lave en delt-dosis injektion eller kassere din nuværende pen og bruge en ny pen til din injektion.
English: • Write down the dose that is left in your pen in column B. Give the injection using the rest of the medicine that is left in your pen.
Danish: • Skriv ned den dosis der er tilbage i pennen i kolonne B. Giv injektionen hvor du anvender resten af lægemidlet der tilbage i pennen.
English: REKOVELLE is a clear and colourless solution for injection (injection).
Danish: REKOVELLE er en klar og farveløs injektionsvæske (injektion).
English: Store in refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: For storage conditions after first use of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter åbning af lægemidlet, se pkt.
English: • See “Examples of how to dial a dose” at Page 20 to 211 if needed.
Danish: • Se “Eksempler på hvordan du indstiller dosis” på side 20 til 211 ved behov.
English: This medicine does not affect your ability to drive and use machines.
Danish: Dette lægemiddel påvirker ikke din evne til at køre motorkøretøj eller betjene maskiner.
English: For use only with the REKOVELLE injection pen.
Danish: Kun til brug med REKOVELLE injektionspen.
English: In case of ovarian hyperresponse in the previous cycle, the daily dose in the subsequent cycle should be decreased by 20% or 33%, according to the extent of response observed.
Danish: I tilfælde af ovarielt hyperrespons i den foregående cyklus skal den daglige dosis i den efterfølgende cyklus reduceres med 20% eller 33%, afhængigt af det observerede respons.
English: In case of ovarian hypo-response in the previous cycle, the daily dose in the subsequent cycle should be increased by 25% or 50%, according to the extent of response observed.
Danish: I tilfælde af et ovarielt hyporespons i den foregående cyklus bør den daglige dosis i den efterfølgende cyklus øges med 25% eller 50%, afhængigt af det observerede respons.
English: Within the therapeutic dose range, exposure to follitropin delta increases proportionally with the dose.
Danish: Eksponeringen for follitropin delta stiger proportionalt med dosis inden for det terapeutiske dosisområde.
English: • Press the injection button all the way in and hold.
Danish: • Tryk indsprøjtningsknappen helt ind og hold
English: The following symptoms may be observed in severe cases of OHSS: abdominal pain, discomfort and distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Danish: Følgende symptomer kan ses ved svære tilfælde af OHSS: abdominalsmerter og abdominalt ubehag og oppustethed, svær ovarieforstørrelse, vægtstigning, dyspnø, oliguri og gastrointestinale symptomer såsom kvalme, opkastning og diarré.
English: For instructions on the administration with the REKOVELLE injection pen, see the ”Instructions for Use” supplied with the pen.
Danish: For instruktioner om administration med REKOVELLE injektionspen, se instruktionsvejledningen, som er vedlagt pennen.
English: • You can inject the medicine left in the pen and complete the prescribed dose with a new pen (split-dose) or use a new pen to give the full prescribed dose.
Danish: • Du kan injektiere den mængde lægemidder der tilbage i pennen og fuldføre den ordinerede dosis med en ny pen (delt-dosis) eller bruge en ny pen til at give den hele ordinerede dosis.
English: mcg mcg/kg
Danish: mikrog mikrog/kg
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg din læge, hvis du har yderligere spørgsmål angående brugen af dette lægemiddel.
English: Before first use, store in the original package in order to protect from light.
Danish: Inden anvendelse: opbevares i den originale yderpakning for at beskytte mod lys.
English: You will need to give part of your prescribed dose using your current pen and the remainder of the dose using a new pen (split-dose injection) or you may throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in 1 injection.
Danish: Du behøver at give en del af din ordinerede dosis med din nuværende pen og den resterende del af dosis med en ny pen (delt-dosis injektion) eller du kan smide pennen ud (bortskaf) og bruge en ny pen til at give din fulde ordinerede dosis i 1 injektion.
English: • primary ovarian failure
Danish: • Primært ovariesvigt
English: Disposal of Needle - (Step 13)
Danish: Afmontering af nål - (Step 13)
English: There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive technology treatment.
Danish: Der er rapporteret vridning af æggestokkene (ovarietorsion) efter reagensglas-behandling.
English: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Danish: Kvinder med tubar sygdom i anamnesen har øget risiko for ekstrauterin graviditet, uanset om graviditeten er opnået ved normal befrugtning eller fertilitetsbehandling.
English: Information about your REKOVELLE pre-filled pen The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in marked increments of 0.33 micrograms.
Danish: Pennen kan indstilles til at give doser fra 0,33 mikrogram til 20 mikrogram REKOVELLE i markerede trin på 0,33 mikrogram.
English: Sodium sulphate decahydrate Disodium phosphate dodecahydrate Phosphoric acid, concentrated (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Danish: Natriumsulfatdecahydrat Dinatriumphosphatdodecahydrat Phosphorsyre, koncentreret (til pH-justering) Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: • Check that a droplet of liquid appears at the tip of the needle.
Danish: • Kontroller at en lille dråbe kommer til syne ved nålespidsen.
English: Renal and hepatic impairment REKOVELLE has not been studied in patients with moderate/severe renal or hepatic impairment.
Danish: REKOVELLE er ikke blevet undersøgt hos patienter med moderat/svært nedsat nyre- eller leverfunktion.
English: • If you dial the incorrect priming dose, the priming dose can be corrected either up or down without loss of medicine by turning the dose knob in either direction until the symbol of a droplet lines up with the dose indicator.
Danish: • Hvis du drejer til en forkert klargøringsdosis, kan klargøringsdosis korrigeres enten op eller ned uden tab af lægemiddel ved at dreje dosisvælgeren i vilkårlig retning indtil dråbesymbolet er ud for dosisindikatoren.
English: Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea.
Danish: Kendte gastrointestinale symptomer forbundet med OHSS inkluderer abdominalsmerter, abdominalt ubehag og oppustethed, kvalme, opkastning og diarré.
English: Do not use a pen with particles or unclear medicine in the cartridge.
Danish: Brug ikke en pen med partikler eller uklar væske i cylinderampullen.
English: REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection).
Danish: REKOVELLE er en klar og farveløs injektionsvæske i en fyldt pen (injektion).
English: • The dose can be corrected either up or down without loss of medicine by turning the dose knob in either direction until the correct dose lines up with the dose indicator.
Danish: • Dosis kan korrigeres op eller ned uden tab af lægemiddel ved at dreje dosisvælgeren i vilkårlig retning indtil den rigtige dosis angives ud for dosisindikatoren.
English: • Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the top of the cartridge.
Danish: • Bank let med fingeret på ampulkammeret for at få evnetuelle luftbobler i cylinderampullen til at nå toppen af ampullen.
English: • you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine
Danish: - du er allergisk over for follikelstimulerende hormon eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: • 72 micrograms/2.16 mL
Danish: • 72 mikrogram/2,16 ml
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled ovarian stimulation for ART than following natural conception.
Danish: Hyppigheden af graviditetstab i form af spontan abort eller provokeret abort er øget hos patienter, der er i kontrolleret ART-stimulationsbehandling, sammenlignet med naturlig befrugtning.
English: OHSS is an intrinsic risk of the ovarian stimulation.
Danish: OHSS er en farmakologisk betinget risiko ved ovariestimulation.
English: REKOVELLE is designed for use in conjunction with the REKOVELLE injection pen provided separately.
Danish: REKOVELLE er udformet til anvendelse sammen med REKOVELLE injektionspen, som anskaffes separat.
English: The instructions for using the pre-filled pen must be followed carefully.
Danish: Brugervejledningen til den fyldte pen skal følges nøje.
English: 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.
Danish: Ved OHSS ses markant forstørrede ovarier, forhøjet serumniveau af kønshormoner og en øget vaskulær permeabilitet, som kan resultere i væskeophobning i bughulen, lungerne og sjældent perikardielt.
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Danish: En klinisk undersøgelse kan påvise hypovolæmi, hæmokoncentration, elektrolytforstyrrelser, ascites, hæmoperitoneum, pleuraeffusion, hydrothorax og akut pulmonal lidelse.
English: It is not known if treatment with fertility medicines increase the risk of these tumours in infertile women.
Danish: Det er ikke fastslået, hvorvidt behandling med fertilitetsmedicin øger risikoen for disse tumorer.
English: Reproductive system neoplasms
Danish: Neoplasmer i reproduktionssystemet
English: If you have any questions or problems related to the pen, contact your healthcare provider or local representative of the marketing authorisation holder (please refer to patient information leaflet for contact details).
Danish: Hvis du har spørgsmål eller problemer i forbindelse med pennen, kontakt dit sundhedspersonale eller den lokale repræsentant for indehaveren af markedsføringstilladelsen (se venligst kontakt information i indlægssedlen).
English: • 36 micrograms/1.08 mL
Danish: • 36 mikrogram/1,08 ml
English: Sodium content REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: REKOVELLE indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: If a pen is damaged, contact your healthcare provider or local representative of the marketing authorisation holder (please refer to patient information leaflet for contact details).
Danish: Hvis en pen er beskadiget, kontakt dit sundhedspersonale eller den lokale repræsentant for indehaveren af markedsføringstilladelsen (se venligst kontakt information i indlægssedlen).
English: REKOVELLE is developed for use in the REKOVELLE injection pen.
Danish: REKOVELLE er udviklet til brug med REKOVELLE injektionspen.
English: See “Examples of how to dial a dose” at Page 20 to 211.
Danish: Se “Eksempler på hvordan du indstiller dosis” på side 20 to 211.
English: You will need it to throw away (dispose of) the needle after injecting the medicine.
Danish: Du skal bruge den når du smider nålen ud (bortskaffer) efter injektion af lægemidlet.
English: There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol.
Danish: Der er ingen erfaring fra kliniske studier med REKOVELLE og en GnRH-agonist (lang protokol).
English: • Before using the pen for the first time, you need to remove air bubbles from the cartridge
Danish: • Inden pennen bruges første gang, skal du fjerne luftbobler fra cylinderampullen (Klargøring) for at få den korekte dosis af lægemidlet.
English: Store at or below 25 °C.
Danish: Opbevares ved eller under temperaturer på 25 °C.
English: • Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the dose display window.
Danish: • Drej dosisvælgeren med uret indtil den ordinerede dosis er ud for dosisindikatoren i doseringsvinduet.
English: In use: 28 days when stored at or below 25 °C.
Danish: Efter ibrugtagning: 28 dage, når det opbevares ved eller under temperaturer på 25 °C.
English: • 12 micrograms/0.36 mL
Danish: • 12 mikrogram/0,36 ml
English: • Click on the needle.
Danish: • Klik nålen på.
English: - The active substance is follitropin delta.
Danish: REKOVELLE indeholder: - Aktivt stof: follitropin delta.
English: For the next treatment cycle, your doctor will in this case give you either a higher or a lower daily dose of REKOVELLE than before.
Danish: I så fald vil din læge give dig enten en højere eller en lavere dosis af REKOVELLE i den næste behandlingscyklus.
English: • Discomfort of the abdomen
Danish: • Ubehag i maven
English: 18 and 2 lines (Dial to 18 plus 2 clicks)
Danish: 18 og 2 linjer (Drej til 18 plus 2 klik)
English: • Do not throw the outer needle cap away.
Danish: • Smid ikke nålehætten væk.
English: Pregnancy loss
Danish: Graviditetstab
English: Symptoms may include pain, discomfort or swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing.
Danish: Symptomerne kan omfatte smerter eller ubehag i maven eller oppustet mave, kvalme, opkastning, diarré, vægtstigning og åndedrætsbesvær.
English: REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI).
Danish: REKOVELLE anvendes ved behandling af manglende frugtbarhed (infertilitet) hos kvinder og hos kvinder, som gennemgår reagensglas-behandling såsom in vitro befrugtning (IVF) eller mikroinsemination (ICSI).
English: The medicine may be stored at or below 25 °C for up to 3 months including the period after first use.
Danish: Lægemidlet kan opbevares ved eller under temperaturer på 25 °C i op til 3 måneder inklusive perioden efter ibrugtagning.
English: There have been reports of ovarian and other reproductive system tumours in women who had undergone infertility treatment.
Danish: Der er rapporteret tilfælde af tumorer i æggestokke og andre kønsorganer hos kvinder behandlet for infertilitet.
English: There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol (see section 5.1).
Danish: Der er ingen erfaring fra kliniske studier med REKOVELLE og en GnRH-agonist (lang protokol) (se pkt.
English: The cartridge may be used for several injections.
Danish: Cylinderampullen kan anvendes til flere injektioner.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkninger opstillet efter, hvor alvorlige de er, med de alvorligste anført først.
English: INFORMATION IN BRAILLE REKOVELLE 72 micrograms/2.16 mL
Danish: INFORMATION I BRAILLESKRIFT REKOVELLE 72 mikrog/2,16 ml
English: • Do not store the pen with the needle attached.
Danish: • Opbevar ikke pennen med nålen påsat.
English: - The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water for injections.
Danish: - Øvrige indholdsstoffer: phenol, polysorbat 20, L-methionin, natriumsulfatdecahydrat, dinatriumphosphatdodecahydrat, koncentreret phosphorsyre, natriumhydroxid og vand til injektionsvæsker.
English: When undergoing assisted reproductive technology treatment the possibility of having a multiple pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the quality of the embryos, and your age.
Danish: Ved reagensglas-behandling er muligheden for at blive gravid med mere end ét foster ”flerfoldsgraviditet” (såsom tvillinger) hovedsageligt relateret til antallet af befrugtede æg/embryoner, som sættes op i din livmoder, kvaliteten af embryonerne samt til din alder. Flerfoldsgraviditet kan medføre komplikationer for dig og børnene.
English: INFORMATION IN BRAILLE REKOVELLE 36 micrograms/1.08 mL
Danish: INFORMATION I BRAILLESKRIFT REKOVELLE 36 mikrog/1,08 ml
English: • Pelvic pain and discomfort, including of ovarian origin
Danish: • Smerte og ubehag i bækkenet, herunder også æggestokkene
English: The trial compared the individualised dosing regimen of REKOVELLE where the daily dose is established for each patient and fixed throughout stimulation with no adjustments (see section 4.2) to follitropin alfa filled-by-mass at a starting dose of 11 micrograms (150 IU) for the first five days followed by dose adjustments from day 6 of stimulation based on follicular development in a GnRH antagonist protocol.
Danish: 4.2), med follitropin alfa ordineret i mikrograms-doser (filled-by-mass) med en startdosis på 11 mikrogram (150 IE) i de første fem dage efterfulgt af dosisjusteringer fra stimulationsdag 6 på basis af follikeludviklingen, i en GnRH-antagonist-protokol.
English: REKOVELLE pre-filled pen and its parts
Danish: REKOVELLE fyldt pen dele
English: (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
Danish: Bivirkningerne er inddelt i henhold til systemorganklasse og hyppighed; almindelig (≥1/100 til <1/10) og ikke almindelig (≥1/1.000 til <1/100).
English: Clear and colourless solution with a pH of 6.0-7.0.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning (injektion) Klar og farveløs opløsning med pH 6,0-7,0.
English: The frequency of these adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical trials.
Danish: Kliniske studier har vist, at hyppigheden af disse bivirkninger kan falde ved efterfølgende behandlingscykli.
English: • Call your healthcare provider or local representative of the marketing authorisation holder (please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE injection if you have questions.
Danish: • Hvis du har spørgsmål, kontakt dit sundhedspersonale eller den lokale repræsentant for markedsføringstilladelsen (se venligst kontaktinformation i indlægssedlen) inden du tager REKOVELLE injektionen.
English: INFORMATION IN BRAILLE REKOVELLE 12 micrograms/0.36 mL
Danish: INFORMATION I BRAILLESKRIFT REKOVELLE 12 mikrog/0,36 ml
English: The instructions for using the injection pen supplied with the pen including loading the cartridge must be followed carefully.
Danish: En brugervejledning til injektionspennen inklusive isætning af cylinderampullen er vedlagt pennen og skal følges nøje.
English: • Do not use the pen if the medicine contains particles or if the medicine is not clear.
Danish: • Brug ikke pennen hvis væsken indeholder partikler eller hvis væsken er uklar.
English: CLINICAL PARTICULARS
Danish: Andre kliniske tilstande
English: The most frequently reported adverse reactions during treatment with REKOVELLE are headache, pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue.
Danish: De hyppigst rapporterede bivirkninger ved behandling med REKOVELLE er hovedpine, underlivsgener, OHSS, bækkensmerter, kvalme, smerter i adnexa uteri og træthed.
English: REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.
Danish: REKOVELLE kan opbevares ved eller under temperaturer på 25 °C i op til 3 måneder inklusive perioden efter ibrugtagning.
English: 12 and 1 line (Dial to 12 plus 1 click)
Danish: 12 og 1 linje (Drej til 12 plus 1 klik)
English: Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den fyldte pens etiket og karton efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Do not use this medicine after the expiry date which is stated on the cartridge label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på cylinderampullens etiket og karton efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.
Danish: • Drej dosisvælgeren med uret indtil et dråbe-symbol er ud for dosisindikatoren.
English: (≥1/1,000 to <1/100)
Danish: Ikke almindelig (≥1/1.000 til <1/100)
English: Dialing the dose - (Step 10)
Danish: Indstil dosis - (Trin 10)
English: Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections
Danish: Hjælpestoffer: phenol, polysorbat 20, L-methionin, natriumsulfatdecahydrat, dinatriumphosphatdodecahydrat, koncentreret phosphorsyre, natriumhydroxid og vand til injektionsvæsker.
English: The solution should not be administered if it contains particles or is not clear.
Danish: Injektionsvæsken må ikke indgives, hvis den indeholder partikler eller er uklar.
English: Breast-feeding REKOVELLE is not indicated during breastfeeding.
Danish: Amning REKOVELLE er ikke indiceret under amning.
English: 0 and 2 lines (Dial to 0 plus 2 clicks)
Danish: 0 og 2 linjer (Drej til 0 plus 2 klik)
English: At the end of the treatment any unused solution must be discarded.
Danish: Når behandlingen er afsluttet, skal ikke anvendt injektionsvæske kasseres.
English: • Hold the pen with the needle pointing upwards.
Danish: • Hold penen med nålen pegende opad.
English: Subcutanous use
Danish: Subkutan anvendelse
English: Attaching needle - (Step 2 to 6)
Danish: Påsæt nålen - (Trin 2 til 6)