FrancophonIA/ELRC3.0 huggingface dataset:
English: Among patients with AMH ≥15 pmol/L, the ovarian response with REKOVELLE (N=355) and follitropin alfa (N=353), respectively, was as follows: mean number of oocytes retrieved 11.6 ± 5.9 and 13.3 ± 6.9, and proportion of patients with ≥20 oocytes 10.1% (36/355) and 15.6% (55/353).
Danish: Blandt patienter med AMH ≥15 picomol/l var det ovarielle respons med henholdsvis REKOVELLE (N=355) og follitropin alfa (N=353) følgende: gennemsnitligt antal oocytter udtaget 11,6 ± 5,9 og 13,3 ± 6,9, og andelen af patienter med ≥20 oocytter 10,1% (36/355) og 15,6% (55/353).
English: • Pinch your skin and insert the needle straight into your skin as shown by your healthcare provider.
Danish: • Knib dit maveskin og stik nålen ind i huden sådan som dit sundhedspersonale har vist.
English: • Carefully replace the outer needle cap over the needle with a firm push (A).
Danish: • Sæt omhyggeligt den ydre nålehætte over nålen med et fast tryk (A).
English: • No. Priming must be performed only before giving the first injection with a new pen.
Danish: Klargøring skal kun udføres inden den første injektion med en ny pen gives.
English: Infertility treatment can increase the risk of this happening, especially if you are overweight or you or someone in your family (blood relative) have a known blood clotting disease (thrombophilia).
Danish: Behandling af infertilitet kan øge risikoen for blodpropper, især hvis du er overvægtig, eller du/eller én i din familie (blodslægt) har tendens til at få blodpropper (har sygdommen trombofili).
English: 20 (Dial to 20)
Danish: 20 (Drej til 20)
English: If the AMH concentration is in ng/mL, the concentration should be converted to pmol/L by multiplying with 7.14 (ng/mL x 7.14 = pmol/L) before use.
Danish: Hvis AMHkoncentration er i nanog/ml, skal koncentrationen omregnes til picomol/l ved at gange med 7,14 (nanog/ml x 7,14 = picomol/l) før brug.
English: Studies in animals have shown reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans (section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet med REKOVELLE ved doser over den anbefalede maksimale dosis hos mennesker (se pkt.
English: One mL of solution contains 33.3 micrograms of follitropin delta* *recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology.
Danish: En ml injektionsvæske indeholder 33,3 mikrogram follitropin delta* * rekombinant humant follikelstimulerende hormon (FSH) produceret i en human cellelinje (PER.C6) ved rekombinant DNA-teknologi.
English: • Check the expiration on the pen label.
Danish: • Kontroller udløbsdato på pennens etiket.
English: Anti-FSH antibodies were measured pre-dosing and post-dosing in patients undergoing up to three repeated treatment cycles with REKOVELLE (665 patients in cycle 1 in the ESTHER-1 trial as well as 252 patients in cycle 2 and 95 patients in cycle 3 in the ESTHER-2 trial).
Danish: Anti-FSH-antistoffer blev målt før og efter administration hos patienter, der gennemgik op til tre gentagne behandlingscykli med REKOVELLE (665 patienter i cyklus 1 i ESTHER 1-studiet og 252 patienter i cyklus 2 og 95 patienter i cyklus 3 i ESTHER 2-studiet).
English: • If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears.
Danish: • Hvis ikke en dråbe kommer til syne gentag trin 7 til 9 (Klargøring) indtil en lille dråbe kommer frem.
English: Excessive ovarian response to gonadotropin treatment seldom gives rise to OHSS unless hCG is administered to trigger final follicular maturation.
Danish: Excessivt ovarierespons ved gonadotropinbehandling medfører sjældent OHSS, medmindre hCG gives for at udløse en afsluttende follikelmodning.
English: If the recommended dose and schedule of administration are followed, ovarian hyperstimulation syndrome is less likely.
Danish: Hvis den anbefalede dosis og doseringsskema følges, er sandsynligheden for ovarielt hyperstimulationssyndrom mindre.
English: • Breast complaints (include breast pain, breast tenderness)
Danish: • Brystproblemer (inklusive brystsmerter og brystømhed)
English: It may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.
Danish: Ovarietorsion kan være forbundet med andre risikofaktorer såsom OHSS, graviditet, tidligere abdominalkirurgi, tidligere ovarietorsion, tidligere eller aktuelle ovariecyster og polycystiske ovarier.
English: For the first treatment cycle, the individual daily dose will be determined on the basis of the woman's serum anti-Müllerian hormone (AMH) concentration and her body weight.
Danish: I den første behandlingscyklus fastsættes den individuelle daglige dosis ud fra kvindens serumkoncentration af antimüllersk hormon (AMH) og kropsvægt.
English: Examples of how to dial a dose using your REKOVELLE pre-filled pen The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses, and what the dose display window looks like for the prescribed doses.
Danish: Eksempler på hvordan du indstiller dosis ved brug af din REKOVELLE fyldt pen Skemaet nedenfor viser eksempler på ordineret dosis, hvad der vælges for den ordinerede dosis, og hvordan ser det ud i doseringsvinduet for den ordinerede dosis.
English: • Calculate and write down the remaining dose to inject in column C by subtracting the number in column B from the number in column A. Use a calculator to check your math if needed.
Danish: • Udregn og nedskriv den resterende dosis der skal injektieres i kolonne C ved at trække tallet i kolonne B fra tallet i kolonne A. Brug en lommeregner til at kontrollere udregningen ved behov.
English: The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in IVF/ICSI patients undergoing COS.
Danish: Den farmakokinetiske profil af follitropin delta er blevet undersøgt hos raske kvindelige forsøgspersoner og hos IVF-/ICSI-patienter, som gennemgår COS.
English: • Throw away (dispose of) the used needle carefully (D).
Danish: • Kasser (bortskaf) forsigtigt den brugte nål (D).
English: Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens anvisning og tag den dosis, som lægen har angivet.
English: Your body weight will also be measured before you start treatment.
Danish: Du vil også blive vejet, inden du påbegynder behandlingen.
English: Split-dosing:
Danish: Delt-dosis:
English: Before use - (Step 1)
Danish: Inden brug - (Trin 1)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Phenol
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Phenol
English: Safety, efficacy and pharmacokinetics of REKOVELLE in patients with renal or hepatic impairment have not been specifically studied in clinical trials.
Danish: REKOVELLEs sikkerhed, virkning og farmakokinetik hos patienter med nedsat nyre- eller leverfunktion er ikke specifikt blevet undersøgt i kliniske studier.
English: For subsequent treatment cycles, the daily dose of REKOVELLE should be maintained or modified according to the patient's ovarian response in the previous cycle.
Danish: I efterfølgende behandlingscykli, skal den daglige REKOVELLE-dosis opretholdes eller ændres i henhold til patientens ovarierespons i den foregående cyklus.
English: Injecting the dose - (Step 11 to 12)
Danish: Injektion af dosis - (Trin 11 til 12)
English: • The number ‘0' is lined up with the dose indicator.
Danish: • Tallet ‘0' er ud for dosisindikatoren.
English: • Always store the pen with the pen cap on and without a needle attached.
Danish: • Opbevar altid pennen med penhætten på og uden en nål påsat.
English: The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation syndrome (OHSS).
Danish: Doseringen af REKOVELLE er individuel for hver patient og tilsigter opnåelse af et ovarielt respons samtidig med en favorabel sikkerheds-/virkningsprofil, dvs. målet er at opnå et passende antal oocytter og mindst mulig intervention for at forebygge ovarielt hyperstimulationssyndrom (OHSS).
English: The dose is to be rounded off to the nearest 0.33 micrograms to match the dosing scale on the injection pen.
Danish: Dosis skal afrundes til nærmeste 0,33 mikrogram for at svare til doseringsskalaen på injektionspennen.
English: Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1).
Danish: Immunogenicitet i form af udvikling af anti-FSH-antistoffer er en potentiel risiko ved gonadotropinbehandling (se pkt.
English: • Check the pen (cartridge) to see that the medicine is clear and does not contain particles.
Danish: • Undersøg pennen (cylinderampul) for at sikre at væsken er klar og ikke indeholder partikler.
English: • Do not tilt the pen during injection and removal from skin.
Danish: • Vip ikke pennen under injektionen og ved fjernelse fra huden.
English: Fixed daily dose of REKOVELLE
Danish: Fast daglig dosis af REKOVELLE
English: Polycystic ovarian syndrome patients with anovulatory disorders Anovulatory patients with polycystic ovarian syndrome have not been studied.
Danish: Patienter med polycystisk ovariesyndrom og anovulatoriske lidelser Anovulatoriske patienter med polycystisk ovariesyndrom er ikke blevet undersøgt.
English: • The pen cap will not fit over a needle.
Danish: • Penhætten passer ikke over en nål.
English: Instructions for use - REKOVELLE (follitropin delta) pre-filled pen
Danish: Brugervejledning - REKOVELLE (follitropin delta) fyldt pen
English: Instructions For Use
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Priming - (Step 7 to 9)
Danish: Klargøring - (Trin 7 til 9)
English: Furthermore, the risk of birth defects may be slightly higher following infertility treatment, which is thought to be due to characteristics of the parents (such as your age, and your partner's sperm characteristics) and multiple pregnancy.
Danish: Endvidere kan risikoen for medfødte misdannelser være lidt højere efter fertilitetsbehandling, hvilket sandsynligvis skyldes forældre-karakteristika (så som din alder og din partners sædkvalitet) og flerfoldsgraviditet.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancy.
Danish: Årsagen til dette antages at være forskelle i forældrenes karakteristika (f.eks. mødrenes alder, spermkvalitet) og flerfoldsgraviditet.
English: • ovarian, uterine or mammary carcinoma (see section 4.4)
Danish: • ovarie-, uterus- eller mammakarcinom (se pkt.
English: After first use (in-use period): • The pen may be stored for up to 28 days at 2°C to 25°C.
Danish: Efter første anvendelse (ibrug perioden): Pennen kan opbevares i op til 28 dage ved 2°C to 25°C.
English: Dose display window for example of prescribed dose
Danish: Doseringsvinduet for eksemplet af ordineret dosis
English: After first use: Use within 28 days.
Danish: Efter ibrugtagning: Anvendes inden for 28 dage.
English: • Ovarian hyperstimulation syndrome (see above)
Danish: • Ovarielt hyperstimulationssyndrom (se ovenfor)
English: Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome.
Danish: Gonadotropiner som dette lægemiddel kan forårsage ovarielt hyperstimulationssyndrom.
English: Table 1 Dosing regimen
Danish: Tabel 1 Dosisregime
English: The prevalence of ectopic pregnancy after ART has been reported to be higher than in the general population.
Danish: Det er rapporteret, at hyppigheden af ekstrauterin graviditet efter ART er højere end hos den generelle befolkning.
English: Fertility REKOVELLE is indicated for use in infertility (see section 4.1).
Danish: Fertilitet REKOVELLE er indiceret til brug ved infertilitet (se pkt.
English: Giving a split-dose of REKOVELLE
Danish: Giv en delt-dosis af REKOVELLE
English: • After pressing in the injection button for 5 seconds, release the injection button.
Danish: • Når du har hold indsprøjtningsknappen inde i 5 sekunder, slip indsprøjtningsknappen.
English: • Check the pen to see that it is not damaged.
Danish: • Kontroller at pennen ikke er beskadiget.
English: Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial REKOVELLE in an individualised dosing regimen (N=665)
Danish: Tabel 3 Rate af igangværende graviditeter og igangværende implantationer i ESTHER 1-studiet REKOVELLE individualiseret doseringsregime (N=665)
English: • After the needle is inserted, place your thumb on the injection button.
Danish: • Efter nålen er indstukket placer tommelfingeren på indsprøjtningsknappen.
English: The apparent clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to high exposure.
Danish: Den tilsyneladende clearance for follitropin delta er lav, dvs. 0,6 l/time efter multiple subkutane injektioner, hvilket medfører høj eksponering.
English: Multiple pregnancy and birth defects
Danish: Flerfoldsgraviditet og medfødte misdannelser
English: The pre-filled pen may be used for several injections.
Danish: Den fyldte pen kan anvendes til flere injektioner.
English: REKOVELLE pre-filled pen follitropin delta
Danish: REKOVELLE fyldt pen follitropin delta
English: In general, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 250 micrograms or 5,000 IU for final development of the follicles.
Danish: Normalt vil du få en enkel injektion af et lægemiddel kaldet humant choriongonadotropin (hCG) i en dosis på 250 mikrogram eller 5.000 IE for den endelige udvikling af folliklerne.
English: • If you are not able to dial your complete dose, this means there is not enough medicine left in the pen.
Danish: • Hvis du ikke er i stand til at vælge din fulde dosis, betyder det at der ikke er tilstrækkelig lægemiddel tilbage i pennen.
English: • gynaecological haemorrhages of unknown aetiology (see section 4.4)
Danish: • gynækologisk blødning af ukendt ætiologi (se pkt.
English: Following subcutaneous administration, the apparent clearance of follitropin delta is 0.6 L/h and the clearance after intravenous is 0.3 L/h.
Danish: Efter subkutan administration er den tilsyneladende clearance af follitropin delta 0,6 l/time og clearance efter intravenøs administration er 0,3 l/time.
English: What you need to know before you use REKOVELLE
Danish: Det skal du vide, før du begynder at bruge REKOVELLE
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det i det væsentlige er natriumfrit.
English: No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins.
Danish: Ingen teratogen risiko er blevet rapporteret efter klinisk anvendelse af gonadotropiner til kontrolleret ovariestimulation.
English: Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider prescribes.
Danish: Brug kun nåle som følger med REKOVELLE fyldt pen eller din læge ordinerer.
English: Hormones used in the treatment of infertility such as this medicine may cause a high level of activity in the ovaries (ovarian hyperstimulation syndrome).
Danish: Hormoner, anvendt til behandling af infertilitet − som dette lægemiddel − kan forårsage et højt aktivitetsniveau i æggestokkene (ovarielt hyperstimulationssyndrom).
English: Manufacturer Ferring GmbH Wittland 11
Danish: Fremstiller Ferring GmbH Wittland 11
English: In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age, although twin pregnancy can in rare occasions develop from single embryo transfers.
Danish: Hos kvinder, der gennemgår ART, er risikoen for flerfoldsgraviditet primært relateret til antallet af oplagte embryoner, deres kvalitet og patientens alder. I sjældne tilfælde kan en tvillingegraviditet forekomme efter oplægning af et enkelt embryon.
English: Twisting of the ovary could cut off the blood flow to the ovary.
Danish: Vridning af en æggestok kan afskære blodtilførslen til æggestokken.
English: Ovulatory patients with polycystic ovaries have been included in clinical trials (see section 5.1).
Danish: Ovulatoriske patienter med polycystiske ovarier indgik i kliniske forsøg (se pkt.
English: Ovarian torsion and thromboembolic events are known to be rare complications of ovarian stimulation treatment (see section 4.4).
Danish: Ovarietorsion og tromboemboliske hændelser er kendt som sjældne komplikationer ved ovariestimulation (se pkt.
English: • If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site.
Danish: • Hvis der kommer blod fra injektionsstedet, tryk et gazebind eller vatkugle let på injektionsstedet.
English: • Firmly replace the pen cap on the pen for protection between injections.
Danish: • Pres penhætten fast på pennen for beskyttelse mellem injektioner.
English: • Do not use the pen after the month of expiration (EXP) printed on the pen label.
Danish: • Brug ikke pennen efter udløbsdatoen (EXP) trykt på pennens label.
English: Marketing Authorisation Holder Ferring Pharmaceuticals A/S Kay Fiskers Plads 11
Danish: Indehaver af markedsføringstilladelsen Ferring Pharmaceuticals A/S Kay Fiskers Plads 11
English: For instructions on the administration with the pre-filled pen, see the ”Instructions for Use”.
Danish: For instruktioner om administration med den fyldte pen, se instruktionsvejledningen.
English: Constipation Abdominal discomfort
Danish: Opkastning Obstipation Abdominalt ubehag
English: REKOVELLE has no or negligible influence on the ability to drive and use machines.
Danish: REKOVELLE påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If the number in column C is 9.67, round your remaining dose to 9.66.
Danish: 9,67, rund din resterende dosis af til 9,66.
English: • If you will use a new pen to give your full prescribed dose instead of giving a split-dose injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a full dose.
Danish: • Hvis du vil bruge en ny pen til at give den fulde ordinerede dosis istedet for at give en delt-dosis injektion smid pennen ud (bortskaf) når der ikke er tilstrækkelig lægemiddel i pennen til en fuld dosis.
English: REKOVELLE contains a potent gonadotropic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Danish: REKOVELLE indeholder et potent gonadotropin, som kan fremkalde lette til alvorlige bivirkninger, og bør derfor kun bruges af læger, som er specialiseret i infertilitetsbehandling.
English: • This medicine should be given by injection just under the skin (subcutaneously) in the stomach-area (abdomen).
Danish: • Dette lægemiddel skal gives ved injektion lige under huden (subkutan) i maveregionen
English: Examples of how to dial a dose
Danish: Eksempler på hvordan du indstiller dosis
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Danish: Meget sjældent kan svær OHSS blive kompliceret af ovarietorsion eller tromboemboliske komplikationer såsom lungeemboli, iskæmisk apopleksi og myokardieinfarkt.
English: What if the dose knob cannot be turned to the required dose?
Danish: Hvorfor kan dosis vælgeren ikke indstilles til den nødvendige dosis?
English: Gonadotropin therapy requires time commitment by physicians and supportive healthcare professionals, as well as the availability of appropriate monitoring facilities.
Danish: Behandling med gonadotropiner er tidskrævende for lægen og øvrigt sundhedspersonale og kræver desuden adgang til særligt monitoreringsudstyr.
English: The instructions for use of the pen must be followed.
Danish: Brugervejledningen for pennen skal følges.
English: This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.
Danish: Dette lægemiddel skal gives som injektion under huden (subkutan injektion) sædvanligvis på maven.
English: • The pen does not allow you to dial a larger dose than the dose that is left in the cartridge.
Danish: • Pennen tillader dig ikke at indstille en større dosis end den mængde der er tilbage i cylinderampullen.
English: If you have a history of tubal disease, you have an increased risk of ectopic pregnancy.
Danish: Hvis du har haft sygdom i æggelederne, har du en øget risiko for ekstrauterin graviditet.
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Danish: Der er rapporteret tilfælde af ovarietumorer og andre tumorer i kønsorganerne, både benigne og maligne, hos kvinder, der har gennemgået multiple behandlingsregimer for infertilitet.
English: Table 2 Adverse reactions in pivotal clinical trials System Organ Class
Danish: Tabel 2 Bivirkninger i de pivotale kliniske studier Systemorganklasse
English: A single injection of 250 micrograms recombinant human chorionic gonadotropin (hCG) or 5,000 IU hCG is administered to induce final follicular maturation.
Danish: En enkelt injektion på 250 mikrogram rekombinant humant choriongonadotropin (hCG) eller 5.000 IE hCG administreres for at inducere follikulær modning.
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
Danish: • forstørrede ovarier eller ovariecyste, som ikke skyldes polycystisk ovariesyndrom
English: • If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months including the in-use period.
Danish: • Ved opbevaring udenfor køl (ved 2 °C to 25 °C), kan pennen holde op til 3 måneder inklusiv ibrug perioden.
English: The terminal elimination half-life after single subcutaneous administration is 40 hours and after multiple subcutaneous administration is 28 hours.
Danish: Den terminale halveringstid er 40 timer efter en enkelt subkutan injektion og 28 timer efter multiple subkutane injektioner.
English: Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Danish: Kontrolleret ovariestimulation med henblik på udvikling af multiple follikler hos kvinder, som gennemgår assisteret reproduktionsteknologi (ART) såsom in vitro befrugtning (IVF) eller intracytoplasmatisk sperm-injektion (ICSI).
English: • Inject the remaining dose of medicine (the number in column C) using your new pen to complete your prescribed dose.
Danish: • Injektier den resterende dosis lægemiddel (tallet i kolonne C) med en ny pen for at fuldføre din ordinerede dosis.
English: Also, as a consequence of the hormonal changes during pregnancy, late development of OHSS can occur.
Danish: Sen udvikling af OHSS kan også forekomme som en konsekvens af hormonændringerne under graviditet.
English: Ovarian hyperstimulation syndrome
Danish: Ovarielt hyperstimulationssyndrom
English: • The cartridge in the pen may not have enough medicine left to deliver the prescribed dose.
Danish: • Cylinderampullen i pennen har ikke tilstrækkelig lægemiddel tilbage for at give den ordinerede dosis.
English: • With the needle still pointing upwards (away from the face) press in the injection button all the way in until you see the number ‘0' lined up with the dose indicator.
Danish: • Mens nålen stadig peger opad (væk fra ansigtet) tryk indsprøjtningsknappen ind så langt den kan komme indtil du ser tallet ‘0' ud for dosisindikatoren.
English: • Sleepiness/drowsiness
Danish: • Søvnighed / døsighed