FrancophonIA/ELRC3.0 huggingface dataset:
English: If your doctor decides to try Bemfola treatment, to monitor the treatment, they may ask you to provide semen for analysis 4 to 6 months after starting treatment.
Danish: Hvis din læge beslutter at prøve behandling med Bemfola, vil du eventuelt blive bedt om at afgive sæd til analyse 4-6 måneder efter start af behandlingen for at overvåge behandlingen.
English: The dose is then adjusted according to the ovarian response.
Danish: Derefter justeres dosis efter det ovarielle respons.
English: In case you are not ovulating, and if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is less likely.
Danish: Hvis du ikke har ægløsning, og hvis den anbefalede dosis og behandlingsplan bliver overholdt, er forekomsten af OHSS mindre sandsynlig.
English: When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.
Danish: Når du gennemgår assisteret befrugtning eller stimulation af æggestokkene for at producere æg, har du større risiko for en abort end den gennemsnitlige kvinde.
English: • if you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for follikelstimulerende hormon (FSH) eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body called “follicle-stimulating hormone” (FSH).
Danish: Dette lægemiddel indeholder det aktive stof follitropin alfa, der næsten er identisk med det naturlige hormon “follikelstimulerende hormon” (FSH), som kroppen selv producerer.
English: One-eighth of the follitropin alfa dose is excreted in the urine.
Danish: En ottendedel af en follitropin alfa-dosis udskilles i urinen.
English: Table 1: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in assisted reproduction technologies) follitropin alfa (n = 130)
Danish: Tabel 1: Resultaterne af studie GF 8407 (randomiseret parallelgruppestudie, der sammenligner virkningen og sikkerheden af follitropin alfa versus FSH udvundet fra urin ved assisteret reproduktionsteknologi).
English: Treatment in men
Danish: Behandling af mænd
English: Hold the pen at approximately a right angle and insert the needle completely in a steady movement.
Danish: Hold pennen i en vinkel på cirka 90°, og indfør kanylen fuldstændigt i en konstant bevægelse.
English: * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: * rekombinant humant follikelstimulerende hormon (r-hFSH) produceret i ovarieceller fra kinesisk hamster (CHO) via rekombinant DNA-teknologi.
English: Bemfola is intended for subcutaneous use.
Danish: Bemfola er beregnet til subkutan anvendelse.
English: Follitropin alfa must not be used when an effective response cannot be obtained, such as in case of:
Danish: Follitropin alfa må ikke anvendes, når effektivt respons ikke kan opnås, som for eksempel:
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and is eliminated from the body with a terminal half-life of about one day.
Danish: Efter intravenøs administration fordeles follitropin alfa til ekstracellulærvæsken med en initial halveringstid på ca. 2 timer og elimineres med en terminal halveringstid på ca. 1 døgn.
English: • Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1,000 people).
Danish: • Komplikationer fra OHSS, f.eks. rotation af en æggestok (ovarietorsion) eller blodpropper kan forekomme sjældent (kan optræde hos op til 1 ud af 1.000 behandlede).
English: In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles.
Danish: Hos kvinder er den vigtigste virkning af parenteralt administreret FSH udviklingen af modne Graafske follikler.
English: 6.6 Special precautions for disposal and other handling The solution should not be administered if it contains particles or is not clear.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Opløsningen må ikke indgives, hvis den indeholder partikler eller ikke er klar.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely (may affect up to 1 in 10,000 people).
Danish: • Alvorlige komplikationer med blodpropper (tromboemboliske hændelser), nogle gange uafhængigt af OHSS kan forekomme meget sjældent (kan optræde hos op til 1 ud af 10.000 behandlede).
English: In other cases, your doctor may first stop you from ovulating by using a gonadotropin-releasing hormone (GnRH) agonist or antagonist.
Danish: I andre tilfælde vil din læge eventuelt først stoppe din ægløsning ved hjælp af et en GnRH-agonist eller -antagonist.
English: • If you are a woman: with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
Danish: • hvis du er kvinde: - med store æggestokke eller væskefyldte hulrum i æggestokkene (ovariecyster) af ukendt oprindelse.
English: Before you start using your pre-filled pen
Danish: Inden du starter med at anvende din fyldte pen
English: • Swelling of the veins above and behind the testicles (varicocele).
Danish: • Opsvulmen af blodårerne over og bag testiklerne (årebrok i pungen)
English: Caution:
Danish: Forsigtig:
English: Once opened, the medicine should be injected immediately.
Danish: Efter åbning skal lægemidlet injiceres straks.
English: Number of oocytes retrieved
Danish: Antal udtagne oocytter
English: Clinical efficacy and safety in men
Danish: Klinisk virkning og sikkerhed hos mænd
English: Comparison with historical data suggests that the ovulation rate obtained with follitropin alfa/LH is similar to that obtained with hMG.
Danish: Sammenligning med historiske data tyder på, at ovulationsraten med follitropin alfa/LH ligner den, der opnås med hMG.
English: Exacerbation or aggravation of asthma Skin and subcutaneous tissue disorders Common:
Danish: Eksacerbationer eller forværring af astma Hud og subkutane væv Almindelig:
English: Your doctor will have told you how many IU to inject each day.
Danish: hvor mange IE, du skal injicere hver dag.
English: If you notice any of the above-listed side effects you should immediately contact your doctor, who might ask you to stop using Bemfola.
Danish: Hvis du bemærker en eller flere af de ovenstående bivirkninger, skal du øjeblikkeligt kontakte lægen, som eventuelt vil bede dig om at holde op med at tage Bemfola.
English: If you forget to use Bemfola, do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, hvis du har glemt at tage Bemfola.
English: Mild or moderate ovarian hyperstimulation syndrome (OHSS) has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Danish: Let eller moderat ovarielt hyperstimulationssyndrom (OHSS) er blevet rapporteret med hyppigheden ”almindelig” og skal anses som en farmakologisk betinget risiko ved stimulationsproceduren.
English: Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady state within 3-4 days.
Danish: Efter gentagen administration akkumuleres follitropin alfa 3 gange og steady state opnås inden for 3-4 dage.
English: In adult men
Danish: Voksne mænd
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Danish: Frekvensen af medfødte misdannelser efter ART kan være en anelse højere end efter spontan undfangelse.
English: You and your partner's fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility disorders.
Danish: Du og din partners frugtbarhed (fertilitet) skal vurderes af en læge med erfaring i at behandle fertilitetsforstyrrelser, før behandlingen starter.
English: diarrhoea
Danish: diarré
English: The used pen needs to be discarded in a sharps container and returned to the pharmacy for a correct disposal.
Danish: Den brugte pen skal lægges i en kanyleboks og afleveres på apoteket til sikker bortskaffelse.
English: • Lower abdominal pain together with nausea or vomiting may be the symptoms of Ovarian Hyper-Stimulation Syndrome (OHSS).
Danish: • Smerter i nederste del af maven i kombination med kvalme eller opkastning kan være symptomer på ovarielt hyperstimulationssyndrom (OHSS).
English: Still holding the pen upright, push the dosage knob in until the activation bar with the small arrow disappears.
Danish: Hold stadig pennen med kanylen opad og tryk doseringsknappen ind, indtil aktiveringsbjælken med den lille pil forsvinder.
English: • Bemfola is supplied in packs with 1, 5 or 10 pre-filled pens, 1, 5 or 10 disposable needles and 1,
Danish: • Bemfola leveres i pakninger med 1, 5 eller 10 fyldte penne, 1, 5 eller 10 engangskanyler og 1,
English: with unexplained vaginal bleeding.
Danish: - med vaginalblødning uden kendt årsag.
English: • Bemfola is intended to be given by injection just under the skin (subcutaneously).
Danish: • Bemfola er beregnet til indsprøjtning under huden (subkutant).
English: Clinical efficacy and safety in women
Danish: Klinisk virkning og sikkerhed hos kvinder
English: Follitropin alfa is a potent gonadotrophic 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: Follitropin alfa er et potent gonadotropinpræparat, som kan fremkalde lette til alvorlige bivirkninger, og bør derfor kun bruges af læger, som er specialiseret i infertilitetsproblemer og -behandling.
English: • Bemfola is presented as a clear, colourless liquid for injection in a pre-filled pen (injection).
Danish: • Bemfola leveres som en klar, farveløs injektionsvæske, opløsning, i en fyldt pen (injektion).
English: Comparative clinical trials have shown that on average patients require a lower cumulative dose and shorter treatment duration with follitropin alfa compared with urinary FSH.
Danish: Sammenlignende kliniske forsøg har vist, at patienter gennemsnitligt har brug for en lavere kumulativ dosis og kortere behandlingsvarighed med follitropin alfa end med u-FSH.
English: Bemfola treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered.
Danish: Bemfola-behandling fører sjældent til svær OHSS, medmindre medicinen, man anvender for at inducere afsluttende follikelmodning (indeholdende humant choriongonadotropin - hCG) er indgivet.
English: Severe OHSS (including associated symptomatology) (see section 4.4)
Danish: Svær OHSS (inklusive associeret symptomatologi) (se pkt.
English: In women whose endogenous gonadotropin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Danish: Hos kvinder, hvis endogene gonadotropin-sekretion er undertrykt, har det ikke desto mindre vist sig, at follitropin alfa effektivt stimulerer follikeludviklingen og steroidgenesen, på trods af umålelige LH-værdier.
English: • OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Danish: • OHSS kan blive alvorligt med tydeligt forstørrede æggestokke, nedsat urinproduktion, vægtøgning, åndedrætsbesvær og/eller mulig væskeophobning i maven eller brystkassen.
English: In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory.
Danish: I kliniske forsøg blev patienter med alvorlig mangel på FSH og LH defineret ved et endogent serumniveau af LH < 1,2 IE/l målt i et centralt laboratorium.
English: Alternatively, intrauterine insemination may be performed by placing the sperm into the womb cavity.
Danish: Alternativt kan intrauterin insemination foretages ved at opsætte sæden i underlivet.
English: • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
Danish: • Stimulation af multipel follikeludvikling hos kvinder, som gennemgår assisteret reproduktionsteknologi (ART) såsom in vitro-befrugtning (IVF), ”gamete intra-fallopian transfer” (GIFT) og ”zygote intra-fallopian transfer” (ZIFT).
English: In adult women
Danish: Voksne kvinder
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Phosphoric acid
Danish: Dinatriumphosphatdihydrat Natriumdihydrogenphosphatdihydrat Phosphorsyre
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Danish: • forstørrede ovarier eller ovariecyste, som ikke er forårsaget af polycystisk ovariesyndrom
English: Hold the pen by its sides and attach the needle by clicking it into place.
Danish: Hold på sidderne af pennen og påsæt kanylen ved at klikke den på plads.
English: Multiple pregnancy, especially of high order, carries an increased risk of adverse maternal and perinatal outcomes.
Danish: Flerfoldsgraviditet, især i mangefold, medfører en øget risiko for skadeligt udfald for moder og foster.
English: Thromboembolism may occur very rarely (see section 4.4).
Danish: Tromboemboli kan forekomme meget sjældent (se pkt.
English: Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
Danish: Der er rapporteret nedsat fertilitet hos rotter, som blev eksponeret for farmakologiske doser af follitropin alfa (≥ 40 IE/kg/dag) gennem længere perioder.
English: In women with anovulation, the objective of therapy with follitropin alfa is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
Danish: Hos kvinder med anovulation er formålet med behandling med follitropin alfa at udvikle en enkelt moden Graafsk follikel, hvorfra oocytten frigøres efter administration af hCG.
English: Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, and without being refrigerated again, may be stored for up to 3 months at or below 25°C.
Danish: Før åbning og inden for holdbarhedstiden kan lægemidlet fjernes fra køleskabet, uden at blive nedkølet igen, i op til 3 måneder ved eller under temperaturer på 25 °C.
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 hændelser, som f.eks. lungeemboli, iskæmisk slagtilfælde og myokardieinfarkt.
English: In men deficient in FSH, follitropin alfa administered concomitantly with hCG for at least 4 months induces spermatogenesis.
Danish: Hos mænd med mangelfuld FSH vil samtidig administration af follitropin alfa og hCG i mindst 4 måneder inducere spermatogenese.
English: What you need to know before you use Bemfola
Danish: Det skal du vide, før du begynder at bruge Bemfola
English: with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.
Danish: - med et helbred, som normalt umuliggør graviditet, f.eks. tidlig overgangsalder (ovariesvigt) eller misdannede kønsorganer.
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Danish: Disse patienter er i kliniske studier blevet identificeret med et endogent LH-serum-niveau på < 1,2 IE/l.
English: No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Danish: Der er ikke fortaget nogen direkte sammenligning mellem follitropin alfa/LH og humant menopausalt gonadotropin (hMG).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Polymun Scientific Immunbiologische Forschung GmbH Donaustraße 99
Danish: Polymun Scientific Immunbiologische Forschung GmbH Donaustraße 99
English: Methionine
Danish: Methionin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 5 OR 10 PRE-FILLED PENS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 1, 5 ELLER 10 FYLDTE PENNE
English: Treatment should recommence in the next cycle at a dose lower than that of the previous cycle.
Danish: Behandling bør genoptages i den næste cyklus på en lavere dosis end den forrige cyklus.
English: Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Danish: Nedregulering med en GnRH-agonist eller -antagonist er nu almindeligt anvendt for at supprimere den endogene LH-stigning og for at kontrollere LH-niveauerne.
English: • together with another medicine called “lutropin alfa” (“luteinising hormone” or LH) to help release an egg from the ovary (ovulation) in women that are not ovulating because their body is producing very little gonadotropins (FSH and LH).
Danish: • sammen med en anden medicin, der kaldes “lutropin alfa” (“luteiniserende hormon” eller LH) til at hjælpe med at frigive æg fra æggestokken (ægløsning) hos kvinder, som ikke har ægløsning, fordi deres krop producerer meget få gonadotropiner (FSH og LH).
English: Before starting treatment, the reason for the couple's infertility must be thoroughly investigated and putative contraindications for pregnancy must be evaluated.
Danish: Før behandlingen begynder, skal årsagen til parrets infertilitet undersøges grundigt, og mulige kontraindikationer for graviditet skal vurderes.
English: To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Danish: For at mindske risikoen for flerfoldsgraviditet anbefales nøje overvågning af ovariestimulationen.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning (injektion).
English: • Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Danish: • Follitropin alfa sammen med et præparat med luteiniserende hormon (LH) anbefales til stimulation af follikeludvikling hos kvinder med svær mangel på LH og FSH.
English: Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Danish: Patienter, som gennemgår stimulation af follikeludvikling, enten i forbindelse med ART eller behandling for anovulatorisk infertilitet, har en øget risiko for at udvikle forstørrede ovarier eller hyperstimulation.
English: Do not throw away any medicines via your sink, toilet or in your household waste.
Danish: Du må ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
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.
Danish: Hos patienter, der gennemgår ART, er risikoen for flerfoldsgraviditet primært relateret til antallet af embryoer, der bliver tilbagelagt, deres kvalitet og patientens alder.
English: No other clinically significant medicinal product interaction has been reported during follitropin alfa therapy.
Danish: Ingen klinisk signifikante interaktioner med andre lægemidler er rapporteret for follitropin alfa.
English: Reproductive system and breast disorders Very common: Ovarian cysts
Danish: Det reproduktive system og mammae Meget almindelig: Ovariecyster Almindelig:
English: For instructions on the administration with the pre-filled pen, see the package leaflet.
Danish: Vejledning i administration med den fyldte pen, se indlægssedlen.
English: Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa.
Danish: Follitropin alfa skal gives som et forløb med daglige injektioner sammen med lutropin alfa.
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Danish: Er du i tvivl, så spørg lægen eller på apoteket, inden du tager denne medicin.
English: • The maximum daily dose of Bemfola is usually not higher than 225 IU (0.375 mL).
Danish: • Den maksimale daglige dosis af Bemfola er sædvanligvis ikke højere end 225 IE (0,375 ml).
English: Severe OHSS is uncommon (see section 4.4).
Danish: Svær OHSS er ikke almindelig (se pkt.
English: For example, following two weeks of treatment with an agonist, 150-225 IU follitropin alfa are administered for the first 7 days.
Danish: Man kan f.eks. efter to ugers behandling med en agonist administrere 150-225 IE follitropin alfa de 7 første dage.
English: Injecting the dose
Danish: Injektion af dosen
English: In clinical trials comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 1 below) and in ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Danish: I kliniske forsøg, der sammenlignede r-hFSH (follitropin alfa) og u-FSH ved ART (se tabel 1 nedenfor) og ved ovulationsinduktion, var follitropin alfa mere potent end u-FSH i form af en lavere total dosis og en kortere behandlingsperiode til at udløse follikulær modning.
English: with cancer in your ovaries, womb or breasts.
Danish: - med kræft i æggestok, livmoder eller bryst.
English: In a commonly used protocol, follitropin alfa is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
Danish: Der påbegyndes normalt med follitropin alfa ca. 2 uger efter starten af agonistbehandlingen, og der fortsættes med begge lægemidler, til adækvat follikeludvikling er opnået.
English: • Your dose of Bemfola may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response or your doctor tells you to stop, see below.
Danish: • Din Bemfola-dosis kan øges hver 7. eller hver 14. dag med 37,5 til 75 IE, indtil du opnår den ønskede virkning, eller din læge siger, at du skal stoppe.
English: • If you use Bemfola with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
Danish: • Hvis du bruger Bemfola sammen med anden medicin, som hjælper med ægløsning (f.eks. hCG eller clomifencitrat), kan det øge folliklernes reaktion.
English: Hold the pen so that the needle is pointing upright.
Danish: Hold pennen, så kanylen peger opad.
English: • Your dose of Bemfola may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
Danish: • Din Bemfola-dosis kan øges hver 7. eller hver 14. dag med 37,5 til 75 IE, indtil du opnår den ønskede virkning.
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or estrogen secretion.
Danish: Behandlingen bør tilpasses den enkelte patients respons, vurderet ud fra måling af follikelstørrelse ved hjælp af ultralyd og/eller østrogensekretion.
English: 10 pre-filled pens 10 injection needles 10 alcohol swabs
Danish: 10 fyldte penne 10 injektionskanyler 10 spritservietter
English: Such patients are unresponsive to follitropin alfa/hCG therapy.
Danish: Hos sådanne patienter er der ingen respons på behandling med follitropin alfa/hCG.
English: Reproductive system and breast disorders Common:
Danish: Det reproduktive system og mammae Almindelig:
English: Caution: Do not push the dosage knob, while inserting the needle.
Danish: Bemærk: Tryk ikke på doseringsknappen, når du indfører kanylen.