FrancophonIA/ELRC3.0 huggingface dataset:
English: Since these patients are amenorrhoeic and have low endogenous estrogen secretion, treatment can commence at any time.
Danish: Da disse patienter er amenorréiske og har lav endogen østrogensekretion, kan behandling påbegyndes når som helst.
English: Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Danish: Sædanalyse anbefales 4-6 måneder efter behandlingens start som en del af vurderingen af behandlingsrespons.
English: If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Danish: Hvis patienten efter denne periode ikke har responderet, kan kombinationsbehandlingen fortsættes; nuværende klinisk erfaring indikerer, at behandling i mindst 18 måneder kan være nødvendig for at opnå spermatogenese.
English: Now you are ready to immediately give yourself the injection: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Danish: Du er nu klar til straks at give dig selv injektionen: Din læge eller sygeplejerske vil allerede have rådgivet dig med hensyn til, hvor du skal injicere (f.eks. maven, forsiden af låret).
English: The medicinal product must be discarded if it has not been used after 3 months.
Danish: Lægemidlet skal kasseres, hvis det ikke er anvendt inden 3 måneder.
English: Do not remove the needle immediately, wait for 5 seconds, before pulling it out.
Danish: Fjern ikke kanylen med det samme, men vent i 5 sekunder, inden du trækker kanylen ud.
English: • If you have not responded to treatment after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.
Danish: • Hvis du ikke har haft nogen virkning af behandlingen efter 4 måneder, kan din læge foreslå at fortsætte med disse to lægemidler i mindst 18 måneder.
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Danish: Det er endnu ikke fastslået, om behandling med gonadotropiner øger risikoen for disse typer af tumorer hos infertile kvinder.
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Danish: Det skal dog noteres, at graviditet i sig selv såvel som OHSS også øger risikoen for en tromboembolisk hændelse.
English: Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.
Danish: Patienterne skal forsynes med det korrekte antal penne til deres behandlingsforløb og uddannes i at anvende korrekt injektionsteknik.
English: Mild or moderate OHSS (including associated symptomatology)
Danish: Let eller moderat OHSS (inklusive associeret symptomatologi)
English: • ovarian, uterine or mammary carcinoma.
Danish: • ovarie-, uterus- eller mammakarcinom.
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Danish: Patienten bør informeres om risikoen for flerfoldsfødsler, før behandling påbegyndes.
English: • If you have irregular periods, start using Bemfola within the first 7 days of your menstrual cycle.
Danish: • Hvis du har uregelmæssig menstruation, skal du starte med at tage Bemfola inden for de første 7 dage af din menstruationscyklus.
English: In menstruating women treatment should commence within the first 7 days of the menstrual cycle.
Danish: Hos kvinder med menstruation bør behandlingen påbegyndes inden for de første 7 dage af menstruationscyklus.
English: In case of the above events your doctor may recommend that you stop treatment.
Danish: I sådanne tilfælde kan din læge anbefale, at du stopper behandlingen.
English: • The first injection of Bemfola should be given under supervision of your doctor.
Danish: • Den første injektion af Bemfola skal gives under overvågning af din læge.
English: When using Bemfola, you have a higher risk of being pregnant with more than one child at the same time (“multiple pregnancy”, mostly twins), than if you conceive naturally.
Danish: Når du bruger Bemfola, har du en højere risiko for at blive gravid med flere end ét foster ad gangen (”flerfoldsgraviditet”, i de fleste tilfælde tvillinger), end hvis du bliver gravid ad naturlig vej.
English: If you are not ovulating and have irregular or no periods
Danish: Hvis du ikke har ægløsning, og du har uregelmæssig eller ingen menstruation
English: The first injection of Bemfola should be performed under direct medical supervision.
Danish: Den første Bemfola-injektion skal udføres under direkte medicinsk overvågning.
English: • you have stomach, arm or leg pain.
Danish: • hvis du har smerter i maven, arme eller ben.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also section 2 under ‘Blood clotting problems').
Danish: Det kan give brystsmerter, stakåndethed, slagtilfælde eller hjerteanfald (se også afsnit 2 under 'Problemer med blodpropper').
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Danish: Bivirkningerne er klassificeret i henhold til hyppighed ved brug af følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) Behandling af kvinder
English: 5 or 10 alcohol swabs.
Danish: 5 eller 10 spritservietter.
English: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Danish: En vis grad af forstørrede ovarier er en forventet effekt af kontrolleret ovariestimulation.
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
Danish: • hvis din hud bliver skrøbelig og let får blærer, specielt på steder, som ofte udsættes for sollys, og/eller
English: Perform the injection every day around the same time.
Danish: Foretag injektionen på omtrent samme tidspunkt hver dag.
English: Blood clotting problems (thromboembolic events)
Danish: Problemer med blodpropper (tromboemboliske hændelser)
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Danish: Farmakoterapeutisk klassifikation: Kønshormoner og modulatorer af det genitale system, gonadotropiner, ATC-kode: G03GA05.
English: urinary FSH (n = 116)
Danish: FSH udvundet fra urin (n = 116)
English: Men with hypogonadotropic hypogonadism
Danish: Mænd med hypogonadotrop hypogonadisme
English: • Your doctor/pharmacist will tell you how many Bemfola pens you need to use for your complete treatment course.
Danish: • Din læge /apoteket vil fortælle dig, hvor mange Bemfola penne du skal bruge for at fuldføre dit behandlingsforløb.
English: • Your doctor or nurse will show you how to use the Bemfola pre-filled pen to inject the medicine.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du bruger Bemfola fyldt pen til at injicere medicinen.
English: There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs.
Danish: Der er evidens, som antyder, at hCG spiller en vigtig rolle i udløsning af OHSS, og at syndromet kan være mere alvorligt og længerevarende, hvis graviditet opstår.
English: Do not use Bemfola
Danish: Brug ikke Bemfola:
English: Investigations Common:
Danish: Undersøgelser Almindelig:
English: Push in the dosage knob slowly and continuously until it stops, and the dose bar has disappeared.
Danish: Tryk doseringsknappen langsomt og kontinuerligt ind, til den standser, og doseringsbjælken er forsvundet.
English: Women
Danish: Kvinder
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Danish: Hvis du udvikler OHSS, vil din læge måske ikke give hCG i denne behandlingscyklus, og du vil muligvis blive bedt om ikke at have samleje eller at bruge barriereprævention i mindst 4 døgn.
English: • primary testicular insufficiency.
Danish: • primær testikelinsufficiens.
English: Note: The pen is now ready for injection.
Danish: Bemærk: Pennen er nu klar til injektion.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Danish: Hos disse kvinder bør fordele ved gonadotropinbehandling opvejes over for risikoen.
English: However, since follitropin alfa is not indicated in pregnancy, these data are of limited clinical relevance.
Danish: Eftersom follitropin alfa ikke er indiceret under graviditet, er disse data dog af begrænset klinisk relevans.
English: In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Danish: Ved ART kan aspiration af alle follikler før ovulation reducere forekomsten af hyperstimulation.
English: Turn the dosage knob until your prescribed dose is in line with the display window.
Danish: Drej doseringsknappen, indtil din ordinerede dosis er på linje med displayvinduet.
English: Mild or moderate OHSS usually resolves spontaneously.
Danish: Let eller moderat OHSS forsvinder sædvanligvis spontant.
English: Then Bemfola is started approximately two weeks after start of agonist treatment.
Danish: Dernæst startes Bemfola ca. to uger efter start af agonistbehandling.
English: In women, FSH is needed for the growth and development of the sacs (follicles) in the ovaries that contain the egg cells.
Danish: Hos kvinder er FSH nødvendigt til vækst og udvikling af ægsækkene (folliklerne) i æggestokkene, som indeholder ægcellerne.
English: Therefore, it is considered appropriate to give a lower total dose of follitropin alfa than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation (see section 5.1).
Danish: Derfor anses det for hensigtsmæssigt at give en lavere total dosis af follitropin alfa end normalt anvendt ved u-FSH, ikke kun med henblik på at optimere follikeludviklingen, men også for at minimere risikoen for uønsket ovariehyperstimulation (se punkt 5.1).
English: If you forget to use Bemfola
Danish: Hvis du har glemt at bruge Bemfola
English: If you need to develop several eggs for collection prior to any assisted reproductive technology
Danish: Hvis du har behov for at udvikle flere æg til udtagning inden assisteret befrugtning
English: • fibroid tumours of the uterus incompatible with pregnancy;
Danish: • fibroide tumorer i uterus, der er uforenelige med graviditet
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Danish: FSH er et gonadotropin, som er en type hormon, der er vigtig for menneskers frugtbarhed og forplantning.
English: The effects of taking too much Bemfola are unknown.
Danish: Virkningerne af en overdosering af Bemfola er ukendt.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Danish: Årsagen til dette antages at være forskellen i forældrenes kendetegn (dvs. moderens alder, spermkvalitet) og flerfoldsgraviditet.
English: • The active substance is follitropin alfa.
Danish: • Aktivt stof: Follitropin alfa
English: Elevated endogenous FSH levels are indicative of primary testicular failure.
Danish: Forhøjede endogene FSH-niveauer er tegn på primært testikelsvigt.
English: • if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
Danish: • hvis du har en tumor i hypotalamus eller hypofysen (begge er dele af hjernen).
English: Do not use this medicine if you notice any visible signs of deterioration, if the liquid contains particles or is not clear.
Danish: Brug ikke dette lægemiddel, hvis du bemærker synlige tegn på nedbrydning, eller hvis væsken indeholder partikler eller er uklar.
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock
Danish: Lette til alvorlige overfølsomhedsreaktioner inklusive anafylaktiske reaktioner og shock
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 forstørrede ovarier er OHSS en tilstand, som manifesteres i stigende grader af alvorlighed.
English: If you are not ovulating, have no periods and have been diagnosed with very low levels of FSH and LH hormones
Danish: Hvis du ikke har ægløsning og ikke får menstruationer, og du er blevet diagnosticeret med meget lave niveauer af FSH- og LH-hormoner
English: Do not push the dosage knob in any further, at this point.
Danish: Tryk ikke doseringsknappen længere ind på dette tidspunkt.
English: In men, FSH is needed for the production of sperm.
Danish: Hos mænd er FSH nødvendigt for sædproduktionen.
English: The steady state volume of distribution and total clearance are 10 L and 0.6 L/h, respectively.
Danish: Steady statefordelingsvoluminet og den totale clearance er henholdsvis 10 liter og 0,6 liter/time.
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also section 2 “Take special care with Bemfola”).
Danish: Dette kan være tegn på, at æggestokkene har overreageret på behandlingen, og at der har udviklet sig store cyster i æggestokkene (se også afsnit 2 ”Vær ekstra forsigtig med at tage Bemfola').
English: It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
Danish: Det ses hyppigere hos kvinder med polycystisk ovariesyndrom og aftager sædvanligvis uden behandling.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Danish: Behandling skal iværksættes under opsyn af en læge, som har erfaring inden for behandling af fertilitetsforstyrrelser.
English: Nevertheless one could expect Ovarian HyperStimulation Syndrome (OHSS) to occur, which is described in section 4.
Danish: Man kan dog antage, at ovarielt hyperstimulationssyndrom (OHSS) indtræder, hvilket beskrives i afsnit.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natrium-fri.
English: Gently tap the pen so that any large air bubbles rise to the top.
Danish: Knips forsigtigt på pennen, så eventuelle store luftbobler stiger opad.
English: Pregnancy and breast-feeding Do not use Bemfola if you are pregnant or breast-feeding.
Danish: Graviditet og amning Brug ikke Bemfola, hvis du er gravid eller ammer.
English: However the OHSS will only occur if hCG is also administered (see section 2, under ‘OHSS').
Danish: OHSS vil kun opstå, hvis hCG også indgives (se afsnit 2, under 'OHSS').
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 ovarie- og andre reproduktionssystemtumorer, både benigne og maligne, hos kvinder, der har gennemgået adskillige behandlinger for infertilitet.
English: If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with Bemfola treatment.
Danish: Hvis du tidligere eller for nylig har haft blodpropper i benene eller i lungerne eller et hjerteanfald eller et slagtilfælde, eller hvis noget sådant er forekommet i din familie, kan du have højere risiko for, at disse problemer opstår eller forværres med Bemfola-behandlingen.
English: Driving and using machines It is not expected that this medicine will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det forventes ikke, at denne medicin vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Use the prefilled pen only once then it should be disposed of in a safe manner.
Danish: Den fyldte pen må kun anvendes én gang, hvorefter den skal kasseres på sikker vis.
English: The prevalence of ectopic pregnancy after ART was reported to be higher than in the general population.
Danish: Hyppigheden af ekstrauterin graviditet efter ART blev rapporteret til at være højere end hos den generelle befolkning.
English: As the Bemfola pre-filled pen with the single-dose cartridge is intended for only one injection, clear instructions should be provided to the patients to avoid misuse of the single dose presentation.
Danish: Da Bemfola fyldt pen med en enkeltdosis-cylinderampul er beregnet til kun én injektion, bør patienten modtage klar instruktion for at undgå forkert brug af enkeltdosisformuleringen.
English: The best time to have sex is on the day of the hCG injection and the day after.
Danish: Det bedste tidspunkt at have samleje er på selve dagen for hCG-injektionen og dagen efter.
English: If you do not have periods you can start using the medicine on any convenient day.
Danish: Hvis du ikke har menstruation, kan du starte med at tage medicinen på en dag, som passer dig.
English: After the injection
Danish: Efter injektionen
English: Follitropin alfa should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
Danish: Follitropin alfa skal gives i doser på 150 IE tre gange ugentligt samtidig med hCG i minimum 4 måneder.
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and should be treated accordingly.
Danish: Specielt skal patienten undersøges for hypotyroidisme, adrenokortikalt svigt, hyperprolaktinæmi, og behandles derfor.
English: Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify risk factors.
Danish: Monitorering af stimulationscyklusser med ultralydsscanning såvel som målinger af estradiol anbefales for tidlig identifikation af risikofaktorer.
English: • gynaecological haemorrhages of unknown aetiology;
Danish: • gynækologiske blødninger af ukendt ætiologi
English: Data on a limited number of exposed pregnant women (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
Danish: Data fra anvendelse af follitropin alfa hos et begrænset antal gravide kvinder (mindre end 300 graviditetsudfald) indikerer ikke misdannelser eller føtal/neonatal toksicitet af follitropin alfa.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i
English: If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation after which she may recommence treatment at a higher starting dose than in the abandoned cycle.
Danish: Hvis der ikke fremkommer et adækvat respons efter 4 ugers behandling, skal den cyklus opgives, og patienten skal gennemgå yderligere evaluering, hvorefter hun evt. kan påbegynde en behandling med en større startdosis end i den afbrudte cyklus.
English: Before you start using your pre-filled pen 3.
Danish: Inden du starter med at anvende din fyldte pen 3.
English: Follitropin alfa should not be used when an effective response cannot be obtained.
Danish: Follitropin alfa må ikke anvendes, når der ikke kan opnås et effektivt respons.
English: If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight away who might ask you to stop using this medicine (see section 4).
Danish: Hvis du får smerter i den nederste del af underlivet, tager meget hurtigt på i vægt, får kvalme eller kaster op, eller hvis du har åndedrætsbesvær, skal du straks tale med lægen, som kan bede dig om at holde op med at tage medicinen (se afsnit 4).
English: Do not use this medicine after the expiry date, which is stated on the pen label and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pennens etiket og karton efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Danish: Ovarielt hyperstimulationssyndrom (OHSS)
English: Self-administration of Bemfola should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Danish: Selvadministration af Bemfola bør kun udføres af patienter, som er motiverede, har modtaget tilstrækkelig instruktion, og som har mulighed for at konsultere kvalificeret fagpersonale.
English: The maximal daily dose is usually not higher than 225 IU FSH.
Danish: Den maksimale daglige dosis er normalt ikke større end 225 IE FSH.
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa.
Danish: Patienter med porfyri eller med porfyri i familieanamnesen skal monitoreres nøje under behandlingen med follitropin alfa.
English: Treatment in women
Danish: Behandling af kvinder
English: In women, safe and effective use of follitropin alfa calls for monitoring of the ovarian response with ultrasound, alone or preferably in combination with measurement of serum estradiol levels, on a regular basis.
Danish: Sikker og effektiv brug af follitropin alfa hos kvinder kræver overvågning af ovarierespons via ultralyd alene eller helst i kombination med regelmæssig måling af serumestradiol.
English: If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing, and that the patient be hospitalised and appropriate therapy be started.
Danish: Hvis svær OHSS opstår, anbefales det at evt. igangværende gonadotropinbehandling stoppes, og patienten indlægges på hospital, og passende behandling for OHSS påbegyndes.
English: Adherence to the recommended follitropin alfa dose and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Danish: Overholdelse af anbefalet follitropin alfa-dosis og administrationsregime samt nøje overvågning af behandlingen vil reducere forekomsten af sådanne hændelser.
English: You should also hear a click, and some liquid will splash out (this is normal).The pen is now ready to set the dose.
Danish: Du vil også høre et klik, og noget af væsken sprøjtes ud (dette er normalt).
English: One needle and one alcohol swab to be used with the pen for administration.
Danish: 1 kanyle og 1 spritserviet til anvendelse med pennen ved administration.
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Danish: Lutealfasestøtte bør overvejes, idet mangel på substanser med luteotropisk aktivitet (LH/hCG) efter ovulation kan føre til for tidligt svigt af corpus luteum.
English: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Danish: Hos kvinder med nylig eller aktuel tromboembolisk sygdom eller med kendt risiko for tromboemboliske hændelser, f.eks. i den personlige eller familiære anamnese, kan behandling med gonadotropiner øge risikoen for forværring eller forekomst af sådanne hændelser yderligere.
English: When GnRH antagonist is used, it is administered from the 5th or 6th day of Bemfola treatment and continued until ovulation induction.
Danish: Når en GnRH-antagonist bruges, indgives den fra den 5. eller 6. dag i behandlingen med Bemfola og fortsættes indtil fremkaldelse af ægløsning.