FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles.
Danish: Din læge vil foretage en ultralydsscanning af æggestokkene for omhyggeligt at overvåge antallet af follikler.
English: Elevated endogenous FSH levels in men are indicative of primary testicular failure.
Danish: Forhøjede endogene FSH-niveauer hos mænd indikerer primær testikellidelse.
English: Start again with Step 1 using a new syringe, new needles and a new vial of Fertavid.
Danish: Start forfra med Trin 1, idet du bruger en ny nål og sprøjte og et nyt hætteglas med Fertavid.
English: • if you already know you have an increased chance of having thrombosis
Danish: • hvis du allerede ved, at du har en forhøjet risiko for blodpropper
English: Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities.
Danish: Intravaskulær trombose, som kan opstå i vener eller arterier, kan give nedsat blodgennemstrømning til vitale organer og ekstremiteter.
English: To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment; the concurrent determination of serum oestradiol levels may also be useful.
Danish: For at overvåge risikoen for OHSS skal der udføres ultralydsscanning af follikeludviklingen før behandlingen og med regelmæssige intervaller under behandlingen; samtidig bestemmelse af estradiol i serum kan også være nyttig.
English: Fertavid can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Danish: Fertavid kan gives enten alene eller i kombination med en GnRH-agonist eller antagonist.
English: Fertavid showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Danish: Fertavid udviste intet mutagent potentiale i Ames' testen eller i in vitro-kromosomafvigelsestesten med humane lymfocytter.
English: Fertavid is unlikely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Fertavid påvirker din evne til at køre motorkøretøj og betjene maskiner.
English: Step 5 - Checking the correct needle position
Danish: Trin 5 - Kontrol af nålens korrekte position
English: OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy (endogenous hCG).
Danish: OHSS kan forårsages af administration af human chorion gonadotropin (hCG) og af graviditet (endogen hCG).
English:  Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation.
Danish:  Regelmæssig kontrol af, hvordan du reagerer på FSH-behandlingen kan medvirke til at forhindre overstimulation af æggestokkene.
English: In these women the benefits of gonadotropin administration, including Fertavid, need to be weighed against the risks.
Danish: Hos disse kvinder skal fordelene ved behandling med gonadotropin, herunder Fertavid, opvejes mod risici.
English: Step 2 - The injection site
Danish: Trin 2 - Indsprøjtningssted
English: Fertavid can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Danish: Fertavid kan derfor bruges til stimulation af follikeludviklingen og produktionen af steroider i udvalgte tilfælde af manglende gonadal funktion.
English: Subcutaneous injection of Fertavid may be carried out by patient or partner, provided that proper instructions are given by the physician.
Danish: Subkutan injektion af Fertavid kan udføres af patienten selv eller dennes partner, forudsat de har modtaget fyldestgørende instruktioner af lægen.
English: Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics, genetic background of both parents) may be associated with an increased risk of birth defects.
Danish: Desuden kan flerfoldsgraviditet samt egenskaber hos patienten, som gennemgår behandling for barnløshed (f.eks. kvindens alder, mandens sædkvalitet, begge forældres genetiske baggrund), muligvis medføre en øget risiko for medfødte misdannelser.
English: To prevent painful injections and minimise leakage from the injection site Fertavid should be slowly administered intramuscularly or subcutaneously.
Danish: For at forhindre smertefuld injektion og minimere udsivning fra injektionsstedet bør Fertavid indgives langsomt, enten intramuskulært eller subkutant.
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; ATC code: G03G A06.
Danish: Farmakoterapeutisk klassifikation: Gonadotropin og andre ovulationsstimulerende midler, gonadotropiner; ATC- kode: G03G A06.
English: Due to the sustained release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours.
Danish: På grund af den vedvarende afgivelse fra injektionsstedet og eliminationshalveringstiden på ca. 40 timer (varierende fra 12 til 70 timer), forbliver FSH-koncentrationen forhøjet i 24-48 timer.
English: To check the effects of treatment, your doctor may ask you for a semen sample to be analysed, four to six months after the start of treatment.
Danish: For at kontrollere effekten af behandlingen vil din læge muligvis bede om en sædprøve til analyse fire til seks måneder efter behandlingens start.
English: Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations.
Danish: Eftersom follikler på mere end 14 mm i diameter kan medføre graviditeter, medfører multiple præovulatoriske follikler på mere end 14 mm i diameter en risiko for flerfoldsgraviditeter.
English: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).
Danish: Hos ca. 4 % af de kvinder, som blev behandlet med follitropin beta i kliniske studier, blev der rapporteret tegn på og symptomer med relation til ovarieoverstimulationssyndrom (OHSS) (se pkt.
English: Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.
Danish: Lægen vil derfor foretage en tidlig ultralydsscanning for at udelukke muligheden for graviditet uden for livmoderen.
English: Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation.
Danish: Tidlig OHSS opstår normalt indenfor 10 dage efter hCG-administration og kan være forbundet med for højt ovarierespons på gonadotropin-stimulation.
English: When using the pen injector, it should be realised that the pen is a precision device which accurately delivers the dose to which it is set.
Danish: Når injektionspennen anvendes skal man være opmærksom på, at pennen meget nøjagtigt afgiver den dosis, som den er indstillet til.
English: Your doctor or nurse will tell you where to inject.
Danish: Din læge eller sygeplejerske vil informere dig om dette.
English: Abdominal distension Abdominal pain
Danish: Abdominal distension Abdominalsmerter
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Danish: Især skal patienterne evalueres for hypotyroidisme, binyrebarkinsufficiens, hyperprolaktæmi, tumorer i hypofyse og hypotalamus, og den rette specifikke behandling gives.
English: Ectopic Pregnancy
Danish: Ektopisk graviditet
English: The daily dose is then maintained until a follicle of proper size is present.
Danish: Derefter vedligeholdes den daglige dosis, indtil der findes en follikel med en passende størrelse.
English: See warnings and precautions in section 2.
Danish: (Se Advarsler og forsigtighedsregler i punkt 2).
English: It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
Danish: Det er påvist, at pennen gennemsnitligt afgiver en 18% højere dosis FSH sammenlignet med en almindelig sprøjte.
English: This leaflet was last revised in Month YYYY.
Danish: Denne indlægsseddel blev senest ændret måned ÅÅÅÅ
English: Do not mix Fertavid with any other medicines.
Danish: Bland ikke Fertavid sammen med anden medicin.
English: Fertavid may affect milk production.
Danish: Fertavid kan påvirke mælkeproduktionen.
English: Pain in the stomach, feeling sick or diarrhoea are the first symptoms.
Danish: Mavesmerter, utilpashed eller diarré er de første symptomer.
English: If you forget to use Fertavid
Danish: Hvis du har glemt at tage Fertavid
English: After treatment with gonadotrophin preparations, there is an increased chance of having multiple pregnancies, even when only one embryo is transferred into the uterus.
Danish: Efter behandling med gonadotropin-præparater er der en øget risiko for flerfoldsgraviditet, selv om kun et fosteranlæg opsættes i livmoderen.
English: Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Fertavid.
Danish: Kvinder med kendte risikofaktorer for højt ovarierespons kan være særligt tilbøjelige til at udvikle OHSS under eller efter behandling med Fertavid.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Fertavid, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: In adult males: • Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Danish: Voksne mænd: • Utilstrækkelig spermatogenese forårsaget af hypogonadotropisk hypogonadisme.
English: Draw the solution up into the syringe (b), and replace the needle with an injection needle (c).
Danish: Træk væsken op i sprøjten (b) og erstat nålen med en injektionsnål (c).
English: When a sufficient number of follicles of proper size are present, the final phase of maturation of the follicles is induced by giving hCG. Retrieval of the egg(s) is performed 34-35 hours later.
Danish: Når der findes et tilstrækkeligt antal follikler med en passende størrelse, fremkaldes den sidste fase af modningen af folliklerne ved indgivelse af hormonet hCG. Ægudtagningen foretages 34-35 timer senere.
English: Talk to your doctor before using Fertavid if you:
Danish: Kontakt lægen, før du tager Fertavid, hvis du:
English: If you are a man:
Danish: Hvis du er en mand:
English: A starting dose of 100-225 IU is recommended for at least the first four days.
Danish: En startdosis på 100-225 IE anbefales i de første 4 dage (eller flere) af behandlingen.
English: For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
Danish: Hos anuvolatoriske kvinder, der gennemgår ovulationsinduktion, kan monitorering af follikeludviklingen med transvaginal ultralydsscanning hjælpe med til at bestemme, om behandlingscyklus skal fortsætte eller stoppes for at reducere risikoen for flerfoldsgraviditet.
English: Ovarian torsion 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 operation i abdomen, ovarietorsion i amnesen, tidligere eller nuværende ovariecyster og polycystiske ovarier.
English: Treatment with Fertavid, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis).
Danish: Behandling med Fertavid kan ligesom graviditet øge risikoen for blodpropper (trombose).
English: In the female the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity.
Danish: Hos kvinder er koncentrationen af FSH kritisk for follikeludviklingens indtræden og varighed, og dermed for tidspunktet for og antallet af follikler som modnes.
English: OHSS is a medical event distinct from uncomplicated ovarian enlargement.
Danish: OHSS er en klinisk tilstand, som er forskellig fra ukompliceret forstørrelse af ovarierne.
English: • have any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).
Danish: • har andre sygdomme (fx sukkersyge (diabetes), hjertesygdom eller anden langvarig sygdom).
English: If you are a woman:
Danish: Hvis du er en kvinde:
English: Adherence to the recommended Fertavid dose and treatment regimen and careful monitoring of ovarian response is important to reduce the risk of OHSS.
Danish: Det er vigtigt at overholde det anbefalede dosis- og behandlingsregime for Fertavid og at overvåge ovarieresponset nøje for at nedsætte risikoen for OHSS.
English: What Fertavid contains
Danish: Fertavid indeholder
English: Injections may be given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or under the skin (in the lower stomach, for example).
Danish: Indsprøjtningen indgives langsomt i en muskel (f.eks. i ballen, låret eller overarmen) eller lige under huden (f.eks. på maven).
English: FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
Danish: FSH er uundværlig for den normale follikelvækst og -modning og den gonadale produktion af steroider.
English: There is a slightly increased risk of a pregnancy outside the uterus (an ectopic pregnancy).
Danish: Der er en let øget risiko for graviditet uden for livmoderen (ektopisk graviditet).
English: The first injection with Fertavid should be performed under direct medical supervision.
Danish: Den første Fertavid-injektion skal foretages under direkte lægelig supervision.
English: Increased FSH blood levels are a sign of damage to the testicles.
Danish: Forhøjet indhold af FSH i blodet er et tegn på, at testiklerne er skadet.
English: • have high prolactin levels in the blood (hyperprolactinemia)
Danish: • har høj koncentration af prolaktin i blodet (hyperprolaktinæmi)
English: • Malformations of the reproductive organs incompatible with pregnancy.
Danish: • Misdannelser af genitalier, som er uforenelige med graviditet.
English: In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Fertavid, may further increase this risk.
Danish: Hos kvinder med almindeligt kendte risikofaktorer for trombose, såsom trombose i anamnesen, familiær disposition, svær overvægt eller trombofili, kan behandling med gonadotropiner, herunder Fertavid, yderligere øge risikoen.
English: Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained.
Danish: Præovulatoriske forhold er nået, når ultrasonografi viser en dominant follikel på mindst 18 mm i diameter, og/eller når plasma estradiolniveauerne er nået op på 300-900 picogram/ml (1.000-3.000 pmol/l).
English: No data on acute toxicity of Fertavid in humans is available, but the acute toxicity of Fertavid and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
Danish: Der er ingen tilgængelige data vedrørende akut toksicitet af Fertavid hos mennesker, men dyreforsøg har vist en meget lav akut toksicitet af Fertavid og gonadotropinpræparater udvundet af urin.
English: Instructions for use
Danish: Instruktion vedrørende brugen
English: Distribution, biotransformation and elimination Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.
Danish: Rekombinant FSH er biokemisk meget lig humant FSH udvundet af urin, og det fordeles, metaboliseres og udskilles på samme måde.
English: No teratogenic effect has been observed in animal studies.
Danish: Dyreforsøg har ikke påvist nogen teratogen effekt.
English: Fertavid is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Danish: Fertavid anvendes i behandlingen af kvinder, som gennemgår ovarieinduktion eller kontrolleret ovarieoverstimulation i forbindelse med medicinsk assisteret reproduktionsbehandling.
English: The best site for an injection under the skin is in the lower stomach around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Danish: Det er bedst at give indsprøjtningen under huden på den nedre del af maven omkring navlen (e), hvor huden er løs og der findes et lag fedtvæv.
English: • Fibroid tumours of the uterus incompatible with pregnancy.
Danish: • Fibromer i uterus, som er uforenelige med graviditet.
English: Fertavid is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months.
Danish: Fertavid ordineres sædvanligvis i en dosis på 450 IE pr. uge, oftest i 3 doser a 150 IE i kombination med et andet hormon (hCG) i mindst 3 til 4 måneder.
English: Place a needle on a syringe and pierce the needle through the rubber stopper of the vial (a).
Danish: Sæt en nål på en sprøjte og stik nålen igennem gummihætten i hætteglasset (a).
English: When used for an ovulation induction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development.
Danish: Når det anvendes til ovulationsinduktion, skal passende FSH-dosisjustering(er) hindre udvikling af multiple follikler.
English: If you forget a dose do not use a double dose to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: In women, FSH is needed for the growth and development of follicles in the ovaries.
Danish: Hos kvinder er FSH nødvendigt for væksten og udviklingen af follikler i æggestokkene.
English: Your doctor may also check blood hormone levels.
Danish: Lægen kan også kontrollere koncentrationen af hormoner i blodet.
English: The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Danish: pH værdien kan være blevet justeret med natriumhydroxid og/eller saltsyre.
English: Antibiotic hypersensitivity reactions
Danish: Overfølsomhedsreaktioner over for antibiotika
English: • have ever had a twisting of an ovary
Danish: • nogensinde har haft vridning af en æggestok
English: In that case hCG should be withheld and pregnancy should be avoided to prevent multiple gestations.
Danish: I sidstnævnte tilfælde bør hCG-behandlingen ikke igangsættes, og graviditet bør undgås for at udelukke flerfoldsgraviditeter.
English: Paediatric population There is no relevant use of Fertavid in the paediatric population for the approved indication.
Danish: Pædiatrisk population Der er ingen relevante indikationer for Fertavid i den pædiatriske population.
English:  Contact your doctor immediately if you are experiencing stomach pains, or any of the other symptoms of ovarian hyperstimulation, also if this occurs some days after the last injection.
Danish:  Kontakt straks din læge, hvis du får mavesmerter eller nogle af de andre symptomer på overstimulation af ovarierne, også hvis disse symptomer først opstår nogle dage efter, indsprøjtningen er givet.
English: Depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Danish: Trin 6 - Indsprøjtning af opløsningen Tryk stemplet langsomt og roligt ned, så opløsningen indsprøjtes korrekt, og huden ikke beskadiges.
English: If necessary, the plunger may be squeezed further, to adjust the volume to be administered.
Danish: Om nødvendigt, kan stemplet trykkes yderligere op for at justere mængden af væske, der skal indsprøjtes.
English: Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
Danish: Midlertidige unormale resultater af leverfunktionstest, der tyder på nedsat leverfunktion med eller uden morfologiske ændringer i leverbiopsien, er også rapporteret i forbindelse med OHSS.
English: In rare instances, thromboembolism has been associated with follitropin beta/hCG therapy as with other gonadotrophins.
Danish: I sjældne tilfælde er tromboembolisme blevet forbundet med follitropin beta/hCG behandling, ligesom ved behandling med andre gonadotropiner.
English: Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Danish: Det er vigtigt tidligt i forløbet at bekræfte ved hjælp af ultralyd, at en graviditet er intrauterin.
English: • have malformations of the sexual organs which make a normal pregnancy impossible
Danish: • du har misdannelser i kønsorganerne, som gør det umuligt at gennemføre en normal graviditet
English: Concomitant use of Fertavid and clomifene citrate may enhance the follicular response.
Danish: Samtidig brug af Fertavid og clomifencitrat kan forstærke folliklernes respons.
English: It is not known if treatment with fertility medicines increases the risk of these tumours in infertile women.
Danish: Det vides ikke, om behandlingen med fertilitetslægemidler øger risikoen for disse tumorer hos infertile kvinder.
English: In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple pregnancy is mainly related to the number of embryos transferred.
Danish: Hos kvinder, der gennemgår ART, er risikoen for flerfoldsgraviditet hovedsageligt relateret til antallet af oplagte embryoner.
English: Multiple Pregnancy or birth defects
Danish: Flerfoldsgraviditet og medfødte misdannelser
English: Multiple gestation, especially high order, carries an increased risk of adverse maternal (pregnancy and delivery complications) and perinatal (low birth weight) outcomes.
Danish: Flerfoldsgraviditet, specielt med mange fostre, indebærer en forøget risiko for uønskede udfald for både kvinden (graviditets- og fødselskomplikationer) og fostrene (lav fødselsvægt).
English: This dose is continued for at least seven days.
Danish: Denne dosis gives i mindst 7 dage.
English: If you inject yourself with Fertavid, follow the instructions carefully to give Fertavid properly and with minimal discomfort.
Danish: Hvis du injicerer dig selv med Fertavid, så følg instruktionerne nøje, for at indgive Fertavid korrekt og med mindst muligt ubehag.
English: How are the injections given
Danish: Sådan gives indsprøjtningerne
English: Dosage in men
Danish: Dosering til mænd
English: Do not use Fertavid after the expiry date which is stated on the label and carton after 'EXP'.
Danish: Brug ikke Fertavid efter den udløbsdato, som er angivet på etiketten og yderkartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest (which may cause sudden weight gain due to fluid buildup) and the occurrence of blood clots in the circulation.
Danish: I mere alvorlige tilfælde kan symptomerne være forstørrelse af æggestokkene, væskeophobning i maven og/eller brystet (som kan medføre pludselig vægtstigning som følge af væskeophobning) og blodpropper i kredsløbet.
English: Fertavid has no or negligible influence on the ability to drive and use machines.
Danish: Fertavid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Pregnancy outside the uterus (an ectopic pregnancy), miscarriage and multiple pregnancies have also been reported.
Danish: Der er også rapporteret om graviditet uden for livmoderen (ektopisk graviditet), abort og flerfoldsgraviditet.