FrancophonIA/ELRC3.0 huggingface dataset:
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 hensigtmæssigt 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 pkt 5.1).
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 er en tilstand, som manifesteres i stigende grader af alvorlighed.
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, som er næsten identisk med et naturligt hormon, som kroppen danner, der kaldes ”follikel-stimulerende hormon” (FSH).
English: Table 3: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in ART)
Danish: Tabel 3: Resultaterne af studie GF 8407 (randomiseret parallelgruppestudie, der sammenligner virkningen og sikkerheden af follitropin alfa versus FSH udvundet fra urin ved ART).
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 gonadotropin-frigivende hormon (GnRH)-agonist eller -antagonist.
English: It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Danish: Det er ikke fastslået om behandling med gonadotropiner øger risikoen for disse typer af tumorer hos infertile kvinder.
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment as well as in pregnant women or while breast-feeding, because of the risk of accumulation and toxicity (metabolic acidosis).
Danish: Store mængder bør anvendes med forsigtighed og kun hvis nødvendigt, især hos personer med nedsat lever eller nedsat nyrefunktion, samt hos gravide eller ammende kvinder, på grund af risikoen for ophobning og toksicitet (metabolisk acidose).
English: • When your eggs are ready, you will be given hCG or r-hCG.
Danish: • Når dine æg er klar, vil du få hCG eller r-hCG.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SmPC.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter enkelte og gentagne doser og genotoksicitet, ud over det, der allerede er beskrevet i andre afsnit i dette produktresumé.
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Danish: Patienten bør informeres om risikoen for flerfoldsgraviditet, før behandling påbegyndes.
English: If your doctor decides to try Ovaleap treatment, they may monitor it by asking you to provide semen for analysis 4 to 6 months after starting treatment.
Danish: Hvis din læge beslutter at prøve behandling med Ovaleap, vil du eventuelt blive bedt om at afgive sæd til analyse 4-6 måneder efter start af behandlingen for at overvåge behandlingen.
English: If you administer this medicine to yourself, please carefully read and follow the “Instructions for Use” of the pen.
Danish: Hvis du giver dig selv lægemidlet, skal du læse og følge ”Brugsanvisning” for pennen
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 reproduktionssystemstumorer, både benigne og maligne, hos kvinder der har gennemgået adskillige behandlinger for infertilitet.
English: • Swelling of the veins above and behind the testicles (a varicocele)
Danish: • Opsvulmen af blodårerne over og bag testiklerne (årebrok i pungen)
English: If you are not ovulating and if the recommended dose and timing are followed, 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: 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: 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: 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 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: Your doctor or nurse will show you how to inject the medicine.
Danish: Lægen eller sundhedspersonalet vil vise dig, hvordan du skal injicere lægemidlet.
English: Ask your doctor or pharmacist for advice if you have a liver or kidney disease, and if you are pregnant or breast-feeding.
Danish: Spørg din læge eller apotek til råds, hvis du har en lever- eller nyresygdom, eller hvis du er gravid eller ammer.
English: • The usual dose of this medicine is 150 IU together with hCG.
Danish: • Den sædvanlige dosis af dette lægemiddel er 150 IE i kombination med hCG.
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,
English: Pregnancy and breast-feeding You should not use this medicine if you are pregnant or breast-feeding.
Danish: Graviditet og amning Du må ikke bruge dette lægemiddel, hvis du er gravid eller ammer.
English: When using this medicine, you have a higher risk of being pregnant with more than one child (i.e. “multiple pregnancy”, typically twins) than if you conceived naturally.
Danish: Når du tager dette lægemiddel, har du en højere risiko for at blive gravid med flere end et foster ad gangen (”flerfoldsgraviditet”, i de fleste tilfælde tvillinger), end hvis du bliver gravid ad naturlig vej.
English: *Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR-) by recombinant DNA technology.
Danish: *Follitropin alfa (rekombinant humant follikel-stimulerende hormon [r-hFSH]) er produceret i ovarieceller fra kinesisk hamster (CHO DHFR-) ved rekombinant DNA-teknologi.
English: • The maximum daily dose of this medicine is usually not higher than 225 IU.
Danish: • Den maksimale daglige dosis af dette lægemiddel er sædvanligvis ikke højere end 225 IE.
English: Other medicines and Ovaleap Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Ovaleap Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
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 indenfor 3-4 dage.
English: • you feel sick or are vomiting,
Danish: • du føler dig utilpas eller kaster op
English: Luteal phase support may be considered since lack of substances with luteotropic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Danish: Lutealfasestøtte bør overvejes idet mangel af substanser med luteotrop aktivitet (LH/hCG) efter ovulation kan føre til for tidlig svigt af corpus luteum.
English: In women, safe and effective use of follitropin alfa calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol 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: Marketing Authorisation Holder Theramex Ireland Limited 3rd Floor, Kilmore House,
Danish: Indehaver af markedsføringstilladelsen Theramex Ireland Limited 3rd Floor, Kilmore House,
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatment given.
Danish: Specielt skal patienten undersøges for hypothyroidisme, adrenokortikalt svigt, hyperprolaktinæmi og adækvat behandling gives.
English: • malformations of sexual organs incompatible with pregnancy;
Danish: • malformation af gonaderne, uforenelig med graviditet,
English: If you notice any of the above-listed side effects you should immediately contact your doctor who may ask you to stop using Ovaleap.
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 Ovaleap.
English: What Ovaleap contains - The active substance is follitropin alfa.
Danish: Ovaleap indeholder: - Aktivt stof: follitropin alfa.
English: Ectopic pregnancy
Danish: Ektopisk graviditet
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 i familieanamnesen, kan behandling med gonadotropiner øge risikoen for forværring eller forekomst af sådanne hændelser.
English: Do not use Ovaleap:
Danish: Brug ikke Ovaleap:
English: The effects of using too much Ovaleap are unknown.
Danish: Virkningen af en overdosering af Ovaleap er ukendt.
English: Table 1: Adverse reactions in women System organ class
Danish: Tabel 1: Bivirkninger hos kvinder Systemorganklasse
English: Ovaleap is a clear and colourless solution.
Danish: Ovaleap er en klar og farveløs opløsning.
English: May be stored before opening not above 25 °C for up to 3 months.
Danish: Kan før åbning opbevares ved temperaturer ikke over 25 °C i op til 3 måneder.
English: • if you are a man with: - testicular failure that is not treatable.
Danish: • hvis du er mand: - med beskadigede testikler, som ikke kan kureres.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and 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: 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: Before the treatment is started you and your partner's fertility should be evaluated by a doctor experienced in treating fertility disorders.
Danish: Før behandlingen påbegyndes bør din og din partners frugtbarhed evalueres af en læge med erfaring i behandling af frugtbarhedsproblemer.
English: Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Danish: Let eller moderat OHSS er blevet rapporteret med hyppigheden ” almindelig” og skal anses som en farmakologisk betinget risiko ved stimulationsproceduren.
English: If your doctor cannot see a response after 5 weeks, that treatment cycle should be stopped.
Danish: Hvis din læge ikke ser en virkning efter 5 uger, bør denne behandlingscyklus stoppes.
English: The pen cap must be put back on the pen after each injection in order to protect from light.
Danish: Pennens hætte skal sættes tilbage på pennen efter hver injektion for at beskytte mod lys.
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 gonadotropin-releasing hormon-(GnRH)-agonist eller -antagonist er nu almindeligt anvendt for at suprimere den endogene LH-stigning og for at kontrollere LH-niveauerne.
English: The Ovaleap Pen is a device (a “pen”) used for giving injections into the tissue just under the skin.
Danish: Ovaleap Pen er et instrument (en ”pen”) til at give injektioner i vævet lige under huden.
English: Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, without being refrigerated again, for up to 3 months.
Danish: Før åbning og inden for holdbarhedstiden kan lægemidlet fjernes fra køleskabet, uden at blive nedkølet igen, i op til 3 måneder.
English: Do not use this medicine after the expiry date which is stated on the label and outer carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og den ydre karton efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other ART
Danish: Kvinder som gennemgår ovariestimulation med henblik på multipel follikeludvikling i forbindelse med in vitro fertilisation eller anden ART
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Danish: Abdominalsmerter, oppustet abdomen, abdominalt ubehag, kvalme, opkastning, diarré
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: Comparative clinical studies 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 studier har vist, at patienter gennemsnitligt har brug for en lavere kumulativ dosis og kortere behandlingsvarighed med follitropin alfa sammenlignet med u-FSH.
English: • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1;
Danish: • Overfølsomhed over for det aktive stof follitropin alfa, FSH eller over for et eller flere af hjælpestofferne anført i pkt 6.1
English: Table 2: Adverse reactions in men System organ class
Danish: Tabel 2: Bivirkninger hos mænd Systemorganklasse
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, skal evt. igangværende gonadotropinbehandling stoppes og patienten indlægges på hospital og passende behandling for OHSS påbegyndes.
English: Treatment with follitropin alfa should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Danish: Behandling med follitropin alfa skal administreres under opsyn af en læge, som har erfaring inden for behandling af fertilitetsforstyrrelser.
English: • The usual starting dose of this medicine is 150 to 225 IU each day, from day 2 or 3 of your menstrual cycle.
Danish: • Den sædvanlige startdosis af dette lægemiddel er 150-225 IE hver dag, fra dag 2 eller 3 i din menstruationsscyklus.
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, samtidig med hCG, i doser på 150 IE 3 gange ugentligt i minimum 4 måneder.
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: • Breast development
Danish: • Brystudvikling
English: Discard used needles immediately after injection.
Danish: Kasser brugte kanyler umiddelbart efter injektionen.
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: • Allergic reactions such as skin rash, raised itchy areas of skin and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported very rarely (may affect up to 1 in 10,000 people).
Danish: • Allergiske reaktioner som hududslæt, kløende hævede hudområder og alvorlige allergiske reaktioner med svaghed, blodtryksfald, åndedrætsbesvær og hævelse af ansigtet er blevet rapporteret meget sjældent (kan forekomme hos op til 1 ud af 10.000 personer).
English: • Lower stomach ache 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 hyper-stimulationssyndrom (OHSS).
English: This could be related to multiple pregnancies or to parent characteristics such as maternal age and sperm characteristics.
Danish: Dette kan være forbundet med flerfoldsgraviditet eller forældrekarakteristik, såsom moderens alder og spermkvalitet.
English: If your doctor cannot see a desired response after 4 weeks, that treatment cycle with Ovaleap should be stopped.
Danish: Hvis din læge ikke kan se den ønskede virkning efter 4 uger, bør denne behandlingscyklus med Ovaleap stoppes.
English: • When you get the desired response, you will be given hCG or r-hCG.
Danish: • Når du får den ønskede virkning, vil du få hCG eller r-hCG.
English: For the following treatment cycle, your doctor will give you a higher starting dose of this medicine than before.
Danish: I den efterfølgende behandlingscyklus vil din læge give dig en højere startdosis af dette lægemiddel end før.
English: • The usual starting dose of this medicine is 75 to 150 IU each day.
Danish: • Den sædvanlige startdosis af dette lægemiddel er 75 til 150 IE hver dag.
English: Adherence to 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 risikoen for disse bivirkninger.
English: Before opening and within its shelf life, you may remove this medicine from the refrigerator, without being refrigerated again, for up to 3 months.
Danish: Før åbning og inden for produktets holdbarhed kan du fjerne lægemidlet fra køleskabet, uden at blive nedkølet igen, i op til 3 måneder.
English: Independent risk factors for developing OHSS include polycystic ovarian syndrome high absolute or rapidly rising serum oestradiol levels (e.g. > 900 pg/mL or > 3,300 pmol/L in anovulation; > 3,000 pg/mL or > 11,000 pmol/L in ART) and large number of developing ovarian follicles (e.g. > 3 follicles of ≥ 14 mm in diameter in anovulation; ≥ 20 follicles of ≥ 12 mm in diameter in ART).
Danish: Uafhængige risikofaktorer for udvikling af OHSS inkluderer polycystisk ovariesyndrom, højt absolut eller hurtigt stigende serumestradiol (f.eks. > 900 picog/ml eller > 3.300 picomol/l i anovulation; > 3.000 picog/ml eller > 11.000 picomol/l i ART) og et stort antal ovariefollikler under udvikling (f.eks. > 3 follikler på ≥ 14 mm i diameter i anovulation; ≥ 20 follikler på ≥ 12 mm i diameter i ART).
English: This medicine is given as an injection into the tissue just under the skin (subcutaneous injection).
Danish: Dette lægemiddel gives som en injektion i vævet lige under huden (subkutan injektion).
English: - unexplained vaginal bleeding.
Danish: - med vaginalblødning uden kendt årsag.
English: Clinical assessment of follitropin alfa indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Danish: Kliniske vurderinger af follitropin alfa tyder på, at de daglige doser, administrationsregimer og monitoreringsprocedurer bør være de samme som bruges i aktuel behandling med lægemidler, der indeholder FSH udvundet fra urin (u-FSH).
English: You must follow the separate instructions for use of the Ovaleap Pen carefully.
Danish: Du skal følge de separate brugsanvisninger for Ovaleap Pen nøje.
English: The pH of the solution is 6.8-7.2.
Danish: Injektionsvæsken har en pH-værdi på 6,8-7,2.
English: Ovaleap treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is given.
Danish: Ovaleap-behandling fører sjældent til svær OHSS, medmindre medicinen man anvender for at inducere afsluttende follikelmodning (indeholdende humant choriongonadotropin - hCG), er indgivet.
English: • you get pain in the lower part of the abdomen (belly),
Danish: • du får smerter i den nederste del af maven
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 skadelig udfald for moder og foster.
English: • The usual starting dose of Ovaleap is 75 to 150 IU together with 75 IU of lutropin alfa.
Danish: • Den sædvanlige startdosis af Ovaleap er 75-150 IE sammen med 75 IE lutropin alfa.
English: • if you have a tumour in your hypothalamus or pituitary gland (parts of the brain).
Danish: • hvis du har en tumor i hypothalamus eller hypofysen (begge er dele af hjernen).
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Danish: Før behandlingen begynder, bør det vurderes om parrets infertilitet er egnet til behandling og mulige kontraindikationer for graviditet vurderes.
English: • Ovaleap 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: • Ovaleap sammen med en luteiniserende hormon (LH) opløsning anbefales til stimulation af follikeludvikling hos kvinder med svær mangel af LH og FSH.
English: A commonly used regimen for superovulation involves the administration of 150-225 IU of follitropin alfa daily, commencing on days 2 or 3 of the cycle.
Danish: En almindeligt anvendt dosering for superovulation omfatter administration af 150-225 IE follitropin alfa pr. dag med start på dag 2 eller 3 af cyklus.
English: If you forget to use Ovaleap
Danish: Hvis du har glemt at bruge Ovaleap
English: Ovaleap is indicated for use in infertility (see section 4.1).
Danish: Ovaleap er indiceret til brug ved infertilitet (se pkt.