FrancophonIA/ELRC3.0 huggingface dataset:
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 spermatogenesen.
English: • to help follicles develop in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as “in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”.
Danish: • til at hjælpe follikeludvikling hos kvinder, som gennemgår assisteret reproduktionsteknologi (procedurer, der kan hjælpe dig med at blive gravid), f.eks. reagensglasbefrugtning (”in vitro-fertilisering”), ”gamete intra-fallopian transfer” eller ”zygote intra-fallopian transfer”.
English: Driving and using machines This medicine does not 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: Benzyl alcohol content
Danish: Benzylalkohol-indhold
English: For the following cycle, your doctor will give you a lower dose of Ovaleap than before.
Danish: I den efterfølgende cyklus vil din læge give dig en lavere dosis af Ovaleap end i den forrige cyklus.
English: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm, Germany
Danish: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm, Tyskland
English: You are more likely to have a pregnancy outside the womb (an ectopic pregnancy) than the average woman when undergoing assisted reproductive technology and if you have damaged fallopian tubes.
Danish: Risikoen for en graviditet uden for livmoderen (en ektopisk graviditet) er større hos dig end hos den gennemsnitlige kvinde, når du gennemgår assisteret befrugtning, og hvis du har beskadigede æggeledere.
English: • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
Danish: • Stimulation af multipel follikeludvikling hos kvinder, som gennemgår assisteret reproduktionsteknologi (ART) såsom in vitro befrugtning (IVF), ”gamete intra-fallopian transfer” og ”zygote intra-fallopian transfer”.
English: Follitropin alfa is a potent gonadotropic substance capable of causing mild to severe adverse reactions and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Danish: Follitropin alfa er et potent gonadotropinpræparat som kan fremkalde lette til alvorlige bivirkninger, og bør derfor kun bruges af læger som er specialiseret i infertilitetsbehandling.
English: Thromboembolism (both in association with and separate from OHSS)
Danish: Tromboemboli, (både i forbindelse med og uden samtidigt OHSS
English: • Your dose of this medicine may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
Danish: • Din dosis af dette lægemiddel kan øges hver 7. eller hver 14. dag med 37,5 til 75 IE, indtil du opnår den ønskede virkning.
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-serumniveau på < 1,2 IE/l.
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: Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Danish: Hvis der opstår tegn på hyperstimulation af ovariet, f.eks. serumestradiolniveau på > 5.500 picog/ml eller > 20.200 picomol/l og/eller ≥ 40 follikler i alt, bør hCG seponeres og patienten tilrådes at afstå fra coitus eller bruge en sikker præventionsmetode i mindst 4 dage.
English: • in combination with a medicine called “lutropin alfa” (a version of another gonadotropin, “luteinising hormone” or LH) to help ovulation in women that are not ovulating because their body is producing too little FSH and LH.
Danish: • i kombination med en medicin, der kaldes ”lutropin alfa” (en anden form for gonadotropin, ”luteiniseringshormon” eller LH) til at hjælpe med ægløsning hos kvinder, som ikke har ægløsning, fordi deres krop producerer for lidt FSH og LH.
English: Safety, efficacy and pharmacokinetics of follitropin alfa in patients with renal or hepatic impairment have not been established.
Danish: Sikkerhed, virkning og farmakokinetik ved brug af follitropin alfa hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt.
English: In women with anovulation, the object of follitropin alfa therapy 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 follitropin alfa-behandling at udvikle en enkelt moden Graafsk follikel, hvorfra oocyten frigøres efter administration af hCG.
English: Number of oocytes retrieved Days of FSH stimulation required Total dose of FSH required (number of FSH 75 IU ampoules) Need to increase the dose (%)
Danish: Nødvendig total dosis af FSH (antal FSH 75 IE ampuller) Behovet for at øge dosis (%)
English: • if you are allergic to follitropin alfa, Follicle Stimulating Hormone (FSH) or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for follitropin alfa, follikel-stimulerende hormon (FSH) eller et af de øvrige indholdsstoffer i Ovaleap (angivet i punkt 6).
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 forekomme hos op til 1 ud af 10.000 personer).
English: - cancer in your ovaries, womb or breasts.
Danish: - med kræft i æggestok, livmoder eller bryst.
English: In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 3 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 studier, der sammenlignede r-hFSH (follitropin alfa) og u-FSH i ART (se tabel 3 nedenfor) og i 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: This medicine also contains 0.02 mg per mL of benzalkonium chloride and 10.0 mg per mL of benzyl alcohol.
Danish: Denne medicin indeholder også 0,02 mg pr. ml benzalkoniumchlorid og 10,0 mg pr. ml benzylalkohol.
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 apotekspersonalet, inden du tager denne medicin.
English: Ovaleap is intended for subcutaneous use.
Danish: Ovaleap er beregnet til subkutan anvendelse.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne anført efter alvorlighedsgrad.
English: Ovaleap contains sodium, benzalkonium chloride and benzyl alcohol This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Ovaleap indeholder natrium, benzalkoniumchlorid og benzylalkohol Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natrium-fri.
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion.
Danish: Behandlingen bør tilpasses den enkelte patients respons, vurderet ud fra måling af follikelstørrelse ved hjælp af ultralyd og/eller østrogensekretion.
English: • primary ovarian failure;
Danish: • primært ovariesvigt,
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Danish: Behandlingen bør tilpasses den enkelte patients respons, vurderet ud fra måling af follikelstørrelse ved hjælp af ultralyd og østrogenrespons.
English: • to help ovulation (release of a mature egg cell from the follicle) in women that cannot ovulate and that have not responded to treatment with a medicine called “clomifene citrate”.
Danish: • til at hjælpe med ægløsning (ovulation, frigivelsen af en moden ægcelle fra folliklen) hos kvinder, som ikke har ægløsning, og som ikke har reageret på behandling med en medicin, der kaldes ”clomifencitrat”.
English: Ovaleap contains 10.0 mg per mL benzyl alcohol
Danish: Ovaleap indeholder 10,0 mg pr. ml benzylalkohol
English: - any condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), fibroid tumours of the womb or malformed reproductive organs.
Danish: - med et helbred, som normalt umuliggør graviditet, f.eks. ovariesvigt (tidlig overgangsalder), fibroide tumorer i livmoderen eller misdannede kønsorganer.
English: Ovaleap cartridges are not designed to allow any other medicinal product to be mixed in the cartridges.
Danish: Ovaleap cylinderampuller er ikke konstrueret, så andre lægemidler kan blandes i cylinderampullerne.
English: When being conceived by assisted reproductive technology, a baby may have a slightly higher risk of birth defects than after natural conception.
Danish: Når et barn undfanges ved hjælp af assisteret befrugtning, kan det have en let forhøjet risiko for medfødte skader end efter naturlig undfangelse.
English: The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Danish: Patienten bør have coitus på selve dagen og på dagen efter hCG indgivelsen.
English: • in combination with a medicine called “human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to low levels of certain hormones.
Danish: • sammen med en anden medicin, som kaldes ”humant choriongonadotropin” (hCG), til at hjælpe med at producere sæd hos mænd, som er ufrugtbare på grund af lave niveauer af visse hormoner.
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and number of fertilised eggs or embryos placed inside you.
Danish: Risikoen for flerfoldsgraviditet som følge af assisteret befrugtning er relateret til din alder, kvaliteten og antallet af befrugtede æg/embryoner, som opsættes i din livmoder.
English: In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
Danish: I kliniske studier så man en øget ovariefølsomhed over for follitropin alfa, når det blev indgivet sammen med lutropin alfa.
English: Safety and effectiveness of follitropin alfa in elderly patients have not been established.
Danish: Follitropin alfas sikkerhed og virkning hos ældre patienter er ikke klarlagt.
English: This medicine is given as an injection into the tissue just under the skin (subcutaneous injection) using the Ovaleap Pen.
Danish: Dette lægemiddel gives som en injektion i vævet lige under huden (subkutan injektion) med Ovaleap Pen.
English: Sodium dihydrogen phosphate dihydrate Sodium hydroxide (2 M) (for pH adjustment) Mannitol
Danish: Natriumdihydrogenfosfatdihydrat Natriumhydroxid (2 M) (til pH-justering) Mannitol
English: • Your dose of Ovaleap may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
Danish: • Din Ovaleap-dosis kan øges hver 7. eller hver 14. dag med 37,5 til 75 IE, indtil du får den ønskede virkning.
English: • Acne
Danish: • Akne
English: • If you use Ovaleap with other medicines which help ovulation such as human chorionic gonadotropin (hCG) or clomifene citrate, this may increase the response of your follicles.
Danish: • Hvis du bruger Ovaleap sammen med anden medicin, som hjælper med ægløsning, f.eks. humant gonadotropin (hCG) eller clomifencitrat, kan det øge folliklernes reaktion.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications In adult women
Danish: 4.1 Terapeutiske indikationer
English: Women with anovulation resulting from severe LH and FSH deficiency In LH and FSH deficient women (hypogonadotropic hypogonadism), the objective of follitropin alfa therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of hCG. Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa.
Danish: Anovulatoriske kvinder grundet svær mangel af LH og FSH Hos kvinder med mangel på LH og FSH (hypogonadotrop hypogonadisme), er formålet med follitropin alfa-behandling i forbindelse med lutropin alfa at udvikle en enkelt Graafsk follikel fra hvilken en oocyt kan frigives efter administration af hCG. Follitropin alfa skal gives som en daglig injektion sammen med lutropin alfa.
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 forekomme hos op til 1 ud af 1.000 personer).
English: Put the pen cap back on the Ovaleap Pen after each injection in order to protect the cartridge from light.
Danish: Sæt låget tilbage på Ovaleap Pen efter hver injektion for at beskytte cylinderampullen mod lys.
English: Ovarian Hyper-Stimulation Syndrome (OHSS)
Danish: Ovarielt hyper-stimulationssyndrom (OHSS)
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Danish: Dette kan være tegn på, at æggestokkene har overreageret på behandlingen, og at der har udviklet sig store cyster i æggestokkene [se også pkt.
English: Write down the date of first use in the patient diary, which will be provided with the Ovaleap Pen.
Danish: Skriv datoen for første brug ned i patientens dagbog, som leveres sammen med Ovaleap Pen.
English: Must be discarded if it has not been used after 3 months.
Danish: Skal kasseres, hvis den ikke er brugt efter 3 måneder.
English: The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Danish: Følgende symptomer kan ses ved alvorlige tilfælde af OHSS: smerter og udspiling af maven, alvorlig forstørrede ovarier, vægtøgning, dyspnø, oligouri og gastrointestinale symptomer såsom kvalme, opkastning og diarré.
English: Once opened, the cartridge in-use in the pen may be stored for a maximum of 28 days.
Danish: Efter åbning kan cylinderampullen i pennen opbevares i højst 28 dage.
English: Blood clotting problems (thromboembolic events)
Danish: 2 under ”Blodstørkningsproblemer (tromboemboliske hændelser)”].
English: Sodium content Ovaleap contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Danish: Ovaleap indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natrium-fri.
English: It comprises marked ovarian enlargement, high serum sex steroids and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Danish: Ved OHSS ses markant forstørrede ovarier, forhøjet serumniveau af kønssteroider og en øget vaskulær permeabilitet, hvilket kan resultere i en ophobning af væske i bughulen, lungerne og meget sjældent, i cavitas pericardialis.
English: There is no relevant use of follitropin alfa in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende follitropin alfa hos den pædiatriske population.
English: The dose recommendations given for follitropin alfa are those in use for urinary FSH.
Danish: Dosisanbefalingerne for follitropin alfa er de samme som for FSH udvundet fra urin.
English: Manufacturer Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Danish: Fremstiller Teva Biotech GmbH Dornierstraße 10 89079 Ulm Tyskland
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Danish: Frekvensen af medfødte misdannelser efter assisteret befrugtning kan være en anelse højere end efter spontan undfangelse.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER CYLINDERAMPUL
English: A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Danish: Dette kan øges fortrinsvist med37,5 IE eller med 75 IE med 7 dage eller fortrinsvist med 14 dages mellemrum hvis nødvendigt, for at opnå et tilstrækkeligt, men ikke for kraftigt respons.
English: In adult women, Ovaleap is used:
Danish: Hos voksne kvinder bruges Ovaleap:
English: There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients and exaggerated response in others.
Danish: Hos visse patienter ses dårligt respons på FSH og hos andre overeksponeret respons.
English: What you need to know before you use Ovaleap
Danish: Det skal du vide, før du begynder at bruge Ovaleap
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,75 ml
English: • If you use Ovaleap at the same time as a “gonadotropin-releasing hormone” (GnRH) agonist or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you may need a higher dose of Ovaleap to produce follicles.
Danish: • Hvis du bruger Ovaleap samtidig med typer af medicin, der nedsætter kønshormonniveauerne og stopper ægløsningen (”gonadotropin-frigivende hormon”-(GnRH)-agonist eller -antagonist), kan du have brug for en højere dosis Ovaleap til at producere follikler.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride and water for injections.
Danish: - Øvrige indholdsstoffer: natriumdihydrogenphosphatdihydrat, natriumhydroxid (2 M) (til justering af pH), mannitol, methionin, polysorbat 20, benzylalkohol, benzalkoniumchlorid, vand til injektionsvæsker.
English: You must discard this medicine if it has not been used after 3 months.
Danish: Du skal kassere dette lægemiddel, hvis det ikke er brugt inden 3 måneder.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments.
Danish: Hvis en øgning af FSH bliver nødvendig, bør dosisændring ske efter 7-14 dages interval og helst med 37,5-75 IE ad gangen.
English: Adherence to recommended follitropin alfa dose and regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Danish: Overholdelse af anbefalet follitropin alfa-dosis og administrationsregime kan minimere risikoen for hyperstimulation af ovariet (se pkt.
English: This side effect is uncommon (may affect up to 1 in 100 people).
Danish: Denne bivirkning er ikke almindelig (kan forekomme hos op til 1 ud af 100 personer).
English: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Danish: Kvinder med tubar sygdom i deres anamnese løber øget risiko for ekstrauterin graviditet, uanset om graviditeten er opnået ved normal befrugtning eller fertilitetsbehandling.
English: Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
Danish: polycystisk ovariesyndrom) Follitropin alfa kan gives som daglige injektioner.
English: Excipients: sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride, water for injections.
Danish: Hjælpestoffer: natriumdihydrogenphosphatdihydrat, natriumhydroxid (2 M) (til justering af pH), mannitol, methionin, polysorbat 20, benzylalkohol, benzalkoniumchlorid, vand til injektionsvæsker.
English: If you experience the above symptoms your doctor might ask you to stop using this medicine (see also section 4 under “Serious side effects in women").
Danish: Hvis du oplever de ovenstående symptomer, kan lægen bede dig om at holde om med at tage medicinen (se også pkt.
English: Birth defects
Danish: Medfødte misdannelser
English: The instructions for use of the pen will be provided together with the Ovaleap Pen.
Danish: Brugsanvisningerne for pennen leveres sammen med Ovaleap Pen.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
Danish: Hvis en øgning af FSH bliver nødvendig, bør dosisøgningen ske i 7-14 dages intervaller og helst med 37,5-75 IE ad gangen.
English: In ART, follitropin alfa at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH.
Danish: I ART resulterede det i, at follitropin alfa ved en lavere total dosis og en kortere behandlingsperiode opnåede et højere antal af udtagne oocyter sammenlignet med u-FSH.
English: If you have ever had blood clots in your leg or lung, or a heart attack or stroke, or if your family have experienced these, inform your doctor.
Danish: Problemer med blodpropper (tromboemboliske hændelser) 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 en højere risiko for, at disse problemer opstår eller forværres med Ovaleap-behandlingen.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For use only with the Ovaleap Pen.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Må kun anvendes sammen med Ovaleap Pen.
English: Benzalkonium chloride content Ovaleap contains 0.02 mg/mL of benzalkonium chloride
Danish: Benzalkoniumchlorid-indhold Ovaleap indeholder 0,02 mg/ml benzalkoniumchlorid
English: Ovaleap is designed for use in conjunction with the Ovaleap Pen only.
Danish: Ovaleap er kun konstrueret til anvendelse sammen med Ovaleap Pen.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld.
Danish: Hvis et for kraftigt ovarielt respons opnås, bør behandlingen stoppes og hCG-injektionen seponeres.
English: • Sacs of fluid within the ovaries (ovarian cysts) Common (may affect up to 1 in 10 people)
Danish: • Væskefyldte hulrum i æggestokkene (ovariecyster) Almindelig (kan forekomme hos op til 1 ud af 10 personer)
English: In adult men, Ovaleap is used:
Danish: Hos voksne mænd bruges Ovaleap:
English: Ovaleap solution for injection in cartridges has been developed for use in the Ovaleap Pen.
Danish: Ovaleap injektionsvæske, opløsning i cylinderampuller er blevet udviklet til brug i Ovaleap Pen.
English: EXP The cartridge in-use in the pen may be stored for a maximum of 28 days not above 25 °C.
Danish: Når cylinderampullen er i brug i pennen, kan den opbevares i op til 28 dage ikke over temperaturer på 25 °C.