FrancophonIA/ELRC3.0 huggingface dataset:
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 svinder normalt uden behandling.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Danish: Man kan forlænge stimulationsbehandlingen op til 5 uger i en cyklus.
English: EU/1/00/155/001 (1 vial/ 1 ampoule) EU/1/00/155/002 (3 vials/ 3 ampoules) EU/1/00/155/003 (10 vials/ 10 ampoules) EU/1/00/155/004 (1 vial/ 1 vial) EU/1/00/155/005 (3 vial/ 3 vials) EU/1/00/155/006 (10 vials/ 10 vials)
Danish: EU/1/00/155/001 (1 hætteglas/1 ampul) EU/1/00/155/002 (3 hætteglas/ 3 ampuller) EU/1/00/155/003 (10 hætteglas/ 10 ampuller) EU/1/00/155/004 (1 hætteglas/1 hætteglas) EU/1/00/155/005 (3 hætteglas/ 3 hætteglas) EU/1/00/155/006 (10 hætteglas/ 10 hætteglas)
English: Other studies have shown that lutropin alfa is not mutagenic.
Danish: Andre studier har vist at lutropin alfa er non-mutagent.
English: Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Danish: Klem fast om huden og indfør nålen i en 45° til 90° vinkel ved at anvende en dart-lignende bevægelse.
English: Inspect for particles as before, and do not use if the solution is not clear.
Danish: Kontroller som før for partikler og anvend ikke opløsningen, hvis den er uklar.
English: In this context, it is difficult to attribute adverse reactions to any one of the substances used.
Danish: På baggrund af dette er det vanskeligt at tilskrive bivirkninger til det ene eller det andet stof.
English: Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Danish: Behandlingen bør i næste cyklus genoptages med en lavere FSH-dosering end i den foregående cyklus.
English: Gently push the plunger until the air bubbles are gone.
Danish: Skub forsigtigt stemplet indtil luftboblerne er væk.
English: • The active substance is lutropin alfa.
Danish: • Aktivt stof: Lutropin alfa.
English: Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Danish: Luveris er beregnet til subkutan anvendelse, hvilket betyder, at det indgives som injektioner under huden.
English: This side effect is very rare (may affect up to 1 in 10,000 people).
Danish: Denne bivirkning er meget sjælden (forekommer hos færre end op til 1 ud af 10.000 personer).
English: For immediate and single use following first opening and reconstitution.
Danish: Til omgående engangsbrug når den først er åbnet og rekonstitueret.
English: Luveris has no or negligible influence on the ability to drive and use machines.
Danish: Luveris påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: As expected from the heterologous protein nature of the hormone, lutropin alfa raised an antibody response in experimental animals after a period that reduced the measurable serum LH levels but did not fully prevent its biological action.
Danish: Som forventet, ud fra hormonets heterologe proteinkarakter, resulterede lutropin alfa i et antistofrespons hos forsøgsdyr hvilket reducerede det målelige niveau af serum LH, men forhindrede ikke helt den biologiske aktivitet.
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, thrombophilia or severe obesity (body mass index >30 kg/m2), 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 kvinder med almindeligt identificerede risikofaktorer for tromboemboliske hændelser, som personlig eller slægtsanamnese, trombofili eller svær fedme (BMI >30 kg/m2), kan behandling med gonadotropiner yderligere øge risikoen for forværring eller forekomst af sådanne hændelser.
English: Important information about some of the ingredients of Luveris Luveris contains less than 1 mmol sodium (23 mg) per dose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Luveris Luveris indeholder mindre end 1 mmol (23 mg) natrium pr. dosis.
English: In addition, patients should be evaluated for hypothyroidism, adrenocortical deficiency and hyperprolactinemia and appropriate specific treatment given.
Danish: Yderligere skal patienten undersøges for hypotyroidisme, adrenokortikalt svigt og hyperprolaktinæmi, og adækvat behandling gives.
English: Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
Danish: Flerfoldsgraviditet indebærer, især hvis antallet er højt, en øget risiko for negative maternelle og perinatale resultater.
English: There is no indication for the use of Luveris during pregnancy.
Danish: Der er ingen indikationer for brug af Luveris under graviditet.
English: No teratogenic effect of Luveris has been observed in animal studies.
Danish: Der er ikke set teratogen effekt af Luveris i dyrestudier.
English: Phosphoric acid, concentrated (for pH adjustment) Sodium hydroxide (for pH adjustment) L-methionine
Danish: Phosphorsyre, koncentreret (til justering af pH) Natriumhydroxid (til justering af pH) L-methionin
English: Adherence to recommended Luveris and FSH dosage and regimen of administration can minimise the risk of ovarian hyperstimulation.
Danish: Overholdelse af den anbefalede dosering af Luveris og FSH og det anbefalede administrationsregime kan minimere risikoen for ovariel hyperstimulation.
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: Luteinfasestøtte kan overvejes, idet mangel på substanser med luteotropisk aktivitet (LH/hCG) efter ovulation kan medføre for tidligt bortfald af corpus luteum.
English: Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Danish: Behandlingen skal tilpasses den enkelte patients respons, vurderet på grundlag af follikelstørrelse, målt ved hjælp af ultralyd, og østrogenrespons.
English: Luveris is recommended for the treatment of adult women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle.
Danish: Luveris er anbefalet til behandling af voksne kvinder, der producerer meget små mængder af nogle af de hormoner, som er involveret i den naturlige menstruationscyklus.
English: In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
Danish: I modsætning til ovarieforstørrelse uden komplikationer er OHSS en tilstand, som kan manifestere sig med stigende grad af alvorlighed.
English: Luveris treatment seldom causes severe OHSS.
Danish: Luveris behandling fører sjældent til alvorlig OHSS.
English: For the following cycle, your doctor will prescribe FSH at a lower dose than that of the previous cycle.
Danish: I den følgende cyklus vil lægen ordinere FSH i en lavere dosering end i den foregående cyklus.
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children).
Danish: Fortæl det til lægen før du starter med behandlingen, hvis du eller et familiemedlem har porfyri (manglende evne til at nedbryde porfyriner), som kan nedarves fra forældre til børn.
English: Luveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Danish: Luveris må ikke indgives blandet med andre lægemidler i samme injektion, dette gælder dog ikke for follitropin alfa, hvor studier har vist, at samtidig injektion ikke signifikant ændrer aktiviteten, stabiliteten, de farmakokinetiske eller de farmakodynamiske egenskaber ved de aktive stoffer.
English: This side effect is common (may affect up to 1 in 10 people).
Danish: Denne bivirkning er almindelig (forekommer hos færre end op til 1 ud af 10 personer).
English: Directly below it is where the neck of the ampoule has been treated to make it easier to break.
Danish: Lige under denne prik er ampullens hals behandlet således, at ampullen er lettere at bryde.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Danish: Flerfoldsgraviditet kan give anledning til komplikationer for både mor og børn.
English: No signs of toxicity due to the development of antibodies to lutropin alfa were observed.
Danish: Der blev ikke observeret tegn på toksisk effekt som følge af antistofudviklingen mod lutropin alfa.
English: Nervous system disorders Common: Headache
Danish: Nervesystemet Almindelig: Hovedpine.
English: The effects of an overdose of Luveris are unknown.
Danish: Effekten af overdosering med Luveris er ukendt.
English: Ovarian torsion has been reported after treatment with other gonadotropins.
Danish: Der er rapporteret om ovarietorsion efter behandling med andre gonadotropiner.
English: Via delle Magnolie 15 (Zona industriale) I-70026 Modugno (Bari) Italy
Danish: Via delle Magnolie 15 (Zona industriale) I-70026 Modugno (Bari) Italien
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet.
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 lægen muligvis undlade at give dig hCG i denne behandlingscyklus, ligesom lægen muligvis vil opfordre dig til ikke at have samleje eller at anvende en barrieremetode i mindst fire døgn.
English: Up to 3 containers of powder may be dissolved in 1 ml of solvent.
Danish: Op til 3 beholdere med pulver kan opløses i 1 ml solvens.
English: In patients undergoing Assisted Reproductive Technology (ART) procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Danish: Hos patienter, der undergår ART-behandlinger (assisteret reproduktionsteknologi), er risikoen for flerfoldsgraviditet hovedsageligt relateret til antallet af embryoner, der bliver lagt op, deres kvalitet og patientens alder.
English: Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation.
Danish: Data fra et begrænset antal eksponerede graviditeter tyder ikke på, at gonadotropiner har en negativ indvirkning på graviditet, embryonal eller føtal udvikling, fødslen eller postnatal udvikling efter kontrolleret ovariestimulation.
English: • If you have unexplained vaginal bleeding.
Danish: • hvis du har uforklarlig blødning fra skeden.
English: Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour.
Danish: Efter intravenøs injektion bliver lutropin alfa hurtigt fordelt med en initial halveringstid på cirka en time.
English: Although these adverse reactions were not observed, there is the possibility that they may also occur with Luveris.
Danish: Selvom disse bivirkninger ikke er set, er det muligt, at de vil kunne forekomme i forbindelse med brug af Luveris.
English: In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4 % and 0.9 % of the injections, respectively.
Danish: I et klinisk studie er der rapporteret om milde og moderate reaktioner på injektionsstedet (mærker, smerte, rødmen, kløe og hævelse) ved henholdsvis 7,4 % og 0,9 % af injektionerne.
English: Following subcutaneous administration of Luveris, lutropin alfa is eliminated from the body with a terminal half-life of about 10-12 hours.
Danish: Efter subkutan injektion af Luveris elimineres lutropin alfa fra kroppen med en terminal halveringstid på ca. 10-12 timer.
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 der opstår alvorlig OHSS, anbefales det, at gonadotropinbehandlingen seponeres, hvis dette ikke allerede er sket, og at patienten indlægges, og passende behandling iværksættes.
English: Luveris must not be used when a condition exists which would make a normal pregnancy impossible, such as:
Danish: Luveris må ikke anvendes, når patientens tilstand umuliggør en normal graviditet så som ved:
English: INFORMATION IN BRAILLE luveris 75 iu
Danish: INFORMATION I BRAILLESKRIFT luveris 75 ie
English: Paediatric population There is no relevant indication for the use of Luveris in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevante indikationer for Luveris i den pædiatriske population.
English: • Open the ampoule of solvent: On the head of the solvent ampoule, you will see a small coloured dot.
Danish: • Åben ampullen med solvens: På toppen af ampullen med solvens kan du se en lille farvet prik.
English: The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Danish: Patienten anbefales coitus samme dag og dagen efter hCG-injektionen.
English: Luveris is intended for subcutaneous use.
Danish: Luveris er beregnet til subkutan anvendelse.
English: Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, there have been rare cases reported following treatment with human menopausal gonadotropin (hMG), a urine-derived medication also containing LH.
Danish: Vridning af æggestokken og blødning i bughulen er ikke rapporteret ved brug af Luveris, men der er rapporteret sjældne tilfælde efter behandling med humant menopausalt gonadotropin (hMG), et urinbaseret lægemiddel, som også indeholder LH.
English: This 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 ovarian syndrome.
Danish: Dette kan være forbundet med andre risikofaktorer som f.eks. OHSS, graviditet, tidligere abdominal kirurgi, tidligere ovarietorsion, tidligere eller aktuel ovariecyste og polycystisk ovariesyndrom.
English: To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is recommended.
Danish: For at reducere risikoen for flerfoldsgraviditet med højt antal fostre anbefales nøje monitorering af ovarieresponset.
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 in section 4 under “Serious side effects”).
Danish: Hvis du oplever underlivssmerter, hurtig vægtøgning, kvalme eller opkastning, eller hvis du har svært ved at trække vejret, skal du straks fortælle det til lægen, som muligvis vil bede dig om at holde op med at bruge medicinen (se pkt.
English: Package leaflet: Information for the user Solvent in ampoules
Danish: Indlægsseddel: Information til brugeren Solvens i ampuller
English: In order to avoid the injection of large volumes, one vial of Luveris can be reconstituted together with one or two ampoule(s)/vial(s) of follitropin alfa, 37.5 IU, 75 IU or 150 IU, in 1 ml of solvent.
Danish: For at undgå injektion af store voluminer kan et hætteglas Luveris opløses sammen med en eller to ampul(ler)/hætteglas follitropin alfa, 37,5 IE, 75 IE eller 150 IE i 1 ml solvens.
English: Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles.
Danish: Uafhængige risikofaktorer for udvikling af OHSS inkluderer ung alder, muskelmasse (lean body mass), polycystisk ovariesyndrom, høje doser af eksogene gonadotropiner, høje absolutte eller hurtigt stigende serum-estradiolniveauer og tidligere episoder af OHSS, stort antal udviklende ovariefollikler og et stort antal oocytter opnået i ART-cyklusser.
English: The first injection of Luveris should be performed under direct medical supervision.
Danish: Den første injektion af Luveris skal foretages under overvågning af en læge.
English: The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers from 75 IU up to 40,000 IU.
Danish: Lutropin alfas farmakokinetik er studeret hos hypofyse nedregulerede frivillige kvinder i doser fra 75 IE op til 40.000 IE.
English: • Remove the protective cap from the solvent vial.
Danish: • Fjern beskyttelseslåget fra hætteglasset med solvens.
English: • If you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone or human chorionic gonadotropin), or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for gonadotropiner (såsom luteiniserende hormon, follikelstimulerende hormon eller humant choriongonadotropin) eller et af de øvrige indholdsstoffer i Luveris
English: Carefully place the open ampoule upright on the worksurface.
Danish: Placer forsigtig den åbne ampul oprejst på arbejdsfladen.
English: In clinical trials, patients were defined by an endogenous serum LH level < 1.2 IU/l as measured in a central laboratory.
Danish: I kliniske studier defineredes patienter med et endogent serum-LH-niveau <1,2 IE/l efter måling på et centralt laboratorium.
English: Name and address of the manufacturer responsible for batch release Merck Serono S.p.A.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Merck Serono S.p.A.
English: Single doses of up to 40,000 IU of lutropin alfa have been administered to healthy female volunteers without serious adverse reactions and were well tolerated.
Danish: Enkeltdoser op til 40.000 IE lutropin alfa er blevet administreret til raske forsøgspersoner uden alvorlige bivirkninger og var veltolereret.
English: In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births is increased compared with natural conception.
Danish: Hos patienter, som undergår behandling til induktion af ovulation, ses en øget hyppighed af flerfoldsgraviditet og fødsler sammenlignet med naturlig konception.
English: When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.
Danish: Når man gennemgår en assisteret reproduktionsbehandling eller stimulering af æggestokkene til at producere æg, er der større sandsynlighed for en spontan abort end hos gennemsnitskvinden.
English: Lutropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Danish: Lutropin alfa er fremstillet i gensplejsede ovarieceller fra kinesisk hamster (CHO).
English: One ampoule of solvent contains: 1 ml water for injection.
Danish: En ampul solvens indeholder: 1 ml vand til injektionsvæsker.
English: There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Danish: Der er ingen farmakokinetisk interaktion med follitropin alfa, når dette injiceres samtidigt.
English: In case you are not ovulating, and if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is less likely.
Danish: Hvis du ikke har ægløsning, og hvis den anbefalede dosis og indgivelsesplan overholdes, er det mindre sandsynligt, at der opstår OHSS.
English: This medicinal product must not be administered as a mixture in the same injection with other medicinal products except follitropin alfa.
Danish: Dette lægemiddel må ikke indgives som en blanding i samme injektion med andre lægemidler end follitropin alfa.
English: In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l.
Danish: I kliniske studier betød dette patienter med et endogent serum-LH-niveau <1,2 IE/l.
English: No severe OHSS was reported (section 4.4).
Danish: Ingen alvorlige tilfælde af OHSS er rapporteret (se pkt.
English: No severe injection site reactions were reported.
Danish: Der blev ikke rapporteret om alvorlige reaktioner.
English: Other common side effects
Danish: Andre almindelige bivirkninger
English: • Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in the sharps container provided.
Danish: • Kasser alle de brugte redskaber: Efter at du har afsluttet injektionen, kasseres alle kanyler og de tomme glasbeholdere i den medfølgende affaldsbeholder.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU increments.
Danish: Hvis en øgning af FSH-dosis vurderes nødvendig, anbefales dosisjustering med 7 - 14 dages interval og fortrinsvis med 37,5 - 75 IE ad gangen.
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Danish: Hvis du ikke er sikker, skal du spørge lægen eller apotekspersonalet, før du bruger denne medicin.
English: What Luveris is
Danish: Hvad er Luveris
English: After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the container with the follitropin alfa powder.
Danish: Efter at have opløst Luveris pulveret, træk opløsningen tilbage i sprøjten og sprøjt den ned i beholderen med follitropin alfa-pulver.
English: Tumours of sexual organs
Danish: Svulster i kønsorganerne
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: After ovulation, LH stimulates progesterone production in the corpus luteum by increasing the conversion of cholesterol to pregnenolone.
Danish: Efter ægløsningen stimulerer LH dannelsen af progesteron i corpus luteum ved at forøge omdannelsen af kolesterol til pregnenolon.
English: Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS
Danish: Vaskulære sygdomme Meget sjælden: Tromboemboli, normalt associeret med alvorlig OHSS.
English: • fibroid tumours of the uterus incompatible with pregnancy
Danish: • fibromer uforenelige med graviditet
English: Warnings and precautions
Danish: “Advarsler og forsigtighedsregler”).
English: Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, pelvic pain
Danish: Almindelig: Let eller moderat OHSS (herunder relateret symptomatologi), ovariecyste, brystsmerter, smerter i pelvis.
English: However this will only occur if hCG is administered (see section ‘Warnings and precautions').
Danish: Det vil kun ske, hvis hCG administreres (se pkt.
English: Presentations other than ampoules should be considered for self administration by patients.
Danish: Andre administrationssystemer end ampuller bør overvejes til patienter, der selv administrerer Luveris.
English: In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa.
Danish: I kliniske studier har Luveris vist at øge ovariernes følsomhed for follitropin alfa.
English: The powder is packaged in 3 ml neutral colourless glass (type I) vials.
Danish: Pulveret er pakket i 3 ml hætteglas, neutralt farveløst glas (type I).