FrancophonIA/ELRC3.0 huggingface dataset:
English: You may be at a higher risk of serious blood clots or existing clots might become worse with Luveris treatment.
Danish: Du kan have en øget risiko for at få en alvorlig blodprop, eller hvis du har blodpropper, kan tilstanden forværres af Luveris-behandling.
English: Name and address of the manufacturer of the biological active substance Merck Serono SA
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Merck Serono S.A.
English: The solution should not be administered if it contains particles or is not clear.
Danish: Opløsningen må ikke anvendes hvis den indeholder partikler eller er uklar.
English: • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
Danish: • ovarieforstørrelse eller ovariecyste, som ikke er relateret til polycystisk ovariesyndrom, og som er af ukendt ætiologi
English: • If you have cancer of ovaries, uterus or breast.
Danish: • hvis du har kræft i æggestokke, livmoder eller bryst.
English: In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in estradiol secretion by the follicles, the growth of which is stimulated by FSH.
Danish: Ved stimulering af follikeludviklingen hos anovulatoriske kvinder med LH- og FSH-mangel, er den primære effekt, der opnås ved behandling med lutropin alfa, en øget estradiolsekretion fra folliklerne, hvis vækst er stimuleret af FSH.
English: The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps.
Danish: Hætteglassene er forseglet med brombutylpropper beskyttet med aluminiumsringe og “flip-off” låg.
English: Safety and effectiveness of Luveris in elderly patients have not been established.
Danish: Luveris' sikkerhed og virkning hos ældre patienter er ikke klarlagt.
English: It is followed by treatment with a single dose of human Chorionic Gonadotropin (hCG), which leads to the release of an egg from the follicle (ovulation).
Danish: Efter behandlingen gives en enkelt dosis af human choriongonadotropin (hCG), som fører til frigivelsen af et æg fra folliklen (ægløsning).
English: It is recommended not to use Luveris if you have any condition that usually makes a normal pregnancy impossible, such as ovaries that do not work because of a condition called primary ovarian failure, or malformations of sexual organs.
Danish: Anvendelse af Luveris frarådes, hvis du har en lidelse, som normalt gør en normal graviditet umulig, som f.eks. æggestokke, som ikke fungerer pga. en tilstand kaldet primært ovariesvigt, eller misdannelser i kønsorganerne.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Danish: Før behandlingen påbegyndes, skal det bedømmes, om parrets infertilitet egner sig for behandlingen, og formodede kontraindikationer for graviditet vurderes.
English: There is no relevant indication for the use of Luveris in the elderly population.
Danish: Der er ingen relevante indikationer for Luveris i den ældre population.
English: Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot.
Danish: Tryk nu kraftig på ampullens hals, og knæk ampullen bort fra den farvede prik.
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: Tilstanden omfatter markant ovarieforstørrelse, højt niveau af kønssteroider i serum og en øget vaskulær permeabilitet, som kan resultere i ophobning af væske i bug- og pleurahulen og mere sjældent, i perkardiet.
English: When the desired response has been obtained, a single injection of hCG is given 24 to 48 hours after the last injections of Luveris and FSH.
Danish: Når det ønskede respons er opnået, indgives en enkelt injektion af hCG ca. 24 - 48 timer efter den sidste injektion af Luveris og FSH.
English: In this case Luveris should be reconstituted first and then used to reconstitute the follitropin alfa powder.
Danish: I dette tilfælde skal Luveris opløses først og derefter benyttes til at opløse follitropin alfa-pulveret.
English: Immune system disorders Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Danish: Meget sjælden: Lette til alvorlige overfølsomhedsreaktioner, herunder anafylaktiske reaktioner og shock.
English: Luveris may be mixed with follitropin alfa and co-administered as a single injection.
Danish: Luveris kan blandes med follitropin alfa og gives som en enkelt injektion.
English: A recommended regimen commences at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.
Danish: Et anbefalet behandlingsregime starter med 75 IE lutropin alfa (dvs. et hætteglas Luveris) dagligt med 75 - 150 IE FSH.
English: The effects of an overdose of Luveris are unknown, nevertheless there is a possibility that Ovarian Hyper-Stimulation Syndrome may occur, which is further described in ‘Possible side effects'.
Danish: Effekterne af en overdosering af Luveris er ukendte, men der er risiko for, at ovarielt hyperstimulationssyndrom kan indtræde, som beskrevet nærmere under ”Bivirkninger”.
English: If you administer Luveris to yourself, please carefully read the following instructions: • Wash your hands.
Danish: Hvis du selv injicerer Luveris, læs omhyggeligt følgende instruktion:
English: One vial of powder for injection contains 75 IU (International Units).
Danish: Et hætteglas med pulver til injektionsvæske indeholder 75 IE (Internationale Enheder).
English: Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Danish: Træk nålen ud straks efter injektionen og rengør huden med cirkulerende bevægelser ved brug af en spritserviet.
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Danish: Alvorlig OHSS kan i meget sjældne tilfælde kompliceres af ovarietorsion eller tromboemboliske hændelser såsom lungeemboli, iskæmisk apopleksi eller myokardieinfarkt.
English: Luveris should be administered concomitantly with follitropin alfa.
Danish: Luveris skal administreres samtidigt med follitropin alfa.
English: Solvent: Water for injection
Danish: Solvens: Vand til injektionsvæsker
English: Luteinising Hormone (LH) binds on the ovarian theca (and granulosa) cells and testicular Leydig cells, to a receptor shared with human chorionic gonadotropin hormone (hCG).
Danish: Luteiniserende hormon (LH) binder sig til æggestokkenes theca (og granulosa) celler og testikulære Leydig-celler, på samme receptor som human choriongonadotropin hormon (hCG).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 75 IU of lutropin alfa (recombinant human Luteinising Hormone {r-hLH}).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas indeholder 75 IE lutropin alfa (rekombinant humant luteiniserende hormon, r-hLH).
English: Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or use barrier contraceptive methods for at least 4 days.
Danish: Derfor anbefales det, at hCG midlertidigt seponeres, hvis der opstår tegn på ovariel hyperstimulation, og at patienten rådes til at undgå coitus eller at anvende barrieremetoder i mindst 4 døgn.
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you.
Danish: Når man gennemgår en assisteret reproduktionsbehandling, er risikoen for en flerfoldsgraviditet relateret til kvindens alder samt kvaliteten og antallet af befrugtede æg eller embryoner, der lægges op.
English: The pharmacokinetic profile of lutropin alfa is similar to that of urinaryderived hLH.
Danish: Den farmakokinetiske profil af lutropin alfa svarer til den farmakokinetiske profil af urinderiveret hLH.
English: • The solvent is water for injection.
Danish: • Solvens er vand til injektionsvæsker.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Following subcutaneous administration, the terminal half-life is slightly prolonged.
Danish: Efter subkutan injektion er den terminale halveringstid en anelse længere.
English: Luveris is a medicine containing lutropin alfa, a recombinant Luteinising Hormone (LH) which is essentially similar to the hormone found naturally in humans, but is made by means of biotechnology.
Danish: Luveris er et lægemiddel, der indeholder lutropin alfa, et rekombinant luteiniserende hormon (LH), som grundlæggende er lig det hormon, som findes naturligt i kroppen, men som er fremstillet ved hjælp af genteknologi.
English: • hypersensitivity to active substances or to any of the excipients listed in section 6.1.
Danish: • overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Safety, efficacy, and pharmacokinetics of Luveris in patients with renal or hepatic impairment have not been established.
Danish: Luveris' sikkerhed, virkning og farmakokinetik hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt.
English: However, drug-related teratogenesis was not observed in either animal model.
Danish: Lægemiddelbetingede svulstdannelser blev imidlertid ikke observeret hos nogen af forsøgsdyrene.
English: The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.
Danish: Solvensen er pakket enten i 2 ml ampuller, neutralt farveløst glas (type I) eller i 2 eller 3 ml hætteglas, neutralt farveløst glas (type I) med en Teflon-belagt gummiprop.
English: What you need to know before you use Luveris
Danish: Det skal du vide, før du begynder at bruge Luveris.
English: Lutropin alfa is a recombinant human Luteinising Hormone (r-hLH), a glycoprotein composed of noncovalently bound α- and ß-subunits.
Danish: Lutropin alfa er et rekombinant humant luteiniserende hormon (r-hLH), et glycoprotein sammensat af non-kovalent bundne α- og β-subenheder.
English: Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea or oliguria.
Danish: Alvorlig OHSS ledsages derudover af symptomer såsom alvorlig ovarieforstørrelse, vægtøgning, dyspnø eller oliguri.
English: • Prepare the injection solution: Remove the protective cap from the Luveris powder vial, pick up your syringe and slowly inject the solvent into the vial of Luveris.
Danish: • Forbered injektionsopløsningen: Fjern beskyttelseslåget fra hætteglasset med Luveris pulver, tag sprøjten op og sprøjt forsigtig solvensen ned i hætteglasset med Luveris.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2 under “Blood clotting problems”).
Danish: Dette kan give brystsmerter, åndenød, slagtilfælde eller hjertetilfælde (se også pkt.
English: Birth defects after Assisted Reproductive Technology (ART) may be slightly higher than after spontaneous conceptions.
Danish: Hyppigheden af medfødte misdannelser efter brug af assisteret reproduktionsteknologi (ART) er muligvis en smule højere end efter spontan befrugtning.
English: The following adverse reactions may be observed after administration of Luveris.
Danish: Følgende bivirkninger kan ses ved brug af Luveris.
English: This leaflet was last revised in .
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Polysorbate 20
Danish: Dinatriumphosphatdihydrat Natriumdihydrogenphosphatmonohydrat Polysorbat 20
English: You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Danish: Du kan også blande Luveris og follitropin alfa i stedet for at injicere hvert produkt for sig.
English: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than following natural conception.
Danish: Hyppigheden af abort i form af spontan abort eller provokeret abort er højere hos patienter, som gennemgår stimulation af follikeludviklingen med henblik på induktion af ovulation, end efter naturlig konception.
English: Luveris is used for the stimulation of follicular development in association with follitropin alfa.
Danish: Luveris anvendes til stimulation af follikeludviklingen i kombination med follitropin alfa.
English: In vitro the affinity binding of recombinant hLH to the LH/CG receptor on Leydig tumour cells (MA-10) is between that for hCG and that of pituitary hLH, but within the same order of magnitude.
Danish: In vitro binder rekombinant hLH til LH/hCG receptoren på de Leydigske tumorceller (MA-10) med en affinitet som ligger mellem den som gælder for hCG og hypofysært hLH, men i samme størrelsesorden.
English: The lutropin alfa pharmacokinetics following single and repeated administration of Luveris are comparable and the accumulation ratio of lutropin alfa is minimal.
Danish: Lutropin alfas farmakokinetik er sammenlignelig (efter enkel og gentagen injektion af Luveris) og akkumulationsratio for lutropin alfa er minimal.
English: More user-friendly presentations are available for self administration by patients at home.
Danish: Mere brugervenlige lægemiddelformer er tilgængelige for patienter, der selv tager Luveris hjemme.
English: Do not use this medicine after the expiry date, which is stated on the vials after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • gynaecological haemorrhages of unknown origin
Danish: • gynækologiske blødninger af ukendt ætiologi
English: Talk to your doctor before using Luveris if you or a member of your family have ever had blood clots in the leg or in the lung, or a heart attack or stroke.
Danish: Problemer med blodpropper (tromboemboliske hændelser) Tal med din læge, inden du begynder at bruge Luveris, hvis du selv eller en i din familie nogensinde har haft blodpropper i benene eller lungerne eller har haft et hjerte- eller slagtilfælde.
English: Do not use Luveris as a mixture with other medicines in the same injection, except for follitropin alfa, if prescribed by your doctor.
Danish: Undlad at bruge Luveris sammen med andre lægemidler i den samme injektion, undtagen follitropin alfa, såfremt det er ordineret af din læge.
English: In the ovaries, during the follicular phase, LH stimulates theca cells to secrete androgens, which will be used as the substrate by granulosa cell aromatase enzyme to produce estradiol, supporting FSH-induced follicular development.
Danish: I æggestokkene, under follikelfasen, stimulerer LH thecacellerne til at udskille androgener, der er substrat for granulosacellernes aromatase enzym til produktion af estradiol, understøttende den FSHinducerede follikeludvikling.
English: Luveris in association with a Follicle Stimulating Hormone (FSH) preparation is recommended for the stimulation of follicular development in adult women with severe Luteinising Hormone (LH) and FSH deficiency.
Danish: Luveris sammen med et follikelstimulerende hormon (FSH) anbefales til stimulation af follikeludviklingen hos voksne kvinder med svær mangel på luteiniserende hormon (LH) og FSH.
English: Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress.
Danish: En klinisk undersøgelse kan vise tegn på hypovolæmi, hæmokoncentration, elektrolytforstyrrelser, ascites, pleuraeffusion eller akut vejrtrækningsbesvær.
English: When an optimal response is obtained, a single injection of 250 microgramsof r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Luveris and FSH injections.
Danish: Når optimalt respons er opnået, gives én injektion a 250 mikrogram af r-hCG eller 5.000 - 10.000 IE hCG inden for 24 - 48 timer efter sidste injektion af Luveris og FSH.
English: You and your partner's fertility should be evaluated before the treatment is started.
Danish: Inden behandlingen begynder, skal din og din partners fertilitet vurderes.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld.
Danish: I tilfælde af overstimulation bør behandlingen stoppes og injektion af hCG undlades.
English: • Local reactions at the injection site, such as pain, itching, bruising, swelling or irritation.
Danish: • Lokale reaktioner på injektionsstedet, som f.eks. smerte, kløe, blå mærker, hævelse eller irritation.
English: Luveris should be given as a course of daily injections simultaneously with FSH.
Danish: Luveris bør indgives som en række daglige injektioner i kombination med FSH.
English: • Change the needle for the fine-bore needle and remove any air bubbles: If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Danish: • Skift til den tynde kanyle og fjern evt. luftbobler: Hvis du ser luftbobler i sprøjten, hold sprøjten med kanylen pegende opad, knips forsigtig på sprøjten indtil luften er samlet i toppen.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Luveris
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til brug med Luveris
English: Miscarriage
Danish: Misdannelser
English: Carefully set the syringe down on the work-surface, taking care not to touch the needle.
Danish: Læg forsigtigt sprøjten ned på arbejdsfladen uden at røre kanylen.
English: Luveris 75 IU Powder for injection Lutropin alfa Subcutaneous use
Danish: Luveris 75 IE Pulver til injektionsvæske Lutropin alfa Subkutan anvendelse
English: Package leaflet: Information for the user Solvent in vials
Danish: Indlægsseddel: Information til brugeren Solvens i hætteglas
English: Other medicines and Luveris
Danish: Brug af anden medicin sammen med Luveris
English: In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Luveris.
Danish: De kliniske data er utilstrækkelige til at udelukke en teratogen effekt af Luveris i tilfælde af eksponering under graviditet.
English: Once the powder has dissolved, draw the solution back into the syringe.
Danish: Så snart pulveret er opløst, trækkes opløsningen tilbage i sprøjten.
English: In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG).
Danish: Hos kvinder med LH- og FSH-mangel er formålet med behandling med Luveris i kombination med FSH at udvikle en enkelt moden Graafsk follikel, hvorfra oocyten kan frigøres efter injektion med humant choriongonadotropin (hCG).
English: • Each vial of powder contains 75 IU of lutropin alfa and each ampoule of solvent contains 1 ml of water for injection.
Danish: • Hvert hætteglas med pulver indeholder 75 IE lutropin alfa, og hver ampul med solvens indeholder 1 ml vand til injektionsvæsker.
English: • Serious blood clotting complications (thromboembolic events) usually with severe OHSS are found very rarely.
Danish: • Alvorlige problemer med blodpropper (tromboemboliske hændelser) opstår i meget sjældne tilfælde - normalt i forbindelse med alvorlig OHSS.
English: In rare instances, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotropin therapy.
Danish: Sjældne tilfælde af adnekstorsion (en komplikation ved ovarieforstørrelse) og hæmoperitoneum er blevet associeret med humant menopausalt gonadotropin behandling.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: one vial of powder contains: lutropin alfa 75 IU.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Sammensætning: et hætteglas med pulver indeholder: lutropin alfa 75 IE.
English: This could be due to parental factors (e.g. maternal age, genetics), ART procedures and multiple pregnancies.
Danish: Dette kan skyldes faktorer hos forældrene (f.eks. moderens alder, genetik), ART-procedurer og flerfoldsgraviditeter.
English: Inject the solution by pushing gently on the plunger.
Danish: Injicer opløsningen ved at presse forsigtig på stemplet.
English: Packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules.
Danish: Pakninger med 1, 3 eller 10 hætteglas med et tilsvarende antal hætteglas eller ampuller med solvens.
English: At doses of 10 IU/kg/day and greater, repeated administration of lutropin alfa to pregnant rats and rabbits caused impairment of reproductive function including resorption of foetuses and reduced body weight gain of the dams.
Danish: Hos drægtige rotter og kaniner resulterede gentagne injektioner af lutropin alfa i doser på 10 IE/kg/dag og mere, i beskadigelse af reproduktionsevnen inklusiv 'resorption' af fostre og reduceret vægtforøgelse hos moderen.
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 tubare sygdomme i anamnesen har risiko for ektopisk graviditet, uanset om graviditet opnås ved spontan befrugtning eller med fertilitetsbehandling.
English: • The usual starting dose is 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH.
Danish: • Den sædvanlige startdosis er 75 IE (1 hætteglas) Luveris sammen med 75 IE eller
English: At mid-cycle, high levels of LH trigger corpus luteum formation and ovulation.
Danish: Midt i cyklus udløser høje LH niveauer dannelsen af corpus luteum og ægløsning.
English: The powder should be reconstituted immediately prior to use with the solvent provided.
Danish: Pulveret skal opløses i den medfølgende solvens umiddelbart før anvendelse.
English: Gastrointestinal disorders Common: Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhoea.
Danish: Mave-tarm-kanalen Almindelig: Abdominalsmerter, abdominalt ubehag, kvalme, opkastning, diaré.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Luveris findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Talk to your doctor, pharmacist or nurse before using Luveris.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Luveris.
English: The medicine is used together with another hormone called Follicle Stimulating Hormone, (FSH), to bring about the development of follicles which are in the ovary, the structures maturing the eggs (ova).
Danish: Medicinen anvendes sammen med et andet hormon, kaldet follikelstimulerende hormon (FSH), for at fremkalde udvikling af follikler, som er de strukturer i æggestokken, der modner æggene (oocytter).
English: One vial of powder for injection contains 75 IU
Danish: Et hætteglas med pulver til injektionsvæske indeholder 75 IE
English: Ovarian Hyper-Stimulation Syndrome
Danish: Ovarielt hyperstimulationssyndrom
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • It is supplied in packs containing 1, 3 or 10 vials of powder, together with the same number of solvent ampoules.
Danish: • Produktet leveres i pakninger indeholdende 1, 3 eller 10 hætteglas sammen med et tilsvarende antal ampuller med solvens.