FrancophonIA/ELRC3.0 huggingface dataset:
English: OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Danish: OHSS skal behandles symptomatisk, f.eks. med hvile, intravenøs infusion af elektrolytopløsninger eller kolloider og heparin.
English: The need for luteal phase support in cycles using Orgalutran has not been studied.
Danish: Behov for støtte i lutealfasen i cyklusser, hvor der anvendes Orgalutran, er ikke undersøgt.
English: Similar comparative studies with corifollitropin alfa using either a GnRH antagonist or long agonist protocol have not been performed.
Danish: Der er ikke udført tilsvarende komparative studier med corifollitropin alfa under anvendelse af enten en GnRH-antagonist eller lang agonist protokol.
English: Do not use Orgalutran during pregnancy and breast-feeding.
Danish: Brug ikke Orgalutran under graviditet og amning.
English: If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible and contact your doctor for further advice.
Danish: Hvis injektionen er givet mere end 6 timer for sent, så tidsrummet mellem to injektioner har oversteget 30 timer, skal du tage injektionen snarest muligt samt kontakte din læge for at få yderligere rådgivning.
English: Please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
Danish: Læs venligst indlægssedlen for den gonadotropinholdige medicin, der er ordineret til dig.
English: Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose.
Danish: De farmakokinetiske parametre efter flere subkutane doser Orgalutran (injektion en gang dagligt) var de samme som efter en enkelt subkutan dosis.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin-releasing hormones, ATC code: H01CC01.
Danish: Farmakoterapeutisk klassifikation: Hypofyse- og hypothalamushormoner og analoger, antigonadotropin frigivende hormon; ATC-kode: H01CC01.
English: The metabolites are small peptide fragments formed by enzymatic hydrolysis of ganirelix at restricted sites.
Danish: Metabolitterne er små peptidfragmenter skabt ved enzymatisk hydrolyse af ganirelix på bestemte steder.
English: Cases of allergic reactions have been reported, as early as with the first dose.
Danish: Der er rapporteret om allergiske reaktioner så tidligt som ved første dosis.
English: If you use more Orgalutran than you should Contact your doctor.
Danish: Hvis du har brugt for meget Orgalutran Kontakt din læge.
English: Following administration of multiple doses of 0.25 mg Orgalutran to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74 %, 32 % and 25 % at 4, 16 and 16 hours after injection, respectively.
Danish: Efter indgift af multiple doser 0,25 mg Orgalutran hos frivillige kvinder var serum-LH-, serum-FSH- og serum-E2-koncentrationerne faldet 74 %, 32 % og 25 % henholdsvis 4, 16 og 16 timer efter indgift.
English: Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: Reproduction studies carried out with ganirelix at doses of 0.1 to 10 g/kg/day subcutaneously in the rat and 0.1 to 50 g/kg/day subcutaneously in the rabbit showed increased litter resorption in the highest dose groups.
Danish: Reproduktionsstudier udført med ganirelix i doser på 0,1 til 10 g/kg/dag subkutant på rotter og 0,1 til 50 g/kg/dag subkutant på kaniner afslørede en stigning i fosterresorption i de højeste dosisgrupper.
English: The injection site should be varied to prevent lipoatrophy.
Danish: Injektionsstedet bør ændres fra gang til gang for at forhindre lipoatrofi.
English: )If a hypersensitivity reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered.
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, skal Orgalutran seponeres og hensigtsmæssig behandling gives.
English: In women, FSH is needed for the growth and development of follicles in the ovaries.
Danish: Hos kvinder bruges FSH til vækst og udvikling af follikler i æggestokkene.
English: Swab the injection site with a disinfectant (for example alcohol) to remove any surface bacteria.
Danish: Injektionsstedet skal renses med et desinficerende middel (f.eks. sprit) for at fjerne bakterier på huden.
English: Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic adverse reactions.
Danish: Kliniske studier med subkutan indgivelse af Orgalutran i doser på op til 12 mg viste ikke systemiske bivirkninger.
English: Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility.
Danish: Orgalutran må kun udskrives af en speciallæge med erfaring inden for infertilitetsbehandling.
English: Latex allergy
Danish: Latexallergi
English: Gonadotrophins play an important role in human fertility and reproduction.
Danish: Gonadotropiner spiller en vigtig rolle i den menneskelige frugtbarhed og graviditet.
English: During Orgalutran treatment the average incidence of LH rises (> 10 IU/L) with concomitant progesterone rise (> 1 ng/mL) was 0.3 - 1.2 % compared to 0.8 % during GnRH agonist treatment.
Danish: Under Orgalutran behandlingen var den gennemsnitlige forekomst af LH-stigning (>10 IE/l) med samtidig stigning i progesteron (>1 mg/ml) 0,3 - 1,2 % sammenlignet med 0,8 % under behandling med GnRH agonist.
English: Use only syringes with clear, particle-free solutions and from undamaged containers.
Danish: Brug kun sprøjter med klare, partikelfrie opløsninger og fra ubeskadigede beholdere.
English: Timing of last injection
Danish: Tidspunkt for sidste injektion
English: After repeated dosing 0.25 mg/day steady-state levels of approximately 0.6 ng/mL were reached within 2 to 3 days.
Danish: Efter gentagen dosering af 0,25 mg/dag opnåedes steady state-niveauer på ca. 0,6 ng/ml inden for 2 til 3 dage.
English: Orgalutran is used for
Danish: Orgalutran anvendes til
English: For posology and method of administration, see section 4.2.
Danish: For dosering og administrationsmåde, se pkt.
English: Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Danish: Det er derfor vigtigt ved hjælp af ultralyd tidligt at bestemme, at graviditeten er intrauterin.
English: Manufacturer N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands.
Danish: Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, Holland.
English: If you stop using Orgalutran
Danish: Hvis du holder op med at bruge Orgalutran
English: Do not mix Orgalutran with any other medicines.
Danish: Bland ikke Orgalutran med anden medicin.
English: In controlled studies of Orgalutran with FSH, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol.
Danish: I kontrollerede studier af Orgalutran med FSH, hvor der er anvendt en lang protokol med GnRHagonist som reference, resulterede Orgalutran-behandlingen i en hurtigere follikelvækst i de første dage af stimulationen, mens den sidste kohorte af voksende follikler var lidt mindre og gennemsnitligt producerede mindre østradiol.
English: Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day 5 or day 6 of stimulation.
Danish: Orgalutran (0,25 mg) skal indsprøjtes lige under huden en gang dagligt, startende på dag 5 eller dag 6 efter stimulation.
English: The starting day of Orgalutran is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol.
Danish: Opstartsdagen for Orgalutran afhænger af ovarieresponset, det vil sige antallet og størrelse af voksende follikler og/eller niveauet af cirkulerende østradiol.
English: The start of Orgalutran may be delayed in absence of follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of stimulation.
Danish: Ved manglende follikelvækst kan start på Orgalutran udskydes, selv om klinisk erfaring er baseret på start med Orgalutran på den 5. eller 6. stimulationsdag.
English: OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
Danish: UDVENDIG KARTON TEKST Orgalutran 1/ 5 fyldte injektionssprøjter
English: Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including in vitro fertilisation (IVF).
Danish: Orgalutran bruges som en del af behandlingen med medicinsk assisteret reproduktionsteknik (ART) inklusive in vitro fertilisation (IVF).
English: Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate size are present.
Danish: Den daglige behandling med Orgalutran skal fortsætte indtil den dag, hvor der findes et tilstrækkeligt antal follikler af passende størrelse.
English: In case of a high ovarian response, either as a result of a high exposure to gonadotrophins in the early follicular phase or as a result of high ovarian responsiveness, premature LH rises may occur earlier than day 6 of stimulation.
Danish: I tilfælde af et højt ovarierespons, enten som resultat af en høj gonadotropineksponering i den tidlige follikelfase eller som resultat af høj ovariel følsomhed, kan for tidlig LH stigning forekomme tidligere end stimulationsdag 6.
English: Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, aqueous solution closed with a rubber piston that does not contain latex.
Danish: Fyldte engangssprøjter (opsiliceret type I-glas) indeholdende 0,5 ml steril vandig opløsning, klar til brug, lukket med et gummistempel, der ikke indeholder latex.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Orgalutran
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Orgalutran.
English: In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH agonist.
Danish: I kliniske studier, hvor reaktionerne var rapporteret af patienterne, var forekomsten af moderat til svær hudreaktion en time efter injektion mindst en gang per behandlingscyklus 12% hos patienter behandlet med Orgalutran og 25% hos patienter behandlet subkutant med en GnRH-agonist.
English: Other ingredients: acetic acid, mannitol, water for injections, sodium hydroxide and/or acetic acid as pH adjustment.
Danish: Andre indholdsstoffer: eddikesyre, mannitol, vand til injektionsvæsker, natriumhydroxid og/ eller eddikesyre som pH justering.
English: Vary the injection site with each injection.
Danish: Du skal ændre injektionssted for hver injektion.
English: Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Danish: Eftersom infertile kvinder, som er i assisteret reproduktionsbehandling og især i in vitro-fertilisering (IVF), ofte har abnormaliteter i æggelederne, kan forekomsten af ektopiske graviditeter være forøget.
English: Orgalutran is supplied in pre-filled syringes and should be injected slowly, just under the skin, preferably in the upper leg.
Danish: Orgalutran findes i fyldte sprøjter og skal indsprøjtes langsomt lige under huden, helst i låret.
English: Clean about 5 cm (two inches) around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Danish: Rens et område på ca. 5 cm rundt om injektionsstedet og lad desinfektionsmidlet tørre i mindst 1 minut, før du går videre.
English: Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Danish: Orgalutran findes i pakker med 1 eller 5 fyldte sprøjter.
English: In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.
Danish: Kliniske studier med mere end 1.000 nyfødte har vist, at incidensen af medfødte misdannelser hos børn født efter COH-behandling med Orgalutran er sammenlignelig med det indrapporterede efter COHbehandling med en GnRH-agonist.
English: Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation.
Danish: Ovarieoverstimulations-syndrom (OHSS) kan forekomme under eller efter ovariestimulation.
English: Women weighing less than 50 kg or more than 90 kg
Danish: Kvinder med kropsvægt under 50 kg eller over 90 kg
English: • Swelling of face, lips, tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis)
Danish: • Hævelse af ansigt, læber, tunge og/eller svælg som kan medføre besvær med at trække vejret og/eller synke (angioødem og/eller anafylaksi)
English: There is a slightly increased risk of pregnancy outside of the uterus (an ectopic pregnancy) in women with damaged fallopian tubes.
Danish: Der er en let øget risiko for graviditet uden for livmoderen (ektopisk graviditet) hos kvinder med beskadigede æggeledere.
English: Very common: may affect more than 1 in 10 women Local skin reactions at the site of injection (predominantly redness, with or without swelling).
Danish: Meget almindelige bivirkninger: kan berøre flere end 1 ud af 10 kvinder - Lokale hudreaktioner på injektionsstedet (især rødmen, med eller uden hævelse).
English: The time between two Orgalutran injections as well as the time between the last Orgalutran injection and hCG injection should not exceed 30 hours, as otherwise a premature ovulation (i.e. release of egg cells) may occur.
Danish: Tidsrummet mellem to Orgalutran-injektioner og mellem den sidste Orgalutran-injektion og hCG-injektionen må ikke overstige 30 timer, idet der ellers kan forekomme for tidlig ægløsning (frigivelse af ægceller).
English: Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes.
Danish: Ganirelix bruges i behandlingen af kvinder, som får kontrolleret ovarieoverstimulation i assisterede reproduktionsprogrammer.
English: If you forget to use Orgalutran
Danish: Hvis du har glemt at bruge Orgalutran
English: Pregnancy complications
Danish: Komplikationer i forbindelse med graviditet
English: This syndrome is related to the stimulation procedure with gonadotrophins.
Danish: Dette relateres til gonadotropinstimulationsproceduren.
English: After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach peak levels (Cmax) of approximately 15 ng/mL within 1 to 2 hours (tmax).
Danish: Efter en enkelt subkutan injektion på 0,25 mg vil ganirelix serumkoncentrationerne stige hurtigt og nå maksimumkoncentration (Cmax) på ca. 15 ng/ml inden for 1 til 2 timer (tmax).
English: GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and follicle stimulating hormone (FSH)).
Danish: GnRH regulerer udskillelsen af gonadotropiner (luteiniserende hormon (LH) og follikelstimulerende hormon (FSH)).
English: During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop.
Danish: Under eller efter hormonel ovariestimulation kan der udvikles ovarieoverstimulations-syndrom.
English: This different pattern of follicular growth requires that FSH dose adjustments are based on the number and size of growing follicles, rather than on the amount of circulating oestradiol.
Danish: Dette ændrede mønster i follikelvæksten kræver, at FSHdosisjusteringer baseres på antal og størrelse af voksende follikler fremfor på mængden af cirkulerende østradiol.
English: Other medicines and Orgalutran 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 Orgalutran Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Cases have been reported, as early as with the first dose, among patients administered Orgalutran.
Danish: Der er rapporteret tilfælde så tidligt som ved første dosis hos patienter, der havde fået Orgalutran.
English: Reported in one subject after the first Orgalutran dose.
Danish: Rapporteret hos en forsøgsperson efter første dosis Orgalutran.
English: Controlled ovarian hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses.
Danish: Kontrolleret ovarieoverstimulation med FSH eller corifollitropin alfa kan starte på menstruationens 2. eller 3. dag.
English: Uncommon: may affect up to 1 in 100 women Headache
Danish: Ikke almindelige bivirkninger: kan berøre op til 1 ud af 100 kvinder - Hovedpine - Kvalme - Utilpashed
English: The other ingredients are acetic acid, mannitol, water for injections.
Danish: - Øvrige indholdsstoffer: eddikesyre, mannitol, vand til injektionsvæsker.
English: In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the womb) and miscarriage (see the patientinformation leaflet of the FSH-containing preparation you are treated with)).
Danish: Herudover er der rapporteret andre bivirkninger, som er kendt for at optræde i forbindelse med den kontrollerede ovarieoverstimulationsbehandling (f.eks. mavesmerter, ovarieoverstimulations-syndrom (OHSS), graviditet uden for livmoderen (når fostret udvikler sig uden for livmoderen) og abort (læs indlægssedlen for det FSH-lægemiddel, du bliver behandlet med)).
English: Moderate or severe impairment of renal or hepatic function.
Danish: - Moderat til svært nedsat nyre- eller leverfunktion.
English: Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
Danish: Orgalutran er en GnRH antagonist, som modulerer hypotalamus-hypofyse-gonadal aksen ved kompetitiv binding til GnRH receptorerne i hypofysen.
English: Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.
Danish: Ganirelix anvendes til forebyggelse af for tidlige LH-stigninger, der ellers kunne opstå hos disse kvinder under ovariestimulationen.
English: If you realise that you forgot a dose, administer it as soon as possible.
Danish: Hvis du opdager, at du har glemt at indsprøjte Orgalutran, skal det gøres snarest muligt.
English: FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1).
Danish: FSH-dosis-justeringerne bør baseres på antal og størrelse af voksende follikler frem for på mængden af cirkulerende østradiol (se pkt.
English: What you need to know before you use Orgalutran
Danish: Det skal du vide, før du begynder at bruge Orgalutran
English: This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques.
Danish: Denne lettere forhøjede forekomst tænkes at skyldes egenskaber ved patienterne i reproduktionsbehandling (f.eks. kvindens alder, karakteristika ved mandens sæd) samt den højere forekomst af befrugtning af flere ægceller efter medicinsk assisteret reproduktionsbehandling.
English: The table below shows all adverse reactions in women treated with Orgalutran in clinical studies using recFSH for ovarian stimulation.
Danish: Tabellen nedenfor viser alle bivirkninger set hos kvinder, som blev behandlet med Orgalutran i kliniske studier, hvor recFSH blev anvendt til ovariestimulation.
English: EU/1/00/130/001, 1 pre-filled syringe EU/1/00/130/002, 5 pre-filled syringes
Danish: EU/1/00/130/001, 1 fyldt injektionssprøjte EU/1/00/130/002, 5 fyldte injektionssprøjter
English: Use the pre-filled syringe only once.
Danish: Brug kun sprøjten en gang.
English: Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.
Danish: - Overfølsomhed over for gonadotropinudskillende hormon (GnRH) eller en GnRH analog.
English: Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “antigonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin releasing hormone (GnRH).
Danish: Orgalutran indeholder det aktive stof ganirelix og tilhører gruppen af medicin, der kaldes ”antigonadotropin-frigivende hormoner”, som virker imod det naturlige gonadotropinudskillende hormon GnRH.
English: Orgalutran inhibits the action of GnRH, resulting in suppression of the release of especially LH.
Danish: Orgalutran hæmmer virkningen af GnRH, resulterende i undertrykkelse af udskillelsen af specielt LH.
English: Supplied in cartons containing 1 or 5 pre-filled syringes.
Danish: Findes i æsker indeholdende 1 eller 5 fyldte sprøjter.
English: These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria.
Danish: Disse hændelser inkluderede anafylaksi (herunder anafylaktisk shock), angioødem og urticaria (se pkt.
English: EU/1/00/130/001 1 pre-filled syringe EU/1/00/130/002 5 pre-filled syringes
Danish: EU/1/00/130/001 1 fyldt injektionssprøjte EU/1/00/130/002 5 fyldte injektionssprøjter
English: In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, respectively.
Danish: I akutte toksicitetsstudier på rotter og aber blev non-specifikke toksiske symptomer som hypotension og bradykardi kun observeret efter i.v.
English: Gently draw back the plunger to check if the needle is positioned correctly.
Danish: Træk forsigtigt stemplet tilbage for at sikre, at kanylen er placeret korrekt.
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant.
Danish: Kvinder i medicinsk assisteret reproduktionsbehandling inklusive in vitro fertilisation (IVF) hvor der sommetider forekommer for tidlig ægløsning, hvilket forårsager en signifikant nedsættelse af chancen for at blive gravid.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.
Danish: Dette skyldes formentlig forskellige forhold ved forældrene (fx moderens alder, spermiedefekter) og en øget incidens af flerfoldsgraviditeter.
English: The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions.
Danish: Forekomsten af medfødte malformationer efter assisteret reproduktionsteknologi (ART) menes at være højere end efter spontan undfangelse.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Danish: Orgalutran indeholder mindre end 1 mmol natrium (23 mg) per injektion (indsprøjtning), dvs. det er stort set "natrium-fri".
English: Congenital malformations
Danish: Medfødte malformationer
English: Injection site
Danish: Injektionsstedet
English: Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
Danish: Træk sprøjten hurtigt ud og pres ned på injektionsstedet med et stykke vat med desinfektionsmiddel.