FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and on the label 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: Any blood drawn into the syringe means the needle tip has penetrated a blood vessel.
Danish: Hvis der suges blod tilbage i sprøjten betyder det, at kanylens spids har gennemtrængt en blodåre.
English: When injecting Orgalutran in the afternoon the last Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.
Danish: Ved indgift om eftermiddagen bør den sidste Orgalutran injektion gives om eftermiddagen før den dag, hvor ovulationen starter.
English: The incidence of congenital malformations after assisted reproduction techniques using Orgalutran is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
Danish: Forekomsten af medfødte misdannelser efter medicinsk assisteret reproduktionsbehandling med Orgalutran adskiller sig ikke fra den ved brug af andre GnRHpræparater til brug i medicinsk assisteret reproduktionsbehandling.
English: The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid.
Danish: pH-værdien (et mål for surhedsgraden) kan være blevet justeret med natriumhydroxid og eddikesyre.
English: Very Common Local skin reaction at the site of injection (predominantly redness, with or without swelling)
Danish: Lokal hudreaktion på injektionsstedet (især rødmen med eller uden hævelse)
English: Orgalutran should be administered subcutaneously, preferably in the upper leg.
Danish: Orgalutran indgives subkutant, helst i låret.
English: The pH may have been adjusted with sodium hydroxide and acetic acid.
Danish: pH-værdien kan være blevet justeret med natriumhydroxid og eddikesyre.
English: Allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) have been reported.
Danish: Der er rapporteret om allergiske reaktioner, både generaliserede og lokale, herunder nældefeber (urticaria), hævelse af ansigt, læber, tunge og/eller svælg, som kan medføre besvær med at trække vejret og/eller synke (angioødem og/eller anafylaksi) (se også punkt 4).
English: Hypersensitivity to the active substance 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: Do not use Orgalutran if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section6); if you are hypersensitive to gonadotrophin releasing hormone (GnRH) ora GnRH analogue; if you have a moderate or severe kidney or liver disease; if you are pregnant or breast-feeding.
Danish: Brug ikke Orgalutran - hvis du er allergisk over for ganirelix eller et af de øvrige indholdsstoffer i Orgalutran (angivet i punkt 6); - hvis du er overfølsom over for gonadotropinudskillende hormon (GnRH) eller en GnRH
English: PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/0.5 mL
Danish: TEKST TIL FORFYLDTE SPRØJTER Orgalutran 0,25 mg/0,5 ml
English: What Orgalutran looks like and contents of the pack Orgalutran is a clear and colourless aqueous solution for injection.
Danish: Orgalutran er en klar og farveløs vandig opløsning til injektion.
English: Solution for injection, 1 pre-filled syringe containing 0.5 mL Solution for injection, 5 pre-filled syringes each containing 0.5 mL
Danish: Injektionsvæske, opløsning, 1 fyldt injektionssprøjte indeholdende 0,5 ml Injektionsvæske, opløsning, 5 fyldte injektionssprøjter indeholdende 0,5 ml
English: In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3).
Danish: Hos dyr behandlet med ganirelix på tidspunktet for implantation, forårsagede dette fosterresorption (se pkt.
English: The use of Orgalutran is contraindicated during pregnancy and breast-feeding (see section 4.3).
Danish: Anvendelse af Orgalutran er kontraindiceret under graviditet og amning (se pkt.
English: Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).
Danish: Sidste fase af follikelmodningen kan induceres ved indgivelse af humant chorion gonadotropin (hCG).
English: The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions.
Danish: Forekomsten af medfødte misdannelser efter medicinsk assisteret reproduktionsbehandling kan være en smule højere end ved naturlig undfangelse.
English: Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Danish: Orgalutran er indiceret til forebyggelse af præmature stigninger i luteiniserende hormon (LH) hos kvinder i kontrolleret ovarieoverstimulations-behandling (COH) i forbindelse med assisteret reproduktionsteknik (ART).
English: Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 of your period.
Danish: Ovariestimulation med follikelstimulerende hormon (FSH) eller corifollitropin kan starte på menstruationens 2. eller 3. dag.
English: What Orgalutran contains
Danish: Orgalutran indeholder:
English: Inspect the syringe before use.
Danish: Kontroller sprøjten før brug.
English: Uncommon Headache
Danish: Ikke almindelig Hovedpine
English: The active substance is ganirelix (0.25 mg in 0.5 mL solution).
Danish: - Aktivt stof: ganirelix (0,25 mg i 0,5 ml opløsning).
English: There is no experience on the use of Orgalutran in subjects with renal impairment, as they were excluded from clinical studies.
Danish: Der er ingen erfaring med anvendelse af Orgalutran hos patienter med nedsat leverfunktion, da de blev ekskluderet fra kliniske studier.
English: The active substance ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH).
Danish: Det aktive lægemiddelstof er et syntetisk decapeptid, som har høj antagonistisk aktivitet med det naturligt forekommende gonadotropinfrigivende hormon (GnRH).
English: Inspect the solution before use.
Danish: Kontroller opløsningen før anvendelse.
English: Each pre-filled syringe is affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into contact with the needle.
Danish: Hver fyldt sprøjte er forsynet med en kanyle, som er lukket med en beskyttelseshætte af tørt naturgummi/latex, som kommer i berøring med kanylen.
English: Worsening of a pre-existing rash (eczema) has been reported in one subject after the first Orgalutran dose.
Danish: • Nældefeber (urticaria) - Forværring af allerede eksisterende udslæt (eksem) er rapporteret hos en patient efter den første Orgalutran-dosis.
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: LH is needed to release the mature egg cells from the follicles and ovaries (i.e. ovulation).
Danish: LH bruges til frigivelse af modnede ægceller fra folliklerne og æggestokkene (ægløsning).
English: Ganirelix is also the main compound found in urine.
Danish: Ganirelix var også hovedbestanddelen målt i urin, mens afføringen kun indeholder metabolitter.
English: The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).
Danish: Orgalutrans sikkerhed og effektivitet er ikke påvist hos kvinder med en kropsvægt på under 50 kg eller over 90 kg (se også pkt.
English: Because of the half-life of ganirelix, the time between two Orgalutran injections as well as the time between the last Orgalutran injection and the hCG injection should not exceed 30 hours, as otherwise a premature LH surge may occur.
Danish: Tidsrummet mellem to Orgalutran-injektioner, og mellem den sidste Orgalutran-injektion og hCG injektionen bør ikke overstige 30 timer på grund af ganirelix' halveringstid, idet der ellers kan forekomme præmature stigninger i LH.
English: Cases of hypersensitivity reactions (both generalised and local), have been reportedwith Orgalutran, as early as with the first dose, during post-marketing surveillance.
Danish: Der er under bivirkningsovervågningen efter markedsføring rapporteret om overfølsomhedsreaktioner (både generaliserede og lokale) med Orgalutran så tidligt som ved første dosis.
English: Removing the syringe
Danish: Fjernelse af sprøjten
English: Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG).
Danish: Sidste fase af modningen af ægcellerne i folliklerne fremskyndes ved indgivelse af humant chorion gonadotropin (hCG).
English: Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe renal impairment (see section 4.3).
Danish: Derfor er Orgalutran kontraindiceret hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.
Danish: I kliniske studier blev Orgalutran anvendt sammen med rekombinant humant follikelstimulerende hormon (FSH) eller corifollitropin alfa, en follikelstimulant med forlænget virkning.
English: Preparing the injection site
Danish: Klargøring af injektionsstedet
English: Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.
Danish: Ved indgift om morgenen bør behandling med Orgalutran derfor fortsætte i hele gonadotropin behandlingsperioden, inkl.
English: Pregnancy or breast-feeding.
Danish: - Graviditet eller amning.
English: Orgalutran is used to prevent the premature LH surge that might cause such a premature release of egg cells.
Danish: Orgalutran anvendes til at forhindre den tidlige bølge af LH, der kan forårsage en for tidlig ægløsning.
English: Remove needle cover.
Danish: Fjern beskyttelseshætten.
English: Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.
Danish: Andre rapporterede bivirkninger skyldes snarere den kontrollerede ovarieoverstimulations-behandling i forbindelse med ART, særligt abdominalsmerter, udspilning af abdomen, OHSS (se også pkt.
English: Do not use this syringe and dispose of it properly.
Danish: Anvend ikke sprøjten og kasser den efter anvisningerne.
English: The adverse reactions with Orgalutran using corifollitropin alfa for ovarian stimulation are expected to be similar.
Danish: Det forventes, at de samme bivirkninger vil ses ved Orgalutranbehandling med anvendelse af corifollitropin alfa til ovariestimulation.
English: Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL aqueous solution.
Danish: Hver af de fyldte sprøjter indeholder 0,25 mg ganirelix i 0,5 ml vandig opløsning.
English: Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria) Worsening of a pre-existing eczema
Danish: Meget sjælden Overfølsomhedsreaktioner (med udslæt, opsvulmet ansigt, dyspnø, anafylaksi (herunder anafylaktisk shock), angioødem og urticaria)
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions.
Danish: Kanylens beskyttelseshætte indeholder tørt naturgummi/latex, som kommer i kontakt med kanylen og kan fremkalde allergiske reaktioner.
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions (see section 6.5).
Danish: Kanylens beskyttelseshætte indeholder tørt naturgummi/latex, som kommer i berøring med kanylen og kan fremkalde allergiske reaktioner (se pkt.
English: Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa.
Danish: Behandlingen med Orgalutran startes på den 5. eller 6. dag med FSHstimulation eller på den 5. eller 6. dag efter administration af corifollitropin alfa.
English: Driving and using machines The effects of Orgalutran on ability to drive and use machines have not been studied.
Danish: Trafik- og arbejdssikkerhed Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil eller betjene maskiner.
English: How to use Orgalutran
Danish: Sådan skal du bruge Orgalutran
English: Orgalutran 0.25 mg/0.5 mL solution for injection Ganirelix
Danish: Orgalutran 0,25 mg/0,5 ml injektionsvæske, opløsning ganirelix
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle.
Danish: Kanylens beskyttelseshætte indeholder tørt naturgummi/latex, som kommer i berøring med kanylen.
English: 1, D-pClPhe
Danish: pC1Phe
English: The solution is ready for use and intended for subcutaneous administration.
Danish: Opløsningen er klar til brug og beregnet til injektion under huden.
English: Uncommon Malaise
Danish: Ikke almindelig Utilpashed
English: 1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 mL aqueous solution.
Danish: 1 fyldt injektionssprøjte indeholder 0,25 mg ganirelix i 0,5 ml vandig opløsning.
English: What Orgalutran is and what it is used for What you need to know before you use Orgalutran How to use Orgalutran
Danish: Det skal du vide, før du begynder at bruge Orgalutran Sådan skal du bruge Orgalutran Bivirkninger
English: Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).
Danish: Orgalutran anvendes under kontrolleret stimulation af æggestokkene i forbindelse med assisteret reproduktionsteknik, ART, (fertilitetsbehandling).
English: Nausea
Danish: • Udslæt
English: N.V. Organon, Kloosterstraat 6 Postbus 20
Danish: Organon, Kloosterstraat 6 Postbus 20, 5340 BH Oss, Holland.
English: Orgalutran 0.25 mg/0.5 mL solution for injection
Danish: Orgalutran 0,25 mg/0,5 ml injektionsvæske, opløsning.
English: Hepatic impairment
Danish: Ikke almindelig Kvalme
English: Orgalutran is used to prevent premature LH surges in women undergoing COH.
Danish: Orgalutran anvendes til at forebygge præmature stigninger i luteiniserende hormon hos kvinder i kontrolleret ovarieoverstimulations-behandling (COH).
English: Orgalutran and FSH should be administered approximately at the same time.
Danish: Orgalutran må ikke blandes med FSH, men begge præparater skal gives næsten samtidig, men ikke samme sted.
English: Ask your doctor for further information.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Solution for injection.
Danish: Injektion af opløsningen
English: However, the preparations should not be mixed and different injection sites are to be used.
Danish: Orgalutran må ikke blandes med FSH, men begge præparater bør injiceres omtrent samtidig, dog ikke samme sted.
English: Malaise
Danish: Amning
English: Inserting the needle
Danish: Indstik af kanylen
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1056/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1056/001
English: Older people/Sex/Race
Danish: Ældre/køn/race
English: Approximately half of the patients in each group were male.
Danish: Ca. halvdelen af patienterne i hver af de 2 grupper var mænd.
English: No other infusion should be administered in parallel via the same intravenous access.
Danish: Ingen anden infusion må administreres parallelt via samme intravenøse adgang.
English: Reversal effects were evident immediately after administration.
Danish: Antidoteffekten var evident umiddelbart efter administration.
English: • In life-threatening or uncontrolled bleeding.
Danish: • Ved livstruende eller ukontrolleret blødning.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Danish: Din læge eller sygeplejerske giver dig dette lægemiddel som en injektion eller infusion i en vene.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis præparatet ikke anvendes straks, er opbevaringstid og -forhold før brug brugerens ansvar.
English: The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established.
Danish: Praxbinds sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2015
Danish: Dato for første markedsføringstilladelse: 20. november 2015
English: Please note this medicine is mainly used in emergency situations and the doctor will have decided that you needed it. - Keep this leaflet.
Danish: Bemærk, at denne medicin primært anvendes i akutte situationer, hvor lægen har besluttet, at du har brug for den. - Gem indlægssedlen.
English: • For emergency surgery/urgent procedures
Danish: • Inden akutte operationer/akutte procedurer
English: - if you have a genetic disease called hereditary fructose intolerance.
Danish: - hvis du har en genetisk sygdom kaldet arvelig fruktoseintolerans.
English: The remaining part of the dose is assumed to be eliminated via protein catabolism, mainly in the kidney.
Danish: Den resterende del af dosis formodes at være udskilt via proteinkatabolisme, primært i nyrerne.
English: • The enclosed package leaflet contains additional information for healthcare professionals
Danish: • Indlægssedlen indeholder yderligere information til sundhedspersonale.
English: 61.5% of patients in Group A and 62.4% of patients in Group B had been treated with dabigatran 110 mg twice daily.
Danish: 61,5 % af patienterne i gruppe A og 62,4 % af patienterne i gruppe B var blevet behandlet med dabigatran 110 mg to gange dagligt.
English: Tell your doctor, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Danish: Fortæl altid lægen, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: All nine patients were redosed within 6 days after the first idarucizumab dose.
Danish: Alle 9 patienter blev igen doseret inden for 6 dage efter den første idarucizumab-dosis.
English: The highest single dose of Praxbind studied in healthy subjects was 8 g. No safety signals have been identified in this group.
Danish: Den højeste enkeltdosis af Praxbind, der er undersøgt hos raske frivillige, er 8 g. Der er ikke set nogen sikkerhedsproblemer hos denne gruppe.
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB37
Danish: Farmakoterapeutisk klassifikation: alle andre terapeutiske produkter, antidoter, ATC-kode: V03AB37
English: This is equivalent to 2.5 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 2,5 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Several pathways have been described that may contribute to the metabolism of antibodies.
Danish: Der er beskrevet flere veje, der potentielt kan bidrage til metabolisering af antistoffer.
English: A maximum daily dose has not been investigated.
Danish: En maksimal daglig dosis er ikke fastlagt.
English: Each pack contains two vials.
Danish: Hver pakning indeholder to hætteglas.
English: The median age was 78 years and the median creatinine clearance was 52.6 mL/min.
Danish: Medianalderen var 78 år, og den mediane kreatininclearance var 52,6 ml/min.
English: All of these pathways involve biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids, which are then reabsorbed and incorporated in the general protein synthesis.
Danish: Alle disse veje omfatter bionedbrydning af antistoffet til mindre molekyler, dvs. små peptider eller aminosyrer, som derefter reabsorberes og inkorporeres i den generelle proteinsyntese.
English: Until now, no side effects have been indentified.
Danish: Hidtil er der ikke påvist bivirkninger.
English: The idarucizumab formulation did not produce haemolysis of human whole blood in vitro.
Danish: Idarucizumabs formulering forårsagede ikke hæmolyse af humant fuldblod in vitro.
English: Your doctor will continue treating you with medicines used to prevent the formation of blood clots as soon as your medical condition allows.
Danish: Lægen vil fortsætte med at behandle dig med medicin, der anvendes til at forhindre dannelse af blodpropper, så snart din helbredstilstand tillader det.
English: Of the total 503 patients, 101 patients died; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.
Danish: Ud af i alt 503 patienter døde 101; alle dødsfald kunne enten tilskrives en komplikation i forbindelse med den oprindelige hændelse eller komorbiditeter.
English: All pigs survived at idarucizumab doses of approximately 2.5 and 5 g. Without idarucizumab, the mortality in the anticoagulated group was 100 %.
Danish: Alle grise overlevede med idarucizumab-doser på cirka 2,5 og 5 g. Uden idarucizumab var mortaliteten i den antikoagulerede gruppe 100 %.
English: In single cases the transient proteinuria persisted for more than 24 hours.
Danish: I enkelte tilfælde varede den forbigående proteinuri over 24 timer.
English: This medicine is for hospital use only.
Danish: Dette lægemiddel er kun til brug på hospitaler.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 4.9 Overdosering
English: Urinary protein testing
Danish: Proteinuri-test
English: In this case, the substance sorbitol contained in this medicine may cause serious adverse reactions.
Danish: I så fald kan stoffet sorbitol i denne medicin give alvorlige bivirkninger.
English: In rare cases you may still have too much dabigatran in your blood after a first dose of Praxbind and your doctor may decide to give you a second 5 g dose in specific situations.
Danish: I sjældne tilfælde kan du stadig have for meget dabigatran i blodet efter en dosis Praxbind, og lægen kan beslutte at give dig endnu en dosis på 5 g.
English: RE-VERSE AD included data for 503 patients: 301 patients with serious bleeding (Group A) and 202 patients requiring an urgent procedure/surgery (Group B).
Danish: RE-VERSE AD omfattede data fra 503 patienter: 301 patienter med alvorlig blødning (gruppe A) og 202 patienter, der krævede en akut procedure/operation (gruppe B).
English: Idarucizumab effectively and rapidly reversed the life-threatening bleeding within 15 min after the injection.
Danish: Idarucizumab standsede effektivt og hurtigt den livstruende blødning inden for 15 minutter efter injektionen.
English: Therefore, preclinical results do not suggest a risk to fertility or embryo-fetal development.
Danish: Derfor tyder prækliniske resultater ikke på risiko for påvirkning af fertilitet eller embryo-føtal udvikling.
English: Hereditary fructose intolerance
Danish: Arvelig fructoseintolerans
English: There is no clinical experience with overdoses of Praxbind.
Danish: Der er ingen klinisk erfaring med overdosering af Praxbind.
English: Praxbind may be used during pregnancy, if the expected clinical benefit outweighs the potential risks.
Danish: Praxbind kan anvendes under graviditet, hvis de forventede kliniske fordele opvejer de potentielle risici.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse.