FrancophonIA/ELRC3.0 huggingface dataset:
English: one dose (0.5 ml) contains: Live attenuated varicella virus (Oka/Merck strain) not less than 1350 PFU*
Danish: En dosis (0,5 ml) indeholder: Levende svækket varicellavirus (Oka/Merck-stamme) ikke mindre end 1.350 PFU*
English: strain, derived from Jeryl Lynn strain)not less than 103.7 CCID50
Danish: Priorix derived from Jeryl Lynn strain) - ikke mindre end 103,7 CCID50
English: GlaxoSmithKline A.E.B.E Kifissias Avenue 266 Halandri 15232, Athens Greece
Danish: Grækenland GlaxoSmithKline A.E.B.E Kifissias Avenue 266
English: Varicella virus OKA/Merck strain (live, attenuated) not less than 1350 PFU*
Danish: Varicellavirus OKA/Merck-stamme (levende, svækket) ikke mindre end 1.350 PFU*
English: 3705 LZ ZEIST
Danish: Huis ter Heideweg 62 3705 LZ ZEIST The Netherlands
English: Live attenuated measles virus (Schwarz strain) -not less than 103.0 CCID50
Danish: Mæslingevirus Schwartz-stamme (levende, svækket) - ikke mindre end 103,0 CCID50
English: Varivax one dose (0.5 ml) contains: Varicella virus (Oka/Merck strain) ≥ 1350 PFU*
Danish: En dosis (0,5 ml) indeholder: Varicellavirus (Oka/Merck-stamme) ≥ 1.350 PFU*
English: Varicella virus, live attenuated, Oka/Merck strain ≥ 1350 PFU*
Danish: Varicellavirus, levende, svækket, Oka/Merckstamme ≥ 1.350 PFU*
English: one dose (0.5 ml) contains: Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 x 10 TCID50
Danish: Fåresygevirus (Jeryl Lynn-stamme - B level) - ikke mindre end 20 x 103,0 TCID50
English: Mumps virus Jeryl Lynn strain (live, attenuated) - 5 x 10
Danish: Fåresygevirus Jeryl Lynn-stamme (levende, svækket) - 5 x 103,0 CCID50
English: Varicella Virus OKA/Merck Strain - not less than 1350 PFU*
Danish: Varicellavirus (OKA/Merck-stamme - ikke mindre end 1.350 PFU *
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50
Danish: Levende svækket røde hundevirus (Wistar RA 27/3 strain) - ikke mindre end 103,0 CCID50
English: Live attenuated varicella virus (OKA strain) - not less than 103.3 PFU*
Danish: Levende, svækket varicella-zostervirus (Oka stamme) - ikke mindre end 103,3 PFU*
English: Powder and solution for injection
Danish: Powder and solvent for solution for injection
English: Rubella virus Wistar RA 27/3 strain (live, attenuated) not less than 10
Danish: Røde hundevirus Wistar RA 27/3-stamme (levende, svækket) ikke mindre end 103,0
English: RUBEATEN BERNA Rubella virus live (Strain Wistar RA 27/3) - not less than 10
Danish: RUBEATEN BERNA Røde hundevirus levende (Wistar RA 27/3stamme) - ikke mindre end 103,0 TCID50
English: Measles and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Danish: Mæslinge og røde hunde vacciner (levende) med markedsføringstilladelse i den europæiske union Medlemsstat
English: Powder and solvent for solution for injection, suspension
Danish: Pulver og solvens til injektionsvæske, suspension
English: Varicella virus, strain Oka/Merck live attenuated - 1350 PFU*
Danish: Varicellavirus, Oka/Merck-stamme levende, svækket - 1.350 PFU*
English: Varicella virus Oka/Merck strain (live, attenuated) ≥1350 PFU*
Danish: Varicellavirus Oka/Merck-stamme (levende, svækket) ≥ 1.350 PFU*
English: Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Danish: Svækket varicella-zostervirus (OKA-stamme)ikke mindre end 103,3 PFU*
English: Live atenuated varicella virus (Strain OKA/Merk) - ≥1350 PFU*
Danish: Levende, svækket varicellavirus (OKA/Merkstamme) - ≥1.350 PFU*
English: Varivax one dose (0.5 ml) contains: not less than 1350 PFU* of the live attenuated varicella virus (OKA.Merck strain)
Danish: Ikke mindre end 1.350 PFU* levende, svækkede varicellavirus (OKA.Merck-stamme)
English: Mumps vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Danish: Skoldkoppe-vacciner (levende) med markedsføringstilladelse i den europæiske union Medlemsstat
English: Belgium GlaxoSmithKline Biologicals S.A.
Danish: Bulgarien GlaxoSmithKline Biologicals S.A.
English: Varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Danish: Mæslinge-vacciner (levende) med markedsføringstilladelse i den europæiske union Medlemsstat
English: Rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Danish: Røde hunde-vacciner (levende)med markedsføringstilladelse i den europæiske union Medlemsstat
English: VARIVAX Powder for Suspension one dose (0.5 ml) contains: Varicella Virus OKA/Merck Strain1350 PFU*
Danish: En dosis (0,5 ml) indeholder: Varicellavirus OKA/Merck-stamme - 1.350 PFU*
English: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 10
Danish: Røde hundevirus Wistar RA 27/3 (levende, svækket) - 103,0 CCID50
English: Package size l t o r
Danish: Paknings-størrelse gem idlet er ikke ngere autoriseret til salg
English: This is a summary of the European public assessment report (EPAR) for Granpidam.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Granpidam.
English: The full EPAR for Granpidam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Granpidam findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This was considered acceptable since Revatio and Viagra have the same composition and are made in the same way by the same manufacturer.
Danish: Dette blev anset for at være acceptabelt, da Revatio og Viagra har samme sammensætning og er produceret på samme måde af fremstilleren.
English: What measures are being taken to ensure the safe and effective use of Granpidam?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Granpidam?
English: It is not intended to provide practical advice on how to use Granpidam.
Danish: Det er ikke en praktisk vejledning i, hvordan Granpidam bør anvendes.
English: The Committee recommended that Granpidam be approved for use in the EU.
Danish: Udvalget anbefalede, at Granpidam godkendes til anvendelse i EU.
English: Other information about Granpidam
Danish: Andre oplysninger om Granpidam
English: Granpidam is available as tablets (20 mg).
Danish: Granpidam fås som tabletter (20 mg).
English: This means that Granpidam is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio.
Danish: Det betyder, at Granpidam er identisk med et referencelægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Revatio.
English: In this case Granpidam was not compared with the reference product Revatio, but with Viagra.
Danish: I dette tilfælde er Granpidam ikke blevet sammenlignet med referencelægemidlet Revatio, men med Viagra.
English: Granpidam contains the active substance sildenafil.
Danish: Granpidam indeholder det aktive stof sildenafil.
English: The active substance in Granpidam, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Danish: Det aktive stof i Granpidam, sildenafil, tilhører en gruppe af lægemidler, der kaldes "phosphodiesterase-type-5 (PDE5)hæmmere", dvs. lægemidler, der blokerer det såkaldte PDE5-enzym.
English: Lower doses of Granpidam may be needed in patients taking some medicines that affect the way Granpidam is broken down in the body.
Danish: Lavere doser af Granpidam kan være nødvendigt hos patienter, der tager visse andre lægemidler, som kan påvirke den måde, hvorpå Granpidam nedbrydes i kroppen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Granpidam was considered to be comparable to Revatio.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Granpidam kan anses for at være sammenligneligt med Revatio.
English: For lower doses, other medicines containing sildenafil should therefore be used.
Danish: Hvis der skal anvendes lavere doser, må man derfor benytte andre sildenafilholdige lægemidler.
English: What are the benefits and risks of Granpidam?
Danish: Hvilken fordel og risiko er der forbundet med Granpidam?
English: What is Granpidam and what is it used for?
Danish: Hvad er Granpidam, og hvad anvendes det til?
English: Granpidam is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries in the lungs).
Danish: Granpidam er et lægemiddel, der anvendes til at behandle voksne og børn i alderen 1 år og derover med pulmonal arteriel hypertension (unormalt højt blodtryk i lungernes arterier).
English: In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Danish: Det anvendes hos voksne patienter med pulmonal arteriel hypertension klasse II (let begrænsning af fysisk aktivitet) eller klasse III (svær begrænsning af fysisk aktivitet).
English: Because Granpidam is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Granpidam er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Granpidam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Granpidam, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Granpidam can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Granpidam udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af pulmonal arteriel hypertension.
English: Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Danish: Da sildenafils virkning og sikkerhed hos patienter med pulmonal arteriel hypertension allerede er almindeligt anerkendt, har patientundersøgelserne været begrænset til at påvise, at lægemidlet er bioækvivalent med andre godkendte sildenafil-holdige tabletter.
English: Why is Granpidam approved?
Danish: Hvorfor blev Granpidam godkendt?
English: When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Danish: Når enzymet blokeres, kan stoffet "cyklisk guaninmonofosfat" (cGMP) ikke nedbrydes; dette stof bliver i blodkarrene og får dem til at slappe af og udvide sig.
English: Therefore, the CHMP's view was that, as for Revatio, the benefit of Granpidam outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene ved Granpidam opvejer de identificerede risici som for Revatio.
English: In adults, Granpidam is taken at a dose of 20 mg three times a day.
Danish: Granpidam-dosen hos voksne er 20 mg tre gang dagligt.
English: In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Danish: Hos patienter med pulmonal arteriel hypertension udvider sildenafil blodkarrene i lungerne, hvorved blodtrykket sænkes, og symptomerne lindres.
English: For practical information about using Granpidam, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Granpidam, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Granpidam have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Granpidam.
English: How is Granpidam used?
Danish: Hvordan anvendes Granpidam?
English: How has Granpidam been studied?
Danish: Hvordan blev Granpidam undersøgt?
English: In children aged 1 to 17 years, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Danish: Hos børn i alderen 1-17 år, der vejer over 20 kg, er den anbefalede dosis 20 mg tre gange dagligt.
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Danish: Pulmonal arteriel hypertension er en invaliderende sygdom med svær forsnævring af blodkarrene i lungerne.
English: The relevance of these data for humans is unknown.
Danish: Relevansen af disse data hos mennesker er ukendt.
English: Date of first authorisation: 17 May 2000 Date of last renewal: 10 May 2010
Danish: Dato for første markedsføringstilladelse: 17. maj 2000 Dato for seneste fornyelse: 10. maj 2010
English: Wash your hands thoroughly with soap and water.
Danish: Vask hænderne omhyggeligt med vand og sæbe.
English: The chance of having a side effect is described by the following categories:
Danish: Risikoen for at få en bivirkning er beskrevet ved hjælp af følgende kategorier:
English: • At the request of the European Medicines Agency:
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: The local reactions generally disappear within 4 hours after administration.
Danish: Lokale reaktioner forsvinder normalt inden for 4 timer efter administration.
English: However, based on the small number of patients treated so far, an effect cannot be excluded.
Danish: Imidlertid kan man ikke, ud fra det lille antal patienter, der indtil nu er behandlet, udelukke en sådan.
English: No teratogenic effects were observed.
Danish: Der blev ikke observeret teratogene virkninger.
English: Overdose in humans may result in a prolonged duration of action.
Danish: Overdosering hos mennesker kan forårsage forlængelse af virkningen.
English: The bioavailability of Orgalutran following subcutaneous administration is approximately 91 %.
Danish: Orgalutrans biotilgængelighed efter subkutan administration er ca. 91%.
English: The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.
Danish: Muligheden for interaktioner med almindeligt anvendte lægemidler, herunder lægemidler der frigiver histamin, kan ikke udelukkes.
English: Excretion occurs via faeces (approximately 75 %) and urine (approximately 22 %).
Danish: Udskillelse sker via afføringen (ca. 75 %) og urinen (ca. 22 %).
English: Start again with a new syringe.
Danish: Du skal starte forfra med en ny sprøjte.
English: Special care should be taken in women with signs and symptoms of active allergic conditions.
Danish: Særlig opmærksomhed bør udvises overfor kvinder med symptomer på aktive allergiske tilstande.
English: ]-GnRH with a molecular weight of 1570.4.
Danish: ]-GnRH med en molekylevægt på 1570,4.
English: Do not stop using Orgalutran unless advised to by your doctor, as this may affect the outcome of your treatment.
Danish: Du må ikke stoppe med Orgalutran, medmindre din læge råder dig til det, da dette kan påvirke resultatet af din behandling.
English: In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
Danish: I tilfælde af overdosering skal Orgalutran-behandlingen (midlertidigt) stoppes.
English: If you have an active allergic condition, please tell your doctor.
Danish: Hvis du har en aktiv allergisk tilstand, skal du fortælle det til din læge.
English: The metabolite profile of Orgalutran in humans was similar to that found in animals.
Danish: Metabolitprofilen af Orgalutran hos mennesker er omtrent den samme som blev fundet hos dyr.
English: Serum hormone levels returned to pre-treatment values within two days after the last injection.
Danish: Serum-hormonniveauerne vendte tilbage til værdierne før behandlingen inden for to dage efter sidste injektion.
English: There are no adequate data from the use of ganirelix in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af ganirelix hos gravide kvinder.
English: Ovarian hyperstimulation syndrome (OHSS)
Danish: Ovarieoverstimulations-syndrom (OHSS)
English: In clinical studies, luteal phase support was given according to study centres' practice or according to the clinical protocol.
Danish: I kliniske studier blev støtte i lutealfasen givet i henhold til centrets praksis eller i henhold til den kliniske protokol.
English: The major circulating component in plasma is ganirelix.
Danish: Den vigtigste cirkulerende bestanddel i plasma er ganirelix.
English: Do not use if the solution contains particles or is not clear.
Danish: Den må ikke anvendes, hvis den indeholder partikler eller er uklar.
English: Based on your ovarian response, your doctor may decide to start on another day.
Danish: Afhængigt af reaktionen fra dine æggestokke kan din læge beslutte at starte behandlingen på en anden dag.
English: The frequency of hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance.
Danish: Hyppigheden af overfølsomhedsreaktioner (meget sjælden, < 1/10.000) er udledt fra post-marketingovervågning.
English: Multiple births or birth defects
Danish: Flere fødsler eller medfødte misdannelser
English: Follicles are small round sacs that contain the egg cells.
Danish: Follikler er små runde poser, der indeholder ægceller.
English: If you have an allergic reaction, stop taking Orgalutran and seek immediate medical assistance.
Danish: Hvis du får en allergisk reaktion, skal du stoppe med at tage Orgalutran og straks søge lægehjælp.
English: There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (> 80 kg), but no effect on clinical outcome was observed.
Danish: Der var en tendens til forhøjet LH og progesteronstigninger hos kvinder med en høj kropsvægt (>80 kg), men der blev ikke observeret nogen indvirkning på det kliniske resultat.
English: In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days.
Danish: Hos patienter i kontrolleret ovariestimulationsbehandling var den gennemsnitlige varighed af Orgalutran behandlingen 5 dage.
English: Your doctor will decide, depending on the severity, if additional monitoring is required during treatment.
Danish: Afhængig af sværhedsgraden vil lægen beslutte, om du skal overvåges særlig omhyggeligt under behandlingen.
English: Orgalutran has shown to be safe and effective in women undergoing multiple treatment cycles.
Danish: Orgalutran har vist sig sikker og effektiv hos kvinder som gennemgår flere behandlingscyklusser.
English: Paediatric population There is no relevant use of Orgalutran in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende Orgalutran hos den pædiatriske population.
English: Pinch up a large area of skin between finger and thumb.
Danish: Tag fat i en stor hudfold med tommel- og pegefinger.
English: Initiation of Orgalutran treatment on day 5 can prevent these premature LH rises without compromising the clinical outcome.
Danish: Initiering af Orgalutran behandling på dag 5 kan forhindre disse for tidlige LH stigninger uden at kompromittere det kliniske slutresultat.
English: The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)
Danish: Aminosyrerne i positionerne 1, 2, 3, 6, 8 og 10 i det naturlige GnRH decapeptid er erstattet og det endelige molekyle bliver N-Ac-D-Nal(2)
English: Pharmacokinetic analysis indicates an inverse relationship between body weight and serum concentrations of Orgalutran.
Danish: Farmakokinetisk analyse indikerer en negativ korrelation mellem kropsvægt og serumkoncentrationer af Orgalutran.
English: OHSS must be considered an intrinsic risk of gonadotrophin stimulation.
Danish: OHSS må betragtes som en reel risiko ved gonadotropinstimulation.
English: As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists.
Danish: Et resultat heraf er en hurtig, kraftig, reversibel undertrykkelse af endogene gonadotropiner uden initial stimulation, som det er tilfældet med GnRH agonister.
English: Children and adolescents There is no relevant use of Orgalutran in children or adolescents.
Danish: Børn og unge Brug ikke Orgalutran til børn eller unge.
English: The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Danish: Bivirkningerne er klassificeret i henhold til MedDRA systemorganklasse og hyppighed; meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 og < 1/100).
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
Danish: Da klinisk erfaring savnes, kan Orgalutran-behandling ikke anbefales til kvinder med alvorlige allergiske tilstande.
English: It is not known whether ganirelix is excreted in breast milk.
Danish: Det vides ikke om ganirelix udskilles i modermælk.
English: If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two.
Danish: Skulle dette ske, skal du ikke indsprøjte Orgalutran, men trække sprøjten ud, dække injektionsstedet med et stykke vat med desinfektionsmiddel og presse ned på injektionsstedet; blødningen vil stoppe efter et par minutter.
English: If you administer the injections yourself or have it done by your partner, follow the instructions below carefully.
Danish: Hvis du selv eller din partner foretager de efterfølgende injektioner, skal du nøje følge instruktionerne nedenfor.
English: • Difficulty breathing (dyspnoea)
Danish: • Vejrtrækningsbesvær (dyspnø)
English: Very rare: may affect up to 1 in 10,000 women Allergic reactions have been observed, as early as with the first dose.
Danish: Meget sjældne bivirkninger: kan berøre op til 1 ud af 10.000 kvinder - Allergiske reaktioner er set så tidligt som ved første dosis.
English: Checking the correct needle position
Danish: Kontrol af kanylens korrekte position
English: Insert the needle at the base of the pinched-up skin at an angle of 45° to the skin surface.
Danish: Stik kanylen ind i bunden af hudfolden i en vinkel på 45° på hudoverfladen.
English: Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Danish: Når kanylen er korrekt placeret, trykkes stemplet langsomt og roligt ned, så opløsningen indsprøjtes korrekt, og hudvævet ikke beskadiges.
English: No data on acute toxicity of Orgalutran in humans are available.
Danish: Der findes ingen data, der omhandler akut toksicitet af Orgalutran hos mennesker.
English: The patient or her partner may perform the injections of Orgalutran themselves, provided that they are adequately instructed and have access to expert advice.
Danish: Subkutan injektion af Orgalutran kan udføres af patienten selv eller dennes partner, forudsat de har fået udførlige instruktioner og har adgang til ekspertråd.
English: The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 L/h.
Danish: Halveringstiden (t½) er på ca. 13 timer og clearance på ca. 2,4 l/time.