FrancophonIA/ELRC3.0 huggingface dataset:
English: Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml)
Danish: Æske med 1 flaske à 10 doser (1 x 10 ml) Æske med 1 flaske à 50 doser (1 x 50 ml) Æske med 10 flasker à 50 doser (10 x 50 ml) Æske med 1 flaske à 100 doser (1 x 100 ml) Æske med 10 flasker à 100 doser (10 x 100 ml)
English: Haemolytic units
Danish: hæmolytiske enheder
English: Shelf life of monovalent or bivalent formulation with Bluetongue Virus serotypes 2 (100 ml, 50 ml and 10 ml bottles) and/or 4 (10 ml bottles): 18 months.
Danish: Opbevaringstid for monovalent eller bivalent formulering af bluetonguevirus med serotyperne 2 (flasker à 100 ml, 50 ml og 10 ml) og/eller 4 (flasker à 100 ml): 18 måneder Opbevaringstid efter første åbning af den indre emballage: anvendes straks.
English: Box of 10 bottles of 100 ml
Danish: Æske med 10 flasker à 100 ml
English: Avoid multiple vial broaching.
Danish: Undgå at anbryde samme flaske flere gange.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Danish: Det tilrådes at afprøve vaccinen på et lille antal dyr før vaccination af hele populationen.
English: Box of 1 bottle of 50 ml,
Danish: Æske med 1 flaske à 50 ml
English: 2.12 log10 pixels/mL
Danish: 2.12 log10 pixel/ml
English: Type I glass bottle of 10 ml with butyl elastomer closure.
Danish: Type I glasflaske à 10 ml med butylelastomer-prop. Æske med 1 flaske à 10 doser (1 x 10 ml)
English: 1.82 log10 pixels/mL
Danish: 1.82 log10 pixel/ml
English: Appearance: homogeneous milky white.
Danish: Udseende: homogen, mælkehvid suspension
English: Box of 10 bottles of 50 ml,
Danish: Æske med 10 flasker à 50 ml
English: Box of 1 bottle of 100 ml,
Danish: Æske med 1 flaske à 100 ml
English: 1.9 log10 pixels/mL
Danish: 1.9 log10 pixel/ml
English: 1.86 log10 pixels/mL
Danish: 1.86 log10 pixel/ml
English: In cattle: - First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle).
Danish: Hos kvæg - Første injektion: fra 1-måneds alderen hos naive dyr (eller fra 2,5-måneders alderen for dyr født af immune køer).
English: In sheep: - First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Danish: Hos får: - Første injektion: fra 1-måneds alderen hos naive dyr (eller fra 2,5-måneders alderen for dyr født af immune får).
English: In cattle st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle).
Danish: Hos kvæg: - Første injektion: fra 1-måneds alderen hos naive dyr (eller fra 2,5-måneders alderen for dyr født af immune køer).
English: Invented name Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke
English: Crospovidone type A
Danish: Crospovidon type A
English: Macrogol 6000
Danish: Makrogol 6000
English: 83714 Miesbach Germany
Danish: 83714 Miesbach Tyskland
English: Do not take a double dose to make up for the forgotten individual doses.
Danish: De må ikke tage en dobbeltdosis som erstatning for glemte enkeltdoser.
English: The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimisation activities have been identified.
Danish: Ansøgningen er baseret på et reference-lægemiddel, for hvilket der ikke er identificeret nogen sikkerhedsproblemer, som kræver yderligere risikominimeringsaktiviteter.
English: • Your doctor may order blood tests.
Danish: • Kan Deres læge bede om blodprøver
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Danish: Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i outcome hos personer med poor metabolisme.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer før og mens produktet markedsføres.
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt Deres læge eller apoteket, før De holder op.
English: However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Danish: Imidlertid er det på grund af manglen på interaktionsforsøg med andre NSAID'er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAID-præparater.
English: Contact your doctor immediately if you experience: fever, signs of infection or extreme tiredness.
Danish: Kontakt Deres læge med det samme, hvis De oplever: - Feber, tegn på infektion eller alvorlig kraftesløshed (asteni).
English: System Organ Class
Danish: Systemorganklasse Almindelig
English: Their frequency is defined using the following conventions: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til <1/100), sjælden (>1/10.000 til <1/10.000), meget sjælden <1/10.000).
English: The clinically relevant adverse reactions observed in the CAPRIE study are discussed below.
Danish: De klinisk relevante bivirkninger observeret i CAPRIE-undersøgelsen beskrives nedenfor.
English: Clopidogrel should be given as a single daily dose of 75 mg.
Danish: Clopidogrel bør gives som en enkelt daglig dosis på 75 mg.
English: Patients should be followed carefully for any signs of bleeding including occult bleeding,especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Danish: Patienterne skal kontrolleres omhyggeligt for tegn på blødninger, herunder okkulte blødninger, især i behandlingens første uger og/eller efter invasive hjerteindgreb eller -kirurgi.
English: Risk Management Plan
Danish: Risikostyringsprogram (RMP)
English: -Very rare side effects:
Danish: - Meget sjældne bivirkninger:
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Danish: Ud over erfaringerne fra de kliniske studier, er der spontant blevet rapporteret bivirkninger.
English: -Rare side effect: Vertigo.
Danish: - Sjældne bivirkninger: Svimmelhed (vertigo).
English: This leaflet was last approved in.
Danish: Denne indlægsseddel blev senest godkendt den
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apoteket til råds, inden De tager nogen form for medicin.
English: Platelets (so-called thrombocytes) are very small structures, which clump together during blood clotting.
Danish: Blodplader (såkaldte trombocytter) er meget små bestanddele, som klumper sig sammen, når blodet størkner.
English: Method of administration For oral use
Danish: Administrationsveje Oral anvendelse
English: Taking Clopidogrel Acino Pharma with food and drink Clopidogrel Acino Pharma may be taken with or without food.
Danish: Brug af Clopidogrel Acino Pharma sammen med mad og drikke Clopidogrel Acino Pharma kan tages med eller uden mad.
English: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Acino Pharma;
Danish: • Hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i Clopidogrel Acino Pharma.
English: Acino AG Am Windfeld 35 83714 Miesbach Germany
Danish: Acino AG Am Windfeld 35 83714 Miesbach Tyskland
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: If you suffer from severe liver disease;
Danish: • Hvis De lider af alvorlig leversygdom.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Danish: Hos poor metabolisers var eksponeringen nedsat med 63-71 % sammenlignet med personer med extensive metabolisme.
English: White to off-white, marbled, round and biconvex film-coated tablets.
Danish: Hvide til råhvide, marmorerede, runde og bikonvekse filmovertrukne tabletter.
English: PSURs The PSUR submission schedule should follow the PSUR schedule for the reference product.
Danish: PSUR'er Planen for PSUR-indsendelse skal følge planen for PSUR-indsendelse for referencelægemidlet
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Danish: Når personer med poor metabolisme fik 600 mg/150 mg regimet var eksponeringen for den aktive metabolit større end ved 300 mg/75 regimet.
English: Some other medicines may influence the use of Clopidogrel Acino Pharma or vice versa.
Danish: Visse andre typer medicin kan påvirke brugen af Clopidogrel Acino Pharma eller omvendt.
English: If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis De skærer Dem eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/549/001-007
Danish: EU/1/09/549/001-007
English: Clopidogrel has been evaluated for safety for 1 year or more.
Danish: Clopidogrel er blevet evalueret sikkerhedsmæssigt hos patienter, der blev behandlet i mindst 1 år.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Danish: Hvis De ammer eller planlægger at amme,skal De tale med Deres læge , før De tager denne medicin.
English: Apart from the specific medicinal products interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Danish: Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktionsforsøg med clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
English: • Paediatric population • Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Danish: • Pædiatrisk population Clopidogrel bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Danish: Andre alleler, der associeres med manglende eller nedsat metabolismeer mindre hyppige og inkluderer CYP2C19*4, *5, *6, *7 og *8.
English: Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Danish: Nyligt myokardieinfarkt (MI), nylig apopleksi eller påvist perifer arteriel lidelse
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Danish: Data fra CAPRIE-undersøgelsen indikerer at phenytoin og tolbutamid, som metaboliseres af CYP2C9, kan administreres samtidig med clopidogrel uden risiko.
English: Store in the original blister in order to protect from moisture.
Danish: Opbevares i den originale blisterpakning for at beskytte mod fugt.
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Danish: Da CAPRIE-undersøgelsen imidlertid ikke havde statistisk styrke til at evaluere virkningen i de enkelte delgrupper, kan det ikke udledes, hvorvidt forskellene i relativ risikoreduktion på tværs af inklusionskriterierne er reelle eller tilfældige.
English: Do not use Clopidogrel Acino Pharma if you notice any visible sign of damage of blister or film-coated tablets.
Danish: Brug ikke Clopidogrel Acino Pharma hvis De bemærker synlige tegn på skade på blisterpakningen eller de filmovertrukne tabletter.
English: Pregnancy and breast-feeding It is preferable not to take this product during pregnancy.
Danish: Graviditet og amning Det er bedst ikke at tage denne medicin under graviditet og amning.
English: The most common side effect reported with clopidogrel is bleeding.
Danish: Den mest almindelige bivirkning der er set med clopidogrel er blødning.
English: Children and adolescents Clopidogrel Acino Pharma is not intended for use in children or adolescents.
Danish: Børn og unge Clopidogrel Acino Pharma må ikke gives til børn og unge.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Danish: Farmakoterapeutisk klassifikation: Trombocytfunktionshæmmende midler eksklusive heparin, ATC-kode: B01AC-04.
English: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Danish: Andre lægemidler: Der er gennemført en række andre kliniske forsøg med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
English: They are supplied in cardboard cartons containing 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters.
Danish: De udleveres i papæsker der indeholder 14, 28, 30, 50, 84, 90 og 100 tabletter i blisterpakninger af aluminium.
English: However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by clopidogrel intake.
Danish: Samtidig indgift af 500 mg ASA to gange daglig på en enkelt dag øgede imidlertid ikke signifikant den forlængede kapillærblødningstid, som indgift af clopidogrel bevirkede.
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Danish: Allelerne CYP2C19*2 og CYP2C19*3 tegner sig for størstedelen af alleler med nedsat funktion hos kaukasiske personer (85 %) og hos asiater (99 %) med nedsat metabolisme.
English: Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel, and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter i behandling med clopidogrel bør informeres om, at det kan tage længere tid end normalt at standse blødninger, samt at de bør kontakte deres læge ved enhver usædvanlig blødning (sted eller varighed).
English: If you take more Clopidogrel Acino Pharma than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis De har taget for meget Clopidogrel Acino Pharma Kontakt Deres læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Danish: CYP2C19*1 allelen svarer til en fuldt funktionel metabolisme, mens CYP2C19*2 og CYP2C19*3 allelerneikke er funktionelle.
English: If you forget to take a dose of Clopidogrel Acino Pharma, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Danish: Hvis De har glemt at tage Clopidogrel Acino Pharma Hvis De glemmer at tage en dosis Clopidogrel Acino Pharma til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal De omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Do not use Clopidogrel Acino Pharma after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke Clopidogrel Acino Pharma efter den udløbsdato, som er angivet på æsken og blisterpakningen.
English: Glomerulonephritis, blood creatinine increased
Danish: Glomerulonefrit, øget blodkreatinin-niveau
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Danish: NSAID'er: I et klinisk forsøg foretaget på raske forsøgspersoner øgede den samtidige administration af clopidogrel og naproxen okkult gastrointestinalt blodtab.
English: Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: Clopidogrel påvirker ikke, eller i ubetydelig grad evnen til at føre bil eller betjene maskiner.
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
Danish: Hos de patienter, som alene indgik i undersøgelsen på grund af et nyligt myokardieinfarkt, lå clopidogrel numerisk lavere, men ikke statistisk forskelligt fra ASA (RRR = 4,0 %, CI: -22,5 til 11,7 [p=0,639]).
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: Mere end 12 timer efter planlagt administration: patienten skal tage næste dosis som planlagt og ikke tage dobbelt dosis.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘POSSIBLE SIDE EFFECTS').
Danish: Hvis De er bekymret over Deres blødning, skal De omgående kontakte Deres læge (se afsnit 4'BIVIRKNINGER').
English: Like all medicines, Clopidogrel Acino Pharma can cause side effects, although not everybody gets them.
Danish: Clopidogrel Acino Pharma kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Danish: I TRITON-TIMI 38 og 3 af kohortestudierne (Collet, Sibbing, Giusti) havde den kombinerede gruppe af patienter med status som enten intermediate eller poor metaboliser en højere hyppighed af kardiovaskulære hændelser (død, myokardieinfarkt og apopleksi) eller stenttrombose sammenlignet med personer med extensive metabolisme.
English: Excipients: each film-coatedtablet contains 3.80 mg of hydrogenated castor oil.
Danish: Hjælpestoffer: Hver filmovertrukket tablet indeholder 3,80 mg hydrogeneret ricinusolie.
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen.
Danish: Herudover blev clopidogrels farmakodynamiske aktivitet ikke påvirket signifikant af samtidig administration af phenobarbital eller østrogen.
English: If you stop taking Clopidogrel Acino Pharma Do not stop the treatment unless your doctor tells you so..
Danish: Hvis De holder op med at tage Clopidogrel Acino Pharma De må ikke ophøre med behandlingen, medmindre Deres læge fortæller Dem, at De skal gøre det.
English: Heparin: in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Danish: Heparin: I et klinisk forsøg med raske forsøgspersoner gav clopidogrel ikke anledning til ændring af heparindosis og det forandrede ikke heparins virkning på koagulationen.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS').
Danish: • Skal De også fortælle det til Deres læge med det samme, hvis De udvikler en medicinsk tilstand (trombocytisk trombocytopenisk purpura eller TTP), der giver feber og blå mærker under huden, der kan fremstå som små røde prikker, med eller uden uforklarlig ekstrem træthed, forvirring, gulning af huden eller øjnene (gulsot) (se afsnit 4'BIVIRKNINGER')
English: Clopidogrel Acino Pharma 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.
Danish: Clopidogrel Acino Pharma 75 mg filmovertrukne tabletter er hvide til råhvide, marmorerede, runde og bikonvekse.
English: Elimination Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Danish: Elimination Efter en oral dosis af 14C-mærket clopidogrel hos mennesker blev ca. 50 % udskilt i urinen og ca. 46 %
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Danish: Gastrointestinal og retroperitoneal blødning med letalt udfald, bugspytkirtelbetændelse, colitis (inklusive ulcerosa eller lymfocytisk colitis), stomatitis
English: As a precautionary measure, breast-feeding should not be continued during treatment with clopidogrel.
Danish: Som forholdsregel bør amning ophøre under behandling med clopidogrel.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Acino Pharma.
Danish: Hvis De er gravid eller har mistanke om, at De kan være gravid, skal De fortælle det til Deres læge eller apoteket, før De tager Clopidogrel Acino Pharma.
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (< 35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Danish: CAPRIE-undersøgelsen omfattede 19.185 patienter med aterotrombose manifesteret ved nyligt myokardieinfarkt (<35 dage), nyligt iskæmisk apopleksi (mellem 7 dage og 6 måneder) eller påviste perifere kredsløbsforstyrrelser (PAD).
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel Acino Pharma').
Danish: Hvis De er bekymret over Deres blødning, skal De omgående kontakte Deres læge (se afsnit 2 'Vær ekstra forsigtig med at tage Clopidogrel Acino Pharma').
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2 - 2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Danish: Den gennemsnitlige peak-plasmakoncentration af uomdannet clopidogrel (ca. 2,2-2,5 ng/ml efter en enkelt oral dosis på 75 mg) forekom ca. 45 minutter efter dosering.
English: Tests are available to identify a patient's CYP2C19 genotype.
Danish: Test er tilgængelige til at identificere en patients CYP2C19-genotype.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Acino Pharma.
Danish: Hvis De mener, at ovenstående gælder for Dem, eller hvis De overhovedet er i tvivl, så rådfør Dem med Deres læge, inden De tager Clopidogrel Acino Pharma.