FrancophonIA/ELRC3.0 huggingface dataset:
English: You have been prescribed Clopidogrel Teva Generics B.V. to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Danish: til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - Du lider af åreforkalkning (også kaldet aterosklerose) - og - Du tidligere har haft et hjerteanfald, slagtilfælde eller kredsløbsforstyrrelser i arme eller ben - eller - Du har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller hjerteanfald (myokardieinfarkt).
English: If you forget to take a dose of Clopidogrel Teva Generics B.V., but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket hvordan du skal aflevere medicinrester.
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 Teva Generics B.V..
Danish: Hvis du mener, at ovenstående gælder for dig, eller hvis du overhovedet er i tvivl, så rådfør dig med din læge, inden du tager Clopidogrel Teva Generics B.V.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Danish: Mavesår og duodenalt ulcus gastritis, opkastning, kvalme, forstoppelse, flatulens
English: Clopidogrel Teva Generics B.V. is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: tages for at forebygge dannelse af blodpropper (trombi) i blodårer (arterier), som er blevet stive ved en proces kaldet aterotrombose, hvilket kan føre til aterotrombotiske hændelser (f.eks. slagtilfælde, hjerteanfald og død).
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Danish: I intention-to-treat-analysen blev der observeret 939 tilfælde i clopidogrelgruppen og 1.020 tilfælde i ASA-gruppen (relativ risikoreduktion (RRR) 8,7 % [95 % CI: 0,2-16,4], p=0,045), hvilket for hver 1.000 patienter, der blev behandlet i 2 år, svarer til, at yderligere 10 [CI: 0-20] patienter beskyttes mod et nyt iskæmisk tilfælde.
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Danish: Alvorlig blødning, blødning i operationssår, vaskulitis, hypotension
English: • if you have kidney or liver disease.
Danish: • du lider af en nyre- eller leversygdom.
English: • Patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Danish: - akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina eller myokardieinfarkt uden forekomst af Q-takker) inklusive patienter, som får indsat stent efter perkutant koronarindgreb, i kombination med acetylsalicylsyre (ASA).
English: Proton Pump Inhibitors (PPI):
Danish: Syrepumpehæmmere (PPI):
English: As a precaution, concomitant use of omeprazole or esomeprozole should be discouraged (see section 4.4).
Danish: Som forholdsregel frarådes samtidig anvendelse af omeprazol eller esomeprazol (se pkt.
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Danish: Patienterne blev randomiseret til clopidogrel (300 mg initialdosis efterfulgt af 75 mg/dag, N=6.259) eller placebo (N=6.303), begge i kombination med ASA (75-325 mg en gang daglig) samt anden standardbehandling.
English: Manufacturer
Danish: Fremstillere:
English: Taking other medicines
Danish: Brug af anden medicin:
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Danish: Antallet af patienter, som oplevede det primære endpoint [kardiovaskulært dødsfald, myokardieinfarkt eller slagtilfælde] var 582 (9,3 %) i clopidogrel-gruppen og 719 (11,4 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 20 % (95 % CI: 10 %-28 %; p=0,00009) for clopidogrelgruppen (en relativ risikoreduktion på 17 %, når patienterne fik konservativ behandling, 29 %, når de fik perkutan transluminal koronar angioplasti (PTCA) med eller uden stent og 10 %, når de fik koronar bypassoperation (CABG)).
English: In CURE, the major bleeding event rate for clopidogrel + ASA was dose-dependent on ASA (<100 mg: 2.6%; 100-200 mg: 3.5%; >200 mg: 4.9%) as was the major bleeding event rate for placebo + ASA (<100 mg: 2.0%; 100-200 mg: 2.3%; >200 mg: 4.0%).The risk of bleeding (life-threatening, major, minor, other) decreased during the course of the trial: 0-1 months (clopidogrel: 9.6%; placebo: 6.6%), 1-3 months (clopidogrel: 4.5%; placebo: 2.3%), 3-6 months (clopidogrel: 3.8%; placebo: 1.6%), 6-9 months (clopidogrel: 3.2%; placebo: 1.5%), 9-12 months (clopidogrel: 1.9%; placebo: 1.0%).
Danish: Risikoen for blødninger (livstruende, større, mindre, andre) faldt under forsøgsforløbet: 0-1 måned (clopidogrel: 9,6 %; placebo: 6,6 %), 1-3 måneder (clopidogrel: 4,5 %; placebo 2,3 %), 3-6 måneder (clopidogrel 3,8 %; placebo: 1,6 %), 6-9 måneder (clopidogrel: 3,2 %; placebo 1,5 %), 9-12 måneder (clopidogrel 1,9 %; placebo 1,0 %).
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Danish: Muskuloskeletal blødning (blødudtrædning i led), artrit, arthralgi, muskelsmerter.
English: Lower active metabolite exposure results in less platelet inhibition or higher residual platelet reactivity.
Danish: Lavere eksponering for den aktive metabolit resulterer i mindre trombocythæmning eller mulighed for trombocytaggregation i de resterende ikke-hæmmede trombocytter.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Generics B.V. (4 tablets of 75 mg) once at the start of treatment.
Danish: Hvis du har haft alvorlige brystsmerter (hjertekrampe (ustabil angina pectoris) eller hjertetilfælde), vil din læge måske indlede behandlingen med at give dig 300 mg Clopidogrel Teva Generics B.V.
English: Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
Danish: Farmakokinetikken og den antitrombotiske effekt, målt ved ex vivo trombocytaggregationsundersøgelse, adskiller sig alt efter CYP2C19 genotype.
English: Lietuva UAB “Sicor Biotech” Tel: +370 5 266 02 03 This leaflet was last approved in {MM/YYYY}.
Danish: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebotreated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogreltreated group.
Danish: Antallet af patienter, som oplevede det primære endpoint [kardiovaskulært dødsfald, myokardieinfarkt, slagtilfælde eller refraktær iskæmi] var 1.035 (16,5 %) i clopidogrelgruppen og 1.187 (18,8 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI: 6 %-21 %; p=0,00005) for clopidogrelgruppen.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva Generics B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Teva Generics B.V.
English: • Severe liver impairment.
Danish: • Stærkt nedsat leverfunktion.
English: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Danish: Hos patienter med akut koronarsyndrom: - Akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker): Behandling med clopidogrel bør indledes med en enkelt initialdosis på 300 mg, hvorefter behandlingen består af 75 mg en gang daglig (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg/dag).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 film-coated tablets)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERPAKNING (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 filmovertrukne tabletter)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En filmovertrukken tablet indeholder 75 mg clopidogrel (som hydrochlorid) Hjælpestoffer:
English: Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Danish: Samtidig indgift af heparin havde ingen virkning på den hæmning af trombocytaggregationen, som clopidogrel inducerer.
English: After repeated doses of 75 mg clopidogrel per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.
Danish: Efter gentagen dosering med clopidogrel 75 mg daglig i 10 dage svarede den ADP-inducerede trombocytaggregation hos patienter med alvorligt nedsat leverfunktion til den, der blev set hos raske forsøgspersoner.
English: Poor metabolism: CYP2C19*2/*2, *2/*3 or *3/*3
Danish: Moderat metabolisme: CYP2C19*1/*2 eller *1/*3 Ringe metabolisme: CYP2C19*2/*2, *2/*3 eller
English: EXPIRY DATE
Danish: UDLØBSDATO Udløbsdato {MM/ÅÅÅÅ}
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Teva Generics B.V..
Danish: Som forholdsregel bør amning ophøre under behandling med Clopidogrel Teva Generics B.V..
English: Published frequencies for the common CYP2C19 phenotypes and genotypes are listed in the table below.
Danish: I tabellen nedenfor ses frekvenserne for de almindelige CYP2C19fænotyper og -genotyper.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Generics B.V.:
Danish: : Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til din læge, før du tager Clopidogrel Teva Generics B.V.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 75 mg clopidogrel (som hydrochlorid).
English: • Pharmacogenetics
Danish: y Farmakogenetik
English: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Danish: : Almindelige bivirkninger (hos 1 til 10 patienter ud af 100 patienter): Diaré, mavesmerter fordøjelsesbesvær eller halsbrand,
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Danish: Patienterne fik clopidogrel (300 mg initialdosis efterfulgt af 75 mg daglig, n=1.752) eller placebo (n=1.739) begge i kombination med ASA (150-325 mg som initialdosis, herefter 75-162 mg dagligt), et fibrinolytisk middel samt heparin, når det var hensigtsmæssigt.
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Danish: Mave-tarmkanalen Gastrointestinal blødning, diarré, mavesmerter, dyspepsi
English: Danmark Teva Denmark A.S. Tlf: +45 44 98 55 11
Danish: Tlf: +45 44 98 55 11
English: Some other medicines may influence the use of Clopidogrel Teva Generics B.V. or vice versa.
Danish: Visse andre typer medicin kan påvirke brugen af Clopidogrel Teva Generics B.V.
English: Bleeding and haematological disorders
Danish: Blødning og hæmatologiske sygdomme
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: INDEHAVERE AF VIRKSOMHEDSGODKENDELSER ANSVARLIGE FOR BATCHFRIGIVELSE
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Danish: Efter gentagen dosering med clopidogrel 75 mg daglig var hæmningen af ADP-induceret trombocytaggregation lavere (25 %) hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance 5-15 ml/min) end der, der blev set hos raske forsøgspersoner.
English: Teva Nederland B.V. Tel: +31 (0) 800 0228400
Danish: Tel: +31 (0) 800 0228400
English: Hydrogenated castor oil
Danish: Hydrogeneret ricinusolie
English: If you experience prolonged bleeding when taking Clopidogrel Teva Generics B.V.
Danish: Hvis du får langvarige blødninger, mens du tager Clopidogrel Teva Generics B.V.
English: Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel
Danish: 75 mg filmovertrukne tabletter Clopidogrel
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Indenfor hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
English: Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Danish: Der er begrænset erfaring med behandling af patienter med nyresygdom.
English: Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.
Danish: Æsker med 28, 30, 50, 56, 84, 90 eller 100 filmovertrukne tabletter i blisterpakning eller æsker med 28x1, 28x1 (kalenderpakning), 30x1, 50x1, 56x1, 84x1, 90x1 og 100x1 filmovertrukne tabletter i perforerede enhedsdosisblistere.
English: If you take more Clopidogrel Teva Generics B.V. than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: : Kontakt din læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister containing 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in a carton.
Danish: Blisterkort af OPA/Al/PVC-Al i æsker med 28, 30, 50, 56, 84, 90 og 100 filmovertrukne tabletter eller perforerede enhedsdosisblistere af OPA/Al/PVC-Al indeholdende 28x1, 28x1 (kalenderpakning), 30x1, 50x1, 56x1, 84x1, 90x1 og 100x1 filmovertrukne tabletter i kartonæsker.
English: As a precaution concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see sections 4.4 and 5.2).
Danish: Som forholdsregel frarådes samtidig anvendelse af lægemidler, der hæmmer CYP2C19 (se pkt.
English: Mon Tue Wed Thu Fri Sat Sun
Danish: Man Tirs Ons Tors Fre Lør Søn
English: Recent ischaemic stroke
Danish: Nyligt iskæmisk slagtilfælde
English: Do not take Clopidogrel Teva Generics B.V.
Danish: Tag ikke Clopidogrel Teva Generics B.V.
English: Each film-coated tablet contains 13 mg hydrogenated castor oil.
Danish: En filmovertrukken tablet indeholder 13 mg hydrogeneret ricinusolie Alle hjælpestoffer er anført under pkt.
English: ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Danish: Imidlertid fik de patienter, som indgik i kliniske forsøg med clopidogrel, en lang række ledsagende lægemidler, såsom diuretika, beta-blokkere, ACE-hæmmere, calciumantagonister, kolesterolsænkende midler, dilatatorer med effekt på koronarkarrene, antidiabetika (inklusive insulin), antiepileptika samt GPIIb/IIIa-hæmmere, uden at der blev påvist klinisk signifikante uønskede interaktioner.
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Danish: En filmovertrukken tablet indeholder 75 mg clopidogrel (som
English: Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Danish: Før planlagt kirurgi og før ordination af nye lægemidler bør patienten informere sin læge og tandlæge om, at de tager clopidogrel.
English: If you forget to take Clopidogrel Teva Generics B.V.
Danish: Hvis du har glemt at tage Clopidogrel Teva Generics B.V.
English: The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
Danish: segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker), som indfandt sig inden for 24 timer efter starten på den seneste periode med brystsmerter eller symptomer, der svarede til iskæmi.
English: Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Danish: Gentagne doser på 75 mg/dag hæmmede i væsentlig grad den trombocytaggregation, som ADP inducerer fra den første dag.
English: Like all medicines, Clopidogrel Teva Generics B.V. can cause side effects, although not everybody gets them.
Danish: have bivirkninger, selvom ikke alle får bivirkninger.
English: What Clopidogrel Teva Generics B.V. contains - The active substance is clopidogrel.
Danish: indeholder - Det aktive stof er clopidogrel.
English: What Clopidogrel Teva Generics B.V. looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Danish: De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
English: Take special care with Clopidogrel Teva Generics B.V.
Danish: Vær ekstra forsigtig med at bruge Clopidogrel Teva Generics B.V.
English: Other side effects reported with Clopidogrel Teva Generics B.V. are:
Danish: Øvrige bivirkninger rapporteret for Clopidogrel Teva Generics B.V.
English: System Organ Class
Danish: Systemorganklasse Almindelig Ikke almindelig Sjælden
English: Medicinal product subject to medical prescription.
Danish: tilhører en gruppe medicin, der kaldes blodfortyndende medicin.
English: Keep out of the reach and sight of children.
Danish: må ikke gives til børn og unge.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects')
Danish: Hvis du er bekymret over blødningen, skal du omgående kontakte din skal du fortælle det til din læge eller på apoteket, hvis du oplever bivirkninger, der ikke står i afsnit 4 'BIVIRKNINGER' i denne indlægsseddel, eller hvis du oplever, at en bivirkning
English: HOW TO TAKE CLOPIDOGREL TEVA GENERICS B.V.
Danish: Brug af Clopidogrel Teva Generics B.V.
English: INFORMATION IN BRAILLE Clopidogrel Teva Generics B.V. 75 mg
Danish: INFORMATION I BRAILLE-SKRIFT Clopidogrel Teva Generics B.V.
English: BEFORE YOU TAKE CLOPIDOGREL TEVA GENERICS B.V.
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE CLOPIDOGREL TEVA GENERICS B.V.
English: Musculoskeletal, connective tissue and bone disorders
Danish: Knogler, led, muskler og bindevæv
English: Excipients
Danish: Øjne
English: The PSUR submission schedule for Clopidogrel Teva Generics B.V. should follow the PSURs submission schedule for the reference medicinal product.
Danish: Hvis du vil have yderligere oplysninger om Clopidogrel Teva Generics B.V., skal du henvende dig til den lokale repræsentant:
English: Taking Clopidogrel Teva Generics B.V. with food and drink Clopidogrel Teva Generics B.V. may be taken with or without food.
Danish: sammen med mad og drikke Clopidogrel Teva Generics B.V.
English: - a proton pump inhibitor (e.g, omeprazole) for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections, - cimetidine, medicine to treat upset stomach, - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy, - ticlopidine, other antiplatelet agent.
Danish: − fluconazol, voriconazol, ciprofloxacin eller chloramphenicol, der anvendes til behandling af bakterie- og svampeinfektioner
English: 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Tabletkerne:
English: National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder sikrer med referencemedlemsstaten som koordinerende instans, når dette er relevant, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: Annex III Conditions of the marketing authorisation
Danish: Betingelser for markedsføringstilladelserne
English: A case-control study shall be performed to further investigate the possibility of an association between pholcodine use and NMBA-related anaphylactic reactions.
Danish: Der udføres en case-kontrolundersøgelse for yderligere at klarlægge den mulige sammenhæng mellem brug af pholcodin og NMBA-relateret anafylaksi.
English: The final study report should be submitted to the National Competent Authorities by December 2016.
Danish: Den endelige undersøgelsesrapport skal forelægges for CHMP inden udgangen af december 2016.
English: A draft protocol should be submitted to CHMP for assessment and approval within 3 months of the Commission Decision.
Danish: Protokoludkast til undersøgelsen skal forelægges for CHMP til vurdering og godkendelse senest 3 måneder efter Kommissionens afgørelse.
English: Absolute bioavailability is greater than 80%.
Danish: Den absolutte biotilgængelighed er større end 80%.
English: In particular, patients have experienced the following serious side effects:
Danish: Patienterne har især oplevet følgende alvorlige bivirkninger:
English: Date of first authorisation: 26 March 2012 Date of latest renewal: 17 February 2017
Danish: Dato for første tilladelse: 26 marts 2012 Dato for seneste fornyelse: 17 februar 2017
English: This is to check that your liver is working normally.
Danish: Dette sker for at checke, at din lever fungerer normalt.
English: OTHER (FOR CALENDARISED PACKS)
Danish: ANDET (TIL KALENDERPAKNING)
English: 31-546, Krakow Poland
Danish: 31-546, Krakow Polen