FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) plus ASA (75-325 mg once daily) or ASA alone (N=6,303), (75-325 mg once daily) and other standard therapies.
Danish: Patienterne blev randomiseret til clopidogrel (300 mg initial støddosis efterfulgt af 75 mg/dag, N = 6.259) plus ASA (75-325 mg en gang daglig) eller ASA alene (N = 6.303), (75-325 mg en gang daglig) i kombination anden standardbehandling.
English: • If you suffer from severe kidney disease.
Danish: • hvis du lider af en alvorlig nyresygdom.
English: The lethal dose of acetylsalicylic acid is 25-30 g. Plasma salicylate concentrations above 300 mg/l (1.67 mmol/l) suggest intoxication.
Danish: Plasmasalicylatkoncentrationer over 300 mg/l (1,67 mmol/l) tyder på forgiftning.
English: Titanium dioxide (E171) Quinoline yellow aluminium lake (E104) Talc
Danish: Quinolin yellow aluminium lake (E104) Talcum
English: Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), quinoline yellow aluminium lake (E104), talc, maltodextrin, medium chain triglycerides and iron oxide yellow (E172).
Danish: Tabletovertræk: hypromellose, polydextrose, titandioxid (E171), quinolin yellow aluminium lake (E104), talcum, maltodextrin, triglycerider, middelkædelængde og gul jernoxid (E172).
English: • probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
Danish: • probenecid, benzbromaron eller sulfipyrazon, lægemidler til behandling af urinsur gigt.
English: White HDPE multi-layer bottles and green polypropylene (PP) child-resistant closures with dessicant.
Danish: Hvide HDPE-tabletbeholdere i flere lag og børnesikrede lukker af grøn polypropylen (PP) med tørremiddel.
English: Light pink to pink, film-coated capsule shaped tablets.
Danish: Svagt lyserøde til lyserøde, filmovertrukne tabletter.
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Danish: Der er dog foretaget et antal retrospektive analyser for at evaluere denne effekt hos patienter i behandling med clopidogrel, for hvem der foreligger resultater af genotyping: CURE (n = 2721), CHARISMA (n = 2428),
English: Other medicines and Clopidogrel/Acetylsalicylic acid Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Clopidogrel/Acetylsalicylsyre Teva Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: The safety of the concomitant administration of the combination of clopidogrel/acetylsalicylic acid with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Danish: Sikkerheden ved samtidig administration af kombinationen clopidogrel/acetylsalicylsyre og andre trombolytika er ikke fastlagt, og der skal derfor udvises forsigtighed (se pkt.
English: Due to the presence of ASA, the combination of clopidogrel/acetylsalicylic acid is contraindicated during the third trimester of pregnancy.
Danish: Da kombinationen clopidogrel/acetylsalicylsyre indeholder ASA, er det kontraindiceret i graviditetens tredje trimester.
English: Clopidogrel/Acetylsalicylic acid Teva contains lactose.
Danish: Clopidogrel/Acetylsalicylsyre Teva indeholder lactose.
English: Breast-feeding should be discontinued during treatment with the combination of clopidogrel/acetylsalicylic acid.
Danish: Som forholdsregel bør amning ophøre under behandling med kombinationen clopidogrel/acetylsalicylsyre.
English: This leaflet was last revised in <MM/YYYY> Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Clopidogrel/Acetylsalicylsyre Teva på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: There is no information concerning overdose with the combination of clopidogrel/acetylsalicylic acid.
Danish: Der findes ingen information vedrørende overdosering af kombinationen clopidogrel/acetylsalicylsyre.
English: • muscular pain
Danish: • muskelsmerter
English: You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Teva.
Danish: Du skal holde op med at tage andre lægemidler, der indeholder clopidogrel, mens du tager Clopidogrel/Acetylsalicylsyre Teva.
English: Film-coated tablet 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter
English: • skin allergy
Danish: • allergiske hudreaktioner
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Danish: heparin, ATC-kode: B01AC30.
English: There are no fertility data with the combination of clopidogrel/acetylsalicylic acid.
Danish: Der findes ingen fertilitetsdata for kombinationen clopidogrel/acetylsalicylsyre.
English: The combination of clopidogrel/acetylsalicylic acid should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Danish: Kombinationen clopidogrel/acetylsalicylsyre skal anvendes med forsigtighed til patienter i samtidig behandling med glykoprotein IIb/IIIa-hæmmere (se pkt.
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 studiepersoner.
English: • sensation of tingling and numbness.
Danish: • svimmelhed • prikkende fornemmelse og følelsesløshed.
English: Other concomitant therapy with ASA
Danish: Anden samtidig behandling med ASA
English: Acute renal impairment (especially in patients with existing renal impairment, heart decompensation, nephritic syndrome, or concomitant treatment with diuretics)*, glomerulonephritis, blood creatinine increased
Danish: Systemorganklasse Almindelig Ikke almindelig Sjælden Meget sjælden, ikke kendt nedsat nyrefunktion, kardial dekompensation, nefrotisk syndrom eller samtidig behandling med diuretika)* glomerulonefrit, forhøjet blodkreatinin
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Danish: Som forholdsregel frarådes samtidig anvendelse af stærke eller moderate CYP2C19-hæmmere (se pkt.
English: Do not take Clopidogrel/Acetylsalicylic acid Teva
Danish: Tag ikke Clopidogrel/Acetylsalicylsyre Teva
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Danish: Samtidig administration af kombinationen clopidogrel/acetylsalicylsyre og orale antikoagulantia kan ikke anbefales, da det kan øge blødningsintensiteten (se pkt.
English: GI undesirable effects including stomach pain, heartburn, nausea, vomiting, and GI bleeding may occur.
Danish: Gastrointestinale (GI) bivirkninger, der omfatter mavesmerter, halsbrand, kvalme, opkastning og gastrointestinal blødning, kan forekomme.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: Each film-coated tablet contains 117.8 mg of lactose (as lactose monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 117,8 mg lactose (som lactosemonohydrat)
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, gastro-duodenal ulcer/perforations*,
Danish: Øvre gastrointestinale lidelser (øsofagitis, øsofageal ulceration, perforation, erosiv gastritis, erosiv duodenitis, gastroduodenal ulcus/perforationer)*,
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia, acquired haemophilia A.
Danish: 4.4), aplastisk anæmi, pancytopeni, agranulocytose, alvorlig trombocytopeni, granulocytopeni, anæmi, erhvervet hæmofili A.
English: • If you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for clopidogrel, acetylsalicylsyre eller et af de øvrige indholdsstoffer i
English: Consistent with the above results, in a meta analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Danish: I overensstemmelse med resultaterne ovenfor, blev det vist i en metaanalyse af 6 studier med 335 clopidogrelbehandlede ved steady-state, at eksponeringen for den aktive metabolit nedsattes med 28 % for personer med moderat metabolisme, og 72 % for personer med ringe metabolisme.
English: Each film-coated tablet contains 102.6 mg of lactose (as lactose monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 102,06 mg lactose (som lactosemonohydrat)
English: Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/75 mg dose.
Danish: Clopidogrel/Acetylsalicylsyre Teva bør gives som en enkelt daglig dosis på 75 mg/75 mg.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter):
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.4).
Danish: Samtidig administration af kombinationen clopidogrel/acetylsalicylsyre og orale antikoagulantia kan ikke anbefales, da det kan øge blødningstendensen (se pkt.
English: Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/100 mg dose.
Danish: Clopidogrel/Acetylsalicylsyre Teva bør gives som en enkelt daglig dosis på 75 mg/100 mg.
English: Anaphylactic shock*, serum sickness, anaphylactoid reactions, aggravation of allergic symptoms of food allergy*, cross-reactive drug hypersensitivity
Danish: Anafylaktisk shock*, serumsygdom, anafylaktoide reaktioner, forværring af symptomer på fødeallergi*, krydsallergiske lægemiddelreaktioner mellem thienopyridiner (såsom ticlopidin, prasugrel), (se pkt.
English: Driving and using machines Clopidogrel/Acetylsalicylic acid Teva should not affect your ability to drive or to use machines.
Danish: Det er usandsynligt, at Clopidogrel/Acetylsalicylsyre Teva vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
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 studiepersoner med alvorlig nyresygdom (kreatininclearance 5-15 ml/min) end den, der blev set hos raske studiepersoner.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Clopidogrel/Acetylsalicylsyre Teva, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: What you need to know before you take Clopidogrel/Acetylsalicylic acid Teva
Danish: Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Teva
English: Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms.
Danish: Selvom mindre GI-symptomer såsom dyspepsi er almindelige og kan forekomme på alle tidspunkter i behandlingen.
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information reported in published information for ASA (frequency “not known”).
Danish: * Rapporteret i publiceret information for ASA (frekvens ”ikke kendt”(.
English: • kidney disease
Danish: • nyresygdom
English: In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in reproductive toxicity (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet efter administration af en prostaglandinsyntesehæmmer (se pkt.
English: Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), talc, maltodextrin, medium chain triglycerides, iron oxide yellow (E172).
Danish: Tabletovertræk: hypromellose, polydextrose, titandioxide (E171), talcum, maltodextrin, triglycerider, middelkædelængde, gul jernoxid (E172), carmin (E120), rød jernoxid (E172).
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • skal du fortælle lægen, at du er i behandling med Clopidogrel/Acetylsalicylsyre Teva: hvis du skal have foretaget en planlagt operation (også hos tandlægen).
English: The combination of clopidogrel/acetylsalicylic acid must not be used in patients with severe renal impairment (see section 4.3).
Danish: Kombinationen clopidogrel/acetylsalicylsyre må ikke anvendes til patienter med stærkt nedsat leverfunktion (se pkt.
English: Medium chain triglycerides Iron oxide yellow (E172) Carmine (E120) Iron oxide red (E172)
Danish: Triglycerider, middelkædelængde Jernoxid, gul (E 172) Carmin (E120)
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg
English: • burning in stomach and/or oesophagus
Danish: • brændende fornemmelse i maven og/eller spiserøret
English: Eye disorders Ear and labyrinth disorders
Danish: Øre og labyrint
English: Gastrointestinal disorders
Danish: Mave-tarm-kanalen Gastrointestinal
English: • omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach,
Danish: • omeprazol, esomeprazol eller cimetidin til behandling af for meget mavesyre.
English: Hypoglycaemia*, gout* (see section
Danish: Hypoglykæmi*, urinsur
English: No clinical data on exposure to the combination of clopidogrel/acetylsalicylic acid during pregnancy are available.
Danish: Der er ingen data fra anvendelse af kombinationen clopidogrel/acetylsalicylsyre til gravide kvinder.
English: Medium chain triglycerides Iron oxide yellow (E172)
Danish: Triglycerider, middelkædelængde Jernoxid, gul (E 172)
English: While you are taking Clopidogrel/Acetylsalicylic acid Teva:
Danish: Mens du er i behandling med Clopidogrel/Acetylsalicylsyre Teva:
English: • ulcer perforation
Danish: • forstoppelse
English: • Severe hepatic impairment.
Danish: • Svært nedsat nyrefunktion.
English: Croscarmellose sodium Hydrogenated vegetable oil Sodium lauril sulfate
Danish: Croscarmellosenatrium Hydrogeneret vegetabilsk olie.
English: Clopidogrel/Acetylsalicylic acid Teva contains lactose If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (f.eks. lactose).
English: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary
Danish: • udsætte fostret for: - Kardiopulmonal toksicitet (med præmatur lukning af ductus arteriosus og pulmonalhypertension); - Renal dysfunktion, der kan udvikle sig til nyresvigt med oligo-hydroamniose.
English: • ticlopidine, other antiplatelet agent.
Danish: • ticlopidin, der er et andet lægemiddel mod dannelse af blodpropper.
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets are yellow, film-coated capsule shaped tablets.
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg filmovertrukne tabletter er gule, filmovertrukne, kapselformede tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for blisters
Danish: YDERKARTON til blisters
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets are light pink to pink, film-coated capsule shaped tablets.
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter er svagt lyserøde til lyserøde, filmovertrukne, kapselformede tabletter.
English: Very rare, not known colitis (including ulcerative or lymphocytic colitis), upper gastro-intestinal symptoms* such as gastralgia (see section 4.4), stomatitis.
Danish: Systemorganklasse Almindelig Ikke almindelig Sjælden Meget sjælden, ikke kendt nedre gastrointestinale lidelser (små [jejunum og ileum] og store [tyktarm og endetarm] tarmsår, colitis og tarmperforation)*, øvre gastrointestinale lidelser* såsom gastralgi (se pkt.
English: Metabolism and nutrition disorders
Danish: Metabolisme og
English: How to take Clopidogrel/Acetylsalicylic acid Teva
Danish: Sådan skal du tage Clopidogrel/Acetylsalicylsyre Teva
English: Polydextrose
Danish: Trombolytika
English: What Clopidogrel/Acetylsalicylic acid Teva contains
Danish: Clopidogrel/Acetylsalicylsyre Teva indeholder:
English: Contact your doctor immediately if you experience: • fever, signs of infection or extreme tiredness.
Danish: • feber, tegn på infektion eller ekstrem træthed.
English: Clopidogrel/Acetylsalicylic acid Teva is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: Clopidogrel/Acetylsalicylsyre Teva tages af voksne for at forebygge dannelse af blodpropper i blodårer, som er blevet stive.
English: Very rare, not known enzymes*, abnormal liver function test
Danish: Systemorganklasse Almindelig Ikke almindelig Sjælden Meget sjælden, ikke kendt ernæring gigt* (se pkt.
English: • If you are allergic to other products called non-steroidal anti-inflammatory products usually used to treat painful and/or inflammatory conditions of muscles or joints.
Danish: • hvis du er allergisk over for medicin, der kaldes non-steroide antiinflammatoriske stoffer
English: carmine (E120), iron oxide red (E172).
Danish: Rød jernoxid (E172)
English: What Clopidogrel/Acetylsalicylic acid Teva is and what it is used for What you need to know before you take Clopidogrel/Acetylsalicylic acid Teva How to take Clopidogrel/Acetylsalicylic acid Teva
Danish: Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Teva Sådan skal du tage Clopidogrel/Acetylsalicylsyre Teva Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter
English: • Hepatic impairment
Danish: • perforeret mavesår
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter Clopidogrel/acetylsalicylsyre
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/acetylsalicylsyre
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Danish: Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre (ASA).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Danish: Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre (ASA).
English: • oral anticoagulants, medicines used to reduce blood clotting,
Danish: • medicin, som modvirker blodets størkning (blodfortyndende medicin, orale antikoagulantia)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Danish: Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Danish: Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre.
English: • changes in taste of foods
Danish: • smagsforstyrrelser
English: Posology
Danish: Hæmaturi
English: • rashes
Danish: • kløe
English: 2 capsules
Danish: 2 kapsler
English: Sachet (PET/Alu/LLDPE)
Danish: Foliepose (PET/alu/LLDPE)
English: 125 mg Powder for oral suspension
Danish: Emend 125 mg Pulver til oral suspension
English: 1 capsule (125 mg) + 2 capsules (80 mg)
Danish: 1 kapsel (125 mg) + 2 kapsler (80 mg)
English: 125 mg + 80 mg
Danish: Emend 125 mg + 80 mg
English: Capsule, hard Oral use
Danish: Kapsel, hård
English: 1 sachet + 2 dispensers + 1 cap + 1 mixing cup
Danish: 1 foliepose + 2 dispenseringssprøjter + 1 låg + 1 blandebæger
English: (Invented) name Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration
English: The marketing authorisation holders should provide convincing and robust data to identify a patient population in which the clinical benefits of ketoconazole-containing products for oral use clearly outweigh the risks.
Danish: Indehaverne af markedsføringstilladelse fremlægger overbevisende og pålidelige data, der udpeger en patientpopulation, hos hvilken de kliniske fordele ved lægemidler indeholdende ketoconazol til oral anvendelse klart opvejer risiciene.
English: Conditions for lifting the suspension of the Marketing Authorisation(s)
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: Annex III Conditions for lifting the suspension of the Marketing Authorisation(s)
Danish: Bilag III Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: What is Cokiera?
Danish: Hvad er Cokiera?
English: It was to be available as tablets.
Danish: Det var hensigten, at det skulle markedsføres som tabletter.
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: Lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.
English: What was Cokiera expected to be used for?
Danish: Hvad forventedes Cokiera anvendt til?
English: Ritonavir itself does not have an antiviral effect on hepatitis C virus.
Danish: Ritonavir har i sig selv ikke nogen antiviral effekt på hepatitis C-virusset.