natgillin/translations-raw huggingface dataset:
• acetylsalicylsyre eller andre non-steroide antiinflammatoriske stoffer (NSAID), der sædvanligvis anvendes til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led (gigt).
• ASA or another non-steroidal anti-inflammatory medicine usually used to treat painful and/or inflammatory conditions of muscle or joints,
Hvide HDPE-tabletbeholdere og børnesikrede lukker af grøn polypropylen (PP) med tørremiddel.
White HDPE bottles and green polypropylene (PP) child-resistant closures with dessicant.
Tabletkernen: lactosemonohydrat, mikrokrystallinsk cellulose, hydroxypropylcellulose 100 cP, crospovidon (type A), stearinsyre, croscarmellosenatrium, hydrogeneret vegetabilsk olie og natriumlaurilsulfat.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose 100 cP, crospovidone (type A), stearic acid, croscarmellose sodium, hydrogenated vegetable oil and sodium lauril sulfate.
Clopidogrel/Acetylsalicylsyre Teva er et fast-dosis kombinationspræparat til fortsat behandling ved:
Clopidogrel/Acetylsalicylic acid Teva is a fixed-dose combination medicinal product for continuation of therapy in:
Clopidogrel/Acetylsalicylsyre Teva udleveres i blisters i pakningsstørrelser på 10, 14, 28, 30, 50, 90 og 100 filmovertrukne tabletter, eller i tabletbeholdere i en pakningsstørrelse på 30 filmovertrukne tabletter.
Clopidogrel/Acetylsalicylic acid Teva is supplied in blisters in pack sizes of 10, 14, 28, 30, 50, 90 and 100 film-coated tablets or in bottles in a pack size of 30 film-coated tablets.
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.
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.
• hvis du lider af en alvorlig nyresygdom.
• If you suffer from severe kidney disease.
Plasmasalicylatkoncentrationer over 300 mg/l (1,67 mmol/l) tyder på forgiftning.
The lethal dose of acetylsalicylic acid is 25-30 g. Plasma salicylate concentrations above 300 mg/l (1.67 mmol/l) suggest intoxication.
Quinolin yellow aluminium lake (E104) Talcum
Titanium dioxide (E171) Quinoline yellow aluminium lake (E104) Talc
Tabletovertræk: hypromellose, polydextrose, titandioxid (E171), quinolin yellow aluminium lake (E104), talcum, maltodextrin, triglycerider, middelkædelængde og gul jernoxid (E172).
Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), quinoline yellow aluminium lake (E104), talc, maltodextrin, medium chain triglycerides and iron oxide yellow (E172).
• probenecid, benzbromaron eller sulfipyrazon, lægemidler til behandling af urinsur gigt.
• probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
Hvide HDPE-tabletbeholdere i flere lag og børnesikrede lukker af grøn polypropylen (PP) med tørremiddel.
White HDPE multi-layer bottles and green polypropylene (PP) child-resistant closures with dessicant.
Svagt lyserøde til lyserøde, filmovertrukne tabletter.
Light pink to pink, film-coated capsule shaped tablets.
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),
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.
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.
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.
Sikkerheden ved samtidig administration af kombinationen clopidogrel/acetylsalicylsyre og andre trombolytika er ikke fastlagt, og der skal derfor udvises forsigtighed (se pkt.
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).
Da kombinationen clopidogrel/acetylsalicylsyre indeholder ASA, er det kontraindiceret i graviditetens tredje trimester.
Due to the presence of ASA, the combination of clopidogrel/acetylsalicylic acid is contraindicated during the third trimester of pregnancy.
Clopidogrel/Acetylsalicylsyre Teva indeholder lactose.
Clopidogrel/Acetylsalicylic acid Teva contains lactose.
Som forholdsregel bør amning ophøre under behandling med kombinationen clopidogrel/acetylsalicylsyre.
Breast-feeding should be discontinued during treatment with the combination of clopidogrel/acetylsalicylic acid.
Du kan finde yderligere oplysninger om Clopidogrel/Acetylsalicylsyre Teva på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
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.
Der findes ingen information vedrørende overdosering af kombinationen clopidogrel/acetylsalicylsyre.
There is no information concerning overdose with the combination of clopidogrel/acetylsalicylic acid.
• muskelsmerter
• muscular pain
Du skal holde op med at tage andre lægemidler, der indeholder clopidogrel, mens du tager Clopidogrel/Acetylsalicylsyre Teva.
You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Teva.
14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter
Film-coated tablet 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets
• allergiske hudreaktioner
• skin allergy
heparin, ATC-kode: B01AC30.
5.1 Pharmacodynamic properties Pharmacotherapeutic group: platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Der findes ingen fertilitetsdata for kombinationen clopidogrel/acetylsalicylsyre.
There are no fertility data with the combination of clopidogrel/acetylsalicylic acid.
Kombinationen clopidogrel/acetylsalicylsyre skal anvendes med forsigtighed til patienter i samtidig behandling med glykoprotein IIb/IIIa-hæmmere (se pkt.
The combination of clopidogrel/acetylsalicylic acid should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
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.
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.
• svimmelhed • prikkende fornemmelse og følelsesløshed.
• sensation of tingling and numbness.
Anden samtidig behandling med ASA
Other concomitant therapy with ASA
Systemorganklasse Almindelig Ikke almindelig Sjælden Meget sjælden, ikke kendt nedsat nyrefunktion, kardial dekompensation, nefrotisk syndrom eller samtidig behandling med diuretika)* glomerulonefrit, forhøjet blodkreatinin
Acute renal impairment (especially in patients with existing renal impairment, heart decompensation, nephritic syndrome, or concomitant treatment with diuretics)*, glomerulonephritis, blood creatinine increased
Som forholdsregel frarådes samtidig anvendelse af stærke eller moderate CYP2C19-hæmmere (se pkt.
As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Tag ikke Clopidogrel/Acetylsalicylsyre Teva
Do not take Clopidogrel/Acetylsalicylic acid Teva
Samtidig administration af kombinationen clopidogrel/acetylsalicylsyre og orale antikoagulantia kan ikke anbefales, da det kan øge blødningsintensiteten (se pkt.
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).
Gastrointestinale (GI) bivirkninger, der omfatter mavesmerter, halsbrand, kvalme, opkastning og gastrointestinal blødning, kan forekomme.
GI undesirable effects including stomach pain, heartburn, nausea, vomiting, and GI bleeding may occur.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 117,8 mg lactose (som lactosemonohydrat)
Each film-coated tablet contains 117.8 mg of lactose (as lactose monohydrate).
Øvre gastrointestinale lidelser (øsofagitis, øsofageal ulceration, perforation, erosiv gastritis, erosiv duodenitis, gastroduodenal ulcus/perforationer)*,
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, gastro-duodenal ulcer/perforations*,
4.4), aplastisk anæmi, pancytopeni, agranulocytose, alvorlig trombocytopeni, granulocytopeni, anæmi, erhvervet hæmofili A.
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia, acquired haemophilia A.
• hvis du er allergisk over for clopidogrel, acetylsalicylsyre eller et af de øvrige indholdsstoffer i
• If you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
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.
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.
Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 102,06 mg lactose (som lactosemonohydrat)
Each film-coated tablet contains 102.6 mg of lactose (as lactose monohydrate).
Clopidogrel/Acetylsalicylsyre Teva bør gives som en enkelt daglig dosis på 75 mg/75 mg.
Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/75 mg dose.
Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter):
Common side effects (may affect up to 1 in 10 people):
Samtidig administration af kombinationen clopidogrel/acetylsalicylsyre og orale antikoagulantia kan ikke anbefales, da det kan øge blødningstendensen (se pkt.
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).
Clopidogrel/Acetylsalicylsyre Teva bør gives som en enkelt daglig dosis på 75 mg/100 mg.
Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/100 mg dose.
Anafylaktisk shock*, serumsygdom, anafylaktoide reaktioner, forværring af symptomer på fødeallergi*, krydsallergiske lægemiddelreaktioner mellem thienopyridiner (såsom ticlopidin, prasugrel), (se pkt.
Anaphylactic shock*, serum sickness, anaphylactoid reactions, aggravation of allergic symptoms of food allergy*, cross-reactive drug hypersensitivity
Det er usandsynligt, at Clopidogrel/Acetylsalicylsyre Teva vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
Driving and using machines Clopidogrel/Acetylsalicylic acid Teva should not affect your ability to drive or to use machines.
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.
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.
Hvis du ønsker yderligere oplysninger om Clopidogrel/Acetylsalicylsyre Teva, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Teva
What you need to know before you take Clopidogrel/Acetylsalicylic acid Teva
Selvom mindre GI-symptomer såsom dyspepsi er almindelige og kan forekomme på alle tidspunkter i behandlingen.
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.
* Rapporteret i publiceret information for ASA (frekvens ”ikke kendt”(.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information reported in published information for ASA (frequency “not known”).
• nyresygdom
• kidney disease
Dyrestudier har påvist reproduktionstoksicitet efter administration af en prostaglandinsyntesehæmmer (se pkt.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in reproductive toxicity (see section 5.3).
Tabletovertræk: hypromellose, polydextrose, titandioxide (E171), talcum, maltodextrin, triglycerider, middelkædelængde, gul jernoxid (E172), carmin (E120), rød jernoxid (E172).
Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), talc, maltodextrin, medium chain triglycerides, iron oxide yellow (E172).
• skal du fortælle lægen, at du er i behandling med Clopidogrel/Acetylsalicylsyre Teva: hvis du skal have foretaget en planlagt operation (også hos tandlægen).
• You should tell your doctor if a surgery (including dental) is planned.
Kombinationen clopidogrel/acetylsalicylsyre må ikke anvendes til patienter med stærkt nedsat leverfunktion (se pkt.
The combination of clopidogrel/acetylsalicylic acid must not be used in patients with severe renal impairment (see section 4.3).
Triglycerider, middelkædelængde Jernoxid, gul (E 172) Carmin (E120)
Medium chain triglycerides Iron oxide yellow (E172) Carmine (E120) Iron oxide red (E172)
Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg
Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg
Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg
Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg
• brændende fornemmelse i maven og/eller spiserøret
• burning in stomach and/or oesophagus
Øre og labyrint
Eye disorders Ear and labyrinth disorders
Mave-tarm-kanalen Gastrointestinal
Gastrointestinal disorders
• omeprazol, esomeprazol eller cimetidin til behandling af for meget mavesyre.
• omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach,
Hypoglykæmi*, urinsur
Hypoglycaemia*, gout* (see section
Der er ingen data fra anvendelse af kombinationen clopidogrel/acetylsalicylsyre til gravide kvinder.
No clinical data on exposure to the combination of clopidogrel/acetylsalicylic acid during pregnancy are available.
Triglycerider, middelkædelængde Jernoxid, gul (E 172)
Medium chain triglycerides Iron oxide yellow (E172)
Mens du er i behandling med Clopidogrel/Acetylsalicylsyre Teva:
While you are taking Clopidogrel/Acetylsalicylic acid Teva:
• forstoppelse
• ulcer perforation
• Svært nedsat nyrefunktion.
• Severe hepatic impairment.
Croscarmellosenatrium Hydrogeneret vegetabilsk olie.
Croscarmellose sodium Hydrogenated vegetable oil Sodium lauril sulfate
Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (f.eks. lactose).
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.
• udsætte fostret for: - Kardiopulmonal toksicitet (med præmatur lukning af ductus arteriosus og pulmonalhypertension); - Renal dysfunktion, der kan udvikle sig til nyresvigt med oligo-hydroamniose.
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary
• ticlopidin, der er et andet lægemiddel mod dannelse af blodpropper.
• ticlopidine, other antiplatelet agent.
Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg filmovertrukne tabletter er gule, filmovertrukne, kapselformede tabletter.
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.
YDERKARTON til blisters
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for blisters
Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter er svagt lyserøde til lyserøde, filmovertrukne, kapselformede tabletter.
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.
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.
Very rare, not known colitis (including ulcerative or lymphocytic colitis), upper gastro-intestinal symptoms* such as gastralgia (see section 4.4), stomatitis.
Metabolisme og
Metabolism and nutrition disorders
Sådan skal du tage Clopidogrel/Acetylsalicylsyre Teva
How to take Clopidogrel/Acetylsalicylic acid Teva
Trombolytika
Polydextrose
Clopidogrel/Acetylsalicylsyre Teva indeholder:
What Clopidogrel/Acetylsalicylic acid Teva contains
• feber, tegn på infektion eller ekstrem træthed.
Contact your doctor immediately if you experience: • fever, signs of infection or extreme tiredness.
Clopidogrel/Acetylsalicylsyre Teva tages af voksne for at forebygge dannelse af blodpropper i blodårer, som er blevet stive.
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).
Systemorganklasse Almindelig Ikke almindelig Sjælden Meget sjælden, ikke kendt ernæring gigt* (se pkt.
Very rare, not known enzymes*, abnormal liver function test
• hvis du er allergisk over for medicin, der kaldes non-steroide antiinflammatoriske stoffer
• 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.
Rød jernoxid (E172)
carmine (E120), iron oxide red (E172).
Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylsyre Teva Sådan skal du tage Clopidogrel/Acetylsalicylsyre Teva Bivirkninger
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
Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets
Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets
• perforeret mavesår
• Hepatic impairment
Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter Clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Clopidogrel/Acetylsalicylsyre Teva 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid
Clopidogrel/Acetylsalicylsyre Teva 75 mg/75 mg filmovertrukne tabletter Clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre (ASA).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre (ASA).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
• medicin, som modvirker blodets størkning (blodfortyndende medicin, orale antikoagulantia)
• oral anticoagulants, medicines used to reduce blood clotting,
Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
• smagsforstyrrelser
• changes in taste of foods
Hæmaturi
Posology
• kløe
• rashes
2 kapsler
2 capsules
Foliepose (PET/alu/LLDPE)
Sachet (PET/Alu/LLDPE)
Emend 125 mg Pulver til oral suspension
125 mg Powder for oral suspension
1 kapsel (125 mg) + 2 kapsler (80 mg)
1 capsule (125 mg) + 2 capsules (80 mg)
Emend 125 mg + 80 mg
125 mg + 80 mg
Kapsel, hård
Capsule, hard Oral use
1 foliepose + 2 dispenseringssprøjter + 1 låg + 1 blandebæger
1 sachet + 2 dispensers + 1 cap + 1 mixing cup
Styrke Lægemiddelform Administration
(Invented) name Strength Pharmaceutical form
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.
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.
Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
Conditions for lifting the suspension of the Marketing Authorisation(s)
Bilag III Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
Annex III Conditions for lifting the suspension of the Marketing Authorisation(s)
Hvad er Cokiera?
What is Cokiera?
Det var hensigten, at det skulle markedsføres som tabletter.
It was to be available as tablets.
Lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.
Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Hvad forventedes Cokiera anvendt til?
What was Cokiera expected to be used for?
Ritonavir har i sig selv ikke nogen antiviral effekt på hepatitis C-virusset.
Ritonavir itself does not have an antiviral effect on hepatitis C virus.
Virksomheden fremlagde også resultaterne af en matematisk beregning (modellering og simulering) til forudsigelse af niveauerne af de aktive stoffer og lægemidlets virkning, hvad angår fjernelse af virusset fra blodet under forskellige omstændigheder.
The company also provided results of a mathematical (modelling and simulation) exercise to predict the levels of the active substances and the medicine's effectiveness in clearing the virus from the blood in different circumstances.