PLAVIX 75mg Film-coated tablet (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Sanofi Pharma Bristol-Myers Squibb SNC |
|---|---|
| Διεύθυνση | 174 Avenue de France, F-75013, Paris, France |
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Name of the medicinal product
Plavix 75 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). Excipients: each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil. For a full list of excipients, ...
Pharmaceutical form
Film-coated tablet. Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.
Therapeutic indications
Prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less ...
Posology and method of administration
Posology Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg. In patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Severe hepatic impairment. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Special warnings and precautions for use
Bleeding and haematological disorders Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever ...
Interaction with other medicinal products and other forms of interaction
Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4). Although the administration ...
Fertility, pregnancy and lactation
Pregnancy As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure. Animal studies do not indicate ...
Effects on ability to drive and use machines
Clopidogrel has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more. Overall, clopidogrel 75 mg/day ...
Overdose
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleedings are observed. No antidote ...
Pharmacodynamic properties
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin ATC Code: B01AC04 Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel must be ...
Pharmacokinetic properties
Absorption After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. Mean peak plasma levels of unchanged clopidogrel (approximately 2.2 -2.5 ng/ml after a single 75 mg oral ...
Preclinical safety data
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes. These occurred at doses representing at least 25 times the exposure seen in humans receiving the ...
List of excipients
Core: Mannitol (E421) Macrogol 6000 Microcrystalline cellulose Hydrogenated castor oil Low substituted hydroxypropylcellulose Coating: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
PVC/PVDC/Aluminium blisters in cardboard cartons containing 30 film-coated tablets.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Sanofi Pharma Bristol-Myers Squibb SNC, 174 Avenue de France, F-75013, Paris, France
Marketing authorization number(s)
EU/1/98/069/005a Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 July 1998 Date of latest renewal: 15 July 2008
Date of revision of the text
27 May 2011