WARFARIN Tablet (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Warfarin 0.5 mg Tablets.
Qualitative and quantitative composition
Each tablet contains Warfarin Sodium 0.5 mg. Excipient with known effect: 98.25 mg lactose anhydrous per tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Warfarin 0.5 mg Tablets are white, flat round tablets, with a 7.0 mm diameter, plain on one side and scored on the other, engraved with W above the score and 0.5 underneath. The tablet can be divided ...
Therapeutic indications
Warfarin is indicated for the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. Warfarin is indicated for the prophylaxis after insertion of prosthetic ...
Posology and method of administration
Posology Adults and elderly patients The typical induction dose of warfarin is 10 mg daily for 2 days, but this should be tailored to individual requirements. Baseline prothrombin measurements (PT) should ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Haemorrhagic stroke (see section 4.4 for further details). Clinically significant bleeding. Within 72 hours of ...
Special warnings and precautions for use
Most adverse events reported with warfarin are a result of over anticoagulation therefore it is important that the need for therapy is reviewed on a regular basis and therapy discontinued when no longer ...
Interaction with other medicinal products and other forms of interaction
Warfarin has a narrow therapeutic range and care is required with all concomitant therapy. The individual product information for any new concomitant therapy should be consulted for specific guidance on ...
Pregnancy and lactation
Pregnancy Based on human experience warfarin causes congenital malformations and foetal death when administered during pregnancy. Warfarin is contraindicated in pregnancy in the first and third trimester. ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Infections and infestations: Fever Immune system disorders: Hypersensitivity Nervous system disorders: Cerebral haemorrhage; Cerebral subdural haematoma Vascular disorders: Haemorrhage Respiratory, thoracic ...
Overdose
The benefit of gastric decontamination is uncertain. If the patient presents within 1 hour of ingestion of more than 0.25 mg/kg or more than the patients therapeutic dose, consider activated charcoal (50 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agent (Vitamin K Antagonist) ATC code: B01AA03 Mechanism of action Warfarin is a synthetic anti-coagulant of the coumarin series and acts by inhibiting the synthesis ...
Pharmacokinetic properties
Warfarin is a racemic mixture of the R- and S-enantiomers with the S-enantiomer exhibiting 2-5 times greater anti-coagulant activity than the R-enantiomer in humans, but generally has a more rapid clearance. ...
Preclinical safety data
Warfarin has been shown to be teratogenic in animal studies and has been suspected of causing abnormalities and foetal death when administered during human pregnancy. Warfarin should not be used during ...
List of excipients
Lactose anhydrous Pregelatinised maize starch Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
HDPE bottle with polyester wad and child resistant polypropylene cap. Contents: 21, 28, 50, 56, 100, 112, 200 or 500 tablets. PVC/PVDC-aluminium foil or Aclar/aluminium foil blisters. Contents: 21, 28, ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
Marketing authorization number(s)
PL 31750/0092
Date of first authorization / renewal of the authorization
07/01/2002
Date of revision of the text
07/02/2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
