MAREVAN TABLET 1 mg (NEW ZEALAND)

Indications

For:

• Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.

• Prophylaxis of thromboembolism after insertion of prosthetic heart valves.

• Prophylaxis and treatment of venous thrombosis and pulmonary embolism.

• Transient attacks of cerebral ischaemia.

Contraindications

Warfarin is contraindicated in:

• Known hypersensitivity to warfarin or to any of the excipients

• Haemorrhagic stroke

• Clinical significant bleeding

• Within 72 hours of major surgery with risk of severe bleeding

• Within 48 hours postpartum

• Pregnancy (first and third trimesters, see section Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant use of fibrinolytic drugs such as streptokinase and alteplase and drugs where interactions may lead to a significantly increased risk of bleeding (see section Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Bacterial endocarditis

• Severe hepatic or renal disease

• Actual or potential haemorrhagic conditions, e.g. haemophilia, hypertension, gastrointestinal ulcerations, threatened abortion.

Dosage and Administration

For oral use.

Adults:

The typical induction dose is 10 mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9 mg taken at the same time each day. The exact maintenance dose depends on the prothrombin time or other appropriate coagulation tests.

Control tests should be made at regular intervals and the warfarin dosage should be adjusted in accordance with the results obtained. Once the maintenance dose is established, it is rarely necessary to alter it.

In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together.

Concomitant heparin therapy affects the results of control tests and should be discontinued at least 6 h before the first test is carried out.

Children:

Dosage for children has not been established.

Elderly:

As for adults, but dosage may need to be lowered.

Renal impairment:

Caution is advised in patients with renal impairment (see section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment:

Caution is advised in patients with hepatic impairment (see section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).