dabigatran etexilate 75 mg
1 INDICATIONS AND USAGE Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 1.2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days. 1.3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. 1.4 Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery Dabigatran etexilate capsules are indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery. Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Pradaxa (dabigatran etexilate) capsules. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Camber Pharmaceuticals, Inc.
CAPSULE WHITE H D10
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dabigatran etexilate 150 mg
Camber Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DABIGATRAN ETEXILATE 75 mg capsules are cream opaque cap/cream opaque body size '2' HPMC capsules imprinted with 'H' on cap and 'D10' on body with black ink, filled with mixture of off-white to yellowish white pellets. The capsules are supplied in the packages listed: Unit of use bottle of 60 capsules NDC 31722-621-60
DABIGATRAN ETEXILATE 110 mg capsules are cream opaque cap/cream opaque body size ‘1’ HPMC capsules imprinted with ‘H’ on cap and ‘D16’ on body with black ink, filled with mixture of off-white to yellowish white pellets. The capsules are supplied in the packages listed: Unit of use bottle of 60 capsules NDC 31722-666-60 Blister package containing 60 capsules (10 x 6 capsule blister cards) NDC 31722-666-32
DABIGATRAN ETEXILATE 150 mg capsules are cream opaque cap/cream opaque body size '0' HPMC capsules imprinted with 'H' on cap and 'D11' on body with black ink, filled with mixture of off-white to yellowish white pellets. The capsules are supplied in the packages listed: Unit of use bottle of 60 capsules NDC 31722-622-60 Bottles Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture. Blisters Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture. Keep out of the reach of children.
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