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Home Drug Development FDA Approvals

B. Braun launches the First FDA-Approved Heparin Sodium Prefilled Syringe with attached safety needle

Content Team by Content Team
2nd May 2019
in FDA Approvals, Press Statements
Prefilled Syringe

B. Braun Medical Inc. announced the launch of its Heparin Sodium Injection, USP – the first Heparin 5,000 USP Unit / 0.5 mL prefilled syringe with attached safety needle for subcutaneous and intravenous use in the United States.

“B. Braun continues to develop products designed to increase patient and clinician safety, while reducing medication errors and improving dosage accuracy and workflows,” said Leigh Nickens, Director of Marketing, Fluid Therapy and Injectable Drugs at B. Braun. “Our prefilled syringe is equipped with a label-integrated Schreiner MediPharm Needle-Trap system that, upon activation, guards against accidental needle stick injuries,” Nickens continued.

The Heparin Sodium Injection, USP prefilled syringe is preservative free, not made with natural rubber latex, and has 24-month stability at room temperature.

Heparin Sodium Injection, USP is indicated for: prophylaxis and treatment of venous thrombosis and pulmonary embolism, prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease, atrial fibrillation with embolization, treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation), prevention of clotting in arterial and cardiac surgery, prophylaxis and treatment of peripheral arterial embolism, anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

For additional information, please see full Prescribing Information.

IMPORTANT SAFETY INFORMATION
Contraindications:

Severe thrombocytopenia
When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals
An uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation

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