August 24, 2016
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Berinert

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Berinert




Overdosage
Contraindications

OVERDOSE

The development of thrombosis has been reported after doses exceeding 20 IU/ kg body weight of Berinert when used for unapproved indications in newborns and young children with congenital heart anomalies during or after cardiac surgery under extracorporeal circulation.1

The maximum dose administered in clinical studies in hereditary angioedema was 20 IU/kg body weight.

CONTRAINDICATIONS

Berinert is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations.

REFERENCES

1. German Medical Profession's Drugs Committee. Severe thrombus formation of Berinert® HS. Deutsches Ärzteblatt. 2000;97:B-864.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/16/2016

Overdosage
Contraindications

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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