Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: C1 esterase inhibitor
laboratory: Csl Behring Gmbh
Powder and solvent for solution for injection IV / infusion
Box of 1 Bottle of powder + 10 ml solvent bottle
Treatment of acute episodes of type I and II (AEH) inheritance disorders in patients for whom there is no suitable therapeutic alternative available.
Dosage BERINERT 500 U / 10 mL Powder and solvent for solution for injection IV / infusion Box of 1 vial of powder + vial of solvent of 10 ml
Treatment should be initiated under the supervision of an experienced physician in the treatment of C1 inhibitor depression.
20 units per kilogram of body weight (20 U / kg bw).
The dosage for newborns, infants and children is the same.
Berinert must be reconstituted according to Special precautions for disposal and other handling . The reconstituted solution should be administered intravenously or as a slow infusion.
Allergy known to one of the components of the drug.
Berinert side effects
The following undesirable actions are based on post-market experience and scientific literature. The following standard categories of frequency are used:
Very common :
1/100 and <1/10
1/1000 and <1/100
1/10 000 and <1/1000
Very rare :
1/10 000 (of which isolated cases)
Undesirable actions with Berinert are rare.
Class of organs
Not very often
Development of thrombosis *
General disorders and abnormalities at the site of administration
Temperature estimation, reactions at the injection site
Immune system disorders
Allergic or anaphylactic reactions (eg tachycardia, hypotension, hypotension, redness, urticaria, dyspnea, headache, dizziness, nausea)
* When attempting treatment with high doses of Berinert prophylaxis or curative capillary leak syndrome before, during or after cardiac surgery with cardiopulmonary bypass (unauthorized indication and dose), in rare cases with Létales issues.
For safety regarding transmissible agents, see the section entitled Special warnings and precautions for use .