Medicinal Products

BERINERT 500 U / 10 mL

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
All forms

Indication

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.

Dosage

20 units per kilogram of body weight (20 U / kg bw).

The dosage for newborns, infants and children is the same.

Administration mode

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.

Against indications

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 :

1/10

Frequently:

1/100 and <1/10

Rare :

1/1000 and <1/100

Rare:

1/10 000 and <1/1000

Very rare :

<

1/10 000 (of which isolated cases)

Undesirable actions with Berinert are rare.

Class of organs

Very frequent

Frequently

Not very often

Rare

Very rare

Vascular disorders

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)

Shock

* 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 .

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