CYANOKIT Powder for solution for infusion Ref.[116063] Active ingredients: Vitamin B12a

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium

Product name and form

Cyanokit 5 g powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

Dark red crystalline powder.

Qualitative and quantitative composition

Each vial contains 5 g of hydroxocobalamin.

After reconstitution with 200 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.

For the full list of excipients, see section 6.1.

Active Ingredient

The action of hydroxocobalamin in the treatment of cyanide poisoning is based on its ability to tightly bind cyanide ions. Each hydroxocobalamin molecule can bind one cyanide ion by substituting the hydroxo ligand linked to the trivalent cobalt ion to form cyanocobalamin. Cyanocobalamin is a stable, non-toxic compound that is excreted in the urine.

List of Excipients

Hydrochloric acid (for pH-adjustment)

Pack sizes and marketing

Type I colourless 250 mL glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.

Each pack contains one vial packed in one cardboard box, one sterile transfer device, one sterile intravenous infusion set and one sterile short catheter for administration to children.

Marketing authorization holder

SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium

Marketing authorization dates and numbers

EU/1/07/420/002

Date of first authorisation: 23 November 2007
Date of latest renewal: 20 July 2012

Drugs

Drug Countries
CYANOKIT Austria, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States

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