Cyanokit

Summary of product characteristics

Detailed information on this medicinal product, including adverse reactions, precautions, contraindications, and method of use can be found in the Summary of Product Characteristics (SmPC) available either on the EMA website http://www.ema.europa.eu for Ireland or on the electronic medicines compendium (emc) https://www.medicines.org.uk/emc/product/4786 for Great Britain.

Cyanokit® 5 g powder for solution for infusion.

Hydroxocobalamin.

THERAPEUTIC INDICATIONS : Treatment of known or suspected cyanide poisoning in all age ranges. Cyanokit® is to be administered ­together with ­appropriate decontamination and supportive measures.

QUALITATIVE AND QUANTITATIVE COMPOSITION : The vial contains 5 g of hydroxocobalamin. After reconstitution with 200 mL of ­diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.

EXCIPIENTS : Hydrochloric acid (for pH-adjustment).

DOSAGE AND METHOD OF ADMINISTRATION : In adults, the initial dose of Cyanokit® is 5 g (200 mL, complete volume of reconstituted solution). In infants to adolescents (0 to 18 years old), the initial dose is 70 mg/kg body weight not exceeding 5 g. Depending upon the ­severity of the poisoning and the clinical response, a second dose may be administered. In adults, the subsequent dose of Cyanokit® is 5 g. In infants to adolescents, the subsequent dose of Cyanokit® is 70 mg/kg body weight not exceeding 5 g. Cyanokit® is administered as an intravenous infusion over 15 minutes for the initial dose and from 15 minutes to 2 hours for the second dose ranges based on patient ­condition. The maximum recommended dose is 10 g in adults. In infants to adolescents (0 to 18 years old), the maximum dose is 140 mg/kg body weight, not exceeding 10 g.

CONTRAINDICATIONS : None.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE : Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration must be given to decontamination measures based on the route of exposure. Cyanokit® does not substitute oxygen therapy and must not delay the set up of the above measures. After Cyanokit® administration, regular monitoring of renal function until 7 days after drug onset. Due to its deep red colour, Cyanokit® may interfere with burn assessment and laboratory tests.

ADVERSE REACTIONS : The following adverse reactions have been reported in association with Cyanokit® use. However, because of the limitations of the available data, it is not possible to apply frequency estimations: Blood and lymphatic system disorders: decrease in the percentage of lymphocytes. Immune system disorders: allergic reactions including angioneurotic oedema, skin eruption, urticaria, pruritus. Psychiatric disorders: restlessness. Nervous system disorders: memory impairment, dizziness. Eye disorders: swelling, irritation, redness. Cardiac disorders: ventricular extrasystoles, increase in heart rate. Vascular disoders: transient increase in blood pressure, hot flush, decrease in blood pressure. ­Respiratory, thoracic and mediastinal disorders: pleural effusion, dyspnea, throat tightness, dry throat, chest discomfort. Gastrointestinal disorders: abdominal discomfort, dyspepsia, diarrhea, vomiting, nausea, dysphagia. Skin and subcutaneous tissues disorders: reversible red colouration of the skin and mucous membranes, pustular rashes which may last for several weeks affecting mainly the face and the neck. Renal and urinary disorders: acute renal failure with acute tubular necrosis, renal impairment, urine calcium oxalate crystals, chromaturia. General disorders and administration site conditions: headache, injection site reaction, peripheral oedema. Investigations: red discolouration of the plasma (which may cause artificial elevation or reduction in the levels of certain laboratory parameters)

Detailed information on this medicinal product, including adverse reactions, precautions, contraindications, and method of use can be found in the Summary of Product Characteristics (SmPC) available either on the EMA website http://www.ema.europa.eu for Ireland or on the electronic medicines compendium (emc) https://www.medicines.org.uk/emc/product/4786 for Great Britain. You can also obtain the SmPC by contacting SERB SA at the address below.

Legal category: POM NHS price: £772

Marketing Authorisation Number: For Ireland: EU/1/07/420/002 – For UK: PLGB 43956/0004. Marketing Authorisation Holder: SERB S.A. Avenue Louise 480, 1050 Brussels, ­BELGIUM.

Date of preparation: March 2021 Job code: UK033