Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
hydroxocobalamin
SERB SA
V03AB33
hydroxocobalamin
All other therapeutic products
Poisoning
Treatment of known or suspected cyanide poisoning.Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Revision: 10
Authorised
2007-11-23
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER CYANOKIT 2.5 G POWDER FOR SOLUTION FOR INFUSION hydroxocobalamin READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cyanokit is and what it is used for 2. What you need to know before Cyanokit is used 3. How Cyanokit is used 4. Possible side effects 5. How Cyanokit is stored 6. Contents of the pack and other information 1. WHAT CYANOKIT IS AND WHAT IT IS USED FOR Cyanokit contains the active substance hydroxocobalamin. Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning in all age ranges. Cyanokit is to be administered together with appropriate decontamination and supportive measures. Cyanide is a highly poisonous chemical. Cyanide poisoning may be caused by exposure to smoke from household and industrial fires, breathing or swallowing cyanide, or contact with cyanide on skin. 2. WHAT YOU NEED TO KNOW BEFORE CYANOKIT IS USED WARNINGS AND PRECAUTIONS Tell your doctor or other health care professional if you are allergic to hydroxocobalamin or vitamin B 12 . They will have to take it into account before treating you with Cyanokit. that you have been treated with Cyanokit if you need to have the following: - any blood or urine tests. Cyanokit may modify the results of these tests. - burn assessement. Cyanokit may interfere with the assessment as it causes red coloration of the skin. - haemodialysis. Cyanokit may lead to shut down of haemodialysis machines until it is eliminated from the blood (at least 5.5 to 6.5 days). monitoring of renal function: Cyanokit may lead to kidney failure and urine crystals. OTHER MEDICINES AND CYANOKIT Tell your doctor Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cyanokit 2.5 g powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2.5 g of hydroxocobalamin. After reconstitution with 100 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. Dark red crystalline powder. 4. CLINICAL PARTICULARS 4.1 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 (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Initial dose _ _Adults_: The initial dose of Cyanokit is 5 g (2 x 100 mL). _Paediatric population:_ In infants to adolescents (0 to 18 years old), the initial dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g. Body weight in kg 5 10 20 30 40 50 60 Initial dose in g in mL 0.35 14 0.70 28 1.40 56 2.10 84 2.80 112 3.50 140 4.20 168 _Subsequent dose _ Depending upon the severity of the poisoning and the clinical response (see section 4.4), a second dose may be administered. _Adults_: The subsequent dose of Cyanokit is 5 g (2 x 100 mL). _Paediatric population: _In infants to adolescents (0 to 18 years old), the subsequent dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g. 3 Maximum dose _Adults_: The maximum total recommended dose is 10 g. _Paediatric population:_ In infants to adolescents (0 to 18 years old), the maximum total recommended dose is 140 mg/kg not exceeding 10 g. Renal and hepatic impairment Although the safety and efficacy of hydroxocobalamin have not been studied in renal and hepatic impairments, Cyanokit is administered as emergency therapy in an acute, life-threatening situation only and no dose adjustment is required in these patients. Method of administration Initial dose of Cyanokit is administered as an intravenous infusion over 15 Aqra d-dokument sħiħ