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

Posology

Initial dose

Adults: The initial dose of Cyanokit is 5 g (200 mL, complete volume of reconstituted solution).

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.

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 (200 mL, complete volume of reconstituted solution).

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.

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 minutes.

The rate of intravenous infusion for the second dose ranges from 15 minutes (for patients extremely unstable) to 2 hours based on patient condition.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Doses as high as 15 g have been administered without reported specific dose related adverse reactions. If overdose occurs, treatment is directed to the management of symptoms. Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin-related toxicity. However, hydroxocobalamin because of its deep red colour may interfere with the performance of haemodialysis machines (see section 4.4).

3 years.

For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5°C to 40°C), transport in the desert (4 days submitted to temperatures ranging from 5°C to 60°C) and freezing/defrosting cycles (15 days submitted to temperatures ranging from -20°C to 40°C). If these temporary conditions have been exceeded, the product should be discarded.

Chemical and physical in-use stability of the reconstituted solution with sodium chloride 9 mg/mL (0.9%) has been demonstrated for 6 hours at a temperature between 2°C and 40°C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8ºC.

Do not store above 25°C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

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.

No special requirements for disposal.

The vial is to be reconstituted with 200 mL of diluent using the supplied sterile transfer device. Sodium chloride 9 mg/mL (0.9%) solution for injection is the recommended diluent. Only when sodium chloride 9 mg/mL (0.9%) solution for injection is not available, Lactated Ringer solution or glucose 50 mg/mL (5%) solution for injection can also be used.

The Cyanokit vial is to be rocked or inverted for at least 1 minute to mix the solution. It must not be shaken as shaking the vial may cause foam and therefore may make checking reconstitution less easy. Because the reconstituted solution is a dark red solution, some insoluble particles may not be seen. The intravenous infusion set provided in the kit must then be used as it includes an appropriate filter and is to be primed with the reconstituted solution.