Cyanokit
Boite CYANOKIT

PRECAUTIONS

Warnings and precautions?

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 exposure1.

Cyanokit® does not substitute oxygen therapy and must not delay the set up of the above measures.1

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.1

What are the contraindications of CYANOKIT?

There are no contraindications.1

What are the possible adverse reactions with CYANOKIT?

Adverse reactions have been reported with the use of Cyanokit®. However, because of the limitations of the available data, it is not possible to apply frequency estimations.1

Please refer to the SmPC (Summary of Product Characteristics) for the complete list of adverse reactions.

What are the precautions for use of CYANOKIT for renal disorders?

Oxalate crystals have been observed in the urine of healthy volunteers given hydroxocobalamin.1

Cases of acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate ­crystals present have been reported in patients treated with hydroxocobalamin following known or ­suspected cyanide poisoning. In some situations, hemodialysis was required to achieve recovery.1

Therefore, as a precaution, after Cyanokit® administration, regular monitoring of renal function (including blood urea nitrogen and serum creatinine) should be performed until 7 days after drug onset.1

Does CYANOKIT contain latex ?

Cyanokit® does not contain latex.

ADMINISTRATION

How long should IV administration last?

Initial dose of Cyanokit® is administered as an intravenous infusion over 15 minutes.1

The rate of intravenous infusion for the second dose ranges from 15 minutes (for patients extremely ­unstable) to 2 hours based on patient condition.1

What diluent is recommended for the reconstitution?

The vial is to be reconstituted with 200 mL of diluent using the supplied sterile transfer device.1

Sodium chloride 9 mg/mL (0.9%) solution for injection is the recommended diluent.1

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. 1

How to manage cases of CYANOKIT overdose?

Doses as high as 15 g have been administered without reported specific dose related adverse reactions.1

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.1

However, hydroxocobalamin because of its deep red colour may interfere with the performance of ­haemodialysis machines.1

STORAGE & STABILITY

What are the CYANOKIT vials storage conditions?

Do not store above 25°C.1

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.1

How long is the stability after the dilution of CYANOKIT?

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.1

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.1

What is the shelf life of CYANOKIT?

Cyanokit® has a shelf life of 3 years from date of manufacture.1

Bibliography

1 – Cyanokit® Summary of Product Characteristics