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AstraZeneca

Cyanokit
hydroxocobalamin

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.


What Cyanokit looks like and contents of the pack


Cyanokit powder for solution for infusion is a dark red crystalline powder supplied in a glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.


Each pack contains two vials (each vial packed in one cardboard box), two sterile transfer devices, one sterile intravenous infusion set and one sterile short catheter for administration to children.


Marketing Authorisation Holder


SERB S.A.

Avenue Louise 480

1050 Brussels Belgium


Manufacturer


Merck Santé s.a.s. / SEMOY 2, rue du Pressoir Vert 45400 Semoy

France Or

SERB S.A.

Avenue Louise 480

1050 Brussels Belgium

Or


SERB

40 avenue George V 75008 Paris

France


This leaflet was last revised in MM/YYYY.

.

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The following information is intended for medical or healthcare professionals only:


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Handling instructions


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.


The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. However, if a cyanide blood level determination is planned, it is recommended to draw the blood sample before initiation of treatment with Cyanokit. Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication. If there is clinical suspicion of cyanide poisoning, it is strongly recommended that Cyanokit be administered without delay.


Preparation of Cyanokit


Each vial is to be reconstituted with 100 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 30 seconds 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. Repeat this procedure if necessary with the second vial.


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


0.35


0.70


1.40


2.10


2.80


3.50


4.20

in g

in mL

14

28

56

84

112

140

168


Subsequent dose

Depending upon the severity of the poisoning and the clinical response, 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.


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


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.


Simultaneous administration of Cyanokit and other products


Cyanokit must not be mixed with diluents other than sodium chloride 9 mg/mL (0.9%) solution for injection or Lactated Ringer solution or glucose 50 mg/mL (5%) solution for injection.


As physical and chemical incompatibilities were observed with a number of selected medicinal products that are frequently used in resuscitation efforts, these and other medicinal products must not be administered simultaneously in the same intravenous line as hydroxocobalamin.


If blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) and hydroxocobalamin are administered simultaneously, use of separate intravenous lines (preferably on contralateral extremities) is recommended.


Combination with another cyanide antidote: Chemical incompatibility was observed with sodium thiosulfate and sodium nitrite. If the decision is made to administer another cyanide antidote with Cyanokit, these medicinal products must not be administered concurrently in the same intravenous line.

In-use stability of the reconstituted solution


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 to 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 8°C.