| 4.4 Changes:
Posology
Initial dose
Cyanokit is administered as an intravenous infusion over 15 minutes.
Adults: The initial dose of Cyanokit is 5 g. (2 x 100 ml).
Paediatric patientspopulation: 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.
Maximum dose
byAdults: 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.
Adults: The subsequent dose of Cyanokit is 5 g.
Paediatric patients: In infants to adolescents, the subsequent dose of Cyanokit is 70 mg/kg body weight not exceeding 5 g.
Maximum dose
Adults: The maximum recommended dose is 10 g.
Paediatric patients: In infants to adolescents, the maximum recommended dose is 140 mg/kg not exceeding 10 g.
Renal and hepatic impairments
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 dosage adjustment is required in these patients.
4.5 changes
Interference with haemodialysis
Because of its deep red color, hydroxocobalamin may cause haemodialysis machines to shut down due to an erroneous detection of a ‘blood leak’. This should be considered before haemodialysis is initiated in patients treated with hydroxocobalamin.
4.6:
Breast-feeding
Because hydroxocobalamin will be administered in potentially life-threatening situations, breast-feeding is not a contraindication to its use. In the absence of data in breast-fed infants, breast-feeding discontinuation is recommended after receiving Cyanokit.
Fertility
No studies on fertility have been performed (see section 5.3).
4.8:
Investigations
Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4. 5).
Cardiac disorders
Ventricular extrasystoles. An increase in heart rate was observed in cyanide-poisoned patients.
Blood and lymphatic system disorders
Decrease in the percentage of lymphocytes.
Immune system disorders
Allergic reactions including angioneurotic oedema, skin eruption, urticaria and pruritus.
Psychiatric disorders
Restlessness.
Nervous system disorders
Memory impairment; dizziness.
Eye disorders
Swelling, irritation, redness.
Cardiac disorders
Ventricular extrasystoles. An increase in heart rate was observed in cyanide-poisoned patients.
Vascular disorders
Transient increase in blood pressure, usually resolving within several hours; hot flush. A decrease in blood pressure was observed in cyanide-poisoned patients.
Nervous system disorders
Memory impairment; dizziness.
Eye disorders
Swelling, irritation, redness.
Respiratory, thoracic and mediastinal disorders
Pleural effusion, dyspnoea, throat tightness, dry throat, chest discomfort.
Gastrointestinal disorders
Abdominal discomfort, dyspepsia, diarrhoea, vomiting, nausea, dysphagia.
Renal and urinary disorders
Chromaturia (see above).
Skin and subcutaneous tissue disorders
Reversible red colouration of the skin and mucous membranes (see above). Pustular rashes, which may last for several weeks, affecting mainly the face and the neck.
Renal and urinary disorders
Chromaturia (see above).
Vascular disorders
Transient increase in blood pressure, usually resolving within several hours; hot flush. A decrease in blood pressure was observed in cyanide-poisoned patients.
General disorders and administration site conditions
Headache; injection site reaction; peripheral oedema.
Investigations
Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4. 4).
Paediatric population
Limited data on children (0 to 18 years old) treated with hydroxocobalamin did not show any difference in the safety profile of hydroxocobalamin between adults and children.
Immune system disorders
Allergic reactions including angioneurotic oedema, skin eruption, urticaria and pruritus.
Psychiatric disorders
Restlessness.
6.3:
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 6 hours at a temperature between 2°C and 40°C.
From a microbiological point of view, the 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.
6.4 Special precautions for storage
Do not store above 25°C.
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.
10:
2009-01-16
04/2011
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