Cyanokit
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
18-01-2019
Produktets egenskaber
(SPC)
18-01-2019
Offentlige vurderingsrapport
(PAR)
23-07-2015
Aktiv bestanddel:
hydroxocobalamin
Tilgængelig fra:
SERB SA
ATC-kode:
V03AB33
INN (International Name):
hydroxocobalamin
Terapeutisk gruppe:
All other therapeutic products
Terapeutisk område:
Poisoning
Terapeutiske indikationer:
Treatment of known or suspected cyanide poisoning.Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Produkt oversigt:
Revision: 10
Autorisation status:
Authorised
Autorisation dato:
2007-11-23
Indlægsseddel
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
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Produktets egenskaber
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
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