SODIUM NITRITE 30 MGML

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

SODIUM NITRITE

Διαθέσιμο από:

HOPE PHARMACEUTICALS LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

V03AB08

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

SODIUM NITRITE 30 MG / 1 ML

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

CANGENE BIOPHARMA INC., USA

Θεραπευτική περιοχή:

SODIUM NITRITE

Θεραπευτικές ενδείξεις:

Sodium nitrite is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with sodium nitrite should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

Ημερομηνία της άδειας:

2022-09-30

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sodium Nitrite 30 mg/mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial contains 300 mg of sodium nitrite (30
mg/mL). For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection
The solution for injection is a clear and colourless solution.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Sodium nitrite is indicated for sequential use with sodium thiosulfate
for the treatment
of acute cyanide poisoning that is judged to be life-threatening. When
the diagnosis of
cyanide poisoning is uncertain, the potentially life-threatening risks
associated with
sodium nitrite should be carefully weighed against the potential
benefits, especially if
the patient is not in extremis.
Sodium nitrite is to be administered together with appropriate
decontamination and
supportive measures (see section 4.4).
Consideration should be given to official guidelines for the treatment
of cyanide
intoxication.
4.2
Posology and method of administration
Posology
For intravenous use. For single use only.
Adults
10 mL (300 mg) of sodium nitrite (rate of 2.5 to 5 mL/minute) should
be administered
intravenously, immediately followed by 50 mL (12.5 g) of sodium
thiosulfate (rate of
5 mL/minute).
Special populations
Older people
No specific dose adjustment is required in elderly patients (aged ˃
65 years).
Paediatric population
In infants to adolescents (0 to 18 years old), 0.2 mL/kg (6 mg/kg or
6-8 mL/m
2
BSA) of sodium nitrite (rate of 2.5 to 5 mL/minute) not to exceed 10
mL should be
administered intravenously, immediately followed by 1 mL/kg of body
weight (250
mg/kg or approximately 30-40 mL/m
2
of BSA) (rate of 5 mL/minute) not to exceed
50 mL total dose of sodium thiosulfate.
NOTE: If no treatment response is observed within 30 to 60 minutes or
if signs of
poisoning reappear, repeat treatment after 30 minutes of initial
administration using
one-half the original dose of both sodium nitrite and sodium
thiosulfate.
In paediatric pat