Sodium Nitrite Hope Pharmaceuticals 30 mg/mL Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM NITRITE

Available from:

Hope Pharmaceuticals Ltd

ATC code:

V03AB08

INN (International Name):

SODIUM NITRITE

Dosage:

30 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

sodium nitrite

Authorization status:

Not marketed

Authorization date:

2019-02-22

Patient Information leaflet

1
_ _
SODIUM NITRITE
READ ALL OF THIS LEAFLET CAREFULLY
This leaflet contains information about sodium nitrite, which will
have already been given to
you by injection into one of your veins.
•
Although you will not be taking this medicine yourself, this leaflet
contains
important information to help you understand how sodium nitrite is
used.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talke to your doctor or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What is sodium nitrite and what it is used for
2. Before you are given sodium nitrite
3. How sodium nitrite is given
4. Possible side effects
5. How to store sodium nitrite
6. Contents of the pack and other information
1.
WHAT SODIUM NITRITE IS AND WHAT IT IS USED FOR
is used as an antidote for cyanide poisoning. Cyanide
poisoning is a
condition that develops when you inhale, touch, or swallow cyanide.
Cyanide is a poisonous
chemical that prevents your body from absorbing oxygen. The lack of
oxygen can damage
your organs and be life-threatening.
2.
BEFORE YOU ARE GIVEN SODIUM NITRITE
Your doctor will take special care if you:
•
are pregnant or breast-feeding (See Pregnancy and breast-feeding);
•
have low blood pressure;
•
have a condition called anaemia (This is a reduction in number of red
blood cells
in the bloodstream. Anaemia can make the skin appear pale and can
cause
weakness or breathlessness);
•
suffer from Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (This
may
result in anaemia.);
•
have a history of elevated levels of methemoglobin (This is a modified
form of
hemoglobin that reduces the amount of oxygen in the bloodstream and
can cause
weakness or breathlessness.);
2
•
have inhaled smoke from a fire;
•
have had an allergic reaction to sodium nitrite.
You will be monitored during use with sodium nitrite, and the dose of
the medicatio

Summary of Product characteristics

Health Products Regulatory Authority
18 September 2023
CRN00DTTF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Nitrite Hope Pharmaceuticals 30 mg/mL Solution for Injection
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 sodiumnitrite
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/m2 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/m2 of BSA) (rate of 2.5 to 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 3