Nithiodote Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM NITRITE; Sodium thiosulfate

Available from:

Hope Pharmaceuticals Ltd

ATC code:

V03AB; V03AB06; V03AB08

INN (International Name):

SODIUM NITRITE; Sodium thiosulfate

Dosage:

30/250 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Antidotes; thiosulfate; sodium nitrite

Authorization status:

Not marketed

Authorization date:

2018-07-06

Patient Information leaflet

1
NITHIODOTE SOLUTION FOR INJECTION_ _
ACTIVE SUBSTANCES
SODIUM NITRITE AND SODIUM THIOSULFATE
READ ALL OF THIS LEAFLET CAREFULLY
This leaflet contains information about Nithiodote, 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 Nithiodote 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, talk 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 Nithiodote and what it is used for
2. Before you are given Nithiodote
3. How Nithiodote is given
4. Possible side effects
5. How to store Nithiodote
6. Further information
1.
WHAT NITHIODOTE IS AND WHAT IT IS USED FOR
Nithiodote is a kit that contains two separate medications: Sodium
Nitrite Solution for
Injection and Sodium Thiosulfate Solution for Injection.
Nithiodote 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 NITHIODOTE
Take special care with Nithiodote 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);
2
•
suffer from Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (This
may
result in anaemia.);
•
have a history of elevated levels of methaemoglobin (This is a
modified form of
haemoglobin that reduces the amount of oxygen in the bloodstream and
can cause
weakness or breathlessness.);
•
have inhaled smoke from a

Summary of Product characteristics

Health Products Regulatory Authority
31 October 2023
CRN00D7ZS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nithiodote Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each kit contains one vial (300 mg) of sodium nitrite (30mg/mL) and
one vial (12.5 g) of sodium thiosulfate (250 mg/mL).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solutions for Injection
The solutions for injection are clear, colourless solutions in single
dose vials
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nithiodote is indicated 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 Nithiodote should be carefully weighed
against the potential benefits, especially if the patient is not in
extremis.
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 populations_
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 5 mL/minute) not to exceed 50 mL total dose of sodium
thiosulfate.
NOTE: If signs of poisoning reappear, repeat treatment using one-half
the original dose of both sodium nitrite and sodium
thiosulfate.
In adult and paediatric patients with known anaemia, it is recommended
that the dosage of sodium nitrite should be reduced
proportionately to the hemoglobin concentration (see section 4.4).
Method of administration
Comprehensive treatment of acute cyanide intoxication r