Sodium Thiosulfate Hope Pharmaceuticals 250 mg/mL Solution for Injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Sodium thiosulfate

Dostupné s:

Hope Pharmaceuticals Ltd

ATC kód:

V03AB; V03AB06

INN (Mezinárodní Name):

Sodium thiosulfate

Dávkování:

250 milligram(s)/millilitre

Léková forma:

Solution for injection

Terapeutické oblasti:

Antidotes; thiosulfate

Stav Autorizace:

Not marketed

Datum autorizace:

2019-08-23

Informace pro uživatele

1
_ _
SODIUM THIOSULFATE
READ ALL OF THIS LEAFLET CAREFULLY
This leaflet contains information about sodium thiosulfate, 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 Thiosulfate 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 sodium thiosulfate and what it is used for
2. Before you are given sodium thiosulfate
3. How sodium thiosulfate is given
4. Possible side effects
5. How to store sodium thiosulfate
6. Contents of the pack and other information
1.
WHAT SODIUM THIOSULFATE 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 THIOSULFATE
Your doctor will take special care if you:
•
have had an allergic reaction to sulfites.
You will be monitored during use with sodium thiosulfate, and the dose
of the medication will
be adjusted if necessary.
This medicine contains approximately 3.6 g of sodium per vial,
equivalent to 180% of the
WHO recommended maximum daily intake of 2g sodium for an adult.
This medicine contains 115 mg of potassium per 50ml vial.
This medicine also contains 140 mg of boric acid per 50ml vial. If you
are pregnant, talk to
your doctor as it contains boron, which may be harmful to your baby.
2
USING OTHER MEDICINES
The following medicines have side effects that are similar to the side
effects that may occur
with sodium thiosulfate.
•
Other solutions for injection

Charakteristika produktu

Health Products Regulatory Authority
09 June 2023
CRN00D7KT
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Thiosulfate Hope Pharmaceuticals 250 mg/mL Solution for
Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mL vial contains 12.5 g of sodium thiosulfate (250 mg/mL).
Excipients of known effect
3.6 g of sodium in 50 ml of solution for injection.
115 mg of potassium in 50 ml of solution for injection.
140 mg of boric acid in 50 mL of solution for injection.
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 thiosulfate is indicated for sequential use
withhydroxocobalamin or sodium nitrite 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 thiosulfate
should be carefully weighed against the potential benefits, especially
if the patient is not in extremis.
Sodium thiosulfate is to be administered together with appropriate
decontamination and supportive measures (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For intravenous use. For single use only.
_Adults_
Initial dose: 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).
Alternatively, an initial dose of 5 g hydroxocobalamin administered as
an intravenous infusion over 15 minutes 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 admini