DBL SODIUM THIOSULFATE INJECTION sodium thiosulfate pentahydrate 2.5g/10mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium thiosulfate pentahydrate, Quantity: 2.5 g

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

sodium thiosulfate pentahydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sulfuric acid; sodium metabisulfite; dibasic sodium phosphate dodecahydrate; water for injections; sodium hydroxide

Administration route:

Intravenous

Units in package:

5 x 10mL vial

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

DBL Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite. Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

Product summary:

Visual Identification: A clear, colourless solution, practically free from particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-08-30

Patient Information leaflet

DBL™ SODIUM
THIOSULFATE INJECTION
_Sodium thiosulfate pentahydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Sodium
Thiosulfate Injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given sodium
thiosulfate against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DBL SODIUM
THIOSULFATE INJECTION
IS USED FOR
This medicine is used:
in the emergency treatment of
cyanide poisoning
to prevent cyanide poisoning when
sodium nitroprusside is given.
This medicine works by helping the
body to convert cyanide to a less
dangerous chemical called
thiocyanate.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
DBL THIOSULFATE
INJECTION
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing sodium
thiosulfate
•
any of the ingredients listed at the
end of this leaflet
•
any other medicines, foods,
preservatives or dyes.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
-
high blood pressure
-
conditions that cause fluid
retention, such as liver disease,
heart failure, kidney disease or
toxaemia of pregnancy.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR ARE BREAST FEEDING.
Your doctor can discuss with you the
risks and benefits involved.
IF YOU HAVE NOT TOLD YOUR DOCTOR
ABOUT ANY OF THE ABOVE, TELL HIM/
HER BEFORE YOU A

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™
SODIUM
THIOSULFATE
INJECTION
(SODIUM
THIOSULFATE PENTAHYDRATE)
1.
NAME OF THE MEDICINE
Sodium thiosulfate pentahydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
10
mL
vial
of
DBL
™
Sodium
Thiosulfate
Injection
contains
Sodium
thiosulfate
pentahydrate 2.5 g.
Each vial also contains 10.5 mg/mL dibasic sodium phosphate
dodecahydrate and 1.0 mg/mL
sodium metabisulfite in water for injections. Sodium hydroxide and
sulfuric acid are added as
necessary to adjust the pH.
EXCIPIENTS WITH KNOWN EFFECT:
•
Sodium metabisulfite
_ _
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL
™
Sodium Thiosulfate Injection is a clear, colourless, sterile solution.
The pH of the
solution is between 7.0 and 9.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
™
Sodium Thiosulfate Injection is indicated as an antidote in the
treatment of cyanide
poisoning. It is frequently used in conjunction with sodium nitrite.
Sodium
thiosulfate
is
also
indicated
to
prevent
sodium
nitroprusside
induced
cyanide
poisoning.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_CYANIDE POISONING _
ADULT DOSE:
The usual adult dose is 12.5 g (50 mL of a 25% solution) administered
intravenously at a rate of 1.25 g/min (5 mL/min). If signs of cyanide
toxicity are still present
30 mins to 2 hours after administration, both sodium nitrite and
sodium thiosulfate may be
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repeated at half the original dose.
PAEDIATRIC DOSE:
The usual paediatric dose is 412.5 mg/kg (1.65 mL/kg of a 25%
solution) or
7 g/m
2
(28 mL/m
2
) administered at a rate of 0.625 to 1.25 g/min (2.5 to 5 mL/min). A
maximum
dose of 12.5 g (50 mL of a 25% solution) is recommended.
Alternatively, a paediatric dose based on haemoglobin concentration
has been recommended.
Haemoglobin concentration
Dose of sodium thiosulfate
80 g/L (8 g/dL)
1.10 mL/kg of 25% solution
100 g/L (10 g/dL)
1.35 mL/kg of 25% solution
120 g/L (12 g/dL)