HOPE PHARMACEUTICALS SODIUM THIOSULFATE INJECTION sodium thiosulfate pentahydrate12.5 g/50 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium thiosulfate pentahydrate, Quantity: 12.5 g

Available from:

Hope Pharmaceuticals Pty Ltd

INN (International Name):

sodium thiosulfate pentahydrate

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: water for injections; potassium chloride; boric acid; sodium hydroxide

Administration route:

Intravenous

Units in package:

1 glass vial

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

HOPE PHARMACEUTICALS 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: Clear and colourless, sterile solution, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2017-05-22

Patient Information leaflet

Page 1
HOPE PHARMACEUTICALS
TM SODIUM THIOSULFATE INJECTION
Sodium thiosulfate pentahydrate
_(SOE-dee-um thye-oh-SUL-fate PEN-tah-hi-drate)_
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about HOPE
PHARMACEUTICALS
TM
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 BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HOPE
PHARMACEUTICALS
TM
SODIUM
THIOSULFATE
I N J E C T I O N
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 YOUR.
Your doctor may have
prescribed it for another reason.
BEFORE YOU ARE GIVEN
HOPE
PHARMACEUTICALS
TM
SODIUM THIOSULFATE
INJECTION
_BEFORE YOU ARE GIVEN 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
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

Summary of Product characteristics

HOPE PHARMACEUTICALS
TM
SODIUM THIOSULFATE INJECTION
(SODIUM THIOSULFATE PENTAHYDRATE)
1. NAME OF THE MEDICINE
Sodium thiosulfate pentahydrate
2. QUALATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 12.5 grams of sodium thiosulfate pentahydrate in 50
mL solution (250
mg/mL).
For the full list of excipients see Section 6.1 List of Excipients
3. PHARMACEUTICAL FORM
HOPE PHARMACEUTICALS
TM
Sodium Thiosulfate Injection is a sterile aqueous solution
and is intended for intravenous injection. HOPE PHARMACEUTICALS
TM
Sodium
Thiosulfate Injection is a clear and colourless solution, practically
free from visual particles,
with a pH between 7.5 and 9.0.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
HOPE PHARMACEUTICALS
TM
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
HOPE PHARMACEUTICALS
TM
Sodium Thiosulfate Injection is for single use in one patient
only. Discard any residue.
HOPE PHARMACEUTICALS
TM
Sodium Thiosulfate Injection is administered by slow
intravenous injection. If sodium nitrite is administered in the
treatment of cyanide poisoning,
sodium thiosulfate should be administered immediately following the
sodium nitrite infusion.
Therapy should be administered immediately based upon reasonable
suspicion of cyanide
toxicity.
The characteristic smell of bitter almonds may not be obvious, and is
not detectable by all
individuals.
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 minutes to 2 hours after administration, both sodium nitrite and
sodium thiosulfate may be
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
) administ