DBL Sodium Thiosulfate Injection
Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
Pakkausseloste
(PIL)
29-05-2024
Valmisteyhteenveto
(SPC)
29-05-2024
Aktiivinen ainesosa:
Sodium thiosulfate
Saatavilla:
Hospira Australia Pty Ltd
luokka:
Medicine Registered
Pakkausseloste
DBL
™
Sodium Thiosulphate cmi
Page 1
DBL™
SODIUM THIOSULPHATE INJECTION
Sodium thiosulphate
_ (SOE-dee-um thye-oh-SUL-fate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
™
Sodium Thiosulphate 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 thiosulphate
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 DBL
™
SODIUM
THIOSULPHATE
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
™
SODIUM
THIOSULPHATE
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
• condi
Lue koko asiakirja
Valmisteyhteenveto
Product Information - Australia
Version 4.0
Page 1
DBL
™
SODIUM THIOSULFATE INJECTION
NAME OF THE MEDICINE
Sodium thiosulfate
DESCRIPTION
The molecular formula of sodium thiosulfate is Na
2
S
2
O
3
.5H
2
O. It has a molecular weight of 248.2.
The CAS registry number of sodium thiosulfate is 10102-17-7.
DBL
™
Sodium Thiosulfate Injection is a clear, colourless, sterile
solution. Each 10 mL vial contains
2.5 g of sodium thiosulfate (25% w/v solution). Each vial also
contains 10.5 mg/mL sodium
phosphate-dibasic dodecahydrate and 1.0 mg/mL sodium metabisulfite in
water for injections.
Sodium hydroxide and sulphuric acid are added as necessary to adjust
the pH. The pH of the solution
is between 7.0 and 9.0.
PHARMACOLOGY
Sodium thiosulfate is an antidote for cyanide poisoning. Cyanide
poisoning can be rapidly fatal.
When hydrogen cyanide gas is inhaled or large doses of cyanide are
taken, toxicity occurs within a
few seconds, and death occurs within minutes. The
potentially lethal dose of potassium or sodium
cyanide is 200 to 300 mg and of hydrocyanic acid is 50 mg. With
smaller doses, toxicity occurs
within minutes, and may include the following symptoms:
constriction of the throat, nausea,
vomiting, giddiness, headache, palpitations, hyperpnoea, then
dyspnoea, bradycardia (which may be
preceded by tachycardia), unconsciousness, violent convulsions
followed by death.
Sodium thiosulfate is generally used in conjunction with
sodium nitrite in the treatment of cyanide
poisoning. Cyanide has a high affinity for ferric ions, and reacts
readily with the ferric ion of
mitochondrial cytochrome oxidase. Sodium nitrite reacts with
haemoglobin to form methaemoglobin,
and cyanide preferentially binds to methaemoglobin, restoring
cytochrome oxidase activity. As
cyanide dissociates from methaemoglobin, it is converted to the
relatively non-toxic thiocyanate by
the enzyme rhodanese.
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