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SODIUM THIOSULFATE 250 MG/ML SOLUTION FOR INJECTION

Active substance(s): SODIUM THIOSULPHATE

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Patient Information Leaflet

SODIUM THIOSULFATE 250 mg/mL
Solution for Injection
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 Sodium Thiosulfate is 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. Further information

1. What Sodium Thiosulfate is
and what it is used for
Sodium Thiosulfate 250 mg/mL Solution for
Injection 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
Take special care with Sodium
Thiosulfate if you:
• have had allergic reactions to sulfites.
You will be monitored during use with
Sodium Thiosulfate, and the dose of the
medication will be adjusted if necessary.

Using other medicines

Tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
The following medicines have side effects
that are similar to the side effects that may
occur with Sodium Thiosulfate.

• Other solutions for injection that contain
sodium, such as Sodium Chloride
It may be necessary for your doctor to adjust
the dose of Sodium Thiosulfate or one of
your other medications.
Do not take sodium thiosulfate concurrently
with hydroxocobalamin.

Pregnancy and breast-feeding

Sodium Thiosulfate should not be used during
pregnancy or while breast-feeding. Tell your
doctor right away if you are pregnant or
breast feeding.

3. How Sodium Thiosulfate will
be given
Sodium Thiosulfate will be given by injection
into a vein by a doctor or nurse. Your doctor
will choose the dose that is right for you.
If signs of cyanide poisoning reappear, your
doctor will decide if you should receive more
Sodium Thiosulfate.
If you have any further questions on the use
of sodium thiosulfate, ask your doctor or
nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

The side effects of sodium thiosulfate
include:
• Cardiovascular: reduced blood pressure
• Hematological: cuts take longer to stop
bleeding than normal
• Central nervous system: headache,
disorientation
• Gastrointestinal: nausea, vomiting
• Body as a whole: salty taste in mouth,
warm sensation over body
The frequencies at which the above reactions
occur are not known yet.

Reporting of side effects:

If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can help
make sure that medicines remain as safe as
possible by reporting any unwanted side effects
directly via www.mhra.gov.uk/ yellowcard.

5. How to store Sodium
Thiosulfate
Keep this medicine out of the sight and reach
of children.
Do not use Sodium Thiosulfate 250 mg/mL
Solution for Injection after the expiry date
which is stated on the vial label and carton.
The expiry date refers to the last day of that
month.

Store below 25°C.
Sodium Thiosulfate 250 mg/mL Solution
for Injection must be clear and colourless.
If particulate matter or discolouration is
present, the solution must not be used and
should be discarded.
For single use only. Use immediately after
opening. Discard any unused portions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

6. Further information
What Sodium Thiosulfate contains
Each 50 mL vial of Sodium Thiosulfate 250
mg/mL Solution for Injection contains 12.5
g of the active ingredient sodium thiosulfate
(250 mg/mL). The other ingredients are
boric acid, potassium chloride, and water for
injections. Sodium hydroxide may also be
used to adjust the pH of the solution.

What Sodium Thiosulfate looks like
and contents of the pack
Each carton of Sodium Thiosulfate 250 mg/
mL Solution for Injection contains one 50 mL
glass vial.

Marketing Authorisation Holder
Hope Pharmaceuticals, Ltd.
120 Baker Street
London W1U 6TU
United Kingdom
Manufacturer
Cangene bioPharma, Inc.
Baltimore MD 21230
USA

This leaflet was last revised on August 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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