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STERILE SODIUM CHLORIDE CONCENTRATE BP 30% W/V

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Package leaflet: information for the user

Sterile Sodium Chloride Concentrate
30% w/v
Concentrate for Solution for Infusion
Sodium Chloride

C9132700000

Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse

In this leaflet:
1. What Sterile Sodium Chloride Concentrate is and what it
is used for
2. Before you are given Sterile Sodium Chloride Concentrate
3. How Sterile Sodium Chloride Concentrate will be given
4. Possible side effects
5. How to store Sterile Sodium Chloride Concentrate
6. Further information

1. What Sterile Sodium Chloride Concentrate is
and what it is used for
Sodium Chloride belongs to a group of medicines called
electrolytes. The balance of the electrolytes in the body is
essential for normal function of our cells and our organs.
Sterile Sodium Chloride Concentrate, when diluted, is used to put
electrolytes back into your body. Electrolytes are lost through too
much sweating, prolonged diarrhoea or vomiting. This can
eventually lead to excess water loss from the body (dehydration).

2. Before you are given Sterile Sodium Chloride
Concentrate
You should not be given Sterile Sodium Chloride Concentrate
if:
• you are allergic (hypersensitive) to Sodium Chloride
If you are unsure about being given this medicine or you have
any questions, talk to your doctor or nurse.
Take special care with Sterile Sodium Chloride Concentrate if:
• you have heart disease or other heart problems
• you suffer from water retention
• you suffer from high blood pressure
• you suffer kidney problems
• you suffer from liver problems
• you suffer from water on the lungs
• you suffer from a serious complication of pregnancy known
as pre-eclampsia (the symptoms of which include 2 or more
of the following; high blood pressure, fluid retention or
protein in the urine).
• you suffer from diabetes
Special care should be taken when Sterile Sodium Chloride
Concentrate is given to children and the elderly.
If any of the above apply to you or your child please tell your
doctor before you are given Sterile Sodium Chloride Concentrate
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.
Medicines which may interact with Sterile Sodium Chloride
Concentrate include:
• streptomycin sulphate, a medicine used to treat tuberculosis
and other bacterial infections
If you have any doubts about whether this medicine should be
administered to you, consult your doctor or nurse.
Pregnancy and breast-feeding
Sterile Sodium Chloride Concentrate is usually suitable for use
whilst you are pregnant or breast-feeding however you should
ask your doctor for advice before you are given this medicine.
Driving and using machines
There are no known effects of having Sterile Sodium Chloride
Concentrate on driving or using machines.

3. How Sterile Sodium Chloride Concentrate will
be given

4. Possible side effects
Like all medicines, Sterile Sodium Chloride Concentrate can
cause side effects, although not everybody gets them.
Possible side effects include:
• feeling or being sick
• stomach pains
• diarrhoea
• feeling thirsty
• a dry mouth or eyes
• sweating
• fever
• a fast or irregular heartbeat
• kidney problems
• water on the lungs
• water retention (the symptoms of which include swelling of
the ankles or shortness of breath)
• headache
• dizziness
• feeling restless or irritable
• feeling weak
• muscle twitching and stiffness
• feeling sleepy or confused
• fits
• breathing difficulties
Infants may experience the following side effects:
• fits
• breathing quickly
• flared nostrils (caused by difficulty breathing)
• coma
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

5. How to store Sterile Sodium Chloride
Concentrate
Keep out of the reach and sight of children.
You should not be given Sterile Sodium Chloride Concentrate
after the expiry date which is printed on the carton and
ampoule label after EXP. The doctor or nurse will check that
the expiry date on the label has not been passed before
administering the injection to you. The expiry date refers to
the last day of that month.
Store below 25°C
The ampoule containing the injection will only be used for you
and if any injection is left over the doctor/ nurse will dispose
of it.

6. Further Information
What Sterile Sodium Chloride Concentrate contains
The active substance is Sodium Chloride 300mg/ml
The other ingredient is water for injections. Sterile Sodium
Chloride Concentrate may also contain hydrochloric acid or
sodium hydroxide.
What Sterile Sodium Chloride Concentrate looks like and
contents of the pack
Sterile Sodium Chloride Concentrate 30% w/v, Concentrate for
Solution for Infusion is a clear colourless solution supplied in 2ml
and 10ml clear glass ampoules. Each pack contains 10 ampoules.
Manufacturer
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford,
Essex, RM3 8UG, UK.
Marketing Authorisation Holder in Ireland
In Ireland the product is marketed by
Martindale Pharmaceuticals, Romford, RM3 8UG,UK.
The PA holder is Marcarthys Laboratories Ltd, Bampton Road,
Harold Hill, Romford, Essex, RM3 8UG, UK.
Marketing Authorisation Holder in UK
Martindale Pharmaceuticals Ltd, Bampton Road, Harold Hill,
Romford, Essex, RM3 8UG, UK.
If you would like any more information, or you would like
the leaflet in a different format, please contact Medical
Information at the above address.
This leaflet was last approved in Nov/2010
Product License Number: PL 01883/6158
PA274/01/01

Adults, the elderly and children
Your doctor will decide the amount of Sterile Sodium Chloride
Concentrate you need depending on your age, weight and
general health. You will be given Sterile Sodium Chloride
Concentrate into a vein (intravenously) once it has been diluted.
If you are given more Sterile Sodium Chloride Concentrate
than you should be
As this medicine will be given to you whilst you are in hospital, it
is unlikely that you will be given too little or too much, however,
tell your doctor or nurse if you have any concerns.
C9132700000

100mm Measurement Verification Bar

91327-01

Expand Transcript

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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