SODIUM CHLORIDE 0.9% W/V INJECTION BP
Active substance(s): SODIUM CHLORIDE
Sodium Chloride 0.9%w/v Injection BP
Please read this leaflet carefully. It provides a summary of information about the product
you may be about to use or be given by your doctor. Keep this leaflet you may need to
read it again.
WHAT IS SODIUM CHLORIDE 0.9%w/v INJECTION BP?
Sodium Chloride 0.9%w/v Injection BP is presented in polyethylene ampoules (MiniPlasco®), in packs of 10 or 100 ampoules.
• A 5ml ampoule contains: 5ml of water and 0.045g of sodium chloride.
• A 10ml ampoule contains: 10ml of water and 0.09g of sodium chloride.
The sodium chloride has an electrolyte value of 308mmol/l in the 10ml ampoule. The
electrolyte value indicates the concentration of sodium and chloride ions present in the
solution. The water present in the ampoules is water for injections Ph. Eur. The sodium
chloride is sodium chloride Ph. Eur.
WHAT IS SODIUM CHLORIDE 0.9%w/v INJECTION BP USED FOR?
Sodium Chloride 0.9%w/v Injection BP is mainly used to dissolve (and dilute) drugs
acting as a carrier solution for injectable drugs.
BEFORE YOU USE SODIUM CHLORIDE 0.9%w/v INJECTION BP
You should not be given Sodium Chloride Injection BP 0.9%w/v if:
. you are sensitive or allergic to Sodium Chloride Injection BP 0.9% w/v or any of the
other ingredients in this injection.
Please tell your doctor or nurse before being given the injection if :
. you suffer from heart-disease or heart failure.
. you have problems with your kidney.
. you have diabetes
. you have high blood pressure during pregnancy (Pre-eclampsia)
. you have fluid retention resulting in swelling of parts of the body, particularly your feet
. you have low level of salts in your blood caused by levels of fat or protein in your body
that are too high (Pseudohyponatraemia).
. you have a raised level of fat in your blood
. you have raised levels of proteins in your blood.
Check the solution in the ampoule is clear and colourless. Do not use the solution if it is
not clear or colourless.
Check the ampoule is intact. Do not use the solution if the ampoule is not intact.
Using 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.
Pregnancy or breast feeding:
Please tell your doctor or nurse before being given this injection if you are pregnant or
breast feeding. The doctor will then decide if the injection is suitable for you.
Driving and using machines:
You should not drive or use machinery if you are affected by the administration of
sodium chloride injection BP 0.9% w/v.
HOW TO USE SODIUM CHLORIDE 0.9%w/v INJECTION BP
Sodium Chloride 0.9%w/v Injection BP is used to first dissolve a drug, it is then injected
into the body via a vein or under the skin.
Always use Sodium Chloride 0.9%w/v Injection BP exactly as your doctor has told you.
•If you miss a dose: follow the advice given to you by your doctor.
•If you take too much Sodium Chloride 0.9%w/v Injection BP follow the advice given to
you by your doctor.
Like all medicines, sodium Chloride Injection BP 0.9% w/v can cause side-effects,
although not everybody gets them.
. pain at the site of injection if administered underneath the skin.
. dehydration of internal organs, particularly the brain, which may result in the
development of blood clots and internal bleeding.
Someone who has too much sodium chloride in their body may also feel or be sick, have
diarrhoea, stomach pain, low blood pressure, an elevated heart rate, excess sweating,
headache, dizziness or fever. Other symptoms of excess sodium chloride include thirst,
dry mouth or eyes, swollen legs or chest pain, difficulty in breathing, irritability,
restlessness, feeling weak, twitching or other unusual muscle movements.
If you think this injection is causing you any problems, or you are at all worried, talk to
your doctor, nurse or pharmacist.
STORING SODIUM CHLORIDE 0.9%w/v INJECTION BP
Keep Sodium Chloride 0.9%w/v Injection BP and all medicines out of the reach and sight
of children. Do not store above 25oC. Do not refrigerate. Do not use Sodium Chloride
0.9%w/v Injection BP after the expiry date shown on the label and carton.
• Use immediately after opening the ampoule.
• Discard any unused contents.
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist. This leaflet
should be read in conjunction with the SPC (Summary of Product Characteristics) leaflet
included in this pack.
The Marketing Authorisation holder is Mercury Pharma International Ltd, 4045,
Kingswood Road, City West Business Park, Co Dublin, Ireland
PL No : PL 02848/0227
The company responsible for manufacture is Aguettant, Parc Scientifique Tony GarnierRhõne, 1 rue Alexander Fleming, BP1744, 69353 Lyon Cedex 07, France.
Date of issue: March 2007
Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland
Date of revision of text: March 2012
Marketing authorization holder
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
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.