Sodium Chloride 0.9% W/V Injection Bp
PATIENT INFORMATION LEAFLET
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 (Mini-Plasco®), 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 and ankles.
. 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.
SIDE EFFECTS
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.
FURTHER INFORMATION
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 Garnier-Rhone, 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.