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_
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
f 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.
f 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
f 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
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.
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
Martindale IkA Pharmaceuticals fVi
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom
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 s unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.
C91 327 CC
91327-01
100mm Measurement Verification Bar