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The product code(s) for this leaflet is: PL 56021/0007.
Sodium Chloride 30% w/v Concentrate for Solution for Infusion
Package Leaflet: Information for the user
Sodium Chloride 30% w/v Concentrate for Solution for Infusion
Sodium chloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Sodium Chloride 30% w/v Concentrate for Solution for Infusion is and what it is used for 2. What you need to know before you use Sodium Chloride 30% w/v Concentrate for Solution for Infusion 3. How to use Sodium Chloride 30% w/v Concentrate for Solution for Infusion 4. Possible Side Effects 5. How to store Sodium Chloride 30% w/v Concentrate for Solution for Infusion 6. Contents of the pack and other information
1. What Sodium Chloride 30% w/v Concentrate for Solution for Infusion is and what it is used for
This medicine is a concentrated electrolyte solution for infusion into a large vein. When diluted and mixed thoroughly with another fluid it is used for rehydration.
2. What you need to know before you use Sodium Chloride 30% w/v Concentrate for Solution for Infusion
You will be given this medicine in hospital by a doctor or nurse.
Do not use this medicine if you:
Have suffered with heart disease
Have suffered with high blood pressure
Have suffered with diabetes mellitus
Check with your doctor if you are concerned about any of the above.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Sodium Chloride 30% w/v Concentrate for Solution for Infusion if:
You are suffering from congestive heart failure
You have problems with your kidneys
You have suffered from pulmonary oedema (fluid on the lungs)
You have suffered from pre-eclampsia (high blood pressure associated with pregnancy)
You have suffered from peripheral oedema (swelling of hands and feet)
If you have high blood pressure, swelling and protein in the urine during the last 3 months of pregnancy (toxaemia of pregnancy)
This medicine is being used in a child
This medicine is being used in an elderly person
This medicine should be given with care if any of the above applies to you.
Check with your doctor if you are concerned about any of the above.
Other Medicines and Sodium Chloride 30% w/v Concentrate for Solution for Infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important if you are taking:
Streptomycin
3. How to use Sodium Chloride 30% w/v Concentrate for Solution for Infusion
The doctor will decide what dose of this medicine you should be given. Check with your doctor if you are not sure.
This medicine is a concentrated solution and must be diluted before use. It is given by infusion into a large vein at a rate not exceeding 100 mL/hr. Doses will be adjusted by the doctor, but the usual Sodium Chloride requirements for an adult can be satisfied by infusion of the equivalent of 1 litre of Sodium Chloride 0.9% w/v daily.
If a dose of this medicine is not given at the correct time – the dose should be given as soon as remembered. The next dose should be given at the usual time. A double dose should not be given.
If more of this medicine is given than should be – tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Characteristics.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are:
Kidney failure
Convulsions
Respiratory arrest
Coma
Tell your doctor, pharmacist or nurse immediately if you think you have symptoms related to the above.
Other side effects
The most common side effects are:
Nausea or vomiting
Diarrhoea
Stomach cramps
Dry mouth or stuffy nose
Sweating and high temperature (fever)
Low blood pressure when standing. This may make you feel dizzy or faint
Fluid on the lungs
Headache
Rapid heartbeat
Feeling weak
Restlessness or irritability
Very rare side effects are:
Muscular twitching
Tell your doctor, pharmacist or nurse immediately if you think you have any of the above symptoms or other problems.
Reporting Side Effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard or Search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sodium Chloride 30% w/v Concentrate for Solution for Infusion
Keep this medicine out of the sight and reach of children.
This medicine has an expiry date printed on the ampoule, vial and carton. Do not use this medicine after the expiry date. The expiry date refers to the last day of the month. Before use the doctor or nurse will check that the medicine has not passed this date and the medicine does not show signs of deterioration.
Store this medicine below 25°C.
Do not throw away any medicines via waste water. These measures will help to protect the environment.
6. Contents of the pack and other information
What Sodium Chloride 30% w/v Concentrate for Solution for Infusion contains
The active substance is sodium chloride at a strength of 300mg per mL (5.13 mmol sodium and chloride per mL).
The other ingredient is Water for Injections.
What Sodium Chloride 30% w/v Concentrate for Solution for Infusion looks like and contents of pack:
This medicine is a clear and colourless solution. This medicine is available in a 10 mL ampoule containing 3 g of Sodium Chloride; a 50 mL vial containing 15 g Sodium Chloride and a 100 mL vial containing 30 g Sodium Chloride. The medicine is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.
Marketing Authorisation Holder and Manufacturer:
Torbay Pharmaceuticals Limited Wilkins Drive Paignton Devon TQ4 7FG UK