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Sterile Sodium Chloride Concentrate Bp 30% W/V

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SOUTH DEV O N

HEALTHCARES

STERILE SODIUM CHLORIDE CONCENTRATE BP 30% W/V Patient Information Leaflet

PLEASE READ THIS LEAFLET CAREFULLY.

IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING,

ASK YOUR DOCTOR OR PHARMACIST.

KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.

1.    WHAT IS STERILE SODIUM CHLORIDE CONCENTRATE BP 30%W/V AND WHAT IS IT USED FOR?

Sterile Sodium Chloride Concentrate 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.    BEFORE USING STERILE SODIUM CHLORIDE CONCENTRATE BP 30% W/V

When Sterile Sodium Chloride Concentrate BP 30%w/v should NOT BE USED:

•    if you have suffered with heart disease

•    if you have suffered with high blood pressure

•    if you have suffered with diabetes mellitus

Check with your doctor if you are concerned about any of the above.

When Sterile Sodium Chloride Concentrate BP 30%w/v should be used with care:

•    if you are suffering from congestive heart failure

•    if you have problems with your kidneys

• if you have suffered from pulmonary oedema (fluid on the lungs)

• if you have suffered from pre-eclampsia (high blood pressure associated with pregnancy)

•    if 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)

•    in children

•    in the elderly

Check with your doctor if you are concerned about any of the above.

Before taking the medicine, please tell your doctor if you are taking any other medication, particularly Streptomycin.

3.    HOW TO USE STERILE SODIUM CHLORIDE CONCENTRATE BP 30% W/V

The doctor will decide what dose of Sterile Sodium Chloride Concentrate 30% you should take. Check the label carefully. If you are not sure, ask your doctor, nurse or pharmacist.

Sterile Sodium Chloride Concentrate BP 30% w/v is a concentrated solution and must be diluted before administration by infusion into a large vein at a rate not exceeding 100ml/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 you forget to take a dose of Sterile Sodium Chloride Concentrate BP 30%w/v - take that dose as soon as possible. Then take the next dose at the usual time. Do not take a double dose.

If you take more Sterile Sodium Chloride Concentrate BP 30%w/v than you should - tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Characteristics, Section 4.9 Overdose.

4. POSSIBLE SIDE EFFECTS OF STERILE SODIUM CHLORIDE CONCENTRATE BP 30% W/V

As with all medicines, there may be some side effects with Sterile Sodium Chloride Concentrate BP 30% w/v.

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

•    kidney failure

•    fluid on the lungs

•    headache

•    rapid heart beat

•    feeling weak

•    restlessness or irritability

Very rare side effects are:-

•    muscular twitching

•    convulsions

•    respiratory arrest

•    coma

Tell your doctor, nurse or pharmacist immediately if you think you have any of these or other problems with Sterile Sodium Chloride Concentrate BP 30% w/v.

5.    HOW TO STORE STERILE SODIUM CHLORIDE CONCENTRATE BP 30% W/V

The product has an expiry date stated on the ampoule, vial and carton. Before use the doctor or nurse will check that the product has not passed this date and the injection does not show signs of deterioration.

No special storage conditions are required.

Store this medicine in a safe place where children cannot see or reach it.

6.    FURTHER INFORMATION

Sterile Sodium Chloride Concentrate BP 30% w/v contains the active ingredient sodium chloride . It also contains the inactive ingredient: Water for Injection.

The following packs are available:

Ampoules containing 3g Sodium Chloride in 10ml Vials containing 15g Sodium Chloride in 50ml Vials containing 30g Sodium Chloride in 100ml

The manufacturer and marketing authorisation holder is:

South Devon Healthcare, Torbay PMU, Long Road, Paignton, Devon, TQ4 7TW The leaflet was revised in: February 2009 PL 13079/0007 PIL/7/2