Skip to Content

STERILE SODIUM CHLORIDE 30% W/V CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): SODIUM CHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet
Sodium Chloride 30% w/v Concentrate for Solution for Infusion






Please read this leaflet carefully before you start using this medicine.
Keep this leaflet in a safe place, you may wish to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
If any side effect gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Sodium Chloride Concentrate for Solution for Infusion is and what
it is used for
2. Before you are given Sodium Chloride Concentrate for Solution for Infusion
3. How Sodium Chloride Concentrate for Solution for Infusion is used
4. Possible Side Effects
5. How to store Sodium Chloride Concentrate for Solution for Infusion
6. Further Information
1. What Sodium Chloride 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. Before you are given Sodium Chloride Concentrate for Solution for Infusion
This medicine should NOT BE USED 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.
This medicine 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 giving this medicine, the doctor will check if you are taking any other medication,
particularly Streptomycin.
3. How Sodium Chloride Concentrate for Solution for Infusion is used
The doctor will decide what dose of this medicine you should be given. Check the label
carefully. If you are not sure, ask your doctor, nurse or pharmacist.
This medicine 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 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.


Additional information for Healthcare Professionals
(as stated on the Summary of Product Characteristics)
Therapeutic Indications
The product is used for rehydration only when diluted. Before administration, the
concetrate must be diluted and thoroughly mixed with a larger volume of fluid.
Posology and Method of Administration
When concentrations of 3 and 5% w/v are indicated, the solution should be administered
into a large vein, at a rate not exceeding 100mL per hour.
Adults, Children and the elderly
Concentration and sodium chloride dosage for intravenous use are determined by several
factors, including age, weight and clinical condition of the patient. The usual sodium and
chloride requirements for adults can be satisfied by infusion of the equivalent of 1 litre of
sodium chloride 0.9% w/v daily.
Sodium Chloride 30% w/v Concentrate for Solution for Infusion should be diluted sufficiently
to obtain an isotonic (0.9% w/v) solution. An isotonic solution can be prepared by diluting
30mL Sodium Chloride 30% w/v Concentrate for Solution for Infusion to 1 litre with a
non-electrolyte solution or water for injections.
Sodium Chloride 0.9% w/v injections are often used as diluents for the infusion of drug
additives, and 0.9% w/v solutions of sodium chloride are widely used for sterile irrigation and
dilution purposes.

4. Possible side effects
As with all medicines, there may be some side effects with this medicine.
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.
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine
5. How to store Sodium Chloride Concentrate for Solution for Infusion
This medicine has an expiry date printed on the ampoule, vial and carton. 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. The expiry date refers to the last day of the month.
Store this medicine below 25°C.
Store this medicine in a safe place where children cannot see or reach it.
6. Further information
What this medicine contains:

The active ingredient is Sodium Chloride.

It also contains the inactive ingredient Water for Injections.
What this medicine looks like and contents of pack:
This medicine is a clear and colourless solution. This medicine is available in a 10mL
ampoule containing 3g of Sodium Chloride; a 50mL vial containing 15g Sodium Chloride and
a 100mL vial containing 30g Sodium Chloride. The medicine is packed into cartons
containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may be available at the
same time.
Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,
Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG
Sites of Manufacture:
Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Long Road
Paignton
Devon
TQ4 7TW

Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Wilkins Drive
Paignton
Devon
TQ4 7FG

This leaflet was last revised in: 12/2015
PL 13079/0007
PIL/7/4



Incompatibilities
Streptomycin sulfate is stated to be incompatible with sodium chloride. The addition of
sodium chloride to mannitol 20 - 25% may cause precipitation of the mannitol.
As with all parenteral concentrate solutions, incompatibility of diluting fluids with the
concentrate should be assessed before addition. In the absence of compatibility studies, this
concentrate must not be mixed with other medicinal products.

Expand view ⇕

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.

Hide