Sterile Sodium Chloride Concentrate BP 30% w/v

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Sodium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Sodium chloride

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

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).

What you need to know before you take it

e Sterile Sodium Chloride Concentrate Do not use Sterile Sodium Chloride Concentrate if:

you are allergic (hypersensitive) to Sodium Chloride If you are unsure about being given this medicine or you have any questions, talk to your doctor or nurse. Warnings and precautions Talk to your doctor or nurse before using 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 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

4. Possible side effects Like all medicines, Sterile Sodium Chloride Concentrate can cause side effects, although not everybody gets them.

How to take it

Sterile Sodium Chloride Concentrate

This leaflet was last approved in November 2021 Product License Number: PL 01883/6158

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. 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 is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

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 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.

D0565100000

100mm Measurement Verification Bar

5651-B

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. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme 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.

How to store it

Sterile Sodium Chloride Concentrate Keep out of the sight and reach of children. Do not use 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.

Special care should be taken when Sterile Sodium Chloride Concentrate is given to children and the elderly. If any of the above apply to you or your child please tell your doctor before you are given Sterile Sodium Chloride Concentrate Other medicines and Sterile Sodium Chloride Concentrate 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 If 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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Official document: view the original leaflet →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine.

Medicines with the same active substance: Sodium chloride (98 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

The product is used for rehydration only when diluted. Before administration, the concentrate must be diluted and thoroughly mixed with a larger volume of fluid.

4.2. 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 100 ml/hr.

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.

Sterile Sodium Chloride Concentrate BP 30% w/v should be sufficiently diluted to produce an isotonic (0.9% w/v) solution. An isotonic solution can be prepared by the addition of 150mEq (60ml of a 2.5mEq/ml solution) to 925ml of non-electrolyte solution or water for injections.

Sodium Chloride 0.9% injections are often used as diluents for the infusion of drug additives, and 0.9% solutions of sodium chloride are widely used for sterile irrigation and dilution purposes.

4.3. Contraindications

Caution hypertonic solution, dilute before use.

4.4. Special warnings and precautions for use

Sodium chloride should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function, or pre-eclampsia. Care should also be taken when administering sodium chloride intravenously to very young or elderly patients. Excessive administration should be avoided as this may result in hypokalaemia.

Pseudohyponatraemia, a condition where spuriously low concentrations of sodium are found, occurs when a high concentration of solid matter (such as lipids and protein) are present in the plasma. This has been reported in patients with diabetes mellitus. False readings for plasma concentrations may be obtained as sodium is present only in the aqueous phase of plasma. Correct values are obtained by referring the concentration to plasma water, thus avoiding unnecessary, and possibly dangerous, treatment with sodium chloride.

Reject if solid particles are present.

4.5. Interaction with other medicinal products and other forms of interaction

Streptomycin sulphate is stated to be incompatible with sodium chloride.

4.6. Pregnancy and lactation

It is safe to use in pregnancy and lactation after risk assessment.

4.7. Effects on ability to drive and use machines

None stated.

4.8. Undesirable effects

General adverse effects of excess sodium chloride in the body include nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.

Infants may appear not to be severely dehydrated, but coma and convulsions may persist due to vascular injury. They may show respiratory distress with tachypnoea and flaring nostrils.

Intra-amniotic injection of hypertonic solutions of sodium chloride can lead to serious adverse effects including disseminated intravascular coagulation, renal necrosis, cervical and uterine lesions, haemorrhage, pulmonary embolism, pneumonia and death.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Excessive administration of sodium chloride causes hypernatraemia, the most serious effect of which is dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage.

Normal serum - sodium concentrations should be carefully restored at a rate not exceeding 10 to 15 mmol per day by administration of hypotonic saline solutions intravenously.

Dialysis may be necessary if there is a significant renal impairment, the patient is moribund, or if the serum - sodium concentration is greater than 200 mmol per litre. Serum electrolyte levels need to be monitored and any imbalance corrected.

💬 Ask about this leaflet

Ask anything about Sterile Sodium Chloride Concentrate BP 30% w/v. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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