Sodium Chloride 30%w/v Concentrate for Solution for Infusion

⚠ 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 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.

What you need to know before you take it

e 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

How to take it

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.

 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 concentrate 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 100 mL 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 30 mL Sodium Chloride 30% w/v Concentrate for Solution for Infusion to 1 litre with a non-electrolyte solution or water for injections. Continued overleaf

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.

How to store it

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.

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 +44 (1803) 664707 [email protected] This leaflet was last revised in: October 2023 PL 56021/0007

PIL/7/8

 Continued from overleaf 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. 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.

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 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 30 mL 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.

4.3. Contraindications

Caution: Sodium Chloride 30% w/v Concentrate for Solution for Infusion is a hypertonic solution, and should be diluted 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 may result in hypokalaemia and should be avoided.

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 condition has been reported in patients with diabetes mellitus. False reading 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, in order to avoid unnecessary, and possibly dangerous, treatment with sodium chloride.

Only use the solution if it is particle free.

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

See section 6.2. for streptomycin incompatibility.

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

The following general adverse effects may occur due to excess sodium chloride in the body: 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 such as 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 10-15 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 Sodium Chloride 30%w/v Concentrate for Solution for Infusion. 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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