0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION

⚠ 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 0.9% Sodium Chloride Intravenous Infusion Solution is a clear colourless to faintly strawcoloured solution of sodium chloride in water. The solution is stored in a sealed flexible plastic bag. Sodium chloride (salt) helps to maintain the correct balance of fluid in and around the body's cells and tissues. Sodium chloride infusions are given to add water to tissues which are dehydrated and to help to restore the normal salt balance. Sodium chloride infusions may be given alone but may be given with other medicines added. You will be given sodium chloride infusions in hospital by a doctor or nurse.

What you need to know before you take it

0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION You MUST NOT be given sodium chloride infusions if you:  have an allergy to sodium chloride or any of the other ingredients. Warnings and precautions Talk to your doctor or nurse if you:  have heart failure, cardio-pulmonary disease, kidney problems, high blood pressure, liver disease, or oedema (swelling)  have high serum levels of sodium ("hypernatraemia")  have pre-eclampsia of pregnancy  are receiving drugs which may increase sodium retention  are very young or elderly.

Other medicines and 0.9% Sodium Chloride Intravenous Infusion Solution Tell your doctor if you are taking or have recently taken any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. Driving and using machines Sodium chloride infusion has no effect on your ability to drive or use machines.

How to take it

Sodium chloride infusion will be given to you in hospital. You will receive the solution by infusion into a vein (usually in the arm), administered by a doctor or nurse. The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct volume for you to receive. Your doctor will check your response to the treatment by the relief of your symptoms, and will probably take samples of blood and urine for laboratory testing. If you are given more sodium chloride infusion than you should It is unlikely you will be given too much solution as your doctor or nurse will be checking your response to the treatment. Infusion of too much sodium chloride solution can lead to the build up of sodium in the blood, which can lead to dehydration of some organs of the body and to loss of potassium. If you are concerned about the volume of solution given, or are worried about any effects you notice, talk to your doctor or nurse.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The infusion should be stopped immediately if you experience an adverse reaction. If you are given the solution for a long time, you may notice the following:  irritation, swelling, redness and tenderness at the site of injection. The balance of some chemicals in your blood may become upset. You may notice the following:  swelling, especially of the legs.  feel tired, weak, dizzy, have a headache or problems with vision  or a fast or irregular heart beat  feel sick (nausea) and have an upset stomach, loss of appetite  drowziness, lack of energy  cramp or discomfort of the muscles, confusion or disorientation  thirst, dry mouth, dark urine

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 national reporting system: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.

How to store it

0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not freeze. Store in the original outer container. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. The solution should only be used if it is clear and the container is not damaged. It should be used immediately on removal from the overwrap. For single use only. Any unused solution in the bag must be discarded. Do not throw away any medicines via wastewater or household waste. The doctor or nurse will dispose of this medicine. These measures will help to protect the environment.

Contents of the pack and other information

What 0.9% Sodium Chloride Intravenous Infusion Solution contains The active substance is sodium chloride. Each litre of solution contains 9g sodium chloride. Each litre contains 154 mmol sodium and 154 mmol chloride. The other ingredient is water for injections. What 0.9% Sodium Chloride Intravenous Infusion Solution looks like and contents of the pack Sodium chloride infusion is a clear, colourless to faintly straw-coloured solution. The solution for infusion is packaged in a plastic bag or flexible container with an integral infusion set for direct connection to a catheter. It is available in sizes of 50ml, 100ml, 250ml, 500ml and, depending on the container type, 1000ml. Not all pack sizes may be marketed. Marketing Authorisation Holder LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 Lyon France Manufacturer

AGUETTANT MOUVAUX Rue Michel Raillard 59420 Mouvaux France This leaflet was last revised in 05/2024 PL 14434/0055 For information on CD, please contact the Royal National Institute of Blind People. Central phone number: (+44) 0800 198 5000.

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

0.9% isotonic saline solution is indicated:

• for fluid replacement and provision of extracellular ions in near physiological concentration in conditions of extracellular-volume depletion, dehydration and electrolyte imbalance such as sodium depletion

• as an isotonic medium for intravenous administration of medicinal products known to be compatible with 0.9% sodium chloride.

4.2. Posology and method of administration

For intravenous infusion under medical supervision.

Single use only.

The pathophysiological response to dehydration, to electrolyte loss and to sodium chloride infusion will vary with the age of the patient being treated and this should be taken into account during rehydration therapy. Fluid replacement therapy should be administered with caution to very young and elderly patients.

The volume of isotonic saline solution needed to replenish fluid deficits varies with age, body weight, complementary treatment and severity of the clinical condition. The dose and rate of administration are subject to clinical and laboratory assessment in each case.

4.3. Contraindications

Sodium chloride infusion solution should be administered with caution to :

- patients with conditions of impaired sodium excretion such as impaired renal function, cardiac failure, cardio-pulmonary disease, peripheral or pulmonary oedema, hypertension, cirrhosis of the liver, pre-eclampsia, severe hepatic insufficiency; hypernatremia

- patients receiving drugs which may promote salt retention, and

- very young and to elderly patients who have reduced capacity to compensate for fluctuations in fluid and electrolyte balance.

4.4. Special warnings and precautions for use

Electrolytes should be monitored prior to and during infusion.

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

Check compatibility of medicinal products with 0.9% sodium chloride before administration with the solution. See Section 6.2 Incompatibilities.

4.6. Fertility, pregnancy and lactation

Administration of intravenous fluids to pregnant or lactating women requires special consideration of the consequences of possible unwanted effects in relation to the desired therapeutic objective.

4.7. Effects on ability to drive and use machines

Not relevant

4.8. Undesirable effects

Infusion of 0.9% sodium chloride infusion may lead to fluid and electrolyte imbalances such as metabolic acidosis, hypokalaemia, sodium retention, hypertension, tachycardia, oedema and gastrointestinal effects. Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site. In the event of adverse reaction, stop infusion immediately.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 national reporting system:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9. Overdose

Excessive administration may give rise to sodium accumulation and hypernatraemia with resultant dehydration of organs particularly the brain, and oedema, hypervolemic haemodilution, and hypokalaemia.

💬 Ask about this leaflet

Ask anything about 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION. 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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