Patient leaflet - Sterile Sodium Chloride concentrate 30% w/v BP
1. What sterile sodium chloride concentrate is and what it is used 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). This medicine is a concentrated electrolyte solution for infusion into a large vein.
2. What you need to know before you are given sterile sodium chloride concentrate
You should not be given sterile sodium chloride concentrate if:
you are allergic (hypersensitive) to sodium
chloride or any of the other ingredients of this medicine (listed in section 6)
- very high sodium or potassium levels
- kidney or heart disorders
too much fluid in the spaces around the
cells of the body (hyperhydration)
uncompensated heart failure (heart failure
that is not adequately treated and causes symptoms such as shortness of breath and swelling of the ankles)
Your doctor will check for these.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given sodium chloride concentrate if:
- you have heart disease or other heart problems
- you suffer from water retention
- you suffer from high blood pressure (hypertension)
- you suffer kidney problems
- you suffer from liver problems
- 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 a disease that causes high
levels of a hormone called aldosterone (aldosteronism)
- any other condition associated with
sodium retention (when the body retains too much sodium), such as treatment with steroids
- you are suffering from congestive heart failure
- you suffer from swelling of the hands and
feet or water on the lungs (peripheral and pulmonary oedema)
- a loss of water from the body (acute
dehydration, e.g. from vomiting or diarrhoeal
Sterile sodium chloride 30% w/v concentrate for solution for infusion
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Tell your doctor if you:
- suffer from acute illness, pain, post-operative stress, infections, burns, or disease of the central nervous system.
- have any type of liver disease.
- have been treated with a medicine increasing the effect of vasopressin (a hormone regulating the body’s water retention) because this may increase the risk of hospital-acquired low sodium levels in the blood (hyponatraemia)
- heat cramp
- have sickle cell disease ( a condition affecting the red blood cells)
- have excess fluids build up around the brain (cerebral oedema)
- have meningitis (swelling of the protective membranes covering brain and spinal cord)
- have any brain injury.
When you are given this infusion, your doctor or nurse will take blood and urine samples and monitor:
- the amount of fluid in your body
- your vital signs
- the amount of chemicals such as sodium, potassium, calcium and chlorides in your blood (plasma electrolytes)
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.
Before giving this medicine, the doctor will check if you are taking any other medication, particularly streptomycin.
Your doctor or nurse will carry out a regular electrolyte test to determine any electrolyte imbalance in your body
Other medicines and sterile sodium chloride concentrate
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Medicines which are not compatible with sterile sodium chloride concentrate include:
- streptomycin sulphate, a medicine used to treat tuberculosis and other bacterial infections
- medicines that retain sodium such as corticosteroids, non-steroidal anti-inflammatory drugs or carbenoxolone Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Sodium chloride concentrate should be given with special caution for pregnant women during labour, if given in combination with oxytocin this may cause low sodium concentration in the blood.
Driving and using machines
There are no known effects of having sterile sodium chloride concentrate on driving or using machines.
Sterile sodium chloride concentrate contains sodium
This medicinal product contains 118.15mg per ml equivalent to 5.9% of the WHO recommended maximum daily intake of 2g sodium for an adult.
3. How sterile sodium chloride concentrate will be given
Sterile sodium chloride concentrate will be given to you by a doctor or nurse.
You will receive your medicine by infusion (an injection into a vein).
Dosage
The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you receive more sterile sodium chloride concentrate than you should
It is very unlikely that you will receive more solution than you should as this medicine will be given to you by a doctor or nurse and you will be closely monitored during treatment.
5310-C If you are given too much sodium chloride concentrate or you are given your infusion too quickly, this may lead to the following symptoms:
water and/or sodium overload with
build-up of liquid in the tissues (oedema) causing swelling, swelling of the legs or ankles
pain that gets worse when you stand and
subsides when you raise your legs
cramping, aching, throbbing, or a feeling
of heaviness in your legs
- itchy or weak legs
- thickening of the skin on your legs or ankles
skin changing colour, especially around
the ankles
- leg ulcers or varicose veins
shortness of breath, rapid or irregular
breathing
- dizziness
- fatigue or weakness
- headache
- neck pain or stiffness
- nausea or vomiting
- decreased appetite
- constipation
- stomach pain
- excessive thirst (polydipsia) or a dry mouth
- chalky taste in the mouth
producing more urine than normal
(polyuria) or dark, concentrated urine
kidney disease due to build-up of calcium
in the kidneys (nephrocalcinosis) or kidney stones
- vision loss or changes
- memory loss
- mental disturbances such as confusion, irritability or depression
difficulty speaking or inability to think
normally
- seizures
- loss of consciousness
inability to walk or inability to move
(paralysis)
- an irregular heartbeat (cardiac arrhythmia)
cardiac arrest (the heart stops beating; if
the infusion is given too quickly)
acidification of the blood (acidosis) leading
to tiredness, confusion, lethargy and increased breathing rate
Dosage System
Fluid balance, glucose and salts along with other electrolytes found within your blood may need to be monitored before and during administration, especially if you are at risk of high blood pressure or kidney problems. Monitoring of your salt levels is important for this type of infusion solution (hypotonic fluid), as it may become very hypotonic after administration due to glucose utilisation in the body.
If you develop any of these symptoms you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment depending on the symptoms.
If you think you have been given too much sterile sodium chloride concentrate.
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
- Your doctor has information on how to
recognise and treat an overdose. If you are concerned about your treatment please talk to your doctor.
4. Possible side effects
If you have a side effect that is not mentioned in this leaflet or if any side effect gets serious, please tell your doctor or pharmacist Possible side effects are listed below: Very common: may affect more than 1 in 10 people
too much fluid in the spaces around the
cells of the body (hyperhydration) and
heart failure in patients with cardiac
disorder or pulmonary oedema Not known: frequency cannot be estimated from the available data
- oedema due to water/sodium overload The following side effects have been reported if the solution is given too quickly:
- heart attack
blood circulation problems
Reactions due to the administration technique:
- fever
- infection at the site of the infusion
- irritation and inflammation of the vein into which the solution is infused (phlebitis). This can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused
- escape of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
5. How to store sterile sodium chloride concentrate
Keep out of the sight and reach of children.
You should not be given sodium chloride concentrate after the expiry date which is stated on the carton and vial label. The doctor or nurse will check that the expiry date on the label has not passed before giving the injection to you. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Any solution remaining after treatment should be disposed of using the approved hospital procedures.
6. Contents of the pack and other information
What sterile sodium chloride concentrate contains
The active substance is sodium chloride 15g/50ml (approximately 5.13mmol/ml of sodium ions and 5.13mmol/ml or chloride ions).
The other ingredient is water for injections.
What sterile sodium chloride concentrate looks like and contents of the pack
Sterile sodium chloride concentrate is a clear, colourless solution supplied in a 50ml clear glass vial with a rubber stopper and aluminium overseal.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
RM3 8UG
UK
Manufacturer
University Hospitals of Derby and Burton NHS Foundation Trust,
Queen’s Hospital Burton,
Pharmacy Manufacturing Unit,
Belvedere Road,
Burton-On-Trent,
DE13 0RB,
United Kingdom
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.
Product licence number:
PL 12064/0021
This leaflet was last revised in May 2021