STERILE SODIUM CHLORIDE CONCENTRATE 30% W/V BP - patient leaflet, side effects, dosage

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
suffer from acute illness, pain, postoperative 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 antiinflammatory 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

100mm Measurement Verification Bar

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.

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

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