SODIUM CHLORIDE 0.18% AND GLUCOSE 4% INFUSION BP POLYFUSOR AS STERIFLEX NO. 18 OR FREEFLEX - patient leaflet, side effects, dosage

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sodium Chloride and Glucose Solution for Infusion contains: The infusions contain sodium chloride, glucose, water for injections, hydrochloric acid, and sodium hydroxide. The concentration of each active ingredient can be seen in the name of product.

What Sodium Chloride and Glucose Solution for Infusion looks like and contents of the pack

Sodium Chloride and Glucose Solution for Infusion is a clear solution of sodium chloride and glucose in water.

The solution is contained in a sealed plastic container known as a Steriflex® bag or in a freeflex® infusion bag. It is available in 500 ml and 1000 ml bags.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way,

Manor Park, Runcorn, Cheshire, WA7 1NT. UK.

Manufacturer:

Fresenius Kabi Deutschland GmbH

Werk Friedberg

Freseniusstrage 1

61169 Friedberg

Germany

Terumo BCT Limited,

Old Belfast Road, Millbrook, Larne, Co. Antrim, BT40 2SH. UK.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Fresenius Kabi Limited

Cestrian Court

Eastgate Way

Manor Park

Runcorn

Cheshire

WA7 1NT

UK

+44 (0) 1928 533 533

This leaflet was last revised in month YYYY.

Sodium Chloride 0.9% and

Sodium Chloride 0.18% and

Sodium Chloride and Glucose

1. WHAT SODIUM CHLORIDE AND GLUCOSE SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR

Sodium Chloride and Glucose Solution for Infusion is a clear solution of sodium chloride and glucose in water.

The solution is contained in a sealed plastic container known as Steriflex® or freeflex®.

Two strengths of solution are available:

Sodium Chloride 0.9%, Glucose 5%

Sodium Chloride 0.18%, Glucose 4%

Sodium chloride (salt) helps to maintain the correct balance of fluid in and around the body’s cells and tissues. Sodium chloride is given by intravenous (into a vein) infusion to patients suffering from water loss or lack of sodium. Glucose is a simple sugar, which provides a source of energy. Sodium Chloride and Glucose Solution for Infusion is used where there has been excessive fluid loss from the body (dehydration) with carbohydrate loss.

2. what you need to know beforeyou are given sodium chloride and glucose solution for infusionyou should not receive sodium chloride and glucose solution for infusion if you have: - a known allergy (hypersensitivity) to sodium chloride, glucose or any of the other ingredients of sodium chloride and glucose solution for infusion (listed in section 6)

• – severely reduced kidney function

• – worsening of existing heart failure

• – reduced liver function

• – too much fluid in the spaces around the cells of body (hyperhydration)

• – a loss of water from the body (dehydration) with low levels of sodium

• – had a stroke resulting in permanent brain injury

• – had a head injury within the last 24 hours

• – very low levels of sodium

• – routine rehydration or fluid maintenance therapy.

Your doctor will check for this.

Warnings and precautions

Talk to your doctor or nurse before being given Sodium Chloride and

Glucose Solution for Infusion if you have:

• – reduced kidney function

• – heart failure

• – high blood pressure (hypertension)

• – build-up of fluid in the tissues, particularly around the ankles (peripheral oedema)

• – build-up of fluid in the lungs (pulmonary oedema)

• – high blood pressure during pregnancy (pre-eclampsia)

• – any other condition associated with sodium retention

(where the body retains too much sodium)

• – diabetes

• – a potassium deficiency

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).

Your doctor or nurse will ensure the solution is clear and free from particles before use.

Other medicines and Sodium Chloride and Glucose Solution for Infusion Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• It is particularly important that you inform your doctor or nurse if you are taking the following medicine as it can cause the body to accumulate sodium and water, leading to tissue swelling (oedema) and high blood pressure (hypertension): Corticosteroids

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 nurse for advice before using this medicine.

The doctor will then decide whether you should receive Sodium chloride and Glucose Solution for Infusion.

Driving and using machines

Sodium Chloride and Glucose Solution for Infusion has no effect on your ability to drive or use machines.

3. how you will be given sodium chlorideand glucose solution for infusionsodium chloride and glucose solution for infusion will be given to you in hospital.

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 nurse.

If you receive more Sodium Chloride and Glucose Solution for Infusion than you should

• It is very unlikely 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. If you are given too much Sodium Chloride and Glucose Solution for Infusion or you are given your infusion too quickly, this may lead to the following symptoms: water and/or sodium overload with build-up of fluid in the tissues (oedema) causing swelling headache
• nausea or vomiting
• diarrhoea or constipation
• abdominal cramping
• dark, concentrated urine
• irregular heartbeat
• fatigue or weakness
• convulsions or seizures
• muscle pain or weakness
• mood changes such as irritability, confusion, depression
• increased thirst
• frequent need to urinate.

4. possible side effects

Like all medicines, Sodium Chloride and Glucose Solution for Infusion can cause side effects, although not everybody gets them.

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 nurse.

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
• escape of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring
• increase in blood volume.

Other possible side effects:

• Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.
• Loss of potassium from the blood may be increased with the use of a sodium chloride-containing infusion. Your doctor may therefore decide to give you potassium supplements
• Reduced sodium levels.

Reporting of side effects

If you get any side effects, talk to your doctor, 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:

By reporting side effects you can help provide more information on the safety of this medicine.

• 5. HOW SODIUM CHLORIDE AND GLUCOSE SOLUTION FOR INFUSION IS STORED