SODIUM CHLORIDE

INJECTION BP/ SODIUM CHLORIDE 0.9%w/v INTRAVENOUS INFUSION BP

Sterile, apyrogenic solutions for Intravenous Infusion

Visual Inspection

1    Ensure that the infusion fluid complies with the written prescription.

2    If ANY fluid is present inside the overwrap, regard the integrity of the pack as suspect and discard the solution.

3    Visually examine the fluid which should be clear and free from particles. If any particles are present, regard the integrity of the pack as suspect and discard the solution.

4    Read all precautionary notes and check the expiry date.

5    Do NOT reconnect partially used bags.

Pack Preparation

1    Remove the pack from the protective overwrap by tearing downwards from the serrated edge.

²    Carefully straighten hanger and ports if necessary.

³    The sterile giving port is protected by a removable section of the port plug. To remove this protector, twist off the top section while holding the bottom section.

4    Insert the giving set fully to produce a leak proof connection and suspend the pack from the infusion stand.

5    Prime and regulate the giving set in accordance with the manufacturer's instructions. If giving set becomes blocked do not pump contents back into pack but replace equipment.

6    An air inlet is not required.

7    Discard any unused portion. Do not store partly used packs.

8    Discard all packs and equipment after use.

Addition of Drugs

This pack has an additive port with a self-sealing septum designed for the addition of drugs using a syringe and needle, or drug transfer device. This is the only site for adding drugs.

Where possible, ready made solutions should be used. Check the drug/solution compatibility. Drugs should only be added immediately prior to use and strict aseptic technique employed throughout the procedure. Do not add drugs until the hanger and ports have been straightened and the container inspected.

1    Swab the drug additive site with the appropriate anti-bacterial fluid in accordance with current recommended practice and procedure.

2    Using a syringe and needle or drug transfer device, puncture the site and transfer the vial contents. Do not leave the needle or device in the site once the drug has been transferred. Removing the needle allows the rubber to reseal.

3    Ensure the adequate mixing of the contents before use. Observe the fluid for any changes which may indicate incompatibility.

4    Ensure that the addition has been recorded on the pack in accordance with routine procedure. The drug additive port should then be covered by an additive port cap to prevent further addition.

⁵    This presentation is latex free.

Terumo BCT Ltd., Larne, BT40 2SH, U.K. Tel: (028) 2827 3631

INJECTION BP/ SODIUM CHLORIDE 0.9%w/v

PATIENT INFORMATION LEAFLET

INTRAVENOUS INFUSION BP

Sodium chloride

Read all of this leaflet carefully before you start taking 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.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Sodium Chloride Injection BP / Sodium chloride 0.9% w/v for Intravenous Infusion BP, which will be referred to as sodium chloride 0.9% throughout this leaflet.

What is in this leaflet

1.    What sodium chloride 0.9% is and what it is used for

2.    What you need to know before you are given sodium chloride 0.9%

3.    How you are given sodium chloride 0.9%

4.    Possible side effects

5.    How to store sodium chloride 0.9%

6.    Contents of the pack and other information

1.    WHAT SODIUM CHLORIDE 0.9% IS AND WHAT IT IS USED FOR

Sodium chloride 0.9% is a sterile fluid for infusion into a vein. Your doctor has prescribed sodium chloride 0.9% to treat water loss (dehydration) and to correct salt (electrolyte) loss. Sodium chloride 0.9% is also used in the treatment of Addison's disease, which causes salt to be lost in the urine.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM CHLORIDE 0.9%

Do not take sodium chloride if you have high levels of sodium in your blood (hypernatremia) or high levels of chloride (hyperchloremia).

Warnings and precautions

Tell your doctor if you have any of the following conditions:

•    heart failure,

•    high blood pressure (hypertension),

•    a kidney disorder,

•    fluid under the skin (peripheral oedema),

•    water on the lungs (pulmonary oedema).

Young children and the elderly should not be given longterm treatment.

Other medicines and sodium chloride 0.9%

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Please tell your doctor if you are pregnant, think you are pregnant or breast-feeding.

Sodium chloride 0.9% will only be given in pregnancy and lactation under close medical supervision. Your doctor will take special care if you have toxaemia of pregnancy (high blood pressure and protein in the urine). This can be detected by a test carried out by a doctor.

Driving and using machines

Sodium chloride solution for injection has no effect on driving or using machines.

Important information about some of the ingredients of Sodium chloride 0.9%

Sodium chloride 0.9% contains sodium. This will be taken into consideration for patients on a controlled sodium diet.

3.    HOW YOU ARE GIVEN SODIUM CHLORIDE 0.9% Sodium chloride 0.9% will be given to you as an infusion (IV) in hospital by a doctor or a nurse.

Adults:

The normal dose is 1 litre over 6-8 hours, increasing to a maximum of 1 litre per hour.

Children:

The dosage depends on body weight and condition of the patient. Sodium chloride 0.9% should not be given for long periods.

Elderly:

The dosage depends on the condition of the patient.

Sodium chloride 0.9% should not be given for long periods.

If you are given more Sodium chloride than you should

It is very unlikely that you will be given too much, as your doctor will know the correct amount to give you. However, tell your doctor if you have any concerns.

Symptoms of overdose include restlessness, weakness, thirst, dry mouth and eyes, swollen tongue, flushing of the skin, fever, dizziness, headache, reduced urine, low blood ressure, fast heart rate, being delirius, panting and stopped reathing.

If overdose occurs, a doctor will correct the fluid and electrolyte imbalance.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Sodium chloride 0.9% can cause side effects, although not everybody gets them.

Swelling of the vein cause by a blood clot is possible with an infusion. If sodium chloride leaks into the tissue it may cause swelling and skin damage.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE SODIUM CHLORIDE 0.9%

Keep this medicine out of the sight and reach of children. Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of sodium chloride 0.9% solution.

Store below 25°C. Do not refrigerate.

Do not use after the expiry date. Any unused solution should be discarded.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Sodium Chloride 0.9% contains:

Each 100 ml contains 0.9 g of sodium chloride.

The only excipient is Water for Injections BP

What Sodium Chloride 0.9% looks like and contents of the pack.

Sodium chloride 0.9% comes in PVC bags in the following sizes: 2000 ml, 1000 ml, 500 ml, 250 ml 100 ml, 70 ml and 50 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Terumo BCT Ltd.

Old Belfast Road

Millbrook

Lame

Northern Ireland BT40 2SH United Kingdom

For any information about this medicinal product, please contact Marketing Authorisation Holder.

This leaflet was last approved in June 2016

LEAF/101/4