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Sterilised Water For Injections

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Package Leaflet: Information for the User


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STERILISED WATER FOR INJECTIONS

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or nurse has told you.

   Keep this leaflet. You may need to read it again.

•    Ask your doctor or nurse if you need more information or advice.

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

What is in this leaflet

1.    What Sterilised Water for Injections is and what it is used for

2.    What you need to know before you use Sterilised Water for Injections

3.    How to use Sterilised Water for Injections

4.    Possible side effects

5.    How to store Sterilised Water for Injections

6.    Contents of the pack and other information

1.    WHAT STERILISED WATER FOR INJECTIONS IS AND WHAT IT IS USED FOR

Sterilised Water for Injections is a special type of water that has been carefully cleaned and purified so it does not contain any other ingredients. Sterilised Water for Injections is called a diluent because its main use is for diluting and preparing medicines before use.

Sterilised Water for Injections is used to dissolve and dilute other drugs that require mixing with water before they can be given as an injection or an infusion (a drip) into your veins, muscles or other tissues in the body.

Follow all directions given to you by your doctor carefully. You must talk to a doctor if you do not feel better or if you feel worse.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE STERILISED WATER FOR INJECTIONS

The contents of the vials should be examined before use to ensure that the liquid is clear, is not discoloured in any way and does not contain any particles. Ensure the glass container is undamaged.

Do not use Sterilised Water for Injections:

-    as an injection or infusion on its own.

Sterilised Water for Injections must not be injected or infused on its own. It must only be used to dissolve or dilute necessary drugs to be administered by your doctor or nurse. Warnings and precautions

Talk to your doctor or nurse before using Sterilised Water for Injections.

-    Sterilised Water for Injections should not be administered alone because it may cause damage to red blood cells (haemolysis).

Other medicines and Sterilised Water for Injections

Please tell your doctor if you are taking, have recently taken or might take any medicines in addition to the medicine that is going to be dissolved or diluted with Sterilised Water for Injections.

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 for advice before taking the medicine that is going to be dissolved or diluted with Sterilised Water for Injections.

Driving and using machines

Ask your doctor for advice before taking the medicine that is going to be dissolved or diluted with Sterilised Water for Injections.

3.    HOW TO USE STERILISED WATER FOR INJECTIONS

In the preparation of the medicine for use, the required volume of Sterilised Water for Injections will vary, depending on the medicine to which it is added. Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure.

Your doctor or nurse will use the correct amount of Sterilised Water for Injections to dissolve or dilute the medicine that you are receiving as an injection, or as an infusion (a drip) into your veins.

Your doctor will decide the dose of your medicine that you should receive and how long you will need to take it for. The dose will depend on the other medicine which is being dissolved or diluted with Sterilised Water for Injections.

If you use more Sterilised Water for Injections than you should

It is most unlikely that you will be given too much medicine by the doctor or nurse. Your doctor and nurse will be monitoring your progress and checking the medicine that you are given. The signs and symptoms of overdose will be related to those of the medicine which is being dissolved or diluted with Sterilised Water for Injections. However, if you feel unwell afterwards or have any discomfort, tell your doctor or nurse.

If you forget to take Sterilised Water for Injections

If you think that you have missed a dose or that you have been given too much of the medicinal product, contact your doctor. Do not take a double dose to make up for a forgotten dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If given on its own, intravenous injection of Sterilised Water for Injections may cause damage to red blood cells (haemolysis).

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 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 STERILISED WATER FOR INJECTIONS

Keep this medicine out of the sight and reach of children. Do not store above 30°C.

DO NOT FREEZE.

Do not use Sterilised Water for Injections if the bottle is damaged or if the contents are discoloured or contain particles.

Do not use Sterilised Water for Injections after the expiry date given on the carton and label. The expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Sterilised Water for Injections contains

Sterilised Water for Injections contains highly purified and sterile water.

What Sterilised Water for Injections looks like and the content of the pack

Sterilised Water for Injections is a clear, colourless, particle-free sterile solution used to prepare medicines for injection. It contains no other substances or anti-microbial agents. This product comes in clear glass vials containing 2.5 mL or 5 mL.

Marketing Authorisation Holder

Bio Products Laboratory Limited

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom

Marketing Authorisation Number

PL 08801/0057 Date of Revision of Text

March 2014

For further information or if you have any questions about the use of this product, please contact BPL via the Marketing Department at the address above or through: medinfo@bpl.co.uk.

Bio Products Laboratory


Bio Products Laboratory Limited

Dagger Lane, Elstree, Herts. WD6 3BX, U.K.

Tel: +44 (0) 20 8957 2200