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Sterile Water For Irrigation

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CLINISOL


INSTRUCTIONS FOR USE

The following information is intended for healthcare professionals only:

Sterile, non pyrogenic solutions for Irrigation

Visual Inspection

1    Ensure that the irrigation 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.


Pack Preparation

1    Remove the pack from the protective overwrap by tearing downwards from the slit.

2    Carefully straighten hanger and ports if necessary.

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

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

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

6    An air inlet is not required.

7    Discard all packs and equipment after use. Do not store partly used packs.

Addition of Drugs

1    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.

2    Where possible, ready made solutions should be used.

3    Check the drug/solution compatibility.

4    Drugs should only be added immediately prior to use and strict aseptic technique employed throughout the procedure.

5    Do not add drugs until the hanger and ports have been straightened and the visual inspection completed.

6    This presentation is latex free.

Product Codes

Sterile Water    For Irrigation 1000ml(GR051)

LEAF/010/4


Terumo BCT Ltd., Larne, BT40 2SH, U.K.

PATIENT INFORMATION LEAFLET

STERILE WATER FOR IRRIGATION

CLINISOL


(WATER FOR INJECTIONS BP)

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 Sterile Water for Irrigation, which will be referred to as Sterile water throughout this leaflet.

What is in this leaflet:

1.    What Sterile water is and what it is used for

2.    What you need to know before you are given Sterile water

3.    How you are given Sterile water

4.    Possible side effects

5.    How to store Sterile water

6.    Contents of the pack and other information

1.    WHAT STERILE WATER IS AND WHAT IT IS USED FOR

Sterile water is a sterile irrigation (washing) fluid. Your doctor has prescribed Sterile water to irrigate wounds and cavities. Sterile water may also be used to dilute antiseptic solutions.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN STERILE WATER

Sterile water should not be infused into a vein.

Other medicine and Sterile water

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.

Driving and using machines

Sterile water has no effect on driving or using machines.

3.    HOW YOU ARE GIVEN STERILE WATER

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Sterile water is used to irrigate wounds and cavities as needed in adults, children and the elderly.

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

If you take more Sterile water than you should

It is very unlikely that you will be given too much, as your doctor will know the correct amount to use. Talk

to your doctor if you have any concerns. However, there is a possibility of fluid absorption if this happens red blood cells may burst and kidney damage may occur. Your doctor will know what to do in this situation.

4.    POSSIBLE SIDE EFFECTS

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

There are no known side effects to this product.

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 STERILE WATER

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 Sterile water.

Store below 25‘C. Do not refrigerate.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

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

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Sterile water contains:

Water for Injections BP100.00% v/v

What Sterile water looks like and contents of the pack.

Sterile water comes in a PVC bags in the following sizes: Pack Sizes: 3000 ml, 1000 ml, 500 ml, 150 ml and 100 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Terumo BCT Ltd.

Old Belfast Road

Millbrook

Larne

Northern Ireland BT40 2SH United Kingdom

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

This leaflet was last approved in October 2016