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Document: leaflet MAH GENERIC_PL 03551-0077 change

• leaflet MAH GENERIC_PL 02848-0228
• leaflet MAH GENERIC_PL 02848-5924R
• leaflet MAH GENERIC_PL 03551-0077

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— PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Melsungen AG • 34209 Melsungen, Germany

Water for Injections BP

solvent for parenteral use

In this leaflet:

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

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

3    How to use Water for Injections BP

4    Possible side effects.

5    How to store Water for Injections BP

6    Contents of the pack and other information

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

Water for Injections BP is sterile water for injections.

This is used for the preparation and dilution of medicines that are to be administered into your vein (parenteral use).

2 What you need to know before you use Water for Injections BP

Do not use Water for Injections BP

There are no known situations in which Water for Injections BP should not be used.

Warnings and precautions

Water for injections BP must not be used alone. Your doctor will dissolve or dilute another medicine in water for injection before the ready prepared medicine is administered to you.

Other medicines and Water for Injections BP

There are no known interactions with other medicines.

Water for Injections BP with food and drink

There are no known interactions with food or drink

Pregnancy and breast-feeding

Water for Injections BP can be used during pregnancy and breast-feeding.

Driving and using machines

Water for Injections BP has no influence on the ability to drive and use machines.

3 How to use Water for Injections BP.

This medicine is administered to you by a doctor or healthcare professional.

The method of administration depends on the instructions given for the medicinal product to be dissolved or diluted. The medicinal product should be reconstituted or diluted immediately before use.

The dosage of Water for Injections BP and the duration of the application are in accordance with the instructions pertaining to the medicine dissolved or diluted.

If you use more Water for Injections BP than you should

An overdose is very unlikely as this medicine is only for preparation and dilution of parenteral preparations.

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

4 Possible side effects.

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

There are no known side effects if the instructions for use are followed. 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: Website: 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 Water for Injections BP

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container and the outer carton after “EXP". The expiry date refers to the last day of the month.

For the product in plastic ampoules: Do not store above 25°C.

There are no special precautions for storage for product in polyethylene containers.

Do not use this medicine if you notice the container is damaged and the liquid is unclear or coloured.

For single use only. Discard any unused medicine.

6. Contents of the pack and other information

What Water for Injection BP contains

• 100 ml Water for Injections BP Water for Injections 100 ml

What Water for Injections BP looks like and contents of the pack

Water for Injections BP is a solvent for parenteral use: it is used to dissolve or dilute medicine that are to be administered into your vein.

It is a clear, colourless liquid

BIBRAUN

Schwarz 210x297 mm 25/13103121/1014 Latus: 733 GroBbritannien Font size 9

It is available in:

•    Plastic polyethylene ampoules, contents: 5 ml, 10 ml, 20 ml supplied in packs of:

20 x 5 ml, 20 x 10 ml, 20 x 20 ml, 100 x 5 ml, 100 x 10 ml, 10 0 x 20 ml

•    Plastic propylene ampoules, contents: 10 ml, 20 ml supplied in packs of:

20 x 10 ml, 100 x 10 ml, 20 x 20 ml, 100 x 20 ml

•    Bottles of low- density polyethylene (LD-PE), contents: 50 ml, 100 ml, 250 ml, 500 ml, 1000ml

supplied in packs of:

20 x 50 ml, 10 x 100 ml, 20 x 100ml, 10 x 250 ml, 20 x 250 ml, 10 x 500 ml, 10 x 1000 ml

Not all pack sizes may be marketed.

The following information is intended for medical or healthcare professionals only:

After preparation of the ready-to-use medicinal product From a microbiological point of view, the ready-to-use preparations should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

For the preparation of parenteral solutions usual hygiene precautions to maintain sterility must be adhered to.