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Water for Injections Ph.Eur

Active Ingredient:

water for injection

Company:

Baxter Healthcare Ltd See contact details

ATC code:

V07AB

About Medicine

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL)

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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.

Last updated on emc: 03 Jun 2025

View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 0116/0324.

Print patient leaflet as text only

Water for Injections Ph.Eur

PACKAGE LEAFLET: INFORMATION FOR THE USER

Water for Injections Ph. Eur.

Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Water for Injections is and what it is used for
2. What you need to know before you are given Water for Injections
3. How you will be given Water for Injections
4. Possible side effects
5. How to store Water for Injections
6. Contents of the pack and other information

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

Water for Injections is pure, sterile water. It is used to dilute medicines before use. For example, medicines that are given by:

injection (given using a needle, for example into your vein)
infusion (slow injection) into a vein, also called a ‘drip’.

2. What you need to know before you are given Water for Injections

Do not receive Water for Injections on its own. If injected into your bloodstream on its own it can cause your red blood cells to take in water and burst (haemolysis). This is because Water for Injections does not have the same consistency as your blood.

Water for Injections will always be mixed with one or more medicines by a healthcare professional before you receive it.

You should read the Package Leaflet of your medicine or medicines that are being mixed with Water for Injections. These will tell you whether or not you can receive the solution.

Warnings and precautions

Water for Injections should not be used on its own. Before you use Water for Injections:

it will always be mixed with one or more medicines
your healthcare professional will make sure that the mixture is roughly the same consistency as your blood (isotonic). Depending on the type of medicine you are given, this will mean that:
- the medicine needs to be diluted with Water for Injections
- another substance needs to be added to your mixture of Water for Injections and medicine before use.

Haemolysis (breaking up of red blood cells) can occur if you are given Water for Injections.

The haemoglobin released by the damaged red blood cells may cause kidney failure in some patients.

To help prevent this, your doctor will take a blood sample to monitor the balance of the chemicals in your blood (the ionic balance).

Before you are given medicines mixed with Water for Injections your doctor will check that:

the medicines are stable in Water for Injections
the medicines will not interact with each other.

Other medicines and Water for Injections

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

The medicines you are using mixed with Water for Injections may interact with each other.

Water for Injections with food, drink and alcohol

You should ask your doctor about what you can eat or drink.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or a planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Any risk to your unborn baby or your pregnancy will depend on which medicines you are using mixed with Water for Injections.

Any risk to your baby during breast-feeding will also depend on which medicines you are using mixed with Water for Injections.

Your doctor will be able to advise you on what risks are involved in taking particular medicines.

Your doctor will only give you medicines during pregnancy or breast-feeding if it is essential.

Driving and using machines

Water for Injections does not affect your ability to drive or use machines.

Any effects on your ability to drive or use machines will depend on which medicines you are using mixed with Water for Injections. Your doctor will be able to advise you on this.

3. How you will be given Water for Injections

Water for Injections will be given to you by a doctor or nurse.

Your doctor will decide on how much you need and when and how it is to be given. This will depend on which medicine or medicines you need to take with Water for Injections.

Your doctor will also consider your age, weight, condition and what other treatments you are receiving.

You should NOT be given Water for Injections if there are particles floating in the water or if the pack is damaged in any way.

If you receive more Water for Injections than you should

if you are given too much Water for Injections (over-infusion) this may lead to haemolysis. Haemolysis is when your red blood cells take in water and burst.

The medicines mixed with Water for Injections may also cause symptoms if administered in too large quantities (over-infusion). Any signs and symptoms of overdose will depend on which medicines you are using mixed with Water for Injections.

If you are accidentally given an overdose your treatment will be stopped and you will be given treatment depending on the symptoms.

You should read the Package Leaflet of the medicines mixed with Water for Injections for a list of possible symptoms of over-infusion.

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

4. Possible side effects

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

You may suffer bursting (haemolysis) of your red blood cells if:

you use Water for Injections on its own
Water for Injections is used to make solutions for injection or infusion that are not of a similar consistency to your blood (isotonic).

If a medicine has been added to Water for Injections, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added. You should read the Package Leaflet of the added medicine for a list of possible symptoms.

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

United Kingdom

Via the

Yellow Card Scheme:

website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL
Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: [email protected]

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Water for Injections

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

This medicine does not require any special storage conditions.

Do not remove Water for Injections from the outer plastic overpouch until it is to be used.

Water for Injections should NOT be given to you after the expiry date which appears on the bag after EXP. The expiry date refers to the last day of that month.

Once the pack is opened Water for Injections should be used straight away.

6. Contents of the pack and other information

What Water for Injections contains

The only ingredient is sterile water for injections.

Each bag contains 100% sterile water for injections.

What Water for Injections looks like and contents of the pack

Water for Injections is a clear and colourless solution. It is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

50 ml
100 ml
250 ml
500 ml
1000 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

50 bags of 50 ml
50 bags of 100 ml
60 bags of 100 ml
30 bags of 250 ml
20 bags of 500 ml
10 bags of 1000 ml
12 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder :

United Kingdom

Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

Ireland and Malta

Baxter Holding B.V.
Kobaltweg 49
3542CE Utrecht
Netherlands

Manufacturers for Great Britain:

Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

Baxter S.A.
Boulevard R. Branquart, 80
7860 Lessines
Belgium

Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñànigo (Huesca)
Spain

Vantive Manufacturing Limited
Moneen Road
Castlebar
County Mayo
Ireland

Manufacturers for Ireland and Malta:

Baxter S.A.
Boulevard R. Branquart, 80
7860 Lessines
Belgium

Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñànigo (Huesca)
Spain

Vantive Manufacturing Limited
Moneen Road
Castlebar
County Mayo
Ireland

This leaflet was last revised in September 2024

For information about Water for Injections or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:

Tel: +44 (0)1635 206345.

Baxter and Viaflo are trademarks of Baxter International lnc.

TH-30-02-248