Water for Injections Ph.Eur

• 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.

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

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.

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.

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

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.

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.

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 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

Ireland

Malta

The only ingredient is sterile water for injections.

Each bag contains 100% sterile water for injections.

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 :

United Kingdom

Ireland and Malta

Manufacturers for Great Britain:

Manufacturers for Ireland and Malta: