Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Water for Injections Ph.Eur
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Water for injection may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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'.
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Your doctor will be able to advise you on what risks are involved in taking particular medicines.
The haemoglobin released by the damaged red blood cells may cause kidney failure in some patients.
Your doctor will only give you medicines during pregnancy or breast-feeding if it is essential.
To help prevent this, your doctor will take a blood sample to monitor the balance of the chemicals in your blood (the ionic balance).
Driving and using machines
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.
Water for Injections does not affect your ability to drive or use machines.
Other medicines and Water for Injections
What you need to know before you take it
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
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.
How to take it
Water for Injections
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
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.
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.
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.
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.
Pregnancy, breast-feeding and fertility
If you receive more Water for Injections than you should
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.
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.
Any risk to your unborn baby or your pregnancy will depend on which medicines you are using mixed with Water for Injections. The medicines mixed with Water for Injections may also cause symptoms if administered in Any risk to your baby during breast-feeding too large quantities (over-infusion). Any signs will also depend on which medicines you are and symptoms of overdose will depend on using mixed with Water for Injections. TH-30-02-248 2
United Kingdom Via the Yellow Card Scheme: website: If you are accidentally given an overdose your www.mhra.gov.uk/yellowcard treatment will be stopped and you will be Ireland given treatment depending on the symptoms. HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; You should read the Package Leaflet of the medicines mixed with Water for Injections for Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; a list of possible symptoms of over-infusion. E-mail: [email protected]. If you have any further questions on the use Malta of this product, ask your doctor. ADR Reporting Website: 4. Possible side effects www.medicinesauthority.gov.mt/adrportal which medicines you are using mixed with Water for Injections.
Like all medicines, this medicine can cause
How to store it
Water for Injections
You may suffer bursting (haemolysis) of your red blood cells if:
Keep this medicine out of the sight and reach of children.
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This medicine does not require any special storage conditions.
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).
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.
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.
Once the pack is opened Water for Injections should be used straight away.
Contents of the pack and other information
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.
What Water for Injections contains The only ingredient is sterile water for injections. Each bag contains 100% sterile water for injections.
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What Water for Injections looks like and contents of the pack
Norfolk – IP24 3SE United Kingdom
Baxter S.A. Water for Injections is a clear and colourless Boulevard R. Branquart, 80 solution. It is supplied in polyolefin/polyamide 7860 Lessines plastic bags (Viaflo). Each bag is wrapped in a Belgium sealed, protective, outer plastic overpouch. Bieffe Medital S.A. The bag sizes are: Ctra de Biescas-Senegüé
- 50 ml 22666 Sabiñànigo (Huesca)
- 100 ml Spain
- 250 ml Vantive Manufacturing Limited
- 500 ml Moneen Road
- 1000 ml Castlebar – County Mayo The bags are supplied in cartons. Each carton Ireland contains one of the following quantities: Manufacturers for Ireland and Malta:
- 50 bags of 50 ml Baxter S.A.
- 50 bags of 100 ml Boulevard R. Branquart, 80
- 60 bags of 100 ml 7860 Lessines
- 30 bags of 250 ml Belgium
- 20 bags of 500 ml Bieffe Medital S.A.
- 10 bags of 1000 ml Ctra de Biescas-Senegüé
- 12 bags of 1000 ml 22666 Sabiñànigo (Huesca) Spain Not all pack sizes may be marketed. Vantive Manufacturing Limited Moneen Road Castlebar – County Mayo Ireland
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder : United Kingdom Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
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.
Ireland and Malta Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
Baxter and Viaflo are trademarks of Baxter International lnc.
Manufacturers for Great Britain: Baxter Healthcare Ltd. Caxton Way Thetford 4
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Water for Injections Ph. Eur. The following information is intended for medical or healthcare professionals only: Handling and Preparation
The following fill volumes should be taken into consideration when preparing infusions :
59 ml for the 50 ml bag 111 ml for the 100 ml bag 271 ml for the 250 ml bag Use only if the solution is clear, without visible 530 ml for the 500 ml bag particles and if the container is undamaged. 1040 ml for the 1000 ml bag Administer immediately following the 1. Opening insertion of an infusion set. a. Remove the Viaflo container from the Do not remove unit from overwrap until ready overpouch just before use. for use. The inner bag maintains the sterility of the b. Check for minute leaks by squeezing product. inner bag firmly. If leaks are found, Do not use plastic containers in series discard solution, as sterility may be connections. Such use could result in air impaired. embolism due to residual air being drawn c. Check the solution for limpidity from the primary container before the and absence of foreign matters. administration of the fluid from the secondary If solution is not clear or contains container is completed. foreign matters, discard the solution. Water for Injections should not be infused 2. Preparation for administration alone. after rendering isotonic The infusion should be made isotonic prior to parenteral administration. a. Suspend container from eyelet Additives may be introduced before support. administration or during administration b. Remove plastic protector from outlet through the re-sealable medication port. port at bottom of container: Thorough and careful aseptic mixing of any
- grip the small wing on the neck additive is mandatory. Solutions containing of the port with one hand, additives should be used immediately and not
- grip the large wing on the cap stored. with the other hand and twist, The infusion should be administered with
- the cap will pop off. sterile equipment using an aseptic technique. c. Use an aseptic method to set up the The equipment should be primed with the infusion. infusion in order to prevent air entering the d. Attach administration set. Refer to system. complete directions accompanying set Discard after single use. for connection, priming of the set and Discard any unused portion. administration of the solution. Do not reconnect partially used bags. 5
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3. Techniques for injection of additive medications
From a microbiological point of view, the diluted product should be used immediately, unless reconstitution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Warning: Additives may be incompatible: To add medication before administration a. Disinfect medication port. b. Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject. c. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.
5. Incompatibilities of additive medications As with all parenteral solutions, before adding medications, compatibility of these additives with the solution in the Viaflo container must be assessed. The Instructions for Use of the medicinal product to be added must be consulted. Before adding a medicinal product, verify it is soluble and stable in water at the pH of Water for Injections (4.5 to 7.0).
Caution: Do not store bags containing added medications. To add medication during administration a. Close clamp on the set. b. Disinfect medication port. c. Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject. d. Remove container from IV pole and/ or turn to an upright position. e. Evacuate both ports by tapping gently while the container is in an upright position. f. Mix solution and medication thoroughly. g. Return container to in-use position, re-open the clamp and continue administration.
4. In-use shelf-life: Additives
Baxter and Viaflo are trademarks of Baxter International lnc.
Chemical and physical stability of any additive at the pH of Water for Injections (4.5 to 7.0) in the container should be established prior to use. 6
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Frequently asked questions about Water for Injections Ph.Eur
What is the active substance in Water for Injections Ph.Eur?
The active substance in Water for Injections Ph.Eur is water for injection.
Are there equivalent medicines to Water for Injections Ph.Eur?
Medicines with the same active substance, strength and form include: Water for Injections BP, Water for Injections BP, solvent for parenteral use. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Water for Injections Ph.Eur, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Water for Injections Ph.Eur without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: water for injection
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Sterile Water for Injection is indicated to serve as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.
4.2. Posology and method of administration
Posology
The dosage administered will be dictated by the nature of the additive used. The administration rate will be dependent upon the dose regimen of the prescribed drug.
Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.
Method of administration
The solution is for dilution and delivery of the therapeutic additives. The directions for use related to the added medicinal product will dictate the appropriate volumes as well as the administration route.
4.3. Contraindications
Water for Injections should not be administered alone.
The contraindications related to the added medicinal product should be considered.
4.4. Special warnings and precautions for use
Water for Injections is hypotonic and should not be administered alone.
Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.
When Water for Injections is used as diluent of hypertonic solutions, appropriate dilution should be applied to bring the solution close to isotonicity.
Haemolysis may occur following infusion of Sterile Water for Injections. Haemoglobin induced renal failure has been reported following haemolysis.
When administering large volumes, the ionic balance should be regularly monitored.
The large volume presentations (500 and 1000ml) are for use as a bulk source of diluent in pharmacy compounding. They are not for direct intravenous administration.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The possible clinical interactions between the different medicinal products to be dissolved should be considered.
4.6. Fertility, pregnancy and lactation
The risks during use in pregnancy and in lactating women are determined by the nature of the added medicinal products.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data.
ADVERSE REACTIONS
System Organ Class (SOC)
MedDRA Preferred Term
Frequency
Blood and lymphatic system disorders
- haemolysis
Not known
The nature of the additive will determine the likelihood of any other undesirable effects.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
Haemolysis may occur following over-infusion of hypotonic solutions using sterile water for injections as diluent (see 4.4 Warnings and Precautions).
The signs and symptoms of overdose will also be related to the nature of the medicinal product being added. In the event of accidental overdose, the treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the medicinal product administered.
💬 Ask about this leaflet
Ask anything about Water for Injections Ph.Eur. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.