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Water for Injections BP

Active Ingredient:
water for injection
hameln pharma ltd See contact details
About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 17 Apr 2023
1. Name of the medicinal product

Water for Injections BP.

2. Qualitative and quantitative composition

Each ml contains 100% Water for Injections Ph. Eur.

3. Pharmaceutical form

Solvent for parenteral use

4. Clinical particulars
4.1 Therapeutic indications

Water for Injections BP is indicated to be used as a solvent for dilution and reconstitution of suitable medicinal products for parenteral administration.

4.2 Posology and method of administration


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. The solution should only be used if it is clear without visible particles.

Method of administration

For parenteral use.

The directions for use will be dependent upon the appropriate medicinal product to which this solvent is added, which will dictate the appropriate volumes as well as administration route.

4.3 Contraindications

Water for Injections should not be administered alone because it may cause haemolysis.

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 as it may cause hemolysis.

4.5 Interaction with other medicinal products and other forms of interaction

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 are determined by the nature of the added medicinal products.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

May cause haemolysis if administered alone.

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 at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

No effects are anticipated if used as instructed.

Haemolysis may occur following infusion of large volumes of hypotonic solutions using water for injections as a diluent.

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Solvents and Diluting Agents.

ATC code: VO7AB.

Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacodynamics will depend on the nature of the drug added.

5.2 Pharmacokinetic properties

Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacokinetics will depend on the nature of the drug added.

5.3 Preclinical safety data

Water for Injections being only the vehicle for the administration of the added medicinal product, the preclinical safety data for the solutions in use will depend on the nature of the drug added.

6. Pharmaceutical particulars
6.1 List of excipients


6.2 Incompatibilities

None known.

6.3 Shelf life

60 months for ampoules.

60 months for 1ml and 30ml vials.

48 months for 20ml vials

36 months for 50ml and 200ml vials.

24 months for 100ml vials

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container


Type I clear glass ampoules, 2ml, 5ml, 10ml and 20ml packed in cardboard cartons to contain 10 ampoules.


Type I clear glass vial, 10ml, with a bromobutyl rubber stopper.

Type I clear glass vial, 20ml, with a chlorobutyl rubber stopper.

Type II clear glass vials, 1ml, 2ml, 30ml, 50ml, 100ml and 200ml, with a bromobutyl rubber stopper.

Plastic outer cap and inner aluminium ring packed in cardboard cartons to contain either 1, 10 vials or 25 vials.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

hameln pharma ltd

Nexus, Gloucester Business Park

Gloucester, GL3 4AG


8. Marketing authorisation number(s)

PL 01502 / 0003R

9. Date of first authorisation/renewal of the authorisation

27th June 1986 / 6th May 2005

10. Date of revision of the text


hameln pharma ltd
Company image
Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
+44 (0)1452 621 661
+44 (0)1452 632 732
Medical Information e-mail
[email protected]