Summary of Product Characteristics (SmPC) - Water for injection BP
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
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. 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: www.mhra.gov.uk/yellowcard 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
None
6.2 Incompatibilities
None known
6.3 Shelf life
60 months for ampoules.
60 months for 1ml, 10ml 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 25ºC
6.5 Nature and contents of container
Ampoules
Type I clear glass ampoules, 2ml, 5ml, 10ml and 20ml packed in cardboard cartons to contain 10 ampoules.
Vials
- Type I clear glass vial, 10ml and 100ml, 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 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
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
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 01502/0003R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/06/1986 / 05/05/2005
10 DATE OF REVISION OF THE TEXT
13/03/2026