Summary of Product Characteristics (SmPC) - Sterilised water for Injections
1 NAME OF THE MEDICINAL PRODUCT
Sterilised water for injections
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solvent contains 1 ml of Sterilised water for injections.
Each 10 ml vial contains 10 ml of Sterilised water for injections.
Each 20 ml vial contains 20 ml of Sterilised water for injections.
3 PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear and colourless liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To be used as a solvent for dilution or reconstitution of suitable medicinal products for parenteral administration.
4.2 Posology and 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
None known.
4.4 Special warnings and precautions for use
None known.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
None known.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
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
None known.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, including irrigating solutions, ATC code V07AB.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics of the specific medicinal product to be reconstituted.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.
6.2 Incompatibilities
None known.
6.3 Shelf life
10 ml vial: 60 months.
20 ml vial: 60 months.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Vials
10 ml
1 x 10 ml vial.
Type I clear glass vial, 10 ml, with either a bromobutyl or chlorobutyl rubber stopper, plastic outer cap and inner aluminium ring.
20 ml
1 x 20 ml vial
Type I clear glass vial, 20 ml, with either a bromobutyl or chlorobutyl rubber stopper, plastic outer cap and inner aluminium ring.
6.6 Special precautions for disposal
Only to be used as a diluent.
The solution should only be used if it is clear without visible particles.
For single use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Bio Products Laboratory Limited,
Dagger Lane, Elstree, Herts, WD6 3BX, U.K.
8 MARKETING AUTHORISATION NUMBER(S)
PL 08801/0061
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 12 October 2021
10 DATE OF REVISION OF THE TEXT
15/04/2025