Summary of medicine characteristics - WATER FOR INJECTIONS CSL BEHRING
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections CSL Behring
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 2, 2.5, 3, 4, 5, 6, 10, 15, 20, 40 or 50 mL Water for Injections
3 PHARMACEUTICAL FORM
Solvent for parenteral use
Clear, colourless liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For use as a solvent for reconstitution of suitable medicinal products for parenteral use
4.2 Posology and method of administration
Dosage and method of administration depend on the instructions given for the medicinal product to be dissolved or diluted.
4.3 Contraindications
Do not administer Water for Injections on its own
4.4 Special warnings and precautions for use
Water for Injections is hypotonic and it should not be administered alone
4.5 Interaction with other medicinal products and other forms of interaction
None
4.6 Fertility, pregnancy and lactation
None
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
None
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 UK Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseNone
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvent and diluting agent
ATC code: V07AB
Pharmacodynamics: Not applicable
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
5.3 Preclinical safety dataNot applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Not applicable
6.2 Incompatibilities
For possible interactions and incompatibilities check Summary of Product Characteristics and Package Information Leaflet of the medicinal product which is intended to be reconstituted with Water for Injections.
Those medicinal products known to be incompatible with Water for Injections must not be used.
6.3 Shelf life
2.5, 3, 4, 5, 6, 10, 15, 20, 40, 50 mL: 5 years
2 mL: 30 months
After opening, the product must be used immediately.
For in use shelf life, after reconstitution of the medicinal product, check Summary of Product Characteristics and Package Information Leaflet of the medicinal product which was reconstituted with Water for Injections.
6.4 Special precautions for storage
Do not freeze.
This medicinal product does not require any special storage conditions.
For storage conditions after first opening and reconstitution of the medicinal product, see section 6.3.
| 6.5 Nature and contents of container | |
| Pack sizes (1 vial per pack) | Container details |
| 2 mL, 2.5 mL, 3 mL, 4 mL, 5 mL | In 6 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and aluminium crimp-cap with polypropylene plastic disc For the filling size: 2 mL (overage 0.3 ml): Blue/ purple 2.5 mL (overage 0.3 mL): Blue/ blue 2.5 mL (overage 0.4 mL): Blue/ lime 2.5 mL (overage 0.6 mL): Blue/ light blue |
| 3 mL (overage 0.4 ml): Blue/ orange 4 mL (overage 0.3 mL): Blue/ grey 5 mL (overage 0.4 mL): Blue/ green | |
| 6 mL, 10 mL | In 10 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and aluminium crimp-cap with polypropylene plastic disc For the filling size: 6 mL (overage 0.1 ml): Blue/ lime 10 mL (overage 0.5 ml): Blue/ blue |
15 mL
In 15 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and aluminium crimp-cap with polypropylene plastic disc For the filling size:
15 mL (overage 0.5 ml): Blue/ blue
20 mL
In 25 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and aluminium crimp-cap with polypropylene plastic disc
For the filling size:
20 mL (overage 1 ml): Blue/ blue
40 mL, 50 mL
In 50 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and aluminium crimp-cap with polypropylene plastic disc For the filling size:
40 mL (overage 1.5 ml): Blue/ blue
50 mL (overage 2 ml): Blue/ blue
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalDiscard after single use.
Use only if the Water for Injections is clear, colourless, without visible particles and if the container is undamaged.
Reconstitution and withdrawal must be carried out under aseptic conditions.
Any unused solution should be disposed of in accordance with local requirements.