Sterilised water for injections 10 ml & 20 ml

To be used as a solvent for dilution or reconstitution of suitable medicinal products for parenteral 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.

None known.

None known.

None known.

None known.

None known.

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.

None known.

Pharmacotherapeutic group: Solvents and diluting agents, including irrigating solutions, ATC code V07AB.

Not applicable.

No further information other than that which is included in the Summary of Product Characteristics of the specific medicinal product to be reconstituted.

None.

None known.

10 ml vial: 60 months.

20 ml vial: 60 months.

Do not store above 25° C.

Vials

10 ml

1 x 10 ml vial.

Type I clear glass vial, 10 ml, with a bromobutyl rubber stopper, plastic outer cap and inner aluminium ring.

20 ml

1 x 20 ml vial

Type I clear glass vial, 20 ml, with a chlorobutyl rubber stopper, plastic outer cap and inner aluminium ring.

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.