Sterilised Water for Injections 2.5 ml & 5 ml

Summary of Product Characteristics Updated 29-Mar-2023 | Bio Products Laboratory Limited

1. Name of the medicinal product

Sterilised Water for Injections

2. Qualitative and quantitative composition

Each ml of solvent contains 1 ml 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

4 years.

6.4 Special precautions for storage

Do not store above 30° C. Do not freeze.

6.5 Nature and contents of container

Type I clear glass 5 ml vial closed with a halobutyl rubber stopper and an aluminium overseal with a polypropylene flip off tamper evident cap.

Pack sizes: 2.5 ml or 5 ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Only to be used as a diluent.

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

Discard after single use.

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

7. Marketing authorisation holder

Bio Products Laboratory Limited,

Dagger Lane, Elstree, Hertfordshire, WD6 3BX,

United Kingdom.

8. Marketing authorisation number(s)

PL 08801/0057

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 15 August 2014

10. Date of revision of the text

03/2023.

Company Contact Details
Bio Products Laboratory Limited
Address

Dagger Lane, Elstree, Hertfordshire, WD6 3BX

Medical Information Direct Line

+44 (0)20 8957 2622

WWW

http://www.bpl.co.uk

Medical Information e-mail
Telephone

+44 (0)20 8957 2200

Customer Care direct line

+44 (0)20 8957 2342

Medical Information Fax

+44 (0)20 8957 2611

Fax

+44 (0)20 8957 2601