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Drug information

POM
Read time: 1 mins
Last updated: 02 Aug 2023
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Summary of product characteristics


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.


4.1. 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.


5.1. 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.


6.1. 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 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.


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.

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

04/2023.

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.

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Disclaimer

The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

Medthority will not be held liable for explicit or implicit errors, or missing data.

Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).