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Sterilised Water for Injections 2.5 ml & 5 ml
Active Ingredient:
Company:
Bio Products Laboratory Limited
See contact details
ATC code:
V07AB
About Medicine
Prescription only medicine
My Account Area
This information is for use by healthcare professionals
Last updated on emc: 29 Mar 2023
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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.
Bio Products Laboratory Limited
Address
Dagger Lane, Elstree, Hertfordshire, WD6 3BX
Telephone
+44 (0)20 8957 2200
Medical Information Direct Line
+44 (0)20 8957 2622
Customer Care direct line
+44 (0)20 8957 2342
Medical Information Fax
+44 (0)20 8957 2611
Medical Information e-mail
[email protected]
Fax
+44 (0)20 8957 2601
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