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WATER FOR INJECTIONS AMPOULES 1ML

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Water for Injections Ampoules 1ml

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterilised water for injections Ph.Eur 1ml.

3.

PHARMACEUTICAL FORM
Ampoules 1 ml.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For use as a diluent for parental products.

4.2.

Posology and Method of Administration
Sterilised water for injections is to be used as required as a diluent for parental
products.
Method of administration.
Injection

4.3.

Contra-Indications
None known.

4.4.

Special Warnings and Special Precautions for Use
None.

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
None known.

4.6.

Pregnancy and Lactation
No special precautions.

4.7.

Effects on Ability to Drive and Use Machines
None.

4.8.

Undesirable Effects
None.

4.9.

Overdose
Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Sterilised Water for injections Ampoules 1ml which complies with the
requirements of Ph.Eur is safe for use as a diluent for parental products.

5.2.

Pharmacokinetic Properties
Sterilised Water for injections Ampoules is used as a diluent for parental
products.

5.3.

Pre-clinical Safety Data
None stated.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
None.

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf Life
60 months.

6.4.

Special Precautions for Storage
No special requirements.

6.5.

Nature and Content of Container
1ml ampoules of uncoloured borosilicate glass type 1 (Ph.Eur)

6.6.

Instructions for Use, Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Novartis Pharmaceuticals UK Limited
Trading as Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
GU17 5SR

8.

MARKETING AUTHORISATION NUMBER
PL 0101/0350.

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
10th June 1992/30th July 1997

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
November 1998

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