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STERILE WATER FOR INJECTION

Active substance(s): STERILE WATER FOR INJECTIONS

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sterile water for injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterile Water for Injection Ph. Eur. 100% w/v.

3

PHARMACEUTICAL FORM
Solution for injection or infusion

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To be used to reconstitute certain medicinal products.

4.2

Posology and method of administration
Intramuscular or intravenous injection.

4.3

Contraindications
Not applicable.

4.4

Special warnings and precautions for use
Not applicable.

4.5

Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6

Fertility, Pregnancy and lactation
Not applicable.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
Not applicable.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not applicable.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Not applicable.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
60 months.

6.4

Special precautions for storage
Discard any remaining solution after use.

6.5

Nature and contents of container
Ampoules:

Glass class I Ph. Eur., containing 1ml, 2ml, 3.2ml, 5ml or 10ml.

Vials: Glass class I Ph. Eur., containing 4ml, 7.8ml, 10ml, 15.6ml or 31.2ml.
All rubber stoppers for the vials used comply with Ph.Eur. testing for rubber closures.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ

8

MARKETING AUTHORISATION NUMBER(S)
PL 00057/1436

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13 February 1990/19 May 1995

10

DATE OF REVISION OF THE TEXT
18/02/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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