Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

SOLVENT AMPOULES WATER FOR INJECTIONS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

1.

NAME OF THE MEDICINAL PRODUCT
Solvent Ampoules (Water for Injections)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Solvent Ampoules containing 100% w/w Water for Injections Ph. Eur.

3.

PHARMACEUTICAL FORM
Solvent for parenteral use.
A clear, colourless solution.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For use as a solvent or diluent for injectable preparations.

4.2.

Posology and Method of Administration
For parenteral administration.

4.3.

Contra-indications
Not applicable.

4.4.

Special Warnings and Precautions for Use
Not applicable.

4.5.

Interactions with other Medicinal Products and other forms of Interaction
Not applicable.

4.6.

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
None.

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf Life
5 years.

6.4.

Special Precautions for Storage
No special precautions for storage.

6.5.

Nature and Contents of Container
Colourless glass ampoules Type I Ph.Eur. containing 1ml, 2ml or 5ml water for
injection.

6.6.

Instruction for Use/Handling
No special requirement.

7.

MARKETING AUTHORISATION HOLDER
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00031/0284

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/04/2006

10

DATE OF REVISION OF THE TEXT

25/04/2006

+ Expand Transcript

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.

Hide