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WATER FOR INJECTIONS PHEUR 100% W/V

Active substance(s): WATER FOR INJECTIONS / WATER FOR INJECTIONS / WATER FOR INJECTIONS

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PRODUCT SUMMARY
1.

NAME OF THE MEDICINAL PRODUCT
Water for Injections, PhEur, 100% w/v.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for Injections PhEur, 100% w/v for reconstitution of vaccines

3.

PHARMACEUTICAL FORM
Diluent containing sterile solution for the reconstitution of lyophilised vaccine
preparations.

4

CLINICAL PARTICULARS

4.1

Therapeutic Indications
For reconstitution of freeze-dried vaccines.

4.2

Posology and Method of administration
As for product to be reconstituted
Route of Administration:
Subcutaneous or intramuscular injection.

4.3

Contra-Indications
As for product to be reconstituted.

4.4

Special Warnings and Special Precautions For Use
As for product to be reconstituted.

4.5
Interactions with other Medicinal Products and other Forms of
Interaction
As for product to be reconstituted.

4.6

Pregnancy and Lactation
As for product to be reconstituted.

4.7

Effects on Ability to Drive and Use Machines
As for product to be reconstituted.

4.8

Undesirable Effects
As for product to be reconstituted.

4.9

Overdose
As for product to be reconstituted.

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
As for product to be reconstituted.

6.3

Shelf Life
24 months.
After reconstitution: 1 Hour.

6.4

Special Precautions for Storage
Protect from light, store between 2 - 8°C. Do not freeze.

6.5

Nature and Contents of Container
Type I, Ph Eur glass syringes with stainless steel needle fitted with rubber
needle shields and stoppers. The stoppers are attached to a polypropylene or
polystyrene plunger.
Type I, Ph Eur clear glass vials with rubber closures and Aluminium overcaps.
Type I, Ph Eur clear glass ampoules (self-sealed, breakable).
Type I, PhEur glass needleless syringe fitted with a rubber tip cap and
backstop device. The stoppers are attached to polypropylene or polystyrene
plunger.

A separate needle fitted with needle shield may be supplied in the carton.
6.6

Instructions for Use/Handling
None

7.

MARKETING AUTHORISATION HOLDER
SmithKline Beecham Plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as:
GlaxoSmithKline UK,
Stockley Park West,
Uxbridge,
Middlesex,
UB11 1BT

8.

MARKETING AUTHORISATION NUMBER(S)
PL 10592/0021

9.
DATE OF
AUTHORISATION

FIRST

AUTHORISATION/RENEWAL

22nd September 1998

10

DATE OF REVISION OF THE TEXT
18/09/2013

OF

THE

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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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