Summary of Product Characteristics (SmPC) - Water for Injections Pheur 100% w/v
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 Limited
980 Great West Road, Brentford,
Middlesex TW8 9GS
Trading as
GlaxoSmithKline UK
8. MARKETING AUTHORISATION NUMBER(S)
PL 10592/0021
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22nd September 1998
10 DATE OF REVISION OF THE TEXT
02/07/2020