Water For Injections
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for Injections BP
3 PHARMACEUTICAL FORM
Solvent for parenteral use
Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.
4.2 Posology and method of administration
Route of administration: As appropriate to the reconstituted drug.
Dosage: In accordance with the particular situation for which Water for Injections BP is being used.
4.3 Contraindications
None known
4.4 Special warnings and precautions for use
None known
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
May be used during this period
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
None known
4.9 Overdose
No effects anticipated with the proposed use.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Not applicable.
6.2 Incompatibilities
Water for Injections BP should not be mixed with any other agents unless their compatibility has been established.
6.3 Shelf life
5 years (60 months).
If only part of the contents of an ampoule is used, the remaining solution should be discarded.
6.4 Special precautions for storage
Keep the container in the outer carton in order to protect from light.
Do not store above 25°C.
6.5 Nature and contents of container
2ml, 5ml and 10ml clear glass ampoules, glass, type 1 Ph. Eur. borosilicate glass packed in cardboard cartons to contain 10 ampoules.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Mercury Pharma International Ltd 4045, Kingswood Road,
City West Business Park,
Co Dublin, Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 02848/5924R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/09/1986 / 08/02/2005
10 DATE OF REVISION OF THE TEXT
23/08/2012