Water for Injections 100% v/v Solvent for Parenteral Use

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Water For Injections

Disponible des:

Norbrook Laboratories Limited

Designació comuna internacional (DCI):

Water For Injections

formulario farmacéutico:

Solvent for parenteral use

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

All species

Área terapéutica:

Diluent

Estat d'Autorització:

Authorized

Data d'autorització:

1994-05-17

Fitxa tècnica

Revised 19 November 2008
AN: 00171/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Water For Injection 100% v/v Solvent for Parenteral Use.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Water for Injections
100% v/v
EXCIPIENTS:
For full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Solvent for parenteral use.
A clear, colourless sterile solvent.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
As required
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use as a sterile solvent for the preparation of medicines intended
for
parenteral administration where water is a component of the
preparation and
for reconstituting or diluting medicines for parenteral administration
immediately before use.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings
Revised 19 November 2008
AN: 00171/2008
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Water for Injections is safe for use during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For parenteral use.
Dosage: as required
4.10
OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY
Not Applicable
4.11
WITHDRAWAL PERIOD
Meat - Zero days
Milk – Zero hours
5.
PHARMACOLOGICAL PROPERTIES
Not applicable.
6.
PHARMACEUTICAL PARTICULARS
6.1
LIST OF EXCIPIENTS
None.
6.2
INCOMPATIBILITIES
None known.
Revised 19 November 2008
AN: 00171/2008
6.3
SHELF LIFE
Shelf life of the veterinary medicinal product as packaged for sale: 2
years.
6.4
SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25

C
Take adequate precautions to maintain sterility.
Any solution remaining in the vial following withdrawal of the
required dose
should be