Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Water For Injections
Norbrook Laboratories Limited
Water For Injections
Solvent for parenteral use
POM-V - Prescription Only Medicine – Veterinarian
All species
Diluent
Authorized
1994-05-17
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 Read the complete document