Water for Injections 100% v/v Solvent for Parenteral Use
Water For Injections
Last verified
Veterinary medicinal product: solvent for parenteral use. Distribution category: POM-V (Veterinary Medicines Regulations 2013, Schedule 3). Active substance: Water For Injections.1
In short: questions and answers
- Does Water for Injections 100% v/v Solvent for Parenteral Use need a prescription?
- Prescription only. As stated in the registration decision.1
- Which animals is Water for Injections 100% v/v Solvent for Parenteral Use for?
- All species.1
- What is the active substance in Water for Injections 100% v/v Solvent for Parenteral Use?
- Water For Injections.1
- What is the withdrawal period of Water for Injections 100% v/v Solvent for Parenteral Use according to the leaflet?
- All species, meat: 0 days; All species, milk: 0 days.3
- Dispensing
- Prescription only1
POM-V: Prescription Only Medicine - Veterinarian. Supplied only on a prescription written by a veterinary surgeon who has assessed the animal.12
Supplied only on a veterinarian's prescription. As stated in the registration decision.
- Animal species
- All species1
- Active substance
- Water For Injections
- Manufacturer
- Marketing authorisation holder: Norbrook Laboratories Limited
Withdrawal period
Summary of product characteristics
Composition
Active Substance:
Water for Injections 100% v/v
Excipients:
For full list of excipients see section 6.1
6.1 List of excipients
None.
Pharmaceutical form
Solvent for parenteral use.
A clear, colourless sterile solvent.
Pharmacological properties
Not applicable.
Target species
As required
Indications
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.
Dosage
For parenteral use.
Dosage: as required
Contraindications
None
Adverse reactions
None
Warnings
Special precautions for use in animals
None
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None
Use during pregnancy, lactation or lay
Water for Injections is safe for use during pregnancy and lactation.
Interactions
None
Overdose
Not Applicable
Special warnings
No special warnings
Withdrawal period
Meat - Zero days
Milk – Zero hours
Incompatibilities
None known.
Immediate packaging
20ml, 50ml and 100ml clear grade I glass vials with bromobutyl bungs and aluminium seals.
Not all pack sizes may be marketed.
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 discarded.
This product does not contain an antimicrobial preservative.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Disposal of unused product
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Additional information
Vm: 02000/4122
9 DATE OF FIRST AUTHORISATION
17th May 1994
10 DATE OF REVISION OF THE TEXT
November 2008.
Registration holder
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
Northern Ireland
Regulations
- Veterinary Medicines Regulations 2013 (SI 2013/2033), Schedule 32