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Date: Monday, June 24, 2024 17:39

Description: Virbac 2013
Release 2.116
Tiacil 0.50% w/v Eye drops, solution
 
Species: Cats, Dogs, Rabbits
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Ear/eye/nose
Active ingredient: Gentamicin
Product:Tiacil 0.50% w/v Eye drops, solution
Product index: Tiacil 0.50% w/v Eye drops, solution
Withdrawal notes: Do not use in rabbits intended for human consumption
Incorporating:
Presentation
Eye drops, solution.
Sterile, opalescent, aqueous solution.
Active substance(s)
Gentamicin sulphate, (activity 600 IU/mg) 0.50% w/v
Excipients
Parahydroxybenzoic acid 0.09% w/v
Disodium Edetate 0.50% w/v
Hypromellose
Povidone K30
Sodium Chloride
Sodium Hydroxide (for pH adjustment)
Trometamol
Water for injection
Uses
Target species
Cats, dogs and rabbits
Indications for use, specifying the target species
For the treatment of blepharitis, conjunctivitis, keratoconjunctivitis (including post- operative keratitis) and anterior uveitis, in dogs, cats and rabbits
Dosage and administration
Apply 1 or 2 drops directly into the conjunctival sac three times a day until control is achieved, which in most cases can be expected after 5 to 7 days.
Care should be taken to avoid contamination of the contents during use. Ocular re-examination should be made at frequent intervals during extended therapy.
If there is no response to treatment withing 7 to 14 days or the condition worsens, the diagnosis should be re-established
Contra-indications, warnings, etc
Contraindications
Do not use in animals with known hypersensitivity to gentamicin or other aminoglycosides.
Special precautions for use
(i) Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Where possible, in vitro sensitivity tests should be undertaken prior to treatment.
Occular re-examination should be made at frequent intervals during prolonged therapy.
Tiacil Ophthalmic solution may be used in case of corneal erosion or superficial ulcer.
ii. Special precautions for the person administering the veterinary medicinal product to animals
People with known allergy (hypersensitivity) to aminoglycosides should avoid contact with this product.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Rare cases of local intolerance (conjunctival inflammatory reactions) can be observed at the onset of treatment. In rare cases acute irritation and pain may occur. These reactions are transitory, and they disappear spontaneously without any specific treatment.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
No special precautions.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cases of severe irritation, the treatment should be stopped immediately and the diagnosis reassessed.
Withdrawal period(s)
Not for use in rabbits intended for human consumption.
Pharmaceutical precautions
Pharmacodynamic properties
Gentamicin is a broad spectrum bactericidal antibiotic, active against such organisms as Klebsiella and Pseudomonas. Gentamicin is particularly effective on rapidly multiplying organisms. Gentamycin is lethal to susceptible bacteria mainly by binding to bacterial ribosomes and impairing protein synthesis.
Pharmacokinetic particulars
The application of one or two drops to the eye enables the persistence of therapeutic levels for more than 6 hours.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2years
Shelf life after opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25°C
Any contents remaining 28 days after the date on which the container was first opened should be discarded.
Care should be taken to avoid contamination of the contents during use. Following withdrawal of first dose, use the product within 28 days.
Nature and composition of immediate packaging
5 ml type II amber glass bottles with blue polyethylene low density cap and blue rubber chlorobutyl dropper.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused product or waste material should be disposed of in accordance with national requirements.
Keep out of the reach of children.
Legal category
Legal category: POM-V
Packaging quantities
Tiacil ophthalmic solution is supplied in 5 ml vials.
Marketing Authorisation Number
5653/4026.
Significant changes
GTIN
GTIN description:Tiacil Ophthalmic Solution 5ml
GTIN:3597133023848