Tiacil 0.50% w/v Eye Drops, Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Gentamicin Sulphate

Available from:

Virbac

ATC code:

QS01AA11

INN (International Name):

Gentamicin Sulphate

Pharmaceutical form:

Eye drops, solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs, Rabbits

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1993-01-29

Summary of Product characteristics

Revised: August 2023
AN: 00016/2023
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tiacil 0.50% w/v Eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
Gentamicin sulphate, (activity 600
IU/mg)…………………………
% W/V
0.50
EXCIPIENTS
Parahydroxybenzoic
acid…………………………………………….
0.09
Disodium
Edetate……………………………………………………..
0.50
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Sterile, opalescent, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats, dogs and rabbits
4.2
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
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to gentamicin or
other
aminoglycosides.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into
Revised: August 2023
AN: 00016/2023
Page 2 of 4
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.
4.6
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
spontaneousl