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)…………………………

Excipients

Parahydroxybenzoic acid…………………………………………….

Disodium Edetate……………………………………………………..

% w/v

0.50

0.09

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

None.

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 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)

In rare cases, acute irritation and pain may occur. This resloves spontaneously.

4.7

Use during pregnancy, lactation or lay

No special precautions.

4.8

Interaction with other medicinal products and other forms of interaction

None known.

4.9

Amount(s) to be administered and administration route

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

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

In cases of severe irritation, the treatment should be stopped immedately and the diagnosis reassessed.

4.11

Withdrawal period(s)

Not for use in rabbits intended for human consumption

5.

PHARMACOLOGICAL PROPERTIES

ATC Vet Code: QS01AA11

Tiacil is an ophthalmic solution containing Gentamicin sulphate as active ingredient, an antibiotic of the aminoglycoside family.

5.1

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.