Isathal 10 mg/g Eye Drops, Suspension for Dogs, Cats and Rabbits

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Fusidic Acid

Dostupné s:

Dechra Veterinary Products A/S

ATC kód:

QS01AA13

INN (Mezinárodní Name):

Fusidic Acid

Léková forma:

Eye drops, suspension

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cats, Dogs, Rabbits

Terapeutické oblasti:

Antimicrobial

Stav Autorizace:

Authorized

Datum autorizace:

1993-11-11

Charakteristika produktu

Revised: April 2022
AN: 02855/2021
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Isathal 10 mg/g eye drops, suspension for dogs, cats and rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 G SUSPENSION CONTAINS:
ACTIVE SUBSTANCE:
Fusidic acid
10 mg
EXCIPIENT:
Benzalkonium chloride 0.11 mg as antimicrobial preservative.
Disodium edetate 0.5 mg as co-preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
A sterile, white to off-white, viscous formulation.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog, cat and rabbit.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dog:
For the topical treatment of conjunctivitis associated with
_Staphylococcus _
_aureus_ and in particular the biotype _Staphylococcus intermedius._
Cat:
For the topical treatment of conjunctivitis associated with secondary
staphylococcal infections.
Rabbit:
For the topical treatment of conjunctivitis associated with
staphylococcal
infections.
4.3
CONTRAINDICATIONS
•
The veterinary medicinal product should not be used in conjunctivitis
cases
associated with _Pseudomonas_ spp.
•
Do not use in cases of known hypersensitivity to the active substance
or any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
•
In cats, the possibility of a primary cause of the conjunctivitis
should be
investigated and treated if possible.
Revised: April 2022
AN: 02855/2021
Page 2 of 4
•
In rabbits, conjunctivitis may be associated with dacryocystitis
and/or dental
disease. In such cases, appropriate additional treatment should be
instituted.
4.5
SPECIAL PRECAUTIONS FOR USE
When using the veterinary medicinal product, official and national
antimicrobial
policies should be taken into account. It is recommended that the use
of the
veterinary medicinal product should be based on bacteriological and
susceptibility
testing. If this is not possible, treatment should be based on
epidemiological
information on the susceptibility of the bacteria concerne