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Date: Thursday, December 2, 2021 16:38

Release 4.66
Isathal® 10 mg/g Eye Drops, Suspension for Dogs, Cats and Rabbits
 
Species: Rabbits, Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Ear/eye/nose
Active ingredient: Fusidic Acid
Product:Isathal® 10 mg/g Eye Drops, Suspension for Dogs, Cats and Rabbits
Product index: Isathal 10 mg/g Eye Drops, Suspension for Dogs, Cats and Rabbits
Withdrawal notes: Not for use in rabbits intended for human consumption
Qualitative and quantitative composition
1 g suspension contains: Active substance: Fusidic acid 10 mg
Excipients: Benzalkonium chloride 0.11 mg as antimicrobial preservative. Disodium edetate 0.5 mg as co-preservative.
Pharmaceutical form
Eye drops, suspension. A sterile, white to off-white, viscous formulation.
Clinical particulars
Target species
Dog, cat and rabbit.
Indications for use
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.
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.
Special warnings for each target species
In cats, the possibility of a primary cause of the conjunctivitis should be investigated and treated if possible.
In rabbits, conjunctivitis may be associated with dacryocystitis and/or dental disease. In such cases, appropriate additional treatment should be instituted.
Special precautions for use
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions for use in animals
For external use only.
When the tube is squeezed, the veterinary medicinal product comes out as a thick (viscous) drop. The drop quickly becomes liquid on contact with tear fluid and does not affect the sight.
Care should be taken to avoid contamination of the contents during use and to avoid the nozzle coming into direct contact with the eye. Avoid fingers touching the tube nozzle.
Do not use the same tube to treat different animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after applying the product.
Adverse reactions
Allergic reactions or hypersensitivity to the active substance or the excipients might occur. Discontinue use if hypersensitivity to the product develops.
Use during pregnancy and lactation
The product may be used safely in pregnant and lactating animals.
Amounts to be administered and administration route
One drop of the veterinary medicinal product should be instilled into the eye once or twice daily. Treatment should be continued for at least 24 hours after the eye has returned to normal.
If a clinical response is not evident after 5 days following the commencement of administration, the diagnosis should be re-established.
If the animal has one infected eye, it may be advisable to treat both eyes to prevent cross-infection. In such cases, it is better to treat the uninfected eye first to avoid transferring infection via the tube nozzle.
Withdrawal periods
Not for use in rabbits intended for human comsumption.
Pharmacological particulars
Pharmacotherapeutic group: Ophthalmologicals containing antibiotics.
ATCvet code: QS01AA13
Pharmacodynamic properties
Fusidic acid, the active substance of the veterinary medicinal product, is active against Staphylococcus aureus and in particular against the biotype Staphylococcus intermedius which is a common isolate from clinical cases of canine conjunctivitis.
In the cat, ocular bacterial infection is usually secondary to viral, Chlamydia or Mycoplasmal infection or trauma. Among the variety of bacteria found, the Staphylococcus spp. are considered to be sensitive to fusidic acid.
In the rabbit, ocular infections are associated with a variety of organisms which are sensitive to fusidic acid, the most common of which are Staphylococci.
Pharmacokinetic properties
The sustained release formulation of the veterinary medicinal product ensures prolonged retention within the conjunctival sac. Once or twice daily applications will provide inhibitory levels of fusidic acid against the sensitive organisms.
Studies have shown that fusidic acid penetrates well into the cornea and anterior chamber in humans and rabbits.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the tube: 1 month.
Special precautions for storage
Do not store above 25˚C.
Replace the cap between applications.
Following withdrawal of first dose, use the product within 1 month.
Immediate packaging
Sterilised aluminium tube laminated on both sides of tube wall with high density polyethylene, with a high density polyethylene nozzle closed with a high density polyethylene screw cap.
Pack sizes: Available in a carton containing a 3 g and 5 g tube. Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark.
Marketing Authorisation Number
Vm 24883/4003
Significant changes
Date of the first authorisation or date of renewal
11 November 1993
Date of revision of the text
June 2014
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Isathal 10 mg/g Eye Drops, Suspension for Dogs, Cats and Rabbits:
GTIN:05701170334869