Open Fri 8:30am : 01582 842096
VioVet Insurance
FREE DELIVERY on most orders over £29

Isathal 10 mg/g Eye Drops for Dogs, Cats and Rabbits (Formerly Fucithalmic)

  • 10mg/ml Suspension » 3g Tube £7.36

Description

Isathal is used in dogs for the topical treatment of conjunctivitis associated with Staphylococcus aureus and in particular the biotype Staphylococcus intermedius. In cats for the topical treatment of conjunctivitis associated with secondary staphylococcal infections and in rabbits for the topical treatment of conjunctivitis associated with staphylococcal infections.

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 in animals

Official, national and regional antimicrobial policies should be taken into account when the product is used. 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 of the tube 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.

Interactions

None known

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.

Overdose

None known.

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

Major incompatibilities

None known

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 25ËšC. 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 reach and sight 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

Presentation

1 g suspension contains: Active substance: Fusidic acid 10 mg

Excipients: Benzalkonium chloride 0.11 mg as an antimicrobial preservative, disodium edetate 0.5 mg as a co-preservative. Also contains mannitol, carbomer, sodium hydroxide and water for injections.

Eye drops, suspension. A sterile, white to off-white, viscous formulation.

Uses

Dog: For the topical treatment of conjunctivitis associated with Staphylococcus aureaus 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.

Dosage and administration

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.

Contraindications, warnings, etc

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 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 of the tube 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 thoroughly 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.

Interactions: None known.

Withdrawal period: Not for use in rabbits intended for human consumption.

Incompatibilities: None known.

Pharmaceutical precautions

Do not store above 25°C. Replace the cap between applications. Following withdrawal of the first dose, use the product within 1 month. Do not use after the expiry date stated on the tube and carton after EXP.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the tube: 1 month.

Disposal: Any unused veterinary medical product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging quantities

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 or 5 g tube. Not all pack sizes may be marketed.

Further information

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the reach and sight of children.

Manufacturer responsible for the batch release: LEO Laboratories Limited, Dublin 12, Ireland.

Date of last review: June 2010

Marketing authorisation holder (if different from distributor)

Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark.

Marketing authorisation number

Vm 24883/4003.

GTIN (Global Trade Item No)

Fucithalmic Vet. 10 mg/g Eye Drops, Suspension for Dogs, Cats and Rabbits

05701170115000

Need help or advice? Contact us:

  • Landline: 01582 842096
  • Freephone*: 0800 084 2608
  • Mon - Fri: 8:30am - 6:00pm
  • Sat: 9:00am - 1:00pm
  • Email: support@viovet.co.uk

All prices include VAT where applicable. *The freephone number is free from most UK landlines only, mobiles are usually charged so we'd recommend calling our landline from your mobile or internationally.

Reviews of Isathal 10 mg/g Eye Drops for Dogs, Cats and Rabbits (Formerly Fucithalmic)

Read our customers' reviews of Isathal 10 mg/g Eye Drops for Dogs, Cats and Rabbits (Formerly Fucithalmic)

Questions & Answers for Isathal 10 mg/g Eye Drops for Dogs, Cats and Rabbits (Formerly Fucithalmic)

There are currently no questions for Isathal 10 mg/g Eye Drops for Dogs, Cats and Rabbits (Formerly Fucithalmic) - be the first to ask one!

Ask A Question