Target Species
Dogs.
Indications for use
For the treatment of chronic, recurrent conjunctivitis resulting from autoimmune disease of the eye. The veterinary medicinal product is indicated for the therapeutic treatment of keratoconjunctivitis sicca (KCS, ‘dry eye’) and chronic superficial keratitis (‘pannus’).
The veterinary medicinal product may be used to augment topical corticosteroids or as a substitute for corticosteroids when these are contraindicated by corneal ulceration.
Contra-indications
Do not use where fungal or viral infection of the eye is suspected.
Special warnings for each target species
Clinical experience has shown than 90% of dogs affected with KCS will require life-long therapy. However, if therapy is maintained, the prognosis is good providing that regular clinical assessment is conducted.
Similarly, chronic superficial keratitis may require continuous therapy although, as the condition is exacerbated by ultraviolet light, requirement for treatment may be suspended or reduced at certain times of the year.
In the treatment of KCS, it is important that continuous treatment is maintained. Studies have shown that stimulation of tear production ceases within 24 hours of withdrawing treatment.
Increase in tear production is expected within 10 days but may not be maximal until 6 weeks from commencement of treatment.
Special precautions for use
For external topical use only.
Operator warnings
The veterinary medicinal product may cause skin and eye irritation. Avoid contact with the skin and eyes.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
Do not eat, drink or smoke while handling the veterinary medicinal product.
Wash hands and contacted skin thoroughly with soap and water immediately after use of the veterinary medicinal product.
In case of contact with the eyes, immediately rinse thoroughly with water.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse Reactions
Dogs:
Rare (1 to 10 animals / 10 000 animals treated): | Eye irritation1 (e.g. eye redness1, blepharospasm1,conjunctivitis1). |
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Eyelid inflammation, swollen eyelid. Application site pruritus2, application site lesion2, application site hair loss2. Lethargy3, inappetence3. Increased salivation3, vomiting3. |
1 Slight eye irritation has been reported in the first days of treatment. If the irritation persists beyond 7 days, treatment should be discontinued.
2 In the area around the eyes. This might be associated with overflow of excess ointment.
3 No confirmed conclusions concerning the causal relationship are available.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Do not use during pregnancy.
Interactions
None known.
Amounts to be administered and administration route
Ocular use.
For topical administration to the conjunctival sac.
Apply a small amount of ointment (approximately ¼ inch or ½ cm) into the affected eye(s) every 12 hours.
Any excessive discharge in the eye should be removed prior to application of the ointment by gently cleansing or flushing the eye with a suitable non-irritating solution.
Avoid contamination of the contents during use.
Handle the tube with care.
When opening the tube for the first time, while breaking the seal on the cap, carefully grip the neck of the tube to avoid exerting a twisting force on the tube and damaging it.
On first opening, a small amount of ointment may be released from the nozzle.
During administration, squeeze the tube carefully from the bottom and do not roll or fold the tube.
Replace cap between applications.
Overdose
Inflammation and swelling of the skin of the lids has been reported in a very few cases. This seems to be associated with overflow of excess ointment. Reduction of the quantity of ointment administered has resulted in resolution.
Withdrawal periods
Not applicable.