Reg. No. 97/17.4/15  

Composition:
Each g contains Cyclosporine A 2 mg.

Pharmacological action:
Cyclosporine A is an immunomodulator, nonpolar, cyclic oligopeptide with lacrimomimetic and anti-inflammatory activities. It is produced by the fungus species Tolypocladium inflatum gams.

Cyclosporine A is a highly lipophilic agent and is absorbed into the cornea in high concentration. It also penetrates the lacrimal gland following administration. Cyclosporine A has no appreciable systemic effect.

Cyclosporine A exerts its immunosuppressive and anti-inflammatory effects by inhibiting the production of cytokines which up-regulate T-helper cell activity. This restores the function of lacrimal acinar epithelium under auto-immune attack and reduces infiltration of ocular tissues by inflammatory cells. In addition to its immunosuppressive activity, cyclosporine A exerts a direct lacrimomimetic effect by blocking the inhibition of tear production by prolactin.

Studies have demonstrated that long term use of OPTIMMUNE does not increase susceptibility of the eye to microbial infection.

Indications:
OPTIMMUNE is indicated for the treatment of chronic idiopathic keratoconjunctivitis sicca (KCS, ‘dry eye’) and chronic superficial keratitis (CSK, ‘pannus’) in dogs.

OPTIMMUNE may be used to augment topical corticosteroids or as a substitute for corticosteroids when these are contra-indicated by corneal ulceration.

Contra-indications:
Do not use where viral or fungal infection of the eye is suspected.

Do not administer to pregnant or lactating bitches.

Dosage and directions for use:
For topical administration to the conjunctival sac.

Any excessive discharge in the eye should be removed prior to application of OPTIMMUNE ointment, by gently cleansing or flushing the eye with a suitable non-irritating solution.

Apply a small strip of ointment (approximately ½ to 1 cm) into the affected eye(s) every 12 hours.

Wear gloves when applying the ointment. Avoid contact with skin. Wash hands after use.

Care should be taken to avoid contamination of the contents during use. Replace cap after use.

It is important that continuous treatment is maintained. Stimulation of tear production ceases within 24 hours of withdrawing treatment.

Keratoconjunctivitis sicca may require life-long therapy.

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.

Side effects and special precautions:
Mild irritation in the first few days of therapy may occur. If such irritation persists beyond the first week, treatment should be discontinued.

Inflammation and swelling of the skin of the eye lids has been reported which could be associated with overflow of excess ointment. Reduction of the quantity of ointment applied has resulted in resolution.

Known symptoms of overdosage and particulars of its treatment:
Inflammation and swelling of the skin of the eye lids.

Identification:
A translucent, colourless to light yellow ointment with no grittiness.

Presentation:
Tamper-evident, multi-dose, aluminium tubes of 3,5 g ointment packed in cardboard cartons.

Storage instructions:
Store below 25 °C.
Keep out of reach of children and uninformed persons.
Any contents remaining one month after date on which the container was first opened should be discarded.

Registration holder:

Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07