SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Optimmune 2mg/g Eye ointment

Active Ingredient mg/g (% w/w)

Ciclosporin 2.0 (0.2)

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Eye Ointment

A translucent colourless to light yellow ointment.

4. CLINICAL PARTICULARS

4.1 Target Species.

Dog

4.2 Indications for use, specifying the target species.

For the treatment of chronic, recurrent conjunctivitis resulting from autoimmune disease of the eye. Indicated for the therapeutic treatment of Keratoconjunctivitis sicca (KCS, ‘dry eye’) and chronic superficial keratitis (‘pannus’) in the dog.

May be used to augment topical corticosteroids or as a substitute for corticosteroids when these are contraindicated by corneal ulceration.

4.3 Contra-indications

Do not use where fungal or viral infection of the eye is suspected.

4.4 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.

4.5 Special precautions for use

i. Special precautions for use in animals

For external topical use only.

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

Replace cap between applications.

ii. Special precautions to be taken by the person administering the product to animals

Avoid contact with skin.

Wear gloves when applying the ointment

Wash hands after use.

4.6 Adverse Reactions (frequency and seriousness)

Mild irritation in the first few days of therapy may occur. If such irritation persists, treatment should be discontinued.

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 has resulted in resolution.

4.7 Use during pregnancy and lactation.

Do not administer to pregnant bitches.

Studies to demonstrate safety in pregnant bitches have not been conducted.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Posology and method of administration

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.

4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)

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 has resulted in resolution.

4.11 Withdrawal periods.

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code:QS01XA18

Pharmacotherapeutic group: Opthalmologicals, other opthalmologicals

Optimmune is a pharmaceutically stable sterile ointment containing 0.2% Ciclosporin A. Administration of the ointment improves chronic diseases of the cornea and conjunctiva resulting from autoimmune disease such as keratoconjunctivitis sicca (KCS, dry eye), chronic superifical keratitis (pannus), and plasmacytic infiltration of the nictitans (‘plasmoma’) in dogs. To be applied topically to each affected eye.

Ciclosporin A is an immunomodulator nonpolar cyclic oligopeptide with lacrimominetic and anti-inflammatory activities. It is produced by the fungus species Tolypocladium inflatum gans. It is a highly lipophilic drug and is absorbed into the cornea in high concentrations. Ciclosporin A also penetrates the lacrimal gland following administration.

Ciclosporin 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 autoimmune attack and reduces infiltration of ocular tissues by inflammatory cells. In addition to its immunosuppressive activity, Ciclosporin A exerts a direct lacrimomimetic effect by blocking the inhibition of tear production by prolactin.

Optimmune thus increases the flow of tears identical to natural tear secretions. As well as lubrication and wetting, epithelial growth factors and other components of tears are necessary for maintenance of corneal health. Studies have demonstrated that long term use of Optimmune does not increase susceptibility of the eye to microbial infection.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipents

Petrolatum Lanolin Alcohol

Maize Oil

Paraffin, White Soft

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 1 month

6.4 Special precautions for storage

Do not Store above 25°C. Do not freeze.

Any contents remaining one month after the date on which the container was first opened should be discarded.

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

Replace cap between applications.

6.5 Nature and composition of immediate packaging

Pack size: 3.5g tube in a cardboard carton

Container: Epoxy-phenol lacquered aluminium aluminium tube with high density polyethylene nozzle

Closure: Tamper-evident high density polyethylene cap, screw fit.

6.6 Special precautions for the disposal of unused product or waste material, if any.

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

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

Vm01708/4589

9. DATE OF FIRST AUTHORISATION

Date:9^thJune 1994

10. DATE OF REVISION OF THE TEXT

Date:August 2012