OPTIMMUNE

Country: New Zealand

Language: English

Source: Ministry for Primary Industries

Active ingredient:

cyclosporin a.

Available from:

Schering-Plough Animal Health Limited

INN (International Name):

cyclosporin a.

Composition:

cyclosporin a. 2 g/kg

Therapeutic area:

Immunomodulator

Authorization status:

ACVM Registered

Authorization date:

1999-09-23

Summary of Product characteristics

OPTIMMUNE
3.5 g – Leaflet, Carton and Vial Label
A007869
Page 1 of 6
OPTIMMUNE
03-Dec-2020
Leaflet
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF THE REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
OPTIMMUNE
® OPHTHALMIC OINTMENT
ACTIVE CONSTITUENT: 2 MG/G CYCLOSPORIN
For the treatment of idiopathic chronic keratoconjunctivitis sicca
(KCS) and chronic
superficial keratitis (CSK) in dogs.
DIRECTIONS FOR USE
DOSAGE AND ADMINISTRATION
Remove debris from affected eye(s) with suitable non-irritating
solution.
For KCS apply a 6 mm strip of ointment to the affected eye(s) every 12
hours.
For CSK apply a 6-10 mm strip of ointment to the affected eye(s) every
12 hours. Place the
ointment directly on the cornea or into the conjunctival sac. Continue
treatment while
condition persists. Dogs afflicted with KCS or CSK may require
lifelong consistent therapy.
GENERAL DIRECTIONS
For best results in treating KCS the ointment should be administered
early in the course of
the disease before irreversible damage to the lacrymal tissue, or
dense corneal scarring or
pigmentation occurs. It is recommended that dogs exhibiting chronic
recurring conjunctivitis
be tested for adequate tear production.
The clinical effect of OPTIMMUNE Ophthalmic Ointment has not been
determined in dogs
with KCS due to the following conditions: congenital alacrima,
sulfonamide usage, canine
distemper virus, metabolic disease, surgical removal of the third
eyelid gland and facial
nerve paralysis with loss of the palpebral reflex. Several days to a
few weeks of application
may be required before the clinical effects of Optimmune are of
sufficient magnitude to allow
the safe withdrawal of previously initiated therapy. Abrupt withdrawal
of a therapeutic agent
immediately upon initiation of treatment with Optimmune can result in
rapid clinical relapse.
CONTRAINDICATIONS AND PRECAUTIONS
Do not use if pre-existing viral or fungal ocular infections are
present. Delay use until such
infections have been successfully treated.
The safety of Optimmune in puppies, pregnant bi