Optimmune® Ophthalmic Ointment 3.5 g

OPTIMMUNE - cyclosporine ointment 
Schering Corporation

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Optimmune® Ophthalmic Ointment 3.5 g

2 mg/g Eye ointment

CICLOSPORIN 2 mg/g (0.2 % w/w)

Description

Optimmune is a white petrolatum-based ointment for ophthalmic use, containing 2 mg/g (0.2 % w/w) ciclosporin.

Activity

Ciclosporin is an immunosuppressant with lacrimomimetic and anti-inflammatory properties.

Indications

In the dog, Optimmune is indicated for the treatment of chronic idiopathic keratoconjunctivitis sicca (KCS, 'dry eye'), and chronic superficial keratitis ("pannus").

Dosage and Administration

Apply a small amount of ointment (approximately 1/4 inch or 1/2 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.

Clinical experience suggests that 90 % of dogs affected with KCS will require life-long therapy.

However, if therapy is maintained the prognosis is good.

Contra-indications, warnings

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

Mild irritation in the first few days of therapy has been seen. If such irritation persists, treatment should be discontinued.

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

Optimmune® Ophthalmic Ointment

2 mg/g Eye ointment

CICLOSPORIN 2 mg/g (0.2 % w/w)

Information for dog owners

Tears, and the tear film which covers the surface of the eye, are of vital importance and help to keep the eye healthy. As well as providing lubrication, natural tears contain substances which prevent infection and are important in the protection and nutrition of the delicate cornea.

Some disorders reduce the production of tears, and the eye becomes dry, damaged and inflamed.

Without treatment, the condition of the eye deteriorates and may eventually lead to blindness. One of the most common of these 'dry eye' disorders is keratoconjunctivitis sicca or KCS. This and similar conditions can be caused by a disorder of the dog's own immune system, and will therefore continue to affect it throughout its life.

Your vet has prescribed Optimmune Ophthalmic Ointment for your dog to help it produce tears and reduce the chronic inflammation which causes damaged and sore eyes.

Unlike treatment with artificial tears or lubricants, Optimmune Ophthalmic Ointment treats the underlying cause so that a normal film of tears is produced, even when the tear glands are diseased.

Optimmune should be administered twice each day, or as recommended by your veterinary surgeon. An increase in tear production is expected within 10 days, but it may take up to 6 weeks, for the full effect to be achieved.

In a few dogs, after perhaps months of treatment, the condition may appear to change making it necessary to alter the dose or give other medication in addition to Optimmune Ophthalmic Ointment. If this happens to your dog, it is important that you consult your vet.

Operator warnings

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

Pharmaceutical Precautions

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

Care should be taken to avoid contamination of the contents during use. Replace cap between applications. Any contents remaining one month after the date on which the container was first opened should be discarded.

When the container is opened for the first time, the date on which any product remaining in the container should be discarded should be calculated. This discard date should be written on the space provided on the carton.

Keep tube in outer carton.

Disposal Advice

Dispose of used packaging in household refuse. Unused product should be returned to the veterinary surgeon.

Further information

Studies have shown that the cornea acts as a depot for ciclosporin, and that in ophthalmic use there is low systemic bioavailability.

For animal treatment only.

Keep out of reach and sight of children.

UK only
Vm 00201/4025
POM-V
To be supplied only on veterinary prescription.
IE only
VPA 10277/072/001
POM
Prescription only medicine

Package quantities: 3.5 g tubes

Marketing authorisation holder
Schering-Plough Limited, Shire Park, Welwyn Garden City, Herts., AL7 1TW, U.K.

Manufacturer: Schering-Plough Sante Animal, La Grindoliere, Zone Artisanale, F-49500 Segre, France

Date of preparation: November 2009

® denotes registered trademark

Points to remember

Continue treatment.
It is important that treatment is continued even when the condition of the eye has improved. If treatment is stopped completely, damage to the eye may occur before the signs of redness and inflammation reappear.
Don't run out of ointment.
In order to maintain and continue improvement make sure that you have sufficient ointment available, and tell your vet in good time before you run out. Do not assume that when you finish one tube that the course of treatment has ended.

Using Optimmune Ophthalmic Ointment

Apply a small amount of Optimmune ointment (approximately 1/4 inch or 1/2 cm) into each affected eye every 12 hours, or as directed by your veterinary surgeon. Gently pull down the lower eyelid, and squeeze the strip of ointment from the tube onto the inside of the eyelid. Optimmune has a special ointment base which helps to spread the treatment over the eye as the dog blinks.

Wear gloves when applying the ointment, and avoid getting the ointment on your skin. Always wash your hands after treating your dog.

The tube may contain some air when first used; this is normal and results from the manufacturing process. The amount of ointment is carefully measured by weight ensuring the correct quantity in each tube of Optimmune.

For external use only.

Storing Optimmune

Optimmune Ophthalmic Ointment should not be stored above 25°C, which means keeping it at normal room temperature. If the ointment appears too soft at room temperature, it may be stored in the refrigerator.

Do not freeze.

For animal treatment only. Keep out of reach and sight of children.

Marketing Authorisation Holder
Schering-Plough Limited, Shire Park, Welwyn Garden City, Herts., AL7 1TW, U.K.

Manufacturer: Schering-Plough Sante Animal, La Grindoliere, Zone Artisanale, F-49500 Segre, France

® denotes registered trademark

104547

PRINCIPAL DISPLAY PANEL - 3.5 g Tube Carton

Optimmune®
Ophthalmic Ointment

2 mg/g Eye ointment
CICLOSPORIN 2 mg/g (0.2 % w/w)

Intervet
Schering-Plough Animal Health

3.5 g

PRINCIPAL DISPLAY PANEL - 3.5 g Tube Carton

OPTIMMUNE 
cyclosporine   ointment
Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)0061-1088
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cyclosporine (Cyclosporine) Cyclosporine2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Paraffin 
Corn Oil 
Petrolatum 
Lanolin Alcohols 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10061-1088-011 TUBE In 1 CARTONcontains a TUBE
13.5 g In 1 TUBEThis package is contained within the CARTON (0061-1088-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14105203/10/2011

Labeler - Schering Corporation (001317601)
Establishment
NameAddressID/FEIOperations
Schering-Plough Sante Animale275254357MANUFACTURE
Revised: 03/2011Schering Corporation