Description : Bic Otivet is used to treat bacterial infections of the outer ear in dogs. (It is Otomax replacement ,all composition is the same as Otomax but cheaper)

Composition :

Each gram contains:

   Gentamicin sulfate eq. to Gentamicin                    3 mg

   Betamethasone valerate eq. to Betamethasone    1 mg

   Clotrimazole                                                         10 mg 
 

INDICATIONS :

Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.

DOSAGE AND ADMINISTRATION :

For otic use only. The outer ear should be cleaned meticulously and dried before treatment. Excess hair around the treatment area should be cut Dogs weighing up to 15 kg (33 lbs): Apply 4 drops of BIC OTIVET ointment into the ear canal. Dogs weighing more than 15 kg (33 lbs): Apply 8 drops of BIC OTIVET ointment into the ear canal. Administer twice daily for 7 consecutive days After application, massage external ear canal carefully after instillation to ensure appropriate distribution of medication

CONTRAINDICATIONS :

Do not ade inister ithe Kaow o perovaninyporsensitirity to any of the ingredients. Do not administer in the case of known hypersensitivity to any of the ingredients. Concomitant use of drugs known to induce ototoxicity should be avoided.

ADVERSE REACTIONS :

Gentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur hen aminoglycosides are applied topically for prolonged periods of time to large wounds burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity

Betamethasone: Side effect such as SAP and SGPT enzyme elevations, weightloss, anorexia polydipsia, and polyuria have occurred following the use of parenteral or systemic synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs and cats. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapv

Clotrimazole : The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin not present before therapy.

PRECAUTIONS FOR USE IN ANIMALS :

- Before the product is applied, the external auditory canal must be examined thoroughly to ensure that the eardrum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus

-Use of the product should be based on susceptibility of isolated bacteria and/or other appropriate diagnostic tests. If this is not possible, therapy should be based on local regional, farm level) epidemiological information about susceptibility of the target bacteria.

-Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to gentamicin and may deerease the effectiveness of treatment with other aminoglycosides, due to the potential for cross resistance

-If overgrowth of nonsusceptible bacteria, fungi, or yeasts occur, or if hypersensitivity develops, treatment should be discontinued and appropriate therapy instituted

PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS :

Wash hands carefully after applying the product. Avoid contact with eyes. If occurs, rinse with copious amounts of water Persons with known hypersensitivity to compounds in the product should avoid any contact with the product

USE DURING PREGNANCY, L?CTATION OR LAY :

Do not administer to pregnant or lactating bitches.

OVERDOSE :

The usual signs of adrenocorticoid overdosage which include sodium retention,potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effect.

INTERACTION WITH OTHER MEDICINAL PRODUCTS :

Do not administer the product concurrently with other substances known to cause ototoxicity.

STORAGE CONDITION : Store below 30°C