מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
GENTAMICIN (GENTAMICIN SULFATE); BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE)
MERCK CANADA INC
S01CA05
BETAMETHASONE AND ANTIINFECTIVES
3MG; 1MG
OINTMENT
GENTAMICIN (GENTAMICIN SULFATE) 3MG; BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE) 1MG
OPHTHALMIC
3.5G
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0205697002; AHFS:
CANCELLED POST MARKET
2013-07-15
PRODUCT MONOGRAPH GARASONE OPHTHALMIC AND OTIC SOLUTION GARASONE OPHTHALMIC OINTMENT (betamethasone sodium phosphate USP and gentamicin sulfate USP) Topical corticosteroid and antibiotic Merck Canada Inc. Date of preparation: 16750 route Transcanadienne March 8, 2011 Kirkland, Quebec H9H 4M7 Control #: 145106 2 NAME OF DRUG GARASONE OPHTHALMIC AND OTIC SOLUTION GARASONE OPHTHALMIC OINTMENT (betamethasone sodium phosphate USP and gentamicin sulfate USP) ACTION AND PHARMACOLOGY In GARASONE, the anti-inflammatory and anti-allergic activity of betamethasone sodium phosphate is combined with the broad spectrum bactericidal activity of gentamicin sulfate. Betamethasone sodium phosphate inhibits the inflammatory response of the eye and ear to irritating agents of a mechanical, chemical or immunological nature, while gentamicin sulfate is active in-vitro against a wide range of pathogenic gram-negative and gram-positive bacteria. INDICATIONS AND CLINICAL USES Ophthalmic use: GARASONE Ophthalmic/Otic Solution and GARASONE Ophthalmic Ointment are indicated for ocular inflammation when concurrent use of an antimicrobial is judged necessary, e.g. staphylococcal blepharoconjunctivitis. GARASONE is indicated for the treatment of non-purulent bacterial infections of the anterior segment of the eye due to organisms sensitive to the antibiotic and when the anti-inflammatory action of betamethasone sodium phosphate is indicated, as in allergic vernal and phlyctenular conjunctivitis; non-purulent blepharitis; interstitial sclerosing post- operative keratitis; superficial chemical and thermal burns of the cornea. 3 In stubborn cases of anterior segment eye disease or in deep-seated ocular diseases, systemic therapy may be required. However, in these diseases GARASONE Ophthalmic/Otic Solution may be used as adjunctive therapy. Otic Use: GARASONE Ophthalmic/Otic Solution may also be used for the treatment of lesions in the external ear canal, such as acute otitis externa, eczematoid-dermatitis, seborrheic dermatitis and contact dermat קרא את המסמך השלם