GARASONE OPHTHALMIC AND OTIC SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE); GENTAMICIN (GENTAMICIN SULFATE)

Dostopno od:

MERCK CANADA INC

Koda artikla:

S03CA06

INN (mednarodno ime):

BETAMETHASONE AND ANTIINFECTIVES

Odmerek:

1MG; 3MG

Farmacevtska oblika:

SOLUTION

Sestava:

BETAMETHASONE (BETAMETHASONE SODIUM PHOSPHATE) 1MG; GENTAMICIN (GENTAMICIN SULFATE) 3MG

Pot uporabe:

OPHTHALMIC

Enote v paketu:

7.5ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTIBACTERIALS

Povzetek izdelek:

Active ingredient group (AIG) number: 0205697002; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2014-04-01

Lastnosti izdelka

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