Država: Kanada
Jezik: engleski
Izvor: Health Canada
BETAMETHASONE (BETAMETHASONE VALERATE); GENTAMICIN (GENTAMICIN SULFATE)
BAUSCH HEALTH, CANADA INC.
D07CC01
BETAMETHASONE AND ANTIBIOTICS
0.1%; 0.1%
CREAM
BETAMETHASONE (BETAMETHASONE VALERATE) 0.1%; GENTAMICIN (GENTAMICIN SULFATE) 0.1%
TOPICAL
30G
Prescription
ANTIBIOTICS
Active ingredient group (AIG) number: 0205697001; AHFS:
APPROVED
2008-07-11
PRODUCT MONOGRAPH INCLUDING THE PATIENT MEDICATION INFORMATION PR VALISONE-G* CREAM PR VALISONE-G* OINTMENT (BETAMETHASONE 17-VALERATE AND GENTAMICIN SULFATE) TOPICAL CORTICOSTEROID AND ANTIBIOTIC VALEANT CANADA LP DATE OF PREPARATION: 2150 St-Elzear Blvd. West August 1, 2018 Laval, Quebec H7L 4A8 CONTROL NO.: 215275 *Reg. T.M. under licence of Schering Canada Inc. _Product Monograph – VALISONE G Page 2 of 12_ NAME OF DRUG Pr VALISONE-G* THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION VALISONE-G is a combination of betamethasone as 17-valerate, an active ester of betamethasone for the topical treatment of allergic and inflammatory dermatoses and of the wide-spectrum antibiotic gentamicin (as gentamicin sulfate). STRUCTURAL FORMULA AND CHEMISTRY GENTAMICIN SULFATE Gentamicin is derived from Micromonospora purpurea of the Actinomycetes group, and is a heat- stable white powder that is soluble in water. Gentamicin is a mixture of three components, namely, gentamicin C 1 R=R ’ =CH 3 gentamicin C 2 R=CH 3 ; R ’ =H gentamicin C 1a R=R ’ =H It has the following structural formula: _Product Monograph – VALISONE G Page 3 of 12_ BETAMETHASONE VALERATE Betamethasone 17-valerate is: 9α-fluoro-11β,17, 21-trihydroxy-16β-methylpregna-1,4-diene-3, 20-dione 17-valerate It has the following structural formula: ACTION VALISONE-G provides the combined anti-inflammatory, anti-allergic, and anti-pruritic actions of betamethasone 17-valerate with the antibacterial topical effect of gentamicin. INDICATIONS VALISONE-G is indicated in the topical management of secondarily infected allergic or inflammatory dermatoses responsive to corticosteroid therapy, such as contact dermatitis, seborrheic dermatitis, neurodermatitis, intertrigo, exfoliative dermatitis, stasis dermatitis and psoriasis. It is also indicated for the treatment of the aforementioned conditions whenever the possibility of secondary infection is present by gram-positive or gram-negative bacteria including Streptococci, Staphylococcus and species of Pseudomonas, Aer Pročitajte cijeli dokument