VALISONE-G CREAM

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

BETAMETHASONE (BETAMETHASONE VALERATE); GENTAMICIN (GENTAMICIN SULFATE)

Prieinama:

BAUSCH HEALTH, CANADA INC.

ATC kodas:

D07CC01

INN (Tarptautinis Pavadinimas):

BETAMETHASONE AND ANTIBIOTICS

Dozė:

0.1%; 0.1%

Vaisto forma:

CREAM

Sudėtis:

BETAMETHASONE (BETAMETHASONE VALERATE) 0.1%; GENTAMICIN (GENTAMICIN SULFATE) 0.1%

Vartojimo būdas:

TOPICAL

Vienetai pakuotėje:

30G

Recepto tipas:

Prescription

Gydymo sritis:

ANTIBIOTICS

Produkto santrauka:

Active ingredient group (AIG) number: 0205697001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2008-07-11

Prekės savybės

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