VALISONE-G OINTMENT

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

BETAMETHASONE (BETAMETHASONE VALERATE); GENTAMICIN (GENTAMICIN SULFATE)

Dostupno od:

BAUSCH HEALTH, CANADA INC.

ATC koda:

D07CC01

INN (International ime):

BETAMETHASONE AND ANTIBIOTICS

Doziranje:

0.1%; 0.1%

Farmaceutski oblik:

OINTMENT

Sastav:

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

Administracija rute:

TOPICAL

Jedinice u paketu:

30G

Tip recepta:

Prescription

Područje terapije:

ANTIBIOTICS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2008-06-11

Svojstava lijeka

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