TARO-BENZOYL PEROXIDE / CLINDAMYCIN KIT GEL

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE); BENZOYL PEROXIDE

Dostupné s:

TARO PHARMACEUTICALS INC

ATC kód:

D10AF51

INN (Mezinárodní Name):

CLINDAMYCIN, COMBINATIONS

Dávkování:

1%; 5%

Léková forma:

GEL

Složení:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 1%; BENZOYL PEROXIDE 5%

Podání:

TOPICAL

Jednotky v balení:

10G (CLINDA) & 2 OZ (BENZ. PEROX))

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTIBIOTICS

Přehled produktů:

Active ingredient group (AIG) number: 0242561001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2017-05-31

Charakteristika produktu

PRODUCT MONOGRAPH
PR
TARO-BENZOYL PEROXIDE / CLINDAMYCIN KIT
TOPICAL GEL
benzoyl peroxide and clindamycin gel, 5% / 1%, w/w
(as clindamycin phosphate)
Acne Vulgaris Therapy
ATC Code: D10AF
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
August 17, 2018
Submission Control No.: 216759
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT
INFORMATION................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
5
DRUG INTERACTIONS
...........................................................................................................
6
DOSAGE AND ADMINISTRATION
.......................................................................................
7
OVERDOSAGE
.........................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
8
STORAGE AND STABILITY
...................................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 8
PART II: SCIENTIFIC INFORMATION
.................................................................................
9
PHARMACEUTICAL INFORMATION
...................................................................................
9
CLINICAL TRIALS
.................................................