PMS-CLINDAMYCIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-07-2016
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Active ingredient:
CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)
Available from:
PHARMASCIENCE INC
ATC code:
J01FF01
INN (International Name):
CLINDAMYCIN
Dosage:
300MG
Pharmaceutical form:
CAPSULE
Composition:
CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 300MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
LINCOMYCINS
Product summary:
Active ingredient group (AIG) number: 0105830003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-10-26
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-CLINDAMYCIN
clindamycin hydrochloride capsules, USP
clindamycin 150 mg, 300 mg
ANTIBIOTIC
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
July 13, 2016
Montréal, Québec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO.: 195698
_pms-CLINDAMYCIN Product Monograph_ Page 2 of 28_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
...........................................................................................................
7
DRUG
INTERACTIONS
............................................................................................................
9
DOSAGE
AND
ADMINISTRATION
......................................................................................
10
OVERDOSAGE
........................................................................................................................
11
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
12
STORAGE
AND
STABILITY..................................................................................................
13
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL
INFORMATION
.................................................................................
15
DETAILED
PHARMACOLOGY...............................................
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