MYLAN-CLINDAMYCIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-11-2017
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Active ingredient:
CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
J01FF01
INN (International Name):
CLINDAMYCIN
Dosage:
150MG
Pharmaceutical form:
CAPSULE
Composition:
CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 150MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
LINCOMYCINS
Product summary:
Active ingredient group (AIG) number: 0105830002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-12
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
MYLAN-CLINDAMYCIN
CLINDAMYCIN HYDROCHLORIDE CAPSULES USP
CLINDAMYCIN 150 MG, 300 MG
ANTIBIOTIC
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, Ontario
Canada, M8Z 2S6
DATE OF REVISION:
November 14, 2017
Control No.: 197322
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..........................................................................................
5
ADVERSE
REACTIONS
...........................................................................................................
8
DRUG
INTERACTIONS
..........................................................................................................
10
DOSAGE
AND
ADMINISTRATION
......................................................................................
11
OVERDOSAGE
........................................................................................................................
13
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
13
STORAGE
AND
STABILITY..................................................................................................
16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 16
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL
INFORMATION
.................................................................................
17
CLINICAL
TRIALS
.................................................................................................................
18
DETAILED
PHA
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