PMS-CLINDAMYCIN CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
14-07-2016
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Aktivna sestavina:
CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)
Dostopno od:
PHARMASCIENCE INC
Koda artikla:
J01FF01
INN (mednarodno ime):
CLINDAMYCIN
Odmerek:
300MG
Farmacevtska oblika:
CAPSULE
Sestava:
CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 300MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
LINCOMYCINS
Povzetek izdelek:
Active ingredient group (AIG) number: 0105830003; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2016-10-26
Lastnosti izdelka
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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