PMS-CLINDAMYCIN CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

J01FF01

INN (Nama Internasional):

CLINDAMYCIN

Dosis:

300MG

Bentuk farmasi:

CAPSULE

Komposisi:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 300MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

LINCOMYCINS

Ringkasan produk:

Active ingredient group (AIG) number: 0105830003; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2016-10-26

Karakteristik produk

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...............................................