MYLAN-CLINDAMYCIN CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

J01FF01

INN (Nama Antarabangsa):

CLINDAMYCIN

Dos:

150MG

Borang farmaseutikal:

CAPSULE

Komposisi:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 150MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

LINCOMYCINS

Ringkasan produk:

Active ingredient group (AIG) number: 0105830002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-07-12

Ciri produk

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