MYLAN-CLINDAMYCIN CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Dostupné s:

MYLAN PHARMACEUTICALS ULC

ATC kód:

J01FF01

INN (Mezinárodní Name):

CLINDAMYCIN

Dávkování:

300MG

Léková forma:

CAPSULE

Složení:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 300MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

LINCOMYCINS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-07-12

Charakteristika produktu

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