MYLAN-CLINDAMYCIN CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Saatavilla:

MYLAN PHARMACEUTICALS ULC

ATC-koodi:

J01FF01

INN (Kansainvälinen yleisnimi):

CLINDAMYCIN

Annos:

150MG

Lääkemuoto:

CAPSULE

Koostumus:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 150MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

LINCOMYCINS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2018-07-12

Valmisteyhteenveto

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