MYLAN-CLINDAMYCIN CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE)

Доступна з:

MYLAN PHARMACEUTICALS ULC

Код атс:

J01FF01

ІПН (Міжнародна Ім'я):

CLINDAMYCIN

Дозування:

150MG

Фармацевтична форма:

CAPSULE

Склад:

CLINDAMYCIN (CLINDAMYCIN HYDROCHLORIDE) 150MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

LINCOMYCINS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2018-07-12

Характеристики продукта

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