DOM-AZITHROMYCIN POWDER FOR SUSPENSION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Предлага се от:

DOMINION PHARMACAL

АТС код:

J01FA10

INN (Международно Name):

AZITHROMYCIN

дозиране:

100MG

Лекарствена форма:

POWDER FOR SUSPENSION

Композиция:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 100MG

Начин на приложение:

ORAL

Броя в опаковка:

15ML

Вид предписание :

Prescription

Терапевтична област:

OTHER MACROLIDES

Каталог на резюме:

Active ingredient group (AIG) number: 0126072002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2007-04-18

Данни за продукта

PRODUCT MONOGRAPH
PR
DOM-AZITHROMYCIN
Azithromycin Tablets
250 mg and 600 mg
USP
Azithromycin for Oral Suspension
100 mg / 5 mL and 200 mg / 5 mL
House Standard
ANTIBACTERIAL AGENT
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4 DATE OF REVISION:
November 29, 2018
Control number: 222071
_Dom-AZITHROMYCIN Product Monograph _
_Page 2 of 82_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................6
WARNINGS AND PRECAUTIONS
....................................................................................6
ADVERSE REACTIONS
....................................................................................................11
DRUG INTERACTIONS
.....................................................................................................18
DOSAGE AND ADMINISTRATION
................................................................................23
OVERDOSAGE
...................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
...............................................................28
STORAGE AND STABILITY
............................................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................32
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL INFORMATION
............................................................................34
CLINICAL TRIALS
.....................................................................................