RIVA-LEVOFLOXACIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Доступна з:

LABORATOIRE RIVA INC.

Код атс:

J01MA12

ІПН (Міжнародна Ім'я):

LEVOFLOXACIN

Дозування:

500MG

Фармацевтична форма:

TABLET

Склад:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

QUINOLONES

Огляд продуктів:

Active ingredient group (AIG) number: 0131663004; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2019-09-30

Характеристики продукта

_RIVA-LEVOFLOXACIN – Product Monograph _
_Page 1 of 74_
PRODUCT MONOGRAPH
PR RIVA-LEVOFLOXACIN
Levofloxacin Tablets, USP
250 mg, 500 mg and 750 mg
Levofloxacin (as Levofloxacin hemihydrate)
Antibacterial Agent
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Preparation:
September 26, 2019
Submission Control No: 224308
_RIVA-LEVOFLOXACIN – Product Monograph _
_Page 2 of 74_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 27
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL INFORMATION
.........................................................................
28
CLINICAL TRIALS
............................................................