LEVOFLOXACIN INJECTION SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Доступна з:

TEVA CANADA LIMITED

Код атс:

J01MA12

ІПН (Міжнародна Ім'я):

LEVOFLOXACIN

Дозування:

5MG

Фармацевтична форма:

SOLUTION

Склад:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 5MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

50/100/150ML

Тип рецепту:

Prescription

Терапевтична области:

QUINOLONES

Огляд продуктів:

Active ingredient group (AIG) number: 0131663001; AHFS:

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2017-02-09

Характеристики продукта

_Page 1 of 71_
PRODUCT MONOGRAPH
Pr
TEVA-LEVOFLOXACIN
(levofloxacin)
250 mg, 500 mg and 750 mg Tablets
and
Pr
LEVOFLOXACIN INJECTION
(levofloxacin)
Sterile
5 mg/mL in 5% dextrose
Antibacterial Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 188951
Date of Revision:
February 22, 2016
_Page 2 of 71_
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
..................................................................................................
11
DRUG INTERACTIONS
..................................................................................................
15
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
.................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 21
STORAGE AND STABILITY
..........................................................................................
26
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL INFORMATION
..........................................................................
28
CLINICAL TRIALS
....................................................................................................