MEROPENEM FOR INJECTION SDZ POWDER FOR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

MEROPENEM (MEROPENEM TRIHYDRATE)

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

J01DH02

ІПН (Міжнародна Ім'я):

MEROPENEM

Дозування:

500MG

Фармацевтична форма:

POWDER FOR SOLUTION

Склад:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

CARBAPENEMS

Огляд продуктів:

Active ingredient group (AIG) number: 0128599001; AHFS:

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2023-07-26

Характеристики продукта

_ _
_Meropenem for Injection _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
(meropenem for injection)
500 mg and 1 g vials
USP
For intravenous use
Antibiotic
Sandoz Canada Inc.
Date of Revision: October 6, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 239077
_ _
_Meropenem for Injection _
_Page 2 of 38_
TABLE OF CONTENT
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
...........................................................................................................
8
DRUG
INTERACTIONS
.........................................................................................................
11
DOSAGE
AND
ADMINISTRATION
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
16
STABILITY AND STORAGE RECOMMENDATIONS
........................................................ 22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL
INFORMATION
.................................................................................
24
CLINICAL
TRIALS
...................................................................