MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

MEROPENEM (MEROPENEM TRIHYDRATE)

Доступна з:

AURO PHARMA INC

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:

10ML

Тип рецепту:

Prescription

Терапевтична области:

CARBAPENEMS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2017-04-06

Характеристики продукта

MEROPENEM FOR INJECTION_ _
PAGE 1 OF 39
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
500 mg and 1 g meropenem (as meropenem trihydrate) per vial
For intravenous use
Sterile
House Std.
Antibiotic
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
May 24, 2023
Woodbridge, Ontario, L4L 8K8,
Canada.
Submission Control No: 270535
MEROPENEM FOR INJECTION_ _
PAGE 2 OF 39
TABLE OF CONTENT
TABLE OF CONTENT
............................................................................................................................
2
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
........................................... 23
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
....................................................................
24
CLINICAL TRIALS
.............................