MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

MEROPENEM (MEROPENEM TRIHYDRATE)

Доступно од:

AURO PHARMA INC

АТЦ код:

J01DH02

INN (Међународно име):

MEROPENEM

Дозирање:

500MG

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

10ML

Тип рецептора:

Prescription

Терапеутска област:

CARBAPENEMS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2017-04-06

Карактеристике производа

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
.............................