MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

MEROPENEM (MEROPENEM TRIHYDRATE)

Dostupné z:

AURO PHARMA INC

ATC kód:

J01DH02

INN (Medzinárodný Name):

MEROPENEM

Dávkovanie:

500MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

10ML

Typ predpisu:

Prescription

Terapeutické oblasti:

CARBAPENEMS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2017-04-06

Súhrn charakteristických

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