MEROPENEM FOR INJECTION USP POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MEROPENEM (MEROPENEM TRIHYDRATE)

Tersedia dari:

STERIMAX INC

Kode ATC:

J01DH02

INN (Nama Internasional):

MEROPENEM

Dosis:

500MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

10 VIALS

Jenis Resep:

Prescription

Area terapi:

CARBAPENEMS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-02-17

Karakteristik produk

PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
500 mg/vial and 1 g/vial
(as meropenem trihydrate)
USP
For intravenous use
Antibiotic
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario L6H 6R4
Date of Preparation:
October 22, 2019
Submission Control No: 213538
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_MEROPENEM FOR INJECTION _
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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
.......................................................................................................
9
DRUG
INTERACTIONS......................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................
12
OVERDOSAGE
....................................................................................................................
16
ACTIONS AND CLINICAL PHARMACOLOGY
.............................................................. 16
STORAGE AND STABILITY
.............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 23
PART II:SCIENTIFIC INFORMATION
.........................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................................
24
CLINICAL
TRIALS………………………………………………………………………..25
DETAILED PHARMACOLOGY
...................................