MEROPENEM FOR INJECTION SDZ POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MEROPENEM (MEROPENEM TRIHYDRATE)

Tersedia dari:

SANDOZ CANADA INCORPORATED

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:

100

Jenis Resep:

Prescription

Area terapi:

CARBAPENEMS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2023-07-26

Karakteristik produk

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_Meropenem for Injection _
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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
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_Meropenem for Injection _
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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
...................................................................