PRIMAXIN 500 POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Boleh didapati daripada:

MERCK CANADA INC

Kod ATC:

J01DH51

INN (Nama Antarabangsa):

IMIPENEM AND CILASTATIN

Dos:

500MG; 500MG

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

25 VIALS (100 OR 250 ML)

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CARBAPENEMS

Ringkasan produk:

Active ingredient group (AIG) number: 0218820001; AHFS:

Status kebenaran:

MARKETED

Tarikh kebenaran:

2006-12-13

Ciri produk

_ _
_PRIMAXIN_
_®_
_ (imipenem and cilastatin sodium for injection, USP) _
_Page 1 of 61 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PRIMAXIN®
imipenem and cilastatin for injection, USP
500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial
Sterile powder for solution, I.V. Infusion
ANTIBIOTIC
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
JUL 07,1987
Date of Revision:
DEC 21, 2021
Submission Control Number: 253551
_ _
_PRIMAXIN_
_®_
_ (imipenem and cilastatin sodium for injection, USP) _
_Page 2 of 61 _
RECENT MAJOR LABEL CHANGES
4. DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2021
4. DOSAGE AND ADMINISTRATION
06/2020
7. WARNINGS AND PRECAUTIONS
06/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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[To update, right-click anywhere in the Table of Contents and select
“Update Field”, “Update entire
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RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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1.1 Pediatrics
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1.2 Geriatrics
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2
CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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