PRIMAXIN 500 POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
21-12-2021

유효 성분:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

제공처:

MERCK CANADA INC

ATC 코드:

J01DH51

INN (국제 이름):

IMIPENEM AND CILASTATIN

복용량:

500MG; 500MG

약제 형태:

POWDER FOR SOLUTION

구성:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

관리 경로:

INTRAVENOUS

패키지 단위:

25 VIALS (100 OR 250 ML)

처방전 유형:

Prescription

치료 영역:

CARBAPENEMS

제품 요약:

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

승인 상태:

MARKETED

승인 날짜:

2006-12-13

제품 특성 요약

                                _ _
_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
table”, click OK.]
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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5
1.1 Pediatrics
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1.2 Geriatrics
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2
CONTRAINDICATIONS
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SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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