MEPERIDINE HYDROCHLORIDE INJECTION USP SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MEPERIDINE HYDROCHLORIDE

Boleh didapati daripada:

ICU MEDICAL CANADA INC

Kod ATC:

N02AB02

INN (Nama Antarabangsa):

PETHIDINE

Dos:

10MG

Borang farmaseutikal:

SOLUTION

Komposisi:

MEPERIDINE HYDROCHLORIDE 10MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

30ML

Jenis preskripsi:

Narcotic (CDSA I)

Kawasan terapeutik:

OPIATE AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0104542003; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-09-28

Ciri produk

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_MEPERIDINE HYDROCHLORIDE INJECTION USP _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
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MEPERIDINE HYDROCHLORIDE INJECTION USP
10 mg/mL
Sterile Solution
OPIOID ANALGESIC
ICU Medical Canada Inc.
2600 Alfred-Nobel boul., suite 100
Saint-Laurent, QC
H4S 0A9
Date of Revision:
July 31, 2018
Submission Control No: 212494
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_MEPERIDINE HYDROCHLORIDE INJECTION USP _
_Page 2 of 32 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
...............................................................