MARCAINE SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

BUPIVACAINE HYDROCHLORIDE

זמין מ:

PFIZER CANADA ULC

קוד ATC:

N01BB01

INN (שם בינלאומי):

BUPIVACAINE

כמות:

2.5MG

טופס פרצבטיות:

SOLUTION

הרכב:

BUPIVACAINE HYDROCHLORIDE 2.5MG

מסלול נתינה (של תרופות):

BLOCK/INFILTRATION

יחידות באריזה:

10ML/20ML

סוג מרשם:

Ethical

איזור תרפויטי:

LOCAL ANESTHETICS

leaflet_short:

Active ingredient group (AIG) number: 0108896001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2004-05-04

מאפייני מוצר

PRODUCT MONOGRAPH
MARCAINE
®
(Bupivacaine Hydrochloride Injection USP)
2.5 mg/mL, 5 mg/mL and 7.5 mg/mL
MARCAINE
® SPINAL
(Bupivacaine Hydrochloride in Dextrose Injection USP)
7.5 mg/mL
MARCAINE
® E
(Bupivacaine Hydrochloride and Epinephrine Injection USP)
Bupivacaine Hydrochloride 2.5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Bupivacaine Hydrochloride 5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Sterile Solution
Local Anesthetic
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 208287
Date of Revision:
September 6, 2017
_Product Monograph – Marcaine_
_®_
_, Marcaine_
_®_
_ Spinal, Marcaine_
_®_
_ E _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION