BUPIVACAINE HEAVY INJECTION BP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-12-2017
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Active ingredient:
BUPIVACAINE HYDROCHLORIDE
Available from:
AURO PHARMA INC
ATC code:
N01BB01
INN (International Name):
BUPIVACAINE
Dosage:
15MG
Pharmaceutical form:
SOLUTION
Composition:
BUPIVACAINE HYDROCHLORIDE 15MG
Administration route:
INTRASPINAL
Units in package:
10X2ML AMPOULE
Prescription type:
Ethical
Therapeutic area:
LOCAL ANESTHETICS
Product summary:
Active ingredient group (AIG) number: 0108896002; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-12-11
Summary of Product characteristics
_PAGE 1 OF 29 _
PRODUCT MONOGRAPH
BUPIVACAINE HEAVY INJECTION BP
Bupivacaine 0.75% in Glucose 7.5 mg/mL
_Local Anesthetic_
AURO PHARMA INC.
Date of Preparation:
3700 Steeles Avenue West, Suite # 402 December 11, 2017
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No: 203187
_PAGE 2 OF 29 _
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
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
DETAILED PHARMACOLOGY
...............................................................
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