BUPIVACAINE HEAVY INJECTION BP SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

BUPIVACAINE HYDROCHLORIDE

Saadav alates:

AURO PHARMA INC

ATC kood:

N01BB01

INN (Rahvusvaheline Nimetus):

BUPIVACAINE

Annus:

15MG

Ravimvorm:

SOLUTION

Koostis:

BUPIVACAINE HYDROCHLORIDE 15MG

Manustamisviis:

INTRASPINAL

Ühikuid pakis:

10X2ML AMPOULE

Retsepti tüüp:

Ethical

Terapeutiline ala:

LOCAL ANESTHETICS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0108896002; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2017-12-11

Toote omadused

_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
...............................................................