BUPIVACAINE INJECTION BP SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

BUPIVACAINE HYDROCHLORIDE

Inapatikana kutoka:

AURO PHARMA INC

ATC kanuni:

N01BB01

INN (Jina la Kimataifa):

BUPIVACAINE

Kipimo:

5MG

Dawa fomu:

SOLUTION

Tungo:

BUPIVACAINE HYDROCHLORIDE 5MG

Njia ya uendeshaji:

BLOCK/INFILTRATION

Vitengo katika mfuko:

10X10ML

Dawa ya aina:

Ethical

Eneo la matibabu:

LOCAL ANESTHETICS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0108896004; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2016-09-15

Tabia za bidhaa

Page 1 of 27
PRODUCT MONOGRAPH
BUPIVACAINE INJECTION BP
Bupivacaine hydrochloride
0.25% (2.5 mg/ml) and 0.5% (5 mg/ml)
_Local Anesthetic_
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision: September 9, 2016
Submission Control No: 185259
Page 2 of 27
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
...................................................................................................9
DRUG INTERACTIONS
.................................................................................................10
DOSAGE AND ADMINISTRATION
.............................................................................11
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................19
SPECIAL HANDLING INSTRUCTIONS
.......................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
..............................................................................20
PHARMACEUTICAL INFORMATION
.........................................................................20
DETAILED PHARMACOLOGY
........................................................................