BUPIVACAINE HEAVY 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:

15MG

Dawa fomu:

SOLUTION

Tungo:

BUPIVACAINE HYDROCHLORIDE 15MG

Njia ya uendeshaji:

INTRASPINAL

Vitengo katika mfuko:

10X2ML AMPOULE

Dawa ya aina:

Ethical

Eneo la matibabu:

LOCAL ANESTHETICS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-12-11

Tabia za bidhaa

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