BUPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

BUPIVACAINE HYDROCHLORIDE

Inapatikana kutoka:

STERIMAX INC

ATC kanuni:

N01BB01

INN (Jina la Kimataifa):

BUPIVACAINE

Kipimo:

2.5MG

Dawa fomu:

SOLUTION

Tungo:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Njia ya uendeshaji:

BLOCK/INFILTRATION

Vitengo katika mfuko:

100

Dawa ya aina:

Ethical

Eneo la matibabu:

LOCAL ANESTHETICS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-09-11

Tabia za bidhaa

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PRODUCT MONOGRAPH
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
2.5 mg/mL,
5 mg
/mL and 7.5 mg/mL Bupivacaine Hydrochloride, USP
Sterile Solution
Local Anesthetic
STERIMAX INC.
Oakville, Ontario
2770 Portland Drive
L6H 6R4
Date of Preparation:
September 8, 2020
Submission Control No: 238228
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
.................................