BUPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BUPIVACAINE HYDROCHLORIDE

Dostupné s:

BAXTER CORPORATION

ATC kód:

N01BB01

INN (Mezinárodní Name):

BUPIVACAINE

Dávkování:

2.5MG

Léková forma:

SOLUTION

Složení:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Podání:

BLOCK/INFILTRATION

Jednotky v balení:

100

Druh předpisu:

Ethical

Terapeutické oblasti:

LOCAL ANESTHETICS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2019-05-23

Charakteristika produktu

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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
BAXTER CORPORATION
Mississauga, Ontario
L5N 0C2
Date of Preparation:
May 22, 2019
Submission Control No: 210568
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35_
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
..................................................