BUPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

BUPIVACAINE HYDROCHLORIDE

Dostopno od:

BAXTER CORPORATION

Koda artikla:

N01BB01

INN (mednarodno ime):

BUPIVACAINE

Odmerek:

2.5MG

Farmacevtska oblika:

SOLUTION

Sestava:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Pot uporabe:

BLOCK/INFILTRATION

Enote v paketu:

100

Tip zastaranja:

Ethical

Terapevtsko območje:

LOCAL ANESTHETICS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2019-05-23

Lastnosti izdelka

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_Bupivacaine Hydrochloride Injection, USP Product Monograph Page 1 of
35_
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
_ _
_Bupivacaine Hydrochloride Injection, USP Product Monograph Page 2 of
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
..................................................