BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BUPIVACAINE HYDROCHLORIDE

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

N01BB01

INN (Nama Internasional):

BUPIVACAINE

Dosis:

5MG

Bentuk farmasi:

SOLUTION

Komposisi:

BUPIVACAINE HYDROCHLORIDE 5MG

Rute administrasi :

BLOCK/INFILTRATION

Unit dalam paket:

100

Jenis Resep:

Ethical

Area terapi:

LOCAL ANESTHETICS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2022-01-27

Karakteristik produk

_Product Monograph - Bupivacaine Hydrochloride Injection USP _
_Page 1 of 34 _
PRODUCT MONOGRAPH
Bupivacaine Hydrochloride Injection USP
2.5 mg/mL, 5 mg/mL and 7.5mg/mL Bupivacaine Hydrochloride
(as bupivacaine hydrochloride monohydrate)
Sterile Solution
Local Anesthetic
MYLAN PHARMACEUTICALS ULC
Date of Preparation: September 08, 2014
85 Advance Rd.
Etobicoke, ON
M8Z 2S6
Canada
Control No: 165243
_Product Monograph - Bupivacaine Hydrochloride Injection USP _
_Page 2 of 34 _
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
................................................................................................................
19
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 INF