BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

BUPIVACAINE HYDROCHLORIDE

Dostupno od:

MYLAN PHARMACEUTICALS ULC

ATC koda:

N01BB01

INN (International ime):

BUPIVACAINE

Doziranje:

2.5MG

Farmaceutski oblik:

SOLUTION

Sastav:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Administracija rute:

BLOCK/INFILTRATION

Jedinice u paketu:

100

Tip recepta:

Ethical

Područje terapije:

LOCAL ANESTHETICS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED PRE MARKET

Datum autorizacije:

2022-01-27

Svojstava lijeka

_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