JAMP-BUPIVACAINE SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BUPIVACAINE HYDROCHLORIDE

Dostupné s:

JAMP PHARMA CORPORATION

ATC kód:

N01BB01

INN (Mezinárodní Name):

BUPIVACAINE

Dávkování:

5MG

Léková forma:

SOLUTION

Složení:

BUPIVACAINE HYDROCHLORIDE 5MG

Podání:

BLOCK/INFILTRATION

Jednotky v balení:

100

Druh předpisu:

Ethical

Terapeutické oblasti:

LOCAL ANESTHETICS

Přehled produktů:

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

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2023-07-12

Charakteristika produktu

_Product Monograph – JAMP-Bupivacaine _
_Page 1 of 32 _
PRODUCT MONOGRAPH
JAMP-Bupivacaine
Bupivacaine Hydrochloride Injection USP
2.5 mg/mL and 5 mg/mL Bupivacaine Hydrochloride
(as bupivacaine hydrochloride monohydrate)
Sterile Solution
Local Anesthetic
JAMP Pharma Corporation
1380-203 newton
Boucherville, Québec
J4B 5H2
Control No. : 178342
Date of Preparation :
October 21, 2014
_Product Monograph – JAMP-Bupivacaine _
_Page 2 of 32 _
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
.......................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
........................