JAMP-BUPIVACAINE SOLUTION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
21-10-2014
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Aktiva substanser:
BUPIVACAINE HYDROCHLORIDE
Tillgänglig från:
JAMP PHARMA CORPORATION
ATC-kod:
N01BB01
INN (International namn):
BUPIVACAINE
Dos:
2.5MG
Läkemedelsform:
SOLUTION
Sammansättning:
BUPIVACAINE HYDROCHLORIDE 2.5MG
Administreringssätt:
BLOCK/INFILTRATION
Enheter i paketet:
100
Receptbelagda typ:
Ethical
Terapiområde:
LOCAL ANESTHETICS
Produktsammanfattning:
Active ingredient group (AIG) number: 0108896001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2023-07-12
Produktens egenskaper
_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
........................
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