Land: Canada
Språk: engelsk
Kilde: Health Canada
BUPIVACAINE HYDROCHLORIDE
JAMP PHARMA CORPORATION
N01BB01
BUPIVACAINE
2.5MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 2.5MG
BLOCK/INFILTRATION
100
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0108896001; AHFS:
CANCELLED PRE MARKET
2023-07-12
_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 ........................ Les hele dokumentet