País: Canadá
Língua: inglês
Origem: Health Canada
BUPIVACAINE HYDROCHLORIDE
OMEGA LABORATORIES LIMITED
N01BB01
BUPIVACAINE
7.5MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 7.5MG
EPIDURAL
100
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0108896002; AHFS:
APPROVED
2020-11-06
_Page 1 of 33 _ PRODUCT MONOGRAPH BUPIVACAINE HYDROCHLORIDE INJECTION USP 7.5 mg / mL Sterile Solution _ _Local Anesthetic _ _ Omega Laboratories Limited Date of Preparation: November 6, 2020 11 177 Hamon Montreal, Quebec H3M 3E4 Submission Control No: 222019 _Page 2 of 33 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................. 3 SUMMARY PRODUCT INFORMATION ........................................................... 3 INDICATIONS AND CLINICAL USE ................................................................. 3 CONTRAINDICATIONS ...................................................................................... 3 WARNINGS AND PRECAUTIONS ..................................................................... 4 ADVERSE REACTIONS ..................................................................................... 10 DRUG INTERACTIONS ..................................................................................... 12 DOSAGE AND ADMINISTRATION ................................................................. 13 OVERDOSAGE ................................................................................................... 18 ACTION AND CLINICAL PHARMACOLOGY ............................................... 20 STORAGE AND STABILITY ............................................................................. 22 SPECIAL HANDLING INSTRUCTIONS .......................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................ 23 PART II: SCIENTIFIC INFORMATION ................................................................... 24 PHARMACEUTICAL INFORMATION ............................................................. 24 DETAILED PHARMACOLOGY ........................................................................ 24 TOXICOLOGY .................................................................................................... 25 REFERENCES .............................................................................. Leia o documento completo