Страна: Канада
мова: англійська
Джерело: Health Canada
BUPIVACAINE HYDROCHLORIDE
OMEGA LABORATORIES LIMITED
N01BB01
BUPIVACAINE
7.5MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 7.5MG
INTRASPINAL
15G/50G
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0108896002; AHFS:
APPROVED
2021-02-11
_Page 1 of 28 _ PRODUCT MONOGRAPH BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP 7.5 mg/mL Sterile Hyperbaric Solution Local Anesthetic for Spinal Use Only _ _ _ _ _ _ _ _ _ _ Omega Laboratories Limited Date of Preparation: February 10, 2021 11 177 Hamon Montreal, Quebec H3M 3E4 Submission Control No.: 229408 _Page 2 of 28 _ 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 ....................................................................................... 7 DRUG INTERACTIONS ..................................................................................... 10 DOSAGE AND ADMINISTRATION ................................................................. 12 OVERDOSAGE .................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ............................................... 17 STORAGE AND STABILITY ............................................................................. 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................ 19 PART II: SCIENTIFIC INFORMATION ................................................................... 20 PHARMACEUTICAL INFORMATION ............................................................. 20 DETAILED PHARMACOLOGY ........................................................................ 20 TOXICOLOGY .................................................................................................... 21 REFERENCES ...................................................................................................... 22 PART I Прочитайте повний документ