Страна: Канада
Язык: английский
Источник: Health Canada
BUPIVACAINE HYDROCHLORIDE
PFIZER CANADA ULC
N01BB01
BUPIVACAINE
125MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 125MG
BLOCK/INFILTRATION
50ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0108896001; AHFS:
APPROVED
2004-05-04
PRODUCT MONOGRAPH MARCAINE ® (Bupivacaine Hydrochloride Injection USP) 2.5 mg/mL, 5 mg/mL and 7.5 mg/mL MARCAINE ® SPINAL (Bupivacaine Hydrochloride in Dextrose Injection USP) 7.5 mg/mL MARCAINE ® E (Bupivacaine Hydrochloride and Epinephrine Injection USP) Bupivacaine Hydrochloride 2.5 mg/mL and Epinephrine Bitartrate 9.1 mcg/mL Bupivacaine Hydrochloride 5 mg/mL and Epinephrine Bitartrate 9.1 mcg/mL Sterile Solution Local Anesthetic Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Submission Control No.: 208287 Date of Revision: September 6, 2017 _Product Monograph – Marcaine_ _®_ _, Marcaine_ _®_ _ Spinal, Marcaine_ _®_ _ E _ _Page 2 of 40_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................4 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ............................................................26 STORAGE AND STABILITY ..........................................................................................28 SPECIAL HANDLING INSTRUCTIONS .......................................................................28 DOSAGE FORMS, COMPOSITION Прочитать полный документ