Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
EUGIA PHARMA INC.
N05CM18
DEXMEDETOMIDINE
100MCG
SOLUTION
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG
INTRAVENOUS
100
Prescription
Active ingredient group (AIG) number: 0152679003; AHFS:
APPROVED
2022-07-08
_Page 1 of 32_ PRODUCT MONOGRAPH PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION CONCENTRATE DEXMEDETOMIDINE (AS DEXMEDETOMIDINE HYDROCHLORIDE) 200 MCG/2 ML (100 MCG/ML) Alpha 2 -adrenergic agonist EUGIA PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario L4L 8K8 Canada SUBMISSION CONTROL NO.: 264435 Date of Preparation: July 8, 2022 _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 ........................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................... 12 DOSAGE AND ADMINISTRATION ..................................................................................... 13 OVERDOSAGE ........................................................................................................................ 16 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 16 STORAGE AND STABILITY ................................................................................................. 19 SPECIAL HANDLING INSTRUCTION...................................................................................19 DOSAGE FORM, COMPOSITION AND PACKAGING………………………………….20 PART II: SCIENTIFIC INFORMATION ............................................................................... 21 PHARMACEUTICAL INFORMATION ................... Đọc toàn bộ tài liệu