Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ACETYLCYSTEINE
EUGIA PHARMA INC.
R05CB01
ACETYLCYSTEINE
200MG
SOLUTION
ACETYLCYSTEINE 200MG
INTRAVENOUS
100
Ethical
Active ingredient group (AIG) number: 0100024001; AHFS:
APPROVED
2023-02-03
Page 1 of 18 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ACETYLCYSTEINE INJECTION 200 mg / mL Sterile Solution for Injection House Standard Antidote for Acetaminophen Poisoning Eugia Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario L4L 8K8, Canada Submission Control No.: 270744 Date of Preparation: FEB 1, 2023 Page 2 of 18 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ..................................................................................................... 3 WARNINGS AND PRECAUTIONS ..................................................................................... 3 ADVERSE REACTIONS .................................................................................................... 5 DRUG INTERACTIONS ..................................................................................................... 5 DOSAGE AND ADMINISTRATION .................................................................................... 5 OVERDOSAGE ................................................................................................................ 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 10 STORAGE AND STABILITY............................................................................................. 11 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 11 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................... 11 PART II: SCIENTIFIC INFORMATION .......................................................................................... 12 PHARMACEUTICAL INFORMATION ..................................... Soma hati kamili