Land: Canada
Språk: engelsk
Kilde: Health Canada
AMIODARONE HYDROCHLORIDE
JAMP PHARMA CORPORATION
C01BD01
AMIODARONE
50MG
SOLUTION
AMIODARONE HYDROCHLORIDE 50MG
INTRAVENOUS
3ML
Prescription
CLASS III ANTIARRYTHMICS
Active ingredient group (AIG) number: 0118593002; AHFS:
APPROVED
2020-11-02
_Amiodarone Hydrochloride for Injection_ _Page 1 of 59_ PRODUCT MONOGRAPH PR AMIODARONE HYDROCHLORIDE FOR INJECTION Amiodarone hydrochloride for injection, USP Vials: 50 mg/mL Antiarrhythmic Agent JAMP Pharma Corporation Date of Preparation: October 27, 2020 1310, rue Nobel Boucherville, Québec, Canada J4B 5H3 Control Number: 235195 _Amiodarone Hydrochloride for Injection_ _Page 2 of 59_ 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 ....................................................................................................................... 15 DRUG INTERACTIONS ....................................................................................................................... 18 DOSAGE AND ADMINISTRATION .................................................................................................... 22 OVERDOSAGE ...................................................................................................................................... 26 ACTION AND CLINICAL PHARMACOLOGY .................................................................................. 27 STORAGE AND STABILITY ............................................................................................................... 30 SPECIAL HANDLING INSTRUCTIONS ............................................................................................. 30 DOSAGE FORMS, COMPOSITION AND PACKAGING .......... Les hele dokumentet