Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
AMIFAMPRIDINE
MEDUNIK CANADA
N07XX05
AMIFAMPRIDINE
10MG
TABLET
AMIFAMPRIDINE 10MG
ORAL
15G/50G
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0162417001; AHFS:
APPROVED
2020-08-10
_RUZURGI (amifampridine tablets) Product Monograph _ _Page 1 of 29 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR RUZURGI ® Amifampridine Tablets 10 mg Potassium Channel Blocker Médunik Canada 950, boul. Michèle-Bohec Blainville, Québec Canada, J7C 5E2 Date of Initial Approval: August 5, 2020 Submission Control No: 234655 _ _ _RUZURGI (amifampridine tablets) Product Monograph _ _Page 2 of 29_ TABLE OF CONTENTS TABLE OF CONTENTS ..............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4 1 INDICATION ......................................................................................................................4 1.1 Pediatrics ....................................................................................................................4 1.2 Geriatrics ....................................................................................................................4 2 CONTRAINDICATIONS ..................................................................................................4 3 DOSAGE AND ADMINISTRATION ...............................................................................4 3.1 Dosing Considerations ...............................................................................................4 3.2 Recommended Dose and Dosage Adjustment ...........................................................5 3.3 Administration ...........................................................................................................6 3.4 Missed Dose ...............................................................................................................7 4 OVERDOSAGE .................................................................................................................7 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................7 6 WARNINGS AND PRECAUTIONS ........................................... Διαβάστε το πλήρες έγγραφο