País: Canadá
Idioma: inglés
Fuente: Health Canada
CLOZAPINE
MYLAN PHARMACEUTICALS ULC
N05AH02
CLOZAPINE
25MG
TABLET
CLOZAPINE 25MG
ORAL
100
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0122583001; AHFS:
APPROVED
2009-08-07
_Page 1 of 47_ _Mylan Pharmaceuticals ULC _ _June 7, 2022 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr GEN-CLOZAPINE Clozapine Tablets Tablets, 25 mg, 50 mg, 100 mg, 200 mg, Oral Mylan Std. Antipsychotic Agent Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: February 17, 2014 Date of Revision: July 18, 2022 Submission Control No: 261515 _GEN-CLOZAPINE (clozapine) Product Monograph _ _June 7, 2022 _ _Page 2 of 47_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin 07/2022 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 07/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ....................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 11 1 INDICATIONS.............................................................................................................. 11 1.1 Pediatrics.......................................................................................................... 12 1.2 Geriatrics .......................................................................................................... 12 2 CONTRAINDICATIONS ............................................................................................... 12 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 13 4 DOSAGE AND ADMINISTRATION .............................................................................. 13 4.1 Dosing Considerations ...................................................................................... 13 4.2 Recommended Dose and Dosage Adjustment................................................... 15 4.4 Administration ............................................ Leer el documento completo