Kraj: Kanada
Język: angielski
Źródło: Health Canada
LOXAPINE (LOXAPINE HYDROCHLORIDE)
PENDOPHARM DIVISION OF PHARMASCIENCE INC
N05AH01
LOXAPINE
25MG
SOLUTION
LOXAPINE (LOXAPINE HYDROCHLORIDE) 25MG
ORAL
100
Prescription
MISCELLANEOUS ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0111557001; AHFS:
CANCELLED POST MARKET
2020-07-17
PRODUCT MONOGRAPH PR XYLAC TM Loxapine Succinate Tablets 2.5, 5, 10, 25 & 50 mg Loxapine Hydrochloride Solution Oral Concentrate 25 mg/mL Antipsychotic ATC Code: N05AH01 PENDOPHARM, DIVISION OF PHARMASCIENCE INC. 6111 Royalmount Ave, Suite 100 Montréal, Canada H4P 2T4 Date of Preparation: May 15, 2012 Control No: 155424 TM Trademark of Pharmascience Inc. _XYLAC_ _TM_ _ Product Monograph Page 1 of 33_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 2 SUMMARY PRODUCT INFORMATION ........................................................................ 2 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................. 3 ADVERSE REACTIONS ................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 10 DOSAGE AND ADMINISTRATION ............................................................................. 13 OVERDOSAGE ................................................................................................................ 14 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 15 STORAGE AND STABILITY ......................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 16 PART II: SCIENTIFIC INFORMATION .............................................................................. 19 PHARMACEUTICAL INFORMATION ......................................................................... 19 CLINICAL TRIALS ............................................................................. Przeczytaj cały dokument