Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
GUAIFENESIN; PHENIRAMINE MALEATE; CODEINE PHOSPHATE
TEVA CANADA LIMITED
R05FA02
OPIUM DERIVATIVES AND EXPECTORANTS
100MG; 7.5MG; 10MG
SYRUP
GUAIFENESIN 100MG; PHENIRAMINE MALEATE 7.5MG; CODEINE PHOSPHATE 10MG
ORAL
500ML/1L
Narcotic (CDSA I)
ANTITUSSIVES
Active ingredient group (AIG) number: 0303191001; AHFS:
APPROVED
2002-10-10
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N CALMYLIN ACE GUAIFENESIN, CODEINE PHOSPHATE AND PHENIRAMINE MALEATE SYRUP Guaifenesin 100 mg/5 mL - Codeine Phosphate 10 mg/5 mL – Pheniramine Maleate 7.5 mg/5 mL EXPECTORANT/ ANTITUSSIVE/ ANTIHISTAMINE TEVA CANADA LIMITED DATE OF REVISION: 30 NOVOPHARM COURT September 02, 2020 TORONTO, ONTARIO CANADA M1B 2K9 WWW.TEVACANADA.COM CONTROL #: 242347 _______________________________________________________________________________ _Product Monograph – CALMYLIN ACE_ Page 2 of 29 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ...................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 12 DRUG INTERACTIONS ......................................................................................................... 12 DOSAGE AND ADMINISTRATION ...................................................................................... 14 OVERDOSAGE ....................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 16 STORAGE AND STABILITY ................................................................................................. 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 16 PART II: SCIENTIFIC INFORMATION ...................................................... Đọc toàn bộ tài liệu