País: Canadá
Idioma: inglés
Fuente: Health Canada
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
VITA HEALTH PRODUCTS INC
M01AE51
IBUPROFEN, COMBINATIONS
200MG; 30MG
TABLET
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
ORAL
10/20
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0222394001; AHFS:
APPROVED
2006-10-17
_ _ _Page 1 of 50_ PRODUCT MONOGRAPH COLD + SINUS CAPLETS Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg USP Analgesic/Antipyretic/Nasal Decongestant Vita Health Products Inc. 150 Beghin Avenue Winnipeg, Manitoba Canada, R2J 3W2 Control No. 151199 Date of Revision: January 30, 2012 _ _ _ _ _Page 2 of 50_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 ADVERSE REACTIONS..................................................................................................11 DRUG INTERACTIONS ..................................................................................................17 DOSAGE AND ADMINISTRATION..............................................................................20 OVERDOSAGE ...............................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................23 STORAGE AND STABILITY..........................................................................................28 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................28 PART II: SCIENTIFIC INFORMATION ...............................................................................29 PHARMACEUTICAL INFORMATION..........................................................................29 CLINICAL TRIALS..........................................................................................................31 DETAILED PHARMACOLOGY.....................................................................................33 TOXICOLOGY ....... Leer el documento completo