Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
VITA HEALTH PRODUCTS INC
M01AE51
IBUPROFEN, COMBINATIONS
200MG; 30MG; 200MG; 30MG; 2MG
KIT
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CHLORPHENIRAMINE MALEATE 2MG
ORAL
12+6
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0553187001; AHFS:
APPROVED
2011-11-04
Page 1 of 66 PRODUCT MONOGRAPH COLD + SINUS NIGHTTIME Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg and Chlorpheniramine Maleate 2 mg Tablets Analgesic/Antipyretic/Nasal Decongestant/Antihistamine Vita Health Products Inc. Date of Revision: 150 Beghin Avenue October 31, 2011 Winnipeg, Manitoba Canada, R2J 3W2 Control# 149333 Page 2 of 66 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................ 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS ................................................................................ 5 ADVERSE REACTIONS ................................................................................................ 12 DRUG INTERACTIONS ................................................................................................ 20 DOSAGE AND ADMINISTRATION ............................................................................ 24 OVERDOSAGE ............................................................................................................... 25 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 28 STORAGE AND STABILITY ........................................................................................ 33 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION ................................................................................ 34 PHARMACEUTICAL INFORMATION ........................................................................ 34 CLINICAL TRIALS ....................................... Διαβάστε το πλήρες έγγραφο