Страна: Канада
Език: английски
Източник: Health Canada
PROPIVERINE HYDROCHLORIDE
DUCHESNAY INC
G04BD06
PROPIVERINE
5MG
TABLET
PROPIVERINE HYDROCHLORIDE 5MG
ORAL
28
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0158750003; AHFS:
APPROVED
2017-01-05
_Mictoryl_ _®_ _/Mictoryl_ _®_ _ Pediatric Product Monograph _ _Page 1 of 39 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr MICTORYL ® Propiverine hydrochloride modified-release capsules 30 mg and 45 mg Pr MICTORYL ® PEDIATRIC Propiverine hydrochloride tablets 5 mg ATC Code: G04BD06 Anticholinergic and antispasmodic agent Duchesnay Inc. 950, boul. Michèle-Bohec Blainville, Québec Canada, J7C 5E2 Date of Revision: January 15, 2018 Submission Control No: 210208 _ _ _Mictoryl_ _®_ _/Mictoryl_ _® _ _Pediatric Product Monograph _ _Page 2 of 39 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .............................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................6 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................12 ACTION AND CLINICAL PHARMACOLOGY ............................................................13 STORAGE AND STABILITY ..........................................................................................16 SPECIAL HANDLING INSTRUCTIONS .......................................................................16 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................16 PART II: SCIENTIFIC INFORMATION ........ Прочетете целия документ