国家: 加拿大
语言: 英文
来源: Health Canada
NITROGLYCERIN
VALEANT CANADA LP / VALEANT CANADA S.E.C.
C01DA02
GLYCERYL TRINITRATE
0.4MG
PATCH
NITROGLYCERIN 0.4MG
TRANSDERMAL
30/100
Ethical
NITRATES AND NITRITES
Active ingredient group (AIG) number: 0103615009; AHFS:
CANCELLED POST MARKET
2021-03-19
_ _ _Product Monograph – MINITRAN_ _®_ _ _ _ _ _Page 1 of 20_ PRODUCT MONOGRAPH MINITRAN ® 0.2 MG/HR MINITRAN ® 0.4 MG/HR MINITRAN ® 0.6 MG/HR Nitroglycerin Transdermal Delivery System Rated Release _in vivo_ 0.2, 0.4, and 0.6 mg/hour Antianginal Valeant Canada LP 2150 St-Elzear Blvd., West Laval (Quebec) H7L 4A8 Canada Date of Preparation: March 6, 2013 Date of Revision: August 19, 2015 Submission Control No: 184516 _ _ _Product Monograph – MINITRAN_ _®_ _ _ _ _ _Page 2 of 20_ 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 ....................................................................................................7 DRUG INTERACTIONS ....................................................................................................7 DOSAGE AND ADMINISTRATION ................................................................................8 OVERDOSAGE ..................................................................................................................9 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY ..........................................................................................12 SPECIAL HANDLING INSTRUCTIONS .......................................................................12 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................12 PART II: SCIENTIFIC INFORMATION ...............................................................................13 PHARMACE 阅读完整的文件