Страна: Канада
Язык: английский
Источник: Health Canada
TACROLIMUS (TACROLIMUS MONOHYDRATE)
JAMP PHARMA CORPORATION
L04AD02
TACROLIMUS
5MG
CAPSULE (IMMEDIATE RELEASE)
TACROLIMUS (TACROLIMUS MONOHYDRATE) 5MG
ORAL
100
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0127857001; AHFS:
CANCELLED PRE MARKET
2022-09-08
_Jamp-Tacrolimus-Product Monograph_ _Page 1 of 70_ PRODUCT MONOGRAPH PR JAMP-TACROLIMUS Tacrolimus Capsules, House Standard IMMEDIATE-RELEASE 1 mg and 5 mg Immunosuppressant Jamp Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3 Date of Preparation: December 30, 2016 CONTROL NUMBER: 1 9 9 8 8 7 _Jamp-Tacrolimus-Product Monograph_ _Page 2 of 70_ 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 ......................................................................................................... 12 DRUG INTERACTIONS ....................................................................................................... 24 DOSAGE AND ADMINISTRATION ................................................................................... 29 OVERDOSAGE ......................................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 32 STORAGE AND STABILITY ............................................................................................... 38 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 38 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................. 39 PART II: SCIENTIFIC INFORMATION ................................................................................. 40 PHARMACEUTICAL INFORMATION ............................ Прочитать полный документ