Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
PIRFENIDONE
JAMP PHARMA CORPORATION
L04AX05
PIRFENIDONE
267MG
TABLET
PIRFENIDONE 267MG
ORAL
15G/50G
Prescription
ANTIFIBROTIC AGENTS
Active ingredient group (AIG) number: 0153328001; AHFS:
APPROVED
2021-05-18
_JAMP Pirfenidone (Pirfenidone Tablets) Page 1 of 45 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP PIRFENIDONE Pirfenidone Tablets Film coated tablets, 267 mg and 801 mg Anti-fibrotic / Anti-inflammatory Agent JAMP Pharma Corporation 1310, rue Nobel Boucherville, Quebec Canada, J4B 5H3 Submission Control No: 260317 Date of Initial Authorization: May 18, 2021 Date of Revision: June 14, 2022 _JAMP Pirfenidone (Pirfenidone Tablets) Page 2 of 45 _ _ _ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment [06/2022] 7 Warnings and Precautions [06/2022] TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .................................................................................. 2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ............................................................................................................ 4 1.2 Geriatrics ........................................................................................................... 4 2 CONTRAINDICATIONS ............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................... 4 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations .................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................. 5 4.3. Reconstitution .............................................. Izlasiet visu dokumentu