Страна: Канада
Язык: английский
Источник: Health Canada
TACROLIMUS (TACROLIMUS MONOHYDRATE)
ACCORD HEALTHCARE INC
L04AD02
TACROLIMUS
5MG
CAPSULE (IMMEDIATE RELEASE)
TACROLIMUS (TACROLIMUS MONOHYDRATE) 5MG
ORAL
100
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0127857001; AHFS:
APPROVED
2016-06-24
Product Monograph ACH-Tacrolimus (tacrolimus immediate release capsules) Page 1 of 87 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACH-TACROLIMUS Tacrolimus Immediate Release Capsules Capsule (Immediate Release); 0.5 mg, 1 mg, and 5 mg; Oral USP (0.5 mg) and House Standard (1 mg and 5 mg) IMMUNOSUPPRESSANT Accord Healthcare Inc. 3535 boul. St. Charles, Suite 704 Kirkland, Quebec, H9H 5B9 Canada Date of Initial Authorization: APR 18, 2016 Date of Revision: June 28, 2023 Submission Control No: 271640 Product Monograph ACH-Tacrolimus (tacrolimus immediate release capsules) Page 2 of 87 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 06/2023 7 WARNINGS AND PRECAUTIONS, GENERAL 06/2023 7 WARNINGS AND PRECAUTIONS, SEXUAL HEALTH REPRODUCTION 06/2023 7 WARNINGS AND PRECAUTIONS, HEMATOLOGIC 06/2023 7 WARNINGS AND PRECAUTIONS, IMMUNE 06/2023 7 WARNINGS AND PRECAUTIONS, RENAL 06/2023 7 WARNINGS AND PRECAUTIONS, 7.1 SPECIAL POPULATIONS, 7.1.1 PREGNANT WOMEN 06/2023 7 WARNINGS AND PRECAUTIONS, 7.1 SPECIAL POPULATIONS, 7.1.2 BREAST-FEEDING 06/2023 TABLE OF CONTENTS 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 .............................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................... 5 4 DOSAGE Прочитать полный документ