ACH-TACROLIMUS CAPSULE (IMMEDIATE RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TACROLIMUS (TACROLIMUS MONOHYDRATE)

Tilgjengelig fra:

ACCORD HEALTHCARE INC

ATC-kode:

L04AD02

INN (International Name):

TACROLIMUS

Dosering :

5MG

Legemiddelform:

CAPSULE (IMMEDIATE RELEASE)

Sammensetning:

TACROLIMUS (TACROLIMUS MONOHYDRATE) 5MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

IMMUNOSUPPRESSIVE AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0127857001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2016-06-24

Preparatomtale

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