SANDOZ TACROLIMUS CAPSULE (IMMEDIATE RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TACROLIMUS (TACROLIMUS MONOHYDRATE)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

L04AD02

INN (nume internaţional):

TACROLIMUS

Dozare:

1MG

Forma farmaceutică:

CAPSULE (IMMEDIATE RELEASE)

Compoziție:

TACROLIMUS (TACROLIMUS MONOHYDRATE) 1MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

IMMUNOSUPPRESSIVE AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0127857002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-11-22

Caracteristicilor produsului

_Sandoz Tacrolimus (tacrolimus) _
_Page 1 of 89_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ
® TACROLIMUS
Tacrolimus
tacrolimus immediate release capsules
0.5 mg, 1 mg and 5 mg, for oral use
USP
IMMUNOSUPPRESSANT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
June 11, 2014
Date of Revision:
April 12, 2023
Submission Control Number: 272173
_Sandoz Tacrolimus (tacrolimus) _
_Page 2 of 89_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
7 WARNINGS AND PRECAUTIONS, Immune
01/2023
7 WARNINGS AND PRECAUTIONS, Renal
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS.............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
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6
4.2
Recommended Dose and Dosage Adjustment
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