MYLAN-HYDROXYUREA CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

HYDROXYUREA

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

L01XX05

INN (Nama Internasional):

HYDROXYCARBAMIDE

Dosis:

500MG

Bentuk farmasi:

CAPSULE

Komposisi:

HYDROXYUREA 500MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0113432001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2009-07-02

Karakteristik produk

_MYLAN-HYDROXYUREA (hydroxyurea capsules) _
_ _
_Page 1 of 27 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-HYDROXYUREA
Hydroxyurea Capsules
Capsules, 500 mg, Oral
USP
Antineoplastic Agent
Mylan Pharmaceuticals ULC
Date of Initial Authorization:
85 Advance Road
October 17, 2000
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
Canada
April 4, 2023
Submission Control Number: 268902
_MYLAN-HYDROXYUREA (hydroxyurea capsules) _
_ _
_Page 2 of 27 _
RECENT MAJOR LABEL CHANGES
1 Indications
04/2023
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
04/2023
7 Warnings and Precautions, Hematologic
04/2023
7 Warnings and Precautions, Reproductive Health: Female and Male
Potential
04/2023
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
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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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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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