AMGEVITA SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ADALIMUMAB

Boleh didapati daripada:

AMGEN CANADA INC

Kod ATC:

L04AB04

INN (Nama Antarabangsa):

ADALIMUMAB

Dos:

50MG

Borang farmaseutikal:

SOLUTION

Komposisi:

ADALIMUMAB 50MG

Laluan pentadbiran:

SUBCUTANEOUS

Unit dalam pakej:

0.4ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0150364003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-11-04

Ciri produk

AMGEVITA
®
(adalimumab) Product Monograph
Page 1 of 169
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMGEVITA
®
adalimumab injection
20 mg in 0.4 mL sterile solution (50 mg/mL), prefilled syringe for
subcutaneous injection
40 mg in 0.8 mL sterile solution (50 mg/mL), prefilled syringe for
subcutaneous injection
40 mg in 0.8 mL sterile solution (50 mg/mL), prefilled SureClick
®
autoinjector for subcutaneous
injection
Professed Standard
Biologic Response Modifier
AMGEVITA (ADALIMUMAB INJECTION) TREATMENT SHOULD BE INITIATED AND
SUPERVISED BY
SPECIALIST PHYSICIANS EXPERIENCED IN THE DIAGNOSIS AND TREATMENT OF
RHEUMATOID ARTHRITIS,
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, PSORIATIC ARTHRITIS,
ANKYLOSING SPONDYLITIS, ADULT
AND PEDIATRIC (13 TO 17 YEARS OF AGE WEIGHING ≥ 40 KG) CROHN’S
DISEASE, ADULT AND
PEDIATRIC (5 TO 17 YEARS OF AGE) ULCERATIVE COLITIS, ADULT AND
ADOLESCENT (12 TO 17 YEARS OF
AGE WEIGHING ≥ 30 KG) HIDRADENITIS SUPPURATIVA, PSORIASIS OR ADULT
AND PEDIATRIC UVEITIS,
AND FAMILIAR WITH THE AMGEVITA EFFICACY AND SAFETY PROFILE.
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, ON L5N 0A4
Date of Initial Approval:
04 November, 2020
Submission Control No: 256159
Date of Revision:
09 September, 2022

2020-2022 Amgen Canada Inc., all rights reserved.
AMGEVITA
®
(adalimumab) Product Monograph
Page 2 of 169
RECENT MAJOR LABEL CHANGES
1 Indications
XX/XXXX
4 Dosage and Administration
07/2021
4 Dosage and Administration
XX/XXXX
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
............................................................................................................
6
1.2
Geriatrics.............................................................................................................
6
2
CONTRAINDICATIONS
............................