País: Canadá
Língua: inglês
Origem: Health Canada
ADALIMUMAB
AMGEN CANADA INC
L04AB04
ADALIMUMAB
50MG
SOLUTION
ADALIMUMAB 50MG
SUBCUTANEOUS
0.4ML
Prescription
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Active ingredient group (AIG) number: 0150364003; AHFS:
APPROVED
2020-11-04
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 ............................ Leia o documento completo