מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
ADALIMUMAB
ABBVIE CORPORATION
L04AB04
ADALIMUMAB
40MG
SOLUTION
ADALIMUMAB 40MG
SUBCUTANEOUS
0.4ML
Prescription
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Active ingredient group (AIG) number: 0150364002; AHFS:
APPROVED
2016-10-13
_ HUMIRA (adalimumab injection) _ _ _ _ _ _Page 1 of 176_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr HUMIRA® adalimumab injection 40 mg in 0.8 mL sterile solution (50 mg/mL) subcutaneous injection 10 mg in 0.1 mL sterile solution (100 mg/mL) subcutaneous injection 20 mg in 0.2 mL sterile solution (100 mg/mL) subcutaneous injection 40 mg in 0.4 mL sterile solution (100 mg/mL) subcutaneous injection 80 mg in 0.8 mL sterile solution (100 mg/mL) subcutaneous injection Biological Response Modifier (ATC Code: L04AB04) AbbVie Corporation 8401 Trans-Canada Highway St-Laurent, QC H4S 1Z1 Date of Initial Authorization: SEP 24, 2004 Date of Revision: SEP 16, 2022 Submission Control Number: 262924 _ _ _HUMIRA (adalimumab injection) _ _ _ _ _ _Page 2 of 176_ RECENT MAJOR LABEL CHANGES SECTION DATE 1 INDICATIONS 04/2021 1 INDICATIONS, 1.1 Pediatrics (< 18 years of age) 04/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 04/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 04/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS .............................................................................................................. 5 1.1 Pediatrics ................................................................................................................... 7 1.2 Geriatrics ................................................................................................................... 7 2 CONTRAINDICATIONS ................................................................................................. 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 8 4 DOSAGE AND ADMINISTRATION ............ קרא את המסמך השלם