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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

INFLECTRA PRODUCT MonographPage 1 of 115 PRODUCT MONOGRAPHINCLUDING PATIENT MEDICATION INFORMATIONPrINFLECTRA (infliximabfor injection)Powder for Solution, Sterile, Lyophilized, 100 mg/vial, Intravenous InfusionProfessed StandardBiological Response ModifierManufactured by:Celltrion Healthcare Co., , Academy-ro 51 beon-gil,Yeonsu-gu, IncheonRepublic of Korea22014 Imported and distributed by:Pfizer Canada ULC17300 Trans-Canada HighwayKirkland, Qu becH9J 2M5 Date of Initial Approval:January 15, 2014 Date of Revision: March 11, 2020 Submission Control No: 237374 Date of Approval: July 6, 2020 INFLECTRA PRODUCT MonographPage 2 of 115 RECENT MAJOR LABEL CHANGESNot applicableTABLE OF CONTENTSPART I: HEALTH PROFESSIONAL Geriatrics ( 65 years of age).. WARNINGS ANDPRECAUTIONS AND Recommended Dose and Dosage Missed FORMS, STRENGTHS, COMPOSITION AND Special (6-17 years of age).. (65 years of age or older).

Patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections (see WARNINGS AND PRECAUTIONS, Risk of Infections). Patients with moderate or severe (NYHA Class III/IV) congestive heart failure (see WARNINGS AND PRECAUTIONS, Cardiovascular and ADVERSE REACTIONS, Congestive Heart Failure).

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