Држава: Канада
Језик: Енглески
Извор: Health Canada
RITONAVIR; NIRMATRELVIR
PFIZER CANADA ULC
J05AE30
NIRMATRELVIR AND RITONAVIR
100MG; 150MG
TABLET
RITONAVIR 100MG; NIRMATRELVIR 150MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0263338001; AHFS:
APPROVED
2022-01-17
_ _ _PAXLOVID_ _TM_ _ (nirmatrelvir; ritonavir) Product Monograph _ _Page 1 of 56 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr PAXLOVID™ nirmatrelvir tablets; ritonavir tablets Tablets, 150 mg nirmatrelvir; 100 mg ritonavir co-packaged for oral use Protease Inhibitor Antiviral Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Initial Authorization: January 17, 2022 Date of Revision: January 2, 2024 Submission Control Number: 278009 _ _ _PAXLOVID_ _TM_ _ (nirmatrelvir; ritonavir) Product Monograph _ _Page 2 of 56 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 06/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 06/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, 4.2 Recommended Dose and Dosage Adjustment 06/2022 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING 06/2022 7 WARNINGS AND PRECAUTIONS 08/2023 7 WARNINGS AND PRECAUTIONS, Immune 11/2023 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 08/2023 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 .................................................................... 4 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics .................................................................................................................. 4 1.2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 8 4 DOSAGE AND ADMINISTRATION .......................................................... Прочитајте комплетан документ