Transcription of Solution for Intramuscular Injection
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Solution for Intramuscular Injection
VAXZEVRIA Product Monograph Page 1 of 31 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION VAXZEVRIA COVID-19 Vaccine (ChAdOx1-S [recombinant]), Solution for Intramuscular Injection Multiple Dose Vial (10 dose vial presentation, 5 x 1010 viral particles per dose) Active Immunizing Agent ATC Code: J07BX03 AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 Date of Initial Authorization: November 19, 2021 Date of Revision: December 14, 2022 Submission Control Number: 267545 VAXZEVRIA is a trademark of AstraZeneca UK Ltd., used under license by AstraZeneca Canada Inc. AstraZeneca Canada Inc. 2022 VAXZEVRIA Product Monograph Page 2 of 31 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 04/2021 2 CONTRAINDICATIONS 06/2021 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 04/2021 4 DOSAGE AND ADMINISTRATION, Administration 03/2021 7 WARNINGS AND PRECAUTIONS, General 03/2021 7 WARNINGS AND PRECAUTIONS, Hematologic 03/2021 7 WARNINGS AND PRECAUTIONS, Pregnant Women 03/2021 7 WARNINGS AND PRECAUTIONS, Hematologic 04/2021 7 WARNINGS AND PRECAUTIONS, Hematologic 06/2021 7 WARNINGS AND PRECAUTIONS, Neurologic 07/2021 7 WARNINGS AND PRECAUTIONS, Hematologic 11/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
Each vaccine dose of 0.5 mL is withdrawn into a syringe for injection to be administered intramuscularly, preferably in the deltoid muscle. Use a separate sterile needle and syringe for each individual. Each vial contains at least the number of doses stated. It is normal for liquid to remain in the vial after withdrawing the final dose.
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