Страна: Канада
Език: английски
Източник: Health Canada
MODIFIED VACCINIA VIRUS (ANKARA-BAVARIAN NORDIC)
BAVARIAN NORDIC AS
J07BX01
SMALLPOX AND MONKEYPOX VACCINES
50000000CCID50
SUSPENSION
MODIFIED VACCINIA VIRUS (ANKARA-BAVARIAN NORDIC) 50000000CCID50
SUBCUTANEOUS
20X0.5ML
Schedule D
VACCINES
Active ingredient group (AIG) number: 0155011001; AHFS:
APPROVED
2013-11-21
_Product Monograph Master Template _ _Template Date: September 2020 _ _IMVAMUNE Smallpox and mpox Vaccine _ _Page 1 of 32_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION IMVAMUNE ® Smallpox and mpox Vaccine Modified Vaccinia Ankara-Bavarian Nordic ® (live-attenuated, non-replicating) Suspension for Injection at least 0.5 x 10 8 Inf.U/ per 0.5 mL single dose Pharmacotherapeutic group: Other viral vaccines ATC code: J07BX Bavarian Nordic A/S Philip Heymans Alle 3 DK-2900 Hellerup Denmark Distributor: Progress Therapeutics Inc. 320 Harry Walker Pky. N., Suite #14 Newmarket, Ontario L3Y 7B4 Date of Initial Approval: November 21, 2013 Date of Revision: August 3, 2023 Submission Control No: 272722 _Product Monograph Master Template _ _Template Date: September 2020 _ _IMVAMUNE Smallpox and mpox Vaccine _ _Page 2 of 32_ RECENT MAJOR LABEL CHANGES Since September 2019, major label changes related to safety and efficacy have been made under the following sections: 1 Indications 11/2020 3 Serious Warnings and Precautions Box 11/2020 4 Dosage and Administration_4.5 Missed Dose 11/2020 7 Warnings and Precautions_7.1 Special Populations 11/2020 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ....................................................................................... 2 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 S Прочетете целия документ