093-Typhim (Salmonella typhi Vi Capsular Polysaccharide ...

Sanofi Pasteur 093 ? TYPHIM Vi?

Product Monograph

PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION

TYPHIM Vi?

Salmonella typhi Vi Capsular Polysaccharide Vaccine

Solution for Muscular Injection A single dose of 0.5 mL contains 25 mcg of Purified Vi capsular polysaccharide of

Salmonella typhi (Ty2 strain) Active Immunizing Agent for the Prevention of Typhoid Fever

ATC: Code J07AP03

Sanofi Pasteur Limited Toronto, ON Canada sanofi.ca

Submission Control Number: 241511

Date of Initial Authorization: December 14, 1994

Date of Revision: June 15, 2021

Typhim Vi? (Salmonella typhi Vi Capsular Polysaccharide Vaccine)

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Sanofi Pasteur 093 ? TYPHIM Vi?

Product Monograph

RECENT MAJOR LABEL CHANGES 6 Dosage Forms, Strengths, Composition and Packaging

12/2018

TABLE OF CONTENTS

Sections or subsections that are not applicable at the time of authorization are not listed.

RECENT MAJOR LABEL CHANGES ............................................................................................. 2

PART I: HEALTH PROFESSIONAL INFORMATION....................................................................... 4

1 INDICATIONS................................................................................................................ 4

1.1 Pediatrics ................................................................................................................. 4

2 CONTRAINDICATIONS .................................................................................................. 4

4 DOSAGE AND ADMINISTRATION .................................................................................. 5

4.1 Dosing Considerations ............................................................................................. 5

4.2 Recommended Dose and Dosage Adjustment ........................................................ 5

4.4 Administration......................................................................................................... 5

5 OVERDOSAGE............................................................................................................... 5

6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 6

7 WARNINGS AND PRECAUTIONS ................................................................................... 7

7.1 Special Populations.................................................................................................. 8

8 ADVERSE REACTIONS ................................................................................................... 8

8.1 Adverse Reaction Overview..................................................................................... 8

8.2 Clinical Trial Adverse Reactions ............................................................................... 9

8.5 Post-Market Adverse Reactions ............................................................................ 11

9 DRUG INTERACTIONS ................................................................................................. 12

9.2 Drug Interactions Overview................................................................................... 12

9.4 Drug-Drug Interactions .......................................................................................... 12

10 CLINICAL PHARMACOLOGY ........................................................................................ 12

10.1 Mechanism of Action....................................................................................... 12

10.2 Pharmacodynamics ......................................................................................... 12

10.3 Pharmacokinetics ............................................................................................ 12

11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 12

Typhim Vi? (Salmonella typhi Vi Capsular Polysaccharide Vaccine)

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Sanofi Pasteur 093 ? TYPHIM Vi?

Product Monograph

12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 12 PART II: SCIENTIFIC INFORMATION ........................................................................................ 13 13 PHARMACEUTICAL INFORMATION ............................................................................. 13 14 CLINICAL TRIALS ......................................................................................................... 13

14.1 Trial Design and Study Demographics ............................................................. 13 14.2 Study Results ................................................................................................... 14 15 MICROBIOLOGY ......................................................................................................... 16 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 16 PATIENT MEDICATION INFORMATION................................................................................... 17

Typhim Vi? (Salmonella typhi Vi Capsular Polysaccharide Vaccine)

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Sanofi Pasteur 093 ? TYPHIM Vi?

Product Monograph

PART I: HEALTH PROFESSIONAL INFORMATION

1 INDICATIONS

TYPHIM Vi? is indicated for active immunization against S. typhi, the organism which causes typhoid fever. TYPHIM Vi? is recommended for active immunization in persons 2 years of age and older, in the following situations:

1. Travellers to endemic or epidemic areas or where sanitary conditions may be doubtful and where travellers may be exposed to potentially contaminated food and water, particularly when prolonged exposure is anticipated.

2. Travellers with reduced or absent gastric acid secretion. 3. People with ongoing household or intimate exposure to an S. typhi carrier. 4. Laboratory workers who frequently handle cultures of S. typhi.

1.1 Pediatrics Pediatrics (2 years of age): TYPHIM Vi? is recommended for active immunization in persons 2 years of age and older. Pediatrics (0 - ................
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