Transcription of PRODUCT MONOGRAPH
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Page 1 of 27 PRODUCT MONOGRAPH DUKORAL Oral, Inactivated Cholera and ETEC diarrhea Vaccine Oral Suspension Active Immunizing Agent for the Prevention of diarrhea Caused by Vibrio cholerae and/or heat-labile toxin producing Enterotoxigenic Escherichia coli ATC Code: J07AE01 Manufactured by: Date of Approval: Valneva Sweden AB, 105 21 Stockholm, Sweden Imported by: Q&C Services 119-2550 Argentia Road Mississauga, Ontario, L5N 5R1 Distributed by: Valneva Canada Inc. 600-3535, Saint-Charles Blvd. Kirkland, Qu bec, H9H 5B9 December 22, 2015 Submission Control No. 188466 Page 2 of 27 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .. 4 SUMMARY PRODUCT INFORMATION .. 4 DESCRIPTION .. 4 INDICATIONS AND CLINICAL USE .. 5 CONTRAINDICATIONS .. 5 WARNINGS AND PRECAUTIONS .. 6 General .. 6 Gastrointestinal .. 6 Immune .. 6 Neurologic .. 7 SPECIAL POPULATIONS .. 7 Pregnant Women.
responsible for acute diarrhea in travelers. DUKORAL® can only confer protection against cholera and LT-producing ETEC. Therefore it should not replace standard preventive hygiene measures. Travellers should use care in the choice of food and water supply and use good hygienic measures. Rehydration measures must be taken in case of diarrhea ...
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