Transcription of PRODUCT MONOGRAPH - Mylan
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Hp-PAC PRODUCT MONOGRAPH Page 1 of 111 Date of Revision: January 8, 2016 and Control No. 186719 PRODUCT MONOGRAPH PrHp-PAC lansoprazole delayed-release capsules (manufacturer s standard), 30 mg clarithromycin tablets, USP, film-coated, 500 mg amoxicillin capsules, 500 mg Helicobacter pylori Eradication Therapy NOTE: THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. THE INDIVIDUAL PRODUCTS CONTAINED IN THE Hp-PAC SHOULD NOT BE USED ALONE OR IN COMBINATION FOR OTHER PURPOSES. THE INFORMATION DESCRIBED IN THIS PRODUCT MONOGRAPH CONCERNS ONLY THE USE OF THESE PRODUCTS AS INDICATED IN THIS DAILY ADMINISTRATION PACK. FOR INFORMATION ON THE USE OF THE INDIVIDUAL COMPONENTS WHEN DISPENSED AS INDIVIDUAL MEDICATIONS OUTSIDE THIS COMBINED USE FOR THE ERADICATION OF HELICOBACTER pylori (H.)
Patients were included in the analysis if they had documented . H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer.
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