País: Canadá
Idioma: inglés
Fuente: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
SANIS HEALTH INC
J01CA04
AMOXICILLIN
500MG
CAPSULE
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG
ORAL
100/500
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0131314006; AHFS:
APPROVED
2010-11-02
AMOXICILLIN 1 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AMOXICILLIN AMOXICILLIN CAPSULES, USP Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate), Oral AMOXICILLIN GRANULES FOR ORAL SUSPENSION, USP Suspension, 250 mg/5 mL amoxicillin (as amoxicillin trihydrate) after reconstitution, Oral AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION, Manufacturer’s Standard Suspension, 250 mg/5 mL amoxicillin (as amoxicillin trihydrate) after reconstitution, Oral Antibiotic Sanis Health Inc. Date of Initial Authorization: 1 President’s Choice Circle JUN 16, 2010 Brampton, Ontario L6Y 5S5 Date of Revision: www.sanis.com AUG 14, 2023 Submission Control Number: 277120 AMOXICILLIN 2 RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 08/2023 7 WARNINGS AND PRECAUTIONS 08/2023 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .................................................................................................................. 4 1.1 Pediatrics ...................................................................................................................... 4 1.2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 5 4 DOSAGE AND ADMINISTRATION ..................................................................................... 5 4.1 Dosing Considerations .................................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment .............................................................. 5 4.3 Reconstitution ..................................................................................... Leer el documento completo