البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
ESTRADIOL
PHARMASCIENCE INC
G03CA03
ESTRADIOL
1MG
TABLET
ESTRADIOL 1MG
ORAL
100
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106457003; AHFS:
APPROVED
2022-10-26
_ _ _ESTRADIOL (17β-estradiol) _ _Page 1 of 32_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ESTRADIOL 17β-estradiol Tablets Tablets 0.5 mg, 1 mg, 2 mg USP Estrogen Pharmascience Inc. 6111 Royalmount Ave., Suite 100 Montreal, Quebec Canada H4P 2T4 www.pharmascience.com Date of Initial Authorization: OCT 25, 2022 Submission Control Number: 267798 _ _ _ _ _ESTRADIOL (17β-estradiol) _ _Page 2 of 32_ TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . 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 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations .............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 6 4.5 Missed Dose .............................................................................................................. 6 5 OVERDOSAGE ............................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. اقرأ الوثيقة كاملة