Država: Kanada
Jezik: angleščina
Source: Health Canada
PROGESTERONE
DR. REDDY'S LABORATORIES INC
G03DA04
PROGESTERONE
100MG
CAPSULE
PROGESTERONE 100MG
ORAL
2X15
Prescription
PROGESTINS
Active ingredient group (AIG) number: 0106327002; AHFS:
APPROVED
2017-04-20
1 PRODUCT MONOGRAPH PR REDDY-PROGESTERONE Progesterone capsules 100 mg Progestin MANUFACTURED BY: DR. REDDY’S LABORATORIES, INC. Princeton, NJ – 08540 USA IMPORTED AND DISTRIBUTED BY: DR. REDDY’S LABORATORIES CANADA INC. Mississauga, ON L4W 4Y1 CANADA Date of Revision: Nov 4, 2022 Submission Control No: 264364 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................3 SUMMARY PRODUCT INFORMATION .................................................................... 3 INDICATIONS AND CLINICAL USE.......................................................................... 3 CONTRAINDICATIONS .............................................................................................. 3 WARNINGS AND PRECAUTIONS ............................................................................... 4 ADVERSE REACTIONS ............................................................................................ 10 DRUG INTERACTIONS ............................................................................................ 15 DOSAGE AND ADMINISTRATION.......................................................................... 16 OVERDOSAGE .......................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 17 STORAGE AND STABILITY..................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 19 PART II: SCIENTIFIC INFORMATION.......................................................................... 20 PHARMACEUTICAL INFORMATION ....................................................................... 20 CLINICAL TRIALS.................................................................................................... 21 TOXICOLOGY......................................................................................................... Preberite celoten dokument