البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
PROGESTERONE
IBSA INSTITUT BIOCHIMIQUE SA
G03DA04
PROGESTERONE
25MG
SOLUTION
PROGESTERONE 25MG
SUBCUTANEOUS
100
Prescription
PROGESTINS
Active ingredient group (AIG) number: 0106327010; AHFS:
APPROVED
2021-04-30
_INPROSUB™ (progesterone injection) _ _ _ _Page 1 of 33_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR INPROSUB™ Progesterone Injection Solution, 25 mg / 1.112 mL (22.5 mg / mL) progesterone, subcutaneous injection House Standard Progestin Institut Biochimique SA (IBSA) Via del Piano 266 CH-6915 Pambio-Noranco, Switzerland Imported by: Progress Therapeutics Inc. 14-320 Harry Walker Parkway North Newmarket ON Canada, L3Y 7B4 Date of Initial Authorization: June 21, 2021 Submission Control No: 239820 _ _ _INPROSUB™ (progesterone injection) _ _Page 2 of 33_ TABLE OF CONTENTS TABLE OF CONTENTS ....................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4 1 INDICATIONS ........................................................................................................... 4 1.1 Pediatr ics.............................................................................................................4 1.2 Ger iatr ics.............................................................................................................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 Administration.....................................................................................................5 4.4 Missed Dose ........................................................................................................6 5 OVERDOSAGE ...................................................... اقرأ الوثيقة كاملة