Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
MELPHALAN (MELPHALAN HYDROCHLORIDE)
EUGIA PHARMA INC.
L01AA03
MELPHALAN
50MG
KIT
MELPHALAN (MELPHALAN HYDROCHLORIDE) 50MG
INTRAVENOUS
100
Prescription
Active ingredient group (AIG) number: 0102597002; AHFS:
APPROVED
2023-04-21
Page 1 of 22 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MELPHALAN FOR INJECTION MELPHALAN (AS MELPHALAN HYDROCHLORIDE) Sterile Lyophilized Powder for Injection (with sterile Diluent) 50 mg / vial Intravenous Perfusion House Standard Antineoplastic (Alkylating) Agent ATC Code: L01AA03 EUGIA PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada Date of Preparation: APR 21, 2023 Submission Control No: 273284 Page 2 of 22 TABLE OF CONTENTS PART I: HEALTH PROFESSION AL INFORMATION………………………………….. 3 1 INDICATIONS……………………………………………………….……………….….. .3 1.1 Pediatrics………………………………………………………………….…….3 1.2 Geriatrics…………………………………………………………………….….3 2 CONTRAINDICATIONS………………………………..……………………………….3 3 SERIOUS WARNINGS AND PRECAUTIONS BOX………………………………... ..3 4 DOSAGE AND ANDMINISTRATION…………………………………………...……..4 4.1. Dosing Considerations……………………………………………………………...….4 4.2. Recommended Dose and Dosage Adjustment………………………………………....4 4.3. Administration……………………………………………………………………...….4 4.4. Reconstitution…………………………………………………………………...……..5 4.5. Missed Dose………………………………………………………………….….……..5 5. OVERDOSAGE……………………………..…………………………………………….6 6. DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING……..……..6 7. WARNING S AND PRECAUTIONS…………………………..………………………...6 7.1. Special Populations………………………………………..…….……………………..9 7.1.1. Pregnant Διαβάστε το πλήρες έγγραφο