Land: Canada
Sprog: engelsk
Kilde: Health Canada
ICATIBANT (ICATIBANT ACETATE)
JUNO PHARMACEUTICALS CORP.
B06AC02
ICATIBANT
10MG
SOLUTION
ICATIBANT (ICATIBANT ACETATE) 10MG
SUBCUTANEOUS
100
Prescription
Active ingredient group (AIG) number: 0155710001; AHFS:
APPROVED
2022-12-05
_Page 1 of 47_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ICATIBANT INJECTION Solution, 30 mg / 3 mL (10 mg / mL) as icatibant acetate Single-Use Prefilled Syringe, Subcutaneous Drugs used in hereditary angioedema ATC Code: B06AC02 Juno Pharmaceuticals Corp. 402-2233 Argentia Road Mississauga, ON, L5N 2X7 Date of Preparation: 14 December 2021 Submission Control No: 242303 _Page 2 of 47_ 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..............................................................................................6 DRUG INTERACTIONS ............................................................................................ 10 DOSAGE AND ADMINISTRATION ......................................................................... 11 OVERDOSAGE ......................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY......................................................... 14 STORAGE AND STABILITY .................................................................................... 16 SPECIAL HANDLING INSTRUCTIONS ................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING........................................... 16 PART II: SCIENTIFIC INFORMATION ......................................................................... 18 PHARMACEUTICAL INFORMATION ..................................................................... 18 CLINICAL TRIALS .......................................... Læs hele dokumentet