ICATIBANT INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ICATIBANT (ICATIBANT ACETATE)

Tersedia dari:

JUNO PHARMACEUTICALS CORP.

Kode ATC:

B06AC02

INN (Nama Internasional):

ICATIBANT

Dosis:

10MG

Bentuk farmasi:

SOLUTION

Komposisi:

ICATIBANT (ICATIBANT ACETATE) 10MG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0155710001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-12-05

Karakteristik produk

_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
..........................................