MINT-ICATIBANT SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ICATIBANT (ICATIBANT ACETATE)

Available from:

MINT PHARMACEUTICALS INC

ATC code:

B06AC02

INN (International Name):

ICATIBANT

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ICATIBANT (ICATIBANT ACETATE) 10MG

Administration route:

SUBCUTANEOUS

Units in package:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-12-05

Summary of Product characteristics

2
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ICATIBANT
icatibant injection
Solution, 30 mg / 3 mL (10 mg / mL) as icatibant acetate Single-Use
Prefilled Syringe, Subcutaneous
Drugs used in hereditary angioedema
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Preparation: January 20, 2022
Submission Control No: 244290
MINT-ICATIBANT Product Monograph
Page 2 of 39
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
................................................................................................
5
DRUG
INTERACTIONS................................................................................................
9
DOSAGE AND ADMINISTRATION
................................................................................10
OVERDOSAGE
.........................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
....................................................................12
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
............................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................14
PART II: SCIENTIFIC
INFORMATION.......................................................................................16
PHARMACEUTICAL INFORMATION
.................