CONSTELLA CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LINACLOTIDE

Available from:

ABBVIE CORPORATION

ATC code:

A06AX04

INN (International Name):

LINACLOTIDE

Dosage:

290MCG

Pharmaceutical form:

CAPSULE

Composition:

LINACLOTIDE 290MCG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS GI DRUGS

Product summary:

Active ingredient group (AIG) number: 0155070002; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-12-02

Summary of Product characteristics

_CONSTELLA (linaclotide) _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CONSTELLA
®
Linaclotide capsules
Capsules of 72 mcg, 145 mcg and 290 mcg linaclotide, for oral use
Guanylate Cyclase-C Agonist (ATC Code: A06AX04)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Date of Initial Authorization:
DEC 02, 2013
Date of Revision:
OCT 13, 2022
Submission Control Number: 267569
_CONSTELLA (linaclotide) _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
07/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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4.4
Administration
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