CONSTELLA CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LINACLOTIDE

Disponibil de la:

ABBVIE CORPORATION

Codul ATC:

A06AX04

INN (nume internaţional):

LINACLOTIDE

Dozare:

72MCG

Forma farmaceutică:

CAPSULE

Compoziție:

LINACLOTIDE 72MCG

Calea de administrare:

ORAL

Unități în pachet:

4/30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS GI DRUGS

Rezumat produs:

Active ingredient group (AIG) number: 0155070003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-11-02

Caracteristicilor produsului

_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
..........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
....................................................