CONSTELLA CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LINACLOTIDE

Tersedia dari:

ABBVIE CORPORATION

Kode ATC:

A06AX04

INN (Nama Internasional):

LINACLOTIDE

Dosis:

72MCG

Bentuk farmasi:

CAPSULE

Komposisi:

LINACLOTIDE 72MCG

Rute administrasi :

ORAL

Unit dalam paket:

4/30

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS GI DRUGS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-11-02

Karakteristik produk

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