국가: 캐나다
언어: 영어
출처: Health Canada
LINACLOTIDE
ABBVIE CORPORATION
A06AX04
LINACLOTIDE
145MCG
CAPSULE
LINACLOTIDE 145MCG
ORAL
4/30
Prescription
MISCELLANEOUS GI DRUGS
Active ingredient group (AIG) number: 0155070001; AHFS:
APPROVED
2013-12-02
_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 .................................................... 전체 문서 읽기