CONSTELLA CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

LINACLOTIDE

থেকে পাওয়া:

ABBVIE CORPORATION

এটিসি কোড:

A06AX04

INN (আন্তর্জাতিক নাম):

LINACLOTIDE

ডোজ:

290MCG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

LINACLOTIDE 290MCG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

30

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

MISCELLANEOUS GI DRUGS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2013-12-02

পণ্য বৈশিষ্ট্য

_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
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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
........................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
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