MODULON TABLET

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

TRIMEBUTINE MALEATE

थमां उपलब्ध:

APTALIS PHARMA CANADA ULC

ए.टी.सी कोड:

A03AA05

INN (इंटरनेशनल नाम):

TRIMEBUTINE

डोज़:

200MG

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

TRIMEBUTINE MALEATE 200MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

100

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

ANTIMUSCARINICS ANTISPASMODICS

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0115865004; AHFS:

प्राधिकरण का दर्जा:

MARKETED

प्राधिकरण की तारीख:

2013-11-06

उत्पाद विशेषताएं

PRODUCT MONOGRAPH
MODULON®
(trimebutine maleate)
Tablets
Lower Gastrointestinal Tract Motility Regulator
Aptalis Pharma Canada, Inc.
DATE OF PREPARATION:
Mont-Saint-Hilaire (Quebec)
November 2, 2011
J3H 6C4
DATE OF REVISION:
Control#: 150622
MODULON
®
(trimebutine maleate) Tablets
Product Monograph
________________________________________________________________________
Aptalis Pharma Canada, Inc.
2
September 30, 2011
NAME
MODULON
®
(trimebutine maleate)
THERAPEUTIC CLASSIFICATION
Lower gastrointestinal tract motility regulator
CLINICAL PHARMACOLOGY
MODULON
®
(trimebutine maleate) is a noncompetitive spasmolytic agent. It
possesses
moderate opiate receptor affinity and has marked anti-serotonin
activity especially on
‘M’ receptors. It induces regulation of spontaneous activity and
increases
synchronization between electrophysiological spikes and contractions
in isolated guinea
pig strips of colon and ileum. However, it does not alter normal
motility, but regulates
abnormal intestinal activity.
INDICATIONS AND CLINICAL USE
MODULON
®
(trimebutine maleate) is indicated:
- for the treatment and relief of symptoms associated with the
irritable bowel
syndrome (spastic colon), and
- in postoperative paralytic ileus in order to accelerate the
resumption of the
intestinal transit following abdominal surgery.
CONTRAINDICATIONS
MODULON
®
(trimebutine maleate) is contraindicated in patients with known
hypersensitivity to trimebutine maleate or any of the excipients.
No other contraindications have been identified at this time.
MODULON
®
(trimebutine maleate) Tablets
Product Monograph
________________________________________________________________________
Aptalis Pharma Canada, Inc.
3
September 30, 2011
WARNINGS
Although teratological studies have not shown any drug related adverse
effects on the
course and outcome of pregnancy in laboratory animals by both oral and
parenteral
routes, the use of
MODULON
®
(trimebutine maleate) in pregnant women is not
recommended.
CHILDREN
:
Not recommended for use in children un