PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION.2MG/ML

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LOPERAMIDE HYDROCHLORIDE

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

A07DA03

INN (Διεθνής Όνομα):

LOPERAMIDE

Δοσολογία:

0.2MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

LOPERAMIDE HYDROCHLORIDE 0.2MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

230ML

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

ANTIDIARRHEA AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0111332002; AHFS:

Καθεστώς αδειοδότησης:

MARKETED

Ημερομηνία της άδειας:

1993-12-31

Αρχείο Π.Χ.Π.

_pms-LOPERAMIDE & pms-LOPERAMIDE HYDROCHLORIDE SOLUTION Product
Monograph _
_Page 1 of 38 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PMS-LOPERAMIDE
Loperamide Hydrochloride Tablets
Caplet, 2 mg, oral
USP
and
PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION
Loperamide Hydrochloride Oral Solution
Solution, 0.2 mg / mL, Oral
USP
Antidiarrheal agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
pms-LOPERAMIDE HYDROCHLORIDE SOLUTION:
June 2, 1993
pms-LOPERAMIDE
August 2, 1996
Date of Revision:
June 26, 2023
Submission Control Number: 272133
_pms-LOPERAMIDE & pms-LOPERAMIDE HYDROCHLORIDE SOLUTION Product
Monograph _
_Page 2 of 38 _
_ _
RECENT MAJOR LABEL CHANGES
5 OVERDOSAGE, Addition of drug withdrawal syndrome
06/2022
7 WARNINGS AND PRECAUTIONS, Addition of drug withdrawal syndrome
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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