PMS-PRUCALOPRIDE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

A06AX05

INN (mednarodno ime):

PRUCALOPRIDE

Odmerek:

2MG

Farmacevtska oblika:

TABLET

Sestava:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 2MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS GI DRUGS

Povzetek izdelek:

Active ingredient group (AIG) number: 0153049002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-06-05

Lastnosti izdelka

_pms-PRUCALOPRIDE – Product Monograph_
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PRODUCT MONOGRAPH
PR
PMS-PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg Prucalopride as Prucalopride Succinate
House Standard
Prokinetic agent
PHARMASCIENCE INC.
Date of Approval:
6111 Royalmount Ave., Suite 100
June 3, 2020
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No: 223701
_pms-PRUCALOPRIDE – Product Monograph_
2 of 37
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
6
DRUG INTERACTIONS
............................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
13
STORAGE AND STABILITY
....................................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 17
PART II: SCIENTIFIC INFORMATION
......................................