JAMP PRUCALOPRIDE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)

Dostopno od:

JAMP PHARMA CORPORATION

Koda artikla:

A06AX05

INN (mednarodno ime):

PRUCALOPRIDE

Odmerek:

1MG

Farmacevtska oblika:

TABLET

Sestava:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 1MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS GI DRUGS

Povzetek izdelek:

Active ingredient group (AIG) number: 0153049001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2019-12-09

Lastnosti izdelka

_ JAMP PRUCALOPRIDE_
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
JAMP PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg prucalopride as prucalopride succinate
Prokinetic agent
Jamp Pharma Corporation
1310 rue Nobel,
Boucherville,
Québec, J4B 5H3
Date of Preparation:
October 28, 2019
Submission Control No: 226302
_ JAMP PRUCALOPRIDE_
_Page 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
......................................................................................................
10
DOSAGE AND ADMINISTRATION
...................................................................................
11
OVERDOSAGE
....................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 12
STORAGE AND STABILITY
..............................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
............................................................................
15
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 16
PART II: SCIENTIFIC INFORMATION
.............................................................................
17
PHARMACEUTICAL INFORMATION
....................................................................