PMS-METOCLOPRAMIDE TABLETS

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

METOCLOPRAMIDE HYDROCHLORIDE

Commercializzato da:

PHARMASCIENCE INC

Codice ATC:

A03FA01

INN (Nome Internazionale):

METOCLOPRAMIDE

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

METOCLOPRAMIDE HYDROCHLORIDE 5MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

PROKINETIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0109394003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

1997-01-08

Scheda tecnica

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_pms-METOCLOPRAMIDE_
_ (metoclopramide) _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-METOCLOPRAMIDE TABLETS
Metoclopramide Tablets
Tablets, 5 mg and 10 mg, oral
USP
PR
PMS-METOCLOPRAMIDE ORAL SOLUTION
Metoclopramide Oral Solution
Solution, 1 mg/mL, oral
USP
Antiemetic
Modifier of Upper Gastrointestinal Tract Motility
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Initial Authorization:
Jan 8, 1997
Date of Revision:
May 24, 2022
www.pharmascience.com
Submission Control Number: 259250
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_pms-METOCLOPRAMIDE (metoclopramide) _
_Page 2 of 35_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................5
1
INDICATIONS
................................................................................................................5
1.1
Pediatrics
............................................................................................................5
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...................................................................................................6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................6
4
DOSAGE AND
ADMINISTRATION...................................................................................7
4.1
Dosing Considerations
.........................................................................................7
4.2
Recommended Dose and Dosage
Adjustment.......................................................7
4.4
Administration.....................................................................................................9
4.5
Missed D