LANSOPRAZOLE CAPSULE (DELAYED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

LANSOPRAZOLE

Disponibil de la:

SIVEM PHARMACEUTICALS ULC

Codul ATC:

A02BC03

INN (nume internaţional):

LANSOPRAZOLE

Dozare:

15MG

Forma farmaceutică:

CAPSULE (DELAYED RELEASE)

Compoziție:

LANSOPRAZOLE 15MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PROTON-PUMP INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0127666002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-12-08

Caracteristicilor produsului

                                PRODUCT MONOGRAPH
PR LANSOPRAZOLE
Lansoprazole Delayed-Release Capsules, USP
15 mg
H
+
, K
+
– ATPase Inhibitor
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control No: 260412
Date of
Initial Authorization:
June
8, 2012
Date of Revision:
January 27, 2022
_ _
_LANSOPRAZOLE Product Monograph _
_Page 2 of 83_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................
5
ADVERSE
REACTIONS
.......................................................................................................................................
12
DRUG
INTERACTIONS
.......................................................................................................................................
22
DOSAGE
AND
ADMINISTRATION....................................................................................................................
24
OVERDOSAGE
.....................................................................................................................................................
27
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
27
STORAGE
AND
STABILITY
...............................................................................................................................
32
DOSAGE
FORMS,
COMPOSITI
                                
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