RIVA-ESOMEPRAZOLE DR CAPSULE (DELAYED RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
16-05-2012

Viambatanisho vya kazi:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Inapatikana kutoka:

LABORATOIRE RIVA INC.

ATC kanuni:

A02BC05

INN (Jina la Kimataifa):

ESOMEPRAZOLE

Kipimo:

40MG

Dawa fomu:

CAPSULE (DELAYED RELEASE)

Tungo:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/90

Dawa ya aina:

Prescription

Eneo la matibabu:

PROTON-PUMP INHIBITORS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0145162002; AHFS:

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2016-05-31

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
RIVA-ESOMEPRAZOLE DR
ESOMEPRAZOLE (AS ESOMEPRAZOLE MAGNESIUM DIHYDRATE)
20 MG AND 40 MG DELAYED-RELEASE CAPSULES
H
+
, K
+
-ATPASE INHIBITOR
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville Québec
J7C 3V4
DATE OF PREPARATION:
May 16, 2012
SUBMISSION CONTROL NO: 154931
_ _
_Riva-ESOMEPRAZOLE DR Product Monograph _
_Page 2 of 48_
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
.........................................................................................................7
DRUG
INTERACTIONS........................................................................................................14
DOSAGE
AND
ADMINISTRATION....................................................................................16
OVERDOSAGE......................................................................................................................18
ACTION
AND CLINICAL PHARMACOLOGY
..................................................................19
STORAGE
AND
STABILITY................................................................................................22
DOSAGE
FORMS, COMPOSITION AND PACKAGING
...................................................22
PART II: SCIENTIFIC INFORMATION
.............................................................................24
PHARMACEUTICAL
INFORMATION...............................................................................24
CLINICAL
TRIALS..........................................................................
                                
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