PANTO-BYK TABLET (ENTERIC-COATED)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Dostupno od:

NYCOMED GMBH

ATC koda:

A02BC02

INN (International ime):

PANTOPRAZOLE

Doziranje:

20MG

Farmaceutski oblik:

TABLET (ENTERIC-COATED)

Sastav:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 20MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

PROTON-PUMP INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0133229002; AHFS:

Status autorizacije:

CANCELLED PRE MARKET

Datum autorizacije:

2017-07-13

Svojstava lijeka

_PANTO-BYK (pantoprazole sodium) _
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PRODUCT MONOGRAPH
PR PANTO-BYK
pantoprazole sodium enteric-coated tablets
(as pantoprazole 20, 40 mg)
H+, K+-ATPase Inhibitor
Nycomed GmbH
Byk-Gulden Strasse 2
78467 Konstanz, Germany
Distributor:
Takeda Canada Inc.
435 North Service Road West, 1st Floor
Oakville, ON L6M 4X8
Date of Revision:
February 21, 2013
SUBMISSION CONTROL NO: 161771
_PANTO-BYK (pantoprazole sodium) _
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_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
......................................................................................................
7
DRUG
INTERACTIONS
.....................................................................................................
11
DOSAGE
AND
ADMINISTRATION
.................................................................................
13
OVERDOSE
.........................................................................................................................
14
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................... 14
STORAGE
AND
STABILITY
............................................................................................
16
SPECIAL
HANDLING
INSTRUCTIONS
..........................................................................
16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ................................................ 17
PART II: SCIENTIFIC INFORMATION
.........................................................................
18
PHA