PANTO-BYK TABLET (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Mevcut itibaren:

NYCOMED GMBH

ATC kodu:

A02BC02

INN (International Adı):

PANTOPRAZOLE

Doz:

40MG

Farmasötik formu:

TABLET (ENTERIC-COATED)

Kompozisyon:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

PROTON-PUMP INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0133229001; AHFS:

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2017-07-13

Ürün özellikleri

_PANTO-BYK (pantoprazole sodium) _
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_Page 1 of 37 _
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