VIVOTIF CAPSULE (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

SALMONELLA TYPHI TY21A LIVE ATTENUATED

Mevcut itibaren:

BAVARIAN NORDIC AS

ATC kodu:

J07AP01

INN (International Adı):

TYPHOID, ORAL, LIVE ATTENUATED

Doz:

10000000000CFU

Farmasötik formu:

CAPSULE (ENTERIC-COATED)

Kompozisyon:

SALMONELLA TYPHI TY21A LIVE ATTENUATED 10000000000CFU

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Schedule D

Terapötik alanı:

VACCINES

Ürün özeti:

Active ingredient group (AIG) number: 0165582001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2002-05-02

Ürün özellikleri

Page 1
PRODUCT MONOGRAPH
VIVOTIF
®
TYPHOID VACCINE LIVE ORAL ATTENUATED TY21A
ACTIVE IMMUNIZING AGENT
A package of Vivotif
®
contains a single foil blister with 4 enteric-coated capsules (each
containing one dose of lyophilized bacteria) for oral administration.
Pharmaceutical Standard: prescribed
Therapeutic Classification: J07AP01
Manufactured by:
Bavarian Nordic A/S
Philip Heymans Alle 3,
DK-2900 Hellerup,
Denmark
Imported by:
Accuristix,
100 Vaughan Valley Blvd,
Vaughan, ON, Canada, L4H 3C5
DIN No: 00885975
Control #: 281197
Date of Approval: DEC 27, 2023
Page 2
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
.......................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................
9
OVERDOSAGE
..................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 10
STORAGE AND STABILITY
...........................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 12
PART II: SCIENTIFIC INFORMATION ..............................................................