VIVOTIF CAPSULE (ENTERIC-COATED)

Land: Canada

Taal: Engels

Bron: Health Canada

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Download Productkenmerken (SPC)
27-12-2023

Werkstoffen:

SALMONELLA TYPHI TY21A LIVE ATTENUATED

Beschikbaar vanaf:

BAVARIAN NORDIC AS

ATC-code:

J07AP01

INN (Algemene Internationale Benaming):

TYPHOID, ORAL, LIVE ATTENUATED

Dosering:

10000000000CFU

farmaceutische vorm:

CAPSULE (ENTERIC-COATED)

Samenstelling:

SALMONELLA TYPHI TY21A LIVE ATTENUATED 10000000000CFU

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Schedule D

Therapeutisch gebied:

VACCINES

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2002-05-02

Productkenmerken

                                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 ..............................................................
                                
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