VIVOTIF CAPSULE (ENTERIC-COATED)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
27-12-2023
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
SALMONELLA TYPHI TY21A LIVE ATTENUATED
Inapatikana kutoka:
BAVARIAN NORDIC AS
ATC kanuni:
J07AP01
INN (Jina la Kimataifa):
TYPHOID, ORAL, LIVE ATTENUATED
Kipimo:
10000000000CFU
Dawa fomu:
CAPSULE (ENTERIC-COATED)
Tungo:
SALMONELLA TYPHI TY21A LIVE ATTENUATED 10000000000CFU
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Schedule D
Eneo la matibabu:
VACCINES
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0165582001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2002-05-02
Tabia za bidhaa
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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