VAXCHORA POWDER FOR SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VIBRIO CHOLERAE, STRAIN CVD 103-HGR, LIVE

Διαθέσιμο από:

BAVARIAN NORDIC AS

Φαρμακολογική κατηγορία (ATC):

J07AE02

INN (Διεθνής Όνομα):

CHOLERA, LIVE ATTENUATED

Δοσολογία:

2000000000UNIT

Φαρμακοτεχνική μορφή:

POWDER FOR SUSPENSION

Σύνθεση:

VIBRIO CHOLERAE, STRAIN CVD 103-HGR, LIVE 2000000000UNIT

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Schedule D

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0164701001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2024-01-09

Αρχείο Π.Χ.Π.

_Product Monograph Master Template _
_ _
_VAXCHORA Cholera Vaccine, Live Attenuated, Oral _
_Page 1 of 34_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VAXCHORA
®
Cholera Vaccine, Live Attenuated, Oral
Each dose of VAXCHORA vaccine is supplied as a foil sachet of buffer
and an accompanying foil sachet
of the active component (lyophilized _V. cholerae_ strain CVD
103-HgR), suspension for oral
administration after reconstitution. Powder for oral suspension
containing 4 × 10
8
to 2 x 10
9
colony
forming units (CFU)/sachet of live attenuated _V. cholerae_ vaccine
strain CVD 103-HgR when
reconstituted.
Therapeutic Classification: bacterial vaccines, cholera, live
attenuated
ATC code: J07AE02
Manufactured by:
Bavarian Nordic A/S
Philip Heymans Alle 3
DK-2900 Hellerup, Denmark
Imported by:
Accuristix
100 Vaughan Valley Blvd.
Vaughan, ON, L4H 3C5
Date of Approval: JAN 09, 2024
Submission Control Number: 281278
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_VAXCHORA® _
_Page 2 of 34_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................