PNEUMOVAX 23 SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A

Διαθέσιμο από:

MERCK CANADA INC

Φαρμακολογική κατηγορία (ATC):

J07AL01

INN (Διεθνής Όνομα):

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN

Δοσολογία:

25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG; 25MCG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 25MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 25MCG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

VACCINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 2352867001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-01-15

Αρχείο Π.Χ.Π.

_PNEUMOVAX® 23 (pneumococcal vaccine, polyvalent) _
_Page 1 of 22 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PNEUMOVAX® 23
(pneumococcal vaccine, polyvalent, MSD Std.)
Solution for injection
Active Immunizing Agent Against Infections Caused by Pneumococci
ATC code: J07AL01
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC H9H 4M7
Canada
www.merck.ca
Date of Initial Authorization:
MAR 23, 1978
Date of Revision:
MAR 21, 2024
Submission Control Number: 279506
_ _
_PNEUMOVAX® 23 (pneumococcal vaccine, polyvalent, MSD Std.)_
_ _
_Page 2 of 22_
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
.................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................................... 4
4.4 Administration
............................................................................................................
5
5
OVERDOSAGE
..............................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................. 6
7
WARNINGS AND PRECAUTIONS
.