PREVNAR 20 SUSPENSION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

J07AL02

INN (nume internaţional):

PNEUMOCOCCUS, PURIFIED POLYSACC.ANTIGEN CONJUGATED

Dozare:

2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 4.4MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 2.2MCG; 51MCG

Forma farmaceutică:

SUSPENSION

Compoziție:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4.4MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2.2MCG; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 2.2MCG; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 51MCG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

1 PRE-FILLED SYR/10 PRE-FILL SYR

Tip de prescriptie medicala:

Schedule D

Rezumat produs:

Active ingredient group (AIG) number: 2163621001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-05-09

Caracteristicilor produsului

_PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM_
_197 _
_Protein]) Product Monograph_
_ _
_Page 1 of 53_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PREVNAR 20

Pneumococcal 20-valent Conjugate Vaccine (Diphtheria CRM
197
Protein)
Suspension for Intramuscular Injection
One-Dose Syringe (0.5 mL)
Active Immunizing Agent (pneumococcal vaccine; ATC code: J07AL02)
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5

Wyeth LLC
©
Pfizer Canada ULC 2023
Date of Initial Authorization:
May 9, 2022
Date of Revision:
November 16, 2023
Submission Control Number:
270196
_ _
_PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM_
_197 _
_Protein]) Product Monograph_
_ _
_Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
1. INDICATIONS, 1.1 Pediatrics
12/2022
4. DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose
Adjustment,
4.4 Administration
12/2022
7. WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
...............................................................................................................
5
1.2
Geriatrics
...............................................................................................................
5
2
CONTRAINDICATIONS
..................................................................................................
5
4
DOSAGE AND ADMINISTRATION
......................................................