NEISVAC-C SUSPENSION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MENINGOCOCCAL POLYSACCHARIDE VACCINE GRP C; TETANUS TOXOID

Sẵn có từ:

PFIZER CANADA ULC

Mã ATC:

J07AH07

INN (Tên quốc tế):

MENINGOCOCCUS C, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

Liều dùng:

10MCG; 20MCG

Dạng dược phẩm:

SUSPENSION

Thành phần:

MENINGOCOCCAL POLYSACCHARIDE VACCINE GRP C 10MCG; TETANUS TOXOID 20MCG

Tuyến hành chính:

INTRAMUSCULAR

Các đơn vị trong gói:

0.5ML/10X0.5ML/20X0.5ML

Loại thuốc theo toa:

Schedule D

Khu trị liệu:

VACCINES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0246022001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2004-10-12

Đặc tính sản phẩm

_NEISVAC-C_
_®_
_ VACCINE (Meningococcal Group C-TT Conjugate Vaccine, Adsorbed) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
NEISVAC-C
® VACCINE
Meningococcal Group C-TT Conjugate Vaccine, Adsorbed Suspension for
Injection
10 mcg _Neisseria meningitidis_ group C polysaccharide suspension for
intramuscular injection
Active Immunizing Agent
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
December 18, 2001
Date of Revision:
October 26, 2021
® Pfizer Ireland Pharmaceuticals
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC 2021
Submission Control Number: 253221
_ _
_NEISVAC-C_
_®_
_ VACCINE (Meningococcal Group C-TT Conjugate Vaccine, Adsorbed) _
_Page 2 of 22_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions
05/2019
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
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................