BOOSTRIX SUSPENSION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DIPHTHERIA TOXOID; TETANUS TOXOID; PERTUSSIS TOXOID; FILAMENTOUS HAEMAGGLUTININ; PERTACTIN

Prieinama:

GLAXOSMITHKLINE INC

ATC kodas:

J07AX

INN (Tarptautinis Pavadinimas):

OTHER BACTERIAL VACCINES

Dozė:

2UNIT; 20UNIT; 8MCG; 8MCG; 2.5MCG

Vaisto forma:

SUSPENSION

Sudėtis:

DIPHTHERIA TOXOID 2UNIT; TETANUS TOXOID 20UNIT; PERTUSSIS TOXOID 8MCG; FILAMENTOUS HAEMAGGLUTININ 8MCG; PERTACTIN 2.5MCG

Vartojimo būdas:

INTRAMUSCULAR

Vienetai pakuotėje:

10X0.5ML (PREFILLED SYRINGE)

Recepto tipas:

Schedule D

Gydymo sritis:

TOXOIDS

Produkto santrauka:

Active ingredient group (AIG) number: 0533121002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2003-05-16

Prekės savybės

_BOOSTRIX, Combined diphtheria, tetanus, acellular pertussis
(adsorbed) vaccine for booster vaccination Page 1 of _
_26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BOOSTRIX
Combined diphtheria, tetanus, acellular pertussis (adsorbed) vaccine
for booster vaccination
Not less than 2.5 limit of flocculation (‘Lf’) or 2 IU
(‘International Units') of diphtheria toxoid;
8 mcg of pertussis toxoid; 8 mcg of filamentous hemagglutinin;
2.5 mcg of pertactin (69 kDa outer membrane protein); and,
not less than 5 Lf (20 IU) of tetanus toxoid, Suspension for
injection, Intramuscular
Active immunizing agent against infection by diphtheria, tetanus and
whooping cough
ATC Code: J07AJ52
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
May 16, 2003
Date of Revision:
November 9, 2023
Submission Control Number: 276309
_©_
_ 2023 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies_
_ _
_BOOSTRIX, Combined diphtheria, tetanus, acellular pertussis
(adsorbed) vaccine for booster vaccination Page 2 of _
_26_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
1 INDICATIONS
AUG 2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
AUG 2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
AUG 2021
7 WARNINGS AND PRECAUTIONS, Guillain-Barré Syndrome
SEP 2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
APR 2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
8
INDICATIONS
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4
9
CONTRAINDICATIONS
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