TETANUS TOXOID ADSORBED SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

TETANUS TOXOID ADSORBED

から入手可能:

ID BIOMEDICAL CORPORATION OF QUEBEC

ATCコード:

J07AM01

INN（国際名）:

TETANUS TOXOID

投薬量:

5LF

医薬品形態:

SUSPENSION

構図:

TETANUS TOXOID ADSORBED 5LF

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

5ML/5 X 0.5ML

処方タイプ:

Schedule D

治療領域:

TOXOIDS

製品概要:

Active ingredient group (AIG) number: 0106214001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2005-08-03

製品の特徴

PRODUCT MONOGRAPH
TETANUS TOXOID ADSORBED
DIN 01914502
Single dose ampoule (0.5 mL)
For active immunization against tetanus
ID Biomedical Corporation
Date of preparation: October 27, 2004
525 Cartier Blvd. West
Laval, PQ
H7V 3S8
Control#: 094858
PMTA01/Version 2.00
PMTA01/Version 2.00
TETANUS
Active immunization
TOXOID
against tetanus
ADSORBED
Keep in the refrigerator between 2
°
C and 8
°
C
DIN 01914502
Page 1 of 5
<
DESCRIPTION
Tetanus Toxoid Adsorbed as supplied by ID Biomedical Corporation is a
sterile, cloudy, uniform
suspension of tetanus toxoid, adsorbed on aluminum phosphate, in an
isotonic sodium chloride
solution.
Each dose (0.5 mL) contains 5 Lf tetanus toxoid, 1.5 mg aluminum
phosphate and 0.01% thimerosal
as a preservative.
<
INDICATIONS
Tetanus Toxoid Adsorbed is indicated for active immunization against
tetanus. It may be used for
primary immunization and reinforcing doses against tetanus, as well as
in the event of injury for
which tetanus prophylaxis is indicated.
<
CONTRA-INDICATIONS
Immunization with Tetanus Toxoid Adsorbed should be postponed in the
presence of any acute
illness, including febrile illness.
It is contra-indication to administer this vaccine to individuals
known to be sensitive to thimerosal.
<
WARNING
If the vaccine is administered to persons receiving immuno suppressive
therapy, it should be borne
in mind that the expected antigenic response may not be obtained.
<
PRECAUTIONS
Individuals who are hypersensitive to the components of the vaccine
may develop allergic reactions.
Sterile epinephrine hydrochloride solution 1:1000 should always be
readily available in case an
acute anaphylactic reaction should occur.
Frequent reinforcing (booster) doses of tetanus toxoid in the presence
of adequate or excessive
serum levels of tetanus antitoxin have been associated with increased
incidence and severity of
reactions and should be avoided
4
.
PMTA01/Version 2.00
TETANUS
Active immunization
TOXOID
against tetanus
ADSORBED
Keep in the refrigerator between 2
°
C and 8
°
C
DIN 01914502