QUADRACEL 0.5mL injection prefilled syringe

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

Tetanus toxoid, Quantity: 40 IU; Pertussis fimbriae 2 + 3, Quantity: 5 microgram; Diphtheria toxoid, Quantity: 30 IU; Poliovirus, Quantity: 29 DAgU; Poliovirus, Quantity: 26 DAgU; Poliovirus, Quantity: 7 DAgU; Pertussis toxoid, Quantity: 20 microgram; Pertactin, Quantity: 3 microgram; Pertussis filamentous haemagglutinin, Quantity: 20 microgram

から入手可能:

Sanofi-Aventis Australia Pty Ltd

医薬品形態:

Injection, suspension

構図:

Excipient Ingredients: polymyxin B sulfate; bovine serum albumin; formaldehyde; phenoxyethanol; glutaral; neomycin; water for injections; polysorbate 80; aluminium phosphate

投与経路:

Intramuscular

パッケージ内のユニット:

10 monodose prefilled syringes

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.,Quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

製品概要:

Visual Identification: Sterile, uniform, cloudy, white to off-white suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2022-05-24

製品の特徴

quad-ccdsv8-piv5-24may22
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – QUADRACEL
(PERTUSSIS VACCINE - ACELLULAR AND DIPHTHERIA AND
TETANUS TOXOIDS (ADSORBED) COMBINED WITH INACTIVATED
POLIOVIRUS TYPES 1, 2 AND 3 (VERO CELL))
1
NAME OF THE MEDICINE
Pertussis Vaccine-Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with
Inactivated Poliovirus Types 1, 2 and 3 (Vero Cell).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5mL dose of Quadracel contains:
Diphtheria toxoid
≥ 30 IU (15 Lf)
Tetanus toxoid
≥ 40 IU (5 Lf)
Pertussis toxoid (PT)
20 microgram
Pertussis filamentous haemagglutinin (FHA)
20 microgram
Pertactin (PRN)
3 microgram
Pertussis fimbriae 2 + 3 (FIM)
5 microgram
Poliovirus inactivated type 1, Vero (Mahoney)
40 D-antigen Units
Poliovirus inactivated type 2, Vero (MEF-1) 8 D-antigen Units
Poliovirus inactivated type 3, Vero (Saukett) 32 D-antigen Units
Absorbed on 1.5 mg Aluminium phosphate (0.33 mg aluminium)
This product does not contain thiomersal.
The manufacture of this product includes exposure to bovine materials.
No evidence exists
that any case of variant Creutzfeldt–Jakob disease (vCJD)
(considered to be the human form
of bovine spongiform encephalopathy) has resulted from the
administration of any vaccine
product.
Diphtheria toxoid is a cell-free preparation of diphtheria toxin
detoxified with formaldehyde.
Tetanus toxoid is prepared by detoxification of tetanus toxin with
formaldehyde.
Each of the three strains of poliovirus is individually grown in Vero
cells cultivated on
microcarriers. The single virus harvest is concentrated and purified,
then inactivated with
formaldehyde to produce the type 1, 2 or 3 monovalent. Monovalents of
each type are then
combined in appropriate quantities to produce a trivalent concentrate.
The 5 component pertussis antigens, pertussis toxoid (PT), pertussis
filamentous
haemagglutinin (FHA), pertactin (PRN) and pertussis fimbriae types 2 +
3 (FIM), contained
in Quadracel are the same as those in TRIPACEL or PEDIACEL. TRIPACEL
consists of a