QUADRACEL 0.5mL injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

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

Commercializzato da:

Sanofi-Aventis Australia Pty Ltd

Forma farmaceutica:

Injection, suspension

Composizione:

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

Via di somministrazione:

Intramuscular

Confezione:

10 monodose vials, 1 monodose vials, 5 monodose vials

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Visual Identification: Sterile, uniform, cloudy, white to off-white suspension; Container Type: Vial; 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

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2002-10-22

Foglio illustrativo

QUADRACEL
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY DOES MY CHILD NEED QUADRACEL?
Quadracel is a vaccine. It is used to help prevent whooping cough
(pertussis), tetanus, diphtheria and polio, in infants and children.
For more information, see Section 1. Why does my child need Quadracel?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN QUADRACEL?
Do not use if your child ever had an allergic reaction to Quadracel or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR HAD ANY OTHER MEDICAL
CONDITIONS OR IS TAKING OTHER MEDICINES.
For more information, see Section 2. What should I know before my
child is given Quadracel? in the full CMI.
3.
WHAT IF MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with Quadracel and affect how it works.
A list of these medicines is in Section 3. What if my child is taking
other medicines? in the full CMI.
4.
HOW QUADRACEL IS GIVEN?
Quadracel is given by a doctor or nurse as an injection into muscle.
More instructions can be found in Section 4. How is Quadracel given?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER MY CHILD IS GIVEN QUADRACEL?
THINGS YOU
SHOULD DO
•
Keep an updated record of vaccinations.
•
Keep follow-up appointments with your doctor or clinic.
LOOKING AFTER
YOUR MEDICINE
Quadracel is usually stored in the doctor’s surgery or clinic, or at
the pharmacy. However, if you need to store
Quadracel:
•
keep in the fridge between 2-8°C. Do not freeze.
For more information, see Section 5. What should I know after my child
is given Quadracel? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects include local reaction around the injection site
(redness, swelling, and tenderness), vomiting, fever, crying,
decreased eating, diarrhoea, fussiness, decreased activity,
sleepiness, listlessness. Serious side effects include abscess

Scheda tecnica

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