ADACEL POLIO pertussis vaccine

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Poliovirus, Quantity: 26 DAgU; Poliovirus, Quantity: 7 DAgU; Pertactin, Quantity: 3 microgram; Tetanus toxoid, Quantity: 20 IU; Diphtheria toxoid, Quantity: 2 IU; Pertussis toxoid, Quantity: 2.5 microgram; Pertussis filamentous haemagglutinin, Quantity: 5 microgram; Pertussis fimbriae 2 + 3, Quantity: 5 microgram; Poliovirus, Quantity: 29 DAgU

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis fimbriae 2 + 3,Pertussis toxoid,Poliovirus,Tetanus to

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: aluminium phosphate; formaldehyde; polysorbate 80; neomycin; water for injections; phenoxyethanol; streptomycin sulfate; polymyxin B sulfate; glutaral; ethanol

Administration route:

Intramuscular

Units in package:

1 x 0.5mL single dose prefilled syringe, 1 x 0.5mL single dose prefilled syringe + 2 needles, 1 x 0.5mL single dose prefilled syringe + 1 needle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adacel Polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation.,Children 4-6 years of age should have already received four doses of DTPa and IPV or OPV.,Adacel Polio is not intended for primary immunisation.,Adacel Polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.,The use of Adacel Polio should be determined on the basis of official recommendations. For further information, refer to the current Immunisation Handbook.

Product summary:

Visual Identification: Sterile, uniform, cloudy, white suspension.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2006-06-06

Patient Information leaflet

ADACEL
® POLIO
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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 AM I USING ADACEL POLIO?
Adacel Polio contains the active ingredients diphtheria toxoid,
tetanus toxoid, pertussis toxoid, pertussis filamentous
haemagglutinin,
pertussis fimbriae 2+3, pertactin and poliovirus types 1,2 and 3
(Vero). Adacel Polio is used to help to protect you or your child
against whooping cough (pertussis), tetanus, diphtheria and polio. For
more information, see Section 1. Why am I using Adacel
Polio? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADACEL POLIO?
Do not use if you or your child has ever had an allergic reaction to
Adacel Polio or any of the ingredients listed at the end of the
CMI, or if you or your child ever had a disease of brain without an
apparent cause within 7 days of a previous pertussis, tetanus or
diphtheria vaccination. Talk to your doctor if you have any other
medical conditions, take any other medicines, or are pregnant or
plan to become pregnant or are breastfeeding. For more information,
see Section 2. What should I know before I use Adacel Polio?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Adacel Polio and affect how it
works. A list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE ADACEL POLIO?
Adacel Polio is given by your doctor, nurse or pharmacist. More
instructions can be found in Section 4. How do I use Adacel Polio?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADACEL POLIO?
THINGS YOU
SHOULD DO
Tell your doctor, nurse or pharmacist before you receive the vaccine
if you or your child
•
is allergic to the active ingredients or any of the other ingredients
in this vaccine.
•
is suffering from an illness
•
has a bleeding problem or bruise easily.
•
ever fainted from an injection
•
has not previously received the comple

Summary of Product characteristics

1
ada-pol-ccdsv12-piv4-20jan22
AUSTRALIAN PRODUCT INFORMATION – ADACEL POLIO
(PERTUSSIS VACCINE - ACELLULAR AND DIPHTHERIA AND
TETANUS TOXOIDS (ADSORBED) COMBINED WITH INACTIVATED
POLIOVIRUS TYPE 1, 2 AND 3 (VERO CELL))
1
NAME OF THE MEDICINE
Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with
Inactivated Poliovirus Type 1, 2 and 3 (Vero cell)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adacel Polio is a sterile, uniform cloudy, white suspension for
injection in prefilled syringes.
Each 0.5 mL dose of Adacel Polio contains:
Diphtheria toxoid

2 IU (2 Lf)
Tetanus toxoid

20 IU (5 Lf
1
)
Pertussis toxoid
2.5 micrograms
Pertussis filamentous haemagglutinin
5 micrograms
Pertactin
3 micrograms
Pertussis fimbriae 2 + 3
5 micrograms
Poliovirus inactivated type 1, Vero (Mahoney)
40 D antigen Units
Poliovirus inactivated type 2, Vero (MEF1)
8 D antigen Units
Poliovirus inactivated type 3, Vero (Saukett)
32 D antigen Units
Adsorbed on aluminium phosphate
1.5 mg (0.33mg aluminium)
1
The formulated content of 5Lf of tetanus toxoid per 0.5 mL is the same
as in the related product
Tripacel®.
This vaccine may contain traces of formaldehyde, glutaral,
streptomycin sulfate, neomycin,
polymyxin B sulfate and bovine serum albumin, and Medium 199 Hanks
without phenol red
(including phenylalanine), which are used during the manufacturing
process.
For the full list of excipients, see Section 6.1 List of excipients.
2
ada-pol-ccdsv12-piv4-20jan22
The vaccine is prepared from: purified formaldehyde-detoxified and
adsorbed diphtheria and
tetanus toxins; purified and glutaral-detoxified and adsorbed
pertussis toxin (pertussis toxoid or
PT); purified formaldehyde treated and adsorbed filamentous
haemagglutinin (FHA); purified and
adsorbed pertactin (PRN) and co-purified and adsorbed fimbriae types 2
and 3 (FIM); and
poliomyelitis viruses type 1, 2 and 3 cultivated on Vero cells,
purified and then inactivated by
formaldehyde.
Adacel Polio is a diphtheria-tetanus-acellular pertussis combination
v