ADACEL pertussis vaccine-acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

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

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: glutaral; formaldehyde; phenoxyethanol; water for injections; aluminium phosphate

Administration route:

Intramuscular

Units in package:

5 x 0.5mL single dose vials, 1 x 0.5mL single dose vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. Adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

Product summary:

Visual Identification: Sterile, uniform, cloudy, white suspension.; Container Type: Vial; 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:

2005-11-21

Patient Information leaflet

ADACEL
®
A
D
A
C
E
L
®
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?
Adacel is a vaccine. It is used to help prevent whooping cough
(pertussis), tetanus and diphtheria in persons aged 10 years and
over as a booster following primary immunisation. Use of Adacel during
pregnancy allows antibodies to be passed to the baby in the
womb from the pregnant woman to protect the baby from whooping cough
during the first few months of life.
For more information, see Section 1. Why am I using Adacel? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADACEL?
Do not use if you have ever had an allergic reaction to Adacel or any
of the ingredients listed at the end of the CMI.
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? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Adacel 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?
Adacel is given as an injection, usually into your upper arm muscle by
a doctor or nurse.
More instructions can be found in Section 4. How do I use Adacel? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADACEL?
THINGS YOU
SHOULD DO
•
Tell your doctor or nurse before you receive this vaccine if you:
•
are allergic to the active substances or any of the other ingredients
in this vaccine
•
are currently suffering from an illness
•
had serious encephalopathy (disease of brain) without an apparent
cause within 7 days of a previous
pertussis, tetanus or diphtheria vaccination
THINGS YOU
SHOULD NOT DO
•
Do not have Adacel if you have a history of severe allergic reactions
to any of the ingredients listed,
previous dose of this v

Summary of Product characteristics

Page 1 of 15
ada-ccdsv20-piv4-10dec21
AUSTRALIAN PI – ADACEL
®
PERTUSSIS VACCINE-ACELLULAR
COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS
(ADSORBED)
1
NAME OF THE MEDICINE
ADACEL

Pertussis Vaccine-Acellular Combined with Diphtheria and Tetanus
Toxoids (Adsorbed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of Adacel contains:
Diphtheria toxoid
≥ 2 IU (2 Lf)
Tetanus toxoid
≥ 20 IU (5 Lf)*
Pertussis toxoid
2.5 micrograms
Pertussis filamentous haemagglutinin
5 micrograms
Pertactin
3 micrograms
Pertussis fimbriae 2+3
5 micrograms
Adsorbed on aluminium phosphate
1.5 mg
(0.33 mg aluminium)
*The formulated content of 5 Lf of tetanus toxoid per 0.5mL dose is
the same as the related product
Tripacel
®
.
This vaccine may contain traces of formaldehyde and glutaral which are
used during the
manufacturing process.
For the full list of excipients, see Section 6.1 List of excipients.
The vaccine is prepared from: purified, formaldehyde-detoxified and
adsorbed diphtheria and
tetanus toxins; purified, 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).
Adacel
is
an
adult/adolescent
formulation
diphtheria-tetanus-acellular
pertussis
(dTpa)
combination vaccine with reduced content of pertussis toxoid,
filamentous haemagglutinin and
diphtheria
toxoid
compared
to
paediatric
diphtheria-tetanus-acellular
pertussis
(DTPa)
formulations.
The manufacture of this product includes exposure to bovine materials.
No evidence exists that
any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has
resulted from the administration of any vaccine product.
Page 2 of 15
ada-ccdsv20-piv4-10dec21
3
PHARMACEUTICAL FORM
Sterile suspension for injection. Adacel appears as a sterile,
uniform, cloudy, white
suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adacel is indicated for active immunis