ADT BOOSTER diphtheria and tetanus vaccine, adsorbed suspension for injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Diphtheria toxoid, Quantity: 4 IU/mL; Tetanus toxoid, Quantity: 40 IU/mL

Available from:

Seqirus Pty Ltd

INN (International Name):

Diphtheria toxoid,Tetanus toxoid

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; aluminium hydroxide hydrate; sodium chloride

Administration route:

Intramuscular

Units in package:

1 x single dose syringe, 5 x single dose syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vaccination of children (greater than or equal to 5 years of age) and adults who have previously received at least 3 doses of a vaccine for primary immunisation against diphtheria and tetanus. ADT Booster is not intended for primary immunisation against diphtheria and tetanus. Use of ADT Booster should be scheduled in accordance with official national recommendations.

Product summary:

Visual Identification: suspension of white or grey particles in colourless or light yellow liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2006-12-11

Patient Information leaflet

1
ADT
™
BOOSTER
_(ay-dee-tee boo-ster)_
DIPHTHERIA AND TETANUS VACCINE, ADSORBED
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ADT
™
BOOSTER.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including vaccines, have risks and benefits. Your
doctor has weighed the risks of you or
your child (of five years or older) having ADT
™
BOOSTER against the benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, TALK TO YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You might need to read it again.
WHAT ADT
™
BOOSTER IS USED FOR
ADT
™
BOOSTER is a “combination” vaccine. It helps prevent TWO diseases,
each caused by a different
infection. The diseases are
•
diphtheria _and_
•
tetanus.
Both of these infections are serious and can be life-threatening.
ADT
™
BOOSTER is used to vaccinate children (≥ 5 years of age) and adults
who have previously
received at least three doses of a vaccine for primary immunisation
against diphtheria and tetanus.
ADT
™
BOOSTER is not intended for primary immunisation against diphtheria
and tetanus.
ADT
™
BOOSTER is given as one ADDITIONAL dose (BOOSTER dose) with intervals
according to national
recommendations.
_HOW ADT_
_™ _
_BOOSTER WORKS_
ADT
™
BOOSTER works by getting your body to produce its own protection
against the two types of
bacteria (germs). The germs are those that cause two different and
serious infections
•
diphtheria _and_
•
tetanus.
The vaccine does not contain live germs and cannot give you these
illnesses.
After you have ADT
™
BOOSTER, your body makes substances called antibodies. These
antibodies fight
both the diphtheria and the tetanus germs. When you come into contact
with these germs, your body is
usually ready to destroy them.
Most people who receive the booster dose (suitable only if in the past
they have had the full primary
course against diphtheria and tetanus) will

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ADT™ BOOSTER
(DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) (DIPHTHERIA
AND TETANUS VACCINE)) – SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Diphtheria and Tetanus toxoids (adsorbed) (Diphtheria and Tetanus
Vaccine).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADT
™ Booster is a suspension for intramuscular injection, containing
aluminium-hydroxide-adsorbed
diphtheria and tetanus toxoids.
Each 0.5mL dose contains no less than 2 International Units (IU) of
purified diphtheria toxoid and no
less than 20 IU of purified tetanus toxoid.
Each dose of ADT
™
Booster also contains the following excipients: aluminium hydroxide
hydrate
corresponding to 0.5 mg aluminium, sodium chloride (4 mg), sodium
hydroxide q.s. to pH 7, and
Water for Injections.
The manufacture of this product includes exposure to bovine derived
materials. No evidence exists
that any case of vCJD (considered to be the human form of bovine
spongiform encephalitis) has
resulted from the administration of any vaccine product.
3
PHARMACEUTICAL FORM
Suspension for intramuscular injection. The vaccine should appear as a
suspension of white or grey
particles in a colourless or light yellow liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vaccination of children (
≥
5 years of age) and adults who have previously received at least 3
doses of
a vaccine for primary immunisation against diphtheria and tetanus. ADT
™
Booster is NOT intended for
primary immunisation against diphtheria and tetanus.
Use of ADT
™
Booster should be scheduled in accordance with official national
recommendations.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose of ADT™ Booster is 0.5 mL. Injections should be given by
the intramuscular route.
For details of recommended vaccination schedules, including for
tetanus prone wounds, refer to The
Australian Immunisation Handbook of the NHMRC in Australia or the New
Zealand Immunisation
Handbook in New Zealand.
ADT™ Booster is recommended for re-vaccination after an initial
primary cour