ADT Booster
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
15-09-2021
Summary of Product characteristics
(SPC)
04-01-2021
Active ingredient:
Diphtheria toxoid, adsorbed 2 [iU] (not less than 2IU/0.5mL); Tetanus toxoid, adsorbed 20 [iU] (not less than 20IU/0.5mL)
Available from:
Seqirus (NZ) Ltd
INN (International Name):
Diphtheria toxoid, adsorbed 2 IU (not less than 2IU/0.5mL)
Dosage:
2IU/20IU
Pharmaceutical form:
Suspension for injection
Composition:
Active: Diphtheria toxoid, adsorbed 2 [iU] (not less than 2IU/0.5mL) Tetanus toxoid, adsorbed 20 [iU] (not less than 20IU/0.5mL) Excipient: Aluminium hydroxide Sodium chloride Sodium hydroxide Water for injection
Units in package:
Syringe, glass, 1 x single-dose syringe, 0.5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
AJ Vaccines A/S
Therapeutic indications:
Vaccination of children (not less than 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.
Product summary:
Package - Contents - Shelf Life: Syringe, glass, 1 x single-dose syringe - 0.5 mL - 3 years unopened stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 5 x single-dose syringe - 2.5 mL - 3 years unopened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, single dose, 1 x vial - 0.5 mL - 3 years unopened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, single dose, 5 x vial - 2.5 mL - 3 years unopened stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization date:
2006-05-09
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
Read the complete document
Summary of Product characteristics
ADT
™
BOOSTER_ _
Data Sheet
VERSION 7
Page 1
1.
PRODUCT NAME
ADT
™
Booster. Diphtheria and Tetanus Vaccine (adsorbed) for
revaccination.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADT
™ Booster is a suspension for intramuscular injection, containing
aluminium-hydroxide-adsorbed diphtheria and tetanus toxoids.
Each 0.5 mL 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 THERAPEUTIC 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 DOSE 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_ _
Data Sheet
VERSION 7
Page 2
ADT
™
Booster is recommended for revaccination after an initial primary
course of vaccination.
The vaccine should be thoroughly shaken before
Read the complete document
![Diphtheria toxoid, adsorbed 2 [iU] (not less than 2IU/0.5mL); Tetanus toxoid, adsorbed 20 [iU] (not less than 20IU/0.5mL)](/web/img/edge.svg){kind=small}