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 produce enough antibodies to protect against both the diphtheria and tetanus diseases. However, as with all vaccines, 100% protection cannot be guaranteed.

Before you or your child are given ADT™ Booster

When you or your child must NOT be given ADT™ Booster

Do not give ADT™ Booster to a child under 5 years of age. ADT™ Booster is not suitable for children under 5 years of age.

Do not use ADT™ Booster after the expiry date printed on the pack.

Do not use ADT™ Booster if the packaging is torn, shows signs of tampering, or does not look quite right.

If you are not sure whether you or your child should have ADT™ Booster, talk to your doctor or pharmacist.

Before you or your child are given ADT™ Booster

Tell your doctor if you or your child have allergies to:

• ADT™ Booster, Tetanus Vaccine, Diphtheria Vaccine or any of the ingredients listed at the end of this leaflet
• any other medicines
• any other substances, such as foods, preservatives or dyes.

As for all vaccines, medical supervision and treatment should be available in case there is a severe allergic reaction.

Tell your doctor if you or the person to be immunised are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of having ADT™ Booster during pregnancy.

How ADT™ Booster is given

ADT™ Booster is given by a trained health professional, as an injection into the muscle.

How much is given and when

For the booster dose, one dose of 0.5 mL is given.

Ask your doctor or pharmacist to answer any questions you may have.

If you are given too much (overdose)

Because each ADT™ Booster contains only one dose, overdosage is unlikely.

If you think you or anyone else may have been given too much of this medicine

• consult your doctor immediately or
• telephone the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 POISON (0800 764 766) in New Zealand) for advice, or
• go to Accident and Emergency at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. Urgent medical attention may be required.

After having ADT™ Booster

Things you must do

Keep an updated record of your vaccinations or your child’s vaccinations.

Side effects

Tell your doctor or pharmacist as soon as possible if you or your child feel unwell after having ADT™ Booster.

All medicines, including vaccines, can have side effects. ADT™ Booster may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You or your child may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you have.

Serious side effects:

Allergic reaction:

As with all vaccines given by injection, there is a very small risk of a severe allergic reaction.

If any of the following happen, consult your doctor or pharmacist immediately, or go to Accident and Emergency at your nearest hospital.

• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body
• shortness of breath
• collapse.

These are very serious side effects. If you or your child have them, you may have had a severe allergic reaction to ADT™ Booster. You or your child may need urgent medical attention or hospitalisation.

This type of side effect mostly occurs within the first few hours of being given the vaccine.

High Fever
A temperature of over 40°C can occur rarely.

Non-serious side effects:

Very common (may affect more than 1 in 10 people)

• reaction at the injection site such as temporary redness, pain, itching or swelling.
• headache and fatigue

Common (may affect up to 1 in 10 people)

• general malaise (feeling unwell) and fever (temperature of 38°C or more)
• pronounced redness and swelling of 5 cm or more at the site of injection
• muscle pain
• dizziness
• nausea, vomiting and diarrhoea

Uncommon (may affect up to 1 in 100 people)

• eczema and inflammation of the skin (dermatitis)

Rare (may affect up to 1 in 1,000 people)

• a small lump at the injection site; sometimes this may last for a few weeks
• hives (urticaria)

Very rare (may affect up to 1 in 10,000 people)

• fainting or feeling faint.

Other side effects not listed above might occur in some people. Tell your doctor or pharmacist if you notice anything that is making you or your child feel unwell.

Do not be alarmed by this list of possible side effects. You or your child may not experience any of them.

Storing ADT™ Booster

ADT™ Booster is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store ADT™ Booster:

• Keep it where children cannot reach it.
• Keep it in the original pack until it is time for it to be injected.
• Keep it in the refrigerator, between 2°C and 8°C. DO NOT FREEZE ADT™ Booster.
  Freezing destroys the vaccine.

Product description

What ADT™ Booster looks like

ADT™ Booster is supplied as a single dose (0.5 mL) in a needle-less pre-filled glass syringe or vial. The vaccine should appear as a suspension of white or grey particles in a colourless or light yellow liquid.

Ingredients

Active ingredients:

• Diphtheria Toxoid: at least 2 International Units (IU)
• Tetanus Toxoid: at least 20 IU.

Other ingredients:

• Aluminium hydroxide
• Sodium chloride
• Sodium hydroxide
• Water for injection.

ADT™ Booster does NOT contain:

• lactose
• sucrose
• gluten
• tartrazine or any other azo dyes
• preservatives.

The tip cap of the ADT™ Booster syringe contains latex (natural rubber). The ADT™ Booster syringe barrel, plunger rod and plunger stopper do not contain latex.

The ADT™ Booster vial and vial stopper do not contain latex.

The manufacture of this product includes exposure to cattle derived materials. There is no evidence that variant Creutzfeldt-Jakob disease, a brain condition linked to the consumption of cattle with ”mad cow disease” has resulted from the administration of any vaccine product.

Manufacturer/Distributor/Supplier

Manufacturer
ADT™ Booster is made in Denmark by:

AJ Vaccines A/S
5, Artillerivej
DK-2300 Copenhagen S
Denmark

Sponsor

ADT™ Booster is distributed in Australia by:

Seqirus Pty Ltd
ABN: 26 160 735 035
63 Poplar Road
Parkville VIC 3052
Australia
Telephone: 1800 642 865
www.seqirus.com.au

ADT™ Booster is distributed in New Zealand by:

Seqirus (NZ) Ltd
PO Box 62 590
Greenlane,
Auckland 1546
New Zealand
Telephone: 0800 502 757

Registration number

Australia
AUST R 130906
AUST R 130919

Date of preparation

December 2021

ADT™ is a trademark of Seqirus UK Limited or its affiliates.

Published by MIMS February 2022

1 Name of 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 0.5 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 is recommended for re-vaccination after an initial primary course of vaccination.
The vaccine should be thoroughly shaken before use to ensure adequate dispersion when it is injected. The vaccine should appear as a suspension of white or grey particles in a colourless or light yellow liquid.
ADT Booster is for single use in one patient only. Discard any residue.

4.3 Contraindications

ADT Booster should not be administered to subjects who have previously experienced a serious reaction (e.g. anaphylaxis) to this vaccine or who are known to be hypersensitive to any of the vaccine components.

4.4 Special Warnings and Precautions for Use

As with other injectable vaccines, appropriate medical treatment and supervision should always be available in the event of anaphylactic reaction. Adrenaline should always be readily available whenever the injection is given.
ADT Booster is not intended for primary immunisation against diphtheria and tetanus.
Vaccination should normally be postponed in persons with moderate or severe acute illness, with or without fever.
Mild common illnesses are not contraindications to vaccination.
In children and adults with compromised immune response, the serological response may be impaired.
Vaccination of children and adults receiving immunosuppressive treatment can take place, but may result in a reduced immunological response.
Formaldehyde is used during the manufacturing process and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde.
Too frequent booster vaccination will increase the risk of adverse reactions.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Following vaccination with ADT Booster, the most common adverse reactions are redness and swelling at the injection site and fever. These reactions most commonly start within 48 hours from the day of vaccination.
Systemic reactions reported for this type of vaccine include pruritus, rash, urticaria and peripheral oedema, anaphylactoid and hypersensitivity reactions, flu-like symptoms (including headache, rigors, asthenia, fatigue and myalgia), pyrexia, nausea, vomiting and dizziness. Postvaccinal neurologic disorders have been reported following the injection of almost all biological products and the possibility of their occurrence must be considered. Such disorders have included hypoaesthesia, paraesthesia and brachial radiculitis.
For the frequency of the adverse effects that have been reported for ADT Booster, see Table 1. The adverse reactions listed in Table 1 are based on data from clinical trials in children, adolescents and adults, and are classified according to MedDRA System Organ Class.
The safety evaluation of ADT Booster also includes adverse reactions from clinical trials and spontaneous reporting with vaccines containing the same or higher antigen content of diphtheria and tetanus than ADT Booster in combination with aluminium hydroxide and other vaccine antigens.

Reporting suspected adverse effects.

4.9 Overdose

There have been no cases of overdosage reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
In New Zealand, call the New Zealand Poisons Centre on 0800 POISON or 0800 764 766 for advice on overdosage management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

ADT Booster should be stored at 2°C to 8°C. It must not be frozen. Discard if vaccine has been frozen.

6.5 Nature and Contents of Container

ADT Booster can be supplied in a 0.5 mL needle-less pre-filled syringe or vial (Type 1 glass). Both these presentations may not necessarily be marketed.
Syringe and vial pack sizes: 1 x 0.5 mL and 5 x 0.5 mL.
ADT Booster does not contain preservatives or ingredients of human origin.
The tip cap of the ADT Booster syringe contains latex (natural rubber). The ADT Booster syringe barrel, plunger rod and plunger stopper do not contain latex.
The ADT Booster vial and vial stopper do not contain latex.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Only Medicine.

Summary Table of Changes