Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before your child is given INFANRIX.

This leaflet answers some of the common questions about INFANRIX vaccine.

It does not contain all the available information.

It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of your child having INFANRIX against the expected benefits.

If you have any concerns about your child receiving INFANRIX talk to your doctor, nurse or pharmacist.

Keep this leaflet with this vaccine. You may need to read it again.

What INFANRIX is used for

INFANRIX is a vaccine used to prevent three diseases, diphtheria, tetanus, and pertussis (whooping cough). The vaccine is sometimes called DTPa vaccine.

Diphtheria, tetanus, and pertussis are all serious life-threatening diseases caused by bacterial infection. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

Diphtheria
Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and death. The risk of serious complications and death is greater in the very young and elderly.

Tetanus (Lockjaw)
Tetanus bacteria enter the body through wounded skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and death. The spasms can be strong enough to cause bone fractures of the spine. The death rate is 30-40% of cases.

Pertussis (Whooping cough)
Pertussis is a highly infectious illness. The disease affects the breathing tract causing severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied by a ‘whooping’ sound. The cough may last for 1-2 months or longer. Pertussis can also cause inner ear infections, long-lasting bronchitis, pneumonia, fits, brain damage and death. The risk of severe complications and death is greatest in infants under 6 months of age. The death rate is 0.5% for infants under 6 months of age.

Vaccination is the best way to protect against these three diseases. INFANRIX vaccine cannot give your child diphtheria, tetanus, or pertussis infection. The vaccine will not protect against diseases caused by other types of bacteria or organisms.

Before vaccination

INFANRIX should not be given if your child has had an allergy to:

• INFANRIX or any ingredient contained in this vaccine
• an allergic reaction to any other diphtheria, tetanus, pertussis containing vaccine (such as Triple Antigen (DTPa) vaccine)

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

INFANRIX should not be given if:

• your child had INFANRIX before and became unwell, tell your doctor, nurse or pharmacist before the dose is given
• your child experienced a disease of the brain within 7 days after previous vaccination with a pertussis containing vaccine
• your child has a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before vaccination
• the expiry date printed on the pack has passed
• the packaging is torn or shows signs of tampering

If you are not sure whether your child should have INFANRIX, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for your child.

Before INFANRIX is given tell your doctor or nurse if:

• your child has any medical problems such as:
  - brain disease or central nervous system (CNS) disease (that is, epilepsy etc)
  - a bleeding problem or bruises easily
  - lowered immunity due to medical treatment or a medical condition
  - a tendency to febrile convulsions (seizures/fits due to a fever or high body temperatures)
  - a family history of seizures/fits
• after having INFANRIX or diphtheria, tetanus, pertussis vaccination (such as Triple Antigen (DTPa) vaccine) your child had any problems, especially:
  - a high temperature (over 40.5ºC) within 2 days of vaccination
  - a collapse or shock-like state within 2 days of vaccination
  - crying lasting 3 hours or more within 2 days of vaccination
  - convulsions (seizures/fits) with or without a fever within 3 days of vaccination
• your child has allergies to any other medicines or substances, such as dyes, foods or preservatives
• your child has received another vaccine recently, or is having any prescription or OTC (over-the-counter) medicines. In particular mention if your child is being given medicines which suppress the immune system, such as high-dose steroids.

Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if INFANRIX is to be given with another vaccine or medicine.

In infants born very prematurely (before or at 28 weeks of pregnancy) breathing difficulties may be more common in the first three days following vaccination.

If your infant was born very prematurely, please discuss with your doctor.

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if your child fainted with a previous injection.

How INFANRIX is given

The doctor or nurse will give INFANRIX as an injection.

If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

How much is given

The dose of INFANRIX is 0.5 mL.

How it is given

INFANRIX will be injected into the upper leg muscle or the upper arm muscle. For infants and children with bleeding problems, the dose may need to be given under the skin (subcutaneously).

The vaccine should never be injected into a vein (intravenously).

When it is given

A primary course of INFANRIX is generally given as a total of three doses. Each dose is given on a separate visit. The first dose of INFANRIX is given at 2 months of age. The second and third doses are given every 2 months, at 4 and 6 months of age.

A fourth dose of INFANRIX may also be given at 18 months of age and a fifth dose at 4 to 6 years of age to children who have previously been immunised with 3 or 4 doses of INFANRIX or another brand of diphtheria, tetanus and pertussis-containing vaccine (such as DTPa).

It is important to return at the recommended times for follow up doses.

If a dose is missed

If your child misses a scheduled dose, talk to your doctor or nurse and arrange another visit as soon as possible.

While using INFANRIX

Things you must do

Keep your child’s follow up visits with the doctor or clinic. It is important the follow-up doses of INFANRIX are given at the correct times. This will ensure the best effect of the vaccine in protecting your child against diphtheria, tetanus, and pertussis infection.

Side effects

Tell your doctor or nurse as soon as possible if your child does not feel or look well during or after having had a dose of INFANRIX.

INFANRIX helps protect most children from diphtheria, tetanus, and pertussis infection, but it may have unwanted side effects in a few children. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment. The chance of your child having a serious side effect is very much less than the chance of your child having a permanent injury from the natural infections.

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

Most unwanted effects with INFANRIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.

Tell your doctor if your child has any of the following that are troublesome or ongoing:

Very common (may occur in more than 1 in 10 doses of the vaccine)

• feeling irritable
• feeling tired
• pain, redness and swelling where the injection was given
• fever of 38°C or higher

Common (may occur in up to 1 in 10 doses of the vaccine)

• loss of appetite
• unusual crying
• feeling restless
• being sick (vomiting)
• diarrhoea
• itchy skin
• pain
• swelling larger than 5 cm where the injection was given

Uncommon (may occur in up to 1 in 100 doses of the vaccine)

• headache
• cough
• upper respiratory tract infection
• rash
• hard lump where the injection was given
• fever higher than 39°C
• feeling sleepy
• large swelling of the vaccinated limb
• bronchitis

Rare (may occur with up to 1 in 1,000 doses of the vaccine):

• hives (urticaria)

Very rare (may occur with up to 1 in 10,000 doses of the vaccine)

• swollen glands in the neck, armpit or groin (lymphadenopathy)

Other side effects that may occur include bleeding or bruising more easily than normal (thrombocytopenia)

Contact your doctor immediately or take your child to the casualty department of your nearest hospital if any of the following happens:

• swelling of limbs, face, eyes, inside of nose, mouth or throat
• shortness of breath, breathing or swallowing difficulties
• hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
• unusual tiredness or weakness that is sudden and severe
• sudden drop in blood pressure and loss of consciousness
  These are signs of an allergic reaction. As with all vaccines given by injection there is a very small risk of such reactions. Allergy to INFANRIX is rare. Any such severe reactions will usually occur within the first few hours of vaccination.
• crying for 3 hours or more
• collapse, or periods of unconsciousness or lack of awareness within 2 to 3 days of vaccination
• seizures (convulsions) or fits
• fever over 40ºC
• your child has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy)

Other side effects not listed above, can also occur during or soon after a dose of INFANRIX.

Check with your doctor or nurse if your child has any other effects.

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

Storage

INFANRIX is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But if you need to store INFANRIX always:

• Keep INFANRIX in the refrigerator stored between +2ºC and +8ºC.
  THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
• Keep the vaccine out of the reach of children.
• Keep INFANRIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over INFANRIX that has expired or has not been used.

Product Description

What it looks like

INFANRIX comes in prefilled syringes. It is a white, slightly milky liquid.

Ingredients

The active ingredients of INFANRIX are non-infectious substances from tetanus, diphtheria bacteria and purified proteins of pertussis bacteria.

The vaccine cannot cause these diseases.

Each 0.5 mL dose contains:

• 30 IU (25Lf) of diphtheria toxoid
• 40 IU (10Lf) of tetanus toxoid
• 25 mcg of pertussis toxoid, 25 mcg of filamentous haemagglutinin and 8mcg of pertactin.

The inactive ingredients in the vaccine are: aluminium hydroxide, sodium chloride (salt) and water.

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 encephalopathy) has resulted from the administration of any vaccine product.

Supplier

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067
Australia.

Further information

INFANRIX is only available if prescribed by a doctor.

Trade marks are owned or licensed to the GSK group of companies.

INFANRIX 0.5 mL injection syringe: AUST R 142370

This leaflet was prepared on:
17 August 2022

Version 5.0

© 2022 GSK group of companies or its licensor.

Published by MIMS December 2022

1 Name of Medicine

Diphtheria-tetanus-acellular pertussis (DTPa) vaccine.

2 Qualitative and Quantitative Composition

Infanrix DTPa vaccine is a sterile suspension which contains diphtheria toxoid, tetanus toxoid and three purified antigens of Bordetella pertussis [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium hydroxide hydrate.
The diphtheria and tetanus toxins are obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani and are then detoxified and purified. The acellular pertussis vaccine components (PT, FHA and PRN) are extracted from phase I Bordetella pertussis, and are then purified and stabilised.
Each 0.5 mL dose of Infanrix contains not less than 30 IU of diphtheria toxoid, 40 IU of tetanus toxoid, 25 microgram of PT, 25 microgram of FHA and 8 microgram of PRN.
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 encephalopathy) has resulted from the administration of any vaccine product.
Infanrix meets the World Health Organisation requirements for biological substances and for diphtheria and tetanus vaccines. No substances of human origin are used in its manufacture.

List of excipients with known effect.

3 Pharmaceutical Form

Suspension for injection.
Turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed.

4 Clinical Particulars

4.1 Therapeutic Indications

Infanrix (DTPa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age.
Infanrix (DTPa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.

4.2 Dose and Method of Administration

All parenteral drug and vaccine products should be inspected visually for any particulate matter or discolouration prior to administration. Before use of Infanrix, the vaccine should be well shaken to obtain a homogenous turbid suspension. Discard the vaccine if it appears otherwise.
As stated in Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Infanrix can be mixed in the same syringe with Hiberix or Act-HIB. In this case, the diluent supplied in the Hiberix or Act-HIB package is replaced by Infanrix.
From the Hiberix or Act-HIB package, discard the vial containing the diluent. The combined vaccine must be reconstituted by adding the entire contents of the Infanrix container to the vial containing the lyophilised powder.
The extemporaneous mix should be handled in the same way as the Infanrix vaccine.

Instructions for the pre-filled syringe.

Dosage.

Administration.

4.3 Contraindications

Infanrix should not be administered to subjects with known hypersensitivity to any components of the vaccine, and should not be administered to subjects having shown signs of hypersensitivity after previous administration of Infanrix, diphtheria and tetanus vaccine and DTPw.
As with other vaccines, the administration of Infanrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
Infanrix is contraindicated if the child has experienced an encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria and tetanus vaccine.

4.4 Special Warnings and Precautions for Use

Infanrix should under no circumstances be administered intravenously.
It is good clinical practice that immunisation should be preceded by a review of the medical history (especially with regard to previous immunisation and possible occurrence of undesirable events) and a clinical examination.
If any of the following events have occurred in temporal relation to receipt of DTPw or DTPa the decision to give subsequent doses of Infanrix, containing the pertussis component, should be carefully considered. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since these events are not associated with permanent sequelae.
Temperature of ≥ 40.5°C within 48 hours of vaccination, not due to another identifiable cause.
Collapse or shock-like state (hypotonic hyporesponsive episode) within 48 hours of vaccination.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunization until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
A history of febrile convulsions and a family history of convulsive fits do not constitute contraindications. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days postvaccination.
Acute encephalopathy has been reported rarely (estimated rate 0-10.5 cases per million vaccinations) following whole cell DTP vaccination; however a causal relationship has not been established. No such cases have been reported to date with acellular DTP vaccines.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
Infanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Human immunodeficiency virus (HIV) infection is not considered a contraindication for diphtheria, tetanus and pertussis (whole cell or acellular) immunisation. However in patients with immunodeficiency or in patients receiving immunosuppressive therapy, an adequate immunologic response may not be achieved. No data currently exist on use of Infanrix in these patients.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Infanrix was administered simultaneously with other paediatric vaccines (e.g. Hib and oral polio) in some studies during the clinical trial programme, however immune responses to the other vaccines were not assessed.
Infanrix can be mixed in the same syringe with Hiberix or Act-HIB. Different injectable vaccines should always be administered at different injection sites.

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)

Clinical trial experience.

Blood and lymphatic system disorders.

Metabolism and nutrition disorders.

Psychiatric disorders.

Nervous system disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Postmarketing experience.

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Respiratory, thoracic and mediastinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

Cases of overdose have been reported during postmarketing surveillance. Adverse events, when reported, are not specific but similar to adverse events reported with normal vaccine administration.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Primary immunisation - protective efficacy studies.

Primary immunisation - immunogenicity studies.

Infanrix booster dosing - following primary DTPw vaccination.

Infanrix booster dosing following primary Infanrix (DTPa) vaccination.

Infanrix booster dosing in children 4-6 years of age following primary DTPa vaccination.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine (DTPa) components are adsorbed on 0.5 mg aluminium in the form of aluminium hydroxide hydrate, and suspended in isotonic sodium chloride and water for injections.

6.2 Incompatibilities

Infanrix should not be mixed with other vaccines in the same syringe, with the exception of Hiberix or Act-HIB (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

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

Infanrix should be stored at +2°C and +8°C. Do not freeze; discard if vaccine has been frozen. The expiry date of the vaccine is indicated on the label and packaging.

6.5 Nature and Contents of Container

Infanrix is presented as 0.5 mL of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.
The tip cap and rubber plunger stopper of the pre-filled syringe are not made with natural rubber latex.
Infanrix is supplied in packs of 1 or packs of 10.
Not all pack sizes and presentations may be distributed in Australia.

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

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes