Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you are given INFANRIX HEXA.

This leaflet answers some of the common questions about INFANRIX HEXA 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 HEXA against the expected benefits.

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

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

What INFANRIX HEXA is used for

INFANRIX HEXA is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

Diphtheria, tetanus, pertussis and Hib are all serious life-threatening diseases caused by bacterial infection. Hepatitis B and poliomyelitis are infectious diseases caused by viral infection.

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 10% 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 chest infections (bronchitis), lung infections (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.

Hepatitis B
Hepatitis B is caused by the hepatitis B virus. It causes the liver to be become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva of infected people. The virus can enter the bloodstream through:

• an infected mother passing the virus onto her baby during or shortly after birth
• sores, cuts or tiny wounds coming into contact with infected fluids (eg from a human bite, sharing razors or toothbrushes, or working with human blood or body fluids)
• injection (eg needlestick injury, or sharing needles for IV drug use)
• sexual intercourse

Some people infected with hepatitis B may not look or feel sick. But others will get symptoms, which may not be seen for 6 weeks to 6 months after infection. Sometimes people will only have mild flu-like symptoms, but other people can become very ill. They may be extremely tired, and have dark urine, pale faeces, yellowish skin and/or eyes (jaundice), and other symptoms possibly requiring hospitalisation.

Most adults fully recover from the disease. However, some people, particularly children, who may not have had symptoms, can remain infected. They are called hepatitis B virus carriers. Hepatitis B carriers can infect others throughout their lives.

Babies infected with hepatitis B at birth almost always become carriers. Often they do not show symptoms, and seem healthy for many years. However, after 30, 40 or 50 years they can become sick and develop symptoms. For all chronic hepatitis B carriers there is a risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.

There is no specific treatment for hepatitis B.

Poliomyelitis (Polio)
Polio is a viral infection that can have variable effects. Often it causes only a mild illness but in some people it causes permanent injury or death.

In its severest form, polio infection causes paralysis of the muscles (unable to move), including those needed for breathing and walking. Polio infection can leave a person unable to breathe without the help of an iron lung machine, unable to walk without leg braces, or confined to a wheel chair. The limbs affected by the disease may be painfully twisted (deformed).

Haemophilus influenzae type b (Hib)
Hib most frequently causes brain inflammation (swelling), which is generally seen in infants under 18 months of age. The death rate is 5-10% of infants in this age group. In 15-30% of surviving infants there will be some type of serious complication such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness. Hib can also causes inflammation of the throat, which is mostly seen in children over 18 months of age. This occasionally causes death by suffocation. Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.

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

If a person is already infected with the hepatitis B virus at the time of vaccination, INFANRIX HEXA may not prevent the disease in these people.

Before INFANRIX HEXA is given

When INFANRIX HEXA must not be given

INFANRIX HEXA should not be given if your child has had an allergic reaction to:

• INFANRIX HEXA or any of the active ingredients in the vaccine
• any of the ingredients listed at the end of this leaflet.
• any other diphtheria, tetanus, hepatitis B, inactivated polio or Haemophilus influenzae type b vaccine (such as ENGERIX-B, H-B-Vax II, INFANRIX, Triple Antigen, Tripacel or IPOL vaccine, HIBERIX).

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

If your child had INFANRIX HEXA before and became unwell, tell your doctor, nurse or pharmacist before the next dose is given.

INFANRIX HEXA should not be given if:

• 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 HEXA vaccine, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for your child.

Before you are given it

Before INFANRIX HEXA is given tell your doctor or nurse if:

• your child has any medical problems such as:
  - brain disease or central nervous system (CNS) disease (for example 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 temperature)
  - a family history of seizures/fits
  - a family history of Sudden Infant Death Syndrome (SIDS)
  - allergy to the antibiotics: neomycin and polymyxin.
• after having INFANRIX HEXA or another pertussis-containing vaccine your child had any problems, especially:
  - a high temperature (over 40.0°C) within 48 hours of vaccination
  - a collapse or shock-like state within 48 hours of vaccination
  - crying lasting 3 hours or more within 48 hours 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

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

Higher incidence of fever (>39.5°C) was reported in infants receiving INFANRIX HEXA and Prevenar compared to infants receiving INFANRIX HEXA alone.

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 HEXA is to be given with another vaccine or medicine.

Increased reporting rates of fits (with or without fever) and collapse or shock-like state were observed in infants receiving INFANRIX HEXA and pneumococcal conjugate vaccine (e.g. Prevenar) at the same visit compared to infants receiving INFANRIX HEXA alone.

How INFANRIX HEXA is given

The doctor or nurse will give INFANRIX HEXA 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 HEXA is 0.5 mL.

How it is given

INFANRIX HEXA will be injected into the upper leg muscle or the upper arm muscle.

The vaccine should never be injected into a vein, artery or the skin.

When it is given

INFANRIX HEXA is usually given as a total of two or three doses with an interval of at least one month between each injection.

If additional injections (boosters) are necessary, the doctor or nurse will tell you.

Each dose is given on a separate visit. INFANRIX HEXA should not be given at birth.

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

INFANRIX HEXA can be given as a booster dose when the child is 18 months old when boosting with hepatitis B and/or poliovirus and/or Haemophilus influenza type b, as well as diphtheria, tetanus and pertussis, is required.

You should discuss with your doctor what is needed for your child.

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 INFANRIX HEXA is given

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

Side effects

Tell your doctor or nurse as soon as possible if your child does not feel or look well during or after being given INFANRIX HEXA vaccine.

INFANRIX HEXA helps protect most children from diphtheria, tetanus, pertussis, hepatitis B, poliovirus infection and Haemophilus influenzae type b, 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.

Do not be alarmed by the following lists of side effects. Your child may not experience any of them.

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

Most unwanted effects with INFANRIX HEXA are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. Side effects are more likely to occur with booster dosing.

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

• pain, redness, swelling, a hard lump, bruising or itching around the injection site
• fever between 38°C and 39.5°C
• unusual crying (for more than 1 hour)
• vomiting, diarrhoea
• loss of appetite
• sleepiness, nervousness, irritability restlessness, fussiness or difficulty sleeping
• upper respiratory tract infection, bronchitis, runny or blocked nose
• skin rash, bruising, or purple or red-brown spots visible through the skin (purpura)

The above list includes the more common side effects of your medicine.

See your doctor immediately if you notice any of the following:

• fever greater than 39.5°C
• crying for 3 hours or more
• collapse, or periods of unconsciousness or lack of awareness
• seizures (convulsions) or fits
• 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).

The above list includes serious side effects that may require medical attention.

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 HEXA vaccine is rare. Any such severe reactions will usually occur within the first few hours of vaccination.

Other events reported after INFANRIX vaccination, but may not be necessarily related to the vaccine include:

• respiratory infections or bronchitis

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

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.

After being given INFANRIX HEXA

Storage

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

• Keep INFANRIX HEXA in the refrigerator stored between +2°C and +8°C.
  THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
• Keep the vaccine out of the reach of children.
• INFANRIX HEXA should not be used 8 hours after opening.
• Keep INFANRIX HEXA in the original pack until it is time for it to be given.

Disposal

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

Product description

What it looks like

INFANRIX HEXA comes in two parts. The first part is a white, milky liquid (0.5 mL) in a pre-filled syringe that consists of the combined diphtheria, tetanus, pertussis, hepatitis B and inactivated poliovirus vaccine.

The second part is the Hib vaccine and is a white pellet in a separate glass vial. These parts are mixed together before use.

When both parts are mixed the vaccine looks like a white, cloudy/milky liquid.

Ingredients

The active ingredients of INFANRIX HEXA are non-infectious substances from tetanus, diphtheria bacteria, purified proteins of pertussis bacteria, the surface protein of the hepatitis B virus (HBsAg, derived from genetically engineered yeast cells) and inactivated poliovirus.

The vaccine cannot cause these diseases.

Each 0.5 mL dose contains:

• ≥30 IU (25 LfU) of diphtheria toxoid
• ≥40 IU (10 Lf U) of tetanus toxoid
• 25 µg of pertussis toxoid, 25 µg of filamentous haemagglutinin and 8 µg of pertactin
• 10 µg of recombinant HBsAg protein.
• 40 D-antigen units of poliovirus Type 1, 8 D-antigen units of poliovirus Type 2 and 32 D-antigen units of poliovirus Type 3
• 10 µg of purified capsular polysaccharide of Hib covalently bound to approximately 20-40 µg of tetanus toxoid.

The inactive ingredients in the vaccine are:

• aluminium hydroxide hydrate
• aluminium phosphate
• lactose
• sodium chloride (salt)
• water for injections
• Medium 199

The following ingredients are present as residues:

• neomycin sulfate
• polymyxin B sulfate

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.

Further Information

INFANRIX HEXA is only available if prescribed by a doctor.

AUST R 132881

Distributed in Australia by:

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

Date of Preparation:
22 March 2022

Version 9.0

Published by MIMS November 2022

1 Name of Medicine

Combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, poliovirus and Haemophilus influenzae type b vaccine.

2 Qualitative and Quantitative Composition

1 dose (0.5 ml) contains:
diphtheria toxoid¹ not less than 30 international units;
tetanus toxoid¹ not less than 40 international units;
Bordetella pertussis antigens: pertussis toxoid (PT)¹ 25 microgram, filamentous haemagglutinin (FHA)¹ 25 microgram, pertactin (PRN)¹ 8 microgram;
hepatitis B surface antigen (HBs)^2,3 10 microgram;
poliovirus (inactivated) (IPV) type 1 (Mahoney strain)⁴ 40 D-antigen unit, type 2 (MEF-1 strain)⁴ 8 D-antigen unit, type 3 (Saukett strain)⁴ 32 D-antigen unit;
Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate, PRP)³ 10 microgram, conjugated to tetanus toxoid as carrier protein 20-40 microgram.
¹ Adsorbed on aluminium hydroxide hydrate (Al(OH)₃) 0.5 milligram Al³⁺.
² Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
³ Adsorbed on aluminium phosphate (AlPO₄) 0.32 milligram Al³⁺.
⁴ Propagated in VERO cells.

List of excipients with known effect.

3 Pharmaceutical Form

Powder and suspension for injection.
The DTPa-HBV-IPV component is presented as a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. This is a normal observation.
The Hib component is presented as a white pellet.

4 Clinical Particulars

4.1 Therapeutic Indications

Infanrix Hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b.
Infanrix Hexa is also indicated for use as booster dose if boosting with hepatitis B, poliomyelitis, and Haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required.
The use of Infanrix Hexa should be in accordance with official recommendations.
See Section 4.2 Dose and Method of Administration for further information.

4.2 Dose and Method of Administration

Infanrix Hexa is for deep intramuscular injection.
Before use of the vaccine, the Infanrix Hexa suspension should be well shaken in order to obtain a homogeneous turbid white suspension. The DTPa-HBV-IPV suspension and the Hib pellet should be inspected visually for any foreign particulate matter and/or any variation of physical aspect. In the event of either being observed, do not administer the vaccine.
Infanrix Hexa must be reconstituted by adding the entire contents of the prefilled syringe containing the liquid component to the vial containing the Hib pellet.
After the addition of the liquid component to the pellet, the mixture should be well shaken until the pellet is completely dissolved in the suspension.
It is good clinical practice to only inject a vaccine when it has reached room temperature. In addition, a vial at room temperature ensures sufficient elasticity of the rubber closure to minimise any coring of rubber particles. To achieve this, the vial should be kept at room temperature (25 ± 3°C) for at least five minutes before connecting the prefilled syringe and reconstituting the vaccine.
The reconstituted vaccine presents as a slightly more cloudy suspension than the liquid component alone. This is a normal observation.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.
After reconstitution, the vaccine should be injected immediately. However, the vaccine may be kept for up to 8 hours at room temperature.
Withdraw the entire contents of the vial.

Instructions for the pre-filled syringe.

Dosage.

Administration.

4.3 Contraindications

Infanrix Hexa should not be administered to subjects with known hypersensitivity to the active substances or to any of the excipients or residues (see Section 2 Qualitative and Quantitative Composition).
Infanrix Hexa should not be administered to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
Infanrix Hexa is contraindicated if the child has experienced encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria, tetanus, hepatitis B, inactivated polio and Hib vaccines.

4.4 Special Warnings and Precautions for Use

Do not administer Infanrix Hexa intravascularly or intradermally.
As with other vaccines, the administration of Infanrix Hexa should be postponed in subjects suffering from acute severe febrile illness (with fever > 38.5°C). The presence of a minor infection, however, is not a contraindication.
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.
A protective immune response may not be elicited in all vaccinees (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Infanrix Hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
If any of the following events are known to have occurred in temporal relation to receipt of whole cell or acellular pertussis containing vaccine, the decision to give further doses of vaccine containing the pertussis component should be carefully considered:
Temperature of ≥ 40.0°C within 48 hours, 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.
No data currently exist on use of Infanrix Hexa in these children. 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.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunisation 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.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Infanrix Hexa should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular injection in these subjects.
A history of febrile convulsions, a family history of convulsions, or sudden infant death syndrome (SIDS) do not constitute contraindications for the use of Infanrix Hexa. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days postvaccination.
Data from clinical studies indicate that, when Infanrix Hexa is coadministered with pneumococcal conjugate vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix Hexa alone.
Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix Hexa and Prevenar 13 (see Section 4.8 Adverse Effects (Undesirable Effects)).
Antipyretic treatment should be initiated according to local treatment guidelines.
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.
Infanrix Hexa should not be administered at birth. Infants born of HBsAg positive mothers should receive hepatitis B immune globulin and hepatitis B vaccine at birth.
The Hib component of the vaccine does not protect against diseases due to other strains of Haemophilus influenzae or against meningitis caused by other organisms.

Special populations.

Preterm infants.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Infanrix Hexa should not be mixed with other vaccines in the same syringe.
Infanrix Hexa can be given concomitantly with pneumococcal conjugate, MenC conjugate, MenACWY conjugate, MenB, rotavirus, measles, mumps, rubella and varicella vaccines. Data have shown no clinically relevant interference in the antibody response to each of the individual antigens.
When Infanrix Hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference.
Data from clinical studies indicate that, when Infanrix Hexa is coadministered with pneumococcal conjugate vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix Hexa alone. (See Section 4.4 Special Warnings and Precautions for Use).
Data from clinical studies indicate a more frequent occurrence of fever, pain at the injection site, appetite lost and irritability when Infanrix Hexa is co-administered with MenB vaccine and 7-valent pneumococcal conjugate vaccine.

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.

Post-marketing experience.

Safety in preterm infants.

Safety in infants and toddlers born to mothers vaccinated with dTpa during pregnancy.

Experience with hepatitis B vaccine which is the same antigen used in Infanrix Hexa.

Reporting suspected adverse effects.

4.9 Overdose

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.

Immunogenicity.

Protective efficacy against pertussis.

Immunogenicity in infants and toddlers born to mothers vaccinated with dTpa during pregnancy.

Immunogenicity in preterm infants.

Persistence of the immune response.

Postmarketing experience.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The final vaccine also contains the excipients lactose, medium 199 (as stabiliser containing amino acids, mineral salts, vitamins and other substances), sodium chloride, aluminium hydroxide hydrate, aluminium phosphate and water for injections. The vaccine also contains the following residues: neomycin sulfate and polymyxin B sulfate.

6.2 Incompatibilities

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 Hexa should be stored at +2°C to +8°C.
The DTPa-HBV-IPV suspension and the reconstituted vaccine must not be frozen. Discard if it has been frozen.
Protect from light.
During transport, recommended conditions of storage must be respected.
Stability data indicate that the vaccine components are stable at temperatures up to 25°C for 72 hours. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

6.5 Nature and Contents of Container

The DTPa-HBV-IPV suspension is presented in a pre-filled syringe.
The lyophilised Hib component is presented in a glass vial.
Powder in a vial (type I glass) containing 1 dose with a stopper (butyl rubber) and 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 and the stopper of the vial are not made with natural rubber latex.
This combination pack is supplied in packs of 1 and 10.
Not all pack sizes 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