SUMMARY CMI

HEXAXIM^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about your child receiving this vaccine, speak to your doctor or pharmacist.

1. Why is my child receiving Hexaxim?

Hexaxim contains the active ingredients diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus influenzae type b conjugate vaccine (adsorbed). Hexaxim is a vaccine used to help protect your child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b.

For more information, see Section 1. Why is my child receiving Hexaxim? in the full CMI.

2. What should I know before my child receives Hexaxim?

Your child should not receive Hexaxim if they have ever had an allergic reaction to Hexaxim or any of the ingredients listed at the end of the CMI.

Talk to your doctor your child has any other medical conditions or takes any other medicines.

For more information, see Section 2. What should I know before my child receives Hexaxim? in the full CMI.

3. What if my child is taking other medicines?

Some medicines may interfere with Hexaxim and affect how it works.

A list of these medicines is in Section 3. What if my child is taking other medicines? in the full CMI.

4. How does my child receive Hexaxim?

• Hexaxim is injected into the muscle in the upper part of your child's leg or upper arm, by a doctor or nurse.
• Your child will receive two injections given at an interval of at least eight weeks apart, or three injections given at an interval of at least four weeks apart. This vaccine should be used according to the local vaccination program.

More instructions can be found in Section 4. How does my child receive Hexaxim? in the full CMI.

5. What should I know after my child receives Hexaxim?

For more information, see Section 5. What should I know after my child receives Hexaxim? in the full CMI.

6. Are there any side effects?

The most common side effects of Hexaxim are pain, redness or swelling at the injection site, loss of appetite, crying, sleepiness, vomiting, irritability, fever (temperature 38°C or higher), abnormal crying (prolonged crying), diarrhoea and injection site hardness.

Serious side effects can include episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE), serious allergic reaction (anaphylactic reaction) and fits (convulsions) with or without fever.

For more information, including what to do if your child has any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

HEXAXIM^®

Active ingredients: acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus influenzae type b conjugate vaccine (adsorbed)

Consumer Medicine Information (CMI)

This leaflet provides important information about receiving Hexaxim. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about your child receiving Hexaxim.

Where to find information in this leaflet:

1. Why is my child receiving Hexaxim?
2. What should I know before my child receives Hexaxim?
3. What if my child is taking other medicines?
4. How does my child receive Hexaxim?
5. What should I know after my child receives Hexaxim?
6. Are there any side effects?
7. Product details

1. Why is my child receiving Hexaxim?

Hexaxim contains the active ingredients diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus influenzae type b conjugate vaccine (adsorbed). Hexaxim is a vaccine used to protect against infectious diseases.

Hexaxim is used to help protect infants against diptheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by haemophilus influenzae type b. Hexaxim can be given to children from six weeks of age.

The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections:

• Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection causes pain and swelling which can lead to suffocation. The bacteria that cause the disease also make a toxin (poison) that can damage the heart, kidneys and nerves.
• Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound. The bacteria make a toxin (poison) that causes spasms of the muscles, leading to inability to breathe and the possibility of suffocation.
• Pertussis (often called whooping cough) is a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a “whooping” sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
• Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer
• Poliomyelitis (often just called polio) is caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness most commonly of the legs. Paralysis of the muscles that control breathing and swallowing can be fatal.
• Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness. Infection can also cause inflammation and swelling of the throat, leading to difficulties in swallowing and breathing, and infection can affect other parts of the body such as the blood, lungs, skin, bones, and joints.

Important information about the protection provided

Hexaxim will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine. Your child could get diseases with similar symptoms if they are caused by other bacteria or viruses.

The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.

This vaccine does not protect against infections caused by other types of Haemophilus influenzae nor against meningitis due to other micro-organisms.

Hexaxim will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E.

Because symptoms of hepatitis B take a long time to develop, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases.

Remember that no vaccine can provide complete, lifelong protection in all people who are vaccinated

2. What should I know before my child receives Hexaxim?

Warnings

Your child should not receive Hexaxim if:

• they have had a previous allergic reaction to Hexaxim, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexaxim
• has had an allergic reaction to any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines
• suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
• has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy

Check with your doctor if your child:

• have any other medical conditions
• has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu). Vaccination with Hexaxim may need to be delayed until your child is better
• has had any of the following events after receiving a pertussis vaccine, as the decision to give further doses of pertussis containing vaccine will need to be carefully considered:
  - fever of 40°C or above within 48 hours not due to another identifiable cause.
  - collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
  - persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
  - fits (convulsions) with or without fever, occurring within 3 days of vaccination.
• previously had Guillain-Barre syndrome (temporary inflammation of nerves causing pain, paralysis and sensitivity disorders) or brachial neuritis (severe pain and decreased mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin). In this case, the decision to give any further vaccine containing tetanus toxoid should be evaluated by your doctor.
• is having a treatment that suppresses her/his immune system (the body's natural defences) or has any disease that causes the weakness of the immune system. In these cases the immune response to the vaccine may be decreased. It is normally recommended to wait until the end of the treatment or disease before vaccinating. However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexaxim but the protection may not be as good as in children whose immune system is healthy.
• is born prematurely. Lower responses to the vaccine may be observed in relation with immaturity of the immune system. However, according to national recommendations, vaccination should not be delayed. In addition, longer gaps than normal between breaths may occur for 2 -3 days after vaccination.
• suffers from an acute or chronic illness including chronic renal insufficiency or failure (inability of the kidneys to work properly).
• suffers from any undiagnosed illness of the brain or epilepsy which is not controlled. Your doctor will assess the potential benefit offered by vaccination.
• has any problems with the blood that cause easy bruising or bleeding for a long time after minor cuts. Your doctor will advise you whether your child should have Hexaxim.
• has fainted when having a previous injection. Fainting can occur before or following needle injection.
• take any medicines for any other condition

During treatment, your child may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

3. What if my child is taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Hexaxim and affect how it works.

Having other vaccines

Your doctor will advise you if Hexaxim is to be given with another vaccine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Hexaxim.

4. How does my child receive Hexaxim?

How is Hexaxim given

• Hexaxim is administered to your child by your doctor or nurse
• Hexaxim is injected into the muscle in the upper part of your child's leg or upper arm

When is Hexaxim given

First course of vaccination (primary vaccination)

• Your child will receive two injections given at an interval of at least eight weeks apart, or three injections given at an interval of at least four weeks apart.
• This vaccine should be used according to the local vaccination programme.

Additional injections (booster)

• After the first course of injections, your child may require a booster dose, in accordance with local recommendations.
• Your doctor will advise you if your child requires a booster dose.

If you forget to use Hexaxim

If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.

It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections. If not, your child may not be fully protected against the diseases.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.

If you use too much Hexaxim

Overdose is unlikely as your doctor is giving you the injection.

If you have any concerns, ask your doctor or nurse.

5. What should I know after my child receives Hexaxim?

Things you should do

• Keep an updated record of your child's vaccination history.
• Attend any appointments made by your doctor or nurse.
• Report any side effects to your doctor.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Hexaxim is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Hexaxim:

• Keep out of reach and sight of children.
• Keep Hexaxim in the original pack until it is time for it to be given.
• Keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Hexaxim.
• Do not use Hexaxim if the packaging is torn or shows signs of tampering.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with Hexaxim:

• temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (Guillain-Barré syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
• inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
• swelling or inflammation of the brain (encephalopathy/encephalitis).
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2 -3 days after vaccination.
• swelling of one or both feet and lower limbs which may occur along with bluish discolouration of the skin, redness, small areas of bleeding under the skin and severe crying following vaccination with Haemophilus influenzae type b containing vaccines. If this reaction occurs, it is mainly after first injections and within the first few hours following vaccination. All symptoms should disappear completely within 24 hours without the need for treatment.

If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems in Australia or to the Medsafe online at pophealth.my.site.com/carmreportnz/s/ in New Zealand. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Hexaxim contains

Do not take this medicine if you are allergic to any of these ingredients.

The vaccine may contain traces of glutaral, formaldehyde, neomycin, streptomycin and polymyxin B. The manufacture of this product includes exposure to bovine 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.

What Hexaxim looks like

Hexaxim is provided as a fully liquid suspension for injection in pre-filled syringe (0.5 mL).

Hexaxim is available in a pack containing 1 pre-filled syringe with 1 or 2 needles.

Hexaxim is available in a pack containing 10 pre-filled syringes with 10 or 20 needles.

Not all pack sizes may be marketed.

After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.(Aust R 215536.)

Who distributes Hexaxim

Distributed in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: [email protected]

Distributed in New Zealand by:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in June 2025.

hexa-ccdsv8-ccdsv10-cmiv5-23jun25

Published by MIMS August 2025

1 Name of Medicine

Hexaxim.
DTPa-hepB-IPV-Hib - Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).

2 Qualitative and Quantitative Composition

Hexaxim is a preservative free liquid formulation for intramuscular administration which combines: diphtheria and tetanus toxoids, acellular pertussis (2-component), recombinant hepatitis B surface antigen, inactivated poliomyelitis virus and Haemophilus influenzae type b polysaccharide conjugated to tetanus protein.
Each 0.5 mL, adsorbed to aluminium hydroxide hydrate (0.6 mg, expressed as Al3+), contains (see Table 1):
The vaccine may contain traces of glutaral, formaldehyde, neomycin, streptomycin and polymyxin B.
Contains phenylalanine. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Hexaxim is a whitish, cloudy suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Use of this vaccine should be in accordance with the national recommendation as per the current immunisation handbook.

4.2 Dose and Method of Administration

Hexaxim is for intramuscular injection according to the dosing schedule in Table 2.
For further information, refer to the current immunisation handbook.

Administration.

4.3 Contraindications

Hexaxim should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine or to any pertussis vaccine, after previous administration of the vaccine or a vaccine containing the same components or constituents.
Vaccination with Hexaxim is contraindicated if the individual has experienced an encephalopathy of unknown aetiology within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines). In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines.
Progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy. Pertussis vaccine should not be administered to individuals with these common conditions until the treatment regimen has been established, the condition has stabilised and the benefit clearly outweighs the risk.
Generally vaccination must be postponed in cases of moderate or severe febrile and/or acute disease and low-grade fever does not constitute a contraindication.

4.4 Special Warnings and Precautions for Use

Do not administer intravenously, intradermally or subcutaneously.

Prior to vaccination.

Anaphylaxis.

Hypersensitivity.

Bleeding disorder.

Previous pertussis vaccination.

Family and individual history.

Protection.

Special patient groups.

Premature and low birth weight infants.

Immunocompromised individuals.

Neurological disorder.

Chronic renal failure.

Genetic polymorphism.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Hexaxim must not be mixed with other vaccines or other parenterally administered drugs.
Separate injection sites must be used in case of concomitant administration.
Data on concomitant administration of Hexaxim with 7-valent or 13-valent pneumococcal polysaccharide conjugate vaccines have shown no clinically relevant interference in the antibody response to each of the individual antigens.
Data on concomitant administration of Hexaxim with measles-mumps-rubella vaccine and with varicella vaccine have shown no clinically relevant interference in the antibody response to each of the antigens when given as a booster vaccination.
Data on concomitant administration of rotavirus vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Data on concomitant administration of Hexaxim with a meningococcal serogroup C-tetanus toxoid conjugate vaccine or a meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Except in the case of immunosuppressive therapy (see Section 4.4 Special Warnings and Precautions for Use), no significant clinical interaction with other treatments or biological products has been reported.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Adverse Effects (Undesirable Effects)

The adverse events are ranked under headings of frequency per dose, using the following convention: very common ≥ 1/10 (≥ 10%); common ≥ 1/100 to < 1/10 (≥ 1% and < 10%); uncommon ≥ 1/1,000 to < 1/100 (≥ 0.1% and < 1%); rare ≥ 1/10,000 to < 1/1000 (≥ 0.01% and < 0.1%); very rare < 1/10,000 (< 0.01%); not known: cannot be estimated from available data.

Clinical trials experience.

Immune system disorders.

Metabolism and nutrition disorders.

Nervous system disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Adverse reactions from post-marketing surveillance.

Immune system disorders.

Nervous system disorders.

Potential adverse events.

4.9 Overdose

Not documented.
For general advice on overdose management, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: vaccines, bacterial and viral combined, ATC code: J07CA09.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hexaxim contains the excipients; dibasic sodium phosphate, monobasic potassium phosphate, trometamol, sucrose, essential amino acids (cystine, tyrosine, arginine hydrochloride, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, threonine, tryptophan and valine) and water for injections.
The manufacture of this product includes exposure to bovine 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.

6.2 Incompatibilities

Hexaxim must not be mixed with other vaccines or other parenterally administered drugs.
Separate injection sites must be used in case of concomitant administration.

6.3 Shelf Life

48 months.

6.4 Special Precautions for Storage

Store in a refrigerator (2°C-8°C). Do not freeze. Discard if vaccine has been frozen.
Protect from light.
Stability data indicate that the vaccine components are stable at temperatures up to 25°C for 72 hours. At the end of this period, Hexaxim should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

6.5 Nature and Contents of Container

Hexaxim is supplied in:
0.5 mL single dose in pre-filled syringe without attached needle and one separate needle in a pack;
0.5 mL single dose in pre-filled syringe without attached needle and two separate needles in a pack.
Pack size of 1 or 10. Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely according to locally agreed procedures.

6.7 Physicochemical Properties

Not applicable.

References

1. The Public Health Agency of Sweden, Pertussis Surveillance in Sweden - Fifteen Year Report, 2013 http://www.folkhalsomyndigheten.se/pagefiles/17379/pertussis-surveillance%20in-sweden-fifteen-year-report%282%29.pdf.
2. Kalies H et al, Four and one-half year follow-up of the effectiveness of diphtheria-tetanus toxoids-acellular pertussis/Haemophilus influenzae type b and diphtheria-tetanus toxoids-acellular pertussis-inactivated poliovirus/H. influenzae type b combination vaccines in Germany. Pediatr Infect Dis J 2004;23(10):944-950.
3. Schmitt HJ et al. Haemophilus influenzae type b disease: impact and effectiveness of diphtheria-tetanus toxoids-acellular pertussis (-inactivated poliovirus)/H. influenzae type b combination vaccines. Pediatr Infect Dis J 2001;20(8):767-774.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Only Medicine.

Summary Table of Changes