SUMMARY CMI

HIBERIX

Consumer Medicine Information (CMI) summary

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

1. Why am I receiving HIBERIX?

HIBERIX is used to used to prevent Haemophilus influenzae type b (Hib) infection in children aged 2 months to 5 years. HIBERIX contains a non-infectious extract from Haemophilus influenzae type b bacteria bound to tetanus toxoid as the active ingredient.

For more information, see Section 1. Why am I receiving HIBERIX? in the full CMI.

2. What should I know before I receive HIBERIX?

Do not use if your child has ever had an allergic reaction to HIBERIX, or any of the ingredients listed at the end of the CMI.

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

For more information, see Section 2. What should I know before I receive HIBERIX? in the full CMI.

3. What if I am taking other medicines?

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

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

4. How is HIBERIX given?

Your doctor or nurse will give you HIBERIX as an injection (dose of 0.5 mL) generally given as a total of three doses at 2, 4 and months of age. A booster dose is recommended at 12 months of age to ensure long term protection.

HIBERIX is injected into the upper leg muscle (infants under 12 months of age) or injected into the upper arm muscle (children over 12 months of age). For some children with bleeding problems, the dose may need to be given under the skin (subcutaneously).

More instructions can be found in Section 4. How is HIBERIX given? in the full CMI.

5. What should I know after receiving HIBERIX?

For more information, see Section 5. What should I know after receiving HIBERIX? in the full CMI.

6. Are there any side effects?

Side effects which have been reported following administration of HIBERIX include pain, redness, swelling around the injection site, restlessness, unusual crying, sleeplessness or tiredness, loss of appetite, vomiting or diarrhoea, fever, cough, runny nose or symptoms of a cold, irritability, skin rash or bruising, breathing difficulties, fainting due to injection, feeling sleepy, temporarily stopping breathing, hives, rash, large swelling of the injected limb and hard lump at the injection site.

Allergic reactions have also occurred following administration of HIBERIX. Allergy is rare and severe reactions will usually occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest hospital immediately.

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

FULL CMI

HIBERIX

Active ingredient(s): inactivated Haemophilus influenzae type b (Hib) bacteria bound to tetanus toxoid

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I receiving HIBERIX?
2. What should I know before I receive HIBERIX?
3. What if I am taking other medicines?
4. How is HIBERIX given?
5. What should I know after receiving HIBERIX?
6. Are there any side effects?
7. Product details

1. Why am I receiving HIBERIX?

HIBERIX is a non-infectious vaccine used to prevent Haemophilus influenzae type b (Hib) infection in children aged 2 months to 5 years.

HIBERIX contains inactivated Haemophilus influenzae type b (Hib) bacteria bound to tetanus toxoid as the active ingredient.

The vaccine works by causing the body to produce its own protection (antibodies) against the disease.

Haemophilus influenzae type b is a bacteria that can cause serious life-threatening illness. Hib infection most frequently causes brain inflammation (swelling), which is generally seen in infants under 18 months of age. Hib can cause invasive diseases in young children and people who are immunocompromised. The case-fatality rate for Hib meningitis is between 3% and 6%. Up to 30% of individuals who survive Hib disease have permanent neurological conditions. Hib infection also causes inflammation of the throat, which is mostly seen in children over 18 months of age. It 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 Hib infection. HIBERIX vaccine is not infectious, and cannot give your child Hib infection. The vaccine will not protect against diseases caused by other types of bacteria or organisms.

2. What should I know before I receive HIBERIX?

Warnings

Do not receive HIBERIX if:

• your child has had an allergic reaction to HIBERIX, or any ingredient contained in this vaccine. The ingredients are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• your child had HIBERIX before and became unwell, tell your doctor or nurse before the vaccine is given.
• your child has had an allergic reaction to any other Haemophilus influenzae type b vaccine.
• your child has a severe infection with a high temperature. Your doctor may decide to delay vaccination with HIBERIX until the illness has passed. A minor infection such as a cold is not usually a reason to delay vaccination but talk to your doctor or nurse about this before being vaccinated.
• 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 HIBERIX, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for your child.

Check with your doctor if your child:

• your child has any medical conditions, such as an immune deficiency condition or a bleeding problem. HIBERIX may need to be given differently in children with bleeding problems.
• your child has allergies to any other medicines or substances, such as dyes, foods or preservatives.

You 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?

Fainting

Fainting can occur following, or even before, any needle injection. Tell the person giving you your injection if you or your child have ever fainted with a previous injection.

3. What if I am taking other medicines?

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

Some medicines and vaccines may interfere with HIBERIX and affect how it works.

• steroids, ciclosporin – medicines used to suppress the immune system

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

4. How is HIBERIX given?

How much is given

• Your doctor or nurse will give you HIBERIX as an injection.
• The dose of HIBERIX is 0.5 mL.

How it is given

HIBERIX will be injected into the upper leg muscle in infants under 12 months of age. In children over 12 months of age the injection will be given in the upper arm muscle. For some children with bleeding problems, the dose may need to be given under the skin (subcutaneously).

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

When is it given

Your doctor or nurse will give your child a HIBERIX as an injection (dose of 0.5mL) at 2, 4 and 6 months of age. Each dose is given on a separate visit.

• First dose:2 months of age
• Second dose: 4 months of age
• Third dose: 6 months of age.

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

To ensure long term protection a booster dose is generally given in the second year of life.

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 you are taking HIBERIX

THINGS YOU MUST DO:

Keep your child's follow up visits with the doctor, nurse or clinic. It is important the 2 follow-up doses of HIBERIX are given at the correct times. This will ensure the best effect of the vaccine in protecting your child against Hib infection.

If you are given too much HIBERIX

If you think that you have been given too much HIBERIX, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know after receiving HIBERIX?

Things you should do

• keep a record of your vaccination history

Looking after your medicine

• HIBERIX will usually be stored at the doctor's clinic or at the pharmacy.
• If you need to store HIBERIX it is important to keep it in the refrigerator between 2°C and 8°C.
• Keep HIBERIX in the original pack until it is time for it to be given.
• DO NOT FREEZE HIBERIX. FREEZING THIS MEDICINE WILL DESTROY THE VACCINE.

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

Getting rid of any unwanted medicine

Do not use this medicine after the expiry date.

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

6. Are there any side effects?

All medicines and vaccines 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.

HIBERIX helps protect most children from Hib infection, but it may have unwanted side effects in a few children.

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

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

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.

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. 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

What HIBERIX contains

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (Variant Creutzfeldt-Jakob disease - considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

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

What HIBERIX looks like

HIBERIX comes as single or 10 dose packs containing:

a white powder in a glass vial, with a sterile saline diluent presented in a prefilled syringe (AUST R 60881).

Who distributes HIBERIX

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

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

© 2023 GSK group of companies or its licensor.

This leaflet was prepared on 24 January 2023.

Version 6.0

Published by MIMS March 2023

1 Name of Medicine

Haemophilus influenzae type b (Hib) vaccine.

2 Qualitative and Quantitative Composition

After reconstitution, 1 dose (0.5 mL) contains:
Haemophilus influenzae type b polysaccharide 10 microgram;
conjugated to tetanus toxoid as carrier protein approximately 25 microgram.
Hiberix is a non-infectious vaccine containing purified polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of Haemophilus influenzae type b covalently bound to tetanus toxoid.
Hiberix is supplied as a white lyophilised powder for reconstitution with a diluent (sterile 0.9% saline solution). The diluent is supplied as a clear and colourless liquid.
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.

List of excipients with known effect.

3 Pharmaceutical Form

Powder and diluent for solution for injection.
Hiberix is presented as a white lyophilised powder in a glass vial. The sterile 0.9% saline diluent is clear and colourless and presented in a pre-filled syringe.

4 Clinical Particulars

4.1 Therapeutic Indications

Hiberix is indicated for active immunisation against Haemophilus influenzae type b infection in children aged from 2 months to 5 years.

4.2 Dose and Method of Administration

Hiberix is supplied as a white lyophilised powder for reconstitution with sterile 0.9% saline diluent. Hiberix is prepared as detailed below (see Section 4.2 Dose and Method of Administration, Directions for reconstitution).
The recommended dose is 0.5 mL.
Hiberix vaccine must be administered by intramuscular injection. In infants and children under 12 months of age it is preferable to inject the vaccine in the anterolateral thigh because of the small size of their deltoid muscle. In children over 12 months of age the injection can alternatively be given in the deltoid region. The vaccine should be administered subcutaneously in patients with thrombocytopenia or bleeding tendencies, e.g. haemophiliacs (see Section 4.4 Special Warnings and Precautions for Use).
Hiberix must not be given intravenously.
The recommended primary vaccination course consists of three doses at 2, 4 and 6 months of age. A booster dose is recommended at 12 months of age to ensure long-term protection.
This is consistent with the National Health and Medical Research Council recommendations for Haemophilus influenzae type b vaccination.

Directions for reconstitution.

Instructions for reconstitution of the vaccine with the diluent presented in pre-filled syringe.

4.3 Contraindications

Hiberix should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of Hib vaccines.
As for any vaccine, Hiberix should not be administered to subjects suffering from acute severe febrile illness. However, the presence of minor infection does not contraindicate vaccination.

4.4 Special Warnings and Precautions for Use

Hiberix should under no circumstances be administered intravenously.
It is good clinical practice that any vaccination be preceded by a review of medical history (especially with regard to previous vaccinations and possible adverse events) and a clinical examination.
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.
Native populations (native Alaskans, native American Indians) with a high incidence of Haemophilus influenzae type b disease have shown a reduced antibody response to conjugated Haemophilus influenzae type b vaccines. The immunogenicity of Hiberix has not been studied in the Australian aboriginal population and the possibility of a lower antibody response than that seen in clinical studies should be borne in mind.
Human Immunodeficiency Virus (HIV) infection is not a contraindication to vaccination. However an adequate antibody response may not be obtained in patients with an immunodeficiency disorder or in patients receiving immunosuppressive therapy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Hiberix should be administered subcutaneously in patients with thrombocytopenia or bleeding disorders (e.g. haemophiliacs) since bleeding after intramuscular injection may occur in these patients (see Section 4.2 Dose and Method of Administration).
Urinary excretion of the capsular polysaccharide antigen has been reported following Hib vaccination. Therefore antigen detection within 1-2 weeks of vaccination may not be of diagnostic value in suspected Hib disease.
An immune response to the tetanus toxoid component may occur following Hiberix vaccination, however this does not substitute for routine tetanus vaccination.
Hiberix will not protect against diseases caused by other types of Haemophilus influenzae, or meningitis caused by other organisms.
The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation 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

Hiberix may be administered either simultaneously, or at any time before or after different live or inactivated vaccines. However, different injectable vaccines administered concurrently should always be given in separate sites using separate syringes.
Clinical trials have shown concomitant administration of Hiberix and the diphtheria-tetanus-pertussis (acellular or whole-cell) combination vaccines does not affect the immunogenicity of either vaccine, provided the vaccines are given at separate sites and not mixed prior to administration.
As with other vaccines, it may be expected patients receiving immunosuppressive therapy (e.g. high-dose steroids or cyclosporin) or patients with an immunodeficiency may not achieve an adequate immune response (see Section 4.4 Special Warnings and Precautions for Use).
Hiberix must not be mixed with other vaccines in the same syringe.

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 data.

Local reactions.

Body as a whole.

Dermatological.

Gastrointestinal.

Musculoskeletal.

Nervous system.

Respiratory.

Special senses.

Post-marketing data.

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

In general, the adverse event profile reported following overdosage was similar to that observed after administration of the recommended dose of Hiberix.
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.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The reconstituted vaccine preparation contains the excipients lactose, sodium chloride and water for injection.

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

Hiberix must be stored between 2°C to 8°C, and protected from light. The lyophilised Hib vaccine is not affected by freezing. The sterile 0.9% saline diluent may be stored in the refrigerator (at 2°C to 8°C) or stored at ambient temperatures, but must not be frozen.

6.5 Nature and Contents of Container

The vials and pre-filled syringes are made of neutral glass type 1.
Hiberix is presented as a singles or tens pack.
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