SUMMARY CMI

Act-HIB^®

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 is my child being given Act-HIB?

Act-HIB is a vaccine that contains the active ingredient Haemophilus type b polysaccharide conjugated to tetanus protein. It is used to protect your child against Haemophilus Influenzae type b infections.

For more information, see Section 1. Why is my child being given Act-HIB? in the full CMI.

2. What should I know before my child is given Act-HIB?

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

Talk to your doctor if your child has or has had any other medical conditions or is taking other medicines.

For more information, see Section 2. What should I know before my child is given Act-HIB? in the full CMI.

3. What if my child am taking other medicines?

Some medicines may interfere with Act-HIB 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 Act-HIB is given

• Act-HIB is given by a doctor or nurse as an injection into muscle

More instructions can be found in Section 4. How Act-HIB is given in the full CMI.

5. What should I know after my child is given Act-HIB?

For more information, see Section 5. What should I know after my child is given Act-HIB? in the full CMI.

6. Are there any side effects?

Common side effects include local reaction around the injection site (pain, redness, swelling, inflammation, hardening of the skin), fever, irritability, vomiting, crying (uncontrollable or abnormal), unusual tiredness, runny nose, diarrhoea. Serious side effects include extensive limb swelling of the vaccinated limb, large injection site reactions (more than 50 mm) such as pain, redness, swelling and/ or inflammation or hardening of the skin, swelling of lower limbs with symptoms that may include blue or purple coloration of the skin, redness, transient discoloration of the skin, itchy rash, rash generalised, rash, itching, face swelling, laryngeal swelling, allergic reactions (such as itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body), 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

Act-HIB^®

Active ingredient(s): Haemophilus Type b Conjugate Vaccine (conjugated to tetanus protein)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Act-HIB. 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 Act-HIB.

Where to find information in this leaflet:

1. Why is my child being given Act-HIB?
2. What should I know before my child is given Act-HIB?
3. What if my child is taking other medicines?
4. How Act-HIB is given
5. What should I know after my child is given Act-HIB?
6. Are there any side effects?
7. Product details

1. Why is my child being given Act-HIB?

Act-HIB contains the active ingredient Haemophilus type b polysaccharide conjugated to tetanus protein. Act-HIB is a conjugate vaccine that helps protect your child against Haemophilus Influenzae type b infections.

This vaccine does not provide protection against infections due to other types of Haemophilus Influenzae or against cases of meningitis of other origins.

The vaccine may be administered to children from 2 months of age to 5 years of age.

Under no circumstances can the tetanus protein contained in this vaccine be used to replace the usual tetanus vaccination.

When an injection of Act-HIB is given, the immune system (body's natural defences) will protect against Haemophilus Influenzae type b infections. However, as with any vaccine, Act-HIB may not protect 100% of vaccinated individuals.

2. What should I know before my child is given Act-HIB?

Warnings

Do not use Act-HIB if your child:

• is allergic to the active substance, formaldehyde or any of the ingredients listed at the end of this leaflet.
  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, skin rash, itching or hives
• has had a life-threatening reaction after previous administration of this vaccine or a vaccine containing the same substances.
• has an illness with febrile or acute infection. The vaccination should be postponed until after your child has recovered.

Check with your doctor if your child:

• has a poor immune response (immunosuppression) due to disease or medicines, because their response to the vaccine may be limited.
• has a bleeding disorder
• has an allergy to latex
• has fainted with previous injections. Fainting can occur following, or even before, any needle injections
• has any other medical conditions
• take any medicines for any other condition

After vaccination, 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 your child is taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Having other vaccines:

• Tell your doctor if your child has had any vaccines in the last 4 weeks.
  Your doctor will advise you if Act-HIB is to be given with another vaccine as a separate injection.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements your child is taking and if these affect Act-HIB.

4. How Act-HIB is given

How much to use

• Act-HIB is administered to your child by your doctor or nurse.
• Act-Hib is given as an injection. For children under the age of 24 months, Act-HIB is injected into the upper thigh muscle. In older children who have started walking, the vaccine is usually injected into the upper arm muscle.

When to use Act-HIB

Infants:

• Before 6 months of age, administration of 3 successive 0.5mL doses at intervals of one to two months.
• Between 6 and 12 months of age, administration of 2 successive 0.5mL doses at intervals of one to two months.
• This is followed in both cases by a booster dose as per the National Immunisation Schedule.

Children:

• In children over 12 months of age, a single dose of 0.5mL.

If your child misses a dose of Act-HIB

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

If your child received too much Act-HIB

Overdose is most unlikely because your doctor or nurse gives the injections. If you have any concerns, ask your doctor.

5. What should I know after my child is given Act-HIB?

Things you should do

• keep an updated record of your vaccinations.
• keep follow-up appointments with your doctor or clinic.
  It is important for your child to have follow-up doses of Act-HIB at the appropriate times to make sure the vaccines are providing protection against Haemophilus Influenzae type b.
• report any side effects to your doctor.

Call your doctor straight away if your child:

• does not feel well after having Act-HIB

Remind any doctor, dentist or pharmacist you visit that your child had Act-HIB.

Looking after your child's medicine

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

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

Keep Act-HIB in the original pack until it is time for it to be given.

Store in a refrigerator (2°C - 8°C). Do not freeze. Freezing destroys the vaccine.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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.

If your child no longer needs this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not use Act-HIB after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

6. Are there any side effects?

All medicines can have side effects. If your child does 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

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making your child 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 your child experienced, you can report side effects as follows:

For Australia: Therapeutic Goods Administration online at: www.tga.gov.au/reporting-problems.

New Zealand: Medsafe online at: www.medsafe.govt.nz/safety/report-a-problem.asp

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 giving any medicines to your child.

7. Product details

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

What Act-HIB contains

Do not take this medicine if your child is allergic to any of these ingredients.

What Act-HIB looks like

Act-HIB is a freeze-dried powder for reconstitution with diluent for injection. Following reconstitution, the solution is clear.

Each pack of Act-HIB contains a single dose vial (containing powder for reconstitution) and 0.5 mL of diluent in a syringe with 2 separate needles.

AUST R 130161

Who distributes Act-HIB

Australia:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park
NSW 2113, Australia
Telephone: 1800 818 806

New Zealand:

sanofi-aventis new zealand limited
56 Cawley Street
Ellerslie
Auckland
New Zealand
Telephone: 0800 283 684

This leaflet was prepared in September 2023.

act-ccdsv10-cmiv4-08sep23

Published by MIMS November 2023

1 Name of Medicine

Act-HIB Haemophilus type b conjugate vaccine (conjugated to tetanus protein).
Haemophilus type b polysaccharide.

2 Qualitative and Quantitative Composition

Act-HIB contains the capsular polysaccharide of the Haemophilus influenzae type b bacterial strain conjugated to tetanus protein. The polysaccharide consists of polyribosyl ribitol phosphate (PRP).

Active ingredients.

3 Pharmaceutical Form

Act-HIB is a freeze-dried powder for reconstitution with diluent for injection. Following reconstitution, the solution is limpid and colourless.

4 Clinical Particulars

4.1 Therapeutic Indications

Act-HIB is indicated for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the Haemophilus influenzae type b.
The vaccine does not protect against infections due to other types of Haemophilus influenzae nor against meningitis from other origins.

Note.

4.2 Dose and Method of Administration

After reconstitution, the vaccine should be administered via the intramuscular or subcutaneous route.
The preferred injection site for children under 2 years of age is anterolateral thigh. In older children the vaccine may be given at the anterolateral thigh or deltoid region.
Vaccine injections should not be given in the dorsogluteal site or upper outer quadrant of the buttock because of the possibility of a suboptimal immune response.
For further information, refer to the current Immunisation Handbook.

Infants.

2-6 months age.

7-11 months age.

In children over 12 months.

4.3 Contraindications

Known systemic hypersensitivity to any component of Act-HIB in particular the tetanus protein or formaldehyde. Life-threatening reaction after previous administration of the vaccine or vaccine containing the same substances.
Vaccination must be postponed in case of febrile or acute disease.

4.4 Special Warnings and Precautions for Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.
Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
As with all injectable vaccines, the vaccine must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Prior to administration of any dose of Act-HIB, the parent or guardian of the recipient must be asked about their personal history, family history, and recent health status, including immunisation history, current health status and any adverse event after previous immunisations. In subjects who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, the course of the vaccination must be carefully considered.
The anticipated antibody response may not be obtained in individuals with impaired immune function due to drugs or disease.
Experience with native populations (Alaska, Native American Indians) generally suggests that response to all conjugated Haemophilus influenzae type b vaccines in these populations may be significantly lower than in Caucasians. The possibility of a lower antibody response in the Australian aboriginal population should be borne in mind.
As with most vaccines, the expected antibody response may not be achieved in 100% of cases.
Information is currently lacking on the value of vaccinating with Act-HIB after exposure to infection.
Cases of Haemophilus influenzae type b disease may occur in the weeks after vaccination prior development of an adequate antibody response.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h 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.
The tip caps of the prefilled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.
Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope.

Use in the elderly.

Paediatric use.

Effects on laboratory test.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administration of Act-HIB and DTP vaccines results in a somewhat lower antibody response to the diphtheria and pertussis components, although the levels are above those considered to be protective.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials experience.

Local.

Systemic.

Rare events.

Adverse reactions from post-marketing surveillance.

Immune system disorders.

Nervous system disorders.

Skin and subcutaneous tissue disorders.

General disorders and application site conditions.

Reporting of 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

Therapeutic class.

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

No data available.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Trometamol, sucrose, sodium chloride, water for injection.
No antimicrobial preservative is added.

6.2 Incompatibilities

Do not mix Act-HIB in the same syringe as other vaccines or medicinal products.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Store at 2°C to 8°C (Refrigerate. Do not freeze). Do not use after the expiry date.

6.5 Nature and Contents of Container

Single dose vial (containing powder for reconstitution) and 0.5 mL diluent in a syringe with 2 separate needles.

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.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Only Medicine.

Summary Table of Changes