Are you a Health Professional? Jump over to the doctors only platform. Click Here

Act-HIB

Print Friendly, PDF & Email

Generic Name: Haemophilus type b conjugate vaccine (conjugated to tetanus protein)
Product Name: Act-HIB

Indication: What Act-HIB is used for

Act-HIB is a 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.

Action: How Act-HIB works

When administered to humans Act-HIB results in an IgG specific anti-PRP response in infants. This response is T-lymphocyte dependent and is characterised by establishment of immunological memory. Antibody response appears to be greater following subcutaneous administration as compared to intramuscular administration.

Although information on the protective efficacy of the Act-HIB from field trials is limited, Act-HIB has been shown to induce antibody levels well above those known to be protective against invasive disease due to Haemophilus influenzae type b bacterial strains, in 97-100% vaccinees. Study of the functional activity of the anti-PRP antibodies induced by Act-HIB (Haemophilus
b conjugate vaccine) in infants and children, showed opsonization and intracellular phagocytic killing properties.

The active substance is Haemophilus type b polysaccharide 10 mcg conjugated to tetanus protein (18 – 30 mcg per 0.5 mL dose).

The other ingredients are trometamol, sucrose, sodium chloride and water for injections.

Dose advice: How to use Act-HIB

Before your child is given Act-HIB

When your child must not be given it

Do not have Act-HIB if your child has an allergy to:

  • The active substance or any of the other ingredients of Act-HIB listed here;
  • Formaldehyde.

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.

Do not have Act-HIB if your child:

  • 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.

Before your child is given it

Tell your doctor before vaccination if your child has a poor immune response (immunosuppression) due to disease or medicines, because your response to the vaccine may be limited.

Tell your doctor if your child has a bleeding disorder.

Taking other medicines

Tell your doctor if your child is taking or any other medicines, including any 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.

How Act-HIB is given

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.

How much is given

Infants:

  • Before 6 months of age, administration of 3 successive 0.5 mL doses at intervals of one to two months;
  • Between 6 and 12 months of age, administration of 2 successive 0.5 mL 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 0.5 mL.

If you miss a dose

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

After having Act-HIB

Things you must 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 of providing protection against Haemophilus influenzae type b.

Report any side effects to your doctor.

Storing Act-HIB

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

  • Keep out of the reach of and sight of children;
  • 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.

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.

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.

Schedule of Act-HIB

Act-HIB is a Schedule 4 – prescription only medicine.

Side effects of Act-HIB

Tell your doctor or pharmacist as soon as possible your child does not feel well after having Act-HIB. Act-HIB may have unwanted side effects in a few people. All medicines, including vaccines, can cause side effects. Sometimes they are serious, most of the time they are not. Your child may need medical treatment if you get some of the side effects.

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

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Fever;
  • Irritability;
  • Injection site reactions such as pain, redness (erythema), swelling, inflammation, hardening of the skin (induration);
  • Vomiting;
  • Crying (uncontrollable or abnormal);
  • Unusual tiredness;
  • Runny nose;
  • Diarrhoea.

These are the more common side effects of Act-HIB. Mostly these are mild and short-lived.

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

  • 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 (oedema) of lower limbs with symptoms that may include blue or purple colouration of the skin (cyanosis), redness, transient discolouration of the skin (purpura);
  • Itchy rash (urticaria), rash, itching (pruritus), face swelling (oedema), laryngeal swelling (oedema).

If any of the following happen, tell your doctor immediately and go to Accident and Emergency at your nearest hospital:

  • Allergic (hypersensitivity) 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).

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making your child feel unwell.

For further information talk to your doctor.

References

  1. Act-HIB Consumer Medicine Information (CMI). Macquarie Park, NSW: Sanofi-Aventis Australia Pty Ltd. February 2018. [PDF]
  2. Act-HIB Product Information (PI). Macquarie Park, NSW: Sanofi-Aventis Australia Pty Ltd. February 2018. [PDF]
Print Friendly, PDF & Email

Dates

Posted On: 12 September, 2018
Modified On: 12 September, 2018
Reviewed On: 12 September, 2018

Tags



Created by: myVMC