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.
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.
3. What if my child am taking other medicines?
Some medicines may interfere with Act-HIB and affect how it works.
4. How Act-HIB is given
Act-HIB is given by a doctor or nurse as an injection into muscle
5. What should I know after my child is given Act-HIB?
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Things you should do
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Keep an updated record of your vaccinations.
Keep follow-up appointments with your doctor or clinic.
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Looking after your medicine
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Act-HIB is usually stored in the doctor’s surgery or clinic, or at the pharmacy.
Store in a refrigerator (2°C - 8°C). Do not freeze.
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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).
Active ingredient(s):
Haemophilus Type b Conjugate Vaccine (conjugated to tetanus protein)
Full 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?
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
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:
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
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Active ingredient
(main ingredient)
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Haemophilus type b polysaccharide 10mcg conjugated to tetanus protein (18 - 30 mcg
per 0.5mL dose)
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Other ingredients
(inactive ingredients)
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trometamol
sucrose
sodium chloride
water for injections
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Potential allergens
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Latex
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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:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
New Zealand
Telephone: 0800 283 684
This leaflet was prepared in September 2023.
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