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ACT-HIB POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCI

Active substance(s): HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE / HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE / HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE

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PR81193 £442
Act-Hib SPMSD MA Licence Transfer
Change of Ownership (including THMPD
registrations)
COA PL Number: PL46602/0011

PATIENT INFORMATION LEAFLET
ACT-HIB® powder and solvent for solution for injection
Haemophilus influenzae type b Conjugate Vaccine

Read all of this leaflet carefully before your child is vaccinated.
 Keep this leaflet. You may need to read it again.
 If you have any other questions, ask your doctor or pharmacist.
 This vaccine has been prescribed for your child. Do not pass it on to
others.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Act-HIB is and what it is used for.
Before Act-HIB is given.
How Act-HIB is given.
Possible side effects.
How to store Act-HIB.
Further information
WHAT Act-HIB IS AND WHAT IT IS USED FOR

Act-HIB is a vaccine. It is used to protect against diseases caused by a bacteria
called Haemophilus influenzae type b.
These diseases include:
 Meningitis - swelling of the outer covering of the brain. This can cause
high temperature, very severe headaches, twitching of the muscles in the
neck and back, a rash, fits, being sick and delirium. It can sometimes be
fatal.
 Sepsis - a very serious generalised infection of the body. This can cause
high temperature and low blood pressure. This may lead to fainting.
 Cellulitis - redness and swelling of the skin and the tissues under the skin.
This also occurs when a cut has become infected.
 A type of arthritis (swelling of the joints), that is often associated with a
high temperature..The larger joints (e.g. knee, elbow, shoulder, hip) are
usually affected, these joints become swollen and painful.
 Epiglottitis - swelling of part of the back of the throat. This can cause
difficulty in swallowing and breathing.

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Act-HIB is used to prevent your child from getting these diseases by protecting
them against these diseases before they come into contact with the bacteria.
Important information about the protection provided
• Act-HIB will only help prevent these diseases if they are caused by the
bacteria Haemophilus influenzae type b. Your child could still get these
diseases if they are caused by another bacteria or a virus.
• Although Act-HIB contains tetanus protein, this vaccine will not protect
your child against tetanus, and they will still need routine tetanus
vaccination.
2.

BEFORE Act-HIB IS GIVEN

Act-HIB must not be given to your child if they:
• have ever had an allergic reaction to a previous injection of Act-HIB, to any of
the ingredients in Act-HIB (see section 6 for information on the other
ingredients), or to formaldehyde (which may be present in the vaccine in
undetectable trace amounts).
 are allergic to any other vaccine against Haemophilus influenzae type b. (An
allergic reaction can include a generalised skin rash, swelling of the face and
throat, difficulty in breathing, blue discoloration of the tongue or lips, low blood
pressure and fainting).
• have an infectious illness at the moment (e.g. temperature, sore throat,
cough, cold or flu). Usually, vaccination will be delayed until after your child
has recovered.
Tell your doctor or nurse if any of the statements above apply to your child. If you
are unsure about anything or if there is anything you do not understand, ask your
doctor or nurse to explain.
Take special care
Tell your doctor before the vaccination if:
 your child has any blood disorders such as haemophilia (a condition where
you bruise or bleed easily), because he or she may get bleeding where they
are injected
 you have been told by your doctor that your child is intolerant to some sugars
as this vaccine contains sucrose (a type of sugar).
Pregnancy and breast feeding
This vaccine is not intended to be given to women of child-bearing age.
Using other medicines or vaccines
Please tell your doctor, nurse or pharmacist if your child is taking or has recently
taken any other medicines (including medicines obtained without a prescription)
or has recently received any other vaccines.

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Act-HIB can be given at the same time as other vaccines such as
 diphtheria, tetanus, pertussis (whooping cough) and inactivated polio
vaccine
 measles, mumps and rubella (German measles) vaccine
 meningococcal serogroup C conjugate vaccine
 hepatitis B vaccine
but will be injected into a different part of the body.
The immune response to this vaccine may be reduced if your child is receiving
immunosuppressive treatment such as corticosteroids, cytotoxic drugs or
radiotherapy.
Important information about some of the ingredients
Act-HIB contains less than 1 mmol sodium (23mg) per dose i.e. essentially
‘sodium-free’.
3.

HOW ACT-HIB IS GIVEN

Act-HIB is for children over 2 months of age up to their fifth birthday.
Although this vaccine can be given to children of any age, it would not normally
be given to those over 4 years of age as they are likely to already have naturally
developed protection against diseases caused by Haemophilus influenzae type
b.
The vaccination should be given in a suitable place where the staff are equipped
to deal with any uncommon severe allergic reaction.
Your nurse or doctor will prepare the vaccine and shake it well before injecting a
small amount (0.5 millilitre) into a muscle or deep under the skin. This will usually
be into the outer part of the upper leg or arm.
Act-HIB can be mixed with either adsorbed diphtheria, tetanus and pertussis
vaccine or with TETRAVAC (Diphtheria, tetanus, pertussis (acellular,
component) and poliomyelitis (inactivated) vaccine, adsorbed) and then be given
as one single injection. Your doctor or nurse will give your child the combined
vaccines as soon as they are mixed
The first course of vaccination
If your child is under 12 months and has never had vaccination against
Haemophilus influenzae type b before, he or she will need three injections of ActHIB, with an interval of at least four weeks between each injection.

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Use in children 12 months and over
A single dose of Act-HIB may be given to children who are 12 months and over
and who have not received a vaccine against Haemophilus influenzae type b
before (children over 12 months need only one dose of vaccine to provide full
protection).
Such children can be given Act-HIB at the same time as measles, mumps and
rubella (German measles) vaccine, but it should be injected into a different part
of the body.
Booster dose
Sometimes an additional dose of Act-HIB is given to children who have had a full
course of vaccinations already. The extra dose is intended to increase (boost)
immunity.
What to do if your child misses a dose of Act-HIB
If a dose is missed, your doctor will advise you on when your child should have
the remaining injection(s).
4.

POSSIBLE SIDE-EFFECTS

Like all vaccines, Act-HIB can cause side effects, although not everybody gets
them.
Serious allergic reactions
If any of these symptoms occur after leaving the place where your child
received his/her injection, you must consult a doctor IMMEDIATELY.
Serious allergic reactions are a very rare possibility (affects less than 1 user in
10,000) after receiving any vaccine. These reactions may include:
 difficulty in breathing
 blueness of the tongue or lips
 a rash
 swelling of the face or throat
 low blood pressure causing dizziness or collapse
When these signs or symptoms occur they usually develop quickly after the
injection is given and while the child is still in the clinic or doctor’s surgery.
Other side effects
If your child experiences any of the following side effects and it gets
serious or if you notice any side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.

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Very common reactions (affects more than 1 user in 10):
 decreased appetite
 irritability
 drowsiness
 pain at the injection site
 injection site redness
 swelling at the injection site
 a hard lump under the skin at the injection site
Common reactions (affects 1 to 10 users in 100):
 abnormal or uncontrollable crying
 vomiting
 fever (temperature above 38°C)
Uncommon reactions (affects 1 to 10 users in 1000):
 fever (above 39°C)
The following additional side effects have been reported during the commercial
use of Act-HIB:
 allergic reactions
 headache
 a fit (convulsion) with or without fever
 floppiness or decreased muscle tone
 skin reactions: wheals (itchy, lumpy skin rash), rash, itching of the skin,
skin redness
 swelling of the face and/or throat
 swelling of one or both lower limbs which is often associated with
blueness, redness, severe crying and sometimes a purple spotted rash of
the legs; this usually disappears within 24 hours without treatment.
 Redness and swelling of 5 cm or more at the site of the injection
 Extensive swelling of vaccinated limb
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of
this medicine.

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5.

HOW TO STORE Act-HIB

Your doctor or nurse will usually store the vaccine before it is used. They will
make sure that the vaccine is stored in a refrigerator between +2°C and +8°C.
Your doctor or nurse should check that the vaccine is not used after the ‘Expiry’
date on the box.
The vaccine should be shaken well before use. Your doctor or nurse should
check that the vaccine is not discoloured and does not contain large particles and
should use it within one hour of being prepared for use.
Your doctor or nurse should make sure that the vaccine is kept out of the reach
and sight of children.
6.

FURTHER INFORMATION

Each 0.5 millilitre dose of the vaccine contains at least 10 micrograms of the
active ingredient which is part (the capsular polysaccharide) of the Haemophilus
influenzae type b bacteria. This active ingredient has been attached to between
18 and 30 micrograms of a harmless part of the bacteria that causes tetanus.
There are also some inactive ingredients; these are trometamol and sucrose
(sugar). The vaccine is prepared by mixing with water for injections and sodium
chloride (salt) solution.
Act-HIB is available as a single dose pack containing a vial (a small glass
container) of freeze-dried vaccine plus a prefilled syringe of solvent (sodium
chloride solution).
Act-HIB is made by Sanofi Pasteur S.A., Campus Mérieux, 1541 avenue Marcel
Mérieux, F-69280, Marcy l’Etoile, Lyon, France.
The company licensed to sell Act-HIB in the UK is Sanofi Pasteur Europe, 2
Avenue Pont Pasteur, 69007 Lyon, France.
This leaflet was last revised in
®

Registered trademark

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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