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HIBERIX VACCINE

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

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Reason for update: GDS 09 – Update 1 – Response to RFI
Market: UK
Agency Approval Date:
Text Date: 26/09/2017
Text Issue and Draft No.: Issue 10 Draft 3

Patient leaflet: Information for the user
Hiberix
Haemophilus influenzae Type b (Hib) Vaccine
Read all of this leaflet carefully before your child receives/ you receive this
vaccine as it contains important information for you.





Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or your pharmacist.
This vaccine has been prescribed for your child/you only. Do not pass it on to
others. It may harm them.
If you get side effects talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

In this leaflet:
1. What Hiberix is and what it is used for
2. What you need to know before your child receives/you receive Hiberix
3. How Hiberix is given
4. Possible side effects
5. How to store Hiberix
6. Contents of the pack and other information
1. What Hiberix is and what it is used for
Hiberix is a vaccine containing a non-infectious extract (polysaccharide) of
Haemophilus influenzae type b (Hib). In order for the polysaccharide to be effective, it
is chemically linked to inactivated tetanus toxoid. The body responds to the vaccine
by making antibodies which will provide long-term protection against the diseases
caused by the bacteria.
Haemophilus influenzae type b most frequently causes meningitis, in which the
coverings of the surface of the brain become infected and inflamed. There can be
serious complications such as mental retardation, cerebral palsy, deafness, epilepsy
or partial blindness. Hib infection also causes inflammation of the throat and
occasionally 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 these diseases. This vaccine will only
protect your child against diseases caused by Haemophilus influenzae type b. Since
the national introduction of Haemophilus influenzae type b vaccine for young children
in 1992, the number of cases of illness in the UK has fallen dramatically. It is very
important for all young children to be vaccinated to maintain this reduction in the
number of cases, and so to save lives and prevent disability.
2. What you need to know before your child receives/you receive Hiberix
Do not take Hiberix:
• if your child has/you have previously had an allergic reaction to Hiberix, to any Hib
vaccine, to tetanus toxoid or to any other ingredients present in the vaccine (listed
in section 6)
• if your child/you have a fever or an infection
• if your child/you have ever been vaccinated against Haemophilus influenzae type b
and felt unwell following the vaccination

Reason for update: GDS 09 – Update 1 – Response to RFI
Market: UK
Agency Approval Date:
Text Date: 26/09/2017
Text Issue and Draft No.: Issue 10 Draft 3

Warnings and precautions:
Talk to your doctor, pharmacist or nurse before receiving Hiberix
 if your child/you have any bleeding or blood disorders
 if your child/you have any illness that may affect the immune system
 if your child/you taking medicines or having any treatment which may affect the
immune system
 if your child was born very prematurely (born ≤28 weeks of gestation), he/she may
have short episodes of breathing difficulties (longer gaps between breaths than
normal) for 2 or 3 days after vaccination. Your doctor will decide if your child
requires monitoring during this time.
Fainting can occur (mostly in adolescents) following, or even before any needle
injection. Therefore tell the doctor or nurse if you or your child fainted with a previous
injection.
Other medicines and Hiberix
Tell your doctor if your child is are taking, has recently taken or might take/you are
taking, have recently taken or might take any other medicines, including medicines
obtained without a prescription or has recently received any other vaccine.
Pregnancy, breast-feeding and fertility
Do not take this medicine if you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby. If pregnancy occurs during the course of
vaccination your doctor should be consulted.
Hiberix contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e.
essentially “sodium free”.
3. How Hiberix is given
0.5 ml of Hiberix is injected into a muscle.
If your child is less than 13 months old, the first vaccination should be given not
earlier than two months of age. Two further injections should then be given at least
one month apart.
If your child is aged over 13 months, only a single injection of Hiberix is needed for
protection.
If your child receives/you receive more Hiberix than he/she/you should
It is very unlikely that your child/you will receive too much or too little vaccine
because each dose is provided in a separate vial and the vaccine is given by a
doctor or nurse. If you are concerned about the dose or doses that have been given,
please talk to your doctor or nurse.
If you forget to take your child for vaccination with Hiberix
Your doctor or nurse will advise when your child should attend for these injections. If
you miss an appointment, it is very important that you contact the surgery or clinic
and make a new appointment for your child to have the missed dose or doses as
soon as possible.

Reason for update: GDS 09 – Update 1 – Response to RFI
Market: UK
Agency Approval Date:
Text Date: 26/09/2017
Text Issue and Draft No.: Issue 10 Draft 3

4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets
them. The following side effects may happen with this vaccine:
Allergic reactions
If your child has an allergic reaction, see your doctor straight away. The signs may
include:
 face swelling
 low blood pressure
 difficulty breathing
 skin going blue
 loss of consciousness.
These signs usually start very soon after the injection has been given. Take your
child to see a doctor straight away if they happen after leaving the clinic.
Side effects that occurred during clinical trials with Hiberix were as follows:
Very common (these may occur with more than 1 in 10 doses of the vaccine)
 irritability
 feeling sleepy
 fever
 swelling, pain and redness at the injection site
 loss of appetite
 unusual crying
 restlessness
 diarrhoea
Common (these may occur with up to 1 in 10 doses of the vaccine):
 vomiting
Rare (these may occur with up to 1 in 1000 doses of the vaccine):
 fits (including fits due to fever)
Side effects not observed in clinical trials but reported after commercialisation
of Hiberix include:
Frequency not known:
 fainting due to injection
 collapse (sudden onset of muscle floppiness), periods of unconsciousness or
lack of awareness, and paleness or bluish skin discoloration
 temporarily stopping breathing
 hives, rash
 large swelling of the injected limb
 hard lump at the injection site
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.

Reason for update: GDS 09 – Update 1 – Response to RFI
Market: UK
Agency Approval Date:
Text Date: 26/09/2017
Text Issue and Draft No.: Issue 10 Draft 3

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 Website www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Hiberix
Keep out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Protect from light.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the
environment.
6. Contents of the pack and other information
What Hiberix contains
-

The active substances are:
Haemophilus type b polysaccharide
10 micrograms
Conjugated to tetanus toxoid as carrier protein approximately 25 micrograms

-

The other ingredients are:
Powder: lactose
Solvent: sodium chloride, water for injections

What Hiberix looks like and contents of the pack
Powder for reconstitution
Hiberix is supplied as a white powder in a vial (Type I neutral glass) with stoppers
(bromobutyl rubber) and overcaps with flip-off tops (aluminium), containing one dose.
Solvent for reconstitution
The diluent (Sterile Saline Solution (0.9%)), when provided, is a clear and colourless
liquid in a glass ampoule or pre-filled syringe. The pre-filled syringe (Type I glass)
contains 0.5 ml, with a plunger stopper (rubber butyl).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SmithKline Beecham plc
Brentford
Middlesex
TW8 9GS

Reason for update: GDS 09 – Update 1 – Response to RFI
Market: UK
Agency Approval Date:
Text Date: 26/09/2017
Text Issue and Draft No.: Issue 10 Draft 3

Manufacturer
GlaxoSmithKline Biologicals s.a.
89 rue de l’Institut
1330 Rixensart
Belgium
This leaflet was last revised in September 2017
Trade marks are owned by or licensed to the GSK group of companies
© 2017 GSK group of companies or its licensor.
---------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals
only.
Instructions for use
The following information is intended for medical or healthcare professionals only:
The diluent and reconstituted vaccine should be inspected visually for any foreign
particulate matter and/or variation apperance of prior to administration. If either is
observed, do not adminster the vaccine
I
Instructions for reconstitution of the vaccine with the diluent presented in prefilled syringe
Hiberix must be reconstituted by adding the entire content of the pre-filled syringe of
diluent to the vial containing the powder.
To attach the needle to the syringe, refer to the drawing below. However, the syringe
provided with Hiberix might be slightly different than the syringe described in the
drawing.

1. Holding the syringe barrel in one hand (avoid holding the syringe plunger),
unscrew the syringe cap by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe
until you feel it lock (see picture).
3. Remove the needle protector, which on occasion can be a little stiff.

Reason for update: GDS 09 – Update 1 – Response to RFI
Market: UK
Agency Approval Date:
Text Date: 26/09/2017
Text Issue and Draft No.: Issue 10 Draft 3

Add the diluent to the powder. After the addition of the diluent to the powder, the
mixture should be well shaken until the powder is completely dissolved in the diluent.
The reconstituted vaccine is a clear to opalescent and colourless solution.
After reconstitution, the vaccine should be used promptly.
A new needle should be used to administer the vaccine.
Withdraw the entire contents of the vial.

Any unused product or waste material should be disposed of in accordance with local
requirements.

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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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