Hiberix Vaccine. Haemophilus influenzae type b (Hib) vaccine.

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

HAEMOPHILUS INFLUENZAE B; TETANUS TOXOID

MAH:

Smithkline Beecham Limited

ATC_code:

J07AG01

INN:

HAEMOPHILUS INFLUENZAE B; TETANUS TOXOID

pharmaceutical_form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

composition:

HAEMOPHILUS INFLUENZAE B 25 µg; TETANUS TOXOID 25 µg

prescription_type:

POM

therapeutic_area:

VACCINES

authorization_status:

Authorised

authorization_date:

2006-08-14

PIL

Reason for update:
Removal of reference to diluents in vials
Agency Approval Date: 8/12/15
Text Date: 16/11/15
Text Issue and Draft No.: Issue 8 Draft 1
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 _Ha

SPC

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hiberix Vaccine
_Haemophilus influenzae_ type b (Hib) vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hiberix is a lyophilised vaccine of purified
polyribosyl-ribitol-phosphate capsular
polysaccharide (PRP) of Hib, covalently bound to tetanus toxoid.
The Hib polysaccharide is prepared from Hib, strain 20,752 and after
activation with
cyanogen bromide and derivatisation with adipic hydrazide spacer is
coupled to
tetanus toxoid via carbodiimide condensation. After purification the
conjugate is
lyophilised in the presence of lactose as a stabiliser.
Hiberix meets the World Health Organisation requirements for
manufacture of
biological substances of Hib conjugated vaccines.
_HIBERIX IS A WHITE POWDER. _
_THE DILUENT IS A CLEAR AND COLOURLESS LIQUID. _
Each 0.5 ml dose of the vaccine contains 10 micrograms of purified
capsular
polysaccharide of Hib covalently bound to approximately 25 micrograms
tetanus
toxoid.
3.
PHARMACEUTICAL FORM
Hib vaccine (lyophilised) for reconstitution.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Active immunisation against invasive disease caused by _Haemophilus
influenzae_
type b.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_PRIMARY SERIES _
Under 13 months of age:
Three 0.5ml doses, with an interval of at least four weeks between
doses, the first
dose to be given not earlier than two months of age.
Page 2 of 10
13 months of age and over:
A single 0.5ml dose.
_BOOSTER _
Following completion of a primary series in which one or more of the
three doses
consisted of Hiberix mixed with Infanrix, an additional (fourth) dose
of Hib conjugate
vaccine should be administered.
Children who were primed with Hiberix may be boosted with Hiberix or
with another
Hib conjugate vaccine. Similarly, Hiberix may be used to boost
children who were
primed with other Hib conjugate vaccines.
The timing of the Hib conjugate booster dose should be in accordance
with official
recommendations (see also section 5.1 Pharma