Hiberix powder & diluent for sol for inj; Haemophilus influenzae type b (Hib) conjugated vaccine

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HAEMOPHILUS INFLUENZAE, B, TETANUS TOXOID

Available from:

GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium

ATC code:

J07AG01

INN (International Name):

HAEMOPHILUS INFLUENZAE B 10 µg TETANUS TOXOID 25 µg

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Composition:

HAEMOPHILUS INFLUENZAE B 10 µg TETANUS TOXOID 25 µg

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Withdrawn

Authorization date:

2006-08-14

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
HIBERIX POWDER AND DILUENT FOR A SOLUTION FOR INJECTION
_Haemophilus influenzae_ Type b Conjugate Vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS
VACCINE AS IT
CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD.
•
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 only. Do not pass it
on to
others.
•
If your child gets side effects to talk to your doctor or pharmacist.
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 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 used to protect your child against the disease
caused by
_Haemophilus influenzae_ type b.
_Haemophilus influenzae _type b (Hib) may cause inflammation of the
brain. Serious
complications can be mental retardation, cerebral palsy, deafness,
epilepsy or partial
blindness. It may also cause inflammation of the throat, which may
lead to death by
suffocation. Less commonly, the bacteria can also infect the blood,
heart, lungs,
bones, joints, and tissues of the eyes and mouth.
Hiberix is indicated in the primary vaccination of children from 2
months of age
included in some of the following groups:
- Children with asplenia, sickle cell anemia or immunodeficiency.
- Children infected with asymptomatic or symptomatic HIV.
- In those situations determined by the corresponding Sanitary
Authorities.
Hiberix helps your child's body create its own protection
(antibodies). This will protect
him/her from the disease.
As with all vaccines, Hiberix may not fully protect all vaccinated
children.
Hiberix only protects against infections caused by _Haemophilus
influenzae_ type b, for
which the

Summary of Product characteristics

Page 1 of 7
1.
NAME OF THE DRUG PRODUCT
Hiberix powder and diluent for a solution for injection.
_Haemophilus influenzae_
type b (Hib) conjugated vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
_Haemophilus influenzae_
type b polysaccharide
10 micrograms
conjugated with tetanus toxoid as carrier protein
approx. 25 micrograms
Excipients with known effect
Sodium chloride
4.5 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and diluent for a solution for injection.
The powder is presented as a white pellet.
The diluent is a clear and colorless liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hiberix is indicated for the primary vaccination of children from 2
months of age included in
some of the following groups:
- Children with asplenia, sickle cell anemia or immunodeficiency.
- Children infected with asymptomatic or symptomatic HIV.
- In those situations determined by the corresponding Sanitary
Authorities.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The primary vaccination regimen consists of administering 3 doses of
Hiberix separated by an
interval of 2 months (between 4-8 weeks) in the first 6-7 months of
life and may start after 2
months of age.
If the administration of a dose is not carried out in accordance with
the expected schedule, the
administration of these doses can be delayed, provided that the 3
doses are administered
during the first year of life maintaining a 2-month interval (between
4 -8 weeks) between
doses.
Occasionally, it may be necessary to administer a booster dose in the
second year of life, as
for example in those children who have not completed the primary
vaccination.
Method of administration
Page 2 of 7
The reconstituted vaccine must be administered through intramuscular
injection. However,
for patients with thrombocytopenia or bleeding disorders, the
injection should be given
subcutaneously.
For instructions on reconstituting the drug product before
administration, see section 6.6.