Hiberix. Haemophilus Type b (Hib) vaccine.Powder and Solvent for Solution for Injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Haemophilus influenzae type b polysaccharide; Conjugate of haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid

Dostupné s:

GlaxoSmithKline (Ireland) Limited

ATC kód:

J07AG51

INN (Mezinárodní Name):

Haemophilus influenzae type b polysaccharide; Conjugate of haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid

Dávkování:

0.5 millilitre(s)

Léková forma:

Powder and solvent for solution for injection

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

hemophilus influenzae B, combinations with toxoids

Stav Autorizace:

Not marketed

Datum autorizace:

1999-06-11

Informace pro uživatele

Hiberix
Haemophilus Type b (Hib) vaccine
Powder and Solvent for Solution for Injection
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, ask your doctor or
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 any side-effects talk to your doctor, pharmacist
or nurse. This includes any possible side-effects not listed
in this leaflet. See section 4.
What is 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 that can be given to children after the age of
2 months to prevent infectious diseases caused by_ Haemophilus _
_influenzae _type b (Hib) bacteria. The vaccine works by causing
the body to produce its own protection (antibodies) against these
bacteria. The vaccine cannot cause Hib.
_Haemophilus influenzae _type b (Hib): Hib bacteria most frequently
cause meningitis (inflammation of the coverings of the brain and
spinal cord). Even after recovery from Hib meningitis there can
be complications such as mental retardation, spastic paralysis,
deafness or epilepsy. Hib infection can also cause a life-threatening
inflammation of the throat with severe swelling that can cause
suffocation. Less commonly, the bacteria can infect other parts of
the body, particularly the lungs (causing pneumonia) and the bones
and joints.
Vaccination is the best way to protect against diseases caused by
Hib. Remember, however, that no vaccine can provide complete,
life-long protection in all people vaccinated. Also, Hiberix can
only protect against meningitis and other infections caused by_ _
_Haemophilus influenzae _type b (H

Charakteristika produktu

Health Products Regulatory Authority
10 January 2020
CRN009K0V
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hiberix. Haemophilus Type b (Hib) vaccine. Powder and Solvent for
Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hiberix is a lyophilized vaccine of purified
polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of
Haemophilus type b
covalently bound to tetanus toxoid.
Each 0.5 ml dose of the vaccine contains 10 micrograms of purified
capsular polysaccharide of Haemophilus type b covalently
bound to approximately 25 micrograms tetanus toxoid.
Excipients with a known effect:
This product contains sodium 77 micromol per dose (see section 4.4).
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Powder and Solvent for Solution for Injection.
Powder: white powder
Solvent: Clear colourless aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hiberix is indicated for active immunisation against disease caused by
_Haemophilus influenzae_ type b in infants from the age of
two months.
Hiberix does not protect against disease caused by other types of _H.
influenzae_ or against meningitis caused by other
organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The primary immunisation course should start at two months of age, and
consists of three doses with an interval of two
months between each dose.
Each dose consists of 0.5 ml of the vaccine by intramuscular
injection.
A single dose of Hib vaccine is recommended if the child presents
after age 13 months and has had no previous Hib vaccine.
_Booster dose_
A fourth, booster dose of vaccine should be administered, if this is
in accordance with official recommendations. Children who
were primed with Hiberix may be boosted with Hiberix or with another
Hib conjugate vaccine (monovalent or combined).
Similarly, Hiberix may be used to boost children who were primed with
other Hib conjugate vaccines (monovalent or
combined).
Method of administration
Health Products Regulatory A