MENITORIX Combined Hib-MenC conjugate vaccine powder for injection vial plus diluent syringe

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Haemophilus influenza type B polyribose ribitol phosphate,Meningococcal polysaccharide group C,Tetanus toxoid

Dostopno od:

GlaxoSmithKline Australia Pty Ltd

INN (mednarodno ime):

Haemophilus influenza type B polyribose ribitol phosphate,Meningococcal polysaccharide group C,Tetanus toxoid

Status dovoljenje:

Registered

Navodilo za uporabo

1
MENITORIX
_Haemophilus influenza _type b Polyribose ribitol phosphate and group
C Meningococcal polysaccharide
conjugate vaccine
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you use
MENITORIX.
This leaflet answers some
common questions about
MENITORIX. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the expected benefits
of your child having
MENITORIX against the
possible risks.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT IS MENITORIX
USED FOR?
MENITORIX is a vaccine that
can be given to children to
prevent illness caused by_ _
_Haemophilus influenzae _type b
(Hib) and _Neisseria _
_meningitidis _group C (MenC)
bacteria. The vaccine works by
causing the body to produce its
own protection (antibodies)
against these bacteria. The
vaccine cannot cause these
serious diseases.

_HAEMOPHILUS INFLUENZAE _
TYPE B (HIB): Hib bacteria
most often cause meningitis
(inflammation of the
coverings of the brain and
spinal cord). Even after
recovery from Hib
meningitis there can be
problems from the illness
such as mental retardation,
spastic paralysis, deafness
or epilepsy. Hib infection
can also cause severe
swelling of the throat that
can cause severe breathing
problems (suffocation).
Less commonly, the
bacteria can infect other
parts of the body, such as
the lungs and the bones
and joints.

_NEISSERIA MENINGITIDIS _
GROUP C (MENC): Like Hib
bacteria, MenC bacteria
most often cause
meningitis. They may also
cause severe blood
infections and infect the
heart, throat and other
organs. Death from MenC
infections may be very
rapid.
As with all vaccines,
MENITORIX may not protect
all people who are vaccinated.
Also, MENITORIX does not
protect against meningitis
caused by other bacteria or
viruses, including other types
and grou

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION
MENITORIX (COMBINED HIB-MENC CONJUGATE) VACCINE, POWDER FOR
INJECTION VIAL PLUS DILUENT SYRINGE
1
NAME OF THE MEDICINE
_Haemophilus influenzae _type b Polyribose ribitol phosphate and
serogroup C Meningococcal
polysaccharide conjugate vaccine (Hib-MenC).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
_ _
_Haemophilus influenzae _type b Polyribose ribitol phosphate
5 micrograms
conjugated to tetanus toxoid as carrier protein
12.5 micrograms
Meningococcal polysaccharide Group C
5 micrograms
conjugated to tetanus toxoid as carrier protein
5 micrograms
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection
White powder in a glass vial, together with clear colourless diluent
in a pre-filled syringe
for a 1 dose vaccine.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MENITORIX is indicated for the prevention of invasive diseases caused
by _Haemophilus _
_influenzae_ type b (Hib) and _Neisseria meningitidis_ serogroup C
(MenC).
4.2
DOSE AND METHOD OF ADMINISTRATION
There are no data on immunogenicity, safety and reactogenicity of
MENITORIX administered
to pre-term infants born before 36 weeks gestation, nor in children
beyond the second year of
life.
MENITORIX is for intramuscular injection only, preferably in the
anterolateral thigh region. In
children 12 to 24 months of age, the vaccine may be administered in
the deltoid region (See
Section
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR
USE
and
Section
4.5
INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS).
MENITORIX
should
not
under
any
circumstances
be
administered
intravascularly
or
intradermally.
Primary vaccination in infants from 6 weeks up to 12 months of age:
2
Three doses, each of 0.5 mL, should be given with an interval of at
least 1 month between
doses.
Booster vaccination of children primed in infancy with Hib and MenC
conjugate vaccines:
A single (0.5 mL) dose of MENITORIX may be use