Menitorix powder and solvent for solution for injection. Haemophilus type b and Meningococcal group C conjugate vaccine

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Conjugate of haemophilus influenzae type b capsular polysaccharide (polyribosylribitol phosphate) and tetanus; Conjugate of neisseria meningitides c capsular polysaccharide and tetanus toxoid (mean tt/ps ratio :1)

Dostupné s:

GlaxoSmithKline (Ireland) Limited

ATC kód:

J07AG53

INN (Mezinárodní Name):

Conjugate of haemophilus influenzae type b capsular polysaccharide (polyribosylribitol phosphate) and tetanus; Conjugate of neisseria meningitides c capsular polysaccharide and tetanus toxoid (mean tt/ps ratio :1)

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 meningococcus C, conjugated

Stav Autorizace:

Marketed

Datum autorizace:

2008-02-15

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
MENITORIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
_Haemophilus _
type b and
_Meningococcal_
group C conjugate vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING
THIS VACCINE BECAUSE 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, pharmacist or
nurse.
-
This vaccine has been prescribed for your child only. Do not pass it
on to others.
-
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 Menitorix is and what it is used for
2.
What you need to know before your child receives Menitorix
3.
How Menitorix is given
4.
Possible side effects
5.
How to store Menitorix
6.
Contents of the pack and other information
1.
WHAT MENITORIX IS AND WHAT IT IS USED FOR
Menitorix is a vaccine that can be given to children after the age of
2 months up to 2 years to prevent
infectious diseases 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 Hib and
MenC.

_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.

_NEISSERIA MENINGITIDIS _GROUP C (MENC):
Like Hib bacteria, MenC bacteria most frequently
cause meningitis. They may also cause severe blood infections and
sp

Charakteristika produktu

Health Products Regulatory Authority
10 January 2020
CRN009K0V
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Menitorix powder and solvent for solution for injection. Haemophilus
type b and Meningococcal group C conjugate vaccine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, each 0.5 ml dose contains:
​
_Haemophilus _type b polysaccharide
(polyribosylribitol phosphate)
5 micrograms
conjugated to tetanus toxoid as carrier protein
12.5 micrograms
_Neisseria meningitidis_ group C (strain C11) polysaccharide
5 micrograms
conjugated to tetanus toxoid as carrier protein
5 micrograms
Excipient with known effect:
This product contains sodium 75 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
White powder and a clear colourless solvent.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunization of infants from the age of 2 months and toddlers
up to the age of 2 years for the prevention of invasive
diseases caused by _Haemophilus influenzae_ type b (Hib) and
_Neisseria meningitidis_ group C (MenC).
See also section 4.4.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Menitorix should be used in accordance with official recommendations.
_Primary vaccination in infants:_
Alternative vaccination schedules in infants are available with
Menitorix.
_Three-dose primary series_
The vaccination schedule consists of three primary doses, each of 0.5
ml, which should be administered from 2 months up to
12 months of age with an interval of at least 1 month between doses
(see section 5.1).
_Two-dose primary series_
The vaccination schedule, consisting of two primary doses, each of 0.5
ml, may be given from 3 months up to 12 months of
age with an interval of at least 2 months between doses (see section
5.1).
_Preterm infants born between 25 weeks and 36 weeks of gestational
age_
Three primary doses, each of 0.5 ml, should be administered from 2
months up to