MENINGOCOCCAL POLYSACCHARIDE VACCINE A+C

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

NEISSERIA MENINGITIDIS A,ΠΟΛΥΣΑΚΧΑΡΊΤΗ, ΜΗΝΙΓΓΙΤΙΔΌΚΟΚΚΟΣ C,ΠΟΛΥΣΑΚΧΑΡΊΤΗ

Διαθέσιμο από:

SANOFI PASTEUR.

Φαρμακολογική κατηγορία (ATC):

J07AH03

INN (Διεθνής Όνομα):

NEISSERIA MENINGITIDIS A,POLYSACCHARIDE, NEISSERIA MENINGITIDIS C,POLYSACCHARIDE

Δοσολογία:

100MCG

Φαρμακοτεχνική μορφή:

POWDER & SOLVENT FOR SUSPENSION FOR INJECTION

Σύνθεση:

8000000697 - NEISSERIA MENINGITIDIS A,POLYSACCHARIDE - 50 UG; 8000000698 - NEISSERIA MENINGITIDIS C,POLYSACCHARIDE - 50 UG

Οδός χορήγησης:

INTRAMUSCULAR USE, ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ

Τρόπος διάθεσης:

Με Ιατρική Συνταγή

Θεραπευτική περιοχή:

MENINGOCOCCUS, BIVALENT PURIFIED POLYSACC. ANTIGEN

Περίληψη προϊόντος:

01 - 1 VIAL WITH POWDER AND 0.5ML DILUENT IN PRE-FILLED SYRINGE - 1 - VIAL - 900000301 - Εγκεκριμένο

Φύλλο οδηγιών χρήσης

POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE
POWDER AND DILUENT FOR SUSPENSION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED.
Keep this leaflet until you have completed the vaccination schedule.
You may need to read it
again.
Follow carefully the advice of your doctor or nurse. Ask your doctor
or your nurse if you need
more information or advice.
Make sure you complete the full vaccination schedule. Otherwise you
may not be fully
protected
_The active substances are: _polysaccharide of _Neisseria meningitidis
_group A (50 micrograms
for one dose of 0.5 mL) and polysaccharide of _Neisseria meningitidis
_group C (50
micrograms for one dose of 0.5 mL).
_The other ingredients are: _powder: monohydrate lactose. Diluent:
sodium chloride, disodium
phosphate dihydrate, monosodium phosphate and water for injection.
MARKETING AUTHORIZATION HOLDER
SANOFI PASTEUR 14 Espace Henry Vallée, 69007 Lyon – France
MANUFACTURER
SANOFI PASTEUR 14 Espace Henry Vallée, 69007 Lyon - France
SANOFI AVENTIS Zrt - 1225 Budapest - Campona u. I. (Harbor park)
- Hungary
1. WHAT POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE IS AND WHAT
IT IS USED FOR
This medicinal product is a vaccine in the form of powder and diluent
for suspension for
injection (1 or 10 doses of 0.5 mL).
POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE is used to prevent diseases
caused by the bacterium _Neisseria meningitidis _(meningococcus) group
A or C in adults and
in children from the age of two years. This vaccine helps your body
create its own protection
(antibodies) against this bacterium.
Group A or C meningococcus may provoke serious and sometimes lethal
infections, such as
meningitis or septicaemia (generalised infection).
This vaccine only protects against the meningococcal bacterium from
groups A or C. It does
not protect against other groups of meningococci or other organisms
responsible for
meningitis or septicaemia (generalised infection).
2. BEFORE YOU USE POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE
Do not use POLYSACCHARIDE MENINGOCOCCAL A+C VA

Αρχείο Π.Χ.Π.

1 N
AME OF THE MEDICINAL PRODUCT
Polysaccharide Meningococcal A+C Vaccine
Powder and diluent for suspension for injection in pre-filled syringe
2 Q
UALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.5 ml) of reconstituted vaccine contains:
Polysaccharide of _Neisseria meningitidis _group A
........................ 50 micrograms
Polysaccharide of _Neisseria meningitidis _group
C.......................... 50 micrograms
For the excipients, refer to 6.1.
3 P
HARMACEUTICAL FORM
Powder and diluent for suspension for injection in pre-filled syringe
4 C
LINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This vaccine is indicated for active immunisation against the invasive
forms of serogroup A and C
meningococcal infections in adults and in children from the age of two
onwards (see section 4.4).
The use of the MENINGOCOCCAL POLYSACCHARIDE A+C VACCINE should be
based on
official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from the age of two years onwards: one single dose
(0.5 mL) of reconstituted
vaccine.
Revaccination is indicated within 2 to 4 years according to the
patient’s age at the time of the first
dose, the risk of exposure, and the serogroup involved.
Method of administration:
The vaccine should be administered by intramuscular or subcutaneous
route.
Administration is generally done into the antero-lateral aspect of the
thigh muscle in children up
to the age of 12 months, and in the shoulder muscle after this age.
This vaccine should in no circumstances be mixed with other vaccines
or other medicinal
products (see section 6.2).
Separate syringes and separate injection sites should be used in case
of concomitant injections.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any excipients of this
vaccine or severe reaction
after a previous injection of the vaccine.
Vaccination should be postponed in case of high fever or acute
illness.
4.4
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Do not inject via the intravascular route: ensure that the needle does
not pene