PENTAXIM POWDER & SUSPENSION FOR SUSPENSION FOR INJECTION

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

DIPHTHERIA TOXOID; POLIOMYELITIS VIRUS TYPE 3; TETANUS TOXOID; PERTUSSIS TOXOID(PT); FILAMENTOUS HAEMAGGLUTININ (FHA); POLIOMYELITIS VIRUS TYPE 2; POLIOMYELITIS VIRUS TYPE 1; HAEMOPHILUS INFL. TYPE B POLYS.CONJ.T.TOXOID

Διαθέσιμο από:

SANOFI PASTEUR. (0000010487) 14 ESPACE HENRY VALLEE, LYON, 69007

Φαρμακολογική κατηγορία (ATC):

J07CA06

INN (Διεθνής Όνομα):

DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS

Φαρμακοτεχνική μορφή:

POWDER & SUSPENSION FOR SUSPENSION FOR INJECTION

Σύνθεση:

DIPHTHERIA TOXOID (8000000804) 0IU; POLIOMYELITIS VIRUS TYPE 3 (8000000485) 32DU; TETANUS TOXOID (8000040440) 0IU; PERTUSSIS TOXOID(PT) (8000001811) 25MCG; FILAMENTOUS HAEMAGGLUTININ (FHA) (8000001813) 25MCG; POLIOMYELITIS VIRUS TYPE 2 (8000000484) 8DU; POLIOMYELITIS VIRUS TYPE 1 (8000000483) 40DU; HAEMOPHILUS INFL. TYPE B POLYS.CONJ.T.TOXOID (8000001810) 10MCG

Οδός χορήγησης:

INTRAMUSCULAR USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή; 1 VIAL WITH POWDER AND 0.5ML SUSPENSION IN PRE-FILLED SYRINGE WITH 2 SEPARATE NEEDLES (230008801) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

ANNEX IIIB
PACKAGE LEAFLET
PENTAXIM, POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION IN
PREFILLED SYRINGE.
DIPHTHERIA,
TETANUS,
PERTUSSIS
(ACELLULAR,
COMPONENT),
POLIOMYELITIS
(INACTIVATED) VACCINE AND _HAEMOPHILUS _TYPE B CONJUGATE VACCINE,
ADSORBED
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GET YOUR CHILD
VACCINATED.

Keep this leaflet. You may need to read it again.

If you have any further questions. If you have a doubt, ask your
doctor or pharmacist.

This medicine has been prescribed for your child only. Never pass it
on to others.

If any of the side effects get serious or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist. See Section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT PENTAXIM IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PENTAXIM
3. HOW TO USE PENTAXIM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PENTAXIM
6. FURTHER INFORMATION
1.
WHAT PENTAXIM IS AND WHAT IT IS USED FOR
Pentaxim is a vaccine. Vaccines are used to protect against infectious
diseases.
When PENTAXIM is injected, the body’s natural defences develop a
protection against those disease.
PENTAXIM is indicated to help protect your child against diphtheria,
tetanus, pertussis, poliomyelitis and against
invasive infections due to the _Haemophilus influenzae _type b
bacterium (such as meningitis, blood poisoning, etc.)
PENTAXIM is indicated in children from the age of 2 months.
It does not protect against infections caused by other types of
_Haemophilus influenzae _or against meningitis due to
other micro-organisms.
1.
WHAT YOU NEED TO KNOW BEFORE YOU USE PENTAXIM
NEVER USE PENTAXIM:

if your child is allergic (hypersensitive):
-
to any of the vaccine components (listed in Section 6. “What
PENTAXIM” contains”),
-
to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during
the manufacturing process and
which may be present as traces),
-
to a pertussis vaccine (acellular or “whole cell”),

if your child had an allergic reaction after a prev

Αρχείο Π.Χ.Π.

1. NAME OF THE MEDICINAL PRODUCT
PENTAXIM, POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION IN
PREFILLED SYRINGE
DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), POLIOMYELITIS
(INACTIVATED) VACCINE AND
HAEMOPHILUS TYPE B CONJUGATE VACCINE, ADSORBED
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution one dose (0.5 ml) contains:
Diphtheria toxoid
(1)
.......................................................................................................................
≥ 30
IU Tetanus toxoid
(1)
..........................................................................................................................
≥ 40
IU _Bordetella pertussis _antigens:
Pertussis toxoid
(1)
............................................................................................................25
micrograms
Filamentous haemagglutinin
(1)
........................................................................................25
micrograms
Poliomyelitis virus (inactivated)
- type 1 (Mahoney strain)
....................................................................................................
40 DU
(2) (3) (4)
- type 2 (MEF-1 strain)
..........................................................................................................
8 DU
(2) (3) (4)
- type 3 (Saukett strain)
......................................................................................................
32 DU
(2) (3)
(4)
Polysaccharide of _Haemophilus influenzae _type b
..........................................................10
micrograms conjugated to the tetanus
protein................................................................................
18-30
micrograms
(1)
adsorbed on aluminium hydroxide,
hydrate.......................................................................
0.3 mg
Al
3+ (2)
DU: D antigen unit.
(3)
or equivalent antigenic quantity determined by a suitable
immunochemical method.
(4)
produced on VERO cells.
PENTAXIM may contain traces of glutaraldehyde, neomycin, streptomycin
and polymyxin B (see S