ACT-HIB 10MCG/0.5ML POWDER & SOLVENT FOR SOLUTION FOR INJECTION

Negara: Siprus

Bahasa: Yunani

Sumber: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Bahan aktif:

HAEMOPHILUS INFLUENZAE TYP B POLYSACCHARID

Tersedia dari:

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

Kode ATC:

J07AG01

INN (Nama Internasional):

HEMOPHILUS INFLUENZA B, PURIFIED ANTIG.CONJUGATED

Dosis:

10MCG/0.5ML

Bentuk farmasi:

POWDER & SOLVENT FOR SOLUTION FOR INJECTION

Komposisi:

HAEMOPHILUS INFLUENZAE TYP B POLYSACCHARID (8000031698) 10UG

Rute administrasi :

INTRAMUSCULAR USE; ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ

Jenis Resep:

Εθνική Διαδικασία

Area terapi:

HEMOPHILUS INFLUENZA B, PURIFIED ANTIG.CONJUGATED

Ringkasan produk:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL POWDER & 1 PRE-FILLED SYRINGE SOLVENT (930028801) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ACT-HIB 10 MICROGRAMS/0.5 ML, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION IN PRE-FILLED
SYRINGE
_HAEMOPHILUS _TYPE B CONJUGATE VACCINE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5-mL dose of reconstituted vaccine contains:
_Haemophilus influenzae _type b
polysaccharide…………………………10 micrograms
Conjugated to tetanus
protein……………………………………………18 - 30
micrograms
Act-HIB may contain traces of formaldehyde used during the
manufacturing process (see
section 4.3)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White powder in vial and colourless solvent in pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This vaccine is indicated for the prevention of _Haemophilus
influenzae _type b invasive infections
(meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.)
in children from the age of 2 months.
This vaccine does not protect against infections due to other types of
_Haemophilus influenzae _or
against meningitis of other origins.
Under no circumstances can the tetanus protein contained in this
vaccine be used to replace the usual
tetanus vaccination.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
P
o
s
o
l
o
gy
•
Before 6 months of age, 3 successive doses of 0.5 ml administered one
or two months apart,
followed by a booster injection (fourth dose) one year after the third
injection.
•
Between 6 and 12 months of age, 2 doses of 0.5 ml administered one
month apart, followed by
a booster injection (0.5 ml) at 18 months of age.
•
From 1 to 5 years of age, a single dose of 0.5 ml.
For contact cases: in the event of a contact with a patient presenting
with invasive _Haemophilus _
_influenzae _type b infection (family or childcare), vaccination
should be implemented as per the
appropriate age schedule according to the official recommendations.
The index case must also be vaccinated.
Method of admin