PNEUMO 23

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

STREPTOCOCCUS PNEUMONIAE

Διαθέσιμο από:

MEDICI MEDICAL LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

J07AL01

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

STREPTOCOCCUS PNEUMONIAE 25 MCG / 0.5 ML

Οδός χορήγησης:

I.M, S.C

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

SANOFI PASTEUR S.A., FRANCE

Θεραπευτική ομάδα:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN

Θεραπευτική περιοχή:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN

Θεραπευτικές ενδείξεις:

Prevention of pneumococcal infections, particularly of the respiratory type, in patients presenting an increased risk over the age of 2 years.

Ημερομηνία της άδειας:

2014-10-31

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
PNEUMO 23, solution for injection in prefilled syringe
Polysaccharide pneumococcal vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_SINGLE DOSE PRESENTATION_
Polysaccharides of Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5,
6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,
17F, 18C, 19A, 19F, 20, 22F, 23F, 33F
25 µg for each of the 23 serotypes,
Per 0.5 ml
Cf. 6.1 for the excipients.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
The vaccine is indicated for the prevention of pneumococcal
infections, in particular pneumonia, caused by the
serotypes contained in the vaccine, for subjects at risk, from the age
of 2 years People at risk who should be
vaccinated are determined in accordance with official recommendations.
The safety and efficacy of the vaccine have not been established in
children under 2 years of age in whom the
antibody response may be limited.
This vaccine is not efficacious in the prevention of acute otitis
media, sinusitis and other common infections of
the upper respiratory tract.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
Adult population
Primary vaccination: injection of a dose of 0.5 ml.
Revaccination: injection of a dose of 0.5 ml.
Paediatric population
The posology used for the paediatric population is the same as that
used for the adult population.
_REVACCINATION_
On the basis of current knowledge, the systematic revaccination of
subjects who have received primary vaccination
is not recommended. The timescale and need for revaccination should be
determined in accordance with official
recommendations.
_METHOD OF ADMINISTRATION_
Administration by the intramuscular (IM) route is preferable. The
subcutaneous (SC) route may also be used.
4.3. CONTRAINDICATIONS
Known hypersensitivity to any of the components of the vaccine or
previous hypersensitivity following the injection
of the same vaccine or a vaccine with a similar composition.
As with other vaccines, the administratio