Pneumo 23 solution for injection in a pre-filled syringe. Polysaccharide pneumococcal vaccine.

Riik: Malta

keel: inglise

Allikas: Malta Medicines Authority

Toimeaine:

STREPTOCOCCUS PNEUMONIAE

Saadav alates:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC kood:

J07AL01

INN (Rahvusvaheline Nimetus):

STREPTOCOCCUS PNEUMONIAE 25 µg

Ravimvorm:

SOLUTION FOR INJECTION

Koostis:

STREPTOCOCCUS PNEUMONIAE 25 µg

Retsepti tüüp:

POM

Terapeutiline ala:

VACCINES

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2007-01-18

Infovoldik

3. HOW TO USE PNEUMO 23?
POSOLOGY:
– primary vaccination: One 0.5 ml injection,
– revaccination: One 0.5 ml injection.
MODE AND ROUTE OF ADMINISTRATION:
The preferred route of administration is intramuscular (IM) or
subcutaneous
(SC).
In all cases, follow your doctor’s prescription strictly.
4. POSSIBLE SIDE EFFECTS
LIKE ALL MEDICINES, PNEUMO 23 CAN HAVE SIDE EFFECTS IN CERTAIN
PERSONS:
– local reactions at the injection site: pain, erythema (redness),
induration and
oedema (swelling). These reactions are mild and transient,
– rare reactions such as the Arthus phenomenon (severe local
reactions) are
reversible without after-effects; they mainly occur in subjects with
high
initial levels of pneumococcal antibody,
– moderate and transient hyperthermia (fever) sometimes
above 39°C which
generally occurs very shortly after vaccination and resolves within
24 hours, 
– other general reactions: adenopathy (inflammation of the lymph
nodes),
rashes, arthralgia (pain in the joints) and allergic reactions
(urticaria,
Quincke'soedema [type of urticaria with sudden swelling of the face
and
neck], anaphylactoid reactions [severe allergic reaction]),
headaches, muscle
pain, malaise, and fatigue have exceptionally been reported.
_IF YOU NOTICE ANY SIDE EFFECTS NOT MENTIONED IN THIS LEAFLET, PLEASE_
_INFORM YOUR DOCTOR OR PHARMACIST._
5. STORING PNEUMO 23
Keep out of the reach and sight of children.
Store between + 2°C and + 8°C (in a refrigerator). Do not freeze.
Unused product or waste materials must be disposed of as per
regulations in
force.
Do not use after the expiry date stated on the label and the box.
THIS LEAFLET WAS LAST APPROVED ON 02/04
PNEUMO 23
VACUNA
NEUMOCÓCCICA
POLISACÁRIDA
SOLUCIÓN INYECTABLE EN JERINGA
PRELLENADA
_Los principios activos son: _Polisacáridos de _Streptococcus
pneumoniae_, serotipos
1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C,
19A, 19F, 20,
22F, 23F, 33F) (25 microgramos de cada uno de los 23 serotipos / para
una
dosis de 0,5 ml)
_Los de

Toote omadused

Page 1 of 4 
 SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 
PNEUMO 23, solution for injection in a pre-filled syringe 
Polysaccharide pneumococcal vaccine  

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
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.  
•  subjects over 65 years of age, particularly elderly persons
living in institutions,  
•  weakened immunocompetent subjects or subjects who
are likely to be frequently hospitalized 
(diabetes, chronic bronchitis, respiratory failure, heart
failure, history of alcohol/tobacco 
dependence, etc.),  
•  immunocompromised subjects: splenectomized subjects, subjects
with sickle cell disease, 
nephrotic syndrome, 
•  subjects with cerebrospinal fluid leaks.  
It should be noted that recurrent upper
respiratory tract infections, particularly otitis media and 
sinusitis, are not indications for pneumococcal vaccination.  
4.2. POSOLOGY AND METHOD OF ADMINISTRATION 
_POSOLOGY _
•  Primary vaccination: One 0.5-ml injection 
•  Revaccination: One 0.5-ml injection  
Revaccination is recommended every 3 to 5 years for
subjects at a high risk of pneumococcal 
infection. 
_METHOD OF ADMINISTRATION _
The preferred route of administration is intramuscular (IM)
although the vaccine may also be given 
subcutaneously (SC