Pneumovax 23 Solution for Injection in pre-filled syringe; Pneumococcal Polysaccharide Vaccine

País: Malta

Idioma: inglés

Fuente: Medicines Authority

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Información para el usuario (PIL)

27-06-2023

Ficha técnica (SPC)

27-06-2023

Ingredientes activos:

PNEUMOCOCCAL POLYSACCHARIDE, SEROTYPE, CONJUGATED TO, CRM, B CONJUGATED, TO CRM, F CONJUGATED, N CONJUGATED, V CONJUGATED, A CONJUGATED

Disponible desde:

Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands

Código ATC:

J07AL01

Designación común internacional (DCI):

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 25 µg PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2 CONJUGATED TO CRM197 25 µg

formulario farmacéutico:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Composición:

tipo de receta:

POM

Área terapéutica:

VACCINES

Estado de Autorización:

Authorised

Fecha de autorización:

2018-12-19

Información para el usuario

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PNEUMOVAX 23 SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Pneumococcal Polysaccharide Vaccine
For adults and children 2 years and above.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE
THIS VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
This vaccine has been prescribed for you or your child. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as yours or your
child's.
•
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
_ _
1.
What PNEUMOVAX 23 is and what it is used for
2.
What you need to know before you or your child use PNEUMOVAX 23
3.
How to use PNEUMOVAX 23
4.
Possible side effects
5.
How to store PNEUMOVAX 23
6.
Contents of the pack and other information
1.
WHAT PNEUMOVAX 23 IS AND WHAT IT IS USED FOR
PNEUMOVAX 23 is a pneumococcal vaccine. Vaccines are used to protect
you or your child against
infectious diseases. Your doctor has recommended that you or your
child (two years of age and older)
have the vaccine
_ _
to help protect against severe infections caused by bacteria that are
called
pneumococci.
Pneumococci can cause infections of the lungs (especially pneumonia)
and of the coverings over the
brain and spinal cord (meningitis) and in the blood (bacteraemia or
septicaemia). The vaccine
_ _
will
only be able to protect you or your child against pneumococcal
infections that are due to the types of
these bacteria that are included in the vaccine. However, the 23
pneumococcal types in the vaccine
include those that cause almost all (about nine out of ten) infections
caused by pneumococci.
When the vaccine is given to you or your child, the body’s natural
defences make antibodies that help
to protect agains

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Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PNEUMOVAX 23 solution for injection in pre-filled syringe
Pneumococcal Polysaccharide Vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 0.5 mL dose of vaccine contains 25 micrograms of each of the
following 23 pneumococcal
polysaccharide serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A,
12F, 14, 15B, 17F, 18C, 19F,
19A, 20, 22F, 23F, 33F.
Excipient(s) with known effect
Sodium less than 1 mmol (23 mg) per dosage unit.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
The vaccine is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Pneumococcal polysaccharide vaccine is recommended for active
immunisation against
pneumococcal disease in children aged from 2 years, adolescents and
adults.
See section 5.1 for information on protection against specific
pneumococcal serotypes.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The immunisation schedules for Pneumococcal polysaccharide vaccine
should be based on official
recommendations.
POSOLOGY
Primary vaccination:
Adults and children of 2 years of age or older- one single dose of 0.5
millilitre by intramuscular or
subcutaneous injection. Pneumococcal polysaccharide vaccine is not
recommended for use in children
below 2 years of age as the safety and efficacy of the vaccine have
not been established and the
antibody response may be poor.
Special dosing:
It is recommended that pneumococcal vaccine should preferably be given
at least two weeks before
elective
_ _
splenectomy or the initiation of chemotherapy or other
immunosuppressive treatment.
Vaccination during chemotherapy or radiation therapy should be
avoided.
Following completion of chemotherapy and/or radiation therapy for
neoplastic disease, immune
responses to vaccination may remain diminished. The vaccine should not
be administered any sooner
than three months after completion of such therapy. A longer delay may
be appropriate for patients

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