PNEUMOVAX 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pneumococcal vaccine

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

J07AL; J07AL01

INN (International Name):

Pneumococcal vaccine

Dosage:

25 mcg/0.5 millilitre(s)

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Pneumococcal vaccines; pneumococcus, purified polysaccharides antigen

Authorization status:

Marketed

Authorization date:

2015-05-22

Patient Information leaflet

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 against pneumoco

Summary of Product characteristics

Health Products Regulatory Authority
15 December 2022
CRN00D9SH
Page 1 of 7
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
PNEUMOVAX 23 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 PNEUMOVAX 23 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. PNEUMOVAX 23 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 who