PNEUMOVAX 25/0.5 Microgram/ML Solution for injection in pre-filled syringe
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
29-09-2016
Summary of Product characteristics
(SPC)
29-09-2016
Active ingredient:
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE TYPE 2 (2), PNEUMOCOCCAL POLYSACCHARIDE TYPE 3 (3), PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE TYPE 8 (8), PNEUMOCOCCAL POLYSACCHARIDE TYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE TYPE 20 (20), PNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE
Available from:
Sanofi Pasteur MSD Ltd
ATC code:
J07AL01
INN (International Name):
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE TYPE 2 (2), PNEUMOCOCCAL POLYSACCHARIDE TYPE 3 (3), PNEUMOCO
Dosage:
25/0.5 Microgram/ML
Pharmaceutical form:
Solution for injection in pre-filled syringe
Administration route:
Muscle injection
Units in package:
Pack size of 1 or 10
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Merck Sharp and Dohme B.V
Therapeutic area:
Pneumococcal vaccines
Therapeutic indications:
It is recommended for active immunisation against disease caused by the pneumococcal serotypes included in the vaccine
Authorization status:
Transfer Pending
Authorization date:
2015-05-22
Patient Information leaflet
1
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 bacteri
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pneumovax 23 solution for injection in pre-filled syringe
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.
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 Sanofi Pasteur MSD is recommended for active immunisation against disease
caused by the pneumococcal serotypes included in the vaccine. The vaccine is recommended for individuals 2 years of
age or older in whom there is an increased risk of morbidity and mortality from pneumococcal disease. The specific at
risk categories of persons to be immunised are to be determined on the basis of official recommendations.
The vaccine is not effective for the prevention of acute otitis media, sinusitis and other common upper respiratory tract
infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 Sanofi Pasteur MSD 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 tr
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