Pneumococcal polysaccharide vaccine solution for injection 0.5ml vials

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Información para el usuario (PIL)

28-06-2018

Ficha técnica (SPC)

28-06-2018

Ingredientes activos:

Streptococcus pneumoniae serotype 9N capsular polysaccharide; Streptococcus pneumoniae serotype 9V capsular polysaccharide; Streptococcus pneumoniae serotype 10A capsular polysaccharide; Streptococcus pneumoniae serotype 11A capsular polysaccharide; Streptococcus pneumoniae serotype 12F capsular polysaccharide; Streptococcus pneumoniae serotype 14 capsular polysaccharide; Streptococcus pneumoniae serotype 15B capsular polysaccharide; Streptococcus pneumoniae serotype 17A or 17F capsular polysaccharide; Streptococcus pneumoniae serotype 18C capsular polysaccharide; Streptococcus pneumoniae serotype 19F capsular polysaccharide; Streptococcus pneumoniae serotype 19A capsular polysaccharide; Streptococcus pneumoniae serotype 20 capsular polysaccharide; Streptococcus pneumoniae serotype 22F capsular polysaccharide; Streptococcus pneumoniae serotype 23F capsular polysaccharide; Streptococcus pneumoniae serotype 33F capsular polysaccharide; Streptococcus pneumoniae serotype 1 capsular polysaccharide; Streptococcus pneumoniae serotype 2 capsular polysaccharide; Streptococcus pneumoniae serotype 3 capsular polysaccharide; Streptococcus pneumoniae serotype 4 capsular polysaccharide; Streptococcus pneumoniae serotype 5 capsular polysaccharide; Streptococcus pneumoniae serotype 6B capsular polysaccharide; Streptococcus pneumoniae serotype 7F capsular polysaccharide; Streptococcus pneumoniae serotype 8 capsular polysaccharide

Disponible desde:

Organon Pharma (UK) Ltd

Código ATC:

J07AL01

Designación común internacional (DCI):

formulario farmacéutico:

Solution for injection

Vía de administración:

Subcutaneous; Intramuscular

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 14040000; GTIN: 5053444050914

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
Pneumococcal polysaccharide vaccine solution for injection in a vial
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 Pneumococcal polysaccharide vaccine is and what it is used for
2.
What you need to know before you or your child use Pneumococcal
polysaccharide vaccine
3.
How to use Pneumococcal polysaccharide vaccine
4.
Possible side effects
5.
How to store Pneumococcal polysaccharide vaccine
6.
Contents of the pack and other information
1.
WHAT PNEUMOCOCCAL POLYSACCHARIDE VACCINE IS AND WHAT IT IS USED FOR
Pneumococcal polysaccharide vaccine 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 pneumo

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Ficha técnica

OBJECT 1
PNEUMOCOCCAL POLYSACCHARIDE VACCINE
Summary of Product Characteristics Updated 30-Apr-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Pneumococcal polysaccharide vaccine solution for injection in a vial
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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in a vial.
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

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