Pneumovax 23 vaccine

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Pneumococcal polysaccharide vaccine 50 µg/mL (25mcg/dose of each of 23 named pneumococcal polysaccharides)

থেকে পাওয়া:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Pneumococcal polysaccharide vaccine 50 µg/mL (25mcg/dose of each of 23 named pneumococcal polysaccharides)

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

রচনা:

Active: Pneumococcal polysaccharide vaccine 50 µg/mL (25mcg/dose of each of 23 named pneumococcal polysaccharides) Excipient: Phenol Sodium chloride Water for injection

প্যাকেজ ইউনিট:

Vial, glass, 10 x 0.5mL, 10 dose units

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

থেরাপিউটিক ইঙ্গিত:

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Syringe, glass, Type 1 with bromobutyl plunger stopper, 1 x 0.5 mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, Type 1 with bromobutyl plunger stopper, 10 x 0.5 mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 10 x 0.5mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 3ml type 1 glass - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

অনুমোদন তারিখ:

1978-05-24

তথ্য লিফলেট

CONSUMER MEDICINE INFORMATION
1
PNEUMOVAX
® 23
_Pneumococcal Vaccine _
Single Dose Vial/Pre-filled Syringe
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PNEUMOVAX 23. It does
not contain
all the available information. It does not take the place of talking
to your doctor or
pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the risks of
you being given PNEUMOVAX 23 against the benefits they expect it will
have for you.
If you have any concerns about being given this vaccine, ask your
doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT PNEUMOVAX 23 IS USED FOR
PNEUMOVAX 23 is a vaccine used to help prevent infections caused by
certain types of
germs or bacteria called pneumococcus. PNEUMOVAX 23 helps protect
against the most
common types of pneumococcal bacteria.
It is given to children 2 years of age and older, teenagers and adults
who:
•
have no spleen or a spleen that does not function properly
•
have long-term diseases and are at increased risk of pneumococcal
infection, or where
pneumococcal infection may be more severe
•
are living in communities or institutions where pneumococcal
infections are spreading
very quickly and who are at increased risk of being infected.
It is also recommended as a routine vaccination for people aged 50
years and older.
Pneumococcal infection is an important cause of death worldwide.
Protection against
pneumococcal infection is important because the germs or bacteria can
cause serious
diseases such as:
•
meningitis, an infection of the brain and/or spinal cord
•
pneumonia, an infection of the lungs
•
otitis media, an infection of the middle ear
•
bacteraemia, an infection in the blood.
Groups of people who are at increased risk of pneumococcal disease
include those who
have poor immune systems, such as people with organ transplants,
certain cancers and
HIV/AIDS. Other people who are at risk of pneumococcal disease include
those with no
spleen, those with long-term problems of th

পণ্য বৈশিষ্ট্য

1
NEW ZEALAND DATA SHEET
1.
PNEUMOVAX
® 23
_Pneumococcal vaccine polyvalent, MSD, 25 microgram/serotype/0.5 mL _
Single Dose Vial/Pre-filled Syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5mL single dose vials/pre-filled syringe contains 25 mcg of
each of the following
pneumococcal polysaccharide serotypes:
1 2 3 4 5 6B** 7F 8 9N 9V** 10A 11A 12F 14** 15B
17F 18C 19A** 19F** 20 22F 23F** 33F.
_** _
_These serotypes most frequently cause medicine-resistant pneumococcal
infections_
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Single dose vials/pre-filled syringes with a sterile clear colourless
solution for intramuscular
or subcutaneous administration.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease
caused by
those pneumococcal types included in the vaccine. Effectiveness of the
vaccine in the
prevention
of
pneumococcal
pneumonia
and
pneumococcal
bacteraemia
has
been
demonstrated in controlled trials in South Africa, France and in
case-controlled studies.
PNEUMOVAX 23 will not prevent disease caused by capsular types of
pneumococcus other
than those contained in the vaccine.
If it is known that a person has not received any pneumococcal vaccine
or if earlier
pneumococcal vaccination status is unknown, then persons in the
categories listed below
should be administered pneumococcal vaccine, however, if a person has
received a primary
dose of pneumococcal vaccine, before administering an additional dose
of vaccine, please
refer
to
the
Revaccination
section
(see
Dosage
and
Administration,
_Revaccination_).
Vaccination with PNEUMOVAX 23 is recommended for selected individuals
as follows:
Immunocompetent persons
•
routine vaccination for persons 50 years of age or older
•
persons aged ≥ 2 years with chronic cardiovascular disease
(including congestive heart
failure and cardiomyopathies), chronic pulmonary disease (including
chronic obstructive
pulmonary disease and emphysema), or diabetes mellitus
•