PNEUMOVAX 23 pneumococcal purified capsular polysaccharides 25 microgram/0.5mL injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

04-11-2020

Summary of Product characteristics (SPC)

04-11-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

Pneumococcal purified capsular polysaccharides, Quantity: 50 microgram/mL

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Pneumococcal purified capsular polysaccharides

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; phenol; sodium chloride

Administration route:

Subcutaneous, Intramuscular

Units in package:

1, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PNEUMOVAX 23 is indicated for immunisation of individuals in the following situations: All individuals over the age of 65 years; Individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; Immunocompromised patients at increased risk of pneumococcal disease (eg patients with HIV infection before the development of AIDS, nephrotic syndrome, multiple myeloma, lymphoma, Hodgkin's Disease and organ transplantation); Aboriginal and Torres Strait Islander people over 50 years of age; Immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); Patients with cerebrospinal fluid leaks. In Australia, the National Health and Medical Research Council (NHMRC) currently recommends the vaccination of tobacco smokers with the 23-valent polysaccharide pneumococcal vaccine. PNEUMOVAX 23 is indicated for immunisation only against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated. In Australia, the National Health and Medical Research Council (NHMRC) currently recommeds the vaccination of tabacco smokers with the 23-valent polysaccharide pneumococcal vaccine. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus othar those contained in the vaccine.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Syringe; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-06-04

Patient Information leaflet

PNEUMOVAX
® 23
_Pneumococcal Vaccine Polyvalent; Pneumococcal purified capsular
polysaccharides_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PNEUMOVAX 23
(pronounced new-mo-vax). 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 (pronounced
new-mo-kock-us). PNEUMOVAX
23 helps protect against the most
common types of pneumococcal
bacteria.
PNEUMOVAX 23 is not
recommended for use in
children below 2 years of age.
It can be given to children 2 years of
age and older, teenagers and adults
who:
•
have no spleen or a spleen that
does not function properly,
including sickle cell disease
•
have a decreased immune system
and are at increased risk of
pneumococcal infection, for
example, people with organ
transplants, HIV or certain
cancers
•
have long-term diseases and are
at increased risk of pneumococcal
infection
•
have leakage of fluid from around
the brain and spinal cord
It can also be given to Aboriginal and
Torres Strait Islander people over 50
years of age.
In addition, PNEUMOVAX 23 is
recommended as a routine
vaccination for people aged 65 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
•
a severe infection of the middle
ear
•
a severe infection in the blood.
Groups o

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Summary of Product characteristics

S-IPC-V110-1-022016
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
PNEUMOVAX
® 23
PNEUMOCOCCAL VACCINE POLYVALENT
PNEUMOCOCCAL PURIFIED CAPSULAR POLYSACCHARIDES
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Pneumococcal purified capsular polysaccharides
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PNEUMOVAX
23
(Pneumococcal
Vaccine
Polyvalent)
is
a
sterile,
liquid
vaccine
for
intramuscular
or
subcutaneous
injection.
It
consists
of
a
mixture
of
purified
capsular
polysaccharides from the 23 most prevalent or invasive pneumococcal
types of _Streptococcus _
_pneumoniae,_ including the six serotypes that most frequently cause
invasive drug-resistant
pneumococcal infections among children and adults in the United States
(see Table 1). The
23-valent
vaccine
accounts
for
at
least
90%
of
pneumococcal
blood
isolates
and
approximately 85% of all pneumococcal isolates from sites which are
generally sterile as
determined by ongoing surveillance of U.S. data.
Table 1
23 Pneumococcal Capsular Types Included in PNEUMOVAX 23
Danish Nomenclature
Pneumococcal Types
1
2
3
4
5
6B*
7F
8
9N
9V*
10A
11A
12F
14*
15B
17F 18C
19F*
19A*
20
22F
23F*
33F
* These serotypes most frequently cause drug-resistant pneumococcal
infections
PNEUMOVAX 23 is manufactured according to methods developed by MSD
Research
Laboratories. Each 0.5 mL dose of vaccine contains 25 microgram of
each polysaccharide
type dissolved in isotonic saline solution containing 0.25% phenol as
preservative.
The manufacture of this product includes exposure to bovine derived
material. No evidence
exists that any case of vCJD (considered to be the human form of
bovine spongiform
encephalopathy) has resulted from the administration of any vaccine
product.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PNEUMOVAX
23
(Pneumococcal
Vaccine,
Polyvalent)
is
a
sterile,
liquid
vaccine
for
intramuscular or subcutaneous injection.
PNEUMOVAX 23 is a clear, colourless solution for injection.
S-IPC-V110-1-022016
Page 2 of 11
4
CLINICAL PARTICULARS
4.1

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