PNEUMOVAX

Main information

  • Trade name:
  • PNEUMOVAX 23 pneumococcal purified capsular polysaccharides 25 microgram/0.5mL injection pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PNEUMOVAX 23 pneumococcal purified capsular polysaccharides 25 microgram/0.5mL injection pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222235
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222235

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

syringe

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/06/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

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

syringe

Product Type

Single Medicine Product

Effective date

14/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Subcutaneous

Visual Identification

Clear colourless solution

Active Ingredients

Pneumococcal purified capsular polysaccharides

50 microgram/mL

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:49:28 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 26.11.2017 at 11:49:28 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

PNEUMOVAX

®

23

Pneumococcal Vaccine, Polyvalent

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

a severe 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 the heart,

lung, kidney or liver, diabetes

mellitus, alcoholics and people aged

65 years and older, and those who

smoke. In Australia, the vaccine is

currently recommended by the

National Health and Medical

Research Council (NHMRC) for

tobacco smokers

Infection from pneumococcal

bacteria usually occurs when you

come into contact with an infected

person. The infection may be spread

when an infected person coughs or

sneezes near another person. Apart

from certain diseases, other situations

that may increase the risk of infection

include:

being around groups of other

children (e.g. Daycare)

living in the same household as

someone who is infected.

How it works

PNEUMOVAX 23 works by causing

your body to produce its own

protection against pneumococcal

infection. It does this by making

disease-fighting substances called

antibodies to fight

the bacteria. The vaccine itself

cannot cause the infection. If a

vaccinated person comes into contact

with live bacteria, the body is usually

ready and produces antibodies to

destroy it.

However, as with all vaccines, 100%

protection against pneumococcal

disease cannot be guaranteed.

The chance of a severe reaction from

PNEUMOVAX 23 is very small, but

the risks from not being vaccinated

may be very serious.

PNEUMOVAX 23 only protects

against infections caused by the most

common types of pneumococcal

bacteria, not against the less common

PNEUMOVAX

types of pneumococcal bacteria or

other germs.

Before you are given

PNEUMOVAX 23

When you or your child

must not be given it

Do not have PNEUMOVAX 23 if:

you have an allergy to

PNEUMOVAX 23 or any of the

ingredients listed at the end of

this leaflet

the expiry date on the pack has

passed

If the vaccine is used after the

expiry date has passed, it may not

work.

If you are not sure whether you or

your child should be given

PNEUMOVAX 23, talk to your

doctor.

Do not give PNEUMOVAX 23 to

children under 2 years of age.

The safety and effectiveness of

PNEUMOVAX 23 in children below

the age of 2 years have not been

established.

Before you or your child are

given it

Tell your doctor if:

1.

you are pregnant or intend to

become pregnant

It is not known whether the

vaccine is harmful to an unborn

baby when given to a pregnant

woman. Your doctor will give

you PNEUMOVAX 23 only if it

is clearly needed.

2.

you are breast-feeding

It is not known whether

PNEUMOVAX 23 passes into

breast milk. Your doctor will

discuss the possible risks and

benefits of you being given

PNEUMOVAX 23 while breast-

feeding.

3.

you have any medical

conditions, especially the

following:

heart or lung problems

idiopathic thrombocytopenic

purpura (ITP), a disease which

causes unusual bleeding or

bruising under the skin

blood problems

4.

you have an infection or a high

temperature

Your doctor may decide to delay

your injection of PNEUMOVAX

5.

you are currently being treated

or have recently been treated

with radiotherapy or

chemotherapy

Your doctor may decide to delay

your injection of PNEUMOVAX

6.

you have been vaccinated with

a pneumococcal vaccine before

Routine revaccination of people

with normal immune systems

previously vaccinated with

PNEUMOVAX 23 is not

recommended.

However, revaccination is

recommended for people at

highest risk of serious

pneumococcal infection, at

different times. Your doctor will

decide if and when you need

another injection of

PNEUMOVAX 23.

7.

you have any allergies to any

other medicines or vaccines, or

any other substances, such as

foods, preservatives or dyes.

If you have not told your doctor

about any of the above, tell them

before you or your child are given

an injection of PNEUMOVAX 23.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

PNEUMOVAX 23 may not work as

well as it should if you or your child

are taking or receiving medicines that

decrease the immune system, such as

corticosteroids (e.g. prednisone),

cyclosporin, or chemotherapy.

PNEUMOVAX 23 should not be

given at the same time as

ZOSTAVAX

. For more information

about these vaccines, talk to your

doctor or health care provider,

because it may be better to get these

vaccines at least 4 weeks apart.

Your doctor will advise you if you

are taking or receiving any of these

or other medicines that decrease the

immune system. Your doctor will

decide whether or not to give the

vaccine.

How PNEUMOVAX 23

is given

How much is given

Your doctor will decide on the dose

of PNEUMOVAX 23 that you or

your child will be given.

The usual dose of PNEUMOVAX 23

is 0.5 mL. The dose of the vaccine is

the same for everyone.

Usually only one injection is needed

to help protect against pneumococcal

disease. However, if you are at

increased risk of serious

pneumococcal infection, you may

need to have a second injection. Your

doctor will decide if and when you

need a second injection of

PNEUMOVAX 23.

How it is given

PNEUMOVAX 23 is given as an

injection by a doctor or trained nurse,

either into a muscle, such as your

upper arm or mid-thigh, or under the

skin. The vaccine should not be

injected directly into veins

(intravenously).

PNEUMOVAX

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well during or after having had an

injection of PNEUMOVAX 23.

PNEUMOVAX 23 helps protect

most people from pneumococcal

infections, but it may have unwanted

side effects in a few people. All

medicines and vaccines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical treatment if you

get some of the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you or your

child has any of the following and

if they are troublesome or ongoing:

soreness, redness, warmth,

swelling or hard lump where you

had the injection. These may be

more common and intense after a

second shot than after the first

shot.

fever

chills

headache

unusual tiredness or weakness

generally feeling unwell

nausea, vomiting

These are usually mild side effects of

PNEUMOVAX 23. They usually

improve or disappear within a few

days.

Tell your doctor immediately if

you or your child notice any of the

following:

aching muscles, muscle

tenderness or weakness, not

caused by exercise

decreased ability to move limb

painful or swollen joints

tingling or numbness of the hands

or feet

swollen and painful lymph glands

unusual bleeding or bruising

convulsions or fits due to fever

These may be serious side effects.

You may need urgent medical

attention. These side effects are rare.

Allergic Reaction or Other

Serious Conditions:

As with all vaccines given by

injection, there is a very small risk of

a serious allergic reaction or other

serious conditions.

Tell your doctor immediately or go

to accident and emergency at your

nearest hospital if you or your

child notice any of the following:

skin rash, itching

pinkish, itchy swellings on the

skin, also called hives or nettle

rash

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

swelling of other parts of the

body

shortness of breath, wheezing or

trouble breathing

These are serious side effects. If you

have them, you may have had a

serious allergic reaction or other

serious reaction to PNEUMOVAX

23. You may need urgent medical

attention or hospitalisation. Most of

these side effects occur within the

first few hours of vaccination but

some may occur later.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Storage

PNEUMOVAX 23 is usually stored

in the doctor's surgery or clinic, or at

the pharmacy. However if you need

to store PNEUMOVAX 23:

Keep it where children cannot

reach it.

Keep it in the refrigerator, but

not in the door compartment.

Do not put PNEUMOVAX 23

in the freezer, as freezing

destroys the vaccine.

Keep the injection in the

original pack until it is time for

it to be given.

Product description

What it looks like

PNEUMOVAX 23 comes in glass

vials or pre-filled syringes.

Ingredients

Active ingredient:

The active ingredient of

PNEUMOVAX 23 is a mixture of

inactive parts from 23 of the most

common types of pneumococcal

bacteria. Each 0.5 mL of vaccine

contains 25 micrograms of each

polysaccharide type.

Inactive ingredients:

phenol

sodium chloride solution

PNEUMOVAX 23 is made without

any human blood or blood

products.

The manufacture of this product

includes exposure to bovine derived

materials. 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.

Supplier

PNEUMOVAX 23 is supplied in

Australia by:

Seqirus Pty Ltd.,

63 Poplar Road

PARKVILLE VIC 3052

This leaflet was prepared in 9 March

2017

PNEUMOVAX

Australian Register Numbers:

PNEUMOVAX 23 vials -

AUST R 10507

PNEUMOVAX 23 pre-filled

syringes - AUST R 222235

S-WPPI-V110-1-022016

PNEUMOVAX

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