fluarix tetra page 6 page 10 does not contain all the available information. it does not take the...

2018 Consumer Medicine Information for the flu vaccine brands that Medimobile use.

• Afluria Quad _________________________ Page 2

• Fluarix Tetra _________________________ Page 6

• FluQuadri ___________________________ 0

• Influvac Tetra ________________________ Page 13

2018 CMI's - Page 1

Consumer Medicine Information (AUST R 262428 and AUST R 294907)

Page 1 of 4

Afluria® QuadInactivated Quadrivalent Influenza Vaccine (Split Virion)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Afluria® Quad

vaccine.

It does not contain all the available information.

It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor considers the risks of you

having Afluria® Quad vaccine and

the benefits they expect it will have.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What Afluria® Quad

vaccine is used for

Afluria® Quad vaccine helps

prevent influenza, often called “the flu”. Influenza is caused by infection with specific influenza viruses. New types of influenza viruses can

appear each year. Afluria® Quad

vaccine contains fragments of four different types of influenza virus. Each year the Australian Influenza Vaccine Committee decides which four types of viruses are most suitable to include in the vaccine.

The virus in the vaccine has been killed. Therefore the vaccine cannot give you “the flu”.

Note: the vaccine will not protect you from the other influenza viruses

that Afluria® Quad vaccine does

not contain.

Afluria® Quad vaccine is a

prescription only medicine. This year (2018) the viruses are A/Michigan/45/2015(H1N1) – like strain, A/Singapore/INFIMH-16-0019/2016 (H3N2) – like strain, B/Brisbane/60/2008 – like strain and B/Phuket/3073/2013 – like strain.

Vaccination against influenza is recommended every year, for anyone wanting to lower their chance of catching influenza.

How Afluria® Quad vaccine

works

Afluria® Quad vaccine works by

causing your body to protect itself against infection by the influenza viruses, types A and B, that are in the vaccine. The vaccine stimulates the body to make substances, called antibodies. Antibodies fight the influenza virus. If you have been vaccinated, when you come into contact with the influenza viruses in the vaccine, your body is usually able quickly to destroy the virus. This prevents you from getting influenza.

Your body takes a few weeks after vaccination to fully develop protection against the influenza virus.

Protection against influenza generally requires one dose of

Afluria® Quad vaccine.

Most people make satisfactory antibodies against the influenza virus. However, as with all vaccines, 100% protection cannot be guaranteed.

The chance of having a severe unwanted reaction after having

Afluria® Quad vaccine is very

small. Whereas, the risks of not being vaccinated against influenza may be very serious.

Before you are given

Afluria® Quad vaccine

When you must not be

given Afluria® Quad

vaccine

Your child must not be given

Afluria® Quad vaccine if they are

under 18 years old. For the 2018

influenza season, Afluria® Quad

vaccine is only for use in adults aged 18 years and over.

Do not have Afluria® Quad

vaccine if you have or previously have had an allergy to:

Afluria® Quad vaccine or any of

the ingredients listed at the endof this leaflet

eggs

the antibiotics neomycin sulfateor polymyxin B sulfate.

Symptoms of an allergic reaction may include:

shortness of breath, wheezingor difficulty breathing

swelling of the face, lips, tongueor other parts of the body

skin rash, itching or hives.


vaccine if you have a temperature higher than 38.5ºC.


vaccine after the expiry date printed on the packaging.

If you are not sure whether you

should have Afluria® Quad

vaccine, talk to your doctor, nurse or pharmacist.

2018 CMI's -


Page 2 of 4

Before you are given

Afluria® Quad vaccine

Tell your doctor if in the past you have reacted to vaccination with any of the following:

severe allergic reaction

difficulty breathing

swelling of the throat

fainting or collapse

fits or convulsions

high temperature (greater than

38.5C)

severe skin reaction at theinjection site, including severebruising.

Tell your doctor if you have an infection or temperature higher than 38.5

oC.

Your doctor may decide to delay vaccination until the illness has passed. A minor illness such as a cold is not usually a reason to delay vaccination.

Tell your doctor if in the past you have had any medical conditions, especially the following:

low immunity due to ill-health,for example some blooddisorders, malaria, kidneydisease requiring dialysis,HIV/AIDS or cancer

low immunity due to treatmentwith medicines such ascorticosteroids, cyclosporin orother medicines, used to treatcancer (including radiationtherapy)

allergies or allergic reactions,including: runny, blocked oritchy nose; itchy rash or hives;swelling of the face, lips, mouthor tongue

Guillain-Barré Syndrome (GBS),an illness which affects thenervous system and causesparalysis.

Tell your doctor if you have allergies to:

any other medicines

any other substances, such asfoods, preservatives or dyes.

Tell your doctor if you are pregnant, or are planning to become pregnant.

Your doctor will discuss the potential risks and benefits of

having Afluria® Quad vaccine

during pregnancy, and advise on

the timing of Afluria® Quad

vaccination with regards to pregnancy.

Tell your doctor if you are breast-feeding. Your doctor will discuss the potential risks and benefits of

having Afluria® Quad vaccine

while you are breast-feeding.

Taking other medicines

Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Afluria®

Quad vaccine may interfere with each other.

The following medicines or treatments may affect how well

Afluria® Quad vaccine works:

medicines which affect thebody’s immune response, suchas corticosteroids, cyclosporinor

some treatments for cancer(including radiation therapy).

Your doctor, nurse or pharmacist will help you decide whether or not you should have the vaccine.

Having other vaccines

Tell your doctor if you have had any vaccines in the last 4 weeks.

Afluria® Quad vaccine can be

given at the same time as other vaccines.

Your doctor will tell you if Afluria®

Quad vaccine is to be given at the same time as another vaccine.

How Afluria® Quad

vaccine is given

How it is given

Afluria® Quad vaccine is given by

a doctor, nurse or pharmacist, as an injection into a muscle or under the skin.

Afluria® Quad vaccine should be

given at facilities able to manage any allergic reaction. Allergy to

Afluria® Quad vaccine is

uncommon, but allergy to any vaccine may occur.

How much is given

Afluria® Quad vaccine is given

once every year, as follows:

Adults 18 years and over: oneinjection of 0.5 mL

Overdose is unlikely as your doctor or nurse gives you the injection and it is pre-packed in individual single-use syringes.

If you have any concerns, ask your doctor, nurse or pharmacist.

When it is given

Afluria® Quad vaccine is usually

given before the start of the influenza season.

Vaccination should be repeated every year as new types of influenza virus can appear each year.

After having Afluria®

Quad vaccine

Things you must do

Keep an updated record of your vaccinations.

Keep any follow-up appointments with your doctor or clinic.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you feel unwell after having the vaccine.

2018 CMI's -


Page 3 of 4

Afluria® Quad vaccine may have

unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. You need medical treatment for some of the side effects.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

The following are the more

common side effects of Afluria®

Quad vaccine. Mostly these are mild and short-lived.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:

reaction around the injection sitesuch as tenderness, bruising,redness, warmth, pain, swellingor the formation of hard lumps

flu-like symptoms, such asheadache, tiredness, fever, sorethroat, runny nose, blockednose, sneezing, cough, chills

vomiting, nausea, diarrhoea

aching muscles

irritability/loss of appetite.

The following may be serious side effects and you may need urgent medical attention. However, these side effects are rare.

Tell your doctor immediately if you notice any of the following:

tingling or numbness.

The following are very serious side effects and you may need urgent medical attention or hospitalisation. All of these side effects are rare.

If any of the following happen to you, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

An allergic reaction: Typicalsymptoms include rash, itchingor hives on the skin, swelling ofthe face, lips, tongue or otherparts of the body

shortness of breath, wheezingor trouble breathing

a fit, convulsion or seizure

bleeding or bruising more easilythan normal

little or no urine

severe stabbing or throbbingnerve pain

neck stiffness, headache andhigh temperature associatedwith hallucinations, confusion,paralysis of part or all of thebody, disturbances of behaviour,speech and eye movements,and sensitivity to light.

Very rarely, a serious disorder called Guillain-Barré syndrome (GBS) may occur. GBS is an autoimmune syndrome caused by your body’s own immune system. GBS may make you feel weak; you may have difficulty moving around or you may experience numbness and tingling in your limbs.

Other side effects not listed may occur in some people. Tell your doctor, nurse or pharmacist if you notice anything that makes you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storing Afluria® Quad

vaccine

Afluria® Quad vaccine is usually

stored in the doctor’s surgery or clinic, or at the pharmacy.

If you need to store Afluria® Quad

vaccine:

Keep it where children cannotreach it

Keep it in the refrigerator,

between 2C and 8C. Do not

freeze Afluria® Quad vaccine.

Protect it from light.Note: Freezing destroys thevaccine.

Keep Afluria® Quad vaccine in

the original pack until it istime for it to be given.

Afluria® Quad vaccine should not

be used after the expiry date on the packaging.

Product description

What it looks like

Afluria® Quad vaccine is supplied

in a glass pre-filled disposable syringe for single use only. Your doctor, nurse or pharmacist will give you the injection.

Afluria® Quad vaccine is supplied

in pack sizes of one or ten syringes.

Ingredients

Active ingredients:

Purified, inactivated virus fragments from influenza types:

H1N1 strain 15 micrograms

H3N2 strain 15 micrograms

B strain 15 micrograms

B strain 15 micrograms

for the Southern Hemisphere winter season 2018.

Other ingredients

Sodium chloride

Dibasic sodium phosphateanhydrous

Monobasic sodium phosphate

Potassium chloride

Monobasic potassiumphosphate

Calcium chloride

Afluria® Quad vaccine may also

contain trace amounts of detergent (sodium taurodeoxycholate), egg protein (ovalbumin), sucrose, neomycin sulfate, polymyxin B sulfate and propiolactone.

Afluria® Quad vaccine does not

contain lactose, gluten, tartrazine or any azo dyes.

Ask your doctor, nurse or pharmacist if you are unsure about anything or want more

information about Afluria® Quad

vaccine.

2018 CMI's -


Page 4 of 4

Name and Address of Sponsor

Seqirus Pty Ltd ABN 26 160 735 035 63 Poplar Road Parkville Victoria 3052 AUSTRALIA

Registration numbers

AUST R 262428 AUST R 294907

Date of preparation

18 October 2017

AFLURIA is a registered trademark of Seqirus UK Limited or its affiliates.

2018 CMI's -

FLUARIX TETRAInactivated Split Influenza Vaccine



This leaflet answers some of the

common questions about FLUARIX

TETRA vaccine. 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 possible risks of you or

your child having FLUARIX TETRA

against the expected benefits.

If you have any concerns about

receiving FLUARIX TETRA talk

to your doctor, nurse or

pharmacist.

Keep this leaflet with this vaccine.

You may need to read it again.

What Fluarix Tetra is used for

FLUARIX TETRA is used to help

prevent certain types of influenza.

The vaccine works by causing the

body to produce its own protection

(antibodies) against four different

types of influenza virus.

The types of influenza antigen

contained in FLUARIX TETRA may

change from one year to another.

Each year, the Australian Influenza

Vaccine Committee (AIVC)

recommends which ones to include.

This decision is based on the types of

influenza virus thought most likely to

occur during the next flu season.

Therefore, influenza vaccination is

recommended every year.

Please note that FLUARIX

TETRA will only protect you

against the four types of influenza

virus used to make the vaccine. It

will not protect you from influenza

caused by other types of influenza

virus or from infections with other

agents causing flu-like symptoms

(such as the common cold).

FLUARIX TETRA cannot give you

or your child influenza because the

viruses in the vaccine have been

killed.

Influenza is an infectious illness and

is spread by small droplets from the

nose, throat or mouth of an infected

person. The most common

symptoms of influenza include fever,

sore throat, runny nose, coughing,

general aches and pains, headache,

weakness and tiredness, Most people

recover completely within a week.

The risk of serious complications

(e.g. pneumonia and death) is greater

in very young, very old and

chronically ill persons.

FLUARIX TETRA can be used in

adults and children older than 3 years

of age.

Before you are given FLUARIX TETRA

When you or your child

must not be given FLUARIX

TETRA

FLUARIX TETRA must not be

given if you or your child:

have had an allergic reaction to

FLUARIX TETRA or any of the

ingredients listed at the end of

this leaflet

have had an allergic reaction or

became unwell after any other

influenza vaccine (e.g. Fluvax,

Vaxigrip etc)

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

FLUARIX TETRA should not be

given after the expiry date printed

on the pack or if the packaging is

torn or shows signs of tampering.

If you are not sure whether you or

your child should have FLUARIX

TETRA, talk to your doctor or nurse.

Do not give this vaccine to anyone

else; your doctor has prescribed it

specifically for you or your child.

Your doctor will discuss with you

the possible risks and benefits of

receiving FLUARIX TETRA.

Before being given FLUARIX

TETRA

Tell your doctor if:

you or your child have a severe

infection with a high temperature.

Your doctor may decide to delay

vaccination until the illness has

passed. A minor infection such

as a cold is not usually a reason to

delay vaccination, but talk to your

doctor or nurse about this before

being vaccinated.

you are or think you may be

pregnant or if you intend to

become pregnant. Your doctor

will discuss with you the possible

risks and benefits of receiving

2018 CMI's -

FLUARIX TETRA during

pregnancy.

you are breast feeding. Your

doctor will discuss the risks and

benefits of vaccination, however

the vaccine is not expected to

cause problems for breast-fed

babies.

you or your child have had or

have Guillain-Barré Syndrome

(an inflammatory illness affecting

nerves resulting in weakness of

muscles).

you or your child have any

medical conditions, such as:

an immune deficiency

condition, or

a bleeding disorder.

you or your child have allergies

to any medicines or substances,

such as latex, dyes, foods or

preservatives.

you or your child have received

another vaccine, or are taking any

prescription (eg theophylline,

phenytoin, phenobarbitone,

carbamazepine or warfarin) or

OTC (over-the-counter)

medicines. In particular mention

if you or your child are taking

medicines which suppress the

immune system, such as steroids

or cyclosporin. Some vaccines

may be affected by other vaccines

or medicines. Your doctor or

pharmacist will be able to tell you

what to do if FLUARIX TETRA

is to be given with another

vaccine or medicine.

Fainting can occur following, or even

before, any needle injection,

therefore tell the doctor or nurse if

you or your child fainted with a

previous injection.

How FLUARIX TETRA is given

The doctor or nurse will give

FLUARIX TETRA as an injection.

If you have any concerns about

how this vaccine is to be given, talk

to your doctor, nurse or

pharmacist.

How much is given

For adults and children over 3 years

of age: 0.5 mL is given.

How it is given

FLUARIX TETRA is generally

injected into the upper arm or upper

thigh muscle.

When it is given

For adults and older children

FLUARIX TETRA is generally

given as a single dose each year

before the start of the influenza

season, which is usually in winter.

First dose: on an elected date

Second dose: 4 weeks after the

first (ONLY for children aged 3

years to 9 years receiving

influenza vaccination for the first

time)

Vaccination should be repeated every

year as new types of influenza virus

can appear each year.

If you miss a dose

If a scheduled dose is missed, talk to

your doctor or nurse and arrange

another visit as soon as possible.

After being given FLUARIX TETRA

Things to be careful of:

Be careful driving or operating

machinery until you know how

FLUARIX TETRA affects you.

FLUARIX TETRA should not

normally interfere with your ability

to drive a car or operate machinery,

but in some people vaccination can

cause dizziness or light headedness.

Make sure you know how you react

to FLUARIX TETRA before you

drive a car or operate machinery, or

do anything that could be dangerous

if you are dizzy or lightheaded.

Side effects

Tell your doctor, nurse or

pharmacist as soon as possible if

you or your child do not feel well

during or after having had a dose

of FLUARIX TETRA.

FLUARIX TETRA helps protect

most people from influenza, 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. Some side

effects may need medical treatment.

Ask your doctor, nurse or

pharmacist to answer any

questions you may have.

Most unwanted effects with

FLUARIX TETRA are mild and

usually clear up within a few days.

These effects, as with other vaccines,

generally occur around the injection

site.

Tell your doctor if you notice any

of the following that are

troublesome or ongoing:

redness, swelling, a hard lump,

soreness, bruising or itching

around the injection site

fever, chills, shivering, sweating,

dizziness, headache, malaise

(generally unwell)

muscle aches and pains

joint pain

loss of appetite, feeling sick,

vomiting, diarrhoea, stomach pain

irritability

drowsiness

The above list includes mild side

effects.

Tell your doctor as soon as possible

if you notice any of the following:

transient swollen glands in the

neck, armpit or groin

2018 CMI's -

painful swelling in the arms or

legs

vomiting

Flu-like symptoms, such as high

temperature, sore throat, runny

nose, cough and chills

weakness of muscles

In very young children high fevers

may result in convulsions (fits). It is

advisable to monitor young children

for high fevers post (influenza)

vaccination.

There have been rare reports of

Guillain-Barré Syndrome (an

inflammatory illness affecting nerves

resulting in weakness of muscles),

however these events have not been

definitely linked to the use of

influenza vaccines.

The above list includes serious side

effects that may require medical

attention.

As with all vaccines given by

injection there is a very small risk

of serious allergic reaction.

Contact your doctor immediately

or go to the casualty department of

your nearest hospital if any of the

following happens:

swelling of limbs, face, eyes,

inside of nose, mouth or throat

shortness of breath, breathing or

swallowing difficulties

hives, itching (especially of the

hands or feet), reddening of skin

(especially around the ears), or

severe skin reactions

unusual tiredness or weakness

that is sudden and severe

Allergy to FLUARIX TETRA is

rare. Any such severe reactions

will usually occur within the first

few hours of vaccination. Tell your

doctor or pharmacist if you notice

anything that is making you feel

unwell during or after a dose of

vaccine.

Other side effects not listed above

may also occur in some people.

After being given FLUARIX TETRA

Storage

FLUARIX TETRA is usually stored

at the doctor’s clinic or surgery, or at

the pharmacy.

If you need to store FLUARIX

TETRA always:

Keep FLUARIX TETRA in the

refrigerator stored between +2C

and +8C.

THE PACK SHOULD NEVER BE

FROZEN. FREEZING

DESTROYS THE VACCINE.

Keep the vaccine out of the reach

of children.

Keep FLUARIX TETRA in the

original pack until it is time for it

to be given.

Ask your pharmacist what to do

with any left over FLUARIX

TETRA that has expired or has not

been used.

Product description

What it looks like

FLUARIX TETRA comes in a pre-

filled syringe in packs of 1 and 10. It

is a colourless, slightly opalescent

liquid.

Ingredients

Each 0.5 mL dose of FLUARIX

TETRA contains 15 micrograms of

each of the four types of influenza

virus fragments.

A/Michigan/45/2015

(H1N1)pdm09-like virus

A/Singapore/INFIMH-16-

0019/2016 (H3N2)-like virus

B/Phuket/3073/2013-like virus

B/Brisbane/60/2008-like virus

The vaccine also contains:

polysorbate 80

octoxinol 10

α-tocopheryl hydrogen succinate

sodium chloride

disodium phosphate

dodecahydrate

potassium dihydrogen phosphate

potassium chloride

magnesium chloride hexahydrate

water for injections

ovalbumin (≤0.05 micrograms)

formaldehyde (≤5 micrograms)

hydrocortisone (trace)

gentamicin sulfate (trace)

sodium deoxycholate (trace)

FLUARIX TETRA is not made with

any human blood or blood products,

or any other substances of human

origin.

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.

Manufacturer/Distributor/

Supplier

FLUARIX TETRA is manufactured

by:

GlaxoSmithKline Biologicals

Branch of SmithKline Beecham

Pharma GmbH & Co KG

Zirkusstrasse 40

01069 Dresden Germany

FLUARIX TETRA is supplied in

Australia by:

GlaxoSmithKline Australia Pty Ltd

Level 4,

436 Johnston Street,

Abbotsford, Victoria, 3067

Registration Numbers:

AUST R 200674 - prefilled syringe

without needle*

AUST R 210806 - prefilled syringe

with needle*

AUST R 242512 – prefilled syringe

with detached needle

*not currently supplied

2018 CMI's -

Date of Preparation:

16 October 2017

Version 5.0

Trade marks are owned by or

licensed to the GSK group of

companies.

© 2017 GSK group of companies or

its licensor.

2018 CMI's -

FluQuadri™FluQuadri™ JuniorInactivated Quadrivalent Influenza Vaccine (Split Virion)



Read all of this leaflet carefullybefore you are vaccinated.

• Keep this leaflet. You may needto read it again.

• If you have any further questions,ask your doctor or pharmacist.

• This vaccine has been prescribedfor you. Do not pass it on toothers.

• If any of the side effects getsserious, or if you notice any sideeffects not listed in this leaflet,please tell your doctor orpharmacist.

In this leaflet:

• What FluQuadri/FluQuadri Juniorare and what they are used for

• Before you are given FluQuadri/FluQuadri Junior

• How FluQuadri/FluQuadri Juniorare given

• Possible side effects

• Storing FluQuadri/FluQuadriJunior

• Further information

What FluQuadri/FluQuadri Junior areand what they areused for

FluQuadri and FluQuadri Junior arevaccines. Vaccines are used toprotect you against infectiousdiseases.

FluQuadri and FluQuadri Junior arerecommended to help protect youagainst influenza. FluQuadri may beadministered to persons aged 36months and older, especially who runan increased risk of influenza-associated complications. FluQuadriJunior is designed for use in childrenaged 6 to 35 months.

Influenza (flu) is a disease caused bydifferent types of virus. Influenzaviruses can spread rapidly, especiallyin homes or institutions, where it canbe very easy for someone to catch fluand spread the disease. The greatestrisk of catching flu is during the coldmonths between May and October.Your doctor will be able torecommend the best time for you tobe vaccinated. Flu is present everyyear, even when epidemics oroutbreaks are not reported.

The vaccine will only help to preventflu if it is caused by one of the fourstrains of virus contained in thevaccine, or other strains closelyrelated to them. FluQuadri/FluQuadriJunior will not prevent flu if you areincubating the disease beforevaccination or if it is caused byanother virus.

You should also note that manygerms can cause influenza-likeillness and the vaccine will notprotect you against these.

Previous injections of flu vaccine areunlikely to give you protectionagainst the current strains of flu viruswhich are most common this year, soyou will need to receive a vaccineagainst flu every year especially ifyou are at risk.

How They Work

FluQuadri and FluQuadri Juniorwork by helping the body to makeantibodies. These antibodies help thebody to recognise the flu virus andprevent the infection. It takes a fewweeks for the body to produce theseantibodies. The vaccine will protectyou only against the influenzaviruses contained in the vaccine (orother strains closely related to them).It will not protect you from virusesthat are unrelated to those containedin the vaccine.

Before you are givenFluQuadri/FluQuadriJunior

When you or your childmust not be given it

Do not have FluQuadri/FluQuadriJunior

• If you or your child ever had asevere allergic reaction to:

• Eggs or egg products

• Any of the other ingredients ofFluQuadri/FluQuadri Junior listedin the FURTHERINFORMATION section.

• If you or your child ever had asevere allergic reaction aftergetting any flu vaccine.

• Before speaking to your doctor, ifyou or your child has an acuteillness with or without hightemperature.

FLUQUADRI™; FLUQUADRI™ JUNIOR 1

2018 CMI's -

Take special care withFluQuadri/FluQuadri Junior

• Tell your doctor if you or yourchild has or has had Guillain-Barré syndrome (severe muscleweakness) after getting a fluvaccine

• Tell your doctor if you or yourchild has or has had an immuneresponse problem because theimmune response to the vaccinemay be diminished

• Tell your doctor if you arepregnant or breast feeding.

Your doctor will discuss the possiblerisks and benefits of havingFluQuadri during pregnancy orbreastfeeding. Sanofi Pasteur iscollecting information on pregnancyoutcomes and the health of newbornfollowing vaccination withFluQuadri during pregnancy. Womenwho receive FluQuadri duringpregnancy are encouraged to contactSanofi Pasteur directly or have theirdoctor contact Sanofi Pasteur at 1800829 468 (in Australia) or 0800 727838 (in New Zealand)

Your doctor should make sure thebenefits of vaccination outweigh therisks when recommendingFluQuadri/FluQuadri Junior.

Taking other medicines

• Medicines that may reduce yourimmune response: such ascorticosteroids (for exampleprednisone), medicines used totreat cancer (chemotherapy),radiotherapy or other medicinesaffecting the immune system. Tellyour doctor if you have beentreated with such medicines.

Please tell your doctor orpharmacist if you are taking orhave recently taken any othermedicines, including medicinesobtained without prescription.

Having other vaccines

• Your doctor will advise you ifFluQuadri/FluQuadri Junior is tobe given with another vaccine.

How FluQuadri/FluQuadri Junior aregiven

FluQuadri/FluQuadri Junior isadministered to you by your doctoror your nurse.

Dose and Schedule

Adults and children over 35 months:A single 0.5 mL injection

Children 6 to 35 months: A single0.25 mL injection

Some children require a secondinjection a month later.

Method of Administration

FluQuadri/FluQuadri Junior isinjected into the muscles of the upperarm (preferably). For infants, theinjection is normally given into themuscle of the thigh.

Possible side effects

Like all medicines, FluQuadri/FluQuadri Junior can cause sideeffects, although not everybody getsthem.

The most common local side effectsof FluQuadri/FluQuadri Juniorinclude:

• pain, tenderness, redness(erythema), swelling, bruising(ecchymosis) and hardness(induration) at the injection site

Systemic side effects include:

• feeling unwell (malaise)

• muscle aches (myalgia)

• headache

• shivering

• fever

• irritability, abnormal crying,drowsiness, appetite loss,vomiting (in children)

These side effects usually clear upwithin a few days. If eventscontinue or become severe, pleasetell your doctor or pharmacist.

Other side effects not listed abovehave been reported occasionally withother flu vaccines and not directlywith FluQuadri/FluQuadri Junior:

• inflammation of nerves leading toweakness, such as weakness offacial muscles (facial palsy) orvisual disturbances (opticneuritis/neuropathy)

• fainting (syncope), dizziness,tingling or numbness of hands orfeet (paraesthesia)

• temporary inflammation of nervescausing pain, paralysis andsensitivity disorders (Guillain-Barré syndrome [GBS])

• fits (convulsions) with or withoutfever

• severe allergic reaction(anaphylaxis)

• temporary reduction in thenumber of blood particles calledplatelets (thrombocytopenia),swollen glands in neck, armpit orgroin (lymphadenopathy)

If any of the side effects getsserious, or if you notice any sideeffects not listed in this leaflet,please tell your doctor orpharmacist.

Storing FluQuadri/FluQuadri Junior

FluQuadri/FluQuadri Junior isusually stored in the doctor’s surgeryor clinic, or at the pharmacy.However, if you need to storeFluQuadri/FluQuadri Junior:

• Keep out of reach and sight ofchildren.

• Keep FluQuadri/FluQuadri Juniorin the original pack until it is timefor it to be given.

• Keep it in the refrigerator,store at 2C to 8C. Do not freezeFluQuadri/FluQuadri Junior.

Do not use FluQuadri/FluQuadriJunior after the expiry date whichis stated on the carton after EXP.


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Do not have FluQuadri/FluQuadriJunior if the packaging is torn orshows signs of tampering.

Medicines should not be disposed ofvia wastewater or household waste.Ask your pharmacist how to disposeof medicines no longer required.These measures will help to protectthe environment.

Further Information

What FluQuadri/FluQuadriJunior contain

Ingredients

Active Ingredients:

FluQuadri/FluQuadri Junior contains4 killed influenza virus strains:

• A/Michigan/45/2015(H1N1)pdm09-like virus (A/Michigan/45/2015 X-275)

• A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus (A/Singapore/INFIMH-16-0019/2016 NIB-104)

• B/Phuket/3073/2013-like virus(B/Phuket/3073/2013)

• B/Brisbane/60/2008-like virus (B/Brisbane/60/2008)

The other ingredients include sodiumchloride, dibasic sodium phosphate,monobasic sodium phosphate,octoxinol-9, water for injection, andtraces of formaldehyde.

Other Ingredients:

FluQuadri contains less than 1microgram ovalbumin (egg protein)per dose.

FluQuadri Junior contains less than0.5 microgram ovalbumin (eggprotein) per dose.

FluQuadri/FluQuadri Junior does notcontain any antibiotics orpreservative.

What FluQuadri/FluQuadriJunior look like andcontents of the pack

FluQuadri is supplied in:

• Prefilled syringe (clear syringeplunger rod), 0.5 mL, for persons36 months of age and older.

FluQuadri Junior is supplied in:

• Prefilled syringe (pink syringeplunger rod), 0.25 mL, forpersons 6 months through 35months of age.

Name and Address ofAustralian Sponsor

sanofi-aventis australia pty ltd

Talavera Corporate Centre - BuildingD

12-24 Talavera Road

Macquarie Park NSW 2113

Australia

Tel: 1800 818 806

Name and Address of NewZealand Sponsor

sanofi-aventis new zealand pty ltd

Level 8

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 234 684

AUST R number

AUST R 213963 (FluQuadri)

AUST R 213964 (FluQuadri Junior)

Date of preparation

28 November 2017

fluq-fluq-jr-ccdsv2-cmiv2-07dec17


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Influvac TetraInactivated Quadrivalent Influenza Vaccine (surface antigen)



This leaflet answers some of thecommon questions aboutINFLUVAC TETRA vaccine. It doesnot contain all the availableinformation. It does not take theplace of talking to your doctor orpharmacist. Please read it carefullyand keep it for future reference.

All medicines and vaccines haverisks and benefits. Your doctor hasweighed the possible risks of youhaving INFLUVAC TETRA againstthe expected benefits.

Talk to your doctor, nurse orpharmacist if you have anyconcerns about receivingINFLUVAC TETRA.

Your doctor and pharmacist havemore information.

What Influvac Tetra isused for

INFLUVAC TETRA is used toprevent certain types of influenza(commonly called flu). The vaccineworks by causing the body toproduce its own protection(antibodies) against four differenttypes of influenza virus.

Each year new types of influenzavirus can appear, so every yearINFLUVAC TETRA is changed tocontain fragments of the new types ofvirus. Therefore, influenzavaccination is recommended everyyear.

Please note that INFLUVACTETRA will only protect youagainst the four types of influenzavirus used to make the vaccine. It

will not protect you from influenzacaused by other types of influenzavirus or from infections with otheragents causing flu-like symptoms(such as the common cold).

Influenza is an infectious illness.Influenza is spread by small dropletsfrom the nose, throat or mouth of aninfected person. Symptoms ofinfluenza begin 48 hours aftercoming into contact with the virus.These consist of chills, fever,generalised aches and pains,headache and respiratory symptoms(sore throat, runny nose, cough). Theseverity and type of symptoms canvary. Most people recovercompletely within a week. The riskof serious complications (e.g.pneumonia and death) is greater invery young, very old and chronicallyill persons.

INFLUVAC TETRA can be used inadults over the age of 18 years.

Talk to your doctor if you have anyquestions.

Before you receiveInfluvac Tetra

Do not have INFLUVAC TETRAif:

• you have had an allergic reactionto INFLUVAC TETRA, or anyingredient listed at the end of thisleaflet

Signs of an allergic reaction mayinclude itchy skin rash, shortnessof breath and swelling of the faceor tongue.

• you have had an allergic reactionor became unwell after any other

influenza vaccine (e.g. Fluvax,Vaxigrip, Fluarix Tetra etc.)

• you are allergic to chickenproteins such as in eggs orfeathers.

• you are allergic to gentamicin

• you have a severe infection with ahigh temperature. Vaccinationshould be postponed until afteryou have recovered.

A minor infection such as a coldshould not be a problem, but talkto your doctor or nurse about thisbefore being vaccinated.

• the expiry date printed on thepack has passed.

• the packaging is torn or showssigns of tampering.

Talk to your doctor or nurse if youare not sure whether you shouldhave INFLUVAC TETRA.

Do not give this vaccine to anyoneelse.

Your doctor has prescribed itspecifically for you.

Before having INFLUVACTETRA

Tell your doctor if:

• you have been allergic to anyother medicines, foods, dyes orpreservatives

• you have had INFLUVACTETRA before and becameunwell, tell your doctor, nurse orpharmacist before the next dose isgiven

• you are pregnant or intend tobecome pregnant. Your doctorwill discuss with you the benefitsand risks of taking INFLUVACTETRA when pregnant

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• you are breast feeding

Your doctor will discuss the risksand benefits of vaccination,however the vaccine is notexpected to cause problems forbreast-fed babies

• you have ever had an illnessaffecting the nervous system,especially Guillain-BarreSyndrome (GBS)

If you have had GBS, you may bemore likely to develop GBSfollowing influenza vaccinationthan someone who has never hadGBS.

• you have any medical conditions,such as an immune deficiencycondition or a bleeding disorder.

Interactions with othermedicines

Tell your doctor if you are takingany other medicines, including anythat you buy without aprescription from a pharmacy,supermarket or health food shop,or have received another vaccine.

How Influvac Tetra isgiven

The doctor or nurse will giveINFLUVAC TETRA as an injection.

Talk to your doctor, nurse orpharmacist if you have anyconcerns about how this vaccine isto be given.

How much is given

Adults over 18 years of age: 0.5 mL

How it is given

The injection may be given in theupper arm muscle.

For some people with bleedingproblems, the injection may need tobe given under the skin(subcutaneously).

INFLUVAC TETRA should neverbe given intravenously.

When it is given

For adults INFLUVAC TETRA isgenerally given as a single dose inautumn each year before the start ofthe influenza season.

Vaccination should be repeated everyyear as new types of influenza viruscan appear each year.

If a dose is missed

Talk to your doctor or nurse andarrange another visit as soon aspossible.

After receivingInfluvac Tetra

Things to be careful of

Be careful driving or operatingmachinery until you know howINFLUVAC TETRA affects you.

INFLUVAC TETRA should notnormally interfere with your abilityto drive a car or operate machinery.But in some people vaccination cancause dizziness or light-headedness.Make sure you know how you reactto INFLUVAC TETRA before youdrive a car, operate machinery, or doanything that could be dangerous ifyou are dizzy or light-headed.

Side effects

Tell your doctor, nurse orpharmacist as soon as possible ifyou do not feel well during or afterhaving had a dose of INFLUVACTETRA.

INFLUVAC TETRA helps protectmost people from influenza, but itmay have unwanted side effects in afew people. All medicines andvaccines can have side effects.Sometimes they are serious; most ofthe time they are not. Some sideeffects may need medical treatment.

Ask your doctor, nurse orpharmacist to answer anyquestions you may have.

Most unwanted effects withINFLUVAC TETRA are mild andusually clear up within a few days.These effects, as with other vaccines,generally occur around the injectionsite.

MILD EVENTS

Tell your doctor as soon as possibleif you notice any of the following:

• redness, swelling, a hard lump,soreness, bruising or itchingaround the injection site

• fever, chills, headache, malaise(generally unwell)

• muscle aches and pains

MORE SERIOUS EFFECTSTHAT MAY OCCUR RARELY

As with all vaccines given byinjection there is a very small riskof serious allergic reaction. Tellyour doctor immediately, or go toAccident and Emergency at yournearest hospital, if you notice anyof the following:

• swelling of limbs, face, eyes,inside of nose, mouth or throat

• shortness of breath, breathing orswallowing difficulties

• hives, itching (especially of thehands or feet), reddening of skin(especially around the ears), orsevere skin reactions

• unusual tiredness or weaknessthat is sudden and severe.

As with all vaccines given byinjection there is a very small risk ofsuch reactions. Allergy toINFLUVAC TETRA is rare. Anysuch severe reactions will usuallyoccur within the first few hours ofvaccination.

Tell your doctor if you noticeanything else that is making youfeel unwell.

Other side effects not listed abovemay occur during or soon after adose of vaccine.

Do not be alarmed by this list ofpossible side effects.

You may not experience any of them.

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Storage

INFLUVAC TETRA is usuallystored at the pharmacy or at thedoctor's clinic or surgery.

If you need to store the vaccine,always:

• Keep INFLUVAC TETRA inthe refrigerator stored between+2°C and +8°C. THE PACKSHOULD NEVER BEFROZEN. FREEZINGDESTROYS THE VACCINE.

• Keep the vaccine out of thereach of children.

• Keep INFLUVAC TETRA inthe original pack until it is timefor it to be given.

Ask your pharmacist what to dowith any left over INFLUVACTETRA that has expired or has notbeen used.

Product Description

What it looks like

INFLUVAC TETRA is a clear,colourless liquid.

Packs of 1 or 10 pre-filled (0.5 mL)glass syringes.

Ingredients

Each 0.5 mL dose of INFLUVACTETRA contains four types ofinfluenza virus fragments in aphosphate buffered salt solution.

• H1N1 strain 15 micrograms

• H3N2 strain 15 micrograms

• B strain 15 micrograms

• B strain 15 micrograms

And:

• potassium chloride, monobasicpotassium phosphate, dibasicsodium phosphate dihydrate,sodium chloride, calcium chloridedihydrate, magnesium chloridehexahydrate and water forinjections.

The vaccine also contains limitedquantities of egg protein (ovalbuminor chicken proteins), formaldehyde,cetrimonium bromide, sodiumcitrate, sucrose, gentamicin sulfate,traces of tylosine tartrate,hydrocortisone and polysorbate 80.

INFLUVAC TETRA is not madewith any human blood or bloodproducts, or any other substances ofhuman origin.

Sponsor

INFLUVAC TETRA ismanufactured in The Netherlands for:

Mylan Health Pty Ltd

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point, NSW 2000 Australia

Telephone: 1800 314 527

Registration numbers:

AUST R 292237

AUST R 292238

AUST R 281035

This leaflet was prepared:

16 February 2018

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