INFLUVAC

Main information

  • Trade name:
  • INFLUVAC inactivated influenza 0.5 mL vaccine long syringe with 16 mm needle 2017
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INFLUVAC inactivated influenza 0.5 mL vaccine long syringe with 16 mm needle 2017
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215555
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215555

INFLUVAC inactivated influenza 0.5 mL vaccine long syringe with 16 mm needle

ARTG entry for

Medicine Registered

Sponsor

Mylan Health Pty Ltd

Postal Address

Level 1 30 The Bond,30-34 Hickson Road,Millers Point, NSW, 2000

Australia

ARTG Start Date

24/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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. INFLUVAC inactivated influenza 0.5 mL vaccine long syringe with 16 mm needle 2017

Product Type

Single Medicine Product

Effective date

3/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the prevention of influenza caused by influenza virus, types A and B. For full details regarding recommendations for influenza vaccination, please

refer to the relevant National Immunistaion Guidelines.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

syringe

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Subcutaneous

Visual Identification

CLEAR, COLOURLESS LIQUID.

Active Ingredients

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

Influenza virus haemagglutinin

15 microgram

© 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 1 of

Produced at 26.11.2017 at 08:33:30 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

Influvac

®

Inactivated influenza vaccine [surface antigen]

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some of the

common questions about Influvac

vaccine. It does not contain all the

available information. It does not

take the place of talking to your

doctor or pharmacist. Please read it

carefully and keep it for future

reference.

All medicines and vaccines have

risks and benefits. Your doctor has

weighed the possible risks of you

having Influvac against the expected

benefits.

Talk to your doctor, nurse or

pharmacist if you have any

concerns about receiving Influvac.

Your doctor and pharmacist have

more information.

WHAT INFLUVAC IS

USED FOR

Influvac is used to prevent certain

types of influenza (commonly called

flu). The vaccine works by causing

the body to produce its own

protection (antibodies) against three

different types of influenza virus.

Each year new types of influenza

virus can appear, so every year

Influvac is changed to contain

fragments of the new types of virus.

Therefore, influenza vaccination is

recommended every year.

Please note that Influvac will only

protect you against the three 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).

Influenza is an infectious illness.

Influenza is spread by small droplets

from the nose, throat or mouth of an

infected person. Symptoms of

influenza begin 48 hours after

coming into contact with the virus.

These consist of chills, fever,

generalised aches and pains,

headache and respiratory symptoms

(sore throat, runny nose, cough). The

severity and type of symptoms can

vary. 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.

Influvac can be used in adults and in

children over the age of 6 months.

For full details regarding

recommendations for influenza

vaccination, please refer to the

relevant National Immunisation

Guidelines.

Influvac may also be prescribed for

other persons at risk of influenza

infection.

Talk to your doctor if you have any

questions.

BEFORE YOU

RECEIVE INFLUVAC

Do not have Influvac if:

you have had an allergic reaction

to Influvac, or any ingredient

contained in this vaccine. The

ingredients are listed at the end of

this leaflet

Signs of an allergic reaction may

include itchy skin rash, shortness

of breath and swelling of the face

or tongue.

you have had an allergic reaction

or became unwell after any other

influenza vaccine (Fluvax or

Fluarix or Fluvirin or Vaxigrip)

you are allergic to chicken

proteins such as in eggs or

feathers

you are allergic to gentamicin

you have a severe infection with a

high temperature

A minor infection such as a cold

should not be a problem, but talk

to your doctor or nurse about this

before being vaccinated.

the expiry date printed on the

pack has passed

the packaging is torn or shows

signs of tampering.

Talk to your doctor or nurse if you

are not sure whether you should

have Influvac.

Do not give this vaccine to anyone

else.

Your doctor has prescribed it

specifically for you.

Before having Influvac

Tell your doctor if:

you have been allergic to any

other medicines, foods, dyes or

preservatives

you have had Influvac before and

became unwell, tell your doctor,

nurse or pharmacist before the

next dose is given

you are pregnant or intend to

become pregnant. Your doctor

will discuss with you the benefits

INFLUVAC

and risks of taking Influvac when

pregnant

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 have ever had an illness

affecting the nervous system,

especially Guillain-Barre

Syndrome (GBS)

If you have had GBS, you may be

more likely to develop GBS

following influenza vaccination

than someone who has never had

GBS.

you have any medical conditions,

such as an immune deficiency

condition or a bleeding disorder.

Interactions with other

medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from a pharmacy,

supermarket or health food shop,

or have received another vaccine.

HOW INFLUVAC IS

GIVEN

The doctor or nurse will give

Influvac as an injection.

Talk to your doctor, nurse or

pharmacist if you have any

concerns about how this vaccine is

to be given.

How much is given

Adults and children over the age of

36 months: 0.5 mL

Children from 6 to 35 months: 0.25

How it is given

The injection may be given in the

upper arm muscle.

For some people with bleeding

problems, the injection may need to

be given under the skin

(subcutaneously).

Influvac should never be given

intravenously.

When it is given

Influvac is generally given as a single

dose each year during autumn.

For some people, particularly those

with low immunity, and children

(aged 6 months to 9 years) who are

receiving influenza vaccination for

the first time, a second dose should

be given 4 weeks after the first dose.

However, one dose is sufficient for

most people and especially those

who have been vaccinated against

influenza in an earlier year.

If a dose is missed

Talk to your doctor or nurse and

arrange another visit as soon as

possible.

AFTER RECEIVING

INFLUVAC

Things to be careful of

Be careful driving or operating

machinery until you know how

Influvac affects you.

Influvac 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

Influvac before you drive a car,

operate machinery, or do anything

that could be dangerous if you are

dizzy or light-headed.

SIDE EFFECTS

Tell your doctor, nurse or

pharmacist as soon as possible if

you do not feel well during or after

having had a dose of Influvac.

Influvac 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 Influvac

are mild and usually clear up within a

few days. These effects, as with other

vaccines, generally occur around the

injection site.

MILD EVENTS

Tell your doctor as soon as possible

if you notice any of the following:

redness, swelling, a hard lump,

soreness, bruising or itching

around the injection site

fever, chills, headache, malaise

(generally unwell)

muscle aches and pains

MORE SERIOUS EFFECTS

THAT MAY OCCUR RARELY

As with all vaccines given by

injection there is a very small risk

of serious allergic reaction. Tell

your doctor immediately, or go to

Accident and Emergency at your

nearest hospital, if you notice any

of the following:

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.

As with all vaccines given by

injection there is a very small risk of

such reactions. Allergy to Influvac is

rare. Any such severe reactions will

usually occur within the first few

hours of vaccination.

Tell your doctor if you notice

anything else that is making you

feel unwell.

INFLUVAC

Other side effects not listed above

may occur during or soon after a

dose of vaccine.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

STORAGE

Influvac is usually stored at the

pharmacy or at the doctor's clinic or

surgery.

If you need to store the vaccine,

always:

Keep Influvac in the

refrigerator stored between

+2°C and +8°C. THE PACK

SHOULD NEVER BE

FROZEN. FREEZING

DESTROYS THE VACCINE.

Keep the vaccine out of the

reach of children.

Keep Influvac in the original

pack until it is time for it to be

given.

Ask your pharmacist what to do

with any left over Influvac that has

expired or has not been used.

PRODUCT

DESCRIPTION

What it looks like

Influvac is a clear, colourless liquid.

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

glass syringes. AUST R 215555

Ingredients

Each 0.5 mL dose of Influvac

contains three types of influenza

virus fragments in a phosphate

buffered salt solution.

H1N1 strain 15 micrograms

H3N2 strain 15 micrograms

B strain 15 micrograms

And:

potassium chloride, monobasic

potassium phosphate, dibasic

sodium phosphate, sodium

chloride, calcium chloride

dihydrate, magnesium chloride

hexahydrate and water for

injections.

The vaccine also contains limited

quantities of egg protein,

formaldehyde, cetrimonium bromide,

polysorbate 80 and gentamicin.

Influvac is not made with any human

blood or blood products, or any other

substances of human origin.

Sponsor

Influvac is manufactured in The

Netherlands for:

BGP Products Pty Ltd

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Australia

This leaflet was prepared:

December 2016

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