Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Influvac Junior 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 your child having Influvac Junior against the expected benefits.
Talk to your doctor, nurse or pharmacist if you have any concerns about receiving Influvac Junior. Your doctor and pharmacist have more information.
WHAT INFLUVAC JUNIOR IS USED FOR
Influvac Junior 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 Junior is changed to contain fragments of the new types of virus. Therefore, influenza vaccination is recommended every year.
Please note that Influvac Junior will only protect your child against the three types of influenza virus used to make the vaccine. It will not protect your child 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 Junior is used in children aged 6 months to 35 months.
Annual vaccination against influenza is especially recommended for the following groups:
- Persons over 65 years of age
- Aboriginal and Torres Strait Islander people over 15 years of age
- Persons over 6 months old who suffer from conditions which may increase their risk for severe influenza such as chronic diseases, especially those with diseases of the heart, lung, kidneys or metabolic system (e.g. diabetics), or neurological conditions
- Persons receiving medicines that lower natural immunity, or patients with HIV
- Pregnant women and those planning a pregnancy
- Residents of nursing homes and other chronic care facilities
- Homeless persons and those providing care to them
- Vaccination may also be given to medical, health and other essential services personnel. Staff of nursing homes and other chronic care facilities, providers of home care to high risk patients and household members of high risk patients may also be vaccinated in an attempt to protect the patients
- Persons working in the poultry industry
- Workers in other industries
Influvac Junior may also be prescribed for other persons at risk of influenza infection.
Talk to your doctor if you have any questions.
BEFORE YOUR CHILD IS GIVEN INFLUVAC JUNIOR VACCINE
When your child must not be given Influvac Junior vaccine
Do not give Influvac Junior vaccine if your child has had:
- an allergic reaction to Influvac Junior, 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.
- an allergic reaction or became unwell after any other influenza vaccine (Fluvax or Fluarix or Fluvirin or Vaxigrip)
- an allergy to chicken proteins such as in eggs or feathers
- an allergy to gentamicin
- a severe infection with a high temperature
Do not give Influvac Junior vaccine if the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.
Talk to your doctor or nurse if you are not sure whether your child should have Influvac Junior.
Tell your doctor if in the past your child has reacted to vaccination with any of the following:
- severe allergic reaction
- difficulty breathing
- fainting or collapse
- high temperature
- severe skin reaction at the injection site
Tell your doctor if in the past your child has had any medical conditions such as:
- an illness affecting the nervous system, especially Guillain-Barre Syndrome (GBS)
- blood disorders
- low immunity due to HIV/AIDS or cancer therapy
Taking other medicines
Tell your doctor if your child is taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop, or has received another vaccine.
The usual dose of some medicines that your child is taking may be affected after administration of Influvac Junior vaccine. These medicines include:
- carbamazepine, used in epilepsy or convulsions
- phenobarbitone, used in epilepsy or convulsions, anxiety, insomnia
- phenytoin, used in epilepsy or convulsions
- theophylline, used for asthma
- warfarin, used to prevent blood clots.
HOW INFLUVAC JUNIOR IS GIVEN
The doctor or nurse will give Influvac Junior as an injection.
In babies under 12 months of age Influvac Junior vaccine is usually given in the upper thigh.
In children 12 months or older it may be injected into the upper arm.
Talk to your doctor, nurse or pharmacist if you have any concerns about how this vaccine is to be given.
How much is given
Children from 6 to 35 months: 0.25 mL
Influvac Junior should never be given intravenously.
When it is given
Influvac Junior is generally given as a single dose each year during autumn.
It is recommended a second dose be given 4 weeks after the first dose if:
- your child is being given Influvac Junior for the first time
- your child has low immunity
One dose is sufficient for most children and especially those who have been vaccinated against influenza in an earlier year.
If a dose is missed
If a second dose of Influvac Junior was recommended for your child by the doctor and it has been missed, talk to your doctor or nurse and arrange another visit as soon as possible.
AFTER HAVING INFLUVAC JUNIOR VACCINE
Things you must do for your child
Keep an updated record of your child’s vaccinations.
Keep any follow-up appointments for your child with your doctor or clinic. It is important to have your child’s second injection of Influvac Junior vaccine at the appropriate time. This ensures the vaccine has the best chance of providing protection against “the flu”.
If your child develops any medical problems after being given Influvac Junior vaccine, tell your doctor.
Tell your doctor, nurse or pharmacist as soon as possible if your child feels unwell after having Influvac Junior vaccine. Influvac Junior 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 Junior 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 as soon as possible if you notice any of the following in your child:
- 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 Junior 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 makes your child feel unwell. 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. Your child may not experience any of them.
Influvac Junior is usually stored at the pharmacy or at the doctor’s clinic or surgery.
If you need to store the vaccine, always:
- Keep Influvac Junior 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 Junior in the original pack until it is time for it to be given.
Ask your pharmacist what to do with any left over Influvac Junior that has expired or has not been used.
What it looks like
Influvac Junior is a clear, colourless, liquid.
Packs of 1 or 10 pre-filled (0.25 mL) glass syringes. AUST R 164381
Each 0.25 mL dose of Influvac Junior contains three types of influenza virus fragments for Southern Hemisphere winter, in a phosphate buffered salt solution.
- H1N1 strain 7.5 micrograms
- H3N2 strain 7.5 micrograms
- B strain 7.5 micrograms
- potassium chloride, potassium dihydrogen phosphate, sodium phosphate-dibasic dihydrate, sodium chloride, calcium chloride, magnesium chloride and water for injections.
The vaccine also contains limited quantities of egg protein, formaldehyde, cetrimonium bromide, polysorbate 80 and gentamicin.
Influvac Junior is not made with any human blood or blood products, or any other substances of human origin.
Influvac Junior is manufactured in The Netherlands for:
Abbott Australasia Pty Ltd
32-34 Lord Street
Botany NSW 2019 Australia
This leaflet was prepared: November 2012
Published by MIMS April 2013