IMUVAC
Imuvac 2009/2010, suspension for injection in prefilled syringe
Influenza vaccine (surface antigen, inactivated)
Read all of this leaflet carefully before you or your child is vaccinated.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This vaccine has been prescribed for you or your child. Do not pass it on to others.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
- 1 WHAT IMUVAC IS AND WHAT IT IS USED FOR
- 2 BEFORE YOU OR YOUR CHILD USE IMUVAC
- 3 HOW TO USE IMUVAC
- 4 POSSIBLE SIDE EFFECTS
- 5 HOW TO STORE IMUVAC
- 6 FURTHER INFORMATION
What Imuvac Is And What It Is Used For
Imuvac is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. The use of Imuvac should be based on official recommendations.
When a person is given the vaccine Imuvac, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child was not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.
Imuvac will protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection.
The incubation period for flu is a few days, so if you are exposed to flu immediately before or after your vaccination, you could still develop the illness.
The vaccine will not protect you against the common cold, even though some of the symptoms are similar to flu.
Before You Or Your Child Use Imuvac
To make sure that Imuvac is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use Imuvac
- If you or your child is allergic (hypersensitive) to the active substances, to any of the ingredients of Imuvac, to eggs, to chicken proteins, to gentamicin (an antibiotic that is used to treat bacterial infections), to formaldehyde, to cetryltrimethylammoniumbromide or to polysorbate 80 (For other ingredients of Imuvac, see section 6 “Further information”).
- If you or your child has an illness with a high temperature or acute infection, the vaccination shall be postponed until after you or your child has recovered.
Take special care with Imuvac
You should tell your doctor before vaccination if you or your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system).
Your doctor will decide if you or your child should receive the vaccine.
If, for any reason, you or your child has a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
As with all vaccines, Imuvac may not fully protect all persons who are vaccinated.
Using other medicines
- Please tell your doctor or pharmacist if you or your child is taking or has recently taken other vaccines or any other medicines, including medicines obtained without a prescription.
- Imuvac can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be stronger.
- The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Limited data from flu vaccinations in pregnant women do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Imuvac may be used during breast-feeding.
Your doctor/pharmacist will be able to decide if you should receive Imuvac.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
The vaccine is unlikely to affect your ability to drive or use machines.
How To Use Imuvac
Dosage
Adults and children aged from 36 months receive one 0.5 ml dose.
Children from 6 months to 35 months may receive one 0.25 ml dose or one 0.5 ml dose.
If your child has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.
Method and/or route(s) of administration
Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Imuvac can cause side effects, although not everybody gets them.
During clinical trials, the following side effects have been observed. Their frequencies have been estimated as Common: affects 1 to 10 users in 100.
- headache
- sweating
- muscular pain (myalgia), joint pain (arthralgia)
- fever, generally feeling unwell (malaise), shivering, fatigue
- local reactions: redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected.
These reactions usually disappear within 1-2 days without treatment.
Next to the above common side effects, the following side effects occurred after the vaccine came on the market:
- allergic reactions:
- leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock) in rare cases
- swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases
- skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash
- blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems
- pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the
limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrom) - temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin
(transient lymphadenopathy)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Imuvac
Keep out of the reach and sight of children.
Do not use Imuvac after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store Imuvac in a refrigerator (+ 2 °C to + 8 °C). Do not freeze.
Store the product in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
The active substances are haemagglutinin and neuraminidase antigens of three different Influenza viruses
A/Brisbane/59/2007 (H1N1)-like strain (A/Brisbane/59/2007 IVR-148 reass.) 15 micrograms HA**
A/Brisbane/10/2007 (H3N2)-like strain (A/Uruguay/716/2007 NYMC X-175C reass.) 15 micrograms HA**
B/Brisbane/60/2008-like strain (B/Brisbane/60/2008) 15 micrograms HA**
Per 0.5 ml dose
* propagated in fertilised hens’eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern hemisphere) and EU decision for the 2009/2010 season.
The other ingredients are potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride, magnesium chloride hexahydrate and water for injections.
What Imuvac looks like and contents of the pack
Imuvac is a suspension for injection presented in prefilled glass syringe (with / without needle) containing 0.5 ml of a colourless clear injection fluid. Each syringe can only be used once.
Pack size of 1 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
Distributed in the UK by:
Registration number: PL 00512/0188
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Fluvaccinol Subunit Impfstoff Injektionssuspension
Bulgaria, Netherlands: Vacciflu 2009/2010
Germany: Grippe-Impfstoff STADAN 2009/2010
Belgium, Spain: Serinflu
United Kingdom: Imuvac 2009/2010
This leaflet was last amended in: September 2009
For information in large print, tape, CD or Braille, phone 02380 467000.
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