- influenza vaccine (surface antigen, inactivated)
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL46302/0039.
Imuvac 2017/2018 (Distributed by Masta)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Imuvac®, suspension for injection
(influenza vaccine, surface antigen, inactivated)
Read all of this leaflet carefully before you or your child are vaccinated, because it contains important information for you and your child.
In this leaflet
1 WHAT IMUVAC IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD USE IMUVAC
3 HOW TO USE IMUVAC
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE IMUVAC
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1. 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 people 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 or your child 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 were 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 or your child are exposed to flu immediately before or after your vaccination, you or your child could still develop the illness.
The vaccine will not protect you or your child against the common cold, even though some of the symptoms are similar to flu.
2. WHAT YOU NEED TO KNOW 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
Warnings and precautions
You should tell your doctor before vaccination if you or your child have a poor immune response (immunodeficiency or taking medicines affecting the immune system).
Fainting, feeling faint or other stress related reactions can occur following, or even before, any needle injection. Therefore tell your doctor or nurse if you have experienced this kind of reaction with a previous injection.
Your doctor will decide if you or your child should receive the vaccine.
If, for any reason, you or your child have 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.
Other medicines and Imuvac
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Flu vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of flu vaccines do not indicate that the vaccine would have harmful effects on the pregnancy or the baby.
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
Imuvac has no or negligible influence on the ability to drive or use machines.
3. HOW TO USE IMUVAC
Adults receive one 0.5 ml dose.
Use in children
Children from 36 months and older receive one 0.5 ml dose.
Children from 6 months to 35 months may receive either one 0.25 ml dose or one 0.5 ml dose in accordance with existing national recommendations.
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.
4. 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:
These reactions usually disappear within 1-2 days without treatment.
In addition to the above common side effects, the following side effects have been reported since the vaccine came on the market:
Reporting of side effects
If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE IMUVAC
Keep out of the sight and reach 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Imuvac contains
The active substances are:
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:
per 0.5 ml dose
* propagated in fertilised hens'eggs from healthy chicken flocks
This vaccine complies with the World Health Organisation (WHO) recommendation (Northern hemisphere) and EU recommendation for the 2017/2018 season.
The other ingredients are potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
What Imuvac looks like and contents of the pack
Imuvac is a suspension for injection presented in a 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:
Distributed in the UK by:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria FluVaccinol Subunit Impfstoff
Germany Grippe-Impfstoff STADA N
United Kingdom Imuvac
This leaflet was last revised in April 2017
20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
+44 (0)1707 853000
+44 (0)1707 853 000