What is a Patient Information Leaflet and why is it useful?

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)

2017/2018 season

Read all of this leaflet carefully before you or your child are vaccinated, because it contains important information for you and your child.

  • 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 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. See section 4.

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

  • If you or your child are allergic (hypersensitive) to:
    • the active substances, or
    • any of the other ingredients of Imuvac (see section 6), or
    • any component that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic that is used to treat bacterial infections)
  • If you or your child have an illness with a high temperature or acute infection, the vaccination shall be postponed until after you or your child have recovered.

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

  • Please tell your doctor or pharmacist if you or your child are taking or have 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.

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

Dosage

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:

  • 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.

In addition to the above common side effects, the following side effects have been reported since 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) and 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 and paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrome)
  • 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) and temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy)

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*:

  • A/Michigan/45/2015 (H1N1)pdm09-like strain
    (A/Singapore/GP1908/2015, IVR-180) 15 micrograms HA**
  • A/Hong Kong/4801/2014 (H3N2)-like strain
    (A/Hong Kong/4801/2014, NYMC X-263B) 15 micrograms HA**
  • B/Brisbane/60/2008-like strain
    (B/Brisbane/60/2008, wild type) 15 micrograms HA **

per 0.5 ml dose

* propagated in fertilised hens'eggs from healthy chicken flocks

** haemagglutinin

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:

Mylan Products Ltd.
20 Station Close
Potters Bar
Herts
EN6 1TL
UK

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
NL - 8121 AA Olst
The Netherlands

Distributed in the UK by:

MASTA Ltd
City Exchange
11, Albion Street
Leeds
LS1 5ES
United Kingdom

Registration number:

PL 46302/0039

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

Netherlands Vacciflu

United Kingdom Imuvac

This leaflet was last revised in April 2017

1110416