Wyeth Pharmaceuticals

PACKAGE LEAFLET: INFORMATION FOR THE USER

 

ENZIRA^Ò Suspension for injection, pre-filled syringe

Influenza vaccine (split virion, inactivated) Ph. Eur.

 

Read all of this leaflet carefully before you are given this vaccination.

·      Keep this leaflet. You may need to read it again.

·      If you have any further questions, ask your doctor or pharmacist.

·      This vaccination has been prescribed for yourself, 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 Enzira is and what it is used for

2.  Before you are given Enzira

3.  How to use Enzira

4.  Possible side effects

5.  How to store Enzira

6.  Further information

 

 

1.       WHAT ENZIRA IS AND WHAT IT IS USED FOR

 

Enzira is a suspension for injection in a pre-filled syringe. It contains a vaccine which stimulates the immune system to produce antibodies against influenza. The vaccine is used for prevention of influenza especially in those who run an increased risk of developing complications. The use of Enzira should be based on official recommendations. Full effect of the vaccine is generally achieved 2-3 weeks after the vaccination and the protection is usually maintained for 6 to 12 months.

 

 

2.       BEFORE YOU ARE GIVEN ENZIRA

 

Do not use Enzira

·      If you are hypersensitive (allergic) to any of the ingredients of Enzira or to eggs and/or chicken proteins which includes ovalbumin, or the antibiotics neomycin or polymyxin.

·      If you have previously had an allergic reaction to this vaccine.

·      If you have a high fever or an acute infection.

 

Take special care with Enzira

Enzira will not work well if you suffer from a disease that lowers your immunity.

Inform your doctor if you have any known allergy or have previously had problems with vaccinations.

The vaccine should not be injected directly into a blood vessel.

 

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription. Enzira will not work well if you are taking medications that lower your immunity.

 

Pregnancy and breast-feeding

The experience from vaccinations in pregnant women is limited.  If you are pregnant, ask your doctor for advice before being vaccinated. The vaccine may be given when you are breast-feeding.

 

Driving and using machines

Enzira is unlikely to produce an effect on your ability to drive and use machinery.

 

Important information about some of the ingredients of Enzira

Enzira does not contain more than 1 µg ovalbumin per dose (0.5 ml).

This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium free”.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”.

 

 

3.       HOW TO USE ENZIRA

 

The vaccine is administered by deep injection (subcutaneously) under your skin or into a muscle (intramuscularly) by a doctor or a nurse:

 

·      Adults and children from 36 months:                                     0.5 ml

·      Children from 6 months to 35 months:                                  0.25 ml or 0.5 ml

·      Children who have not previously been vaccinated:             a second dose is given after
                                                                                                 an interval of at least 4 weeks.

 

Other vaccinations can be given at the same time, provided that different injection sites are used. It should be noted that the adverse reactions may be intensified.

 

 

4.       POSSIBLE SIDE EFFECTS

 

Like all vaccines, Enzira can have side effects, although not everybody gets them.

 The following undesirable effects have been reported in clinical studies:

 

Common side effects (in more than 1 out of 100 but fewer than 1 out of 10 vaccinees):

·      Reaction around the injection site (such as redness, pain, swelling), unusual purplish patches on the skin, hardening of skin at injection site,

·      Fever, feeling generally unwell, chills, tiredness,

·      Headache, dizziness,

·      Sweating,

·      Muscle pain or joint pain.

 

Most of these reactions usually disappear within 1 to 2 days without treatment.

 

In addition to the reactions which have been observed during clinical trials, the following adverse reactions have been reported after the introduction of trivalent influenza vaccines to the market:

·      Severe stabbing or throbbing nerve pain,

·      Numbness or a pricking sensation in the arms or legs,

·      Fits,

·      Inflammation of the brain or spinal cord, inflammation of nerves, or Guillain-Barré syndrome, which causes extreme weakness and paralysis,

·      Transient blood coagulation disorder increasing the risk of bleeding or bruising (reduction in blood platelets),

·      Temporary swelling of glands in the neck, armpit and groin (lymph nodes),

·      Allergic reactions (in rare cases leading to anaphylactic shock) such as skin rash or hives, itchiness, swelling of the face, lips, tongue, throat or other parts of the body, tightness of the chest, wheezing, collapse,

·      Blood vessel inflammation with transient kidney involvement and little or no urine passed.

 

If any of the following happen, contact your doctor immediately or go to the Emergency Department at your nearest hospital:

·      A sudden allergic reaction (such as skin rash or hives, itchiness, swelling of the face, lips, tongue, throat or other parts of the body),

·      Shortness of breath, wheezing or trouble breathing,

·      Fits,

·      Little or no urine passed.

 

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.

 

 

5.       HOW TO STORE ENZIRA

 

Keep out of the reach and sight of children.

Do not use Enzira after the expiry date which is stated on the label and carton.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Keep the syringe in the outer carton in order to protect from light.

 

 

6.       FURTHER INFORMATION

 

What Enzira contains

 

The active substance is:

Split influenza virus*, inactivated with β-Propiolactone, containing antigens equivalent to:

A/Brisbane/59/2007 (H1N1) – like strain (A/Brisbane/59/2007 IVR-148)	15 micrograms HA**
A/Brisbane/10/2007 (H3N2) – like strain (A/Uruguay/716/2007 NYMC X-175C)	15 micrograms HA**
B/Florida/4/2006 – like strain (B/Florida/4/2006)	15 micrograms HA**

per 0.5 ml dose.

 

* propagated in fertilised hens' eggs from healthy chicken flocks

** haemagglutinin

 

This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2008/2009 season.

 

Other ingredients are:

sodium chloride, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, potassium chloride, potassium dihydrogen phosphate, calcium chloride and water for injections.

 

What Enzira looks like and contents of the pack

Enzira contains 0.5 ml of suspension for injection in a pre-filled syringe with plunger stopper (chlorobutyl rubber) with attached needle in pack sizes of 1 or 10.

 

The suspension is a clear to slightly opaque liquid with some sediment that resuspends upon shaking.

 

Marketing Authorisation Holder and Manufacturer

CSL Biotherapies GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

 

Distributors:

Wyeth Pharmaceuticals Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire

SL6 0PH, UK

Wyeth Pharmaceuticals Ltd., Plaza 254, Blanchardstown Corporate Park 2, Ballycoolin, Blanchardstown, Dublin 15, Ireland

 

 

This leaflet was last approved in 06/2008