Enzira^® Suspension for injection, pre-filled syringe

Influenza vaccine (split virion, inactivated)

Influenza vaccine (split virion, inactivated), pre-filled syringe

Split influenza virus* (inactivated with β-Propiolactone) of the following strains:

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 2011/2012 season.

For a full list of excipients, see section 6.1.

Suspension for injection in a pre-filled syringe.

Clear to slightly opaque liquid with some sediment that resuspends upon shaking.

Prophylaxis of influenza, especially in those who run an increased risk of associated complications.

The use of Enzira/Influenza vaccine (split virion, inactivated) should be based on official recommendations.

Posology

For children aged less than 9 years, who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Method of administration

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

For instructions for preparation, see section 6.6.

Hypersensitivity to the active substances, to any of the excipients (see section 6.1), to eggs, ovalbumin or chicken proteins.

The vaccine may contain residues of the following substances: neomycin, polymyxin.

Immunisation shall be postponed in patients with febrile illness or acute infection.

During the 2010 Southern Hemisphere influenza season, there was an unexpected increase in reports of fever and febrile convulsions in children aged less than 5 years following seasonal influenza vaccination with the flu vaccine of the same strain composition as contained in this product. Febrile convulsions were reported uncommonly (i.e. reporting frequency estimated to be in the range 1/1000 to < 1/100)*.

An increased number of reports of fever was also reported in the age group 5 to less than 9 years. On the basis of the increased risk of febrile convulsions in children less than 5 years of age, the vaccine indication has been restricted to use in adults and children from 5 years of age only.

(*estimated from epidemiological investigations).

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.

Enzira/Influenza vaccine (split virion, inactivated) should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

Enzira/Influenza vaccine (split virion, inactivated) may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

Following influenza vaccination, false positive results in serological tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response to the vaccine.

Pregnancy

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. 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 influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Lactation

Enzira/Influenza vaccine (split virion, inactivated) may be used during lactation.

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

Adverse reactions observed from clinical trials

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirements, including at least 50 adults aged 18 – 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first three days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies: Very common (>1/10), common (1/100, <1/10), uncommon (1/1,000, <1/100), rare (1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.

* These reactions usually disappear within 1-2 days without treatment

Adverse reactions reported from post-marketing surveillance

Adverse reactions reported from post marketing surveillance are, in addition to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders

Allergic reactions, in rare cases leading to anaphylactic shock, angioedema

Nervous system disorders

Neuralgia, paraesthesia, convulsions (including febrile convulsions)

Neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barré syndrome

Vascular disorders

Vasculitis associated in very rare cases with transient renal involvement

Skin and subcutaneous tissue disorders

Generalised skin reactions including pruritus, urticaria or non-specific rash

Overdosage is unlikely to have any untoward effects.

Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07B B02

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6 to 12 months.

Not applicable.

Not applicable.

Sodium chloride

Anhydrous disodium phosphate

Sodium dihydrogen phosphate dihydrate

Potassium chloride

Potassium dihydrogen phosphate

Calcium chloride

Water for injection

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

15 months.

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.

0.5 ml suspension in pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) with or without attached needle in pack sizes of 1 or 10, respectively.

Not all pack sizes may be marketed.

The vaccine should be allowed to reach room temperature before use. Shake before use. After shaking, the vaccine should appear as a homogenous suspension. The vaccine must be inspected visually prior to administration and should not be used if there is any variation of physical appearance (see section 3).

Enzira/Influenza vaccine (split virion, inactivated) is presented as a single use syringe and any remaining contents should be disposed of in accordance with local requirements.

CSL Biotherapies GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

PL 22236/0001

19 April 2005 / 29 March 2009

15 July 2011

Ref: EZ 3_0