UK abbreviated prescribing information
Enzira® Suspension for Injection, pre-filled syringe Influenza Vaccine (Split Virion, inactivated) Influenza vaccine (split virion, inactivated), pre-filled syringe
Presentation
Each 0.5 ml dose contains 15 micrograms of each of three purified influenza virus antigens prepared from the strains of influenza virus that comply with the WHO recommendations (northern hemisphere) and EU decision for the current season.
Indications
Prophylaxis of influenza, especially in those groups who run an increased risk of associated complications. The use of Enzira should be based on official recommendations.
Dosage and administration
Adults and children from 5 years: 0.5 ml. 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. Immunisation should be carried out by intramuscular or deep subcutaneous injection.
Contra-indications
Hypersensitivity to the active substances, to any of the excipients and to eggs and/or chicken proteins (which includes ovalbumin = 1 µg /dose), neomycin and polymyxin. Immunisation shall be postponed in patients with febrile illness or acute infection.
Warnings and precautions
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)*.
However, the vaccine is recommended for use in children only from 5 years of age. (*estimated from epidemiological investigations).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic event following administration of the vaccine. Enzira®/Influenza Vaccine (Split Virion, inactivated) Ph.Eur should under no circumstances be administered intravascularly. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Interactions
Enzira®/Influenza Vaccine (Split Virion, inactivated) Ph.Eur 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 results. The transient false positive reactions could be due to the IgM response to the vaccine.
Pregnancy and lactation
Limited data from vaccination 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. Enzira®/Influenza Vaccine (Split Virion, inactivated) Ph.Eur may be used during lactation.
Side effects
Adverse reactions observed from clinical trials: Commonly reported are administration site conditions (for example redness, swelling, or pain), ecchymosis, induration, fever, malaise, shivering, fatigue, headache, sweating, myalgia and arthralgia. Adverse reactions from post marketing surveillance: Generalised skin reactions including pruritus, urticaria and non-specific rash. Neuralgia, paraesthesia, convulsions (including febrile convulsions), neurological disorders including encephalomyelitis, neuritis and Guillain-Barré syndrome. Transient thrombocytopenia and transient lymphadenopathy. Allergic reactions, in rare cases leading to anaphylactic shock and angioedema. Vasculitis associated in very rare cases with transient renal involvement.
Legal Category: POM.
Package Quantities: Packs of 1 or 10 pre-filled syringes with
25G 5/8” needles
Product Licence Number for Enzira and Influenza Vaccine (Split Virion, inactivated) Ph.Eur: PL 22236/0001
Basic NHS Cost for Enzira: 0.5ml disposable syringe £6.33, 10 pack £63.30 Basic NHS Cost for Influenza Vaccine (Split Virion, inactivated)
Ph.Eur: 0.5ml disposable syringe £4.40, 10 pack £44.00
For full prescribing information and details of other side effects see Summary of Product Characteristics.
Further information is available on request from the Medical Information Department at Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK.
Marketing Authorisation Holder: CSL Biotherapies GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany. Further information is available on request.
Date of Prescribing Information: November 2010
Doc ID: 62474
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk. Adverse events should also be reported to Pfizer Medical Information on 01304 616161
Further information on adverse event reporting can be found by clicking here.
Summary of Product Characteristics can be found on electronic Medicines Compendium (eMC) click here to view.