TACTICS ! Because we know that planning to
vaccinate your at-risk patients can seem like a military operation, we’re giving you all the back up we can this fl u season. Talk to your local Sanofi Pasteur MSD Vaccine Account Manager about our range of fl u support materials or visit www.fl
u-protect.co.uk
ABRIDGED PRESCRIBING INFORMATION Inactivated Infl uenza Vaccine (Split Virion) BP
Refer to Summary of Product Characteristics for full product information. Presentation: Inactivated Infl uenza Vaccine (Split Virion) BP contains 15 micrograms of antigen (per 0.5 millilitre) from each of the three virus strains recommended by the World Health Organization for the present infl uenza season. It is supplied as single dose prefi lled syringes each containing 0.5 millilitre of suspension for injection. The vaccine may contain traces of eggs, such as ovalbumin, neomycin, formaldehyde and octoxinol 9 which are used during the manufacturing process. Indications: Prophylaxis of infl uenza especially in those who run an increased risk of associated complications. Inactivated Infl uenza Vaccine (Split Virion) BP is indicated in adults and children from 6 months of age. Dosage and administration: Adults and children from 36 months should receive one 0.5 millilitre dose. In children aged 6 months to 35 months clinical data are limited and dosages of 0.25 or 0.5 millilitre have been used. Children who have not been previously vaccinated should receive a second dose of vaccine after an interval of at least 4 weeks. Doses should be administered intramuscularly or deep subcutaneously. Contraindications: Hypersensitivity to
the active substances, to any of the excipients, to eggs, chicken protein, neomycin, formaldehyde, and octoxinol 9. Immunisation should be postponed in patients with febrile illness or acute infection. Warnings and precautions: Do not administer intravascularly. Medical treatment should be available in the event of rare anaphylactic reactions following administration of the vaccine. Immunosuppressed subjects may not produce adequate antibodies. Other vaccines may be given at the same time at different sites, however adverse reactions may be intensifi ed. Pregnancy and lactation: Inactivated infl uenza vaccines can be used in all stages of pregnancy. May be administered during lactation. Undesirable effects: Common side effects include: injection site reactions (redness, swelling, pain, ecchymosis, induration) and systemic reactions (fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia). These usually disappear within 1 to 2 days. Other serious side effects have been reported and include, allergic reactions (in rare cases leading to shock, angioedema), convulsions, transient thrombocytopenia, vasculitis with transient renal involvement and neurological disorders such as encephalomyelitis, neuritis and
Guillain-Barré syndrome. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities and basic NHS cost: Single dose prefi lled syringes in single packs, basic NHS cost £6.59; packs of 10 single dose prefi lled syringes, basic NHS cost £65.90. Marketing authorisation holder: Sanofi Pasteur MSD Limited, Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP. Marketing authorisation number: PL 6745/0095 Legal category: POM. Date of last review: April 2012
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard Adverse events should also be reported to
Sanofi Pasteur MSD, telephone number 01628 785291.
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