Prescribing Information
INFLUVAC SUB-UNIT AND IMUVAC VACCINES:
PRESCRIBING INFORMATION
Presentation: Influenza vaccine (surface antigen, inactivated) containing the purified haemagglutinin and neuraminidase
antigens prepared from the A and B influenza virus strains recommended by WHO.
Indication: Prophylaxis of influenza.
Dosage and Administration: Adults and children from 36 months: 0.5 ml.
Children from 6-35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.
Children not previously vaccinated require a second dose after an interval of at least 4 weeks.
Immunisation should be by intramuscular or deep subcutaneous injection.
Contraindications, Warnings, Precautions etc:
Contraindications: Hypersensitivity to active ingredients or excipients (see SPC) and to eggs, chicken proteins (such as ovalbumin),
formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin. Postpone immunisation in patients with febrile illness or acute infection.
Warnings/Precautions: Appropriate medical treatment and supervision should be available in case of a rare anaphylactic event.
Not to be administered intravascularly. Antibody response may be insufficient in immunosuppressed patients or those receiving immunosuppressive
treatment.
Drug Interactions: Influvac or Imuvac may be given at the same time as other vaccines, but separate limbs should be used.
Following influenza vaccination, false positive results using the ELISA method to detect HIV1, Hepatitis C and HTLV1 antibodies have been seen.
Immunological response may be reduced in patients on immunosuppressant treatment.
Pregnancy and Lactation: Limited data in pregnant women do not indicate adverse foetal and maternal outcomes. May be used from the
second trimester. Recommended for pregnant women with medical conditions that increase the risk of complications from influenza, irrespective
of their stage of pregnancy. May be given during lactation.
Ability to Drive and Operate Machinery: The vaccine is unlikely to affect your ability to drive or use machines.
Side-effects: Headache, sweating, myalgia, arthralgia, fever, malaise, shivering, fatigue.
Local reactions: redness, swelling, pain, ecchymosis, induration. Transient thrombocytopenia, transient lymphadenopathy, allergic reactions
in rare cases leading to shock, angioedema. Neuralgia, paraesthesia, febrile convulsions, neurological disorders such as encephalomyelitis,
neuritis and Guillain Barré syndrome. Vasculitis associated in rare cases with transient renal involvement. Generalised skin reactions
e.g. pruritus, urticaria, rash.
Marketing Authorisation Holder: Abbott Healthcare Products Ltd, Mansbridge Road, West End, Southampton, SO18 3JD
| PL numbers: |
Influvac |
PL 0512/0156 |
| |
Imuvac |
PL 0512/0188 |
| Basic NHS price: |
Influvac 1 x 0.5 ml and 10 x 0.5 ml syringe packs. Basic NHS price £5.22 and £52.20 |
| |
Imuvac 1 x 0.5 ml and 10 x 0.5 ml syringe packs. Basic NHS price £6.59 and £65.90. |
Legal Category: POM
Further Information is available from: Abbott Healthcare Products Ltd, Mansbridge Road, West End, Southampton, SO18 3JD
Date of last review:13th June 2011
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.
Adverse events should also be reported phone to Abbott on 0800 121 8267.