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Drug Details

IMUVAC 2008/2009

• Drug Class Description
  Postvaccinal Immunity
• Generic Name
  Haemagglutinin and Neuraminidase
• Presentation
  Suspension for injection in prefilled syringes; a colourless clear liquid, filled in single-dose syringes (glass, type I).
• Description
  Imuvac 2008/2009, suspension for injection (influenza vaccine, surface antigen, inactivated).
• Indications
  Prophylaxis of influenza, especially in those who run an increased risk of associated complications. The use of Imuvac 2008/2009 should be based on official recommendations.
• Adult Dosage
  

  Adults and children from 36 months: 0.5 ml.

  Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.

  For children 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, chicken protein (Imuvac 2008/2009 does not contain more than 1 µg ovalbumin per dose), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.

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

• Special Precautions
  

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

  Imuvac 2008/2009 should under no circumstances be administered intravascularly.

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

• Interactions
  

  Imuvac 2008/2009 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 serology 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 by the vaccine.

• Adverse Drug Reactions
  

  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 requirement, 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 3 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 (1/1000, <1/100); rare (1/10000, <1/1000); very rare (<1/10000), including isolated reports.

  Organ class	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
  Nervous system disorders		Headache*
  Skin and subcutaneous tissue disorders		Sweating*
  Musculoskeletal and connective tissue disorders		Myalgia, arthralgia*
  General disorders and administration site conditions		fever, malaise, shivering, fatigue Local reactions: redness, swelling, pain, ecchymosis induration*

  * 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, next 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 shock, angioedema

  Nervous system disorders:

  Neuralgia, paraesthesia, febril 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