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Drug Details

MASTAFLU

• Drug Class Description
  Influenza Vaccine
• Generic Name
  Surface antigen, inactivated
• Presentation
  Suspension for injection in pre-filled syringes
• Description
  MASTAFLU®, suspension for injection (influenza vaccine, surface antigen, inactivated)
• Indications
  Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
• Adult Dosage
  

  Adults and children from 36 months: 0.5 ml.

  Children from 6 months to 35 months: Clinical data are limited; doses 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.

• Child Dosage
  Children from 6 months to 35 months: Clinical data are limited; doses 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 (MASTAFLU does not contain more than 1 microgram 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 a rare anaphylactic event following the administration of the vaccine.

  MASTAFLU should under no circumstances be administered intravascularly.

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

• Interactions
  

  MASTAFLU 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 results. The transient false positive reactions could be due to the IgM response by the vaccine.

• Adverse Drug Reactions
  

  Adverse events 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 and at least 50 elderly subjects aged 60 or older. Safety evaluation is performed during the first 3 days following vaccination.

  Undesirable effects reported are listed according to the following frequency:

  Adverse events from clinical trials:

  Common (>1/100, <1/10)

  Local reactions: redness, swelling, pain, ecchymosis, induration.

  Systemic reactions: fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia. These reactions usually disappear within 1-2 days without treatment.

  From post-marketing surveillance additionally, the following adverse events have been reported:

  Uncommon (>1/1,000, <1/100)

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

  Rare (>1/10,000, <1/1,000)

  Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.

  Allergic reactions, in rare cases leading to shock, have been reported.

  Very rare (<1/10,000)

  Vasculitis with transient renal involvement. Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.