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Drug Details

OPTAFLU Vaccine

• Drug Class Description
  Influenza vaccine
• Generic Name
  Vaccine
• Presentation
  Suspension for injection in pre-filled syringe Clear to slightly opalescent.
• Description
  Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2007/2008 season)
• Indications
  Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. The use of Optaflu should be based on official recommendations.
• Adult Dosage
  

  Adults: 0.5 ml.

  Immunisation should be carried out by intramuscular (into the deltoid muscle) injection.

  Children and adolescents (<18 years of age):

  Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy.

• Child Dosage
  Children and adolescents (<18 years of age): Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy.
• Contra Indications
  

  Hypersensitivity to the active substances or to any of the excipients.

  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.

  Optaflu should under no circumstances be administered intravascularly.

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

• Interactions
  

  Optaflu may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that 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 HIV-1, Hepatitis C and especially HTLV-1 have been observed. The Western Blot technique disproves the results. The transient false positive reactions may be due to the IgM response to the vaccine.

• Adverse Drug Reactions
  

  Adverse reactions from clinical trials:

  The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials performed as part of the development program. Overall 3439 single doses of Optaflu were administered to 2366 adults aged 18 – 60 years of age and to 1073 elderly (aged 61 years or older). Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 3100 vaccinees during six months of follow-up.

  So far there are no data from post-marketing experiences with Optaflu. In adults, the following undesirable effects have been observed during clinical trials with Optaflu:

  Very common (1/10); common (1/100 to <1/10); uncommon (1/1000 to <1/100); rare (1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  Frequency in adults (18-60 years of age)

  Organ class	Very common 1/10	Common 1/100 to < 1/10	Uncommon 1/1000 to < 1/100	Rare 1/10,000 to <1/1000	Very rare <1/ 10,000
  Blood and lymphatic system disorders					Transient thrombocytopenia
  Nervous system disorders	Headache*				Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
  Skin and subcutaneous tissue disorders		Sweating*	Generalised skin reactions including pruritus, urticaria or non-specific rash
  Musculoskeletal and connective tissue disorders		Myalgia*, arthralgia*
  Vascular disorders					Vasculitis, possibly associated with transient renal involvement
  General disorders and administration site disorders	Erythema*, pain* Malaise*, fatigue*	Swelling*, ecchymosis*, induration* Fever*, shivering* Gastrointestinal disorders such as abdominal pain, diarrhoea or dyspepsia*		Local lymphadeno-pathy Fever greater than 39.0°C
  Immune system disorders					Allergic reactions, in very rare cases leading to shock

  * These reactions usually disappeared within 1-2 days without treatment.

  In the elderly frequencies were similar, exept for headache and pain which were classified as 'common'. The incidence rates for moderate and severe pain after Optaflu vaccination are similar to those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to 6% with egg-derived influenza vaccine).

  With egg-derived influenza vaccines neuralgia, paraesthesia and febrile convulsions have been observed rarely.