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Afluria
Generic Name: Influenza Virus Vaccine
Drug Category: Inactivated Influenza Vaccine
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 5 years old for a maximum duration of 0 year.
| Approved Uses |
|
AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. For intramuscular (IM) injection only, by needle and syringe (5 years of age and older) or by PharmaJet Stratis Needle-Free Injection System (18 through 64 years of age). A single dose is 0.5 mL. Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 through 8 years of age. If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks. Safety and effectiveness of AFLURIA have not been established in pregnant women or nursing mothers. |
| Off-label Uses |
|
• Use in patients under the age of 5. GoToSource |
| Adverse Events |
|
Paralysis, movement disorders, muscular weakness and guillain-barre syndrome. GoToSource Fever and febrile seizure. GoToSource Syncope (fainting). GoToSource Lymphadenitis (lymph node inflammation). GoToSource Vasculitic neuropathy (systemic illness with inflammation in blood vessels). GoToSource Urticaria (hives). GoToSource Anaphylaxis and allergic asthma. angioedema and cardiac arrest. GoToSource Encephalitis, encephalomyelitis, encephalopathy, transverse myelitis, optic neuritis and brachial neuritis. GoToSource Trigeminal neuralgia. GoToSource Hypoesthesia (reduced sense of touch or sensation). GoToSource Demyelinating disorders. GoToSource |
| Litigation |
|
Claims filed for febrile seizures. |
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