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Essential Prescribing Information

Fluad® [Pre-filled syringe]

Novartis Vaccines [ Novartis ]
MIMS Class : Vaccines, Antisera & Immunologicals
 
See related Fluad Pre-filled syringe information
Contents
Influenza vaccine, surface antigen, inactivated, adjuvanted w/ MF59C.1
Indications
Active immunisation against influenza in elderly ≥65 yr, esp for those w/ increased risk of associated complications (ie patients affected by underlying chronic diseases including diabetes, CVS & resp diseases).
Dosage
0.5 mL as a single dose to be administered IM into the deltoid muscle.
Contraindications
Hypersensitivity to egg or chicken proteins, aminoglycosides, formaldehyde, cetyltrimethylammonium Br, polysorbate 80. Postpone immunisation in febrile illness or acute infection. Childn & elderly patients on warfarin.
Special Precautions
Do not administer SC or intravascularly. Ab response in patients w/ endogenous or iatrogenic immunosuppression may be insufficient.
Adverse Drug Reactions
Commonly, local inj site reactions eg redness, swelling, pain, ecchymosis, induration; fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia. Uncommonly, generalised skin reactions eg pruritus, urticaria or nonspecific rash. Rarely, neuralgia, paraesthesia, convulsions, transient thrombocytopenia, allergic reactions rarely leading to shock. Very rarely, vasculitis w/ transient renal involvement, exudative erythema multiforme, encephalomyelitis, neuritis, Guillain-Barre syndrome.
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Drug Interactions
Immunosuppressants.
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Pregnancy Category (US FDA)
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Description
View Fluad description for details of the chemical structure and excipients (inactive components).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.
Poison Schedule
POM
Presentation/Packing
FormPacking/PricePhoto
Fluad Pre-filled syringe
Fluad 0.5 mL x 1's

Manufacturer:Novartis Vaccines
Distributor:Novartis
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