Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Blood and lymphatic system disorders: Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3 lymphadenopathy
),
General disorders and administration site conditions: Extensive swelling of injected limb lasting more than one week, injection site cellulitis-like reactions (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week)
Immune system disorders: Allergic reactions including anaphylactic shock, anaphylaxis and angioedema
Musculoskeletal and connective tissue disorders: Muscular weakness
Nervous system disorders: Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, paraesthesia, syncope, presyncope
Skin and subcutaneous tissue disorders: Generalized skin reactions including erythema multiforme, urticaria pruritus or non-specific rash
Vascular disorders: Vasculitis with transient renal involvement
7 DRUG INTERACTIONS
7.1 Concomitant Use With Other Vaccines There are no data to assess the concomitant administration of FLUAD with other vaccines. If FLUAD is to be given at the same time as other injectable vaccine(s), the vaccine(s) should be administered at different injection sites.
Do not mix FLUAD with any other vaccine in the same syringe.
7.2 Concurrent Use With Immunosuppressive Therapies Immunosuppressive or corticosteroid therapies may reduce the immune response to FLUAD.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy Pregnancy Category B: A reproductive and developmental toxicity study has been performed in rabbits with a dose level that was approximately 15 times the human dose based on body weight. The study revealed no evidence of impaired female fertility or harm to the fetus due to FLUAD. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed.
In a reproductive and developmental toxicity study, the effect of FLUAD on embryo-fetal and post-natal development was evaluated in pregnant rabbits.
Animals were administered FLUAD by intramuscular injection twice prior to gestation, during the period of organogenesis (gestation day 7) and later in pregnancy (gestation day 20), 0.5 mL (45 mcg)/ rabbit/occasion (approximately 15-fold excess relative to the adult human dose based on body weight). No adverse effects on mating, female fertility, pregnancy, embryo-fetal development, or post-natal development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.
8.4 Pediatric Use The safety and effectiveness of FLUAD in the pediatric population has not been established.
8.5 Geriatric Use Safety and immunogenicity of FLUAD have been evaluated in adults 65 years of age and older. [See Adverse Reactions (6.1) and Clinical Studies (14)]
FLUAD is a registered trademark of Seqirus Inc. Manufactured by: Seqirus Inc.
An affiliate of: Seqirus Inc., Holly Springs, NC 27540 1-855-358-8966
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