Do not use salicylates in children and adolescents for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection. No data exist regarding the safety of intranasal administration of Fluenz Tetra in children with unrepaired craniofacial malformations.ĭo not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3). In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.įluenz Tetra should under no circumstances be injected. Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.Īs with most vaccines, appropriate medical treatment and supervision should always be readily available to manage an anaphylactic event or serious hypersensitivity event following the administration of Fluenz Tetra.įluenz Tetra should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies. The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml).įor the full list of excipients, see section 6.1. The vaccine may contain residues of the following substances: egg proteins (e.g. This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2022/2023 season. This product contains genetically modified organisms (GMOs). ** produced in VERO cells by reverse genetic technology. * propagated in fertilised hens' eggs from healthy chicken flocks. Date of first authorisation/renewal of the authorisationĪ/Victoria/2570/2019 (H1N1)pdm09 - like strain
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