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“Possible latex presence, risk for allergy sufferers”



Flu alert for 7 vaccines. Aifa: “Possible latex presence, risk for allergy sufferers”

Flu vaccines, hvisible traces of latex in the components of pre-filled syringes or nasal applicators of 7 influenza vaccines produced by three pharmaceutical companies for the 2019-2020 season. The possibility is not excluded fromItalian Medicines Agency (Aifa), and it can be dangerous for latex allergy sufferers which, in the presence of this substance, even in the tracks, will be at risk of allergic reactions. Therefore, the Agency invites allergy sufferers to consult a doctor before administering the vaccine.

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Possible traces of latex do not concern the vaccines themselves, but rather external components, such as, in fact, syringe elements such as a cylinder, piston, needle guard and tip cap, or they could be determined by contact during production. Therefore, it has nothing to do with cases such as the Novartis influenza vaccine, of which, in 2014, some consignments were withdrawn after reporting various suspected deaths after administration of the drug.

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In case of latex riskAIFA actually conducted an in-depth study with companies that conduct vaccines to obtain marketing authorization (AIC) specifically to protect people with allergies. Based on EU guidelines, a warning is already included in the product information sheet if latex is present in any quantity. However, in the absence of latex, the inclusion of specific declarations is not required. To better protect people with allergies, AIFA, however, asked for confirmation, where not indicated on the leaflet, of the presence or absence of latex in the primary packaging components by contacting all participating companies.

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Verification showed that for 7 vaccines, the presence of latex is not excluded. This is Mylan IRE HEALTHCARE LIMITED with the Influvac S tetrà vaccine, for which AIFA indicates that “it does not contain latex,” but “it cannot be ruled out that the vaccine comes into contact with tools that contain latex”; Mylan Italia Srl with Influvac S * vaccine; Seqirus srl with Agrippal S1, Fluad, Influpozzi, Innoflu *, Flucelvax tetra vaccines. For these latter vaccines, “it cannot be ruled out that needle caps and syringe caps are latex free.” AIFA advises latex-sensitive patients consultant Contact your doctor before administering the vaccine, so ifa notes that the goal is to provide “summary information to further contribute to the safe and proper use of seasonal influenza vaccines, even in those with a history of severe allergic reactions.” on latex. "

THIS IS THE DETAIL OF VACCINES
– Influvak s tetra * (Mylan Ire Healthcare Limited) “does not contain latex – it cannot be ruled out that the vaccine will come into contact with latex-containing instruments during production. Before administering the vaccine, latex-sensitive patients are advised to consult a physician. ”

– Influwak C * (Mylan Italia S.r.l.) “does not contain latex – it cannot be ruled out that the vaccine will come into contact with latex-containing instruments during the manufacturing process. Before administering the vaccine, latex-sensitive patients are advised to consult a physician. ”

Fluarix tetra * (Glaxo Smith Kline Biologicals Sa) "does not contain latex – is not used in the manufacturing process."

Vaxigrip tetra * (Sanofi Pasteur Europe) "does not contain latex – is not used in the manufacturing process."

Regarding Agrippal S1 *, Fluad *, Influpozzi subunit *, Innoflu * and Flucelvax tetra * (Seqirus srl) “it cannot be ruled out that the needle caps and syringe caps are latex free. Before administering the vaccine, latex-sensitive patients are advised to consult a physician. ” Finally, Fluenz tetra * (AstraZeneca AB) "does not contain latex – is not used in the manufacturing process."

Last update: 19:28


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