FLUENZ - FLUENZ - CT 12345 - Version anglaise

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Description

Présentation FLUENZ, suspension pour pulvérisation nasale. Vaccin grippal (vivant atténué, nasal) B/10 pulvérisateurs de 0,2 ml - Code CIP : 2238846 Mis en ligne le 19 mars 2013 Substance active (DCI) virus grippal réassorti, vivant atténué Code ATC J07BB03 Laboratoire / fabricant Laboratoire ASTRAZENECA FLUENZ, suspension pour pulvérisation nasale. Vaccin grippal (vivant atténué, nasal) B/10 pulvérisateurs de 0,2 ml - Code CIP : 2238846 Mis en ligne le 19 mars 2013

Sujets

• Pédiatrie
• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 18 juillet 2012
• Nombre de lectures: 20
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

 

 

      The legally binding text is the original French version   TRANSPARENCY COMMITTEE   OPINION   18 July 2012       FLUENZ, nasal spray suspension Influenza vaccine (live attenuated, nasal) B/10 nasal applicators, 0.2 ml each (CIP code: 34009 223 884 65)     Applicant: ASTRAZENECA   Reassortant influenza virus, live attenuated ATC code (2012): J07BB03 (influenza vaccines, influenza live attenuated)   List I   Medicinal product subject to medical prescription     Date of MA (centralised procedure): 27 January 2011     Reason for request: Following the request from the Directorate-General for Health received on 26 June 2012, the Committee is examining FLUENZ with a view to including it on the list of medicines approved for hospital use.                                   Medical, Economic and Public Health Assessment Division

 

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1. CHARACTERISTICS OF THE MEDICINAL PRODUCT

    1.1. Active ingredient   Reassortant live attenuated, trivalent influenza virus*, each dose of 0.2 ml containing 10 7.0±0.5 viral particles of the strains** A/H1N1, A/ H3N2 and B. Each of the strains of a vaccine is obtained from a reassortment of the wild and an attenuated strain (donor virus).   * propagated in fertilised hen’s eggs from healthy chicken flocks. ** produced in Vero cells by reverse genetic technology. This product contains genetically modified organisms (GMOs).     1.2. Background  

FLUENZ is the first nasally administered influenza vaccine.     1.3. Indication   “Prophylaxis of influenza in individuals 24 months to less than 18 years of age. The use of FLUENZ should be based on official recommendations.”     1.4. Dosage  

"Children and adolescents from 24 months:   0.2 ml (administered as 0.1 ml per nostril). For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.   FLUENZ should not be used in infants and toddlers below 24 months of age because of safety concerns.   Method of administration: Immunisation must be carried out by nasal administration. DO NOT INJECT FLUENZ."     1.5. Contraindications   "Hypersensitivity to the active substances, to any of the excipients (e.g. gelatin), to gentamicin (a possible trace residue), to eggs or to egg proteins (e.g. ovalbumin).   Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high dose corticosteroids.   FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. 

 

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