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Important Safety Warning: Relenza inhalation powder must not be nebulised or administered by mechanical ventilation.
Notice type:
Warning
Date:
14/10/2009
Product name or type:
Relenza
Problem Or Issue:
Relenza 5mg/dose, inhalation powder is
not
intended to be reconstituted in any liquid formulation and is
not recommended for use in any nebulizer or mechanical ventilator.
This applies to all presentations of lactose-containing zanamivir inhalation powder (Relenza Diskhaler or Rotacaps).
Background Information Or Related Documents:
GlaxoSmithKline (GSK) has received a report of the death of a patient with influenza who received Relenza 5mg/dose, inhalation powder, pre-dispensed which was solublized and administered by mechanical ventilation. GSK is aware that Relenza 5mg/dose, inhalation powder, is being removed from its approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza 5mg/dose, inhalation powder using the Diskhaler or Rotacaps.
• Relenza 5mg/dose, inhalation powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
• This applies to all presentations of lactose-containing zanamivir inhalation powder (Relenza Diskhaler or Rotacaps).
• Relenza or zanamivir for nebulization has not been approved by any regulatory authority and the safety, effectiveness and stability of zanamivir use by nebulization have not been established.
Relenza 5mg/dose, inhalation powder should only be used as directed in the prescribing information by using the Diskhaler or Rotacaps devices provided with the drug product. Relenza 5mg/dose, inhalation powder is a mixture of zanamivir active drug substance (5 mg) and lactose drug carrier (20 mg). This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.
Important Safety Warning: Relenza inhalation powder must not be nebulised or administered by mechanical ventilation Document
Further Information:
Relenza DHCP Warning
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Date Printed: 19/05/2024