An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection

Exclusion Criteria

• •Participants who are known or suspected to be hypersensitive to any component of the study medication.
• •Participants with a disease process which is likely to be irreversible.
• •Liver function:
• •* Participants who meet the following criteria at Baseline:
• •1. Alanine transaminase (ALT) \>=3 times upper limit of normal (ULN) with bilirubin \>=2 times ULN
• •2. or isolated bilirubin \>=2 times ULN and \>50 percent (%) direct bilirubin
• •3. or ALT \>=5 times ULN Inclusion of participants with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor.
• •* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilbert's syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor (Not-applicable for Great Britain).
• •Participants who require concurrent therapy with another anti influenza drug.
• •Participants who have participated in a study using an investigational drug within 30 days prior to Baseline.
• •Child in care (CiC), as defined below:
• •* A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
• •* The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
• •Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration.
• •Participants who are positive for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening