Dectova

1). 3 Adults The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion. Paediatric population Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1).

Table 1:

Weight-based dose regimen by age for infants, children and adolescents with normal renal function Age range Weight-based dose regimen 6 months to < 6 years 14 mg/kg twice daily  6 years to < 18 years 12 mg/kg twice daily up to a maximum dose of 600 mg twice daily Elderly No dose adjustment is required based on age.

Renal impairment Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).

73m2 for children 6 years to less than 13 years. Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.

73m2 for children 6 years to less than 13 years. 4 mg/kg twice daily Begin twice daily maintenance dosing 48 hours after the initial dose For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after completion of the dialysis session.

5 For patients receiving continuous renal replacement therapy, the dose should be selected using the appropriate CRRT clearance (CLCRRT in mL/min). 2). Paediatric population The safety and efficacy of Dectova in children aged under 6 months have not been established.

No data are available. Method of administration Intravenous use Dectova is administered by intravenous infusion over 30 minutes. 6.

Summary of the safety profile The safety profile of zanamivir is based primarily on data from a single Phase II and a single Phase III study, with support from Phase I studies, a compassionate use programme, and adverse drug reactions reported for inhaled zanamivir.

The frequency of adverse reactions is based on the number of reports in the adult population receiving zanamivir 600 mg twice daily intravenously in the Phase II and Phase III studies. Adverse reactions are listed by MedDRA system organ class.

The most commonly reported adverse reactions considered possibly or probably related to zanamivir are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%).

The most important serious adverse reaction was hepatocellular injury, observed in two patients (< 1%). Tabulated list of adverse reactions The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from available data).

System Organ Class Adverse reactions Frequency Immune system disorders oropharyngeal oedema facial oedema anaphylactic/anaphylactoid reactions not known Psychiatric disorders abnormal behaviour hallucinations delirium not known Nervous system disorders convulsions depressed level of consciousness not known Gastrointestinal disorders diarrhoea common Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known 8 Paediatric population The adverse reaction profile in the paediatric population is based on 71 patients aged ≥ 6 months to < 18 years in the Phase II study.

2). All patients must have their renal function assessed before and regularly during treatment. 8). If any hypersensitivity reaction occurs during infusion of Dectova, the infusion must be stopped immediately and appropriate management should be instituted.

Neuropsychiatric events Influenza can be associated with a variety of neurological and behavioural symptoms. Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir in patients with influenza, especially in children and adolescents.

8). 1). Selection of influenza resistant viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider switching to alternative therapies where appropriate.

1). Risk of bacterial infections Dectova has not been shown to reduce the risk of bacterial complications associated with influenza infection. 54% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1.