DECTOVA Solution for infusion Ref.[27672] Active ingredients: Zanamivir

Posology

Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of symptoms of influenza (see section 5.1).

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:

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 (CL_CRRT) <80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).

Table 2. Initial and maintenance dose regimens for adults and children (6 years and over with a body weight of 50 kg or above) with renal impairment:

^* CL_cr or CL_CRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m² 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 (CL_cr) or clearance by continual renal replacement therapy (CL_CRRT) <80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.

Table 3. Initial and maintenance dose regimens for children and adolescents (6 years to less than 18 years, with a body weight less than 50 kg) with renal impairment:

^* CL_cr or CL_CRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m² for children 6 years to less than 13 years.

Table 4. Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight of 42.8 kg or above) with renal impairment:

Table 5. Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight less than 42.8 kg) with renal impairment:

For patients on intermittent haemodialysis or intermittent peritoneal dialysis, the dose should be given after completion of the dialysis session.

For patients receiving continuous renal replacement therapy, the dose should be selected using the appropriate CRRT clearance (CL_CRRT in mL/min).

Hepatic impairment

No dose modification is required (see section 5.2).

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.

For instructions on dilution of the medicinal product before administration, see section 6.6.

There is limited experience of overdose from administration of Dectova. There is no specific antidote to treat an overdose of this medicine. Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Zanamivir is cleared by renal excretion and is expected to be removed by haemodialysis.

Unopened vials:

5 years.

After dilution:

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special storage conditions.

For storage conditions after dilution of the medicinal product, see section 6.3.

26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.

Pack size: 1 vial.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Preparation of Dectova:

• The volume of Dectova and total volume for infusion will depend on the patient’s age, weight and renal function (see section 4.2).
• The dose can be infused as supplied or diluted in sodium chloride 9 mg/mL (0.9%) solution for injection down to any concentration greater than or equal to 0.2 mg/mL.
• Each vial is for single use only; once the seal has been broken, the remaining volume must be discarded.

How to prepare the infusion for intravenous administration:

• Use aseptic techniques throughout preparation of the dose.
• Calculate the required dose and volume of Dectova.
• Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for infusion.
• Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL (0.9%) solution for injection (equal to the volume of Dectova) from the infusion bag.
• Infusion bags may have a further overage of sodium chloride 9 mg/mL (0.9%) solution for injection included – this can also be removed if considered necessary.
• Using a sterile needle and syringe withdraw the volume of Dectova from the vial(s) and add to the infusion bag.
• Discard any unused portion of the vial.
• The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly.
• If refrigerated, the infusion bag should be removed from the refrigerator and brought up to room temperature before use.