RAPIVAB Solution for injection Ref.[10158] Active ingredients: Peramivir

2.1 Dosage in Acute Uncomplicated Influenza

Administer RAPIVAB within 2 days of onset of symptoms of influenza.

Adults and Adolescents (13 years of age and older)

The recommended dose of RAPIVAB in adult and adolescent patients 13 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

Pediatric Patients (2 to 12 years of age)

The recommended dose of RAPIVAB in pediatric patients 2 to 12 years of age with acute uncomplicated influenza is a single 12 mg/kg dose (up to a maximum dose of 600 mg), administered via intravenous infusion for 15 to 30 minutes.

2.2 Dosing in Patients with Renal Impairment

Significantly increased drug exposures were observed when RAPIVAB was administered to adult subjects with renal dysfunction [see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1 and Table 2. No dose adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher [see Clinical Pharmacology (12.3)].

In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1 and Table 2) [see Clinical Pharmacology (12.3)].

Table 1. Dosage Adjustment for Adults and Adolescents (13 years and older) with Altered Creatinine Clearance:

* Calculated using the Cockcroft and Gault equation.

Table 2. Dosage Adjustment for Pediatric Patients (2 to 12 years of age) with Altered Creatinine Clearance:

* Calculated using the Cockcroft and Gault equation.
** Up to maximum dose of 600 mg

2.3 Preparation of RAPIVAB for Intravenous Infusion

Use aseptic technique during the preparation of RAPIVAB to prevent inadvertent microbial contamination. There is no preservative or bacteriostatic agent present in the solution.

Follow the steps below to prepare a diluted solution of RAPIVAB:

• Do not use if seal over bottle opening is broken or missing.
• Visually inspect RAPIVAB for particulate matter and discoloration prior to administration.
• Dilute an appropriate dose of RAPIVAB 10 mg/mL solution [see Dosage and Administration (2)] in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s to a maximum volume of 100 mL.
• Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
• Discard any unused diluted solution of RAPIVAB after 24 hours.

Once a diluted solution of RAPIVAB has been prepared, administer immediately or store under refrigerated conditions (2° to 8°C or 36° to 46°F) for up to 24 hours. If refrigerated, allow the diluted solution of RAPIVAB to reach room temperature then administer immediately.

2.4 Drug Compatibility

RAPIVAB injection is compatible with 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s. Do not mix or co-infuse RAPIVAB with other intravenous medications.

RAPIVAB injection is compatible with materials commonly used for administration such as polyvinylchloride (PVC) bags and PVC-free bags, polypropylene syringes, and polyethylene tubing.

There is no human experience of acute overdosage with RAPIVAB. Treatment of overdosage with RAPIVAB should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with RAPIVAB.

RAPIVAB is cleared by renal excretion and can be cleared by hemodialysis.

Store vials of RAPIVAB injection in original cartons at 20° to 25°C (68° to 77°F). Excursions are permitted to 15° to 30°C (59° to 86°F).

Do not use if seal over bottle opening is broken or missing.