Intravenous TAMIFLU

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COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) 10. PREPARATION, ADMINISTRATION AND MONITORING OF OSELTAMIVIR IV THERAPY 10.1. IV Formulation The reconstituted drug product (with 1.1 mL of Water for Injection) has a concentration of 100 mg/mL of OP, is hypertonic (osmolarity approximately 687 mosm/kg) with a pH of about 4 (specified as 3.0 - 5.0). The compatibility of OP with 0.9 % sodium chloride has been established. When diluted to a final volume of 25 mL with 0.9 % sodium chloride, the resulting concentration of about 4 mg/mL has an osmolarity almost similar to that of plasma. Infusion site pain has been observed in a clinical trial when OP was administered at a concentration of 8 mg/mL. The compatibility of OP with other drugs and intravenous solutions other than 0,9% sodium chloride has not been established. OP is incompatible with reducing sugars (e.g. glucose). Oseltamivir IV is theoretically incompatible with solutions containing calcium ions, due to the risk of calcium phosphate precipitation. Monitoring of vital parameters and the infusion site for thrombophlebitis and extravasation are mandatory when OP is administered intravenously. 10.2. Preparation In preparing the IV solution for administration, always take care to minimize direct exposure of oseltamivir to the skin and eyes. A responsible qualified individual should dispense the correct dose according to the dosing instructions given in Section 8 above. Oseltamivir IV is supplied as a bulk supply of open-label vials containing formulation Ro 064-0796/F09-01. Each 3 mL glass vial, with a 13 mm butyl rubber stopper, contains 157.6 mg of oseltamivir phosphate, corresponding to 120.0 mg of oseltamivir free base as a lyophilizate; this provides a 20% overage to compensate for the non-removable volume of reconstituted solution. Dissolve vial content with 1.1 ml of water for injection. This concentrated solution must be further diluted with 100 ml of 0.9% sodium chloride prior to administration by infusion to give a final concentration of 1 mg/ml for administration. For adults and children > 40kg, the whole volume (100 ml) should be administered over 2 hours. For children < 40kg, calculate the required volume for administration (1 mg/ml), based on dosing instructions outlined in Section 9, using the concentration of 1 mg/ml. Discard any volume in excess of this, and administer the calculated volume over 2 hours. Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December 2011 8/15
COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) For example, a child aged ≥ 1 year with a weight of 20 kg should be dosed at 3 mg/kg. This would require 60 mg for each dose, which equates to 60 ml of 1 mg/ml solution. Thus 40 ml of the 1 mg/ml solution should be discarded prior to commencement of the IV infusion. In cases where the volume of infusion needs to be decreased in adults, the final concentration of oseltamivir should not exceed 2 mg/ml. Dilution should be as follows: dilute 1 ml of the reconstituted solution to a final volume of 50 ml with 0.9% sodium chloride. In children the concentration should never exceed 1 mg/ml. 10.3. Administration of Oseltamivir IV Oseltamivir IV should be administered by a slow volume and time controlled infusion over 2 hours between 12h intervals. PASSIVE DRIP INFUSION IS NOT ALLOWED. 10.3.1. Vascular access A multi-port (multi-lumen) central venous line or a peripherally inserted long line (or central catheter) is ideal. Alternatively, a peripheral venous canula may be used, provided the site of infusion is clearly visible for inspection. When administered through a peripheral venous canula, if there is any evidence of extravasation or thrombophlebitis the infusion must be immediately stopped, It may be resumed at an alternate site. 10.3.2. Infusion Pump An infusion pump, which can be programmed to accurately administer at the desired rate of infusion should be used. The rate of infusion should be such that each dose is administered over 2 hours. For small volumes of infusion, a piston driven syringe pump is recommended. The dead space in the IV tubing between syringe pump and patient should be as small as possible. After the infusion is completed, this dead space must be slowly cleared over several minutes. 10.3.3. Co-administration of Other Drugs Oseltamivir IV should be administered through one lumen alone. Co-administration of other IV drugs via other lumens of a multi-lumen port, or intravenous lines is allowed. Co-administration implies simultaneous administration of more than one drug through the same port/lumen of a vascular access. The simultaneous use of different ports in a multi-lumen central line is not considered co-administration. The only drug/IV solution that oseltamivir has been shown to be compatible with is 0.9% sodium chloride. Oseltamivir may therefore be co-administered only with 0.9% sodium chloride. Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December 2011 9/15
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Intravenous TAMIFLU

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