Intravenous TAMIFLU

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COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) If OP is administered through peripheral venous access, the site of administration must be monitored frequently for extravasation, thrombophlebitis and infusion site pain. If there is any evidence for extravasation or thrombophlebitis the infusion must be stopped promptly and resumed at an alternate site. Please refer to Section 10.5 for additional information. For the established safety information on oral Tamiflu® please refer to the Summary of product Characteristics and Package Insert of the oral product 11.1. Contraindications Hypersensitivity to the active substance or any of the excipient. 11.2. Interaction with other medicinal products Tamiflu IV should not be used in patients on probenecid as probenecid inhibits organic anion transporters (OAT) function. 11.3. Pregnancy and lactation Pregnant patients may be considered for treatment with Tamiflu IV only if the potential benefit justifies the potential risk to the fetus. 11.4. Incompatibilities The only IV solution that oseltamivir has been shown to be compatible with is 0.9% sodium chloride. Oseltamivir is incompatible with reducing sugars i.e. glucose or fructose. Oseltamivir as a primary amine reacts with reducing sugars forming degradation products in situ. The reconstituted solution must not be co-administered or added to infusion solutions containing reducing sugars. Oseltamivir IV is theoretically incompatible with solutions containing calcium ions, due to the risk of calcium phosphate precipitation. The compatibility of oseltamivir has not been evaluated with any other IV drug. 11.5. Overdose If Tamiflu IV is administered at a concentration exceeding 4 mg/mL, the medication-related adverse events should be closely monitored, especially vital signs and symptoms and infusion site side effect. 12. PRECLINICAL DATA Key findings from preclinical studies and their implication for use in humans are presented below. Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December 2011 12/15
COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) 12.1. Toxicity in Animal Studies In animal studies, no toxicity was observed at levels of oseltamivir which are 126- and 11-fold higher based on C max and AUC, respectively for the IV dose of 100 mg in human adults. This margin is expected to be similar for children 1 year of age. 12.2. Fatality in Animal Studies Following Bolus Administration A bolus injection of 100 mg/kg of oseltamivir, resulted in death of some mice, while the same dose at a slower infusion rate was well tolerated. OP should be administered over 2 hours. Residual OP in IV lines must be cleared gradually over several minutes (depending on the dead space of the line and the concentration of oseltamivir). Oseltamivir must NEVER be administered by bolus (“IV push”) injection. 12.3. Risk from IV Extravasation In a local tolerance study in rabbits, the administration of OP at oseltamivir concentrations of 4 and 8 mg/mL by perivenous injection was well tolerated. However, administration of 16 mg/mL by perivenous injection was associated with erythema, discoloration, and an increased incidence of severity of hemorrhage at the injection site. If OP is administered through a peripheral venous canula, the site of administration must be monitored frequently for extravasation, thrombophlebitis and infusion site pain. 13. SAFETY REPORTING Reporting of spontaneously mentioned adverse events (AEs) has to be done to either one of the following: 1. the FAMHP, by means of the dedicated yellow form: in paper copy to: Centre National de Pharmacovigilance/Nationaal Centrum voor Geneesmiddelenbewaking Eurostation II (8° étage/verdieping) Victor Hortaplein 40 B10 1060 Bruxelles-Brussel OR electronic version to: adversedrugreactions@fagg-afmps.be Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December 2011 13/15
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Intravenous TAMIFLU

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