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Body weight in kg Recommended dose for 5 days Volume of 6 mg/mL oral suspension ≤15 kg 30 mg twice daily 5.0 mL twice daily > 15 - 23 kg 45 mg twice daily 7.5 mL twice daily > 23 - 40 kg 60 mg twice daily 10.0 mL twice daily > 40 kg 75 mg twice daily 12.5 mL twice daily Paediatric patients ≥ 1 year old who are able to swallow capsules may receive treatment with 30 mg, 45 mg or 75 mg capsules twice daily. A 75 mg dose may be achieved with a 75 mg capsule twice daily or one 30 mg capsule plus one 45 mg capsule twice daily. Paediatric patients ≥ 1 year old who are unable to swallow capsules may receive the appropriate dose of TAMIFLU oral suspension or home-prepared or pharmacy-compounded TAMIFLU capsules (see instructions below). For the oral suspension a 10 mL oral dosing dispenser is provided. It is recommended that TAMIFLU powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient. Prophylaxis of Influenza Adults and Adolescents The recommended oral dose of TAMIFLU for prevention of influenza following close contact with an infected individual is 75 mg once daily for 10 days. Therapy should begin within two days of exposure. The recommended dose for prevention during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to six weeks. The duration of protection lasts for as long as dosing is continued. Adults and adolescents 13 years of age and older who are unable to swallow capsules may receive the appropriate dose of TAMIFLU 6 mg/mL oral suspension (12.5 mL delivers a 75 mg dose) or home-prepared or pharmacy-compounded TAMIFLU capsules (see instructions below). Infants and Children ≥ 1 – < 13 years of age The recommended weight-adjusted prophylactic oral dosing regimens of TAMIFLU for infants and children ‡ 1 year old are: Body weight in kg Recommended dose for 10 days Volume of 6 mg/mL oral suspension ≤ 15 kg 30 mg once daily 5.0 mL once daily > 15 - 23 kg 45 mg once daily 7.5 mL once daily > 23 - 40 kg 60 mg once daily 10.0 mL once daily > 40 kg 75 mg once daily 12.5 mL once daily Tamiflu <strong>PI</strong> 6 mg/mL oral suspension and capsules 120119 20 of 28 CDS 10.0
Paediatric patients ≥ 1 year old who are able to swallow capsules may receive treatment with 30 mg, 45 mg or 75 mg capsules. A 75 mg dose may be achieved with a 75 mg capsule once daily or one 30 mg capsule plus one 45 mg capsule once daily. Paediatric patients ≥ 1 year old who are unable to swallow capsules may receive the appropriate dose of TAMIFLU oral suspension or home-prepared or pharmacy-compounded TAMIFLU capsules (see instructions below). For the oral suspension a 10 mL oral dosing dispenser is provided. It is recommended that TAMIFLU powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient. Special Patient Populations Hepatic Impairment No dose adjustment is required for patients with mild or moderate hepatic dysfunction in the treatment or prevention of influenza (see PHARMACOLOGY). The safety and pharmacokinetics in patients with severe hepatic impairment have not been studied. No studies have been carried out in paediatric patients with hepatic impairment. Renal Impairment Treatment of influenza In adults, no dose adjustment is necessary for patients with creatinine clearance above 60 mL/min. In patients with a creatinine clearance of > 30 – 60 mL/min, it is recommended that the dose be reduced to 30 mg of TAMIFLU twice daily for 5 days. In patients with a creatinine clearance of 10 – 30 mL/min, it is recommended that the dose is reduced to 30 mg of TAMIFLU once daily, for 5 days. In patients undergoing routine haemodialysis, an initial dose of 30 mg of TAMIFLU can be administered prior to the start of dialysis if influenza symptoms develop during the 48 hours between dialysis sessions. To maintain plasma concentrations at a therapeutic level, a dose of 30 mg should be administered after every haemodialysis session. For peritoneal dialysis, a dose of 30 mg of TAMIFLU administered prior to the start of dialysis followed by further 30 mg doses administered every 5 days is recommended for treatment (see PHARMACOKINETICS). The pharmacokinetics of oseltamivir have not been studied in patients with end stage renal disease (i.e. creatinine clearance of < 10 mL/min) not undergoing dialysis. Hence, dosing recommendation can not be provided for this group. Prophylaxis of influenza In adults, no dose adjustment is necessary for patients with creatinine clearance above 60 mL/min. In patients with a creatinine clearance of > 30 – 60 mL/min, it is recommended that the dose be reduced to 30 mg of TAMIFLU once daily. In patients with creatinine clearance between 10 – 30 mL/min receiving TAMIFLU it is recommended that the dose be reduced to 30 mg of TAMIFLU every other day. In patients undergoing routine haemodialysis, an initial Tamiflu <strong>PI</strong> 6 mg/mL oral suspension and capsules 120119 21 of 28 CDS 10.0
Page 1 and 2: NAME OF THE MEDICINE TAMIFLU 6 mg/
Page 3 and 4: Adults and Adolescents 4/1245 (0.32
Page 5 and 6: available capsule formulations were
Page 7 and 8: Table 3: Summary of Secondary Effic
Page 9 and 10: In a pooled analysis of two seasona
Page 11 and 12: Prophylaxis of Influenza in Immunoc
Page 13 and 14: toxicities were observed, respectiv
Page 15 and 16: Information derived from pharmacolo
Page 17 and 18: TAMIFLU and placebo arm was < 1%, w
Page 19: Skin and subcutaneous tissue disord
Page 23 and 24: Adults, adolescents, children and i
Page 25 and 26: 3. Add one-third (1/3) of the speci
Page 27 and 28: TAMIFLU 75 mg capsules are supplied

Product Information PI - Roche Australia

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