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Penciclovir/Raltegravir 1009 disorders. Peptide T has also been tried in the treatment of clinical studies to date the FDA considers that it may rarely References. psoriasis. cause anaphylaxis or serious skin reactions. As with other 1. Hirayama C, et al. Propagermairlum: a nonsped.fic immune modulator for chronic hepatitis B. J Gastroenterol 2003; 38: 525-32. neuraminidase inhibitors, neurologic and behavioral symptoms have been infrequently reported. For further Peramivir (USAN, r/NN} information on neurological and other adverse effects �r.��.��!�<?.�� .......................................................................... .. associated with neuraminidase inhibitors, see under ProprielaryPreparations (details are given in Volume B) Oseltamivir, p. I 007 .2. Patients with known or suspected renal insufficiency Single-ingredient Preparations.Jp n: Serocion. should have a baseline creatinine clearance measurement before taking peramivir. Dosage adjustments may be necessary in patients with renal impairment. �.��P.�.��.!�<>.��... ........................................................................ (details are given in Volume B) Uses and Administration ProprielaryPreparations Single-ingredient Preparations.Jp n: Rapiacta. Peramivir is a neuraminidase inhibitor that is given intravenously; it is being evaluated in phase 3 clinical studies for the treatment of influenza (see p. 960.2). Although it has not yet been approved for marketing, the FDA has authorised the emergency use of peramivir in the USA to treat certain adult and paediatric patients with suspected or laboratory-confirmed pandemic (HINI) 2009 influenza, or infection due to nonsubtypable influenza A virus suspected to be 2009 HINI based on community epidemiology. The recommended dose for patients from 18 years of age is 600 mg given intravenously over 30 minutes once daily for s to 10 days. Dose adjustments are needed in patients with renal impairment, see below. For details of doses in children, see below. Profile Administration in children. Peramivir may be given to Pleconaril is an antiviral with activity against a range of children in the treatment of pandemic (HINI) 2009 influ­ picomaviruses. It has been investigated for the oral enza, similarly to adults (see above). Doses may be given treatment of viral meningitis and encephalitis, upper intravenously over 60 minutes once daily for S to 10 days Uses and Administration respiratory-tract viral infections, and other enteroviral according to age as follows: Raltegravir is an inhibitor of HIV integrase, an enzyme infections. However, there have been concerns over birth to 30 days old: 6 mg/kg essential for insertion of viral DNA into the host genome, • efficacy, viral resistance, and interactions with oral 31 to 90 days old: 8 mg/kg and thus for replication. It is used with other antiretrovirals • contraceptives. Development of an intranasal formulation 91 to 180 days old: I 0 mg/kg for treatment of HIV infection and AIDS (p. 957.2) and is • for the common cold has also been investigated. • 18I days old to S years of age: 12 mg/kg licensed for use in both treatment-naive and treatment­ 6 to 17 years of age: I 0 mg/kg References. experienced patients. • l. The maximum daily dose is 600 mg. For details of dose Nowak·Wegrzyn A. et al. Successful treatment of enterovirus infection It is given orally as the potassium salt but doses are with the use of pleconaril in 2 infants with severe combined adjustments in children with renal impairment, see below. immunodefidency. Clin Infect Dis 2001; 32: El3-E l4. expressed in terms of the base; 434 mg of raltegravir 2. Rotbart HA, Webster Treatment of potentially life-threatening AD. potassium is equivalent to about 400 mg of raltegravir. The Administration in renol impairment. Intravenous doses of enterovirus infections with pleconaril. Clin Infect Dis 2001; 32: 228-35. usual dose is the equivalent of 400 mg of raltegravir twice 3. Aradottir E, et al. Severe neonatal enteroviral hepatitis treated with peramivir should be reduced in patients with renal impair­ daily, with or without food. For details of doses in children pleconaril. Pediatr Infect Dis J 2001; 20: 457-9. ment, according to creatinine clearance (CC): 4. Starlin R, et al. Acute flaccid paralysis syndrome associated with and adolescents, see below. Adultsfrom years of age. echovirus 19, managed with pleconaril and intravenous immunoglobu­ Doses of raltegravir may need to be amended when given lin. Clin Infect 2001; 33: 730-2. • CC 31 to18 49 mL/minute: ISO mg daily Dis with rifampicin: a dose of 800 mg twice daily has been CC 10 to 30mL/minute: IOOmg daily 5. Hayden FG, et al. Oral pleconaril treatment of picornavirus-associated suggested. • viral respiratory illness in adults: efficacy and tolerability in phase II CC less than IOmL/minute: IOOmg on day I, then ISmg • clinical trials. Antivir Ther 2002; 7: 53--65. References. daily thereafter 6. Abzug MJ, et al. Double blind placebo-controlled trial of pleconaril in 1. Iwamoto M, et al. Safety, tolerability, and pharmacokinetics of infants with enterovirus meningitis. Pediatr Infect Dis J 2003; 22: 335-41. • Intermittent haemodialysis: IOOmg on day I, and 2 raltegravir after single and multiple doses in healthy subjects. Clin hours after the end of each dialysis session 7. Hayden FG, et al. Efficacy and safety of oral pleconaril for treatment of Pharmacol Ther 2008; 83: 293-9. colds due to picornaviruses in adults: results of 2 double-blind, 2. Croxtall JD, et al. Raltegravir. Druos 2008; 68: 131-8. Infantsand children. 36: randomized, placebo-controlled trials. Clin Infect Dis 200?; 1523-32. 3. Croxtall JD, Kearn SJ. Raltegravir: a review of its use in the management • CC 31 to 49 mL/minute per !.73m2: 8. Webster AD. Pleconaril-an advance in the treatment of enteroviral of infection in treatment-experienced patients. Drugs 2009; 69: infection in immuno-compromised patients. J Clin Virol 2005; 32: 1-6. mv • l.S mg/kg daily in those from birth to 30 days old 1059-75. 2 mg/kg daily in those from 31 to 90 days old 9. Desmond RA, et al. Enteroviral meningitis: natural history and outcome 4. Hicks C, Gulick RM. Raltegravir: the first HIV type 1 integrase inhibitor. • of pleconaril therapy. Antimicrob Agents Chemother 2006; 50: 2409-14. 48: 2.5 mg/kg daily in those from 91 to 180 days old Clin Infect Dis 2009; 931-9. • 5. Lennox JL, et al. Safety and efficacy of raltegravir-based versus • 3 mg/kg daily in those from 181 days old to S years of efavirenz-based combination therapy in treatment-naive piltients with age HIV-1 infection: a multicentre, double-blind randomised controlled trial. C12U Lancet 2009; 374: 796-806. Correction. ibid.; 786. • 2.S mg/kg daily in those from 6 to I7 years of age 6. Croxtall JD, Scott Raltegravir: in treatment-naive patients with HIV- CC 10 to 30mL/minute per !.73m2: IJ. • 1 infection. Druos 2010; 70: 631-42. ' • I mg/kg daily in those from birth to 30 days old 7. Steigbigel RT, et al. BENCHMRK Study Teams. Long-term efficacy and • 1.3mg/kg daily in those from 31 to 90 days old safety of raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant mv infection: week • 1.6mg/kg dally in those from 91 to 180 days old Profile 96 results of the BENCHMRK 1 and 2 phase trials. Clin Infect Dis 2010; I.9 mg/kg daily in those from 181 days old to S years m • Poly I.poly CI2U is a synthetic mismatched polymer of 50: 605-12. of age double-stranded RNA with antiviral and immunomodula­ 8. Ramkumar K, Neamati N. Raltegravir: the evidence of its therapeutic 1.6 mg/kg daily in those from 6 to 17 years of age value in HIV-1 infection. Core Evid2010 ; 4: 131-47. • tory activity (see also Poly I. Poly C, p. 2S94. 1). It is under 2 9. Ski est DJ, et al. Similar efficacy of raltegravir when used with or without • CC less than IOmL/minute per !.73m : investigation in the treatment of HIV infection, and also in I mg/kg on day I, then O.IS mg/kg daily in those from a protease inhibitor in treatment-experienced patients. HN Clin Trials • renal cell carcinoma, chronic fatigue syndrome, invasive 2011; 12: 131-40. birth to 30 days old melanoma, and hepatitis B and C. 10. Brainard DM, et al. Clinical pharmacology profile of raltegravir, an IDV-1 51: • 1.3 mg/kg on day I, then 0.2 mg/kg dally in those integrase strand transfer inhibitor. J Clin Pharmaco/ 2011; 1376-1402. from 31 to 90 days old 11. Rokas KEE, et al. Role of raltegravir in HIV-1 management. Ann Pharmacother 2012; 46: 578-89. • 1.6 mg/kg on day I, then 0.2S mg/kg daily in those �r.��.�?.!�<?.�� ............................................................................ from 91 to 180 days old ProprielaryPreparations (details are given in Volume B) 1.9mg/kg on day I, then 0.3mg/kg daily in those Administration in children. For the treatment of HIV • USA: from I81 days to S years of age Single-ingredient Preparations. Ampligen. infection in children from 2 years of age and adolescents raltegravir is given with other antiretroviral drugs. In the • 1.6 mg/kg on day I, then 0.2S mg/kg daily in those from 6 to 17 years of age USA, oral film-coated or chewable tablets are available; the two formulations are not interchangeable as the chewable • For children on intermittent haemodialysis, the following doses, based on age and weight, are given on tablet has a higher bioavailability compared with the rum­ day I, and then 2 hours after each dialysis session: coated tablets. Doses are based on body-weight. In children from 2 years (and weighing at least 10 kg) to • I mg/kg for those from birth to 30 days old less than 12 years of age, the following dose recommenda­ • I.3 mg/kg for those from 31 to 90 days old lions are made for chewable tablets: • 1.6mg/kg for those from 91 to 180 days old I 0 to less than 14 kg: 7 S mg twice daily • I.9 mg/kg for those from 181 days to S years of age • 14 to less than 20 kg: 100 mg twice daily • 1.6 mg/kg for those from 6 to 17 years of age • Profile • 20 to less than 28 kg: ISO mg twice daily AdverseEffects • 28 to less than 40 kg: 200 mg twice daily Propagermanium is an immunomodulator that has been • at least 40 kg: 300 mg twice daily (maximum dose) Safety and efficacy data for peramivir are limited.
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    22 February 2018 EMA/CHMP/148367/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Alpivab International non-proprietary name: peramivir Procedure No. EMEA/H/C/004299/0000 authorised Note longer Assessment report as adopted by the CHMP with allno information of a commercially confidential nature deleted. Product Medicinal 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.2. Epidemiology and risk factors, screening tools/prevention ...................................... 8 2.1.3. Aetiology and pathogenesis ...............................................................................