FDA approves using Relenza to prevent flu

first_imgMar 29, 2006 (CIDRAP News) – The US Food and Drug Administration (FDA) today approved the use of the antiviral drug zanamivir (Relenza) to prevent—not just treat—influenza in adults and children aged 5 and older.Zanamivir, one of the two flu drugs known as neuraminidase inhibitors, was approved in 1999 for treating flu in people aged 7 and older, but not for prophylactic use. The other neuraminidase inhibitor, oseltamivir (Tamiflu), was approved for both treatment and prevention in adults and children from the age of 1 year.”This approval is a welcome addition to the available defenses against the flu,” Dr. Steven Galson, director of the FDA’s center for Drug Evaluation and Research, said in an FDA news release. “This new use offers the medical community another option to prevent and control influenza A and B.”Many countries are stockpiling oseltamivir, made by Roche, in the hope that it will offer some help in the next flu pandemic. Stockpiling of zanamivir, made by GlaxoSmithKline, has been less prevalent, but the United States is stocking up on both.”We have purchased, as of today, 4 million treatment courses of Relenza and 22 million treatment courses of Tamiflu,” Bill Hall, a spokesman for the Department of Health and Human Services, told CIDRAP News today. “We expect all of them to be in the stockpile by the end of this calendar year.”Hall said HHS is aiming for a total of 81 million treatment courses of the two antivirals by 2008, with zanamivir making probably up about 20%.Zanamivir is a powder that is inhaled by mouth with a “Diskhaler” device. Oseltamivir comes in capsule form.Four large, placebo-controlled studies have shown the effectiveness of Relenza for preventing flu, the FDA reported. In two trials, the incidence of flu in households whose members received the drug was 4.1%, versus 19.0% in households where people received a placebo.In a third trial, involving only adults, 2.0% of people in the Relenza group experienced flu symptoms, versus 6.1% of those in the placebo group, the FDA reported. In the fourth study, which involved mostly older adults, flu symptoms occurred in 1.4% of placebo group members and 0.2% of the treatment group.The FDA said zanamivir has not been found effective for preventing flu in nursing homes. Also, it is not recommended as a substitute for flu vaccine, the primary tool for preventing flu.The drug is not recommended for people who have asthma or other chronic respiratory disease, the FDA noted. After zanamivir’s initial approval, bronchospasm, in some cases fatal, was reported in some patients, most of whom had asthma or chronic obstructive pulmonary disease, the agency said.See also:Mar 29 FDA news releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108622.htmFDA background information on Relenzahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183783.htmGlaxoSmithKline’s detailed information on Relenzahttp://us.gsk.com/products/assets/us_relenza.pdfCIDRAP overview on use of antiviral agents for pandemic flulast_img read more

Impact of Man Utd’s summer signings

first_img Press Association Memphis Depay lit up Old Trafford with his Champions League double in Manchester United’s 3-1 victory over Club Brugge on Tuesday night. The 21-year-old made a slow start to life at United following his £25million transfer from PSV Eindhoven. But switching from the number 10 position behind Wayne Rooney to the left flank appears to suit a player given the iconic number seven shirt at Old Trafford. His stunning brace against Club Brugge underlined his reputation in Dutch football as a goalscorer and his cross for Marouane Fellaini’s precious third goal was Beckham-like in its delivery. Looks the complete player and will only get better. BASTIAN SCHWEINSTEIGER Yet to start a game since his high-profile move from Bayern Munich, with Van Gaal admitting the Germany midfielder is still short of full match fitness. But the 31-year-old is a leader and has provided a stabilising influence in his three substitute appearances, replacing fellow veteran Michael Carrick on each occasion. Van Gaal will want to get Schweinsteiger up to speed as quickly as possible to add craft to his midfield, but at this stage it looks a straight choice between him and Carrick to partner the younger Morgan Schneiderlin in the United engine room. MORGAN SCHNEIDERLIN Settled smoothly into the United midfield since his undisclosed transfer from Southampton. The 25-year-old has provided an effective shield with Carrick in front of a much-maligned back four and that should not be under-estimated with only one goal conceded in three matches. Possesses an excellent engine and the Frenchman has also shown he is capable of breaking into forward areas and joining the attack, but the concern for United would be that there is not creativity in central areas to damage top opposition. MATTEO DARMIAN Van Gaal said on United’s pre-season tour of the United States that he was bought for the “second position” behind Antonio Valencia but Darmian has looked anything but back-up since his £12.7million move from Torino. Strong in the tackle and good in the air, the Italy international looks a proper defender, focusing on that side of the job first while still possessing the energy to add attacking penetration. Valencia looks to have a big fight to get his place back after returning late to pre-season from the Copa America. SERGIO ROMERO Has filled the goalkeeping gap with David De Gea apparently unsettled by Real Madrid’s attempts to sign the Spaniard. Argentina’s 2014 World Cup goalkeeper has started all three United games and, in truth, has not had too much to do given the protection in front of him. Romero’s handling has been pretty safe but he was almost embarrassed against Club Brugge when he delayed a clearance and fears persist that he could be prone to the odd error as he grows accustomed to English football. center_img Here, Press Association Sport looks at the impact Louis van Gaal’s summer signings have made so far. MEMPHIS DEPAY last_img read more

Job Vacancy: Maintenance Manager sought for Lough Derg

first_imgJob Vacancy: The Lough Derg Pilgrimage Centre in Co. Donegal is currently recruiting for a Maintenance Manager to join their team on a full-time permanent basis. Lough Derg is a pilgrimage centre situated on a small island in Lough Derg, near Pettigo.The pilgrimage season runs from early April until the end of October when over 10,000 people will visit the island on retreat/pilgrimage. Maintenance of buildings and services is therefore extensive and is carried out both in season and out of season making this a permanent position. Reporting directly to the Prior, Fr La Flynn, the Maintenance Manager will join a team of eight permanent staff and up to fifty seasonal staff. The successful candidate will shadow the present Maintenance Manager for the first three months and will then be subject to a further three month probationary period. This will be a full-time, permanent position. Job OverviewThe Maintenance Manager will be responsible for the maintenance and repair of plant on the island, the lakeshore and administration office in Pettigo. This includes preventative maintenance and repair of all buildings and the mechanical, electrical, plumbing, heating, alarm and telecommunication systems. The Maintenance Manager will also assume the role of Safety Coordinator. Due to the island location they will also be required to drive the boat when circumstances necessitate. Responsibilities and Duties Inspect, repair and maintain buildings and plant; this includes mechanical, electrical, plumbing, heating and alarm systems as well as security cameras and telecommunication services.Employ preventative maintenance.Keep detailed records of work schedule and maintenance log.Ensure all Health and Safety regulations are adhered to.Oversee health and safety training for employees.Drive boat when necessary (on-the-job training will be provided).Order and control stock of oil, gas and equipment spares.Schedule and oversee work of specialist service contractors when necessaryPerson SpecificationThe successful candidate for the position of Maintenance Manager at Lough Derg will have the following characteristics:A self-motivated individual who is able to work on own initiative while being a member of a dynamic team of staffHave a background in general plant maintenance with at least 3 years’ experience and a proven record in a similar roleHave a good working knowledge of mechanical, electrical and plumbing and heating systems. A relevant qualification will be an advantage.Have the flexibility to work weekends and/or evenings when necessaryPossess good organizational and problem-solving skillsBe computer-literatePossess full clean driving licence and have the use of personal vehicleThis position includes the role of Safety Coordinator, responsible for all matters related to Safety, Health and Welfare of both employees and customers.The Maintenance Manager will work alternate weekends during the Pilgrimage Season. Application is by submission of C.V. , either by post to The Prior, Lough Derg, Pettigo, Co. Donegal or by email to hr@loughderg.org . Applications must be received before 12noon on Friday 28th June 2019. Further information on Lough Derg is available at www.loughderg.orgJob Vacancy: Maintenance Manager sought for Lough Derg was last modified: June 10th, 2019 by Staff WriterShare this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window)Tags:caretakerelectricalHeatingJob VacancyLough Dergmaintenance managerMechanicalPettigoPlumbingSafety Coordinatorlast_img read more