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product news 50 New product information: Combineb Nebuliser Solution and Ipravent Nebuliser Solution Breathe Pharmaceuticals have announced the launch of a further two nebuliser solutions in the family of respiratory drugs for delivery by a nebuliser from Breathe Pharmaceuticals in Ireland Combineb (Ipratropium Bromide/Salbutamol) 0.5mg/2.5mg per 2.5ml nebuliser solution. Combineb is indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD) who require regular treatment with both ipratropium bromide and salbutamol. Combineb nebuliser solution can be administered using the same nebuliser as the originator brand of Ipratropium Bromide/ Salbutamol solution. Ipravent (Ipratropium bromide 250mcg/1ml, 500mcg/2ml) nebuliser solution. Ipravent is indicated for reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD) and the treatment of reversible airways obstruction as in acute and chronic asthma, when used concomitantly with inhaled beta 2 - agonists. Clonmel Healthcare has announced the launch of Lochol – Fluvastatin 20mg & 40 mg Capsules. This product will join the other cardiovascular medicine product listings within the Ethical Prescription Division of Clonmel Healthcare. Lochol is indicated for hypercholesterolaemia. Its mode of action is the reduction of elevated total cholesterol (total-C) and elevated low-density lipoprotein cholesterol (LDL-C). It is also indicated for the secondary prevention of major adverse cardiac events in patients with coronary heart disease. Lochol 20 mg & 40 mg Capsules are 48% cheaper than the brand originator.   Breathe Pharmaceuticals is a joint venture between Breath Ltd, specialists in the anti-asthmatic field already marketing nebule products in the UK, and Clonmel Healthcare Ltd, who have been providing high quality, affordable medicines in Ireland since 1970. Together as Breathe Pharmaceuticals, we hope to build on the vast experience of both companies to provide the best levels of service and care possible in this specialist field. combineb and Ipravent have been approved for reimbursement by the general medical services as of 1st November 2009, see codes below: • Combineb 0.5mg/2.5mg per 2.5ml x 60 – 18745 • Ipravent 250mcg/1ml x 20 - 77507 • Ipravent 500mcg/2ml x 20 - 77509 To access the SPCs please go to www.clonmel-health.ie. Ipravent and Combineb join Budesitan in the family of respiratory drugs for delivery by a nebuliser from Breathe Pharmaceuticals in Ireland. If you require any additional information on any of these Breath products please contact Clonmel Healthcare on 01 620-4000. Clonmel Healthcare launch LOCHOL – Fluvastatin 20mg, 40mg hard capsules www.your     Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Lochol – Fluvastatin 20mg & 40 mg Capsules.  
  Coversyl Arginine Plus Servier Laboratories have announced that Coversyl Arginine Plus 10mg/2.5mg will be available for prescription in Ireland from January 2010. Produced in Arklow, Coversyl Arginine Plus 10mg/2.5mg contains 10mg of perindopril arginine and 2.5mg of indapamide, extending the range and providing more powerful antihypertensive efficacy. Coversyl Arginine Plus 10mg/2.5mg provides a high level of control with 68% of hypertensive patients normalized at 8 weeks. The uptitration to Coversy Arginine Plus 10mg/2.5mg provides incremental and progressive blood pressure reductions reaching -23mmHg/15mmHg. The renal benefits of Coversyl Arginine Plus 10mg/2.5mg are greater than those for the lower dose Coversyl Arginine Plus 5mg/1.25mg, with albumin excretion rate reduced by 48%. Further confirmation of renal and cardiac benefits are demonstrated in the ADVANCE trial of over 11,000 patients with Type II diabetes, of whom 70% also had hypertension. Coversyl Arginine Plus 10mg/2.5mg is indicated as a substitution therapy for the treatment of essential hypertension in patients already controlled with perindopril arginine and indapamide given concurrently at the same dose level. Coversyl Arginine Plus10mg/2.5mg is taken once daily and will be available in pots containing 30 tablets providing one month of treatment and will be available on the GMS scheme. For full prescribing information see www.medicines.ie or please contact Servier Laboratories Ireland Ltd, Block 2, West Pier Business Campus, Old Dunleary road, Dún Laoghaire, Co Dublin or on (01) 6638110. Landmark 100th worldwide license for Cervarix GlaxoSmithKline (GSK) announced in October that the US Food and Drug Administration (FDA) has approved Cervarix for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18. The vaccine will be licensed for use in girls and young women (aged 10-25). This approval makes the US the 100 th country to grant licensing for Cervarix, following a recent approval in Japan and previous licenses obtained around the world, including in the 27 member states of the European Union, Australia, Brazil, South Korea, Mexico and Taiwan. “We are extremely proud to know that our cervical cancer vaccine will soon be available to millions of young women product news Flibanserin demonstrates efficacy and tolerability in pivotal phase III trials in pre-menopausal women with hypoactive sexual desire disorder Data from pooled, pivotal Phase III clinical trials demonstrate that flibanserin 100 mg taken once daily at bedtime significantly increased the number of satisfying sexual events (SSEs) and sexual desire while significantly decreasing the distress associated with hypoactive sexual desire disorder (HSDD). Flibanserin is an investigational compound that is being developed by Boehringer Ingelheim for the treatment of pre-menopausal women with HSDD. HSDD is a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties. Women with HSDD often feel a loss of intimacy and closeness that they used to enjoy. The condition can negatively impact a woman´s life and her relationship with her partner. The complete flibanserin pivotal trial programme was presented recently at the 12th Congress of the European Society for Sexual Medicine in Lyon, France. It included an analysis of three pivotal Phase III North American trials (DAISy, VIOLET and DAHLIA) and the pivotal Phase III European data (ORCHID). In addition results from a pooled analysis of two pivotal Phase III North American trials (DAISy and VIOLET) and a pooled analysis of the North American and European data (DAISy, VIOLET and ORCHID) were presented, assessing the safety and efficacy of flibanserin 100 mg in pre-menopausal women suffering with HSDD. "Despite studies demonstrating that HSDD is a common form of female sexual dysfunction, there is currently no approved prescription treatment for pre-menopausal women suffering from the condition” said Professor Rossella Nappi, director of the Gynaecological Endocrinology & Menopause Unit at the Maugeri Foundation, University of Pavia, Italy, and primary investigator of the European pivotal trial. "Flibanserin is a novel, non-hormonal compound, that has been investigated as a treatment for pre-menopausal women with HSDD. Based on the clinical trial results presented at ESSM it has the potential to help many women suffering from their lack of sexual desire." across the US,” said Jean Stéphenne, President and General Manager, GSK Biologicals. “Alongside our existing access programmes in Europe, Australia, across emerging markets and Asia Pacific, this approval marks an important turning point in our dedicated mission to provide women everywhere with effective protection against the world’s second-most common female cancer.” It is estimated that in 2009, approximately 11,000 women in the U.S. will be diagnosed with cervical cancer and 4,000 women will die from the disease. Worldwide, these numbers are estimated at more than 500,000 diagnoses per year and globally, cervical cancer kills one woman every two minutes. medicines.ie 51
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