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AOP Orphan Press Briefing
„Agitation – Symptom or Syndrome?“

Prim. Dr. Georg Psota
„Agitation – what is agitation?”
Agitation is just a word, a small word to describe a number of different emotions and special kinds of behaviour. About 100 years ago Ludwig Wittgenstein wrote in his famous “tractatus logico-philosophicus”: “All that we see could also be different” and using this as a metaphor I would argue: All that we see, could also be described with Consequently, semantics is key: we use one term in different languages differently (having different meanings and connotations), e.g. in English and German - and Language is an important One of the most useful books of psychopathology in German language is: Allgemeine Psychopathologie (General Psychopathology) by Prof. Dr. Christian Scharfetter. We will not find the term “agitation” in the entire index list of this publication; 376 pages and only one reference to “agitation”: Being agitated, as an abnormal, increased form of motoric behaviour. The term “Agitation” as a noun is not so widely used in german psychopathology. Other terms, like “high-tension” are used more frequently, especially in acute psychiatric wards. Besides all those semantic differences – what is agitation, how can we Agitation is a state – in all psychopathological languages – close to high motor activity, high frequency of words, excessive verbal activity combined with high-tension and impatience. Last but not least it can lead to aggression, against others, or against the patient him/herself. Agitation is correlated with complex interactions between patient and environment; it occurs in outpatients as well as in hospitalized patients and can also happen “in-between”, in the ambulance when bringing patients to Agitation – as a symptom – occurs in mania as well in depression, also in anxiety disorders, in dementia, in psychotic states and diverse kinds of delirious states.

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Agitation as a syndrome has a lot of symptoms, a lot of colours and different ways of courses; it can be dangerous and is an expression of a human being’s suffering. When suffering, treatment is needed and the range of treatment, of response to agitation reaches from soft factors like developing a calm atmosphere, verbal interventions to medication and even physical restraint. The softer – the better and, equally important, the safer- the better, that should be the motto.(2) Answering the question whether agitation is a symptom or a syndrome: there are some slightly different ways of psychopathological wordings, some slightly different semantic meanings – but without any doubt agitation is a symptom of a lot of psychiatric illnesses and in itself – as a clinical presentation – it is a Lindemayer et. al. “the pathophysiology of agitation”, Journal Clinical Psychiatry 2000; 61) Georgiva, Mulder et al “ perceived restrictions of human rights” BMC Psychiatry 2012 Prof. Philippe Nuss (MD, PhD)
„Decision-making process in the treatment of agitation: The French experience”
The overall treatment of agitated patients in the context of emergency is a crucial issue for individuals with schizophrenia and bipolar disorder. This frequent situation needs to be properly managed as its impact is major in terms of short and long term outcome and treatment adherence. Despite this importance, the number of published data dedicated to the management of agitation is limited. Ethical issues are often put forward to explain this paucity. Agitation and tranquillisation are indeed complex entities, difficult to operationalize and this may also explain this fact. In addition, the evaluation and treatment of agitation also depend on the appraisal of associated environmental variables such as for instance the type of interaction with the family, economic conditions, and substance use. In addition, the type of health care system strongly influences the kind of proposed management. Furthermore, intangible assets must also be considered such as patients' preference, tranquilising treatment habits, local specificities. It is understandable that facing this complexity, professional associations have mainly developed guidelines and treatment algorithms for the initial management of acute state of mental disorders. In most cases, agitation treatment recommendations are poorly developed and based on a mix of scarce evidence-based data and local expert consensus. Overall, first (FGA) and second (SGA) generations antipsychotic drugs as well as benzodiazepines (BZD) are recommended in various order of priority, and authors usually recommend to restrict the prescription of parenteral high doses of FGAs to very severe or violent cases of mania or in non-collaborative conditions. In a safety perspective, it is also recommended that concomitant use of two or more antipsychotics should be avoided due to greater QT prolongation risk. The management of agitated states relies on a careful analysis of the clinical condition. Clinicians need to disentangle to what extend agitation is related to (i) symptom exacerbation caused by the relapse of a known disorder, (ii) symptom exacerbation due to a comorbid condition such as anxiety, substance use, stressful conditions, (iii) destabilisation of the environment in which the patients interacts. De-escalation is the initial goal for clinicians and carers. This can be achieved by pharmacological and non- pharmacological means in order to develop an alliance with the patient and family and prepare future treatment strategy. In this context of optimal cooperation, oral administration of medications is preferable to parenteral administration, and the lowest effective dose should be given. Every country has developed pharmacological and non-pharmacological strategies. In France, Loxapine (oral or IM), a typical antipsychotic with a good neurological profile, has been used for decades in various situations for the treatment of psychiatric emergencies. An algorithm has been developed distinguishing controllable agitation with or without risk of self/others harm and uncontrollable agitation. Loxapine use will be described in each of these conditions. Prof. Richard Louis Jaffe
„Rapid onset treatment option – is there more than iv / im?”
One of the ongoing challenges in the treatment of agitated patients is in providing a rapidly-acting, non invasive form of medication. Oral agents are non-invasive but have a delayed onset of action; intramuscular administration is rapid in onset but can be painful and perceived as distressing by the patient. Adasuve offers a new technology whereby a single dose of loxapine can be inhaled into the lungs, thus offering an oral medication with intravenous pharmakokinetics. Two phase-three clinical trials demonstrated significant improvement in agitation symptoms, compared to placebo, at two hours, with a positive effect being seen as early as ten minutes after administration. The medication was well tolerated, with rare incidence of pulmonary side-effects that were easily managed. Further inquiries

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