Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati...ents 6 years of age and older and weighing at least 20 kg.
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)]
more
Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
more
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
more
Modern healthcare has given rise to extremely complex and multifaceted ethical dilemmas. All too often physicians are unprepared to manage these competently. This publication is specifically structured to reinforce and strengthen the ethical mindset and prac...tice of physicians and provide tools to find ethical solutions to these dilemmas. It is not a list of “rights and wrongs” but an attempt to sensitise the conscience of the physician, which is the basis for all sound and ethical decision-making. To this end, you will find several case studies in the book, which are intended to foster individual ethical reflection as well as discussion within team settings.
more
Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV.
Das BfArM bietet eine Liste von Antigen-Tests zum dir...ekten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
more
Trypanosoma cruzi is the etiological agent of Chagas disease (CD), considered one of the most important parasitic infections in Latin America. Between 25 and 90 million humans are at infection risk via at least one of multiple infection mechanisms. Under natural conditions, the principal transmissio...n modes are transplacental or via one of more than 140 hematophagous triatomine bugs (Reduviidae: Triatominae). Triatomines acquire the parasite from mammal reservoirs due to their obligate blood-feeding (albeit triatomines can also feed on non-reservoir vertebrates such as birds and reptiles). The disease burden for CD in the Latin America and Caribbean region, based on disability-adjusted life-years (DALYs), is at least five times greater than that of malaria, and is approximately one-fifth that of HIV/AIDS. In recent decades, CD has extended to other continents outside natural reservoir or vector distributions due to human migration, with a minimum estimated 10 million individuals infected worldwide.
more
WHO has updated its guidelines for COVID-19 therapeutics, with revised recommendations for patients with non-severe COVID-19. This is the 13th update to these guidelines.
Updated risk rates for hospital admission in patients with non-severe COVID-19
The guidance includes updated risk rates for... hospital admission in patients with non-severe COVID-19.
The current COVID-19 virus variants tend to cause less severe disease while immunity levels are higher due to vaccination, leading to lower risks of severe illness and death for most patients.
This update includes new baseline risk estimates for hospital admission in patients with non-severe COVID-19. The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease. The updated risk estimates will assist healthcare professionals to identify individuals at high, moderate or low risk of hospital admission, and to tailor treatment according to WHO guidelines:
**High: **People who are immunosuppressed remain at higher risk if they contract COVID-19, with an estimated hospitalization rate of 6%.
**Moderate: **People over 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.
Low: Those who are not in the high or moderate risk categories are at low risk of hospitalization (0.5%). Most people are low risk.
Review of COVID-19 treatments for people with non-severe COVID-19
WHO continues to strongly recommend nirmatrelvir-ritonavir (also known by its brand name ‘Paxlovid’) for people at high-risk and moderate risk of hospitalization. The recommendations state that nirmatrelvir-ritonavir is considered the best choice for most eligible patients, given its therapeutic benefits, ease of administration and fewer concerns about potential harms. Nirmatrelvir-ritonavir was first recommended by WHO in April 2022.
If nirmatrelvir-ritonavir is not available to patients at high-risk of hospitalization, WHO suggests the use of molnupiravir or remdesivir instead.
WHO suggests against the use of molnupiravir and remdesivir for patients at moderate risk, judging the potential harms to outweigh the limited benefits in patients at moderate risk of hospital admission.
For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol.
WHO also recommends against use of a new antiviral (VV116) for patients, except in clinical trials.
The update also includes a strong recommendation against the use of ivermectin for patients with non-severe COVID-19. WHO continues to advise that in patients with severe or critical COVID-19, ivermectin should only be used in clinical trials.
more
HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ...require personnel and laboratory infrastructure that are often lacking. An alternative specimen type is dried blood spots (DBS), which can be made without special laboratory processing. DBS are more easily transported than plasma because they can be shipped at ambient temperature as non-hazardous materials using regular mail or courier services.
3rd edition
more
GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
...
and delivering more than $200 million worth of diagnostic equipment
more
HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu...blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
more
This global guidance provided the framework for over 100 countries to develop their NDVPs. This updated (second) version supersedes the previous version published in 16 November 2020. New information has been added on the following areas:
the COVID-19 Partners Platform;
the use of COVID...-19 simulation exercises to test deployment strategies;
the indemnity agreement and no-fault compensation programme for vaccines secured through the COVAX Facility in the Advance Market Commitment (AMC) eligible economies;
the availability and use of the WHO-UNICEF COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool;
the COVAX Facility’s humanitarian buffer that enables allocation of vaccine to cover high-risk populations in humanitarian settings;
recommendations for vaccination of pregnant and lactating women;
supplementary information on infection prevention and control (IPC) measures to be used to deliver COVID-19 vaccines safely;
the WHO licensed COVID-19 vaccines product-specific information;
use of geospatial data and digital micro plans for equitable access and delivery of COVID-19 vaccines;
lessons learned from the development of NDVPs and early experiences in COVID-19 vaccine deployment in countries; and
updated additional resources at the end of each chapter.
more
The International Pharmaceutical Federation (FIP) is a global federation of national associations of pharmacists and
pharmaceutical scientists. In order to support these associations in their fight against AMR, FIP has prepared this
briefing document. It is an overview of the different activities ...that community and hospital pharmacists are involved
into prevent AMR and to reverse AMR rates.
more
The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th...e document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
regulatory framework, mental health support, response, rehabilitation and recovery, etc. It specifically lays down the approach for implementation of the guidelines by the central ministries/departments, states, districts and other stakeholders, in a time bound manner.
more
The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed and deployed when resources and political will were abundant. This rapidity was also due to the f...act that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
more
Chromoblastomycosis (CMB) is a chronic fungal infection of the skin and the subcutaneous tissue caused by a transcutaneous traumatic inoculation of a specific group of dematiaceous fungi occurring mainly in tropical and subtropical zones worldwide. If not diagnosed at early stages, patients with CBM... require long term therapy with systemic antifungals, sometimes associated with physical methods. Unlike other neglected endemic mycoses, comparative clinical trials have not been performed for this disease. Nowadays, therapy is based on a few open trials and on expert opinion. Itraconazole either as monotherapy or associated with other drugs, or with physical methods, is widely used. Recently, photodynamic therapy has been successfully employed in combination with antifungals in patients presenting with CBM. In the present revision the most used therapeutic options against CBM are reviewed as well as the several factors that may have impact on the patient's outcome.
more
Addressing comorbidities and risk factors for tuberculosis (TB) is a crucial component of the World Health Organization (WHO)’s End TB Strategy. This WHO operational handbook on tuberculosis. Module 6: tuberculosis and comorbidities aims to support countries in scaling up people-centred care, ...based on the latest WHO recommendations on TB and key comorbidities, and drawing upon additional evidence, best practices and inputs from various experts and stakeholders obtained during WHO processes. It is intended for use by people working in ministries of health, particularly TB programmes and the relevant departments or programmes responsible for comorbidities and health-related risk factors for TB such as HIV, diabetes, undernutrition, substance use, and tobacco use, as well as programmes addressing mental health and lung health.
more
This guideline provides evidence-informed guidance on the use of non-sugar sweeteners to reduce the risk of unhealthy weight gain and diet-related noncommunicable diseases in adults and children. The guidance in this guideline is not based on toxicological assessments of the safety of individual no...n-sugar sweeteners and is therefore not intended to update or replace guidance on safe or maximal levels of intake established by the Joint Food and Agriculture Organization of the United Nations (FAO)/WHO Expert Committee on Food Additives (JECFA) or other authoritative bodies.
more
The Ministry of Health together with its partners realizes that efficient and effective
delivery of clinical care is highly dependent on the availability of appropriately
upgraded environment, which is in well facilitated space. Such facilities and utilities
should always be properly designed, bu...ilt, and maintained, so as to ensure efficient
treatment in clean and safe from infection.
The main challenges in achieving this include the lack of, appropriate holistic and
futuristic management plans, human resource for facility/utility management and
maintenance, adequate budget funds for renovation/maintenance activities at all
levels which means daily and long-term of facility maintenance plans and executions.
It is hoped that the guidelines will help to standardise
design of medical facilities and utilities country wide and result in efficient and
effective establishment of these life-saving function
more
The document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf...rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
more