In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous
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and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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3rd edition!Large File 17 MB!
Document No. : FDA/SMC/CTD/GL-CCT/2013/01
with recommended essential medicines for common diseases in patients in Stockholm County Council (Healthcare Region), Sweden
This document focuses on the management of patients affected by gambiense HAT and
constitutes an update to the WHO therapeutic guidance issued in 2013. The main changes in recommendations concern the criteria
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and methods for deciding the treatment among the new set of therapeutic options and the particular conditions that apply to treatment with fexinidazole, as outlined below. Because HAT is a serious, life-threatening disease and because the efficacy of fexinidazole depends on swallowing the medicine after an appropriate intake of food as well as on completing the full 10-day
treatment schedule, the recommendations regarding fexinidazole administration are considered key elements that must be carefully followed. When the conditions listed in these guidelines are not met for any individual patient, the alternative available treatments should be prescribed.
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in An
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gola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Including Therapeutic Food, Dietary Vitamin and Mineral Supplementation - 2nd edition
Three Years After Enactment of the Drug Quality and Security Act
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products
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to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
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Severe Acute Malnutrition (SAM) is one of the greatest child survival challenges in the world today and
reportedly affects more than 16.2 million children each year1. High impact, proven treatment interventions exist
yet sadly approximately only 3
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.2 million children with SAM have access to treatment each year2. Thus, there
is a need to scale up interventions to improve coverage and access across high burden countries. While efforts
are currently underway to expand services in many countries, obstacles remain.
One critical barrier to expanding SAM treatment services is the acceptance, accessibility and utilisation of
ready-to-use therapeutic food (RUTF). In some countries and contexts, RUTF is still not fully accepted by
community members; while other countries face problems with procurement, storage and supply chain
management which impact on availability and use3. Reports from Ghana and Zambia highlighted that stock-
outs and logistical challenges are often noted as key contributors to high default rates in outpatient treatment
centres4.
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For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety
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and efficacy of “re-purposed” drugs that have been widely used to treat other infections but are also showing promise in the treatment of DR-TB, including linezolid and clofazimine. This special supplemental guide has been developed for nurses, because it is essential that nurses be provided with material that maximizes their ability to provide optimal support to patients who are receiving new and re-purposed drugs
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HIV & AIDS Treatment in Practice No.202
Document No. : FDA/SMC/SMD/GL-RAR/2013/01