Healthcare professionals including hematologists, oncologists, hospital and oncology pharmacists, and cancer clinic staff
Key Messages
Serious and fatal adverse reactions including “gasping syndrome” can occur in pediatric patients, particularly in neonates and infants treated with BLINCYTO containing benzyl alcohol as a preservative.
BLINCYTO has recently been authorized with an additional option of preparing a 7-day infusion bag containing benzyl alcohol for patients weighing greater than or equal to 22 kg. It is not recommended for use in patients weighing less than 22 kg.
When preparing bags of BLINCYTO solution for infusion in neonates, infants and patients weighing less than 22 kg, healthcare professionals are advised to only utilize preservative-free saline.
The Canadian Product Monograph has been updated to reflect this new safety information
Para recibir aportes y comentarios a norma que busca garantizar el derecho a la salud y acceso a su uso terapéutico
16-05-2018
El Ministerio de Salud (Minsa) publicó el Proyecto de Reglamento de la Ley N° 30681, Ley que regula el uso medicinal y terapéutico del Cannabis y sus derivados, en su Portal Web Institucional.
El objetivo de la publicación es recibir las sugerencias, comentarios o recomendaciones de las entidades públicas o privadas y de la ciudadanía en general, por un plazo de noventa (90) días calendario las cuales podrán ser formuladas escribiendo al correo webmaster@minsa.gob.peconforme a lo dispuesto por la Resolución Ministerial N° 435-2018/MINSA suscrita por la ministra de Salud, Silvia Pessah.
The Ministry of Health will be hosting its 9th Annual National Health Research Conference in November.
Research being conducted in four (4) main areas: (i) Oral Health (ii) Intentional and Unintentional Injuries (iii) Non-communicable Diseases, featuring cancers and (iv) Family Planning, will be showcased.
This guidance describes FDA’s enforcement approach with respect to over-the-counter (OTC) sunscreen products marketed without approved applications during the period before a final sunscreen monograph becomes effective. It is intended for manufacturers who market OTC sunscreen drug products without an approved application. OTC sunscreens are not yet the subject of an effective final monograph, and we continue to evaluate information relevant to defining conditions under which such products are generally recognized as safe and effective (GRASE) and not misbranded. However, OTC sunscreens marketed without approved applications and containing specified active ingredients (see section II., Background) are subject to labeling and testing requirements located at 21 CFR 201.327. Several other ongoing and planned rulemaking proceedings will also address these products.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Técnicos de la Coordinación Zonal 3 de la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) visitaron laboratorios de productos naturales de Ambato, con el objetivo de verificar las condiciones higiénico-sanitarias, almacenamiento y procesos de producción empleados para la elaboración de este tipo de productos que son distribuidos a nivel nacional.
“Este tipo de inspecciones se las realiza de manera permanente en toda la zona con el fin de brindar recomendaciones de mejora en la elaboración de productos naturales y suplementos alimenticios, para precautelar la salud de la población que los consume”, dijo Carlos Barreno, técnico de la Coordinación Zonal 3 de Arcsa.
Como parte del control, se verificó que los productos cumplan con el etiquetado aprobado en el Registro Sanitario, así como con la normativa sanitaria vigente, para evitar posibles casos de publicidad engañosa y confusión en las propiedades alimenticias y terapéuticas de dichos productos.
De acuerdo con la Resolución ARCSA-DE-008-2018-JCGO sobre Buenas Prácticas de Manufactura para Laboratorios Farmacéuticos: “Los laboratorios farmacéuticos nacionales de medicamentos en general que adicionalmente fabriquen productos naturales procesados de uso medicinal, deben fabricar estos productos bajo la modalidad de campaña o de preferencia en áreas autónomas e independientes, cumpliendo con Buenas Prácticas de Manufactura respectivas para cada tipo de producto”.
Arcsa motiva a laboratorios de productos naturales y suplementos alimenticios a cumplir con la normativa sanitaria vigente, para evitar posibles procesos sancionatorios y perjuicios en la salud de los consumidores.
El Comisionado para la Protección contra Riesgos Sanitarios, Julio Sánchez y Tépoz, inauguró hoy el “Segundo Simposio de cannabis medicinal para profesionales de la salud”, organizado por la Directora de CannabiSalud, Lorena Beltrán.
La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) y la Federación Nacional de la Industria Herbolaria, Medicina Alternativa Tradicional y Naturista A.C. (FNIHMATN), firmaron hoy un convenio de colaboración que tiene como objetivo principal establecer las acciones necesarias para contar con la regulación sanitaria que norme a los productos y plantas utilizadas por este sector así como mejorar y actualizar los procesos técnicos y de capacitación continua.
Ante la constatación de nuevos eventos centinelas vinculados al uso de fármacos diferentes envasados en ampollas de similar apariencia, el Ministerio de Salud Pública alerta a las instituciones de salud a extremar las precauciones en la compra de medicaciones de alto riesgo.
FDA offers a variety of patient and prescriber outreach materials, including graphics, drop-in content, and social media messages, to help promote understanding of biosimilars and interchangeable products:
Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the availability, access to, and the quality of information available on medical devices in Canada. Continuous and significant technological advancement in the field of medical devices makes it necessary for Health Canada to implement a nomenclature designed to keep pace with medical devices innovations.
Health Canada’s decision to use the GMDN is in line with the recommendation of the International Medical Device Regulators Forum (IMDRF) and supports the Federal Government’s Open Government initiative by improving the quality of medical devices data available to the public and leading to greater transparency.
The GMDN is an identification tool used worldwide by several medical device regulators. It is a list of generic names used to identify medical device products, allowing for efficient and timely information exchange between jurisdictions and effective monitoring by regulators. The GMDN database currently includes over 23 000 active terms covering all major technologies and intended uses, and is in constant evolution.
By adopting the GMDN, Health Canada will be in a better position to fulfill its mission to help Canadians maintain and improve their health, since better quality information will be available to Canadian health authorities, health care providers, manufacturers, and Canadians. This initiative will also lead to improved communication within the health-sector, will help Health Canada better understand and monitor medical device safety, and allow timely provision of more accurate information in response to internal and external stakeholders’ requests for information.
