Publicación: Evaluación del cumplimiento de los requisitos de etiquetado en medicamentos veterinarios
| dc.contributor.advisor | Mendizábal Solé, Ana Luisa | |
| dc.contributor.author | Morán Guzmán, Miriam Georgina | |
| dc.contributor.jury | Paz Díaz, Maria Eugenia | |
| dc.contributor.jury | López García, Élfego Rolando | |
| dc.date.accessioned | 2026-07-14T17:45:24Z | |
| dc.date.issued | 2025 | |
| dc.description | Formato PDF digital — 74 páginas — incluye gráficos, tablas y referencias bibliográficas. | |
| dc.description.abstract | En el presente trabajo se evaluó el cumplimiento de los requisitos de etiquetado en medicamentos veterinarios comercializados en la Ciudad de Guatemala, con base en lo establecido en la norma RTCA 65.05.51:18. La investigación incluyó tanto el sector formal como el informal, con el propósito de obtener un panorama integral de la situación. Se analizaron tres clases farmacológicas de uso frecuente en la medicina veterinaria, permitiendo conocer las principales deficiencias en la información disponible para los consumidores. El objetivo principal fue establecer un diagnóstico del nivel de cumplimiento regulatorio en el etiquetado de medicamentos veterinarios. La investigación se desarrolló con 36 medicamentos veterinarios obtenidos en farmacias veterinarias y mercados municipales. Asimismo, las muestras fueron analizadas mediante un instrumento de evaluación elaborado a partir de la normativa vigente. Los datos recolectados se procesaron con técnicas estadísticas básicas, permitiendo establecer los niveles de cumplimiento en función de las características de los productos. Los resultados mostraron que solo el 22.2% de los productos cumplió con todos los requisitos de etiquetado, mientras que el cumplimiento promedio fue de 87.2% (desviación estándar 12.2). El sector formal presentó un cumplimiento mayor (91.1%) que el informal (83.3%), evidenciando menor cumplimiento de los requisitos de etiquetado en este. Se identificaron posibles casos de medicamentos de contrabando, deficiencias en el etiquetado de antibióticos, entre otros. Además, los requisitos relacionados con fechas de vencimiento y producción, advertencias y contraindicaciones presentaron cumplimiento bajo (63.9%, 36.1% y 63.9 respectivamente). Los hallazgos reflejaron que, aunque el nivel de cumplimiento promedio fue relativamente aceptable, las deficiencias representan riesgos para la salud animal y pública; resaltando la necesidad de que fabricantes cumplan con la normativa, y del fortalecimiento en la supervisión de estos productos. | spa |
| dc.description.abstract | This study evaluated compliance with labeling requirements for veterinary medicines marketed in Guatemala City, based on the provisions established in RTCA 65.05.51:18. The research included both the formal and informal sectors in order to provide a comprehensive overview of the current situation. Three commonly used pharmacological classes in veterinary medicine were analyzed, allowing the identification of the main deficiencies in the information available to consumers. The primary objective was to establish a diagnosis of the level of regulatory compliance with veterinary medicine labeling requirements. The study included 36 veterinary medicinal products obtained from veterinary pharmacies and municipal markets. The samples were evaluated using an assessment instrument developed in accordance with the current regulatory standard. The collected data were analyzed using basic statistical techniques to determine compliance levels based on the characteristics of the products. The results showed that only 22.2% of the products complied with all labeling requirements, while the overall average compliance rate was 87.2% (standard deviation = 12.2). The formal sector demonstrated a higher level of compliance (91.1%) than the informal sector (83.3%), indicating lower adherence to labeling requirements among products marketed informally. Potential cases of smuggled veterinary medicines were identified, along with deficiencies in the labeling of antibiotics, among other issues. In addition, the requirements related to expiration and production dates, warnings, and contraindications showed relatively low compliance rates (63.9%, 36.1%, and 63.9%, respectively). Although the overall average level of compliance was relatively acceptable, the identified deficiencies represent potential risks to both animal and public health. These findings highlight the need for manufacturers to comply fully with current regulations and for regulatory authorities to strengthen the monitoring and oversight of veterinary medicinal products. | eng |
| dc.description.degreelevel | Pregrado | |
| dc.description.degreename | Licenciado en Química Farmacéutica | |
| dc.format.extent | 74 p. | |
| dc.format.mimetype | application/pdf | |
| dc.identifier.uri | https://repositorio.uvg.edu.gt/handle/123456789/6648 | |
| dc.language.iso | spa | |
| dc.publisher | Universidad del Valle de Guatemala | |
| dc.publisher.branch | Campus Central | |
| dc.publisher.faculty | Facultad de Ciencias y Humanidades | |
| dc.publisher.place | Guatemala | |
| dc.publisher.program | Licenciatura en Química Farmacéutica | |
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| dc.rights.accessrights | info:eu-repo/semantics/openAccess | |
| dc.rights.coar | http://purl.org/coar/access_right/c_abf2 | |
| dc.rights.license | Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) | |
| dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
| dc.subject.armarc | Salud animal | |
| dc.subject.armarc | Registro sanitario | |
| dc.subject.armarc | Industria farmacéutica | |
| dc.subject.armarc | Calidad de los productos | |
| dc.subject.armarc | Medicamentos veterinarios | |
| dc.subject.armarc | Medicamentos -- Normas | |
| dc.subject.armarc | Medicamentos -- Control de calidad | |
| dc.subject.ddc | 610 - Medicina y salud::615 - Farmacología y terapéutica | |
| dc.subject.ocde | 1. Ciencias Naturales::1D. Ciencias químicas | |
| dc.subject.ods | ODS 3: Salud y bienestar. Garantizar una vida sana y promover el bienestar de todos a todas las edades | |
| dc.title | Evaluación del cumplimiento de los requisitos de etiquetado en medicamentos veterinarios | spa |
| dc.title.translated | Evaluation of compliance with labeling requirements for veterinary medicinal products | |
| dc.type | Trabajo de grado - Pregrado | |
| dc.type.coar | http://purl.org/coar/resource_type/c_7a1f | |
| dc.type.coarversion | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |
| dc.type.content | Text | |
| dc.type.driver | info:eu-repo/semantics/bachelorThesis | |
| dc.type.version | info:eu-repo/semantics/publishedVersion | |
| dc.type.visibility | Public Thesis | |
| dspace.entity.type | Publication |
