Magister Scientiae (Medical Bioscience) - MSc(MBS) / Background: Veterinary medicines play an imperative role in the diagnosis, prevention and treatment of animal diseases. Many veterinary stock remedies in South Africa are available to the public without the intervention or supervision of a veterinarian or healthcare worker. Therefore, the accompanying package insert with product information and directions for use is central in promoting the safe and effective use of stock remedies. Information such as the dosage, warnings, precautions and storage instructions are essential to assist the user in their treatment decision-making. While local regulatory authority guidelines prescribe and control the minimum information that should be available in the package insert or product label, it is questioned whether the information contained in package inserts of products on the market complies with these regulatory requirements. Methodology: Using simple random sampling of veterinary stock remedies, 159 package inserts or product labels from various animal health companies were selected and evaluated against the prescribed labelling guidelines of the local regulatory authority responsible for the registration and control of stock remedies. The contents of each package insert or label in the sample were assessed for the presence of the prescribed information statements and were accordingly classified as non-compliant, partially compliant or compliant. Results: Among the 159 package inserts, 48 were for antimicrobials, 49 for ectoparasiticides, 44 for anthelmintics and the remaining 18 for endectocides. It was observed that none of the package inserts met all of the criteria and that the package inserts were inadequate in many aspects. The average percentage of compliance was 69.43%, with a range of 36.21% to 87.93%. Conclusion: The study indicated that many package inserts do not fully comply with the prescribed regulatory guidelines and that information related to the safe and appropriate use of stock remedies is insufficient.

Nesta dissertação, foi desenvolvida uma análise linguística contrastiva de bulas de medicamento brasileiras e alemãs. O principal objetivo dessa análise era identificar o grau de compreensibilidade de cada um dos textos, segundo as dimensões do modelo de Karlsruhe: Concisão, Correção, Motivação, Estrutura, Simplicidade e Perceptibilidade. Para isso, foram retomados conceitos da Linguística Textual e procedimentos da Textologia Contrastiva, como as definições de texto e gênero textual, o método de comparação de textos paralelos e o estabelecimento de um termo de comparação. De maneira geral, os resultados da análise contrastiva indicaram que termos técnicos (no âmbito da simplicidade) e fonte pequena (no âmbito da perceptibilidade) não são as principais causas de incompreensão na leitura das bulas, como se supôs inicialmente. O estudo evidenciou que desvios na estrutura e na concisão das bulas podem ter um impacto tão ou mais negativo na compreensão desses textos do que os aspectos anteriormente citados. Além disso, foi possível constatar que cada uma das dimensões possui um peso diferente na compreensibilidade das bulas analisadas devido a diferenças linguísticas e culturais entre os pares alemão/português e Alemanha/Brasil. / In this research, a contrastive linguistic analysis of German and Brazilian package inserts was developed. The main aim of this analysis was to identify the degree of comprehensibility in each text, according to the Karlsruhe model dimensions: concision, correctness, motivation, structure, simplicity and perceptibility. To achieve this aim, it was necessary to review some concepts of the Textual Linguistics and procedures of the Contrastive Textology, such as the definitions of text and textual genre, the method of comparing parallel texts and the establishment of a point of comparison. In general, the results of the contrastive analysis have shown that technical terms (in the scope of simplicity) and small font (perceptibility) are not the main causes of misunderstanding of package inserts, as it was supposed initially. The study has highlighted that deviances in the structure and in the concision of package inserts may have an impact in the comprehension of these texts as negative as the aspects forementioned, if not more. Moreover, it was possible to notice that each dimension has a different weight in the comprehensibility of the analyzed package inserts because of the linguistic and cultural differences between German/Portuguese and Germany/Brazil.

Nesta dissertação, foi desenvolvida uma análise linguística contrastiva de bulas de medicamento brasileiras e alemãs. O principal objetivo dessa análise era identificar o grau de compreensibilidade de cada um dos textos, segundo as dimensões do modelo de Karlsruhe: Concisão, Correção, Motivação, Estrutura, Simplicidade e Perceptibilidade. Para isso, foram retomados conceitos da Linguística Textual e procedimentos da Textologia Contrastiva, como as definições de texto e gênero textual, o método de comparação de textos paralelos e o estabelecimento de um termo de comparação. De maneira geral, os resultados da análise contrastiva indicaram que termos técnicos (no âmbito da simplicidade) e fonte pequena (no âmbito da perceptibilidade) não são as principais causas de incompreensão na leitura das bulas, como se supôs inicialmente. O estudo evidenciou que desvios na estrutura e na concisão das bulas podem ter um impacto tão ou mais negativo na compreensão desses textos do que os aspectos anteriormente citados. Além disso, foi possível constatar que cada uma das dimensões possui um peso diferente na compreensibilidade das bulas analisadas devido a diferenças linguísticas e culturais entre os pares alemão/português e Alemanha/Brasil. / In this research, a contrastive linguistic analysis of German and Brazilian package inserts was developed. The main aim of this analysis was to identify the degree of comprehensibility in each text, according to the Karlsruhe model dimensions: concision, correctness, motivation, structure, simplicity and perceptibility. To achieve this aim, it was necessary to review some concepts of the Textual Linguistics and procedures of the Contrastive Textology, such as the definitions of text and textual genre, the method of comparing parallel texts and the establishment of a point of comparison. In general, the results of the contrastive analysis have shown that technical terms (in the scope of simplicity) and small font (perceptibility) are not the main causes of misunderstanding of package inserts, as it was supposed initially. The study has highlighted that deviances in the structure and in the concision of package inserts may have an impact in the comprehension of these texts as negative as the aspects forementioned, if not more. Moreover, it was possible to notice that each dimension has a different weight in the comprehensibility of the analyzed package inserts because of the linguistic and cultural differences between German/Portuguese and Germany/Brazil.