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Preliminary consultation on preferred product characteristics of benzathine penicillin G for secondary prophylaxis of rheumatic fever

机译:苄星青霉素G优选用于风湿热继发预防的产品特性的初步咨询

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摘要

Rheumatic fever is caused by an abnormal immune reaction to group A streptococcal infection. Secondary prophylaxis with antibiotics is recommended for people after their initial episode of rheumatic fever to prevent recurrent group A streptococcal infections, recurrences of rheumatic fever and progression to rheumatic heart disease. This secondary prophylaxis must be maintained for at least a decade after the last episode of rheumatic fever. Benzathine penicillin G is the first line antibiotic for secondary prophylaxis, delivered intramuscularly every 2 to 4 weeks. However, adherence to recommended secondary prophylaxis regimens is a global challenge. This paper outlines a consultation with global experts in rheumatic heart disease on the characteristics of benzathine penicillin G formulations which could be changed to improve adherence with secondary prophylaxis. Characteristics included dose interval, pain, administration mechanism, cold chain independence and cost. A sample target product profile for reformulated benzathine penicillin G is presented.
机译:风湿热是由对A组链球菌感染的异常免疫反应引起的。对于风湿热初期发作的人群,建议对抗生素进行二次预防,以防止复发的A组链球菌感染,风湿热复发和发展为风湿性心脏病。在风湿热最后一次发作后,这种二级预防必须维持至少十年。苄星青霉素G是用于二级预防的一线抗生素,每2至4周肌注一次。然而,坚持推荐的二级预防方案是一项全球性挑战。本文概述了与风湿性心脏病全球专家就苄星青霉素G制剂的特征进行的协商,该制剂可进行更改以改善对二级预防的依从性。特征包括剂量间隔,疼痛,给药机制,冷链独立性和成本。给出了重新配制的苄星青霉素G的样品目标产品概况。

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