Yazar "Derici M.K." seçeneğine göre listele

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    Öğe
    Regulatory aspects of vaccines [Aşılarda yasal düzenlemeler]
    (Society of Pharmaceutical Sciences of Ankara (FABAD), 2020) Şenel S.; Derici M.K.; Devrim B.
    in order to get a marketing authorisation, a vaccine product must fullfill the national/international requriements for efficiency, safety and quality. Due to its complex structure, the manufacture, control and regulation of a vaccine requires special expertise and procedures when compared to that of a small molecule drug. in this paper, the registration procedures of vaccines in different countries including Turkey, european Union, UsA and the countries covered by the world Health Organization (wHO) will be reviewed and the regulatory requirements and related guidelines are summarised. © 2020 Society of Pharmaceutical Sciences of Ankara (FABAD). All rights reserved.
  • [ X ]
    Öğe
    Short-term use of metamizole sodium versus diclofenac sodium in acute renal colic pain in Turkish patients; a double-blind, observational study
    (Refik Saydam National Public Health Agency (RSNPHA), 2019) Derici M.K.; Ergün H.
    Objective: Renal colic pain is one of the most frequent reasons for emergency department visits. Metamizole sodium and diclofenac are the most common used non-narcotic drugs in available countries. The objective of this study was to compare the effectiveness and safety of metamizole sodium and diclofenac in treatment of acute renal colic pain in emergency room services in Ankara, Turkey. Methods: Eighty-eight patients with renal colic were treated intramuscularly (i.m.) with metamizole sodium (1 g) (n=48) or diclofenac sodium (75 mg) (n=40). Pain intensity was measured by using visual analogue scale (0-100 mm) and 5-point verbal score before (baseline) and after 30, 60, 90 and 120 minutes of i.m. drug administration. Results: Both of the treatment groups were homogeneous when analyzed by age, sex and baseline pain intensity. Both treatments were well tolerated and none of the observed side effects were serious. Five patients in the metamizole sodium and three patients in the diclofenac group needed extra treatment. The average pain intensity difference between groups for all time points measured was not significantly different. There was no significant difference in physician and patient evaluations for both drugs. Conclusion: Our results indicate that i.m. 1 g metamizole sodium is equally effective as i.m. 75 mg diclofenac sodium for two hours of observation period in acute renal colic treatment. © 2019, Refik Saydam National Public Health Agency (RSNPHA).Amaç: Renal kolik ağrisi, acil servis başvurularinin en sik nedenlerinden biridir. Metamizol sodyum ve diklofenak, ilaçlarin bulunduğu ülkelerde en yaygin kullanilan narkotik olmayan ilaçlardir. Bu çalişmanin amaci, Ankara'daki acil servislerde akut renal kolik ağrisinin tedavisinde metamizol sodyum ve diklofenak'in etkinliğini ve güvenliğini karşilaştirmaktir. Yöntem: Renal kolik ağrisi olan 88 hasta intramüsküler metamizol sodyum (1 g) (n=48) veya diklofenak sodyum (75 mg) (n=40) ile tedavi edildi. Ağri şiddeti, ilaç uygulanmadan önce (başlangiç düzeyi) ve uygulandiktan 30, 60, 90 ve 120 dakika sonra, Görsel Analog Skala (0-100 mm) ve 5-Nokta Sözel Derecelendirme ölçeği ile ölçüldü. Bulgular: Her iki tedavi grubu da yaş, cinsiyet ve başlangiçtaki ağri şiddeti yönlerinden analiz edildiğinde homojendi. Her iki tedavi de iyi tolere edildi ve gözlenen yan etkilerin hiçbiri ciddi değildi. Metamizol sodyum grubunda beş, diklofenak grubunda ise üç hasta ek tedaviye ihtiyaç duydu. ölçülen tüm zaman noktalari için gruplar arasindaki ortalama ağri şiddeti farki anlamli değildi. Her iki ilaç için de hekim ve hasta değerlendirmeleri arasinda anlamli fark yoktu. Sonuç: Sonuçlarimiz akut renal kolik tedavisinde i.m. 1 g metamizol sodyumun, iki saatlik gözlem dönemi için i.m. 75 mg diklofenak sodyum kadar etkili olduğunu göstermektedir. © 2019, Refik Saydam National Public Health Agency (RSNPHA).