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Source text - English Disorders of hyperpigmentation are difficult to treat, particularly in dark-skinned individuals. The goal is to reduce the hyperpigmentation without causing undesirable hypopigmentation or irritation in the surrounding normally pigmented skin. The psychosocial impact caused by these disorders must be considered. Although there are many effective therapeutic modalities available, there are potentially significant side-effects associated with treatment. The most commonly used treatment is topical hydroquinone. There are other phenolic agents, such as Nacetyl- 4-cystaminylphenol (NCAP), that are currently being studied and developed. The nonphenolic agents, which include tretinoin, adapalene, topical corticosteroids, azelaic acid, arbutin, kojic acid, and licorice extract, are also used for hyperpigmentation disorders.
Translation - Turkish Hiperpigmentasyon bozukluklarının tedavisi, özellikle koyu renk ciltli bireylerde zordur. Tedavide amaç çevreleyen normal pigmente dokuda istenmeyen hipopigmentasyon veya irritasyona neden olmaksızın hiperpigmentasyonu azaltmaktır. Bu bozuklukarın sebep olduğu psikososyal etki göz önünde bulundurulmalıdır. Mevcut çok sayıda etkili terapötik yöntem olsa da, tedaviyle ilişkili potansiyel olarak belirgin yan etkiler bulunmaktadır. En yaygın kullanılan tedavi topikal hidrokinondur. Nasetil-2-Sisteaminilfenol (NCAP) gibi, halen çalışılmakta ve geliştirilmekte olan diğer fenolik ajanlar vardır. Treitonin, adapalen, topical kortikosteroidler, azelaik asit, arbutin, kojik asit ve meyan kökü ekstresi içeren nonfenolik ajanlar da hiperpigmentasyon bozukluğu için kullanılmaktadır.
English to Turkish: Pharmaceutical Development
Source text - English 3.2.P.2 Pharmaceutical Development
QLT USA, Inc. has developed a sustained release formula for parenteral application of leuprorelin acetate in a polymeric delivery system. XX®7,5mg is indicated in the palliative treatment of advanced prostatic cancer as an alternative to orchiectomy or estrogen therapy. XX® 7,5mg is provided in direct application syringe containers so that the end user may blend the leuprorelin acetate with the YY® delivery system together for use. XX® 7,5mg is administered by injecting the formulation into the subcutaneous tissue. After injection, the formulation solidifies upon contact with bodily fluids in the subcutaneous tissue to form a solid mass via coagulation of the polymer, allowing for release of the leuprorelin acetate in a sustained manner as the polymer erodes.
XX® 7,5mg has not demonstrated significant adverse systemic or local effects in either nonclinical evaluations or clinical studies. The product is manufactured with components that have low toxicity profiles, have been used previously in human drug products, and have proven to be compatible in the final product.
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance
Leuprorelin acetate [leuprorelin. (D-Leu6 des-Gly10) - LH-RH ethylamide] is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormones. The LH-RH agonist is supplied and used as the acetate salt of the peptide. Leuprorelin acetate is provided as a sterile lyophilized solid that is mixed with the sterile, polymeric delivery system prior to administration.
Translation - Turkish 3.2.P.2 Farmasötik Gelişme
QLT ABD Şti. bir polimerik taşıyıcı sisteminde Leuprorelin asetatın parenteral uygulamasına yönelik sürekli salınım yapan bir formül geliştirmiştir. XX®7,5mg orşiektomi veya östrojen tedavisine alternatif olarak ilerlemiş prostat kanserinin palyatif tedavisinde endikedir. XX®7,5mg doğrudan uygulama şırıngası haznelerinde sunulur, böylelikle son kullanıcı, leuprorelin asetatı, birlikte kullanmak üzere YY® taşıyıcı sistemi ile karıştırabilir. XX® 7,5mg formülün subkutan dokuya enjekte edilmesi yoluyla verilir. Enjeksiyonun ardından, formül subkutan dokudaki vücut sıvıları ile temas ettikten sonra katılaşarak, polimerin koagülasyonu yoluyla katı bir kitle oluşturur, polimer yıkıma uğradıkça leuprorelin asetatın sürekli olarak salınımına olanak sağlar.
XX® 7,5mg klinik dışı çalışmalarda veya klinik çalışmalarda belirgin advers sistemik veya lokal etkiler göstermemiştir. Ürün düşük toksisite profilleri olan, daha önce insan ilaç ürünlerinde kullanılmış ve son üründe uyumlu olduğu kanıtlanmış bileşenlerle imal edilmiştir.
3.2.P.2.1 İlaç Ürününün Bileşenleri
3.2.P.2.1.1 İlaç Maddesi
Leuprorelin asetat (leuprorelin (D-Leu6 des-Gly10) - LH-RH etilamid] doğal yolla oluşan gonadotropin-releasing(gonadotropin salınımı sağlayan) hormonların sentetik nonapeptid bir analoğudur. LH-RH agonisti peptidin asetat tuzu olarak temin edilir ve kullanılır. Leuprorelin asetat, vücuda verilmeden önce steril, polimerik taşıyıcı sistemi ile karıştırılan steril liyofilize bir katı olarak sunulur.
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Years of experience: 24. Registered at ProZ.com: May 2005.
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MD
Certification from Ankara 17th Notary of Turkish Republic
9 years of experience translating and editing drug licensing sheets, medical instrument manuals, articles for medical journals etc.
RECENT PROJECTS
Medical Validation of Mammography Device Manuals (Over 300,000 words)
Translation of medical articles on cardiac valves (Over 100,000 words)
Translation of drug licensing sheets for a major drug company (Over 100,000 words)
Translation and medical validation of EEG and ECG device manuals (Over 100,000 words)
Translation of infant food and nutritional supplement brochures, information sheets (Over 30,000 words)
Translation of articles on dietary supplements, nutritional medicine etc.
Translation and/or Review of Clinical Trial Protocols
Translation and/or Review of Informed Consent Forms
Translation and/or Review of Patient Surveys
Translation and/or Review of Pharmaceutical Product Certificates
Translation of radiology reports for major private hospitals in Ankara and Istanbul on a regular basis for 8 years
Translation of articles on all medical subjects ( Pediatry, Gynecology and Obstetrics, Cardiology, Pulmonary Diseases, Infectious Diseases etc) for various translation agencies on a regular basis for 8 years
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