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English to Indonesian: Annual Report Sample General field: Bus/Financial Detailed field: Finance (general)
Source text - English Corporate Secretary
The Corporate Secretary is a key role for the Company in implementing GCG principles and best practices. This is related to the commitment to upholding the implementation of information disclosure as an important aspect of implementing GCG. With the Corporate Secretary, the Company always maintains good relations and communication with stakeholders, both to the government, regulators, investors, and the public.
Corporate Secretary Guideline
The Corporate Secretary carries out duties and responsibilities based on Regulation of Financial Services Authority No. 35/POJK.04/2014 concerning the Corporate Secretary of Issuers or Public Companies.
Duties and Responsibilities of
Corporate Secretary
Duties and responsibilities of Corporate Secretary are as follows:
1. Following the development of capital market particularly the applicable laws and regulations of capital market.
2. Providing suggestions to the Board of Directors and the Board of Commissioners to comply with the provisions of the laws and regulation of capital market.
3. Assisting the Board of Directors and Board of Commissioners in the implementation of corporate governance which includes:
a. The disclosure of information to public, as well as the information availability in the Company’s website;
b. The submission of reports to Financial Services Authority in timely manner;
c. Organizing and documenting and documenting General Meeting of Shareholders;
d. Organizing and documenting the Board of Directors and/or Board of Commissioners meeting; and
e. The implementation of an orientation program to companies for the Board of Directors and/or Board of Commissioners.
4. As a liaison among Company and the Shareholders, Financial Services Authority, and other stakeholders.
Profile of Corporate Secretary
The Corporate Secretary of the Company is held by Dedi Tedjakusnadi based on the Decree of the Board of Directors No. 002/MHI-DIR/IX/2019 dated September 19, 2019. The complete profile of the Corporate Secretary can be seen in the Company Profile chapter in this Annual Report.
Implementation of Duties of the Corporate Secretary
Throughout 2019, the Corporate Secretary has provided input to the Board of Directors regarding the principles of GCG, as well as maintaining good relations with shareholders, regulators, business partners, and other stakeholders.
Competence Development for The Corporate Secretary
The Company has policies related to the development and enhancement of competence for the Corporate Secretary which is carried out through various training and education that is fully funded by the Company. The competence development of the Corporate Secretary can be seen in the Corporate Governance chapter, the description of the Board of Directors in this Annual Report.
Translation - Indonesian Sekretaris Perusahaan
Sekretaris Perusahaan merupakan organ yang sangat penting bagi Perseroan dalam mengimplementasikan prinsip-prinsip dan praktik terbaik GCG. Hal tersebut berkenaan dengan komitmen menjunjung tinggi pelaksanaan keterbukaan informasi sebagai aspek penting dalam penerapan GCG. Melalui Sekretaris Perusahaan, Perseroan senantiasa menjaga hubungan dan komunikasi yang baik dengan para pemangku kepentingan, baik dari pemerintah, regulator, investor maupun publik.
Pedoman Sekretaris Perusahaan
Sekretaris Perusahaan menjalankan tugas dan tanggung jawab berdasarkan Peraturan Otoritas Jasa Keuangan No. 35/POJK.04/2014 tentang Sekretaris Perusahaan Emiten atau Perusahaan Publik.
Tugas dan Tanggung Jawab Sekretaris Perusahaan
Berikut uraian tugas dan tanggung jawab yang diemban oleh Sekretaris Perusahaan:
1. Mengikuti perkembangan pasar modal khususnya peraturan-peraturan yang berlaku di bidang pasar modal;
2. Memberikan masukan kepada Direksi dan Dewan Komisaris Perseroan untuk mematuhi ketentuan peraturan perundang-undangan di bidang pasar modal;
3. Membantu Direksi dan Dewan Komisaris dalam pelaksanaan tata kelola Perseroan yang meliputi:
a. Keterbukaan informasi kepada masyarakat, termasuk ketersediaan informasi pada situs web Perseroan;
b. Penyampaian laporan kepada Otoritas Jasa Keuangan tepat waktu;
c. Penyelenggaraan dan dokumentasi RUPS;
d. Penyelenggaraan dan dokumentasi rapat Direksi dan/atau Dewan Komisaris; dan
e. Pelaksanaan program orientasi terhadap Perseroan bagi Direksi dan/atau Dewan Komisaris.
4. Sebagai penghubung atau contact person antara Perseroan dengan Pemegang Saham Perseroan, Otoritas Jasa Keuangan, dan pemangku kepentingan lainnya.
Profil Sekretaris Perusahaan
Sekretaris Perusahaan Perseroan dijabat oleh Dedi Tedjakusnadi berdasarkan Surat Keputusan Direksi No. 002/MHI-DIR/IX/2019 tanggal 19 September 2019 Profil lengkap Sekretaris Perusahaan dapat dilihat pada bab Profil Perusahaan dalam Laporan Tahunan ini.
Pelaksanaan Tugas Sekretaris Perusahaan
Sepanjang tahun 2019, Sekretaris Perusahaan telah memberikan masukan kepada Direksi mengenai prinsip-prinsip GCG, serta menjalin hubungan baik dengan para Pemegang Saham, regulator, mitra usaha, dan pemangku kepentingan lainnya.
Pengembangan Kompetensi Sekretaris Perusahaan
Perseroan memiliki kebijakan terkait pengembangan dan peningkatan kompetensi bagi Sekretaris Perusahaan yang dilakukan melalui berbagai pelatihan dan pendidikan dengan pendanaan sepenuhnya menjadi tanggung jawab Perseroan. Pengembangan kompetensi Sekretaris Perusahaan dapat dilihat pada bab Tata Kelola Perusahaan uraian Direksi dalam Laporan Tahunan ini.
English to Indonesian: Pharma Product Monograph General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 2.3.2 Pharmacokinetics
The pharmacokinetics (PK) of remdesivir have been evaluated in adults in several phase 1 trials.
Following single-dose, 2-hour IV administration of remdesivir solution formulation at doses ranging from 3 to 225 mg, remdesivir exhibited a linear PK profile.
Following single-dose, 2-hour IV administration of remdesivir at doses of 75 and 150 mg, both the lyophilized and solution formulations provided comparable PK parameters (AUCinf, AUClast, and Cmax), indicating similar formulation performance.
Remdesivir 75 mg lyophilized formulation administered IV over 30 minutes provided similar peripheral blood mononuclear cell (PBMC) exposure of the active triphosphate metabolite GS-443902 as remdesivir 150 mg lyophilized formulation administered IV over two hours.
Following a single 150 mg intravenous dose of [14C]-remdesivir, mean total recovery of the dose was greater than 92%, consisting of approximately 74% and 18% recovered in urine and faeces, respectively. The majority of remdesivir dose recovered in urine was metabolite GS-441524 (49%), while 10% was recovered as remdesivir.
Specific Populations
Sex, Race, and Age
Pharmacokinetic differences based on sex, race, and age have not been evaluated.
Pediatric Patients
The pharmacokinetics of remdesivir in pediatric patients has not been evaluated.
Physiologically-based pharmacokinetic models were developed to estimate remdesivir and GS-441524 exposure and predict pediatric patient exposure based on age-dependent physiologic changes (e.g. organ volume/function, blood flow). These simulations do not account for the impact of infection on the pharmacokinetics of remdesivir and GS-441524, which is currently unknown.
Renal Impairment
Because the excipient SBECD is renally cleared and accumulates in patients with decreased renal function, administration of drugs formulated with SBECD (such as remdesivir) is not recommended in adult and pediatric patients (>28 days old) with estimated glomerular filtration rate (eGFR) less than 30 mL per minute or in full-term neonates (≥7 days and ≤28 days old) with serum creatinine clearance ≥1 mg/dL unless the potential benefit outweighs the potential risk.
Translation - Indonesian 2.3.2 Farmakokinetik
Farmakokinetik (PK) remdesivir telah dievaluasi pada orang dewasa dalam beberapa uji coba fase 1.
Setelah pemberian formulasi larutan remdesivir dosis tunggal selama 2 jam secara intravena (IV) dengan dosis mulai dari 3 hingga 225 mg, remdesivir menunjukkan profil PK linier.
Setelah pemberian remdesivir dosis tunggal selama 2 jam secara IV dengan dosis 75 dan 150 mg, formulasi liofilisasi dan larutan memberikan parameter PK yang sebanding (AUCinf, AUClast, dan Cmax), menunjukkan kinerja formulasi yang serupa.
Formulasi liofilisasi Remdesivir 75 mg diberikan secara IV selama 30 menit memberikan paparan yang sama pada sel mononuklear darah perifer (PBMC) dari metabolit trifosfat aktif GS-443902 sebagaimana formulasi liofilisasi remdesivir 150 mg yang diberikan secara IV selama dua jam.
Setelah dosis tunggal intravena 150 mg [14C]-remdesivir diberikan, rata-rata total pemulihan dosis lebih besar dari 92%, masing-masing terdiri dari sekitar 74% dan 18% pulih dalam urin dan feses. Mayoritas dosis remdesivir yang ditemukan dalam urin adalah metabolit GS-441524 (49%), sementara yang 10% pulih sebagai remdesivir.
Populasi Khusus
Jenis Kelamin, Ras, dan Usia
Perbedaan farmakokinetik berdasarkan jenis kelamin, ras, dan usia belum dievaluasi.
Pasien Anak
Farmakokinetik remdesivir pada pasien anak belum dievaluasi.
Model farmakokinetik berbasis fisiologis dikembangkan untuk memperkirakan paparan remdesivir dan GS-441524, serta memprediksi paparan pasien anak berdasarkan perubahan fisiologis yang bergantung pada usia (misalnya volume/fungsi organ, serta aliran darah). Simulasi ini tidak memperhitungkan dampak infeksi pada farmakokinetik remdesivir dan GS-441524 yang saat ini tidak diketahui.
Gangguan ginjal
Karena eksipien SBECD dibersihkan ginjal dan terakumulasi pada pasien dengan penurunan fungsi ginjal, maka pemberian obat yang diformulasikan dengan SBECD (seperti remdesivir) tidak dianjurkan pada pasien dewasa dan anak-anak (> 28 hari) dengan perkiraan laju filtrasi glomerulus (eGFR) lebih rendah dari 30 mL per menit atau pada neonatus cukup bulan (≥7 hari dan ≤28 hari) dengan klirens kreatinin serum ≥1 mg/dL, kecuali potensi manfaatnya melebihi potensi risikonya.
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A full-time freelance translator with 9 years of experience. Holding a BA degree in English Language and Literature. Capable of using the CAT tools (SDL Trados 2019, MemoQ, and Subtitle Edit). Member of Association of Indonesian Translators.
Specialization: Banking & Finance,Marketing & Advertising, Information Technology, and Medical Translation.
Keywords: Indonesian, academic, journals, linguistic, social science, humanities, theology, historical