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English to Lithuanian: Summary of Product Characteristics General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 1. NAME OF THE MEDICINAL PRODUCT
XYZ 5 mg solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 5 mg of ZYX* in 0.5 ml solution for injection. The concentration is 10 mg/ml based on protein only**.
Excipient(s) with known effect:
Each pre-filled syringe contains less than 1 mmol (23 mg) sodium.
Each pre-filled syringe contains 50 mg sorbitol (E420) (see section 4.4).
For the full list of excipients, see section 6.1.
The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see section 5.1
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
** The concentration is 20 mg/ml if the PEG moiety is included.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to slightly yellowish solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of myelodysplastic syndromes and chronic myeloid leukaemia).
4.2 Posology and method of administration
XYZ therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Posology
One 5 mg dose (a single pre-filled syringe) of XYZ is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. In randomised clinical trials, a subcutaneous dose of 230 μg/m2 /day (4.0 to 8.4 μg/kg/day) was used.
Method of administration
XYZ is injected subcutaneously. The injections should be given into the upper arm, abdomen or thigh. For instructions on handling of the medicinal product before administration, see section 6.6.
Patients with renal impairment
No dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Paediatric population
The safety and efficacy of XYZ in children has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for ZYX to YXZ in patients with de novo acute myeloid leukaemia (see section 5.1). However, the long-term effects of XYZ have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
The safety and efficacy of XYZ administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established. XYZ is not indicated for use in these conditions. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
The safety and efficacy of XYZ have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
The safety and efficacy of XXXX administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Translation - Lithuanian 1. VAISTINIO PREPARATO PAVADINIMAS
XYZ 5 mg injekcinis tirpalas.
2. KOKYBINĖ IR KIEKYBINĖ SUDĖTIS
Kiekviename 0,5 ml injekcinio tirpalo užpildytame švirkšte yra 5 mg ZYX *. Vien baltymo koncentracija yra 10 mg/ml**.
Pagalbinė (-s) medžiaga (-os), kurios (-ių) poveikis žinomas:
Kiekviename užpildytame švirkšte yra mažiau kaip 1 mmol (23 mg) natrio.
Kiekviename užpildytame švirkšte yra 50 mg sorbitolio (E420) (žr. 4.4 skyrių).
Visos pagalbinės medžiagos išvardytos 6.1 skyriuje.
Šio preparato poveikio stiprumo negalima lyginti su kitų tos pačios terapinės grupės pegiliuotų ar nepegiliuotų baltymų poveikio stiprumu. Daugiau informacijos žr. 5.1 skyriuje
*Gaminamas Escherichia coli ląstelėse rekombinantinės DNR technologijos būdu ir konjuguojamas su polietilenglikoliu (PEG).
** Koncentracija yra 20 mg/ml, jei išreiškiama kartu su PEG dalimi.
3. FARMACINĖ FORMA
Injekcinis tirpalas.
Skaidrus, bespalvis arba vos gelsvas injekcinis tirpalas.
4. KLINIKINĖ INFORMACIJA
4.1 Terapinės indikacijos
Neutropenijos trukmės ir febrilinės neutropenijos pasireiškimo dažnio mažinimas suaugusiems pacientams, kurių onkologinės ligos (išskyrus mielodisplazinius sindromus ir lėtinę mieloidinę leukemiją) gydomos citotoksine chemoterapija.
4.2 Dozavimas ir vartojimo metodas
Gydymą XYZ turi skirti ir prižiūrėti gydytojai, turintys patirties onkologijos ir (arba) hematologijos srityse.
Dozavimas
Rekomenduojama per kiekvieną chemoterapijos ciklą, praėjus mažiausiai 24 valandoms po citotoksinės chemoterapijos, suleisti vieną XYZ 5 mg dozę (vieną užpildytą švirkštą). Atsitiktinių imčių klinikiniuose tyrimuose buvo naudojama 230 μg/m2 per parą (4,0–8,4 μg/kg per parą) dozė į poodį.
Vartojimo metodas
XYZ leidžiamas po oda. Galima leisti žasto, pilvo arba šlaunies srityje. Vaistinio preparato ruošimo prieš vartojant instrukcija pateikiama 6.6 skyriuje.
Pacientai, kuriems sutrikusi inkstų veikla
Pacientams, kuriems sutrikusi inkstų veikla, įskaitant galutinės stadijos inkstų liga sergančius pacientus, dozės keisti nerekomenduojama.
Vaikų populiacija
XYZ saugumas ir veiksmingumas vaikams dar neištirti. Turimi duomenys pateikiami 4.8, 5.1 ir 5.2 skyriuose, tačiau dozavimo rekomendacijų pateikti negalima.
4.3 Kontraindikacijos
Padidėjęs jautrumas veikliajai arba bet kuriai pagalbinei medžiagai.
4.4 Specialūs įspėjimai ir atsargumo priemonės
Nedidelis kiekis klinikinių duomenų rodo, kad ZYX turėjo panašų poveikį pacientų, sergančių de novo diagnozuota ūmine mieloidine leukemija, sunkios neutropenijos normalizavimosi trukmei kaip ir YXZ (žr. 5.1 skyrių). Tačiau ilgalaikis XYZ poveikis ūmine mieloidine leukemija sergantiems pacientams neištirtas, todėl šiai pacientų populiacijai jį reikia skirti atsargiai.
XYZ skyrimo mielodisplaziniu sindromu arba lėtine mielogenine leukemija sergantiems pacientams saugumas ir veiksmingumas neištirti. XYZ neskirtas vartoti esant šioms būklėms. Ypač svarbu užtikrinti, kad diagnozuojant lėtinės mieloidinės leukemijos blastų transformacija būtų atskiriama nuo ūminės mieloidinės leukemijos.
XYZ saugumas ir veiksmingumas pacientams, kuriems taikoma didelių dozių chemoterapija, neištirti. Šio vaistinio preparato negalima vartoti norint padidinti citotoksinių chemoterapinių preparatų dozes daugiau negu nurodyta nustatytose dozavimo schemose.
XXXX skyrimo de novo ŪML pacientams, kurių amžius < 55 metai ir kurie pasižymi gera citogenetika [t(8;21), t(15;17) ir inv(16)], saugumas ir veiksmingumas neištirti.
Granulocitų kolonijas stimuliuojantis faktorius gali skatinti mieloidinių ląstelių augimą in vitro, ir gali būti stebimas panašus poveikis in vitro kai kurioms nemieloidinėms ląstelėms.
English to Lithuanian: My entry for ProZ.com Translation Contest "The Sounds of Silence" General field: Other Detailed field: Poetry & Literature
Source text - English A theme of the age, at least in the developed world, is that people crave silence and can find none. The roar of traffic, the ceaseless beep of phones, digital announcements in buses and trains, TV sets blaring even in empty offices, are an endless battery and distraction. The human race is exhausting itself with noise and longs for its opposite—whether in the wilds, on the wide ocean or in some retreat dedicated to stillness and concentration. Alain Corbin, a history professor, writes from his refuge in the Sorbonne, and Erling Kagge, a Norwegian explorer, from his memories of the wastes of Antarctica, where both have tried to escape.
And yet, as Mr Corbin points out in "A History of Silence", there is probably no more noise than there used to be. Before pneumatic tyres, city streets were full of the deafening clang of metal-rimmed wheels and horseshoes on stone. Before voluntary isolation on mobile phones, buses and trains rang with conversation. Newspaper-sellers did not leave their wares in a mute pile, but advertised them at top volume, as did vendors of cherries, violets and fresh mackerel. The theatre and the opera were a chaos of huzzahs and barracking. Even in the countryside, peasants sang as they drudged. They don’t sing now.
What has changed is not so much the level of noise, which previous centuries also complained about, but the level of distraction, which occupies the space that silence might invade. There looms another paradox, because when it does invade—in the depths of a pine forest, in the naked desert, in a suddenly vacated room—it often proves unnerving rather than welcome. Dread creeps in; the ear instinctively fastens on anything, whether fire-hiss or bird call or susurrus of leaves, that will save it from this unknown emptiness. People want silence, but not that much.
Translation - Lithuanian Viena iš amžiaus temų – bent jau išsivysčiusiose šalyse – yra apie tai, kad žmonės trokšta tylos, bet niekaip jos neranda. Eismo ūžesys, nesiliaujantis telefonų pypsėjimas, skaitmeninių pranešėjų balsai autobusuose ir traukiniuose, televizoriai, kurie nenutyla netgi tuščiuose biuruose, be atvangos vargina ir blaško mus. Žmonių vaikai patys kamuoja save triukšmu ir ilgisi jo priešingybės, ieškodami jos dykynėse, vandenynų toliuose ar kitoje rimtį ir susitelkimą žadančioje priebėgoje. Istorijos profesorius Alenas Corbin‘as rašo apie tai iš savo jaukaus kampelio Sorbonoje, o norvegų tyrinėtojas Erlingas Kagge dalijasi prisiminimais iš Antarktidos platybių, kuriose vienumos yra ieškoję jie abu.
Vis dėlto, kaip knygoje „Tylos istorija“ pažymi A. Corbin‘as, šiandien triukšmo turbūt nėra daugiau nei kadaise. Prieš atsirandant pneumatinėms padangoms miestų gatvėse galva plyšo nuo metalu kaustytų ratų dardesio ir pasagų kaukšėjimo į akmeninį grindinį. Kol žmonės dar nebuvo užsisklendę mobiliųjų telefonų pasaulyje, autobusai ir traukiniai skardėjo nuo pašnekovų balsų. Spaudos pardavėjai nerymojo sau tyliai prie laikraščių krūvelės – ne, jie reklamavo savo prekę visa gerkle, nuo jų neatsiliko prekiautojai vyšniomis, našlaitėmis ir šviežiomis skumbrėmis. Teatre ir operoje panirdavai į ovacijų ir švilpimo erzelynę. Netgi valstiečiai kaime plušdami prie ūkio darbų traukė dainas. Dabar jie nebedainuoja.
Padidėjo ne tiek triukšmo lygis (juo žmonės skundėsi ir praėjusiais amžiais), kiek blaškanti jo skvarba netgi į tas sritis, kuriose turėtų karaliauti tyla. Čia stebina kitas paradoksas – kai, pavyzdžiui, pušyno gūdumoje, nykioje dykumoje ar staiga ištuštėjusiame kambaryje tyla vis dėlto paima viršų, užuot suteikusi ramybės ji neretai ima bauginti. Širdį užvaldo baimė, ir ausis instinktyviai „užsikabina“ už bet ko – ugnies spragsėjimo, paukščio giesmės ar lapų šiugždesio, – kas gali išgelbėti nuo tos nepažįstamos tuštumos. Žmonės nori tylos, bet ne per daugiausiai.
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Years of experience: 20. Registered at ProZ.com: Oct 2012.
Across, Adobe Acrobat, memoQ, MemSource Cloud, Microsoft Excel, Microsoft Word, Translator Work Space, Passolo, Powerpoint, SDLX, Trados Studio, Wordbee
Working full time as a translator since 2004, I provide high quality translation, editing and machine translation post-editing (MTPE) services in English>Lithuanian and Lithuanian>English language pairs. Lithuanian is my native language.
My main specialization is translation and editing of Clinical Trial and Pharmaceutical texts. In clinical trials, I have been working regularly on ICFs and other patient-facing documentation, study protocols, correspondence with regulatory authorities, legal contracts, etc. In pharmaceuticals, I have been dealing constantly with SPCs, PILs and other documentation. You may also find my name in the pool of pharmaceutical translators pre-screened by ProZ.com.
I am also providing linguistic validation services involving medical questionnaires (coordinating a team of translators/proofreaders, finding patients/clinicians for cognitive debriefing interviews and conducting the interviews with them).
Depending on time and availability, I may be able to help you in other areas that I have worked at. Alternatively, if you wish, I can arrange for a team of reliable translators and editors to do a job for you.
Some of these other fields are mentioned below:
- Automotive: hundreds of thousands words translated for major Asian, European and American car manufacturers, including marketing and technical brochures, dealer staff e-learning courses, internal dealer communication, etc.
- Finance, insurance: financial reports, contracts, insurance product descriptions and procedures (general insurance, life insurance, credit insurance).
- Marketing, market research: my clients value my creative abilities to adapt marketing texts to local culture and make them really appealing for Lithuanian readers. Also, I have been working on survey questionnaires for restaurant chains, hotels, high education institutions, etc.&
- Technical: fiber laser tube cutting machine (117k words), electric power tools, pneumatic tools, compressors, lifting equipment, roofing materials, batteries, ATMs (cash dispensers), smart phones, TVs, computers, photo cameras, etc.
- Websites: I have localized various websites into Lithuanian, ranging from sports and travel to heavy-duty machinery.
CAT tools I use include Trados Studio 2022, MemoQ, Phrase (Memsource), Across, Wordbee, Translation Workspace, etc.
I promise you professional and ethical cooperation. Looking forward to hear from you soon!
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Keywords: English to Lithuanian medical translator, English to Lithuanian medical editor, English to Lithuanian medical linguist, English to Lithuanian medical translation, native speaker, Lithuania, translator, translation, interpreter, interpretation. See more.English to Lithuanian medical translator, English to Lithuanian medical editor, English to Lithuanian medical linguist, English to Lithuanian medical translation, native speaker, Lithuania, translator, translation, interpreter, interpretation, automotive, cars, trucks, technical, engineering, medical, clinical trial, clinical trials, clinical study, informed consent, subject information, trial protocols, pharmaceutical, SPC, PIL, medical equipment, surgical, diagnostic, user manual, operating manual, experience, finance, financial, banking, economics, insurance, general insurance, life insurance, credit insurance, website translation, localization, high education, EU, certified, legal, marketing, electric power tools, pneumatic tools, compressors, lifting equipment, roofing materials, batteries, ATMs (cash dispensers), smart phones, TVs, computers, photo cameras, fiber laser tube cutting machine, EUIPO, linguistic validation, questionnaires, depression questionnaire, medical questionnaire, cognitive debriefing interviews, MTPE, machine translation post editing. See less.
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