FrancophonIA/ELRC3.0 huggingface dataset:
English: A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose.
Bulgarian: En 100 mg peroral dos är jämförbar med en 75 mg intravenös dos; en 400 mg peroral dos är jämförbar med en 200 mg intravenös dos. Variabilitet av exponering hos en och samma patient (d.v.s. mellan cykler) är större vid peroral administrering än efter intravenös administrering (se avsnitt 4.4 och 5.2).
English: See section 4.
Bulgarian: som anges i kapitel 4 i avdelning III
English: • 0.47 mg of sodium propyl parahydroxybenzoate (E217).
Bulgarian: 0,47 mg av natriumpropylparahydroxybensoat (E217).
English: nausea, vomiting, cortical blindness, hypersensitivity reactions with hypotension.
Bulgarian: som exempelvis utmattning, sömnighet, illamående, kräkningar, kortikal blindhet samt överkänslighetsreaktioner med blodtrycksfall.
English: General disorders and administration site conditions very common asthenia, malaise rare pyrexia
Bulgarian: symtom vid administreringsstället mycket vanliga asteni, sjukdomskänsla sällsynta feber
English: • 0.61 mg of sodium propyl parahydroxybenzoate (E217).
Bulgarian: 0,61 mg av natriumpropylparahydroxybensoat (E217).
English: Measured Creatinine Clearance
Bulgarian: Uppmätt kreatininclearance
English: As with all medicines used to treat cancer, care must be taken when handling VEPESID and associated names capsules.
Bulgarian: så måste försiktighet iakttas när man hanterar VEPESID och associerade namn kapslar.
English: Combination therapy
Bulgarian: Kombinationsbehandling
English: The dose multiple (based on mg/m2 doses) for these findings at the no-observed adverse-effect-level in the preclinical studies were ≥ approximately
Bulgarian: Dosmultipeln (baserad på mg/m2-doser) för dessa fynd vid nivån för icke observerad biverkning i prekliniska studier var ≥ ungefär 0,05 gånger jämfört med högsta kliniska dos. Historiskt sett har prekliniska arter varit mer känsliga jämfört med människor mot cytotoxiska ämnen.
English: Frequency Adverse Reaction (MedDRA Terms)
Bulgarian: Biverkning (MedDRA-terminologi)
English: APPROPRIATE
Bulgarian: Dessutom
English: • 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and
Bulgarian: 1,22 mg av natriumetylparahydroxybensoat (E215) och
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory non-Hodgkin's lymphoma in adults.
Bulgarian: i kombination med andra godkända kemoterapeutiska medel för behandling av recidiverande eller refraktär non-Hodgkins lymfom hos vuxna.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults.
Bulgarian: i kombination med andra godkända kemoterapeutiska medel för behandling av recidiverande eller refraktär testikelcancer hos vuxna.
English: The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells.
Bulgarian: sen S- och tidig G2-del av cellcykeln i mammaliska celler. Två dosberoende responser ses:
English: SUMMARY OF PRODUCT CHARACTERISTICS
Bulgarian: Tabell över sammanfattning av biverkningar
English: The usual dose of VEPESID and associated names administered orally is 100 to 200 mg/m2/day on days 1 to 5 or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.
Bulgarian: som administreras peroralt är 100 till 200 mg/m2/dag på dag 1
English: Hypersensitivity
Bulgarian: Överkänslighet
English: Doses subsequent to initial dose should be adjusted if neutrophil count less than 500 cells/mm occurs for more than 5 days or is associated with fever or infection, if platelet count less than 25,000 cells/mm occurs, if any grade 3 or 4 toxicity develops or if renal clearance is less than 50 ml/min.
Bulgarian: infektion, om trombocytantalet är lägre än 25 000 celler/mm3, om någon annan grad 3- eller 4-toxicitet utvecklas eller om njurclearance är lägre än 50 ml/min.
English: Drug interactions
Bulgarian: Läkemedelsinteraktioner
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Bulgarian: i kombination med andra godkända kemoterapeutiska medel för behandling av småcellig lungcancer hos vuxna.
English: • dizziness
Bulgarian: aptitlöshet
English: Detailed information on this medicinal product is available on the website of [name of MS Agency link].
Bulgarian: Ytterligare information om detta läkemedel finns på Europeiska läkemedelsmyndighetens webbplats http://www.ema.europa.eu, och på Läkemedelsverkets webbplats http://www.lakemedelsverket.se.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Bulgarian: i kombination med andra godkända kemoterapeutiska medel för behandling av icke-epitelial ovarialcancer hos vuxna.
English: Impaired renal function
Bulgarian: Nedsatt njurfunktion
English: • difficulty swallowing
Bulgarian: svårighet att svälja
English: 4.9 Overdose
Bulgarian: Överdosering
English: • tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
Bulgarian: som släpps ut från cancercellerna tar sig in i blodbanan)
English: No studies on the effects on the ability to drive and use machines have been performed.
Bulgarian: Påverkan på förmågan att framföra fordon eller använda maskiner har inte studerats. Etoposid kan orsaka biverkningar
English: • temporary hair loss
Bulgarian: tillfälligt håravfall
English: Reproductive system and breast disorders not known infertility
Bulgarian: ingen känd frekvens infertilitet
English: Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100 to 600 mg/m2.
Bulgarian: som en bifasisk process med en distribueringshalveringstid på ungefär 1,5 timmar och terminal eliminationshalveringstid varierande mellan 4 till 11 timmar. Totala kroppsclearancevärden varierar mellan 33 till 48 ml/min eller 16 till 36 ml/min/m2 och, liksom den
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults.
Bulgarian: i kombination med andra godkända kemoterapeutiska medel för behandling av recidiverande eller refraktär akut myeloisk leukemi hos vuxna.
English: Bacterial infections should be brought under control before treatment with VEPESID and associated names.
Bulgarian: signifikanta toxiciteten vid behandling med VEPESID och associerade namn.
English: nausea and vomiting common diarrhoea, mucositis (including stomatitis and esophagitis)
Bulgarian: Magtarmkanalen mycket vanliga buksmärta, anorexi, förstoppning, illamående och kräkningar vanliga diarré, mukosit (innefattande stomatit och esofagit)
English: 6.4 Special precautions for storage
Bulgarian: SÄRSKILDA FÖRVARINGSANVISNINGAR
English: The daily dose may sometimes be split to be taken morning and evening.
Bulgarian: i rad eller 200 mg/m2 kroppsyta på dag 1, 3 och 5. Den dagliga dosen kan ibland delas upp för att tas morgon och kväll.
English: VEPESID and associated names 50mg Soft Capsules VEPESID and associated names 100mg Soft Capsules [See Annex I - To be completed nationally]
Bulgarian: VEPESID och associerade namn 100 mg mjuka kapslar [Se bilaga I - Kompletteras nationellt]
English: Do not open any blister in which there is evidence of capsule leakage.
Bulgarian: Öppna inte någon burk om det finns tecken på kapselläckage.
English: VEPESID and associated names (see Annex 1) 50 mg capsule, soft VEPESID and associated names (see Annex 1) 100 mg capsule, soft [See Annex I - To be completed nationally]
Bulgarian: VEPESID och associerade namn (se Bilaga 1) 100 mg mjuka kapslar [Se bilaga I - Kompletteras nationellt]
English: For oral use.
Bulgarian: som behandling.
English: Date
Bulgarian: ÖGA
English: INSTRUCTIONS ON USE [To be completed nationally]
Bulgarian: BRUKSANVISNING [Kompletteras nationellt]
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Bulgarian: LÄKEMEDEL OCH AVFALL I FÖREKOMMANDE FALL Ej använt läkemedel och avfall
English: Etoposide has been shown to be teratogenic in mice and rats (see section 5.3).
Bulgarian: ska etoposid administreras i minskad dos (se avsnitt 4.2).
English: The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of VEPESID and associated names: platelet count, haemoglobin, white blood cell count and differential.
Bulgarian: trombocytantal, hemoglobinvärde, antal vita blodkroppar och differentialräkning.
English: • convulsions (seizure)
Bulgarian: • krampanfall
English: • bleeding
Bulgarian: • rodnad
English: • nausea and vomiting
Bulgarian: illamående och kräkningar
English: In all instances where the use of VEPESID and associated names is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
Bulgarian: ska läkaren väga behovet och nyttan av läkemedlet mot risken för biverkningar.
English: Posology
Bulgarian: svalget
English: [See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Bulgarian: Denna bipacksedel ändrades senast <{MM/ÅÅÅÅ}><{månad ÅÅÅÅ}>. [Kompletteras nationellt]
English: OTHER Cytotoxic.
Bulgarian: TILLVERKNINGSSATSNUMMER Batch nr. ÖVRIGT Cytostatikum.
English: Hypertension
Bulgarian: blödning
English: Sodium ethyl parahydroxybenzoate (E215) Sodium propyl parahydroxybenzoate (E217) Titanium dioxide (E171) Red iron oxide (E172)
Bulgarian: Natriumpropylparahydroxybensoat (E217)
English: Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy (see section 4.4), which may have compromised bone marrow reserve.
Bulgarian: i kombinationen eller utifrån effekterna av tidigare strål- eller cytostatikabehandling (se avsnitt 4.4)
English: Etoposide may cause adverse reactions that affect the ability to drive and use machines such as fatigue, somnolence,
Bulgarian: Påverkan på förmågan att framföra fordon eller använda maskiner har inte studerats. Om du känner dig trött, mår illa, känner dig yr eller
English: Breastfeeding
Bulgarian: Amning
English: Talk to your doctor or pharmacist before taking VEPESID and associated names
Bulgarian: ska avbrytas eller om behandlingen med VEPESID och associerade namn
English: Low serum albumin
Bulgarian: serumalbumin
English: Events are death due to any cause.
Bulgarian: Събитията са смъртни случаи поради всякаква причина.
English: The MTD was not reached.
Bulgarian: MTD не е постигната.
English: Do NOT use Adcetris if you:
Bulgarian: Не използвайте Adcetris, ако:
English: Represents pooling of preferred terms.
Bulgarian: Представлява обединяване на предпочитани термини.
English: The dose of this medicine depends on your body weight.
Bulgarian: Дозата на това лекарство зависи от телесното Ви тегло.
English: Death without either prior progression or more than one missed assessment visit.
Bulgarian: Смъртен случай или без предшестваща прогресия или повече от едно пропуснато посещение за оценка.
English: The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Bulgarian: Безопасността и ефикасността на ADCETRIS при деца на възраст под 18 години все още не са установени.
English: Representative risk factors for these analyses were:
Bulgarian: Представителните рискови фактори за тези анализи са:
English: A risk to the newborn/infant cannot be excluded.
Bulgarian: Не може да се изключи риск за новородените/кърмачетата.
English: 4 years.
Bulgarian: 4 години.
English: Eligible patients were required to have at least one of the following risk factors:
Bulgarian: От подходящите пациенти се изисква да имат най-малко един от следните рискови фактори:
English: In this study in 36 patients, no new safety concerns were reported.
Bulgarian: В това проучване при 36 пациенти не се съобщават нови съображения за безопасност.
English: In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Bulgarian: Като цяло този вид реакции възникват в рамките на минути до няколко часа след приключване на вливането.
English: It is not for use in children.
Bulgarian: Той не е предназначен за употреба при деца.
English: It is given by your doctor or nurse over 30 minutes.
Bulgarian: То се прилага от Вашия лекар или медицинска сестра в продължение на 30 минути.
English: Indicates results from non-stratified analysis.
Bulgarian: Посочва резултати от нестратифициран анализ.
English: However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C-8 °C.
Bulgarian: Все пак, химическа и физическа стабилност е доказана за 24 часа при температура 2 °C-8 °C.
English: However, they may develop more than several hours after completion of the infusion but this is uncommon.
Bulgarian: Въпреки това, те могат да възникнат след повече от няколко часа след приключване на вливането, но това не е често.
English: Thus, it is not likely to have any substantial contribution to the systemic effects of MMAE.
Bulgarian: Следователно е малко вероятно да има някакъв съществен принос към системните ефекти на ММАЕ.
English: Table 14 includes the results for ORR4 and other key secondary endpoints.
Bulgarian: Таблица 14 включва резултатите за ORR4 и други ключови вторични крайни точки.
English: Your doctor will perform regular blood tests to make sure that it is safe for you to receive this medicine.
Bulgarian: Вашият лекар редовно ще прави кръвни изследвания, за да се увери, че за Вас е безопасно да получавате това лекарство.
English: See the package leaflets for these medicines for additional information on their use and effects.
Bulgarian: Вижте листовките на тези лекарства за допълнителна информация за тяхната употреба и ефекти.
English: Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Bulgarian: Не е изключен принос към механизма на действие от други функции, свързани с антитялото.
English: You and your partner must use two methods of effective contraception during your treatment with this medicine.
Bulgarian: Вие и Вашият партньор трябва да използвате два метода на ефективна контрацепция по време на лечението Ви с това лекарство.
English: • Two or more prior salvage therapies.
Bulgarian: Две или повече предходни спасителни терапии.
English: Your doctor or nurse will also monitor you during and after the infusion.
Bulgarian: Вашият лекар или медицинска сестра също така ще Ви наблюдават по време на и след вливането.
English: Other medicines and Adcetris
Bulgarian: Други лекарства и Adcetris
English: Calculated from a weighted Holm's procedure
Bulgarian: Изчислена от претеглена процедура на Holm
English: After reconstitution/dilution, from a microbiological point of view, the product should be used immediately.
Bulgarian: След разтваряне/разреждане от микробиологична гледна точка, продуктът трябва да се използва незабавно.
English: The doctor or nurse will dispose of this medicine.
Bulgarian: Лекарят или медицинската сестра ще изхвърлят това лекарство.
English: The safety and efficacy results in these studies were consistent with results in Study C25001.
Bulgarian: Резултатите за безопасност и ефикасност в тези проучвания са в съответствие с резултатите от проучване C25001.
English: There are no data from the use of ADCETRIS in pregnant women.
Bulgarian: Липсват данни от употребата на ADCETRIS при бременни жени.
English: Continue with the same dose and schedule
Bulgarian: Продължаване със същата доза и схема
English: The investigator assessments were generally consistent with the independent review of the scans.
Bulgarian: Изследователските оценки са като цяло съответстващи на независимия преглед на резултатите от сканирането.
English: Like all medicines, this medicine may cause side effects, although not everybody gets them.
Bulgarian: Както всички лекарства, това лекарство може да предизвика нежелани реакции, въпреки че не всеки ги получава.
English: Dose and frequency
Bulgarian: Доза и честота
English: Exposures were approximately dose proportional.
Bulgarian: Експозициите са приблизително пропорционални на дозата.
English: Frequencies of adverse reactions described below and in Table 3 have been determined based on data generated from clinical studies.
Bulgarian: Честотата на нежеланите реакции, описани по-долу и в Таблица 3, е определена въз основа на данните, получени от клинични изпитвания.
English: Infusion reactions to this medicine may affect more than 1 in 10 people.
Bulgarian: Реакции, свързани с вливането на това лекарство могат да засегнат повече от 1 на 10 души.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Bulgarian: При липса на проучвания за несъвместимости този лекарствен продукт не трябва да се смесва с други лекарствени продукти, освен тези посочени в точка 6.6.
English: Per Ann Arbor Staging IPFP = International Prognostic Factor Project
Bulgarian: По системата на Ann Arbor IPFP = International Prognostic Factor Project
English: Procedures for proper handling and disposal of anticancer medicines should be considered.
Bulgarian: Трябва да се имат предвид процедурите за правилна работа и изхвърляне на противоракови лекарства.
English: In the study, patients were to receive their first dose after recovery from ASCT (between days 30-45 following ASCT).
Bulgarian: В проучването пациентите са получили първата си доза след възстановяване от ASCT (между дни 30-45 след ASCT).
English: The results of these post-hoc analyses suggest increased clinical benefit for patients with two or more risk factors but no difference based on any of the individual risk factors.
Bulgarian: Резултатите от тези post-hoc анализи показват повишена клинична полза за пациенти с два или повече рискови фактори, но няма разлика, дължаща се на някой от индивидуалните рискови фактори.
English: ECOG status
Bulgarian: ECOG статус
English: Your treatment may influence your ability to drive or operate machines.
Bulgarian: Вашето лечение може да повлияе способността Ви да шофирате или да работите с машини.
English: Post-hoc analyses were performed to evaluate the impact of increased risk (number of risk factors) on clinical benefit (Table 8).
Bulgarian: Post-hoc анализите са извършени, за да се оцени въздействието на повишен риск (брой рискови фактори) върху клиничната полза (Таблица 8).
English: Discontinue treatment a.
Bulgarian: Прекратяване на лечението a.
English: The dosing recommendations for patients aged 65 and older are the same as for adults.
Bulgarian: Препоръките за дозиране при пациенти на възраст 65 и повече години са същите като при възрастни.
English: You should also inform your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.
Bulgarian: Освен това трябва да уведомите партньора или болногледачите си за лечението, тъй като те може да забележат симптоми, които
English: Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
Bulgarian: Степен 1 (парестезия и/или загуба на рефлекси, без загуба на функция)
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Bulgarian: За да се подобри възможността за проследяване на биологичните лекарствени продукти, името и партидният номер на прилагания продукт трябва да бъдат ясно отбелязани.
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Bulgarian: Наличните в момента данни са описани в точки 4.8, 5.1 и 5.2.
English: Number of patients with disease progression or death a
Bulgarian: Брой пациенти с прогресия на заболяване то или смъртни случаи a
English: The efficacy results are shown in Table 7.
Bulgarian: Резултатите за ефикасност са представени в Таблица 7.
English: If you feel unwell during treatment then do not drive or operate machines.
Bulgarian: Ако не се чувствате добре по време на лечението, не шофирайте и не работете с машини.
English: Determining dosage amount:
Bulgarian: Определяне на количество за доза:
English: Total storage time of the solution from reconstitution to infusion should not exceed 24 hours.
Bulgarian: Общото време за съхранение на разтвора от момента на разтваряне до инфузията не трябва да надвишава 24 часа.
English: It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Bulgarian: Вашия лекар преди и по време на лечението, ако сте бременна, смятате, че може да сте бременна или планирате да забременеете.
English: HL at increased risk of relapse or progression
Bulgarian: HL с повишен риск от рецидив или прогресия
English: MMAE does not inhibit other isoforms.
Bulgarian: MMAE не инхибира други изоформи.
English: You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.
Bulgarian: Не трябва да използвате това лекарство, ако сте бременна, освен ако Вие и Вашият лекар не решите, че ползата за Вас надхвърля потенциалния риск за нероденото бебе.
English: Once steady-state was achieved, the PK of ADC did not appear to change with time.
Bulgarian: След като се достигне стационарно състояние, ФК на ADC изглежда не се променя с течение на времето.
English: Lonza AG Lonzastrasse 3930 Visp Switzerland
Bulgarian: Lonza AG Lonzastrasse 3930 Visp Швейцария
English: These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes.
Bulgarian: Тези данни предполагат, че ефикасността и безопасността могат да бъдат екстраполирани към други подтипове на CD30+ CTCL.
English: Patients with Stage IV Disease
Bulgarian: Пациенти със заболяване стадий IV
English: If you are an older patient (≥ 65 years of age) you may experience serious adverse events more frequently.
Bulgarian: Ако сте по-възрастен пациент (≥ 65 години), при Вас може по-често да се появяват сериозни нежелани реакции.
English: Date of renewal: 10 September 2018
Bulgarian: 10 септември 2018 г.
English: A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman.
Bulgarian: Трябва да се вземе решение дали да се преустанови кърменето или да се преустанови/не се приложи тази терапия, като се вземат предвид потенциалният риск от кърменето за детето и ползата от терапията за жената.
English: At least one metabolite of MMAE has been shown to be active in vitro.
Bulgarian: Поне един метаболит на MMAE е доказано активен in vitro.
English: Median per IRF
Bulgarian: Медиана според IRF
English: Insomnia a.
Bulgarian: Безсъние а.
English: • Best response of PR or SD to most recent salvage therapy as determined by CT and/or PET scanning
Bulgarian: Най-добър отговор на PR или SD към последната спасителна терапия, както е определено от CT и/или PET скенер
English: For further efficacy results, see Table 12 and Figure 5.
Bulgarian: За допълнителни резултати за ефикасност вижте Таблица 12 и Фигура 5.
English: This includes herbal medicines and other medicines you can obtain without a prescription.
Bulgarian: Това включва билкови и други лекарства, които се продават без рецепта.
English: Data in HL Patients Who Are Not Stem Cell Transplant (SCT) Candidates
Bulgarian: Данни за пациенти с HL, които не са кандидати за трансплантация на стволови клетки (SCT)
English: The median number of cycles was approximately 12 cycles in the ADCETRIS arm.
Bulgarian: Медианата на броя цикли е била приблизително 12 цикъла в рамото с ADCETRIS.
English: Of the ITT population, 846 patients (64%) had Stage IV disease.
Bulgarian: Oт ITT популацията 846 пациенти (64%) имат заболяване стадий IV.