FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nivestim have been included in the summary of product characteristics and the package leaflet.
Bulgarian: Препоръките и предпазните мерки за безопасната и ефективна употреба на Nivestim, които следва да се спазват от медицинските специалисти и пациентите, са включени в кратката характеристика на продукта и в листовката.
English: Nivestim contains the active substance filgrastim.
Bulgarian: Nivestim съдържа активното вещество филграстим (filgrastim).
English: Nivestim is a ‘biosimilar' medicine.
Bulgarian: Nivestim e „биоподобно“ лекарство.
English: The reference medicine for Nivestim is Neupogen.
Bulgarian: Референтното лекарство за Nivestim е Neupogen.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Bulgarian: за повишаване на нивата на неутрофилите и за намаляване на риска от инфекции при пациенти с неутропения, които имат анамнеза за тежки, повтарящи се инфекции;
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Bulgarian: за намаляване на продължителността на неутропенията (ниски нива на неутрофилите, вид бели кръвни клетки) и за предотвратяване на фебрилна неутропения (неутропения с повишена температура) при пациенти с рак (с изключение на пациенти с хронична миелоидна левкемия или с миелодиспластични синдроми).
English: Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity.
Bulgarian: Лабораторните проучвания, сравняващи Nivestim с Neupogen, показват, че активното вещество в Nivestim е много подобно на това в Neupogen по структура, чистота и биологична активност.
English: How is Nivestim used?
Bulgarian: Как се използва Nivestim?
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Bulgarian: за намаляване на продължителността на неутропенията при пациенти, подложени на лечение за унищожаване на клетките на костния мозък преди трансплантация на костен мозък (напр. при някои пациенти с левкемия), ако са изложени на риск от продължителна, тежка неутропения;
English: Therefore, the Agency's view was that, as for Neupogen, the benefits of Nivestim are greater than its risks and it can be authorised or use in the EU.
Bulgarian: Агенцията счита, че както при Neupogen, ползите при Nivestim превишават установените рискове и този продукт може да бъде разрешен за употреба в ЕС.
English: Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Bulgarian: Неутропенията е често срещана нежелана реакция при лечение на рак и може да предизвика уязвимост към инфекции;
English: infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Bulgarian: при лечение на персистираща неутропения при пациенти с напреднала инфекция на човешки имунодефицитен вирус (HIV) за намаляване на риска от бактериални инфекции, когато други лечения са неподходящи.
English: The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
Bulgarian: Приемалите Nivestim пациенти имат сходна продължителност на периода на тежка неутропения, с тази на пациентите, получаващи Neupogen.
English: The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.
Bulgarian: Безопасността на Nivestim е оценена и въз основа на всички извършени проучвания се счита, че Nivestim и референтното лекарство Neupogen са сравними по отношение на нежеланите реакции.
English: How does Nivestim work?
Bulgarian: Как действа Nivestim?
English: Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Bulgarian: Проучванията показват също, че приемът на Nivestim води до сходни нива на активното вещество в организма като Neupogen.
English: Why is Nivestim approved?
Bulgarian: Защо Neupogen е разрешен за употреба?
English: The first European approval was in NL on 29 May 1981.
Bulgarian: Det första europeiska godkännandet var i NL den 29 maj 1981.
English: A text to consider preservation of the sperm has been included in this section.
Bulgarian: En text om att överväga bevarandet av spermier har tagits med i detta avsnitt.
English: The pregnancy section has been revised in line with the relevant guideline[9].
Bulgarian: Avsnittet om graviditet har ändrats i enlighet med den relevanta vägledningen[9].
English: The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Bulgarian: Produkten godkändes sedan i AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI och UK.
English: Overall summary of the scientific evaluation by the CHMP
Bulgarian: Övergripande sammanfattning av CHMP:s vetenskapliga utvärdering
English: Annex II Scientific conclusions
Bulgarian: Bilaga II Vetenskapliga slutsatser
English: The CHMP also noted that etoposide may decrease male fertility.
Bulgarian: CHMP noterade även att etoposid kan minska den manliga fertiliteten.
English: Vepesid is available as 50mg and 100 mg capsules for oral use.
Bulgarian: Vepesid finns som 50 mg och 100 mg kapslar för oral användning.
English: This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer).
Bulgarian: Detta är särskilt relevant när patienter får kurativ behandling (t.ex. för testikelcancer).
English: Etoposide is used for the treatment of various neoplastic diseases.
Bulgarian: Etoposid används vid behandlingen av olika neoplastiska sjukdomar.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Bulgarian: Kommittén har beaktat hänskjutningen enligt artikel 30 i direktiv 2001/83/EG.
English: Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child.
Bulgarian: Amning har tagits med som en kontraindikation, då ammande kvinnor kan ersätta amningen med mejeriprodukter för att mata sitt barn.
English: The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously.
Bulgarian: De tillgängliga effektuppgifterna för etoposid vid de olika indikationerna är främst baserade på studier där etoposid användes intravenöst.
English: This has been addressed by a warning in section 4.2 of the SmPC.
Bulgarian: Detta har åtgärdats med en varning i avsnitt 4.2 i produktresumén.
English: Minor changes were included in the remaining sections of the SmPC.
Bulgarian: Mindre ändringar har gjorts i de återstående avsnitten i produktresumén.
English: In section 4.5 of the SmPC the interactions that were documented in the majority of current national SmPCs have been retained in the harmonised text.
Bulgarian: I avsnitt 4.5 i produktresumén har interaktionerna som dokumenterats i de flesta nuvarande nationella produktresuméerna behållits i den harmoniserade texten.
English: • The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Bulgarian: Produktresumén som föreslogs av innehavarna av godkännande för försäljning har bedömts baserat på den inlämnade dokumentationen och den vetenskapliga diskussionen inom kommittén.
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[3][4][5][6][7].
Bulgarian: Hos patienter med nedsatt njurfunktion enades CHMP om att inte rekommendera en dosminskning när kreatininclearance är > 50 ml/min vilket stöds av tillgänglig litteratur[3][4][5][6][7].
English: The coefficient of variation is around 30% for oral administration, versus 10% for intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30-40%).
Bulgarian: Variationskoefficienten är cirka 30 procent vid oral administrering, jämfört med 10 procent vid intravenös administrering (variationen mellan patienter är liknande efter intravenös eller oral administrering, dvs. 30-40 procent).
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Vepesid and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Bulgarian: som medlemsstaterna har fattat vad gäller godkännandet av ovanstående läkemedel, lämnade Europeiska kommissionen den 14 oktober 2015 in en anmälan om hänskjutning till CHMP/Europeiska läkemedelsmyndigheten enligt artikel 30 i direktiv 2001/83/EG för Vepesid och associerade namn, för att åtgärda skillnaderna mellan de nationellt godkända produktinformationerna och därmed harmonisera de olika produktinformationerna inom EU.
English: For this reason, the CHMP agreed to include additional information in section 4.2 and 4.4 to inform physicians about the potential disadvantages of oral versus intravenous administration of etoposide.
Bulgarian: CHMP enades därför om att ytterligare information bör tas med i avsnitt 4.2 och 4.4 för att informera läkarna om de potentiella nackdelarna med oral jämfört med intravenös administrering av etoposid.
English: In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
Bulgarian: Vid nedsatt njurfunktion (kreatininclearance (CrCl) 15-5 ml/min) rekommenderas en dosminskning på 25 procent.
English: Vepesid contains etoposide, a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Bulgarian: Vepesid innehåller etoposid, ett semisyntetiskt derivat av podofyllotoxin som bryter upp dubbelsträngat DNA genom en interaktion med DNA-topoisomeras II, eller genom bildningen av fria radikaler.
English: • The Committee agreed on a harmonised product information for Vepesid and associated names.
Bulgarian: Kommittén enades om en harmoniserad produktinformation för Vepesid och associerade namn.
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: within-patient variability, myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Bulgarian: Följande särskilda varningar och försiktighet har harmoniserats i avsnitt 4.4 där de redan ingick i vissa eller de flesta av de nationella produktresuméerna: variation hos en och samma patient, myelosuppression, sekundär leukemi, överkänslighet, reaktion på injektionsstället, lågt serumalbumin, nedsatt njur- och leverfunktion, tumörlyssyndrom och mutagen potential.
English: - Recurrent or refractory testicular cancer
Bulgarian: - Återkommande eller refraktär testikelcancer
English: The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[8].
Bulgarian: Uppgifterna i litteraturen för patienter med CrCl under 15 ml/min och som står på dialys tyder starkt på att ytterligare dosminskning behövs för patienter enligt granskningen av Inoue et al. (2004)[8].
English: • The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information.
Bulgarian: Kommittén beaktade de avvikelser som hade identifierats i anmälan för Vepesid och associerade namn, liksom de återstående avsnitten i produktinformationen.
English: Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days.
Bulgarian: Baserat på data om biotillgängligheten[1][2], är den rekommenderade orala dosen 100200 mg/m2/dag under dag 1-5 i en cykel på 21 eller 28 dagar; eller 200 mg/m2/dag under
English: - Acute myeloid leukaemia
Bulgarian: - Akut myeloisk leukemi
English: With regards to lactation, etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) and it has been included as a contraindication.
Bulgarian: Vad gäller amning, utsöndras etoposid i mjölken (Medications and Mothers' Milk: Thomas W.
English: - Small-cell lung cancer
Bulgarian: - Småcellig lungcancer
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Bulgarian: - Äggstockscancer: icke-epitelial äggstockscancer och platina-resistent/refraktär epitelial äggstockscancer
English: As regards the posology, all 17 SmPCs state in section 4.2 that the oral dose of etoposide capsules is based on the recommended intravenous (IV) dose and mention the need to consider bioavailability when prescribing, since it varies from patient to patient.
Bulgarian: Alla 17 produktresuméer anger i avsnitt 4.2, avseende doseringen, att den orala dosen av etoposid kapslar bygger på den rekommenderade intravenösa (i.v.) dosen och nämner att biotillgängligheten behöver övervägas vid förskrivning, eftersom den varierar från patient
English: In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC.
Bulgarian: I synnerhet vid samtidig användning av levande vacciner är immunsuppression en vanlig biverkning till etoposid och betecknas som mycket vanlig i produktresumén.
English: • The scope of the referral was the harmonisation of the product information,
Bulgarian: Hänskjutningen gällde harmonisering av produktinformationen.
English: It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration.
Bulgarian: Vid oral administrering har det konstaterats att variationen hos en och samma patient vad gäller exponeringen (dvs. mellan cykler) är tydligt större än efter intravenös administrering.
English: For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration, which should be evaluated on an individual basis.
Bulgarian: Det är därför viktigt att fördelarna av den orala administreringsvägen noga vägs mot nackdelarna av större variation hos en och samma patient vid exponering efter oral administrering, vilket
English: In section 4.3 of the SmPC Contraindications, the inclusions of hypersensitivity and concomitant use of live vaccines have been agreed as these are in line with the SmPC guidelines.
Bulgarian: I avsnitt 4.3 i produktresumén, kontraindikationer, har införandet av överkänslighet och samtidig användning av levande vacciner avtalats eftersom dessa är i linje med riktlinjerna för produktresuméer.
English: The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Bulgarian: Innehavaren av godkännande för försäljning diskuterade även en dosminskning för patienter med terminal njursvikt (CrCl < 15 ml/min).
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Bulgarian: Kommittén granskade samtliga data som lämnats in av innehavaren av godkännandet för försäljning till stöd för den föreslagna harmoniseringen av produktinformationen.
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Bulgarian: Ändringar som infördes i produktresumén återgavs i relevanta fall genomgående i märkningen, men de flesta avsnitt har
English: 8 Inoue, A. et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis.
Bulgarian: et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis. Ann.
English: - Non-Hodgkin's lymphoma
Bulgarian: - Non-Hodgkin lymfom
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Bulgarian: Ändringarna i produktresumén, när de är relevanta för användaren, har även återgetts i bipacksedeln och godkänts av CHMP. Skäl till CHMP:s yttrande Skälen är följande:
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Bulgarian: Vad gäller fertilitet, graviditet och amning i produktresuméns avsnitt 4.6, infördes information till kvinnor
English: 7 Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
Bulgarian: 7 Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy
English: Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment
Bulgarian: Ökad variation hos en och samma patient vid exponering kan leda till större variation i dosresponsförhållandet, dvs. leda till större variation i patienternas känslighet för att uppleva behandlingsrelaterad toxicitet från en cykel till nästa, och påverkar potentiellt behandlingens totala effekt hos vissa patienter.
English: - Hodgkin's lymphoma
Bulgarian: - Hodgkin lymfom
English: Appendix 3 (EMEA/CHMP/203927/2005).
Bulgarian: Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labellingAppendix 3 (EMEA/CHMP/203927/2005).
English: The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
Bulgarian: Avsnittet om dosering hos vuxna innehåller uppgifter om monoterapi, kombinationsbehandling, ett alternativt doseringsschema och dosjusteringar vid ett lågt antal neutrofiler. Säkerhet och effekt av Vepesid och associerade namn för barn under 18 års ålder har inte fastställts.
English: 3 Kreusser W, Herrmann R, Tschope W, et al. Nephrological complications of cancer therapy.
Bulgarian: 3 Kreusser W, Herrmann R, Tschope W, et al.
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Vepesid and associated names (see Annex I).
Bulgarian: CHMP rekommenderade ändring av villkoren för godkännandena för försäljning för vilka produktinformationen återfinns i bilaga III för Vepesid och associerade namn (se bilaga I). Till följd av detta drog CHMP slutsatsen att nytta-riskförhållandet för Vepesid och associerade namn är fortsatt gynnsamt, förutsatt att de avtalade ändringarna införs i produktinformationen.
English: 1 Hande KR, Krozely MG, Greco FA et al. Bioavailability of Low-Dose Oral Etoposide.
Bulgarian: Hande KR, Krozely MG, Greco FA et al.
English: Vepesid and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Bulgarian: ska utarbetas. CMD(h) upprättade förteckningen i enligt artikel 30.2 i direktiv 2001/83/EG.
English: Toffoli G, Corona G, Basso B et al. Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
Bulgarian: Toffoli G, Corona G, Basso B et al.
English: 4 Arbuck SG, Douglass HO, Crom WR et al. Etoposide Pharmacokinetics in Patients With Normal and Abnormal Organ
Bulgarian: 4 Arbuck SG, Douglass HO, Crom WR et al.
English: The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Bulgarian: De ändrade indikationerna i avsnitt 4.1
English: The text on breastfeeding has been amended accordingly.
Bulgarian: Hale) och den lagts in som en kontraindikation. Texten om amning har ändrats i enlighet med detta.
English: Other information about Firmagon:
Bulgarian: Допълнителна информация за Firmagon:
English: The full EPAR for Firmagon can be found here.
Bulgarian: Пълният текст на EPAR относно Firmagon може да се намери тук.
English: This was compared with 96% of patients receiving leuprorelin.
Bulgarian: Това е сравнено с 96% от пациентите, приемащи леупрорелин.
English: It contains the active substance degarelix.
Bulgarian: Съдържа активното вещество дегареликс.
English: Which measures are being taken to ensure the safe use of Firmagon?
Bulgarian: Какви мерки се предприемат за осигуряване на безопасната употреба на Firmagon?
English: This means that patients do not need to take other medicines to block testosterone at the start of treatment.
Bulgarian: Това означава, че пациентите не трябва да приемат други лекарства за блокиране на тестостерона при започване на лечението.
English: The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment.
Bulgarian: Основната мярка за ефективност е броят на пациентите, чиито нива на тестостерон са по-ниски от нивата, наблюдавани при мъжете, чиито тестиси не произвеждат тестостерон, през първата година от лечението.
English: The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine.
Bulgarian: Компанията производител на Firmagon ще се увери, че са предоставени образователни материали на всички лекари във всички държави-членки, в които ще се предписва лекарството.
English: When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.
Bulgarian: Когато се инжектира, Firmagon образува гел под кожата, който бавно освобождава активното вещество в продължение на няколко седмици.
English: The materials will include information on Firmagon's safety and remind doctors how to administer the medicine.
Bulgarian: Материалите ще включват информация за безопасността на Firmagon и ще напомнят на лекарите как да се предписва лекарството.
English: By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells.
Bulgarian: Като блокира тези процеси, Firmagon намалява количеството на тестостерон в организма и забавя растежа на раковите клетки.
English: During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level.
Bulgarian: По време на първата година 97% от пациентите, приемащи Firmagon в одобрената доза от 80 mg веднъж месечно, имат нива на тестостерон под необходимото ниво.
English: The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness.
Bulgarian: Най-честите нежелани реакции при Firmagon (наблюдавани при повече от 1 на 10 пациенти) са горещи вълни и реакции на мястото на инжектиране като болка и зачервяване.