natgillin/translations-raw huggingface dataset:
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.
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.
Как се използва Nivestim?
How is Nivestim used?
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;
• 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;
Агенцията счита, че както при Neupogen, ползите при Nivestim превишават установените рискове и този продукт може да бъде разрешен за употреба в ЕС.
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.
Неутропенията е често срещана нежелана реакция при лечение на рак и може да предизвика уязвимост към инфекции;
Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
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.
infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Приемалите Nivestim пациенти имат сходна продължителност на периода на тежка неутропения, с тази на пациентите, получаващи Neupogen.
The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
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.
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.
Как действа Nivestim?
How does Nivestim work?
Проучванията показват също, че приемът на Nivestim води до сходни нива на активното вещество в организма като Neupogen.
Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Защо Neupogen е разрешен за употреба?
Why is Nivestim approved?
Det första europeiska godkännandet var i NL den 29 maj 1981.
The first European approval was in NL on 29 May 1981.
En text om att överväga bevarandet av spermier har tagits med i detta avsnitt.
A text to consider preservation of the sperm has been included in this section.
Avsnittet om graviditet har ändrats i enlighet med den relevanta vägledningen[9].
The pregnancy section has been revised in line with the relevant guideline[9].
Produkten godkändes sedan i AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI och UK.
The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Övergripande sammanfattning av CHMP:s vetenskapliga utvärdering
Overall summary of the scientific evaluation by the CHMP
Bilaga II Vetenskapliga slutsatser
Annex II Scientific conclusions
CHMP noterade även att etoposid kan minska den manliga fertiliteten.
The CHMP also noted that etoposide may decrease male fertility.
Vepesid finns som 50 mg och 100 mg kapslar för oral användning.
Vepesid is available as 50mg and 100 mg capsules for oral use.
Detta är särskilt relevant när patienter får kurativ behandling (t.ex. för testikelcancer).
This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer).
Etoposid används vid behandlingen av olika neoplastiska sjukdomar.
Etoposide is used for the treatment of various neoplastic diseases.
Kommittén har beaktat hänskjutningen enligt artikel 30 i direktiv 2001/83/EG.
• The Committee considered the referral under Article 30 of Directive 2001/83/EC
Amning har tagits med som en kontraindikation, då ammande kvinnor kan ersätta amningen med mejeriprodukter för att mata sitt barn.
Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child.
De tillgängliga effektuppgifterna för etoposid vid de olika indikationerna är främst baserade på studier där etoposid användes intravenöst.
The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously.
Detta har åtgärdats med en varning i avsnitt 4.2 i produktresumén.
This has been addressed by a warning in section 4.2 of the SmPC.
Mindre ändringar har gjorts i de återstående avsnitten i produktresumén.
Minor changes were included in the remaining sections of the SmPC.
I avsnitt 4.5 i produktresumén har interaktionerna som dokumenterats i de flesta nuvarande nationella produktresuméerna behållits i den harmoniserade texten.
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.
Produktresumén som föreslogs av innehavarna av godkännande för försäljning har bedömts baserat på den inlämnade dokumentationen och den vetenskapliga diskussionen inom kommittén.
• The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
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].
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].
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).
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%).
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.
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.
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.
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.
Vid nedsatt njurfunktion (kreatininclearance (CrCl) 15-5 ml/min) rekommenderas en dosminskning på 25 procent.
In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
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.
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.
Kommittén enades om en harmoniserad produktinformation för Vepesid och associerade namn.
• The Committee agreed on a harmonised product information for Vepesid and associated names.
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.
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.
- Återkommande eller refraktär testikelcancer
- Recurrent or refractory testicular cancer
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].
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].
Kommittén beaktade de avvikelser som hade identifierats i anmälan för Vepesid och associerade namn, liksom de återstående avsnitten i produktinformationen.
• The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information.
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
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.
- Akut myeloisk leukemi
- Acute myeloid leukaemia
Vad gäller amning, utsöndras etoposid i mjölken (Medications and Mothers' Milk: Thomas W.
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.
- Småcellig lungcancer
- Small-cell lung cancer
- Äggstockscancer: icke-epitelial äggstockscancer och platina-resistent/refraktär epitelial äggstockscancer
- Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
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
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.
I synnerhet vid samtidig användning av levande vacciner är immunsuppression en vanlig biverkning till etoposid och betecknas som mycket vanlig i produktresumén.
In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC.
Hänskjutningen gällde harmonisering av produktinformationen.
• The scope of the referral was the harmonisation of the product information,
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.
It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration.
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
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.
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.
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.
Innehavaren av godkännande för försäljning diskuterade även en dosminskning för patienter med terminal njursvikt (CrCl < 15 ml/min).
The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Kommittén granskade samtliga data som lämnats in av innehavaren av godkännandet för försäljning till stöd för den föreslagna harmoniseringen av produktinformationen.
• The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Ändringar som infördes i produktresumén återgavs i relevanta fall genomgående i märkningen, men de flesta avsnitt har
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis. Ann.
8 Inoue, A. et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis.
- Non-Hodgkin lymfom
- Non-Hodgkin's lymphoma
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:
The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Vad gäller fertilitet, graviditet och amning i produktresuméns avsnitt 4.6, infördes information till kvinnor
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.
7 Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy
7 Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
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.
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
- Hodgkin lymfom
- Hodgkin's lymphoma
Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labellingAppendix 3 (EMEA/CHMP/203927/2005).
Appendix 3 (EMEA/CHMP/203927/2005).
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.
The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
3 Kreusser W, Herrmann R, Tschope W, et al.
3 Kreusser W, Herrmann R, Tschope W, et al. Nephrological complications of cancer therapy.
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.
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).
Hande KR, Krozely MG, Greco FA et al.
1 Hande KR, Krozely MG, Greco FA et al. Bioavailability of Low-Dose Oral Etoposide.
ska utarbetas. CMD(h) upprättade förteckningen i enligt artikel 30.2 i direktiv 2001/83/EG.
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.
Toffoli G, Corona G, Basso B et al.
Toffoli G, Corona G, Basso B et al. Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
4 Arbuck SG, Douglass HO, Crom WR et al.
4 Arbuck SG, Douglass HO, Crom WR et al. Etoposide Pharmacokinetics in Patients With Normal and Abnormal Organ
De ändrade indikationerna i avsnitt 4.1
The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Hale) och den lagts in som en kontraindikation. Texten om amning har ändrats i enlighet med detta.
The text on breastfeeding has been amended accordingly.
Допълнителна информация за Firmagon:
Other information about Firmagon:
Пълният текст на EPAR относно Firmagon може да се намери тук.
The full EPAR for Firmagon can be found here.
Това е сравнено с 96% от пациентите, приемащи леупрорелин.
This was compared with 96% of patients receiving leuprorelin.
Съдържа активното вещество дегареликс.
It contains the active substance degarelix.
Какви мерки се предприемат за осигуряване на безопасната употреба на Firmagon?
Which measures are being taken to ensure the safe use of Firmagon?
Това означава, че пациентите не трябва да приемат други лекарства за блокиране на тестостерона при започване на лечението.
This means that patients do not need to take other medicines to block testosterone at the start of treatment.
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.
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.
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.
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.
Когато се инжектира, Firmagon образува гел под кожата, който бавно освобождава активното вещество в продължение на няколко седмици.
When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.
Материалите ще включват информация за безопасността на Firmagon и ще напомнят на лекарите как да се предписва лекарството.
The materials will include information on Firmagon's safety and remind doctors how to administer the medicine.
Като блокира тези процеси, Firmagon намалява количеството на тестостерон в организма и забавя растежа на раковите клетки.
By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells.
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.
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.
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.
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.
Лечението започва с две инжекции по 120 mg всяка, последвани от една инжекция от 80 mg всеки месец.
Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
Firmagon не трябва да се инжектира във вена или мускул.
Firmagon must not be injected into a vein or a muscle.
Две дози от Firmagon са сравнени с леупрорелин в едно основно проучване, обхващащо 610 мъже с рак на простатата на всички стадии на заболяването.
Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease.
Комитетът препоръчва на Firmagon да бъде издадено разрешение за употреба.
The Committee recommended that Firmagon be given marketing authorisation
„Напреднал“ означава, че ракът се е разпространил извън жлезата до някои лимфни възли, но не е достигнал до други органи.
‘Advanced' means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Въпреки това, тъй като основното проучване разглежда по-скоро ефектите на лекарството върху нивата на тестостерон, отколкото самия рак или непосредствения резултат за пациента, както и поради факта, че леупрорелин се използва само при рак на простатата в напреднал стадий, Комитетът решава, че използването на Firmagon трябва да се ограничи до показанието напреднал рак на простатата.
However, because the main study looked at the medicine's effects on testosterone levels rather than the cancer or the patient's outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.
Подобни резултати се наблюдават при пациентите, приемащи Firmagon в доза, по-висока от 160 mg веднъж месечно.
Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.
GnRH обикновено стимулира хипофизната жлеза в основата на мозъка да произвежда два хормона, които от своя страна са причина тестисите да произвеждат тестостерон.
GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.
Активното вещество във Firmagon, дегареликс, е антагонист на гонадотропин-освобождаващия хормон, което означава, че блокира ефекта на естествения хормон, наречен гонадотропин-освобождаващ хормон (GnRH).
The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH).
За пълния списък на всички наблюдавани при Firmagon нежелани реакции - вижте листовката.
For the full list of all side effects reported with Firmagon, see the Package Leaflet.
Комитетът отбелязва също така, че лечението с Firmagon не предизвиква временно рязко покачване на нивата на тестостерон, наблюдавано при „агонистите на GnRH“ (други лекарства за рак на простатата, които стимулират производството на GnRH).
The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists' (other medicines for prostate cancer that stimulate the production of GnRH).