natgillin/translations-raw huggingface dataset:
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.
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z zgoraj navedenim zdravilom, je Evropska komisija 14. oktobra 2015 obvestila odbor CHMP pri Evropski agenciji za zdravila o napotitvi v skladu s členom 30 Direktive 2001/83/ES za zdravilo Vepesid in povezana imena z namenom odprave neskladij med nacionalno odobrenimi informacijami o zdravilu in uskladitve različnih informacij o zdravilu po vsej EU.
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].
Pri bolnikih z ledvično okvaro se je odbor CHMP strinjal, da ne priporoči zmanjšanega odmerka, kadar je očistek kreatinina > 50 ml/min, kot podpira razpoložljiva literatura[3][4][5][6][7].
In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
Pri ledvični okvari (očistek kreatinina (CrCl) 15-5 ml/min) se priporoča zmanjšanje odmerka za 25 %.
The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously.
Razpoložljivi podatki o učinkovitosti za etopozid pri različnih indikacijah večinoma temeljijo na študijah, v katerih so etopozid uporabljali intravensko.
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.
Kar zadeva dojenje, se etopozid izloča v materino mleko (Medications and Mothers' Milk (Zdravila in materino mleko): Thomas W. Hale), zato je bilo dojenje vključeno med kontraindikacije.
This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer).
To je zlasti pomembno pri kurativnem zdravljenju bolnikov (npr. pri raku mod).
Vepesid is available as 50mg and 100 mg capsules for oral use.
Zdravilo Vepesid je na voljo v obliki 50- in 100-miligramskih kapsul za peroralno uporabo.
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.
V poglavju 4.4 so bili usklajeni naslednja posebna opozorila in previdnostni ukrepi, ki so bili v nekatere ali večino nacionalnih povzetkov glavnih značilnosti zdravila že vključeni: razlike pri posameznem bolniku, mielosupresija, sekundarna levkemija, preobčutljivost, reakcija na mestu injiciranja, nizka raven albumina v serumu, oslabljeno delovanje ledvic in jeter, sindrom tumorske lize in mutageni potencial.
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%).
Koeficient variacije pri peroralni uporabi je približno 30 %, pri intravenski pa 10 % (razlike med bolniki so pri intravenski in peroralni uporabi podobne, tj. 30-40 %).
The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Revidirane indikacije v poglavju 4.1 povzetka glavnih značilnosti zdravila so naslednje:
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].
Podatki v literaturi za bolnike s CrCl pod 15 ml/min, ki se zdravijo z dializo, jasno kažejo, da je pri teh bolnikih potrebno nadaljnje zmanjšanje odmerka, kot so v preglednem članku objavili Inoue et al. (2004)[8].
• The Committee agreed on a harmonised product information for Vepesid and associated names.
• odbor se je strinjal z usklajenimi informacijami o zdravilu Vepesid in povezanih imenih.
The CHMP as a consequence, concluded that the benefit-risk balance of Vepesid and associated names remains favourable, subject to the agreed changes to the product information.
Posledično je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Vepesid in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
• The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information.
• odbor je obravnaval razlike, ugotovljene v obvestilu za zdravilo Vepesid in povezana imena, ter preostala poglavja informacij o zdravilu;
- Acute myeloid leukaemia
- akutna mieloična levkemija;
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.
Zdravilo Vepesid in povezana imena so vključena na seznam zdravil, pri katerih je potrebna uskladitev povzetkov glavnih značilnosti zdravila, ki ga je sestavila skupina CMD(h) v skladu s členom 30(2) Direktive 2001/83/ES.
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).
Odbor CHMP je priporočil spremembo pogojev dovoljenj za promet z zdravilom Vepesid in povezanimi imeni, za katera so v Prilogi III navedene informacije o zdravilu (glejte Prilogo I).
It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration.
Ugotovili so, da so pri peroralni uporabi razlike v izpostavljenosti pri posameznem bolniku (tj. med cikli) bistveno večje kot po intravenski uporabi.
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, kadar je bilo to ustrezno, vendar je bilo treba večino poglavij dopolniti na nacionalni
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.
Zato je nujno skrbno pretehtati prednosti peroralne uporabe in slabosti večjih razlik v izpostavljenosti pri posameznem bolniku po peroralni uporabi, kar je treba ovrednotiti pri vsakem bolniku posebej.
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
Večje razlike v izpostavljenosti pri posameznem bolniku lahko privedejo do večjih razlik v odvisnosti odziva od odmerka, tj. večjih razlik v bolnikovi občutljivosti za toksičnost, povezano z
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.
Zato se je odbor CHMP strinjal, da se v poglavji 4.2 in 4.4 vključijo dodatne informacije, s katerimi se zdravnike obvesti o morebitnih slabostih peroralne uporabe etopozida v primerjavi z intravensko uporabo.
The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
Poglavje o odmerjanju pri odraslih vsebuje podrobne podatke o monoterapiji, kombiniranem zdravljenju, alternativnem režimu odmerjanja in prilagajanju odmerkov pri nizkih vrednostih nevtrofilcev.
Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child.
Med kontraindikacije je bilo vključeno tudi dojenje, saj doječe matere lahko nadomestijo dojenje z mlečnimi formulami.
The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Zdravilo je v nadaljevanju dovoljenje za promet pridobilo v Avstriji, Belgiji, Estoniji, Italiji, Luksemburgu, Nemčiji, Romuniji, Sloveniji, Španiji, na Danskem, Finskem, Hrvaškem, Irskem, Norveškem, Švedskem in v Združenem kraljestvu.
related toxicity from cycle to cycle, and potentially affecting overall efficacy of treatment in somepatients.
zdravljenjem, med posameznimi cikli, kar lahko pri nekaterih bolnikih vpliva na skupno učinkovitost zdravljenja.
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.
Zdravilo Vepesid vsebuje etopozid, polsintetični derivat podofilotoksina, ki reagira z DNKtopoizomerazo II ali sproži nastajanje prostih radikalov in tako prekine dvoverižno DNK.
- Hodgkin's lymphoma
- Hodgkinov limfom;
In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC.
Imunosupresija je še zlasti pri sočasni uporabi živih cepiv pogost neželeni učinek etopozida, ki je v povzetku glavnih značilnosti zdravila naveden kot zelo pogost.
- Non-Hodgkin's lymphoma
- ne-Hodgkinov limfom;
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.
Kar zadeva poglavje 4.6 povzetka glavnih značilnosti zdravila o plodnosti, nosečnosti in dojenju, so bile vključene informacije, namenjene ženskam v rodni dobi, v zvezi s kontracepcijo pri moških in ženskah.
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.
Kar zadeva način odmerjanja, vseh 17 povzetkov glavnih značilnosti zdravila v poglavju 4.2 navaja, da je peroralni odmerek kapsul etopozida odvisen od priporočenega intravenskega (i.v.)
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.
Dogovorili so se, da v poglavje 4.3 povzetka glavnih značilnosti zdravila, Kontraindikacije, vključijo preobčutljivost in sočasno uporabo živih cepiv, kar je v skladu s smernicami za povzetke glavnih značilnosti zdravila.
• The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
• odbor CHMP je na podlagi predložene dokumentacije in znanstvene razprave v odboru ocenil informacije o zdravilu, ki so jih predlagali imetniki dovoljenj za promet z zdravilom;
- Recurrent or refractory testicular cancer
- ponavljajoči se ali refraktarni rak mod;
Other information about Firmagon:
Druge informacije o zdravilu Firmagon:
Which measures are being taken to ensure the safe use of Firmagon?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Firmagon?
The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Firmagon, veljavno po vsej Evropski uniji, odobrila družbi Ferring Pharmaceuticals A/S dne 17. februarja 2009.
Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
Zdravljenje se začne z dvema 120-miligramskima injekcijama, ki jima sledi ena 80-miligramska injekcija vsak mesec.
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.
Družba, ki proizvaja zdravilo Firmagon, bo poskrbela, da bo z učnim gradivom oskrbela vse zdravnike v vseh državah članicah, kjer se bo predpisovalo zdravilo.
Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.
Podobne rezultate so opazili pri bolnikih, ki so zdravilo Firmagon prejemali v večjem odmerku 160 mg enkrat mesečno.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FIRMAGON EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FIRMAGON Povzetek EPAR za javnost
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.
Najpogostejši neželeni učinki zdravila Firmagon (opaženi pri več kot 1 bolniku izmed 10) so vročinski valovi in težave na mestu injiciranja, kot sta bolečina in rdečina.
What benefit has Firmagon shown during the studies?
Kakšne koristi je zdravilo Firmagon izkazalo med študijami?
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.
Ker pa so v glavni študiji raziskovali učinke zdravila na koncentracijo testosterona in ne neposredno na raka ali izid za bolnika ter ker se levprorelin uporablja samo za napredovalega raka prostate, se je Odbor odločil omejiti uporabo zdravila Firmagon na napredovalega raka prostate.
The Committee recommended that Firmagon be given marketing authorisation
Odbor je priporočil, da se za zdravilo Firmagon odobri dovoljenje za promet.
This means that patients do not need to take other medicines to block testosterone at the start of treatment.
To pomeni, da bolnikom na začetku zdravljenja ni treba jemati drugih zdravil za zaviranje testosterona.
It contains the active substance degarelix.
Vsebuje zdravilno učinkovino degareliks.
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.
Med prvim letom je imelo 97 % bolnikov, ki so prejemali zdravilo Firmagon pri odobrenem odmerku 80 mg enkrat mesečno, nižjo koncentracijo testosterona od zahtevane.
Firmagon must not be injected into a vein or a muscle.
Zdravilo Firmagon se ne sme injicirati v veno ali mišico.
‘Advanced' means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Izraz „napredovali“ pomeni, da se je rak iz žleze razširil na nekatere bezgavke, ne pa tudi na druge organe.
The materials will include information on Firmagon's safety and remind doctors how to administer the medicine.
Ta gradiva bodo vključevala informacije o varnosti zdravila Firmagon in zdravnike opominjala na pravilen način dajanja zdravila.
Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients.
Zdravila Firmagon ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) degareliks ali katero koli drugo sestavino zdravila.
Firmagon can be used if the cancer is ‘hormone-dependent', which means that it responds to treatments that reduce the levels of the hormone testosterone.
Zdravilo Firmagon se lahko uporablja, če je rak „hormonsko odvisen“, kar pomeni, da se odziva na zdravljenja, ki zmanjšajo koncentracijo hormona testosterona.
What is the risk associated with Firmagon?
Kakšna tveganja so povezana z zdravilom Firmagon?
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.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila koncentracija testosterona v prvem letu zdravljenja nižja od tiste pri moških, katerih modi nista proizvajali testosterona.
The effects of Firmagon were first tested in experimental models before being studied in humans.
Učinki zdravila Firmagon so bili najprej preskušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
Firmagon should be used with caution in patients who have severe kidney or liver problems.
Zdravilo Firmagon je treba uporabljati previdno pri bolnikih s hudimi ledvičnimi ali jetrnimi težavami.
The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je bilo zdravilo Firmagon v glavni študiji enako učinkovito kot levprorelin.
By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells.
Zdravilo Firmagon z zaviranjem teh procesov zmanjša količino testosterona v telesu in upočasni rast rakastih celic.
This was compared with 96% of patients receiving leuprorelin.
Pri bolnikih, ki so prejemali levprorelin, je bila ta vrednost 96 %.
Why has Firmagon been approved?
Zakaj je bilo zdravilo Firmagon odobreno?
Firmagon is used to treat patients with advanced prostate cancer.
Zdravilo Firmagon se uporablja za zdravljenje bolnikov z napredovalim rakom prostate.
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).
Zdravilna učinkovina zdravila Firmagon, degareliks, je antagonist gonadotropin sproščujočega hormona, kar pomeni, da zavira učinkovanje naravnega hormona, imenovanega gonadotropin sproščujoči hormon.
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).
Odbor je prav tako ugotovil, da zdravljenje z zdravilom Firmagon ne sproži začasnega hitrega dviga koncentracije testosterona, ki je značilna za „agoniste gonadotropin sproščujočega hormona“ (druga zdravila za raka prostate, ki spodbujajo tvorjenje gonadotropin sproščujočega hormona).
PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.
Za prostato specifični antigen je beljakovina, ki jo tvori prostata in je pogosto prisotna v visokih koncentracijah pri moških z rakom prostate.
Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA).
Zdravniki morajo spremljati učinkovitost zdravljenja z zdravilom Firmagon, tako da opazujejo krvne koncentracije testosterona in za prostato specifičnega antigena.
When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.
Z injiciranjem zdravila Firmagon se pod kožo ustvari gel, iz katerega se zdravilna učinkovina nekaj tednov počasi sprošča.
Firmagon is a powder and solvent that are made up into a solution for injection.
Zdravilo Firmagon sestavljata prašek in vehikel, iz katerih se pripravi raztopina za injiciranje.
For the full list of all side effects reported with Firmagon, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Firmagon, glejte navodilo za uporabo.
Firmagon is injected under the skin of the abdomen.
Zdravilo Firmagon se injicira pod kožo trebuha.
GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.
Gonadotropin sproščujoči hormon običajno spodbuja hipofizo na dnu možganov k tvorjenju dveh hormonov, ki delujeta na modi in njuno proizvajanje testosterona.
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen.
Ta vrsta raka prizadene prostato, žlezo pod sečnim mehurjem pri moških, v kateri nastaja semenska tekočina.
Therefore, the CHMP decided that Firmagon's benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Zaradi tega je CHMP zaključil, da so koristi zdravila Firmagon pri zdravljenju odraslih moških bolnikov z napredovalim rakom prostate, ki je odvisen od hormonov, večje od z njim povezanih tveganj.
How has Firmagon been studied?
Kako je bilo zdravilo Firmagon raziskano?
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.
V eni glavni študiji, ki je vključevala 610 moških z rakom prostate v vseh stadijih te bolezni, so dva odmerka zdravila Firmagon primerjali z levprorelinom.
Firmagon was as effective as leuprorelin at reducing testosterone levels.
Zdravilo Firmagon je bilo pri nižanju koncentracije testosterona enako učinkovito kot levprorelin.
How does Firmagon work?
Kako zdravilo Firmagon deluje?
What is Firmagon?
Kaj je zdravilo Firmagon?
The full EPAR for Firmagon can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Firmagon je na voljo tukaj.
What is Firmagon used for?
Za kaj se zdravilo Firmagon uporablja?
How is Firmagon used?
Kako se zdravilo Firmagon uporablja?
Testosterone can make prostate cancer cells grow.
Rakaste celice v prostati lahko začnejo pod vplivom testosterona rasti.
Prevention of rejection
Preprečevanje zavrnitve organa
Treatment of S-LAM
Zdravljenje S-LAM
Further information on Rapamune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Rapamune so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showing altered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne.
Najpogostejši neželeni učinki zdravila Rapamune (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe, vročina, počasno celjenje ran, majhno število različnih krvnih celic, krvne preiskave, ki pokažejo spremenjene ravni različnih snovi (vključno z nizko ravnijo kalija in fosfata; zvišane ravni maščob, holesterola, glukoze in označevalcev razkroja tkiv ter delovanja jeter in ledvic), sladkorna bolezen, limfokela (nabiranje tekočine, običajno v spodnjem predelu trebuha), bolečina v različnih delih telesa, pospešen srčni utrip, zvišan krvni tlak, težave s črevesjem, proteinurija (beljakovine v seču), menstruacijske motnje, edemi (otekanje zaradi nabiranja tekočine), izpuščaj in akne.
The main measure of effectiveness was a change of FEV1 (the maximum volume of air a person can breathe out in 1 second).
Glavno merilo učinkovitosti je bila sprememba FEV1 (največja količina zraka, ki jo oseba lahko izdihne v 1 sekundi).
The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months.
Glavno merilo učinkovitosti je bilo število neuspelih zdravljenj (zavrnitve ali izgube presajene ledvice ali smrti) po šestih mesecih.
Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001.
Za zdravilo Rapamune je bilo 14. marca 2001 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Rapamune?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rapamune?