natgillin/translations-raw huggingface dataset:
The PRAC therefore concluded that the benefit-risk balance of almitrine containing medicinal products for oral administration is not favourable.
Na koncu je PRAC zaključil, da razmerje med tveganji in koristmi za zdravila za peroralno uporabo, ki vsebujejo almitrin, ni pozitivno.
Based on the published literature and post marketing data, the PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
Na podlagi objavljene literature in podatkov iz obdobja trženja je PRAC menil, da z ukrepi za zmanjšanje tveganja, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, ne bi bilo mogoče zmanjšati tveganja za resne neželene učinke na klinično sprejemljivo raven: dodatna opozorila o tveganjih za nevropatijo in zmanjšanje telesne mase, ki jih zdravniki, ki predpisujejo tovrstna zdravila, že dobro poznajo, ne bi pripomogla k varnejši uporabi zdravila.
• The PRAC took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of oral almitrine in chronic obstructive pulmonary disease (COPD).
• PRAC je upošteval, da je imetnik dovoljenja za promet z zdravilom menil, da je predložil vse razpoložljive podatke in da ne more predložiti nobenih dodatnih podatkov, ki bi dokazovali klinično korist almitrina za peroralno uporabo pri kronični obstruktivni pljučni bolezni (KOPB);
Further to the review of the available efficacy data, including data which became available since the initial marketing authorisation, the PRAC concluded that the available data only showed very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Na podlagi pregleda razpoložljivih podatkov o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvega dovoljenja za promet, je PRAC zaključil, da ti kažejo zelo omejeno učinkovitost almitrina za peroralno uporabo pri odobrenih indikacijah, pri čemer ni dokazov o koristi za bolnike v okviru trenutnega načina zdravljenja in znanja na področju bolezni dihal.
Overall, based on the available published data and data from spontaneous reports, the PRAC considers that almitrine use is associated with serious cases of peripheral neuropathy, some with positive rechallenge, and weight loss.
Na podlagi razpoložljivih javno dostopnih podatkov in podatkov iz spontanih poročil je PRAC na splošno menil, da je uporaba almitrina povezana z resnimi primeri periferne nevropatije, vključno s primeri ponovnega pojava simptomov po ponovni uporabi, in zmanjšanjem telesne mase.
However, no data supports the restrictive indication proposed by the MAH.
Vendar pa omejene indikacije, ki jo je predlagal imetnik dovoljenja za promet, ne podpirajo nobeni podatki.
With regards to peripheral neuropathy, a total of 2304 cases of peripheral neuropathy have been spontaneously reported in patients exposed to almitrine since the launch of the product (from 1983 to December 2012).
Od začetka trženja zdravila (od leta 1983 do decembra 2012) so spontano poročali o 2 304 primerih periferne nevropatije pri bolnikih, ki so bili izpostavljeni almitrinu.
The PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
PRAC meni, da z ukrepi za zmanjšanje tveganja, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, ne bi bilo mogoče zmanjšati tveganja za resne neželene učinke na klinično sprejemljivo raven: dodatna opozorila o tveganjih za nevropatijo in zmanjšanje telesne mase, ki jih zdravniki, ki predpisujejo tovrstna zdravila, že dobro poznajo, ne bi pripomogla k varnejši uporabi zdravila.
Based on the above, the PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Na podlagi zgoraj navedenega je PRAC menil, da razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvega dovoljenja za promet, kažejo zelo omejeno učinkovitost almitrina za peroralno uporabo pri odobrenih indikacijah, pri čemer ni dokazov o koristi za bolnike v okviru trenutnega načina zdravljenja in znanja na področju bolezni dihal.
In addition to peripheral neuropathies with abnormal sensations in the lower limb or paraesthesia and weight loss up to -6%, in the publications reporting clinical studies with continuous administration, the following adverse events were also more frequent in the almitrine groups:
Iz publikacij, v katerih so poročali o kliničnih študijah z neprekinjenim dajanjem odmerkov, je razvidno, da so bili poleg periferne nevropatije z nenavadnimi občutki v spodnjih okončinah ali parestezijo in zmanjšanja telesne mase za do 6 % v skupinah z almitrinom pogostejši tudi naslednji neželeni dogodki:
The PRAC took in account the MAH's position.
PRAC je upošteval mnenje imetnika dovoljenja za promet z zdravilom.
France has taken a number of national regulatory actions to minimise the risk of these adverse reactions associated with almitrine for oral use.
Za zmanjšanje tveganja za te neželene učinke, povezane z almitrinom za peroralno uporabo, je Francija uvedla več nacionalnih regulativnih ukrepov.
Pneumology 1998 Mar;52(3):121-7 (PE24412) Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of Almitrine in patients with chronic obstrutive lung disease.
Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of Almitrine in patients with chronic obstrutive lung disease.
2003 ; 70 : 275-283 (PE32001) Nowak D., Wywiol A., Magnussen H.. Almitrine in the treatment of chronic obstructive pulmonary disease with hypoxemia - a multicentre clinical study comparing two dosages.
Nowak D., Wywiol A., Magnussen H.. Almitrine in the treatment of chronic obstructive pulmonary disease with hypoxemia - a multicentre clinical study comparing two dosages.
• Central nervous events (sleep disorders such as insomnia, drowsiness, agitation, anxiety, palpitations, dizziness) Based on the available publications of clinical studies with sequential treatment scheme891011 (i.e. two months of treatment followed by one month treatment interruption), the rate of withdrawal remained predominant in the almitrine groups as compared to placebo groups in the majority of the publications.
Glede na razpoložljive objavljene klinične študije s sekvenčno shemo zdravljenja891011 (tj. dvomesečno zdravljenje, ki mu sledi enomesečna prekinitev zdravljenja) je bila stopnja prekinitve zdravljenja v večini študij še vedno višja v skupinah z almitrinom kot v skupini s placebom.
In addition, the benefit claimed by the MAH that long-term oxygen therapy can be delayed with almitrine is not substantiated by supporting data.
Poleg tega podporni podatki ne dokazujejo trditve imetnika dovoljenja za promet, da je mogoče z almitrinom odložiti trajno zdravljenje s kisikom.
No published data focusing on the proper mechanism of almitrine in the occurrence of those adverse events was provided by the MAH.
Imetnik dovoljenja za promet z zdravilom ni predložil nobenih javno dostopnih podatkov o mehanizmu almitrina pri pojavu teh neželenih učinkov.
Despite sequential doses regimen and amendments in the SmPC, the PRAC noted serious cases of neuropathy and weight loss continued to be reported, including some cases with positive rechallenge, and leading sometimes to sequelae.
PRAC je upošteval, da kljub sekvenčni shemi odmerjanja in spremembam povzetka glavnih značilnosti zdravila še vedno poročajo o resnih primerih nevropatije in zmanjšanja telesne mase, ki vključujejo primere ponovnega pojava simptomov po ponovni uporabi zdravila in lahko včasih pustijo posledice.
• The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
• PRAC je menil, da je uporaba almitrina za peroralno uporabo povezana z resnima neželenima učinkoma periferno nevropatijo in zmanjšanjem telesne mase, ki včasih lahko pustita posledice;
Based on the above the PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Na podlagi zgoraj navedenega je PRAC menil, da je uporaba almitrina za peroralno uporabo povezana z resnima neželenima učinkoma periferno nevropatijo in zmanjšanjem telesne mase, ki včasih lahko pustita posledice.
No benefit has been demonstrated when almitrine was used as an adjuvant of that intervention.
Pri uporabi almitrina kot adjuvantnega zdravljenja k zdravljenju s kisikom niso opazili nobenih koristi.
The PRAC considered the risk minimisations measures already implemented (reduction of the dose and implementation of a sequential treatment scheme) to mitigate the risk of neuropathies and weight loss.
PRAC je menil, da je uporaba almitrina za peroralno uporabo povezana z resnima neželenima učinkoma periferno nevropatijo in zmanjšanjem telesne mase, ki včasih pustita posledice; PRAC je obravnaval že obstoječe ukrepe za zmanjšanje tveganja (zmanjšanje odmerka in uvedba sekvenčne sheme zdravljenja), ki so namenjeni zmanjšanju tveganja za nevropatijo in zmanjšanje telesne mase.
Voisin C., Howard P., Ansquer J.C. Almitrine bismesylate: a long-term placebo- controlled double-blind study in COAD.
Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Voisin C.. Long-term Almitrine bismesylate treatment in patients with chronic bronchitis and emphysema: a multicentre double-blind placebo controlled study.
Important weight losses and peripheral neuropathies which can potentially not recover or lead to sequelae, are still reported with almitrine despite risk minimisation measures in place for several years.
Kljub ukrepom za zmanjšanje tveganja, ki se izvajajo že več let, v povezavi z almitrinom še vedno poročajo o velikem zmanjšanju telesne mase in periferni nevropatiji, ki se ne popravita oziroma lahko pustita posledice.
It is available as tablets (200 mg; 400 mg).
Na voljo je v obliki tablet (200 mg; 400 mg).
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Votrient on 14 June 2010.
Evropska komisija je pogojno dovoljenje za promet z zdravilom Votrient, veljavno po vsej Evropski uniji, odobrila dne 14. junija 2010.
Other information about Votrient:
Druge informacije o zdravilu Votrient:
Votrient should be taken with water but without food, at least one hour before or two hours after a meal.
Zdravilo Votrient je treba jemati z vodo, brez hrane, vsaj eno uro pred obrokom ali dve uri po njem.
EPAR summary for the public pazopanib
Povzetek EPAR za javnost pazopanib
The full EPAR for Votrient can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Votrient je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is 800 mg once a day, but this may need to be reduced if the patient has side effects.
Priporočeni odmerek znaša 800 mg enkrat dnevno, vendar bo morda treba odmerek zmanjšati, če se pri bolniku pojavijo neželeni učinki.
This was switched to a full marketing authorisation on 1 July 2013.
To je bilo 1. julija 2013 spremenjeno v običajno dovoljenje za promet.
The safety profile of Votrient is considered acceptable and generally manageable.
Varnostni profil zdravila Votrient je sprejemljiv in načeloma obvladljiv.
In patients with moderate liver problems the dose should be reduced to 200 mg once a day.
Pri bolnikih z zmernim obolenjem jeter je treba odmerek zmanjšati na 200 mg enkrat na dan.
Votrient is used to treat adults with the following types of cancer:
Zdravilo Votrient se uporablja za zdravljenje odraslih z naslednjimi vrstami raka:
The most common side effects with Votrient (seen in more than 1 patient in 10) include reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, pain, hair colour change, fatigue (tiredness), skin hypopigmentation (discolouration of the skin), exfoliative (flaky) rash, headache, stomatitis (inflammation of the lining of the mouth), decreased weight and increased blood levels of certain liver enzymes.
Najpogostejši neželeni učinki zdravila Votrient (opaženi pri več kot 1 bolniku od 10) so zmanjšan tek, disgevzija (motnje okušanja), hipertenzija (povišan krvni tlak), driska, navzeja (slabost), bruhanje, bolečine, sprememba barve las, utrujenost, razbarvanje kože, eksfoliacija kože (luščenje kože), glavobol, stomatitis (vnetje ustne sluznice), zmanjšanje telesne mase ter povečanje vrednosti nekaterih jetrnih encimov v krvi.
What benefit has Votrient shown during the studies?
Kakšne koristi je zdravilo Votrient izkazalo med študijami?
This document is a summary of the European Public Assessment Report (EPAR) for Votrient.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Votrient.
For more information about treatment with Votrient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Votrient preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
By blocking these enzymes, Votrient can reduce the growth and spread of the cancer.
Zdravilo Votrient lahko z zaviranjem teh encimov zmanjša rast in širjenje raka.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Ker je družba predložila dodatne zahtevane podatke, je bilo dovoljenje za promet z zdravilom spremenjeno iz pogojnega v običajno.
Votrient must not be used in people who are hypersensitive (allergic) to pazopanib or any of the other ingredients.
Zdravila Votrient ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pazopanib ali katero koli drugo sestavino zdravila.
It is used in patients who have been previously treated with chemotherapy (medicines to treat cancer) because their cancer had spread, or in patients whose cancer has progressed within 12 months after receiving adjuvant or neoadjuvant therapy (treatment received after or before their main treatment).
Uporablja se pri bolnikih, ki so bili predhodno zdravljeni s kemoterapijo (zdravili proti raku), ker se je rak pri njih razširil, ali pri bolnikih, pri katerih se je rak razširil v 12 mesecih po prejemu adjuvantne ali neoadjuvantne terapije (zdravljenja, ki ga prejmejo po glavnem zdravljenju ali pred njim).
What is the risk associated with Votrient?
Kakšna tveganja so povezana z zdravilom Votrient?
Treatment with Votrient should only be started by a doctor who has experience in giving anticancer medicines.
Zdravljenje z zdravilom Votrient sme uvesti le zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Votrient.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Votrient, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.
Bolniki, ki so jemali zdravilo Votrient, so brez poslabšanja bolezni živeli v povprečju 9,2 meseca, v primerjavi s 4,2 meseca pri bolnikih, ki so jemali placebo.
Therefore, the Committee decided that Votrient's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je CHMP zaključil, da so koristi zdravila Votrient večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In all of the studies, the main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
V vseh študijah je bilo glavno merilo učinkovitosti čas, ko je bolnik živel, ne da bi bolezen napredovala, oziroma se poslabšala.
Votrient was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Zdravilo Votrient je prvotno pridobilo „pogojno dovoljenje za promet“, ker so pričakovali še več dokazov o zdravilu, zlasti o njegovi uporabi pri zdravljenju karcinoma ledvičnih celic.
• certain forms of soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.
• nekaterimi oblikami sarkoma mehkega tkiva, vrsto raka, ki se začne razvijati na mehkih vezivnih tkivih v telesu.
On average, the patients who took Votrient lived for 20 weeks without their disease getting worse, compared with seven weeks for the patients who took placebo.
Bolniki, ki so jemali zdravilo Votrient, so brez poslabšanja bolezni živeli v povprečju 20 tednov, v primerjavi s sedmimi tedni pri bolnikih, ki so jemali placebo.
Votrient is not recommended in patients with severe liver problems.
Zdravilo Votrient ni priporočljivo za bolnike z resno okvaro jeter.
These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR', ‘PDGFR' and ‘KIT'.
Ti encimi se nahajajo v nekaterih receptorjih na površini celic, ki sodelujejo pri rasti in širjenju rakavih celic, kot so receptorji za žilni endotelijski rastni faktor (VEGFR), trombocitni rastni faktor (PDGFR) in receptorji za faktor matičnih celic (KIT).
For the full list of all side effects reported with Votrient, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Votrient, glejte navodilo za uporabo.
It is used in patients who have not received any previous treatment or in patients who have already been treated for their advanced disease with anticancer medicines called ‘cytokines'.
Uporablja se pri bolnikih, ki predhodno še niso bili zdravljeni, ali pri bolnikih, ki so zaradi napredovale bolezni predhodno že prejemali zdravila za zdravljenje rakavih obolenj, imenovana „citokini“.
The CHMP considered that Votrient has been shown to be an effective medicine for patients with advanced renal cell carcinoma and soft-tissue sarcoma, with a clinically relevant improvement in progression-free survival.
CHMP je menil, da je bilo dokazano, da je zdravilo Votrient učinkovito za bolnike z napredovalim karcinomom ledvičnih celic in sarkomom mehkih tkiv, s klinično pomembnim izboljšanjem preživetja brez napredovanja bolezni.
Votrient is a medicine that contains the active substance pazopanib.
Votrient je zdravilo, ki vsebuje zdravilno učinkovino pazopanib.
• advanced renal cell carcinoma, a type of kidney cancer.
• napredovalim karcinomom ledvičnih celic, vrsto raka ledvic.
Votrient has also been compared with placebo in a main study involving 369 patients with soft-tissue sarcoma whose disease had progressed during or following previous chemotherapy.
Zdravilo Votrient so primerjali tudi s placebom v glavni študiji, v katero je bilo vključenih 369 bolnikov s sarkomom mehkega tkiva, pri katerih je bolezen napredovala med prejšnjo kemoterapijo ali po njej.
The active substance in Votrient, pazopanib, is a protein kinase inhibitor.
Zdravilna učinkovina zdravila Votrient, pazopanib, je zaviralec proteinske kinaze.
Why has Votrient been approved?
Zakaj je bilo zdravilo Votrient odobreno?
Votrient has been compared with placebo (a dummy treatment) in one main study involving 435 patients with advanced renal cell carcinoma, some of whom had previously been treated with cytokines.
Zdravilo Votrient so primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v kateri je sodelovalo 435 bolnikov z napredovalim karcinomom ledvičnih celic, od katerih jih je bilo nekaj že predhodno zdravljenih s citokini.
Votrient was more effective than placebo at treating advanced renal cell carcinoma.
Zdravilo Votrient je bilo učinkovitejše od placeba pri zdravljenju bolnikov z napredovalim rakom ledvičnih celic.
Votrient was also more effective than placebo at treating soft-tissue sarcoma.
Zdravilo Votrient je bilo pri zdravljenju sarkoma mehkega tkiva učinkovitejše od placeba.
How has Votrient been studied?
Kako je bilo zdravilo Votrient raziskano?
What is Votrient used for?
Za kaj se zdravilo Votrient uporablja ?
How does Votrient work?
Kako zdravilo Votrient deluje?
How is Votrient used?
Kako se zdravilo Votrient uporablja?
What is Votrient?
Kaj je zdravilo Votrient?
It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Na voljo je v obliki tablet (250 mg, 500 mg, 750 mg in 1 000 mg).
This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
To je vrsta epilepsije, pri kateri prevelika električna aktivnost na samo eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Natančen način delovanja levetiracetama ni pojasnjen, znano pa je, da se pritrdi na beljakovino, imenovano sinaptični vezikularni protein 2A, ki sodeluje pri sproščanju kemičnih prenašalcev iz živčnih celic.
The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Levetiracetam Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For patients weighing less than 50 kg, the dose depends on body weight.
Za bolnike, ki tehtajo manj kot 50 kg, je priporočeni odmerek odvisen od telesne mase.
What measures are being taken to ensure the safe and effective use of Levetiracetam Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Levetiracetam Accord?
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.
Evropska komisija je dovoljenje za promet z zdravilom Levetiracetam Accord, veljavno po vsej Evropski uniji, izdala 3. oktobra 2011.
This means that Levetiracetam Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Keppra.