natgillin/translations-raw huggingface dataset:
Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic.
Zdravilo Brinavess vsebuje vernakalant, vrsto snovi, znano kot antiaritmik.
The company that markets Brinavess will ensure that healthcare professionals expected to use the medicine are provided with educational material explaining how the medicine should be used.
Podjetje, ki trži zdravilo Brinavess, bo zagotovilo, da bodo zdravstveni delavci, ki naj bi uporabljali to zdravilo, prejeli izobraževalno gradivo o njegovi uporabi.
The dose of Brinavess depends on the patient's body weight.
Odmerek zdravila Brinavess je odvisen od bolnikove telesne mase.
In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo.
V prvih dveh študijah se je pri bolnikih z nedavnim pojavom atrijske fibrilacije srčni utrip normaliziral pri 51 % (118 od 231) prejemnikov zdravila Brinavess in pri 4 % (6 od 159) prejemnikov placeba.
In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.
V tretji študiji se je srčni utrip normaliziral pri 47 % bolnikov, ki so prejemali zdravilo Brinavess, in pri 14 % prejemnikov placeba.
What are the risks associated with Brinavess?
Kakšna tveganja so povezana z zdravilom Brinavess?
Patients should not be given more than 5 mg of Brinavess per kg body weight within any 24-hour period, or a maximum of 565 mg in patients weighing more than 113 kg.
Če se srčni utrip ne normalizira v 15 minutah po koncu prve infuzije, je treba dati drugi, manjši odmerek Bolniki ne smejo prejeti več kot 5 mg zdravila Brinavess na kilogram telesne mase v katerem koli 24-urnem obdobju ali največ 565 mg pri bolnikih, ki tehtajo več kot 113 kg.
Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation.
Brinavess je zdravilo, ki se uporablja za hitro obnovitev normalnega srčnega utripa pri odraslih bolnikih z nedavno nastalo atrijsko fibrilacijo.
A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery.
V tretji glavni študiji so zdravilo Brinavess primerjali s placebom pri 161 odraslih z atrijsko fibrilacijo po kirurškem posegu na srcu.
Brinavess contains the active substance vernakalant hydrochloride.
Zdravilo Brinavess vsebuje učinkovino vernakalantijev klorid.
Patients on Brinavess must not be given medicines called ‘class I and III anti-arrhythmics' intravenously during the four hours before or after their Brinavess infusion.
Bolniki, ki prejemajo zdravilo Brinavess, štiri ure pred infundiranjem in štiri ure po njem ne smejo intravensko prejemati zdravil, imenovanih „antiaritmitiki razreda I in III‟.
Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation.
Zdravilo Brinavess je bilo učinkovitejše od placeba pri zdravljenju bolnikov z nedavnim pojavom atrijske fibrilacije.
Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes.
Zdravilo Brinavess je raztopina, ki se daje z desetminutnim infundiranjem (kapalno infuzijo) v veno.
For the full list of side effects of Brinavess, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Brinavess glejte navodilo za uporabo.
Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm.
Atrijska fibrilacija je neredno in hitro krčenje atrijev (zgornjih preddvorov srca), kar povzroči nenormalen srčni utrip.
In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment).
Zdravilo Brinavess so v dveh glavnih študijah, v katerih je sodelovalo 596 odraslih z atrijsko fibrilacijo, primerjali s placebom (zdravilom brez učinkovine).
How is Brinavess used?
Kako se zdravilo Brinavess uporablja?
Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).
Deluje predvsem v preddvoru, in ne v prekatih (spodnjih srčnih votlinah).
How does Brinavess work?
Kako zdravilo Brinavess deluje?
Mysimba naltrexone / bupropion
Mysimba naltrekson/bupropion
The European Commission granted a marketing authorisation valid throughout the European Union for Mysimba on 26 March 2015.
Evropska komisija je dovoljenje za promet z zdravilom Mysimba, veljavno po vsej Evropski uniji, izdala 26. marca 2015.
What measures are being taken to ensure the safe and effective use of Mysimba?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mysimba?
It will also carry out a further study to assess the effect of the medicine on the heart and blood vessels.
Prav tako bo izvedla dodatno študijo za oceno učinkov zdravila na srce in ožilje.
The full EPAR and risk management plan summary for Mysimba 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) in povzetek načrta obvladovanja tveganj za zdravilo Mysimba sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Mysimba.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mysimba.
Other information about Mysimba
Druge informacije o zdravilu Mysimba
Treatment with Mysimba is started with a single tablet each morning, with the dose gradually increased over 4 weeks to the recommended dose of two tablets twice a day, preferably taken with food.
Zdravljenje z zdravilom Mysimba se začne z eno tableto vsako jutro, nato pa se odmerek štiri tedne postopoma povečuje do priporočenega odmerka, tj. dve tableti dvakrat na dan, ki se po možnosti vzameta skupaj s hrano.
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that although the effectiveness of the medicine in promoting weight loss was limited, it was sufficient to be clinically significant, and mandatory re-assessment of treatment after 4 months should ensure that the medicine only continues to be used in those in whom the medicine provides adequate benefit.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da je omejena učinkovitost zdravila pri spodbujanju izgube telesne mase kljub vsemu zadostna, da se lahko oceni kot klinično pomembna, in da bo obvezno ponovno ocenjevanje zdravljenja po štirih mesecih zagotovilo, da se bo zdravljenje z zdravilom nadaljevalo samo pri tistih, pri katerih ima zdravilo dovolj velike koristi.
Mysimba is available as prolonged-release tablets containing 7.2 mg naltrexone and 78 mg bupropion and can only be obtained with a prescription.
Zdravilo Mysimba je na voljo v obliki tablet s podaljšanim sproščanjem, ki vsebujejo 7,2 mg naltreksona in 78 mg bupropiona), in se izdaja le na recept.
• who are obese (have a body-mass index - BMI - of 30 or more);
• ki so debeli (imajo indeks telesne mase (ITM) 30 ali več);
In addition, the company that markets Mysimba will produce an information pack for doctors prescribing the medicine, including guidance on stopping treatment in patients who do not respond or if there are concerns about side effects.
Poleg tega bo družba, ki trži zdravilo Mysimba, pripravila gradivo z informacijami za zdravnike, ki bodo predpisovali zdravilo, vključno z navodili glede prekinitve zdravljenja pri bolnikih, ki se ne odzivajo ali pri katerih obstajajo pomisleki glede neželenih učinkov.
• who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, or high blood pressure.
• ki imajo čezmerno telesno maso (ITM med 27 in 30) in s tem povezane težave, kot so sladkorna bolezen, nenormalno visoke ravni maščob v krvi ali visok krvni tlak.
The main measures of effectiveness were the percentage reduction in body weight over 28 or 56 weeks of treatment, and the proportion of patients who achieved at least a 5% weight reduction; the studies also looked at the number of patients who achieved at least a more stringent 10% reduction in weight, and the results were analysed using various methods to take account of the number of patients who did not complete the studies (around 50% over one year).
Glavni merili učinkovitosti sta bila odstotek zmanjšanja telesne mase v 28 ali 56 tednih zdravljenja ter delež bolnikov, katerih telesna masa se je zmanjšala za vsaj 5 %, v študijah pa so ugotavljali tudi število bolnikov, pri katerih se je telesna masa zmanjšala vsaj za 10 %, in rezultate analizirali z uporabo različnih metod, da bi upoštevali število bolnikov, ki niso dokončali študij (približno 50 % v enem letu).
Prolonged-release means that naltrexone and bupropion are released slowly from the tablet over a few hours.
Podaljšano sproščanje pomeni, da se naltrekson in bupropion iz tablete počasi sproščata več ur.
A risk management plan has been developed to ensure that Mysimba is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Mysimba je bil pripravljen načrt obvladovanja tveganj.
What is Mysimba and what is it used for?
Kaj je zdravilo Mysimba in za kaj se uporablja?
What benefits of Mysimba have been shown in studies?
Kakšne koristi je zdravilo Mysimba izkazalo v študijah?
The exact way that Mysimba works is not fully understood, but the two active substances, naltrexone and bupropion, act on the parts of the brain that control food intake and energy balance, as well as reducing the effect of the part of the brain that controls the pleasure associated with eating food.
Natančen način delovanja zdravila Mysimba ni v celoti znan, vendar pa zdravilni učinkovini, naltrekson in bupropion, delujeta na dele možganov, ki nadzorujejo vnos hrane in ravnovesje energije, ter zmanjšata vpliv dela možganov, ki nadzoruje ugodje, povezano z uživanjem hrane.
Mysimba is a medicine used along with diet and exercise to help manage weight in adults:
Mysimba je zdravilo, ki se uporablja skupaj z dieto in telesno dejavnostjo za obvladovanje telesne mase pri odraslih:
When given together, their actions reduce appetite and the amount that patients eat, and increase energy expenditure, helping them to stick to a calorie-controlled diet and to reduce their body weight.
Kadar se učinkovini dajeta skupaj, delujeta tako, da zmanjšata tek in količino hrane, ki jo zaužijejo bolniki, ter povečata porabo energije, s čimer bolnikom pomagata, da se držijo diete z nadzorovanim vnosom kalorij in zmanjšajo telesno maso.
Interim data from an ongoing study of cardiovascular outcomes were reviewed during the assessment although the CHMP also recommended ongoing monitoring of the medicine's cardiovascular effects.
Med ocenjevanjem so bili pregledani vmesni podatki iz potekajoče študije o srčno-žilnih izidih, čeprav je odbor prav tako priporočil stalno spremljanje učinkov zdravila na srce in ožilje.
Regarding safety, although the CHMP had some concerns about possible effects on the heart and blood vessels (cardiovascular outcomes) and a slightly increased risk of seizures (fits), the most common side effects were largely manageable, as patients could stop taking the medicine if they were bothersome.
Kar zadeva varnost, je odbor imel nekaj pomislekov glede možnih neželenih učinkov na srce in ožilje (srčno-žilnih izidov) ter nekoliko povišanega tveganja za epileptične napade (krče), vendar so najpogostejši neželeni učinki večinoma obvladljivi, saj bolniki lahko prenehajo uporabljati zdravilo, če so ti moteči.
What are the risks associated with Mysimba?
Kakšna tveganja so povezana z zdravilom Mysimba?
Patients should have their response and tolerability to the medicine checked regularly and treatment should be stopped in patients who have certain side effects such as an increase in blood pressure.
Pri bolnikih je treba redno preverjati njihov odziv in sposobnost prenašanja zdravila ter prekiniti zdravljenje pri tistih, pri katerih se pojavijo določeni neželeni učinki, kot je povišan krvni tlak.
Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Bolniki v študiji so prejemali zdravilo v okviru programa za zmanjšanje telesne mase, ki je vključeval še svetovanje o dieti in telesno dejavnost.
The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea and vomiting (feeling and being sick) and constipation; dizziness and dry mouth were also common (seen in up to 1 patient in 10).
Najpogostejši neželeni učinki zdravila Mysimba (ki lahko prizadenejo več kot 1 osebo od 10) so navzeja (slabost) in bruhanje ter zaprtost, pogosta pa sta tudi omotica in suha usta (opažena pri največ 1
The treatment effect was more marked in patients who completed 56 weeks of treatment, or who had lost at least 5% of their original body weight by 4 months.
Učinek zdravljenja je bil izrazitejši pri bolnikih, ki so dokončali 56-tedensko zdravljenje, in pri tistih, ki so v prvih štirih mesecih izgubili vsaj 5 % izhodiščne telesne mase.
For more information about treatment with Mysimba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mysimba preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The effects of Mysimba in reducing body weight have been shown in 4 main studies involving around 4,500 obese or overweight patients, in which Mysimba was compared with placebo (a dummy treatment).
Učinke zdravila Mysimba na zmanjšanje telesne mase so dokazali v štirih glavnih študijah s približno 4 500 debelimi bolniki ali bolniki s čezmerno telesno maso, v katerih so zdravilo Mysimba primerjali s placebom (zdravilom brez zdravilne učinkovine).
On the balance of the available evidence the CHMP decided that Mysimba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Na podlagi razpoložljivih dokazov je zato zaključil, da so koristi zdravila Mysimba večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Why is Mysimba approved?
Zakaj je bilo zdravilo Mysimba odobreno?
The degree of improvement with Mysimba over placebo was similar using different methods of analysis, although the benefits were smallest with the most conservative methods that assumed patients who did not complete the study would not have seen any improvement.
Z uporabo različnih metod analize so ugotovili podobne stopnje izboljšanja pri uporabi zdravila Mysimba v primerjavi s placebom, vendar pa so najmanjše koristi zabeležili z najkonzervativnejšimi metodami s predpostavko, da pri bolnikih, ki niso dokončali študije, ni bilo nobenega izboljšanja.
Mysimba contains the active substances naltrexone and bupropion, which are licensed individually in the EU for other uses.
Zdravilo Mysimba vsebuje zdravilni učinkovini naltrekson in bupropion, ki sta ločeno že odobreni v EU za uporabo v druge namene.
In the other study, in which patient counselling was also more intensive, the overall weight loss was greater over the study period: 8.1% with Mysimba and 4.9% with placebo.
V drugi študiji, v kateri so bili bolniki med drugim deležni intenzivnejšega svetovanja, je bilo skupno zmanjšanje telesne mase v času študije večje: 8,1-odstotno pri uporabi zdravila Mysimba in 4,9-odstotno pri uporabi placeba.
Mysimba should also be stopped if patients have not lost at least 5% of their initial body weight after 4 months of treatment.
Zdravljenje z zdravilom Mysimba je treba prekiniti tudi pri bolnikih, ki po štirih mesecih zdravljenja ne izgubijo vsaj 5 % izhodiščne telesne mase.
It is not intended to provide practical advice on how to use Mysimba.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects reported with Mysimba, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mysimba, glejte navodilo za uporabo.
In three of the studies, the average weight loss in patients treated with Mysimba was around 3.7 to 5.7%, compared with 1.3 to 1.9% with placebo; the proportion of Mysimba-treated patients who achieved 5% weight loss ranged from 28 to 42% compared with 12 to 14% with placebo.
V treh študijah se je telesna masa bolnikov, ki so jih zdravili z zdravilom Mysimba, v povprečju zmanjšala za približno od 3,7 do 5,7 %, pri uporabi placeba pa za od 1,3 do 1,9 %, medtem ko je bil delež bolnikov, ki so jih zdravili z zdravilom Mysimba in so izgubili 5 % telesne mase, od 28 do 42 %, pri uporabi placeba pa je bil ta delež od 12 do 14 %.
For practical information about using Mysimba, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Mysimba naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
About 13 to 22% of those taking Mysimba achieved at least a 10% reduction in weight, while 5 to 6% of placebotreated patients did so.
Približno od 13 do 22 % bolnikov, ki so prejemali zdravilo Mysimba, je izgubilo vsaj 10 % telesne mase, medtem ko je bilo med bolniki, zdravljenimi s placebom, takšnih od 5 do 6 %.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mysimba, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Some 46% and 30% of patients given Mysimba achieved 5 and 10% weight reductions respectively, compared with 34% and 17% respectively with placebo.
Približno 46 % oziroma 30 % bolnikov, ki so prejemali zdravilo Mysimba, je izgubilo 5 oziroma 10 % telesne mase, v primerjavi s 34 % oziroma 17 % bolnikov, ki so prejemali placebo.
How does Mysimba work?
Kako zdravilo Mysimba deluje?
Mysimba must not be used in certain patients at particular risk of side effects, including patients with severely reduced kidney or liver function, those with high blood pressure that is not under control,
Zdravilo Mysimba se ne sme uporabljati pri določenih bolnikih s posebnim tveganjem za neželene učinke, kot so bolniki z močno zmanjšanim delovanjem ledvic ali jeter, bolniki z visokim krvnim tlakom, ki ni pod nadzorom, bolniki, ki so kdaj imeli epileptične napade (krče) ali določene psihološke težave, in bolniki, ki imajo možganski tumor ali se trenutno odvajajo alkohola ali določenih drog.
How is Mysimba used?
Kako se zdravilo Mysimba uporablja?
26 July 2012
26. julij 2012
The full European Public Assessment Report for Velcade 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 Velcade je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness was progression free survival (how long the patients lived without their disease getting worse).
Glavno merilo učinkovitosti je bil čas preživetja brez napredovanja bolezni (kako dolgo so bolniki živeli brez poslabšanja bolezni).
It blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Zavira proteasom, tj. sistem v celicah, ki razgrajuje beljakovine, ko te niso več potrebne.
After the CHMP had assessed the company's responses to its first round of questions, there were still some unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na prva vprašanja, so nekatera vprašanja še vedno ostala nerešena.
The CHMP had concerns about the methodology used to analyse the results, which left some uncertainties about the size of the effect seen.
Izrazil je zadržke glede uporabljene metodologije za analizo rezultatov, ki je povzročila nekaj negotovosti glede obsega opaženega učinka.
When the proteins in cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and eventually die.
Če se beljakovine v rakavih celicah, na primer beljakovine, ki nadzorujejo rast celic, ne razgradijo, to vpliva na celice, ki sčasoma odmrejo.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in pripravil sezname vprašanj.
The CHMP questioned the relevance of the study results which showed that, overall, patients treated with Velcade plus rituximab lived without their disease getting worse for an average of 1.8 months longer than patients treated with rituximab alone (12.8 months compared with 11 months).
CHMP je podvomil o ustreznosti rezultatov študije, ki so pokazali, da so bolniki, zdravljeni z zdravilom Velcade v kombinaciji z rituksimabom, na splošno živeli brez poslabšanja bolezni povprečno 1,8 meseca dlje kot bolniki, zdravljeni samo z rituksimabom (12,8 meseca v primerjavi z 11 meseci).
In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not support a positive benefit-risk balance.
Družba je v uradnem dopisu navedla, da je vlogo sklenila umakniti, ker je CHMP menil, da predloženi podatki ne dokazujejo pozitivnega razmerja med koristmi in tveganji.
The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab.
Po mnenju Odbora je malo verjetnosti, da bi bila ta razlika pomembna, prav tako pa ni bil prepričan, da je bila opredeljena podskupina bolnikov, ki bi imeli koristi zaradi dodajanja zdravila Velcade rituksimabu.
There are no consequences on the use of Velcade in its authorised indications.
Umik nima nobenih posledic za uporabo zdravila Velcade pri odobrenih indikacijah.
It is also used on its own in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.
Uporablja se tudi samostojno pri bolnikih z napredovalo boleznijo, ki se niso odzvali na vsaj eno drugo zdravljenje in katerim so že presadili kostni mozeg ali pri katerih presaditev kostnega mozga ni mogoča.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Velcade.
Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih uporabe zdravila Velcade.
The applicant presented the results of a study involving 676 patients with follicular non-Hodgkin lymphoma that had relapsed or progressed despite previous treatments, designed to assess the effects of using Velcade in combination with rituximab compared with using rituximab alone in these patients.
Predlagatelj je predstavil rezultate študije, v katero je bilo vključenih 676 bolnikov s folikularnim neHodgkinovim limfomom, ki se je ponovil ali napredoval kljub predhodnim zdravljenjem, in katere namen je bil oceniti učinek uporabe zdravila Velcade v kombinaciji z rituksimabom v primerjavi z uporabo samo rituksimaba pri teh bolnikih.
Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).
Zdravilo Velcade naj bi se uporabljalo tudi za folikularni ne-Hodgkinov limfom (rak limfnega tkiva (dela imunskega sistema), ki prizadene vrsto belih krvnih celic, imenovanih B-limfociti ali B-celice) v kombinaciji z rituksimabom pri bolnikih, pri katerih se je bolezen ponovno pojavila (ponovila po zdravljenju).