natgillin/translations-raw huggingface dataset:
The CHMP noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD.
Odbor CHMP je ugotovil, da je imelo zdravilo Seebri Breezhaler skromne, vendar koristne učinke za bolnike pri izboljšanju delovanja pljuč ter da je izboljšalo tudi simptome kronične obstruktivne pljučne bolezni.
The CHMP noted that Selincro was shown to be effective in reducing alcohol consumption in men drinking more than 60 g and women drinking more than 40 g a day.
CHMP je menil, da se je zdravilo Selincro izkazalo za učinkovito pri zmanjševanju uživanja alkohola pri moških, ki uživajo več kot 60 g, in pri ženskah, ki uživajo več kot 40 g alkohola na dan.
The CHMP noted that the benefit of Cyramza in prolonging the lives of gastric and gastro-oesophageal junction cancer patients was clearly demonstrated when Cyramza was given with paclitaxel.
Odbor je upošteval, da je bila korist zdravila Cyramza pri podaljšanju življenja bolnikov z rakom želodca in rakom gastro-ezofagealnega prehoda jasno dokazana ob dajanju tega zdravila v kombinaciji s paklitakselom.
The CHMP noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable.
CHMP je zaključil, da so koristi zdravila Bydureon, na primer učinek na zniževanje ravni HbA1c, ustrezno primerljive z učinki primerjalnih zdravil in da so neželeni učinki pri jemanju tega zdravila obvladljivi.
The CHMP noted that the degree of improvement seen with Senshio was comparable to that seen with oestrogen treatments that are applied to the vagina.
CHMP je opozoril, da je bila stopnja izboljšanja, ugotovljena pri zdravilu Senshio, primerljiva s stopnjo izboljšanja pri estrogenskih zdravilih, ki se dajejo v nožnico.
The CHMP noted that the effectiveness of Nplate had been shown in patients who had had their spleen removed, as well as in patients who had not had their spleen removed.
CHMP je menil, da je bila učinkovitost zdravila Nplate dokazana pri bolnikih, ki so jim odstranili vranico, pa tudi pri bolnikih, ki so vranico še imeli.
The CHMP noted that the immune system’s response to Synflorix was comparable to that of the comparator vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU.
CHMP je ugotovil, da je odziv imunskega sistema na cepivo Synflorix primerljiv z odzivom na primerjalno cepivo, ki je v EU že odobreno za zaščito otrok proti bakteriji S. pneumoniae.
The CHMP noted that the studies showed that Dexdor compared well with other sedatives and will serve as an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
CHMP je ugotovil, da so študije pokazale dobro primerljivost zdravila Dexdor z drugimi sedativi in da se lahko uporablja kot dodatno nadomestno zdravilo za doseganje blage stopnje sedacije pri primernih bolnikih.
The CHMP noted that there is a need for a new effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
Ugotovil je, da obstaja potreba po novem, učinkovitem zdravilu za zdravljenje bolezni kosti pri napredovalem raku, zlasti pri bolnikih z ledvičnimi težavami, saj so trenutno razpoložljiva zdravljenja lahko toksična za ledvice.
The CHMP noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer.
CHMP je ugotovil, da obstaja potreba po hitro delujočih protibolečinskih zdravilih za zdravljenje prebijajoče bolečine pri bolnikih z rakom.
The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas in patients with severe COPD.
CHMP je ugotovil, da obstaja potreba po novih načinih zdravljenja kronične obstruktivne pljučne bolezni in da sta glavni študiji pokazali skromno korist zdravila Daxas pri bolnikih s hudo kronično obstruktivno pljučno boleznijo.
The CHMP noted that Thymanax’s benefits in terms of treating depression might be lower than seen with other antidepressants.
CHMP je menil, da so koristi zdravila Thymanax pri zdravljenju depresije morda manjše kot pri drugih antidepresivih.
The CHMP noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD.
Odbor CHMP je ugotovil, da je imelo zdravilo Tovanor Breezhaler skromne, vendar koristne učinke za bolnike pri izboljšanju delovanja pljuč ter da je izboljšalo tudi simptome kronične obstruktivne pljučne bolezni.
The CHMP noted that Valdoxan’s benefits in terms of treating depression might be lower than seen with other antidepressants.
CHMP je menil, da so koristi zdravila Valdoxan pri zdravljenju depresije morda manjše kot pri drugih antidepresivih.
The CHMP noted that Votubia has been shown to reduce the size of the brain tumours in adults and children with tuberous sclerosis and that this is expected to reduce the signs and symptoms of SEGA such as seizures, hydrocephalus (accumulation of fluid in the brain), and increased pressure within the brain.
Odbor CHMP je menil, da je bilo dokazano, da zdravilo Votubia zmanjšuje velikost možganskih tumorjev pri odraslih in otrocih s tuberozno sklerozo, s čimer naj bi pripomoglo k zmanjšanju znakov in simptomov subependimskega gigantoceličnega astrocitoma, kot so epileptični napadi, hidrocefalus (nabiranje tekočine v možganih) in povišan tlak v možganih.
The CHMP noted that Yervoy has been shown to improve survival in a condition where overall survival rates are low.
CHMP je menil, da je za zdravilo Yervoy bilo dokazano, da izboljšuje preživetje pri bolezni, za katero je značilna nizka stopnja celokupnega preživetja.
The CHMP noted that young children are most at risk, followed by adolescents, and that there is no other vaccine authorised in the EU for meningitis caused by this group of the bacterium.
Opozoril je, da so najbolj ogroženi majhni otroci, sledijo pa jim najstniki, ter da v EU ni drugega odobrenega cepiva proti meningitisu, ki ga povzroča ta skupina bakterije.
The CHMP noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive’ melanoma which has spread or cannot be surgically removed.
Odbor za zdravila za uporabo v humani medicini (CHMP) ugotavlja, da je zdravilo Zelboraf prepričljivo dokazalo, da izboljšuje celokupno preživetje in odlaga poslabšanje melanoma s pozitivno BRAF V600 mutacijo, ki se je razširil ali ga ni mogoče kirurško odstraniti.
The CHMP noted that Zinforo had shown activity in experimental models against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work such as MRSA.
CHMP je ugotovil, da je zdravilo Zinforo pri poskusnih modelih izkazalo delovanje na določene bakterije, na katere drugi antibiotiki iz skupine betalaktamov ne delujejo, kot je MRSA.
The CHMP noted that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and was generally well tolerated in both adults and children.
CHMP je ugotovil, da je bilo zdravilo Zinforo učinkovito pri zdravljenju zapletenih okužb kože in mehkega tkiva ter zunajbolnišnične pljučnice in da so ga bolniki na splošno dobro prenašali.
The CHMP noted that Zytiga in combination with prednisone or prednisolone improved survival compared with placebo in patients whose disease had got worse despite castration treatment and chemotherapy with docetaxel.
CHMP je menil, da zdravilo Zytiga v kombinaciji s prednizonom ali prednizolonom izboljšuje možnost preživetja v primerjavi s placebom pri bolnikih, katerih bolezen se je kljub zdravljenju s kastracijo in kemoterapiji z docetakselom poslabšala.
The CHMP noted that, despite limited data and studies that did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy.
CHMP je zaključil, da je kljub omejenim podatkom in dejstvu, da v študijah niso primerjali zdravila Adcetris s kontrolnim zdravljenjem, zdravilo Adcetris koristno za bolnike s Hodgkinovim limfomom in sistemskim anaplastičnim limfomom velikih celic, pri katerih se je rak ponovil ali se na zdravljenje niso odzvali.
The CHMP noted that, due to the small number of patients with these diseases, the information to support the approval of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive bone-marrow transplantion, increasing their chances of survival.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da so zaradi majhnega števila bolnikov s tema boleznima informacije v podporo izdaji dovoljenja za zdravilo Atriance omejene, vendar se je strinjal, da bi zdravilo utegnilo nekaterim bolnikom omogočiti presaditev kostnega mozga in tako povečati njihove možnosti za preživetje.
The CHMP noted the unmet medical need for patients with multiple myeloma who no longer respond to the available therapies.
Odbor CHMP je opozoril na neizpolnjene medicinske potrebe pri bolnikih z multiplim mielomom, ki se ne odzivajo več na razpoložljivo zdravljenje.
The CHMP noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and possibly the decline in kidney function in patients with the condition, although further long-term data are awaited.
Odbor CHMP je upošteval, da je zdravilo za avtosomno dominantno policistično bolezen ledvic potrebno, in menil, da zdravilo Jinarc učinkovito upočasni nastajanje cist ter verjetno tudi poslabšanje delovanja ledvic pri bolnikih s to boleznijo, vendar pa se pričakujejo dodatni dolgoročni podatki.
The CHMP recommends that the terms of the Marketing Authorisation should be varied.
CHMP priporoča, da se pogoji dovoljenja za promet z zdravilom spremenijo.
The CHMP recommends that the terms of the Marketing Authorisation should be varied.
CHMP priporoča, da se spremenijo pogoji dovoljenja za promet.
The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenj za promet z zdravilom.
The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Odbor CHMP priporoča, da se pogoje dovoljenja za promet z zdravilom spremeni.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenja(-a) za promet z zdravilom.
The CHMP recommends that the terms of the Marketing Authorisations should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenj(-a) za promet z zdravilom.
The CHMP recommends that the terms of the marketing authorisations should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
The CHMP therefore concluded that MACI’s benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP je tako zaključil, da so koristi zdravila MACI večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore concluded that Nulojix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je tako zaključil, da so koristi zdravila Nulojix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP therefore concluded that Simbrinza’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor CHMP je zato zaključil, da so koristi zdravila Simbrinza večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
CHMP je tako sklenil, da koristi zdravila Fampyra odtehtajo z njim povezana tveganja pri bolnikih ki ne morejo hoditi, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore concluded that the benefits of Votubia outweigh its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da koristi zdravila Votubia odtehtajo z njim povezana tveganja, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP therefore concluded the benefits of Lonquex outweigh its risks and recommended that it be approved for use in the EU.
Zato je CHMP zaključil, da so koristi zdravila Lonquex večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore decided that Betmiga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Betmiga večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP therefore decided that Bydureon’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je tako sklenil, da so koristi zdravila Bydureon večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP therefore decided that Constella’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Constella večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Copalia HCT’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Copalia HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Dafiro HCT’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Dafiro HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Exforge HCT’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Exforge HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Farydak’s benefits are greater than its risks in this group and recommended that it be approved for use in the EU.
Odbor CHMP je zato zaključil, da so koristi zdravila Farydak večje od z njim povezanih tveganj pri tej skupini, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore decided that Fortacin’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Fortacin večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore decided that Imprida HCT’s benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
CHMP je torej zaključil, da so koristi zdravila Imprida HCT pri zdravljenju esencialne hipertanzije pri odraslih, pri katerih je krvni tlak že ustrezno nadzorovan s kombinacijo amlodipina, valsartana in hidroklorotiazida, večje od z njim povezanih tveganj.
The CHMP therefore decided that Inlyta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zato zaključil, da so koristi zdravila Inlyta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP therefore decided that Krystexxa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Krystexxa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Neofordex’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Neofordex večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore decided that Odefsey’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor je zato zaključil, da so koristi zdravila Odefsey večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The CHMP therefore decided that Pantecta Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Pantecta Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Pantoloc Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Pantoloc Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Pantozol Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Pantozol Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Picato’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Picato večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Somac Control’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Somac Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Synflorix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi cepiva Synflorix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP therefore decided that Yervoy’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Yervoy večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP therefore decided that Zyclara’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zyclara večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP was also of the opinion that the data provided support the use of Signifor in patients with acromegaly when surgery has failed or was not an option and for whom treatment with another somatostatin analogue did not work.
Odbor CHMP je prav tako menil, da predloženi podatki podpirajo uporabo zdravila Signifor pri bolnikih z akromegalijo, pri katerih kirurški poseg ni bil uspešen ali zanje ni primeren in pri katerih zdravljenje z drugim analogom somatostatina ni učinkovalo.
The CHMP was satisfied with the studies in patients with MMN, where Kiovig was shown to be effective.
CHMP je bil zadovoljen s študijami pri bolnikih z multifokalno motorično nevropatijo, v katerih se je zdravilo Kiovig izkazalo kot učinkovito.
The CHMP’s recommendation is based on an initial assessment by the CAT.
Priporočilo CHMP temelji na prvotni oceni Odbora za napredno zdravljenje.
The choice between the 3 elimination procedures should depend on the patient’s tolerability.
Odločitev med 3 postopki izločanja naj temelji na bolnikovem prenašanju.
The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing (see section 5.1).
Izbira zdravila, ki ga bomo uporabili po nevirapinu, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti (glejte poglavje 5.1.).
The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Izbira zdravila, ki ga bomo uporabili po zdravilu Viramune, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti (glejte poglavje 5.1.).
The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Izbira zdravila, ki ga bomo uporabili po zdravilu Viramune, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti. (glejte poglavje 5.1)
The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Izbira zdravila, ki ga bomo uporabili po zdravilu Viramune, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti. (glejte poglavje 5.1).
The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Izbira zdravila, ki ga bomo uporabili po zdravilu Viramune, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti. (glejte poglavje 5.1.).
The choice of antihypertensive treatment should be individualised to the patient’s clinical circumstances and follow standard medical practice.
Izbiro antihipertenzivnega zdravljenja je treba pri vsakem bolniku prilagoditi njegovim kliničnim okoliščinam in ravnati v skladu s standardno medicinsko prakso.
The choice of combination regimen is based on the characteristics of the patient.
Izbira režima kombiniranega zdravljenja je odvisna od značilnosti bolnika.
The choice of EVOTAZ in adult patients should be based on individual viral resistance testing and the patient’s treatment history (see section 5.1).
Izbira zdravila EVOTAZ pri odraslih bolnikih mora temeljiti na osnovi testiranja odpornosti virusa in anamneze predhodnega zdravljenja pri vsakem posameznem bolniku (glejte poglavje 5.1).
The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
Izbira zdravila Kaletra za zdravljenje s HIV-1 okuženih in z zaviralci proteaz izkušenih bolnikov mora temeljiti na individualnem preizkusu odpornosti virusa in anamnezi bolnikovega zdravljenja (glejte poglavji 4.4 5.1).
The choice of REYATAZ in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).
Pri predhodno že zdravljenih odraslih in pediatričnih bolnikih mora izbira zdravila REYATAZ temeljiti na individualnem testiranju virusne odpornosti in na anamnezi bolnikovega zdravljenja (glejte poglavji 4.4 in 5.1).
The choice of tablet strength to start with depends on the patient’s current treatment and the expected effects of Eucreas, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Eucreas, vendar je priporočljivo, da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
The choice of tablet strength to start with depends on the patient’s current treatment and the expected effects of Icandra, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Icandra, vendar je priporočljivo,da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
The choice of tablet strength to start with depends on the patient’s current treatment and the expected effects of Zomarist, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Zomarist, vendar je priporočljivo, da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
The choice of tablet strength to start with depends on the patient’s current treatment.
Jakost tablete na začetku zdravljenja se izbere glede na zdravljenje, ki ga bolnik trenutno prejema.