natgillin/translations-raw huggingface dataset:
The Committee also noted the risk of side effects affecting the kidneys, and recommended that kidney function should be carefully assessed before patients start taking Stribild and should be monitored during treatment.
Odbor je prav tako zabeležil tveganje neželenih učinkov za ledvice in priporočil, da se pri bolnikih natančno spremlja delovanje ledvic pred začetkom jemanja zdravila Stribild in med samim zdravljenjem.
The Committee concluded that benefits of Zelboraf are greater than its risks and recommended that it be granted marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zelboraf večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee concluded that Imnovid is effective at delaying the progression of multiple myeloma in patients whose disease does not respond to or comes back after previous treatment, who have very limited treatment options.
Odbor je zaključil, da je zdravilo Imnovid učinkovito pri upočasnitvi napredovanja multiplega mieloma pri bolnikih, pri katerih se bolezen ne odzove na predhodna zdravljenja ali pa se ponovno pojavi in ki imajo zelo omejene možnosti zdravljenja.
The Committee concluded that it also was effective in children.
Odbor je zaključil, da je učinkovito tudi pri otrocih.
The Committee concluded that the effect of Xadago on the daily time that patients lived without motor symptoms was of clinical relevance, also taking into account the response reported in the literature for other Parkinson’s medicines.
Ob upoštevanju poročil o odzivu na druga zdravila za zdravljenje Parkinsonove bolezni v literaturi je zaključil, da je učinek zdravila Xadago na čas, ki ga bolnik dnevno preživi brez motoričnih simptomov, klinično pomemben.
The Committee concluded that Truvada’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Truvada večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee considered that adding this medicine to other diabetes medicines offers better control of blood glucose and having an alternative treatment option is valuable in individualising treatment.
Odbor je menil, da jemanje zdravila Xultophy skupaj z drugimi zdravili za zdravljenje sladkorne bolezni prispeva k učinkovitejšemu nadzoru ravni glukoze v krvi in da je ta alternativna možnost lahko koristna pri individualiziranem zdravljenju.
The Committee considered that Mekinist when used alone or in combination with dabrafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation.
Menil je, da je zdravilo Mekinist, kadar se je uporabljajo kot samostojno zdravilo ali v kombinaciji z dabrafenibom, izkazalo klinično pomembne koristi pri bolnikih z melanomom z mutacijo BRAF V600.
The Committee considered that Perjeta has been shown to benefit patients with metastatic cancer by extending the amount of time patients lived without their disease getting worse as well as how long they lived.
Menil je, da je zdravilo Perjeta izkazalo koristi pri podaljšanju časa, ki so ga bolniki z metastatskim rakom dojk preživeli brez poslabšanja bolezni, in pri podaljšanju življenja teh bolnikov nasploh.
The Committee considered that Raplixa is effective at reducing the time to stop mild or moderate bleeding during surgery when standard surgical techniques, such as stitches, are insufficient.
Odbor je menil, da je zdravilo Raplixa učinkovito pri skrajševanju časa, potrebnega za ustavitev krvavitve med kirurškim posegom, ko standardne kirurške tehnike, kot je šivanje, ne zadoščajo.
The Committee considered that Tafinlar (alone or in combination with trametinib) had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation and had spread or was not surgically removable.
Menil je, da je zdravilo Tafinlar (kot samostojno zdravilo ali v kombinaciji s trametinibom), izkazalo klinično pomembne koristi pri bolnikih z melanomom z mutacijo BRAF V600, ki se je razširil ali ga ni bilo mogoče kirurško odstraniti.
The Committee considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Odbor je menil, da so bile koristi zdravila Deltyba dokazane pri bolnikih s tuberkulozo z vplivom na pljuča, ki je odporna proti več zdravilom.
The Committee considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.
5-fluorouracilom in levkovorinom, pomembno pri predhodno zdravljenih bolnikih z metastatskim adenokarcinomom trebušne slinavke, za katerega so na voljo omejene možnosti zdravljenja; varnostni profil zdravila Onivyde je v skladu s profilom standardnega irinotekana in stranski učinki so obvladljivi.
The Committee considered that Xgeva was shown to be effective in preventing bone-related events and was less toxic to the kidneys and easier to administer than existing treatments.
Odbor je menil, da se je zdravilo Xgeva izkazalo za učinkovito pri preprečevanju z okostjem povezanih dogodkov in da je bilo v primerjavi z obstoječimi oblikami zdravljenja manj toksično za ledvice ter preprostejše za uporabo.
The Committee decided that Abraxane’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Abraxane večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that ACOMPLIA’s benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Odločil je, da so koristi zdravila ACOMPLIA, kadar se uporablja kot dodatek k dieti in telesni dejavnosti pri zdravljenju debelih bolnikov in bolnikov s čezmerno telesno maso z dodatnimi dejavniki tveganja kot so diabetes tipa 2 ali dislipidemija, večje od z njim povezanih tveganj.
The Committee decided that Adenuric’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je sklenil, da so koristi zdravila Adenuric večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Arepanrix’s benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Odbor je odločil, da so koristi zdravila Arepanrix za preprečevanje gripe v primeru uradne razglasitve pandemije H1N1 večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Atripla’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Atripla večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that ATryn’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila ATryn večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Azarga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Azarga večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Benlysta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Benlysta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Busilvex’s benefits are greater than its risks in these settings and recommended that Busilvex be given marketing authorisation.
Sklenil je, da so koristi zdravila Busilvex večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Cerezyme’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Cerezyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Competact’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Sklenil je, da so koristi zdravila Competact večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Corlentor’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Corlentor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The committee decided that Cystadane’s benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Odbor je sklenil, da so koristi zdravila Cystadane, če se uporablja v skladu z indikacijo, večje od z njim povezanih tveganj pri dopolnilnem zdravljenju homocistinurije.
The Committee decided that DepoCyte’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila DepoCyte večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Dukoral’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi cepiva Dukoral večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Elaprase’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Elaprase večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Evista’s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Odbor je sklenil, da so koristi zdravila Evista pri zdravljenju in preprečevanju osteoporoze pri ženskah po menopavzi večje od z njim povezanih tveganj.
The Committee decided that Evoltra’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Evoltra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Gilenya’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Gilenya večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Gliolan’s benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Odbor je sklenil, da so koristi zdravila Gliolan za vizualizacijo malignega tkiva med operacijo malignega glioma večje od z njim povezanih tveganj.
The Committee decided that Glubrava’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Glubrava večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Humenza’s benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Odbor je sklenil, da so koristi cepiva Humenza za preprečevanje uradno razglašene pandemije gripe H1N1večje od z njim povezanih tveganj ter priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Invanz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Invanz večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Ivabradine Anpharm’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Ivabradine Anpharm večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Mircera’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Mircera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Noxafil’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Noxafil večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Onduarp’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Onduarp večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Optruma’s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Odbor je sklenil, da so koristi zdravila Optruma pri zdravljenju in preprečevanju osteoporoze pri ženskah po menopavzi večje od z njim povezanih tveganj.
The Committee decided that Orencia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je sklenil, da so koristi zdravila Orencia večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Posaconazole SP’s benefits are greater than its risks for treatment of invasive aspergillosis, fusariosis, coccidioidomycosis, chromoblastomycosis and mycetoma in patients who cannot tolerate other antifungal drugs or have not improved after at least 7 days of treatment.
Odbor je odločil, da so koristi zdravila Posaconazole SP večje od z njim povezanih tveganj pri zdravljenju invazivne aspergiloze, fuzarioze, kokcidioidomikoze, kromoblastomikoze in micetoma pri bolnikih, ki ne prenašajo drugih antimikotikov, ali pri katerih se stanje po 7 dneh zdravljenja ni izboljšalo.
The Committee decided that Procoralan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Procoralan večje od z njim povezanih tveganj, in priporočil, da se za zanj izda dovoljenje za promet.
The Committee decided that Ranexa’s benefits are greater than its risks as an add-on treatment of the symptoms of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal medicines (such as beta-blockers and/or calcium antagonists).
Odbor je zaključil, da so koristi zdravila Ranexa kot dodatek k zdravljenju simptomov pri bolnikih s stabilno angino pektoris, katerih bolezen ni ustrezno nadzorovana ali ki se ne odzivajo na antianginozna zdravila prve izbire (kot so zaviralci receptorjev beta in antagonisti kalcija), večje od z njim povezanih tveganj.
The Committee decided that Reyataz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Reyataz večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Savene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Savene večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Suboxone’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Suboxone večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Tandemact’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Tandemact večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that the medicine’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Arzerra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Tractocile’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Tractocile večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that Trizivir’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Trizivir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Twynsta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Twynsta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Tysabri’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Tysabri večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee decided that Xagrid’s benefits are greater than its risks as second-line treatment in at-risk patients with essential thrombocythaemia.
Zaključil je, da so koristi zdravila Xagrid kot zdravljenja druge izbire pri ogroženih bolnikih z esencialno trombocitemijo večje od z njim povezanih tveganj.
The Committee decided that Xeplion’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Xeplion večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that ZIMULTI’s benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Odločil je da so koristi zdravila ZIMULTI večje od z njim povezanih tveganj, kadar se uporablja kot dodatek k dieti in telesni dejavnosti pri zdravljenju debelih bolnikov in bolnikov s čezmerno telesno maso z dodatnimi dejavniki tveganja kot so diabetes tipa 2 ali dispidemija.
The Committee decided that Zypadhera’s benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Zypadhera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee decided that, based on available published information, Tepadina’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je na podlagi razpoložljivih objavljenih podatkov zaključil, da so koristi zdravila Tepadina večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta’s benefits are greater than its risks for the treatment of invasive candidiasis in adult patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ecalta pri zdravljenju invazivne kandidoze pri odraslih bolnikih, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet.
Odbor za zdravila za uporabo v humani medicini (CHMP) je navkljub maloštevilnim sistematičnim raziskavam zdravila Cystadane sklenil, da je zdravilo koristno kot dodatek k obstoječim načinom zdravljenja homocistinurije, kot so dodajanje vitaminov in posebna dieta.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Krka has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Krka primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel TAD has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel TAD primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ribavirin Teva Pharma B.V. primerljivo raven kakovosti kot zdravilo Rebetol ter da mu je biološko enakovredno.
The Committee for Medicinal products for Human Use (CHMP) considered that, in accordance with EU requirements, Omnitrope has been shown to have a comparable quality, safety and efficacy profile to Genotropin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Omnitrope podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Genotropin.
The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf’s benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Advagraf pri preprečevanju zavrnitve presadka pri odraslih prejemnikih alogenskega presadka ledvic ali jeter ter pri zdravljenju zavrnitve alogenskega presadka, odporne na zdravljenje z drugimi imunosupresivnimi zdravili, pri odraslih bolnikih večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze’s benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion and recommended that Aerinaze be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Aerinaze pri simptomatskem zdravljenju sezonskega alergijskega rinitisa, ki ga spremlja kongestija nosne sluznice, večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet z zdravilom.