natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Neupopeg’s benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Neupopeg pri skrajšanju trajanja nevtropenije in zmanjševanju pojavljanja febrilne nevtropenije pri bolnikih z malignimi obolenji, ki se zdravijo s citotoksično kemoterapijo, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoNorm’s benefits are greater than its risks for the treatment of type 2 diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila NovoNorm za zdravljenje sladkorne bolezni tipa 2 večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Parareg’s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Parareg večje od z njim povezanih tveganj pri zdravljenju sekundarnega hiperparatiroidizma pri dializnih bolnikih s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju in za zmanjšanje hiperkalciemije pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom, pri katerih bi bila kirurška odstranitev obščitnic indicirana na osnovi ravni kalcija v krvi, vendar pa taka odstranitev zanje ni klinično ustrezna ali je kontraindicirana.
The Committee for Medicinal Products for Human Use (CHMP) decided that Paxene’s benefits are greater than its risks for treatment of advanced AIDS-related Kaposi’s sarcoma, metastatic breast cancer, advanced cancer of the ovary in combination with cisplatin, metastatic cancer of the ovary where platinum-containing combination therapy has failed, and non-small cell lung cancer.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Paxene pri zdravljenju napredovalega Kaposijevega sarkoma, povezanega z AIDS-om, metastatskega raka dojk, napredovalega raka jajčnikov v kombinaciji s cisplatinom, metastatskega raka jajčnikov, pri katerem kombinacijsko zdravljenje z zdravili na osnovi platine ni bilo uspešno, in nedrobnoceličnega pljučnega raka, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pelzont’s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Pelzont pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Prandin’s benefits are greater than its risks for the treatment of type 2 diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Prandin za zdravljenje sladkorne bolezni tipa 2 večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX’s benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila PROCOMVAX pri cepljenju proti invazivni bolezni, ki jo povzroča Hib, ter proti okužbi, ki jo povzročajo vsi znani podtipi virusa hepatitisa B, pri otrocih, starih od 6 tednov do 15 mesecev, večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) decided that Protopy’s benefits are greater than its risks for the treatment of moderate to severe atopic dermatitis in adults and children over the age of 2 who are not adequately responsive to or are intolerant of conventional therapies.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristni učinki zdravila Protopy pri zdravljenju zmernega do hudega atopičnega dermatitisa pri odraslih in otrocih, starih 2 leti ali več, ki se neustrezno odzivajo na običajne terapije ali pa jih ne prenašajo, večji od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon’s benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Puregon pri zdravljenju neplodnosti pri ženskah in nezadostne spermatogeneze zaradi hipogonadotropnega hipogonadizma pri moških, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell’s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Pylobactell za in vivo diagnostiko okužb želodca in dvanajstnika s H. pylori večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that QUADRAMET’s benefits are greater than its risks for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila QUADRAMET pri lajšanju bolečin v kosteh pri bolnikih z množičnimi bolečimi osteoblastnimi kostnimi metastazami večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix’s benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster immunisation of young children during the second year of life.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Quintanrix večje od z njim povezanih tveganj primarnega cepljenja dojenčkov (med prvim letom starosti) proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in invazivni bolezni, ki jo povzroči Hib, in tveganj obnovitvenega cepljenja majhnih otrok med drugim letom starosti.
The Committee for Medicinal Products for Human Use (CHMP) decided that Quixidar’s benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Quixidar tako pri preprečevanju kot zdravljenju venskih trombotičnih dogodkov, nestabilne angine pektoris in miokardnega infarkta večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza’s benefits are greater than its risks and recommended that Qutenza be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Qutenza večje od z njim povezanih tveganj, in je priporočil, da se zanj izda dovoljenje za promet.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rasagiline ratiopharm’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Razagilin ratiopharm večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee for Medicinal products for Human Use (CHMP) decided that Revasc’s benefits are greater than its risks to prevent deep vein thrombosis in patients undergoing hip or knee replacement.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Revasc pri preprečevanju globoke venske tromboze pri bolnikih, pri katerih se bo opravila menjava kolka ali kolena, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect’s benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Simulect za zaščito pred akutno zavrnitvijo organa pri de novo alogeni presaditvi ledvice pri odraslih bolnikih in otrocih večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata’s benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Sonata pri zdravljenju hude nespečnosti, ki težko zaspijo, kadar je motnja huda, ki osebo onesposobi ali ji povzroča izjemno neugodje, večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) decided that Starlix’s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Starlix večje od z njim povezanih tveganj pri zdravljenju sladkorne bolezni tipa 2 v kombinaciji z metforminom pri bolnikih, pri katerih ni bil dosežen zadosten nadzor bolezni kljub prejemanju največjega dnevnega odmerka metformina.
The Committee for Medicinal products for Human Use (CHMP) decided that Targretin’s benefits are greater than its risks for the treatment of the skin manifestations of advanced stage cutaneous T-cell lymphoma patients refractory to at least one systemic treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Targretin pri zdravljenju kožnih manifestacij pri bolnikih s kožnim T-celičnim limfomom v napredovalem stadiju, ki se ni odzval na najmanj eno sistemsko zdravljenje, večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) decided that TESLASCAN’s benefits are greater than its risks as a contrast medium for diagnostic MRI, for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas, and as an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Odbor za zdravila za uporabo v humani medicini (CHMP) je mnenja, da so koristi zdravila TESLASCAN večje od z njim povezanih tveganj pri uporabi kot kontrastno sredstvo pri diagnostičnem magnetno resonančnem slikanju za odkrivanje lezij jeter, do katerih naj bi predvidoma prišlo zaradi metastaznega stadija bolezni ali hepatoceličnih karcinomov, in kot dodatka pri magnetno resonančnem slikanju za pomoč pri preiskovanju fokalnih lezij trebušne slinavke.
The Committee for Medicinal products for Human Use (CHMP) decided that Trazec’s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Trazec večje od z njim povezanih tveganj pri zdravljenju sladkorne bolezni tipa 2 v kombinaciji z metforminom pri bolnikih, pri katerih ni bil dosežen zadosten nadzor bolezni kljub prejemanju največjega dnevnega odmerka metformina.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive’s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Tredaptive pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in pri bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Trevaclyn’s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Trevaclyn pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tritanrix HepB’s benefits are greater than its risks for active immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Tritanrix HepB večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa’s benefits are greater than its risks for treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults when other treatments have been inadequate.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristni učinki zdravila Trudexa večji od z njim povezanih tveganj pri zdravljenju zmernega do hudega revmatoidnega artritisa, psoriatičnega artritisa in ankilozirajočega spondilitisa pri odraslih, če se druge oblike zdravljenja niso izkazale za primerne.
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult’s benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Twinrix Adult pri uporabi pri neimunih odraslih in mladostnikih, starih 16 let ali več, pri katerih obstaja tveganje okužbe s hepatitisom A in hepatitisom B, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric’s benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Twinrix Paediatric za uporabo pri neimunih dojenčkih, otrocih in mladostnikih, starih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom A in hepatitisom B, večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) decided that Ultratard’s benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Ultratard pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Vedrop’s benefits are greater than its risks for vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vedrop, pri pomanjkanju vitamina E zaradi digestivne malabsorpcije pri pediatričnih bolnikih s kongenitalno kronično holestazo ali dedno kronično holestazo od rojstva (tj. kot novorojenci) do 16. ali 18. leta starosti, odvisno od regije, večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) decided that Velosulin’s benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Velosulin pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Victoza’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 Victoza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The Committee for Medicinal Products for Human Use (CHMP) decided that Viramune’s benefits are greater than its risks in combination with other antiviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viramune v kombinaciji z drugimi protivirusnimi zdravili pri zdravljenju odraslih, mladostnikov in otrok katerekoli starosti, okuženih z virusom HIV-1, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide’s benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vistide pri zdravljenju citomegalovirusnega retinitisa pri bolnikih z AIDS-om, ki nimajo obolenja ledvic, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical’s benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/m2, or overweight patients (BMI ≥ 28 kg/m2) with associated risk factors.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Xenical v kombinaciji z zmerno nizkokalorično dieto za zdravljenje debelosti pri bolnikih z indeksom telesne mase 30 kg/m² ali več ali pri bolnikih s preveliko telesno maso (ITM ≥ 28 kg/m2) in hkratnimi ogrožajočimi dejavniki večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve’s benefits are greater than its risks for the treatment of moderate to severe SUI.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Yentreve pri zdravljenju zmerne do hude stresne urinske inkontinence večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ytracis’s benefits are greater than its risks for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Ytracis pri radioaktivnem označevanju nosilnih molekul, ki so bile posebej razvite in odobrene za radioaktivno označevanje s tem radionuklidom, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax’s benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristni učinki zdravila Zenapax pri preprečevanju akutne zavrnitve organa pri de novo alogeni ledvični transplantaciji pri bolnikih, ki niso visoko senzibilizirani, ob sočasnem režimu imunosupresivnih zdravil, vključno s ciklosporinom in kortikosteroidi, večji od z njim povezanih tveganj.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zerene’s benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Zerene pri zdravljenju hude nespečnosti, ki težko zaspijo, kadar je motnja huda, ki osebo onesposobi ali ji povzroča izjemno neugodje, večje od z njim povezanih tveganj.
The Committee for Medicinal products for Human Use (CHMP) noted that psoriasis was more severe in ‘high-need’ patients, and that the effectiveness of Raptiva is relevant for these patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je upošteval, da je bila psoriaza hujša pri bolnikih z „visoko potrebo“ in da je učinkovitost zdravila Raptiva pomembna za te bolnike.
The Committee for Medicinal Products for Human Use (CHMP) noted that the benefit of Truvada for treating HIV-1 infection has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da so bile koristi zdravila Truvada dokazane le pri bolnikih, ki predhodno zaradi okužbe z virusom HIV še niso bili zdravljeni, vendar lahko poenostavljen način odmerjanja kombinirane tablete enkrat na dan bolnikom pomaga, da vztrajajo pri zdravljenju.
The Committee for Medicinal products for Human Use (CHMP) noted that Wilson’s disease is a fatal disease and the other medicines already being used for the disease can have severe side effects.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je Wilsonova bolezen smrtna in da imajo zdravila, ki so že v uporabi, hude neželene učinke.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Circovac outweigh its risks for the approved indications and recommended that Circovac should be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da koristi cepiva Circovac odtehtajo z njim povezana tveganja, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Econor exceed the risks for the approved indications.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Econor pri odobrenih indikacijah večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Ibraxion are greater than any risks to immunise cattle to reduce the clinical signs of IBR and reduce field virus excretion.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) se je strinjal, da so koristi zdravila Ibraxion pri imuniziranju goveda za zmanjšanje kliničnih znakov IBR in zmanjšanje izločanja virusa na terenu, večje od kakršnih koli tveganj.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Quadrisol to reduce of inflammation and relieve pain caused by musculoskeletal disorders and trauma are greater than any risks associated with this treatment.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristni učinki zdravila Quadrisol pri zmanjšanju in lajšanju vnetja in bolečine zaradi mišično-skeletnih bolezni ter travmatskih poškodb večji od z njim povezanih tveganj.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Broadline exceed the risks for the approved indications and recommended that Broadline be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Broadline večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.