natgillin/translations-raw huggingface dataset:
a Resumption criteria applied to the start of the next cycle for all patients regardless of whether or not the interruption criteria were met.
a Kriterija za ponovno uvedbo odmerka na začetku naslednjega cikla se nanašata na vse bolnike ne glede na to, ali so bili izpolnjeni kriteriji za prekinitev zdravljenja.
a retinal break;
raztrganje mrežnice;
A retrospective observational study was conducted in young children with hemodynamically significant congenital heart disease (HSCHD) comparing the occurrence of primary serious adverse events (PSAEs: infection, arrhythmia, and death) between those who did (1009) and did not receive Synagis prophylaxis (1009) matched by age, type of cardiac lesion, and prior corrective surgery.
Pri majhnih otrocih s hemodinamično značilno prirojeno boleznijo srca (HSCHD) so izvedli retrospektivno opazovalno raziskavo, v kateri so primerjali pojav primarnih resnih neželenih učinkov (PSAEs: okužba, aritmija in smrt) med tistimi, ki so (1009) in ki niso prejeli profilakse z zdravilom Synagis (1009) razvrščeno po starosti, tipu srčne lezije in predhodne korekcijske operacije.
A retrospective, chart review, post authorisation safety study (PASS) shall be
Izvedena bo naknadna študija o varnosti zdravila po pridobitvi dovoljenja za
A reversible prostatic atrophy is often observed in entire male dogs treated with spironolactone.
Pri nekastriranih samcih psov zdravljenih s spironolaktonom je pogosto opažena reverzibilna atrofija prostate.
A review of 46 cases with blurred vision, some with close temporal relationship and positive dechallenge support a causal relationship between Ganfort and Vision blurred.
Obravnava 46 primerov zamegljenega vida, od tega nekaterih s tesno časovno povezavo in pozitivnim odzivom na prenehanje uporabe, podpira vzročno povezavo med zdravilom Ganfort in zamegljenim vidom.
A review of cardiac events showed that infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre-existing cardiac manifestations of Fabry disease.
Pregled srčnih dogodkov je pokazal, da so lahko reakcije na infundiranje povezane s hemodinamičnim stresom, ki sproži srčne dogodke pri bolnikih z obstoječimi srčnimi manifestacijami Fabryjeve bolezni.
A review of concomitant medicinal products should be conducted when initiating ketoconazole treatment since ketoconazole is a known strong CYP3A4 inhibitor.
Pri uvedbi zdravljenja s ketokonazolom je treba pregledati sočasna zdravila, saj je ketokonazol znan močan zaviralec CYP3A4.
A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal impairment (n=487) poses an additional safety risk during silodosin therapy (such as an increase in dizziness or orthostatic hypotension) as compared to patients with normal renal function (n=955).
Pregled varnostnih podatkov bolnikov, vključenih v vse klinične študije, ne nakazuje, da bi blago okvarjeno delovanje ledvic (n=487) v primerjavi z normalnim delovanjem ledvic (n=955) pri zdravljenju s silodozinom predstavljalo dodatno varnostno tveganje (kot je npr. porast omotičnosti ali ortostatske hipotenzije).
A review of the dose of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
Ponovna ocena odmerka osnovne opioidne terapije bo potrebna, če imajo bolniki dosledno po več kot 4 epizode BTP na 24 ur.
A review of the patient’s current medicines is an essential part of the evaluation of patients for whom treatment with NUEDEXTA is proposed.
Pregled trenutnih bolnikovih zdravil je ključen del ocene bolnikov, za katere se predlaga zdravljenje z zdravilom NUEDEXTA.
A review of the toxicological data available for the constituent lipids (DOPC and DPPG) or similar phospholipids to those in DepoCyte indicates that such lipids are well tolerated in various animal species even when administered for prolonged periods at doses in the g/kg range.
Pregled toksikoloških podatkov, ki so na voljo za sestavne lipide (DOPC in DPPG) ali fosfolipide, podobne tistim v zdravilu DepoCyte, kaže, da različne živalske vrste dobro prenašajo take lipide tudi, kadar jih prejemajo daljše obdobje v odmerkih ranga g/kg.
A revised supporting TSE compliance table should be provided with deletion of the words ‘or equivalent’ after the source companies for the tryptose and NZ-Amines and ‘e.g.’ before the corresponding lists of source countries.
Predložiti je treba revidirano tabelo o skladnosti za transmisivno spongiformno encefalopatijo, v kateri je treba izbrisati besedi 'ali enakovredna' za podjetji izvora za triptozo in NZ-amini ter 'npr.' pred ustreznimi seznami držav izvora.
A ring-opened hydroxycyclopropyl moiety, and two mono-oxygenated metabolites (each ~10%) were the major circulating components, with one of the mono-oxygenated metabolites also being the major metabolite in the excreta (6% and 5% of the urinary and faecal radioactivity respectively).
Glavne snovi v obtoku so bile hidroksiciklopropilna skupina z razklenjenim obročem in dva monooksigenirana presnovka (vsak ~10 %); eden od obeh monooksigeniranih presnovkov je bil tudi glavni izločeni presnovek (6 % radioaktivnosti v urinu in 5 % radioaktivnosti v blatu).
A rinse of the infusion line must be performed between each product administration (see section 6.6).
Med aplikacijami posameznih zdravil je potrebno infuzijske sisteme sprati (glej poglavje 6.6).
A rinse procedure of the pump is performed to reverse this condition.
Za odpravo te motnje je treba opraviti izpiranje črpalke.
A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided.
Izogibati se je treba zviševanju hemoglobina za več kot 2 g/dl (1,25 mmol/l) v obdobju štirih tednov.
A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/l) over a four week period should be avoided.
V času štirih tednov se morate izogibati dvigu koncentracije hemoglobina, ki presega 2 g/dl (1,25 mmol/l).
A risk for the breast-fed child cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Inflectra cannot be excluded (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Inflectra, ne moremo izključiti tveganja za pojav hepatospleničnega limfoma celic T (glejte poglavje 4.8).
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remsima cannot be excluded (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Remsima, ne moremo izključiti tveganja za pojav hepatospleničnega limfoma celic T (glejte poglavj 4.8).
A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Pri otrocih in mladostnikih, ki se zdravijo z zaviralci TNF, torej ni mogoče izključiti tveganja za nastanek malignomov.
A risk for the environment due to use of Gilenya by patients with relapsing multiple sclerosis is not expected.
Zaradi uporabe zdravila Gilenya pri bolnikih z recidivno multiplo sklerozo ni pričakovati povečanega tveganja za okolje.
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Tveganja za prenos Creutzfeld-Jakobove bolezni (CJD) ni možno izključiti.
A risk management plan has been developed to ensure that Abilify is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Abilify je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Abseamed is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Abseamed je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Adempas is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Adempas je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Anoro is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Anoro je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Arzerra is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Arzerra je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Atriance is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Atriance je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Avastin is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Avastin je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Benepali is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Benepali je bil pripravljen načrt za obvladovanja tveganj.
A risk management plan has been developed to ensure that Bexsero is used as safely as possible.
Za zagotovitev čim varnejše uporabe cepiva Bexsero je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Binocrit is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Binocrit je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Blincyto is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Blincyto je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Bortezomib Accord is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Bortezomib Accord je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Bosulif is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Bosulif je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Briviact is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Briviact je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Budesonide/Formoterol Teva Pharma B.V. je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Bydureon is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Bydureon je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Ceplene is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Ceplene je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Cerdelga is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cerdelga je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Cimzia is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cimzia je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Clopidogrel ratiopharm is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Clopidogrel ratiopharm je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Coagadex is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Coagadex je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Corlentor is used as safely and effectively as possible.
Za zagotovitev čim varnejše uporabe zdravila Corlentor je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Cubicin is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cubicin je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Cyramza is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Cyramza je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Darzalex is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Darzalex je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Daxas is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Daxas je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Defitelio is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Defitelio je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Deltyba is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Deltyba je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Ebilfumin is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Ebilfumin je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Ebymect is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Ebymect je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Edistride is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Edistride je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Eliquis is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Eliquis je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Elocta is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Elocta je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Elonva is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Elonva je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Empliciti is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Empliciti je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Epoetin Alfa Hexal is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Epoetin Alfa Hexal je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Esbriet is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Esbriet je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Esmya is used as safely and effectively as possible.
Za zagotovitev čim varnejše in učinkovitejše uporabe zdravila Esmya je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Exjade is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Exjade je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Exviera is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Exviera je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Eylea is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Eylea je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Feraccru is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Feraccru je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Foclivia is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Foclivia je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Genvoya is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Genvoya je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Gilenya is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Gilenya je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Grastofil is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Grastofil je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Harvoni is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Harvoni je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Hizentra is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Hizentra je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Iclusig is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Iclusig je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Imatinib Accord is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Imatinib Accord je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Imatinib Actavis is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Imatinib Actavis je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Imnovid is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Imnovid je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Incruse is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Incruse je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Instanyl is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Instanyl je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Intelence is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Intelence je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Invega is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Invega je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Invirase is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Invirase je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Isentress is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Isentress je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Ivabradine Anpharm is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Ivabradine Anpharm je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Ixiaro is used as safely as possible.
Za zagotovitev čim varnejše uporabe cepiva Ixiaro je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Izba is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Izba je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Jardiance is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Jardiance je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Jetrea is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Jetrea je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Jevtana is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Jevtana je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Kalydeco is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Kalydeco je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Kineret is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Kineret je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Kiovig is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Kiovig je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Kuvan is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Kuvan je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Laventair is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Laventair je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Leflunomide Winthorp is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Leflunomide Winthorp je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lenvima is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lenvima je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lixiana is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lixiana je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lonquex is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lonquex je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lonsurf is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lonsurf je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lucentis is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lucentis je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lumark is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lumark je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Lynparza is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lynparza je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Mekinist is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Mekinist je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Methylthioninium chloride Proveblue is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Metiltioninijev klorid Proveblue je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that NovoEight is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila NovoEight je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that NovoSeven is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila NovoSeven je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Nplate is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Nplate je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Nucala is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Nucala je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Nuwiq is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Nuwiq je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Olysio is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Olysio je bil pripravljen načrt obvladovanja tveganj.
A risk management plan has been developed to ensure that Oncaspar is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Oncaspar je bil pripravljen načrt obvladovanja tveganj.