natgillin/translations-raw huggingface dataset:
Based on these limited data, there does not appear to be any clinically relevant difference in the safety profile of Quinsair in these subsets of the paediatric population compared to adults.
Na podlagi teh omejenih podatkov ne kaže, da bi obstajale klinčino pomembne razlike v profilu varnosti zdravila Quinsair v teh podskupinah pediatrične populacije v primerjavi z odraslimi.
Based on these pharmacokinetic results, when used in children with PAH 1 year and older, the recommended starting and maintenance dose is 2 mg/kg morning and evening
Na podlagi teh farmakokinetičnih rezultatov pri uporabi pri otrocih s PAH, starih 1 leto in več, je priporočeni začetni in vzdrževalni odmerek 2 mg/kg zjutraj in zvečer.
Based on these pharmacokinetic results, when used in children with PAH 1 year and older, the recommended starting and maintenance dose is 2 mg/kg morning and evening.
Na podlagi teh farmakokinetičnih rezultatov pri uporabi pri otrocih s PAH, starih 1 leto in več, je priporočeni začetni in vzdrževalni odmerek 2 mg/kg zjutraj in zvečer..
Based on these pooled data, retigabine did not cause clinically significant effects on the plasma trough concentrations of the following antiepileptic medicinal products: carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
Na podlagi teh kumulativnih podatkov retigabin ni klinično pomembno vplival na najmanjšo plazemsko koncentracijo naslednjih antiepileptikov: karbamazepina, klobazama, klonazepama, gabapentina, lamotrigina, levetiracetama, okskarbazepina, fenobarbitona, fenitoina, pregabalina, topiramata, valproata, zonisamida.
Based on these results Vivanza 10 mg orodispersible tablets can be taken with or without food.
Glede na te izsledke, se lahko orodisperzibilne tablete po 10 mg vardenafila jemlje z ali brez hrane.
Based on these results, a positive benefit-risk of bosutinib in patients with previously untreated CML in the chronic phase has not been established.
Na osnovi teh rezultatov pozitivno razmerje med koristmi in tveganji za uporabo bosutiniba pri bolnikih s predhodno nezdravljeno KML v kronični fazi ni bilo ugotovljeno.
Based on these results, no dose adjustment for warfarin is required when co-administered with lixisenatide; however, frequent monitoring of INR in patients on warfarin and/or coumarin derivatives is recommended at the time of initiation or ending of lixisenatide treatment.
Na podlagi teh rezultatov odmerka varfarina med sočasno uporabo z liksisenatidom ni treba prilagoditi, je pa v času uvedbe zdravljenja ali ob koncu zdravljenja z zdravilom Lyxumia priporočljivo pogosto kontrolirati INR bolnikov, ki prejemajo varfarin in/ali kumarinske derivate.
Based on these risk factors, prevention of osteoporosis with Optruma is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Glede na naštete dejavnike tveganja je preventiva osteoporoze z zdravilom Optruma indicirana v obdobju desetih let po nastopu menopavze pri tistih ženskah, ki imajo vrednosti BMD za hrbtenico za 1,0 do 2,5 SD nižje od srednje vrednosti zdrave mlade populacije, upoštevajoč, da obstaja pri teh ženskah veliko tveganje za zlome kosti zaradi osteoporoze skozi vso nadaljnjo življenjsko dobo.
Based on these trial results, INTELENCE is not recommended for use in combination with N(t)RTIs only in patients who have experienced virological failure on an NNRTI- and N(t)RTI-containing regimen.
Na podlagi izsledkov teh preskušanj lahko ugotovimo, da zdravilo INTELENCE ni priporočljivo za uporabo v kombinaciji z N(t)RTI samo pri tistih bolnikih, pri katerih je bilo protivirusno zdravljenje s shemo z NNRTI in N(t)RTI virološko neuspešno.
Based on this and all other available data, the Committee decided that Metalyse’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Na podlagi te ugotovitve in drugih razpoložljivih podatkov je zaključil, da so koristi zdravila Metalyse večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Based on this limited experience the safety profile of Odefsey in patients with HIV/HBV co-infection appears to be similar to that in patients with HIV-1 monoinfection.
Na podlagi teh omejenih izkušenj kaže, da je varnostni profil zdravila Odefsey pri bolnikih s sočasno okužbo s HIV/HBV podoben kot pri bolnikih z okužbo samo s HIV-1.
Based on this limited experience, the safety profile of Descovy in patients with HIV/HBV co-infection appears to be similar to that in patients with HIV-1 monoinfection (see section 4.4).
Na podlagi teh omejenih izkušenj kaže, da je varnostni profil zdravila Descovy pri bolnikih s sočasno okužbo s HIV/HBV podoben kot pri bolnikih z okužbo samo s HIV-1 (glejte poglavje 4.4).
Based on this limited experience, the safety profile of Genvoya in patients with HIV/HBV co-infection appears to be similar to that in patients with HIV-1 monoinfection.
Na podlagi teh omejenih izkušenj kaže, da je varnostni profil zdravila Genvoya pri bolnikih s sočasno okužbo s HIV/HBV podoben kot pri bolnikih z okužbo samo s HIV-1.
Based on this model, it is estimated that average duration of protection will be 14 years and 75% of vaccinees will retain protective antibody levels (PRNT50≥1:10) for 10 years.
Na osnovi tega modela je ocenjeno, da bo povprečno trajanje zaščite znašalo 14 let, 75 % cepiv pa bo ohranilo zaščitne ravni protiteles (PRNT50 ≥ 1 : 10) v obdobju 10 let.
Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogen- based contraceptives.
Na podlagi te farmakokinetične študije ni pričakovati, da bi ambrisentan pomembno vplival na izpostavljenost estrogenskim oz. progestogenskim kontraceptivom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Abilify in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abseamed, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adempas, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Adempas in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Anoro, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Anoro in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Arzerra, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atriance, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Avastin, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Benepali, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Benepali in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bexsero, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti cepiva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Binocrit, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Blincyto, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bortezomib Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Bortezomib Accord in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bosulif, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Bosulif vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Briviact, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bydureon, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Celvapan, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti cepiva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ceplene, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu z njim so bile v povzetek glavnih značilnosti zdravila Ceplene in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cerdelga, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Cerdelga in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cimzia, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Clopidogrel ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Clopidogrel ratiopharm in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Coagadex, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Coagadex in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Corlentor, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Corlentor in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyramza, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Darzalex, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Darzalex in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Defitelio, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Defitelio vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Deltyba, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Deltyba in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ebilfumin, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Ebilfumin in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ebymect, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edistride, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eliquis, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Eliquis in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Elocta, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Elonva, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Elonva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Empliciti, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epoetin Alfa Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Esbriet, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Esmya, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Exjade, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Exviera, including information on the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eylea, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.