natgillin/translations-raw huggingface dataset:
The company that markets Ilaris will provide doctors who will use Ilaris with educational material containing the prescribing information, the patient alert card and information for doctors containing important safety information about Ilaris, including precautions to be taken when using the medicine.
Družba, ki trži zdravilo Ilaris, bo zdravnikom, ki predpisujejo to zdravilo, priskrbela izobraževalno gradivo o predpisovanju zdravila, opozorilno kartico za bolnike in informacije za zdravnike s pomembnimi podatki o njegovi varnosti, vključno s previdnostnimi ukrepi, ki jih je treba upoštevati pri njegovi uporabi.
The company that markets Ilaris will provide regular information on the long-term safety and effectiveness of Ilaris in adults and children suffering from CAPS.
Družba, ki trži zdravilo Ilaris, bo redno zagotavljala informacije o dolgoročni varnosti in učinkovitosti tega zdravila pri odraslih in otrocih, ki so zboleli za obolenji CAPS.
The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.
Družba, ki trži zdravilo Incivo, bo vsem zdravnikom, za katere se pričakuje, da bodo predpisovali to zdravilo, zagotovila izobraževalno gradivo s pomembnimi varnostnimi informacijami glede glavnih tveganj, povezanih z zdravilom Incivo, zlasti glede tveganja za pojav izpuščajev in hudih kožnih reakcij.
The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy during treatment.
Družba, ki trži zdravilo Jinarc, bo zagotovila informacije za bolnike in zdravnike, ki naj bi predpisovali zdravilo, o tveganju za toksičnost za jetra in pomembnosti preprečevanja nosečnosti med zdravljenjem.
The company that markets Privigen will make some changes in the way it is produced and will carry out a study to monitor the effect of the changes.
Družba, ki trži zdravilo Privigen, bo spremenila način proizvodnje zdravila ter izvedla študijo spremljanja učinka sprememb.
The company that markets Simponi must provide educational packs for doctors who prescribe Simponi with information on the safety of the medicine.
Družba, ki trži zdravilo Simponi, mora zdravnikom, ki predpisujejo to zdravilo, priskrbeti izobraževalno gradivo z informacijami o varnosti zdravila.
The company that markets Stivarga will also carry out studies to look for ways of identifying patients who are more likely to respond to treatment.
Poleg tega bo družba, ki trži zdravilo Stivarga, izvedla študije, s katerimi bo poskušala poiskati načine za opredelitev bolnikov, pri katerih obstaja večja verjetnost, da se bodo odzvali na zdravljenje.
The company that markets the medicine will provide follow-up data on patients’ survival from the main studies submitted in HL and sALCL.
Družba, ki trži zdravilo, bo zagotovila spremljevalne podatke o preživetju bolnikov iz glavnih študij za bolnike s Hodgkinovim limfomom in sistemskim anaplastičnim limfomom velikih celic.
The company that markets Truvada will provide an information pack to doctors which covers the risk of kidney disease with Truvada and use in pre-exposure prophylaxis.
Družba, ki trži zdravilo Truvada, bo pripravila informacijski komplet za zdravnike, ki bo obsegal opis tveganj za obolenje ledvic pri tem zdravilu in uporabo za predekspozicijsko profilakso.
The company that markets Vectibix will also ensure that all doctors who are expected to prescribe Vectibix are provided with educational material informing them of the importance of carrying out a RAS test before treatment with Vectibix and only using Vectibix in patients whose tumour is confirmed to contain the wild-type RAS gene.
Družba, ki trži zdravilo Vectibix, bo zagotovila tudi, da bodo vsi zdravniki, ki naj bi ga predpisovali, dobili izobraževalno gradivo z obvestilom o pomenu izvajanja testiranj gena RAS pred zdravljenjem z zdravilom Vectibix, tako da se zagotovi njegova uporaba samo pri bolnikih, katerih tumor zagotovo vsebuje divji tip gena RAS.
The company that markets Xagrid will regularly inform the CHMP of all information published on the effectiveness of the medicine.
Družba bo odbor CHMP redno obveščala o vseh objavljenih informacijah o učinkovitosti zdravila.
The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive educational material containing important safety information about the medicine, including the risk of QT prolongation, and a patient alert card.
Družba, ki trži zdravilo Xalkori, bo zagotovila, da bodo zdravniki, ki naj bi ga predpisovali, prejeli izobraževalno gradivo, ki zajema pomembne informacije o varnosti zdravila, tudi o tveganju podaljšanja intervala QT, in kartico z opozorili za bolnika.
The company that markets Xalkori will provide the final results of a study in patients with ALK-positive NSCLC comparing the safety and effectiveness of Xalkori and chemotherapy treatments, to confirm how long patients lived overall.
Družba, ki trži zdravilo Xalkori, bo zagotovila končne rezultate študije pri bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom, v okviru katere varnost in učinkovitost tega zdravila primerjajo s kemoterapijo, da bi potrdila celokupni čas preživetja bolnikov.
The company that markets Xarelto will provide an educational pack for doctors expected to prescribe Xarelto for patients with atrial fibrillation, DVT, pulmonary embolism, or who have had acute coronary syndrome, containing important safety information including on the risk of bleeding during treatment with Xarelto and how to manage this risk.
Gradivo bo vsebovalo pomembne varnostne informacije, vključno z informacijami o tveganju za krvavitev med zdravljenjem z zdravilom Xarelto in o tem, kako ta tveganja obvladovati.
The company that markets Xiapex must also ensure that all doctors expected to use the medicine are properly trained on the use of the medicine and experienced in diagnosing and managing Dupuytren’s contracture or Peyronie’s disease.
Poleg tega mora družba, ki izdeluje zdravilo Xiapex, zagotoviti, da so vsi zdravniki, ki naj bi uporabljali zdravilo, ustrezno usposobljeni za pravilno dajanje zdravila ter da imajo izkušnje z diagnosticiranjem in vodenjem zdravljenja Dupuytrenove kontrakture ali Peyroniejeve bolezni.
The company that markets Zydelig will provide final results of the ongoing main studies in patients with chronic lymphocytic leukaemia and follicular lymphoma.
Družba, ki trži zdravilo Zydelig, bo zagotovilakončne rezultate glavnih študij pri bolnikih s kronično limfocitno levkemijo in folikularnim limfomom, ki še potekajo.
The company that marktes Nimenrix will carry out a study to assess how long the protective immune response provided by one or two doses of Nimenrix lasts in young children under 2 years old.
Družba, ki izdeluje cepivo Nimenrix, bo izvedla študijo, s katero bo ocenila, kako dolgo traja zaščitni imunski odziv pri otrocih, mlajših od dveh let, pri injiciranju enega ali dveh odmerkov cepiva Nimenrix.
The company will also carefully control the distribution of the medicine in each Member State, and collect information on its use in patients with systemic sclerosis and ongoing digital ulcers.
Družba bo v vsaki državi članici tudi natančno nadzorovala trženje zdravila ter zbirala informacije o njegovi uporabi pri bolnikih s sistemsko sklerozo in napredujočo boleznijo razjed prstov.
The company will also carefully control the distribution of the medicine in each Member State, and collect information on its use in patients with systemic sclerosis and ongoing digital ulcers.
Prav tako bo družba skrbno nadzorovala distribucijo zdravila v posameznih državah članicah in zbrala podatke o uporabi zdravila pri bolnikih s sistemsko sklerozo in dolgotrajnimi razjedami prstov.
The company will also carry out a large study to gather more data on the safety of Xarelto when used in patients who have had acute coronary syndrome.
Družba bo izvedla tudi obširno študijo, da bo zbrala več podatkov o varnosti zdravila Xarelto pri uporabi pri bolnikih, ki so doživeli akutni koronarni sindrom.
The company will also carry out a study on the use of Nuedexta and a study to monitor Nuedexta’s safety including its effects on the heart and potential for interactions with other medicines.
Prav tako bo družba izvedla študijo uporabe zdravila Nuedexta in študijo, namenjeno spremljanju varnosti zdravila Nuedexta, vključno z njegovimi učinki na srce in možnostmi medsebojnega delovanja z drugimi zdravili.
The company will also carry out a study to explore how adult patients respond to the dose of Strensiq given to children.
Družba bo prav tako izvedla študijo, s katero bo raziskala, kako se odrasli bolniki odzivajo na odmerek zdravila Strensiq, ki se daje otrokom.
The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity, a study on the long-term effectiveness of the medicine, and a study on the effectiveness in patients with severely reduced kidney function.
Prav tako bo izvedla študijo, v kateri bo dodatno raziskala varnost zdravila, vključno s toksičnostjo za jetra, študijo o dolgoročni učinkovitosti zdravila ter študijo o učinkovitosti pri bolnikih z močno zmanjšanim delovanjem jeter.
The company will also carry out two further studies to look into the long-term benefits and safety of Perjeta when used in patients with earlier stages of breast cancer.
Družba bo poleg tega izvedla še drugi dve študiji, v katerih bo raziskala dolgoročne prednosti in varnost zdravila pri bolnikih z zgodnjim stadijem raka dojk.
The company will also collect information on whether the medicine is used outside its approved indication.
Družba bo hkrati zbirala informacije o tem, ali se zdravilo uporablja zunaj odobrene indikacije.
The company will also complete a study on Eurartesim’s effects on the heart.
Družba bo tudi izvedla študijo o učinkih zdravila Eurartesim na srce.
The company will also keep record of patients treated with Cerdelga to look at the long-term safety of the medicine.
Družba bo poleg tega vodila evidenco bolnikov, ki prejemajo zdravilo Cerdelga, da bi proučila dolgoročno varnost zdravila.
The company will also monitor side effects, provide educational material, and improve the design of the blister packs so that it is easier to tell the difference between the 1 mg and 3 mg doses.
Podjetje bo tudi spremljalo neželene učinke, priskrbelo izobraževalno gradivo in izboljšalo zasnovo pretisnih omotov, da bo lažje razlikovati med odmerki po 1 mg in 3 mg.
The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Družba bo priskrbela tudi opozorilno kartico za bolnike, ki bo vsebovala informacije o tveganjih tega zdravila in navodila, kdaj se posvetovati z zdravnikom, če se pojavijo simptomi.
The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Priskrbela bo tudi opozorilno kartico za bolnike, ki bo vsebovala informacije o tveganjih, povezanih s tem zdravilom, in navodila, kdaj se posvetovati z zdravnikom, če se pojavijo simptomi.
The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daxas is appropriate for them.
Zagotovila bo tudi kartice za bolnike z informacijami, ki jih morajo sporočiti zdravniku o simptomih in preteklih boleznih, da bo ta lahko presodil, ali je zdravilo Daxas zanje primerno.
The company will also provide data on the potential side effects in children under 18 years of age including the immune reactions.
Prav tako bo družba zagotovila podatke o možnih neželenih učinkih, vključno z imunskim odzivom, pri otrocih, mlajših od 18 let.
The company will also provide further data on the long-term benefits of Opdivo and carry out analyses to try to identify which patients are most likely to benefit from treatment with the medicine.
Predložila bo tudi dodatne podatke o dolgotrajni koristi zdravila Opdivo in izvedla analize, s katerimi bo poskušala ugotoviti, katerim bolnikom bo zdravljenje s tem zdravilom najverjetneje koristilo.
The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if a (re)-vaccination is needed for patients taking Soliris.
Zdravnikom, ki predpisujejo zdravilo, in bolnikom bo družba priskrbela tudi informacije o varnosti zdravila ter poslala opomnike zdravnikom, ki predpisujejo zdravilo, in farmacevtom, da preverijo ali je cepljenje oziroma ponovno cepljenje za bolnike, ki prejemajo zdravilo Soliris, potrebno.
The company will also provide prescribers with an alert card for their patients.
Družba bo zdravnikom, ki bodo predpisovali zdravilo, priskrbela tudi opozorilno izkaznico za bolnike.
The company will also set up a registry of patients treated with Imnovid in order to monitor the side effects reported and whether the medicine is used within its approved indication and in compliance with the pregnancy-prevention programme.
Družba bo vzpostavila tudi register bolnikov, zdravljenih z zdravilom Imnovid, namenjen spremljanju neželenih učinkov, o katerih bodo poročali, in preverjanju, ali se zdravilo uporablja za odobreno indikacijo ter v skladu s programom za preprečevanje nosečnosti.
The company will also set up a registry of patients with congenital or hereditary chronic cholestasis.
Prav tako bo pripravila seznam bolnikov s kongenitalno ali dedno kronično holestazo.
The company will also set up a system to monitor Thelin’s side effects, suspected interactions with other medicines and the outcome of any pregnancies that may happen in women using the medicine.
Poleg tega bo družba vzpostavila sistem za spremljanje neželenih učinkov zdravila Thelin, domnevnih interakcij z drugimi zdravili in izide nosečnosti, do katerih je prišlo pri ženskah, ki jemljejo to zdravilo.
The company will also set up an EU- based registry of patients treated with Provenge in order to monitor overall survival and side effects reported (particularly stroke and heart attack), and will provide data from a US-based registry.
Prav tako bo družba v EU vzpostavila register bolnikov, zdravljenih z zdravilom Provenge, ki bo namenjen spremljanju celokupnega preživetja in poročil o neželenih učinkih (zlasti možganski in srčni kapi), ter priskrbela podatke iz registra v ZDA.
The company will also submit a full report on the study once it has finished.
Po zaključku študije bo predložila tudi celotno poročilo o opravljeni študiji.
The company will carry out further studies to look in more detail at the effectiveness of the combination of Ceplene and interleukin-2 and at how the combination works.
Družba bo izvedla nadaljnje študije, ki bodo podrobneje raziskale učinkovitost kombinacije zdravila Ceplene in interlevkina-2 ter mehanizem delovanja te kombinacije.
The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Družba bo zagotovila, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo, prejeli informacije o tem, kako vnesti svoje bolnike v register.
The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Družba bo zagotovila, da bodo zdravstveni delavci, ki naj bi uporabljali zdravilo, prejeli informacije o tem, kako lahko vključijo bolnike v register.
The company will further study the vaccine in adults not vaccinated before in order to compare the effectiveness of Imvanex with that of a conventional smallpox vaccine.
Družba bo cepivo Imvanex nadalje proučevala pri odraslih, ki predhodno še niso bili cepljeni, da bi primerjala njegovo učinkovitost z običajnim cepivom proti črnim kozam.
The company will provide further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-up of previously treated patients from the first study.
Družba bo dodatne podatke o koristih zdravila Imbruvica pri zdravljenju kronične limfocitne levkemije zagotovila na podlagi spremljanja predhodno zdravljenih bolnikov iz prve študije.
The company will provide further information on the safety of Benlysta from a study and from a register of patients being followed up long-term.
Družba bo zagotovila dodatne podatke o varnosti zdravila Benlysta iz študije in registra bolnikov, ki se jih dolgoročno spremlja.
The company will use specific databases to monitor ACOMPLIA’s side effects, especially those linked to the nervous system.
Podjetje bo uporabilo specifične zbirke podatkov za spremljanje neželenih učinkov zdravila ACOMPLIA, zlasti tistih, povezanih z živčnim sistemom.
The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold drug accumulation after repeated once-daily dosing.
AUC(0-24) 8. dne in 1. dne ob odmerku 340 mg/m2 je pokazala 1,7-kratno kopičenje zdravila po ponavljajočem se odmerjanju enkrat na dan.
The comparison of these data to those in adult healthy volunteers is of limited relevance and no valid conclusions can be drawn regarding the pharmacokinetic properties of fingolimod in children.
Primerjava teh podatkov s podatki odraslih zdravih prostovoljcev nima velikega pomena in na njeni osnovi ni mogoče priti do utemeljenih zaključkov glede farmakokinetičnih lastnosti fingolimoda pri otrocih.
The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established.
Združljivost rekonstituiranega zdravila ECALTA z intravenskimi snovmi, aditivi ali zdravili, razen 9 mg/ml (0,9 %) natrijevega klorida za infundiranje ali 50 mg/ml (5 %) glukoze za infundiranje, ni ugotovljena.
The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
Kompatibilnost rekonstituiranega koncentrata zdravila Xydalba je bila ugotovljena le s 50 mg/ml (5 %) raztopine glukoze za infundiranje.
The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
Kompatibilnost rekonstituiranega koncentrata zdravila Xydalba je bila ugotovljena samo z 50 mg/ml (5 %) raztopine glukoze za infundiranje.
The compatibility of VFEND with diluents other than listed above (or listed below under ‘Incompatibilities’) is unknown.
Združljivost zdravila VFEND z drugimi tekočinami razen zgoraj naštetih (ali omenjenih spodaj pod "Inkompatibilnosti") ni znana.
The compatibility of Voriconazole Hospira with diluents other than listed above (or listed below under ‘Incompatibilities’) is unknown.
Združljivost zdravila Vorikonazol Hospira z drugimi tekočinami razen zgoraj naštetih (ali omenjenih spodaj pod "Inkompatibilnosti") ni znana.
The compatibility of voriconazole with diluents other than described above or in section 6.2 is unknown.
Združljivost zdravila Vorikonazol Hospira z drugimi tekočinami razen zgoraj naštetih ali omenjenih v poglavju 6.2 ni znana.
The complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%, 53.1%).
Stopnja popolnega izginotja (imikvimod minus placeba) pri združenih preizkušanjih je bila 46,1%(IZ 39,0%, 53,1%).
The complete metabolic profile and mode of elimination of delamanid has not yet been fully elucidated (see sections 4.4 and 5.2)
Celoten presnovni profil in način izločanja delamanida še nista bila v celoti pojasnjena (glejte poglavji 4.4 in 5.2)
The complete SmPC of Amyvid is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Povzetek glavnih značilnosti zdravila Amyvid je v celoti podan kot ločen dokument navodil za uporabo zdravila, in sicer z namenom, da zdravstvenemu osebju nudi dodatne znanstvene in praktične informacije o uporabi tega radiofarmaka.
The complete SmPC of EndolucinBeta is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Celotni povzetek glavnih značilnosti zdravila za radionuklidni predhodnik EndolucinBeta je na voljo kot ločen dokument v pakiranju radionuklidnega predhodnika z namenom omogočiti zdravstvenemu osebju še druge, dodatne, znanstvene in praktične informacije o dajanju in uporabi tega radiofarmaka.
The complete SmPC of Quadramet is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Povzetek glavnih značilnosti zdravila Quadramet je v celoti podan kot ločen dokument navodil za uporabo zdravila, in sicer z namenom, da zdravstvenemu osebju nudi dodatne znanstvene in praktične informacije o uporabi tega radiofarmaka.
The complete SmPC of Xofigo is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Povzetek glavnih značilnosti zdravila Xofigo je v celoti podan kot ločen dokument na koncu priloženega navodila za uporabo zdravila, in sicer z namenom, da zdravstvene delavce obvesti o drugih znanstvenih in uporabnih informacijah, povezanih z uporabo tega radiofarmaka.
The complete Summary of Product Characteristics (SmPC) of Cuprymina is provided as a separate document in the product pack, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this product.
Celoten povzetek glavnih značilnosti zdravila za radiofarmacevtski predhodnik Cuprymina je na voljo kot ločen dokument v pakiranju zdravila, zato da zdravstveno osebje seznani z dodatnimi znanstvenimi in praktičnimi informacijami o ravnanju s tem zdravilom.
The complexing agent and other reagents should be added to the vial with Lutetium (177Lu)-chloride.
Kompleksirajoči reagent in druge reagente je treba dodati v vialo z lutecijevim (177Lu) kloridom.
The composite endpoint of adjudicated cardiovascular and cerebrovascular (CCV) events [acute coronary syndrome (ACS), transient ischaemic attack (with imaging evidence of infarction), stroke or CCV death], was similar for vildagliptin versus combined active and placebo comparators [Mantel– Haenszel risk ratio 0.84 (95% confidence interval 0.63 1.12)].
Rezultati pri sestavljenem cilju opazovanja, ki je obsegal dogodke, ocenjene kot kardiovaskularne ali cerebrovaskularne [akutni koronarni sindrom, tranzitorno ishemično atako (z znaki infarkta pri slikanju), možgansko kap ali cerebrovaskularno oziroma kardiovaskularno smrt], so bili pri uporabi vildagliptina podobni kot pri uporabi aktivnih primerjalnih zdravil oziroma placeba [razmerje tveganj po Mantel–Haenszelovi metodi 0,84 (95- odstotni interval zaupanja 0,63-1,12)].