natgillin/translations-raw huggingface dataset:
The company must also ensure that all doctors who are expected to prescribe Esbriet are provided with information material containing safety information on liver function and light-sensitive reactions.
Družba mora tudi zagotoviti, da vsi zdravniki, ki naj bi predpisovali zdravilo Esbriet, prejmejo informativno gradivo za zdravnike, ki vsebuje podatke o varnosti v zvezi z delovanjem jeter in reakcijami preobčutljivosti na svetlobo.
The company presented information from scientific articles already published on 90Y. The company also presented published information on the effect of using 90Y to radiolabel other medicines, including one study of non-Hodgkin’s lymphoma (a cancer of the lymph tissue, part of the immune system).
Družba je predložila podatke iz že objavljenih znanstvenih člankov o 90Y. Predstavila je tudi že objavljene podatke o učinku uporabe 90Y za radioaktivno označevanje drugih zdravil, vključno s študijo ne-Hodgkinovega limfoma (raka limfnega tkiva, ki je del imunskega sistema).
The company presented information from studies carried out with an earlier version of Arepanrix, containing the ‘bird flu’ strain H5N1.
Družba je predložila podatke iz študij, izvedenih s starejšo različico zdravila Arepanrix, ki vsebuje sev H5N1 „ptičje gripe“.
The company presented information on Cystadane from the scientific literature.
Podjetje je predložilo informacije o zdravilu Cystadane iz znanstvene literature.
The company presented information used in the assessment of aliskiren and from the published literature to support its application for Rasilez HCT, as well as information from additional studies.
Družba je v podporo svoji vlogi za zdravilo Rasilez HCT predstavila informacije, ki so bile uporabljene pri oceni aliskirena, ter informacije iz objavljene literature in dodatnih študij.
The company presented the results of studies across Europe in dogs looking at the effectiveness of Procox against the specified roundworms and coccidia.
Družba je predstavila rezultate študij, izvedenih na psih po Evropi, v katerih so preučevali učinkovitost zdravila Procox pri zatiranju določenih valjastih črvov in kokcidij.
The company provided data from the published literature on methotrexate.
Družba je predstavila podatke o metotreksatu iz objavljene literature.
The company provided data from the published literature on voriconazole.
Družba je predstavila podatke o vorikonazolu iz objavljene literature.
The company provided data on the medicine’s solubility, composition and absorption in the body.
Družba je predložila podatke o topnosti in sestavi zdravila ter o njegovi absorpciji v telesu.
The company provided data on the medicine’s solubility, composition and absorption in the body.
Družba je predstavila podatke o topnosti in sestavi zdravila ter njegovi absorpciji v telesu.
The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVaxPro.
Družba je priskrbela informacije o primerjavi z drugimi cepivi s tiomersalom ali brez njega, vključno s študijami cepiva, ki vsebuje enako zdravilno učinkovino kot cepivo HBVaxPro.
The company that made the Celvapan H5N1 mock-up vaccine has agreed that its scientific data can be used for Pandemic Influenza Vaccine H5N1 Baxter AG (‘informed consent’).
Družba, ki proizvaja modelno cepivo Celvapan H5N1, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za cepivo Pandemic Influenza Vaccine H5N1 Baxter AG („uporaba dokumentacije s soglasjem“).
The company that makes Afinitor will provide the results of a main study comparing treatment with Afinitor alone, treatment with Afinitor and exemestane in combination, and treatment with capecitabine (another cancer medicine).
Družba, ki izdeluje zdravilo Afinitor, bo priskrbela rezultate glavne študije, v kateri primerjajo uporabo zdravila Afinitor kot samostojnega zdravila z zdravljenjem z zdravilom Afinitor v kombinaciji z eksemestanom in zdravljenjem s kapecitabinom (drugim zdravilom za zdravljenje raka).
The company that makes Arava has agreed that its scientific data can be used for Leflunomide Winthrop (‘informed consent’).
Družba, ki izdeluje zdravilo Arava, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Leflunomide Winthrop („uporaba dokumentacije s soglasjem“).
The company that makes Axura has agreed that its scientific data can be used for Memantine Merz (‘informed consent’).
Družba, ki izdeluje zdravilo Axura, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Memantine Merz („uporaba dokumentacije s soglasjem“).
The company that makes Azilect has agreed that its scientific data can be used for Rasagiline ratiopharm (‘informed consent’).
Družba, ki proizvaja zdravilo Azilect, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Razagilin ratiopharm („uporaba dokumentacije s soglasjem“).
The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Družba, ki izdeluje zdravilo Betaferon, je privolila v to, da se znanstveni podatki tega zdravila uporabljajo tudi za zdravilo Extavia.
The company that makes Brinavess will ensure that healthcare professionals expected to use the medicine in all Member States are provided with educational material explaining how the medicine should be used.
Družba, ki izdeluje zdravilo Brinavess bo zagotovila, da bo zdravstveno osebje iz vseh držav članic, kjer se bo zdravilo uporabljalo, prejelo izobraževalno gradivo o njegovi uporabi.
The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will administer the medicine at home are properly trained.
Družba, ki proizvaja zdravilo Cinryze, bo zagotovila, da bodo vsi zdravstveni delavci v vseh državah članicah, za katere se pričakuje, da bodo predpisovali zdravilo Cinryze, prejeli izobraževalno gradivo z navodili, da morajo biti negovalci in bolniki, ki si bodo zdravilo injicirali sami doma, za to ustrezno usposobljeni.
The company that makes Cymbalta has agreed that its scientific data can be used for Duloxetine Lilly (‘informed consent’).
Družba, ki proizvaja zdravilo Cymbalta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Duloxetine Lilly („uporaba dokumentacije s soglasjem“).
The company that makes Cystadane will set up a register of patients taking the medicine to monitor its safety.
Podjetje, ki proizvaja zdravilo Cystadane, bo vzpostavilo register bolnikov, ki jemljejo zdravilo, da bi tako nadzorovalo njegovo varnost.
The company that makes Entresto has agreed that its scientific data can be used for Neparvis (‘informed consent’).
Družba, ki proizvaja zdravilo Entresto, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Neparvis („uporaba dokumentacije s soglasjem“).
The company that makes Esbriet will set up a post-authorisation safety study in order to collect additional information on patients prescribed Esbriet and suspected side effects.
Družba, ki proizvaja zdravilo Esbriet, bo pripravila varnostno študijo po izdaji dovoljenja za promet z njim in tako zbrala dodatne podatke o bolnikih, ki se zdravijo s tem zdravilom, in možnih neželenih učinkih.
The company that makes Evoltra will set up a registry to monitor the medicine’s side effects.
Družba, ki izdeluje zdravilo Evoltra, bo vzpostavila register za spremljanje neželenih učinkov tega zdravila.
The company that makes Eylea will also provide up-to-date educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Družba, ki izdeluje zdravilo Eylea, bo zagotovila izobraževalno gradivo za zdravnike (da bi tako čim bolj zmanjšali tveganja, povezana z injiciranjem v oko) in bolnike (da bi lahko prepoznali morebitne resne neželene učinke in tako vedeli, kdaj naj poiščejo nujno pomoč pri zdravniku).
The company that makes Fampyra will carry out a long term study on the effectiveness and safety of Fampyra.
Družba, ki izdeluje zdravilo Fampyra, bo izvedla dolgoročno študijo o učinkovitosti in varnosti zdravila Fampyra.
The company that makes Forxiga has agreed that its scientific data can be used for Edistride (‘informed consent’).
Družba, ki proizvaja zdravilo Forxiga, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Edistride („uporaba dokumentacije s soglasjem“).
The company that makes Hirobriz Breezhaler will ensure that doctors who are expected to prescribe the medicine and pharmacists in all Member States are provided with a card containing information on how the medicine is used.
Družba, ki izdeluje zdravilo Hirobriz Breezhaler, bo zdravnikom, ki naj bi predpisovali zdravilo, in farmacevtom v vseh državah članicah zagotovila kartico z informacijami o tem, kako se zdravilo uporablja.
The company that makes Instanyl will also provide educational materials in all Member States to be supplied to patients, doctors and pharmacists, to explain the correct and safe use of the medicine.
Družba, ki izdeluje zdravilo Instanyl, bo v vseh državah članicah za bolnike, zdravnike in farmacevte priskrbela izobraževalno gradivo s pojasnili glede pravilne in varne uporabe zdravila.
The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (‘informed consent’).
Družba, ki proizvaja zdravilo Lyrica, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Pregabalin Pfizer („uporaba dokumentacije s soglasjem“).
The company that makes M-M-RVAXPRO will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVAXPRO leads to side effects such as allergic reactions.
Družba, ki izdeluje cepivo M-M-RVAXPRO, bo spremljala neželene učinke, da se ugotovi, ali uporaba rekombinantnega albumina v postopku izdelave cepiva M-M-RVAXPRO povzroča neželene učinke, kot so alergijske reakcije.
The company that makes MabCampath will provide a brochure containing information on the medicine’s safety to all doctors in all Member States who prescribe the medicine.
Družba, ki izdeluje zdravilo MabCampath, bo zdravnikom v vseh državah članicah, ki predpisujejo zdravilo, zagotovila brošuro z informacijami o varnosti zdravila.
The company that makes Multaq must ensure that healthcare professionals who prescribe and dispense the medicine in all Member States are provided with a ‘prescriber checklist’ and a special ‘information card’.
Družba, ki izdeluje zdravilo Multaq, bo zagotovila, da zdravstveno osebje, ki predpisuje zdravilo, in farmacevti v vseh državah članicah prejmejo kontrolni seznam, sestavljen posebej zanje, ter posebno kartico z informacijami o varni uporabi zdravila.
The company that makes Naglazyme is carrying out studies looking at the long-term safety and effectiveness of Naglazyme in pregnant and breast-feeding women and in children under the age of five years, to see if they develop antibodies (proteins that are produced in the body in response to Naglazyme that could affect the response to treatment) and to look at the medicine’s side effects.
Družba, ki izdeluje zdravilo Naglazyme, bo izvedla študije za proučitev dolgoročne varnosti in učinkovitosti zdravila Naglazyme pri nosečih in doječih ženskah ter pri otrocih, mlajših od pet let, da bi ugotovili, ali pri njih nastanejo protitelesa (beljakovine, ki jih telo tvori kot odziv na zdravilo Naglazyme in ki lahko vplivajo na odziv na zdravljenje), ter proučili neželene učinke zdravila.
The company that makes Neupro has agreed that its scientific data can be used for Leganto (‘informed consent’).
Družba, ki izdeluje zdravilo Neupro, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Leganto („uporaba dokumentacije s soglasjem“).
The company that makes Nobivac L4 has agreed that its scientific data can be used for Canigen L4 (‘informed consent’).
Družba, ki proizvaja zdravilo Nobivac L4, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Canigen L4 („uporaba dokumentacije s soglasjem“).
The company that makes Nplate will provide doctors in each Member State a ‘dosing calculator’ to help them calculate the sometimes very small volumes of Nplate that need to be injected.
Družba, ki trži zdravilo Nplate, bo zdravnikom v vseh državah članicah priskrbela računalo za odmerjanje, ki jim bo pomagalo izračunati odmerek zdravila Nplate, ki ga je treba injicirati in ki je včasih zelo majhen.
The company that makes Omnitrope will study in more detail potential long-term side effects of the medicine, such as the possible risk of developing diabetes or re-occurrence of some types of cancer when receiving long-term somatropin treatment, and implications of the development of antibodies on effectiveness.
Podjetje, ki proizvaja zdravilo Omnitrope, bo podrobneje raziskalo potencialne dolgoročne neželene učinke zdravila, kot npr. možno tveganje za razvoj sladkorne bolezni ali ponovitev nekaterih vrst raka pri dolgotrajnem zdravljenju s somatropinom ter kakšne posledice ima pojav protiteles na učinkovitost.
The company that makes Onbrez Breezhaler will ensure that doctors who are expected to prescribe the medicine and pharmacists in all Member States are provided with a card containing information on how the medicine is used.
Družba, ki izdeluje zdravilo Onbrez Breezhaler, bo zdravnikom, ki naj bi predpisovali zdravilo, in farmacevtom v vseh državah članicah zagotovila kartico z informacijami o tem, kako se zdravilo uporablja.
The company that makes Onsenal has committed to carrying out a study in patients with FAP, in order to collect more information on the medicine’s safety and effectiveness.
Družba, ki izdeluje zdravilo Onsenal, bo opravila študijo pri bolnikih s familiarno adenomatozno polipozo, da bi zbrala več podatkov o varnosti in učinkovitosti zdravila.
The company that makes Oslif Breezhaler will ensure that doctors who are expected to prescribe the medicine and pharmacists in all Member States are provided with a card containing information on how the medicine is used.
Družba, ki izdeluje zdravilo Oslif Breezhaler, bo zdravnikom, ki naj bi predpisovali zdravilo, in farmacevtom v vseh državah članicah zagotovila kartico z informacijami o tem, kako se zdravilo uporablja.
The company that makes PecFent will also provide educational materials in each European Union (EU) Member State to make sure that patients, doctors and pharmacists are aware of how PecFent should be used, the risk of accidental exposure to fentanyl and how to dispose of the medicine.
Družba, ki proizvaja zdravilo PecFent, bo v vseh državah članicah Evropske unije (EU) priskrbela tudi izobraževalno gradivo, s katerim bo zagotovila, da so bolniki in zdravniki poučeni o varnem načinu jemanja zdravila, tveganjih v primeru nenamerne izpostavitve fentanilu in načinu odstranjevanja zdravila.
The company that makes Previcox has agreed that its scientific data can be used for EQUIOXX.
Družba, ki izdeluje zdravilo Previcox, je privolila, da se znanstveni podatki tega zdravila uporabljajo tudi za zdravilo EQUIOXX.
The company that makes Procoralan has agreed that its scientific data can be used for Ivabradine Anpharm (‘informed consent’).
Družba, ki proizvaja zdravilo Procaralan, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Ivabradine Anpharm („uporaba dokumentacije s soglasjem“).
The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent’).
Družba, ki izdeluje zdravilo Relvar Ellipta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Revinty Ellipta („uporaba dokumentacije s soglasjem“).
The company that makes Remicade will set up an educational programme for doctors who intend to prescribe the medicine to children with Crohn’s disease or ulcerative colitis, to explain the risks of treatment.
Družba, ki izdeluje zdravilo Remicade, bo pripravila izobraževalni program za zdravnike, ki nameravajo predpisovati zdravilo otrokom s Crohnovo boleznijo ali ulcerativnim kolitisom, s katerim bo predstavila tveganja, povezana z zdravljenjem.
The company that makes Renvela has agreed that its scientific data can be used for Sevelamer carbonate Zentiva (‘informed consent’).
Družba, ki proizvaja zdravilo Renvela, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Sevelamer carbonate Zentiva („uporaba dokumentacije s soglasjem“).
The company that makes Revlimid will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining that the medicine is expected to be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Družba, ki proizvaja zdravilo Revlimid, bo zdravstvenim delavcem priskrbela dopis in izobraževalni komplet, bolnikom pa knjižico, v katerih bo razloženo, da je zdravilo lahko škodljivo za nerojene otroke, in ki bodo vsebovali podrobnosti o varni uporabi zdravila.
The company that makes Rilutek has agreed that its scientific data can be used for Riluzole Zentiva (‘informed consent’).
Družba, ki proizvaja zdravilo Rilutek, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Riluzole Zentiva („uporaba dokumentacije s soglasjem“).
The company that makes RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information tailored to the needs of doctors, nurses and patients on the safety and correct use of RoActemra.
Družba, ki izdeluje zdravilo RoActemra, mora vsem zdravnikom, ki naj bi predpisovali zdravilo, zagotoviti izobraževalno gradivo s pomembnimi informacijami o varni in pravilni uporabi zdravila RoActemra, prilagojenimi potrebam zdravnikov, medicinskih sester in bolnikov.
The company that makes Stalevo has agreed that its scientific data can be used for Corbilta (‘informed consent’).
Družba, ki proizvaja zdravilo Stalevo, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Corbilta („uporaba dokumentacije s soglasjem“).
The company that makes Tasigna will provide an information pack in each Member State for doctors and pharmacists who will prescribe or dispense the medicine.
Družba, ki izdeluje zdravilo Tasigna, bo v vsaki državi članici pripravila informativni paket za zdravnike in farmacevte, ki bodo predpisovali ali izdajali zdravilo.
The company that makes Tracleer has agreed that its scientific data can be used for Stayveer (‘informed consent’).
Družba, ki proizvaja zdravilo Tracleer, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Stayveer („uporaba dokumentacije s soglasjem”).
The company that makes Twynsta has agreed that its scientific data can be used for Onduarp (‘informed consent’)
Družba, ki proizvaja zdravilo Twynsta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Onduarp („privolitev po pojasnilu“).
The company that makes Tysabri will agree on measures to further enhance the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri.
Družba, ki izdeluje zdravilo Tysabri, se bo dogovorila o ukrepih za nadaljnje izboljšanje spremljanja bolnikov v posameznih državah članicah, kot so registri in študije bolnikov, ki prejemajo zdravilo Tysabri.
The company that makes Ultibro Breezhaler has agreed that its scientific data can be used for Ulunar Breezhaler (‘informed consent’).
Družba, ki izdeluje zdravilo Ultibro Breezhaler, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Ulunar Breezhaler („uporaba dokumentacije s soglasjem“).
The company that makes Vedrop will work with other companies to assess the possible effects of propylparaben (a preservative used in Vedrop) on the reproductive organs.
Družba, ki izdeluje zdravilo Vedrop bo sodelovala z drugimi družbami, da bi ocenila morebitne učinke propilparabena (konzervansa v zdravilu Vedrop) na spolne organe.
The company that makes Viread will also ensure that all doctors who are expected to prescribe or use Viread are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Družba, ki izdeluje zdravilo Viread, bo zagotovila, da bodo vsi zdravniki, ki naj bi predpisovali ali uporabljali zdravilo Viread, prejeli izobraževalno gradivo, ki bo vsebovalo pomembne varnostne informacije, zlasti o tveganjih in previdnostnih ukrepih, ki se nanašajo na delovanje ledvic in kosti.
The company that makes Xigduo has agreed that its scientific data can be used for Ebymect (‘informed consent’).
Družba, ki proizvaja zdravilo Xigduo, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Ebymect („uporaba dokumentacije s soglasjem“).
The company that makes Zaltrap will analyse the blood and tissue of patients involved in the clinical trial programmes.
Družba, ki izdeluje zdravilo Zaltrap, bo analizirala kri in tkiva bolnikov, ki sodelujejo v programih kliničnih preskušanj.
The company that markets Atripla will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with tenofovir disoproxil-containing medicines such as Atripla.
Družba, ki trži zdravilo Atripla, bo zagotovila, da bodo vsi zdravniki, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo informacije o povečanem tveganju za razvoj ledvičnega obolenja pri jemanju zdravil, ki vsebujejo tenofovir-dizoproksil, kot je npr. zdravilo Atripla.
The company that markets Blincyto will also provide patients and healthcare professionals with educational materials with information on how to administer Blincyto and how to manage risks with the medicine.
Družba, ki trži zdravilo Blincyto, bo bolnikom in zdravstvenim delavcem zagotovila tudi izobraževalno gradivo z informacijami o dajanju tega zdravila ter o obvladovanju tveganj, povezanih z njim.
The company that markets Cabometyx will provide the final results of the overall survival of patients in the main study.
Družba, ki trži zdravilo Cabometyx, bo zagotovila končne rezultate celokupnega preživetja bolnikov v glavni študiji.
The company that markets Caprelsa will ensure that doctors who are expected to prescribe Caprelsa receive educational material containing important safety information about Caprelsa, including measures to manage the risk of QTc prolongation and other potential side effects, and a patient alert card.
Družba, ki trži zdravilo Caprelsa, bo zdravnikom, za katere se pričakuje, da bodo zdravilo Caprelsa predpisovali, priskrbela izobraževalno gradivo, ki bo vsebovalo pomembne informacije o varnosti zdravila Caprelsa, vključno z ukrepi za obvladovanje tveganja podaljšanja intervala QTc in drugih možnih neželenih učinkov, ter opozorilno kartico za bolnike.
The company that markets Cimzia will also provide educational packs for doctors who will prescribe Cimzia.
Družba, ki trži zdravilo Cimzia, bo poleg tega zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali to zdravilo.
The company that markets Elaprase will investigate the long-term effects of the medicine, particularly on the lungs, the heart and the blood vessels, and whether the body produces antibodies that could affect the medicine’s safety and effectiveness.
Družba, ki trži zdravilo Elaprase, bo proučila njegove dolgoročne učinke, zlasti na pljuča, srce in krvne žile in raziskala, ali telo proizvaja protitelesa, ki bi lahko vplivala na varnost in učinkovitost zdravila.
The company that markets Humira must provide educational packs for doctors who will prescribe Humira.
Družba, ki trži zdravilo Humira, mora zagotoviti izobraževalno gradivo za zdravnike, ki ga bodo predpisovali.