natgillin/translations-raw huggingface dataset:
In addition, the company that makes Exjade must prepare an education pack for healthcare professionals.
Poleg tega mora družba, ki izdeluje zdravilo Exjade, pripraviti izobraževalno gradivo za zdravstvene delavce.
In addition, the company that makes Gilenya will carry out a study to assess the risk of side effects on the heart and circulation.
Poleg tega bo družba, ki izdeluje zdravilo Gilenya izvedla študijo za oceno tveganja neželenih učinkov na srce in krvni obtok.
In addition, the company that makes Imnovid will set up a pregnancy-prevention programme in each Member State.
Poleg tega bo družba, ki izdeluje zdravilo Imnovid, v vsaki državi članici vzpostavila program za preprečevanje nosečnosti.
In addition, the company that makes Kineret will provide educational material for healthcare providers and for patients or their caregivers.
Poleg tega bo družba, ki izdeluje zdravilo Kineret, zagotovila izobraževalno gradivo za zdravstvene delavce in bolnike ali njihove negovalce.
In addition, the company that makes Libertek will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used.
Poleg tega bo družba, ki izdeluje zdravilo Libertek, zagotovila, da bodo v vseh državah članicah Evropske unije (EU) zdravstveni delavci, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo o neželenih učinkih zdravila in njegovi uporabi.
In addition, the company that makes Lucentis will provide all clinics where Lucentis is expected to be used with information packs for doctors (including information on the measures needed to minimise the risk of infection associated with injections into the eye) and packs for patients (to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor).
Poleg tega bo družba, ki izdeluje to zdravilo, vsem bolnišnicam, v katerih naj bi se zdravilo uporabljalo, zagotovila informativne brošure za zdravnike (vključno z informacijami o ukrepih, ki so potrebni za zmanjšanje tveganj, povezanih z injiciranjem v oko) in informativno gradivo za bolnike (da bi se lažje pripravili na zdravljenje z zdravilom Lucentis, prepoznali resne neželene učinke in tako vedeli, kdaj naj poiščejo nujno zdravniško pomoč).
In addition, the company that makes Nulojix will include an alert card in each medicine’s pack to increase awareness of the benefits and risks with Nulojix.
Poleg tega bo družba, ki izdeluje zdravilo Nulojix, vsaki embalaži zdravila priložila opozorilno kartico o koristih in tveganjih jemanja tega zdravila.
In addition, the company that makes Ozurdex will ensure that doctors who are expected to use Ozurdex will be provided with an information pack that will include diagrams showing how the injections are given and how to recognise serious side effects.
Poleg tega bo družba, ki izdeluje zdravilo Ozurdex, zagotovila, da bodo v vseh državah članicah zdravniki, ki naj bi uporabljali zdravilo Ozurdex, prejeli informativni paket s shemami o načinu dajanja injekcij in prepoznavanju resnih neželenih učinkov.
In addition, the company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it.
Poleg tega bo družba, ki izdeluje zdravilo Pradaxa, pripravila izobraževalno gradivo za vse zdravnike, ki bodo predpisovali zdravilo, in tako povečala ozaveščenost o tveganjih za krvavitve ter zagotovila smernice za njihovo obvladovanje.
In addition, the company that makes Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy.
Poleg tega bo družba, ki izdeluje zdravilo Ruconest, zdravstvenim delavcem, ki naj bi predpisovali zdravilo Ruconest, zagotovila izobraževalno gradivo z informacijami o pravilni uporabi zdravila in opozorili glede tveganja za pojav alergije.
In addition, the company that makes Stayveer will provide an educational kit for prescribers and an information booklet for patients in each Member State, explaining the safety of Stayveer (especially its effects on the liver and in pregnancy) and its interactions.
Poleg tega bo družba, ki izdeluje zdravilo Stayveer, v vseh državah članicah zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in brošuro za bolnike z informacijami o varnosti zdravila Stayveer (zlasti glede njegovih učinkov na jetra in nosečnost) ter medsebojnem delovanju z drugimi zdravili.
In addition, the company that makes Thymanax will supply educational material for doctors prescribing Thymanax.
Družba, ki izdeluje zdravilo Thymanax, bo zdravnikom, ki ga predpisujejo, priskrbela izobraževalno gradivo.
In addition, the company that makes Tracleer will provide an educational kit for prescribers and an information booklet for patients in each Member State, explaining the safety of Tracleer (especially its effects on the liver and in pregnancy) and its interactions.
Poleg tega bo družba, ki izdeluje zdravilo Tracleer, priskrbela izobraževalno gradivo za predpisovalce zdravila in informativno knjižico za bolnike v vsaki državi članici, v kateri bosta pojasnjeni varnost zdravila (zlasti učinki na jetra in nosečnost) ter medsebojno delovanje z drugimi zdravili.
In addition, the company that makes Valdoxan will supply educational material for doctors prescribing Valdoxan.
Družba, ki izdeluje zdravilo Valdoxan, bo zdravnikom, ki ga predpisujejo, priskrbela izobraževalno gradivo.
In addition, the company that makes Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are provided with a brochure with safety information on the medicine including the side effects related to the excessive activity of the immune system.
Družba, ki izdeluje zdravilo Yervoy, mora poleg tega zagotoviti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo, ter vsi bolniki prejeli brošuro z informacijami o varnosti zdravila ter njegovih neželenih učinkih zaradi čezmerne aktivnosti imunskega sistema.
In addition, the company that markets Abilify will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Poleg tega bo družba, ki trži zdravilo Abilify, priskrbela izobraževalno gradivo, ki ga bodo prejeli bolniki ali njihovi negovalci ter zdravniki, v katerem bo pojasnjena varna uporaba zdravila pri bolnikih, starih od 13 do 17 let.
In addition, the company that markets Cerdelga will provide doctors and patients with educational materials to ensure that only patients with type-1 Gaucher disease are treated with Cerdelga and that Cerdelga is not used together with other medicines which can significantly alter its blood levels.
Poleg tega bo družba, ki trži zdravilo Cerdelga, zdravnikom in bolnikom priskrbela izobraževalno gradivo za zagotovitev, da bodo z zdravilom Cerdelga zdravljeni le bolniki z Gaucherjevo boleznijo tipa 1 in da se zdravilo Cerdelga ne bo uporabljalo skupaj z drugimi zdravili, ki lahko znatno spremenijo njegovo raven v krvi.
In addition, the company that markets Cubicin will provide all doctors who are expected to use Cubicin with a dosage card to ensure the safe use of the medicine.
Poleg tega bo družba, ki trži zdravilo Cubicin, vsem zdravnikom, ki bodo predpisovali to zdravilo, priskrbela kartico s predpisanimi odmerki, s čimer bo zagotovila varno uporabo zdravila.
In addition, the company that markets Cyramza will carry out a study on the safety of Cyramza when used on its own for gastric cancer, including at doses higher than the approved dose, and a study to try to further characterise those patients with colorectal cancer who may respond better to Cyramza.
Poleg tega bo družba, ki trži zdravilo Cyramza, izvedla študijo o varnosti tega zdravila, kadar se uporablja samostojno za zdravljenje raka želodca, vključno z višjimi odmerki od odobrenih, ter študijo za nadaljnjo opredelitev značilnosti tistih bolnikov s kolorektalnim rakom, ki bi se morda bolje odzvali na to zdravilo.
In addition, the company that markets Darzalex will provide educational material to all healthcare professionals expected to use the medicine, to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions.
Poleg tega bo družba, ki trži zdravilo Darzalex, priskrbela izobraževalni material za vse zdravstvene delavce, za katere se pričakuje, da bodo uporabljali to zdravilo, in jih obvestila, da zdravilo lahko vpliva na rezultat krvnega testa (indirektni Coombsov test), ki se uporablja za določanje primernosti za transfuzijo krvi.
In addition, the company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely in order to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Poleg tega bo družba, ki trži zdravilo Deltyba, priskrbela izobraževalno gradivo za zdravstvene delavce, ki razlaga, kako varno uporabljati zdravilo, da se preprečijo težave, kot so razvoj odpornosti in neželeni učinki na srce, ter tveganja v nosečnosti ter pri doječih materah.
In addition, the company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment.
Poleg tega bo družba, ki trži zdravilo Eliquis, zagotovila izobraževalno gradivo za zdravstvene delavce, ki naj bi predpisovali zdravilo Eliquis, v katerem bo obravnavano tveganje za pojav krvavitev med zdravljenjem.
In addition, the company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material containing important safety information about Esmya, including recommendations for monitoring and managing endometrial changes that occur with Esmya treatment.
Podjetje, ki trži zdravilo Esmya, bo poleg tega zagotovilo, da bodo zdravniki, ki naj bi predpisovali to zdravilo, prejeli izobraževalno gradivo s pomembnimi informacijami o njegovi varnosti, vključno s priporočili za spremljanje in obravnavanje sprememb endometrija, ki se pojavijo pri zdravljenju z zdravilom Esmya.
In addition, the company that markets Grastofil will carry out studies to confirm the long-term safety of Grastofil.
Poleg tega bo družba, ki trži zdravilo Grastofil, izvedla študije za potrditev varnosti njegove dolgotrajne uporabe.
In addition, the company that markets Iclusig will provide educational material for all doctors who are expected to prescribe this medicine highlighting important risks for which monitoring and dose adjustments are recommended.
Poleg tega bo družba, ki trži zdravilo Iclusig, pripravila izobraževalno gradivo za vse zdravnike, ki bodo predpisovali zdravilo, v katerem bo poudarila pomembna tveganja, v zvezi s katerimi se priporoča spremljanje bolnikov in prilagoditev odmerkov.
In addition, the company that markets Ivabradine Anpharm must carry out a further study of the patients using the medicine and the way that it is used, and of how well measures to reduce the risks of treatment are being followed.
Poleg tega mora družba, ki trži zdravilo Ivabradine Anpharm, izvesti dodatno študijo načina uporabe pri bolnikih, ki uporabljajo to zdravilo, in o tem, kako se upoštevajo ukrepi za zmanjševanje tveganja pri zdravljenju.
In addition, the company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive an information pack containing key information on how to use the medicine as well as an information pack to be given to patients.
Poleg tega mora družba, ki izdeluje zdravilo Jetrea, zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi zdravilo Jetrea uporabljali, prejeli informativno brošuro s ključnimi informacijami o uporabi zdravila in informativno gradivo za bolnike.
In addition, the company that markets Leflunomide Winthrop will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Leflunomide Winthrop and the monitoring that should be carried out in patients.
Poleg tega bo družba, ki izdeluje zdravilo Leflunomide Winthorp, zdravnikom, ki naj bi predpisovali zdravilo, zagotovila informativno gradivo, ki bo vsebovalo pomembne informacije o tveganjih, povezanih z zdravilom Leflunomide Winthorp, in spremljanju, ki ga je treba izvajati pri bolnikih.
In addition, the company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.
Poleg tega bo družba, ki trži zdravilo Lixiana, zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in opozorilno kartico za bolnike, na kateri bodo pojasnjena tveganja krvavitve pri uporabi zdravila in navodila za njihovo obvladovanje.
In addition, the company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit of the medicine in patients with ovarian cancer.
Poleg tega bo družba, ki trži zdravilo Lynparza, izvedla študije, da bi nadalje potrdila njegove koristi, vključno z dolgoročnimi koristmi zdravila pri bolnicah z rakom jajčnikov.
In addition, the company that markets MabThera will also submit reports from studies on the long- term safety of MabThera.
Poleg tega bo družba, ki trži zdravilo MabThera, posredovala tudi poročila študij o dolgoročni varnosti zdravila MabThera.
In addition, the company that markets Oncaspar will complete two more studies on the safety and effectiveness of Oncaspar, which will help further clarify the benefits and risks of this medicine in adults and in newly diagnosed patients.
Poleg tega bo podjetje, ki trži zdravilo Oncaspar, izvedlo še dve študiji o varnosti in učinkovitosti zdravila Oncaspar, ki bosta pripomogli k pojasnitvi koristi in tveganj tega zdravila pri odraslih in bolnikih z novo diagnozo.
In addition, the company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit.
Poleg tega bo družba, ki trži zdravilo Opsumit, bolnikom in zdravstvenim delavcem razdelila izobraževalno gradivo, ki bo vsebovalo informacije o previdnostnih ukrepih, ki jih je treba upoštevati pri uporabi zdravila Opsumit.
In addition, the company that markets Perjeta will carry out two studies to assess the effects of using Perjeta and trastuzumab together with two different types of cancer medicine, in patients with HER2- positive breast cancer that is metastatic or has come back after treatment.
Družba, ki trži zdravilo Perjeta, bo izvedla dve študiji, namenjeni oceni učinkov uporabe tega zdravila in trastuzumaba v kombinaciji z dvema drugima vrstama zdravil za zdravljenje raka, pri bolnikih z metastatskim HER2-pozitivnim rakom dojk ali s HER2-pozitivnim rakom dojk, ki se je po zdravljenju ponovil.
In addition, the company that markets Prolia will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Poleg tega bo družba, ki trži to zdravilo, pripravila kartico, s katero bo bolnike seznanila s tveganjem pojava osteonekroze čeljusti in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
In addition, the company that markets Raplixa will ensure that all surgeons using Raplixa are provided with educational material to inform them of the risk of air or gas embolism and how to use the spray correctly.
Poleg tega bo družba, ki trži zdravilo Raplixa, zagotovila, da bodo vsi kirurgi, ki uporabljajo zdravilo Raplixa, prejeli izobraževalno gradivo z informacijami o tveganju zračne ali plinske embolije ter o pravilni uporabi pršila.
In addition, the company that markets Ravicti will set up a registry of patients to obtain further information on the long-term benefits and safety of the medicine.
Poleg tega je podjetje, ki trži zdravilo Ravicti, vzpostavilo register bolnikov za pridobivanje dodatnih informacij o dolgoročnih koristih in varnosti zdravila.
In addition, the company that markets Relvar Ellipta will conduct further studies to investigate the risk of pneumonia with this medicine in comparison with other COPD and asthma medicines.
Poleg tega bo podjetje, ki trži zdravilo Relvar Ellipta, izvedlo nadaljnje študije, s katerimi bodo preučili tveganje pljučnice pri tem zdravilu v primerjavi z drugimi zdravili za zdravljenje kronične obstruktivne pljučne bolezni in astme.
In addition, the company that markets Remsima will provide educational material to doctors who are expected to prescribe the medicine in adults and children, including information on the safety of the medicine and an alert card to be given to patients.
Poleg tega bo družba, ki trži zdravilo Remsima, zagotovila izobraževalno gradivo za zdravnike, ki naj bi predpisovali zdravilo odraslim in otrokom, vključno z informacijami o varnosti zdravila in opozorilno kartico za bolnike.
In addition, the company that markets Revinty Ellipta will conduct further studies to investigate the risk of pneumonia with this medicine in comparison with other COPD and asthma medicines.
Poleg tega bo podjetje, ki trži zdravilo Revinty Ellipta, izvedlo nadaljnje študije, s katerimi bodo preučili tveganje pljučnice pri tem zdravilu v primerjavi z drugimi zdravili za zdravljenje kronične obstruktivne pljučne bolezni in astme.
In addition, the company that markets Revolade will ensure that doctors in all Member States who will prescribe the medicine are provided with educational materials reminding them how the medicine should be used and of the medicine’s possible side effects such as liver problems, thromboembolic complications and the recurrence of bleeding.
Poleg tega bo družba, ki trži zdravilo Revolade, zdravnikom v vseh državah članicah, ki bodo predpisovali zdravilo, zagotovila izobraževalno gradivo z informacijami o njegovi pravilni uporabi in morebitnih neželenih učinkih, kot so težave z jetri, trombembolični zapleti in ponoven pojav krvavitev.
In addition, the company that markets Senshio will carry out an observational study to further investigate long-term potential risks such as endometrial hyperplasia, stroke and venous thromboembolism.
Poleg tega bo družba, ki trži zdravilo Senshio, izvedla opazovalno študijo, da bi nadalje raziskala morebitna dolgoročna tveganja, kot so hiperplazija endometrija, kap in venska tromboembolija.
In addition, the company that markets Sevelamer carbonate Zentiva will make sure that educational material is available in all Member States for patients and healthcare professionals.
Poleg tega bo družba, ki trži zdravilo Sevelamer carbonate Zentiva, zagotovila, da je v vseh državah članicah bolnikom in zdravstvenim delavcem na voljo izobraževalno gradivo.
In addition, the company that markets Soliris will ensure that distribution of the medicine occurs only after checking that the patient has been vaccinated appropriately.
Poleg tega bo družba, ki trži zdravilo Soliris, zagotovila, da se lahko zdravilo izda šele potem, ko se preveri, ali je bil bolnik ustrezno cepljen.
In addition, the company that markets Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Poleg tega bo družba, ki izdeluje zdravilo Thalidomide Celgene, v vsaki državi članici vzpostavila program za preprečevanje nosečnosti.
In addition, the company that markets the medicine will carry out a study to further investigate the effects of Lonquex on the patients’ cancer - the possibility of cancer worsening during treatment with G‑CSF medicines was a concern raised during the evaluation of the medicine though this was not established.
Poleg tega bo družba, ki trži zdravilo, izvedla študijo, v kateri bo podrobneje raziskala učinke zdravila Lonquex na bolnike z rakom – med postopkom ocenjevanja zdravila se je pojavil zadržek v zvezi z možnostjo, da bi se rak med zdravljenjem z zdravili z G-CSF poslabšal, vendar tega niso uspeli dokazati.
In addition, the company that markets Vizamyl will provide access to a training course for all nuclear- medicine physicians expected to use this product in the European Union, in order to ensure accurate and reliable reading of the PET scan images.
Poleg tega bo družba, ki trži zdravilo Vizamyl, omogočila dostop do izobraževalnega tečaja za vse zdravnike nuklearne medicine, za katere se pričakuje, da bodo uporabljali to zdravilo v Evropski uniji, s čimer bo zagotovila točno in zanesljivo tolmačenje posnetkov PET.
In addition, the company that markets Volibris has agreed with EU Member States on systems to control the distribution of Volibris.
Poleg tega se je družba, ki izdeluje zdravilo Volibris, z državami članicami EU dogovorila glede sistemov za nadzor distribucije tega zdravila.
In addition, the company that markets Xgeva will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Poleg tega bo družba, ki trži zdravilo Xgeva, pripravila kartico, s katero bo bolnike seznanila s tveganjem pojava osteonekroze čeljustnice in jih pozvala, naj v primeru, da se pojavijo simptomi, poiščejo zdravniško pomoč.
In addition, the company that markets Xultophy will provide educational materials for healthcare professionals, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Poleg tega bo družba, ki trži zdravilo, priskrbela izobraževalno gradivo za zdravstvene delavce, kjer bo obrazloženo, kako varno uporabljati zdravilo, da se zmanjša tveganje za napake pri njegovi uporabi.
In addition, the company will carry out a study in patients with myelodysplastic syndromes to gather further safety data, as well as a safety study in patients with newly diagnosed multiple myeloma not eligible for transplant.
Poleg tega bo družba izvedla študijo pri bolnikih z mielodisplastičnimi sindromi za zbiranje nadaljnjih podatkov o varnosti, in študijo o varnosti zdravila pri bolnikih z novo odkritim multiplim mielomom, pri katerih presaditve kostnega mozga ni mogoče izvesti.
In addition, the company will carry out a study investigating extended treatment intervals with Eylea in diabetic macular oedema, as well as a study looking at the effects of Eylea treatment when given on an as- needed basis in wet AMD.
Poleg tega bo izvedla študijo, v kateri bo proučila podaljšane razmike med zdravljenjem z zdravilom Eylea pri makularnem edemu, ki je posledica sladkorne bolezni, kot tudi študijo, v kateri bo proučila učinke zdravljenja s tem zdravilom, če se uporabi po potrebi pri vlažni obliki starostne degeneracije makule.
In addition, the company will carry out two further studies on the benefits of the medicine and a safety study in a larger population of HL and sALCL patients.
Poleg tega bo izvedla dve nadaljnji študiji o koristih zdravila in varnostno študijo na večji populaciji bolnikov s Hodgkinovim limfomom in sistemskim anaplastičnim limfomom velikih celic.
In addition, the company will provide patients and carers with educational materials to ensure that Strensiq is used correctly and to minimise the risk of medication errors.
Poleg tega bo družba za bolnike in negovalce pripravila izobraževalno gradivo, ki bo zagotavljalo, da se zdravilo Strensiq uporablja pravilno, in zmanjšalo tveganje za napake pri uporabi zdravila.
In addition, the company will provide the final results of the studies with Keytruda to confirm the long- term benefits of the medicine.
Poleg tega bo družba predložila tudi končne rezultate študij o zdravilu Keytruda, ki bodo podprli dolgoročne koristi tega zdravila.
In addition, the company will provide the results of studies to try to further characterise those patients who respond better to Vectibix.
Poleg tega bo objavila rezultate študij, ki bodo še natančneje opredelili bolnike, ki se dobro odzivajo na zdravilo Vectibix.