natgillin/translations-raw huggingface dataset:
The MAH must inform the European Medicines Agency and the CHMP of the results of the surveillance programme in each Member State.
Imetnik dovoljenja za promet z zdravilom mora obvestiti Evropsko agencijo za zdravila in Odbor za zdravila za uporabo v humani medicini (CHMP) o rezultatih raziskovalnega programa v vsaki državi članici.
The MAH proposes that ‘pupillary reflex impaired’ be listed in section 4.8 of the SmPC, and this is considered appropriate.
MAH predlaga navedbo ‘zmanjšan pupilarni refleks’ v poglavju 4.8 SmPC, kar je primerno.
The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be distributed.
Imetnik dovoljenja za promet z zdravilom se o načinu posredovanja obvestila DHPC dogovori s pristojnim nacionalnim organom v državah članicah, v katerih bo obvestilo razdeljeno.
The MAH shall agree the content and format of the educational materials with the National Competent Authorities in each Member State where Kineret is marketed and prior to marketing in any additional Member State.
Imetnik dovoljenja za promet z zdravilom uskladi vsebino in obliko izobraževalnega gradiva z nacionalnim pristojnim organom v vsaki državi članici, v kateri se zdravilo Kineret trži, in pred začetkom trženja v vsaki dodatni državi članici.
The MAH shall agree the content and format of the Kadcyla educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla is launched in each Member State.
Imetnik dovoljenja za promet se mora o vsebini in obliki izobraževalnega gradiva za zdravilo Kadcyla dogovoriti z organom, prisotojnim za zdravila, v vsaki državi članici pred dajanjem zdravila Kadcyla na trg.
The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National Competent Authority and must implement such programmes nationally to ensure that:
Imetnik dovoljenja za promet z zdravilom mora s pristojnimi nacionalnimi organi uskladiti podrobnosti nadzorovanega distribucijskega sistema zdravila in izobraževalnega gradiva, vključno z opozorilnimi karticami za bolnika, ter na nacionalni ravni izvesti programe, ki bodo zagotovili, da:
The MAH shall agree the details of an educational brochure with the National Competent Authorities.
Imetnik dovoljenja za promet se bo o podrobnostih izobraževalne brošure dogovoril s pristojnimi nacionalnimi programi.
The MAH shall agree the details of the Prescriber kit and a controlled distribution system with the National Competent Authority and implement it prior to launch in that Member State.
Imetnik dovoljenja za promet z zdravilom se bo s pristojnim nacionalnim organom dogovoril o vsebini kompleta za zdravnike, ki zdravilo predpisujejo, in glede nadzorovanega sistema razdeljevanja ter ga uvedel pred začetkom dajanja zdravila na trg v tej državi članici.
The MAH shall agree the exact content and format of the educational material and educational program with the national competent authority.
Natančno vsebino in obliko izobraževalnega materiala in programa mora imetnik dovoljenja za promet z zdravilom uskladiti s pristojnimi nacionalnimi organi.
The MAH shall agree the final text and the context of the educational material for HCPs and patients together with a communication plan, with the National Competent Authority in each Member State prior to launch of the medicinal product.
Imetnik dovoljenja za promet se bo o končnem besedilu in kontekstu izobraževalnega gradiva z zdravstvene delavce in bolnike ter o načrtu komuniciranja pred začetkom njihove uporabe uskladil s pristojnim nacionalnim organom s pristojnimi v vsaki državi članici.
The MAH shall agree the final text of the Direct Healthcare Professional Communication letter and the content of the patient brochure together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational pack in the Member State.
Imetnik dovoljenja za promet bo končno besedilo neposrednega pisma zdravstvenim delavcem, vsebino brošure za bolnike in načrt komuniciranja pred distribucijo izobraževalnega gradiva v državi članici uskladil v dogovoru s pristojnim nacionalnim organom v vsaki državi članici.
The MAH shall agree the text of a Dear Healthcare Professional letter with the CHMP (and if necessary with the National Competent Authorities) prior to launch of the medicinal product and shall ensure that it is provided to all physicians experienced in neonatal intensive care prior to or at the launch of the medicinal product in each Member State.
Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila na trg glede uvodnega pisma za strokovno osebje dogovoriti z odborom CHMP (in po potrebi z nacionalnimi pristojnimi organi) in poskrbeti, da bodo pismo dobili vsi zdravniki, ki imajo izkušnje v intenzivnemu negovanju novorojenčkov pred ali ob prihodu zdravila na trg v vsaki državi članici.
The MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following:
Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Celvapan.
Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravstvenim delavcem omogočili stalen dostop do posodobljenih informacij o cepivu Celvapan.
The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Focetria.
Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o mehanizmih, ki bodo bolnikom in zdravnikom omogočali stalen dostop do posodobljenih informacij o cepivu Focetria.
The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding HUMENZA.
Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravnikom omogočali stalen dostop do posodobljenih informacij o cepivu HUMENZA.
The MAH shall agree with Member States on the provision of a targeted communication to health care professionals which should address the following:
Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljnega obveščanja za zdravnike, ki mora obravnavati naslednje:
The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/(H1N1)v vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost cepiva A/(H1N1)v, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost pandemskega cepiva A/H1N1, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o ukrepih za lažjo identifikacijo in sledljivost cepiva proti virusu A/H1N1, ki se bo uporabilo pri posameznem bolniku, da bi se zmanjšale napake pri uporabi zdravila ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
The MAH shall agree with the National Competent Authorities to provide physicians with an educational material that will include the following components of information:
Imetnik dovoljenja za promet se mora z nacionalnim organom, pristojnim za zdravila dogovoriti o izobraževalnem gradivu, ki ga bo zagotovil zdravnikom in bo vključeval naslednje informacije:
The MAH shall also agree the details of the controlled access programme to ensure distribution of Scenesse only to centres where the physicians received the educational materials and have been trained.
Imetnik dovoljenja za promet z zdravilom se bo prav tako dogovoril glede programa z nadzorovanim dostopom, ki bo zagotavljal distribucijo zdravila Scenesse samo centrom, v katerih so zdravniki prejeli izobraževalno gradivo in opravili usposabljanje.
The MAH shall also ensure that all health care professionals who might prescribe defibrotide are provided with information on the importance of, and how to enter patients in, the registry.
Imetnik dovoljenja za promet z zdravilom bo prav tako zagotovil, da bodo vsi zdravstveni delavci, ki lahko predpišejo defibrotid, prejeli informacije o pomembnosti registra in o vključevanju bolnikov v register.
The MAH shall also provide a Patient Alert Card in each medication pack, the text of which is included in Annex III.
Imetnik dovoljenja za promet z zdravilom bo opozorilno kartico za bolnika priložil v vsako pakiranje zdravila; besedilo je vključeno v Dodatek III..
The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Imetnik dovoljenja za promet z zdravilom bo za vsako pakiranje pripravil kontrolno kartico za bolnika, to je besedilo, ki se nahaja v prilogi III.
The MAH shall complete, the measures described below:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
The MAH shall complete, within the stated timeframe, the below measures:
Imetnik dovoljenja za promet mora v določenem časovnem okviru izvesti naslednje ukrepe:
The MAH shall complete, within the stated timeframe, the below measures:
Markaðsleyfishafi skal ljúka eftirfarandi innan tilgreindra tímamarka:
The MAH shall complete, within the stated timeframe, the following measure:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji ukrep:
The MAH shall complete, within the stated timeframe, the following measures:
Imetnik dovoljenja za promet mora v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
The MAH shall complete, within the stated timeframe, the following measures:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
The MAH shall complete, within the stated timeframe, the following measures:
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
The MAH shall complete, within the stated timeframe, the following measures:
Imetnik dovoljenja za promet z zdravilom mora v spodaj navedenem časovnem okvirju izvesti naslednje ukrepe:
The MAH shall complete, within the stated timeframe, the measure below:
Imetnik dovoljenja za promet z zdravilom mora v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
The MAH shall conduct a retrospective study comparing long term safety data and outcome endpoints in patients receiving and not receiving Scenesse, or having discontinued Scenesse use.
Imetnik dovoljenja za promet z zdravilom bo izvedel retrospektivno študijo, ki bo primerjala dolgoročne varnostne podatke in opazovane dogodke pri bolnikih, ki so prejemali zdravilo Scenesse, bolnikih, ki ga niso prejemali ali ki so prekinili uporabo zdravila Scenesse.
The MAH shall conducts a study on enzymatic debridement in burns patients (children and adults): A comparison to standard of care (protocol MW2010-03- 02), based on a CHMP approved protocol.
Imetnik dovoljenja za promet z zdravilom bo opravil študijo encimskega čiščenja ran pri bolnikih z opeklinami (otroci in odrasli): Primerjava s standardno nego (protokol MW2010-03-02), na podlagi protokola, ki ga je odobril CHMP.
The MAH shall continue to monitor the activity of telavancin and the microbiological resistance as compared to other agents, through the longitudinal resistance surveillance program.
telavancina in mikrobiološko odpornost v primerjavi z drugimi učinkovinami prek
The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following:
Imetnik dovoljenja za promet mora konstantno zagotavljati, da vsi zdravniki, ki bodo predpisovali zdravilo Erivedge prejmejo naslednje:
The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Imetnik dovoljenja za promet mora ob dajanju zdravila na trg poslati neposredno obvestilo zdravstvenim delavcem (pismo DHCP), ki mora vsebovati naslednje podatke:
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Imetnik dovoljenja za promet z zdravilom bo zagotovil realizacijo opozorilne kartice za bolnika glede osteonekroze čeljustnic.
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Imetnik dovoljenja za promet z zdravilom bo zagotovil uvedbo opozorilne kartice za bolnika z opozorili glede osteonekroze čeljusti.
The MAH shall ensure that all eye surgeons in the EU Countries in which silodosin will be marketed are provided with the following information:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da prejmejo vsi očesni kirurgi v državah EU, v katerih se bo silodozin prodajal, naslednje informacije:
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib SUN are provided with educational materials.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali, izdajali ali uporabljali zdravilo, prejeli izobraževalno gradivo.
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Deltyba are provided with educational material.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo z izobraževalnim gradivom seznanjeni vsi zdravstveni delavci, ki zdravilo Deltyba predpisujejo, ga izdajajo, z njim ravnajo ali ga dajejo.
The MAH shall ensure that all healthcare professionals involved in treatment and monitoring of patients will receive the Administration and monitoring guide.
Imetnik dovoljenja za promet bo zagotovil, da bo vso zdravstveno osebje, ki bo vključeno v zdravljenje in spremljanje bolnikov prejelo Priročnik o uporabi zdravila in spremljanju bolnikov.
The MAH shall ensure that all healthcare professionals who are expected to prescribe or use Provenge are provided with the following items:
Imetnik dovoljenja za promet mora zagotoviti, da se vsem zdravstvenim delavcem, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Provenge, da na razpolago naslednje postavke
The MAH shall ensure that all physicians who are expected to prescribe/use Xiapex are appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren’s contracture and Peyronie’s disease.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da so vsi zdravniki, ki bodo predvidoma predpisovali/uporabljali zdravilo Xiapex ustrezno usposobljeni za pravilno dajanje zdravila ter izkušeni v vodenju in zdravljenju Dupuytrenove kontrakture in Peyroniejeve bolezni.
The MAH shall ensure that all physicians who intend to prescribe KINERET are provided with the following items:
Imetnik dovoljenja za promet z zdravilom zagotovi, da vsi zdravniki, ki nameravajo predpisati zdravilo KINERET, prejmejo naslednje:
The MAH shall ensure that at launch all physicians expected to prescribe the product are provided with information on the correct and safe use of the product.
Imetnik dovoljenja za promet z zdravilom mora ob dajanju zdravila v promet zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali to zdravilo, prejeli informacije o njegovi pravilni in varni uporabi.
The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Humalog should be trained on the correct use of the prefilled pen before prescribing or dispensing Humalog.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo zdravstveni delavci obveščeni, da morajo biti vsi bolniki, ki jim je bilo predpisano zdravilo Humalog, usposobljeni za pravilno uporabo napolnjenega peresnika, preden jim bo zdravilo Humalog predpisano ali izdano.
The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Tresiba should be provided with a patient brochure and be trained on the correct use of the prefilled pen before prescribing or dispensing Tresiba.
Imetnik dovoljenja za promet bo poskrbel za seznanitev zdravstvenih delavcev z dejstvom, da je treba vsem bolnikom, ki bodo prejemali zdravilo Tresiba, izročiti brošuro za bolnika ter jih je treba usposobiti za pravilno uporabo napolnjenega injekcijskega peresnika, preden jim je zdravilo Tresiba predpisano ali izdano.
The MAH shall ensure that in each Member State where BLINCYTO is marketed, all healthcare professionals (HCP) and patients / caregivers who are expected to prescribe, dispense and use BLINCYTO are provided with the following educational packages:
Imetnik dovoljenja za promet mora zagotoviti, da bodo v vsaki državi članici, ki bodo tržila zdravilo BLINCYTO, vsi zdravstveni delavci in bolniki / negovalci, od katerih se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo BLINCYTO prejeli sledeče izobraževalne pakete:
The MAH shall ensure that in each Member State where Cerdelga is marketed, all healthcare professionals who are expected to prescribe Cerdelga are provided with a prescriber guide.
Imetnik dovoljenja za promet z zdravilom bo v vseh državah članicah, kjer bo zdravilo Cerdelga na trgu, vse zdravnike, ki bodo predvidoma predpisovali to zdravilo, oskrbel z navodilom za predpisovalca.
The MAH shall ensure that in each Member State where Cerdelga is marketed, all patients who are prescribed Cerdelga are provided with a patient alert card.
Imetnik dovoljenja za promet z zdravilom bo v vseh državah članicah, kjer bo zdravilo Cerdelga na trgu, vse bolnike, ki jim bo predpisano zdravilo Cerdelga, oskrbel z opozorilno kartico za bolnika.
The MAH shall ensure that in each Member State where IMLYGIC is marketed, a system aimed to control distribution to IMLYGIC beyond the level of control ensured by routine risk minimisation measures.
Imetnik dovoljenja za promet mora zagotoviti, da bodo v vsaki državi članici, ki bo tržila zdravilo IMLYGIC, imeli sistem, namenjen za nadzor nad distribucijo zdravila IMLYGIC, ki presega raven nadzora, ki je zagotovljena z rutinskimi ukrepi za zmanjšanje tveganja.
The MAH shall ensure that in each Member State where IMLYGIC is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense and use IMLYGIC have access to/are provided with the following educational package:
Imetnik dovoljenja za promet mora zagotoviti, da bodo v vsaki državi članici, ki bodo tržila zdravilo IMLYGIC, vsi zdravstveni delavci in bolniki/negovalci, od katerih se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo IMLYGIC, imeli dostop do/prejeli sledeče izobraževalne pakete:
The MAH shall ensure that in each Member State where KEYTRUDA is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe and use KEYTRUDA have access to/are provided with the following educational package:
Imetnik dovoljenja za promet mora zagotoviti, da bodo v vseh državah članicah, kjer bo zdravilo KEYTRUDA na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali in uporabljali zdravilo KEYTRUDA, imeli dostop do/prejeli naslednji izobraževalni paket:
The MAH shall ensure that in each Member State where Mysimba is marketed, all healthcare professionals who are expected to prescribe Mysimba are provided with a prescriber guide.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da v vsaki državi članici, kjer se zdravilo Mysimba trži, vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Mysimba, prejmejo navodila za predpisovalce zdravila.
The MAH shall ensure that in each Member State where Nivolumab BMS is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Nivolumab BMS have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, v kateri bo tržil zdravilo Nivolumab BMS, zagotoviti, da bodo vsi zdravstveni delavci, ki bodo predpisovali zdravilo Nivolumab BMS, in bolniki/osebe, ki zanje skrbijo, ki bodo zdravilo uporabljali, imeli dostop/bodo prejeli naslednji izobraževalni paket:
The MAH shall ensure that in each Member State where Scenesse is marketed, all healthcare professionals who are expected to use the product are provided with the following educational package and trained:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vsaki državi članici, kjer je v prometu zdravilo Scenesse, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo, prejeli naslednji izobraževalni paket in usposabljanje:
The MAH shall ensure that in each Member State where Strensiq is marketed all patients/parents or caregivers who are expected to use Strensiq are provided with the following educational package:
MAH bo zagotovil, da bodo v vseh državah članicah, kjer se trži zdravilo Strensiq, imeli vsi bolniki in njihovi starši ali skrbniki, za katere se pričakuje, da bodo uporabljali zdravilo Strensiq, na voljo naslednji izobraževalni paket:
The MAH shall ensure that in each Member State where Toujeo 300 units/ml is marketed, all healthcare professionals (HCPs) who are expected to prescribe or dispense Toujeo 300 units/ml, as well as all patients or their carers who are expected to use Toujeo 300 units/ml, are provided with educational material to address the risk(s) of Medication error (switching between 100 units/ml and 300 units/ml without dose adjustment).
Imetnik dovoljenja za promet bo v vseh državah članicah, kjer bo na trgu zdravilo Toujeo 300 enot/ml, poskrbel, da bodo vsi zdravstveni delavci, ki bodo predvidoma predpisovali ali izdajali zdravilo Toujeo 300 enot/ml, ter vsi bolniki ali njihovi negovalci, ki bodo predvidoma uporabljali zdravilo Toujeo 300 enot/ml, prejeli izobraževalno gradivo, ki bo obravnavalo tveganje/tveganja za napake z zdravilom (prehod med zdravilom s 100 enot/ml in zdravilom s 300 enot/ml brez prilagoditve odmerka).
The MAH shall ensure that in each MS where Cellcept is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Cellcept are provided with the following educational package:
Imetnik dovoljenja za promet mora zagotoviti, da v vseh državah članicah, kjer je zdravilo CellCept na tržišču, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo CellCept, prejeli naslednja izobraževalna gradiva: