natgillin/translations-raw huggingface dataset:
Prior to initiation of dapagliflozin and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Pred začetkom zdravljenja z dapagliflozinom in nato vsaj enkrat letno (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
Prior to initiation of Ilaris therapy it is recommended that adult and paediatric patients receive all vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine (see section 4.5).
Priporočeno je, da odrasli in pediatrični bolniki že pred začetkom zdravljenja z zdravilom Ilaris opravijo vsa cepljenja, ki jih potrebujejo, tudi cepljenje proti pnevmokoku in cepljenje z inaktiviranim virusom gripe (glejte poglavje 4.5).
Prior to initiation of Revolade, examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities.
Pred uvedbo zdravila Revolade je treba natančno pregledati razmaz periferne krvi za ugotovitev izhodiščne ravni morfoloških nepravilnosti celic.
Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of the solution at 25 μg/ml.
Pred začetkom terapije mora biti implantacijska črpalka trikrat izprana z 2 ml zdravila Prialt v koncentraciji 25 µg/ml.
Prior to initiation of this medicinal product and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Pred uvedbo tega zdravila in vsaj enkrat na leto po uvedbi (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
Prior to initiation of treatment
pred začetkom zdravljenja
Prior to initiation of treatment and at least yearly thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Pred uvedbo zdravljenja in nato vsaj enkrat na leto (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
Prior to initiation of treatment, patient’s cardiovascular status including heart rate and blood pressure parameters, family history of sudden cardiac death /unexplained death, should be assessed to identify patients at increased risk of hypotension, bradycardia, and QT-prolongation/risk of arrhythmia.
Pred uvedbo zdravila moramo oceniti bolnikov kardiovaskularni status, vključno s parametri srčne frekvence in krvnega tlaka ter z rodbinsko anamnezo nenadne srčne smrti/ smrti iz neznanega vzroka, da bomo ugotovili, pri katerih bolnikih je zvečano tveganje hipotenzije, bradikardije in podaljšanja intervala QT/aritmije.
Prior to injection you may need to shave any hair around the injection site to facilitate the fixing and removal of the adhesive pad and ensure that the administration system is firmly attached to your thigh.
Pred injiciranjem bo morda v okolici mesta injiciranja treba obriti dlake, da se olajša pritrditev in odstranitev lepljive podlage aplikacijskega sistema in zagotovi, da je aplikacijski sistem trdno pritrjen na stegno.
Prior to injection, change the needle for one suitable for the administration.
Pred injiciranjem zamenjajte iglo in namestite iglo, primerno za injiciranje.
Prior to launch in any EU Member State, the MAH will set up an immunosurveillance programme and provide antibody testing for anti-ATryn antibodies to physicians.
Pred začetkom trženja v katerikoli državi članici EU bo imetnik dovoljenja za promet z zdravilom vzpostavil program nadziranja delovanja imunskega statusa in zdravnikom omogočil testiranje na protitelesa proti zdravilu ATryn.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme for Health Care Professionals (HCP) and patients with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se pred začetkom trženja s pristojnim nacionalnim organom v vsaki državi članici dogovori o izobraževalnem programu za zdravstvene delavce in bolnike.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) dogovoriti s pristojnim nacionalnim organom glede izobraževalnega programa.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the educational material with the National Competent Authority.
Pred prihodom zdravila na trg mora Imetnik dovoljenja za promet z zdravilom v vsaki državi članici od Nacionalnega pristojnega organa pridobiti soglasje za izobraževalno gradivo.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se bo pred prihodom na trg dogovoril z nacionalnim regulatornim organom v vsaki državi članici o končni verziji izobraževalnega gradiva.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora pred začetkom trženja zdravila dogovoriti s pristojnim nacionalnim organom v vsaki državi članici o vsebini končnega izobraževalnega gradiva.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Pred prihodom zdravila na trg v vsaki državi članici se bo imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoril za končno različico izobraževalnega gradiva.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Pred začetkom trženja v vsaki državi članici se mora imetnik dovoljenja za promet ( MAH) s pristojnim organom dogovoriti glede končnega izobraževalnega materiala.
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using Enbrel.
Imetnik dovoljenja za promet z zdravilom se mora pred pričetkom trženja napolnjenega peresnika v vsaki državi članici s pristojnim organom v tej državi dogovoriti glede končnega izobraževalnega gradiva, sestavljenega iz informacij za predpisovalce glede pravilne in varne uporabe napolnjenega peresnika, ter opozorilne kartice za bolnika, ki jo morajo izročiti bolnikom, ki se zdravijo z zdravilom Enbrel.
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State, consisting of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen/pre- filled syringes and to inform them that the product is not for paediatric use, and a Patient Alert Card which is to be given to patients using Benepali.
Pred prihodom na trg v vsaki državi članici se bo imetnik dovoljenja za promet s pristojnim organom v državi članici dogovoril glede končnega izobraževalnega gradivo, ki ga bodo sestavljale informacije za vse zdravstvene delavce, za katere se pričakuje, da bodo zdravilo predpisovali, glede pravilne in varne uporabe napolnjenih injekcijskih peresnikov in napolnjenih injekcijskih brizg, z obvestilom o neprimernosti zdravila za pediatrično uporabo, in opozorilno kartico za bolnika, ki jo bo pred uporabo zdravila Benepali prejel bolnik.
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State, consisting of information provided to all healthcare professionals expected to prescribe the product.
Pred začetkom trženja v vsaki od držav članic se bo imetnik dovoljenja za promet s pristojnim organom v tej državi članici dogovoril o končni obliki izobraževalnih materialov z informacijami, ki bodo podane vsem zdravstvenim delavcem, za katere se pričakuje, da bodo predpisovali zdravilo.
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State.
Pred dajanjem zdravila v promet v posameznih državah članicah mora imetnik dovoljenja za promet v sodelovanju s pristojnim organom v zadevni državi članici pripraviti končno izobraževalno gradivo.
Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se bo o formatu in vsebini navodila za zdravnika dogovoril s pristojno nacionalno agencijo pred začetkom prodaje zdravila v državi članici.
Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se bo pred začetkom prodaje zdravila v državi članici o vsebini in obliki izobraževalnega gradiva dogovoril z nacionalnim pristojnim organom.
Prior to launch in Member States, the MAH shall establish a disease registry to gather long term safety data and outcome endpoints in patients with EPP.
Pred dajanjem zdravila v promet v državah članicah bo imetnik dovoljenja za promet vzpostavil register bolezni, s katerim bo zbiral dolgoročne varnostne podatke in opazovane dogodke pri bolnikih z EPP.
Prior to launch of BLINCYTO in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Še pred začetkom trženja zdravila BLINCYTO v vsaki državi članici, se mora imetnik dovoljenja za promet z zdravilom uskladiti z nacionalnimi pristojnimi organi o vsebini in obliki izobraževalnih gradiv, vključno s komunikacijskimi mediji, načini distribucije in vseh drugih vidikov gradiv.
Prior to launch of Cerdelga in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Cerdelga na trg v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načinom distribucije in morebitnimi drugimi vidiki programa.
Prior to launch of IMLYGIC in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Še pred začetkom trženja zdravila IMLYGIC v vsaki državi članici, se mora imetnik dovoljenja za promet z zdravilom uskladiti z nacionalnimi pristojnimi organi o vsebini in obliki izobraževalnih gradiv in programu nadzorovane distribucije, vključno s komunikacijskimi mediji, načini distribucije in vseh drugih vidikov gradiv in programa.
Prior to launch of KEYTRUDA in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred začetkom trženja zdravila KEYTRUDA v vsaki posamezni državi članici mora imetnik dovoljenja za promet pridobiti soglasje pristojnega nacionalnega organa glede vsebine in oblike izobraževalnega programa, vključno o sredstvih obveščanja, načinom obveščanja in vseh drugih vidikih programa.
Prior to launch of OPDIVO in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred začetkom trženja zdravila OPDIVO mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načinom distribucije in vseh drugih vidikih programa.
Prior to launch of Portrazza (necitumumab) in each Member State the MAH must agree about the content and format of the educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred pričetkom trženja zdravila Portrazza (necitumumab) se mora imetnik dovoljenja za promet v vsaki državi članici strinjati z vsebino in obliko izobraževalnega gradiva, vključno s sredstvi komunikacije, načini razširjanja in vsemi drugimi vidiki programa, s pristojnim nacionalnim organom.
Prior to launch of Provenge in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational materials with the National Competent Authority.
Pred lansiranjem zdravila Provenge v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom (MAH) dobiti soglasje pristojnega državnega organa za vsebino in obliko izobraževalnega gradiva.
Prior to launch of Scenesse in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational package, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Pred dajanjem zdravila Scenesse v promet v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom v sodelovanju z nacionalnim pristojnim organom pripraviti vsebino in obliko izobraževalnega paketa, vključno s komunikacijskimi mediji, načini razdeljevanja in kakršnimi koli drugimi vidiki.
Prior to launch of Strimvelis in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for parents/carers and health professionals, restricted prescription details and controlled access/product consent form, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Strimvelis na trg v posamezni državi članici mora imetnik dovoljenja za promet (MAH) s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnih gradiv za starše/negovalce in zdravstvene delavce, podrobnosti o omejenem predpisovanju in obrazec soglasja o nadzorovanem dostopu/zdravilu, vključno s komunikacijskimi mediji, načinom distribucije in morebitnimi drugimi vidiki programa.
Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Pred prihodom zdravila na trg v posameznih državah članicah morata imetnik dovoljenja za promet z zdravilom in nacionalni pristojni organ soglašati z vsebino in obliko izobraževalnega materiala.
Prior to launch of the new indication of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Pred uvedbo nove indikacije za zdravilo v državi članici, naj imetnik dovoljenja za promet z zdravilom pridobi soglasje o vsebini in obliki izobraževalnega gradiva od pristojnega nacionalnega organa.
Prior to launch of the product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora, preden da zdravilo v promet, v vsaki posamezni državi članici z nacionalnimi pristojnimi organi dogovoriti glede vsebine in oblike izobraževalnega gradiva.
Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se mora pred dajanjem zdravila v promet v posamezni državi članici z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva.
Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Pred prihodom zdravila na tržišče v vsaki državi članici se bo imetnik dovoljenja za promet dogovoril glede vsebine in oblike izobraževalnega gradiva z nacionalnim organom, pristojnim za zdravila.
Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Pred uvedbo zdravila na trg v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom uskladiti vsebino in obliko izobraževalnega gradiva z nacionalnim pristojnim organom.
Prior to launch of Toujeo 300 units/ml in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Pred prihodom zdravila Toujeo 300 enot/ml na trg v posamezni državi članici mora imetnik dovoljenja za promet (MAH) s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načinom distribucije in morebitnimi drugimi vidiki.
Prior to launch of Zalmoxis in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for the Health Care Professionals (HCPs), with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se bo o obliki in vsebini izobraževalnega gradiva za zdravstvene delavce dogovoril s pristojnim nacionalnim organom pred prihodom zdravila na trg v posamezni državi članici.
Prior to launch of Zalviso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred sprostitvijo zdravila Zalviso na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) uskladiti glede vsebine in oblike izobraževalnega programa, vključno z sredstvi obveščanja, načini distribucije in kakršnimi koli drugimi vidiki programa s pristojnimi državnimi organi.
Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below.
Pred uvedbo zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Pismo za zdravstvene delavce, kot je opisano spodaj;
Prior to launch, the Marketing Authorisation Holder (MAH) shall set up a patient registry to investigate the long term safety, health outcomes and patterns of utilisation of defibrotide during normal use.
Pred dajanjem v promet mora imetnik dovoljenja za promet z zdravilom vzpostaviti register bolnikov, da se bodo lahko proučili dolgoročna varnost, zdravstveni izidi in vzorci uporabe defibrotida med normalno uporabo.
Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
Pri bolnikih, ki se zaradi tromboprofilakse zdravijo ali se bodo zdravili z antikoagulanti, je pred nevroaksialnimi posegi treba skrbno ovrednotiti vsa možna tveganja in koristi takih posegov.
Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’s Kit containing the following:
Pred predpisovanjem prejmejo vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje:
Prior to radiolabelling, inspect the tilmanocept powder vial for any damage.
Pred označevanjem preglejte vialo s praškom tilmanocepta in se prepričajte, da ni poškodovana.
Prior to radiolabelling, write the radioactivity amount, the reconstituted vial volume, date and time, expiration time and lot number in the space provided on the radioactive product vial label and affix it to the tilmanocept powder vial.
Pred radiooznačevanjem na prostor na nalepki viale z radioaktivnim zdravilom zabeležite količino radioaktivnosti, rekonstituirano prostornino, datum in čas, rok uporabnosti ter številko serije in nalepko nalepite na vialo s praškom tilmanocepta.
Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the haemoglobin concentration (the "set-point") which would define each patient’s haemoglobin stabilization and transfusion outcomes.
Pred randomizacijo so bili vsi bolniki na uvodnem opazovanju, da bi tako lahko potrdili potrebo po transfuziji eritrocitov in ugotovili koncentracijo hemoglobina (»nastavitveno točko«), ki bi naj določila stabilizacijo hemoglobina pri posameznem bolniku ter izide transfuzij(e).
Prior to randomization, OBT were selected by the investigator based on the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance testing.
Pred randomizacijo so raziskovalci določili OBT na osnovi bolnikovega predhodnega zdravljenja in na osnovi testiranja genotipske in fenotipske odpornosti virusa.
Prior to Ranexa treatment
Pred zdravljenjem z zdravilom Ranexa
Prior to reconstitution, do not store above 25°C. Store in the original package in order to protect from light.
Pred rekonstitucijo shranjujte pri temperaturi do 25 °C. Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Prior to reconstitution, do not store above 25°C. Store in the original package, in order to protect from light.
Pred rekonstitucijo shranjujte pri temperaturi do 25 °C. Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Pred pripravo je viala z liofiliziranim praškom lahko do 24 ur zunaj hladilnika (temperatura 25 °C ali manj).
Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators.
Pred obdobjem uvajanja so bolniki prenehali uporabljati predhodna zdravila za KOPB razen kratkodelujočih bronhodilatatorjev.
Prior to Simponi treatment:
Pred zdravljenjem z zdravilom Simponi:
Prior to starting treatment for apnoea of prematurity with Peyona other causes of apnoea should have been excluded or properly treated by your baby’s doctor.
Pred začetkom zdravljenja apneje z zdravilom Peyona zaradi prezgodnjega rojstva je treba druge vzroke za apnejo izključiti ali jih mora otrokov zdravnik ustrezno pozdraviti.
Prior to study enrollment, diagnosis of BCC was confirmed by histology.
Pred vključitvijo v študijo je bila diagnoza bazalnoceličnega karcinoma potrjena histološko.
Prior to study enrolment, diagnosis of BCC was confirmed by histology.
Pred vključitvijo v študijo so diagnozo bazalnoceličnega karcinoma potrdili histološko.
Prior to taking the medicine, please inform your doctor if you are breast-feeding.
Prosimo, da pred uporabo zdravila obvestite svojega zdravnika, če dojite.