natgillin/translations-raw huggingface dataset:
the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti v živih živalih ali v živilih ali v drugih proizvodih, pridobljenih iz zdravljenih živali. bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni prisotna.
The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe febrile illness.
Cepljenje s cepivom Tritanrix HepB je treba odložiti pri osebah s hujšimi akutnimi vročinskimi boleznimi.
The administration of Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness.
Cepljenje s cepivom Twinrix za odrasle je treba odložiti pri osebah, ki imajo težjo akutno vročinsko bolezen.
The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe febrile illness.
Cepljenje s cepivom Twinrix za otroke je treba odložiti pri osebah, ki imajo težjo akutno vročinsko bolezen.
The administration of two concurrent Xiapex injections into Dupuytren’s cords in the same hand was evaluated in clinical study AUX-CC-867, a historically-controlled, open-label multi-centre trial in 715 adult subjects (1450 Xiapex injections) with Dupuytren’s contracture.
Dajanje dveh sočasni injekcij zdravila Xiapex v Dupuytrenove vozličke v isto roko so ocenili v klinični študiji AUX-CC-867, z obstoječimi podatki nadzorovanem, odprtem multicentričnem preskušanju s 715 odraslimi osebami (1.450 injekcij zdravila Xiapex) z Dupuytrenovo kontrakturo.
The administration of vandetanib with substances known to prolong the ECG QTc interval is contraindicated or not recommended (see sections 4.3 and 4.5).
Dajanje vandetaniba skupaj z zdravili, ki podaljšajo interval QTc je kontraindicirano ali pa ni priporočljivo (glejte poglavji 4.3 in 4.5).
The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
Injicirati je treba izmenično levo in desno v anterolateralni ali posterolateralni predel trebušne stene.
The administration system also includes a power pack (plastic), a body sensor (plastic) and a body interface (polyethylene carrier with acrylic adhesive).
Aplikacijski sistem vsebuje tudi napajalnik (iz plastike), senzor telesa (iz plastike) in vmesnik za povezavo s telesom (polietilenski nosilec z akrilnim lepilom).
The administration system and the battery should be disposed of in accordance with local requirements.
Aplikacijski sistem in baterijo je treba zavreči v skladu z lokalnimi predpisi.
The administration system cannot be restarted once this error occurs.
Če pride do te napake, aplikacijskega sistema ni mogoče ponovno zagnati.
The administration system contains 600 mg of trastuzumab in 5 mL.
Aplikacijski sistem vsebuje 600 mg trastuzumaba v 5 ml.
The administration system is for single use only.
Aplikacijski sistem je samo za enkratno uporabo.
The administration system is for single-use only.
Aplikacijski sistem je le za enkratno uporabo.
The administration system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Aplikacijski sistem je namenjen za uporabo v elektromagnetnem polju, v katerem so morebitne motnje zaradi RF valovanj pod nadzorom.
The administration system is intended for use in the electromagnetic environment specified below.
Aplikacijski sistem je namenjen uporabi v spodaj navedenem elektromagnetnem okolju.
The administration system is suitable for use in all establishments, including domestic establishments.
Aplikacijski sistem je primeren za uporabo v vseh okoljih, tudi v domačem okolju.
The administration system should not be allowed to come into contact with water.
Aplikacijski sistem ne sme priti v stik z vodo.
The administration system should not be exposed to direct sunlight or warmed up in any other way (e.g. heat source exposure), as this can degrade the medicine.
Ne izpostavljajte ga neposredni sončni svetlobi in ga ne segrevajte kakor koli drugače (npr. z izpostavitvijo virom toplote), saj lahko to razgradi zdravilo.
The administration system should not be used if it has been dropped, or if it is visibly damaged.
Aplikacijskega sistema se ne sme uporabljati, če je padlo na tla ali je vidno poškodovano.
The administration system should not be used near powerful sources of electromagnetic radiation such as X-ray and MRI equipment in a medical facility.
Aplikacijskega sistema ne smemo uporabljati blizu močnih virov elektromagnetnega sevanja, kot so naprave za rentgensko in magnetnoresonančno slikanje v zdravstveni ustanovi.
The administration system uses RF energy only for its internal function.
Aplikacijski sistem uporablja energijo RF le za svoje notranje funkcije.
The admixture of Torisel in sodium chloride 9 mg/ml (0.9%) solution for injection should be protected from excessive room light and sunlight.
Mešanico zdravila Torisel ter raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje morate zavarovati pred močno sobno in sončno svetlobo.
The admixture should be mixed by inversion of the bag or bottle, avoiding excessive shaking, as this may cause foaming.
Nastalo raztopino premešajte z obračanjem vrečke ali steklenice, ne stresajte preveč, da ne bo nastala pena.
The admixture should be mixed by inversion of the bag or bottle, avoiding excessive shaking, as this may cause foaming.
Premešajte pripravljeno raztopino z obračanjem vrečke ali steklenice, ne stresajte preveč, da ne bo nastala pena.
The ADRs are listed by system organ class (SOC) and frequency.
Neželeni učinki so razvrščeni po organskih sistemih in po pogostnosti.
The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”.
Neželeni učinki ugotovljeni v obdobju trženja, za katere pogostnosti ni mogoče oceniti, so navedeni pod „neznana pogostnost“.
The ADRs in1871 patients treated with trastuzumab emtansine are presented in Table 6.
Neželeni učinki pri 1871 bolnikih, zdravljenih s trastuzumabom emtanzinom, so prikazani v preglednici 6.
The ADRs reported in fourtrials are summarised and categorised according to the MedDRA system organ class and frequency below.
Neželeni učinki, o katerih so poročali v teh štirih preskušanjih, so glede na organski sistem in pogostnost povzeti ter razporejeni po MedDRA klasifikaciji.
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Odmerek tablet zdravila Kaletra za odrasle (400/100 mg dvakrat na dan) lahko uporabite pri otrocih, ki tehtajo 40 kg ali več ali imajo telesno površino* večjo od 1,4 m2.
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Pri otrocih s telesno maso 40 kg ali več ali s telesno površino* več kot 1,4 m2 se lahko uporabi odmerek tablet zdravila Kaletra za odrasle (400/100 mg dvakrat na dan).
The adult dose of lopinavir/ritonavir tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2.
Odmerek tablet lopinavir/ritonavir za odrasle (400 mg/100 mg dvakrat na dan) lahko uporabite pri otrocih, ki tehtajo 40 kg ali več ali imajo telesno površino* večjo od 1,4 m2.
The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
Za otroke s telesno maso vsaj 39 kg, ki lahko pogoltnejo tablete, lahko uporabite odmerek za odrasle: 700 mg zdravila Telzir v tabletah dvakrat na dan in 100 mg ritonavirja dvakrat na dan.
The adult effective dose resulting from the administration of a maximal recommended activity of 185 MBq dose for an adult weighing 70 kg is approximately 5.9 mSv.
Učinkoviti odmerek pri odraslem po dajanju odmerka največje priporočene aktivnosti 185 MBq za odraslo osebo, ki tehta 70 kg je približno5,9 mSv.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) imatiniba na dan.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) zdravila Imatinib Actavis na dan.
The adult patients reported in the published literature were treated with either 400 mg (4cases) or 800 mg (1case) imatinib daily.
Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v
The adult studies of peginterferon alfa-2a in combination with telaprevir and ribavirin or with boceprevir and ribavirin showed that these combinations significantly increased the proportion of patients who responded to treatment compared with peginterferon alfa-2a plus ribavirin.
Študije na odraslih, pri katerih so se kombinirala zdravila peginterferon alfa-2a s telaprevirom in ribavirinom oziroma z boceprevirom in ribavirinom so pokazale, da se je delež bolnikov, ki so se odzvali na zdravljenje s temi kombinacijami, precej višji od števila bolnikov, ki so se odzvali na zdravljenje s kombinacijo peginterferona alfa-2a in ribavirina.
The ADVANCE MPI 1 and ADVANCE MPI 2 studies, individually and combined, demonstrated that Rapiscan is similar to adenosine in assessing the extent of reversible perfusion abnormalities:
Študiji ADVANCE MPI 1 in ADVANCE MPI 2 sta posamično in kombinirano pokazali, da je zdravilo Rapiscan podobno adenozinu pri ocenjevanju obsega reverzibilnih perfuzijskih abnormalnosti:
The adverse drug reactions (ADRs) described in this section were identified during treatment and follow up in the two pivotal clinical studies, BO21004/CLL11, N=781, and GAO4753g, N=396 patients, in previously untreated CLL patients, and indolent Non Hodgkin Lymphoma (iNHL) patients (81.1% of the patients had FL) who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Neželene učinke, opisane v tem poglavju, so ugotovili med zdravljenjem in spremljanjem v dveh ključnih kliničnih študijah BO21004/CLL11, n = 781, in GAO4753g, n = 396 bolnikov pri predhodno nezdravljenih bolnikih s KLL in bolnikih z indolentnim ne-Hodgkinovim limfomom (iNHL) (81,1 % bolnikov je imelo FL), pri katerih ni bilo odziva ali pri katerih se je bolezen ponovila v 6 mesecih po zdravljenju z rituksimabom ali shemami, ki vsebujejo rituksimab.
The adverse drug reactions (ADRs) most frequently reported in clinical trials were insomnia, headache, anxiety, upper respiratory tract infection, injection site reaction, parkinsonism, weight increased, akathisia, agitation, sedation/somnolence, nausea, constipation, dizziness, musculoskeletal pain, tachycardia, tremor, abdominal pain, vomiting, diarrhoea, fatigue, and dystonia.
Najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so bili nespečnost, glavobol, anksioznost, okužba zgornjih dihal, reakcija na mestu injiciranja, parkinsonizem, zvečana telesna masa akatizija, agitacija, sedacija/somnolenca, navzea, obstipacija, omotica, mišično-skeletna bolečina, tahikardija, tremor, bolečina v trebuhu, bruhanje, driska, utrujenost in distonija.
The adverse drug reactions are ranked by frequency with the most frequent reactions first.
Neželeni učinki zdravila so razvrščeni po pogostnosti, pri čemer so najpogostejši neželeni učinki našteti prvi.
The adverse drug reactions are ranked by frequency with the most serious reactions first.
Neželeni učinki zdravila so razvrščeni po pogostnosti, pri čemer so najresnejši neželeni učinki našteti prvi.
The adverse drug reactions observed from the 533 patients with metastatic colorectal cancer, treated with a starting dose of 35 mg/m2/dose of Lonsurf, in the placebo-controlled Phase III (RECOURSE) clinical trial, are shown in Table 5.
Neželeni učinki, o katerih so poročali pri 533 bolnikih z metastatskim kolorektalnim rakom, zdravljenih z začetnim odmerkom 35 mg/m2/odmerek zdravila Lonsurf v preskušanju III. faze (RECOURSE), nadzorovanem s placebom, so navedeni v Preglednici 5.
The adverse drug reactions reported in the table below are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Neželeni učinki v preglednici so dogodki, ki so se pojavili pri 0,1 % ali več s pramipeksolom zdravljenih bolnikov, in so o njih poročali značilno pogosteje pri bolnikih, ki so jemali pramipeksol, kot pri bolnikih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
The adverse drug reactions reported in the table below are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Neželeni učinki v spodnji preglednici so dogodki, ki so se pojavili pri 0,1 % ali več s pramipeksolom zdravljenih bolnikov, in so o njih poročali značilno pogosteje pri bolnikih, ki so jemali pramipeksol, kot pri bolnikih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
The adverse drug reactions reported in these tables are those events that occurred in 0.1 % or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Neželeni učinki v preglednicah, o katerih so poročali, so dogodki, ki so se pojavili pri 0,1 % s pramipeksolom zdravljenih bolnikov ali več, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali pramipeksol, kot pri tistih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Neželeni učinki v preglednicah, o katerih so poročali, so dogodki, ki so se pojavili pri 0,1 % s pramipeksolom zdravljenih bolnikov ali več, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali pramipeksol, kot pri tistih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
Neželeni učinki zdravila, o katerih so poročali z idelalizibom samim ali v kombinaciji z monoklonskimi protitelesi proti CD20 (rituksimabom ali ofatumumabom), so navedeni v preglednici 2.
The adverse drug reactions were determined based on data from the apremilast clinical development programme.
Neželene učinke zdravila so določili na podlagi podatkov, pridobljenih v programu kliničnega razvoja apremilasta.
The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
Profil neželenih učinkov topotekana v kliničnih preskušanjih kombinirane terapije raka materničnega vratu s cisplatinom je bil enak kot pri monoterapiji s topotekanom.
The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
Profil neželenih dogodkov iz teh študij v celoti gledano ne kaže razlik od tistega, ki so ga ugotovili v študijah revmatoidnega artritisa.
The adverse event profile of ofatumumab in bulky fludarabine refractory CLL patients who had failed at least 2 prior therapies was consistent with the overall established safety profile from other CLL studies, as described in the tabulated list below.
Pri masivni, proti fludarabinu odporni KLL se je profil neželenih učinkov ofatumumaba pri bolnikih z vsaj 2 neuspešnima predhodnima zdravljenjema skladal s celotnimi varnostnimi značilnostmi, ugotovljenimi v drugih študijah KLL, kot je opisano v tabelaričnem seznamu spodaj.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
Neželeni učinki, opaženi v študiji farmakokinetike in prenašanja, v kateri so sodelovali bolniki, stari od 3 mesecev do 16 let (N = 65), so bili podobni tistim pri odraslih.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
Neželeni učinki, opaženi v študiji farmakokinetike in prenašanja, v kateri so sodelovali bolniki, stari od 3 mesecev do 16 let (n=65), so bili podobni tistim pri odraslih.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) were similar to those observed in adults.
Neželeni učinki,opaženiv študiji farmakokinetikeinprenašanja,v kateri so sodelovali bolniki, stariod 3 mesecev do16 let(N = 65),so bili podobni tistimpri odraslih.
The adverse reaction described in this section is gathered from a combination of adverse reactions from clinical trial data and the post-marketing experience of Oncaspar in ALL patients.
Neželeni učinki, opisani v tem poglavju, so zbrani z združevanjem neželenih učinkov iz podatkov kliničnih preskušanj in neželenih učinkov, ugotovljenih v obdobju trženja zdravila Oncaspar, pri bolnikih z akutno limfoblastno levkemijo (ALL).
The Adverse Reaction Management Guide shall contain the following key elements:
Priročnik za ukrepanje v primeru pojava neželenih učinkov mora vsebovati naslednje ključne elemente:
The adverse reaction most commonly leading to discontinuation (≥2% in the perampanel group and greater than placebo) was dizziness.
Neželeni učinek, ki je najpogosteje povzročil prekinitev jemanja (≥ 2 % v skupini, ki je prejemala perampanel, in pogostejši kot v skupini s placebom), je bila omotica.
The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medicinal products.
Profil neželenih učinkov, povezan z imunosupresivi, je pogosto težko ugotoviti zaradi osnovne bolezni in sočasne uporabe več zdravil.
The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil fumarate in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Profil neželenih učinkov efavirenza, emtricitabina in dizoproksiltenofovirijevega fumarata pri bolnikih, sočasno okuženih z virusoma HIV in HBV ali virusoma HIV in HCV, je bil podoben profilu, ki so ga opazili pri bolnikih, okuženih z virusom HIV, ki pa niso sočasno okuženi z drugim virusom.
The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIV- infected patients in study GS-01-934 who were co-infected with HBV (n=13) or HCV (n=26) was similar to that observed in patients infected with HIV without co-infection.
Neželeni učinki emtricitabina in dizoproksiltenofovirata v študiji GS-01-934 pri omejenem številu bolnikov s HIV, ki so bili hkrati okuženi še s HBV (n=13) ali HCV (n=26), so bili podobni tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe.
The adverse reaction profile of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Neželeni učinki emtricitabina, rilpivirinijevega klorida in dizoproksiltenofovirijevega fumarata pri bolnikih, ki so hkrati okuženi še s HIV/HBV ali HIV/HCV, so bili podobni tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe.
The adverse reaction profile of Telzir should be borne in mind when considering the patient’s ability to drive or operate machinery (see section 4.8).
Pri presojanju bolnikovih sposobnosti za vožnjo in upravljanje s stroji je potrebno upoštevati profil neželenih reakcij zdravila Telzir (glejte poglavje 4.8).
The adverse reaction profile of tolvaptan in the ADPKD indication is based on a clinical trial database of 1444 treated patients (961 patients treated with tolvaptan, 483 treated with placebo) and is consistent with the pharmacology of the active substance.
Profil neželenih učinkov tolvaptana za indikacijo ADPKD temelji na zbirki podatkov kliničnih preskušanj 1.444 zdravljenih bolnikov (961 bolnikov, zdravljenih s tolvaptanom, 483 bolnikov s placebom), in ustreza farmakologiji zdravilne učinkovine.
The adverse reaction profile of tolvaptan is based on a clinical trials database of 3294 tolvaptan- treated patients and is consistent with the pharmacology of the active substance.
Profil neželenih učinkov tolvaptana temelji na podatkovni bazi kliničnih preskušanj 3294 bolnikov, ki so prejemali tolvaptan, in ustreza farmakologiji zdravilne učinkovine.
The adverse reaction profile presented below is based on the analysis of pooled placebo- controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Profil neželenih učinkov, ki je opisan spodaj, temelji na analizi združenih s placebom nadzorovanih kliničnih preskušanj za vse preučevane indikacije, v katerih so z levetiracetamom zdravili 3416 bolnikov.
The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Profil neželenih učinkov, ki je opisan spodaj, temelji na analizi združenih, s placebom nadzorovanih kliničnih preskušanj za vse preučevane indikacije, v katerih so z levetiracetamom zdravili 3.416 bolnikov.
The adverse reaction rates reported after either vaccination dose (i.e.
Stopnje neţelenih učinkov, o katerih so poročali po kateremkoli odmerku cepljenja (tj.
The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤18 years of age) than in adults.
Med neželenimi učinki, poročanimi v postmarketinških raziskavah, se pri otrocih in mladostnikih (starih  18 let) v primerjavi z bolniki starimi >18 let, relativno pogosteje pojavljajo reakcije na mestu injiciranja (bolečina na injekcijskem mestu, reakcija na mestu injiciranja) in kožne reakcije (srbenje, urtikarija).