natgillin/translations-raw huggingface dataset:
Therapy with medicines which help to suppress the body’s natural defence mechanisms can increase the risk for developing malignancies or infections.
Zdravljenje z zdravili, ki pomagajo zavreti naraven obrambni mehanizem telesa, lahko poveča tveganje za razvoj malignosti ali okužb.
Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be considered.
Zdravljenje z več antiepileptičnimi zdravili spremlja večje tveganje za prirojene malformacije kot monoterapijo, zato je treba razmisliti o monoterapiji.
Therapy with Myocet causes myelosuppression.
Zdravljenje z zdravilom Myocet povzroča mielosupresijo.
Therapy with pasireotide should be discontinued if the patient develops jaundice or other signs suggestive of clinically significant liver dysfunction, in the event of a sustained increase in AST (aspartate aminotransferase) or ALT of 5 x ULN or greater, or if ALT or AST elevations greater than 3 x ULN occur concurrently with bilirubin elevations greater than 2 x ULN.
Zdravljenje s pasireotidom je treba prekiniti, če pride do ikterusa ali drugih znakov, ki nakazujejo klinično pomembno motnjo delovanja jeter, v primeru vztrajno zvišanih vrednosti AST (aspartat- aminotransferaze) ali ALT do 5-kratnika ZMN ali več ali v primeru, da so sočasno zvišane vrednosti ALT ali AST nad 3-kratnik ZMN in vrednosti bilirubina nad 2-kratnik ZMN.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih s povišanimi izhodiščnimi ravnmi jetrnih encimov (ALT > 2,5-kratna zgornja meja normalnih vrednosti) ali s kakršnimi koli drugimi znaki jetrne bolezni, zdravljenja s pioglitazonom ne smemo začeti.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5 X upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih s povišanimi izhodiščnimi ravnmi jetrnih encimov (ALT > 2,5-kratna zgornja meja normalnih vrednosti) ali s kakršnimi koli drugimi znaki jetrne bolezni, zdravljenja s pioglitazonom ne smemo začeti.
Therapy with SUTENT should be initiated by a physician experienced in the administration of anti-cancer agents.
Zdravljenje z zdravilom SUTENT mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
Therapy with Tandemact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih s povišanimi izhodiščnimi vrednostmi jetrnih encimov (ALT > 2,5- kratna zgornja meja normalnih vrednosti) ali s kakršnimi koli drugimi znaki jetrne bolezni, zdravljenja z zdravilom Tandemact ne smemo začeti.
There appeared to be no difference in percentage responders: saxagliptin 37.9% (saxagliptin) and 38.2% (glimepiride) achieved the primary endpoint.
Odstotek takšnih bolnikov se ni razlikoval: primarni opazovani dogodek je doseglo 37,9 % prejemnikov saksagliptina in 38,2 % prejemnikov glimepirida.
There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults.
Kaže, da je farmakokinetika maropitanta odvisna od starosti živali, pri čemer je očistek pri mladih mačkah večji kot pri odraslih.
There appears to be no resistance development to valnemulin to date by M. hyopneumoniae and L. intracellularis.
Po opažanjih M. hyopneumoniae in L. intracellularis do sedaj nista razvili odpornosti na valnemulin.
There are 2 blister cards in each wallet.
V vsaki zloženki sta dva pretisna omota.
There are 2 phases of treatment with Uptravi: Titration
Zdravljenje z zdravilom Uptravi poteka v 2 fazah: Titriranje
There are 600 IU (44 micrograms) of follitropin alfa in each millilitre of liquid.
V enem mililitru tekočine je 600 i.e. (44 mikrogramov) folitropina alfa.
There are a limited number of studies that have demonstrated that cholic acid administered orally for up to 26 weeks at doses significantly greater than the therapeutic dose, was well tolerated in animals with no mortalities, no effects on bodyweight or food consumption and no evidence of significant macroscopic or microscopic findings in the liver.
Obstaja majhno število študij, ki so pokazale, da so živali holno kislino, ki se je dajala peroralno do 26 tednov v odmerkih, pomembno večjih od terapevtskega odmerka, dobro prenašale brez smrti, brez učinkov na telesno maso ali uživanje hrane ter brez dokazov pomembnih makro- ali mikroskopskih ugotovitev v jetrih.
There are a number of known interactions between non selective MAO inhibitors and other medicinal products.
Obstajajo številne znane interakcije med neselektivnimi inhibitorji MAO in drugimi zdravili.
There are a number of potential side effects that patients should be aware of.
Bolniki morajo biti seznanjenimi z možnimi neželenimi učinki.
There are conflicting data in some comparative studies with Kivexa i.e.
Nekatere primerjalne študije zdravila Kivexa tj.
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil fumarate and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil fumarate without cobicistat.
Na osnovi trenutno razpoložljivih podatkov ni mogoče oceniti, če je sočasna uporaba dizoproksiltenofovirat fumarata in kobicistata morda povezana z večjim tveganjem za pojav neželenih učinkov za ledvice v primerjavi s shemami zdravljenja, ki vključujejo dizoproksiltenofovirat fumarat brez kobicistata.
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil fumarate and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil fumarate without cobicistat.
Trenutni podatki ne zadoščajo za ugotovitev, ali je sočasna uporaba dizoproksiltenofovirat fumarata in kobicistata povezana z večjim tveganjem za ledvične neželene učinke v primerjavi z režimi, ki vključujejo dizoproksiltenofovirat fumarat brez kobicistata.
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil fumarate and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil fumarate without cobicistat.
Trenutno ni dovolj podatkov, da bi ugotovili, ali je sočasna uporaba dizoproksiltenofovirijevega fumarata in kobicistata povezana z večjim tveganjem za neželene učinke na ledvice, v primerjavi z režimi, ki vključujejo dizoproksiltenofovirijev fumarat brez kobicistata.
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil fumarate and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil fumarate without cobicistat.
Zaenkrat ni na voljo zadosti podatkov, da bi lahko ugotovili, ali je sočasna uporaba dizoproksiltenofovirat fumarata in kobicistata povezana z večjim tveganjem za ledvične neželene učinke kot režimi, ki vključujejo dizoproksiltenofovirat fumarat brez kobicistata.
There are currently insufficient data available for the use of Mycamine in patients with severe hepatic impairment and its use is not recommended in these patients (see section 4.4 and 5.2).
Trenutno ni zadostnih podatkov o uporabi zdravila Mycamine pri bolnikih s hudimi motnjami v delovanju jeter, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavji 4.4 in 5.2).
There are currently insufficient data to evaluate the effects of ATA on the efficacy of Perjeta in combination with trastuzumab and docetaxel.
Trenutno ni na voljo dovolj podatkov, da bi lahko ocenili vplive teh protiteles na učinkovitost zdravila Perjeta v kombinaciji s trastuzumabom in docetakselom.
There are currently no marketed medicinal products known to cause clinically significant drug-drug interactions through inhibition or induction of amidase enzymes.
Trenutno na trgu ni zdravil, za katera bi bilo znano, da povzročajo klinično pomembne interakcije z drugimi zdravili prek inhibicije ali indukcije encimov amidaz.
There are few data available on patients of African origin.
O bolnikih afriškega izvora je na voljo zelo malo podatkov.
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Za bolnike z recidivno- remitentno multiplo sklerozo obstajajo podatki o spremljanju v kontroliranih kliničnih pogojih za obdobje do 5 let, za bolnike s sekundarno progresivno multiplo sklerozo za obdobje do 3 let.
There are four groups:
Obstajajo štiri skupine teh bolnikov:
There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used) and the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too).
Obstajajo pomembna nerešena vprašanja glede razlik med izdelavo in nadzorom v različnih proizvodnih obratih (vključno z lastnostmi uporabljenih jajc) in ni validacijske študije za test moči (potency test) na končnem izdelku (zdi se, da se testi končnega cepiva izvajajo le v Weespu, vendar pa morajo biti testi med postopkom, kakršna sta titracija in količinska opredelitev HA, prav tako enakovredni).
There are individuals with an inherited deficiency of the TPMT enzyme activity who are very sensitive to the myelosuppresive effect of 6–mercaptopurine and prone to developing rapid bone marrow depression following the initiation of treatment with 6–mercaptopurine.
Nekateri ljudje z dedno oslabljenim delovanjem encima TPMT so zelo občutljivi na mielosupresivni učinek 6-merkaptopurina in nagnjeni k hitremu razvoju depresije kostnega mozga po začetku zdravljenja s 6-merkaptopurinom.
There are insufficient clinical data regarding the use of Ketoconazole HRA in pregnant women.
O uporabi zdravila Ketokonazol HRA pri nosečnicah ni zadostnih kliničnih podatkov.
There are insufficient data available to recommend dose modifications of Abraxane in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Na voljo je premalo podatkov, da bi omogočili priporočila za odmerjanje zdravila Abraxane pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo (ocenjeni očistek kreatinina < 30 ml/min) (glejte poglavje 5.2).
There are insufficient data for the withdrawal of concomitant anti epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Ni zadostnih podatkov za ukinitev sočasno uporabljenih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Ni zadostnih podatkov za ukinitev sočasno uporabljenih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Ni zadostnih podatkov za ukinitev sočasnouporabljenih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with Zonegran has been achieved in the add-on situation, in order to reach monotherapy with Zonegran.
Za morebitno monoterapijo z zdravilom Zonegran in ukinitvijo drugih antiepileptičnih zdravil po tem, ko dosežemo nadzor nad napadi, ni dovolj podatkov.
There are insufficient data in this population to support a recommendation for or against dose adjustment.
Za to populacijo je premalo podatkov v podporo prilagoditvi odmerka oz. proti njej.
There are insufficient data on the diagnostic reliability of the Pylobactell test to recommend its use in patients with partial gastrectomy and in patients younger than 18 years (see section 4.2).
Ni zadostnih podatkov o diagnostični zanesljivosti testa Pylobactell, da bi ga lahko priporočali za uporabo pri bolnikih z delno gastrektomijo in bolnikih mlajših od 18 let (glejte poglavje 4.2).
There are insufficient data on the use of artenimol and piperaquine in pregnant women.
Ni dovolj podatkov o uporabi artenimola in piperakina pri nosečnicah.
There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of rufinamide.
O ukinjanju sočasnih antiepileptičnih zdravil, potem ko obvladamo epileptične napade z dodatkom rufinamida, ni na voljo dovolj podatkov.
There are insufficient data regarding the withdrawal of concomitant antiepileptic medicinal products to achieve monotherapy with lacosamide.
O prekinitvi zdravljenja z drugimi antiepileptiki, ki jih bolnik jemlje sočasno, za doseganje monoterapije z lakozamidom, ni na voljo zadostnih podatkov.
There are insufficient data to evaluate Accofil use in elderly subjects for other approved Accofil indications.
Za ovrednotenje uporabe zdravila Accofil pri starejših osebah pri drugih odobrenih indikacijah ni dovolj podatkov.
There are insufficient data to evaluate filgrastim use in elderly subjects for other approved Grastofil indications.
Za ovrednotenje uporabe filgrastima pri starejših osebah pri drugih odobrenih indikacijah ni dovolj podatkov.
There are insufficient data to evaluate the potential effect of race on dabrafenib pharmacokinetics.
Za ovrednotenje morebitnega vpliva rase na farmakokinetiko dabrafeniba ni dovolj podatkov.
There are insufficient data to evaluate the potential effect of race on ibrutinib pharmacokinetics.
Za oceno morebitnega vpliva rase na farmakokinetiko ibrutiniba ni dovolj podatkov.
There are insufficient data to evaluate the potential effect of race on olaparib pharmacokinetics as clinical experience is predominantly in Caucasians (94% of patients included in the population analysis were Caucasian).
Za oceno morebitnega vpliva rase na farmakokinetiko olapariba ni dovolj podatkov, kajti klinične izkušnje so pridobljene pretežno pri belkah (94 % bolnic, vključenih v populacijsko analizo, je bilo belk).
There are insufficient data to recommend the use of fosamprenavir with ritonavir in heavily pre-treated patients.
Pri bolnikih, ki so predhodno že bili intenzivno zdravljeni, zaradi pomanjkanja podatkov uporabe fosamprenavirja v kombinaciji z ritonavirjem ne moremo priporočiti.
There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Da bi priporočali uporabo zdravila Nonafact pri otrocih, mlajših od 6 let, ni zadostnih podatkov.
There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Ni zadostnih podatkov, da bi lahko priporočali uporabo zdravila Nonafact pri otrocih, mlajših od 6 let.
There are insufficient paediatric data to evaluate this risk in younger patients (below 18 years of age), but there is evidence that the risk of suicide persists beyond the first 4 weeks of treatment for atypical antipsychotics, including aripiprazole.
Pri mlajših bolnikih (starost pod 18 let) ni zadostnih pediatričnih podatkov za oceno tega tveganja, obstajajo pa dokazi, da tveganje za samomor tudi po prvih 4 tednih zdravljenja z atipičnimi psihotiki, vključno z aripiprazolom, še vedno obstaja.
There are insufficient pharmacokinetic data in paediatric patients.
Farmakokinetičnih podatkov za pediatrične bolnike ni dovolj.
There are limited amount of data from the use of dabigatran etexilate in pregnant women.
Podatki o uporabi dabigatran eteksilata pri nosečnicah so omejeni.
There are limited amount of data from the use of dolutegravir in pregnant women.
Podatki o uporabi dolutegravirja pri nosečnicah so omejeni.
There are limited amount of data from the use of L-asparaginase and no data from the use of Oncaspar, in pregnant women.
Podatki o uporabi L-asparaginaze pri nosečnicah so omejeni, podatkov o uporabi zdravila Oncaspar pri nosečnicah ni.
There are limited amount of data from the use of roflumilast in pregnant women.
Podatkov o uporabi roflumilasta pri nosečnicah je malo.
There are limited amount of data from the use of vedolizumab in pregnant women.
Podatki o uporabi vedolizumaba pri nosečnicah so omejeni.
There are limited amount of data in pregnant women from the use of Bosulif.
Podatkov o uporabi zdravila Bosulif pri nosečnicah je malo.
There are limited clinical data available in non-Caucasian patients.
Kliničnih podatkov o bolnicah, ki niso belke, je malo.
There are limited clinical data on the use of INCIVO in HCV patients aged ≥ 65 years.
Kliničnih podatkov o uporabi zdravila INCIVO pri bolnikih s HCV, starih ≥ 65 let, je malo.
There are limited clinical data to assess the sensitisation potential of NexoBrid.
Kliničnih podatkov o oceni možne senzibilizacije z zdravilom NexoBrid je malo.
There are limited clinical data with respect to the effect of tenofovir disoproxil fumarate on fertility.
Klinični podatki o vplivu dizoproksiltenofovirijevega fumarata na plodnost so nezadostni.
There are limited clinical trial data on the use of Senshio in patients with other gynaecological conditions.
Pri bolnicah z drugimi ginekološkimi boleznimi so podatki iz kliničnih preskušanj glede uporabe zdravila Senshio omejeni.
There are limited data (less than 300 pregnancy outcomes) from the use of mannitol in pregnant women.
Podatki o uporabi manitola pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti).
There are limited data available from a renal transplant study that included 7 children above 11 years of age (study FTY720A0115).
Na voljo je le omejen obseg podatkov iz študije z bolniki po presaditvi ledvic, v katero je bilo vključenih 7 otrok, starih več kot 11 let (študija FTY720A0115).
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah, starejših od 70 let, je malo.
There are limited data available on patients with hepatic impairment (see section 4.2).
Na voljo je le malo podatkov o bolnikih z okvaro jeter (glejte poglavje 4.2).
There are limited data available on the use of dolutegravir in patients aged 65 years and over.
Na voljo so omejeni podatki o uporabi dolutegravirja pri bolnikih starih 65 let ali več.
There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Glede zdravljenja starejših s Simulectom je na voljo malo podatkov, vendar ni dokazov, ki bi narekovali pri starejših bolnikih drugačne odmerke kot pri mlajših odraslih bolnikih.
There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Podatkov iz kličnih študij z bolniki s telesno maso manj kot 20 kg je malo.
There are limited data from the use of FLUENZ in pregnant women.
Podatkov o uporabi cepiva FLUENZ pri nosečnicah je malo.
There are limited data from the use of Fluenz Tetra in pregnant women.
Podatkov o uporabi cepiva Fluenz Tetra pri nosečnicah je malo.
There are limited data from the use of naloxegol in pregnant women.
Podatkov o uporabi naloksegola pri nosečnicah je malo.
There are limited data from the use of omalizumab in pregnant women.
Podatki o uporabi omalizumaba pri nosečnicah so omejeni.
There are limited data from the use of varenicline in pregnant women.
Podatki o uporabi vareniklina pri nosečnicah so omejeni.
There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65 years.
Pri odraslih, starih med 56 in 65 let, so na voljo le omejeni podatki, za bolnike, starejše od 65 let, pa podatkov ni.
There are limited data in patients aged 75 and over.
Podatkov o bolnicah, starih 75 let ali več, je malo.
There are limited data in patients taking the combination of Cotellic with vemurafenib who have progressed on a prior BRAF inhibitor.
Podatkov pri bolnikih, zdravljenih z zdravilom Cotellic v kombinaciji z vemurafenibom, katerih bolezen je med predhodnim zdravljenjem z zaviralcem BRAF napredovala, je malo.
There are limited data in patients with malignant pleural mesothelioma treated with pemtrexed alone.
O bolnikih z malignim plevralnim mezoteliomom, zdravljenih samo s pemetreksedom, so na voljo le omejeni podatki.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Podatkov za bolnike z zmerno okvaro jeter je malo, podatkov za bolnike s hudo okvaro jeter pa ni.
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Za bolnike z zmerno okvaro jeter je podatkov malo, za bolnike s hudo okvaro jeter pa podatkov ni.
There are limited data in patients with somatic BRCA-mutated tumours (see section 5.1).
Podatkov pri bolnicah s somatskimi tumorji z mutacijo gena BRCA je malo (glejte poglavje 5.1).
There are limited data of the use of pazopanib in patients aged 65 years and older.
Podatkov o uporabi pazopaniba pri bolnikih, starih 65 let in starejših, je malo.
There are limited data on long-term use.
Podatki o dolgotrajni uporabi so omejeni.
There are limited data on the efficacy and safety of Brilique beyond 3 years of extended treatment.
Podatkov o učinkovitosti in varnosti zdravila Brilique po več kot 3 letih podaljšanega zdravljenja je malo.
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min).
Podatki o varnosti in učinkovitosti dizoproksiltenofovirijevega fumarata pri odraslih bolnikih z zmerno in hudo ledvično okvaro (očistek kreatinina < 50 ml/min) so nezadostni, dolgoročni podatki o varnosti pri bolnikih z blago ledvično okvaro (očistek kreatinina 50-80 ml/min) niso bili ovrednoteni.
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in HBV infected patients with decompensated liver disease and who have a Child-Pugh-Turcotte (CPT) score > 9.
Podatki o varnosti in učinkovitosti dizoproksiltenofovirijevega fumarata pri bolnikih okuženih s HBV, ki imajo dekompenzirano jetrno bolezen in imajo po lestvici Child-Pugh-Turcott (CPT) > 9 točk, so omejeni.
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in patients with impaired renal function.
Podatki o varnosti in učinkovitosti dizoproksiltenofovirijevega fumarata pri bolnikih z oslabljenim delovanjem ledvic so pomanjkljivi.
There are limited data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age.
Podatkov o uporabi zdravila Aloxi za preprečevanje navzee in bruhanja pri otrocih, mlajših od 2 let, je malo.