natgillin/translations-raw huggingface dataset:
Since available data in treatment of the elderly are limited, SCENESSE should not be used in patients over 70 years of age.
Ker so razpoložljivi podatki o zdravljenju starejših bolnikov omejeni, se zdravilo SCENESSE ne sme uporabljati pri bolnikih, starejših od 70 let.
Since Blincyto has been granted a conditional approval, the company that markets Blincyto will provide data from a larger study comparing the effectiveness Blincyto to standard chemotherapy (cancer medicines) in Ph- B-precursor ALL patients.
Ker je zdravilo Blincyto pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila nove podatke iz večje študije, v kateri bodo učinkovitost tega zdravila primerjali s standardno kemoterapijo (zdravili proti raku) pri bolnikih z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia.
Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Ker je zdravilo Bosulif pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, opravila obsežnejšo študijo z zdravilom Bosulif pri bolnikih s KML Ph+, ki so bili v preteklosti že zdravljeni z enim ali več zaviralci tirozinske kinaze in za katere se imatinib, nilotinib in dasatinib ne štejejo za primerne možnosti zdravljenja in predložila rezultate te študije.
Since both roflumilast and roflumilast N-oxide contribute to PDE4 inhibitory activity in vivo, pharmacokinetic considerations are based on total PDE4 inhibitory activity (i.e. total exposure to roflumilast and roflumilast N-oxide).
Ker tako roflumilast kot tudi roflumilast N-oksid prispevata k inhibitornemu delovanju na PDE4 in vivo, so farmakokinetične lastnosti opisane za skupno inhibitorno delovanje na PDE4 (t.j. skupna izpostavljenost roflumilastu in roflumilast N-oksidu).
Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Ker so v predkliničnih preskušanjih z velikimi odmerki ugotovili, da so ledvice in jetra tarčni organi za toksičnost, je treba pri zdravljenju spremljati ledvično in jetrno funkcijo.
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Ker brahikardija predstavlja dejavnik tveganja za pojav torsades de pointes, je kombinirano uporabo rivastigmina in zdravil, ki lahko sprožijo torsades de pointes, kot so antipsihotiki, na primer nekateri fenotiazini (klorpromazin, levomepromazin), benzamidi (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), ter pimozid, haloperidol, droperidol, cisaprid, citalopram, difemanil, intravenski eritromicin, halofantrin, mizolastin, metadon, pentamidin in moksifloksacin, potrebno obravnavati previdno, morda bo potrebno tudi klinično spremljanje (EKG).
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Ker bradikardija predstavlja dejavnik tveganja za pojav torsades de pointes, je potrebna previdnost in morebiten klinični nadzor (EKG) pri uporabi rivastigmina v kombinaciji z zdravili, ki inducirajo torsades de pointes, kot so npr. antipsihotiki, t.j. nekateri fenotiazini (klorpromazin, levomepromazin), benzamidi (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), pimozid, haloperidol, droperidol, cisaprid, citalopram, difemanil, eritromicin iv, halofantrin, mizolastin, metadon, pentamidin in moksifloksacin.
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Ker bradikardija predstavlja dejavnik tveganja za pojav torsades de pointes, je potrebna previdnost in morebiten klinični nadzor (EKG) pri uporabi rivastigmina v kombinaciji z zdravili, ki inducirajo torsades de pointes, kot so npr. antipsihotiki, t.j. nekateri fenotiazini (klorpromazin, levomepromazin), benzamidi (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), pimozid, haloperidol, droperidol, cisaprid, citalopram, difemanil, eritromicin iv., halofantrin, mizolastin, metadon, pentamidin in moksifloksacin.
Since Budesonide/Formoterol Teva Pharma B.V. contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Ker zdravilo Budezonid/formoterol Teva Pharma B.V. vsebuje tako budezonid kot formoterol, lahko pri bolnikih pričakujemo enak vzorec neželenih učinkov, kot so jih opažali pri posameznih učinkovinah.
Since bupropion is extensively metabolised, caution is advised when naltrexone / bupropion is co-administered with medicinal products known to induce CYP2B6 (e.g., carbamazepine, phenytoin, ritonavir, efavirenz) as these may affect the clinical efficacy of naltrexone / bupropion.
Bupropion se obsežno presnavlja, zato se priporoča previdnost pri sočasni uporabi kombinacije naltrekson/bupropion in zdravil, za katere je znano, da inducirajo encim CYP2B6 (npr. karbamazepin, fenitoin, ritonavir, efavirenz), saj lahko vplivajo na klinično učinkovitost naltreksona/bupropiona.
Since Busilvex in combination with fludarabine has been used in clinical practice for many years, data from 7 studies (involving 731 patients) which looked at the effectiveness of Busilvex and fludarabine as ‘reduced-intensity’ conditioning treatment were presented.
Ker se zdravilo Busilvex v kombinaciji s fludarabinom že več let uporablja v klinični praksi, so bili predstavljeni podatki iz sedmih študij, v katere je bilo vključenih 731 bolnikov in v katerih so proučevali učinkovitost zdravila Busilvex in fludarabina kot pripravljalnega zdravljenja z zmanjšano jakostjo.
Since canakinumab binds to marmoset (C. jacchus) and human IL-1 beta with a similar affinity, the safety of canakinumab has been studied in the marmoset.
Varnost kanakinumaba so raziskovali na marmozetkah (C. jacchus), ker se kanakinumab pri človeku in pri marmozetkah veže na IL-1 beta s podobno veliko afiniteto.
Since certain patients are at increased risk of bleeding, a number of precautions were included in the prescribing information.
Ker so nekateri bolniki izpostavljeni povečanemu tveganju za krvavitve, so bili v informacije o predpisovanju vključeni številni previdnostni ukrepi.
Since chronic progressive nephropathy and corticomedullar nephrocalcinosis are most likely rat-specific nephropathies, these findings are presumably not relevant for humans.
Ker sta kronična progresivna nefropatija in kortikomedularna nefrokalcinoza najverjetneje nefropatiji, ki sta značilni za podgane, te ugotovitve verjetno niso pomembne za ljudi.
Since citrate is known to increase aluminium absorption, aluminium-based compounds should be avoided while patients receive Fexeric.
Ker je znano, da citrat poveča absorpcijo aluminija, se je treba med jemanjem zdravila Fexeric izogibati spojinam na osnovi aluminija.
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Ker se klopidogrel deloma presnovi v aktivni presnovek s CYP2C19, je mogoče pričakovati, da zdravila, ki zavrejo delovanje tega encima, zmanjšajo koncentracijo aktivnega presnovka klopidogrela.
Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example lymphoma, including skin lymphoma, and other skin tumours).
Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali zdravilo Protopic, pojavili malignomi (na primer limfom, vključno s kožnim limfomom, in drugi kožni tumorji).
Since constipation may be an early symptom of a blockage in your intestine, please inform your doctor or pharmacist if you experience it.
Ker je lahko zaprtost zgodnji simptom blokade v črevesju, o tem obvestite svojega zdravnika ali farmacevta.
Since constipation may be an early symptom of a blockage in your intestine, please inform your doctor or pharmacist.
Ker je lahko zaprtost zgodnji simptom blokade v črevesju, o tem obvestite svojega zdravnika ali farmacevta.
Since current safety and efficacy data are based upon administration with food and with dietary restrictions, it is recommended that Pravafenix is administered with food. (see sections 4.2 and 5.2).
Ker trenutni podatki o varnosti in učinkovitosti temeljijo na jemanju skupaj s hrano in upoštevanju dietnih omejitev, se priporoča jemanje zdravila Pravafenix skupaj s hrano (glejte poglavji 4.2 in 5.2).
Since Darzalex has been granted a conditional approval, the company that markets Darzalex will provide the results of two studies comparing the effect of Darzalex used in combination with other cancer treatments (i.e. lenalidomide and dexamethasone, or bortezomib and dexamethasone) with that of these other treatments given on their own.
Ker je zdravilo Darzalex pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila rezultate dveh študij, v katerih primerjajo učinke zdravila Darzalex, kadar se uporabi v kombinaciji z dvema drugima zdraviloma proti raku (tj. lenalidomidom in deksametazonom oziroma bortezomibom in deksametazonom), in učinke teh zdravil, kadar se dajejo samostojno.
Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an overdose.
Zdravilo DaTSCAN vam bo dal zdravnik pod strogo nadzorovanimi pogoji, zato ni verjetno, da bi prejeli prevelik odmerek.
Since decreased concentrations
artemeter:
Since decreased concentrations
Pri sočasni uporabi efavirenza in
Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when Atripla and artemether/lumefantrine tablets are co-administered.
Ker lahko zmanjšane koncentracije artemetra, dihidroartemizinina ali lumefantrina povzročijo zmanjšanje učinkovitosti proti malariji, je potrebna previdnost ob sočasnem dajanju zdravila Atripla in tablet artemetra/lumefantrina. artemeter/lumefantrin/emtricitabin Interakcij niso preučevali.
Since deferiprone is eliminated mainly via the kidneys, there may be an increased risk of complications in patients with impaired renal function.
Ker se deferipron poglavitno izloča preko ledvic, obstaja večje tveganje zapletov pri bolnikih z motnjami v delovanju ledvic.
Since Defitelio has been approved under exceptional circumstances, the company that markets the medicine is required to set up a patient registry to provide further data on long-term safety, health outcomes, and the way the medicine is used in practice.
Ker je zdravilo Defitelio pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, zagotovila vzpostavitev registra bolnikov, s katerim bo pridobila dodatne podatke o dolgoročni varnosti, zdravstvenih izidih in načinu uporabe zdravila v praksi.
Since Deltyba has been granted a conditional approval, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Ker je zdravilo Deltyba pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, izvedla dodatne študije, ki bodo potrdile dolgoročno učinkovitost in varnost zdravila Deltyba.
Since DepoCyte’s particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examination following administration.
Delci zdravila DepoCyte so po velikosti in izgledu podobni belim krvnim celicam, zato morate biti po njegovi uporabi pri interpretiranju rezultatov pregleda cerebrospinalne tekočine previdni.
Since depreotide also binds to somatostatin receptors, caution should be exercised when administering this medicinal product to patients with insulinomas or diabetes mellitus.
Ker se tudi depretoid veže na somatostatinske receptorje, je potrebna previdnost pri uporabi tega zdravila pri bolnikih z insulinomom ali diabetesom mellitusom.
Since dexrazoxane possesses mutagenic activity, men being treated with dexrazoxane are advised not to father a child during and up to three months after treatment and/or should use contraceptives for the same time period.
Ker je deksrazoksan mutagen, moškim, ki se zdravijo z deksrazoksanom, odsvetujemo spočetje otroka med zdravljenjem in tri mesece po zdravljenju in svetujemo uporabo kontracepcije za to časovno obdobje.
Since dialysis clearance of Kyprolis concentrations has not been studied, the medicinal product should be administered after the dialysis procedure (see section 5.2).
Očistek zdravila Kyprolis med dializo ni raziskan, zato je treba zdravilo uporabiti po koncu dializnega postopka (glejte poglavje 5.2).
Since dopamine and 5- hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Ker dopamin in 5-hidroksitriptamin sodelujeta pri shizofreniji in bipolarni motnji, aripiprazol pomaga normalizirati delovanje možganov, zmanjšati psihotične ali manične simptome in preprečiti njihov ponoven pojav.
Since DuoResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Ker zdravilo DuoResp Spiromax vsebuje tako budezonid kot formoterol, lahko pri bolnikih pričakujemo enak vzorec neželenih učinkov, kot so jih opažali pri posameznih učinkovinah.
Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Efavirenz se močno veže na beljakovine, zato je malo verjetno, da bi z dializo iz krvi lahko odstranili večjo količino.
Since either repeat exposure with any GP IIb/IIIa ligand-mimetic agent (like abciximab or eptifibatide) or first-time exposure to a GP IIb/IIIa inhibitor may be associated with immune-mediated thrombocytopenic responses, monitoring is required, i.e. platelet counts should be monitored prior to treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
Ker je lahko tako ponavljajoča se izpostavljenost kateremukoli ligandomimetiku GP IIb/IIIa (npr. abciksimabu ali eptifibatidu) kot prva izpostavljenost zaviralcu GP IIb/IIIa povezana z imunskimi trombocitopeničnimi odzivi, so potrebne kontrole: število trombocitov morate spremljati pred zdravljenjem in v roku 6 ur po dajanju zdravila, potem pa najmanj enkrat na dan v času zdravljenja in tudi takoj ob pojavu kliničnih znakov nepričakovane nagnjenosti h krvavitvam.
Since elderly individuals frequently have reduced glomerular function, particular attention should be paid to assessing renal function before and during administration of Vistide.
Starejši imajo pogosto zmanjšano delovanje glomerulov, zato je treba pred aplikacijo zdravila Vistide in med njo posebno pozornost nameniti oceni delovanja ledvic.
Since etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Ker se etravirin v veliki meri veže na beljakovine, je malo verjetno, da se bo z dializo odstranila bistvena količina zdravilne učinkovine.
Since Eviplera is a combination product and the dosing interval of the individual components cannot be altered, treatment with Eviplera must be interrupted in patients with confirmed creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Ker je zdravilo Eviplera kombinirano zdravilo in intervala odmerjanja posameznih sestavin ni mogoče spreminjati, je treba zdravljenje z zdravilom Eviplera pri bolnikih s potrjenim zmanjšanjem očistka kreatinina na < 50 ml/min ali zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) prekiniti.
Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Ker glimepepirid sodi v kemijsko skupino zdravil, imenovanih sulfonilsečnine, je potrebna previdnost pri bolnikih s pomanjkanjem glukoze-6-fosfat-dehidrogenaze in je potrebno pretehtati o možnosti zdravljenja z zdravili, ki ne sodijo v skupino sulfonilsečnin.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
Ker je znano, da glukokortikosteroidi upočasnjujejo rast, se mora pri mladih živalih (ki še nimajo 7 mesecev) zdravilo uporabljati v skladu z oceno razmerja korist/tveganje in odvisno od rednega kliničnega ocenjevanja.
Since glucocorticosteroids can slow growth, use in young, growing animals should be well controlled and large lesions should not be treated.
Ker lahko glukokortikosteroidi upočasnijo rast, moramo njihovo uporabo pri mladih živalih, ki še rastejo, skrbno nadzorovati, in jih ne smemo uporabljati za zdravljenje velikih poškodb.
Since half-life is prolonged in these patients, therapeutic monitoring of the medicinal product after a loading dose or a change of dose should be performed for a prolonged period of time until stable concentrations are reached (see sections 4.2 and 5.2).
Ker je razpolovni čas pri teh bolnikih podaljšan, je po polnitvenem odmerku ali spremembi odmerka potrebno dolgotrajno terapevtsko spremljanje koncentracije zdravila, dokler se ne dosežejo stabilne koncentracije (glejte poglavji 4.2 in 5.2).
Since human alpha1-proteinase inhibitor is a protein and a physiological constituent of human blood, it is not expected to present carcinogenic, genotoxic, or teratogenic effects.
Ker je humani zaviralec alfa1- proteinaze beljakovina in fiziološka sestavina krvi pri človeku, se kancerogeni, genotoksični ali teratogeni učinki ne pričakujejo.
Since human alpha1-proteinase inhibitor is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses.
Ker je humani zaviralec alfa1- proteinaze endogena človeška beljakovina, ni verjetno, da bi v priporočenih odmerkih povzročili neželene učinke na plodnost.
Since Humira is injected under the skin (subcutaneously), food and drink should not affect Humira.
Ker se zdravilo Humira injicira pod kožo (subkutano), naj hrana in pijača ne bi vplivali na zdravilo Humira.
Since HYCAMTIN contains a 10 % overage, the clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg per ml of topotecan.
Ker vsebuje HYCAMTIN 10 % prebitek, ima pripravljena bistra, rumena do rumeno-zelena raztopina koncentracijo 1 mg topotekana na ml.
Since IgE may be involved in the immunological response to some helminth infections, Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
Ker je IgE lahko vpleten v imunski odziv na nekatere infestacije s helminti, lahko zdravilo Xolair posredno zmanjša učinkovitost zdravil za zdravljenje infestacij s helminti ali z drugimi paraziti (glejte poglavje 4.4).
Since IgE may be involved in the immunological response to some helmith infections, Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
Ker jeIgE lahko vpleten v imunski odziv na nekatere infestacije s helminti, lahko zdravilo Xolair posredno zmanjša učinkovitost zdravil za zdravljenje infestacij s helminti ali z drugimi paraziti (glejte poglavje 4.4).
Since iloprost inhibits platelet function its use with the following substances may enhance iloprost- mediated platelet inhibition, thereby increasing the risk of bleeding:
Ker iloprost zavira delovanje trombocitov, lahko njegova uporaba z naslednjimi učinkovinami okrepi z iloprostom posredovano zaviranje trombocitov in tako poveča tveganje za krvavitev:
Since immediate-release exenatide has been marketed, acute pancreatitis has been reported with a frequency not known and acute renal failure has been reported uncommonly (see section 4.4).
Po začetku trženja eksenatida v obliki s takojšnim sproščanjem so poročali o akutnem pankreatitisu z neznano pogostnostjo in o akutni odpovedi ledvic z občasno pogostnostjo (glejte poglavje 4.4).
Since immunoglobulins are excreted into human breast milk, a risk to the breastfeeding child cannot be excluded.
Ker se imunoglobulini izločajo v materino mleko, tveganja za dojenega otroka ni mogoče izključiti.
Since Imvanex has been approved under exceptional circumstances, the company that markets Imvanex will provide further data from studies on the changes in antibody levels over time seen in people who have been vaccinated.
Ker je cepivo Imvanex pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki trži cepivo, zagotovila dodatne podatke iz študij o spremembah koncentracij protiteles v odvisnosti od časa pri cepljenih posameznikih.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3).
Ker lahko večja koncentracija zaviralcev reduktaze HMG-CoA povzroči miopatijo, vključno z rabdomiolizo, je uporaba teh zdravil hkrati z zdravilom Kaletra kontraindicirana (glejte poglavje 4.3).
Since initiation of Gilenya treatment results in decreased heart rate, Gilenya should not be used concomitantly with these medicinal products.
Ker uvedba zdravila Gilenya povzroča znižanje srčne frekvence, se ga ne sme uporabljati sočasno z navedenimi zdravili.
Since insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not interchangeable, switching may result in the need for a change in dose and should only be done under strict medical supervision (see section 4.2).
Ker insulin glargin 100 enot/ml in zdravilo Toujeo nista bioekvivalentna in nista medsebojno zamenljiva, je ob prehodu lahko potrebna sprememba odmerka; takšen prehod se sme opraviti le pod strogim zdravniškim nadzorstvom (glejte poglavje 4.2).
Since interactions with medicinal products undergoing intracellular phosphorylation, such as antiviral agents, or with inhibitors of adenosine uptake may be expected, their concomitant use with cladribine is not recommended.
Ker lahko pričakujemo medsebojna delovanja z zdravili, ki so podvržena znotrajcelični fosforilaciji, kot so protivirusne zdravilne učinkovine, ali z zaviralci privzema adenozina, njihova sočasna uporaba s kladribinom ni priporočena.
Since it cannot be excluded that olaparib may reduce exposure to substrates of CYP3A through enzyme induction, the efficacy of hormonal contraceptives may be reduced if co-administered with olaparib.
Ker ni mogoče izključiti, da olaparib zaradi indukcije encimov zmanjša izpostavljenost substratom CYP3A, je možno, da se učinkovitost hormonskih kontraceptivov med sočasno uporabo z olaparibom zmanjša.