natgillin/translations-raw huggingface dataset:
Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine.
Čeprav se zdravilo ARICLAIM ne uporablja za zdravljenje depresije, se njegova zdravilna učinkovina (duloksetin) uporablja tudi kot antidepresiv.
Although at therapeutic doses no effects on the breastfed newborn/infant are anticipated, in the absence of human data, the use during breast-feeding is not recommended.
Čeprav učinkov za dojenega novorojenca/dojenčka pri terapevtskih odmerkih ni pričakovati, zaradi odsotnosti podatkov o takšni uporabi zdravila pri ljudeh, uporabe linaklotida med dojenjem ne priporočamo.
Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with
Čeprav se takšne oblike vedenja, kot je vožnja v polsnu, lahko pojavijo, če bolnik vzame samo sedativ/hipnotik v terapevtskih odmerkih, se zdi, da uživanje alkohola in drugih depresorjev centralnega živčnega sistema (CŽS) skupaj s sedativi/hipnotiki zveča nevarnost takšnih oblik vedenja, isto pa velja za prekoračitev največjega priporočenega odmerka zdravila.
Although bleeding is an expected adverse reaction of nintedanib due to its mechanism of action, the bleeding incidence was comparable between the 2 treatment groups (placebo: 11.1 %, nintedanib: 10.9 %) in adenocarcinoma patients.
Čeprav je krvavitev zaradi mehanizma delovanja pričakovan neželeni učinek nintedaniba, je bila pri bolnikih z adenokrcinomom pojavnost krvavitve med 2 zdravljenima skupinama primerljiva (placebo: 11,1 %, nintedanib: 10,9 %).
Although cases of hepatic dysfunction (elevated aminotransferase with increase in bilirubin or International Normalized Ratio [INR]) or hepatic failure have not been reported, there is concern that lomitapide could induce steatohepatitis, which can progress to cirrhosis over several years.
Čeprav niso poročali o primerih jetrne disfunkcije (povišani ravni aminotransferaze skupaj s povečanjem vrednosti bilirubina ali mednarodnega umerjenega razmerja (INR – International Normalized Ratio)) ali jetrni odpovedi, obstajajo pomisleki, da bi lahko lomitapid sprožil steatohepatitis, ki lahko v več letih napreduje v cirozo.
Although caution is appropriate, the results suggest the possibility that everolimus may have benefit in the treatment of TSC brain disease, including infantile spasms.
Čeprav previdnost ni odveč, rezultati nakazujejo možnost ugodnega delovanja everolimusa pri zdravljenju možganskih sprememb v okviru tuberozne skleroze, vključno z infantilnimi spazmi.
Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.
Čeprav se citalopram primarno ne presnavlja z encimom CYP2D6, sta se v eni študiji zaradi uporabe bupropiona povečali vrednosti Cmax in AUC za citalopram za 30 % oziroma 40 %.
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended.
Čeprav je sistemska izpostavljenost po uporabi mazila s takrolimusom glede na klinične podatke majhna, dojenje med zdravljenjem z zdravilom Protopic ni priporočljivo.
Although combined hormonal contraceptives may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetes during use of combined hormonal contraceptives.
Čeprav kombinirani hormonski kontraceptivi lahko vplivajo na periferno rezistenco za insulin in toleranco za glukozo, ni dokaza, da bi bilo treba pri sladkorni bolezni med uporabo kombiniranih hormonskih kontraceptivov spreminjati režim zdravljenja.
Although concomitant administration of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John’s wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of efficacy.
Sočasna uporaba induktorjev CYP3A4 (npr. rifampicina, fenitoina, fenobarbitala, karbamazepina, šentjanževke) sicer ni raziskana, a pričakovati je, da lahko sočasna uporaba močnih induktorjev CYP3A4 zmanjša koncentracijo rimonabanta v plazmi in tako zmanjša njegovo učinkovitost.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4200 subjects who received Rotarix concomitantly with OPV.
Zaradi sočasnega dajanja cepiva Rotarix in OPV se imunski odziv na cepivo proti rotavirusom sicer lahko nekoliko zmanjša, vendar pa je klinično preskušanje, v katerega je bilo vključenih več kot 4.200 oseb, ki so cepivo Rotarix prejele skupaj z OPV, pokazalo, da se je klinična zaščita proti hudi obliki rotavirusnega gastroenteritisa ohranila.
Although concomitant use of MTX results in higher steady-state trough concentrations of Simponi in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either Simponi or MTX (see section 5.2).
Čeprav sočasna uporaba metotreksata vodi do večjih najnižjih koncentracij zdravila Simponi v stanju dinamičnega ravnovesja pri bolnikih z revmatoidnim artritisom, psoriatičnim artritisom ali ankilozirajočim spondilitisom, pa podatki, ki so na voljo, ne kažejo potrebe po prilagoditvi odmerka, bodisi pri zdravilu Simponi ali pri metotreksatu (glejte poglavje 5.2).
Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for the elderly people.
Čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
Although dabrafenib and its metabolites, hydroxy-dabrafenib, carboxy-dabrafenib and desmethyl- dabrafenib, were inhibitors of human organic anion transporter (OAT) 1 and OAT3 in vitro, the risk of a drug-drug interaction is minimal based on clinical exposure.
Dabrafenib in njegovi presnovki hidroksidabrafenib, karboksidabrafenib in dezmetildabrafenib in vitro sicer zavirajo humani prenašalec organskih anionov (OAT) 1 in OAT3, vendar je tveganje za medsebojno delovanje zdravil glede na klinično izpostavljenost minimalno.
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Čeprav darunavirja niso proučevali pri bolnikih z ledvično okvaro, pa je populacijska analiza farmakokinetike pokazala, da farmakokinetika darunavirja ni pomembno spremenjena pri bolnikih z zmerno ledvično okvaro, okuženih s HIV (očistek kreatinina med 30-60 ml/min, n=20) (glejte poglavji 4.2 in 4.4).
Although data are limited, the pharmacokinetics of Ketoconazole HRA are not significantly different in patients with renal failure compared to healthy subjects, and no specific dose adjustment is recommended in this population.
Čeprav so podatki omejeni, se farmakokinetika zdravila Ketokonazol HRA znatno ne razlikuje med bolniki z ledvično odpovedjo in zdravimi preizkušanci, zato se pri tej populaciji ne priporoča posebno prilagajanje odmerka.
Although data in renal impaired patients are not available, renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol.
Čeprav podatki o bolnicah z ledvično okvaro niso na voljo, je malo verjetno, da bi ledvična okvara vplivala na izločanje nomegestrolacetata in estradiola.
Although dehydration may be an indirect effect of lomitapide use and related to other gastrointestinal effects of lomitapide, the MAH’s proposal to include this safety information in the product information is accepted since healthcare professionals and patients should become aware of the risk of dehydration with lomitapide use.
Čeprav je lahko dehidracija posredni učinek uporabe lomitapida in je povezana z drugimi gastrointestinalnimi učinki lomitapida, je bil sprejet predlog imetnika dovoljenja za promet za vključitev tega varnostnega podatka v informacije o zdravilu, saj se morajo zdravstveni delavci in bolniki zavedati tveganja dehidracije pri uporabi lomitapida.
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus, which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with Capecitabine Accord (see section 4.3).
Čeprav pomanjkanja DPD ne moremo natančno določiti, je znano, da imajo bolniki z določenimi homozigotnimi ali določenimi sestavljenimi heterozigotnimi mutacijami v lokaciji gena DPYD, ki povzroči popolno ali skoraj popolno pomanjkanje encimske aktivnosti DPD (določene z laboratorijskim testom), največje tveganje za življensko ogrožujočo ali smrtno toksičnost in jih ne smemo zdraviti z zdravilom Kapecitabin Accord (glejte poglavje 4.3).
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus, which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with Capecitabine Teva (see section 4.3).
Čeprav pomanjkanja DPD ne moremo natančno določiti, je znano, da imajo bolniki z določenimi homozigotnimi ali določenimi sestavljenimi heterozigotnimi mutacijami v lokaciji gena DPYD, ki povzroči popolno ali skoraj popolno pomanjkanje encimske aktivnosti DPD (določene z laboratorijskim testom), največje tveganje za življensko ogrožujočo ali smrtno toksičnost in jih ne smemo zdraviti z zdravilom Kapecitabin Teva (glejte poglavje 4.3).
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus, which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with Ecansya (see section 4.3).
Čeprav pomanjkanja DPD ne moremo natančno določiti, je znano, da imajo bolniki z določenimi homozigotnimi ali določenimi sestavljenimi heterozigotnimi mutacijami v lokaciji gena DPYD, ki povzroči popolno ali skoraj popolno pomanjkanje encimske aktivnosti DPD (določene z laboratorijskim testom), največje tveganje za življensko ogrožujočo ali smrtno toksičnost in jih ne smemo zdraviti z zdravilom Ecansya (glejte poglavje 4.3).
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus, which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with Xeloda (see section 4.3).
Čeprav pomanjkanja DPD ne moremo natančno določiti, je znano, da imajo bolniki z določenimi homozigotnimi ali določenimi sestavljenimi heterozigotnimi mutacijami v lokaciji gena DPYD, ki povzroči popolno ali skoraj popolno pomanjkanje encimske aktivnosti DPD (določene z laboratorijskim testom), največje tveganje za življensko ogrožujočo ali smrtno toksičnost in jih ne smemo zdraviti z zdravilom Xeloda (glejte poglavje 4.3).
Although endometrial thickening was seen in some patients, it normally disappeared after stopping treatment.
Čeprav so pri nekaterih bolnicah opazili odebelitev endometrija, je ta po zdravljenju običajno izginila.
Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child- Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Čeprav je bila izpostavljenost erlotinibu pri bolnikih z zmerno jetrno okvaro (7–9 točk po Child-Pughovi lestvici) in bolnikih z ustreznim delovanjem jeter podobna, je pri dajanju zdravila Tarceva bolnikom z jetrno okvaro potrebna previdnost.
Although experience is limited, patients who were re-treated generally did not experience a worsening in severity of thyroid disorders.
Čeprav so izkušnje omejene, pri bolnikih, ki so bili ponovno zdravljeni, na splošno ni prišlo do poslabšanja bolezni ščitnice.
Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis.
Čeprav so eksperimentalne študije prevelikih odmerkov pokazale, da je zdravilo varno za pse, ki imajo dirofilariozo, pa terapevtsko ni učinkovit.
Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic efficacy against adult Dirofilaria immitis.
Čeprav so eksperimentalne študije prevelikih odmerkov pokazale, da je zdravilo varno za pse, ki imajo dirofilariozo, pa terapevtsko ni učinkovito.
Although expressed in the same unitage (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4).
Čeprav se odmerki zdravila NovoThirteen izražajo z enakimi enotami (i.e.), kot so v uporabi pri odmernih shemah drugih zdravil, ki vsebujejo FXIII, je njegovo odmerjanje drugačno (glejte poglavje 4.4).
Although Foclivia in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Čeprav zdravilo Foclivia v večodmernih vialah vsebuje konzervans, ki zavira rast mikrobov, je uporabnik odgovoren za zmanjšanje tveganja kontaminacije večodmerne viale med odvzemom vsakega odmerka.
Although greater sensitivity to develop adverse reactions in some older patients and Asian patients cannot be ruled out, overall, no major differences were observed in the safety and effectiveness of axitinib between patients who were ≥ 65 years of age and non-elderly, and between White patients and patients of other races.
Čeprav večje občutljivosti za pojav neželenih učinkov pri nekaterih starejših bolnikih in bolnikih azijskega porekla ni mogoče izključiti, pa na splošno niso opažali nobenih večjih razlik glede varnosti in učinkovitosti aksitiniba med bolniki, starimi 65 let ali več, in mlajšimi bolniki ter med bolniki bele rase in bolniki drugih ras.
Although group B meningococcal disease is relatively uncommon in Europe, the CHMP noted that it is more common in certain regions of Europe.
Čeprav je meningokokna bolezen skupine B v Evropi sorazmerno redka, je opozoril, da je v določenih evropskih regijah pogostejša.
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Čeprav se je hematološka toksičnost v obliki nevtropenije, trombocitopenije in anemije pogosteje pojavljala pri bolnikih, ki so bili sočasno okuženi s HCV/HIV, so lahko pri večini teh bolnikov toksične učinke odpravili s prilagoditvijo odmerka in je bila zaradi njih le redko potrebna predčasna ukinitev zdravila (glejte poglavje 4.4).
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Čeprav so se hematološke toksičnosti nevtropenija, trombocitopenija in anemija pri bolnikih, okuženih s HIV in HCV, pojavile pogosteje, so večino lahko uravnali s spremembo odmerka in uporabo rastnih dejavnikov; predčasna prekinitev zdravljenja je bila potrebna zelo redko.
Although hidden from view the needle tip is now uncovered.
Čeprav je skrita pred pogledom, je konica injekcijske igle sedaj odkrita.
Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BzmbR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BzmbR-CAP 68 % v primerjavi z 42 % v skupini R- CHOP.
Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the R- CHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BzR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BzR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R- CHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, VcR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini VcR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, VcR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini VcR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
Although in placebo-controlled pivotal phase III studies, JETREA has shown benefit in inducing closure of macular holes associated with vitreomacular traction, in some instances increased traction with subsequent progression or development of new macular hole has been observed.
Čeprav se je zdravilo JETREA v osrednjih, s placebom kontroliranih študijah faze III, izkazalo koristno pri induciranju zaprtja foramna makule, povezanega z vitreomakularno trakcijo, so v nekaterih primerih opazili povečano trakcijo s posledično progresijo ali razvojem novega foramna makule.
Although in vitro studies indicated that raltegravir is not an inhibitor of the UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, one clinical study has suggested that some inhibition of UGT1A1 may occur in vivo based on effects observed on bilirubin glucuronidation.
Čeprav so in vitro študije pokazale, da raltegravir ni zaviralec UDP glukuronoziltransferaz (UGT) 1A1 in 2B7, je ena klinična študija na podlagi učinkov, opaženih pri glukuronidaciji bilirubina, pokazala, da se in vivo lahko pojavi inhibicija UGT1A1.
Although in vitro studies suggest a role for CYP2D6 and CYP3A4 in the oxidative metabolism of mirabegron, in vivo results indicate that these isozymes play a limited role in the overall elimination.
Študije in vitro sicer kaţejo vlogo CYP2D6 in CYP3A4 v oksidativni presnovi mirabegrona, toda rezultati in vivo kaţejo, da imata ta izoencima v celotnem odstranjevanju majhno vlogo.
Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant.
Čeprav na voljo ni nezadostnih kliničnih podatkov o uporabi cepiva Menveo med dojenjem, ni verjetno, da bi protitelesa, ki se izločijo v mleko, škodovala dojenemu otroku.
Although it is not known if Imlygic could be transmitted through sexual contact, it is known that wild- type HSV-1 can be transmitted through sexual contact.
Ali se zdravilo Imlygic lahko prenaša s spolnim stikom, ni znano, znano pa je, da se s spolnim stikom lahko prenaša divji tip HSV-1.
Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival.
Čeprav ni bilo mogoče opraviti študije, v kateri bi neposredno primerjali zdravilo Defitelio s placebom (zdravilom brez zdravilne učinkovine), je družba predložila dovolj podatkov, s katerimi je dokazala, da imajo bolniki, zdravljeni s tem zdravilom, izboljšane možnosti preživetja.
Although limited by the low number of patients, median OS appeared consistent with data in patients with BRAF V600E positive tumours.
Kljub omejitvi zaradi majhnega števila bolnikov se mediano celokupno preživetje po vsem sodeč sklada s podatki bolnikov z BRAF V600E pozitivnimi tumorji.
Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
Čeprav je podatkov malo, je pričakovati, da se lahko pri pediatrični populaciji pojavijo enake interakcije.
Although limited with regard to the number of subjects, data from both studies showed a success rate around 70% of treated cases in the elderly population.
Čeprav je bilo število oseb omejeno, podatki iz obeh študij kažejo na približno 70- odstotno stopnjo uspeha, pri zdravljenih primerih iz starejše populacije.
Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 15).
Čeprav so podatki omejeni, kažejo na to, da je skrajšanje zdravljenja na 24 tednov lahko povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 15).
Although limited, evidence from the clinical trials suggests that patients not responding to tocilizumab or anakinra, may respond to canakinumab.
Podatki iz kliničnih študij, čeprav omejenega obsega, kažejo, da pri bolnikih, ki se ne odzivajo na zdravljenje s tocilizumabom oziroma anakinro, lahko pride do odziva na zdravljenje s kanakinumabom.
Although low in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Čeprav je v kliničnih raziskavah sicer redka po pogostnosti, se lahko pojavi večja ali huda krvavitev in ne glede na mesto krvavitve lahko povzroči invalidnost, življenjsko ogroženost ali je celo usodna.
Although meals (low or high fat content) have been shown to reduce the absorption of Rasilez substantially, the efficacy of aliskiren was shown to be similar when taken either with a light meal or without a meal (see section 4.2).
Kljub temu, da se je pokazalo, da obroki (z veliko ali z majhno vsebnostjo maščob) bistveno zmanjšajo absorpcijo zdravila Rasilez, se je izkazalo, da je učinkovitost aliskirena podobna, če se ga jemlje z lahkim obrokom ali brez (glejte poglavje 4.2).
Although medicines containing the same active substance are available for injection into the eye, Zaltrap must not be injected into the eye as it was not developed for such use and may cause local damage.
Čeprav so druga zdravila, ki vsebujejo isto zdravilno učinkovino, na voljo za injiciranje v oko, se zdravilo Zaltrap ne sme injicirati v oko, saj ni namenjeno tovrstni uporabi in lahko poškoduje oko.
Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms.
Manj izraziti gastrointestinalni simptomi ko je. dispepsija, so pogosti in se lahko pojavijo kadarkoli med zdravljenjem, zato morajo zdravniki ostati pozorni na gastrointestinalne znake razjede in krvavitve, četudi bolnik pred tem ni imel takšnih simptomov.