natgillin/translations-raw huggingface dataset:
However, an increased number of serious adverse events were reported in elderly patients treated with Vectibix in combination with FOLFIRI or FOLFOX chemotherapy compared to chemotherapy alone (see section 4.8).
Vendar pa je bilo pri starejših bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo FOLFIRI ali FOLFOX opisanih več resnih neželenih učinkov, kot pri tistih, ki so prejemali samo kemoterapijo (glejte poglavje 4.8).
However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility.
Študije na živalih ne kažejo vpliva salmeterola ali flutikazonpropionata na plodnost.
However, APCR is a phospholipid-based test and it cannot be ruled out that higher concentrations of oritavancin that may occur during clinical use could interfere with this test.
Vendar preizkus APCR temelji na fosfolipidih in ni mogoče izključiti, da bi višje koncentracije oritavancina, ki se lahko pojavijo med klinično uporabo, vplivale nanj.
However, arsenic trioxide and other inorganic arsenic compounds are recognised as human carcinogens.
Vendar arzenov trioksid in druge anorganske arzenove spojine veljajo za snovi, ki so karcinogene za človeka.
However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co- administered with 5-ARIs.
Ker pa uradna študija medsebojnega delovanja zdravil, ki bi ocenila učinke tadalafila in zaviralcev 5-alfa reduktaze (5-ARI), ni bila opravljena, je potrebna previdnost ob sočasni uporabi tadalafila s 5-ARI.
However, as a precaution, it is not recommended to bath animals within 2 days after treatment.
Kot previdnosti ukrep ni priporočljivo kopanje živali do 2 dni po nanosu zdravila.
However, as a precaution, lactating mothers receiving enoxaparin should be advised to avoid breast-feeding.
Kljub temu je treba doječim materam, ki prejemajo enoksaparin, zaradi previdnosti odsvetovati dojenje.
However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.
Ker pa so študije na živalih pokazale, da ima zdravilo Opsumit neželene učinke na razvoj zarodkov, se v nobenem primeru ne sme uporabljati pri nosečnicah in ženskah, ki bi lahko zanosile in ne uporabljajo zanesljive metode kontracepcije.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Ker so klinične izkušnje z olanzapinom pri bolnikih s sočasnimi drugimi boleznimi omejene, se priporoča previdnost pri predpisovanju bolnikom s hipertrofijo prostate ali paralitičnim ileusom in povezanimi stanji.
However, as cystic fibrosis caused by F508del mutation is particularly severe the CHMP considered that the observed effects seen were clinically relevant for patients with no other alternative options.
Ker pa je cistična fibroza, ki jo povzroča mutacija F508del, še posebno težka, je odbor CHMP presodil, da so opaženi učinki za bolnike, ki nimajo druge možnosti, klinično pomembni.
However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Toda, kot pri drugih antagonistih 5-HT3 je potrebna previdnost pri uporabi palonosetrona pri bolnikih, ki imajo ali pri katerih se bo verjetno razvilo podaljšanje intervala QT.
However, as for other serotonergic medicinal products, caution should be exercised when vortioxetine is combined with oral anticoagulants or antiplatelet medicinal products due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction (see section 4.4).
Vendar pa je, kot pri drugih serotonergičnih zdravilih, pri kombinaciji vortioksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili potrebna previdnost zaradi možnega povečanega tveganja za krvavitev, ki se lahko pripiše farmakodinamični interakciji (glejte poglavje 4.4).
However, as in younger patients, renal function must be determined prior to administration of ribavirin (see section 5.2).
Kot pri mlajših bolnikih pa morate pred začetkom uporabe ribavirina opraviti preiskave delovanja ledvic (glejte poglavje 5.2).
However, as orlistat is minimally absorbed, no dose adjustment is necessary in the elderly.
Ker se orlistat le neznatno absorbira, odmerka pri starostnikih ni potrebno prilagajati
However, as patients with peripheral arterial disease have a high risk of atherothrombotic events and the treatment options for prevention of these events are limited, the CHMP considered that Zontivity’s benefits are greater than its risks for this condition.
Ker so bolniki s periferno arterijsko boleznijo močno izpostavljeni tveganju za aterotrombotične dogodke, možnosti za preprečevanje le-teh pa je malo, je CHMP menil, da so koristi zdravila Zontivity za to bolezen večje od tveganj, povezanih z njim.
However, as renal function generally declines with age, consideration should be given to the patient’s renal function (see patients with renal impairment).
Ker pa se delovanje ledvic z leti slabša, je pozornost potrebno posvetiti bolnikovemu delovanju ledvic (glejte Okvara ledvic).
However, as specific information on possible interactions of interferon with other products are missing, supplementary supportive treatments should be used cautiously and after a thorough risk/benefit analysis.
Podatkov o interakciji interferona z drugimi proizvodi ni, zato svetujemo previdno izvajanje dopolnilnega podpornega zdravljenja ter le po temeljiti oceni razmerjatveganja/koristi.
However, as the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent.
Vendar, ker je imunski odziv na antigen pertusisa po uporabi cepiva Infanrix hexa enak kot po uporabi cepiva Infanrix, je pričakovati, da bo zaščitni učinek obeh cepiv enak.
However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Lilly 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Vendar pa je, kot pri vseh zdravilih, pri zdravljenju starejših potrebna previdnost, posebno z zdravilom Duloxetine Lilly 120 mg na dan za zdravljenje velike depresivne motnje ali generalizirane anksiozne motnje, za kar je na voljo malo podatkov (glejte poglavji 4.4 in 5.2).
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Vendar pa je potrebna previdnost, kadar predpisujemo olanzapin skupaj z zdravili, za katera je znano, da podaljšujejo QTc interval, posebno pri starejših, pri bolnikih s prirojenim sindromom dolgega QT intervala, kongestivnim popuščanjem srca, hipertrofijo srca, hipokaliemijo ali hipomagneziemijo.
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Ker pa je topotekan – tako kot druga citotoksična zdravila – genotoksičen, ni mogoče izključiti učinkov na plodnost, vključno s plodnostjo samcev.
However, as with other cytotoxic medicinal products, topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Ker pa je topotekan – tako kot druga citotoksična zdravila – genotoksičen, ni mogoče izključiti učinkov na plodnost, vključno s plodnostjo samcev.
However, at a maternally toxic dose of 60 mg/kg/day (6 times the human clinical exposure in ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) in rats, eltrombopag treatment was associated with embryo lethality (increased pre- and post-implantation loss), reduced foetal body weight and gravid uterine weight in the female fertility study and a low incidence of cervical ribs and reduced foetal body weight in the embryofoetal development study.
Pri študiji vplivov na plodnost samic so pri podganah pri odmerku 60 mg/kg/dan, ki je bil toksičen za matere (6-kratna izpostavljenost človeka pri klinični uporabi pri bolnikih z ITP pri odmerkih 75 mg/dan in 3-kratna izpostavljenost človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan, na osnovi vrednosti AUC), poročali, da je bila uporaba eltrombopaga povezana z odmrtjem zarodkov (povečane predimplantacijske in poimplantacijske izgube), manjšo telesno maso plodov in manjšo maso gravidnega uterusa, pri študiji vplivov na embriofetalni razvoj pa so poročali o manjšem pojavu vratnih reber in manjši telesni masi plodov.
However, at high MPAG plasma concentrations (> 100µg/mL), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
However, at high MPAG plasma concentrations (>°100 g/mL), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
However, at high MPAG plasma concentrations (>°100°g/mL), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
However, at initiation of treatment you will have to stay at the doctor’s surgery or clinic for 6 hours after taking the first dose of Gilenya.
Vendar boste po prvem odmerku zdravila Gilenya morali ostati v ambulanti oziroma bolnišnici na 6- urnem opazovanju.
However, at therapeutic doses of Resolor, no effects on breastfed newborns/infants are anticipated.
Vendar se pri terapevtskih odmerkih zdravila Resolor ne pričakuje učinkov na dojene novorojence/dojenčke.
However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant.
Vendar pri terapevtskih odmerkih timolola v kapljicah za oko ni verjetno, da bodo v materino mleko prišle zadostne količine zdravila, da bi povzročile klinične simptome zaviranja adrenergičnih receptorjev beta pri dojenčku.
However, based on individual response, the dose may be increased.
Glede na odziv posameznika se odmerek lahko zveča;
However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy.
Na podlagi znanih mehanizmov delovanja povzroča trabektedin resne okvare ploda, če se ga daje med nosečnostjo.
However, based on results from general animal toxicity studies, adverse effects on fertility can be expected.
Vendar je na podlagi rezultatov splošnih študij toksičnosti na živalih mogoče pričakovati neželene učinke na plodnost.
However, based on the immunomodulatory effect of AUBAGIO, if a patient develops a serious infection, suspending treatment with AUBAGIO should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Vendar je treba v primeru pojava resne okužbe zaradi imunomodulatornega učinka zdravila AUBAGIO preučiti možnost začasne prekinitve zdravljenja z zdravilom AUBAGIO ter pred ponovno uvedbo zdravljenja pretehtati koristi in tveganja.
However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Vendar pa na osnovi podatkov o izločanju zdravilne učinkovine ni teoretičnega razloga za morebitne zahteve po prilagajanju odmerka pri starostnikih.
However, based on the therapeutic need the use of NovoThirteen as a replacement therapy may be considered during pregnancy.
Vendar lahko, glede na terapevtske potrebe, pride uporaba zdravila NovoThirteen med nosečnostjo v poštev kot nadomestno zdravljenje.
However, baseline PCSK9 levels and the degree and time course of PCSK9 neutralisation were found to be similar between patients with mild or moderate hepatic impairment and healthy volunteers.
Vendar se je izkazalo, da so bili izhodiščna koncentracija PCSK9 ter stopnja in časovni potek nevtralizacije PCSK9 pri 13 bolnikih z blago ali zmerno okvaro jeter podobni kot pri zdravih osebah.
However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended.
Vendar rutinska revakcinacija po koncu primarnega cepljenja ni priporočljiva, ker ni dovolj podatkov o varnosti cepiva proti hepatitisu B, uporabljenega v več odmerkih, kot jih obsega priporočeni niz.
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Humira treatment.
Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju z zdravilom Humira.
However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with MabThera and for 12 months following MabThera treatment.
A zaradi dejstva, da se materini IgG izločajo v materino mleko, in da so rituksimab našli v mleku doječih opic, ženske med zdravljenjem z zdravilom MabThera in 12 mesecev po njem ne smejo dojiti.
However, because of its safety profile, the Committee concluded that Gilenya should only be used in patients who have a real need for the medicine either because they have failed to respond to at least one other disease modifying therapy or because their disease is severe and getting worse rapidly.
Vendar je zaradi varnostnega profila zdravila Gilenya sklenil, da se lahko uporablja samo pri bolnikih, ki zdravilo resnično potrebujejo, ker se niso odzvali na vsaj eno drugo zdravljenje za modificiranje bolezni ali ker je njihova bolezen huda in se hitro poslabšuje.
However, because of the design of the repeat dose toxicity studies and differences in pharmacokinetics in animals and humans, continuous exposure of animals was not assured in these studies.
Vendar zaradi zasnove študij toksičnosti ponavljajočih odmerkov in razlik v farmakokinetiki pri živalih in ljudeh, dolgotrajna izpostavljenost živali v teh študijah ni bila zagotovljena.
However, because of the potential for serious adverse reactions in infants, breastfeeding should be discontinued.
Dojenje je treba prekiniti pred začetkom zdravljenja, ker se pri dojenem otroku lahko pojavijo hudi neželeni učinki.
However, because removal of the spleen is a potential cure for ITP, the Committee concluded that Nplate should only be used in patients with a spleen if they are not able to undergo surgery.
Zato je treba pri bolnikih, pri katerih vranica še ni bila odstranjena, nujnost operativnega posega redno ocenjevati.
However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Ker se sitagliptin izloča predvsem preko ledvic, ni pričakovati, da bi huda okvara jeter vplivala na farmakokinetiko sitagliptina.
However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Ker pa so bili odmerki, ki naj bi povzročili degeneracijo mrežnice, v razponu letalnih odmerkov in v kliničnih študijah niso opažali podobnih učinkov, so menili, da ta ugotovitev ni klinično pomembna.
However, because the main study looked at the medicine’s effects on testosterone levels rather than the cancer or the patient’s outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.
Ker pa so v glavni študiji raziskovali učinke zdravila na koncentracijo testosterona in ne neposredno na raka ali izid za bolnika ter ker se levprorelin uporablja samo za napredovalega raka prostate, se je Odbor odločil omejiti uporabo zdravila Firmagon na napredovalega raka prostate.
However, benefits of conferred immunity through breast-milk may outweigh the risks of potential exposure to alemtuzumab for the breastfed child.
Vendar lahko koristi imunosti, ki se prenaša z materinim mlekom, odtehtajo tveganje potencialne izpostavljenosti dojenega otroka alemtuzumabu.
However, bioequivalence of Eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Dokazali pa so bioekvivalenco zdravila Eucreas s sočasno uporabljanima vildagliptinom in metforminom (glejte poglavje 5.2).
However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Oba sta splošno znana pod imenom nukleozidni zaviralci reverzne transkriptaze (NRTI-nucleoside reverse transcriptase inhibitors) in delujeta tako, da vplivata na normalno delovanje encima (reverzne transkriptaze), ki je bistven za reproduciranje virusa.
However, brief contact of the animal with water on one or two occasions within the month following application is unlikely to significantly reduce its efficacy.
Kljub temu je malo verjetno, da bi enkratni ali dvakratni kratkotrajen stik živali z vodo v mesecu po zdravljenju, pomembno zmanjšal učinkovitost zdravila.
However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure.
Toda po 8. dneh uporaba rifampicina v stanju dinamičnega ravnovesja ni klinično pomembno vplivala na izpostavljenost ambrisentanu.
However, by recommended patient usage vortioxetine is considered to pose negligible risk to the aquatic and terrestrial environment (for instruction on disposal see section 6.6).
Vendar se smatra, da vortioksetin pri priporočeni uporabi pri bolnikih predstavlja zanemarljivo tveganje za vodno in kopensko okolje (za navodila glede odstranjevanja glejte poglavje 6.6).
However, cardiovascular events were similar between linagliptin and placebo (1.03% with linagliptin versus 1.35% with placebo).
Srčno žilni dogodki so bili namreč primerljivi med linagliptinom in placebom (1,03 % pri linagliptinu in1,35 % pri placebu).
However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, phenylbutazone).
Pri predpisovanju oseltamivirja bolnikom, ki sočasno jemljejo zdravila, ki se izločajo enako kot oseltamivir in imajo ozko terapevtsko okno (npr. klorpropamid, metotreksat, fenilbutazon), je potrebna previdnost.
However, cases of alcohol intolerance and intoxication have been reported during post-marketing use.
Kljub vsemu so v obdobju trženja zdravila poročali o primerih intolerance in zastrupitve z alkoholom.
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
So pa pri uporabi pri takšnih bolnikih poročali o primerih smrtno nevarnega pljučnega edema ob uporabi vazodilatatorjev (predvsem prostaciklina).
However, cases with second and third degree AV Block associated with lacosamide treatment have been reported in post- marketing experience.
Vendar pa so v obdobju trženja poročali o primerih atrioventrikularnega bloka druge in tretje stopnje, povezanih z zdravljenjem z lakozamidom.
However, cataracts were not observed in juvenile rats given tolerated doses at 5 times the human clinical exposure in pediatric ITP patients, based on AUC.
Pri tem pa pojavljanja katarakt niso opazili pri mladih podganah pri odmerkih, ki so jih živali prenašale, in so glede na AUC dosegali 5-kratnik klinične izpostavljenosti pri pediatričnih bolnikih z ITP.
However, caution is advised during such activities when beginning Brintellix treatment or changing the dose.
Vseeno svetujemo previdnost med takimi aktivnostmi, ko začnete z zdravljenjem z zdravilom Brintellix ali spremenite odmerek.
However, caution is recommended in these patients (see section 4.4).
Kljub temu je pri teh bolnikih potrebna previdnost (glejte poglavje 4.4).
However, caution is recommended when administering lumacaftor/ivacaftor to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease.
Vendar je priporočljiva previdnost pri dajanju lumakaftorja/ivakaftorja bolnikom s težko ledvično okvaro (očistek kreatinina 30 ml/min ali manj) ali z boleznijo ledvic v končnem stadiju.
However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections.
Pri populaciji starejših oseb je potrebna previdnost pri njihovem zdravljenju, še posebej zaradi večje možnosti za okužbe.
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Vendar je med vožnjo in upravljanjem strojev potrebna previdnost, če utrujenost in astenija še trajata.
However, Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of efficacy.
Tablet Cerenia ne dajemo zavitih ali skritih v hrano, saj to lahko zadrži raztopitev tablete in posledično nastop učinka.
However, certain adverse reactions may affect the ability to drive and use machines (see section 4.8).
Vendar nekatere neželene reakcije lahko poslabšajo sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
However, certain medicines are especially likely to affect the amount of sugar in your blood:
A pri nekaterih zdravilih je še posebej verjetno, da vplivajo na količino sladkorja v krvi:
However, certain medicines are especially likely to affect the amount of sugar in your blood:
Vendar pa nekatera zdravila še posebej verjetno lahko vplivajo na količino sladkorja v krvi:
However, certain medicines are especially likely to affect the amount of sugar in your blood:
Vendar pa nekatera zdravila še posebej verjetno vplivajo na količino sladkorja v krvi:
However, certain monkey species, e.g., Rhesus monkeys are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Rhesus opice, občutljive na farmakodinamično stimulacijo s človeškimi interferoni tipa 1.
However, chemical and physical in use stability has been demonstrated for 8 hours at 2°C-8°C in the original carton, and protected from bright light.
Ugotovilo pa se je, da kemijska in fizikalna stabilnost med uporabo traja 8 ur pri 2 °C - 8 °C, v originalni embalaži in zaščiteno pred močno svetlobo.
However, chemical and physical in use stability has been demonstrated for 8 hours at 2°C-8°C in the original carton, and protected from bright light.
Ugotovilo pa se je, da kemijska in fizikalna stabilnost med uporabo traja 8 ur pri 2 °C – 8 °C, v originalni ovojnini in zaščiteno pred močno svetlobo.
However, chemical and physical in- use stability has been demonstrated for 72 hours at 15-25°C for a concentration range of 4 mg/mL to 20 mg/mL in sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion at 15-25ºC for 72 hours.
Vendar pa so kemično in fizikalno stabilnost pokazali za 72 ur pri temperaturi 15–25 °C in razponu koncentracije od 4 mg/ml do 20 mg/ml v raztopini za infundiranje z natrijevem kloridom 9 mg/ml (0,9 %) ali 5-odstotno glukozo.
However, chemical and physical in-use stability has been demonstrated for 1 hour at room temperature (up to 25°C +/-2°C).
Dokazano pa je bilo, da je raztopina za infundiranje kemično in fizikalno stabilna še 1 uro pri sobni temperaturi (do 25 °C +/– 2 °C).
However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8C when stored under protection from light.
Vendar je bila dokazana kemična in fizikalna stabilnost za 24 ur pri 2 C do 8 C, če je zdravilo shranjeno v temnem prostoru.