natgillin/translations-raw huggingface dataset:
Although more data are needed to determine the size of the benefit, the Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zalmoxis’ benefits are greater than its risks and recommended that it be approved for use in the EU.
Čeprav je za določitev obsega koristi potrebnih več podatkov, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji zaključil, da so koristi zdravila Zalmoxis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2- adrenergic agonists.
Kot velja za druge agoniste adrenergičnih receptorjev beta-2, je tudi pri indakaterolu potrebna previdnost pri uporabi pri bolnikih s kardiovaskularnimi boleznimi (s koronarno boleznijo, po akutnem miokardnem infarktu, z aritmijami, s hipertenzijo), pri bolnikih s konvulzivnimi motnjami ali s hipertiroidizmom in pri bolnikih, ki so neobičajno odzivni na agoniste adrenergičnih receptorjev beta-2, čeprav pri uporabi zdravila Hirobriz Breezhaler v okviru priporočenega odmerjanja običajno ni opaziti klinično pomembnih učinkov na kardiovaskularni sistem.
Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2- adrenergic agonists.
Kot velja za druge agoniste adrenergičnih receptorjev beta-2, je tudi pri indakaterolu potrebna previdnost pri uporabi pri bolnikih s kardiovaskularnimi boleznimi (s koronarno boleznijo, po akutnem miokardnem infarktu, z aritmijami, s hipertenzijo), pri bolnikih s konvulzivnimi motnjami ali s hipertiroidizmom in pri bolnikih, ki so neobičajno odzivni na agoniste adrenergičnih receptorjev beta-2, čeprav pri uporabi zdravila Onbrez Breezhaler v okviru priporočenega odmerjanja običajno ni opaziti klinično pomembnih učinkov na kardiovaskularni sistem.
Although no data are available on the immune response to the Bacille-Calmette- Guérin (BCG) antigen, no interference is expected.
Glede imunskega odziva na antigen BCG (Bacille-Calmette-Guérin) sicer ni podatkov, vendar pa se oviranje imunskega odziva na cepivo MMR ne pričakuje.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of Zavesca having an efficacy or safety advantage over ERT.
Čeprav neposredne primerjave z zdravljenjem z encimskim nadomestnim zdravljenjem (ERT - Enzyme Replacement Therapy) pri bolnikih z Gaucherevo boleznijo tipa 1, ki predhodno niso bili zdravljeni, niso bile opravljene, ni dokazov, da bi bilo zdravilo Zavesca učinkovitejše ali varnejše kot ERT.
Although no direct drug-drug interactions have been demonstrated, chronic use of loperamide with eluxadoline should be avoided as this may increase the risk of constipation.
Čeprav niso dokazali nobenega neposrednega medsebojnega delovanja med zdravili, se kronična uporaba loperamida z eluksadolinom odsvetuje zaradi možnosti zvečanja tveganja za zaprtost.
Although no dose adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) or mild renal impairment (creatinine clearance 50-80 mL/min), careful clinical monitoring is advised during the treatment with enoxaparin sodium.
Čeprav pri bolnikih z zmerno (kreatininski očistek 30–50 ml/min) ali blago (kreatininski očistek 50–80 ml/min) ledvično okvaro odmerka ni treba prilagoditi, je med zdravljenjem z natrijevim enoksaparinatom priporočljivo natančno klinično spremljanje.
Although no dose adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) or mild renal impairment (creatinine clearance 50-80 mL/min), it is advised that your doctor carefully monitors your treatment.
Čeprav pri bolnikih z zmerno (kreatininski očistek 30–50 ml/min) ali blago (kreatininski očistek 50–80 ml/min) ledvično okvaro odmerka ni treba prilagoditi, je priporočljivo, da zdravnik natančno spremlja vaše zdravljenje.
Although no dose adjustments is necessary in patients with moderate (creatinine clearance 30 to 50 mL/min) and mild (creatinine clearance 50 to 80 mL/min) renal impairment, careful clinical monitoring of these patients should be carried out during treatment with enoxaparin sodium (see also sections 4.2 and 5.2).
Čeprav pri bolnikih z zmerno (kreatininski očistek 30–50 ml/min) in blago (kreatininski očistek 50–80 ml/min) ledvično okvaro ni treba prilagoditi odmerka, je pri njih priporočljivo natančno klinično nadziranje ves čas zdravljenja z natrijevim enoksaparinatom (glejte tudi poglavji 4.2 in 5.2).
Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Čeprav pri bolnikih z okvarami ledvic ali jeter, ki so peroralno in intravensko prejemali granisetron, niso opazili znakov zvečane pogostnosti neželenih učinkov, na podlagi farmakokinetike granisetrona, je pri tej skupini bolnikov potrebna določena previdnost.
Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Čeprav formalnih raziskav o medsebojnem delovanju in vivo niso izvedli, so pri sočasni uporabi aklidinijevega bromida in drugih zdravil za KOPB, vključno s simpatomimetičnimi bronhodilatatorji, metilksantini in steroidi za peroralno inhalacijo, niso zasledili kliničnih znakov medsebojnega delovanja zdravil.
Although no formal in vivo interaction studies have been performed, inhaled umeclidinium bromide has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.
Čeprav uradnih študij medsebojnega delovanja in vivo še niso izvedli, je bil umeklidinijev bromid za inhaliranje sočasno že uporabljan z drugimi zdravili za KOPB, vključno s kratko- in dolgodelujočimi simpatikomimetičnimi bronhodilatatorji in inhalacijskimi kortikosteroidi, vendar kliničnih dokazov za medsebojno delovanje z drugimi zdravili ni.
Although no information is available specifically regarding the use of haemodialysis to treat overdose, it should be noted that in a Phase 1 study in patients with renal impairment, less than 6 % of the recommended dalbavancin dose was removed after 3 hours of haemodialysis.
Čeprav informacij, posebej v zvezi z uporabo hemodialize pri prevelikem odmerjanju, sicer ni na voljo, je treba opozoriti, da je bilo v študijah 1.faze pri pacientih z okvaro ledvic manj kot 6 % priporočenega odmerka dalbavancina izločenega po treh urah hemodialize.
Although no intravenous data are available for Teysuno in humans, the volume of distribution could be roughly estimated from the apparent volume of distribution and urinary excretion data as 16 l/m2, 17 l/m2, and 23 l/m2 for tegafur, gimeracil and oteracil, respectively.
Čeprav ni na voljo nobenih intravenskih podatkov za zdravilo Teysuno pri ljudeh, je mogoče na grobo oceniti volumen porazdelitve na podlagi navideznega volumna porazdelitve in podatkov o izločanju z urinom, namreč kot 16 l/m2 za tegafur, 17 l/m2 za gimeracil in 23 l/m2, za oteracil..
Although no new safety concerns have been identified, the MAH proposed two changes to the product information.
Čeprav novi varnostni zadržki niso bili ugotovljeni, je imetnik dovoljenja za promet z zdravilom predlagal dve spremembi informacij o zdravilu.
Although no safety issues were observed in patients over 75 years, data are limited in this age subgroup.
Med bolniki, starejšimi od 75 let, niso ugotovili varnostnih težav, vendar pa je podatkov za to starostno podskupino malo.
Although no safety issues were observed in patients over 75 years, data are limited in this age subgroup.
Med bolniki, starejšimi od 75 let, niso ugotovili varnostnih težav, vendar pa so podatki za to starostno podskupino omejeni.
Although no significant QTc increases were seen in a thorough QT study in healthy volunteers, based on PK/PD modelling, eliglustat plasma concentrations 11-fold the predicted human Cmax are predicted to cause mild increases in the PR, QRS, and QTc intervals (see section 5.1, Electrocardiographic evaluation).
Čeprav v poglobljeni študiji intervala QT pri zdravih prostovoljcih niso opazili nobenega pomembnega povečanja intervala QTc, se na osnovi farmakokinetično/farmakodinamičnega modeliranja predvideva, da bodo plazemske koncentracije eliglustata, ki so 11-krat večje od pričakovane koncentracije Cmax pri človeku, povzročile rahlo povečanje intervalov PR, QRS in QTc (glejte poglavje 5.1 »Ocena elektrokardiograma«).
Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with Inflammatory Bowel Disease patients is not known.
Pri zdravih osebah sistemskega zaviranja imunske odzivnosti sicer niso opazili, vendar pa sistemski vplivi na delovanje imunskega sistema pri bolnikih z vnetno črevesno boleznijo niso znani.
Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Ni nujno, da se bodo pri vas pojavili vsi ti neželeni učinki, če pa se pojavijo, boste zaradi njih lahko potrebovali zdravniško pomoč.
Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway and the potential exists to affect medicinal products metabolised by CYP2D6.
Čeprav se bupropion in njegov glavni presnovek, hidroksibupropion, ne presnavljata z izoencimom CYP2D6, pa ovirata pot encimu CYP2D6, zato obstaja možnost vpliva na zdravila, ki jih presnavlja encim CYP2D6.
Although not specifically studied with the Irbesartan Hydrochlorothiazide Zentiva, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Posebnih študij z zdravilom Irbesartan Hydrochlorothiazide Zentiva ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
Although not studied clinically,
Čeprav ni klinično raziskano, lahko
Although not studied clinically, voriconazole is likely to increase
Čeprav ni klinično raziskano, lahko vorikonazol poveča plazemsko koncentracijo statinov, ki se presnavljajo preko CYP3A4, in tako povzroči rabdomiolizo.
Although not studied clinically, voriconazole is likely to increase the plasma concentrations of benzodiazepines that are
Čeprav ni klinično raziskano, lahko vorikonazol poveča plazemsko koncentracijo
Although not studied,
Niso klinično preučili.
Although not studied, voriconazole
Čeprav ni raziskano, lahko
Although not studied, voriconazole is likely to increase the plasma concentrations of sulfonylureas and cause hypoglycaemia.
Čeprav ni raziskano, lahko vorikonazol poveča koncentracijo alkaloidov rožnatega zimzelena v plazmi in povzroči nevrotoksične učinke.
Although once daily dosing comes with a risk of cortisol levels being too low in the afternoon, this can be managed by adding further doses of hydrocortisone if needed.
Čeprav pri odmerjanju zdravila enkrat dnevno obstaja nevarnost, da raven kortizola popoldan preveč upade, se ta težava lahko reši z jemanjem dodatnih odmerkov hidrokortizona, če je to potrebno.
Although Orbactiv’s safety profile overall is similar to that of other glycopeptides, the CHMP noted that some side effects occurred more frequently such as abscesses and bone infections.
Čeprav je varnostni profil zdravila Orbactiv na splošno podoben varnostnemu profilu drugih glikopeptidov, je odbor CHMP opozoril, da se nekateri neželeni učinki, kot so abscesi in kostne okužbe, pojavljajo pogosteje.
Although other dose regimens/combinations are under investigation, a combination regimen of Paxene and cisplatin is recommended.
Čeprav druge režime odmerjanj in kombinacije še raziskujejo, se priporoča kombinacija zdravila Paxene in cisplatina.
Although other doses have been studied, the recommended dose of Zurampic is 200 mg once daily in combination with a xanthine oxidase inhibitor.
Raziskani so bili sicer tudi drugi odmerki zdravila Zurampic, a njegov priporočeni odmerek v kombinaciji z zaviralcem ksantin- oksidaze je 200 mg enkrat na dan.
Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded.
Čeprav so bili v nekaterih primerih prisotni drugi dejavniki tveganja (na primer uporaba kortikosteroidov in izpostavljenost sevanju), ni mogoče izključiti možnega tveganja, ki bi ga lahko pripisali ivakaftorju.
Although Pandemic influenza vaccine H5N1 MedImmune might increase wheezing in children aged 1 to 2 years, the risk is considered acceptable in a pandemic situation.
Zaradi cepiva proti pandemski gripi H5N1 MedImmune je lahko pri otrocih, starih od 1 do 2 leti, pogostejše piskajoče dihanje, vendar je tveganje v primeru pandemije ocenjeno kot sprejemljivo.
Although patients had medical conditions that may be associated with localised or diffuse reduction of structural integrity in the wall of the GI tract (e.g., cancer, peptic ulcer, pseudo-obstruction), the use of methylnaltrexone bromide may have contributed to these events.
Čeprav so imeli bolniki stanja, ki jih lahko povezujemo z lokalno ali sistemsko oslabitvijo strukturne integritete stene prebavne cevi (npr. rak, peptična razjeda, psevdoobstrukcija), je k težavam morda prispevala tudi uporaba metilnaltreksonijevega bromida.
Although patients with hepatic impairment were not studied with ZYPADHERA, it is recommended that a well-tolerated and effective dosage regimen using oral olanzapine is established in patients with hepatic impairment before treatment with ZYPADHERA is initiated (see section 4.2).
Čeprav z zdravilom ZYPADHERA niso preiskovali bolnikov z okvarjenim delovanjem jeter, pred začetkom zdravljenja z zdravilom ZYPADHERA priporočamo, da se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina pri bolnikih z okvarjenim delovanjem jeter (glejte poglavje 4.2).
Although PD-L1 status is predictive of response in advanced melanoma patients, durable responses have been observed in PD-L1 negative patients.
Čeprav je PD-L1 status napovednik odziva pri bolnikih z napredovalim melanomom, so trajne odzive opazili pri PD-L1 negativnih bolnikih.
Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gram- negative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications (see section 4.2) and in accordance with the prudent use recommendations in section 4.5 of this SPC.
Kljub temu, da pradofloksacin in vitro deluje na številne grampozitivne in gramnegativne organizme ter anaerobne bakterije, se to zdravilo lahko uporablja le za odobrene indikacije (glej poglavje 4.2) in v skladu s priporočili o preudarni uporabi v poglavju 4.5 tega SPC.
Although proteinuria (> 2 g/day) increased belimumab clearance and decreases in creatinine clearance decreased belimumab clearance, these effects were within the expected range of variability.
Proteinurija (> 2 g/dan) je očistek belimumaba povečala, zmanjšanje očistka kreatinina pa ga je zmanjšalo, toda ta učinka sta bila znotraj pričakovanega razpona variabilnosti.
Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Čeprav ni pričakovati, da bi zdravilo Rapamune vplivalo na vašo sposobnost vožnje, se, če ste v dvomih, posvetujte z zdravnikom.
Although rare (may affect up to 1 in 1,000 people taking CELSENTRI), severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking CELSENTRI.
Poročali so o redkih (pojavijo se lahko pri največ 1 od 1.000 bolnikov, ki so jemali zdravilo CELSENTRI), resnih in življenjsko nevarnih kožnih reakcijah in alergijskih reakcijah pri nekaterih bolnikih, ki so jemali zdravilo CELSENTRI.
Although rare 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.
V kliničnih raziskavah, sicer redko, se lahko pojavi večja ali huda krvavitev in ne glede na mesto krvavitve lahko povzroči invalidnost, življenjsko ogroženost ali je celo usodna.
Although rare, pancreatitis should be considered in somatropin-treated children who develop abdominal pain.
Primeri so sicer redki, vendar pa je pri otroku, ki se zdravi s somatropinom, v primeru pojava bolečine v trebuhu treba pomisliti na vnetje trebušne slinavke.
Although Revestive was not shown to have an effect on initiating tumours, the company will closely monitor the medicine’s safety and effectiveness by setting up a registry of patients.
Čeprav zdravilo Revestive ni izkazalo vpliva na nastanek tumorjev, bo družba podrobno spremljala varnost in učinkovitost zdravila z vzpostavitvijo registra bolnikov.
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to
Rilpivirin je in vitro v manjši meri pokazal tudi delovanje proti HIV-2, in sicer z vrednostmi EC50 od
Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Čeprav se pri bolnikih s hudo ledvično okvaro, ki prejemajo 20 mg/m2 na dan, pričakuje, da bo dnevna izpostavljenost 5-fluorouracilu približno enaka kot pri bolnikih z normalnim delovanjem ledvic, ki prejemajo 30 mg/m2 dvakrat na dan (glejte poglavje 5.2), se dajanje zdravila Teysuno ne priporoča, saj obstaja možnost večje incidence neželenih dogodkov bolezni krvi in limfatičnega sistema, razen če je jasno, da so koristi večje od tveganja (glejte poglavji 4.4 in 4.8).
Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Čeprav se pri bolnikih s hudo ledvično okvaro, ki prejemajo 20 mg/m2 na dan, pričakuje, da bo dnevna izpostavljenost 5-fluorouracilu, približno enaka kot pri bolnikih z normalnim delovanjem ledvic, ki prejemajo 30 mg/m2 dvakrat na dan, (glejte poglavje 5.2), se dajanje zdravila Teysuno ne priporoča, saj obstaja možnost večje incidence neželenih dogodkov bolezni krvi in limfatičnega sistema, razen če je jasno, da so koristi večje od tveganja (glejte poglavji 4.4 in 4.8).
Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Čeprav varnost pri tej skupini ni bila ogrožena, se lahko zaradi nizke Cmax prilagodi odmerek.
Although serious ARRs, including dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation and respiratory distress, were not reported in the clinical trial with the Herceptin subcutaneous formulation, caution should be exercised as these have been associated with the intravenous formulation.
Čeprav o resnih neželenih reakcijah, povezanih z aplikacijo, vključno z dispnejo, hipotenzijo, piskanjem, bronhospazmom, tahikardijo, zmanjšano saturacijo arterijske krvi s kisikom in dihalno stisko, v kliničnih preskušanjih subkutane oblike zdravila Herceptin niso poročali, je potrebna previdnost, saj so te povezane z intravensko obliko.
Although side effects with Unituxin can be severe, and medication is required to prevent allergic reactions and pain, the medicine’s risks are considered acceptable given the severity of the disease.
Čeprav so lahko neželeni učinki zdravila Unituxin hudi in so potrebna zdravila za preprečevanje alergijskih reakcij ter bolečin, so tveganja zdravila sprejemljiva zaradi resnosti te bolezni.
Although significant systemic exposure to free cytarabine is not expected following intrathecal treatment, some effects on bone marrow function cannot be excluded.
Po intratekalnem zdravljenju ni pričakovati značilne sistemske izpostavljenosti prostemu citarabinu, vendar učinkov na delovanje kostnega mozga ni mogoče izključiti.
Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in patients receiving therapeutic doses of Rapamune.
V in vitro poskusih sirolimus zavira humani jetrni mikrosomski citokrom P450 CYP2C9, CYP2C19, CYP2D6 in CYP3A4/5, vendar ni pričakovati, da bi zdravilna učinkovina zavirala aktivnost teh izoencimov tudi in vivo, saj so koncentracije sirolimusa, ki so potrebne za inhibicijo, mnogo višje od tistih, ki jih izmerijo pri bolnikih, ki jemljejo terapevtske odmerke zdravila Rapamune.
Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the exposed area immediately, as GnRH analogues may be absorbed through the skin.
Čeprav stik kože z zdravilom ni verjeten, je treba, če do njega pride, nemudoma sprati izpostavljeni predel, ker se analogi GnRH lahko absorbirajo skozi kožo.
Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the exposed area immediately, as GnRH analogues may be absorbed through the skin.
Čeprav stik kože z zdravilom za uporabo v veterinarski medicini ni verjeten, je treba, če do njega pride, nemudoma sprati izpostavljeni predel, ker se analogi GnRH lahko absorbirajo skozi kožo.
Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
Čeprav so pri mnogih ženskah, ki jemljejo COC, poročali o majhnem povečanju krvnega tlaka, pa je klinično pomembno povečanje redko.
Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
Čeprav so pri mnogih ženskah, ki jemljejo KPK, poročali o majhnem povečanju krvnega tlaka, pa je klinično pomembno povečanje redko.
Although small increases of blood pressure have been reported in many women using hormonal contraceptives, clinically relevant increases are rare.
Čeprav so poročali, da se je pri mnogih ženskah, ki uporabljajo hormonske kontraceptive, krvni tlak nekoliko zvišal, so klinično pomembna zvišanja redka.
Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.
Po cepljenju lahko pride do določene tvorbe protiteles proti davičnemu toksoidu, vendar to cepivo ni nadomestilo za običajno cepljenje proti davici.