natgillin/translations-raw huggingface dataset:
The risk of toxicity rises with increasing cumulative doses of those medicinal products and is higher in individuals with a history of cardiomyopathy, or mediastinal irradiation or pre-existing cardiac disease.
Tveganje toksičnosti narašča s povečanjem kumulativnih odmerkov teh zdravil in je večje pri osebah, ki imajo ali so imele kardiomiopatijo, mediastinalno obsevanje ali že obstoječo srčno bolezen.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Tveganje za vensko trombembolijo se nadaljuje še 4-6 tednov po ukinitvi jemanja kombinirane peroralne kontracepcije.
The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Tveganje za virusni neodziv bi lahko bilo pri zdravilu Kivexa večje kot pri drugih terapevtskih možnostih (glejte poglavje 5.1).
The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective oestrogen receptor modulators (SERMs).
Tveganje za VTE (globoka venska tromboza in pljučna embolija) se poveča z drugimi selektivnimi modulatorji estrogenskih receptorjev (SERM, selective estrogen receptor modulators).
The risk of withdrawal symptoms seen with SSRI’s and SNRI’s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Tveganje za pojav odtegnitvenih simptomov opaženih pri SSRI in SNRI je odvisno od številnih dejavnikov, med drugim od trajanja zdravljenja in predpisanega odmerka ter stopnje zmanjševanja odmerka zdravila.
The risk of you having bone problems is higher if you:
Tveganje, da boste imeli težave s kostmi, je večja, če:
The risk on virus shedding vertical viral transmission is theoretically negligible however not excluded.
Tveganje za vertikalni prenos virusa zaradi izločanja virusa je teoretično zanemarljivo, ni pa izključeno.
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favor of the TCF arm.
V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favour of the TCF arm.
V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Zmanjšanje tveganja je bilo 51- odstotno v skupini bolnikov, ki še niso jemali difosfonatov, in 42-odstotno pri bolnikih, ki so lahko sočasno jemali druga zdravila za zdravljenje osteoporoze.
The risk requires assessment on a case-by-case basis (see section 4.2).
Tveganje zahteva oceno na podlagi posameznega primera (glejte poglavje 4.2).
The risk to the unborn child is unknown.
Tveganje za nerojenega otroka ni znano.
the risk, co-administration of
tveganja, je pri sočasni uporabi
The risk-benefit balance should be considered in patients at risk of thromboembolic events (TEEs) of any aetiology.
Pri bolnikih s tveganjem za pojav trombemboličnih dogodkov katerekoli etiologije je treba poskrbeti za ravnovesje med tveganjem in koristjo.
The risk-benefit for the treatment of thrombocytopenia outside of the registered indication has not been established.
Koristi in tveganja zdravljenja trombocitopenije zunaj okvira odobrenih indikacij niso ugotovljene.
The risk-benefit of Revolade in paediatric HCV-associated thrombocytopenia and SAA has not been established.
Koristi in tveganja zdravila Revolade pri pediatričnih bolnikih s trombocitopenijo povezano s HCV ali s hudo aplastično anemijo niso ugotovljene.
The risk/benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Razmerja med tveganjem in koristnostjo mofetilmikofenolata v kombinaciji s takrolimusom ali sirolimusom niso raziskali (glejte tudi poglavje 4.5).
The risk/benefit should be considered in patients with established hyperlipidaemia before initiating an immunosuppressive regimen, including Rapamune.
Pri bolnikih z ugotovljeno hiperlipidemijo je treba pred začetkom zdravljenja z zaviralci imunske odzivnosti, vključno z zdravilom Rapamune, pretehtati pričakovano korist in tveganje.
The risk/benefit-ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Razmerja med tveganjem in koristnostjo mofetilmikofenolata v kombinaciji s takrolimusom ali sirolimusom še niso raziskali (glejte tudi poglavje 4.5).
The risks and benefits of Imlygic should be considered before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune- mediated events.
Pred uvedbo zdravljenja bolnikom, ki imajo osnovno avtoimunsko bolezen, in pred nadaljevanjem zdravljenja bolnikov, ki se jim pojavijo imunsko pogojeni učinki, je treba razmisliti o tveganjih in koristih zdravila Imlygic.
The risks and benefits of Imlygic should be considered in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Pri bolnikih z diseminiranim plazmocitomom in bolnikih, ki se jim plazmacitom pojavi med zdravljenjem, je treba razmisliti o tveganjih in koristih zdravila Imlygic.
The risks and benefits of pazopanib should be considered before beginning therapy in patients who have pre-existing cardiac dysfunction.
Pred začetkom zdravljenja bolnikov s predobstoječim motenim delovanjem srca je treba upoštevati tveganja in koristi pazopaniba.
The risks associated with incorrect storage and mishandling
tveganja, povezana z nepravilnim shranjevanjem in ravnanjem
the risks of ectopic bone formation
tveganju ektopične tvorbe kosti,
The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause:
Med tveganja zaradi prenehanja jemanja zdravila Soliris sodi povečana razgradnja rdečih krvničk, kar lahko povzroči:
The risks of stopping Soliris include an increase in the inflammation of your platelets, which may cause:
Med tveganja zaradi prenehanja jemanja zdravila Soliris sodi povečano vnetje trombocitov, kar lahko povzroči:
The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines.
Pri bolnikih, ki že imajo kakšno bolezen srca, in bolnikih, ki se zdravijo z drugimi zdravili, je tveganje za pojav motenj srčnega ritma lahko večje.
the risks of treatment with eculizumab
tveganja zdravljenja z ekulizumabom,
The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects.
Tveganja, ki so jih ugotovili za zdravilo Zebinix, so pretežno od odmerka odvisni neželeni u činki, ki so zna čilni za to skupino zdravil.
The rivaroxaban clinical program was designed to demonstrate the efficacy of Xarelto for the prevention of cardiovascular (CV) death, MI or stroke in subjects with a recent ACS (ST-elevation myocardial infarction [STEMI], non- ST-elevation myocardial infarction [NSTEMI] or unstable angina [UA]).
Klinični program rivaroksabana je bil zasnovan tako, da dokaže učinkovitost zdravila Xarelto pri preprečevanju kardiovaskularne (KV) smrti, miokardnega infarkta ali možganske kapi pri bolnikih z nedavnim AKS (miokardnega infarkta z elevacijo spojnice ST [STEMI], miokardnega infarkta brez elevacije spojnice ST [NSTEMI] ali nestabilno angino pektoris).
The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
Klinični program z rivaroksabanom je bil zasnovan tako, da dokaže učinkovitost rivaroksabana pri preprečevanju VTE, tj. proksimalne in distalne globoke venske tromboze (GVT) in pljučne embolije (PE), pri bolnikih z velikimi ortopedskimi kirurškimi posegi na spodnjih okončinah.
The role and use of patient alert card.
Vloga in uporaba opozorilne kartice za bolnika
The role and use of the Patient Alert Card
Vloga in uporaba Opozorilne kartice za bolnika.
The role and use of the Patient Alert Card.
Namen in uporaba opozorilne izkaznice za bolnika.
The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing.
Vlogo in uporabo kontrolnega seznama za predpisovalce zdravila, ki je vključen v pakiranje za evidentiranje ugotovljene nosečnosti pred dajanjem zdravila.
The role of Ceplene is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune- mediated destruction of residual leukaemic cells.
Vloga zdravila Ceplene je zaščititi limfocite, zlasti celice ubijalke (NK celice) in T celice, ki so odgovorne za imunsko uničevanje preostalih levkemičnih celic.
The role of golimumab as a contributing or aggravation factor cannot be excluded.
Vloge golimumaba pri tem dogodku ni mogoče izključiti.
The role of the patient card in ensuring that patients are aware of the product they are taking and the recommendations for safe and effective use in particular once daily dose and the importance of avoiding switching between other tacrolimus containing products except under the advice and supervision of your doctor
Vloga opozorilne kartice za bolnike pri zagotavljanju, da se bolnik zaveda, kakšno zdravilo uporablja, in priporočilu za varno in učinkovito uporabo, zlasti odmerka, ki se uporablja enkrat na dan, in da je pomembno, da ne pride do menjavanja z drugimi zdravili, ki vsebujejo takrolimus, razen po nasvetu in pod nadzorom zdravnika.
The room requirements for Zalmoxis administration
Prostorske zahteve pri dajanju zdravila Zalmoxis
The rSBA GMTs were significantly lower in the subjects who had received a dose of ACWY-PS vaccine 30-42 months prior to Nimenrix (Table 14) (see section 4.4).
Pri preskušancih, ki so prejeli odmerek cepiva ACWY-PS 30 do 42 mesecev pred cepivom Nimenrix, so opazili signifikantno nižje GMT rSBA (preglednica 14) (glejte poglavje 4.4).
The rubber stopper of the vial may be safely punctured up to 20 times.
Gumijasti zamašek stekleničke lahko varno preluknjate do 20-krat.
The rubber stopper of the vial may be safely punctured up to 20 times.
Gumijasti zamašek viale lahko varno preluknjate do 20-krat.
The rubber top should be cleaned and a new syringe with needle inserted into the vial .
Gumijasti pokrovček očistite in v vialo vstavite novo brizgo z iglo.
The rules for stopping when target liver iron concentration and serum ferritin are reached
pravila za zaključek zdravljenja, ko je dosežena ciljna koncentracija železa v jetrih in feritina v serumu,
The S- COMT activity inhibition was significantly increased in elderly subjects.
Zaviranje aktivnosti S-COMT je bilo pri starejših osebah občutno povečano.
The sachet containing the Drug Unit should be opened starting at the pre-cut notch, then by carefully tearing along the top of the sachet.
Vrečko, ki vsebuje zdravilno enoto, začnite odpirati ob zarezi, nato pa previdno odtrgajte vrh vrečke.
The sachet foil is comprised of a lamination of nylon, aluminium foil and a heat seal layer of a copolymer of polyethylene and polymethacrylic acid.
Vrečka iz folije sestoji iz laminata najlona, aluminijaste folije in toplotno zavarjene plasti kopolimera polietilena in polimetakrilne kisline.
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not bioequivalent.
Prašek za peroralno suspenzijo v vrečkah ima nekoliko višji Cmax kot kapsule, zato farmacevtski obliki nista bioekvivalentni.
The sachets can be stored below 25°C up to 24 hours after first opening.
Vrečke lahko po prvem odprtju shranjujete največ 24 ur pri temperaturi do 25 °C.
The sachets should only be opened immediately prior to use.
Vrečke odprite le neposredno pred uporabo.
The safe use of CELSENTRI in pregnancy has not been proven.
Varnost uporabe zdravila CELSENTRI med nosečnostjo ni bila dokazana.
The safe use of Kalydeco during breast-feeding has not been established.
Varne uporabe zdravila Kalydeco v času dojenja niso dokazali.
The safe use of pazopanib during lactation has not been established.
Varnost uporabe pazopaniba med dojenjem ni bila dokazana.
The safety analyses were done considering the clinical study 1 [CCG-1962] and study 2 [AALL07P4] adverse drug reactions (see section 5.1).
Analize varnosti so bile opravljene z upoštevanjem neželenih učinkov iz 1. klinične študije [CCG-1962] in 2. klinične študije [AALL07P4] (glejte poglavje 5.1).
The safety and antibody persistence data up to year 5 and the data on co-administration of MenACWY-TT with Prevenar 13 will be provided in sequential study reports at 1, 3 and 5 years after vaccination.
podani v zaporednih poročilih študije ob 1, 3 in 5 letih po cepljenju.
The safety and effectiveness of Lojuxta in children below the age of 18 have not been established;
Varnost in učinkovitost zdravila Lojuxta pri otrocih, mlajših od 18 let, nista bili dokazani;
The safety and effectiveness of SonoVue in patients under 18 years old has not been established and the product should not be used in these patients.
Varnost in učinkovitost zdravila SonoVue pri bolnikih mlajših od 18 let ni bila ugotovljena, zato zdravila ne smemo uporabljati pri teh bolnikih.
The safety and effectiveness of Tecfidera in this age group are not known.
Varnost in učinkovitost zdravila Tecfidera v tej starostni skupini nista bili ugotovljeni.
The safety and efficacy have not been studied in patients with hepatic impairment.
Študij varnosti in učinkovitosti pri bolnikih z motnjami v delovanju jeter niso izvedli.
The safety and efficacy have not been studied in patients with renal impairment.
Študij varnosti in učinkovitosti pri bolnikih z motnjami v delovanju ledvic niso izvedli.
The safety and efficacy in children (below the age of 18 years) has not been studied.
Varnosti in učinkovitosti pri otrocih (starih do 18 let) niso preučevali.
The safety and efficacy in children (below the age of 18 years) has not been studied.
Varnosti in učinkovitosti zdravila Renagel pri otrocih (starih do 18 let) niso preučevali.
The safety and efficacy in children (below the age of 18 years) has not been studied.
Varnosti in učinkovitosti zdravila Renvela (starih do 18 let) niso preučevali.
The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established in controlled clinical studies.
Varnost in učinkovitost pri otrocih (vključno z novorojenčki) starimi manj kot 4 mesece, zdravljenih za invazivno kandidozo, ki vključuje okužbo CŽS, v odmerkih 4 in 10 mg/kg, v kontroliranih kliničnih študijah ni bila ustrezno ugotovljena.
The safety and efficacy in children have not been established.
Varnost in učinkovitost pri otrocih nista bili dokazani.
The safety and efficacy of 1.5 mg has not been studied (see section 4.4.)
Varnost in učinkovitost odmerka 1,5 mg nista raziskani (glejte poglavje 4.4).
The safety and efficacy of 80 mg once-daily TAGRISSO was explored in an expansion cohort of 63 previously-treated patients with centrally confirmed T790M positive NSCLC.
Varnost in učinkovitost 80 mg zdravila TAGRISSO enkrat na dan so raziskali pri razširjeni kohorti 63 predhodno zdravljenih bolnikov, ki so imeli centralno potrjen T790M-pozitiven NSCLC.
The safety and efficacy of abatacept were assessed in a three-part study.
Varnost in učinkovitost abatacepta je bila vrednotena v tridelni študiji.
The safety and efficacy of ABILIFY solution for injection in children and adolescents aged 0-17 years have not been established.
Varnost in učinkovitost zdravila ABILIFY pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
The safety and efficacy of Abraxane in children and adolescents aged 0-17 years has not been established.
Varnost in učinkovitost zdravila Abraxane pri otrocih in mladostnikih, starih 0 – 17 let, nista bili dokazani.
The safety and efficacy of Aclasta in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zdravila Aclasta pri otrocih in mladostnikih starih do 18 let nista bili dokazani.
The safety and efficacy of ADCIRCA in individuals below 18 years of age has not yet been established.
Varnost in učinkovitost zdravila ADCIRCA pri posameznikih, starih do 18 let, še ni bila dokazana.
The safety and efficacy of Aerivio Spiromax in children and adolescents aged less than 18 years of age has not been established.
Varnost in učinkovitost zdravila Airexar Spiromax pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
The safety and efficacy of Aerivio Spiromax in this young population have not been established.
Varnost in učinkovitost zdravila Airexar Spiromax pri tej mladi populaciji še nista bili dokazani.
The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established.
Varnost in učinkovitost afamelanotida pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
The safety and efficacy of Akynzeo in the paediatric population have not been established.
Varnost in učinkovitost zdravila Akynzeo pri pediatrični populaciji nista bili dokazani.
The safety and efficacy of alli in children below 18 years of age has not been established.
Varnost in učinkovitost zdravila alli pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of alogliptin when used as triple therapy with metformin and a sulphonylurea have not been fully established.
Varnost in učinkovitost uporabe alogliptina v okviru trotirnega zdravljenja z metforminom in s sulfonilsečnino nista bili popolnoma dokazani.
The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four open- label, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative disorders (MPDs).
Varnost in učinkovitost anagrelida kot sredstva za zniževanja krvnih ploščic so ovrednotili v štirih odprtih, nekontroliranih študijah, z vsem sodelujočim znanim zdravilom (številke študij 700-012, 700-014, 700-999 in 13970-301), ki so vključevale več kot 4000 bolnikov z mieloproliferativno boleznijo (MPD).
The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1790 RA patients  18 years of age with varying degrees of disease severity.
Varnost in učinkovitost anakinre v kombinaciji z metotreksatom so dokazali pri 1790 bolnikih z RA, starih 18 let, z različnimi stopnjami izraženosti bolezni.
The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, double- blind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Varnost in učinkovitost anidulafungina so ocenili v ključni študiji 3. faze; to je bila randomizirana, dvojno slepa, multicentrična, multinacionalna študija predvsem nenevtropeničnih bolnikov s kandidemijo ter omejenega števila bolnikov z okužbami globokih tkiv s Candido ali bolnikov z boleznijo, povezano z nastajanjem abscesov.
The safety and efficacy of apremilast were evaluated in 3 multi-center, randomized, double-blind, placebo- controlled studies (Studies PALACE 1, PALACE 2, and PALACE 3) of similar design in adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with small molecule or biologic DMARDs.
Varnost in učinkovitost apremilasta so ovrednotili v treh podobno zasnovanih multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih študijah (študije PALACE 1, PALACE 2 in PALACE 3) pri odraslih bolnikih z aktivnim PsA (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) kljub predhodnemu zdravljenju z nizkomolekularnimi ali biološkimi DMARDs.
The safety and efficacy of apremilast were evaluated in two multicenter, randomized, double-blind, placebo- controlled studies (Studies ESTEEM 1 and ESTEEM 2) which enrolled a total of 1257 patients with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥ 10%, Psoriasis Area and Severity Index (PASI) score ≥ 12, static Physician Global Assessment (sPGA) of ≥ 3 (moderate or severe), and who were candidates for phototherapy or systemic therapy.
Varnost in učinkovitost apremilasta so ocenili v dveh multicentričnih, randomiziranih, dvojno slepih študijah, kontroliranih s placebom (študiji ESTEEM 1 in ESTEEM 2), v katerih je bilo vključenih vsega skupaj 1.257 bolnikov z zmerno do hudo psoriazo v plakih, ki so imeli prizadete ≥ 10 % telesne površine (BSA - Body Surface Area), rezultat indeksa jakosti psoriaze in telesne površine, prizadete s psoriazo (PASI - Psoriasis Area and Severity Index) ≥ 12, statično zdravnikovo splošno oceno (sPGA static Physician Global Assessment) ≥ 3 (zmerna ali huda), in ki so bili kandidati za fototerapijo ali sistemsko zdravljenje.
The safety and efficacy of Aptivus capsules in children aged 2 to 12 years has not been established.
Varnost in učinkovitost kapsul Aptivus pri otrocih, starih 2 do 12 let, nista dokazani.
The safety and efficacy of Aptivus in children under 2 years of age has not been established.
Varnost in učinkovitost kapsul Aptivus pri otrocih, starih 2 do 12 let, nista dokazani.
The safety and efficacy of Aptivus in children under 2 years of age has not been established.
Varnost in učinkovitost zdravila Aptivus pri otrocih, mlajših od 2 let, nista dokazani.
The safety and efficacy of ataluren in patients aged 65 and older have not yet been established. (See Section 5.2)
Varnost in učinkovitost atalurena pri bolnikih, starih 65 let ali več, še nista bili dokazani. (Glejte poglavje 5.2.)
The safety and efficacy of atosiban in pregnant women aged less than 18 years have not been established.
Varnost in učinkovitost atosibana pri nosečnicah, starih manj kot 18 let, nista bili dokazani.
The safety and efficacy of Atripla in children under the age of 18 years have not been established (see section 5.2).
Varnost in učinkovitost zdravila Atripla pri otrocih starih do 18 let še nista bili dokazani (glejte poglavje 5.2).
The safety and efficacy of AUBAGIO in children aged from 10 to less than 18 years has not yet been established.
Varnost in učinkovitost zdravila AUBAGIO pri otrocih, starih od 10 do manj kot 18 let, nista bili dokazani.
The safety and efficacy of Avastin in children less than 18 years old have not been established.
Varnost in učinkovitost zdravila Avastin pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Avastin in the front-line treatment of patients with epithelial ovarian, fallopian tube or primary peritoneal cancer were studied in two phase III trials (GOG-0218 and BO17707) that evaluated the effect of the addition of Avastin to carboplatin and paclitaxel compared to the chemotherapy regimen alone.
Varnost in učinkovitost zdravila Avastin v prvem zdravljenju bolnic z epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim peritonealnim karcinomom so proučevali v dveh preskušanjih faze III (GOG-0218 in BO17707), kjer so ocenjevali vpliv dodajanja zdravila Avastin karboplatinu in paklitakselu v primerjavi s kemoterapijo samo.
The safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g).
V randomiziranem, dvojno slepem, s placebom nadzorovanem preskušanju faze III (AVF4095g) so proučevali varnost in učinkovitost zdravila Avastin pri zdravljenju bolnic s ponovitvijo raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivih na platino, ki pri ponovnem pojavu bolezni še niso prejele kemoterapije in se še niso zdravile z bevacizumabom.