natgillin/translations-raw huggingface dataset:
No formal studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of ramucirumab.
Formalne študije, ki bi ocenjevale učinek jetrne okvare na farmakokinetiko ramucirumaba, niso bile opravljene.
No formal studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of ramucirumab.
Formalne študije, ki bi ocenjevale učinek ledvične okvare na farmakokinetiko ramucirumaba, niso bile opravljene.
No formal studies have been conducted to investigate the effect of hepatic impairment on the pharmacokinetics of mepolizumab.
Formalnih študij o vplivu okvare jeter na farmakokinetiko mepolizumaba niso izvedli.
No formal studies of daratumumab in patients with hepatic impairment have been conducted.
Formalnih študij uporabe daratumumaba pri bolnikih z okvaro jeter niso izvedli.
No formal studies of daratumumab in patients with renal impairment have been conducted.
Formalnih študij uporabe daratumumaba pri bolnikih z okvaro ledvic niso izvedli.
No formal studies of the effect of axitinib on wound healing have been conducted.
Formalnih študij o vplivu aksitiniba na celjenje ran niso izvedli.
No formal studies on elimination have been performed.
Formalne študije izločanja niso bile izvedene.
No formal studies on the effect of pazopanib on wound healing have been conducted.
Formalne študije o vplivu pazopaniba na celjenje ran niso bile izvedene.
No formal studies were performed to assess pharmacokinetics in ethnic groups.
Uradnih študij za oceno farmakokinetike pri posameznih etničnih skupinah niso izvedli.
No formal study of the effect of renal impairment on the pharmacokinetics of siltuximab has been conducted.
Formalnih študij vpliva okvare ledvic na farmakokinetiko siltuksimaba niso izvedli.
No FPV/RTV drug
Ni FPV/RTV študij
No FPV/RTV drug interaction studies.
Ni FPV/RTV študij interakcij
No further reconstitution or dilution is required.
Nadaljnja rekonstitucija ali redčenje nista potrebna.
No further stirring during administration is necessary.
Medtem ko živali pijejo medicirano vodo, nadaljnje mešanje ni potrebno.
No gender differences were observed.
Niso opazili nobenih razlik med spoloma.
No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
Pri odraslih bolnikih v študijah faze III niso ugotovili s spolom povezanih farmakokinetičnih razlik.
No gender-specific pharmacokinetic studies have been done with NutropinAq.
Za spol specifične farmakokinetične študije z zdravilom NutropinAq niso bile izvedene.
No genotoxicity studies have been performed with ONIVYDE.
Študij genotoksičnosti zdravila ONIVYDE niso izvedli.
No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
O nenormalnih laboratorijskih izvidih AST/ALT ali zvečanju koncentracije transaminaz, stopnje 3-4, niso poročali.
No Grade 3-4 laboratory abnormalities for AST/ALT or Grade 3-4 adverse reactions of transaminase increased were reported (see section 5.1).
Poročali niso o nobenih laboratorijskih anomalijah stopnje 3–4 za AST/ALT ali neželenih učinkov z zvišanjem transaminaz stopnje 3–4 (glejte poglavje 5.1).
No Grade 3-5 cases were reported in these studies.
O primerih stopnje 3-5 v teh študijah niso poročali.
No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Po infundiranju prvih 1000 mg v 1. ciklusu ni bilo več opisanih reakcij, povezanih z infuzijo od 3. do 5. stopnje.
No Grade 4 or 5 cases reported in these studies.
O primerih stopnje 4 ali 5 v teh študijah niso poročali.
No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies.
O primerih nefritisa ali okvare delovanja ledvic stopnje 4 ali 5 v teh študijah niso poročali.
No Grade 4 or 5 rash was reported in these studies.
O izpuščaju stopnje 4 ali 5 v teh študijah niso poročali.
No Grade 4 rash or diarrhoea was observed in either study.
Kožnega izpuščaja in driske stopnje 4 niso opazili v nobeni od študij.
No HBV-HIV co-infected patients were included in these clinical trials.
V ta klinična preskušanja bolniki, sočasno okuženi s HBV in HIV, niso bili vključeni.
No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ml in human whole blood and washed human erythrocytes.
Pri uporabi komercialnih oblik fosaprepitanta v koncentraciji do 1 mg/ml hemolize v polni človeški krvi ali pri izpranih eritrocitih niso opazili.
No hepatic effects were observed after chronic dosing in rats (28 weeks) and in dogs (52 weeks) at 4 or 2 times the human clinical exposure in adult ITP and 3 or 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Učinkov na jetra niso opazili pri dolgotrajni uporabi pri podganah (28 tednov) in psih (52 tednov) pri izpostavljenosti, ki je ustrezala 4- ali 2-kratni izpostavljenosti človeka pri klinični uporabi pri odraslih bolnikih z ITP in 3- ali 2-kratni izpostavljenosti pri pediatričnih bolnikih z ITP pri odmerkih 75 mg/dan in 2-kratni ali enaki izpostavljenosti človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan na osnovi vrednosti AUC.
No human data on the effect of asparaginase on fertility are available.
Ni podatkov o učinku asparaginaze na plodnost pri ljudeh.
No human data on the effect of Enzepi on fertility are available.
Na voljo ni nobenih podatkov o učinku zdravila Enzepi na plodnost pri ljudeh.
No ICS (SABA alone)
Brez IKS (samo KDAB)
No imbalance was observed in postmenopausal women or men with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer.
Razlike niso opazili pri ženskah po menopavzi ali moških z osteoporozo in pri ženskah, ki so se zdravile z zaviralcem aromataze zaradi nemetastatskega raka dojke.
No immunogenic response was detected in a 12-week study in mice in which pegaspargase was weekly administered at the dose of 10.5 U/mouse intramuscular or intraperitoneally.
V 12-tedenski študiji na miših, katerim so tedensko dajali pegaspargazo v odmerku 10,5 e./miš intramuskularno ali intraperitonealno, niso ugotovili imunogenega odziva.
No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed in these subjects.
Pri teh preizkušancih niso opazili vpliva na farmakokinetiko ali učinka izničenja idarucizumaba ali preobčutljivostnih reakcij.
No impairment of fertility has been observed in nonclinical studies (see section 5.3).
V nekliničnih študijah niso opazili nikakršnega zmanjšanja plodnosti (glejte poglavje 5.3).
No impairment of fertility has been observed in nonclinical studies (see section 5.3).
V predkliničnih študijah niso opazili škodljivih vplivov na plodnost (glejte poglavje 5.3).
No impairment of fertility was observed in a fertility and general reproduction toxicity study in mice performed with an analogous antibody that inhibits IL-5 in mice.
V študiji toksičnosti za plodnost in splošno reproduktivno sposobnost pri miših, pri katerih so uporabili analogno protitelo, ki pri njih zavira IL-5, niso ugotovili okrnjene plodnosti.
No important adverse reactions were observed in healthy kittens aged 7 weeks or more, topically treated 7 times at 2 week intervals and with up to 4 times the highest recommended dose except transient oedema or dry skin at the application site.
Razen prehodnega edema ali suhe kože na mestu nanosa, ni bilo opaženih neželenih učinkov pri zdravih mladičih starih 7 tednov ali več, ki so jim dali sredstvo topikalno 7 krat v dvotedenskih razmikih in v najvišjem priporočenem odmerku.
No improvement
brez izboljšanja
No improvement was seen with the higher dose (80 mg/kg/day).
Pri uporabi večjega odmerka (80 mg/kg/dan) niso opazili nobenega izboljšanja.
No in vivo human pharmacokinetic interaction studies have been performed.
Farmakokinetične študije medsebojnega delovanja zdravila z drugimi zdravili in vivo pri ljudeh niso izvedli.
No in vivo human pharmacokinetic interaction studies have been performed.
In vivo študij farmakokinetičnih interakcij na ljudeh niso izvedli.
No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed.
Med zdravilom Benlysta in polivinilkloridnimi ali poliolefinskimi vrečkami niso ugotovili nekompatibilnosti.
No incompatibilities between Perjeta and polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene have been observed.
Med zdravilom Perjeta in polivinilkloridnimi (PVC), polietilenskimi ali ne-PVC poliolefinskimi vrečkami niso ugotovili inkompatibilnosti.
No incompatibilities have been observed between Gazyvaro, in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of Gazyvaro with sodium chloride 9 mg/mL (0.9%) solution for injection, and:
Inkompatibilnosti niso ugotovili med zdravilom Gazyvaro v razponu koncentracij od 0,4 mg/ml do 20,0 mg/ml po razredčenju z 0,9-% (9 mg/ml) raztopino natrijevega klorida za injekcije in:
No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Med zdravilom Yondelis in stekleničkami iz stekla tipa I, polivinilkloridnimi (PVC), poliizoprenskimi vsebniki ter polietilenskimi (PE) vrečkami in cevkami ter titanijevimi vsadljivimi žilnimi dostopnimi sistemi niso opazili inkompatibilnosti.
No increase in adverse events related to exemestane was observed in patients with hormone receptor-positive advanced breast cancer receiving the combination.
Pri bolnicah z napredovalim rakom dojke, pozitivnim na hormonske receptorje, ki so prejemale kombinacijo obeh zdravil, niso opažali povečanega obsega neželenih dogodkov, ki bi bili povezani z eksemestanom.
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Pri moških, ki so prejemali pioglitazon, delež zlomov ni bil večji (1,3 %) kot med tistimi, ki so prejemali primerjalno zdravilo (1,5 %).
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Pri moških, ki so prejemali pioglitazon, delež zlomov ni bil večji (1,3 %) kot pri moških, ki so prejemali primerjalno zdravilo (1,5 %).
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Pri moških, zdravljenih s pioglitazonom, niso opazili povečane stopnje zlomov (1,3 %) v primerjavi s primerjalnim zdravilom (1,5%).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Pri moških, ki so prejemali pioglitazon, delež zlomov ni bil večji (1,7 %) kot med tistimi, ki so prejemali primerjalno zdravilo (2,1 %).
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Pri moških, zdravljenih s pioglitazonom, niso opazili večjega deleža zlomov (1,7 %) v primerjavi s primerjalnim zdravilom (2,1 %).
No increase in incidence of ALT elevations was observed with other types of estrogens commonly used for hormone replacement therapy (e.g. estradiol and conjugated estrogens).
Z drugimi vrstami estrogenov, ki se pogosto uporabljajo za hormonsko nadomestno zdravljenje (npr. z estradiolom in konjugiranimi estrogeni), niso opažali večje incidence zvišanj ALT.
No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens).
Z drugimi vrstami sistemskih estrogenov, ki se pogosto uporabljajo za hormonsko nadomestno zdravljenje (npr. z estradiolom in konjugiranimi estrogeni), niso opažali večje incidence zvišanj ALT.
No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy, add-on to metformin, add-on to metformin and a sulfonylurea, add-on to pioglitazone with or without metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components.
Povečanja pojava hude hipoglikemije niso opazili z empagliflozinom v primerjavi s placebom kot samostojno zdravljenje, kot dodatno zdravljenje z metforminom, kot dodatno zdravljenje z metforminom in sulfonilsečnino, kot dodatno zdravljenje s pioglitazonom z metforminom ali brez njega in za zdravljenje s kombinacijo empagliflozina z metforminom pri predhodno nezdravljenih bolnikih v primerjavi z bolniki, zdravljenimi z empagliflozinom in metforminom kot posameznima komponentama.
No increase in mean heart rate patients with type 2 diabetes was seen in all placebo controlled phase III studies.
V nobeni kontrolirani študiji III. faze niso opazili povečanja povprečne srčne frekvence pri bolnikih s sladkorno boleznijo tipa II.
No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years) receiving Avastin as compared to those aged ≤ 65 years treated with Avastin.
Pri starejših bolnikih (> 65 let), zdravljenih z zdravilom Avastin, v primerjavi z bolniki, starimi 65 let ali manj, zdravljenimi z zdravilom Avastin, ni bilo opaziti povečanja incidence drugih neželenih učinkov, vključno s perforacijami prebavil, zapleti pri celjenju ran, kongestivnim srčnim popuščanjem in krvavitvami.
No increased bleeding tendency is observed in the elderly within the prophylactic dose ranges.
Pri starejših v območju profilaktičnih odmerkov niso opazili večje nagnjenosti h krvavitvam.
No increased risk of Kawasaki disease was observed among infants receiving RotaTeq in a large post- marketing observational safety surveillance study (see section 5.1).
V obsežni opazovalni študiji varnosti v obdobju trženja pri dojenčkih, ki so prejeli cepivo RotaTeq, niso opazili povečanega tveganja za Kawasakijevo bolezen (glejte poglavje 5.1).
No individual sale.
Ne prodaja se posamezno
No induction of human anti-mouse antibody (HAMA) reactive with fragment was observed in any patient administered LeukoScan.
Pri nobenem od bolnikov, ki je prejel zdravilo LeukoScan, niso opazili indukcije človeških protiteles proti mišjim antigenom (HAMA), ki bi reagirali s fragmentom.
No influence
ni vpliva
No information is available concerning treatment of patients on renal dialysis and therefore ticagrelor is not recommended in these patients.
Informacij o zdravljenju bolnikov na dializi ni, zato zdravila Brilique pri teh bolnikih ni priporočljivo uporabljati.
No information is available on the effects of interferon beta-1a on male fertility.
Podatkov o učinku interferona beta-1a na plodnost moških ni na voljo.
No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek’s disease, Newcastle disease and Infectious bronchitis.
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerimkoli drugim razen z Merialovim atenuiranim cepivom proti Marekovi bolezni, atipični kokošji kugi in infekcioznemu bronhitisu.
No information is available on the safety and efficacy in other categories such as breeding or pet rabbits.
Ni informacij o varnosti in učinkovitosti pri drugih kategorijah, kot so pasemski kunci in domači ljubljenčki.
No information is available on the safety and efficacy in other categories such as breeds or pet rabbits.
Ni informacij o varnosti in učinkovitosti pri drugih kategorijah, kot so pasemski kunci in domači ljubljenčki.
No information is available on the safety and efficacy of the concurrent use of this product with vaccines.
Ni podatkov o varnosti in učinkovitosti ob sočasni uporabi tega zdravila in cepiv.
No information is available on the safety and efficacy of this product when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega imunološkega zdravila s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Ni podatkov o varnosti in učinkovitosti tega cepiva, kadar se uporabi s katerimkoli drugim zdravilom za uporabo v veterinarski medicini razen z omenjenim zgoraj.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Ni podatkov o varnosti in učinkovitosti tega cepiva, če ga uporabljate s katerim drugim veterinarskim izdelkom, razen za zgoraj omenjenocepivo.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim veterinarskim zdravilom razen z proizvodoma omenjena zgoraj.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen s cepivoma Versican Plus DHHPi in Versican Plus Pi.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versiguard Rabies and Versican Plus L4.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen za Versiguard Rabies in Versican Plus L4.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Informacije o varnosti in učinkovitosti cepiva, uporabljenega z drugim zdravilom za uporabo v veterinarski medicini niso na voljo.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti tega cepiva kadar se uporablja s kakšnim drugim zdravilom za uporabo v veterinarski medicini.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti tega cepiva ob sočasni uporabi s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti tega cepiva ob uporabi s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
O varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini ni podatkov.
No information is available on the safety and efficacy of this vaccine with any other veterinary medicinal product.
Ni podatkov o varnosti in učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Na voljo ni nobenih informacij o uporabi cepiva pri seropozitivnem govedu niti pri govedu z maternalnimi protitelesi..
No information is available on use in future breeding birds.
Ni podatkov o uporabi pri bodočih matičnih jatah.
No information is available on vaccination in the presence of maternally derived antibodies.
Ni podatkov o cepljenju pri prisotnosti maternalnih protiteles.
No information is available that the use of Benepali effects the ability to drive or use machines.
Ni informacij o tem, da bi uporaba zdravila Benepali vplivala na sposobnost upravljanja vozil in strojev.
No information is available with regards to a possible immune reaction towards the product or towards the endogenous molecule (bG-CSF) after repeated use of the product in cows.
Ni podatkov o morebitni imunski reakciji na zdravilo ali na endogeno molekulo (faktor, ki spodbuja nastajanje kolonij govejih granulocitov, bG-CSF) po ponavljajoči se uporabi zdravila pri kravah.
No information is available.
Podatki niso na voljo.
No information on overdose is currently available in the target species. (See section 4.6.)
Podatki o prevelikem odmerjanju pri ciljni živalski vrsti trenutno niso na voljo. (Glejte poglavje 4.6.)
No information on overdose is currently available in the target species. (See section “Adverse reactions”.)
Podatki o prevelikem odmerjanju pri ciljni živalski vrsti trenutno niso na voljo. (Glejte poglavje Neželeni učinki.)
No information on the ability to drive and use machines is available.
Podatkov o vplivu na sposobnost upravljanja vozil in strojev ni na voljo.
No information on the tolerability of tolcapone in these populations is available (see section 5.2)
Podatkov o prenašanju tolkapona pri tej populaciji ni na voljo (glejte poglavje 5.2).
No information on the tolerability of tolcapone in these populations is available (see section 5.2).
Podatkov o prenašanju tolkapona pri teh skupinah bolnikov ni na voljo (glejte poglavje 5.2).
No information relating to potential cross- resistance with other cytostatics products is available.
Podatki o morebitni navzkrižni rezistenci z drugimi citostatičnimi produkti niso na voljo.
No information relating to the potential of cross-resistance with other cytostatics products is available.
Podatki o morebitni navzkrižni rezistenci z drugimi citostatičnimi produkti niso na voljo.
No inhibitory effect of 40 mg single-dose omeprazole (CYP2C19 inhibitor) was observed on the multiple-dose pharmacokinetics of vortioxetine in healthy subjects.
Inhibicijskega učinka omeprazola (inhibitor CYP2C19) v enkratnem odmerku 40 mg na farmakokinetiko večkratnih odmerkov vortioksetina pri zdravih osebah niso opazili.
No initial dose titration is required.
Začetnega odmerka ni treba titrirati.
No injection should be given into areas where the skin is red, bruised, tender or hard.
Injekcij ne dajemo na področja, kjer je koža rdeča, ima modrice, je nežna ali trda.
No intact active substance is excreted in urine or faeces.
Od količine zdravila, ki se izloči s sečem in z blatom, ga nič ne ostane v nespremenjeni obliki.
No interaction expected when gemfibrozil is used in
brez interakcije, če je gemfibrozil uporabljen v kombinaciji
no interaction expected.
medsebojno delovanje ni pričakovano.
No interaction has been observed during the treatment with VIRBAGEN OMEGA together with antibiotics, solution for rehydration, vitamins and non steroidal anti-inflammatory agents.
Med zdravljenjem z VIRBAGEN OMEGA ni prišlo do interakcij z antibiotiki, raztopinami za ponovno hidracijo, vitamini in nesteroidnimi protivnetnimi zdravili.
No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL’s inactivated vaccine against rabies.
Pri sočasnem dajanju cepiva, vendar na različnih mestih niso ugotovili nobenih interakcij, z MERIALovim inaktiviranim cepivom proti steklini.
No interaction is expected for either INTELENCE or enfuvirtide when
Pri sočasni uporabi zdravila INTELENCE in enfuvirtida ni pričakovati medsebojnih
No interaction of ONIVYDE (liposomal irinotecan) with other medicinal products is known.
Medsebojno delovanje med zdravilom ONIVYDE (liposomskim irinotekanom) in drugimi zdravili ni znano.
No interaction studies have been conducted with Imlygic.
Študij medsebojnega delovanja z zdravilom Imlygic niso izvedli.
No interaction studies have been performed in children and adolescents.
Študij medsebonega delovanja pri otrocih in mladostnikih niso izvedli.
No interaction studies have been performed in humans.
Pri ljudeh niso izvedli študij medsebojnega delovanja.
No interaction studies have been performed in this population.
V tej populaciji niso izvajali študij medsebojnega delovanja zdravil.
No interaction studies have been performed with GRANUPAS.
Študij medsebojnega delovanja z zdravilom GRANUPAS niso izvedli.