natgillin/translations-raw huggingface dataset:
In one study the AUC of the simvastatin acid (SVA), a major active metabolite of simvastatin, was reduced by 42% (90% CI 24%-56%) when a single dose of 40 mg simvastatin was combined with repeated administration of fenofibrate 160 mg.
V eni od študij se je pri kombinaciji enkratnega odmerka simvastatina 40 mg in večkratnega dajanja fenofibrata 160 mg vrednost AUC simvastatinske kisline (SVK), glavnega aktivnega presnovka simvastatina, zmanjšala za 42 % (90-odstotni IZ 24 %–56 %).
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
V eni študiji je sočasna uporaba telmisartana in ramiprila povzročila do 2,-kraten porast AUC0–24 in Cmax ramiprila in ramiprilata.
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
V eni študiji sta se med sočasnim dajanjem telmisartana in ramiprila do 2,5-krat povečala AUC0–24 in Cmax ramiprila in ramiprilata.
In one study, 10.7% of patients treated with thalidomide and dexamethasone experienced grade 3/4 neuropathic reactions, compared to 0.9% of patients treated with dexamethasone alone.
V eni od študij so opazili nevropatije 3./4. stopnje pri 10,7 % bolnikov, zdravljenih s talidomidom in deksametazonom, v primerjavi z 0,9 % bolnikov, ki so jih zdravili samo z deksametazonom.
In one study, 46 patients (29 with parathyroid carcinoma and 17 with primary HPT and severe hypercaelcemia (who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
V eni študiji je 46 bolnikov (29 s paratiroidnim karcinomom in 17 s primarnim hiperparatiroidizmom in hudo hiperkalciemijo, pri katerih paratiroidektomija ni bila uspešna ali je bila kontraindicirana) dobivalo cinakalcet do 3 let (povprečje pri bolnikih s paratiroidnim karcinomom je bilo 328 dni, pri bolnikih s primarnim hiperparatiroidizmom pa 347 dni).
In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73).
V eni študiji pri 66 % bolnikov (104 od 158), zdravljenih z zdravilom Yellox, po dveh tednih ni bilo nobenih znakov vnetja, v primerjavi z 48 % bolnikov, ki so prejemali placebo (35 od 73).
In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes.
V eni študiji so zdravilo Abasaglar in zdravilo Lantus, ki so ju dodajali zdravljenju s kratkodelujočim insulinom, primerjali pri 536 bolnikih s sladkorno boleznijo tipa 1.
In one study, amenorrhea was reported in 97% of the women who received CE 0.45 mg/bazedoxifene 20 mg during months 10 to 12.
V eni študiji so o amenoreji poročali pri 97 % žensk, ki so prejemale kombinacijo 0,45 mg CE/20 mg bazedoksifena, med 10. in 12. mesecem zdravljenja.
In one study, hypothyroidism was reported in 15 (13.6%) subjects on sunitinib and 3 (2.9%) subjects on standard of care.
V eni študiji so o hipotiroidizmu poročali pri 15 (13,6 %) preskušankah, ki so prejemale sunitinib, in pri 3 (2,9 %) preskušankah, ki so prejemale standardno zdravljenje.
In one study, patients with type 2 diabetes also received antidiabetes medicines by mouth.
V eni študiji so bolniki s sladkorno boleznijo tipa 2 prejeli tudi peroralna zdravila za zdravljenje sladkorne bolezni.
In one study, subjects received 800 mg naltrexone hydrochloride daily (equivalent to 25 times the recommended daily dose of naltrexone / bupropion) for up to one week showing no evidence of toxicity.
V eni študiji so preiskovanci prejemali 800 mg naltreksonijevega klorida dnevno (kar ustreza 25-kratniku priporočenega dnevnega odmerka kombinacije naltrekson/bupropion) v obdobju do enega tedna, pa niso kazali nobenih znakov toksičnosti.
In one study, the average reduction in pain during the first 30 minutes after use was 6.6 points in patients receiving PecFent compared with 4.5 in those receiving placebo.
V eni študiji se je intenzivnost bolečine v prvih 30 minutah po uporabi zdravila v povprečju zmanjšala za 6,6 točke pri bolnikih, ki so prejemali zdravilo PecFent, v primerjavi s 4,5 točke pri bolnikih, ki so prejemali placebo.
In one study,46 patients (29 with parathyroid carcinoma and 17 with primary HPT and severe hypercalcaemia who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
V eni študiji je 46 bolnikov (29 s paratiroidnim karcinomom in 17 s primarnim hiperparatiroidizmom in hudo hiperkalciemijo, pri katerih paratiroidektomija ni bila uspešna ali je bila kontraindicirana) dobivalo cinakalcet do 3 let (povprečje pri bolnikih s paratiroidnim karcinomom je bilo 328 dni, pri bolnikih s primarnim hiperparatiroidizmom pa 347 dni).
In one subject, treatment-emergent anti- idarucizumab antibodies were detected after the second administration.
Pri enem preizkušancu so po drugi uporabi opazili iz zdravljenja izvirajoča protitelesa proti idarucizumabu.
In one-year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
V enoletnih kliničnih preskušanjih je pioglitazon dosledno statistično značilno znižal razmerje albumin/kreatinin v primerjavi z izhodiščnimi vrednostmi.
In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes’.
V zdravilu Onivyde je irinotekan vključen v drobne maščobne delce, imenovane liposomi.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Tudi v odprtih nadaljevalnih preizkušanjih, ki so trajala več kot tri leta, se učinek zdravila ni zmanjšal.
In open-label follow-up of LEMTRADA clinical trials, some patients received additional “as needed” treatment with LEMTRADA upon documented evidence of resumed MS disease activity.
V nezaslepljenem nadaljevanju kliničnih preskušanj zdravila LEMTRADA, so nekateri bolniki prejeli dodatno zdravljenje z zdravilom LEMTRADA "po potrebi" glede na dokumentiran dokaz nadaljevanja aktivnosti MS.
In operations
Med operacijo
in operations
med operacijo,
In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped’ until it is eliminated from the body in the urine.
V zdravilu Optimark je gadolinij vezan na drugo kemijsko spojino, tako da se kovina v telesu ne sprosti, ampak ostane „ujeta“, dokler se z urinom ne izloči iz telesa.
In oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
V študijah kancerogenosti peroralnega paliperidona na podganah in miših so opazili adenome hipofize (pri miših), adenome endokrinega dela trebušne slinavke (pri podganah) in adenome mlečnih žlez (pri obeh vrstah).
In order for CYSTAGON to work correctly, you must do the following:
Da bi CYSTAGON deloval pravilno, morate upoštevati naslednje:
In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required
Za zagotovitev prenosa imunosti na mladiče, je potreben zadosten vnos kolostruma.
In order for Spedra to be effective, sexual stimulation is required.
Zdravilo Spedra je učinkovito le ob spolnem vzburjenju.
In order for this medicine to work correctly, you must do the following:
Da bi zdravilo delovalo pravilno, morate upoštevati naslednje:
In order for Vivanza to be effective, sexual stimulation is required.
Zdravilo Vivanza je učinkovito le ob spolnem vzburjenju.
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 2,500 kg total pig weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used).
Da boste dosegli pravilni odmerek, boste mogoče morali pripraviti koncentrirano raztopino (npr. za zdravljenje prašičev s skupno telesno težo 2500 kg uporabite le 50 % koncentrirane raztopine, pripravljene iz 40-gramske vrečke).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 500 kg total bird weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used).
Da boste dosegli pravilni odmerek, boste mogoče morali pripraviti koncentrirano raztopino (npr. za zdravljenje ptic s skupno telesno težo 500 kg boste uporabili le 50 % koncentrirane raztopine, ki ste jo pripravili iz 40-gramske vrečice).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 500 kg total bird weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used).
Da boste dosegli pravilni odmerek, boste mogoče morali pripraviti koncentrirano raztopino (npr. za zdravljenje ptic s skupno telesno težo 500 kg uporabite le 50 % pripravljene koncentrirane raztopine, pripravljene iz 40-gramske vrečke).
In order to address the uncertainties related to the single arm design of the pivotal study supporting the approval of DARZALEX, the MAH should submit the results of study MMY3003, a phase III randomised study investigating lenalidomide and dexamethasone with or without daratumumab in patients with previously treated multiple myeloma.
Da bi odgovorili na pomisleke povezane z zasnovo študije (študija s samo eno skupino bolnikov), ki je bila predložena za pridobitev dovoljenja za promet z zdravilom DARZALEX, mora MAH predložiti rezultate študije MMY3003 (randomizirana študija faze III zdravljenja z lenalidamidom in deksametazonom z ali bez daratumumaba pri bolnikih z že zdravljenim diseminiranim plazmocitomom).
In order to address the uncertainties related to the single arm design of the pivotal study supporting the approval of DARZALEX, the MAH should submit the results of study MMY3004, a phase III randomised study investigating bortezomib and dexamethasone with or without daratumumab in patients with previously treated multiple myeloma.
Da bi odgovorili na pomisleke povezane z zasnovo študije (študija s samo eno skupino bolnikov), ki je bila predložena za pridobitev dovoljenja za promet z zdravilom DARZALEX, mora MAH predložiti rezultate študije MMY3004 (randomizirana študija faze III zdravljenja z bortezomibom in deksametazonom z ali bez daratumumaba pri bolnikih z že zdravljenim diseminiranim plazmocitomom).
In order to allow proper dosing, the dog should be weighed on day 1 and day 35 (this is at the start of each treatment period).
Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi dan in 35. dan (tj. na začetku vsakega obdobja zdravljenja).
In order to allow proper dosing, the dog should be weighed on day 1 and on day 35 (i.e. at the start of each treatment period).
Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi in 35. dan (na začetku vsakega obdobja zdravljenja).
In order to assist patients in avoiding foetal exposure to thalidomide and to provide additional important safety information, the Marketing Authorisation holder will provide educational material to healthcare professionals.
Da bi pomagali bolnikom pri preprečevanju izpostavitve ploda talidomidu in za dodatno informiranje o pomembnih varnostnih vidikih bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalno gradivo za zdravnike.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi- injection type vaccination system when larger dose presentations are used.
Da bi se izognili naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi- injection type vaccination system when larger dose presentations are used.
Da se izognete naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
In order to avoid inappropriate schedule of drug administration, section 4.2 of the SmPC and package leaflet should be revised to clarify that both subcutaneous injections of 120 mg each have to be administered consecutively.
Da bi se izognili neprimerni shemi odmerjanja zdravila, bi bilo treba spremeniti poglavje 4.2 Povzetka glavnih značilnosti zdravila in Navodilo za uporabo, da se pojasni, da morata biti obe 120 mg subkutani injekciji aplicirani zaporedoma.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling this product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic in zaščitnih očal.
In order to avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% dextrose solution.
Da se izognemo možnim nezdružljivostim, lahko koncentrat za raztopino za infundiranje Iasibon razredčimo le z izotonično raztopino natrijevega klorida ali 5-% raztopino glukoze.
In order to avoid potential incompatibilities, Bondronat concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Da se izognemo možnim nezdružljivostim, lahko koncentrat za raztopino za infundiranje Bondronat razredčimo le z izotonično raztopino natrijevega klorida ali 5-% raztopino glukoze.
In order to avoid restarting abacavir and dolutegravir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Triumeq tablets.
Da bi se izognili ponovni uporabi abakavirja in dolutegravirja, je treba bolnikom, pri katerih se je pojavil sum na preobčutljivostno reakcijo, naročiti, da preostale tablete zdravila Triumeq zavržejo.
In order to avoid restarting abacavir patients who have experienced a suspected HSR should be instructed to dispose of their remaining Trizivir tablets
Da bi preprečili ponovno uporabo abakavirja, je treba bolnikom, ki so imeli sum na HSR, naročiti, naj preostale tablete zdravila Trizivir zavržejo.
In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Kivexa tablets
Da bi preprečili ponovno uporabo abakavirja, je treba bolnikom, ki so imeli sum na HSR, naročiti, naj preostale tablete zdravila Kivexa zavržejo.
In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Ziagen tablets
Da bi preprečili ponovno uporabo abakavirja, je treba bolnikom, ki so imeli sum na HSR, naročiti, naj preostale tablete zdravila Ziagen zavržejo.
In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Ziagen tablets
Da bi preprečili ponovno uporabo abakavirja, je treba bolnikom, ki so imeli sum na HSR, naročiti, naj preostalo peroralno raztopino zdravila Ziagen zavržejo.
In order to avoid the potential contamination of the medicine by microbes, the product should be used immediately.
Da preprečite morebitno kontaminacijo zdravila z mikrobi, je treba zdravilo uporabiti takoj.
In order to avoid the product running onto the coat of the animal (especially in larger dogs) do not apply an excessive amount of solution to any one spot.
Da ne bi zdravilo teklo po dlaki živali (posebno pri velikih psih), ne nanašajte prevelike količine raztopine.
In order to avoid this rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Da bi se izognili ponovnemu pridobivanju telesne teže, je pomembno, da psa po koncu zdravljenja hranite po vzdrževalnem režimu.
In order to avoid this rebound weight gain, it is necessary to feed the animals to maintenance energy requirements.
potrebno hrani živali tako, da se vzdržujejo enegetske potrebe.
In order to avoid this rebound weight gain, it is necessary to feed the dogs to maintenance energy requirements.
Da se izognete ponovnemu povečanju telesne mase, je potrebno hraniti živali tako, da prejemajo le vzdrževalno količino energije.
In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog or cat.
Če želimo, da so bolhe in klopi izpostavljeni zdravilni učinkovini, se morajo pritrditi na kožo ter začeti hraniti s krvjo psa ali mačke.
In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog’s blood.
Da bi bili izpostavljeni zdravilni učinkovini, se morajo bolhe in klopi pritrditi na kožo in začeti hraniti s krvjo psa.
In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog’s blood.
Da so lahko izpostavljeni zdravilni učinkovini, se morajo bolhe in klopi pritrditi na kožo psa in se začeti hraniti z njegovo krvjo.
In order to confirm the validity of the applicant’s claims regarding changes in antibody titres over time, the applicant should provide status reports on additional batched serum analysis of future clinical studies
Za potrditev veljavnosti trditev predlagatelj o spremembah titrov protiteles s časom bo predlagatelj predložil poročilo stanja o dodatnih združenih serumskih analizah prihodnjih kliničnih študij
In order to correct your anaemia, your initial dose will be
Za odpravljanje anemije, boste dobili začetni odmerek:
In order to define the shelf life of Pandemic influenza vaccine H5N1 MedImmune on a strain-specific basis, the MAH should generate strain-specific stability data for the actual pandemic strain.
Za določitev roka uporabnosti za Cepivo proti pandemski gripi H5N1 MedImmune specifično glede na seve mora imetnik dovoljenja za promet z zdravilom pripraviti za sev specifične podatke o stabilnosti za dejanski sev pandemije.
In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR in patients with CP-CML, the MAH should conduct and submit the results of a dose- ranging study.
Za določitev optimalnega začetnega odmerka zdravila Iclusig in karakterizacijo varnosti in učinkovitosti zdravila Iclusig po zmanjšanju odmerka po doseženem MCyR pri bolnikih s CP-KML, bo imetnik dovoljenja za promet z zdravilom izvedel in predložil rezultate študije o razponu odmerka.
In order to ensure optimum response to erythropoietin, adequate iron stores should be assured:
Da je odziv na eritropoetin optimalen, je treba poskrbeti za ustrezne zaloge železa:
In order to ensure the accuracy of the dosing this presentation should be prescribed for infants and young children aged from 6 months to less than 4 years.
Da zagotovimo točnost odmerjanja moramo pri dojenčkih, starejših od 6 mesecev, in otrocih, mlajših od 4 leta, predpisati to pakiranje.
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Da zagotovimo točnost odmerjanja moramo pri dojenčkih, starih od 1 do manj kot 6 mesecev, predpisati to pakiranje.
In order to evaluate cardiac safety and provide further efficacy data in the neoadjuvant setting, the MAH should submit the results of study WO29217 (BERENICE), a multicentre, multinational, Phase II study to evaluate pertuzumab in combination with trastuzumab and standard neoadjuvant anthracycline-based chemotherapy in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer.
Za oceno srčne varnosti in zagotovitev nadaljnjih podatkov o učinkovitosti neoadjuvantnega zdravljenja, mora imetnik dovoljenja promet predložiti rezulatate študije WO29217 (BERENICE), multicentrične, mednarodne študije faze II za oceno pertuzumaba v kombinaciji s trastuzumabom in standardno neoadjuvantno kemoterapijo na osnovi antraciklina pri bolnikih s HER2-pozitivnim, lokalno napredovalim, vnetnim ali zgodnjim rakom dojk
In order to flush the vein, administration of diluted Javlor should always be followed by at least an equal volume of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion.
Za spiranje vene morate po dajanju razredčene raztopine zdravila Javlor infundirati še najmanj enako količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje.
In order to further confirm the efficacy and safety of osimertinib in the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, the applicant should submit the clinical study report of the phase III study AURA3 comparing osimertinib to platinum-based doublet chemotherapy.
Za nadaljnjo potrditev učinkovitosti in varnosti osimertiniba za zdravljenje bolnikov z lokalno napredovalim ali metastatskim NSCLC, pozitivnim za mutacijo T790M EGFR, mora predlagatelj predložiti poročilo o klinični študiji III. faze AURA3, ki primerja osimertinib s kemoterapijskim dvojčkom na podlagi platine.
In order to further confirm the efficacy of ceritinib in the treatment of patients previously treated with crizotinib, the MAH should submit the final results of the phase III efficacy study A2303 comparing ceritinib to chemotherapy.
Za dodatno potrditev učinkovitosti ceritiniba pri zdravljenju bolnikov, ki so predhodno prejemali krizotinib, mora imetnik dovoljenja za promet z zdravilom predložiti končne rezultate študije učinkovitosti faze III s primerjavo ceritiniba in kemoterapije (študije A2303).
In order to further corroborate the efficacy of Pandemic influenza vaccine H5N1 MedImmune, the MAH should conduct an observational effectiveness study in community dwelling children and adolescents from 12 months to less than 18 years of age against laboratory confirmed influenza during the next declared pandemic.
Za dodatno potrditev učinkovitosti Cepiva proti pandemski gripi H5N1 MedImmune mora imetnik dovoljenja za promet z zdravilom med naslednjo razglašeno pandemijo opraviti opazovalno študijo učinkovitosti proti laboratorijsko potrjeni gripi med otroki in mladostniki, starimi od 12 mesecev do manj kot 18 let, ki bivajo v domačem okolju.
In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should conduct and submit the results of an external natural history controlled, open-label intervention study to assess the efficacy and safety of Raxone in the treatment of LHON patients, including long-term treatment.
Za dodatno proučitev koristi zdravila Raxone pri zdravljenju bolnikov z LHON mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate zunanje, nadzorovane, odprte, intervencijske študije pojava in poteka LHON, ki bo ocenila učinkovitost in varnost zdravila Raxone pri zdravljenju bolnikov z LHON, vključno z dolgotrajnim zdravljenjem.
In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should maintain and extend the Historical Case Record Survey of Visual Acuity Data from Patients with LHON to serve as the external control to the open label study.
Za dodatno proučitev koristi zdravila Raxone pri zdravljenju bolnikov z LHON mora imetnik dovoljenja za promet z zdravilom vzdrževati in razširiti pregled zgodovinskih poročil o primerih glede na podatke o vidni ostrini pri bolnikih z LHON, ki bo podlaga za zunanjo kontrolo odprte študije.