natgillin/translations-raw huggingface dataset:
In juvenile idiopathic polyarthritis, RoActemra given by infusion has been compared with placebo in one main study involving 166 children from 2 years of age who could not take or had inadequate response to methotrexate.
Pri juvenilnem idiopatskem poliartritisu so zdravilo RoActemra, ki je bilo dajano z infundiranjem, v eni študiji, v kateri je sodelovalo 166 otrok, starejših od dveh let, ki niso mogli jemati metotreksata ali so se nanj nezadostno odzvali, primerjali s placebom.
In juvenile rats, cobimetinib administration resulted in similar changes as seen in the pivotal toxicity studies in adults, including reversible degenerative changes in the thymus and liver, decreased spleen and thyroid/parathyroid weights, increased phosphorus, bilirubin and red blood cell mass and decreased triglycerides.
Pri mladih podganah je uporaba kobimetiniba povzročila podobne spremembe, kot so jih opazili v ključnih študijah toksičnosti pri odraslih, vključno z reverzibilnimi degenerativnimi spremembami v timusu in jetrih, zmanjšanjem mase vranice in ščitnice/obščitnic, zvišanjem fosforja, bilirubina in eritrocitne mase ter znižanjem trigliceridov.
In juvenile rats, increased heart weight with no histopathology was observed at 0.35 mg/kg/day (approximately 2 times adult human clinical exposure based on AUC).
Pri mladih podganah so opažali povečanje mase srca brez histopatoloških sprememb pri odmerku 0,35 mg/kg/dan (kar je na podlagi AUC približno 2-kratnik klinične izpostavljenosti pri človeku).
In juvenile toxicity studies, when pre-weaning rats were dosed from day 9 post partum through day 14 postpartum, pazopanib caused mortalities and abnormal organ growth/maturation in kidney, lung, liver and heart, at a dose approximately 0.1 times the clinical exposure based on AUC in adult humans.
V študijah juvenilne toksičnosti, v katerih so podgane pred prenehanjem dojenja prejemale pazopanib od 9. do 14. postpartalnega dneva, je pazopanib povzročil poginjanje in nenormalno rast/dozorevanje organov (ledvic, pljuč, jeter in srca) v odmerkih, ki so bili približno 0,1-kratnik klinične izpostavljenosti na podlagi AUC pri odraslih ljudeh.
In Kaletra, lopinavir provides the activity and ritonavir is used as a ‘booster’ that slows down the rate at which lopinavir is broken down by the liver.
Lopinavir v zdravilu Kaletra zagotavlja učinkovanje, ritonavir pa služi kot „stopnjevalec“, ki upočasni razgradnjo lopinavirja v jetrih.
In kennels with recurring outbreaks of clinical disease due to Isospora infection, each litter should be treated for an extended period of time in order to control, and gradually reduce, the level of infection.
V pesjakih s ponavljajočimi izbruhi klinične oblike okužbe z Isosporo, mora biti vsako leglo zdravljeno daljše obdobje, da bi nadzorovali okužbo in sčasoma zmanjšali stopnjo okužbe.
In Kineret treated CAPS patients, there is a risk for disease flares when discontinuing Kineret treatment.
Pri bolnikih s CAPS, zdravljenih z zdravilom Kineret obstaja tveganje za izbruh bolezni po prekinitvi zdravljenja s tem zdravilom.
In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ml and higher, dependent on the formulation.
Pri laboratorijskih živalih je bila uporaba nekomercialnih oblik fosaprepitanta povezana z vaskularno toksičnostjo in hemolizo pri koncentracijah, manjših od mg/ml ali večjih, odvisno od oblike.
In laboratory conditions Purevax RC was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je zdravilo Purevax RC dokazalo, da nudi zaščito proti zgoraj navedenima boleznima.
In laboratory conditions Purevax RCP was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je zdravilo Purevax RCP dokazalo, da nudi zaščito proti zgoraj navedenim boleznim.
In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RCPCh FeLV zagotavlja zaščito pred zgoraj navedenimi boleznimi.
In laboratory safety studies, no interactions were observed when sarolaner was co-administered with milbemycin oxime, moxidectin and pyrantel pamoate. (In these studies efficacy was not investigated).
Med laboratorijskimi varnostnimi testiranji niso opazili nobenih interakcij med sarolanerjem in sočasnim dajanjem milbemicin oksima, moksidektina ali pirantel pamoata. (Pri tem učinkovitost ni bila raziskana).
In laboratory species, after intra-peritoneal administration, dinotefuran is rapidly eliminated as the unchanged parent molecule mainly via the urine.
V laboratorijskih vrstah, se po intraperiotnealni aplikaciji, dinotefuran hitro izloči kot nespremenjena matična molekula, v glavnem preko urina.
In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
V laboratorijskih študijah so po uporabi zdravila v priporočenem odmerku opazili zmanjšanje vrednosti albumina, globulina, skupnih beljakovin, kalcija in alkalne fosfataze v serumu ter povečanje vrednosti alanin-aminotransferaze (ALT) in aspartat- aminotransferaze (AST).
In lactating rats, oseltamivir and the active metabolite are excreted in milk.
Pri podganah so med laktacijo opazili izločanje oseltamivirja in aktivnega presnovka v mleko.
In lactating rats, oseltamivir and the active metabolite are excreted in the milk.
Pri podganah sta se v mleko med laktacijo izločala oseltamivir in aktivni presnovek.
In lactating rats, the concentration of 35S-enoxaparin or its labelled metabolites in milk is very low.
Pri doječih podganah je koncentracija 35S-enoksaparina in njegovih označenih presnovkov v mleku zelo majhna.
In LAL-CL03, 6 of 9 KANUMA-treated infants survived beyond 12 months (67% 12-month survival, 95% CI: 30% to 93%).
LAL-CL03 je 6 od 9 dojenčkov, zdravljenih z zdravilom KANUMA, živelo več kot 12 mesecev (67% 12-mesečno preživetje, 95% IZ: 30% do 93%).
In large placebo-controlled clinical studies, the percentage of patients experiencing an adverse event suggestive of hypersensitivity, including urticaria, rash and allergic reactions was slightly higher in the Raptiva group (8%) than in the placebo group (7%). (See section 4.4).
V velikih s placebom kontroliranih kliničnih študijah, je bil delež bolnikov, ki so doživeli neželene dogodke, ki bi lahko kazali na preobčutljivost, vključno z urtikarijo, izpuščajem in alergijskimi reakcijam, rahlo večji v skupini bolnikov, ki so prejemali Raptivo (8 %) kot v skupini bolnikov, ki so prejemali placebo (7 %). (Glejte poglavje 4.4).
In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of Raptiva-treated patients and 24% in placebo-treated patients over 12 weeks of treatment.
V velikih s placebom kontroliranih kliničnih študijah so opazili te reakcije pri približno 41 % bolnikov, ki so se zdravili z Raptivo in pri 24 % bolnikov, ki so prejemali placebo tekom 12 tednov zdravljenja.
In larger dogs, the entire contents of the pipette(s) should be applied evenly to two or three or four spots, all located at different application sites along the backline from the shoulder to the base of the tail.
Pri večjih psih je treba vso vsebino merilne kapalke nanesti enakomerno na dve ali tri ali štiri mesta, vsa vzdolž hrbtenice od ramen do korena repa.
In less severe situations when intravenous administration of hydrocortisone is not required, for instance low grade infections, fever of any aetiology and stressful situations such as minor surgical procedures, the normal oral daily replacement dose must be increased temporarily; the total daily dose should be increased by administering the maintenance dose twice or thrice daily with 8 ± 2 hours intervals (an increase in number of administrations, not increasing the morning dose).
V manj hudih primerih, kadar intravenska uporaba hidrokortizona ni potrebna, na primer pri blagih okužbah, zvišani telesni temperaturi katerekoli etiologije in stresnih situacijah, kot so manjši kirurški posegi, je treba običajni dnevni peroralni nadomestni odmerek začasno povečati; skupni dnevni odmerek je treba povečati z uporabo vzdrževalnega odmerka dvakrat ali trikrat na dan, v časovnih razmikih 8 ur ± 2 uri (povečati je treba število dnevnih odmerkov, ne jutranjega odmerka).
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Bemfola therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG).
Pri ženskah s pomanjkanjem LH in FSH (hipogonadotropni hipogonadizem) je cilj zdravljenja z zdravilom Bemfola skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
In LH and FSH deficient women (hypogonadotropic hypogonadism), the objective of follitropin alfa therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of hCG.
Pri ženskah s pomanjkanjem LH in FSH (hipogonadotropni hipogonadizem), je cilj zdravljenja s folitropinom alfa skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju hCG.
In lifetime toxicology studies in rats and mice, there was no evidence for a tumorigenic potential of dabigatran up to maximum doses of 200 mg/kg.
V doživljenjskih toksikoloških raziskavah pri podaganah in miših niti pri dajanju največjih odmerkov do 200 mg/kg ni bilo znakov možnih tumorogenih učinkov dabigatrana.
In line with the Guideline on Summary of Product Characteristics (SmPC) this should also be reflected in section 4.5 of the SmPC.
V skladu s smernico glede priprave Povzetka glavnih značilnosti zdravila (SmPC) mora biti to navedeno tudi v poglavju 4.5 SmPC.
In line with these observations, related study endpoints such as disease control and change in tumour size showed significant improvements.
Skladno s temi opažanji so povezani opazovani dogodki v študiji, na primer kontrola bolezni in spremenjena velikost tumorja, pokazali značilna izboljšanja.
In locally advanced head and neck cancers, the patients lived for longer without their disease getting worse when Erbitux was added to radiotherapy (24.4 months compared with 14.9 months, on average).
Pri lokalno napredovalem raku glave in vratu je bil čas do poslabšanja bolezni daljši pri bolnikih, ki so prejemali zdravilo Erbitux kot dodatek k obsevanju (povprečno 24,4 meseca v primerjavi s
In locally advanced or metastatic breast cancer, Xeloda combined with docetaxel was more effective that docetaxel on its own in increasing how long it took for the disease to get worse (186 days compared with 128 days).
Pri lokalno napredovalem ali metastatskem raku dojk je bilo zdravilo Xeloda v kombinaciji z docetakselom učinkovitejše od docetaksela kot samostojnega zdravila, z vidika podaljševanja časa do napredovanja bolezni (186 dni v primerjavi s 128 dnevi).
In locally advanced or metastatic breast cancer, Xeloda with docetaxel has been compared with docetaxel on its own in 511 women.
Pri lokalno napredovalem ali metastatskem raku dojk so zdravilo Xeloda v kombinaciji z docetakselom pri 511 ženskah primerjali z docetakselom kot samostojnim zdravilom.
In long hair breeds, special attention should be paid to apply the product onto the skin, and not on the hair to ensure optimal efficacy.
Pri pasmah z dolgo dlako je potrebno posvetiti posebno pozornost pravilnemu nanosu na kožo, ne na dlako, da se zagotovi optimalna učinkovitost zdravila.
In long-term carcinogenicity studies at doses of ranolazine up to 50 mg/kg/day (150 mg/m2/day) in mice and 150 mg/kg/day (900 mg/m2/day) in rats, no relevant increases in the incidence of any tumour types were seen.
V dolgotrajnih študijah kancerogenosti pri odmerkih ranolazina do 50 mg/kg/dan (150 mg/m2/dan) pri miših in 150 mg/kg/dan (900 mg/m2/dan) pri podganah niso opazili pomembnih povečanj pojavnosti nobene vrste tumorjev.
In long-term carcinogenicity studies with amprenavir in mice and rats, there were benign hepatocellular adenomas in males at exposure levels equivalent to 2.0-fold (mice) or 3.8-fold (rats) those in humans given 1200 mg twice daily of amprenavir alone.
V dolgotrajnih študijah kancerogenega potenciala amprenavirja na miših in podganah je pri samcih ob izpostavi odmerkom, ekvivalentni 2,0-kratnim (miši) ali 3,8-kratnim (podgane) odmerkom, ki se dajejo človeku (1200 mg amprenavirja samega dvakrat dnevno), prihajalo do benignih hepatocelularnih adenomov.
In long-term extensions of clinical studies, protection has been observed postdose 3 in the PPE population.
V dolgotrajnih podaljšanjih kliničnih študij so po 3. odmerku opazili zaščito v PPE populaciji.
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients- years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6234 bolnikih x letih (3210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6234 bolnikih x letih (3210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
In long-term studies, renal tumours (adenomas and carcinomas) were observed at all doses tested, most likely as a consequence of this chronic renal damage.
V dolgotrajnih študijah so pri vseh preizkušenih odmerkih opazili tumorje na ledvicah (adenome in karcinome), ki so bili najverjetneje posledica teh kroničnih poškodb ledvic.
In Lonquex, the filgrastim has been ‘pegylated’ (attached to a chemical called polyethylene glycol).
Filgrastim v zdravilu Lonquex je bil „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster’ that slows down the rate at which lopinavir is broken down by the liver.
Lopinavir v zdravilu Lopinavir/ritonavir Mylan zagotavlja učinkovanje, ritonavir pa služi kot „stopnjevalec“, ki upočasni razgradnjo lopinavirja v jetrih.
In lumacaftor/ivacaftor-treated patients, approximately two-thirds of these reactions resolved, and the median duration was 10 days.
Pri bolnicah, zdravljenih z lumakaftorjem/ivakaftorjem, sta se približno dve tretjini teh reakcij razrešili, mediano trajanje pa je bilo 10 dni.
In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells.
V rakavih celicah pljuč je EGRF pogosto čezmerno aktiven in povzroča nenadzorovano delitev rakavih celic.
In macular oedema due to retinal vein occlusion, Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in another study.
Pri makularnem edemu, ki nastane zaradi zapore mrežnične vene, je bilo zdravilo Lucentis učinkovitejše od navideznih injekcij: bolniki, ki so šest mesecev prejemali zdravilo Lucentis v odmerku 0,5 mg, so v eni študiji videli 11 črk več kot tisti, ki so prejemali navidezne injekcije, v drugi študiji pa 14 črk več.
In maintenance treatment, it is used in patients who usually have four or more flare- ups per year and who have had a response to an initial course of Protopic used twice a day for up to six weeks.
V okviru vzdrževalnega zdravljenja se uporablja pri bolnikih, ki so običajno imeli štiri ali več ponovnih izbruhov na leto in ki so se odzvali na začetno zdravljenje z zdravilom Protopic dvakrat na dan šest tednov zapored.
In major surgery, the dose should be continued at 2 – 4 hour intervals for 6 – 7 days.
Po večjih operacijah je treba z odmerkom nadaljevati v 2- do 4-urnih presledkih 6 do 7 dni.
In male paediatric Fabry patients plasma Gb3 decreased 40-50% after 6 months of Replagal therapy 0.2 mg/kg and this reduction persisted after a total 4 years of treatment in 11 patients.
Pri moških pediatričnih bolnikih s Fabryjevo boleznijo se je po 6 mesecih zdravljenja z zdravilom Replagal v odmerku 0,2 mg/kg vrednost Gb3 v plazmi zmanjšala za 40–50 %; to zmanjšanje pa se je pri 11 bolnikih ohranilo tudi po 4 letih zdravljenja.
In male paediatric patients ≥ 7 years of age, heart rate variability was abnormal at baseline and improved after 6 months of Replagal therapy in 15 boys and the improvement was sustained through
Pri moških pediatričnih bolnikih, starih ≥ 7 let, je bila variabilnost srčnega utripa na izhodišču abnormalna in se je pri 15 dečkih izboljšala po 6 mesecih zdravljenja z zdravilom Replagal.
in males
pri moških, zmanjšan
In males Primary Testicular Failure
Pri moških Primarna odpoved testisov
In mammals toltrazuril is absorbed slowly after oral administration.
Pri sesalcih se toltrazuril po oralnem dajanju počasi absorbira.
In man, the apparent terminal elimination half-life (T1/2) of 5-FU observed after administration of Teysuno (containing tegafur, a 5-FU prodrug) was longer (approximately 1.6 - 1.9 hours) than that previously reported after intravenous administration of 5-FU (10 to 20 minutes).
Pri moških je bil navidezni končni razpolovni čas izločanja (T1/2) snovi 5-FU, ugotovljen po uporabi zdravila Teysuno (vsebuje tegafur, predzdravilo snovi 5-FU), daljši (približno 1,6–1,9 ure) kot tisti, o katerem so predhodno poročali po intravenski uporabi snovi 5-FU (10–20 minut).
In man, the combination of angiotensin converting enzyme (ACE) inhibitors and non-steroidal anti- inflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function.
Pri ljudeh lahko kombinacija zaviralcev angiotenzinske konvertaze (ACE) in nesteroidnih protivnetnih zdravil (NSAID) vodi do zmanjšane antihipertenzivne učinkovitosti ali do okvare delovanja ledvic.
In mantle cell lymphoma patients, lenalidomide is associated with a higher incidence of grade 3 or 4 neutropenia (43.7% in lenalidomide-treated patients compared with 33.7% in patients in the control arm in the Phase II study).
Pri bolnikih z limfomom plaščnih celic je lenalidomid povezan z večjo incidenco nevtropenije 3. ali 4. stopnje (43,7 % pri bolnikih, zdravljenih z lenalidomidom, v primerjavi s 33,7 % pri bolnikih v kontrolni skupini v študiji faze II).
In mantle cell lymphoma patients, the monitoring scheme should be every 2 weeks in Cycles 3 and 4, and then at the start of each cycle.
Pri bolnikih z limfomom plaščnih celic je spremljanje potrebno v 3. in 4. ciklu vsaka 2 tedna, nato pa v začetku vsakega cikla.
In mantle cell lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Revlimid is used in adults whose disease has come back after treatment, or does not respond to treatment.
Pri limfomu plaščnih celic, vrsti krvnega raka, ki prizadene vrsto belih krvnih celic, imenovanih limfociti B, se zdravilo Revlimid uporablja pri odraslih, pri katerih se je bolezen po zdravljenju ponovila ali se nanj ne odziva.
In mantle cell lymphoma, AML, B-cell malignancies and non-melanoma skin cancer (NMSC) are potential risks.
Pri limfomu plaščnih celic so možna tveganja za AML, malignosti celic B in nemelanomski kožni rak (NMSC– non-melanoma skin cancer).
In mantle cell lymphoma, Torisel has been studied in 162 patients whose disease had come back after previous treatment or had not responded to other treatments.
Pri limfomu plaščnih celic so zdravilo Torisel proučevali pri 162 bolnikih, pri katerih se je bolezen ponovila po predhodnem zdravljenju oziroma se na druga zdravljenja niso odzvali.
In many cases the presence of pre-existing mitochondrial impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
V mnogih primerih lahko k temu prispevajo že obstoječe okvare mitohondrijev (genetska bolezen, abnormalnosti jetrnih encimov, okužba z virusom hepatitisa B ali C, zloraba alkohola, anoreksija, sočasna uporaba drugih morebitno hepatotoksičnih zdravil) in sočasna uporaba zdravil za injiciranje.
In mdr1 mutant (-/-) Collies the margin of safety appears lower compared to the normal dog population, with mild transient tremor and/or ataxia occasionally observed after twice the recommended dose, in dogs fasted as recommended.
Pri kolijih, z mutacijo gena MDR1, se je je pri zaužitju 2-kratnega terapevtskega odmerka (pri priporočenem postenju psa) občasno pojavilo prehodno mišično drgetanje in nekoordiniranost gibov ker je varnost zdravila pri le-teh manjša v primerjavi z običajno populacijo.
In MDS Del (5q), lenalidomide was shown to selectively inhibit the abnormal clone by increasing the apoptosis of Del (5q) cells.
Pri MDS del(5q) so pokazali, da lenalidomid selektivno zavira abnormalni klon, tako da zveča apoptozo celic del(5q).
In MDS-003, a large proportion of patients with myelodysplastic syndromes achieved transfusion independence (>182 days) on lenalidomide 10 mg (58.1%).
V MDS-003 je neodvisnost od transfuzij (>182 dni) dosegel velik delež bolnikov z mielodisplastičnimi sindromi, ki so prejemali lenalidomid 10 mg (58,1 %).
In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.
Študije mehanizma so pokazale, da je povečanje telesne mase pretežno posledica povečanja podkožnega maščevja ob zmanjšanju visceralnega in intrahepatičnega maščevja.
In melanoma tumours with the BRAF V600 mutation, an abnormal form of BRAF is present which plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
V tumorjih melanoma z mutacijo BRAF V600 je prisotna neobičajna oblika BRAF, ki vpliva na razvoj raka tako, da omogoča nenadzorovano deljenje tumorskih celic.
In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Pri melanomih z mutacijo BRAF V600 je prisotna nenormalna oblika beljakovine BRAF, ki aktivira drugo beljakovino, imenovano MEK, ki sodeluje pri spodbujanju delitve celic.
In melanoma with the BRAF V600 mutation, the abnormal form of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
V melanomih z mutacijo BRAF V600, neobičajna oblika BRAF vpliva na razvoj raka tako, da omogoča nenadzorovano deljenje tumorskih celic.
In melanoma, Opdivo used on its own was studied in two main studies in patients with advanced disease.
Pri melanomu je bilo zdravilo Opdivo uporabljeno samostojno v dveh glavnih študijah pri bolnikih z napredovalo boleznijo.
In Member States where the EU safety registry will be available, the educational materials should include details on the registry and how to enter patients in it.
V državah članicah, v katerih bodo registri o varnosti za EU na voljo, naj v izobraževalno gradivo vključijo podrobnosti o registru in kako vanj vnašati bolnike.
In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated (see section 4.3)
Pri moških, starih več kot 75 let, je sočasna uporaba vardenafila in itrakonazola ali ketokonazola kontraindicirana (glejte poglavje 4.3).
In men receiving treatment for prostate cancer, Prolia was more effective than placebo at treating bone loss.
Pri moških, ki so se zdravili zaradi raka prostate, je bilo zdravilo Prolia učinkovitejše od placeba pri zdravljenju izgube kostne mase.