natgillin/translations-raw huggingface dataset:
Utöver biverkningarna som rapporterades hos vuxna (se avsnitt 4.8, Sammanfattning av biverkningar i tabellform) var incidensen av följande biverkningar högre hos pediatriska patienter: anemi var vanlig (9,5 %) och missfärgning av huden (ökad pigmentering) var mycket vanlig (31,8 %) hos pediatriska patienter.
In addition to the adverse reactions reported in adults (see section 4.8, Tabulated summary of adverse reactions), the following adverse reactions were observed more frequently in paediatric patients: anaemia was common (9.5%) and skin discolouration (increased pigmentation) was very common (31.8%) in paediatric patients.
Utöver biverkningarna som rapporterades hos vuxna var incidensen av anemi (9,5 %) och missfärgning av huden (31,8 %) högre i kliniska studier där hiv-infekterade pediatriska patienter ingick.
In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials involving HIV infected paediatric patients.
uurenenud higistamine
increased sweating
Uusaru 5
171 21 Solna
Uxbridge
Harefield Uxbridge
Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Velká Británie
Sanderson Road Uxbridge UB8 1DH United Kingdom
Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Великобритания
Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Обединено кралство
Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Učinek na krvne ploščice
Effects on platelets
Učinek na plodnost pri plemenskih samcih ni raziskan.
The influence on fertility in male breeding dogs has not been studied.
Učinek palonosetrona na interval QTc so ocenili v dvojno slepem, randomiziranem, paralelnem, s placebom in pozitivno (moksifloksacin) kontroliranem preskušanju na odraslih moških in ženskah.
The effect of palonosetron on QTc interval was evaluated in a double blind, randomised, parallel, placebo and positive (moxifloxacin) controlled trial in adult men and women.
Učinek tekočine tretjega prostora, denimo plevralnega izliva ali ascitesa, na pemetreksed ni popolnoma opredeljen.
The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Učinek zdravila Pramipeksol Accord na nerojenega otroka ni znan.
The effect of Pramipexole Accord on the unborn child is not known.
Učinka na nosečnost in dojenje pri človeku niso raziskovali.
The effect on pregnancy and lactation has not been investigated in humans.
Učinke intravenske zoledronske kisline pri pediatričnih bolnikih s hudo osteogenesis imperfecta tipov I, III in IV (starih od 1 do 17 let), so primerjali z intravenskim pamidronatom v eni mednarodni, multicentrični, randomizirani, odprti študiji s 74 oziroma 76 bolniki v vsaki od zdravljenih skupin.
The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Učinke v nekliničnih študijah so opazili samo pri izpostavljenosti, ki je zadostno presegla največjo izpostavljenost pri človeku, kar kaže majhen pomen za klinično uporabo.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Učinki zdravila Pravafenix 40 mg/160 mg so bili potrjeni v podobnem multicentričnem 64-tedenskem preskušanju, ki je vključevalo 12-tedensko randomizirano, dvojno slepo študijo, ki je potekala v ZDA in je primerjala zdravilo Pravafenix 40 mg/160 mg z monoterapijo s fenofibratom 160 mg in monoterapijo s pravastatinom 40 mg pri bolnikih z mešano dislipidemijo.
The effects of Pravafenix 40 mg/160 mg were confirmed in a similar multicenter, 64-week trial including a 12 week randomized, double-blind phase in a study performed in the USA and comparing Pravafenix 40 mg/160 mg to Fenofibrate 160 mg monotherapy and Pravastatin 40 mg monotherapy in patients with mixed dyslipidaemia.
Učinki zdravljenja so bili manj izraziti pri bolnikih z blastnimi lezijami.
The treatment effects were less pronounced in patients with blastic lesions.
Učinkovitost in predvsem varnost PDT s PhotoBarrom ni bila ugotovljena pri bolnikih s kontraindikacijami ali pri tistih, ki niso primerni za ezofagektomijo.
Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with contraindications to, or not being eligible for, oesophagectomy.
Učinkovitost in varnost so merili od časa randomizacije po zaključku terapije prvega izbora (indukcijske terapije).
Efficacy and safety were measured from the time of randomisation after completion of first-line (induction) therapy.
Učinkovitost je temeljila na prikazu ne-manjvrednosti intravenskega palonosterona v primerjavi z intravenskim ondansetronom.
Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu
Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Učinkovitost po dajanju palonosetrona 10 µg/kg je bila 54,1 % in učinkovitost palonosetrona 3 µg/kg je bila 37,1 %.
Efficacy after palonosetron 10 μg/kg compared to palonosetron 3 μg/kg was 54.1% and 37.1% respectively.
Učinkovitost pramipeksola (0,0625 do 0,5 mg na dan) pri 6 do 17 let starih pediatričnih bolnikih s Tourettovim sindromom so ocenili v 6-tedenski, dvojno slepi, s placebom nadzorovani raziskavi z naključnim izborom preizkušancev, v kateri so uporabili fleksibilno odmerjanje.
The efficacy of pramipexole (0.0625-0.5 mg/day) with paediatric patients aged 6-17 years with Tourette Disorder was evaluated in a 6-week, double-blind, randomised, placebo-controlled flexible dose study.
Učinkovitost ustekinumaba so preučevali v multicentrični, randomizirani, dvojno slepi s placebom nadzorovani študiji faze 3 (CADMUS) pri 110 pediatričnih bolnikih z zmerno do hudo psoriazo s plaki, starih 12 do 17 let.
The efficacy of ustekinumab was studied in 110 paediatric patients aged 12 to 17 years with moderate to severe plaque psoriasis in a multicenter, Phase 3, randomised, double blind, placebo controlled study (CADMUS).
Učinkovitost zdravila INOmax so raziskovali pri novorojenčkih s hipoksično respiratorno odpovedjo kot posledico različnih etiologij, ki so se rodili v roku ali blizu roka.
The efficacy of INOmax has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of aetiologies.
Učinkovitosti in varnosti zdravila STELARA pri otrocih s psoriazo, mlajših od 12 let, ali pri otrocih s psoriatičnim artritisom, mlajših od 18 let, niso ugotovili.
The safety and efficacy of STELARA in children with psoriasis less than 12 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Ušesa: vertigo, zamašitev ušesa, neprijeten občutek v ušesu
Ear: vertigo, ear clogging, ear discomfort
Ušesne bolezni
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta
Ear and labyrinth disorders
Užitečné rady k dietě a k dosažení cílového množství kalorií a tuku při užívání alli
Helpful tips on your diet and your calorie and fat targets while taking alli
Užívání alli
Taking alli
Užívání alli v době těhotenství je kontraindikováno (viz bod 4.3).
alli is contraindicated in pregnancy (see section 4.3).
Užívání přípravku Clopidogrel BMS s jídlem a pitím
Taking Clopidogrel BMS with food and drink
Užíváte-li alli, informujte svého lékaře nebo lékárníka:
Talk to your doctor or pharmacist when taking alli
UБиотрансформацияU
Biotransformation
UБъбречна недостатъчност
Renal Insufficiency
UЕдновременно прилагане с тромбоцитни антиагреганти или антикоагуланти
Co-administration with platelet inhibitors or anti-coagulants
UЕлиминиранеU
Elimination
UИме
UStrength
UКоличество в опаковка
UPackage size
UКръвоизлив
Haemorrhage
UОпаковка
UPackaging
UПроучване ACUITY (Пациенти с нестабилна стенокардия/миокарден инфаркт без ST- елевация (UA/NSTEMI)
The ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI))
UРазпределение
Distribution
UСвръхчувствителност
Hypersensitivity
UЧернодробна недостатъчност
Hepatic Insufficiency
V 1. študiji predhodno zdravljenje z zaviralcem tumorske nekroze (TNF-anti-tumour necrosis factor) α ni bilo dovoljeno.
In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
V 1. študiji PsA je v 100. tednu odziv ACR 20 doseglo 57% bolnikov, ki so prejemali 45 mg in 64% bolnikov, ki so prejemali 90 mg.
In PsA Study 1, ACR 20 responses at week 100 were achieved by 57% and 64%, for 45 mg and 90 mg, respectively.
V 1. študiji psoriaze (PHOENIX 1) so ovrednotili podatke za 766 bolnikov.
Psoriasis Study 1 (PHOENIX 1) evaluated 766 patients.
V 1. študiji psoriaze je bilo ohranjanje PASI 75 bistveno boljše pri neprekinjenem zdravljenju kot pri prenehanju zdravljenja (p < 0,001).
In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment compared with treatment withdrawal (p < 0.001).
V 1. študiji psoriaze so v 2. in 12. tednu dokazali bistveno izboljšanje DLQI glede na začetek študije v vseh terapevtskih skupinah z ustekinumabom v primerjavi s placebom.
In Psoriasis Study 1, at week 2 and week 12, significantly greater improvements from baseline were demonstrated in the DLQI in each ustekinumab treatment group compared with placebo.
V 12. tednu so bolniki, ki so prejemali placebo prešli na zdravljenje z ustekinumabom.
At week 12, placebo treated patients crossed over to receive ustekinumab.
V 12. tednu so pri preiskovancih, zdravljenih z ustekinumabom ugotovili večje izboljšanje psoriaze in z zdravjem povezane kakovosti življenja v primerjavi s preiskovanci, ki so prejemali placebo (glejte preglednico 7).
At week 12, subjects treated with ustekinumab showed significantly greater improvement in their psoriasis and health related quality of life compared with placebo (Table 7).
V 2. študiji je bila večina (58%, n = 180) bolnikov že zdravljenih z enim ali več zaviralci TNFα, 70% teh bolnikov je zdravljenje zaradi pomankanja učinkovitosti ali intolerance prekinilo.
In Study 2, the majority of patients (58%, n = 180) had been previously treated with one or more anti-TNFα agent(s), of whom over 70% had discontinued their anti-TNFα treatment for lack of efficacy or intolerance at any time.
V 2. študiji PsA je v 52. tednu odziv ACR 20 doseglo 47% bolnikov, ki so prejemali 45 mg in 48% bolnikov, ki so prejemali 90 mg.
In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
V 2. študiji PsA so v skupini, ki je 24 tednov prejemala ustekinumab, dokazali značilno izboljšanje funkcijske ocene zdravljenja kronične bolezni - utrujenosti (FACIT-F- Functional Assessment of Chronic Illness Therapy – Fatigue) v primerjavi s skupino, ki je prejemala placebo.
In PsA Study 2 there was a significant improvement in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores in the ustekinumab groups when compared with placebo at week 24.
V 2. študiji psoriaze (PHOENIX 2) so ovrednotili 1.230 bolnikov.
Psoriasis Study 2 (PHOENIX 2) evaluated 1,230 patients.
V 4 % ciklov zdravljenja so bile uporabljene transfuzije trombocitov.
Platelet transfusions were given in 4 % of courses.
V 8. tednu po enkratnem infuzijskem indukcijskem odmerku je bila sprememba indeksa SES-CD večja v skupini, ki je prejemala ustekinumab (n = 155, povprečna sprememba = -2,8) kot v skupini, ki je prejemala placebo (n = 97, povprečna sprememba = -0,7, p = 0,012).
At week 8, after a single intravenous induction dose, the change in SES-CD score was greater in the ustekinumab group (n = 155, mean change = -2.8) than in the placebo group (n = 97, mean change = -0.7, p = 0.012).
V 9-mesečni študiji, ki so jo izvedli na psih pasme beagle tako, da so jim dajali intravenske injekcije v bolusu, so opazovali spremembe na testisih (degeneracija/nekroza seminifernega epitelija).
In a study conducted in beagle dog by intravenous bolus injection for 9 months, testicular findings (degeneration/necrosis of the seminiferous epithelium) have been observed.
V analizi populacijske farmakokinetike na podlagi študij faze III so raziskovali vpliv zdravil, ki jih najpogosteje sočasno uporabljamo pri bolnikih s psoriazo (vključno s paracetamolom, ibuprofenom, acetilsalicilno kislino, metforminom, atorvastatinom in levotiroksinom), na farmakokinetiko ustekinumaba.
In the population pharmacokinetic analyses of the phase III studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
V analizi populacijske farmakokinetike ni bilo znakov vpliva tobaka ali alkohola na farmakokinetiko ustekinumaba.
In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or alcohol on the pharmacokinetics of ustekinumab.
V analizi populacijske farmakokinetike pri bolnikih s psoriazo je znašal navidezni očistek zdravila (CL/F) 0,465 l/dan, navidezni porazdelitveni volumen (V/F) pa 15,7 l.
In a population pharmacokinetic analysis, the apparent clearance (CL/F) and apparent volume of distribution (V/F) were 0.465 l/day and 15.7 l, respectively, in patients with psoriasis.
V analizi populacijske farmakokinetike, kjer so uporabili podatke bolnikov s psoriazo, so ugotovili, da je med drugimi spremenljivkami, ki vplivajo na očistek ustekinumaba, najpomembnejša telesna masa.
In a population pharmacokinetic analysis using data from patients with psoriasis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
V analýze údajů pacientů, u kterých ve studii GS-US-216-0114 selhala léčba v průběhu 48. týdne a kteří dostávali atazanavir 300 mg podávaný současně s kobicistatem 150 mg, byla k dispozici hodnotitelná data o genotypu z párových výchozích izolátů a izolátů získaných po selhání léčby pro 11 z 12 virologických selhání v této skupině (3%, 11/344).
In an analysis of treatment-failure subjects who received atazanavir 300 mg co-administered with cobicistat 150 mg in study GS-US-216-0114 through Week 48, evaluable genotypic data from paired baseline and treatment-failure isolates were available for 11 of the 12 virologic failures in this group (3%, 11/344).
V celkové populaci pacientů bylo 19,7 % žen, 29,2% pacientů bylo ve věku 65 a více let.
The patient population included 19.7% women and 29.2% patients ≥ 65 years.
V dlouhodobých studiích karcinogenity atazanaviru na myších a potkanech byl pozorován zvýšený výskyt benigních jaterních adenomů pouze u myších samic.
In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
V dolgoročnih študijah na živalih zoledronska kislina zavira resorpcijo kosti, ne da bi neugodno vplivala na nastajanje, mineralizacijo ali mehanske lastnosti kosti.
In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
V dolgoročnih živalskih študijah ponavljajočih se parenteralnih odmerkov so bile varnostne meje glede na ledvične učinke ozke, toda kumulativna raven brez neželenih učinkov (NOAEL) v študijah enkratnega odmerka (1,6 mg/kg) in večkratnih odmerkov do en mesec (0,06 do 0,6 mg/kg/dan) niso pokazale ledvičnih učinkov v odmerkih, ki so bili enakovredni največjemu terapevtskemu odmerku za človeka ali večji od njega.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
V drugem primeru je prišlo do okrevanja po prekinitvi zdravljenja po invaziji roženice z atipičnim epitelom.
In another case, positive dechallenge was also seen after discontinuation of treatment after invasion of the cornea by atypical epithelium.
V důsledku snížení plazmatických koncentrací kobicistatu může dojít ke snížení plazmatických koncentrací atazanaviru, což může mít za následek ztrátu terapeutického účinku a rozvoj rezistence.
Atazanavir plasma concentrations may decrease as a consequence of a reduction in cobicistat plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
V eni od kliničnih študij (NINOS) je bila pri skupinah bolnikov, ki so prejemali zdravilo, podobna incidenca in intenzivnost intrakranialnih krvavitev, krvavitev 4. stopnje, periventrikularne levkomalacije, možganske kapi, epileptičnih napadov, ki so zahtevali zdravljenje s protikonvulzivnimi zdravili, pljučnih krvavitev in krvavitev v prebavilih.
In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
V eni študiji so otroci (stari od 2 do 12 let, n = 18), mladostniki (stari od 12 do 16 let, n = 9) in mlajši odrasli (stari od 16 do 21 let, n = 9) z neodzivnim solidnim tumorjem prejemali odmerek od 1,4 mg/m2 do 2,4 mg/m2.
One study included a dose range of 1.4 mg/m2 to 2.4 mg/m2 in children (aged 2 up to 12 years, n = 18), adolescents (aged 12 up to 16 years, n = 9), and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
V enih od dveh študij medsebojnega delovanja s pravastatinom in eritromicinom so opazili statistično pomembno zvišanje površine pod krivuljo (AUC) (70 %) in Cmax (121 %) za pravastatin.
In one of two interaction studies with pravastatin and erythromycin a statistically significant increase in the area under the curve (AUC) (70%) and Cmax (121%) of pravastatin was observed.
V ex vivo farmakologické studii s králíky byla izolovaná srdce vystavena atazanaviru, kobicistatu nebo kombinaci atazanaviru a kobicistatu.
In an ex vivo rabbit pharmacology study, isolated hearts were exposed to atazanavir, cobicistat, or atazanavir and cobicistat in combination.
V farmakoepidemiološki študiji so uporabo pramipeksola v primerjavi z njegovo neuporabo povezovali s povečanim tveganjem srčnega popuščanja (razmerje tveganja je bilo 1,86; 95-odstotni IZ, 1,21-2,85).
In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21- 2.85).
V glavnem se presnavlja s hidrolizo laktonskega obroča do karboksilata z odprtim obročem.
A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
v i
0.020
V in vivo studiích na potkanech atazanavir neovlivňoval mikrojádra v kostní dřeni, nepoškozoval DNA v duodenu (comet assay) nebo neočekávanou DNA reparaci v játrech při plazmatických a tkáňových koncentracích převyšující koncentrace, které byly klastogenní in vitro.
In in vivo studies in rats, atazanavir did not induce micronuclei in bone marrow, DNA damage in duodenum (comet assay), or unscheduled DNA repair in liver at plasma and tissue concentrations exceeding those that were clastogenic in vitro.
v inhibici CYP2D6 kobicistatem.
inhibition of CYP2D6 by
v inhibici CYP3A4 a/nebo
inhibition of CYP3A4 and/or
v inhibici P-gp kobicistatem.
inhibition of P-gp by cobicistat.
V isti študiji so poročali o statistično pomembnem povečanju pogostosti pojavljanja pljučne embolije (0,7 % v skupini, ki je prejemala placebo, v primerjavi z 1,1 % v skupini, ki je prejemala fenofibrat; p = 0,022) in o statistično nepomembnem povečanju pogostosti globoke venske tromboze (1,0 % v skupini, ki je prejemala placebo (48/4.900 bolnikov), v primerjavi z 1,4 % v skupini, ki je prejemala fenofibrat (67/4.895); p = 0,074).
In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4,900 patients] versus fenofibrate 1.4% [67/4,895 patients]; p = 0.074).
V izjemnih okoliščinah, ko je potrebno podaljšano sistemsko zdravljenje s fusidno kislino, npr. za zdravljenje hudih okužb, je sočasna uporaba pravastatina in fusidne kisline upoštevna le v posameznih primerih in pod strogim zdravniškim nadzorom.
In exceptional circumstances, where prolonged systemic fusidic acid is needed e.g for the treatment of severe infections, the need for co-administration of pravastatin and fusidic acid should only be considered on a case by case basis and under close medical supervision.
V japonski študiji faze I, pri kateri so uporabili 5 skupin z odmerki med 25 in 200 mg/telesno maso, so ugotovili povečano izpostavljenost, sorazmerno z odmerkom, za tegafur, gimeracil in oteracil.
In a Japanese Phase I study that utilized 5 dose groups with doses ranging from 25 to 200 mg/body, there was a dose-proportional increase in exposure for tegafur, gimeracil and oteracil.
v jednotlivé dávce
ingle dose
V jetrih se zaradi majhne prepustnosti presnavlja samo majhna količina oteracila.
Only a small amount of oteracil is metabolised in the liver because of its low permeability.
V každé skupině podle četnosti výskytu jsou nežádoucí účinky prezentovány v pořadí klesající závažnosti.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V každé skupině četností jsou nežádoucí účinky prezentovány v pořadí se snižující se závažností.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V klinických studiích antiretrovirové léčby u dříve neléčených pacientů, kteří byli léčeni neposíleným atazanavirem, je substituce I50L, někdy v kombinaci se změnou A71V, známkou substituce pro rezistenci na atazanaviru.
In clinical trials of antiretroviral treatment naive patients treated with unboosted atazanavir, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
V klinických studiích bylo prokázáno, že atazanavir vyvolává dyslipidemii nižšího rozsahu než komparátory.
In clinical studies, atazanavir has been shown to induce dyslipidaemia to a lesser extent than comparators.
V klinických studiích s atazanavirem, složkou přípravku EVOTAZ, bylo pozorováno asymptomatické prodloužení PR intervalu závislé na velikosti dávky.
Dose related asymptomatic prolongations in PR interval with atazanavir, a component of EVOTAZ have been observed in clinical studies.
V klinických studiích u pediatrických pacientů ve věku od 3 měsíců do 18 let byla průměrná doba léčby atazanavirem 115 týdnů.
In clinical studies, paediatric patients 3 months to less than 18 years of age had a mean duration of treatment with atazanavir of 115 weeks.
V klinických studiích zůstaly u převážné většiny jedinců léčených orlistatem po dobu nepřekračující 4 plné roky hladiny vitamínů A, D, E, K a beta karotenu v normálních hodnotách.
The vast majority of subjects receiving up to 4 full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
V klinične študije niso vključevali bolnikov s serumskim kreatininom > 265 mikromolov/l ali > 3,0 mg/dl.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
V klinične študije niso vključevali bolnikov s serumskim kreatininom > 400 mikromolov/l ali > 4,5 mg/dl.
In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.