natgillin/translations-raw huggingface dataset:
Substances that inhibit (such as ketoconazole, itraconazole, ritonavir or cyclosporine) or induce (such as rifampicin, barbiturates, carbamazepine, phenytoin) these enzymes and transporters may affect the plasma concentrations of silodosin and its active metabolite.
Zdravila, ki zavirajo (kot so ketokonazol, intrakonazol, ritonavir ali ciklosporin) ali inducirajo (kot so rifampicin, barbiturati, karbamazepin, fenitoin) te encime in prenašalce, lahko vplivajo na plazemske koncentracije silodozina in njegovega aktivnega presnovka.
10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
10 trdih kapsul 20 trdih kapsul 30 trdih kapsul 50 trdih kapsul 90 trdih kapsul 100 trdih kapsul
It is important that you immediately inform your eye specialist if you are using or have previously used Silodosin Recordati.
Pomembno je, da takoj obvestite svojega očesnega zdravnika, če uporabljate ali ste v preteklosti uporabljali zdravilo Silodosin Recordati.
• If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodosin Recordati.
• Če ste kdajkoli omedleli ali občutili omotico ob nenadnem vstajanju v pokončni položaj, povejte svojemu zdravniku pred pričetkom jemanja zdravila Silodosin Recordati.
Common Uncommon Rare
Neznana pogostnost
Silodosin is excreted mainly as metabolites, very low amounts of unchanged drug are recovered in urine.
Silodozin se pretežno izloča v obliki presnovkov, z urinom se izločijo zelo majhne količine nespremenjenega zdravila.
No dose adjustment is required in the elderly (see section 5.2).
Pri starejših bolnikih prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
If dizziness when standing up or fainting occurs, please inform your doctor as soon as possible.
Če se ob vstajanju v pokončni položaj pojavi omotica ali omedlevica, čim prej obvestite svojega zdravnika.
The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons.
Kapsule so na voljo v pretisnih omotih iz PVC/PVDC/aluminijaste folije, pakiranih v škatli.
In all studies, patients who did not respond to placebo during a 4-week placebo run-in phase were randomised to receive the study treatment.
V vseh študijah so bolnike, ki se v 4-tedenski fazi uvajanja, izvedeni s placebom, niso odzvali na placebo, randomizirali v skupine, ki so prejemale preiskovano zdravilo.
Silodosin administered orally is well absorbed and absorption is dose proportional.
Po peroralnem vnosu se silodozin dobro absorbira, absorpcija je sorazmerna z odmerkom.
Diarrhoea Nausea Dry mouth
Bolezni prebavil driska slabost suha usta
Silodosin 8 mg and 24 mg daily had no statistically significant effect on ECG intervals or cardiac repolarisation relative to placebo.
Silodozin v odmerku 8 mg oziroma 24 mg v primerjavi s placebom ni imel statistično pomembnega učinka na EKG intervale ali repolarizacijo srca.
Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7.
Silodozin se obsežno presnavlja, pretežno preko encimov CYP3A4, alkohol-dehidrogenaze in UGT2B7.
In the subjects over 65 years, the mean decreases at the various time points were between 5 and 15 mmHg (systolic) and 0 and 10 mmHg (diastolic).
Pri osebah, starejših od 65 let, so srednji padci krvnega tlaka, merjeni ob različnih časih, znašali od 5 do 15 mm Hg (sistolični) in od 0 do 10 mm Hg (diastolični).
Silodosin and its glucuronide reach steady-state after 3 days and 5 days of treatment, respectively.
Silodozin in njegov glukuronid dosežeta stanje dinamičnega ravnotežja po 3 oziroma po 5 dneh.
Urticaria1
urtikarija1
Silodosin Recordati may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Zdravilo Silodosin Recordati lahko povzroči zaplete med operacijo sive mrene (operacija očesa zaradi zamotnitve leče, glejte poglavje »Opozorila in previdnostni ukrepi«).
The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2% with silodosin and 1.0% with placebo.
V s placebom nadzorovanih kliničnih študijah je bila pogostnost ortostatske hipotenzije ob uporabi silodozina 1,2% in ob uporabi placeba 1,0%.
During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with silodosin, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Očesni kirurgi in oftalmološke skupine morajo med pripravo na operacijo preveriti, če se bolniki, ki so predvideni za operacijo sive mrene, zdravijo ali so se zdravili s silodozinom, da bi lahko pripravili vse potrebno za obvladovanje IFIS med operacijo.
In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
Pri zdravih moških v starosti ciljne skupine (n = 16, povprečna starost 55 ± 8 let) so bili po peroralnem vnosu 8 mg enkrat na dan takoj po zajtrku v obdobju 7 dni izmerjeni sledeči farmakokinetični parametri: Cmax 87 ± 51 ng/ml (SD), tmax 2,5 uri (razpon 1,0-3,0), AUC 433 ± 286 ng • h/ml.
The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23%.
Najpogostejši neželeni učinki, o katerih so poročali ob uporabi silodozina v s placebom nadzorovanih kliničnih študijah in ob dolgoročni uporabi, so bile je bile motnje ejakulacije kot je retrogradna ejakulacija in anejakulacija (zmanjšana količina ejakulata ali brez njega), s pogostnostjo 23%.
Should overdose of silodosin lead to hypotension, cardiovascular support has to be provided.
Če prevelik odmerek silodozina vodi v hipotenzijo, je treba zagotoviti ustrezno podporo srčno-žilnemu sistemu.
This may lead to increased procedural complications during the operation.
To lahko poveča tveganje za morebitne zaplete med posegom.
Dizziness when standing up and occasionally fainting may occur when taking Silodosin Recordati, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Ob jemanju zdravila Silodosin Recordati se lahko pojavita omotica ob vstajanju v pokončni položaj in občasno tudi omedlevica, še zlasti na začetku zdravljenja ali če jemljete druga zdravila za zniževanje krvnega tlaka.
In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
V klinični študiji IV. Faze, izpeljani v Evropi, s povprečnim izhodiščnim rezultatom vprašalnika IPSS 18,9 točk, se je 77,1%, bolnikov odzvalo na silodozin (kot je bilo ocenjeno s spremembo izhodiščnega rezultata vprašalnika IPSS za vsaj 25%).
Do not take Silodosin Recordati if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste vzeli zdravilo Silodosin Recordati Ne jemljite zdravila Silodosin Recordati če ste alergični na silodozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Total score
Celokupni rezultat
• medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodosin Recordati may be reduced.
• zdravila za zdravljenje epilepsije ali rifampicin (zdravilo za zdravljenje tuberkuloze), ker se učinek zdravila Silodosin Recordati lahko zmanjša.
Silodosin Recordati may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Zdravilo Silodosin Recordati lahko zmanjša količino sperme, zaradi česar lahko začasno vpliva na sposobnost zaploditve otroka.
• If you have severe liver problems, you should not take Silodosin Recordati, as it was not tested in this condition.
• Če imate hude težave z jetri, ne smete jemati zdravila Silodosin Recordati, ker zdravilo pri takih bolnikih ni bilo preizkušeno.
Protein binding of silodosin glucuronide is 91%.
Vezava na beljakovine pri glukuronidnemu konjugatu silodozina je 91%.
Alpha-blockers There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Blokatorji alfa Podatki o varni uporabi silodozina v povezavi z drugimi antagonisti α-adrenergičnih receptorjev so nezadostni.
Silodosin Recordati belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Silodosin Recordati sodi v skupino zdravil, imenovanih zaviralci alfa1A-adrenergičnih receptorjev.
In subjects with severe renal impairment (n = 5) increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC.
Pri bolnikih s hudo okvaro delovanja ledvic (n = 5) se je Cmax ob izpostavitvi povečala za 2,2-krat in AUC za 3,7-krat.
Body clearance of silodosin was approximately 0.28 L/h/kg.
Očistek silodozina je bil približno 0,28 l/h/kg.
For special patient populations, one capsule of Silodosin Recordati 4 mg daily is recommended (see below).
Pri posebnih skupinah bolnikov je priporočena ena kapsula zdravila Silodosin Recordati 4 mg na dan (glejte spodaj).
• If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Silodosin Recordati.
• Če se pripravljate na očesno operacijo zaradi zamotnitve očesne leče (katarakta, operacija sive mrene), je pomembno, da takoj poveste svojemu očesnemu zdravniku, da uporabljate ali ste uporabljali zdravilo Silodosin Recordati.
In the long-term open-label extension phase of these controlled studies, in which patients received silodosin for up to 1 year, the symptom improvement induced by silodosin at week 12 of treatment was maintained over 1 year.
V dolgoročni odprti podaljšani fazi teh nadzorovanih študij so bolniki prejemali silodozin do 1 leta.
Silodosin Recordati is not intended for use by women.
Zdravilo Silodosin Recordati ni namenjeno ženskam.
• Symptoms of allergic reaction affecting the skin like rash, itching, hives and rash caused by a medicine
• simptomi alergijske reakcije, ki prizadenejo kožo, na primer izpuščaj, srbenje, koprivnica in medikamentni izpuščaj
• Faster heart rate
• hitrejše bitje srca
A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient's response.
Pri bolnikih z zmerno okvaro delovanja ledvic (CLCR ≥ 30 do < 50 ml/min) je priporočljivo uporabiti začetni odmerek 4 mg enkrat na dan, ki se ga glede na odziv posameznega bolnika po enem tednu zdravljenja lahko poveča na 8 mg enkrat na dan.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodosin Recordati.
• zdravila proti glivicam (kot sta ketokonazol ali itrakonazol), zdravila za zdravljenje okužbe z virusom HIV/AIDS (kot je ritonavir) ali zdravila, ki se uporabljajo po presaditvi organov za preprečevanje zavrnitve organa (kot je ciklosporin), ker ta zdravila lahko zvišajo koncentracijo zdravila Silodosin Recordati v krvi.
In a placebo-controlled study in 24 subjects 45-78 years of age receiving silodosin, the co-administration of sildenafil 100 mg or tadalafil 20 mg induced no clinically meaningful mean decreases in systolic or diastolic blood pressure, as assessed by orthostatic tests (standing versus supine).
V s placebom nadzorovani študiji pri 24 osebah v starosti od 45-78 let, ki so jemale silodozin, sočasno zaužitje 100 mg sildenafila ali 20 mg tadalafila ni povzročilo klinično pomembnih srednjih padcev sistoličnega ali diastoličnega krvnega tlaka, kar so ocenili z ortostatskimi testi (v stoječem položaju v primerjavi s položajem leže na hrbtu).
Nevertheless, caution should be exercised when starting concomitant use with antihypertensives and patients should be monitored for possible adverse reactions.
Vseeno je na začetku zdravljenja sočasno z antihipertenzivi potrebna previdnost in bolnike je treba zaradi možnih neželenih učinkov nadzorovati.
The main metabolite in plasma, the glucuronide conjugate of silodosin (KMD-3213G), that has been shown to be active in vitro, has an extended half-life (approximately 24 hours) and reaches plasma concentrations approximately four times higher than those of silodosin.
Glavni plazemski presnovek, glukuronidni konjugat silodozina (KMD-3213G), za katerega se je izkazalo, da je in vitro aktiven, ima podaljšano razpolovno dobo (približno 24 ur) in doseže približno štirikrat višje plazemske koncentracije kakor silodozin.
Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra.
Silodozin se visoko selektivno veže ne α1A adrenergične receptorje, ki se prvenstveno nahajajo v humani prostati, bazi mehurja, vratu mehurja, kapsuli prostate in prostatičnem delu sečnice.
If you have severe kidney problems, you should not take Silodosin Recordati.
Če imate hude težave z ledvicami, ne smete jemati zdravila Silodosin Recordati.
If you have taken more than one capsule, inform your doctor as soon as possible.
Če ste vzeli večji odmerek zdravila Silodosin Recordati, kot bi smeli Če ste vzeli več kot eno kapsulo, čimprej obvestite svojega zdravnika.
The dose-limiting adverse reaction was postural hypotension.
Odmerek omejujoč neželeni učinek je bila posturalna hipotenzija.
• medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodosin Recordati might lead to a slight decrease in blood pressure.
• zdravila za zdravljenje težav z nastankom ali ohranitvijo erekcije (kot sta sildenafil ali tadalafil), ker uporaba skupaj z zdravilom Silodosin Recordati lahko vodi v rahlo znižanje krvnega tlaka.
Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility.
Zdravljenje s silodozinom povzroča zmanjšanje količine ejakulata, ki se sprosti med orgazmom, kar lahko začasno prizadene moško plodnost.
• medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodosin Recordati.
• zdravila za zniževanje krvnega tlaka (zlasti zdravila, imenovana zaviralci alfa1 kot sta prazosin ali doksazosin), ker obstaja tveganje, da se ob jemanju zdravila Silodosin Recordati učinek teh zdravil okrepi.
A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal impairment (n = 487) poses an additional safety risk during silodosin therapy (such as an increase in dizziness or orthostatic hypotension) as compared to patients with normal renal function (n = 955).
Pregled varnostnih podatkov bolnikov, vključenih v vse klinične študije, ne nakazuje, da bi blago okvarjeno delovanje ledvic (n = 487) v primerjavi z normalnim delovanjem ledvic (n = 955) pri zdravljenju s silodozinom predstavljalo dodatno varnostno tveganje (kot je npr. porast omotičnosti ali ortostatske hipotenzije).
Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks of treatment did not change in patients with mild impairment (n = 70), compared to patients with normal renal function (n = 155), while the levels were doubled on average in patients with moderate impairment (n = 7).
Spremljanje plazemskih ravni v klinični študiji Faze III je pokazalo, da se ravni celokupnega silodozina po 4 tednih zdravljenja pri bolnikih z blago okvarjenim delovanjem (n = 70) v primerjavi z bolniki z normalnim delovanjem ledvic (n = 155) niso spremenile, pri bolnikih z zmerno okvarjenim delovanjem (n = 7) pa so bile v povprečju podvojene.
In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
V z učinkovino nadzorovani klinični študiji, izpeljani v Evropi, se je pokazalo, da 8 mg silodozina enkrat na dan ni dajalo slabših rezultatov od 0,4 mg tamsulozina enkrat na dan: prilagojena povprečna razlika (95% CI) v rezultatu vprašalnika IPSS med posameznimi s protokolom določenimi populacijami je znašala 0,4 (-0,4 do 1,1).
The most common side effect is a decrease in the amount of semen released during sex.
Najpogostejši neželeni učinek je zmanjšanje količine sperme, izločene pri spolnem odnosu.
NAME OF THE MARKETING AUTHORISATION HOLDER Recordati Ireland Ltd.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Recordati Ireland Ltd.
Silodosin Recordati does not treat prostate cancer.
Zdravilo Silodosin Recordati ne zdravi raka prostate.
The responder rate (i.e. improvement in the IPSS total score by at least 25%) was significantly higher in the silodosin (68%) and tamsulosin group (65%), as compared to placebo (53%).
izboljšanje rezultata vprašalnika IPSS za vsaj 25%) v skupini, ki je prejemala silodozin (68%) oziroma tamsulozin (65%) statistično značilno višja.
• Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Silodosin Recordati.
• Ker imata nenevarno povečanje prostate in rak prostate lahko enake simptome, vas bo zdravnik pred pričetkom zdravljenja z zdravilom Silodosin Recordati poslal na kontrolni pregled za raka prostate.
Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Po peroralnem vnosu s 14C-označenega silodozina je bilo po 7 dneh v urinu zaznane približno 33,5%
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
4.1 Terapevtske indikacije Zdravljenje znakov in simptomov benigne hiperplazije prostate (BHP) pri odraslih moških.
In patients with orthostatic hypotension, treatment with silodosin is not recommended.
Pri bolnikih z ortostatsko hipotenzijo zdravljenje s silodozinom ni priporočljivo.
Silodosin Tamsulosin Placebo
Evropa silodozin tamsulozi n placebo
Dizziness, including dizziness when standing up, and occasionally fainting, may occur.
Pojavita se lahko omotica, vključno z omotico ob vstajanju v pokončni položaj, in občasno ome dle vica.
The pharmacokinetics of silodosin in patients with severe hepatic impairment has not been studied.
Farmakokinetika silodozina pri bolnikih s hudo okvaro delovanja jeter ni bila raziskana.
PDE-5 inhibitors
Zaviralci PDE-5
• Runny or blocked nose
• izcedek iz nosu ali zamašen nos • driska
Patients with kidney problems
Bolniki s težavami z delovanjem ledvic
In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Klinična učinkovitost in varnost V dvojno slepi s placebom nadzorovani klinični študiji Faze II za določanje odmerka s 4 ali 8 mg silodozinom enkrat na dan je bilo v primerjavi s placebom (-4,0 ± 5,5, n = 83) pri uporabi 8 mg silodozina (-6,8 ± 5,8, n = 90; p = 0,0018) in 4 mg silodozina (-5,7 ± 5,5, n = 88; p = 0,0355) opaženo večje izboljšanje točkovnega rezultata po vprašalniku Ameriškega urološkega združenja (AUA - American Urologic Association).
There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Pediatrična populacija Zdravilo Silodosin Recordati ni namenjeno za uporabo pri pediatrični populaciji za indikacijo benigne hiperplazije prostate (BHP).
This effect disappears after discontinuation of Silodosin Recordati.
Ta učinek izzveni po prekinitvi zdravljenja z zdravilom Silodosin Recordati.
In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
< 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Since BPH and prostate carcinoma may present the same symptoms and can co-exist, patients thought to have BPH should be examined prior to starting therapy with silodosin, to rule out the presence of carcinoma of the prostate.
Ker imata BHP in karcinom prostate lahko enake simptome in ima bolnik lahko sočasno obe bolezni, je treba pred pričetkom zdravljenja s silodozinom bolnike s sumom na BHP pregledati in izključiti karcinom prostate.
If you stop treatment, your symptoms may re-appear.
Če ste prenehali jemati zdravilo Silodosin Recordati Če ste prenehali z zdravljenjem, se vaši simptomi lahko ponovno pojavijo.
Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Silodozin se obsežno presnavlja z glukuronidacijo (UGT2B7), alkohol- in aldehid-dehidrogenazo in po oksidativnih poteh, predvsem z encimom CYP3A4.
How to store Silodosin Recordati Contents of the pack and other information
Shranjevanje zdravila Silodosin Recordati Vsebina pakiranja in dodatne informacije
The incidence of orthostatic effects with silodosin is very low.
Pogostnost ortostatskih učinkov je ob uporabi silodozina zelo nizka.
Allergictype reactions including facial swelling, swollen tongue and pharyngeal oedema1
vključno z oteklostjo obraza, oteklostjo jezika in faringealnim edemom1
In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with moderate hepatic impairment (Child-Pugh scores 7 to 9), compared to nine healthy subjects.
V študiji enkratnega odmerka farmakokinetika silodozina pri devetih bolnikih z zmerno okvarjenim delovanjem jeter (7 do 9 po lestvici Child-Pugh) v primerjavi z devetimi zdravimi prostovoljci ni bila spremenjena.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
PRETISNI OMOTI IZ PVC/PVDC/ALUMINIJASTE FOLIJE
The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
II-III Faze (z 931 bolniki, ki so prejemali 8 mg silodozina enkrat na dan in 733 bolniki, ki so prejemali placebo) in v dveh dolgoročnih odprtih podaljšanih študijah.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, carcinogenic, mutagenic and teratogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, kancerogenega, mutagenega in teratogenega potenciala ne kažejo posebnega tveganja za človeka.
Accordingly, no dose adjustment is required in patients with mild renal impairment.
V skladu s tem prilagoditev odmerka pri bolnikih z blago okvarjenim delovanjem ledvic ni potrebna.