FrancophonIA/ELRC3.0 huggingface dataset:
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Croatian: N-dezmetil metabolit se dalje metabolizira, s terminalnim poluvremenom od približno 4 sata.
English: Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji i blisteru nakon EXP.
English: The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina.
Croatian: Rezultati nisu pokazali klinički značajne razlike između sildenafila i placeba u vremenu do popuštanja angine.
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Croatian: Maksimalne koncentracije uočene u plazmi postižu se unutar 30 do 120 minuta (medijan 60 minuta) od oralnog doziranja natašte.
English: Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine.
Croatian: Potrebno je napomenuti kako je većina muškaraca, ali ne i svi, koji su imali ove nuspojave, imala probleme sa srcem i prije uzimanja ovog lijeka.
English: Protein binding is independent of total drug concentrations.
Croatian: Vezanje na proteine ne ovisi o ukupnim koncentracijama lijeka.
English: You should not take Sildenafil ratiopharm more than once a day.
Croatian: Sildenafil ratiopharm se ne smije uzeti više od jednom dnevno.
English: Patients should be advised that in the event of any sudden visual defect, they should stop taking sildenafil and consult a physician immediately (see section 4.3).
Croatian: Bolesnike treba savjetovati da u slučaju bilo kakvog iznenadnog poremećaja vida prestanu uzimati sildenafil i odmah zatraže savjet liječnika (vidjeti dio 4.3).
English: Effects on vision
Croatian: Učinak na vid
English: The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Croatian: Fiziološki mehanizam odgovoran za erekciju penisa uključuje otpuštanje dušikovog oksida (NO) u korpus kavernozumu tijekom seksualne stimulacije.
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people).
Croatian: Produljene i ponekad bolne erekcije - javljaju se rijetko (mogu se javiti u najviše 1 na 1000 osoba).
English: In order for sildenafil to be effective, sexual stimulation is required.
Croatian: Kako bi sildenafil djelovao, neophodna je seksualna stimulacija.
English: Myalgia, Pain in extremity
Croatian: Mialgija, bol u ekstremitetima
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Croatian: Profil sigurnosti sildenafila temelji se na podacima dobivenim od 9570 bolesnika koji su sudjelovali u 74 dvostruko slijepa, placebom kontrolirana klinička ispitivanja.
English: You should NOT take this medicine - if you are already undergoing other treatments for erectile dysfunction.
Croatian: NE smijete uzimati ovaj lijek - ako već uzimate druge terapije za erektilnu disfunkciju.
English: Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Croatian: Ne očekuje se da renalna dijaliza ubrza klirens jer je sildenafil u velikoj mjeri vezan na proteine plazme i ne eliminira se urinom.
English: - if you have recently had a stroke or a heart attack.
Croatian: 4. ako ste nedavno imali moždani ili srčani udar.
English: If you are taking ritonavir, you may not exceed a maximum dose of 25 mg sildenafil within a period of 48 hours.
Croatian: Ako uzimate ritonavir, ne smijete uzeti dozu veću od 25 mg sildenafila u razdoblju od 48 sati.
English: Paediatric population Sildenafil ratiopharm is not indicated for individuals below 18 years of age.
Croatian: Pedijatrijska populacija Sildenafil ratiopharm nije indiciran za primjenu u osoba mlađih od 18 godina.
English: Sildenafil had no effect on ritonavir pharmacokinetics.
Croatian: Sildenafil nije imao učinak na farmakokinetiku ritonavira.
English: In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Croatian: U zasebnom RigiScan ispitivanju, sildenafil je još uvijek bio u mogućnosti dovesti do erekcije u odgovoru na seksualnu stimulaciju 4-5 sati nakon doziranja.
English: This is when a man cannot get or keep a hard, erect penis suitable for sexual activity.
Croatian: Do toga dolazi kada muškarac nije u mogućnosti postići ili održati ukrućenost penisa u mjeri dovoljnoj za primjerenu spolnu aktivnost.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Croatian: Ako se prijapizam odmah ne liječi, moguće je oštećenje tkiva penisa i trajan gubitak potencije.
English: If you take more Sildenafil ratiopharm than you should, tell your doctor.
Croatian: Ako ste uzeli više tableta Sildenafil ratiopharm nego što trebate, javite se svom liječniku.
English: Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation.
Croatian: Dva klinička ispitivanja posebno su dizajnirana kako bi se procijenio vremenski okvir nakon doziranja tijekom kojeg bi sildenafil mogao dovesti do erekcije u odgovoru na seksualnu stimulaciju.
English: Sildenafil is an oral therapy for erectile dysfunction.
Croatian: Sildenafil je oralna terapija za erektilnu disfunkciju.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja ovog lijeka koji sadrži sildenafil u svim podskupinama pedijatrijske populacije za liječenje erektilne disfunkcije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: These symptoms usually occur within 4 hours of taking Sildenafil ratiopharm.
Croatian: Ti se simptomi obično javljaju unutar 4 sata od primjene lijeka Sildenafil ratiopharm.
English: In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Croatian: U ispitivanjima s jednokratnim dozama do 800 mg primijenjenim na dobrovoljcima, nuspojave su bile slične onima uočenim pri nižim dozama, međutim stope incidencije i težina bile su povećane.
English: Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue.
Croatian: Sildenafil nema izravni relaksirajući učinak na izolirani ljudski korpus kavernozum, ali izrazito pojačava relaksirajući učinak NO na to tkivo.
English: Talk to your doctor or pharmacist before taking Sildenafil ratiopharm - if you have problems with your heart.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Sildenafil ratiopharm. - ako imate problema sa srcem.
English: After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%).
Croatian: Nakon jednokratne oralne doze od 100 mg, srednja maksimalna ukupna koncentracija sildenafila u plazmi iznosi približno 440 ng/ml (CV 40%).
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Croatian: Blage i prolazne razlike u raspoznavanju boja (plava/zelena) opažene su u nekih ispitanika uz primjenu Farnsworth-Munsell 100 hue testa kod 1 sata nakon doze od 100 mg, bez učinaka vidljivih nakon 2 sata poslije primjene doze.
English: Sildenafil has no effect on visual acuity or contrast sensitivity.
Croatian: Sildenafil nema učinak na oštrinu vida ili osjetljivost na kontrast.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 µM).
Croatian: Sildenafil je slabi inhibitor citokroma P450 izoformi 1A2, 2C9, 2C19, 2D6, 2E1 i 3A4 (IC50 >150 µM).
English: Posology Use in adults
Croatian: Primjena u odraslih osoba
English: The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into the tissues.
Croatian: Srednji volumen distribucije u stanju dinamičke ravnoteže (Vd) za sildenafil iznosi 105 l, što ukazuje na distribuciju u tkiva.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Croatian: U dvostruko slijepom, placebom kontroliranom ispitivanju stresa izazvanog vježbanjem procijenjeno je 144 bolesnika s erektilnom disfunkcijom i kroničnom stabilnom anginom koji su redovito uzimali lijekove protiv angine (osim nitrata).
English: Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through postmarketing surveillance
Croatian: Tablica 1: Medicinski značajne nuspojave zabilježene s incidencijom većom od placeba u kontroliranim kliničkim ispitivanjima i medicinski značajne nuspojave zabilježene u razdoblju nakon stavljanja lijeka u promet
English: Use in patients taking other medicinal products
Croatian: Primjena u bolesnika koji uzimaju druge lijekove
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Croatian: Jednokratne doze antacida (magnezijev hidroksid/aluminijev hidroksid) nisu utjecale na bioraspoloživost sildenafila.
English: Sildenafil potentiates the hypotensive effect of nitrates (see section 4.3).
Croatian: Sildenafil pojačava hipotenzivne učinke nitrata (vidjeti dio 4.3).
English: After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Croatian: Nakon oralnog doziranja sildenafila AUC i Cmax rastu proporcionalno s dozom u preporučenom rasponu doze (25-100 mg).
English: Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Croatian: Jednokratne oralne doze sildenafila do 100 mg u zdravih dobrovoljaca nisu dovela do klinički značajnih učinaka na EKG.
English: These are symptoms of a fall in blood pressure upon rising quickly from sitting or lying (postural hypotension).
Croatian: To su simptomi pada krvnog tlaka nakon naglog ustajanja iz sjedećeg ili ležećeg položaja (posturalna hipotenzija).
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to sildenafil, before driving or operating machinery.
Croatian: Budući da su omaglica i poremećaj vida zabilježeni u kliničkim ispitivanjima sa sildenafilom, bolesnici moraju uzeti u obzir način na koji oni reagiraju na sildenafil, prije upravljanja vozilima ili rada sa strojevima.
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Croatian: Dušikov oksid zatim aktivira enzim gvanilat ciklazu, što rezultira porastom razina cikličnog gvanozin monofosfata (cGMP), što dovodi do relaksacije glatkih mišića u korpus kavernozumu omogućavajući dotok krvi.
English: Some patients taking alpha blockers may experience dizziness or light-headedness when getting up.
Croatian: Neki bolesnici koji uzimaju alfa-blokatore mogu osjetiti omaglicu ili ošamućenost pri ustajanju.
English: Epistaxis, Sinus congestion
Croatian: Epistaksa, sinusna kongestija
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by 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)].
Croatian: U donjoj tablici navedene su sve medicinski značajne nuspojave, koje su se javile u kliničkim ispitivanjima s učestalošću većom nego kod placeba, razvrstane prema organskim sustavima i učestalosti (vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000).
English: In vivo studies
Croatian: In vivo ispitivanja:
English: Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects.
Croatian: Sildenafil uzrokuje blago i prolazno sniženje krvnog tlaka koje u većini slučajeva ne dovodi do kliničkih učinaka.
English: Sildenafil ratiopharm is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Croatian: Sildenafil ratiopharm je indiciran je u odraslih muškaraca s erektilnom disfunkcijom, odnosno nemogućnošću postizanja ili održavanja penilne erekcije dostatne za zadovoljavajuću seksualnu aktivnost.
English: In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Croatian: U zdravih dobrovoljaca koji su primali sildenafil (100 mg u jednokratnoj dozi), manje od 0,0002% (prosječno 188 ng) primijenjene doze prisutno je u ejakulatu 90 minuta nakon doziranja.
English: The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
Croatian: Pretpostavljeni mehanizam za ovu promjenu u raspoznavanju boje povezan je s inhibicijom PDE6, koja je uključena u fototransdukcijsku kaskadu mrežnice.
English: From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su rijetki slučajevi nestabilne angine (srčani poremećaj) i iznenadne smrti.
English: When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Croatian: Kada su sildenafil i doksazosin istodobno primjenjivani bolesnicima stabiliziranima na terapiji doksazosinom, bilo je povremenih izvještaja o bolesnicima koji su imali simptomatsku posturalnu hipotenziju.
English: Sildenafil has a peripheral site of action on erections.
Croatian: Sildenafil ima periferno mjesto djelovanja na erekcije.
English: - An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people).
Croatian: Alergijska reakcija - javlja se manje često (može se javiti u najviše 1 na 100 osoba).
English: Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Croatian: Sildenafil (50 mg) nije potencirao hipotenzivne učinke alkohola u zdravih dobrovoljaca sa srednjim maksimalnim razinama alkohola u krvi od 80 mg/dl.
English: If sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Croatian: Ako se sildenafil uzima s hranom, nastup djelovanja može biti odgođen u usporedbi s uzimanjem natašte (vidjeti dio 5.2).
English: If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:
Croatian: Ako primijetite bilo koju od sljedećih ozbiljnih nuspojava, prestanite uzimati Sildenafil ratiopharm i odmah zatražite medicinsku pomoć:
English: When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in tmax of 60 minutes and a mean reduction in Cmax of 29%.
Croatian: Prilikom uzimanja sildenafila s hranom, brzina apsorpcije je smanjena sa srednjom odgodom tmax od 60 minuta i srednjim smanjenjem Cmax od 29%.
English: What you need to know before you take Sildenafil ratiopharm
Croatian: Što morate znati prije nego počnete uzimati Sildenafil ratiopharm
English: Given sildenafil peak plasma concentrations of approximately 1 µM after recommended doses, it is unlikely that sildenafil will alter the clearance of substrates of these isoenzymes.
Croatian: S obzirom da su nakon preporučenih doza vršne koncentracije sildenafila u plazmi približno 1 µM, nije vjerojatno da će sildenafil promijeniti klirens supstrata tih izoenzima.
English: The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Croatian: Sljedeće skupine nisu dobro zastupljene ili su isključene iz kliničkih ispitivanja: bolesnici s operacijom u području zdjelice, bolesnici nakon radioterapije, bolesnici s teškim poremećajem funkcije bubrega ili jetre i bolesnici s određenim kardiovaskularnim stanjima (vidjeti dio 4.3).
English: In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil.
Croatian: Ispitivanjem pomoću penilne pletizmografije (RigiScan) u bolesnika natašte, medijan vremena do pojave za one koji su postigli erekcije od 60% rigiditeta (dovoljno za spolni odnos) iznosila je 25 minuta (raspon 12-37 minuta) za sildenafil.
English: Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM).
Croatian: Budući da je sildenafil (i njegov glavni cirkulirajući N-dezmetil metabolit) 96% vezan na proteine u plazmi, to rezultira srednjom maksimalnom koncentracijom slobodnog sildenafila u plazmi od 18 ng/ml (38 nM).
English: The major circulating metabolite results from N-demethylation of sildenafil.
Croatian: Glavni cirkulirajući metabolit nastaje N-demetilacijom sildenafila.
English: Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Croatian: Sildenafil ima vazodilatatorna svojstva, što rezultira blagim i prolaznim sniženjem krvnog tlaka (vidjeti dio 5.1).
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Croatian: U ispitivanoj populaciji nije dokazan povoljan klinički učinak kombinirane terapije.
English: This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4).
Croatian: Do toga će najvjerojatnije doći unutar 4 sata nakon primjene doze sildenafila (vidjeti dijelove 4.2 i 4.4).
English: Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Croatian: Sildenafil nije imao učinka na farmakokinetiku sakvinavira (vidjeti dio 4.2).
English: In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Croatian: U normalnih, zdravih muških dobrovoljaca, nije bilo dokaza o utjecaju azitromicina (500 mg dnevno tijekom 3 dana) na AUC, Cmax, tmax, konstantu brzine eliminacije ili poluvrijeme sildenafila ili njegovog glavnog cirkulirajućeg metabolita.
English: There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration.
Croatian: Nema informacija o sigurnosti primjene sildenafila u bolesnika s poremećajima krvarenja ili aktivnim peptičnim ulkusom.
English: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Croatian: In vitro ispitivanja pokazala su da je sildenafil selektivan za PDE5, koja je uključena u proces erekcije.
English: At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was administered alone.
Croatian: U 24 sata, razine sildenafila u plazmi bile su još uvijek približno 200 ng/ml, u usporedbi s približno 5 ng/ml kada se sildenafil davao zasebno.
English: Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.
Croatian: Zbog toga se kod istodobne primjene jakih CYP3A4 induktora, kao što je rifampin, očekuju veća smanjenja koncentracije sildenafila u plazmi.
English: Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 10 years.
Croatian: Nuspojave nakon stavljanja lijeka u promet prikupljene su u razdoblju procijenjenom na >10 godina.
English: Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
Croatian: Doze od 200 mg nisu rezultirale povećanom djelotvornošću, već je porasla incidencija nuspojava (glavobolja, naleti crvenila, omaglica, dispepsija, nazalna kongestija, promjenjen vid).
English: Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Croatian: Sildenafil je kontraindiciran u bolesnika koji su izgubili vid na jednom oku zbog nearteritične anteriorne ishemijske optičke neuropatije (NAION), bez obzira je li ta epizoda bila u vezi ili ne s prethodnom izloženošću PDE5 inhibitoru (vidjeti dio 4.4).
English: - Serious skin reactions - this occurs rarely.
Croatian: Ozbiljne kožne reakcije - javljaju se rijetko.
English: Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Croatian: Riociguat: Pretklinička ispitivanja pokazala su aditivan učinak na snižavanje krvnog tlaka kada su se inhibitori PDE5 primjenjivali u kombinaciji sa riociguatom.
English: Do NOT take Sildenafil ratiopharm: - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Croatian: NEMOJTE uzimati Sildenafil ratiopharm - ako ste alergični na sildenafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: How to store Sildenafil ratiopharm Contents of the pack and other information
Croatian: Kako čuvati Sildenafil ratiopharm Sadržaj pakiranja i druge informacije
English: The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Croatian: Zastupljene su sljedeće skupine bolesnika: stariji (19,9%), bolesnici s hipertenzijom (30,9%), dijabetes melitusom (20,3%), ishemijskom bolesti srca (5,8%), hiperlipidemijom (19,8%), ozljedom leđne moždine (0,6%), depresijom (5,2%), transuretralnom resekcijom prostate (3,7%), radikalnom prostatektomijom (3,3%).
English: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Croatian: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Njemačka