FrancophonIA/ELRC3.0 huggingface dataset:
English: • a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information
Croatian: • podsjetnik o indikaciji, dozi, trajanju liječenja i kontraindikacijama te potrebi sukladnosti s informacijama o lijeku
English: • the new additional risk minimisation measures.
Croatian: • nove dodatne mjere svođenja rizika na najmanju moguću razinu.
English: Each marketing authorisation holder shall complete the below conditions, within the stated timeframe, and the competent authorities shall ensure that the following is fulfilled:
Croatian: Svaki nositelj odobrenja za stavljanje u promet mora ispuniti uvjete u nastavku u navedenom roku, a nadležna tijela osiguravaju ispunjavanje sljedećih uvjeta:
English: The final study report shall be submitted for assessment by the PRAC:
Croatian: Završno izvješće o ispitivanju dostavlja se PRAC-u na procjenu:
English: Protocol to be submitted for assessment by the PRAC:
Croatian: Protokol se dostavlja PRAC-u na procjenu:
English: Each MAH shall develop training materials according to the following core elements:
Croatian: Svaki nositelj odobrenja za stavljanje u promet mora pripremiti obrazovne materijale uzimajući u obzir sljedeće temeljne elemente:
English: The MAH should submit and agree with the National Competent Authorities: - the details of the controlled access program and the modalities of its implementation - the final training materials, including communication media and distribution modalities.
Croatian: Nositelj odobrenja za stavljanje u promet trebao bi se s nacionalnim nadležnim tijelima dogovoriti o sljedećem te im dostaviti: - pojedinosti programa kontroliranog pristupa i načine njegove provedbe - konačne materijale za obrazovanje i osposobljavanje, uključujući sredstva komunikacije i načine distribucije.
English: Each MAH of HES solutions for infusion shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures implemented as an outcome of this referral procedure.
Croatian: Svaki nositelj odobrenja za stavljanje u promet otopina za infuziju koje sadrže hidroksietil škrob mora provesti ispitivanje potrošnje lijeka kako bi procijenio učinkovitost mjera svođenja rizika na najmanju moguću mjeru koje su provedene kao rezultat ovog postupka upućivanja.
English: • the risks related to the use of HES solutions for infusion outside the terms of the MA
Croatian: • rizike povezane s primjenom otopina za infuziju koje sadržavaju hidroksietil škrob izvan uvjeta odobrenja za stavljanje u promet
English: These measures should be submitted with a risk management plan (RMP):
Croatian: Te se mjere trebaju dostaviti zajedno s planom upravljanja rizicima: Program kontroliranog pristupa mora se učinkovito provesti najkasnije:
English: • the results from the DUSs
Croatian: • rezultate ispitivanja potrošnje lijeka.
English: The MAH shall implement a controlled access program to ensure that HES solutions for infusion are only delivered to accredited hospitals / centres where healthcare professionals expected to prescribe / administer these medicinal products have been trained on their appropriate use.
Croatian: Nositelj odobrenja za stavljanje u promet provodi program kontroliranog pristupa kako bi osigurao da se otopine za infuziju koje sadržavaju hidroksietil škrob dostavljaju akreditiranim bolnicama/centrima gdje su zdravstveni radnici koji propisuju/primjenjuju te lijekove osposobljeni za njihovu odgovarajuću upotrebu.
English: The MAHs are strongly encouraged to collaborate to perform a joint study.
Croatian: Nositelje odobrenja za stavljanje u promet potiče se da provedu zajedničko ispitivanje.
English: - managing the accreditation system - ensuring HES solutions for infusion are only delivered to accredited hospital/centres, i.e where all relevant HCPs have been trained.
Croatian: Osposobljavanje se treba redovito ponavljati, - upravljanje sustavom akreditacije - osiguravanje da se otopine za infuziju koje sadrže hidroksietil škrob dostavljaju samo akreditiranim bolnicama/centrima, tj. mjestima gdje su osposobljeni svi relevantni zdravstveni radnici.
English: As a consequence, the MAH shall be responsible of: - delivering the training to all relevant HCPs prescribing / administering HES solutions for infusion through agreed training material.
Croatian: U skladu s time, nositelj odobrenja za stavljanje u promet odgovoran je za: - osposobljavanje svih relevantnih zdravstvenih radnika koji propisuju/primjenjuju otopine za infuziju koje sadržavaju hidroksietil škrob prema dogovorenom obrazovnom materijalu.
English: Some of these serious side effects may lead to death.
Croatian: Neke od ovih ozbiljnih nuspojava mogu dovesti do smrti.
English: This 4 week period is called a ‘cycle.'
Croatian: Ova četiri tjedna se nazivaju jedan ciklus.
English: You start a new cycle every 4 weeks.
Croatian: Novi ciklus započinjete svaka 4 tjedna.
English: Take your pack(s) of medicine with you.
Croatian: Ponesite pakiranje(a) lijeka sa sobom.
English: Macrogol (8000)
Croatian: Makrogol (8000)
English: • It is used when the cancer has spread to other parts of the body.
Croatian: • Koristi se kada se rak proširio na druge dijelove tijela.
English: Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.
Croatian: Nemojte voziti ili koristiti bilo koje alate ili strojeve ako doživite simptome koji mogu utjecati na Vašu sposobnost koncentracije i reagiranja.
English: Lonsurf may harm your unborn baby.
Croatian: Lonsurf može naškoditi Vašem nerođenom djetetu.
English: Dosing adjustments may be required based on individual safety and tolerability.
Croatian: Prilagodbe doze mogu biti potrebne zbog individualne sigurnosti i podnošljivosti.
English: You should also do this for 6 months after you stop taking the medicine.
Croatian: Morate je također koristiti i šest mjeseci nakon što prestanete uzimati ovaj lijek.
English: • Week 3 - No medicine
Croatian: • 3. tjedan - bez lijeka
English: This is because it may not work or be safe.
Croatian: To je zbog toga što može biti nedjelotvoran ili nije siguran.
English: Therefore, Lonsurf should be treated as a potential carcinogen.
Croatian: Zbog toga se Lonsurf treba tretirati kako potencijalni kancerogen.
English: • Swallow the tablets whole with a glass of water.
Croatian: • Tablete progutatajte cijele s čašom vodom.
English: This medicine is not indicated for use in children and adolescents below the age of 18 years.
Croatian: • Ovaj lijek nije indiciran za primjenu u djece i adolescenata mlađih od 18 godina.
English: • Wash your hands after handling this medicine.
Croatian: • Operite ruke nakon rukovanja lijekom.
English: Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: • It is used when other treatments have not worked - or when other treatments are not suitable for you.
Croatian: • Koristi se kada drugi lijekovi nisu bili učinkoviti - ili kada se ne možete liječiti drugim lijekovima.
English: • Your doctor will decide the right dose for you - the dose depends on your weight and height.
Croatian: • Vaš Liječnik će odrediti dozu koja je za Vas najbolja - doza ovisi o Vašoj težini i visini.
English: • changes in the menstrual cycle
Croatian: • promjene u menstrualnom ciklusu
English: Do not take Lonsurf :
Croatian: Nemojte uzimati Lonsurf :
English: • low or high blood pressure
Croatian: • niski ili visoki krvni tlak
English: Do not take Lonsurf if the above applies to you.
Croatian: Nemojte uzimati Lonsurf ako se gore navedeno odnosi na Vas.
English: • Your doctor will tell you how many tablets to take each time.
Croatian: • Liječnik će Vam reći koliko točno tableta morate uzimati.
English: Effect of food
Croatian: Djelovanje hrane
English: Lonsurf comes in two strengths.
Croatian: Lonsurf dolazi u dvije jačine.
English: If you become pregnant, you and your doctor will have to decide if the benefits of Lonsurf are greater than the risk of harm to the baby.
Croatian: Ako zatrudnite, Vi i Vaš liječnik ćete morati odlučiti je li korist od primjene lijeka Lonsurf veća od potencijalnog rizika za dijete.
English: 36 months.
Croatian: 6.3 Rok valjanosti 36 mjeseci.
English: • Trifluridine stops the growth of cancer cells.
Croatian: • Trifluridin zaustavlja rast stanica raka.
English: • You will take a dose 2 times a day.
Croatian: • Uzimati ćete dozu dva puta na dan.
English: Dose escalation is not permitted after it has been reduced.
Croatian: Povećanje doze nije dozvoljeno nakon što je smanjena.
English: Survival Probability (%)
Croatian: Vjerojatnost preživljenja (%)
English: Tumor assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were performed by the investigator/local radiologist every 8 weeks.
Croatian: Procjene tumora, prema Kriterijima procjene odgovora kod čvrstih tumora (RECIST), verzija 1.1, provodio je istraživač / lokalni radiolog svakih 8 tjedana.
English: Tell your doctor immediately if you notice any of the following serious side effects (many of the side effects are shown in laboratory tests - for example those affecting your blood cells):
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih ozbiljnih nuspojava (mnoge nuspojave vidljive su u laboratorijskim pretragama - npr. one koje utječu na Vaše krvne stanice):
English: Other medicines and Lonsurf
Croatian: Drugi lijekovi i Lonsurf
English: b. Fatal cases have been reported.
Croatian: Prijavljeni su slučajevi sa smrtnim ishodom.
English: Tell your doctor if you notice any of the following side effects.
Croatian: Obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava.
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling the tablets.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Ruke se trebaju oprati nakon rukovanja s tabletama.
English: Efficacy and safety data in patients over 75 years old is limited.
Croatian: Ograničeni su podaci o djelotvornosti i sigurnosti u bolesnika starijih od 75 godina.
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: Ovo uključuje lijekove koji se nabavljaju bez recepta i biljne lijekove.
English: General physical health deterioration
Croatian: Pogoršanje općeg tjelesnog zdravlja
English: • Take this medicine by mouth.
Croatian: • Uzmite ovu tabletu kroz usta.
English: Your doctor may prescribe both strengths for your prescribed dose.
Croatian: Vaš liječnik može Vam propisati obje jačine zbog postizanja potrebne doze.
English: • pain, including pain from the cancer
Croatian: • bol, uključujući bol povezanu s rakom
English: • Week 4 - No medicine You will then start again with another cycle of 4 weeks following the above pattern.
Croatian: • 4. tjedan - bez lijeka Zatim ćete započeti sa sljedećim ciklusom u trajanju od 4 tjedna na isti način kako je gore navedeno.
English: 92284 Suresnes Cedex France
Croatian: 92284 Suresnes Cedex
English: Months from Randomisation
Croatian: Mjeseci od randomizacije
English: You and your partner should use effective methods of contraception while taking this medicine.
Croatian: Vi i Vaš partner morate koristiti pouzdane metode kontracepcije tijekom primjene ovog lijeka.
English: The tests are needed because Lonsurf can sometimes affect your blood cells.
Croatian: Ove su pretrage potrebne budući da Lonsurf može ponekad utjecati na Vaše krvne stanice.
English: All AUC groups performed better than placebo throughout the follow-up period.
Croatian: Sve AUC skupine imali su bolje opće stanje nego placebo skupine tijekom praćenja.
English: What you need to know before you take Lonsurf 3.
Croatian: Što morate znati prije nego počnete uzimati Lonsurf 3.
English: Tests and checks
Croatian: Pretrage i kontrole
English: There is limited data on Lonsurf in Black/African American patients but there is no biological rationale to expect any difference between this subgroup and the overall population.
Croatian: Postoje ograničeni podaci o primjeni Lonsurfa u bolesnika crne rase/Afroamerikanaca, ali ne postoji biološka opravdanost za očekivanje razlike između ove skupine i ukupne populacije.
English: • if you are allergic to trifluridine or tipiracil or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na trifluridin ili tipiracil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: What Lonsurf looks like and contents of the pack
Croatian: Kako Lonsurf izgleda i sadržaj pakiranja
English: If you take more Lonsurf than you should
Croatian: Ako uzmete više lijeka Lonsurf nego što ste trebali
English: The tablets must be taken with a glass of water within 1 hour after completion of the morning and evening meals.
Croatian: Tablete se moraju uzeti s čašom vode unutar 1 sata od završetka jutarnjeg i večernjeg obroka.
English: Therefore, caution is required when using medicinal products that interact with these transporters.
Croatian: Shodno tome, preporučuje se oprez pri primjeni lijekova koji imaju interakcije s ovim prijenosnicima.
English: The CHMP reviewed the data submitted by the marketing authorisation holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
Croatian: CHMP je pregledao podatke koje je dostavio nositelj odobrenja, uzevši u obzir odredbe čl. 14(11) Uredbe (EZ) br. 726/2004, te smatra da nova terapijska indikacija donosi značajnu kliničku korist u usporedbi s postojećim terapijama, što je dodatno pojašnjeno u Europskom javnom izvješću o ocjeni lijeka.
English: • Anaemia (very common).
Croatian: • Anemija (vrlo često).
English: Your doctor will be looking out for these side effects in your test results.
Croatian: Vaš liječnik će tražiti te nuspojave u rezultatima Vaših pretraga.
English: Treatment may lead to the following side effects (see section 4):
Croatian: Liječenje može dovesti do sljedećih nuspojava (pogledajte dio 4):
English: • a reduced number of red blood cells (anaemia)
Croatian: • smanjenje broja crvenih krvnih stanica (anemija)
English: Lonsurf on overall survival was similar in patients <65 years and ≥65 years of age.
Croatian: Učinak lijeka Lonsurf na ukupno preživljenje bio je sličan u bolesnika koji su <65 godina i ≥65 godina.
English: Many of the side effects are shown in laboratory tests - for example those affecting your blood cells.
Croatian: Mnoge od nuspojava su vidljive na laboratorijskim pretragama - primjerice one koje utječu na Vaše krvne stanice.
English: Protein total decreased
Croatian: Sniženi ukupni proteini
English: • problem with sleeping or falling asleep
Croatian: • poteškoće sa spavanjem ili usnivanjem
English: The dosage must not exceed 80 mg/dose.
Croatian: Doza ne smije biti veća od 80 mg po dozi.
English: It is unknown whether Lonsurf may reduce the effectiveness of hormonal contraceptives.
Croatian: Nije poznato može li Lonsurf smanjiti učinkovitost hormonskih kontraceptiva.
English: The 2 treatment groups were comparable with respect to demographic and baseline disease characteristics.
Croatian: Obje skupine bolesnika su bile usporedive s obzirom na demografske i početne karakteristike bolesti.
English: • Do not increase dose after it has been reduced.
Croatian: • Nemojte povećavati dozu lijeka nakon što je smanjena.
English: Lonsurf should not be used during pregnancy unless the clinical condition of the woman requires treatment with Lonsurf.
Croatian: Lonsurf se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene zahtijeva liječenje s Lonsurfom.
English: • sweating more than normal, sensitivity to light, nail problems
Croatian: • znojenje više nego što je normalno, osjetljivost na svjetlo, poteškoće s noktima
English: • increased bilirubin in your blood - can cause yellowing of skin or eyes
Croatian: • povećana vrijednost bilirubina u krvi - može izazvati žutilo kože ili očiju
English: Aluminium/Aluminium blister with laminated desiccant (Calcium oxide) containing 10 tablets.
Croatian: Aluminij/aluminij blister sa laminiranim sredstvom za sušenje (kalcijev oksid) koji sadrži 10 tableta.
English: The influence of gastrectomy on PK parameters was not able to be examined in the population PK analysis because there were few patients who had undergone gastrectomy (1% of overall).
Croatian: Utjecaj gastrektomije na PK parametre se nije mogla ispitati u analizi populacijske PK jer je samo nekoliko bolesnika prošlo gastrektomiju (1% od ukupnog broja).
English: If doses were missed or held, the patient must not make up for missed doses.
Croatian: Ako se propusti ili odgodi uzimanje doze lijeka, bolesnik ne smije nadoknaditi propuštene doze.
English: Medical management of an overdose should include customary therapeutic and supportive medical intervention aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Croatian: Liječenje predoziranja treba uključivati uobičajene terapijske i suportivne medicinske mjere s ciljem korekcije nastalih kliničkih manifestacija i sprečavanja njihovih mogućih komplikacija.
English: • Vomiting (very common) and diarrhoea (very common), which may lead to a dehydration if severe or persistent.
Croatian: • Povraćanje (vrlo često) i proljev (vrlo često), koje mogu dovesti do dehidracije ako su ozbiljne i potraju.
English: What Lonsurf is and what it is used for 2.
Croatian: Što je Lonsurf i za što se koristi 2.
English: Therefore, women using hormonal contraceptive must also use a barrier contraceptive method.
Croatian: Zbog toga žene koje uzimaju hormonske kontraceptive moraju također koristiti mehaničku metodu kontracepcije.
English: • one-year marketing protection
Croatian: • Jednogodišnja zaštita stavljanja lijeka u promet
English: Other minor metabolites, 5-carboxyuracil and 5-carboxy-2'-deoxyuridine, were detected, but those levels in plasma and urine were at low or trace levels.
Croatian: Ostali manji metaboliti, 5-karboksiuracil i 5-karboksi-2'-deoksiuridin, su otkriveni, ali njihove razine u plazmi i urinu su niske ili u tragovima.
English: • CTCAE* Grade 4 neutropenia (< 0.5 x 109/L) or thrombocytopenia (< 25 × 109/L) that results in more than 1 week's delay in start of next cycle
Croatian: • CTCAE* 4. stupanj neutropenije (< 0,5 x 109/L) ili thrombocitopenije (< 25 × 109/L) koji rezultira odgađanjem početka idućeg ciklusa za više od tjedan dana
English: What Lonsurf is and what it is used for
Croatian: Što je Lonsurf i za što se koristi
English: Each pack contains 20 film-coated tablets (2 blisters of 10 tablets each) or 40 film-coated tablets (4 blisters of 10 tablets each), or 60 film-coated tablets (6 blisters of 10 tablets each).
Croatian: Jedno pakiranje sadrži 20 filmom obloženih tableta (2 blistera po 10 tableta) ili 40 filmom obloženih tableta (4 blistera po 10 tableta), ili 60 filmom obloženih tableta (6 blistera po 10 tableta).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 April 2016
Croatian: Datum prvog odobrenja: 25. travnja 2016.
English: Women of childbearing potential / Contraception in males and females
Croatian: Žene reproduktivne dobi/ Kontracepcija u muškaraca i žena
English: • changes in your heart trace (ECG - electrocardiogram)
Croatian: • promjene u EKG-u (elektrokardiogram)
English: • low levels of albumin or total protein in the blood
Croatian: • niska vrijednost albumina ili ukupnih proteina u krvi
English: The highest dose of Lonsurf administered in clinical trials was 180 mg/m2 per day.
Croatian: Najviša doza Lonsurfa koja se primjenjivala u kliničkim ispitivanjima bila je 180 mg/m2 na dan.
English: The primary site of disease was colon (62%) or rectum (38%).
Croatian: Primarno sijelo tumora je bio kolon (62%) ili rectum (38%).
English: Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); and uncommon (≥1/1,000 to < 1/100).
Croatian: Skupine prema učestalosti definirane su na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); i manje često (≥1/1000 i < 1/100).
English: The majority of recovered radioactivity was eliminated into urine (55% of the dose) within 24 hours, and the excretion into faeces and expired air was less than 3% for both.
Croatian: Većina radioaktivnosti je bila eliminirana urinom (55% doze) unutar 24 sata, a izlučivanje fecesom i izdahnutim zrakom je bilo manje od 3% za oba načina.
English: If you forget to take Lonsurf
Croatian: Ako ste zaboravili uzeti Lonsurf
English: As for the other exposure parameters of trifluridine and tipiracil hydrochloride, those appeared to be dose proportional.
Croatian: Kao i kod drugih parametara izloženosti trifluridinu i tipiracilkloridu i ovi su čini se proporcionalni dozi.
English: The primary anticipated complication of an overdose is bone marrow suppression.
Croatian: Glavna očekivana komplikacija predoziranja je supresija koštane srži.
English: For low albumin values ranging from 2.2 to 3.5 g/dL, the corresponding clearance values range from 4.2 to 3.1 L/h.
Croatian: Za niske razine vrijednosti albumina od 2,2 do 3,5 g/dl, odgovarajuće vrijednosti klirensa iznose od 4,2 do 3,1 l/h.
English: Les Laboratoires Servier 50 rue Carnot 92284 Suresnes Cedex France
Croatian: Les Laboratoires Servier 50 rue Carnot 92284 Suresnes Cedex Francuska
English: • a reduced number of certain types of white blood cells (neutropenia) which are important for protecting the body against bacterial or fungal infections.
Croatian: • smanjenje broja određenih vrsta bijelih krvnih stanica (neutropenija) koje su važne za zaštitu tijela od bakterijskih ili gljivičnih infekcija.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: If you take more Lonsurf than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako ste uzeli više lijeka Lonsurf nego što ste trebali, obratite se liječniku ili odmah otiđite u bolnicu.
English: • feeling of spinning (vertigo)
Croatian: • osjećaj vrtoglavice (vertigo)
English: If you are pregnant or breast-feeding, or if you think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: • feeling of being cold
Croatian: • osjećaj hladnoće
English: • blood test result indicating inflammation (C-Reactive Protein increased)
Croatian: • krvne pretrage koje upućuju na upalu (povišena razina C reaktivnog proteina)
English: DATE OF REVISION OF THE TEXT MM/YYYY
Croatian: DATUM REVIZIJE TEKSTA MM/GGGG
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC59 Mechanism of action
Croatian: Farmakoterapijska skupina: antineoplastici, antimetaboliti, ATK oznaka: L01BC59
English: What you need to know before you take Lonsurf
Croatian: Što morate znati prije nego počnete uzimati Lonsurf
English: Recommended dose adjustments
Croatian: Preporučene prilagodbe doze
English: Feeling of body temperature change Xerosis
Croatian: Osjećaj promjene tjelesne temperature
English: In clinical studies Lonsurf was administered within 1 hour after completion of the morning and evening meals (see section 4.2).
Croatian: Lonsurf je primjenjivan unutar 1 sata nakon završetka jutarnjih i večernjih obroka (vidjeti dio 4.2).
English: ANNEX IV CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE ZAHTJEVU ZA JEDNOGODIŠNJU ZAŠTITU STAVLJANJA LIJEKA U PROMET