natgillin/translations-raw huggingface dataset:
It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet. 
Uporablja se kot dodatek drugim zdravilom, na primer vitaminu B6 (piridoksin), vitaminu B12 (kobalamin), folatu in posebni dieti.
Cystadane is supplied with 3 measuring spoons to measure 100 mg, 150 mg and 1 g of the powder. 
Zdravilo Cystadane se dobavlja s tremi merilnimi žličkami za odmerjanje 100 mg, 150 mg in 1 g praška.
The company presented information on Cystadane from the scientific literature. 
Družba je predložila informacije o zdravilu Cystadane iz znanstvene literature.
Other information about Cystadane 
Druge informacije o zdravilu Cystadane
The medicine was effective in patients with all three types of homocystinuria. 
Zdravilo je bilo učinkovito pri bolnikih z vsemi tremi vrstami homocistinurije.
The standard dose of Cystadane is 100 mg per kilogram of body weight a day, divided into two equal doses. 
Običajni odmerek zdravila Cystadane je 100 mg na kilogram telesne mase vsak dan, razdeljen v dva ločena odmerka.
The dose can be adjusted depending on the response to treatment (monitored by measuring the level of homocysteine in the blood). 
Odmerek je mogoče prilagoditi glede na odziv bolnika na zdravljenje (kar se nadzoruje z merjenjem ravni homocisteina v krvi).
The company that makes Cystadane will set up a register of patients taking the medicine to monitor its safety. 
Družba, ki izdeluje zdravilo Cystadane, bo vzpostavila register bolnikov, ki jemljejo zdravilo, da bi tako nadzorovala njegovo varnost.
The Committee noted that Cystadane is not a substitute for other treatments. 
Ugotovil je, da zdravilo Cystadane ne more nadomestiti drugih načinov zdravljenja.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cystadane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Patients with symptoms of cerebral oedema, such as morning headaches with vomiting, or changes in vision, should speak to their doctor, as treatment with Cystadane may have to be interrupted. 
Bolniki s simptomi možganskega edema, kot so jutranji glavobol z bruhanjem, ali spremembami vida, naj se posvetujejo z zdravnikom, saj bo mogoče treba zdravljenje z zdravilom Cystadane prekiniti.
The most common side effect when taking Cystadane (seen in more than 1 patient in 10) is elevated levels of methionine in the blood. 
Najpogostejši neželeni učinek zdravila Cystadane (opažen pri več kot 1 bolniku od 10) so povišane ravni metionina v krvi.
Because the number of patients with homocystinuria is low, the disease is considered ‘rare', and Cystadane was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001. 
Ker je bolnikov s homocistinurijo malo, velja ta bolezen za redko, zato je bilo zdravilo Cystadane 9. julija 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
This included 202 reports that described the effects of Cystadane, given at a variety of doses, on homocysteine levels in homocystinuria patients of various ages. 
Te so obsegale 202 poročili, ki opisujejo učinke zdravila Cystadane, uporabljenega v različnih odmerkih, na raven homocisteina pri bolnikih različnih starosti, ki imajo homocistinurijo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cystadane have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cystadane upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Treatment with Cystadane should be supervised by a doctor who has experience in the treatment of patients with homocystinuria. 
Zdravljenje z zdravilom Cystadane mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s homocistinurijo.
What are the risks associated with Cystadane? 
Kakšna tveganja so povezana z zdravilom Cystadane?
What is Cystadane and what is it used for? 
Kaj je zdravilo Cystadane in za kaj se uporablja?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je navkljub maloštevilnim sistematičnim študijam zdravila Cystadane sklenil, da je zdravilo koristno kot dodatek k obstoječim načinom zdravljenja homocistinurije, kot so dodajanje vitaminov in posebna dieta.
Patients taking Cystadane appeared to have greater reductions in homocysteine levels than untreated patients. 
Pri bolnikih, ki so prejemali zdravilo Cystadane, je očitno prišlo do večjega znižanja ravni homocisteina kot pri nezdravljenih bolnikih.
In homocystinuria, betaine reduces homocysteine levels in the blood by transforming homocysteine into the amino acid methionine. 
Pri homocistinuriji betain znižuje raven homocisteina v krvi tako, da homocistein ponovno pretvarja v aminokislino metionin.
It is not intended to provide practical advice on how to use Cystadane. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Cystadane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Cystadane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Cystadane is a medicine used to treat homocystinuria, an inherited disease where the amino acid homocysteine cannot be broken down and therefore builds up in the body. 
Zdravilo Cystadane je namenjeno za zdravljenje homocistinurije, tj. dedne bolezni, pri kateri se aminokislina homocistein, ne more razgraditi in se zato kopiči v telesu.
What benefits of Cystadane have been shown in studies? 
Kakšne koristi je zdravilo Cystadane izkazalo v študijah?
The full EPAR for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cystadane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Why is Cystadane approved? 
Zakaj je bilo zdravilo Cystadane odobreno?
It recommended that Cystadane be given marketing authorisation. 
Priporočil je, da se zanj izda dovoljenje za promet.
Methionine levels should be monitored in patients taking Cystadane, as it might lead to cerebral oedema (swelling in the brain). 
Pri bolnikih, ki jemljejo zdravilo Cystadane, je treba nadzorovati raven metionina, saj lahko povzroči možganski edem (otekanje v možganih).
For practical information about using Cystadane, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Cystadane naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Cystadane betaine anhydrous 
Cystadane brezvodni betain
Cystadane is available as a powder to be taken by mouth. 
Zdravilo Cystadane je na voljo v obliki praška, ki se jemljejo peroralno.
Cystadane contains the active substance betaine anhydrous. 
Zdravilo Cystadane vsebuje zdravilno učinkovino brezvodni betain.
How is Cystadane used? 
Kako se zdravilo Cystadane uporablja?
How does Cystadane work? 
Kako zdravilo Cystadane deluje?
The Committee decided that Cystadane's benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication. 
Zato je sklenil, da so koristi zdravila Cystadane, če se uporablja v skladu z indikacijo, večje od z njim povezanih tveganj pri dopolnilnem zdravljenju homocistinurije.
This dose is expected to be used in only a limited number of the treatments (less than 1%). 
Ta odmerek naj bi se po pričakovanjih uporabil le pri zelo majhnem številu zdravljenj (manj kot 1 %).
The European Commission granted a marketing authorisation valid throughout the European Union for Bridion on 25 July 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Bridion, veljavno po vsej Evropski uniji, izdala 25. julija 2008.
This might be necessary if patients need to be able to start to breathe on their own again during the operation. 
To utegne biti potrebno pri bolnikih, ki morajo že med operacijo začeti znova dihati samostojno.
What measures are being taken to ensure the safe and effective use of Bridion? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bridion?
The full EPAR for Bridion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bridion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Bridion 
Druge informacije o zdravilu Bridion
This is a summary of the European public assessment report (EPAR) for Bridion. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bridion.
There were too few children aged below two years to determine the safety and effectiveness of Bridion in this age group. 
Otrok, mlajših od dveh let, je bilo premalo za določitev varnosti in učinkovitosti zdravila Bridion v tej starostni skupini.
For more information about treatment with Bridion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Bridion preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Bridion's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Bridion večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
A risk management plan has been developed to ensure that Bridion is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Bridion je bil pripravljen načrt obvladovanja tveganj.
What benefit has Bridion shown during the studies? 
Kakšne koristi je zdravilo Bridion izkazalo med študijami?
What is the risk associated with Bridion? 
Kakšna tveganja so povezana z zdravilom Bridion?
In all of the studies, the main measure of effectiveness was how long it took for the muscles to recover. 
Glavno merilo učinkovitosti v vseh študijah je bil čas, ki je bil potreben, da so si mišice opomogle.
Bridion is a solution for injection that contains the active substance sugammadex (100 mg/ml). 
Bridion je raztopina za injiciranje, ki vsebuje zdravilno učinkovino sugamadeks (100 mg/ml).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bridion. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Bridion can only be given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). 
Zdravilo Bridion se lahko daje le pod nadzorom anestezista (zdravnika, ki je specializiran za anestezijo).
In contrast, muscle relaxation recovered spontaneously after 7.1 minutes. 
V nasprotju s tem so si bolniki spontano opomogli po 7,1 minute.
This means that it attaches to the muscle relaxants rocuronium and vecuronium forming a ‘complex' that inactivates the muscle relaxants and stops them having an effect. 
To pomeni, da se veže na mišična relaksanta rokuronij in vekuronij ter tako tvori „kompleks“, ki inaktivira mišične relaksante in jim prepreči, da bi učinkovali še naprej.
The most common side effects with Bridion (seen in between 1 and 10 patients in 100) are cough, airway problems due to the anaesthesia wearing off, reduced blood pressure and other complications such as changes in heart rate. 
Najpogostejši neželeni učinki zdravila Bridion (opaženi pri 1 do 10 bolnikov od 100) so kašelj, težave z dihali zaradi pojenjanja učinkov anestezije), nižji krvni tlak ali drugi zapleti, kot so spremembe srčnega utripa.
In children and adolescents from two to 17 years of age, the recommended dose is 2 mg/kg body weight. 
Priporočeni odmerek pri otrocih in mladostnikih, starih od 2 do 17 let, je 2 mg/kg telesne mase.
It is given as a single intravenous ‘bolus' injection (given into a vein all at once). 
Zdravilo se daje v obliki ene same intravenske „bolusne“ injekcije (injekcije, ki se cela naenkrat vbrizga v veno).
Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants. 
Zdravilo Bridion so raziskovali v štirih glavnih študijah pri skupno 579 odraslih, pri katerih je bil opravljen kirurški poseg, pri katerem so bili uporabljeni mišični relaksanti.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bridion, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu z njim so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. 
Mišični relaksanti so zdravila, ki se uporabljajo pri nekaterih vrstah operacij za sprostitev mišic, vključno s tistimi, ki bolniku omogočajo dihanje.
Bridion can be used in adults who have received rocuronium and vecuronium, and in children and adolescents who have received rocuronium. 
Zdravilo Bridion se lahko uporablja pri odraslih, ki so prejeli rokuronij ali vekuronij, in pri otrocih ter mladostnikih, ki so prejeli rokuronij.
Bridion must not be used in people who are hypersensitive (allergic) to sugammadex or any of the other ingredients. 
Zdravila ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sugamadeks ali katero koli drugo sestavino zdravila.
For the full list of all side effects reported with Bridion, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bridion, glejte navodilo za uporabo.
This was compared with spontaneous recovery after muscle relaxation using succinylcholine (another muscle relaxant). 
To so primerjali s spontanim okrevanjem po relaksaciji mišic, sproženi s sukcinilholinom (drugo vrsto mišičnega relaksanta).
Why has Bridion been approved? 
Zakaj je bilo zdravilo Bridion odobreno?
When used for rapid recovery, patients receiving 16 mg/kg Bridion recovered after 4.2 minutes. 
Kadar se zdravilo uporablja za hitro okrevanje, so si bolniki, ki so prejeli 16 mg/kg zdravila Bridion, opomogli po 4,2 minute.
As a result, the effect of blockade of the muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work normally again, including the muscles that help the patient to breathe. 
Posledično učinek blokade mišic zaradi učinkovanja rokuronija in vekuronija na mišice popusti, tako da začnejo te zopet delovati normalno, kar vključuje tudi tiste, ki bolniku omogočajo dihanje.
The active substance in Bridion, sugammadex, is a ‘selective relaxant binding agent'. 
Zdravilna učinkovina zdravila Bridion, sugamadeks, je „selektiven vezalec mišičnih relaksantov“.
After moderate muscle relaxation, the average time for recovery was between 1.4 and 2.1 minutes for 2 mg/kg Bridion, compared with 17.6 to 18.9 minutes for neostigmine. 
Po zmerni sprostitvi mišic je povprečen čas, potreben za okrevanje, znašal od 1,4 do 2,1 minute pri odmerku 2 mg/kg zdravila Bridion v primerjavi z od 17,6 do 18,9 minute pri uporabi neostigmina.
Bridion is not recommended for use in children and adolescents for recovery after vecuronium, or for rapid recovery after any muscle relaxant. 
Uporaba zdravila Bridion pri otrocih in mladostnikih ni priporočena za okrevanje po uporabi vekuronija ali za hitro okrevanje po uporabi katerega koli mišičnega relaksanta.
The standard dose of Bridion is between 2 and 4 mg per kilogram body weight, depending on how much the muscle relaxant is affecting the muscles. 
Običajni odmerek zdravila Bridion znaša od 2 do 4 mg na kilogram telesne mase, odvisno od jakosti učinka relaksanta na mišice.
Muscle relaxants make it easier for the surgeon to do the operation. 
Kirurg s pomočjo mišičnih relaksantov lažje izvede kirurški poseg.
Bridion is used to speed up the recovery from the muscle relaxant, usually at the end of the operation. 
Zdravilo Bridion se uporablja za pospeševanje okrevanja po uporabi mišičnih relaksantov, po navadi ob koncu kirurškega posega.
Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium. 
Zdravilo Bridion se uporablja za odpravljanje učinkov mišičnih relaksantov rokuronija in vekuronija.
The effect of Bridion seen in adults was similar in adolescents and children aged over two years. 
Pri mladostnikih in otrocih, starejših od dveh let, je bil učinek zdravila Bridion podoben tistemu, opaženemu pri odraslih.
The fourth study, involving 115 patients, looked at the effectiveness of 16 mg/kg Bridion in producing rapid reversal of the muscle relaxation using rocuronium. 
V četrti študiji, v katero je bilo vključenih 115 bolnikov, so opazovali učinkovitost odmerka 16 mg/kg zdravila Bridion pri hitrem odpravljanju mišične sprostitve, sprožene z uporabo rokuronija.
After deep muscle relaxation, recovery took an average of around 3.0 minutes with 4 mg/kg Bridion, compared with around 49.5 minutes for neostigmine. 
Po globoki sprostitvi mišic so bile za okrevanje potrebne približno 3,0 minute z odmerkom 4 mg/kg zdravila Bridion v primerjavi z 49,5 minute pri uporabi neostigmina.
Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/kg Bridion in reversing moderate relaxation of the muscles due to rocuronium or vecuronium. 
V dveh študijah, ki sta vključevali skupaj 282 bolnikov, so proučevali učinkovitost odmerka v višini 2 mg/kg zdravila Bridion pri odpravljanju zmerne sprostitve mišic zaradi uporabe rokuronija ali vekuronija.
Bridion was compared with neostigmine (another medicine used to stop the effect of muscle relaxants) given after rocuronium or vecuronium in the first study and after cis-atracurium (another muscle relaxant) in the second. 
Zdravilo Bridion so primerjali z neostigminom (drugim zdravilom za odpravljanje učinkov mišičnih relaksantov), ki so ga v prvi študiji bolnikom dali za rokuronijem in vekuronijem, v drugi študiji pa za cisatrakurijem (drugo vrsto mišičnega relaksanta).
What is Bridion used for? 
Za kaj se zdravilo Bridion uporablja?
How does Bridion work? 
Kako zdravilo Bridion deluje?
How has Bridion been studied? 
Kako je bilo zdravilo Bridion raziskano?
What is Bridion? 
Kaj je zdravilo Bridion?
Bridion was more effective than neostigmine in reducing the time it took for the muscles to recover, after both moderate and deep muscle relaxation using rocuronium or vecuronium. 
Zdravilo Bridion je bilo pri skrajšanju časa, ki je potreben, da si mišice opomorejo po zmerni in globoki relaksaciji mišic, ki so jo dosegli z rokuronijem ali vekuronijem, učinkovitejše od neostigmina.
How is Bridion used? 
Kako se zdravilo Bridion uporablja?
The third study compared the effectiveness of 4 mg/kg Bridion with that of neostigmine after deep relaxation of the muscles using rocuronium or vecuronium in 182 patients. 
V tretji študiji so pri 182 bolnikih učinkovitost odmerka 4 mg/kg zdravila Bridion primerjali z učinkovitostjo neostigmina po globoki relaksaciji mišic, doseženi z uporabo rokuronija ali vekuronija.
An additional study looked at the effectiveness of Bridion given after rocuronium in 90 children and adolescents. 
V dodatni študiji so pri 90 otrocih in mladostnikih primerjali učinkovitost zdravila Bridion, ki so ga dali za rokuronijem.
A dose of 16 mg/kg can be used if rapid recovery from muscle relaxation is needed. 
Če je treba mišice hitro vrniti iz sproščenega v prvotno stanje, se lahko uporabi odmerek 16 mg/kg.
Further information on Segluromet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Več informacij o zdravilu Segluromet je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The dose is one tablet twice a day with food. 
Odmerek je ena tableta, ki se jemlje dvakrat na dan s hrano.
Segluromet is available as tablets in 4 strengths of ertugliflozin and metformin (2.5 mg/850 mg, 2.5 mg/1,000 mg, 7.5 mg/850 mg and 7.5 mg/1,000 mg). 
Zdravilo Segluromet je na voljo v obliki tablet s štirimi jakostmi ertugliflozina in metformina (2,5 mg/850 mg, 2,5 mg/1 000 mg, 7,5 mg/850 mg in 7,5 mg/1 000 mg).
The European Medicines Agency concluded that Segluromet's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Segluromet večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Segluromet? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Segluromet?
Segluromet (ertugliflozin / metformin hydrochloride) 
Segluromet (ertugliflozin/metformin hidroklorid)
Other information about Segluromet 
Druge informacije o zdravilu Segluromet
It must also not be used in patients with severe kidney problems or certain heart, circulatory, breathing or liver problems and in patients who drink alcohol to excess. 
Prav tako se ne sme uporabljati pri bolnikih s hudimi okvarami ledvic ali nekaterimi težavami s srcem, obtočili, dihanjem ali jetri ter pri bolnikih, ki čezmerno pijejo alkohol.
Treatment will not be started if the kidney function is poor. 
Zdravljenje se ne uvede, če je delovanje ledvic slabo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Segluromet have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Segluromet upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The most common side effects with Segluromet (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system and problems with the gut such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. 
Najpogostejši neželeni učinki zdravila Segluromet (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glivične okužbe nožnice in druge okužbe ženskih spolovil ter težave s prebavili, kot so slabost, bruhanje, driska, bolečine v trebuhu in izguba teka.
The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after 6 months or one year of treatment. 
V študijah so proučevali predvsem učinke na vrednost HbA1c (merilo za glukozo v krvi) po šestih mesecih ali enem letu zdravljenja.
What benefits of Segluromet have been shown in studies? 
Kakšne koristi zdravila Segluromet so se pokazale v študijah?
As for all medicines, data on the use of Segluromet is continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Segluromet stalno spremljajo.
Why is Segluromet authorised in the EU? 
Zakaj je bilo zdravilo Segluromet odobreno v EU?
An overview of Segluromet and why it is authorised in the EU 
Pregled zdravila Segluromet in zakaj je odobreno v EU