natgillin/translations-raw huggingface dataset:
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 Pravafenix. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pravafenix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further. 
Ker jetra holesterol potrebujejo za proizvajanje žolča, znižana raven holesterola v krvi povzroča, da celice jeter proizvajajo receptorje, ki črpajo holesterol iz krvi in tako njegovo raven še bolj znižujejo.
Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients. 
Zdravila Pravafenix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilni učinkovini ali katero koli drugo sestavino zdravila.
The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes. 
Najpogostejši neželeni učinki zdravila Pravafenix (opaženi pri 1 do 10 bolnikih izmed 100) so napihnjenost trebuha, bolečina v trebuhu, zaprtost, driska, suha usta, dispepsija (zgaga), kolcanje (spahovanje), napenjanje (plini), navzeja (slabost), neugodje v trebuhu, bruhanje in povečana koncentracija jetrnih encimov v krvi.
The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats. 
Družba je izvedla eno glavno študijo, v kateri so zdravilo Pravafenix primerjali z monoterapijo s pravastatinom pri 248 bolnikih z visokim tveganjem za bolezen srca, ki so imeli nenormalno raven holesterola in trigliceridnih maščob.
What benefit has Pravafenix shown during the studies? 
Kakšne koristi je zdravilo Pravafenix izkazalo med študijami?
Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone. 
Raven holesterola zaradi lipoproteinov nevisoke gostote se je v povprečju znižala za okoli 14 % pri bolnikih, ki so jemali zdravilo Pravafenix, v primerjavi s 6 % pri bolnikih, ki so jemali samo pravastatin.
Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat). 
Zdravilo Pravafenix se uporablja za zdravljenje odraslih bolnikov z visokim tveganjem za bolezen srca, pri katerih so vrednosti holesterola zaradi „lipoproteinov nizke gostote“ (holesterol LDL ali slabi holesterol) že nadzirane z monoterapijo s pravastatinom, vendar morajo kljub temu še izboljšati raven holesterola in zmanjšati raven trigliceridov (vrsta maščob).
For the full list of all side effects reported with Pravafenix, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pravafenix, glejte navodilo za uporabo.
Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen. 
Ne smejo ga uporabljati bolniki, mlajši od 18 let, ali bolniki s hudimi težavami z jetri, zmernimi do hudimi težavami z ledvicami, s fotoalergijo ali fototoksičnimi reakcijami (alergijskimi reakcijami ali poškodbami kože zaradi izpostavljenosti svetlobi) pri zdravljenju s fibrati ali ketoprofenom.
It must also not be used in patients with gall bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate. 
Prav tako ga ne smejo uporabljati bolniki z boleznijo žolčnika, s kroničnim ali akutnim pankreatitisom (vnetjem trebušne slinavke) ali bolniki z anamnezo miopatije (mišične motnje) ali rabdomiolize (razpadanjem mišičnih vlaken) po zdravljenju s statinom ali fibratom.
What is the risk associated with Pravafenix? 
Kakšna tveganja so povezana z zdravilom Pravafenix?
Other information about Pravafenix 
Druge informacije o zdravilu Pravafenix:
When the receptors are activated, the breakdown of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides. 
Aktiviranje receptorjev pospeši razgradnjo maščob, kar pomaga pri odstranjevanju holesterola in trigliceridov iz krvi.
It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol. 
Zmanjšuje raven skupnega holesterola z zaviranjem delovanja reduktaze HMG-CoA, encima v jetrih, ki sodeluje pri proizvajanju holesterola.
In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing nonHDL-cholesterol levels. 
V glavni študiji se je zdravilo Pravafenix izkazalo kot učinkovitejšega od samega pravastatina pri zniževanju ravni holesterola zaradi lipoproteinov nevisoke gostote.
The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels of triglyceride fats and low levels of HDL cholesterol. 
Menil je, da se koristi zdravila Pravafenix kažejo predvsem pri bolnikih z visoko ravnjo trigliceridnih maščob in nizko ravnjo holesterola HDL.
Why has Pravafenix been approved? 
Zakaj je bilo zdravilo Pravafenix odobreno?
How has Pravafenix been studied? 
Kako je bilo zdravilo Pravafenix raziskano?
What is Pravafenix used for? 
Za kaj se zdravilo Pravafenix uporablja?
What is Pravafenix? 
Kaj je zdravilo Pravafenix?
How does Pravafenix work? 
Kako zdravilo Pravafenix deluje?
How is Pravafenix used? 
Kako se zdravilo Pravafenix uporablja?
Ref. EMEA/263700/2008 
: EMEA/263700/2008
1 Procedure under Article 107 of Directive 2001/83/EC, as amended. 
1 Postopek v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena.
Nimesulide is available as branded and generic medicines in the following Member States: Austria, Bulgaria, the Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia. 
Nimesulid je sestavina originatorskih in generičnih zdravil v naslednjih državah članicah: Avstrija, Bolgarija, Češka, Ciper, Francija, Grčija, Madžarska, Italija, Latvija, Litva, Malta, Poljska, Portugalska, Romunija, Slovaška in Slovenija.
Until December 2007, it was also available in Belgium. 
Do decembra 2007 je bil odobren tudi v Belgiji.
The European Commission issued a decision on 16 October 2009. 
Evropska komisija je sklep izdala dne 16. oktobra 2009.
London, 16 October 2009 Doc. 
London, 16. oktobra 2009 Sklic dok.
What are the conclusions of the review? 
Kakšni so zaključki pregleda?
This should be carried out in a separate ‘Article 31' referral procedure. 
To je treba izvesti v ločenem napotitvenem postopku v skladu s členom 31.
The CHMP opinion adopted in September 2007 was transmitted to the European Commission so that it could issue a final decision. 
Mnenje CHMP iz septembra 2007 je bilo predloženo Evropski komisiji, da bi ta lahko izdala končni sklep.
Questions and answers on the outcome of the review of nimesulide-containing medicines1 
Vprašanja in odgovori v zvezi z izidom pregleda zdravil, ki vsebujejo nimesulid1
The Committee has also reviewed the results of an Italian ‘simulation study', carried out by the Italian medicines regulatory authority. 
Odbor je pregledal tudi rezultate italijanske „simulacijske študije,“ ki jo je izvedel italijanski regulativni organ za zdravila.
Products containing nimesulide have been available since 1985 and are authorised in a number of Member States2. 
Zdravila, ki vsebujejo nimesulid, se uporabljajo od leta 1985 in so odobrena v številnih državah članicah2.
3 The details on the actions taken by the EMEA and of their outcome can be found in the question-and-answer document published in September 2007. 
3 Podrobnosti o ukrepih agencije EMEA in njihovih izidih lahko najdete v dokumentu z vprašanji in odgovori, ki je bil objavljen septembra 2007.
This process involves a consultation step with the Standing Committee for Medicinal Products for Human Use, a body of representatives from Member States. 
Ta postopek vključuje posvetovanje s Stalnim odborom za zdravila za uporabo v humani medicini, ki je organ predstavnikov držav članic.
However, the CHMP further concluded that the benefits and risks of nimesulide should be assessed in a wider context. 
Vendar pa je CHMP nadalje zaključil, da je treba koristi in tveganja nimesulida proučiti v širšem kontekstu.
‘Systemic formulations' are medicines that are given as a treatment throughout the body, such as tablets, solutions and suppositories. 
„Sistemske formulacije“ so zdravila, ki se uporabljajo na celem telesu, npr. tablete, raztopine in svečke.
It is used to treat acute (short-term) pain, and the symptoms of painful osteoarthritis (swelling in the joints) and primary dysmenorrhoea (period pains). 
Uporablja se za zdravljenje akutnih (kratkotrajnih) bolečin ter simptomov bolečega osteoartritisa (otekanja sklepov) in primarne dismenoreje (boleče menstruacije).
The European Commission asked the Committee to prepare an opinion on whether the marketing authorisations for products containing nimesulide should be maintained, changed, suspended or withdrawn across the EU. 
Evropska komisija je pozvala Odbor, da oblikuje mnenje, ali naj se dovoljenja za promet z zdravili, ki vsebujejo nimesulid, v EU ohranijo, spremenijo, začasno prekličejo ali umaknejo.
At the end of the review in September 2007, the CHMP concluded that the available data did not support a suspension of all marketing authorisations in Europe. 
Ob zaključku pregleda septembra 2007 je CHMP zaključil, da razpoložljivi podatki niso potrdili začasnega preklica vseh dovoljenj za promet v Evropi.
The Commission also made it clear that the companies that market nimesulide-containing medicines should inform doctors about the medicines' risks. 
Komisija je tudi jasno navedla, da morajo družbe, ki tržijo zdravila, ki vsebujejo nimesulid, zdravnike obvestiti o tveganjih, povezanih z njim.
Because of the severity of the side effects, the European Commission recommended that further measures be taken to ensure that the risk of these side effects is lowered. 
Zaradi resnosti neželenih učinkov je Evropska komisija priporočila sprejetje nadaljnjih ukrepov, da se zagotovi zmanjšanje tveganja teh neželenih učinkov.
However, it recommended that some restrictions should be placed on the way these medicines are prescribed, including limiting the pack size to 30 doses, and that the information provided to doctors and patients be amended to limit the risk of liver injury 
Vendar pa je priporočil uvedbo nekaterih omejitev v zvezi z načinom predpisovanja teh zdravil, vključno z omejitvijo velikosti pakiranja na 30 odmerkov, ter dopolnitev informacij za zdravnike in bolnike, tako da se omeji tveganje za okvaro jeter3.
The Standing Committee could not reached an agreement, and, on 8 February 2008, the European Commission therefore asked the CHMP to further consider its opinion, taking new data on the risk of liver problems into account, in particularly new data supplied by Ireland, and looking at ways of minimising the risk associated with nimesulide. 
Stalni odbor ni uspel doseči sporazuma, zato je 8. februarja 2008 Evropska komisija odbor CHMP pozvala, naj nadaljuje s presojo, pri čemer naj upošteva nove podatke o tveganju težav z jetri, zlasti nove podatke, ki jih je predložila Irska, in obravnava načine zmanjšanja tveganj v zvezi z nimesulidom.
The simulation took the impact of patients switching to alternative painkiller medicines into account. 
Simulacija je upoštevala vpliv na bolnike, ki so prešli na drugo zdravilo proti bolečinam.
This review should look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original Article 107 procedure. 
Ta pregled mora upoštevati vsa morebitna tveganja zdravila, zlasti tveganja neželenih učinkov na želodec in črevesje, ki jih izvirni postopek v skladu s členom 107 ni urejal.
The European Commission endorsed the CHMP opinion with a further restriction to limit the use of these medicines to ‘second-line' (used when at least one other medicine has failed). 
Evropska komisija je potrdila mnenje CHMP z nadaljnjo omejitvijo, da se ta zdravila uporabljajo šele kot zdravilo druge izbire (tj. če je bilo vsaj eno drugo zdravilo neuspešno).
The CHMP noted that the only additional measures taken by Member States were changes to the prescription status or reimbursement levels for nimesulide-containing medicines. 
CHMP je ugotovil, da so edini dodatni ukrepi držav članic spremembe načina predpisovanja ali ravni povračil za zdravila, ki vsebujejo nimesulid.
This type of referral is used when it is of ‘Community interest' (for the benefit of all Member States) to have a common view on the benefit-risk balance of a medicine. 
Ta vrsta napotitvenega postopka se uporablja, kadar je skupno mnenje o razmerju med koristmi in tveganji za zdravilo „pomembno za Skupnost“ (v korist vseh držav članic).
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines still outweigh their risks, and that there is a need to restrict their use to ensure that the risk of patients developing liver problems is kept to a minimum. 
Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zaključil, da koristi teh zdravil še vedno odtehtajo z njimi povezana tveganja ter da je treba na najmanjšo možno mero omejiti njihovo uporabo, da se zagotovi zmanjšanje tveganja za bolnike, pri katerih se pojavijo težave z jetri.
The review of the liver-related safety of ‘systemic formulations' of medicines containing nimesulide has been completed. 
Pregled „sistemskih formulacij“ zdravil, ki vsebujejo nimesulid, glede varnosti za jetra je zaključen.
The review was an article 107 procedure triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, mainly because of liver problems. 
Pregled je bil izveden po postopku v skladu s členom 107, sprožil pa ga je sklep irskega regulativnega organa za zdravila maja 2007, da se začasno prekliče dovoljenje za promet s sistemskimi zdravili, ki vsebujejo nimesulid, predvsem zaradi težav z jetri.
This suggested that the measures recommended in September 2007, including the changes to the prescribing information, were appropriate to reduce the risk of liver problems associated with nimesulide. 
To pomeni, da so bili ukrepi, priporočeni septembra 2007, vključno s spremembami navodil za predpisovanje, primerni za zmanjšanje tveganje težav z jetri, povezanih z nimesulidom.
Based on the additional information reviewed, the CHMP has not changed its conclusions from September 2007, namely that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum. 
Na podlagi dodatnih pregledanih informacij CHMP ni spremenil svojih sklepov iz septembra 2007, namreč da koristi sistemskih formulacij nimesulida še vedno odtehtajo z njimi povezana tveganja, če je uporaba teh zdravil omejena tako, da so tveganja za nastanek težav z jetri pri bolnikih zmanjšana na najmanjšo možno mero.
Nimesulide was reviewed by the CHMP in 2007 because of concerns with liver injury. 
CHMP je leta 2007 pregledal nimesulid glede zadržkov zaradi okvar jeter.
In the latest review, the CHMP has looked at all the reports of side effects affecting the liver in patients taking nimesulide reported since April 2007, including those from Ireland. 
V zadnjem pregledu je CHMP proučil vsa poročila o neželenih učinkih na jetra pri bolnikih, ki prejemajo nimesulid, prejeta od aprila 2007, vključno s poročili iz Irske.
The restriction was therefore added into the prescribing information for nimesulide-containig medicines. 
Omejitev je bila tako dodana navodilom za predpisovanje zdravil, ki vsebujejo nimesulid.
This study used existing reports of the rate of side effects with all NSAIDs to simulate the possible effect that a suspension of nimesulide would have on the rates of side effects affecting the stomach and gut. 
V študiji so bila uporabljena obstoječa poročila o stopnji neželenih učinkov pri vseh nesteroidnih protivnetnih zdravilih za okrepitev morebitnega učinka, ki bi ga imel začasen umik nimesulida na stopnjo neželenih učinkov na želodec in črevesje.
The European Commission noted that, in some Members States, nimesulide was restricted to second-line treatment. 
Evropska komisija je opozorila, da se v nekaterih državah članicah nimesulid uporablja šele kot zdravilo druge izbire.
The Committed has also looked at whether Member States took additional measures to those proposed by the CHMP in September 2007, in order to minimise the risk of liver problems in patients using nimesulide-containing medicines. 
Odbor je pregledal tudi, ali so države članice sprejele dodatne ukrepe k ukrepom, ki jih je CHMP predlagal septembra 2007, da se zmanjša tveganje težav z jetri pri bolnikih, ki prejemajo zdravila, ki vsebujejo nimesulid.
Invented name Strength Pharmaceutical Form Route of administration 
Izmišljeno ime Jakost
Further information on EndolucinBeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu EndolucinBeta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These tumours affect hormonesecreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs. 
Ti tumorji prizadenejo celice, ki izločajo hormone, v številnih delih telesa, vključno s trebušno slinavko, črevesjem, želodcem in pljuči.
EndolucinBeta received a marketing authorisation valid throughout the EU on 6 July 2016. 
Za zdravilo EndolucinBeta je bilo 6. julija 2016 izdano dovoljenje za promet, veljavno po vsej EU.
The most common side effects with EndolucinBeta (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss. 
Najpogostejši neželeni učinki zdravila EndolucinBeta (ki se lahko pojavijo pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), trombocitopenija (nizko število trombocitov), levkopenija (nizko število belih krvnih celic), limfopenija (nizko število limfocitov, posebne vrste belih krvnih celic), navzeja (slabost), bruhanje in blago, začasno izpadanje las.
However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low. 
Kljub temu je količina zdravila EndolucinBeta, ki jo je treba uporabiti, zelo majhna, zato je tudi to tveganje majhno.
EndolucinBeta (lutetium (177Lu) chloride) EMA/554249/2018 
EndolucinBeta (lutecijev [177Lu] klorid) EMA/554249/2018
What measures are being taken to ensure the safe and effective use of EndolucinBeta? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila EndolucinBeta?
EndolucinBeta is never given to a patient on its own. 
Zdravilo EndolucinBeta se bolniku nikoli ne daje samostojno.
The doctor will ensure that the expected benefit to the patients of using EndolucinBeta outweigh the risks linked to the radioactivity. 
Zdravnik bo poskrbel, da bodo pričakovane koristi uporabe zdravila EndolucinBeta za bolnike večje od tveganj, povezanih z radioaktivnostjo.
When a medicine radiolabelled with EndolucinBeta is given to a patient, it carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis). 
Ko se zdravilo, radioaktivno označeno z zdravilom EndolucinBeta, da bolniku, to prenese sevanje v tiste dele telesa, kjer je potrebno, da uniči rakave celice (kadar se uporablja za zdravljenje) ali da se pridobijo slike na zaslonu (kadar se uporablja za diagnostične namene).
The Agency concluded that the benefits of EndolucinBeta outweigh the risks and it can be authorised for use in the EU. 
Agencija je zaključila, da so koristi zdravila EndolucinBeta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of EndolucinBeta 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 EndolucinBeta upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Radiolabelling with EndolucinBeta takes place in a laboratory. 
Radiooznačevanje z zdravilom EndolucinBeta poteka v laboratoriju.
Side effects reported with EndolucinBeta are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu EndolucinBeta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well documented in the scientific literature. 
Evropska agencija za zdravila je menila, da je uporaba lutecija (177Lu) za radiooznačevanje zdravil dobro dokumentirana v znanstveni literaturi.
The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information. 
Nato bolnik prejme radioaktivno označeno zdravilo v skladu z navodili iz informacij o označenem zdravilu.
Other information about EndolucinBeta 
Druge informacije o zdravilu EndolucinBeta
An overview of EndolucinBeta and why it is authorised in the EU 
Pregled zdravila EndolucinBeta in zakaj je odobreno v EU
As for all medicines, data on the use of EndolucinBeta are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila EndolucinBeta stalno spremljajo.
Medicines radiolabelled with EndolucinBeta must not be used in women unless pregnancy has been ruled out. 
Zdravila, radiooznačena z zdravilom EndolucinBeta, se ne smejo uporabljati pri nosečnicah ali ženskah, ki bi lahko bile noseče.
Why is EndolucinBeta authorised in the EU? 
Zakaj je bilo zdravilo EndolucinBeta odobreno v EU?
What is EndolucinBeta and what is it used for? 
Kaj je zdravilo EndolucinBeta in za kaj se uporablja?
What benefits of EndolucinBeta have been shown in studies? 
Kakšne koristi zdravila EndolucinBeta so se pokazale v študijah?
EndolucinBeta is only used by specialists who have experience in radiolabelling. 
Zdravilo EndolucinBeta smejo uporabljati samo zdravniki specialisti, ki imajo izkušnje na področju radiooznačevanja.
Information on how to minimise the risks is included in the product information for EndolucinBeta. 
Navodila, kako zmanjšati tveganja, so vključena v informacije o zdravilu EndolucinBeta.