natgillin/translations-raw huggingface dataset:
• The PRAC took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases. 
• odbor PRAC je upošteval, da linearni sredstvi za intravensko uporabo Multihance (gadobenska kislina) in Primovist (gadoksetna kislina) prehajata v hepatocite, zato sta klinično koristni za slikanje slabo vaskulariziranih jetrnih lezij, zlasti pri slikanju v zapozneli fazi, ki jih s sredstvi, ki ne prehajajo v hepatocite, ni mogoče ustrezno proučiti, ter tako omogočata zgodnje diagnosticiranje morebitnih življenjsko nevarnih bolezni.
• Although no adverse neurological effects, such as cognitive or movement disorders, have been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited. 
• čeprav niso bili dokazani neželeni nevrološki učinki, kot so kognitivne motnje ali motnje gibanja, ki naj bi jih povzročilo kopičenje gadolinija v možganih, so podatki o dolgoročni varnosti omejeni.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intraarticular gadopentetic acid. 
Odbor CHMO zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo gadobutrol, gadotersko kislino, gadoteridol, gadoksetno kislino za intravensko uporabo, gadobensko kislino za intravensko uporabo za indikacijo slikanja jeter ter gadotersko kislino za intraartikularno uporabo in gadopentetsko kislino za intraartikularno uporabo.
The PRAC also concluded that there are practical difficulties for an effective restriction of the number of doses administered during the lifetime of a patient. 
Odbor PRAC je tudi zaključil, da obstajajo praktične težave za učinkovito omejitev števila odmerkov, ki jih bolnik prejme v svojem življenju;
Taking into account the extensive exposure and the absence of clinical or non-clinical adverse outcomes of gadolinium accumulation in the brain, CHMP considered that such harmful effects and potential interaction with disease processes are “possible” rather than “plausible”, as the latter would imply a stronger potential for harm; in this sense, “yet” was also removed. 
Škodljivi učinki in morebitna interakcija z bolezenskimi procesi so verjetni glede na podatke, ki dokazujejo dekelacijo linearnih sredstev in vivo, in ugotovljeno toksičnost nekelatiranega gadolinija na podlagi nekliničnih podatkov.“ Odbor CHMP je ob upoštevanju velike izpostavljenosti in neobstoja kliničnih ali nekliničnih neželenih izidov kopičenja gadolinija v možganih menil, da so taki škodljivi učinki in morebitna interakcija z bolezenskimi procesi „mogoči“ in ne „verjetni“, saj bi to pomenilo večjo možnost za škodljive učinke; zato je bil tudi „še“ izbrisan;
PRAC maintained its view that conducting clinical studies to fully address the potential risk associated with Gd accumulation in the brain would not be feasible within a reasonable period of time. 
Odbor PRAC je vztrajal pri stališču, da v razumnem času ne bi bilo mogoče izvesti kliničnih študij za popolno obravnavanje morebitnega tveganja, povezanega s kopičenjem gadolinija v možganih.
The benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid is favourable subject to agreed changes to the product information: 
je razmerje med koristmi in tveganji zdravil, ki vsebujejo gadobutrol, gadotersko kislino, gadoteridol, gadoksetno kislino, gadobensko kislino za intravensko uporabo za indikacijo slikanja jeter ter gadotersko kislino za intraartikularno uporabo in gadopentetsko kislino za intraartikularno uporabo, ugodno, vendar je treba v informacijah o izdelku upoštevati dogovorjene spremembe:
Toxicity of accumulation of Gd in the brain 
Toksičnost kopičenja gadolinija v možganih
The CHMP, as a consequence, considers that the benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid remains favourable subject to amendments to the product information. 
Odbor CHMP zato meni, da je razmerje med koristmi in tveganji zdravil, ki vsebujejo gadobutrol, gadotersko kislino, gadoteridol, gadoksetno kislino za intravensko uporabo, gadobensko kislino za intravensko uporabo za indikacijo slikanja jeter ter gadotersko kislino za intraartikularno uporabo in gadopentetsko kislino za intraartikularno uporabo, ugodno, vendar je treba informacije o izdelku spremeniti.
• Although no adverse neurological effects, such as cognitive or movement disorders, have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited. 
• čeprav še ni bilo dokazano, da neželene nevrološke učinke, kot so kognitivne motnje ali motnje gibanja, povzroči kopičenje gadolinija v možganih, so podatki o dolgoročni varnosti omejeni.
Duration of gadolinium retention in the brain 
Kako dolgo gadolinij ostane v možganih
Harmful effects and potential interaction with disease processes are plausible in view of stability data suggesting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium. 
Škodljivi učinki in morebitna interakcija z bolezenskimi procesi so verjetni, glede na to da podatki o stabilnosti kažejo dekelacijo linearnih sredstev in vivo in ugotovljeno toksičnost nekelatiranega gadolinija.
• High Gd levels with high inter-individual variability were detected in saline-treated controls. 
• med kontrolami z raztopino natrijevega klorida so bile ugotovljene visoke ravni gadolinija z veliko spremenljivostjo med posamezniki.
Harmful effects and potential interaction with disease processes are possible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium based on non-clinical data. 
Škodljivi učinki in morebitna interakcija z bolezenskimi procesi so mogoči glede na podatke, ki dokazujejo dekelacijo linearnih sredstev in vivo, in toksičnost nekelatiranega gadolinija, ugotovljeno na podlagi nekliničnih podatkov;
Therefore, the PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh the risks related to these products in the context of liver imaging. 
Zato je menil, da pri slikanju jeter koristi gadobenske kisline in gadoksetne kisline prevladajo nad tveganji, povezanimi s tema izdelkoma;
The PRAC also noted that high GdCAs doses were tested (20x2.5 mmol) by McDonald et al., and the study duration is comparably short (e.g. the total doses tested in Frenzel et al 2017 was half that of McDonald et al (10x2.5mmol), while the time period to the last tissue sampling in Frenzel et al 2017 was 24 days instead of 7 days in McDonald 2017.) 
preskusili visoke odmerke sredstev GdCA (20 x 2,5 mmol) in da je študija trajala sorazmerno kratek čas (npr. skupno število odmerkov, ki so jih preskusili Frenzel idr.
Gadolinium-associated plaques with sclerotic bodies on histology have been reported with some gadolinium-containing contrast agents in patients who do not otherwise have symptoms or signs of nephrogenic systemic fibrosis. 
Poročalo se je, da so bili pri bolnikih brez simptomov ali znakov nefrogene sistemske fibroze na podlagi histologije pri nekaterih kontrastnih sredstvih, ki vsebujejo gadolinij, ugotovljeni plaki s sklerotičnimi spremembami, povezani z gadolinijem.
• Only a small signal was detected in a brain region which McDonald et al. assumed to be the dentate nucleus (DN), but this assignment is not convincing when regarding the figures shown. 
predpostavili, da je dentatno jedro (DN), vendar pa ta določitev glede na navedene podatke ni prepričljiva;
Harmful effects and potential interaction with disease processes are plausible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium. 
Škodljivi učinki in morebitna interakcija z bolezenskimi procesi so glede na podatke, ki dokazujejo dekelacijo linearnih sredstev in vivo, ter ugotovljeno toksičnost nekelatiranega gadolinija verjetni.
Therefore, PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh their risks in the context of delayed phase liver imaging. 
Odbor PRAC je zato menil, da pri slikanju jeter v zapozneli fazi koristi gadobenske kisline in gadoksetne kisline prevladajo nad njunimi tveganji.
With regards to the MAH's claim that linear GdCAs do not cause more marked Gd retention and do not have a slower release from brain tissues compared to macrocyclic GdCAs, PRAC considered that the study of McDonald et al. (2017), confirming T1 hyperintensity in the rat lateral dentate nucleus 1 week after administration of macrocyclic agents (Gadovist and Prohance), has several shortcomings: 
(2017) za potrditev hiperintenzivnost T1 v lateralnem dentatnem jedru podgan en teden po vbrizganju makrocikličnih sredstev (Gadovist in Prohance), več pomanjkljivosti:
Enhancement of the DN and globus pallidus (GP) in unenhanced scans after previous use of linear GdCAs has been observed across multiple studies in humans. 
V več študijah na ljudeh se je po predhodni uporabi linearnih sredstev GdCA na slikah z izboljšanim kontrastom opazilo povečanje dentatnega jedra (DN) in globusa pallidusa (GP).
It should be noted that McDonald et al. (2017) reported very little Gd deposition. 
(2017) poročali o zelo majhni količini odloženega gadolinija.
Furthermore, as no specific patient group with less risk of accumulation in the brain or a safe threshold level for retention in the brain could be identified, the restriction of the use of linear GdCAs to certain indications or certain groups of patients was considered not appropriate. 
Poleg tega je menil, da omejitev uporabe linearnih sredstev GdCA na nekatere indikacije ali nekatere skupine ne bi bila primerna, saj ne bi bilo mogoče opredeliti specifične skupine bolnikov z manjšim tveganjem kopičenja v možganih ali varne mejne vrednosti za zadrževanje v možganih.
However, as no specific patient group with less risk of accumulation in the brain or a safe threshold level for retention in the brain could be identified, the restriction of the use of linear GdCAs to certain indications or certain groups of patients was considered not appropriate. 
Vendar je menil, da omejitev uporabe linearnih sredstev GdCA na nekatere indikacije ali nekatere skupine ne bi bila primerna, saj ne bi bilo mogoče opredeliti specifične skupine bolnikov z manjšim tveganjem za odlaganje v možganih ali varne mejne vrednosti za zadrževanje v možganih.
No such enhancement was observed with gadoterate meglumine (Dotarem). 
Pri gadoterat meglominu (Dotarem) tako povečanje ni bilo ugotovljeno.
Indeed there are two phases of liver MRI enhancement with GdCAs: 
Magnetnoresonančno slikanje jeter, pri katerem se kontrast izboljša s sredstvi GdCA, je dejansko sestavljeno iz dveh faz:
In very rare cases they may be serious or fatal. 
V zelo redkih primerih so lahko hudi ali smrtni.
This summary was last updated on 18/09/2015. 
Povzetek je bil nazadnje posodobljen 18/09/2015.
A response is normally seen within three to four days. 
Odziv je običajno opazen v treh do štirih dneh.
Treatment should be discontinued after 10 days if no improvement is seen. 
Zdravljenje je treba prekiniti po 10 dneh, če ni opaznega izboljšanja.
The European Commission granted a marketing authorisation valid throughout the European Union, for RevitaCAM on 23/02/2012. 
Evropska komisija je dovoljenje za promet z zdravilom RevitaCAM, veljavno po vsej Evropski uniji, odobrila dne 23/02/2012.
These generally occur within the first week of treatment and usually disappear once treatment has stopped. 
Večinoma se pojavijo v prvem tednu zdravljenja in po navadi izginejo po prekinitvi zdravljenja.
Other information about RevitaCAM: 
Druge informacije o zdravilu RevitaCAM:
If accidental exposure occurs, hands should be washed immediately with soap and water. 
Če pride do nenamerne izpostavitve, si je treba roke takoj umiti z milom in vodo.
Hands should always be washed after administrating the medicine. 
Po dajanju zdravila si je vedno treba umiti roke.
It can be used for chronic (long term) musculo-skeletal disorders and for acute (sudden and short-lived) disorders, for instance, due to injury. 
Lahko se uporablja pri kroničnih (dolgotrajnih) mišično-skeletnih obolenjih in akutnih (nenadnih in kratkotrajnih) boleznih, npr. zaradi poškodbe.
What benefit has RevitaCAM shown during the studies? 
Kakšne koristi je zdravilo RevitaCAM izkazalo med študijami?
It is available in pumps of different sizes (6 ml, 11 ml and 33 ml) delivering appropriate amounts of meloxicam for dogs of different weights. 
Zdravilo je na voljo v razpršilnikih različnih velikosti (6 ml, 11 ml in 33 ml), ki odmerijo ustrezno količino meloksikama za različno težke pse.
For longer term treatment, the dose can be decreased to the lowest effective dose once a response has been seen. 
Pri dolgotrajnejšem zdravljenju lahko, ko opazite odziv, odmerek prilagodite na najmanjši še učinkoviti odmerek.
RevitaCAM must not be used in dogs less than six weeks of age and should not be used in cats. 
Ne sme se uporabljati pri psih, mlajših od šestih mesecev, in pri mačkah.
People who are hypersensitive to NSAIDs should avoid contact with RevitaCAM. 
Osebe, ki so preobčutljive za nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom RevitaCAM.
It must not be used in dogs that are hypersensitive (allergic) to the active substance or to any of the other ingredients. 
Ne sme se uporabljati pri psih, ki so preobčutljivi za (alergični na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
What is the risk associated with RevitaCAM? 
Kakšna tveganja so povezana z zdravilom RevitaCAM?
RevitaCAM contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). 
Zdravilo RevitsCAM vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSPVZ).
As prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these signs and symptoms. 
Prostaglandini povzročajo vnetje, bolečino, izločanje tekočine in povišano telesno temperaturo, meloksikam pa zmanjšuje obseg teh znakov in simptomov.
It is available as a 5 mg/ml oromucosal spray (a spray administered to the back of the mouth, towards the gums and /or inner cheek) for dogs. 
Na voljo je kot oralno pršilo v odmerku 5 mg/ml (pršilo, ki se nanese na zadnji del gobca proti dlesnim in/ali notranji ličnici) za pse.
Treatment should be started at a single dose of 0.2 mg/kg body weight on the first day, and then continued at a maintenance dose of 0.1 mg/kg body weight once a day. 
Velikost razpršilnika in število razprškov, ki jih je treba nanesti, sta odvisna od telesne mase psa. Zdravljenje se začne z enim odmerkom 0,2 mg/kg telesne mase prvi dan in nato nadaljuje z vzdrževalnim odmerkom 0,1 mg/kg telesne mase enkrat na dan. Pršilo se nanese v gobec psa, pršenje pa se usmeri nazaj in proti dlesnim in/ali notranjim ličnicam.
RevitaCAM is used in dogs to relieve inflammation and pain. 
Zdravilo RevitaCAM se uporablja za ublažitev vnetja in bolečine pri psih.
Why has RevitaCAM been approved? 
Zakaj je bilo zdravilo RevitaCAM odobreno?
Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with RevitaCAM. 
Občasni neželeni učinki, opazni pri drugih nesteroidnih protivnetnih zdravilih, kot so izguba teka, bruhanje, driska, kri v blatu, ledvična odpoved in apatija (pomanjkanje vitalnosti), se včasih pojavijo tudi ob uporabi zdravila RevitaCAM.
Various studies looked at how RevitaCAM was absorbed and its effects in the body, in comparison with Metacam. 
V več študijah so proučevali, kako se zdravilo RevitaCAM v primerjavi z zdravilom Metacam absorbira v telesu in kako v njem deluje.
Consequently, RevitaCAM's benefit is taken as being the same as that of the reference medicine. 
Zaradi tega velja, da so njegove koristi enake kot pri referenčnem zdravilu.
RevitaCAM is similar to Metacam oral solution containing the same active substance, but given in a different way, as an oromucosal spray. 
Podobno je peroralni raztopini zdravila Metacam, ki vsebuje isto zdravilno učinkovino, a se daje drugače, kot oralno pršilo.
RevitaCAM is a medicine that contains the active substance meloxicam. 
RevitaCAM je zdravilo, ki vsebuje zdravilno učinkovino meloksikam.
What is RevitaCAM used for? 
Za kaj se zdravilo RevitaCAM uporablja?
The CVMP considered that, in accordance with European Union requirements, RevitaCAM has been shown to be bioequivalent to Metacam. 
CVMP je ugotovil, da je zdravilo RevitaCAM v skladu z zahtevami Evropske unije biološko enakovredno zdravilu Metacam.
In some dogs sneezing, coughing, gagging or drooling may be seen immediately after treatment administration. 
Pri nekaterih psih so takoj po dajanju zdravila opazili kihanje, kašljanje, davljenje ali slinjenje.
RevitaCAM must not be used in dogs with liver, heart or kidney problems, bleeding disorders, or dogs suffering from irritation or ulcers of the digestive tract. 
Zdravilo RevitaCAM se ne sme uporabljati pri psih z okvarjenim delovanjem jeter, srca ali ledvic, krvavitvami ali tistimi, ki imajo razdražena prebavila ali razjede v prebavilih.
RevitaCAM should not be used in pregnant or lactating animals. 
Ne sme se uporabljati pri brejih živalih ali živalih v laktaciji.
Therefore the CVMP's view was that, as for Metacam, RevitaCAM's benefits are greater than its risks when used for the approved indications and the 
Zato je menil, da so njegove koristi , tako kot pri zdravilu Metacam, večje od z njim povezanih tveganj pri uporabi za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
How has RevitaCAM been studied? 
Kako je bilo zdravilo RevitaCAM raziskano?
Studies provided for RevitaCAM were tests to determine that it is bioequivalent to the reference medicine, Metacam. 
Predložene študije v podporo zdravilu RevitaCAm so bila preskušanja za ugotavljanje, ali je biološko enakovredno zdravilu Metacam.
What is RevitaCAM? 
Kaj je zdravilo RevitaCAM?
Based on the findings of the study, RevitaCAM was considered to be bioequivalent to the reference medicine. 
V študiji je bilo ugotovljeno, da je zdravilo RevitaCAM biološko enakovredno referenčnemu zdravilu.
How does RevitaCAM work? 
Kako zdravilo RevitaCAM deluje?
The final opinion was converted into a decision by the European Commission on 9 September 2008. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 9. septembra 2008.
Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008. 
Imetniki dovoljenja za promet z zdravilom so pisna pojasnila poslali 14. decembra 2007, 5. maja 2008, 12. junija 2008 in 20. junija 2008.
During the February 2008 plenary meeting Dr. Rafe Survana was appointed Co-Rapporteur, replacing Dr. Matthew Thatcher. 
Med plenarnim zasedanjem februarja 2008 je bil za soporočevalca imenovan dr. Rafe Survana, ki je zamenjal dr. Matthewa Thatcherja.
London, 23 October 2008 EMEA/438258/2008 
London, 23. oktober 2008 EMEA/CHMP/619546/2008
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008. 
∗ Opombe: Informacije, podane v tem dokumentu in dodatkih, odražajo zgolj mnenje CHMP z dne 26. junija 2008.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter). 
Zdravstveni delavci bodo o teh ukrepih opozorjeni s posebnim dopisom („Spoštovani zdravstveni delavec“).
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr. Karl Broich) and Co-Rapporteur (Dr. Matthew Thatcher) were appointed. 
Arbitražni postopek je CHMP obravnaval na svojem plenarnem zasedanju septembra 2007, imenovana pa sta bila tudi poročevalec (dr. Karl Broich) in soporočevalec (dr. Matthew Thatcher).
As these concerns were not resolved during the course of the procedure, a notification of an official referral for arbitration under Article 6(12) of Commission Regulation EC No 1084/2003 to the CHMP was made by France on 19 September 2007. 
Ker ti zadržki niso med postopkom niso bili odpravljeni, je Francija 19. septembra 2007 CHMP poslala obvestilo o uradni napotitvi na arbitražo v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Arcoxia International non-proprietary name (INN): etoricoxib BACKGROUND INFORMATION * 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6(12) ZA zdravilo Arcoxia Mednarodno nelastniško ime (INN): etorikoksib OSNOVNE INFORMACIJE*
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV. 
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, spremenjene informacije o zdravilu v Dodatku III, pogoji dovoljenja za promet z zdravilom pa v Dodatku IV.
France considered that a review of the benefit/risk profile of Arcoxia was needed. 
Francija je ocenila, da je potrebna presoja profila razmerja med koristmi in tveganjem zdravila Arcoxia.
At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication. 
Ob koncu postopka medsebojnega priznavanja se je med različnimi državami članicami Evropske unije (EU) pojavila neskladnost glede varnosti etorikoksiba v 90-miligramskem odmerku v novi predlagani indikaciji.
It was therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs. 
Zato je težko določiti tveganja v zvezi z etorikoksibom v primerjavi z ibuprofenom, ketoprofenom ali drugimi, manj pogosto uporabljenimi nesteroidnimi protivnetnimi zdravili.
The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients. 
Zato CHMP priporoča, da se študije o odmerjanju posebej proučijo za ugotovitev, ali bi zdravljenje s 60-miligramskim odmerkom enkrat dnevno zadostovalo za določene bolnike.
The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs). 
Napotitveni postopek se je začel 20. septembra 2007 s sprejetjem seznama vprašanj CHMP, na katera so morali odgovoriti imetniki dovoljenja za promet z zdravilom.
The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure). 
CHMP je zaključil, da podatki potrjujejo znan renovaskularni varnostni profil etorikoksiba (povišan krvni tlak, edemi in kongestivna odpoved srca).