FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vipidia on 19 September 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vipidia, veljavno po vsej Evropski uniji, odobrila dne 19. septembra 2013.
English: What measures are being taken to ensure the safe and effective use of Vipidia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vipidia?
English: The full EPAR for Vipidia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vipidia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vipidia has been studied in seven main studies involving 5,675 adults with type 2 diabetes.
Slovenian: Zdravilo Vipidia so proučevali v sedmih glavnih študijah, v katere je bilo vključenih 5 675 odraslih s sladkorno boleznijo tipa 2.
English: Other information about Vipidia
Slovenian: Druge informacije o zdravilu Vipidia
English: Vipidia is available as tablets (6.25, 12.5 and 25 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Vipidia je na voljo v obliki tablet (6,25 mg, 12,5 mg in 25 mg) in se izdaja le na recept.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vipidia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vipidia večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Vipidia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vipidia.
English: A risk management plan has been developed to ensure that Vipidia is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vipidia je bil pripravljen načrt obvladovanja tveganj.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Slovenian: Deluje tako, da zavira razgradnjo „inkretinskih“ hormonov v telesu.
English: The recommended dose is 25 mg taken by mouth once daily, in combination with other diabetes medicines as prescribed by a doctor.
Slovenian: Priporočeni odmerek je 25 mg, ki se vzame enkrat na dan peroralno, v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, kot jih predpiše zdravnik.
English: What benefits of Vipidia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vipidia izkazalo v študijah?
English: The most common side effect with Vipidia (which may affect up to 1 in 10 people) is pruritus (itching).
Slovenian: Najpogostejši neželeni učinki zdravila Vipidia (ki lahko prizadenejo največ 1 osebo od 10) so pruritus (srbenje).
English: What is Vipidia and what is it used for?
Slovenian: Kaj je zdravilo Vipidia in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Vipidia.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What are the risks associated with Vipidia?
Slovenian: Kakšna tveganja so povezana z zdravilom Vipidia?
English: The active substance in Vipidia, alogliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Slovenian: Zdravilna učinkovina zdravila Vipidia, alogliptin, je zaviralec dipeptidil peptidaze-4 (DPP-4).
English: When Vipidia is added to a sulphonylurea (a type of diabetes medicine) or insulin, the doctor may need to lower the dose of these medicines to reduce the risk of hypoglycaemia (low blood sugar level).
Slovenian: Kadar se zdravilo Vipidia doda sulfonilsečnini (vrsti zdravila za zdravljenje sladkorne bolezni) ali insulinu, bo morda moral zdravnik zmanjšati odmerek teh zdravil za zmanjšanje tveganja za pojav hipoglikemije (nizke ravni sladkorja v krvi).
English: Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Slovenian: Ti procesi skupaj znižajo raven glukoze v krvi in pripomorejo k uravnavanju sladkorne bolezni tipa 2.
English: In patients with reduced kidney function, the daily dose of Vipidia should be reduced.
Slovenian: Pri bolnikih s zmanjšanim delovanjem ledvic bo odmerek zdravila Vipidia morda treba znižati.
English: Alogliptin does not work when the blood glucose is low.
Slovenian: Alogliptin ne deluje, če je vrednost glukoze v krvi nizka.
English: Why is Vipidia approved?
Slovenian: Zakaj je bilo zdravilo Vipidia odobreno?
English: For more information about treatment with Vipidia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vipidia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje primerne ravni glukoze v krvi ali pri kateri telo tega ne more učinkovito izrabljati.
English: It is used, together with diet and exercise, as an addition to other diabetes medicines in adults with type 2 diabetes, to control their blood glucose (sugar) level.
Slovenian: V kombinaciji z dieto in telesno vadbo se uporablja kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni pri odraslih s sladkorno boleznijo tipa 2 za uravnavanje njihove ravni glukoze (sladkorja) v krvi.
English: When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
Slovenian: Kadar se je zdravilo Vipidia uporabljalo kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, so se ravni HbA1c zmanjšale za 0,480,61 % bolj kot pri jemanju placeba.
English: Regarding its safety, Vipidia's safety profile was consistent with that seen with other DPP-4 inhibitors.
Slovenian: V zvezi z varnostjo zdravila Vipidia je njegov varnostni profil skladen s tistim, ki ga je mogoče opaziti pri drugih zaviralcih DPP-4.
English: For practical information about using Vipidia, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vipidia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Vipidia must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any DPP 4 inhibitor.
Slovenian: Zdravila Vipidia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine ali katero koli drugo sestavino zdravila ali pri katerih se je kdaj v preteklosti pojavila huda alergijska reakcija na zaviralec DPP-4.
English: The CHMP considered that the effects of Vipidia on HbA1c levels were similar to those of other DPP-4 inhibitors and were modest but clinically relevant.
Slovenian: Menil je, da so učinki zdravila Vipidia na znižanje ravni HbA1C podobne tistim, ki jih imajo drugi zaviralci DDP-4, in so zmerni, a klinično pomembni.
English: Vipidia is a diabetes medicine that contains the active substance alogliptin.
Slovenian: Vipidia je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilno učinkovino alogliptin.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vipidia, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu z njim so bile v povzetek glavnih značilnosti zdravila Vipidia in navodilo za uporabo vključene informacije o njegovi varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In all of the studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Slovenian: Glavno merilo učinkovitosti v vseh študijah je bila sprememba ravni glikoziliranega hemoglobina (HbA1c), kar je odstotek hemoglobina v krvi, na katerega je vezana glukoza.
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Slovenian: Zmanjša tudi količino glukoze, ki jo tvorijo jetra, tako da poviša raven insulina in zniža raven hormona glukagona.
English: Five of the studies compared Vipidia with placebo (a dummy treatment), when used alone or added to other diabetes medicines, in patients in whom previous treatment had failed.
Slovenian: V petih študijah so zdravilo Vipidia primerjali s placebom (zdravilom brez zdravilne učinkovine), kadar se je to uporabljalo kot samostojno zdravilo ali kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni) pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno.
English: Vipidia was as least as affective as pioglitazone in lowering HbA1c when added to metformin, but the study comparing Vipidia with glipizide was not conclusive.
Slovenian: Zdravilo Vipidia je bilo pri zniževanju ravni HbA1c vsaj tako učinkovito kot pioglitazon, kadar se je dodajalo metforminu, izsledki študije, v kateri so zdravilo Vipidia primerjali z glipizidom, pa niso dokončni.
English: HbA1c levels were measured after 26 weeks when Vipidia was used alone or added to other diabetes medicines, and after 52 weeks when Vipidia was compared with glipizide or pioglitazone.
Slovenian: Te ravni so merili po 26 tednih, kadar se je zdravilo Vipidia uporabljalo kot samostojno zdravilo ali kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni, in po 52 tednih, kadar so to zdravilo primerjali z glipizidom ali pioglitazonom.
English: HbA1c levels give an indication of how well the blood glucose is controlled.
Slovenian: Ravni HbA1c kažejo, kako dobro je raven glukoze v krvi urejena.
English: For the full list of all side effects reported with Vipidia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vipidia, glejte navodilo za uporabo.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Slovenian: Ti se sproščajo po zaužitju hrane in spodbujajo trebušno slinavko k tvorjenju insulina.
English: By blocking the breakdown of incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Slovenian: Alogliptin s podaljševanjem delovanja inkretinskih hormonov v krvi spodbuja trebušno slinavko k tvorjenju večje količine insulina, kadar so ravni glukoze v krvi visoke.
English: How does Vipidia work?
Slovenian: Kako zdravilo Vipidia deluje?
English: In all studies Vipidia led to a decrease in HbA1c indicating that blood glucose levels had been reduced.
Slovenian: V vseh študijah se je z jemanjem zdravila Vipidia zmanjšala raven HbA1c, kar je pokazatelj, da so ravni glukoze v krvi nižje.
English: In two other studies, Vipidia was compared with the diabetes medicines glipizide and pioglitazone in patients who were already taking metformin.
Slovenian: V dveh drugih študijah so pri bolnikih, ki so že jemali metformin, zdravilo Vipidia primerjali z zdravili za zdravljenje sladkorne bolezni, ki so vsebovala glipizid in pioglitazon.
English: How is Vipidia used?
Slovenian: Kako se zdravilo Vipidia uporablja?
English: 8 January 2010
Slovenian: 8. januar 2010
English: Committee for medicinal products for veterinary use (CVMP)
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP)
English: Tylosin is a macrolide antibiotic.
Slovenian: Tilozin je makrolidni antibiotik.
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Slovenian: 1 Člen 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.
English: The final opinion was converted into a Decision by the European Commission on 8 January 2010.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 8. januarja 2010.
English: The Decentralised Procedure NL/V/0127/001/DC started on 23 March 2007.
Slovenian: Decentralizirani postopek NL/V/0127/001/DC se je začel dne 23. marca 2007.
English: Opinion following an Article 33(4)
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)
English: The referral procedure started on 14 May 2008.
Slovenian: Napotitveni postopek se je začel dne 14. maja 2008.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the reference member state was the Netherlands and the concerned member states (CMSs) were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Spain, Hungary, Ireland, Italy, Poland, Portugal, Romania and United Kingdom.
Slovenian: Vloga je bila predložena v okviru člena 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bila referenčna država članica Nizozemska, zadevne države članice pa Avstrija, Belgija, Bolgarija, Češka republika, Nemčija, Danska, Španija, Madžarska, Irska, Italija, Poljska, Portugalska, Romunija in Združeno kraljestvo.
English: It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.
Slovenian: Njegov protimikrobni učinek zavira sintezo beljakovin v občutljivih mikroorganizmih.
English: On 29 April 2008 the Netherlands referred the matter to the European Medicines Agency (the Agency) under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that tylosin may present a potential serious risk to the environment (risk to algae and to terrestrial plants).
Slovenian: Dne 29. aprila 2008 je Nizozemska v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na Evropsko agencijo za zdravila (Agencijo) zaradi zadržkov, ki jih je izrazila Nemčija, da lahko tilozin predstavlja možno resno tveganje za okolje (tveganje za alge in kopenske rastline).
English: On 24 December 2008, Huvepharma NV, notified the Agency of his intention to request the reexamination of the CVMP opinion.
Slovenian: Dne 24. decembra 2008 je družba Huvepharma NV obvestila Agencijo o svoji nameri, da bo zahtevala ponovno preučitev mnenja CVMP.
English: Written explanations were provided by the applicant on 18 August 2008.
Slovenian: Predlagatelj je pisna pojasnila predložil dne 18. avgusta 2008.
English: The detailed grounds for the request were submitted to the Agency on 5 February 2009.
Slovenian: Podrobna utemeljitev za ponovno preučitev je bila Agenciji predložena dne 5. februarja 2009.
English: The rapporteur and co-rapporteur appointed were: Dr Cristina Muñoz Madero (Spain) and Dr Boris Kolar (Slovenia), respectively.
Slovenian: Za poročevalko je bila določena dr. Cristina Muñoz Madero (Španija), za soporočevalca pa dr. Boris Kolar (Slovenija).
English: Furthermore, the CVMP recommended the revocation of the marketing authorisations for the above-mentioned product already granted in Austria, Ireland, the Netherlands and the United Kingdom.
Slovenian: Poleg tega je CVMP priporočil razveljavitev dovoljenj za promet z zgoraj omenjenim zdravilom, ki so že bila odobrena v Avstriji, na Irskem, Nizozemskem in v Združenem kraljestvu.
English: The re-examination procedure started on 6 February 2009 and oral explanations were given by Huvepharma NV on 10 March 2009.
Slovenian: Postopek ponovne preučitve se je začel dne 6. februarja 2009, družba Huvepharma NV pa je ustna pojasnila podala dne 10. marca 2009.
English: On 16 September 2008 the CVMP agreed a list of outstanding issues and the written explanations were provided by the applicant on 12 November 2008.
Slovenian: Dne 16. septembra 2008 je CVMP pripravil seznam nerešenih vprašanj, predlagatelj pa je dne 12. novembra 2008 predložil pisna pojasnila.
English: Furthermore, the CVMP recommended that the existing marketing authorisations for the abovementioned product should be revoked.
Slovenian: Poleg tega je CVMP priporočil, da se obstoječa dovoljenja za promet z zgoraj omenjenim zdravilom razveljavijo.
English: The rapporteur and co-rapporteur appointed for the re-examination were: Dr Ruth Kearsley as the rapporteur and Dr Michael Holzhauser-Alberti as the co-rapporteur respectively.
Slovenian: Za poročevalko pri ponovni preučitvi je bila za določena dr. Ruth Kearsley, za soporočevalca pa dr. Michael Holzhauser-Alberti.
English: The applicant, Huvepharma NV, submitted an application for a decentralised procedure for Pharmasin 100% W/W Water Soluble Granules and associated names indicated for oral use in pigs, chickens (broilers, pullets), turkeys and calves.
Slovenian: Predlagatelj, družba Huvepharma NV, je predložil vlogo za decentraliziran postopek za zdravilo Pharmasin 100 % m/m vodotopna zrnca in z njim povezana imena, indicirano za peroralno uporabo pri prašičih, kokoših (pitovnih piščancih, kokoškah), puranih in teletih.
English: During its 9-11 December 2008 meeting, the CVMP in light of the overall data submitted and the scientific discussion within the Committee, considered by consensus that the application did not satisfy the criteria for authorisation in respect of environmental risk.
Slovenian: CVMP je na svojem zasedanju 9.-11. decembra 2008 ob upoštevanju vseh predloženih podatkov in znanstvene razprave znotraj Odbora soglasno sprejel mnenje, da vloga za dovoljenje za promet z zdravilom ne izpolnjuje meril za odobritev zaradi tveganja za okolje.
English: During its 10-12 March 2009 meeting, the Committee, having considered the grounds for appeal and the oral explanations provided by Huvepharma NV, concluded by consensus that its opinion of 10 December 2008 should not be revised and that the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names should be refused by the member states.
Slovenian: Odbor je na svojem zasedanju 10.-12. marca 2009 ob upoštevanju podlage za priziv in ustnih pojasnil družbe Huvepharma NV soglasno zaključil, da se njegovo mnenje z dne 10. decembra 2008 ne sme spremeniti in da morajo države članice zavrniti dovoljenja za promet z zdravilom Pharmasin 100 % m/m vodotopna zrnca in z njim povezanimi imeni.
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredients.
Slovenian: Smiselna uporabnost zaključkov za druga odobrena zdravila z enako zdravilno učinkovino ni bila obravnavana in glede tega niso bili sprejeti nobeni zaključki.
English: In line with the restrictions in legislation with respect to data on environmental risk, the Committee limited its considerations to the data presented by Huvepharma NV in the dossier for Pharmasin 100% W/W Water Soluble Granules and associated names.
Slovenian: Odbor je v skladu z omejitvami v zakonodaji glede podatkov o tveganju za okolje svojo obravnavo omejil na podatke, ki jih je predložila družba Huvepharma NV v dokumentaciji za zdravilo Pharmasin 100 % m/m vodotopna zrnca in z njim povezana imena.
English: Therefore the CVMP recommended the refusal of the granting of the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names.
Slovenian: Zato je priporočil zavrnitev odobritve dovoljenja za promet z zdravilom Pharmasin 100 % m/m vodotopna zrnca in z njim povezanimi imeni.
English: Opinion following an Article 33(4)F F referral for Pharmasin 100% W/W Water Soluble Granules and associated names
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)F F za zdravilo Pharmasin 100 % m/m vodotopna zrnca in z njim povezana imena EMA/303258/2010
English: 100% W/W Water Soluble Granules and associated names
Slovenian: za zdravilo Pharmasin 100 % m/m vodotopna zrnca in z njim povezana imena
English: This summary was last updated in 10-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2016.
English: It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain.
Slovenian: Deluje na dva načina, in sicer s stimulacijo receptorjev MT1 in MT2 ter zaviranjem receptorjev 5-HT2C v možganih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax on 19 February 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Thymanax, veljavno po vsej Evropski uniji, izdala 19. februarja 2009.
English: Thymanax agomelatine
Slovenian: Thymanax agomelatin
English: Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Slovenian: Bolnike z depresijo je treba zdraviti vsaj šest mesecev, da se zagotovi popolna odprava simptomov.
English: If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime.
Slovenian: Če se po dveh tednih simptomi ne izboljšajo, lahko zdravnik poveča odmerek na dve tableti, ki se vzameta sočasno pred spanjem.
English: The full EPAR for Thymanax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Thymanax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose is one tablet once a day, taken at bedtime.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan, ki se vzame pred spanjem.
English: This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.
Slovenian: To naj bi pripeljalo do povišanih ravni živčnih prenašalcev dopamina in noradrenalina.
English: ‘Neurotransmitters' are chemicals that allow nerve cells to communicate with each other.
Slovenian: Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic.
English: Since dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain is believed to help relieve the symptoms of depression.
Slovenian: Ker dopamin in noradrenalin sodelujeta pri nadzoru razpoloženja, se domneva, da bo povečanje njunih ravni med živčnimi celicami v možganih pripomoglo k lajšanju simptomov depresije.
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Slovenian: Simptomi pogosto vključujejo globoko žalost, občutek ničvrednosti, izgubo zanimanja za stvari, ki so jih prej veselile, motnje spanja, občutek splošne upočasnjenosti, občutek anksioznosti in spremembo telesne mase.
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Slovenian: Huda depresija je stanje, za katerega so pri bolnikih značilne motnje razpoloženja, ki vplivajo na vsakodnevno življenje.
English: The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih so se simptomi ponovno pojavili med 24. in 26. tednom zdravljenja.
English: This is a summary of the European public assessment report (EPAR) for Thymanax.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Thymanax.