natgillin/translations-raw huggingface dataset:
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.
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.
When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
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.
Regarding its safety, Vipidia's safety profile was consistent with that seen with other DPP-4 inhibitors.
V zvezi z varnostjo zdravila Vipidia je njegov varnostni profil skladen s tistim, ki ga je mogoče opaziti pri drugih zaviralcih DPP-4.
For practical information about using Vipidia, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vipidia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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.
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.
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.
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.
Vipidia is a diabetes medicine that contains the active substance alogliptin.
Vipidia je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilno učinkovino alogliptin.
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.
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.
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.
Glavno merilo učinkovitosti v vseh študijah je bila sprememba ravni glikoziliranega hemoglobina (HbA1c), kar je odstotek hemoglobina v krvi, na katerega je vezana glukoza.
Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Zmanjša tudi količino glukoze, ki jo tvorijo jetra, tako da poviša raven insulina in zniža raven hormona glukagona.
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.
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.
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.
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.
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.
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.
HbA1c levels give an indication of how well the blood glucose is controlled.
Ravni HbA1c kažejo, kako dobro je raven glukoze v krvi urejena.
For the full list of all side effects reported with Vipidia, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vipidia, glejte navodilo za uporabo.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Ti se sproščajo po zaužitju hrane in spodbujajo trebušno slinavko k tvorjenju insulina.
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.
Alogliptin s podaljševanjem delovanja inkretinskih hormonov v krvi spodbuja trebušno slinavko k tvorjenju večje količine insulina, kadar so ravni glukoze v krvi visoke.
How does Vipidia work?
Kako zdravilo Vipidia deluje?
In all studies Vipidia led to a decrease in HbA1c indicating that blood glucose levels had been reduced.
V vseh študijah se je z jemanjem zdravila Vipidia zmanjšala raven HbA1c, kar je pokazatelj, da so ravni glukoze v krvi nižje.
In two other studies, Vipidia was compared with the diabetes medicines glipizide and pioglitazone in patients who were already taking metformin.
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.
How is Vipidia used?
Kako se zdravilo Vipidia uporablja?
8 January 2010
8. januar 2010
Committee for medicinal products for veterinary use (CVMP)
Odbor za zdravila za uporabo v veterinarski medicini (CVMP)
Tylosin is a macrolide antibiotic.
Tilozin je makrolidni antibiotik.
1 Article 33(4) of Directive 2001/82/EC, as amended.
1 Člen 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.
The final opinion was converted into a Decision by the European Commission on 8 January 2010.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 8. januarja 2010.
The Decentralised Procedure NL/V/0127/001/DC started on 23 March 2007.
Decentralizirani postopek NL/V/0127/001/DC se je začel dne 23. marca 2007.
Opinion following an Article 33(4)
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)
The referral procedure started on 14 May 2008.
Napotitveni postopek se je začel dne 14. maja 2008.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II.
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.
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.
It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.
Njegov protimikrobni učinek zavira sintezo beljakovin v občutljivih mikroorganizmih.
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).
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).
On 24 December 2008, Huvepharma NV, notified the Agency of his intention to request the reexamination of the CVMP opinion.
Dne 24. decembra 2008 je družba Huvepharma NV obvestila Agencijo o svoji nameri, da bo zahtevala ponovno preučitev mnenja CVMP.
Written explanations were provided by the applicant on 18 August 2008.
Predlagatelj je pisna pojasnila predložil dne 18. avgusta 2008.
The detailed grounds for the request were submitted to the Agency on 5 February 2009.
Podrobna utemeljitev za ponovno preučitev je bila Agenciji predložena dne 5. februarja 2009.
The rapporteur and co-rapporteur appointed were: Dr Cristina Muñoz Madero (Spain) and Dr Boris Kolar (Slovenia), respectively.
Za poročevalko je bila določena dr. Cristina Muñoz Madero (Španija), za soporočevalca pa dr. Boris Kolar (Slovenija).
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.
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.
The re-examination procedure started on 6 February 2009 and oral explanations were given by Huvepharma NV on 10 March 2009.
Postopek ponovne preučitve se je začel dne 6. februarja 2009, družba Huvepharma NV pa je ustna pojasnila podala dne 10. marca 2009.
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.
Dne 16. septembra 2008 je CVMP pripravil seznam nerešenih vprašanj, predlagatelj pa je dne 12. novembra 2008 predložil pisna pojasnila.
Furthermore, the CVMP recommended that the existing marketing authorisations for the abovementioned product should be revoked.
Poleg tega je CVMP priporočil, da se obstoječa dovoljenja za promet z zgoraj omenjenim zdravilom razveljavijo.
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.
Za poročevalko pri ponovni preučitvi je bila za določena dr. Ruth Kearsley, za soporočevalca pa dr. Michael Holzhauser-Alberti.
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.
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.
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.
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.
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.
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.
No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredients.
Smiselna uporabnost zaključkov za druga odobrena zdravila z enako zdravilno učinkovino ni bila obravnavana in glede tega niso bili sprejeti nobeni zaključki.
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.
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.
Therefore the CVMP recommended the refusal of the granting of the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names.
Zato je priporočil zavrnitev odobritve dovoljenja za promet z zdravilom Pharmasin 100 % m/m vodotopna zrnca in z njim povezanimi imeni.
Opinion following an Article 33(4)F F referral for Pharmasin 100% W/W Water Soluble Granules and associated names
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
100% W/W Water Soluble Granules and associated names
za zdravilo Pharmasin 100 % m/m vodotopna zrnca in z njim povezana imena
This summary was last updated in 10-2016.
Povzetek je bil nazadnje posodobljen 10-2016.
It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain.
Deluje na dva načina, in sicer s stimulacijo receptorjev MT1 in MT2 ter zaviranjem receptorjev 5-HT2C v možganih.
The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax on 19 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Thymanax, veljavno po vsej Evropski uniji, izdala 19. februarja 2009.
Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Bolnike z depresijo je treba zdraviti vsaj šest mesecev, da se zagotovi popolna odprava simptomov.
If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime.
Če se po dveh tednih simptomi ne izboljšajo, lahko zdravnik poveča odmerek na dve tableti, ki se vzameta sočasno pred spanjem.
The full EPAR for Thymanax 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 Thymanax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The recommended dose is one tablet once a day, taken at bedtime.
Priporočeni odmerek je ena tableta enkrat na dan, ki se vzame pred spanjem.
This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.
To naj bi pripeljalo do povišanih ravni živčnih prenašalcev dopamina in noradrenalina.
‘Neurotransmitters' are chemicals that allow nerve cells to communicate with each other.
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic.
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.
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.
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.
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.
Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Huda depresija je stanje, za katerega so pri bolnikih značilne motnje razpoloženja, ki vplivajo na vsakodnevno življenje.
The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih so se simptomi ponovno pojavili med 24. in 26. tednom zdravljenja.
This is a summary of the European public assessment report (EPAR) for Thymanax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Thymanax.
The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Glavno merilo učinkovitosti v teh petih študijah je bila sprememba simptomov po šestih tednih, ocenjenih po standardni lestvici za merjenje depresije, imenovani Hamiltonova lestvica za merjenje depresije (HAM D).
Thymanax is a medicine used to treat major depression in adults.
Thymanax je zdravilo, ki se uporablja za zdravljenje hude depresije pri odraslih.
Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.
Zdravljenje je treba nemudoma prekiniti, če bolnik kaže simptome ali znake morebitne okvare jeter.
What measures are being taken to ensure the safe and effective use of Thymanax?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Thymanax?
Therefore, the CHMP decided that Thymanax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Thymanax večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Vendar je druga študija pokazala, da so se simptomi ponovno pojavili pri 21 % (34 od 165) bolnikov, ki so 24 tednov jemali zdravilo Thymanax, medtem ko je ta delež pri bolnikih, ki so jemali placebo, znašal 41 % (72 od 174).
Thymanax can only be obtained with a prescription and is available as tablets (25 mg).
Predpisovanje in izdaja zdravila Thymanax je le na recept, na voljo pa je v obliki tablet (25 mg).
Most side effects were mild or moderate in intensity, happened within the first two weeks of treatment and were temporary.
Večina neželenih učinkov je bila blagih ali zmernih, pojavili pa so se v prvih dveh tednih zdravljenja in polagoma izzveneli.
However, no effect of fluoxetine or paroxetine was seen in two of these studies, making the results difficult to interpret.
Vendar je glede na to, da v dveh študijah niso bili ugotovljeni nobeni učinki fluoksetina ali paroksetina, te rezultate težko pojasniti.
Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'.
Tri od teh študij so vključevale nekaj bolnikov, zdravljenih z drugimi antidepresivi, in sicer s fluoksetinom ali paroksetinom kot „aktivnim primerjalnim zdravilom“.
The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Skupine bolnikov, ki so prejemali aktivno primerjalno zdravilo, so vključili zato, da bi preverili, ali je bilo v študiji mogoče izmeriti učinkovitost zdravil pri zdravljenju depresije.
In the first study, there was no difference between Thymanax and placebo in preventing symptoms from returning during 26 weeks of treatment.
V prvi študiji ni bilo razlik med zdravilom Thymanax in placebom pri preprečevanju ponovnega pojava simptomov v 26 tednih zdravljenja.
This material explains the safety of the medicine, its interactions with other medicines, and includes guidance on the monitoring of liver function and management of possible symptoms of liver problems.
To gradivo vsebuje pojasnila glede varnosti zdravila in medsebojnega delovanja z drugimi zdravili ter napotke za spremljanje delovanja jeter in obvladovanje morebitnih simptomov težav z jetri.
Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Zdravilo Thymanax so primerjali s placebom (zdravilom brez zdravilne učinkovine) v petih glavnih kratkoročnih študijah, ki so vključevale skupaj 1 893 bolnikov odraslih s hudo obliko depresije.
The company that markets Thymanax will supply educational material for doctors prescribing Thymanax.
Družba, ki trži zdravilo Thymanax, bo zdravnikom, ki predpisujejo zdravilo Thymanax, priskrbela izobraževalno gradivo.
The most common side effects with Thymanax (seen in more than 1 patient in 100) are headache, nausea (feeling sick) and dizziness.
Najpogostejši neželeni učinki zdravila Thymanax (opaženi pri več kot 1 bolniku od 100) so glavobol, navzeja (slabost) in omotica.
Thymanax might also help to normalise the patient's sleep patterns.
Zdravilo Thymanax lahko pomaga tudi pri uravnavanju bolnikovega vzorca spanja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax's benefits in terms of treating depression might be lower than seen with other antidepressants.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da so koristi zdravila Thymanax pri zdravljenju depresije morda manjše kot pri drugih antidepresivih.
The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant), which showed that Thymanax was more effective than sertraline, with a reduction in HAM D scores after six weeks.
Družba je predstavila tudi rezultate dodatne študije, v kateri so zdravilo Thymanax primerjali s sertralinom (drugim antidepresivom), ki je pokazala, da je bilo zdravilo Thymanax učinkovitejše od sertralina, saj so se rezultati na lestvici HAM D po šestih tednih zmanjšali.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thymanax 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 Thymanax upoštevati zdravstveni delavci in bolniki, so tudi vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Vendar je glede na drugačen način delovanja zdravila, majhno število neželenih učinkov in drugačen varnostni profil v primerjavi z obstoječimi antidepresivi, zaključil, da bi bilo zdravilo Thymanax lahko pomembno za zdravljenje nekaterih bolnikov, pri čemer pa bi bilo treba redno preverjati delovanje jeter.
For more information about treatment with Thymanax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Thymanax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Thymanax, agomelatine, is an antidepressant.
Zdravilna učinkovina v zdravilu Thymanax, agomelatin, je antidepresiv.