natgillin/translations-raw huggingface dataset:
The full EPAR for Atazanavir Mylan 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 Atazanavir Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.
Uporablja se skupaj z majhnim odmerkom ritonavirja in drugimi protivirusnimi zdravili za zdravljenje bolnikov, starih 6 let in več.
This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Atazanavir Mylan.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Mylan have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Atazanavir Mylan, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.
Ni pričakovati, da bi zdravilo učinkovalo pri bolnikih, pri katerih številna zdravila istega razreda kot zdravilo Atazanavir Mylan (zaviralci proteaze) ne učinkujejo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Atazanavir Mylan primerljivo raven kakovosti kot zdravilo Reyataz ter da mu je biološko enakovredno.
Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Atazanavir Mylan v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Atazanavir Mylan?
The Committee recommended that Atazanavir Mylan be approved for use in the EU.
Priporočil je, da se zdravilo Atazanavir Mylan odobri za uporabo v EU.
Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Zdravilo Atazanavir Mylan je zdravilo proti virusu HIV, ki se uporablja za zdravljenje bolnikov, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Zdravilo Atazanavir Mylan se običajno daje z ritonavirjem za okrepitev njegovega delovanja, zdravniki pa lahko v nekaterih posebnih primerih razmislijo o prenehanju dajanja ritonavirja pri odraslih.
Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Atazanavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Atazanavir Mylan ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
Doctors should prescribe Atazanavir Mylan only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Mylan.
Zdravniki lahko zdravilo Atazanavir Mylan predpišejo šele, ko preverijo, katera zdravila je bolnik jemal prej, in ko opravijo preiskave za ugotovitev verjetnosti, da se bo virus odzval na zdravilo Atazanavir Mylan.
For more information about treatment with Atazanavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Atazanavir Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This means that Atazanavir Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Reyataz.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Reyataz.
In younger patients, the dose of Atazanavir Mylan depends on body weight.
Pri mlajših bolnikih je odmerek zdravila Atazanavir Mylan odvisen od njihove telesne mase.
What are the benefits and risks of Atazanavir Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Atazanavir Mylan?
For practical information about using Atazanavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Atazanavir Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Therefore, the CHMP's view was that, as for Reyataz, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Reyataz odtehtajo znana tveganja.
Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz.
Ker je zdravilo Atazanavir Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Reyataz.
Atazanavir Mylan is a ‘generic medicine'.
Zdravilo Atazanavir Mylan je „generično zdravilo“.
Other information about Atazanavir Mylan
Druge informacije o zdravilu Atazanavir Mylan
What is Atazanavir Mylan and what is it used for?
Kaj je zdravilo Atazanavir Mylan in za kaj se uporablja?
The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Atazanavir Mylan, atazanavir, je zaviralec proteaze.
Why is Atazanavir Mylan approved?
Zakaj je bilo zdravilo Atazanavir Mylan odobreno?
Atazanavir Mylan contains the active substance atazanavir.
Zdravilo Atazanavir Mylan vsebuje zdravilno učinkovino atazanavir.
How is Atazanavir Mylan used?
Kako se zdravilo Atazanavir Mylan uporablja?
How does Atazanavir Mylan work?
Kako zdravilo Atazanavir Mylan deluje?
The European Commission granted a marketing authorisation valid throughout the European Union for Atazanavir Mylan on 22 August 2016.
Evropska komisija je dovoljenje za promet z zdravilom Atazanavir Mylan, veljavno po vsej Evropski uniji, izdala <datum izdaje dovoljenja za promet z zdravilom>.
How has Atazanavir Mylan been studied?
Kako je bilo zdravilo Atazanavir Mylan raziskano?
It is not intended to provide practical advice on how to use Atazanavir Mylan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The application was submitted to the reference Member State (RMS): Austria and the concerned Member States (CMS): Denmark, Spain, Finland, France, Germany, Ireland, The Netherlands, Poland, Portugal, Sweden and the United Kingdom.
Vloga je bila predložena referenčni državi članici Avstriji in zadevnim državam članicam Danski, Španiji, Finski, Franciji, Nemčiji, Irski, Nizozemski, Poljski, Portugalski, Švedski in Združenemu kraljestvu.
Furthermore, reference to other existing marketing authorisations is not relevant due to different targets populations and/or safety profile.
Poleg tega sklicevanje na druga obstoječa dovoljenja za promet z zdravilom zaradi različnih ciljnih populacij in/ali varnostnega profila ni relevantno.
Following the adoption of the CHMP Opinion during the June 2017 CHMP meeting, the applicant Debrégeas & Associés (D&A) requested a re-examination of the Opinion.
Po sprejetju mnenja odbora CHMP na seji odbora CHMP junija 2017 je predlagatelj, družba Debrégeas & Associés (D&A), zahteval ponovno preučitev mnenja.
The application in Germany was withdrawn during the DCP.
Vloga v Nemčiji je bila med decentraliziranim postopkom umaknjena.
The study duration should enable to conclude on efficacy and include at least 3 months of treatment and a predefined follow-up period.
Študija bi morala trajati vsaj tako dolgo, da bo mogoče izpeljati zaključke o učinkovitosti, vključevati vsaj tri mesece zdravljenja in vnaprej opredeljeno obdobje spremljanja.
The CHMP consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by Debrégeas & Associés (D&A).
Odbor CHMP se je posvetoval s strokovnjaki na izrednem sestanku glede nekaterih vidikov, ki so del podrobno opisanih razlogov, ki jih je predložila družba Debrégeas & Associés (D&A).
As the efficacy of the medicinal product is not established, the relevance of the risk minimization measures could not be confirmed.
Ker učinkovitost zdravila ni bila dokazana, ustreznosti ukrepov za zmanjšanje tveganja ni mogoče potrditi.
However, it was recognised that it could be useful from the clinical perspective to have a product that could be used in both settings (acute withdrawal and maintenance of abstinence).
Priznali pa so, da bi bilo s kliničnega stališča koristno imeti zdravilo, ki bi se lahko uporabljalo v obeh primerih (pri akutni odtegnitvi in vzdrževanju abstinence).
As none of the subgroup analyses had been pre-specified, these are inherently weakened by their post-hoc derived nature.
Ker nobena od analiz podskupin ni bila vnaprej opredeljena, so že same po sebi šibke zaradi svoje post-hoc narave.
The experts agreed that while the data currently available support a plausible effect and is encouraging, the strength of efficacy evidence is insufficient.
Strokovnjaki so se strinjali, da trenutno razpoložljivi podatki sicer podpirajo verjeten učinek in so spodbudni, vendar je moč dokazov o učinkovitosti nezadostna.
With regards to the treatment of acute withdrawal syndrome, the experts shared the views that there are well-established, evidence-based pharmacological treatments currently available, namely benzodiazepines, which are used throughout the European Union.
Kar zadeva zdravljenje akutnega odtegnitvenega sindroma, so strokovnjaki menili, da so trenutno na voljo dobro uveljavljena, na dokazih utemeljena farmakološka zdravljenja, in sicer benzodiazepini, ki se uporabljajo po vsej Evropski uniji.
Furthermore, it was noted by the CHMP that, despite the limited sample size in the clinical trials, this patient population cannot be considered as a ‘small population' as defined by the EMA Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005).
Odbor CHMP je ugotovil tudi, da kljub omejeni velikosti vzorca v kliničnih preskušanjih te populacije bolnikov ni mogoče šteti za „majhno populacijo“, kot jo opredeljuje smernica EMA o kliničnih preskušanjih pri majhnih populacijah (CHMP/EWP/83561/2005).
The experts noted that only a minority of those patients receive indeed a pharmacotherapy and usually only a limited proportion of them respond to these treatments.
Strokovnjaki so opozorili, da se le manjšina teh bolnikov res zdravi z zdravili in da se le omejen del teh bolnikov na zdravila odzove.
Whilst such studies could confirm or further characterise the efficacy of a medicinal product, they cannot replace the demonstration of efficacy in the claimed indications, which is a requirement of a marketing authorisation.
Tudi če bi takšni študiji lahko potrdili ali nadalje opredelili učinkovitost zdravila, pa ne moreta nadomestiti dokaza učinkovitosti za predloženi indikaciji, kar je zahtevano za dovoljenje za promet z zdravilom.
Also experts were in favor of further monitoring the risk of seizures, particularly without convulsions.
Strokovnjaki so podprli nadaljnje spremljanje tveganja za epileptične napade, zlasti brez konvulzij.
However the experts acknowledged that it may be difficult to evaluate and to have successful results for both endpoints within the same trial design.
Vendar pa so strokovnjaki priznali, da je morda težavno ovrednotiti oba opazovana dogodka in imeti uspešne rezultate v okviru iste zasnove preskušanja.
Regarding the outcome measures, the experts considered that data should be collected both on continuous abstinence and harm reduction.
Kar zadeva merila izidov, so strokovnjaki presodili, da je treba zbirati podatke tako o neprekinjeni abstinenci kot o zmanjševanju škode.
A stronger signal of efficacy was found in the most severe population which was a promising result as those patients are less prone to placebo response and have limited therapeutic options.
Pri populaciji z najtežjo obliko odvisnosti je bil ugotovljen močnejši signal učinkovitosti, kar je obetaven rezultat, saj so ti bolniki manj nagnjeni k odzivu na placebo in imajo omejene možnosti zdravljenja.
The reference Member State RMS Austria considered that based on the studies submitted within the application, a lack of efficacy, as raised by some Member states, could not be supported.
Referenčna država članica Avstrija je presodila, da na podlagi študij, predloženih v vlogi, ni mogoče potrditi pomanjkljive učinkovitosti, kot so trdile nekatere države članice.
It is also highlighted that post-authorisation efficacy studies, as governed by Commission Delegated Regulation (EU) No 357/2014, should not be used as a justification for the premature granting of a marketing authorisation or for granting a marketing authorisation for medicinal products for which the risk-benefit balance is not considered positive.
Poudaril je tudi, da se študije učinkovitosti po pridobitvi dovoljenja za promet z zdravilom, kot to ureja Delegirana uredba Komisije (EU) št. 357/2014, ne smejo uporabljati kot utemeljitev za predčasno izdajo dovoljenja za promet z zdravilom ali za izdajo dovoljenja za promet z zdravilom za zdravila, pri katerih razmerje med tveganji in koristmi ni ocenjeno kot pozitivno.
As the objections raised on the efficacy, safety and overall benefit-risk during the procedure were considered to be a potential serious risk to public health and no agreement could be reached during the CMDh procedure, the procedure was referred to the CHMP under Article 29(4) of Directive 2001/83/EC by the RMS Austria.
Ker so med postopkom navedli pomisleke o učinkovitosti, varnosti in splošnem razmerju med tveganji in koristmi, ki naj bi pomenili morebitno resno tveganje za javno zdravje, in ker med postopkom skupine CMDh ni bilo mogoče doseči dogovora, je referenčna država članica Avstrija napotila postopek na odbor CHMP v skladu s členom 29(4) Direktive 2001/83/ES.
It was underlined, however, that the pharmacokinetics properties of the product may be unfavourable for substitution due to short half-life and from clinical perspective the complete abstinence may not always be achievable.
Poudarili pa so, da farmakokinetične lastnosti zdravila zaradi kratke razpolovne dobe morda niso ugodne za nadomestno zdravljenje in s kliničnega vidika popolna abstinenca morda ni vedno dosegljiva.
Finally, it was noticed that it could be anticipated that long-term use of sodium oxybate might have effects on cognitive function.
Opozorili so tudi, da je mogoče predvidevati, da bi dolgoročna uporaba natrijevega oksibata lahko vplivala na kognitivno funkcijo.
In particular, there could be an advantage, for pragmatic reasons, to have a medicine which has a favourable impact on the craving process and thereby allow in-patient to become out-patient.
Zlasti iz pragmatičnih razlogov bi bila prednost imeti zdravilo z ugodnim vplivom na proces hlepenja, ki bi omogočilo, da bi bolnišnični bolnik postal ambulantni bolnik.
Like GABA, it exerts an overall inhibiting effect on the central nervous system (CNS).
Tako kot GABA ima zdravilo Alcover splošen zaviralni učinek na centralni živčni sistem.
The target population expected to benefit most should be refined based on the data available and expert advice.
Ciljno populacijo, ki naj bi imela od zdravljenja največjo korist, bi morali na podlagi razpoložljivih podatkov in strokovnega nasveta natančneje opredeliti.
The experts considered that the company has generated an interesting hypothesis which requires confirmation in a prospective, well designed trial in the target population.
Strokovnjaki so presodili, da je družba postavila zanimivo hipotezo, ki jo je treba potrditi s prospektivnim, dobro zasnovanim preskušanjem pri ciljni populaciji.
Further investigation is also needed to assess the risk of abuse in the sub-population of interest with psychiatric comorbidities.
Potrebne so nadaljnje preiskave za oceno tveganja za zlorabo v želeni podpopulaciji s psihiatričnimi soobolevnostmi.
The experts agreed that psychiatric comorbidities in stabilised patients should not be an exclusion criterion, considering the high medical need in this patient group.
Strokovnjaki so se strinjali, da psihiatrične soobolevnosti pri stabiliziranih bolnikih glede na visoko medicinsko potrebo v tej skupini bolnikov ne morejo biti izključitveno merilo.
Considering that the presented evidence mainly relied on post-hoc analyses, and that there is also significant heterogeneity in the study populations, the overall evidence for efficacy was not considered robust enough.
Glede na to, da so se predstavljeni dokazi v glavnem sklicevali na posthoc analize in da so bile študijske populacije močno heterogene, celokupni dokazi o učinkovitosti niso bili ocenjeni kot dovolj robustni.
• The Committee considered the notification of the referral initiated by Austria under Article 29(4) of Directive 2001/83/EC, where Denmark, Spain, Finland, France, Ireland, the Netherlands, Portugal, Sweden and the United Kingdom raised objections to the marketing authorisation application for Alcover and associated names, 750 mg, 1250 mg, 1750 mg granules in sachets, which were considered to be a potential serious risk to public health;
• odbor je preučil obvestilo o napotitvi, ki jo je predložila Avstrija v skladu s členom 29(4) Direktive 2001/83/ES, pri čemer so Danska, Španija, Finska, Francija, Irska, Nizozemska, Portugalska, Švedska in Združeno kraljestvo nasprotovali vlogi za pridobitev dovoljenja za promet z zdravilom za zdravilo Alcover in povezana imena, 750 mg, 1 250 mg, 1 750 mg zrnca v vrečkah, saj naj bi ta zdravila pomenila resno tveganje za javno zdravje;
With regard to the indication for the maintenance of alcohol abstinence, none of these studies can be seen as being in line with the scientific requirements for a clinical efficacy/safety study that would provide clear evidence of efficacy in the aimed at Very High DRL patient group.
V zvezi z indikacijo za vzdrževanje abstinence od alkohola za nobeno od teh študij ni mogoče trditi, da je v skladu z znanstvenimi zahtevami za študijo klinične učinkovitosti/varnosti, ki bi zagotovila jasne dokaze o učinkovitosti pri ciljni skupini bolnikov z zelo visoko stopnjo tveganja za zlorabo alkohola.
Therefore, it would be advisable to monitor the cognitive adverse effects of sodium oxybate, particularly in patients with pre-existing cognitive impairments.
Zato bi bilo priporočljivo spremljati neželene učinke natrijevega oksibata na kognitivno funkcijo, zlasti pri bolnikih z obstoječimi kognitivnimi motnjami.
The applicant performed a subpopulation analysis (meta-analysis of seven RCTs and observational studies), which was not sufficiently robust to establish efficacy of the medicinal product in the claimed indication.
Predlagatelj je opravil analizo podpopulacij (metaanalizo sedmih randomiziranih kliničnih preskušanj in opazovalnih študij), kar ni bilo dovolj robustno, da bi ugotovili učinkovitost zdravila pri predloženi indikaciji.
Furthermore, the number of patients included was quite small, and only Gallimberti showed positive results, whereas the results on abstinence rate in Very High DRL patients from study SMO032/10/03 and Di Bello 1995 are deemed inconclusive.
Poleg tega je bilo število vključenih bolnikov precej majhno, in le Gallimberti je pokazal pozitivne rezultate, medtem ko so rezultati o stopnji abstinence pri bolnikih z zelo visoko stopnjo tveganja za zlorabo alkohola iz študij SMO032/10/03 in Di Bello 1995 nejasni.
However, the conduct of the proposed post-authorisation study would not impact or change the Committee's conclusion that the efficacy of the medicinal product is not established.
Vendar izvedba predlagane študije po pridobitvi dovoljenja za promet z zdravilom ne bi vplivala na stališče odbora, da učinkovitost zdravila ni dokazana, oziroma ga ne bi spremenila.
The Committee also carefully considered the proposal from the applicant to perform a post-authorisation efficacy study.
Odbor je tudi skrbno preučil predlagateljev predlog, da bi izvedel študijo učinkovitosti po pridobitvi dovoljenja za promet z zdravilom.
Sodium oxybate is a partial agonist on both GABAA and GABAB receptors and also binds with high affinity to GHB-specific receptors.
Natrijev oksibat je delni agonist receptorjev GABAA in GABAB, z visoko afiniteto pa se veže tudi na receptorje, specifične za GHB.
Overall, whilst the experts considered that conditions of taking the medication are well-controlled and that no major safety issues have been reported so far, concerns were raised regarding the use of the product in patients of high risk groups, e.g. with renal impairment, liver dysfunction and/or electrolytes imbalance.
Strokovnjaki so sicer presodili, da so pogoji jemanja zdravila dobro nadzorovani in da do zdaj še niso poročali o večjih težavah z varnostjo, vendar so se pojavili pomisleki o uporabi zdravila pri bolnikih iz skupin z visokim tveganjem, npr. z ledvično okvaro, jetrno okvaro in/ali neravnovesjem elektrolitom.
• The Committee was of the view that the data submitted in support of the efficacy of Alcover granules in sachets in the claimed indications suffers from relevant methodological limitations relating to the design of the studies (such as insufficient sample size, selection of the patient population, post-hoc analyses).
• odbor je menil, da imajo podatki, predloženi v podporo učinkovitosti zdravila Alcover zrnca v vrečkah, pri predloženih indikacijah metodološke omejitve glede zasnove študij (kot so nezadostna velikost vzorca, izbira populacije bolnikov, post-hoc analize).
As an additional point, the experts commented on the potential place of this medicine as substitution treatment or reduction of craving and prolongation of abstinence.
Strokovnjaki so podali dodatno pripombo na morebitno mesto zdravila pri nadomestnem zdravljenju ali zmanjševanju hlepenja ter podaljšanju abstinence.
The experts considered that sodium oxybate could potentially be a valuable addition to the current therapeutic armamentarium in the maintenance of abstinence from alcohol, if supported by adequate data.
Strokovnjaki so presodili, da bi bil natrijev oksibat morebiti lahko pomemben dodatek trenutnemu naboru zdravil pri vzdrževanju abstinence od alkohola, če bi bilo to podprto z ustreznimi podatki.
In absence of a positive benefit-risk balance established, the Committee is not in position to recommend grant of the marketing authorisation and the proposed post-authorisation study is not relevant.
Ker pozitivno razmerje med tveganji in koristmi ni bilo potrjeno, odbor ni v takšnem položaju, da bi lahko priporočil izdajo dovoljenja za promet z zdravilom, in torej predlagana študija po pridobitvi dovoljenja za promet ni relevantna.