natgillin/translations-raw huggingface dataset:
Some people taking Combivir develop a condition called lactic acidosis, together with an enlarged liver.
Laktacidoza je redek, vendar resen neželeni učinek Pri nekaterih ljudeh, ki jemljejo zdravilo Combivir, se lahko razvije stanje, ki se imenuje laktacidoza,
Cardiac disorders Rare :Cardiomyopathy
Redko: kardiomiopatija Bolezni dihal, prsnega koša in mediastinalnega prostora
MA (EU) number (Invented) name
Št. dovoljenja za promet (EU)
Oral use bottle (HDPE)
150 mg Filmsko obložena tableta peroralna uporaba plastenka (HDPE)
The standard dose is one tablet once a day.
Standardni odmerek je ena tableta enkrat dnevno.
Dopamine is important for controlling movement and coordination.
Dopamin je pomemben za nadzor gibanja in koordinacije.
The full EPAR for Rasagiline 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 Razagilin Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Rasagiline Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Razagilin Mylan.
Rasagiline Mylan EMA/281859/2016
Razagilin Mylan EMA/75811/2016
They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Povezana so z zmanjšanim učinkom levodope, ko bolnik doživlja nenadne preskoke med stanjem, ko se lahko giba, in stanjem, ko ima z gibanjem težave.
Rasagiline Mylan is available as tablets (1 mg).
Zdravilo Razagilin Mylan je na voljo v tabletah (1 mg).
The Committee recommended that Rasagiline Mylan be approved for use in the EU.
Priporočil je, da se zdravilo Razagilin Mylan odobri za uporabo v EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect.
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 Rasagaline Mylan primerljivo raven kakovosti kot zdravilo Azilect ter da mu je biološko enakovredno.
What measures are being taken to ensure the safe and effective use of Rasagiline Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Razagilin Mylan?
This means that Rasagiline Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Azilect.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Azilect.
Because Rasagiline 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 Razagilin Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
A risk management plan has been developed to ensure that Rasagiline Mylan is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Razagilin Mylan je bil pripravljen načrt obvladovanja tveganj.
What are the benefits and risks of Rasagiline Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Razagilin Mylan?
By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline Mylan reduces the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
S povečevanjem ravni dopamina v delih možganov, ki nadzorujejo gibe in koordinacijo, zdravilo Razagilin Mylan lajša simptome Parkinsonove bolezni, kot sta okornost in počasnost gibov.
For more information about treatment with Rasagiline Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Razagilin Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Rasagiline Mylan can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Zdravilo Razagilin Mylan se lahko uporablja samostojno ali kot dodatek levodopi (drugemu zdravilu, ki se uporablja pri Parkinsonovi bolezni) pri bolnikih z nihanji pri nadzoru njihovega stanja.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Razagilin Mylan in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Therefore, the CHMP's view was that, as for Azilect, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Azilect odtehtajo znana tveganja.
Because Rasagiline Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Azilect.
Ker je zdravilo Razagilin Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Azilect.
For practical information about using Rasagiline Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Razagilin Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Rasagiline Mylan is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Zdravilo Razagilin Mylan se uporablja za zdravljenje Parkinsonove bolezni (napredujoče okvare možganov, ki povzroča tresavico, upočasnjeno gibanje in okorelost mišic) pri odraslih.
Rasagiline Mylan rasagiline
Razagilin Mylan razagilin
Other information about Rasagiline Mylan
Druge informacije o zdravilu Razagilin Mylan
Rasagiline Mylan is a ‘generic medicine'.
Zdravilo Razagilin Mylan je „generično zdravilo“.
What is Rasagiline Mylan and what is it used for?
Kaj je zdravilo Razagilin Mylan in za kaj se uporablja?
It is not intended to provide practical advice on how to use Rasagiline Mylan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Rasagiline Mylan approved?
Zakaj je bilo zdravilo Razagilin Mylan odobreno?
Rasagiline Mylan contains the active substance rasagiline.
Zdravilo Razagilin Mylan vsebuje zdravilno učinkovino razagilin.
It blocks the enzyme monoamine oxidase type B, which breaks down a substance called dopamine in the brain.
Zdravilna učinkovina v zdravilu Razagilin Mylan je razagilin, zaviralec monoaminooksidaze tipa B. Razagilin blokira encim monoaminooksidaze tipa B, ki v možganih razgrajuje snov, imenovano dopamin.
How has Rasagiline Mylan been studied?
Kako je bilo zdravilo Razagilin Mylan raziskano?
How does Rasagiline Mylan work?
Kako zdravilo Razagilin Mylan deluje?
How is Rasagiline Mylan used?
Kako se zdravilo Razagilin Mylan uporablja?
Intramuscular use vial (glass)
100 enot prašek za raztopino za injiciranje intramuskularna uporaba viala (steklena)
dextropropoxyphene/ paracetamol/ caffeine
Jakost/ dekstropropoksifen/ paracetamol/ kofein
ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION
DODATEK III POGOJI ZA PREKLIC UMIKA
For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Da bi umik dovoljenj za promet prenehal veljati, bi morali njihovi imetniki nacionalnim pristojnim organom predložiti naslednje:
Intramuscular, intravenous use
Intramuskularna uporaba, Intravenska uporaba
In addition, in some member states it had been both difficult and time-consuming to collate the relevant data for the purposes of the Article 31 referral, and it would be impractical and, in the medium term, unfeasible to monitor the effectiveness of risk minimization activities in these countries.
Poleg tega je bila v nekaterih državah primerjava ustreznih podatkov za namene napotitve iz člena 31 težka in dolgotrajna, zato bi bilo v teh državah spremljanje učinkovitosti dejavnosti za zmanjšanje tveganja nepraktično in srednjeročno celo neizvedljivo.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
- The Committee concluded that the risks associated with the use of parenteral dextropropoxyphene medicinal products in the treatment of symptomatic pain outweigh the potential benefit as the efficacy has not been demonstrated.
- Odbor je zaključil, da tveganja, povezana z uporabo zdravil, ki vsebujejo parenteralni dekstropropoksifen pri zdravljenju simptomatske bolečine presegajo morebitne koristi, saj učinkovitost ni bila dokazana.
Since the benefit/risk reviews of dextropropoxyphene containing products were carried out in the UK, Sweden, France, and Ireland in 2005 - following which the fixed dose combination product (paracetamol + dextropropoxyphene) was withdrawn from the market in the UK, Sweden, and Ireland - a substantial body of important new safety information has become available.
Odkar so v Združenem kraljestvu, na Švedskem, v Franciji in na Irskem leta 2005 opravili pregled razmerja med koristmi in tveganji zdravil, ki vsebujejo dekstropropoksifen, kar je povzročilo umik zdravil s kombinacijo fiksnih odmerkov (paracetamol + dekstropropoksifen ) s tržišč v Združenem kraljestvu, na Švedskem in Irskem, je bila dana na razpolago obsežna količina pomembnih novih informacij o varnosti.
On the basis of evidence of harm from reports of fatal overdose, of divergent safety reviews and previous regulatory action taken in several Member States, the European Commission initiated a referral under Article 31(2) of Directive 2001/83/EC, as amended, to address this public health issue for medicinal products containing dextropropoxyphene and paracetamol, and therefore referred the matter to the CHMP on 30 November 2007.
Na osnovi dokazov o škodljivih učinkih iz poročil o smrtnih izidih zaradi prevelikih odmerkov, različnih varnostnih pregledih in preteklih regulativnih ukrepov, opravljenih v več državah članicah, je Evropska komisija za obravnavo tega vprašanja javnega zdravja sprožila napotitveni postopek po členu 31(2) Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo dekstropropoksifen in paracetamol, in je zato dne 30. novembra 2007 napotila zadevo na CHMP.
Dextropropoxyphene containing medicinal products (as single component or combination with paracetamol or paracetamol/caffeine) are used in the symptomatic treatment of pain and are currently authorised in several Member States.
Zdravila, ki vsebujejo dekstropropoksifen (kot edino sestavino ali v kombinaciji s paracetamolom ali paracetamolom in kofeinom) se uporabljajo za simptomatsko zdravljenje bolečine in so trenutno odobrena v več državah članicah.
For a single dose of dextropropoxyphene 65 mg in postoperative pain the number needed to treat to benefit for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours.
Za enojni odmerek dekstropropoksifena 65 mg za postoperativno bolečino je bilo število bolnikov, potrebnih za doseganje koristi vsaj 50-odstotnega olajšanja bolečine, 7,7 (95-odstotni interval zaupanja od 4,6 do 22) v primerjavi s placebom v obdobju 4-6 ur.
However no consideration was given to the need for national mortality data, and in particular forensic pathology data, to ensure that any risk minimisation measures are working: it is not possible to use routinely-collected (spontaneous) data to assess the effectiveness of the risk minimisation measures, because of the significant under-reporting of even serious adverse events, including death.
Vendar pa se ni upoštevalo, da so potrebni nacionalni podatki o smrtnosti, zlasti forenzični patološki podatki, da bi zagotovili, da ukrepi za zmanjšanje tveganja delujejo: rutinsko zbranih (spontanih) podatkov za ocenjevanje učinkovitosti ukrepov za zmanjšanje tveganja ni mogoče uporabiti, ker so celo resni neželeni učinki, vključno s smrtjo, nezadostno sporočeni.
The narrow therapeutic index means that accidental overdose is a real possibility under normal conditions of use, particularly for patients on certain concomitant medications or when combined with even a small amount of alcohol.
Ozek terapevtski indeks pomeni, da je nenamerno preveliko odmerjanje realna možnost v normalnih pogojih uporabe, zlasti pri bolnikih, ki prejemajo določena sočasna zdravljenja ali pri zaužitju že majhne količine alkohola.
Although available meta-analyses mostly included single dose studies, these data also provided further insights in the efficacy of the dextropropoxyphene containing medicinal products.
Čeprav so bile v razpoložljive metaanalize večinoma vključene študije enojnih odmerkov, pa ti podatki omogočajo dodaten vpogled v učinkovitost zdravil, ki vsebujejo dekstropropoksifen.
Risk Minimisation measures proposed by the MAHs included restriction of the use of the product (i.e. changes in SPC to restrict the population; pack size reduction), modification of the posology (e.g. reduction of posology in elderly population) and addition of further safety warnings (e.g. on concomitant use with alcohol, dependence and tolerance, combination with other central acting analgesics and overdose in children).
Ukrepi za zmanjšanje tveganja, ki jih je predlagal imetnik dovoljenja za promet z zdravilom so omejitev uporabe zdravila (tj. sprememba v povzetku glavnih značilnosti zdravila za omejitev populacije, manjša velikost pakiranj), sprememba odmerjanja (tj. manjše odmerjanje pri starejši populaciji) ter dodatna varnostna opozorila (npr. o sočasni uporabi alkohola, odvisnosti in toleranci, kombinaciji z drugimi osrednje delujočimi analgetiki ter prevelikem odmerjanju pri otrocih).
Similarly in Ireland, analysis in 2009 of further data from the Alcohol and Drug Research Unit of the Health Research Board revealed significant under-reporting of deaths associated with dextropropoxyphene-containing products - indicating fatality rates fifteen-fold higher than previously reported.
Podobno je na Irskem leta 2009 analiza dodatnih podatkov iz Enote za raziskave alkohola in drog odbora za zdravstvene raziskave razkrila precejšnje število smrti, povezanih z uporabo zdravil, ki vsebujejo dekstropropoksifen, ki niso bile sporočene, kar kaže na petnajstkrat višjo stopnjo smrtnosti, kot je bila sporočena.
In addition, the CHMP considered other known risks associated with the use of parenteral opioids such as the risk of abuse and dependence.
Poleg tega je CHMP upošteval druga znana tveganja, povezana z uporabo parenteralnih opioidov, kot sta tveganje zlorabe in odvisnost;
The availability of a parenteral formulation might be viewed as providing a further therapeutic option, since it would arguably reduce the risk of an accidental overdose (by the patient taking more, because of lack of efficacy) and of intentional overdose (depending on where supplies were held).
Razpoložljivost parenteralne formulacije se lahko vzame kot ponudba dodatne terapevtske možnosti, saj bi mogoče zmanjšala tveganje nenamernega prevelikega odmerka (da bi bolnik vzel več zdravila zaradi pomanjkanja učinkovitosti) in namernega prevelikega odmerka (odvisno od mesta hrambe zalog).
However, the CHMP took note of the narrow therapeutic index of dextropropoxyphen containing products.
Vendar pa je CHMP upošteval ozek terapevtski indeks zdravil, ki vsebujejo dekstropropoksifen.
Therefore the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing dextropropoxyphene.
Zato je priporočil umik vseh dovoljenj za promet z zdravili, ki vsebujejo dekstropropoksifen.
In view of the complex context in which cases of fatal overdose occurred under normal conditions of use and in view of the narrow therapeutic index and the potential for rapid death, the CHMP was of the opinion that the above proposed risk minimisation activities of narrowing the indication, reducing the pack sizes and/or introducing further safety warnings and contraindications (including those beyond the Product Information) would not be able to reduce the risks to an acceptable level.
Zaradi zapletenega ozadja primerov prevelikega odmerjanja s smrtnim izidom ob normalnih pogojih uporabe ter ozkega terapevtskega indeksa in možnosti hitre smrti je CHMP menil, da zgoraj predlagani ukrepi zmanjšanja tveganja, tj. zoženje indikacije, zmanjšanje velikosti pakiranja in/ali uvedba dodatnih varnostnih opozoril ter kontraindikacij (vključno s takimi, ki niso naštete v informacijah o zdravilu) ne bi zmanjšali tveganja na sprejemljivo raven.
On the basis of the available data sources, the CHMP was of the opinion that spontaneous reporting was significantly underestimating the number of reported deaths associated with dextropropoxyphene.
CHMP je na osnovi razpoložljivih virov podatkov menil, da spontana poročila bistveno podcenjujejo število sporočenih smrti, povezanih z dekstropropoksifenom.
A substantial proportion of the fatal overdoses are accidental - occurring under normal conditions of use, for the licensed indication of painand there is a significant public health impact in relation to these cases alone.
Precejšen delež primerov prevelikega odmerjanja s smrtnim izidom je nenameren in se zgodi ob normalnih pogojih uporabe za odobreno indikacijo bolečine, vendar je vpliv na javno zdravje že samo v zvezi s temi primeri pomemben.
Based on the limited efficacy and the significant risk of fatal overdose (in particular accidental overdose), the CHMP was of the opinion that the benefit/risk balance of dextropropoxyphene containing medicinal products was negative.
Na osnovi omejene učinkovitosti in pomembnega tveganja prevelikega odmerjanja s smrtnim izidom (zlasti nenamernega) je CHMP menil, da je razmerje med koristmi in tveganji zaradi zdravil z dekstropropoksifenom negativno.
Although spontaneous reporting suggested that the safety signal concerning the overdose was not significant, other more complete data, particularly from forensic centres and national mortality statistics confirmed that the risk of accidental fatal overdose under normal conditions of use associated with dextropropoxyphene containing products is of major concern, mainly due to their narrow therapeutic index and high case fatality.
Čeprav so spontana poročila kazala, da varnostni signal v zvezi s prevelikim odmerjanjem ni pomemben, so drugi, popolnejši podatki, zlasti iz forenzičnih centrov in nacionalnih statistik umrljivosti, potrdili, da je tveganje nenamernega prevelikega odmerka s smrtnim izidom ob normalnih pogojih uporabe, povezano z zdravili z dekstropropoksifenom, poglaviten zadržek, zlasti zaradi ozkega terapevtskega indeksa in visoke smrtnosti ob uporabi teh zdravil.
In particular, more comprehensive mortality data at a national level from France, notably forensic toxicology results, provided evidence of a significantly greater number of deaths associated with the use of dextropropoxyphene-containing products than had previously been estimated.
Zlasti iz Francije so obsežni podatki o smrtnosti na nacionalni ravni, in sicer pomembni forenzični toksikološki rezultati, zagotovili dokaz o znatno večjem številu smrtnih primerov, povezanih z uporabo zdravil, ki vsebujejo dekstropropoksifen, kot so domnevali prej.
After considering the CHMP's major concerns over the toxicity of dextropropoxyphene, given its narrow therapeutic index and its adverse effects on the cardio - respiratory system as well as the lack of information in relation to the use of single component dextropropoxyphene medicinal products, the European Commission agreed on 31 March 2009 to the extension of the scope of the referral to also include authorised medicinal products containing only dextropropoxyphene.
Po obravnavi poglavitnih zadržkov CHMP glede toksičnosti dekstropropoksifena in ob upoštevanju njegovega ozkega terapevtskega indeksa ter njegovih neželenih učinkov na srčno-dihalni sistem ter pomanjkanja podatkov o uporabi zdravil z dekstropropoksifenom kot edino sestavino, se je Evropska komisija dne 31. marca 2009 odločila razširiti obseg napotitvenega postopka z vključitvijo odobrenih zdravil, ki vsebujejo le dekstropropoksifen.
However, the CHMP considered that parenteral opioids carry further significant risks in themselves, such as abuse/dependence and diversion which are also of major concern.
Vendar je CHMP menil, da parenteralni opioidi sami po sebi pomenijo precejšnja dodatna tveganja, kot so zloraba/odvisnost in rekreativna uporaba, ki so tudi poglaviten razlog za zaskrbljenost.
Also, research in the UK demonstrated the benefits of the withdrawal of dextropropoxyphene from the market - with clear evidence of a fall in number of deaths associated with dextropropoxyphene, but without any rise in mortality from poisoning with other common analgesics.
Raziskava v Združenem kraljestvu je pokazala koristi umika dekstropropoksifena s trga: zmanjšanje števila smrti, povezanih z dekstropropoksifenom, je bilo jasno razvidno, hkrati pa število smrtnih primerov zaradi zastrupitev z drugimi običajnimi analgetiki ni naraslo.
Apart from the strengthened warnings, and more extensive contra-indications, proposed by several MAHs, the other proposals for changes in the SPCs and PLs - for example, in relation to indication - reflected the existing variations across Europe and were often not internally consistent.
Poleg okrepljenih opozoril in podrobnejših kontraindikacij, ki so jih predlagali nekateri imetniki dovoljenja za promet, so bile iz drugih predlaganih sprememb povzetka glavnih značilnosti zdravila in navodila za uporabo, na primer v zvezi z indikacijo, razvidne razlike, ki obstajajo po Evropi, ki pogosto niti notranje niso bile dosledne.
Though a parenteral formulation of dextropropoxyphene might be viewed as providing a further therapeutic option, parenteral opioids carry further significant risks in themselves, such as abuse/dependence and diversion, which would appear difficult to justify in this instance given the lack of evidence of efficacy.
Čeprav lahko parenteralno formulacijo dekstropropoksifena jemljemo kot ponudbo dodatne terapevtske možnosti, parenteralni opioidi sami po sebi pomenijo precejšnja dodatna tveganja, kot so zloraba/odvisnost in rekreativna uporaba, kar je v tem primeru težko utemeljiti, če upoštevamo pomanjkanje dokazov o učinkovitosti.
- Evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
- dokaz o bolnikih, pri katerih je razmerje med koristmi in tveganji pri uporabi zdravila s parenteralnim dekstropropoksifenom pozitivno.
The Committee noted that this risk is limited for the parenteral dextropropoxyphene medicinal products, given the administration under hospital setting (given by healthcare professionals) and the classification of these medicinal products as narcotic prescription (in the Member State where the product is authorised).
Odbor je menil, da je za zdravila, ki vsebujejo parenteralni dekstropropoksifen, omejeno, saj se običajno prejema v bolnišnici (in ga daje usposobljeno zdravstveno osebje), poleg tega so ta zdravila razvrščena kot narkotiki, ki se dobijo na recept (v državi članici, kjer je zdravilo odobreno).
For the suspension to be lifted, the Marketing Authorisation Holders would need to provide evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
Da bi umik dovoljenj za promet prenehal veljati, bi morali njihovi imetniki predložiti dokaze o bolnikih, pri katerih je razmerje med koristmi in tveganji pri uporabi zdravil s parenteralnim dekstropropoksifenom pozitivno.