natgillin/translations-raw huggingface dataset:
In particular, three open randomised studies conducted in the EU and the US and two placebo controlled studies conducted in the US showed that dexrazoxane significantly reduced the incidence of cardiac events (primarily a fall in left ventricular ejection fraction - LVEF) in breast cancer patients treated with doxorubicin.
Zlasti so tri odprte randomizirane študije, opravljene v EU in ZDA, ter dve s placebom nadzorovani študiji, opravljeni v ZDA, pokazale, da je deksrazoksan bistveno zmanjšal pojavnost srčnih dogodkov (zlasti upad iztisnega deleža levega prekata - LVEF) pri bolnikih z rakom dojke, zdravljenih z doksorubicinom.
The fact that clinical trials of razoxane (a racemic mixture of S(+)dexrazoxane and R(-) levrazoxane) were suspended due to safety concerns related to AML added to the concerns.
Zadržke je okrepilo dejstvo, da so bila klinična preskušanja razoksana (racemna zmes S(+)deksrazoksana in R(-) levrazoksana) zaustavljena zaradi varnostnih zadržkov v zvezi z AML.
The role of dexrazoxane in preventing epirubicin cardiotoxicity was also investigated in clinical studies which reported a reduction in the incidence of cardiac events (primarily a fall in LVEF) in patients treated with dexrazoxane and epirubicin compared with epirubicin alone.
Vlogo deksrazoksana pri preprečevanju kardiotoksičnosti epirubicina so raziskovali tudi v kliničnih študijah, v katerih so poročali o zmanjšani pojavnosti srčnih dogodkov (predvsem upadu LVEF) pri bolnikih, zdravljenih z deksrazoksanom in epirubicinom, v primerjavi z epirubicinom kot samostojnim zdravilom.
During the evaluation of a periodic safety update report (PSUR), concerns were raised regarding an increase risk of second malignancies neoplasms (SMN), in particular acute myelogenous leukaemia (AML)/myelodyspastic syndrome (MDS) and solid tumours in paediatric patients observed in studies reported in the literature.
Med vrednotenjem z zadnjimi podatki dopolnjenega rednega poročila o varnosti zdravila (PSUR) so se pojavili zadržki glede povečanega tveganja sekundarnih malignih novotvorb, zlasti akutne mielogene levkemije (AML)/mielodisplastičnega sindroma (MDS) in čvrstih tumorjev pri pediatričnih bolnikih, ki so jih opazovali v študijah iz literature.
A significantly increased risk of other toxicities compared to controls were also reported in the study in paediatric patients with Hodgkin's disease and included grade 4 neutropenia, grade 3/4 thrombocytopenia, grade 3/4 sepsis and grade 3/4 pulmonary toxicity.
O bistveno večjem tveganju drugih toksičnosti v primerjavi s kontrolami so poročali tudi v študiji pri pediatričnih bolnikih s Hodgkinovo boleznijo, in sicer o nevtropeniji 4. stopnje, trombocitopeniji 3/4.
An increased risk of myelosuppression and infection was also observed in paediatric patients.
Pri pediatričnih bolnikih so ugotovili tudi povečano tveganje mielosupresije in okužbe.
Dexrazoxane efficacy in the prevention of anthracycline cardiotoxicity is supported by available clinical trial data.
Razpoložljivi podatki iz kliničnih preskušanj podpirajo učinkovitost deksrazoksana pri preprečevanju kardiotoksičnosti antraciklina.
Two large randomised open studies in childhood Hodgkin's disease and acute lymphoblastic leukaemia (ALL) reported a three-fold increase in the incidence of second primary malignancies (particularly AML and MDS) in dexrazoxane treated patients compared with controls.
V dveh velikih randomiziranih odprtih študijah otroške Hodgkinove bolezni in akutne limfoblastne levkemije (ALL) so poročali o trikrat večji pojavnosti drugih primarnih malignih tvorb (zlasti AML in MDS) pri bolnikih, zdravljenih z deksrazoksanom, v primerjavi s kontrolami.
the CHMP recommends the variation to the terms of the marketing authorisation of dexrazoxanecontaining medicinal products (see Annex I), for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III.
Odbor priporoča spremembo pogojev dovoljenja za promet z zdravili, ki vsebujejo deksrazoksan (glejte Dodatek I), katerih zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so navedena v Dodatku III. CHMP priporoča tudi pogoje dovoljenj za promet z zdravili, kot so navedeni v Dodatku IV.
Regarding use of dexrazoxane in paediatric patients, available data on the efficacy of dexrazoxane was considered very limited by the CHMP, as only one adequately sized randomised study which used troponin T as a surrogate endpoint is available.
CHMP je v zvezi z uporabo deksrazoksana pri pediatričnih bolnikih menil, da je razpoložljivih podatkov o učinkovitosti deksrazoksana zelo malo ter da je na voljo le ena primerno velika randomizirana študija, v kateri so kot nadomestno končno točko uporabili troponin T. Čeprav so v zgodnjem poročilu ugotovili pomemben učinek na ravni troponina T, v posodobljeni analizi po petletnem spremljanju mediane niso dokazali klinične koristi.
Grounds for amendment of the summary of product characteristics and package leaflet
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
You should specifically tell your doctor if you take:
Zdravnika zlasti obvestite, če jemljete:
What you need to know before you take [X] Other medicines and [X]
Kaj morate vedeti, preden boste vzeli zdravilo [X] Druga zdravila in zdravilo [X]
- anti-retroviral medicines (medicines to treat HIV infections).
- protiretrovirusna zdravila (zdravila za zdravljenje okužbe z virusom HIV).
Adopted at the 13-16 May 2019 PRAC
Sprejeto na seji odbora PRAC med 13. in 16. majem 2019
There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.
Poročali so o dolgotrajni spolni disfunkciji, pri kateri so se simptomi nadaljevali kljub prekinitvi zdravljenja s SSRI/SNRI.
Rare: spots in front of eyes, glaucoma, double vision, light hurts eye, blood in the eye, unequal sized pupils, vision abnormal, tear problem
Redki: pike pred očmi, glavkom, dvojni vid, boleče oči zaradi svetlobe, kri v očesu, zenice neenake velikosti, nenormalen vid, težave s solzenjem
2 Desvenlafaxine; duloxetine; milnacipran; venlafaxine
2 Desvenlafaksin; duloksetin; milnacipran; venlafaksin.
Not known: partial loss of vision
Neznana pogostnost: delna izguba vida
Sertraline - Maculopathy (EPITT no 19341)
Sertralin - makulopatija (št. EPITT 19341)
Not known: maculopathy
Neznana pogostnost: makulopatija
Medicines like [Invented name] (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Zdravila, kot je zdravilo [izmišljeno ime] (t. i. SSRI/SNRI), lahko povzročijo simptome spolne disfunkcije (glejte poglavje 4).
Pantoprazole - Colitis microscopic (EPITT no 19342)
Pantoprazol - mikroskopski kolitis (št. EPITT 19342)
Serotonin and noradrenaline reuptake inhibitors (SNRI)2; selective serotonin reuptake inhibitors (SSRI)3 4 - Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)
Zaviralci ponovnega privzema serotonina in noradrenalina (SNRI)2; selektivni zaviralci ponovnega privzema serotonina (SSRI)3 4 - trajna spolna disfunkcija po prekinitvi zdravila (št. EPITT 19277)
Clopidogrel; clopidogrel, acetylsalicylic acid - Interaction with boosted antiviral human immunodeficiency virus (HIV) therapy leading to insufficient inhibition of platelet aggregation (EPITT no 19325)
Klopidogrel; klopidogrel, acetilsalicilna kislinainterakcija z okrepljenim protiretrovirusnim zdravljenjem okužbe z virusom humane imunske pomanjkljivosti (HIV), ki privede do nezadostnega zavrtja agregacije trombocitov (št. EPITT 19325)
Inflammation in the large bowel, that causes persistent watery diarrhoea
Neznana pogostnost: vnetje v debelem črevesu, ki povzroča dolgotrajno vodeno drisko
Undesirable effects Eye disorders
Preglednica z neželenimi učinki Bolezni prebavil
Interaction with other medicinal products and other forms of interaction A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri bolnikih, okuženih z virusom HIV, ki se zdravijo s protiretrovirusnim zdravljenjem, okrepljenim z ritonavirjem ali kobicistatom, so dokazali pomembno zmanjšano izpostavljenost aktivnemu presnovku klopidogrela in zmanjšano zaviranje trombocitov.
Undesirable effects Tabulated list of adverse reactions Gastrointestinal disorders Frequency not known: Microscopic colitis
Neznana pogostnost: mikroskopski kolitis
3 Citalopram; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline 4 Clomipramine and vortioxetine were part of the signal assessment but are not concerned by the recommendation to update the product information.
4 Klomipramin in vortioksetin sta bila del ocenjevanja signala, vendar ju priporočilo za posodobitev informacij o zdravilu ne zadeva.
PRESENT DECISION:
SEDANJA ODLOČBA
It follows from the above:
Iz zgoraj navedenega sledi:
BACKGROUND:
OZADJE
Moreover, the relevance of new information was discussed in the meeting.
Na sestanku je bil poleg tega obravnavan tudi pomen novih informacij.
• This disagreement was also observed in the Standing Committee meeting of 20 January 2008.
• to nasprotovanje je bilo opaziti tudi na sestanku Stalnega odbora 20. januarja 2008.
The Standing Committee for Medicinal Products for Human Use discussed the matter on 20 January 2008.
Stalni odbor za zdravila za ljudi je zadevo obravnaval 20. januarja 2008.
The CHMP could not reach a majority for the adoption of the opinion with the same recommendations.
CHMP ni mogel doseči večine za sprejetje mnenja z enakimi priporočili.
ANNEX V DETAILED EXPLANATION OF THE REASONS FOR THE ADDITIONAL CONDITIONS AND RESTRICTIONS TO THE CHMP OPINION
DODATEK V PODROBNA RAZLAGA VZROKOV ZA DODATNE POGOJE IN OMEJITVE GLEDE MNENJA CHMP
The majority view within the CHMP sustained such maintenance when the committee adopted its opinion of 20 September 2007 and it appears adequate to follow this majority view.
Večina v CHMP je podprla takšno ohranitev, ko je odbor 20. septembra 2007 sprejel mnenje, in zdi se ustrezno, da se temu večinskemu mnenju sledi.
The European Commission considers it appropriate to maintain the marketing authorisation for medicinal products containing nimesulide.
Evropska komisija meni, da je ohranitev dovoljenj za promet za zdravila, ki vsebujejo nimesulid, primerna.
The restriction of the indication in the summary of the product characteristics should ensure that this prescription practice is followed in all Member States where the product is authorised.
Omejitev indikacij v povzetku značilnosti proizvoda mora zagotoviti, da se takšno predpisovanje zdravila izvaja v vseh državah članicah, v katerih je proizvod dovoljen.
The use of nimesulide in second line treatment is already recommended in some Member States via prescription guidelines.
Uporaba nimesulida v sekundarnem zdravljenju se v nekateri državah članicah že priporoča v smernicah za predpisovanje zdravil.
These relate in particular to restrictions to the indications (with a limitation to second line treatment) and to conditions of use and prescription practices.
To je zlasti povezano z omejitvami glede indikacij (z omejitvijo glede sekundarnega zdravljenja) ter pogoji uporabe in načini predpisovanja zdravil.
However, in view of the severity of the adverse events, these measures should in the Commission's perspective be further intensified by (1) limiting the prescription of nimesulide to second line treatment and by (2) introducing a clear obligation upon the marketing authorisation holder to inform healthcare professionals of the safety risks associated with this product.
Toda glede na resnost neželenih učinkov je treba po mnenju Komisije te ukrepe nadalje okrepiti z (1) omejevanjem predpisovanja nimesulida v sekundarnem zdravljenju in z (2) uvajanjem jasne obveznosti imetnika dovoljenja za promet z zdravilom, da zdravstvene delavce obvesti glede tveganj za varnost, povezanih s tem proizvodom.
The opinion adopted by the Committee for Medicinal Products for Human Use on 20 September 2007 recommended the maintenance of the national marketing authorisations for nimesulide-containing medicinal products with the introduction of several risk minimisation measures (limitation of the maximum duration of treatment, safety warnings in the product information, additional safety studies).
V mnenju, ki ga je 20. septembra 2007 sprejel Stalni odbor za zdravila za ljudi, je priporočena ohranitev nacionalnih dovoljenj za promet za zdravila, ki vsebujejo nimesulid, z uvedbo več ukrepov za zmanjševanje tveganj (omejitev najdaljšega trajanja zdravljenja, varnostna opozorila v informacijah o proizvodu, dodatne študije o varnosti).
It also appeared from the discussions that certain Member States were applying at national level measures not reflected in the harmonised product information and intended to further reduce the risks associated with nimesulide.
Razprave so pokazale, da so nekatere države članice na nacionalni ravni uporabljale ukrepe, ki jih usklajene informacije o proizvodu ne odražajo in ki so bili namenjeni nadaljnjemu zmanjševanju tveganj, povezanih z nimesulidom.
In view of this situation, the Commission chairman decided not to submit the draft decision to a vote by the Standing Committee during the meeting but to refer the matter to the CHMP for further examination of any new reports of suspected hepatotoxicity related to nimesulide and identification and consideration of existing national measures, such as guidelines or recommendations, in relation to the use of nimesulide with a view to recommending necessary risk minimisation measures.
Glede na navedene okoliščine se je predsednik Komisije odločil, da Stalnemu odboru ne bo posredoval osnutka Odločbe Komisije v odločanje med sestankom, temveč bo predložil zadevo CHMP za nadaljnjo proučitev kakršnih koli poročil o sumu jetrne toksičnosti, povezane z nimesulidom, ter za ugotavljanje in pregled obstoječih nacionalnih ukrepov, kot so smernice ali priporočila, v zvezi z uporabo nimesulida, da se priporočijo potrebni ukrepi za zmanjšanje tveganja.
It was furthermore noted that alternative products also present some risks, namely of gastrointestinal bleeding.
Opozorjeno je bilo tudi, da tudi drugi proizvodi povzročajo tveganje, zlasti krvavitev iz prebavil.
• On the other hand, the switching from nimesulide to other Non-Steroidal Anti-inflamatory drugs may lead to an increase of gastrointestinal toxicity occurrences.
• po drugi strani lahko prehod z nimesulida na druga nesteroidna protivnetna zdravila povzroči povečanje gastrointestinalne toksičnosti.
The relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of nimesulide and of the Conditions of the Marketing Authorisation are amended as set out in Annexes III and IV of this Decision.
Ustrezni oddelki Povzetka glavnih značilnosti zdravila in Navodila za uporabo za zdravila za sistemsko uporabo, ki vsebujejo nimesulid, ter Pogoji dovoljenj za promet z zdravilom so spremenjeni, kot je določeno v Dodatkih III in IV te odločbe.
These additional measures should contribute to minimising the risks associated with the use of nimesulide whilst awaiting the results of the Article 31 referral.
Ti dodatni ukrepi morajo prispevati k zmanjševanju tveganj, povezanih z uporabo nimesulida, dokler ne bodo na voljo rezultati postopka iz člena 31.
• There are divergent views within the CHMP on the assessment of whether this risk may be addressed through risk minimisation measures allowing maintenance of the products on the market or whether the risk is such that the authorisation should be revoked.
• v CHMP obstajajo nasprotna mnenja o oceni, ali bi se to tveganje lahko odpravilo z ukrepi zmanjševanja tveganja ob ohranitvi proizvodov na trgu ali če je to tveganje takšno, da bi bilo treba dovoljenja ukiniti,
By letter dated 26 June 2008, the Chairman of the CHMP has informed the Commission that following the assessment of the new additional reports and consideration of other risk minimisation measures, the assessment report was updated with the new factual information and a CHMP opinion containing the same recommendations as the September opinion was put to a vote in the CHMP.
Z dopisom z dne 26. junija 2008 je predsednik CHMP obvestil Komisijo, da se je poročilo o oceni po oceni novih dodatnih poročil in ob upoštevanju drugih ukrepov za zmanjševanje tveganja posodobilo z novimi dejstvi, o mnenju CHMP, ki zajema enaka priporočila kot septembrsko mnenje, pa se je glasovalo v CHMP.
The restriction of the indication to second line treatment is intended to ensure that nimesulide is not used as a routine pain killer where other treatment options which present a reduced hepatotoxic risk are available.
Z omejitvijo indikacij za sekundarno zdravljenje se želi zagotoviti, da se nimesulid ne uporablja kot rutinsko zdravilo proti bolečinam, če so na voljo druge možnosti zdravljenja z manjšim hepatotoksičnim tveganjem.
The risk minimisation measures proposed by the CHMP shall also be introduced as it is uncontested that the maintenance of the product in the market has to be accompanied by measures aiming at lowering the possibility of adverse events.
Prav tako se vključijo tudi ukrepi za zmanjševanje tveganja, ki jih predlaga CHMP, saj je neizpodbitno, da mora ohranjanje proizvoda na trgu spremljati ukrep za zmanjšanje možnosti neželenih učinkov.
In the course of the meeting, it became clear that there would be neither a qualified majority in support of a draft Commission decision following the opinion of the CHMP nor a qualified majority against it.
Med sestankom je postalo jasno, da osnutka Odločbe Komisije na podlagi mnenja CHMP ne bo podprla kvalificirana večina, prav tako pa kvalificirana večina ne bo proti njemu.
This approach is strengthened by the fact that a full risk-benefit assessment is to be conducted in the framework an Article 31 procedure, where the risks of nimesulide will be weighted vis-à-vis the gastrointestinal risks of other products.
Ta pristop krepi dejstvo, da je treba celovito oceno tveganja in koristi izvesti v okviru postopka iz člena 31, med katerim se bodo tveganja v zvezi z nimesulidom obravnavala glede na gastrointestinalna tveganja drugih proizvodov.
A significant number of members of the Committee expressed however a divergent opinion, sustaining that the benefit/risk profile of these products should be considered negative and that the marketing authorisations should rather be revoked.
Precejšnje število članov odbora pa je kljub temu nasprotno menilo, da je treba lastnosti glede koristi/tveganja teh proizvodov obravnavati negativno in da je treba dovoljenja za promet ukiniti.
Upon recommendation from the CHMP, given that an assessment of the gastrointestinal toxicity of nimesulide was outside the scope of the review procedure under Article 107, the Commission will initiate a referral under Article 31 of Directive 2001/83/EC, under which a full risk-benefit assessment will be undertaken.
Glede na to, da je bila ocena gastrointestinalne toksičnosti nimesulida zunaj obsega revizijskega postopka iz člena 107, bo Komisija na podlagi priporočila CHMP začela postopek iz člena 31 Direktive 2001/83/ES, v okviru katerega se bo izvedla celovita ocena tveganja in koristi.
It also appeared that a fundamental disagreement persisted among Member States competent authorities on whether risk minimisation measures were capable of addressing the risk of hepatotoxicity of the product.
Izkazalo se je tudi, da pri pristojnih organih držav članic ostaja temeljno nesoglasje o tem, ali je bilo z ukrepi za zmanjševanje tveganj mogoče odpraviti tveganje jetrne toksičnosti proizvoda.
• Nimesulide presents a risk of hepatotoxicity, including risk of fulminant hepatic failure.
• nimesulid povzroča tveganje za jetrno toksičnost, vključno s fulminantno jetrno odpovedjo,
Therefore, an increase in gastrointestinal toxicity events may occur if nimesulide ceases to be available.
Če nimesulid ne bi bil več na voljo, se lahko poveča število pojavov gastrointestinalne toksičnosti,
This is a summary of the European public assessment report (EPAR) for Tolucombi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tolucombi.
The full EPAR for Tolucombi 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 Tolucombi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Tolucombi on 13 March 2013.
Evropska komisija je dovoljenje za promet z zdravilom Tolucombi, veljavno po vsej Evropski uniji, odobrila dne 13. marca 2013.
What measures are being taken to ensure the safe and effective use of Tolucombi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tolucombi?
This means that Tolucombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu MicardisPlus.
The Committee recommended that Tolucombi be approved for use in the EU.
Priporočil je, da se zdravilo Tolucombi odobri za uporabo v EU.
Tolucombi telmisartan / hydrochlorothiazide
Tolucombi telmisartan/hidroklorotiazid
Because Tolucombi 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 Tolucombi generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Other information about Tolucombi
Druge informacije o zdravilu Tolucombi
Tolucombi is a ‘generic medicine'.
Zdravilo Tolucombi je „generično zdravilo“.
A risk management plan has been developed to ensure that Tolucombi is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Tolucombi je bil izdelan načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tolucombi, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Tolucombi vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Tolucombi is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Zdravilo Tolucombi je na voljo v obliki tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida), ki se zaužijejo peroralno enkrat dnevno skupaj s tekočino.
What are the benefits and risks of Tolucombi?
Kakšne so koristi in tveganja, povezani z zdravilom Tolucombi?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tolucombi has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Tolucombi primerljivo raven kakovosti kot zdravilo MicardisPlus ter da mu je biološko enakovredno.
For more information about treatment with Tolucombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tolucombi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Because Tolucombi is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Ker je zdravilo Tolucombi generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu MicardisPlus.