natgillin/translations-raw huggingface dataset:
The infusion should last one to two hours, but it may last longer if the patient has certain side effects.
Infundiranje mora trajati od ene do dveh ur, lahko pa tudi dlje, če se pri bolniku pojavijo določeni neželeni učinki.
What measures are being taken to ensure the safe and effective use of Trisenox?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trisenox?
The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Trisenox večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Looking at the results of these two studies together, 87% of the patients had complete remission (45 out of 52).
Pri pregledu rezultatov obeh študij skupaj je popolno remisijo doseglo 87 % (45 od 52)bolnikov.
• Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
• bolnikih, katerih bolezen se ni odzvala na predhodno zdravljenje z retinoidi in zdravili za zdravljenje raka ali kadar se je bolezen po taki vrsti zdravljenja ponovila.
The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Najpogostejši neželeni učinki zdravila Trisenox (opaženi pri 1 bolniku od 10) so hiperglikemija (povečane ravni glukoze v krvi), hipomagneziemija (nizke ravni magnezija v krvi), hipokaliemija (nizke ravni kalija v krvi), parestezija (nenavadni občutki zbadanja), omotica, glavobol, tahikardija (hitro bitje srca), dispneja (oteženo dihanje), sindrom diferenciacije (morebitni usodni zapleti pri kemoterapiji pri bolnikih z akutno promielocitno levkemijo), driska, bruhanje, navzeja (slabost), pruritus (srbenje), izpuščaj, mialgija (bolečine v mišicah), pireksija (povišana telesna temperatura), bolečine, utrujenost, edem (otekanje), podaljšan interval QT na elektrokardiogramu (sprememba električne dejavnosti srca) ter povišane ravni alanin aminotrasferaze in aspartat aminotransferaze (jetrnih encimov).
97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.
Pri 97 % (72 od 74) bolnikov, ki so bili zdravljeni z zdravilom Trisenox, se ni pojavil noben dogodek primerjavi s 86 % (65 od 76) bolnikov, ki so bili zdravljeni s antraciklini.
This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered.
To pomeni, da v kostnem mozgu ni bilo več levkemičnih celic, ravni trombocitov in belih krvnih celic v krvi pa so se popravile.
Trisenox was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Zdravilo Trisenox je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
During the induction phase, Trisenox is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Med uvodno stopnjo se zdravilo daje vsak dan, dokler se ne pojavijo znaki, da zdravljenje deluje (kostni mozeg ne vsebuje več levkemičnih celic).
The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia.
Zdravilna učinkovina v zdravilu Trisenox, arzenov trioksid, je kemikalija, ki se v zdravilih uporablja že mnogo let, vključno pri zdravljenju levkemije.
Other information about Trisenox
Druge informacije o zdravilu Trisenox
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trisenox have 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 Trisenox upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
During the consolidation phase, Trisenox is given once a day for five days, followed by a two-day break, repeated for four or five weeks.
Med utrditveno stopnjo se zdravilo daje enkrat na dan pet dni zapored, čemur sledi dvodnevna prekinitev, vse skupaj pa je treba ponavljati štiri ali pet tednov.
Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Bolniki z akutno promielocitno levkemijo se navadno zdravijo z retinoidi (snovmi, pridobljenimi iz vitamina A).
The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Translokacija prizadene rast belih krvnih celic, zaradi česar posledično ne morejo izrabljati retinojske kisline (vitamina A).
Trisenox is used in:
Zdravilo Trisenox se uporablja pri:
Trisenox was not compared with any other medicine in either study.
V nobeni študiji zdravila Trisenox niso primerjali z drugimi zdravili.
Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Zdravilo Trisenox se uporablja za zdravljenje odraslih (starejših od 18 let) z akutno promielocitno levkemijo (APL), tj. redko obliko levkemije (rakom belih krvnih celic)., ki jo povzroča genetska „translokacija“ (zamenjava genov med dvema kromosomoma).
For the full list of all side effects and restrictions with Trisenox, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Trisenox glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Trisenox.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Trisenox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Trisenox preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Trisenox?
Kakšna tveganja so povezana z zdravilom Trisenox?
Why is Trisenox approved?
Zakaj je bilo zdravilo Trisenox odobreno?
Trisenox can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Predpisovanje in izdaja zdravila Trisenox je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi oblikami levkemije.
The recommended dose of Trisenox depends on the body weight of the patient.
Priporočeni odmerek zdravila Trisenox je odvisen od telesne mase bolnika.
What benefits of Trisenox have been shown in studies?
Kakšne koristi je zdravilo Trisenox izkazalo v študijah?
Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid.
Zdravilo Trisenox je bilo raziskano tudi v dveh študijah, v katerih je skupaj sodelovalo 52 bolnikov z akutno promielocitno levkemijo, ki so bili predhodno zdravljeni z antraciklinom in retinoidom.
What is Trisenox and what is it used for?
Kaj je zdravilo Trisenox in za kaj se uporablja?
• Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA).
• bolnikih z novo diagnosticirano nizko ali srednjo stopnjo tveganja za nastanek akutne promielocitne levkemije, kadar se zdravilo jemlje skupaj z zdravilom, ki vsebuje vse-transretinojsko kislino (ATRA);
For practical information about using Trisenox, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Trisenox naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Trisenox arsenic trioxide
Trisenox arzenov trioksid
The number of times these cycles are repeated depends on whether patients have received previous treatment or not.
Število ponovljenih ciklov je odvisno od tega, ali so bili bolniki predhodno že zdravljeni ali ne. Za več informacij glejte navodilo za uporabo.
Trisenox contains the active substance arsenic trioxide.
Zdravilo Trisenox vsebuje zdravilno učinkovino arzenov trioksid.
How does Trisenox work?
Kako zdravilo Trisenox deluje?
How is Trisenox used?
Kako se zdravilo Trisenox uporablja?
Trisenox has been investigated in 159 newly diagnosed patients who had not yet received any treatment for APL. Trisenox was compared with an anthracycline (a type of cancer medicine), both taken in combination with ATRA, and the measure of effectiveness was the number of patients who did not experience any event (such as worsening of their disease or death) 2 years after diagnosis.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se dve leti po postavljeni diagnozi ni pojavil noben dogodek (npr. poslabšanje bolezni ali smrt).
At the request of the CHMP, an ad-hoc expert advisory group meeting was convened in February 2013.
Na zahtevo odbora CHMP je bil februarja 2013 sklican sestanek ad hoc svetovalne strokovne skupine.
However these imbalances involved small numbers of events.
Vendar pa razlike temeljijo na majhnem številu dogodkov.
Overall summary of the scientific evaluation of cilostazol containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo cilostazol (glejte Prilogo I)
Results for secondary efficacy endpoints were consistent with the results for ACD.
Rezultati za sekundarne opazovane dogodke učinkovitosti so bili skladni z rezultati za ACD.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC on cilostazolcontaining medicinal products;
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo cilostazol;
The protocol of the studies was agreed by the CHMP.
Protokol študij je odobril CHMP.
It was recognised that less adverse events than expected had been reported.
Strinjali so se, da je bilo poročil o neželenih dogodkih manj, kot so pričakovali.
The CASTLE study included patients who were treated up to 3 years.
V študiji CASTLE so bolniki zdravilo prejemali do 3 leta.
• The Committee reviewed all the data provided by the MAHs in writing and in the oral explanation and the outcome of the ad-hoc expert advisory group meeting;
• Odbor je preučil vse podatke, ki so jih imetniki dovoljenj za promet z zdravili podali v obliki pisne dokumentacije in ustnih obrazložitev, ter ugotovitve s sestanka ad hoc strokovne svetovalne skupine;
The CHMP also agreed to the introduction of measures to ensure health care professionals are informed on the conditions of use of the product.
CHMP je odobril uvedbo ukrepov, s katerimi bi zagotovili seznanjenost zdravstvenih delavcev s pogoji uporabe zdravila.
The primary objective of the CASTLE trial was to assess the long-term effect of cilostazol on all-cause mortality.
Glavni cilj študije CASTLE je bil oceniti dolgoročni učinek cilostazola na smrtnost iz katerega koli razloga.
This Article 31 referral was initiated by Spain following review of safety reports received in association with cilostazol during the first 18 months of marketing in Spain (cilostazol was licenced in Spain in 2008).
Napotitev v skladu s členom 31 je sprožila Španija, potem ko je pregledala poročila o varnosti, povezana z uporabo cilostazola v prvih 18 mesecih trženja zdravila v Španiji (cilostazol je bil v Španiji odobren leta 2008).
The CHMP also concluded that the risk of bleeding was higher in patients treated concomitantly with two or more additional antiplatelet or anticoagulants agents.
CHMP je zaključil tudi, da je bilo tveganje za krvavitve večje pri bolnikih, ki so bili sočasno zdravljeni z dvema ali več drugimi antiagregacijskimi ali antikoagulacijskimi zdravili.
In order to measure the effectiveness of the above measures, the CHMP has agreed on two drug utilisation studies (DUS).
Da bi ocenili učinkovitost omenjenih ukrepov, je CHMP odobril dve študiji uporabe zdravila.
Suitability of treatment with cilostazol should be carefully considered, alongside other treatment options such revascularisation.
Primernost zdravljenja s cilostazolom je treba skrbno preučiti skupaj z drugimi možnostmi zdravljenja, kot je na primer revaskularizacija.
The need to review the patient's response to treatment at 3 months and to continue treatment only if positive was agreed by all.
Vsi so se strinjali, da je treba po treh mesecih preučiti odziv bolnika in nadaljevati zdravljenje samo, če je ta pozitiven.
Therefore the CHMP recommended the variation to the terms of the Marketing Authorisations for the cilostazol-containing medicinal products referred to in Annex I, in accordance to the amendments to the Summary of Product Characteristics, Labelling and Package Leaflet set out in Annex III and subject to the conditions set out in Annex IV.
Zato je CHMP priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo cilostazol, navedenimi v Prilogi I, skladno s spremembami povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, opredeljenimi v Prilogi III, ter s pogoji, navedenimi v Prilogi IV.
To ensure that health care professionals are informed of the correct indication for use of the product, the MAH has introduced the following measures: proactive communication to physicians on the Otsuka Europe website, re-training of the Medical Information teams and Sales Force teams in the countries where cilostazol is marketed.
Za zagotovitev seznanjenosti zdravstvenih delavcev z ustrezno indikacijo za uporabo zdravila je imetnik dovoljenja za promet z zdravilom predlagal naslednje ukrepe: aktivno obveščanje zdravnikov prek spletne strani družbe Otsuka Europe ter ponovno usposabljanje ekip za posredovanje zdravstvenih informacij in prodajnih ekip v državah, v katerih se trži cilostazol.
Spain therefore referred cilostazol to the CHMP/EMA, requesting that it gives its opinion under Article 31 of Directive 2001/83/EC, on whether the marketing authorisations for medicinal products containing cilostazol should be maintained, varied, suspended or withdrawn.
Zato je Španija za cilostazol sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in zahtevala, da CHMP/EMA poda mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo cilostazol, ohraniti, spremeniti, začasno umakniti ali preklicati.
The efficacy of cilostazol has been evaluated in 14 clinical trials which enrolled more than 4000 intermittent claudication (IC) patients.
Klinično učinkovitost cilostazola so ocenjevali v 14 kliničnih preskušanjih, v katera je bilo vključenih več kot 4 000 bolnikov z intermitentno klavdikacijo (IK).
This leads to inhibition of platelet activation and aggregation and prevents the release of prothrombotic inflammatory and vasoactive substances.
Tako zavira aktiviranje in agregacijo trombocitov ter preprečuje sproščanje protrombotičnih vnetnih in vazoaktivnih snovi.
The group considered that it was feasible to exclude high cardiovascular risk patients in practice, and that this would also limit the risk of drug interaction with antiplatelet agents (as most patients in these groups would receive dual antiplatelet therapy).
Skupina je menila, da je mogoče v praksi izključiti bolnike z visokim kardiovaskularnim tveganjem, s čimer bi omejili tudi tveganje za medsebojno delovanje z antiagregacijskimi zdravili (ker večina bolnikov iz te skupine prejema dvotirno antiagregacijsko zdravljenje).
In total 3,122 patients were randomised and received at least one dose of investigational product in the 9 efficacy trials.
V devetih študijah učinkovitosti so skupno randomizirali 3 122 bolnikov, ki so prejeli vsaj en odmerek preiskovanega zdravila.
It was noted by the CHMP that the increase in walking distance on flat ground is likely to be greater than the increase measured on the treadmill - which is set on an incline.
CHMP je upošteval, da bi bilo povečanje prehojene razdalje na ravnih tleh verjetno večje kot tisto, ki so ga izmerili na tekočem traku (ki je nameščen pod naklonom).
Cilostazol is mainly metabolised by CYP3A4, and CYP2C19 and has two main active metabolites, OPC13015 (dehydrocilostazol, 3-7 times more potent than cilostazol), and OPC-13213 (trans-hydroxycilostazol, 2 - 5 times less potent than cilostazol).
Cilostazol se pretežno presnavlja s CYP3A4 in CYP2C19 ter ima dva glavna aktivna presnovka, OPC-13015 (dehidrocilostazol, 3- do 7-krat močnejši od cilostazola) in OPC-13213 (trans-hidroksicilostazol, 2- do 5-krat šibkejši od cilostazola).
• The Committee has reviewed all adverse drug reaction data and clinical trial data associated with Cilostazol; in particular the cardiovascular events and bleeding reactions.
• Odbor je preučil vse podatke o neželenih učinkih zdravila in podatke iz kliničnih študij, povezane s cilostazolom; še zlasti podatke o kardiovaskularnih dogodkih in krvavitvah.
The experts were first asked to discuss the current standard approach to the clinical management of peripheral arterial occlusive disease (PAOD), the characteristics of the patients treated with cilostazol and the clinical relevance of the benefits of cilostazol.
Strokovnjaki so najprej razpravljali o trenutnem standardnem pristopu h kliničnemu zdravljenju periferne arterijske okluzivne bolezni (PAOB), značilnostih bolnikov, zdravljenih s cilostazolom, in kliničnem pomenu koristi cilostazola.
It also inhibits the vascular smooth muscle cell proliferation as well as decreases triglycerides and increases HDL-cholesterol.
Prav tako zavira proliferacijo celic žilnih gladkih mišic in znižuje ravni trigliceridov ter zvišuje ravni holesterola HDL.
In view of this, the CHMP considered that patients treated concomitantly with two or more additional antiplatelet or anticoagulant agents (e.g. aspirin acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban) should not be treated with cilostazol-containing products.
Zato je CHMP menil, da bolniki, ki sočasno uporabljajo dva ali več antiagregacijskih ali antikoagulacijskih zdravil (npr. acetilsalicilno kislino (aspirin), klopidogrel, heparin, varfarin, acenokumarol, dabigatran, rivaroksaban ali apiksaban), ne bi smeli uporabljati zdravil, ki vsebujejo cilostazol.
The experts agreed that the CASTLE study had some limitations (including early termination and high rate of dropout, study restrictive in certain patient groups, exclusion of high risk patients, and review of the patients by their doctors in a 6-month period) but that some of those were expected with such a long term Phase IV study.
Strokovnjaki so se strinjali, da je študija CASTLE imela nekaj pomanjkljivosti (vključno s predčasnim zaključkom in visoko stopnjo prekinitve zdravljenja, omejitvami v nekaterih skupinah bolnikov, izločanjem bolnikov z visokim tveganjem in zdravniškim pregledom v šestmesečnem obdobju), vendar pa so bile nekatere pričakovane glede na tako dolgo trajanje študije IV. faze.
The range of improvement was between +28% to +100% for cilostazol, and -10% to +42% for placebo in the individual trials.
Obseg izboljšanja je bil v posameznih preskušanjih od +28 % do +100 % pri cilostazolu in od -10 % do +42 % pri placebu.
Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili
A closer monitoring of treatment success after 3 months instead of 6 months, with a view to discontinuing cilostazol where the treatment effect is considered to be inadequate is now recommended.
Priporočil je tudi natančnejše spremljanje uspešnosti zdravljenja po treh namesto šestih mesecih in prekinitev zdravljenja s cilostazolom, kadar je učinek zdravljenja nezadosten.
Excesses in bleeding time during cilostazol treatment outside a prespecified range as to be defined in the protocol will be assessed and appropriate risk minimisation measures will be proposed when the final study report is available.
V njej bodo ocenjevali čas krvavitev med zdravljenjem s cilostazolom, daljšim od dopustnega, ki bo določen v protokolu, nato pa bodo po predložitvi končnega poročila o študiji sprejeti primerni ukrepi za zmanjšanje tveganja.
It was recognised by the experts that the benefit of cilostazol products was small but was clinically significant, and enough to restore independence for some patients and to get them started with their rehabilitation program.
Strokovnjaki so potrdili, da so koristi zdravil, ki vsebujejo cilostazol, majhne, vendar klinično pomembne in zadostne, da lahko nekateri bolniki znova postanejo samostojni in začnejo program rehabilitacije.
The Committee is of the opinion, considering the metabolism of cilostazol, that there is a potential for interactions that could increase the risks associated with cilostazol.
Odbor meni, da zaradi načina presnove cilostazola obstaja možnost medsebojnega delovanja, ki bi lahko povečalo tveganja, povezana s cilostazolom;
The study was terminated prematurely as a result of a lower than expected event rate and higher than expected drop-out rate.
Študijo so predčasno zaključili zaradi dejstva, da je bila pogostnost dogodkov manjša, stopnja prekinitve zdravljenja pa višja od pričakovane.
A drug utilisation study conducted in one region of Spain found that patients receiving cilostazol were older and used more concomitant medications than those in the clinical trials.
Študija uporabe zdravila, ki so jo izvedli v eni od španskih pokrajin, je pokazala, da so bili bolniki, ki so jim predpisali cilostazol, starejši in so sočasno uporabljali več zdravil kot tisti v kliničnih preskušanjih.
The primary endpoint in the nine efficacy trials (called mid-term trials) was maximum walking distance (absolute claudication distance - ACD), measured by exercise treadmill testing.
Primarni opazovani dogodek v devetih študijah učinkovitosti (imenovanih srednjeročne študije) je bila najdaljša prehojena razdalja (absolutna klavdikacijska razdalja - ACD), izmerjena med preskusom s hojo po tekočem traku.
However, they recognised that there is a risk of bleeding with triple therapy and that triple therapy should be avoided (cilostazol and two antiplatelet drugs).
So pa strokovnjaki potrdili, da obstaja tveganje za krvavitve pri tritirnem zdravljenju, ki se mu je zato treba izogniti (cilostazol in dve antiagregacijski zdravili).
• In view of the above safety concerns, the Committee agreed on a number of risk minimisation measures, including changes to the product information to strengthen the wording of the PI to reduce the risk of haemorrhagic events, cardiac events and potential drug-drug interactions (contra-indication in at-risk patients, recommendation of adjustment of the dose, strengthening of the warning to ensure suitability of the treatment with cilostazol).
• ob upoštevanju zgoraj navedenih zadržkov glede varnosti je Odbor določil več ukrepov za zmanjšanje tveganja, ki vključujejo spremembe informacij o zdravilu, s katerimi bi spremenili besedilo tako, da bi zmanjšali tveganje za krvavitve, srčne dogodke in morebitno medsebojno delovanje zdravil (kontraindikacija pri bolnikih s povečanim tveganjem, priporočena prilagoditev odmerka, okrepitev opozoril za zagotovitev ustreznosti zdravljenja s cilostazolom).