natgillin/translations-raw huggingface dataset:
Further information on Deferiprone Lipomed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Deferiprone Lipomed so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects.
Odmerki nad 100 mg/kg na dan niso priporočljivi zaradi morebitnega povečanja tveganja za neželene učinke.
Over time, the excess iron can damage important organs such as the heart or liver.
Sčasoma lahko odvečno železo poškoduje pomembne organe, kot so srce ali jetra.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Dve zdravili sta bioekvivalentni, kadar dosegata enake ravni učinkovine v telesu in se zato pričakuje, da bosta imeli enak učinek.
Patients with thalassaemia major need frequent blood transfusions.
Bolniki s talasemijo major potrebujejo pogosto transfuzijo krvi.
The doctor may interrupt treatment if iron levels in the body get too low.
Zdravnik lahko prekine zdravljenje, če se ravni železa v telesu spustijo prenizko.
The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Podjetje je izvedlo tudi študijo, ki je pokazala, da je zdravilo „bioekvivalentno“ referenčnemu zdravilu.
The usual dose of Deferiprone Lipomed is 75 mg per kilogram body weight each day, divided into three separate doses.
Običajni odmerek zdravila Deferiprone Lipomed je 75 mg na kilogram telesne mase vsak dan, razdeljenih v tri ločene odmerke.
• on its own, when standard iron chelator treatment cannot be used or is inadequate;
• samostojno, kadar standardnega zdravljenja s kelatorjem železa ni mogoče uporabiti ali ni ustrezno;
The doctor may adjust the dose of Deferiprone Lipomed depending on the patient's response, which should be measured every two to three months with blood tests.
Zdravnik lahko prilagodi odmerek zdravila Deferiprone Lipomed glede na bolnikov odziv, ki ga je treba s krvno preiskavo izmeriti vsaka dva do tri mesece.
This helps to correct the iron overload and prevent damage due to excess iron.
To pomaga odpraviti prenasičenost z železom in preprečevati poškodbe zaradi njegovega presežka.
• in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions requires rapid or intensive correction of iron levels.
• v kombinaciji z drugim kelatorjem železa, kadar samostojno zdravljenje z enim kelatorjem železa ni učinkovito ali kadar preprečevanje ali zdravljenje življenjsko nevarnih bolezni zahteva hitro ali intenzivno spremembo ravni železa.
It attaches to iron in the body to form a compound that can be excreted by the body, mainly in the urine, and to a lesser extent in the stools.
Veže se na železo v telesu in pri tem tvori spojino, ki jo telo lahko izloča, predvsem z urinom in v manjši meri z blatom.
What measures are being taken to ensure the safe and effective use of Deferiprone Lipomed?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Deferiprone Lipomed?
This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.
To je dedna bolezen, pri kateri bolniki ne morejo tvoriti dovolj hemoglobina, beljakovine v rdečih krvničkah, ki po telesu prenaša kisik.
Because Deferiprone Lipomed 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 Deferiprone Lipomed generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Medicines Agency concluded that, in accordance with EU requirements, Deferiprone Lipomed has been shown to have comparable quality and to be bioequivalent to Ferriprox.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Deferiprone Lipomed primerljivo raven kakovosti in je bioekvivalentno z zdravilom Ferriprox.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ferriprox, and do not need to be repeated for Deferiprone Lipomed.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Ferriprox, zato jih ni treba ponoviti za zdravilo Deferiprone Lipomed.
When patients receive repeated transfusions, the transfused red cells bring iron into the body.
Če bolniki prejmejo večkratno transfuzijo, prenesene rdeče krvničke s seboj prinesejo tudi železo.
As for every medicine, the company provided studies on the quality of Deferiprone Lipomed.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Deferiprone Lipomed.
Why is Deferiprone Lipomed authorised in the EU?
Zakaj je bilo zdravilo Deferiprone Lipomed odobreno v EU?
The company that markets Deferiprone Lipomed will ensure that patients taking the medicine, or their carers, are provided with a reminder card with information on how to take the medicine safely.
Podjetje, ki trži zdravilo Deferiprone Lipomed, bo zagotovilo, da bodo bolniki, ki jemljejo to zdravilo, ali njihovi skrbniki prejeli opozorilno kartico s podatki o varnem jemanju zdravila.
An overview of Deferiprone Lipomed and why it is authorised in the EU
Pregled zdravila Deferiprone Lipomed in zakaj je odobreno v EU
Side effects reported with Deferiprone Lipomed are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Deferiprone Lipomed, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Deferiprone Lipomed is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Zdravilo Deferiprone Lipomed je „kelator železa“ (snov, ki se veže na železo), ki se uporablja za zdravljenje prenasičenosti z železom (prevelike količine železa v krvi) pri bolnikih s talasemijo major.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferiprone Lipomed have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Deferiprone Lipomed upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
This means that Deferiprone Lipomed contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Ferriprox.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Ferriprox.
What is Deferiprone Lipomed and what is it used for?
Kaj je zdravilo Deferiprone Lipomed in za kaj se uporablja?
As for all medicines, data on the use of Deferiprone Lipomed are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Deferiprone Lipomed stalno spremljajo.
What are the benefits and risks of Deferiprone Lipomed?
Kakšne so koristi in tveganja zdravila Deferiprone Lipomed?
However, the body does not have a natural way of removing excess iron, so it builds up.
Vendar telo presežne količine železa ne more odstraniti po naravni poti, zato se to kopiči.
For more information about using Deferiprone Lipomed, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Deferiprone Lipomed glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Deferiprone Lipomed
Druge informacije o zdravilu Deferiprone Lipomed
The active substance in Deferiprone Lipomed, deferiprone, is an iron chelator.
Učinkovina zdravila Deferiprone Lipomed, deferipron, je kelator železa.
Deferiprone Lipomed can only be obtained with a prescription and treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.
Predpisovanje in izdaja zdravila Deferiprone Lipomed je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem bolnikov s talasemijo.
Deferiprone Lipomed contains the active substance deferiprone and is a ‘generic medicine'.
Zdravilo Deferiprone Lipomed vsebuje učinkovino deferipron in je „generično zdravilo“.
Deferiprone Lipomed is available as 500 mg tablets to be taken by mouth.
Na voljo je v obliki 500-miligramskih tablet, ki se jemljejo peroralno.
How has Deferiprone Lipomed been studied?
Kako je bilo zdravilo Deferiprone Lipomed raziskano?
Therefore, the Agency's view was that, as for Ferriprox, the benefit of Deferiprone Lipomed outweighs the identified risk and it can be authorised for use in the EU.
Zato je agencija menila, da koristi zdravila Deferiprone Lipomed, enako kot pri zdravilu Ferriprox, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
Deferiprone Lipomed is used:
Zdravilo Deferiprone Lipomed se uporablja:
How is Deferiprone Lipomed used?
Kako se zdravilo Deferiprone Lipomed uporablja?
How does Deferiprone Lipomed work?
Kako zdravilo Deferiprone Lipomed deluje?
* Withdrawal period (milk): - Zero hours after calving (when the dry period length is 32 days or more) - 4 days (8 milkings) after calving (when the dry period length is less than 32 days)
* Karenca (mleko): - Nič ur po telitvi (ko je doba presušitve 32 dni ali več) - 4 dni (8 molž) po telitvi (ko je doba presušitve manj kot 32 dni)
Annex A EU (MA) Number Invented name
EU (MA) številka Izmišljeno ime
Cattle (dairy cows)
Govedo (krave molznice)
5 vials Meat and offal: 23 days
Meso in organi: 23 dni
Packaging Content Package size
Način uporabe Pakiranje Vsebina Velikost pakiranja
Route of administration
5 vial
More information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Več informacij o zdravilih sirotah je na voljo tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The applicant requested a re-examination of the opinion.
Vlagatelj je zahteval ponovni pregled mnenja.
What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 1 April 2016.
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in dne 1. aprila 2016 potrdil zavrnitev vloge za dovoljenje za promet.
The Committee confirmed the opinion that the effectiveness of Dropcys in the treatment of corneal deposits had not been sufficiently demonstrated and that there were unresolved issues regarding the formulation and long-term safety and sterility of the medicine.
Odbor je potrdil mnenje, da učinkovitost zdravila Dropcys pri zdravljenju depozitov v roženici ni bila zadostno dokazana in da obstajajo nerešena vprašanja v zvezi s formulacijo, varnostjo pri dolgoročni uporabi in sterilnostjo zdravila.
What is Dropcys?
Kaj je zdravilo Dropcys?
During the re-examination, the CHMP looked again at the data from the company.
Odbor CHMP je pri ponovnem pregledu spet pregledal podatke družbe.
The CHMP considered that the studies from the medical literature presented to support the application were insufficient.
Odbor CHMP je menil, da so študije iz medicinske literature, predstavljene v podporo vlogi, nezadostne.
In addition, the CHMP had concerns regarding other ingredients of the medicine, their impact on long-term safety, particularly in children, and how stable and sterile the solution would be once prepared.
Poleg tega je imel odbor CHMP zadržke glede drugih sestavin zdravila, njihovega učinka na varnost pri dolgoročni uporabi, zlasti pri otrocih, ter stabilnosti in sterilnosti raztopine po pripravi.
Although the role of mercaptamine eye drops in the treatment of corneal deposits appears sufficiently supported by the literature, current clinical recommendations and its routine use in hospital preparations, there were few data supporting the effectiveness of the concentration of mercaptamine used in Dropcys (0.1% solution).
Čeprav vlogo merkaptamina v obliki kapljic za oči pri zdravljenju oblog roženice v zadostni meri podpira literatura, trenutna klinična priporočila in rutinska uporaba bolnišničnih pripravkov, je malo podatkov, ki podpirajo učinkovitost koncentracije merkaptamina, uporabljene v zdravilu Dropcys (0,1 % raztopina).
The build-up of cystine crystals inside corneal cells can damage the eyes and cause serious vision problems.
Kopičenje kristalov cistina v celicah roženice lahko poškoduje oči in povzroči hude težave z vidom.
Because mercaptamine has been used for many years to treat cystinosis and its use is well established, the applicant presented data from the medical literature to support its application for Dropcys.
Ker se merkaptamin uporablja že vrsto let za zdravljenje cistinoze in je njegova uporaba dobro uveljavljena, je predlagatelj v podporo svoji vlogi za zdravilo Dropcys predstavil podatke iz medicinske literature.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Dropcys.
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Dropcys.
Dropcys is a medicine that contains the active substance mercaptamine hydrochloride (also known as cysteamine hydrochloride).
Dropcys je zdravilo, ki vsebuje zdravilno učinkovino merkaptaminijev hidroklorid (znan tudi kot cisteaminijev hidroklorid).
Cystinosis is a rare inherited disease caused by the accumulation of a substance called cystine, which forms crystals inside cells, particularly cells in the cornea and kidneys.
Cistinoza je redka dedna bolezen, ki nastane kot posledica kopičenja snovi, imenovane cistin, ki tvori kristale v celicah, zlasti v celicah roženice in ledvic.
Dropcys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 October 2014 for the treatment of cystinosis.
Zdravilo Dropcys je bilo dne 15. oktobra 2014 določeno kot »zdravilo sirota« (zdravilo za zdravljenje redkih boleznih) za zdravljenje cistinoze.
Medicines containing mercaptamine hydrochloride are authorised in the EU for use by mouth in the treatment of cystinosis.
Zdravila, ki vsebujejo merkaptaminijev klorid so dovoljena v EU za peroralno uporabo pri zdravljenju cistinoze.
On 17 December 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dropcys, intended to prevent and treat the build-up of the amino acid cystine in the cornea (the transparent layer in front of the eye).The company that applied for authorisation in the EU is Lucane Pharma.
Dne 17. decembra 2015 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje in priporočil zavrnitev dovoljenja za promet z zdravilom Dropcys, namenjenim preprečevanju in zdravljenju kopičenja aminokisline cistina v roženici (prozorne plasti na prednji strani očesa).
When the medicine is applied to the eye, the amount of cystine in the cells of the cornea was expected to be reduced, limiting the amount of eye damage.
Pričakovati je bilo, da se bo po vkapanju zdravila v oko količina cistina v celicah roženice zmanjšala in s tem omejila obseg poškodb očesa.
The active substance in Dropcys, mercaptamine hydrochloride, was expected to react with cystine to dissolve it and to form substances that could be removed from the cells.
Zdravilna učinkovina v zdravilu Dropcys, merkaptaminijev klorid, naj bi reagirala s cistinom, ga raztopila in tvorila snovi, ki se lahko odstranijo iz celic.
It was to be available as a powder and a solvent, to make a solution for eye drops.
Bilo je na voljo v obliki praška in vehikla za pripravo kapljic za oko.
Therefore, the CHMP was of the opinion that the benefits of Dropcys did not outweigh its risks and recommended that it be refused marketing authorisation.
Posledično je odbor CHMP tedaj menil, da koristi zdravila Dropcys ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z njim zavrne.
What was Dropcys expected to be used for?
Za kaj naj bi se zdravilo Dropcys uporabljalo?
Ophthalmic (eye) formulations of mercaptamine are made up locally and used for the management of eye symptoms.
Formulacije merkaptamina za oko se pripravljajo lokalno in se uporabljajo za zdravljenje očesnih simptomov.
Thus, the CHMP reaffirmed its previous recommendation that the medicine be refused marketing authorisation.
Tako je odbor CHMP potrdil svoje prejšnje priporočilo, da se dovoljenje za promet z njim zavrne.
What were the CHMP's main concerns that led to the refusal?
Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP predlagal zavrnitev dovoljenja za promet?
Dropcys was expected to be used to prevent and treat cystinosis affecting the cornea.
Zdravilo Dropcys naj bi se uporabljalo za preprečevanje in zdravljenje cistinoze v roženici.
How was Dropcys expected to work?
Kako naj bi zdravilo Dropcys delovalo?
Immediate Packaging
Stična ovojnina Velikost pakiranja
Pack size
Jakost
Overall summary of the scientific evaluation
Splošni povzetek znanstvenega vrednotenja
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for metformin containing medicinal products.
• odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metformin;
These patients form a large population which currently may have not access to the benefits of metformin across the Union.
Ti bolniki tvorijo veliko populacijo iz celotne EU, ki trenutno morda nima dostopa do metformina in njegovih koristi.
On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Zato je Nizozemska 25. januarja 2016 sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosila, naj oceni vpliv navedenih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, ter izda mnenje o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
The risk of lactic acidosis is very rare in clinical practice and in the majority of cases only observed in emergency care.
Tveganje za laktacidozo je v klinični praksi zelo redko in so ga v večini primerov opazili le pri nujni medicinski oskrbi.
Moreover, metformin treatment slows the further deterioration of renal function and provides additional significant micro-and macrovascular benefits in this patient population.
Poleg tega zdravljenje z metforminom upočasni nadaljnje slabšanje delovanja ledvic in tej populaciji bolnikov zagotavlja dodatne pomembne mikro- in makrovaskularne koristi.
Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Metformin, ki se jemlje samostojno ali v kombinaciji z drugimi zdravili, velja za prvo izbiro pri zdravljenju sladkorne bolezni tipa 2 in se v EU pogosto uporablja.
Recent scientific data have concluded that the main causes of lactic acidosis are cardiogenic or hypovolemic shock, severe heart failure, severe trauma, and sepsis; therefore lactic acidosis is not primarily caused by metformin treatment.
Najnovejši znanstveni podatki kažejo, da so glavni vzroki za laktacidozo kardiogeni ali hipovolemični šok, hudo srčno popuščanje, huda travma in sepsa, zato zdravljenje z metforminom ni primarni vzrok za laktacidozo;
Grounds for CHMP opinion
Podlaga za mnenje odbora CHMP
As there is a clear relationship between renal function and metformin exposure, a recommendation for a daily dose of 2000 mg/day and 1000 mg/day dose in patients with moderate renal impairment stages 3a and 3b, respectively, can be concluded from the data provided.
Ker obstaja jasna povezava med delovanjem ledvic in izpostavljenostjo metforminu, se lahko iz predloženih podatkov izpelje priporočilo za dnevni odmerek 2000 mg/dan za bolnike z zmerno ledvično okvaro stopnje 3a in 1000 mg/dan za bolnike z zmerno ledvično okvaro stopnje 3b.
It is considered in the interest of the Union that the adequacy of the current recommendations for metformin containing products is re-evaluated with respect to the use in patients with moderate renal failure, taking into account the available information on the risk of lactic acidosis.
V interesu EU je, da se primernost trenutnih priporočil za zdravila, ki vsebujejo metformin, v zvezi z uporabo pri bolnikih z zmerno ledvično okvaro ponovno ovrednoti, pri čemer je treba upoštevati razpoložljive informacije o tveganju za laktacidozo.
Moreover, recent clinical guidelines in the treatment of T2DM recommend the use of metformin in moderate renal impairment.
Poleg tega najnovejše klinične smernice za zdravljenje sladkorne bolezni tipa 2 priporočajo uporabo metformina pri zmerni ledvični okvari.
Currently the use of metformin in patients with renal failure is not harmonised across the EU, being contraindicated in patients with different stages of moderate renal failure depending on the member state and product.
Trenutno uporaba metformina pri bolnikih z ledvično okvaro po EU ni usklajena, saj je kontraindiciranost pri bolnikih z različnimi stopnjami zmerne ledvične okvare odvisna od države članice in zdravila.
Based on the review of all available data on safety and efficacy, the benefit-risk balance of medicinal products containing metformin remains favourable and it is recommended that the marketing authorisations are varied regarding the use in renal impairment.
Na podlagi vseh razpoložljivih podatkov o varnosti in učinkovitosti ostaja razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, še naprej ugodno, priporoča pa se, da se dovoljenja za promet z zdravilom v zvezi z uporabo pri ledvični okvari spremenijo.
The benefits of metformin in the treatment of T2DM in patients with moderate renal impairment have been demonstrated in terms of the reduction of cardiovascular risk and all-cause mortality.
Ugodni učinki metformina pri zdravljenju sladkorne bolezni tipa 2 pri bolnikih z zmerno ledvično okvaro so dokazani v smislu zmanjšanja kardiovaskularnega tveganja in smrtnosti iz vseh vzrokov.
In addition, published epidemiological studies indicate that metformin is often used in clinical practice in patients with moderate renal impairment as reflected in current clinical guidelines without a marked increase in risk of lactic acidosis or other serious side effects.
Poleg tega objavljene epidemiološke študije kažejo, da se metformin pri bolnikih z zmerno ledvično okvaro v klinični praksi pogosto uporablja, kar odražajo tudi sedanje klinične smernice, ne da bi se bistveno povečalo tveganje za laktacidozo ali druge resne neželene učinke;
• The CHMP considered that publications in the medical literature have shown that metformin at reduced dose may be safely used in patients with moderate renal impairment.
• odbor CHMP je menil, da objave v medicinski literaturi kažejo, da se metformin v zmanjšanem odmerku pri bolnikih z zmerno ledvično okvaro lahko varno uporablja.