FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum dose 28 mg/kg/day Consider interruption
Slovenian: 500- 1.000 µg/l najvišji odmerek 28 mg/kg/dan razmislek o prekinitvi zdravljenja pri <500 µg/l
English: Close clinical monitoring is required when deferasirox is combined with these substances.
Slovenian: V primerih uporabe deferasiroksa v kombinaciji z navedenimi zdravilnimi učinkovinami je treba bolnike natančno klinično pregledovati.
English: 6 months)
Slovenian: 6.3 Rok uporabnosti
English: Postmarketing cases of hepatic failure, sometimes fatal, have been reported in patients treated with deferasirox.
Slovenian: Poročali so o primerih resnih preobčutljivostnih reakcij (kot sta anafilaksija in angioedem) pri bolnikih, ki so prejemali deferasiroks.
English: Creatinine clearance
Slovenian: peroralna uporaba
English: • That deferasirox causes rises in serum creatinine in some patients ◦ The need to monitor serum creatinine On two occasions prior to initiation of treatment Every week during the first month of initiation of treatment or after therapy modification
Slovenian: • dejstvo, da deferasiroks pri nekaterih bolnikih povzroča zvišanje koncentracije kreatinina v serumu o potreba po spremljanju koncentracije kreatinina v serumu,
English: Liver function test elevations have been observed in patients treated with deferasirox.
Slovenian: Pri bolnikih, zdravljenih z deferasiroksom, so opazili zvišanje vrednosti testov jetrne funkcije.
English: Frequency
Slovenian: Odmerjanje
English: Immune system disorders Not known:
Slovenian: vnetje požiralnika neznana pogostnost:
English: Tablet core:
Slovenian: 6.1 Seznam pomožnih snovi Jedro tablete:
English: - if you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”).
Slovenian: Pred začetkom jemanja zdravila Deferasiroks Mylan se posvetujte z zdravnikom ali farmacevtom: - če imate težave z ledvicami ali z jetri, - če imate težave s srcem zaradi preobremenitve z železom, - če opazite izrazito zmanjšanje izločanja urina (znak težav z ledvicami), - če dobite hud izpuščaj, če začnete težko dihati, postanete omotični ali začnete otekati pretežno v obraz in grlo/žrelo (znaki hude alergične reakcije, glejte tudi poglavje 4 “Možni neželeni učinki”), - če opazite kombinacijo katerih koli izmed naslednjih simptomov: izpuščaj, predeli rdeče kože,
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Slovenian: Deferasiroks Mylan360 mg filmsko obložene tablete Ovalna bikonveksna filmsko obložena tableta marelične barve z vtisnjeno oznako “ ” na eni strani tablete in ‘DF 2' na drugi strani.
English: Other considerations
Slovenian: DRUGI PODATKI
English: This summary was last updated in August 2012.
Slovenian: Povzetek je bil nazadnje posodobljen avgusta-2012.
English: It is available as a 4mg/5ml concentrate for a solution for infusion.
Slovenian: Na voljo je v obliki 4 mg/5 ml koncentrata za raztopino za infundiranje.
English: The full EPAR for Zoledronic acid Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about treatment with Zoledronic acid Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zoledronska kislina Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Slovenian: Ta zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
English: This leads to less bone loss.
Slovenian: To povzroči zmanjšanje izgube kostne mase.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina Mylan, veljavno po vsej Evropski uniji, odobrila dne 23 avgusta 2012.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Slovenian: Ti zapleti so zlomi kosti, spinalna kompresija (ko hrbtenjačo stisne kost), kostni zapleti, ki zahtevajo radioterapijo (zdravljenje z obsevanjem) ali operacijo, ter hiperkalciemija (visoke ravni kalcija v krvi).
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Slovenian: Pri uporabi za preprečevanje zapletov, povezanih z okostjem, je infundiranje mogoče ponoviti vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D. Pri bolnikih s kostnimi metastazami (kadar se je rak razširil na kost), ki imajo blage do zmerne težave z ledvicami, je priporočljiv manjši odmerek zdravila.
English: Because Zoledronic acid 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.
Slovenian: Ker je zdravilo Zoledronska kislina Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Mylan.
English: This means that Zoledronic acid Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zometa.
English: The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes.
Slovenian: Običajni odmerek zdravila Zoledronska kislina Mylan je ena 4-miligramska infuzija v trajanju najmanj 15 minut.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Zoledronska kislina Mylan primerljivo raven kakovosti kot zdravilo Zometa ter da mu je biološko enakovredno.
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Zometa, odtehtajo znana tveganja.
English: What are the benefits and risks of Zoledronic acid Mylan?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Zoledronska kislina Mylan?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Mylan.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zoledronska kislina Mylan, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It is not recommended for patients with severe kidney problems.
Slovenian: Za bolnike z resnimi težavami z ledvicami zdravilo ni priporočljivo.
English: EPAR summary for the public zoledronic acid
Slovenian: Povzetek EPAR za javnost zoledronska kislina
English: The company provided data from the published literature on zoledronic acid.
Slovenian: Družba je predstavila podatke o zoledronski kislini iz objavljene literature.
English: Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Slovenian: Zdravilo Zoledronska kislina Mylan se lahko uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih z napredovalim rakom, ki zajame kosti.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Slovenian: To pripomore k manjši verjetnosti zloma, kar je koristno za preprečevanje zlomov pri bolnikih z rakom in metastazami v kosteh.
English: Other information about Zoledronic acid Mylan
Slovenian: Druge informacije o zdravilu Zoledronska kislina Mylan
English: Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Slovenian: Zdravilo Zoledronska kislina Mylan smejo uporabljati le zdravniki z izkušnjami z uporabo te vrste zdravil za intravensko uporabo.
English: Zoledronic acid Mylan can also be used to treat the hypercalcaemia caused by tumours.
Slovenian: Zdravilo Zoledronska kislina Mylan se lahko uporablja tudi za zdravljenje hiperkalciemije, ki jo povzročijo tumorji.
English: The Committee recommended that Zoledronic acid Mylan be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Zoledronska kislina Mylan odobri dovoljenje za promet.
English: By preventing the breakdown of bones, Zoledronic acid Mylan also helps to reduce the amount of calcium released into the blood.
Slovenian: Zdravilo Zoledronska kislina Mylan s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
English: Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid.
Slovenian: Zoledronska kislina Mylan je zdravilo, ki vsebuje zdravilno učinkovino zoledronska kislina.
English: The active substance in Zoledronic acid Mylan, zoledronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina zdravila Zoledronska kislina Mylan, zoledronska kislina, je difosfonat.
English: Zoledronic acid Mylan is a ‘generic medicine'.
Slovenian: Zdravilo Zoledronska kislina Mylan je generično zdravilo.
English: Why has Zoledronic acid Mylan been approved?
Slovenian: Zakaj je bilo zdravilo Zoledronska kislina Mylan odobreno?
English: No additional studies in patients were needed as Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Slovenian: Ker je zdravilo Zoledronska kislina Mylan generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Zometa, niso bile potrebne nobene dodatne študije pri bolnikih.
English: What is Zoledronic acid Mylan?
Slovenian: Kaj je zdravilo Zoledronska kislina Mylan?
English: How has Zoledronic acid Mylan been studied?
Slovenian: Kako je bilo zdravilo Zoledronska kislina Mylan raziskano?
English: How does Zoledronic acid Mylan work?
Slovenian: Kako zdravilo Zoledronska kislina Mylan deluje?
English: How is Zoledronic acid Mylan used?
Slovenian: Kako se zdravilo Zoledronska kislina Mylan uporablja?
English: What is Zoledronic acid Mylan used for?
Slovenian: Za kaj se zdravilo Zoledronska kislina Mylan uporablja?
English: Annex
Slovenian: Aneks
English: - The educational pack must be available for distribution for both therapeutic indications prior to the launch of the new indication (prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors) in the Member State.
Slovenian: - Izobraževalno gradivo za obe terapevtski indikaciji mora biti pripravljeno za distribucijo pred lansiranjem nove indikacije (preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo in enim ali več dejavniki tveganja) v državi članici.
English: This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk.
Slovenian: Namen izobraževalnega gradiva je osveščanje o možnem tveganju krvavitev med zdravljenjem s Pradaxo in svetovanje o načinih obvladovanja tega tveganja.
English: - The content and format of the educational material, together with a communication plan, is agreed with the MAH prior to distribution of the educational pack.
Slovenian: - Vsebina in oblika izobraževalnega gradiva ter načrt sporočanja morata biti pred distribucijo usklajena z imetnikom dovoljenja za promet.
English: The Prescriber Guide should contain the following key safety messages: - Details of populations potentially at higher risk of bleeding - Recommendation not to use Pradaxa in patients with prosthetic heart valves - Recommendation for kidney function measurement - Recommendations for dose reduction in at risk populations - Management of overdose situations - The use of coagulation tests and their interpretation - That all patients should be provided with a Patient alert card and be counselled about:
Slovenian: Navodilo za predpisovalca mora vsebovati naslednje ključne varnostne podatke: - podroben opis populacij, pri katerih je predvidoma povečano tveganje krvavitve - priporočilo, da zdravilo Pradaxa ni primerno za uporabo pri bolnikih z umetnimi srčnimi zaklopkami - priporočilo za merjenje ledvičnega delovanja - priporočila o zmanjšanju odmerka pri populacijah s povečanim tveganjem
English: o An instruction how to take Pradaxa
Slovenian: o Navodila za jemanje zdravila Pradaxa
English: - An instruction how to take Pradaxa
Slovenian: - Navodila za jemanje zdravila Pradaxa
English: The physician educational pack should contain: - The Summary of Product Characteristics - Prescriber Guide - Patient Alert Cards
Slovenian: - navodilo za predpisovalca - kontrolno kartico za zdravnika
English: o Importance of treatment compliance o The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Slovenian: o podatke o znakih in simptomih krvavitev in navodilo, kdaj poiskati zdravstveno pomoč o opozorilo o pomembnosti upoštevanja navodil o jemanju zdravila o navodilo, da mora imeti bolnik kontrolno kartico vedno pri sebi o opozorilo, da mora bolnik zdravstveno osebje pred vsako operacijo ali invazivnim posegom opozoriti, da jemlje Pradaxo.
English: The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: - The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Slovenian: - Imetnik dovoljenja za promet z zdravilom bo za vsako terapevtsko indikacijo pripravil izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali ali uporabljali Pradaxo.
English: The Patient alert card should contain the following key safety messages: o Signs or symptoms of bleeding and when to seek attention from a health care provider.
Slovenian: - navodilo, da morajo vsi bolniki prejeti kontrolno kartico in da jih je treba podučiti o: o znakih in simptomih krvavitev ter o tem, kdaj poiskati zdravstveno pomoč o pomenu upoštevanja navodil o jemanju zdravila o da morajo imeti kontrolno kartico vedno pri sebi o da morajo zdravstveno osebje pred vsako operacijo ali invazivnim posegom opozoriti,
English: 15 OTHER INFORMATION
Slovenian: 15 DRUGE INFORMACIJE
English: All risks relating to the target animal, the user and the environment are adequately addressed in the product literature.
Slovenian: Vsa tveganja, povezana s ciljno živaljo, uporabnikom in okoljem, so ustrezno obravnavana v literaturi o zdravilu.
English: All three field studies were performed in animal shelter situations within a limited geographical area.
Slovenian: Vse tri terenske študije so bile opravljene v okoliščinah živalskega zavetišča na omejenem geografskem območju.
English: Due to the use of a very low sample size in two of the studies, only one study was considered to have produced reliable results and so the following comments are based on just this study.
Slovenian: Ker je bil v dveh študijah uporabljen zelo majhen vzorec, se je samo za eno študijo štelo, da je dala zanesljive rezultate, zato naslednje pripombe temeljijo samo na tej študiji.
English: Overall summary of the scientific evaluation of Seresto and its associated name Foresto (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Seresto in povezanega imena Foresto (glejte Prilogo I)
English: The dogs were each infested with 80 female sand flies on 13 occasions (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, and 222).
Slovenian: Vsak pes je bil trinajstkrat izpostavljen 80 samicam peščene muhe (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215 in 222).
English: The study duration was 300 days ± 10 days, and the treated animals wore the collar for the first 210 ± 10 days of this period.
Slovenian: Študija je trajala 300 dni ± 10 dni, zdravljene živali pa so ovratnico nosile prvih 210 ± 10 dni v tem obdobju.
English: Netherlands Bayer B.V., Animal Health Division Energieweg 1
Slovenian: Nizozemska Bayer B.V., Animal Health Division Energieweg 1
English: An animal was considered positive for leishmaniosis if positive to one or more tests used.
Slovenian: Žival je bila ocenjena kot pozitivna za leishmaniozo, če je bila pozitivna pri eni ali več uporabljenih preiskav.
English: In summary, the UK considered that the efficacy of Seresto for the proposed indication has not been sufficiently demonstrated and that accepting the indication could pose a serious risk to animal and human health.
Slovenian: Skratka, Združeno kraljestvo je menilo, da učinkovitost zdravila Seresto za predlagano indikacijo ni dovolj dokazana in da bi sprejem te indikacije lahko pomenil resno tveganje za zdravje živali in ljudi.
English: In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
Slovenian: V tej laboratorijski študiji je bilo 14 psov randomiziranih na zdravljenje z ovratnico z zdravilom Seresto (n = 7) ali nezdravljeno kontrolo (n = 7).
English: 12 SPECIAL WARNING(S)
Slovenian: 12 POSEBNO(A) OPOZORILO(A)
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnika dovoljenja za promet v državah članicah
English: However, as they were conducted in animal shelters in Southern Italy, the UK considered that it is not possible to extrapolate the findings from these studies relating to transmission of leishmaniosis to all areas of the EU where the disease is endemic.
Slovenian: Ker pa so bile izvedene v zavetiščih za živali v južni Italiji, je Združeno kraljestvo menilo, da ugotovitev teh študij o prenosu leishmanioze ni mogoče prenesti na vsa območja EU, na katerih je bolezen endemična.
English: This is a variation application for an already-authorised product (Seresto); no further risks have been identified in the studies provided.
Slovenian: To je vloga za spremembo za že odobreno zdravilo (zdravilo Seresto); v predloženih študijah niso bila ugotovljena nobena nadaljnja tveganja.
English: The benefit-risk balance for the agreed indication is considered favourable.
Slovenian: Razmerje med tveganji in koristmi pri sprejeti indikaciji je ugodno.
English: 1 Guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a) - link
Slovenian: 1 Guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a) - link leishmanioze.
English: Of the thirteen assessment time points, an anti-feeding efficacy above 80% was only achieved on three occasions.
Slovenian: Od trinajstih časovnih točkah ocenjevanja je bila učinkovitost, večja od 80%, pri preprečevanju hranjenja dosežena samo trikrat.
English: Both Guideline 7AE17a and Guideline EMEA/CVMP/EWP/005/2000-Rev.2 state that field studies should be performed in at least two geographical regions and the animal population studied should be representative of the target population.
Slovenian: V skladu s smernicami 7AE17a in EMEA/CVMP/EWP/005/2000-Rev.2 je treba terenske študije opraviti na vsaj dveh geografskih območjih, proučevana populacija živali pa mora predstavljati ciljno populacijo.
English: In the same studies, the incidence density rates in untreated dogs (60.7%, 46.2% and 67.0% respectively) demonstrated the high infection pressure present in the field situations used.
Slovenian: V istih študijah je stopnja pojavnosti pri nezdravljenih psih (60,7%, 46,2% in 67,0%) v uporabljenih terenskih okoliščinah pokazala velik okužbeni pritisk.
English: Treated dogs were continually treated with Seresto throughout the study period, with the collar being replaced as necessary due to growth of the animal or according to the label instructions for the product.
Slovenian: Zdravljeni psi so bili v obdobju študije stalno zdravljeni z zdravilom Seresto, pri čemer je bila ovratnica po potrebi zamenjana zaradi rasti živali ali skladno z navodili za uporabo zdravila.
English: Furthermore, there are specific difficulties inherent in the demonstration of such a claim: there is, at present, no validated laboratory model which can determine the efficacy of a veterinary medicinal product against leishmaniosis.
Slovenian: Poleg tega so z dokazovanjem te trditve povezane določene težave: trenutno ni potrjenega laboratorijskega modela, ki lahko dokaže učinkovitost veterinarskega zdravila proti leishmaniozi.
English: The study ran between April/May and December 2013 (approximately eight months), and there was a post-treatment phase which ran until April/May 2014.
Slovenian: Študija je potekala med aprilom/majem in decembrom 2013 (približno osem mesecev), nato pa je do aprila/maja 2014 potekala stopnja po zdravljenju.
English: The efficacy threshold of 80-100% (preferably 90%) as recommended in the guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a)1 was not met at sufficient time points.
Slovenian: Prag učinkovitosti od 80 do 100% (po možnosti 90%), kot je priporočeno v smernicah Dokazovanje učinkovitosti ektoparaziticidov (7AE17a),1 ni bil dosežen v dovolj časovnih točkah.
English: The amended summary of product characteristics, labelling and package leaflet are set out in Annex III.
Slovenian: Spremenjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Prilogi III.
English: According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
Slovenian: V skladu s smernicami 7AE17a bi moral biti prag učinkovitosti pri dvokrilcih 80-100% (po možnosti več kot 90%).
English: The use of fed to unfed female sand flies ratios in Abbott's formula is not considered acceptable as a method for calculation of percentage efficacy as ratios have been used incorrectly to approximate risks (probabilities).
Slovenian: Uporaba razmerja med hranjenimi in nehranjenimi peščenimi muhami v Abbottovi formuli ne šteje za sprejemljivo metodo za izračun učinkovitosti v odstotkih, saj so bila razmerja za približno oceno tveganj (verjetnosti) uporabljena nepravilno.
English: In support of this application, the MAH provided laboratory and field studies.
Slovenian: V podporo tej vlogi je imetnik dovoljenja za promet z zdravilom predložil laboratorijske in terenske študije.
English: Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Slovenian: Zdravilo Seresto vsebuje zdravilni učinkovini imidakloprid 10% in flumetrin 4,5%.
English: Czech Republic
Slovenian: Republika Češka