FrancophonIA/ELRC3.0 huggingface dataset:
English: phaeochromocytoma (a tumour of the adrenal gland); a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Slovenian: feokromocitomom (tumorjem nadledvične žleze); anamnezo nevroleptičnega malignega sindroma (nevarne bolezni živčnega sistema, ki jo običajno povzročijo antipsihotična zdravila) ali rabdomiolizo (razgradnjo mišičnega tkiva).
English: The company used some of the data from Comtess/Comtan to support the use of Stalevo and presented data from the published literature for levodopa and carbidopa.
Slovenian: Družba je v podporo uporabi zdravila Stalevo uporabila nekatere podatke o zdravilu Comtess/Comtan in predstavila podatke iz objavljene literature o levodopi in karbidopi.
English: Stalevo must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Slovenian: Zdravilo Stalevo se ne sme uporabljati skupaj z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrsta antidepresivov).
English: The most common side effects with Stalevo (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), aggravated Parkinsonism (worsening of Parkinson's disease), nausea (feeling sick) and harmless urine discoloration.
Slovenian: Najpogostejši neželeni učinki zdravila Stalevo (opaženi pri več kot 1 bolniku od 10) so diskinezija (nekontrolirani gibi), poslabšanje parkinsonizma (Parkinsonove bolezni), slabost in neškodljivo razbarvanje urina.
English: In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo začnejo celice v možganih, ki tvorijo živčni prenašalec dopamin, odmirati, količina dopamina v možganih pa se zmanjša.
English: Stalevo is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Slovenian: Stalevo je zdravilo, ki vsebuje tri zdravilne učinkovine: levodopo, karbidopo in entakapon.
English: Stalevo should not be used in people who may be hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients.
Slovenian: Zdravila Stalevo ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) levodopo, karbidopo, entakapon ali katero koli drugo sestavino zdravila.
English: Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT).
Slovenian: Karbidopa in entakapon zavirata nekatere encime, ki sodelujejo pri razgrajevanju levodope v telesu: karbidopa zavira encim dopa dekarboksilazo, entakapon pa zavira encim katehol-O-metiltransferazo (COMT).
English: Why has Stalevo been approved?
Slovenian: Zakaj je bilo zdravilo Staleva odobreno?
English: Each Stalevo tablet contains one complete dose of levodopa, in seven strengths, with corresponding amounts of carbidopa and entacapone to improve its effectiveness.
Slovenian: Vsaka tableta zdravila Stalevo vsebuje en poln odmerek levodope v sedmih jakostih, za izboljšanje njene učinkovitosti pa še ustrezne količine karbidope in entakapona.
English: For the full list of all side effects reported with Stalevo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stalevo, glejte navodilo za uporabo.
English: Stalevo must not be used in patients with: severe liver disease; narrow-angle glaucoma (increased pressure within the eye);
Slovenian: Zdravila Stalevo ne smejo uporabljati bolniki: s hudimi obolenji jeter; glavkomom z zaprtim zakotjem (povečan pritisk v očesu);
English: Levodopa/carbidopa/entacapone
Slovenian: Povzetek EPAR za javnost levodopa/karbidopa/entakapon
English: Stalevo is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Slovenian: Zdravilo Stalevo se uporablja pri bolnikih, ki se zdravijo s kombinacijo levodope in zaviralca dopa dekarboksilaze (dveh običajnih zdravil za Parkinsonovo bolezen), pri katerih pa se proti koncu obdobja med dvema odmerkoma zdravila pojavijo fluktuacije.
English: What is Stalevo used for?
Slovenian: Za kaj se zdravilo Stalevo uporablja?
English: The company carried out ‘bioequivalence' studies to show that taking Stalevo produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Slovenian: Izvedla je tudi bioekvivalenčne študije, da bi dokazala, da so ravni levodope, karbidope in entekapona v krvi pri jemanju zdravila Stalevo enake kot pri jemanju zdravilnih učinkovin v ločenih tabletah, od katerih ene vsebujejo entakapon, ter v kombiniranih tabletah, ki vsebujejo levodopo in karbidopo.
English: The CHMP decided that Stalevo's benefits are greater than its risks for the treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment.
Slovenian: CHMP je zaključil, da so koristi zdravila Stalevo pri zdravljenju bolnikov s Parkinsonovo boleznijo in motoričnimi fluktuacijami ob koncu odmernega obdobja, ki jih zdravljenje z levodopo/zaviralci dopa dekarboksilaze ne stabilizira, večje od z njim povezanih tveganj.
English: How does Stalevo work?
Slovenian: Kako zdravilo Stalevo deluje?
English: They should be used with caution in patients with mild to moderate problems with their liver or severe problems with their kidneys.
Slovenian: Bolniki z blagimi do zmerno resnimi težavami z jetri ali hudimi težavami z ledvicami morajo tablete jemati previdno.
English: How has Stalevo been studied?
Slovenian: Kako je bilo zdravilo Stalevo raziskano?
English: How is Stalevo used?
Slovenian: Kako se zdravilo Stalevo uporablja?
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Slovenian: Posledično ostane levodopa aktivna dlje časa, kar pomaga izboljšati simptome Parkinsonove bolezni, kot sta okorelost mišic in počasnost gibov.
English: What is Stalevo?
Slovenian: Kaj je zdravilo Stalevo?
English: See the Summary of Product Characteristics (also part of the EPAR) for full instructions on how patients should be switched to Stalevo, and on how the dose is adjusted during treatment.
Slovenian: Za vsa navodila o tem, kako naj bolniki preidejo na jemanje zdravila Stalevo in kako je treba odmerek med zdravljenjem prilagajati, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: These combinations are not covered in this summary.
Slovenian: Teh kombinacij ta povzetek ne zajema.
English: Moreover, the intended use does not require medical supervision.
Slovenian: Poleg tega namenska uporaba ne zahteva zdravniškega nadzora.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Slovenian: To pomeni, da je kljub pomanjkanju dokazov iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da so na voljo dokazi, da se zdravila na ta način varno uporabljajo vsaj 30 let (od tega vsaj 15 let v EU).
English: White horehound should only be used in adults and adolescents aged over 12 years.
Slovenian: Zel navadne črne mete se lahko uporablja le pri odraslih in mladostnikih, starejših od 12 let.
English: If symptoms of cough persist for longer than one week, patients should consult a qualified healthcare practitioner.
Slovenian: Če simptomi kašlja trajajo več kot en teden, se morajo bolniki posvetovati z usposobljenim zdravstvenim delavcem.
English: • in patients with a temporary loss of appetite.
Slovenian: • pri bolnikih z začasno izgubo teka.
English: In addition, there were published experimental studies suggesting a number of properties that could plausibly help in patients with mild dyspepsia.
Slovenian: Poleg tega so bile objavljene poskusne študije, ki kažejo na številne lastnosti, ki verjetno lahko pomagajo bolnikom z blago dispepsijo.
English: • as an expectorant (a medicine to help bring up phlegm) in patients with cough associated with a cold;
Slovenian: • kot ekspektorans (zdravilo za lažje izločanje sluzi) pri bolnikih s kašljem, povezanim s prehladom;
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Slovenian: V času ocenjevanja s strani odbora HMPC niso bili znani nobeni neželeni učinki pri uporabi teh zdravil.
English: • for treating mild dyspepsia symptoms, such as bloating and flatulence;
Slovenian: • za lajšanje blagih simptomov dispepsije, kot so napenjanje in vetrovi;
English: For dyspepsia and loss of appetite, patients are advised to consult healthcare practitioner if symptoms last longer than two weeks.
Slovenian: Pri dispepsiji in izgubi teka se morajo bolniki posvetovati z zdravstvenim delavcem, če simptomi trajajo več kot dva tedna.
English: The HMPC conclusions on the use of white horehound medicines in patients with cough, dyspepsia symptoms and loss of appetite are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil iz zeli navadne črne mete pri bolnikih s kašljem, simptomi dispepsije in izgubo teka temeljijo na njihovi „tradicionalni uporabi“.
English: White horehound EMA/HMPC/446032/2013
Slovenian: Zel navadne črne mete EMA/HMPC/446032/2013
English: This summary is not intended to provide practical advice on how to use medicines containing white horehound.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel navadne črne mete.
English: White horehound is the common name for the plant Marrubium vulgare L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Slovenian: Zel navadne črne mete je slovensko ime za rastlino Marrubium vulgare L. Rastlina se goji ali nabira za pridobivanje nadzemnih delov za medicinsko uporabo.
English: Further information on the risks associated with white horehound medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel navadne črne mete, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC noted that the bitter substances and essential oils the medicine contains may stimulate appetite and secretions from the lining of the airways.
Slovenian: Odbor HMPC je ugotovil, da grenke snovi in esencialna olja, ki jih vsebuje zdravilo, lahko spodbudijo tek in izločanje sluzi iz dihalnih poti.
English: The HMPC concluded that, on the basis of its long-standing use, white horehound can be used in the following ways:
Slovenian: Odbor HMPC je zaključil, da se zel navadne črne mete glede na njeno dolgotrajno uporabo lahko uporablja na naslednje načine:
English: Herbal medicines containing white horehound are usually available in a comminuted form for herbal tea, or in solid or liquid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo zel navadne črne mete, so običajno na voljo v zdrobljeni obliki za zeliščni čaj oziroma v trdni ali tekoči obliki za zaužitje.
English: In its assessment the HMPC considered the well documented and longstanding use of white horehound in the approved indications.
Slovenian: Pri svoji oceni je odbor HMPC upošteval dobro dokumentirano in dolgotrajno uporabo zeli navadne črne mete pri odobrenih indikacijah.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing white horehound.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel navadne črne mete.
English: Information on the use and licensing of white horehound medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo zel navadne črne mete, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of white horehound.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli navadne črne mete.
English: Any applications for the licensing of medicines containing white horehound have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel navadne črne mete, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Detailed instruction on how to take white horehound medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila glede tega, kako se uporabljajo zdravila iz zeli navadne črne mete in kdo jih lahko uporablja, najdete v navodilu za uporabo, ki je priloženo zdravilu.
English: Further information on the HMPC assessment of white horehound medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo zel navadne črne mete, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: White horehound preparations are obtained by comminuting (reducing into tiny pieces) or powdering the above-ground parts of the plant, by making a liquid extract or pressing the juice from the plant.
Slovenian: Pripravki iz zeli navadne črne mete se pridobivajo z drobljenjem ali upraševanjem nadzemnih delov rastline, s pripravo tekočega ekstrakta ali z iztiskanjem soka iz rastline.
English: What evidence supports the use of white horehound medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel navadne črne mete?
English: How are white horehound medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo zel navadne črne mete, odobrena v EU?
English: EMA/HMPC/446032/2013
Slovenian: EMA/HMPC/446032/2013 Odbor za zdravila rastlinskega izvora (HMPC)
English: What is white horehound?
Slovenian: Kaj je zel navadne črne mete?
English: For more information about treatment with white horehound medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo zel navadne črne mete, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with white horehound medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo zel navadne črne mete?
English: For practical information about using white horehound medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about white horehound medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo zel navadne črne mete
English: White horehound can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: V nekaterih zdravilih rastlinskega izvora se zel navadne črne mete uporablja tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Recommendation
Slovenian: Priporočilo
English: The administration started within 2-20 hours prior to surgery.
Slovenian: Zdravilo so začeli dajati od 2-20 ur pred operacijo.
English: Furthermore, not all indications are approved in each country.
Slovenian: Prav tako v nekaterih državah niso odobrene vse indikacije.
English: • Clinical aspects
Slovenian: • Klinični vidiki
English: Not all strengths and pharmaceutical forms are registered in each country.
Slovenian: Nekatere jakosti in farmacevtske oblike niso registrirane v vseh državah.
English: A number of areas of disharmony in the Product Information have been considered as follows:
Slovenian: Številna neskladja v informacijah o zdravilu so obravnavali, kot sledi:
English: Although the proposed text was already approved in the majority of EU countries, the CHMP is of the opinion that some structural modification of the text was needed.
Slovenian: Čeprav je bilo predlagano besedilo že odobreno v večini držav članic EU, je CHMP menil, da so potrebne nekatere strukturne spremembe besedila.
English: • Psoriasis
Slovenian: • Psoriaza
English: This section contains general parts as well as separate sub-sections for each indication.
Slovenian: To poglavje vsebuje tako splošne odstavke kot tudi posebna podpoglavja za vsako od indikacij.
English: Overall summary of the scientific evaluation of Sandimmun Neoral and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Sandimmun Neoral in povezanih imen (glejte Prilogo I)
English: Sections 4.3 to 4.9 - from “Contraindications” to “Overdose”
Slovenian: Poglavja od 4.3 do 4.9 - od „Kontraindikacije“ do „Preveliko odmerjanje“
English: At the time of submission, patients of 17 years of age maximum qualified as “children”.
Slovenian: V času predložitve so bili kot „otroci" opredeljeni bolniki do vključno 17. leta starosti.
English: Subsequent, studies using lower doses showed a better risk-benefit ratio.
Slovenian: Poznejše študije, v katerih so uporabili manjše odmerke, so pokazale ugodnejše razmerje med tveganji in koristmi.
English: The CHMP agreed that general information applicable to all these indications was relevant to include.
Slovenian: CHMP se je strinjal, da je vključitev splošnih informacij, ki se nanašajo na vse te indikacije, smiselna.
English: The promising benefit was offset by the renal dysfunction and hypertension.
Slovenian: Obetavne koristi so zasenčile ledvične disfunkcije in hipertenzija.
English: Section 4.7 - Effects on Ability to Drive and Use Machines
Slovenian: Poglavje 4.7 - Vpliv na sposobnosti vožnje in upravljanja s stroji
English: The MAH proposed two different wordings for each of the paragraphs on transplantation:
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal dve različni besedili za vsakega od odstavkov o presaditvi:
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Slovenian: Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja za promet z zdravilom
English: In the following, the entire section 4.2 is reviewed, sub-section by sub-section.
Slovenian: V nadaljevanju je pregled celotnega poglavja 4.2 po posameznih podpoglavjih.
English: 15 EU countries already have exactly the proposed label and in those which do not, the deviations are not considered large.
Slovenian: 15 držav EU že ima povsem enako besedilo, kot je bilo predlagano, v drugih državah pa odstopanja niso velika.
English: • Endogenous uveitis
Slovenian: • Endogeni uveitis
English: Moreover, recent trials have confirmed the benefit of Sandimmun Neoral in different forms of nephrotic syndrome in children and adults.
Slovenian: Poleg tega so v nedavnih preskušanjih potrdili koristi zdravila Sandimmun Neoral pri različnih oblikah nefrotskega sindroma pri otrocih in odraslih.
English: The CHMP also raised questions regarding the risk of aggravation of the neurological manifestations of Behcet's disease by Ciclosporin.
Slovenian: CHMP je imel tudi vprašanja v zvezi s tveganjem za poslabšanje nevroloških znakov Behçetove bolezni zaradi ciklosporina.
English: The indication aplastic anemia is only approved in France.
Slovenian: Indikacija aplastična anemija je odobrena samo v Franciji.
English: This was supported since it is of interest in the states where both formulations are used.
Slovenian: CHMP je to odobril, saj je to v interesu držav, kjer se uporabljata oba pripravka.
English: The review of the original Sandimmun Dossiers from major markets such as France, the U.S. and UK which contains the clinical results from a total of 15 global studies has been performed.
Slovenian: Pregledali so prvotno dokumentacijo zdravila Sandimmun iz najpomembnejših trgov, kot so Francija, Združene države in Združeno kraljestvo, ki vsebuje klinične podatke iz skupno 15 globalnih študij.
English: However the CHMP considers that data of use in children in nephrotic syndrome should be included under the heading Paediatric population.
Slovenian: Vendar pa je menil, da bi morali podatke o uporabi zdravila pri otrocih z nefrotskim sindromom vključiti pod naslovom Pediatrična populacija.
English: Switching between oral ciclosporin formulations
Slovenian: Prehod med različnimi peroralnimi oblikami ciklosporina
English: The CHMP noted that the majority of patients benefited from ciclosporin treatment in all reports.
Slovenian: CHMP je ugotovil, da je v vseh poročilih večina bolnikov imela koristi od zdravljenja s ciklosporinom.
English: In the original Sandimmun studies, initial doses in the range 14-18 mg/kg/day have been used and these were subsequently reduced to a maintenance dose in the range 6-10 mg/kg/day.
Slovenian: V prvotnih študijah zdravila Sandimmun so uporabili začetne odmerke v razponu od 14-18 mg/kg/dan, ki so jih postopoma zmanjševali do vzdrževalnega odmerka v razponu od 6-10 mg/kg/dan.
English: Seven trials were conducted for the prevention of graft-versus host disease (GVHD), one trial for the treatment of acute GVHD.
Slovenian: Poleg tega so izvedli sedem preskušanj v zvezi s preprečevanjem reakcije presadka proti gostitelju (GVHD) in eno preskušanje v zvezi z zdravljenjem akutne GVHD.
English: The MAH proposed wordings for the sub-sections “Absorption, Distribution, Biotransformation and Elimination, Special populations and Paediatric population.” based on a harmonized text already approved in 13 EU countries.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal besedila za podpoglavja „Absorpcija, Porazdelitev, Biotransformacija in izločanje, Posebne skupine bolnikov in Pediatrična populacija“, ki temeljijo na usklajenem besedilu, ki je že odobreno v 13 državah EU.
English: The control groups were either using placebo, or azathioprine, or D-penicillamine.
Slovenian: V kontrolnih skupinah so uporabljali placebo, azatioprin ali D-penicilamin.
English: Finally the inclusion of the term “cellular” rejection was also discussed since the diagnosis of humoral rejection episodes is controversial.
Slovenian: Obravnavali so tudi vključitev pojma „celična" zavrnitev, saj je diagnoza humoralnih zavrnitvenih reakcij sporna.