FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC recommended as part of the PSUSA procedure the addition of warnings related to serious reactions temporally associated with alemtuzumab infusion including pulmonary alveolar haemorrhage, myocardial infarction, stroke (including ischaemic and haemorrhagic stroke), cervicocephalic (e.g. vertebral, carotid) arterial dissection.
Slovenian: Odbor PRAC je v sklopu postopka PSUSA priporočil vključitev opozoril, povezanih z resnimi reakcijami, časovno povezanimi z infuzijo alemtuzumaba, vključno s pljučno alveolarno krvavitvijo, miokardnim infarktom, možgansko kapjo (vključno z ishemično in hemoragično možgansko kapjo) in cervikocefalično (npr. vertebralno, karotidno) arterijsko disekcijo.
English: There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Slovenian: Na nevtrofilcih, plazemskih in matičnih celicah kostnega mozga je antigena CD52 le malo ali sploh nič.
English: In addition, there are serious doubts
Slovenian: Poleg tega
English: The mechanism by which alemtuzumab exerts its therapeutic effects in MS is unknown but may involve immunomodulation through the depletion and repopulation of lymphocytes.
Slovenian: Alemtuzumab deluje s celično citolizo, odvisno od protiteles, in s komplementom posredovano lizo, ki sledi vezavi na celično površino limfocitov T in B. Mehanizem terapevtskega učinka alemtuzumaba pri multipli sklerozi je neznan, vendar lahko vključuje imunomodulacijo z deplecijo in ponovno populacijo limfocitov.
English: • The applicant should submit the final results of the study 14701 by 28 February 2013.
Slovenian: • Predlagatelj mora končne rezultate študije 14701 predložiti do 28. februarja 2013.
English: National Competent Authorities, coordinated by the Reference Member State as applicable, shall ensure the following:
Slovenian: Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, kot je ustrezno, morajo zagotoviti naslednje:
English: Conditions of the marketing authorisation
Slovenian: Pogoji dovoljenja za promet z zdravilom
English: EMA/513708/2016
Slovenian: EMA/513708/2016 EMEA/H/C/004267
English: For further information, see the package
Slovenian: Za več informacij glejte navodilo za
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Slovenian: Pojasnjuje, kako je agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
English: Each inhalation provides a fixed dose of the medicine.
Slovenian: Z vsako inhalacijo se dovede fiksni odmerek zdravila.
English: The full EPAR for Airexar Spiromax 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 Airexar Spiromax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu.
English: Fluticasone propionate belongs to a group of anti-inflammatory medicines known as corticosteroids.
Slovenian: Flutikazonpropionat spada v skupino protivnetnih zdravil, ki jih imenujemo kortikosteroidi.
English: This is a summary of the European public assessment report (EPAR) for Airexar Spiromax.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Airexar Spiromax.
English: Since Airexar Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Slovenian: Ker je zdravilo Airexar Spiromax na voljo samo v eni visoki jakosti (ta vsebuje 50 mikrogramov salmeterola in 500 mikrogramov flutikazonpropionata), morajo v primeru, da postane primerna nižja jakost, bolniki preiti na alternativno kombinacijo salmeterola in flutikazonpropionata, ki vsebuje manjši odmerek
English: The Committee recommended that Airexar Spiromax be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Airexar Spiromax odobri za uporabo v EU.
English: Patients should be regularly assessed by a doctor to ensure that they receive the lowest dose sufficient to control symptoms.
Slovenian: Priporočeni odmerek je ena inhalacija dvakrat na dan. Bolnike mora redno pregledovati zdravnik, ki poskrbi za to, da prejemajo najmanjši zadostni odmerek za nadzor simptomov.
English: Because Airexar Spiromax is a hybrid 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 Airexar Spiromax hibridno zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This means that Airexar Spiromax is similar to a ‘reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, in sicer zdravilu Seretide Diskus (znanemu tudi kot Seretide Accuhaler), ki vsebuje isti zdravilni učinkovini.
English: What measures are being taken to ensure the safe and effective use of Airexar Spiromax?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Airexar Spiromax?
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Slovenian: S tem se zmanjša sproščanje snovi, ki sodelujejo v procesu vnetja, na primer histamina, kar pripomore k ohranjanju prehodnosti dihalnih poti in bolniku olajša dihanje.
English: In asthma, Airexar Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled
Slovenian: Pri astmi se lahko zdravilo Airexar Spiromax uporablja pri bolnikih, pri katerih bolezen ni pod ustreznim nadzorom kljub zdravljenju s kombinacijo agonista adrenergičnih receptorjev beta-2 in manjšega odmerka inhalacijskega kortikosteroida, in pri bolnikih, pri katerih je astma nadzorovana že z dolgodelujočim agonistom adrenergičnih receptorjev beta-2 in velikim odmerkom inhalacijskega
English: It works by attaching to receptors known as beta-2 receptors in the muscles of the airways.
Slovenian: Deluje tako, da se veže na receptorje, imenovane adrenergični receptorji beta-2, ki so v mišicah dihalnih poti.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Slovenian: Deluje podobno kot kortikosteroidni hormoni, ki naravno nastajajo v telesu, pri čemer se veže na receptorje v različnih vrstah imunskih celic in tako zmanjša dejavnost imunskega sistema.
English: However, Airexar Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Slovenian: Vendar je zdravilo Airexar Spiromax na voljo samo v eni visoki jakosti, referenčno zdravilo pa je na voljo v treh jakostih, in sicer enaki visoki jakosti in dveh nižjih jakostih.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Airexar Spiromax have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Airexar Spiromax upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Salmeterol is a long-acting beta-2 agonist.
Slovenian: Salmeterol je dolgodelujoči agonist adrenergičnih receptorjev beta-2.
English: Airexar Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing).
Slovenian: Airexar Spiromax je zdravilo, ki se uporablja za redno zdravljenje odraslih s hudo astmo in za lajšanje simptomov kronične obstruktivne pljučne bolezni (KOPB, dolgotrajna bolezen, pri kateri pride do poškodbe ali zapore dihalnih poti in zračnih mešičkov v pljučih, kar oteži dihanje).
English: Airexar Spiromax is a ‘hybrid medicine'.
Slovenian: Zdravilo Airexar Spiromax je „hibridno zdravilo“.
English: In COPD, Airexar Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and have significant symptoms despite regular treatment.
Slovenian: Pri KOPB se zdravilo Airexar Spiromax uporablja pri odraslih s poslabšanji (izbruhi) bolezni v preteklosti, ki imajo izrazite simptome kljub rednemu zdravljenju.
English: Other information about Airexar Spiromax
Slovenian: Druge informacije o zdravilu Airexar Spiromax
English: The two active substances in Airexar Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Slovenian: Zdravilni učinkovini v zdravilu Airexar Spiromax sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme in KOPB.
English: Therefore, the CHMP's view was that, as for Seretide Diskus, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Seretide Diskus odtehtajo znana tveganja.
English: What are the benefits and risks of Airexar Spiromax?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Airexar Spiromax?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Airexar Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo Airexar Spiromax primerljivo raven kakovosti kot zdravilo Seretide Diskus ter da mu je biološko enakovredno.
English: Studies in people have been limited to tests to determine that Airexar Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Slovenian: Študije pri bolnikih so bile omejene na preskuse za ugotavljanje, ali je zdravilo Airexar Spiromax biološko enakovredno referenčnemu zdravilu Seretide Diskus.
English: For more information about treatment with Airexar Spiromax, read the package leaflet (also part of the EPAR) or contact your
Slovenian: Za več informacij o zdravljenju z zdravilom Airexar Spiromax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Airexar Spiromax and what is it used for?
Slovenian: Kaj je zdravilo Airexar Spiromax in za kaj se uporablja?
English: It contains the active substances salmeterol (a so-called long-acting beta-2 agonist) and fluticasone
Slovenian: Vsebuje zdravilni učinkovini salmeterol (t. i. dolgodelujoči agonist adrenergičnih receptorjev beta-2) in
English: For practical information about using Airexar Spiromax, patients should read the package leaflet or
Slovenian: Za praktične informacije o uporabi zdravila Airexar Spiromax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Airexar Spiromax is available as an inhalation powder in a portable inhaler device.
Slovenian: Na voljo je v obliki praška za inhaliranje v prenosnem inhalatorju.
English: When it attaches to these receptors in the airways, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Slovenian: Salmeterol z vezavo na omenjene receptorje sprošča mišice, kar razširi dihalne poti in bolniku olajša dihanje.
English: As Airexar Spiromax is only available in one high strength, its use in asthma has been restricted to
Slovenian: Spiromax na voljo samo v eni visoki jakosti, je njegova uporaba pri astmi omejena na bolnike s hudo obliko bolezni.
English: How has Airexar Spiromax been studied?
Slovenian: Kako je bilo zdravilo Airexar Spiromax raziskano?
English: Airexar Spiromax can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Airexar Spiromax je le na recept.
English: How is Airexar Spiromax used?
Slovenian: Kako se zdravilo Airexar Spiromax uporablja?
English: It is not intended to provide practical advice on how to use Airexar Spiromax.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Page 2/2
Slovenian: stran 2/2
English: These combinations are not covered in this summary.
Slovenian: Te kombinacije niso vključene v ta povzetek.
English: Moreover, the intended use does not require medical supervision.
Slovenian: Poleg tega predvidena uporaba ne zahteva zdravniškega nadzora.
English: 2 February 2016 EMA/283374/2014
Slovenian: februar 2016 EMA/283374/2014
English: Herbal medicine: summary for the public
Slovenian: Zdravilo rastlinskega izvora: povzetek za javnost
English: Eleutherococcus root should only be used in adults and adolescents over the age of 12 years and should not be taken for more than 2 months.
Slovenian: Korenina elevterokoka se sme uporabljati samo pri odraslih in mladostnikih, starejših od 12 let, in se ne sme uporabljati več kot 2 meseca.
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 pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedeni način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
English: Although a possible effect on tiredness and weakness was observed, shortcomings in the design of the studies prevented any firm conclusions being drawn.
Slovenian: Čeprav je bil ugotovljen možen učinek na utrujenost in oslabelost, zaradi pomanjkljivosti pri zasnovi študij ni bilo možno sprejeti trdnih zaključkov.
English: A doctor or a qualified healthcare practitioner should be
Slovenian: treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom consulted if the symptoms continue for more than 2 weeks of treatment.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2.
English: Eleutherococcus root EMA/283374/2014
Slovenian: Korenina elevterokoka EMA/283374/2014
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Slovenian: Za podrobnejše informacije o študijah, ki jih je ocenil odbor HMPC, glejte njegovo poročilo o oceni zdravila.
English: What are the HMPC conclusions on its medicinal uses?
Slovenian: Kakšne so ugotovitve odbora HMPC v zvezi z medicinsko uporabo?
English: In some cases the solvent is evaporated to obtain a dry extract.
Slovenian: V nekaterih primerih se topilo odpari, s čimer se pridobi suhi ekstrakt.
English: The HMPC concluded that, on the basis of its long-standing use, eleutherococcus root can be used for the relief of symptoms of asthenia (abnormal loss of strength and energy) such as tiredness and weakness.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko korenina elevterokoka uporablja za lajšanje simptomov astenije (neobičajne izgube moči in energije), kot sta utrujenost in oslabelost.
English: This summary is not intended to provide practical advice on how to use medicines containing eleutherococcus root.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo korenino elevterokoka.
English: Insomnia, irritability, tachycardia (rapid heartbeat) and headaches have been reported as side effects with eleutherococcus root medicines, although their frequency is not known.
Slovenian: Poročali so o nespečnosti, razdražljivosti, tahikardiji (pospešenem srčnemu utripu) in glavobolih kot o neželenih učinkih zdravil, ki vsebujejo korenino elevterokoka, vendar njihova pogostnost ni znana.
English: They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract).
Slovenian: Pridobivajo se tudi z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol ali vodo) in se pridobi tekoči ekstrakt ali tinktura (alkoholni ekstrakt).
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of eleutherococcus root.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo korenine elevterokoka.
English: Further information on the risks associated with eleutherococcus root 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 s temi zdravili, ki vsebujejo korenino elevterokoka, vključno z ustreznimi previdnostnimi 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: Eleutherococcus root is the common name for the root of the plant Eleutherococcus senticosus (Rupr.
Slovenian: Korenina elevterokoka je splošno ime za korenino rastline Eleutherococcus senticosus (Rupr.
English: Herbal medicines containing eleutherococcus root are usually available as herbal teas to be drunk, or in solid or liquid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo korenino elevterokoka, so navadno na voljo kot zdravilni čaj, ki se popije, ali v tekoči ali trdni obliki za jemanje skozi usta.
English: In its assessment, the HMPC also considered numerous clinical studies with eleutherococcus root.
Slovenian: V svoji oceni je odbor HMPC prav tako upošteval številne klinične študije s korenino elevterokoka.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing eleutherococcus root.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo korenino elevterokoka.
English: The HMPC conclusions on the use of eleutherococcus root medicines for relieving symptoms of asthenia are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo korenino elevterokoka, za lajšanje simptomov astenije temeljijo na njihovi „tradicionalni uporabi“ pri tej bolezni.
English: Further information on the HMPC assessment of eleutherococcus root 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 korenino elevterokoka, 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: Any applications for the licensing of medicines containing eleutherococcus root 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 korenino elevterokoka, 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: Eleutherococcus root preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the root.
Slovenian: Pripravki s korenino elevterokoka se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) ali drobljenjem korenine v prah.
English: Information on the use and licensing of eleutherococcus root medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo korenino elevterokoka, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Eleutherococcus root can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Korenina elevterokoka je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Detailed instructions on how to take eleutherococcus root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo korenino elevterokoka, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: For more information about treatment with eleutherococcus root 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 korenino elevterokoka, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: How are eleutherococcus root medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo korenino elevterokoka, odobrena v EU?
English: Therefore, the HMPC conclusions on the use of eleutherococcus root medicines are based on their long-standing use.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo korenino elevterokoka, zato temeljijo na njihovi dolgotrajni uporabi.
English: What are the risks associated with eleutherococcus root medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo korenino elevterokoka?
English: For practical information about using eleutherococcus root 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: What evidence supports the use of eleutherococcus root medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo korenino elevterokoka?
English: Other information about eleutherococcus root medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo korenino elevterokoka
English: What is eleutherococcus root?
Slovenian: Kaj je korenina elevterokoka?
English: This summary was last updated in 04-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2009.
English: Its use during the first three months of pregnancy is not recommended.
Slovenian: Uporaba zdravila v prvih treh mesecih nosečnosti ni priporočena.
English: This medicine is the same as Karvezide, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Karvezide, ki je že odobreno v Evropski uniji (EU).
English: It must not be used in women who are more than three months pregnant.
Slovenian: Ne smejo ga uporabljati bolnice, ki so noseče več kot tri mesece.