natgillin/translations-raw huggingface dataset:
These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No 726/2004.
Ti začasni ukrepi ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
Cases of Haemophagocytic lymphohistocytosis (HLH) were identified.
Ugotovljeni so bili primeri hemofagocitne limfohistocitoze (HLH).
These cases are characterised by specific MRI lesions and unexpected high total B cell count which may suggest a B-cell-mediated activation of disease.
Za te primere so značilne posebne lezije, vidne z MRS, in nepričakovano veliko skupno število celic B, kar lahko kaže na s celicami B posredovano aktivacijo bolezni.
The temporal onset corresponded to the time of reconstitution of the immune system after depletion of B- and T-lymphocytes following Lemtrada treatment.
Časovni pojav se je skladal s časom rekonstitucije imunskega sistema po depleciji limfocitov B in T po zdravljenju z zdravilom Lemtrada.
Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system that is characterized by inflammation, demyelination and neuronal loss.
Multipla skleroza je vnetna in nevrodegenerativna bolezen centralnega živčnega sistema, za katero so značilni vnetje, demielinizacija in propadanje nevronov.
• The PRAC noted that although efficacy of alemtuzumab in relapsed remitting multiple sclerosis patients is well established, these emerging and serious safety concerns can impact the benefit-risk balance of Lemtrada, and that until a thorough review is finalised, it would be appropriate as a provisional measure to limit the patients exposed to alemtuzumab.
• odbor PRAC je opozoril, da lahko kljub dobro dokazani učinkovitosti alemtuzumaba pri bolnikih z recidivno-remitentno multiplo sklerozo ti porajajoči se in resni varnostni pomisleki vplivajo na razmerje med tveganji in koristmi zdravila Lemtrada in da je primerno omejiti izpostavljenost bolnikov alemtuzumabu, dokler ne bo končan temeljit pregled podatkov.
Grounds for PRAC recommendation Whereas
Podlaga za priporočilo odbora PRAC Ob upoštevanju naslednjega:
Cardiovascular (including cerebrovascular) reactions temporally associated with alemtuzumab administration
Srčno-žilne (vključno s možgansko-žilnimi) reakcije, časovno povezane z dajanjem alemtuzumaba
HLH is a life-threatening condition of severe hyperinflammation caused by uncontrolled proliferation of activated lymphocytes and macrophages.
HLH je smrtno nevarno stanje hudega čezmernega vnetja, ki je posledica nenadzorovanega razmnoževanja aktiviranih limfocitov in makrofagov.
Both T and B lymphocytes are involved in the pathogenesis of MS. Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T and B lymphocytes, and at lower levels on natural killer cells, monocytes and macrophages.
V patogenezo multiple skleroze so vključeni limfociti T in B. Alemtuzumab se veže na CD52, antigen celične površine, ki je v večji meri prisoten na limfocitih T in B, v manjši pa na naravnih celicah ubijalkah, monocitih in makrofagih.
Lemtrada (alemtuzumab) is indicated for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Zdravilo Lemtrada (alemtuzumab) je indicirano za odrasle bolnike z recidivno-remitentno multiplo sklerozo (RRMS) z aktivno boleznijo, ki je kot taka opredeljena na podlagi kliničnih ali slikovnih ugotovitev.
Therefore, in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to restrict use of alemtuzumab in new patients to adults with highly active relapsing remitting multiple sclerosis despite a full and adequate course of treatment with at least two other disease modifying treatments, or to adults with highly active relapsing remitting multiple sclerosis where all other disease modifying treatments are contraindicated or otherwise unsuitable.
Zato glede na resnost opaženih dogodkov odbor PRAC priporoča začasne spremembe informacij o zdravilu, s katerimi se uporaba alemtuzumaba pri novih bolnikih omeji le na odrasle z recidivno-remitentno multiplo sklerozo, ki je močno aktivna kljub celotnemu in ustreznemu ciklu zdravljenja z vsaj dvema drugima imunomodulirajočima zdraviloma, ali odrasle z močno aktivno recidivno-remitentno multiplo sklerozo, pri katerih so druga imunomodulirajoča zdravila kontraindicirana ali kako drugače neprimerna;
Therefore PRAC recommended that new treatment with Lemtrada should only be initiated in adult patients with highly active relapsing remitting multiple sclerosis despite a full and adequate course of treatment with at least two other disease modifying treatments, or in adult patients with highly active relapsing remitting multiple sclerosis where all other disease modifying treatments are contraindicated or otherwise unsuitable.
Zato odbor PRAC priporoča, da se novo zdravljenje z zdravilom Lemtrada uvede le pri odraslih bolnikih z recidivno-remitentno multiplo sklerozo, ki je močno aktivna kljub celotnemu in ustreznemu ciklu zdravljenja z vsaj dvema drugima imunomodulirajočima zdraviloma, ali pri odraslih bolnikih z močno aktivno recidivno-remitentno multiplo sklerozo, pri katerih so druga imunomodulirajoča zdravila kontraindicirana ali kako drugače neprimerna.
• The PRAC reviewed the available data on cardiovascular reactions, including data provided by the marketing authorisation holder in the context of the PSUSA procedure.
• odbor PRAC je pregledal razpoložljive podatke o srčno-žilnih reakcijah, vključno s podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom v sklopu postopka PSUSA.
- Immune-mediated diseases such as auto-immune hepatitis, hepatic injury, auto-immune-mediated central nervous system disease and Guillain-Barre syndrome.
- Imunsko posredovane bolezni, kot so avtoimunski hepatitis, poškodba jeter, avtoimunsko posredovana bolezen centralnega živčnega sistema in Guillain-Barréjev sindrom.
This temporal relationship to alemtuzumab infusions is suggestive of a causal association.
Ta časovna povezava z infuzijami alemtuzumaba kaže na vzročno povezavo.
The PRAC also noted that recent literature reports have highlighted B-cell mediated central nervous system (CNS) lesions with temporal onset of 6 months after infusion of alemtuzumab.
Odbor PRAC je opozoril tudi, da nedavna poročila v literaturi poudarjajo s celicami B posredovane lezije centralnega živčnega sistema, ki se pojavijo v 6 mesecih po infuziji alemtuzumaba;
Common to these cardiovascular reactions was a close temporal relationship to an alemtuzumab infusion, which is suggestive of a causal association.
Skupno tem srčno-žilnim reakcijam je bila tesna časovna povezava z infuzijo alemtuzumaba, kar kaže na vzročno povezavo;
According to existing recommendations, observation for infusion associated reactions (IARs) should be undertaken during and for two hours after infusion.
V skladu z obstoječimi priporočili je treba med infuzijo in še dve uri po njej bolnika opazovati, da ne pride do reakcij, povezanih z infuzijo.
New life-threatening and potentially fatal immune-mediated adverse reactions were identified, including haemophagocytic lymphohistocytosis and autoimmune hepatitis.
Ugotovljene so bile nove smrtno nevarne in potencialno usodne imunsko posredovane reakcije, vključno s hemofagocitno limfohistiocitozo in avtoimunskim hepatitisom.
• The PRAC also reviewed the available data on immune-mediated adverse events, including data provided by the marketing authorisation holder in the context of the PSUSA procedure.
• odbor PRAC je pregledal tudi razpoložljive podatke o imunsko posredovanih neželenih učinkih, vključno s podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom v sklopu postopka PSUSA.
Literature reports1, 2, 3 have highlighted B-cell mediated central nervous system (CNS) lesions with temporal onset of 6 months after infusion of alemtuzumab.
Poročila v literaturi1, 2, 3 poudarjajo s celicami B posredovane lezije centralnega živčnega sistema, ki se pojavijo v 6 mesecih po infuziji alemtuzumaba.
Several cases with various cardiovascular reactions with close temporal relationship with alemtuzumab administration were identified.
Ugotovljenih je bilo več primerov z različnimi srčno-žilnimi reakcijami s tesno časovno povezavo z dajanjem alemtuzumaba.
- Cardiovascular adverse events in close temporal association with Lemtrada infusions (e.g. cardiac ischaemia and myocardial infarction, ischaemic and haemorrhagic stroke, arterial dissection, pulmonary haemorrhage and embolism, vasculitis and thrombocytopenia), including a possible mechanistic relation to these adverse events.
- Srčno-žilni neželeni dogodki v tesni časovni povezavi z infuzijami zdravila Lemtrada (npr. srčna ishemija in miokardni infarkt, ishemična in hemoragična možganska kap, arterijska disekcija, pljučna krvavitev in embolija, vaskulitis in trombocitopenija), vključno z morebitno mehanicistično povezavo s temi neželenimi dogodki.
New warnings on autoimmune hepatitis, hepatic injury and haemophagocytic lymphohistiocytosis are also added.
Dodajo se tudi nova opozorila o avtoimunskem hepatitisu, poškodbi jeter in hemofagocitni limfohistiocitozi.
In addition the PRAC considered important that the risk minimisation measures recommended within the assessment of the current PSUSA procedure are also implemented together with the provisional measures.
Poleg tega je odbor PRAC kot pomembno ocenil, da se skupaj z začasnimi ukrepi uvedejo tudi ukrepi za zmanjšanje tveganja, priporočeni v sklopu ocenjevanje trenutnega postopka PSUSA.
Several cases with various cardiovascular reactions were identified, including pulmonary alveolar haemorrhage, myocardial infarction, and ischaemic and haemorrhagic stroke as well as arterial dissection.
Ugotovljenih je bilo več primerov z različnimi srčno-žilnimi reakcijami, vključno s pljučno alveolarno krvavitvijo, miokardnim infarktom ter ishemično in hemoragično možgansko kapjo ter arterijsko disekcijo.
• In addition the PRAC considered important that the risk minimisation measures recommended within the assessment of the current PSUSA procedure are also implemented together with the provisional measures.
• odbor PRAC je kot pomembno ocenil tudi, da se skupaj z začasnimi ukrepi uvedejo tudi ukrepi za zmanjšanje tveganja, priporočeni v sklopu ocenjevanja trenutnega postopka PSUSA.
Furthermore, the following new adverse reactions are added: pulmonary alveolar haemorrhage, haemophagocytic lymphohistiocytosis, myocardial infarction, stroke (including ischemic and haemorrhagic stroke), cervicocephalic arterial dissection and neutropenia.
Poleg tega se dodajo naslednji novi neželeni učinki: pljučna alveolarna krvavitev, hemofagocitna limfohistiocitoza, miokardni infarkt, možganska kap (vključno z ishemično in hemoragično možgansko kapjo), cervikocefalična arterijska disekcija in nevtropenija.
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.
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.
There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Na nevtrofilcih, plazemskih in matičnih celicah kostnega mozga je antigena CD52 le malo ali sploh nič.
In addition, there are serious doubts
Poleg tega
The mechanism by which alemtuzumab exerts its therapeutic effects in MS is unknown but may involve immunomodulation through the depletion and repopulation of lymphocytes.
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.
• The applicant should submit the final results of the study 14701 by 28 February 2013.
• Predlagatelj mora končne rezultate študije 14701 predložiti do 28. februarja 2013.
National Competent Authorities, coordinated by the Reference Member State as applicable, shall ensure the following:
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, kot je ustrezno, morajo zagotoviti naslednje:
Conditions of the marketing authorisation
Pogoji dovoljenja za promet z zdravilom
For further information, see the package
Za več informacij glejte navodilo za
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Pojasnjuje, kako je agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
Each inhalation provides a fixed dose of the medicine.
Z vsako inhalacijo se dovede fiksni odmerek zdravila.
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.
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.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu.
Fluticasone propionate belongs to a group of anti-inflammatory medicines known as corticosteroids.
Flutikazonpropionat spada v skupino protivnetnih zdravil, ki jih imenujemo kortikosteroidi.
This is a summary of the European public assessment report (EPAR) for Airexar Spiromax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Airexar Spiromax.
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
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
The Committee recommended that Airexar Spiromax be approved for use in the EU.
Priporočil je, da se zdravilo Airexar Spiromax odobri za uporabo v EU.
Patients should be regularly assessed by a doctor to ensure that they receive the lowest dose sufficient to control symptoms.
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.
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.
Ker je zdravilo Airexar Spiromax hibridno zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
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.
To pomeni, da je podobno „referenčnemu zdravilu“, in sicer zdravilu Seretide Diskus (znanemu tudi kot Seretide Accuhaler), ki vsebuje isti zdravilni učinkovini.
What measures are being taken to ensure the safe and effective use of Airexar Spiromax?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Airexar Spiromax?
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.
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.
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
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
It works by attaching to receptors known as beta-2 receptors in the muscles of the airways.
Deluje tako, da se veže na receptorje, imenovane adrenergični receptorji beta-2, ki so v mišicah dihalnih poti.
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.
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.
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.
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.
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.
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.
Salmeterol is a long-acting beta-2 agonist.
Salmeterol je dolgodelujoči agonist adrenergičnih receptorjev beta-2.
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).
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).
Airexar Spiromax is a ‘hybrid medicine'.
Zdravilo Airexar Spiromax je „hibridno zdravilo“.
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.
Pri KOPB se zdravilo Airexar Spiromax uporablja pri odraslih s poslabšanji (izbruhi) bolezni v preteklosti, ki imajo izrazite simptome kljub rednemu zdravljenju.
Other information about Airexar Spiromax
Druge informacije o zdravilu Airexar Spiromax
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.
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.
Therefore, the CHMP's view was that, as for Seretide Diskus, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Seretide Diskus odtehtajo znana tveganja.
What are the benefits and risks of Airexar Spiromax?
Kakšne so koristi in tveganja, povezani z zdravilom Airexar Spiromax?
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.
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.
Studies in people have been limited to tests to determine that Airexar Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Študije pri bolnikih so bile omejene na preskuse za ugotavljanje, ali je zdravilo Airexar Spiromax biološko enakovredno referenčnemu zdravilu Seretide Diskus.
For more information about treatment with Airexar Spiromax, read the package leaflet (also part of the EPAR) or contact your
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.
What is Airexar Spiromax and what is it used for?
Kaj je zdravilo Airexar Spiromax in za kaj se uporablja?
It contains the active substances salmeterol (a so-called long-acting beta-2 agonist) and fluticasone
Vsebuje zdravilni učinkovini salmeterol (t. i. dolgodelujoči agonist adrenergičnih receptorjev beta-2) in
For practical information about using Airexar Spiromax, patients should read the package leaflet or
Za praktične informacije o uporabi zdravila Airexar Spiromax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Airexar Spiromax is available as an inhalation powder in a portable inhaler device.
Na voljo je v obliki praška za inhaliranje v prenosnem inhalatorju.
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.
Salmeterol z vezavo na omenjene receptorje sprošča mišice, kar razširi dihalne poti in bolniku olajša dihanje.
As Airexar Spiromax is only available in one high strength, its use in asthma has been restricted to
Spiromax na voljo samo v eni visoki jakosti, je njegova uporaba pri astmi omejena na bolnike s hudo obliko bolezni.
How has Airexar Spiromax been studied?
Kako je bilo zdravilo Airexar Spiromax raziskano?
Airexar Spiromax can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Airexar Spiromax je le na recept.
How is Airexar Spiromax used?
Kako se zdravilo Airexar Spiromax uporablja?
It is not intended to provide practical advice on how to use Airexar Spiromax.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
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These combinations are not covered in this summary.
Te kombinacije niso vključene v ta povzetek.
Moreover, the intended use does not require medical supervision.
Poleg tega predvidena uporaba ne zahteva zdravniškega nadzora.
2 February 2016 EMA/283374/2014
februar 2016 EMA/283374/2014
Herbal medicine: summary for the public
Zdravilo rastlinskega izvora: povzetek za javnost
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.
Korenina elevterokoka se sme uporabljati samo pri odraslih in mladostnikih, starejših od 12 let, in se ne sme uporabljati več kot 2 meseca.
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).
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).