FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC considered a recommendation for a longer follow-up period in hospital (for up to 5 days after the last infusion) to allow for prompt identification and management of serious adverse reactions that may occur.
Slovenian: Odbor PRAC je proučil priporočilo za daljše obdobje spremljanja v bolnišnici (do 5 dni po zadnji infuziji), da se omogoči takojšnje prepoznavanje in obvladovanje resnih neželenih učinkov, ki se lahko pojavijo.
English: These risks are considered to be related to cytokine release syndrome, which has been described in the literature for alemtuzumab1,2.
Slovenian: Šteje se, da so ta tveganja povezana s sindromom sproščanja citokinov, ki je za alemtuzumab opisan v literaturi1,2.
English: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or
Slovenian: • bolniki z boleznijo, ki je zelo aktivna kljub celotnemu in ustreznemu poteku zdravljenja z vsaj enim zdravilom, ki spreminja potek bolezen (DMT), ali
English: The efficacy of alemtuzumab in relapsing remitting multiple sclerosis patients across multiple parameters of the disease is well established and maintained over long term follow up.
Slovenian: Učinkovitost alemtuzumaba pri bolnikih z recidivno-remitentno multiplo sklerozo po več parametrih bolezni je dobro ugotovljena in se ohranja pri dolgoročnem spremljanju.
English: A matter of concern is the post-marketing reporting rate of fatalities, including those with short latency after alemtuzumab infusion.
Slovenian: Zaskrbljujoče je število smrtnih primerov, o katerih se poroča po pridobitvi dovoljenja za promet z zdravilom, vključno s tistimi s kratko latenco po infuziji alemtuzumaba.
English: Thus, due to the long term effect of alemtuzumab, treatment discontinuation has limited value from a risk management perspective.
Slovenian: Zaradi dolgoročnega učinka alemtuzumaba je prekinitev zdravljenja z vidika obvladovanja tveganja omejena.
English: Patients with other concomitant autoimmune diseases (besides MS) should also be contraindicated to minimise the risk of development of additional autoimmune disorders.
Slovenian: Tudi bolnike z drugimi sočasnimi avtoimunskimi boleznimi (poleg multiple skleroze) je treba kontraindicirati, da se zmanjša tveganje za razvoj dodatnih avtoimunskih motenj.
English: The MAH for Lemtrada will also disseminate a DHPC to inform healthcare professionals of the outcome of this review, and the educational material for both healthcare professionals and patients will be updated.
Slovenian: Imetnik dovoljenja za promet z zdravilom Lemtrada bo razposlal tudi neposredno obvestilo zdravstvenim delavcem, s katerim jih bo obvestil o rezultatih tega pregleda, izobraževalno gradivo za zdravstvene delavce in bolnike pa bo posodobljeno.
English: Limited information, including lack of detailed information on the individual cases, was available on these concerns during the PSUSA assessment, precluding a thorough evaluation.
Slovenian: Med ocenjevanjem PSUSA so bile za te pomisleke na voljo omejene informacije, vključno s pomanjkanjem podrobnih informacij o posameznih primerih, kar onemogoča temeljito oceno.
English: This includes not just a restricted therapeutic indication but also contraindications in subpopulations anticipated, due to risk factors, to be at higher risk of developing the serious adverse reactions.
Slovenian: To ne vključuje le omejitve indikacije zdravljenja, temveč tudi kontraindikacije za podskupine bolnikov, za katere se pričakuje, da bodo zaradi dejavnikov tveganja izpostavljeni večjemu tveganju za nastanek resnih neželenih učinkov.
English: • PRAC also made additional recommendations for monitoring of patients before, during and after infusion to ensure timely diagnosis and management of adverse reactions.
Slovenian: • odbor PRAC je pripravil tudi dodatna priporočila za spremljanje bolnikov pred in med infuzijo ter po njej, da se zagotovi pravočasna diagnoza in obvladovanje neželenih učinkov;
English: The MAH proposed to include also specialised infusion centres with ready access to intensive care.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal, da se vključijo tudi specializirani infuzijski centri z ustreznim dostopom do intenzivne nege.
English: As part of the current review, a number of serious, life-threatening and disabling risks associated with Lemtrada have been assessed.
Slovenian: V okviru sedanjega pregleda je bilo ocenjenih več resnih, smrtno nevarnih tveganj in tveganj za prizadetost, povezanih z zdravilom Lemtrada.
English: • PRAC also considered that the data currently available on mortality incidence is limited and therefore the MAH shall investigate the incidence of mortality in patients treated with Lemtrada compared with a relevant patient population.
Slovenian: • odbor PRAC meni tudi, da so trenutno razpoložljivi podatki o pojavnosti umrljivosti omejeni, zato mora imetnik dovoljenja za promet z zdravilom proučiti pojavnost umrljivosti pri bolnikih, ki se zdravijo z zdravilom Lemtrada, v primerjavi z ustrezno skupino bolnikov.
English: There are uncertainties about a potential causal relationship with a number of other autoimmune adverse events reported in temporal association with Lemtrada, and these will have to continue to be closely monitored in the future.
Slovenian: Obstajajo negotovosti glede možne vzročne povezave z več drugimi avtoimunskimi neželenimi učinki, o katerih poročajo, da so časovno povezani z zdravilom Lemtrada in jih bo treba še naprej natančno spremljati.
English: In addition to close monitoring of cardiovascular function before, during and after the infusion, this also includes new recommendations for platelet count measurement during the infusion cycle and for post-infusion monthly liver transaminase testing.
Slovenian: Ta navodila poleg natančnega spremljanja delovanja srca in ožilja pred in med infuzijo ter po njej vključujejo tudi nova priporočila za merjenje števila trombocitov med infuzijskim ciklusom in za mesečno testiranje jetrne transaminaze po infuziji.
English: Cases of poly-autoimmunity associated with Lemtrada have also been identified.
Slovenian: Ugotovljeni so tudi primeri poliavtoimunosti, povezane z zdravilom Lemtrada.
English: o history of arterial dissection of the cervicocephalic arteries,
Slovenian: o anamnezo disekcije cervikocefalnih arterij,
English: As a consequence, PRAC recommended the variation to the terms of the marketing authorisation for Lemtrada.
Slovenian: Posledično je priporočil spremembo pogojev dovoljenja za promet z zdravilom Lemtrada.
English: In view of the above, PRAC concluded that the benefit-risk balance of Lemtrada remains favourable subject to changes to the product information, the educational materials and additional pharmacovigilance activities described above.
Slovenian: Ob upoštevanju vsega navedenega je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravila Lemtrada ugodno, če se upoštevajo zgoraj navedene spremembe informacij o zdravilu, izobraževalnega gradiva in dejavnosti na področju farmakovigilance.
English: • Lemtrada should also be contraindicated in patients with:
Slovenian: • zdravilo Lemtrada je treba kontraindicirati pri bolnikih z/s:
English: In order to ensure adequate monitoring of patients before, during and after the infusion of alemtuzumab, rapid diagnosis and prompt and adequate treatment of the above mentioned risks, the infusion of alemtuzumab should take place in a hospital with availability of experts and adequate
Slovenian: Da bi zagotovili ustrezno spremljanje bolnikov pred in med infuzijo alemtuzumaba ter po njej, hitro diagnozo ter hitro in ustrezno obravnavo navedenih tveganj, je treba infuzijo alemtuzumaba opraviti v
English: • PRAC reviewed data currently available from post-marketing setting and from clinical trials on fatal cases, cardiovascular adverse events in close temporal association with Lemtrada infusions and immune-mediated diseases, including data provided in writing and at an oral explanation.
Slovenian: • odbor PRAC je pregledal podatke, ki so trenutno na voljo po pridobitvi dovoljenja za promet z zdravilom in iz kliničnih preskušanj, o smrtnih primerih, srčno-žilnih neželenih dogodkih, ki so tesno časovno povezani z infuzijami zdravila Lemtrada in imunsko povzročenimi boleznimi, vključno s podatki, predloženimi v pisni obliki in ustno razlago.
English: Vulnerable patient groups such as patients with severe active infections until complete resolution, uncontrolled hypertension, a history of arterial dissection of the cervicocephalic arteries, of stroke, angina pectoris or myocardial infarction and patients with known coagulopathy, on anti-platelet or anticoagulant therapy, should be contraindicated.
Slovenian: Ranljive skupine bolnikov, kot so bolniki s hudimi aktivnimi okužbami do popolne ozdravitve, nenadzorovano hipertenzijo, anamnezo disekcije cervikocefalnih arterij, možgansko kapjo, angino pektoris ali miokardnim infarktom, bolnike z znano koagulopatijo, na antitrombocitni ali antikoagulacijski terapiji pa je treba kontraindicirati.
English: A post authorisation safety study is needed to address these concerns.
Slovenian: Za obravnavo teh pomislekov je potrebna študija varnosti zdravila po pridobitvi dovoljenja za promet.
English: As a provisional measure, it was 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.
Slovenian: Kot začasni ukrep je bilo priporočeno, da se zdravljenje z zdravilom Lemtrada pri novih bolnikih uvede le v primeru, če gre za odrasle bolnike, ki imajo zelo aktivno recidivno-remitentno multiplo sklerozo in so se neustrezno odzvali na celotna, ustrezna ciklusa zdravljenja z vsaj dvema drugima zdraviloma, ki spreminjata potek bolezni, ali odrasle bolnike z zelo aktivno recidivno-remitentno multiplo sklerozo, pri katerih so druga zdravila, ki spreminjajo potek bolezni, kontraindicirana ali kako drugače neprimerna.
English: o history of angina pectoris or myocardial infarction,
Slovenian: o anamnezo angine pektoris ali miokardnega infarkta,
English: • As a consequence, PRAC recommended that treatment with Lemtrada should be restricted to patients with highly active relapsing remitting multiple sclerosis for the following patient groups:
Slovenian: • zato je odbor PRAC priporočil, da je treba zdravljenje z zdravilom Lemtrada omejiti na bolnike z zelo aktivno recidivno-remitentno multiplo sklerozo, in sicer na naslednje skupine bolnikov:
English: • Furthermore, PRAC recommended that Lemtrada should only be administered in a hospital setting with ready access to intensive care.
Slovenian: • odbor PRAC je poleg tega priporočil, da se zdravilo Lemtrada daje le v bolnišničnem okolju, kjer je neposreden dostop do intenzivne nege;
English: In this context, and taking also into account the advice of the SAG, PRAC concluded that Lemtrada should be indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:
Slovenian: V tem okviru in ob upoštevanju nasvetov znanstveno svetovalne skupine (SAG) je odbor PRAC ugotovil, da je treba zdravilo Lemtrada označiti kot zdravilo, ki spreminja potek posamezne bolezni pri odraslih z zelo aktivno recidivno-remitentno multiplo sklerozo (RRMS), in sicer za naslednje skupine bolnikov:
English: No surrogate or biomarker for patients at risk for serious cytokine release or autoimmunity was identified.
Slovenian: Za bolnike, pri katerih obstaja tveganje za resno sproščanje citokinov ali avtoimunost, ni bil opredeljen nadomestek ali biološki označevalec.
English: Cases of pulmonary embolism, vasculitis, central nervous system autoimmune disease and GuillainBarre Syndrome (GBS) have been reported.
Slovenian: Opisani so primeri pljučne embolije, vaskulitisa, avtoimunske bolezni centralnega živčnega sistema in Guillain-Barréjevega sindroma (GBS).
English: Following the review, it has been reconfirmed that Lemtrada causes secondary autoimmune disease including auto-immune hepatitis, thyroiditis, immune thrombocytopenic purpura, acquired haemophilia A, nephropathies, cytopenias and serious immunological reactions such as haemophagocytic lymphohistiocytosis.
Slovenian: Po pregledu je bilo ponovno potrjeno, da zdravilo Lemtrada povzroča sekundarno avtoimunsko bolezen, vključno z avtoimunskim hepatitisom, tiroiditisom, imunsko trombocitopenično purpuro, pridobljeno hemofilijo A, nefropatijami, citopenijami in resnimi imunološkimi reakcijami, kot je hemofagocitna limfohistiocitoza.
English: • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Slovenian: • bolniki s hitro razvijajočo se hudo recidivno-remitentno multiplo sklerozo, ki se kaže z dvema ali več recidivi prizadetosti v enem letu ter eno ali več lezijami, vidnimi z gadolinijem pri magnetni resonanci možganov, ali znatnim povečanjem površine lezij T2 v primerjavi s predhodnim nedavnim slikanjem z magnetno resonanco.
English: In future PSURs, the MAH is expected to submit cumulative reviews and discuss the following safety concerns: vasculitis, CNS inflammation, GBS, diabetes type 1, myasthenic syndrome, myositis, sarcoidosis, GBS, pneumonitis and EBV hepatitis.
Slovenian: V prihodnjih redno posodobljenih poročilih o varnosti zdravila (PSUR) naj bi imetnik dovoljenja za promet z zdravilom predložil kumulativne preglede in obravnaval naslednje varnostne pomisleke: vaskulitis, vnetje centralnega živčnega sistema, Guillain-Barréjev sindrom, sladkorna bolezen tipa 1, miastenični sindrom, miozitis, sarkoidoza, pnevmonitis in hepatitis EBV.
English: - 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.
Slovenian: - srčno-žilni neželeni učinki v tesni časovni povezavi z infuzijami zdravila Lemtrada (npr. srčna ishemija in miokardni infarkt, ishemična in hemoragična možganska kap, disekcija arterij, pljučna krvavitev in embolija, vaskulitis in trombocitopenija), vključno z morebitno mehansko povezavo s temi neželenimi učinki;
English: o patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy, or o patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Slovenian: o bolniki z boleznijo, ki je zelo aktivna kljub celotnemu in ustreznemu poteku zdravljenja z vsaj enim zdravilom, ki spreminja potek bolezni, ali o bolniki s hitro razvijajočo se hudo recidivno-remitentno multiplo sklerozo, ki se kaže z dvema ali več recidivi prizadetosti v enem letu ter eno ali več lezijami, vidnimi z gadolinijem pri slikanju z magnetno resonanco možganov, ali znatnim povečanjem površine lezij T2 v primerjavi s predhodnim nedavnim slikanjem z magnetno resonanco;
English: - Immune-mediated diseases such as auto-immune hepatitis, hepatic injury, auto-immune-mediated central nervous system disease and Guillain-Barre Syndrome (GBS).
Slovenian: - imunsko povzročene bolezni, kot so avtoimunski hepatitis, poškodba jeter, avtoimunsko povzročena bolezen centralnega živčnega sistema in Guillain-Barréjev sindrom.
English: Specialists from other medical disciplines (e.g. cardiologists) and equipment for timely diagnosis and management of adverse reactions however requires, in the view of PRAC, a hospital setting.
Slovenian: Po mnenju odbora PRAC je treba infuzijo zaradi strokovnjakov iz drugih medicinskih disciplin (npr. kardiologi) ter opreme za pravočasno diagnozo in obvladovanje neželenih učinkov opraviti v bolnišnici.
English: With this conclusion, PRAC acknowledges that early initiation of high-efficacy DMTs in patients with highly active (aggressive) or rapidly evolving RRMS is increasingly viewed as a strategy to prevent or postpone irreversible damage that occurs early in the disease course3.
Slovenian: Odbor PRAC s to ugotovitvijo potrjuje, da se zgodnja uvedba visoko učinkovitega zdravila, ki spreminja potek bolezen, pri bolnikih z zelo aktivno (agresivno) ali hitro razvijajočo se recidivno-remitentno multiplo sklerozo vse pogosteje obravnava kot strategija za preprečevanje ali odlaganje nepopravljive škode, ki nastane zgodaj v poteku bolezni.3 Nedavne študije recidivno-remitentne multiple skleroze z dolgoročnim spremljanjem so pokazale, da zdravila, ki spreminjajo potek bolezni, zmanjšajo delež bolnikov, pri katerih se pojavi sekundarna progresivna multipla skleroza (SPMS), v primerjavi z deležem nezdravljenih bolnikov.
English: o coagulopathy, on antiplatelet or anti-coagulant therapy o concomitant autoimmune diseases other than multiple sclerosis.
Slovenian: o koagulopatijo, na antitrombocitni ali antikoagulantni terapiji,
English: equipment to manage the risks.
Slovenian: bolnišnici, kjer so na voljo strokovnjaki in ustrezna oprema za obvladovanje tveganja.
English: Acute coronary syndrome and cerebrovascular events including arterial dissection and haemorrhagic stroke, pulmonary haemorrhage and transient thrombocytopenia have been identified as risks in close temporal association with the infusion of alemtuzumab.
Slovenian: Kot tveganja v tesni časovni povezavi z infuzijo alemtuzumaba so bili opredeljeni akutni koronarni sindrom in cerebrovaskularni učinki, vključno z disekcijo arterij in hemoragično možgansko kapjo, krvavitev v pljučih in prehodna trombocitopenija.
English: Grounds for PRAC recommendation
Slovenian: Podlaga za priporočilo odbora PRAC Ob upoštevanju naslednjega:
English: • PRAC concluded that myocardial ischaemia, myocardial infarction, haemorrhagic stroke, dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage and thrombocytopenia may occur in close temporal association with the infusion of Lemtrada.
Slovenian: • odbor PRAC je ugotovil, da se lahko v tesni časovni povezavi z infuzijo zdravila Lemtrada pojavijo miokardna ishemija, miokardni infarkt, hemoragična možganska kap, disekcija cervikocefalnih arterij, pljučna alveolarna krvavitev in trombocitopenija; odbor PRAC je tudi ugotovil, da je alemtuzumab povezan z imunsko povzročenimi boleznimi, kot so avtoimunski hepatitis, hemofilija A in hemofagocitna limfohistiocitoza (HLH), ki se lahko pojavijo z zamudo več mesecev ali let po zadnjem zdravljenju.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: Številka (EU) dovoljenja za promet
English: This summary was last updated in 10/2017.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2017.
English: Other information about Stribild
Slovenian: Druge informacije o zdravilu Stribild
English: The full EPAR for Stribild 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 Stribild je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stribild on 24/05/2013
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Stribild, veljavno po vsej Evropski uniji, izdala 24. maja 2013.
English: What measures are being taken to ensure the safe and effective use of Stribild?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Stribild?
English: What is Stribild and what is it used for?
Slovenian: Kaj je zdravilo Stribild in za kaj se uporablja?
English: This will cover information on the risk of kidney disease in adults and adolescents and the measures to reduce this risk, including appropriate screening and monitoring of patients.
Slovenian: Vključevalo bo informacije o tveganju ledvične bolezni pri odraslih in mladostnikih ter o ukrepih za zmanjševanje tega tveganja, vključno z ustreznim presejanjem in spremljanjem bolnikov.
English: Stribild contains four active substances.
Slovenian: Zdravilo Stribild vsebuje štiri zdravilne učinkovine.
English: The company that markets Stribild will ensure that all doctors who are expected to prescribe Stribild are provided with educational materials containing important safety information.
Slovenian: Družba, ki trži zdravilo Stribild, bo zagotovila, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali to zdravilo, prejeli izobraževalno gradivo s pomembnimi informacijami o varnosti zdravila.
English: The main measure of effectiveness was based on the reduction in viral load (the amount of HIV-1 virus in the blood).
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje virusnega bremena (količine virusa HIV-1 v krvi).
English: It is not intended to provide practical advice on how to use Stribild.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Stribild have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Stribild izkazalo v študijah?
English: This is a summary of the European public assessment report (EPAR) for Stribild.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Stribild.
English: Stribild is available as tablets (150 mg elvitegravir/150 mg cobicistat /200 mg emtricitabine/245 mg tenofovir disoproxil).
Slovenian: Zdravilo Stribild je na voljo v obliki tablet (150 mg elvitegravirja/150 mg kobicistata/200 mg emtricitabina/245 mg dizoproksiltenofovirata).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stribild have also 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 Stribild upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Stribild?
Slovenian: Kakšna tveganja so povezana z zdravilom Stribild?
English: Why is Stribild approved?
Slovenian: Zakaj je bilo zdravilo Stribild odobreno?
English: The European Medicines Agency decided that Stribild's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Stribild večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Stribild must not be used with several other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Slovenian: Zdravilo Stribild se ne sme uporabljati skupaj z več drugimi zdravili, saj lahko pride do medsebojnega delovanja, pri čemer se zmanjša učinkovitost zdravljenja ali poveča tveganje za neželene učinke.
English: For more information about treatment with Stribild, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Stribild preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.