natgillin/translations-raw huggingface dataset:
Nonetheless, considering the seriousness of those events, and following the SAG advice, the PRAC recommended that patients with evidence of prior CMV infection should undergo regular clinical and laboratory monitoring and patients with CMV viremia should be carefully monitored.
Kljub temu je odbor PRAC, ob upoštevanju resnosti teh dogodkov in po upoštevanju nasvetov znanstvene svetovalne skupine, priporočil, da je treba pri bolnikih z znaki predhodne okužbe s CMV redno izvajati klinično in laboratorijsko spremljanje in redno spremljati bolnike s CMV v krvi.
Therefore while the relevance of these results are also limited for the authorised use in patients refractory to two prior lines of follicular lymphoma treatment, where idelalisib has been demonstrated to be effective and no other effective treatment options exist, they highlight the importance of minimising the risk of serious infection.
Ker pa je pomen teh rezultatov omejen tudi za pooblaščeno uporabo pri bolnikih s folikularnim limfomom, neodzivnih na dve predhodni obliki zdravljenja, kjer se je idelalizib pokazal za učinkovitega, in ker ne obstajajo nobene druge učinkovite možnosti, poudarjajo pomembnost zmanjševanja tveganja za resno okužbo.
No low-risk population or risk-free period could be identified and the risk may persist after end of therapy, therefore, taking into account current guidelines on PJP prophylaxis and in line with the advice from experts consulted during the review (scientific advisory group [SAG]), the PRAC recommended that PJP prophylaxis should be administered to all patients throughout idelalisib treatment and prolonged afterward for up to 6 months based on clinical judgement.
Ker ni bilo mogoče opredeliti populacije z majhnim tveganjem ali obdobje brez tveganja in ker se lahko tveganje ohrani po koncu zdravljenja, je odbor PRAC, ob upoštevanju sedanjih smernic o profilaktičnem zdravljenju za pljučnico, ki jo povzroča PJP, in v skladu s posvetom s strokovnjaki med pregledom (znanstvena svetovalna skupina [SAG]), priporočil, da je treba skozi celotno zdravljenje z idelalizibom vsem bolnikom dajati profilaktično zdravljenje za pljučnico, ki jo povzroča PJP, in ga na osnovi klinične presoje podaljšati do 6 mesecev po zdravljenju.
• The PRAC reviewed the preliminary data provided by the marketing authorisation holder on the interim results of studies GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib.
• Odbor PRAC je pregledal preliminarne podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, o vmesnih rezultatih študij GS-US-312-0123, GS-US-313-0124, GS-US-313-0125, ki kažejo na povečano tveganje za smrt in resne okužbe pri idelalizibu.
CMV infections were also notably reported in the idelalisib treatment arms, however, in controlled studies where idelalisib was administered in combination with rituximab or ofatumumab and not bendamustine, the reported rate was low.
O okužbah s CMV so prav tako poročali v krakih zdravljenja z idelalizibom, vendar je bila v nadzorovanih študijah, kjer je bil dajan idelalizib v kombinaciji z rituksimabom ali ofatumumabom in ne bendamustinom, poročana stopnja nizka.
While these risks were considered acceptable due to the demonstrated beneficial effect observed in the studies that supported the initial marketing authorisation and later extension of indication, these three new studies indicate that in patients with early disease (CLL or
Medtem ko so bila ta tveganja ocenjena kot sprejemljiva zaradi dokazano blagodejnega vpliva, opaženega v študijah, predloženih v podporo prvemu dovoljenju za promet z zdravilom in kasnejše razširitve indikacije, te tri nove študije kažejo, da pri bolnikih v zgodnjem stadiju bolezni (KLL ali iNHL) koristi ne odtehtajo tveganj (predvsem za resne okužbe).
If the benefits of resuming idelalisib are judged to outweigh the risks of CMV, consideration should be given to administering pre-emptive CMV therapy.
Če se oceni, da so koristi ponovnega začetka zdravljenja z idelalizibom večje od tveganja za okužbo s CMV, je treba premisliti o dajanju preventivnega zdravljenja za CMV.
This text was considered not to be contributory as adequate information on the benefit-risk balance of idelalisib in these patients is already included in other sections of the product information.
Menil je, da to besedilo ne prispeva ustreznih informacij glede razmerja med koristjo in tveganjem idelaliziba pri teh bolnikih, ki so že vključene v druga poglavja informacij o zdravilu.
The PRAC considered the new interim safety data and very limited efficacy data from three studies (-0123,0124, -0125), that have been terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL) as well as the results of all other relevant trials including those that supported the above listed indications.
Odbor PRAC je proučil nove začasne podatke o varnosti in zelo omejene podatke o učinkovitosti iz treh zaključenih študij (-0123, -0124, -0125), v katerih so vrednotili dodajanje idelaliziba standardnim terapijam pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu (iNHL)/limfomu malih limfocitov (SLL), ter tudi rezultate vseh drugih ustreznih preskušanj, vključno s tistimi, ki so podprli zgoraj navedene indikacije.
In particular, PRAC recommended that treatment should not be initiated in patients with evidence of ongoing systemic infection, that patients should be monitored for respiratory signs and symptoms throughout treatment and advised to report new respiratory symptoms promptly.
Odbor PRAC je priporočil, da se zdravljenje ne sme uvesti pri bolnikih z znaki potekajoče sistemske okužbe, da je treba pri bolnikih ves čas zdravljenja spremljati respiratorne znake in simptome in jih opozoriti, da nemudoma poročajo o novih respiratornih simptomih.
The PRAC considered that the benefit-risk balance in this indication remained positive provided the risk minimisation measures are implemented.
Odbor PRAC je menil, da je razmerje med tveganji in koristmi pri tej indikaciji še naprej pozitivno, pod pogojem, da se izvajajo dejavnosti za zmanjševanje tveganja.
To this effect, the PRAC recommended that treatment with idelalisib should not be initiated in patients with evidence of systemic infections, that patients should be monitored for respiratory symptoms and that they should be administered Pneumocystis jirovecii pneumonia prophylaxis throughout and after idelalisib treatment.
V zvezi s tem je odbor PRAC priporočil, da se zdravljenje z idelalizibom ne sme uvesti pri bolnikih z znaki sistemskih okužb, da je treba bolnike opazovati zaradi respiratornih simptomov in da jim je treba dajati profilaktično zdravljenje proti pljučnici, ki jo povzroča Pneumocystis jirovecii, skozi celotno zdravljenje z idelalizibom in po njem.
The PRAC considered that these measures should be applied for the use of idelalisib in combination with ofatumumab in CLL patients.
Odbor PRAC je menil, da bi te ukrepe bilo treba izvajati pri uporabi idelaliziba v kombinaciji z ofatumumabom pri bolnikih s KLL.
The benefit-risk balance of idelalisib in combination with rituximab in treatment naïve and relapsed/refractory CLL is therefore considered to remain positive provided the recommended risk minimisation measures are applied.
Zato se šteje, da razmerje med tveganji in koristmi idelaliziba v kombinaciji z rituksimabom pri zdravljenju še nezdravljene in relapsne/refraktorne KLL, ostane pozitivno, pod pogojem, da se upoštevajo priporočene dejavnosti za zmanjšanje tveganja.
However as patients with 17p deletion or TP53 mutation have a poor prognosis, the extrapolation of the positive results observed in relapsed/refractory subjects with 17p deletion or TP53 mutation that supported the initial granting of the indication in patients unsuitable for chemoimmunotherapy is not questioned.
Ker pa imajo bolniki z delecijo 17p ali mutacijo TP53 slabo prognozo, ni vprašljiva ekstrapolacija pozitivnih rezultatov pri relapsnih/refraktornih preiskovancih z delecijo 17p ali mutacijo TP53, ki je podpirala začetno pridobitev indikacije pri bolnikih, neprimernih za kemoimunoterapijo.
In particular an increased incidence of PJP, carrying a high risk of morbidity and mortality, was observed in the idelalisib treatment arms compared to controls in all the studies, and appeared to be significantly lower in patients administered PJP prophylaxis.
Povečana incidenca pljučnice, ki jo povzroča Pneumocystis jirovecii (PJP) in predstavlja veliko tveganje za obolevnost in umrljivost, je bila ugotovljena v veji zdravljenja z idelalizibom v primerjavi s kontrolno skupino v vseh študijah in se je zdela znatno nižja pri bolnikih, ki so prejemali profilaktično zdravljenje za pljučnico, ki jo povzroča PJP.
The results of study -0123 are considered of limited relevance to the benefit-risk balance of idelalisib in the authorised CLL indication, due to the added toxicity of bendamustine.
Rezultati študije -0123 se štejejo za manj pomembne za razmerje med koristjo in tveganjem idelaliziba v odobreni indikaciji za KLL zaradi dodane toksičnosti bendamustina.
The PRAC noted that in study -0123, idelalisib was administered in combination with rituximab and bendamustine (an unauthorised combination) in previously untreated CLL patients with and without 17p deletion/TP53 mutation, which is not the same population as the one in the current CLL indication in first line.
Odbor PRAC je ugotovil, da so idelalizib v študiji -0123 dajali v kombinaciji z rituksimabom in bendamustinom (neodobreno kombinacijo) pri predhodno nezdravljenih bolnikih s KLL z in brez delecije 17p/mutacije TP53, kar ni enaka populacija kot tista v trenutni indikaciji KLL prve izbire.
On 10 March 2016, the European Commission was informed that an increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups had been observed in three clinical trials by the independent safety data monitoring group.
10. marca 2016 je neodvisna skupina za spremljanje podatkov o varnosti Evropsko komisijo obvestila, da so v treh kliničnih preskušanjih opazili povečano tveganje za smrt in višjo pojavnost resnih neželenih učinkov pri preiskovancih, ki so prejemali idelalizib, v primerjavi s kontrolnimi skupinami.
There was however no indication that treatment-naïve CLL patients constitute a population more at risk of developing idelalisib-related adverse events compared to relapsed/refractory patients.
indikacije, da bolniki s KLL, ki še niso bili zdravljeni, predstavljajo populacijo s povečanim tveganjem za razvoj neželenih učinkov, povezanih z jemanjem idelaliziba v primerjavi z relapsnimi/refraktornimi bolniki.
In view of the above, the PRAC concluded that the benefit-risk balance of Zydelig is favourable subject to changes to the product information, as described above.
Z upoštevanjem zgoraj navedenega je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravila Zydelig ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
The PRAC considered the results of these studies of limited relevance for the benefit-risk balance of idelalisib in its authorised indications and ongoing extension of indication in combination with ofatumumab for the treatment of CLL.
Odbor PRAC je menil, da so rezultati teh študij manj pomembni za razmerje med tveganji in koristmi idelaliziba v njegovih odobrenih indikacijah in potekajoči razširitvi indikacij v kombinaciji z ofatumumabom za zdravljenje KLL.
Zydelig (idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Zydelig (idelalizib) je centralno odobreno zdravilo in je trenutno indicirano v kombinaciji z rituksimabom za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL), ki so pred tem prejeli vsaj eno zdravljenje, ali kot zdravilo prve izbire v prisotnosti delecije 17p ali mutacije TP53 pri bolnikih, pri katerih kemoimunoterapija ni primerna.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zydelig (idelalisib).
Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Zydelig (idelalizib).
The PRAC concluded that the benefit-risk balance in the authorised indications remained positive, provided that first line treatment with idelalisib is only used in patients with 17p deletion or TP53 mutation that are not eligible for any other therapies and that changes are implemented in the product information to minimise the risk of serious infections.
Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi v odobrenih indikacijah še naprej pozitivno, če se zdravljenje prve izbire z idelalizibom uporablja samo pri bolnikih z delecijo 17p ali mutacijo TP53, ki niso primerni za kakršno koli drugo zdravljenje, in da se informacije o zdravilu popravijo, da se zmanjša tveganje za resno okužbo.
For the same reasons, the relevance of the results of study -0123 is considered limited for the benefit-risk balance of idelalisib in combination with ofatumumab in the same types of CLL
Iz istega razloga se rezultati študije -0123 štejejo za manj pomembne za razmerje med koristjo in tveganjem idelaliziba v kombinaciji z ofatumumabom pri bolnikih z enakimi vrstami KLL.
The CHMP discussed the statement proposed to be added in section 4.4 of the SmPC that limited efficacy and safety data explain why idelalisib is to be used as a first line treatment only in those patients with the 17p deletion or TP53 mutation who are not eligible for any other therapies.
Odbor CHMP je razpravljal o stavku, predlaganem, da se ga doda v poglavje 4.4 povzetka glavnih značilnosti zdravila, ki je omejeval učinkovitost in podatke o varnosti in pojasnjeval, zakaj je treba idelalizib uporabljati kot zdravljenje prve izbire samo pri tistih bolnikih z delecijo 17p ali mutacijo TP53, ki niso primerni za drugo zdravljenje.
The CHMP, as a consequence, considers that the benefit-risk balance of Zydelig (idelalisib) remains favourable subject to the amendments to the product information.
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravila Zydelig (idelalizib) še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
Following the same precautionary principle, in view of the limited data available in treatment naïve patients with 17p deletion or TP53 mutation it was also considered that idelalisib in combination with ofatumumab should be only be used first-line in CLL patients with 17p deletion or TP53 mutation who are not eligible for any other therapies.
Po istem previdnostnem načelu in ker so na voljo samo omejeni podatki pri predhodno nezdravljenih bolnikih z delecijo 17p ali mutacijo TP53, se je prav tako štelo, da se idelalizib v kombinaciji z ofatumumabom lahko uporablja kot zdravilo prve izbire za KLL pri bolnikih z delecijo 17p ali mutacijo TP53, ki niso primerni za kakršno koli drugo zdravljenje.
1 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL
GS-US-312-0123, randomizirana dvojno slepa s placebom kontrolirana študija faze 3 o učinkovitosti in varnosti idelaliziba v kombinaciji z bendamustinom in rituksimabom za predhodno nezdravljeno KLL.
Nevertheless, as a precaution and in view of the fact that limited data are available in treatment-naïve CLL patients with 17p deletion or TP53 mutation, the PRAC recommended that idelalisib should only be used in this group of patients if they are not eligible for any other therapies.
Odbor PRAC je kot previdnostni ukrep in ob upoštevanju dejstva, da so na voljo omejeni podatki za bolnike s KLL z delecijo 17p ali mutacijo TP53, ki še niso bili zdravljeni, priporočil, da se lahko idelalizib uporablja samo v tej skupini bolnikov, če niso primerni za kakršno koli drugo zdravljenje.
Nevertheless, in view of the limited data available in this subset and considering availability of other options for first line treatment for CLL patients, the PRAC was of the view that as a precaution, idelalisib should only be used in patients with 17p deletion or TP53 mutation if they are not eligible for any other therapies.
Odbor PRAC je zaradi omejenih podatkov, ki so na voljo v tej skupini, in z upoštevanjem razpoložljivosti drugih možnosti za zdravljenje prvega izbora za bolnike s KLL, ocenil, da je kot previdnostni ukrep idelalizib lahko uporabljen samo pri bolnikih z delecijo 17p ali mutacijo TP53, če niso primerni za kakršno koli drugo zdravljenje.
The European Commission granted a marketing authorisation valid throughout the European Union for Menveo on 15 March 2010.
Evropska komisija je dovoljenje za promet z zdravilom Menveo, veljavno po vsej Evropski uniji, izdala 15. marca 2010.
The vaccine should be given according to official recommendations.
Cepivo je treba dajati v skladu z uradnimi priporočili.
This helps to enhance the immune response.
To pomaga okrepiti imunski odziv.
What measures are being taken to ensure the safe and effective use of Menveo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Menveo?
The full EPAR for Menveo 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 Menveo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A risk management plan has been developed to ensure that Menveo is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Menveo je bil pripravljen načrt obvladovanja tveganj.
In children between two and 10 years old, the most common side effects were similar and also included sleepiness and irritability.
Pri otrocih, starih od dveh do deset let, so bili najpogostejši neželeni učinki podobni, obsegali pa so še zaspanost in razdražljivost.
Other information about Menveo
Druge informacije o zdravilu Menveo
The ability of Menveo to trigger the production of antibodies (immunogenicity) was assessed in a main study involving almost 4,000 participants aged 11 years and above and in a second main study involving almost 3,000 children between two and 10 years old.
Sposobnost cepiva Menveo pri spodbujanju tvorbe protiteles (imunogenost) je bila ovrednotena v glavni študiji, v katero je bilo vključenih skoraj 4 000 oseb, starejših od 11 let, in v drugi glavni študiji, v katero je bilo vključenih skoraj 3 000 otrok, starih od dve do deset let.
What benefit has Menveo shown during the studies?
Kakšne koristi je zdravilo Menveo izkazalo med študijami?
It contains parts of the bacterium Neisseria meningitidis (N. meningitidis).
Vsebuje dele bakterije Neisseria meningitidis (N. meningitidis).
For more information about treatment with Menveo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Menveo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Menveo?
Kakšna tveganja so povezana z zdravilom Menveo?
The vaccine must not be given to anyone who has had a life-threatening reaction to a vaccine that contains similar components in the past.
Cepivo se ne sme dati osebam, ki so v preteklosti imele smrtno nevarne reakcije na cepivo, ki vsebuje podobne sestavine.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Menveo, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Why has Menveo been approved?
Zakaj je bilo zdravilo Menveo odobreno?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Menveo.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Invazivna bolezen se pojavi, ko se bakterija razširi po telesu in povzroči resne okužbe, kot sta meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo) in sepsa (okužba krvi).
Menveo is a vaccine.
Zdravilo Menveo je cepivo.
The number of people who had an immune response against the oligosaccharides was similar for the two vaccines.
Število ljudi, pri katerih se je pokazal imunski odziv proti oligosaharidom, je bilo pri obeh cepivih podobno.
Menveo is used in people who are at risk of exposure to the bacterium.
Uporablja se pri ljudeh, pri katerih obstaja nevarnost izpostavljenosti tem bakterijam.
This document is a summary of the European Public Assessment Report (EPAR) for Menveo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Menveo.
The Committee noted that Menveo offers the benefits of conjugated vaccines, including producing a stronger immune response in young children.
Ugotovil je, da zdravilo Menveo zagotavlja koristi konjugiranih cepiv, vključno s spodbujanjem močnejšega imunskega odziva pri mlajših otrocih.
When the person is exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Ko je oseba izpostavljena bakteriji, ta protitelesa skupaj z drugimi deli imunskega sistema uničijo bakterije in pomagajo pri obrambi proti bolezni.
Menveo must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, including diphtheria toxoid.
Zdravila Menveo ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila, vključno s toksoidom davice.
The most common side effects with Menveo in adults and children from the age of 11 (seen in more than 1 patient in 10) are headache, nausea (feeling sick), malaise (feeling unwell), myalgia (muscle pain), as well as pain, erythema (reddening of the skin) and induration (hardening) at the site of injection.
Najpogostejši neželeni učinki zdravila Menveo pri odraslih in otrocih, starejših od 11 let, (opaženi pri več kot 1 bolniku od 10) so glavobol, navzeja (slabost), slabo počutje, mialgija (bolečine v mišicah) ter bolečine, eritem (pordelost kože) in otrdelost na mestu injiciranja.
Menveo is given as a single injection preferably into the shoulder muscle.
Cepivo Menveo se injicira v enem odmerku, po možnosti v ramensko mišico.
Menveo must not be given into a blood vessel or into or under the skin.
Ne sme se injicirati v žilo oziroma v kožo ali podkožje.