FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in light of the emerging safety data, the European Commission (EC) considered that the findings from the clinical trials and all available safety data related to idelalisib should be reviewed in order to assess their potential impact on the benefit-risk balance of Zydelig in the approved indications and relevant ongoing variations.
Slovenian: Glede na nove podatke o varnosti je Evropska komisija (EK) menila, da je treba pregledati izsledke kliničnih preskušanj in vse razpoložljive podatke o varnosti, povezane z idelalizibom, da bi ocenili njihov morebiten vpliv na razmerje med tveganji in koristmi zdravila Zydelig pri odobrenih indikacijah in ustreznih potekajočih postopkih za spremembo.
English: Whilst the matter is being further reviewed, the PRAC recommended as a provisional measure an update of the posology and warnings to take due account that treatment should not be initiated in patients with systemic infections, patients should be monitored for respiratory symptoms and be administered Pneumocystis jirovecii pneumonia prophylaxis.
Slovenian: Čeprav se zadeva še nadalje preučuje, je odbor PRAC kot začasni ukrep priporočil, da se odmerjanje in opozorila posodobijo tako, da upoštevajo dejstvo, da se zdravljenje ne sme uvesti pri bolnikih s sistemskimi okužbami, da je treba bolnike spremljati v zvezi z respiratornimi simptomi in da morajo prejemati profilaktično zdravljenje proti pljučnici, ki jo povzroča Pneumocystis jirovecii.
English: The PRAC also considered available safety data from clinical trials submitted in support of the initial marketing authorisation and extensions of indication and Eudravigilance data in relation to the overall risk of treatment with idelalisib.
Slovenian: Odbor PRAC je preučil tudi razpoložljive podatke o varnosti iz kliničnih preskušanj, predložene v podporo prvotnemu dovoljenju za promet z zdravilom in razširitvam terapevtske indikacije, ter podatke iz sistema Eudravigilance v povezavi s celotnim tveganjem zdravljenja z idelalizibom.
English: The trials evaluated combinations with chemotherapy and immunotherapy which are currently not authorised for Zydelig (idelalisib), or authorised combination of Zydelig and immunotherapy but in a population with earlier disease characteristics than the currently approved indication.
Slovenian: V preskušanjih so vrednotili kombinacije s kemoterapijo in imunoterapijo, ki trenutno za zdravilo Zydelig (idelalizib) niso odobrene, ali odobreno kombinacijo zdravila Zydelig in imunoterapije, vendar v populaciji z značilnostmi zgodnejše bolezni, kot je trenutno odobrena indikacija.
English: The PRAC took into account the data submitted by the marketing authorisation holder (MAH).
Slovenian: Odbor PRAC je upošteval podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom.
English: Therefore, the PRAC recommended that idelalisib should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
Slovenian: Zato je odbor PRAC priporočil, da se idelalizib ne sme uvesti pri bolnikih z znaki potekajoče sistemske bakterijske, glivne ali virusne okužbe.
English: • The PRAC noted that the use of idelalisib in studies -0123, -0124 and -0125 was in different conditions than those currently authorised, and at earlier stages of the diseases.
Slovenian: • Odbor PRAC je ugotovil, da se je idelalizib v študijah -0123, -0124 in -0125 uporabljal drugače, kot je trenutno odobreno, in v zgodnejših stadijih bolezni.
English: 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.
Slovenian: 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 zdravljenje prve izbire v prisotnosti delecije 17p ali mutacije TP53 pri bolnikih, pri katerih kemoimunoterapija ni primerna.
English: For CLL patients with 17p deletion or TP53 mutation already on idelalisib therapy as first line, clinicians should carefully consider individual benefit-risk balance and decide whether to continue treatment.
Slovenian: Pri bolnikih s KLL z delecijo 17p ali mutacijo TP53, ki se že zdravijo z idelalizibom kot zdravljenjem prve izbire, morajo zdravniki skrbno pretehtati razmerje med tveganji in koristmi pri posameznem bolniku ter se odločiti, ali naj nadaljujejo z zdravljenjem.
English: In view of the above, the Committee considers that the benefit-risk balance of Zydelig remains favourable subject to the agreed provisional amendments to the product information and other risk minimisation measures.
Slovenian: Z upoštevanjem zgoraj navedenega odbor meni, da je razmerje med tveganji in koristmi zdravila Zydelig še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene začasne spremembe informacij o zdravilu in drugi ukrepi za zmanjševanje tveganja.
English: Although the potential impact of these new safety findings in the current authorised indications is presently unknown, the PRAC recommended provisional amendments of the indication of idelalisib and considered that as a precautionary measure, idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation.
Slovenian: Čeprav morebitni vpliv teh novih izsledkov o varnosti za trenutno odobrene indikacije še ni znan, je odbor PRAC priporočil začasne spremembe indikacije za idelalizib in menil, da se kot previdnostni ukrep idelalizib ne sme uvesti kot zdravljenje prve izbire pri bolnikih s KLL z delecijo 17p ali mutacijo TP53.
English: Based on the inhibitory effects of idelalisib on the PI3K pathway, it is possible that the increased risk of serious infection observed in studies 0123, -0124 and -0125 could be relevant to the authorised indications.
Slovenian: Na podlagi zaviralnih učinkov idelaliziba na pot PI3K je mogoče, da je povečano tveganje za resne okužbe, opaženo v študijah 0123, -0124 in -0125, pomembno tudi za odobrene indikacije.
English: Regular clinical and laboratory screening for cytomegalovirus should also be performed.
Slovenian: Treba je izvajati tudi redno klinično in laboratorijsko presejalno testiranje okužbe s citomegalovirusom.
English: • The PRAC reviewed the very limited and preliminary data provided by the marketing authorisation holder on the interim results of study GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib.
Slovenian: • Odbor PRAC je pregledal zelo omejene in preliminarne podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, o vmesnih rezultatih študij GS-US-312-0123, GS-US-3130124, GS-US-313-0125, ki kažejo na povečano tveganje za smrt in resne okužbe pri idelalizibu.
English: • The PRAC noted that most of the serious adverse events reported in studies 0123, -0124 and -0125 were related to infections.
Slovenian: • Odbor PRAC je ugotovil, da je bila večina resnih neželenih učinkov, o katerih so poročali v študijah 0123, -0124 in -0125, povezana z okužbami.
English: The PRAC considered the very limited new safety data from three studies (GS-US-312-0123, GSUS-313-0124, GS-US-313-0125), now terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL).
Slovenian: Odbor PRAC je preučil zelo omejene nove podatke o varnosti iz treh študij (GS-US-312-0123, GS-US313-0124, GS-US-313-0125), ki so se že zaključile in v katerih so vrednotili dodatek idelaliziba standardnim terapijam pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu (iNHL)/limfomu malih limfocitov (SLL).
English: The PRAC noted that in study -0123, idelalisib was administered in combination with bendamustine and rituximab (which is not an authorised combination) and CLL patients were previously untreated, which is not consistent with the current CLL indication.
Slovenian: Odbor PRAC je ugotovil, da so idelalizib v študiji -0123 dajali v kombinaciji z bendamustinom in rituksimabom (kar ni odobrena kombinacija), bolniki s KLL pa predhodno še niso prejeli zdravljenja, kar ni v skladu s trenutno indikacijo za KLL.
English: Idelalisib is also indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Slovenian: Idelalizib je indiciran tudi kot monoterapija za zdravljenje odraslih bolnikov s folikularnim limfomom (FL), neodzivnim na dve predhodni obliki zdravljenja.
English: 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.
Slovenian: 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.
English: A table to guide physicians was proposed for the posology section.
Slovenian: Za poglavje o odmerjanju je bila predlagana preglednica kot smernica za zdravnike.
English: The impact of the new safety findings in the currently authorised indications and extension of indication for use in CLL in combination with ofatumumab cannot be evaluated with certainty at present in view of the limited data available.
Slovenian: Ker so na voljo samo omejeni podatki, vpliva novih izsledkov o varnosti pri trenutno odobrenih indikacijah in razširitvi terapevtske indikacije za uporabo pri KLL v kombinaciji z ofatumumabom trenutno ni mogoče z gotovostjo ovrednotiti.
English: The MAH suggested that in studies -0123, -0124 and -0125 lines of therapy (i.e. increased risk in earlier stages of disease) and concomitant medication (such as bendamustine) may have increased the risk of infection.
Slovenian: Imetnik dovoljenja za promet z zdravilom je domneval, da je povečano tveganje za okužbo v študijah -0123,0124 in -0125 morda posledica oblik zdravljenja (tj. povečano tveganje v zgodnejših stadijih bolezni) in sočasnega zdravila (kot je bendamustin).
English: As a temporary measure, the PRAC recommended that idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation.
Slovenian: Kot začasni ukrep je odbor PRAC priporočil, da se idelalizib pri bolnikih s KLL z delecijo 17p ali mutacijo TP53 ne sme uvesti kot zdravljenje prve izbire.
English: However, the committee recommended that idelalisib could be used for continuing treatment in those patients who had already initiated the medicine as first line treatment based on individual benefit-risk balance assessment and with the addition of new risk minimisation measures.
Slovenian: Vendar pa je priporočil, da se na podlagi posamične ocene razmerja med tveganji in koristmi ter z dodatnimi novimi ukrepi za zmanjševanje tveganja idelalizib lahko uporablja za nadaljevanje zdravljenja pri tistih bolnikih, ki so se že začeli zdraviti s tem zdravilom kot zdravljenjem prve izbire.
English: Annex IV Conditions of the marketing authorisations
Slovenian: Priloga IV Pogoji dovoljenj za promet z zdravili
English: Updates on the registry will be submitted to national competent authorities with periodic safety update reports (PSURs).
Slovenian: Posodobitve registra bodo predložene pristojnim nacionalnim organom skupaj s periodičnimi poročili o varnosti (PSUR).
English: Marketing authorisation holders of aprotinin containing medicinal products shall submit to the national competent authorities, further to the issuing of the Commission Decision and prior to relaunch of the medicinal product to the European market, an update of the risk management plan (RMP) referring to the agreed products' safety concerns as described in the assessment report of the referral procedure and their risk minimisation which includes a direct healthcare professional communication.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin, morajo pristojnim nacionalnim organom predložiti, in sicer po izdaji sklepa Odbora in pred začetkom ponovnega trženja zdravila na evropskem trgu, posodobitev načrta za obvladovanje tveganj (RMP), ki se nanaša na pomisleke v zvezi z varnostjo zdravil, opisane v poročilu o oceni napotitvenega postopka, in na zmanjševanje tveganj, ki vključuje neposredno komunikacijo z zdravstvenimi delavci.
English: The MAH shall take due account of the draft protocol and comments received during assessment.
Slovenian: Imetnik dovoljenja za promet bo upošteval osnutek protokola in pripombe, prejete med ocenjevanjem.
English: This RMP shall follow the EU RMP template and shall include the measures to assess the effectiveness of the risk minimisation.
Slovenian: Ta načrt za obvladovanje tveganj mora ustrezati predlogi EU RMP in vključevati ukrepe za oceno učinkovitosti zmanjševanja tveganja.
English: The registry shall record utilisation information on patients at cardiac surgery centres exposed to aprotinin in participating countries.
Slovenian: V registru se bodo zbirale informacije o uporabi pri bolnikih, izpostavljenih aprotininu, v centrih za srčno kirurgijo v sodelujočih državah.
English: The registry's protocol shall be submitted to the national competent authorities within 2 months of Commission Decision.
Slovenian: V dveh mesecih od sklepa Odbora bo pristojnim nacionalnim organom predložil protokol registra.
English: National Competent Authorities shall ensure that the following conditions are fulfilled by the MAHs of aprotinin containing medicinal products:
Slovenian: Pristojni nacionalni organi morajo zagotoviti, da imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin, izpolnijo naslednje pogoje:
English: Marketing authorisation holders shall conduct a registry, in order to monitor the pattern of use of aprotinin.
Slovenian: Imetniki dovoljenj za promet z zdravili bodo vodili register, namenjen spremljanju vzorca uporabe aprotinina.
English: It shall thus be set up in advance of placing the product on the market.
Slovenian: To je treba opraviti pred začetkom trženja zdravil.
English: A restricted distribution of aprotinin with the above mentioned registry, with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry.
Slovenian: Omejena distribucija aprotinina z zgoraj-omenjenim registrom, tako da bo aprotinin na voljo samo v zdravstvenih centrih, ki izvajajo operacije srca z vstavitvijo obvoda koronarne arterije in ki sodelujejo pri registru.
English: None.
Slovenian: Nobenih.
English: This summary was last updated in February 2016.
Slovenian: Povzetek je bil nazadnje posodobljen februarja 2016.
English: This will help to protect against the disease.
Slovenian: To bo pripomoglo k obrambi pred boleznijo.
English: The full EPAR for Letifend can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Letifend je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Letifend.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Letifend.
English: It is not intended to provide practical advice on how to use Letifend.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The European Commission granted a marketing authorisation valid throughout the EU for Letifend on 20.04.2016.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Letifend, veljavno po vsej Evropski uniji, izdala 20. aprila 2016.
English: In the future, if the animals are exposed to the parasite, the immune system will be able to respond more quickly.
Slovenian: Ob ponovni izpostavitvi živali parazitu v prihodnosti se bo imunski sistem tako hitreje odzval.
English: Letifend is a vaccine.
Slovenian: Zdravilo Letifend je cepivo.
English: In a field study in France and Spain 275 dogs were vaccinated with Letifend and 274 dogs received placebo (a dummy vaccination).
Slovenian: V terenski študiji v Franciji in Španiji je bilo 275 psov cepljenih z zdravilom Letifend, 274 psov pa je prejelo placebo (cepivo brez zdravilne učinkovine).
English: The most common side effect with Letifend (which may affect more than 1 in 10 animals) is scratching at the injection site which resolves within four hours.
Slovenian: Najpogostejši neželeni učinek zdravila Letifend (ki lahko prizadene več kot 1 od 10 živali), je praskanje na mestu injiciranja, ki izgine v štirih urah.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Letifend's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Letifend večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The parasite is widespread in countries bordering the Mediterranean Sea and is transmitted by the bites of sand flies.
Slovenian: Ta parazit je razširjen v deželah ob Sredozemskem morju in se prenaša s pikom peščenih muh.
English: The vaccine is given to dogs from 6 months of age as a single injection under the skin.
Slovenian: Cepivo se daje psom, starejšim od šestih mesecev, kot ena injekcija pod kožo.
English: Dogs that have been infected may show no signs of infection, but some have active disease with symptoms such as fever, hair and weight loss, and skin sores.
Slovenian: Okuženi psi morda ne bodo kazali znakov okužbe, pri nekaterih pa se razvije aktivna bolezen s simptomi, kot so zvišana temperatura, izpadanje dlake in izguba telesne mase ter rane na koži.
English: What is Letifend and what is it used for?
Slovenian: Kaj je zdravilo Letifend in za kaj se uporablja?
English: Over a two year period there were 8 confirmed cases of leishmaniasis in the vaccinated group compared with 19 cases in the placebo group, showing that Letifend was effective in reducing the occurrence of the disease.
Slovenian: V dveh letih so potrdili 8 primerov leishmanioze v skupini, ki je prejela cepivo, v primerjavi z 19 primeri v skupini, ki je prejela placebo, kar je dokazalo, da je zdravilo Letifend učinkovito pri zmanjševanju pojavnosti bolezni.
English: What benefits of Letifend have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Letifend izkazalo v študijah?
English: Why is Letifend approved?
Slovenian: Zakaj je bilo zdravilo Letifend odobreno?
English: Only non-infected animals should be vaccinated.
Slovenian: Cepite le neokužene živali.
English: What are the risks associated with Letifend?
Slovenian: Kakšna tveganja so povezana z zdravilom Letifend?
English: Letifend is available as a freeze-dried powder (lyophilisate) and solvent that are made up into a solution for injection, and can only be obtained with a prescription.
Slovenian: Zdravilo Letifend je na voljo v obliki praška, sušenega z zamrzovanjem (liofilizata) in vehikla za pripravo raztopine za injiciranje, njegova izdaja pa je le na recept.
English: Infected dogs can help spread the disease to humans.
Slovenian: Z okuženih psov se bolezen lahko prenese tudi na človeka.
English: Protection starts four weeks after vaccination and lasts one year.
Slovenian: po cepljenju in traja eno leto.
English: Letifend contains the active substance protein Q, which is made of different fragments of proteins from Leishmania infantum.
Slovenian: Zdravilo Letifend vsebuje zdravilno učinkovino protein Q, narejeno iz različnih fragmentov proteinov parazita Leishmania infantum.
English: The dogs were exposed to natural infection with Leishmania infantum.
Slovenian: Psi so bili izpostavljeni naravni okužbi s parazitom Leishmania infantum.
English: Other information about Letifend?
Slovenian: Druge informacije o zdravilu Letifend
English: Letifend canine leishmaniasis vaccine (recombinant protein)
Slovenian: Letifend cepivo za pse proti leishmaniozi (rekombinantni protein)
English: For practical information about using Letifend, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Letifend naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with Letifend, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Letifend naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Letifend is a veterinary vaccine used in dogs to protect them against leishmaniasis due to the parasite Leishmania infantum.
Slovenian: Letifend je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito psov pred leishmaniozo, ki jo povzroča parazit Leishmania infantum.
English: When Letifend is given to dogs the immune system recognises the Leishmania protein as ‘foreign' and makes defences against it.
Slovenian: Ko pes prejme zdravilo Letifend, imunski sistem prepozna protein parazita Leishmania kot tujek in proti njemu tvori protitelesa.
English: How does Letifend work?
Slovenian: Kako zdravilo Letifend deluje?
English: Before vaccination, dogs should be tested for Leishmania infection.
Slovenian: Pred cepljenjem je treba pse testirati na okužbo s parazitom Leishmania.
English: A ‘booster' injection should be given every year to maintain the vaccine's effect.
Slovenian: Za vzdrževanje učinka cepiva je treba nato vsako leto psu injicirati obnovitveni odmerek.
English: How is Letifend used?
Slovenian: Kako se zdravilo Letifend uporablja?
English: vaccinated dogs since the vaccine does not prevent Leishmania infection.
Slovenian: Pri cepljenih psih je treba upoštevati ukrepe za zmanjšanje izpostavljenosti peščenim muham, saj cepivo ne preprečuje okužbe s parazitom Leishmania.
English: 3 years.
Slovenian: 3 mesece.
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 tablet
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Slovenian: Pogostnost je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: 84 tablets
Slovenian: 84 tablet
English: Headache Mild or moderate severity headache was reported in 5.8% of patients.
Slovenian: O blagem ali zmernem glavobolu so poročali pri 5,8 % bolnic.
English: Patients with controlled bleedingb,c, d
Slovenian: Bolnice z nadzorovano krvavitvijob,c,d
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).
Slovenian: Opažena pogostost je bila skladna s kontrolnimi skupinami in prevalenco, o kateri poročajo v literaturi, pri simptomatskih ženskah pred menopavzo v tej starostni skupini (povprečno 40 let).
English: EU/1/18/1309/001 28 tablets EU/1/18/1309/002 84 tablets EU/1/18/1309/003 30 tablets EU/1/18/1309/004 28 tablets EU/1/18/1309/005 84 tablets
Slovenian: EU/1/18/1309/001 28 tablet EU/1/18/1309/002 84 tablet EU/1/18/1309/003 30 tablet EU/1/18/1309/004 28 tablet EU/1/18/1309/005 84 tablet