FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the above, the PRAC considered that the benefit-risk balance of Forxiga, XigDuo, Invokana, Vokanamet, Jardiance and Synjardy remains favourable subject to the agreed amendments to the product information.
Slovenian: Glede na zgoraj navedeno je odbor PRAC menil, da je razmerje med tveganji in koristmi zdravil Forxiga, XigDuo, Invokana, Vokanamet, Jardiance in Synjardi še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
English: By blocking the action of SGLT2, these substances cause more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood via an insulinindependent mechanism.
Slovenian: Te snovi z zaviranjem delovanja SGLT2 povzročijo večje izločanje glukoze z urinom, s čimer se znižajo ravni glukoze v krvi s pomočjo mehanizma, ki je neodvisen od insulina.
English: Based on the data available, the PRAC considered that there was no indication of a different risk between the products.
Slovenian: Na podlagi razpoložljivih podatkov je odbor PRAC menil, da se zdravila med seboj ne razlikujejo po tveganju.
English: Moreover, risk factors reported in the cases are consistent with those previously reported in the literature and the risks factors inherent to the patient population (e.g. patients with low beta-cell function reserve, restricted food intake or severe dehydration, sudden reduction in insulin dose and increased insulin requirements due to acute medical illness, surgery or alcohol abuse).
Slovenian: Dejavniki tveganja, o katerih poročajo v teh primerih, so skladni z dejavniki, o katerih so poročali že v literaturi, in dejavniki tveganja, povezanimi z določenimi populacijami bolnikov (npr. bolniki z majhno rezervo delovanja celic beta, omejenim vnosom hrane ali hudo dehidracijo, nenadnim zmanjšanjem odmerka insulina in povečanimi potrebami po insulinu zaradi akutne bolezni, kirurškega posega ali čezmernega uživanja alkohola).
English: The glucose is partially excreted via the urine, leading to polyuria, dehydration, and compensatory thirst and polydipsia.
Slovenian: Glukoza se delno izloča z urinom, kar povzroča poliurijo, dehidracijo, kompenzacijsko žejo in kompenzacijsko polidipsijo.
English: In a study that reported population-based rates of DKA, the incidence rate of DKA in T2DM patients, requiring hospital admission, was reported to be 0.5 per 1,000 patient-years.
Slovenian: V študiji, kjer so poročali o populacijski pojavnosti DKA, je bila pojavnost DKA pri bolnikih s sladkorno boleznijo tipa 2, ki so potrebovali hospitalizacijo, 0,5 na 1 000 bolnik-let.
English: In addition, the low levels of insulin along with a rise in plasma glucagon levels lead to the release of glucose by the liver.
Slovenian: Poleg tega nizke ravni insulina in dvig ravni glukagona v plazmi povzročajo sproščanje glukoze iz jeter.
English: In order to minimise this risk, the PRAC considered that physicians and patients should be warned through the PI to consider the risk of atypical DKA in the occurrence of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Slovenian: Da bi to tveganje čim bolj zmanjšali, je odbor PRAC menil, da je treba zdravnike in bolnike v informacijah o zdravilu opozoriti na upoštevanje tveganja za atipično DKA pri pojavu nespecifičnih simptomov, kot so navzeja, bruhanje, anoreksija, bolečine v trebuhu, čezmerna žeja, težave z dihanjem, zmedenost, neobičajna utrujenost ali zaspanost.
English: DKA most commonly occurs in patients with type 1 diabetes mellitus (T1DM) and is usually accompanied by high blood glucose levels (>250 mg/dL).
Slovenian: DKA se najpogosteje pojavlja pri bolnikih s sladkorno boleznijo tipa 1, po navadi pa jo spremljajo zvišane ravni glukoze v krvi (> 250 mg/dl).
English: DKA cases were reported in all three SGLT2 currently authorised in the EU, suggestive of a class effect.
Slovenian: O primerih DKA so poročali pri vseh treh zaviralcih SGLT2, ki so trenutno odobreni v EU, kar kaže na učinek razreda zdravil.
English: In absence of insulin the metabolism switches from using glycogenolysis to lipolysis as a source of energy, which produces ketone bodies.
Slovenian: V odsotnosti insulina presnova preklopi z glikogenolize na lipolizo kot vir energije, pri čemer nastajajo ketonska telesa.
English: In addition, a DUS, ideally based on secondary observational data via existing databases, is also required to be undertaken by the MAH of canagliflozin-containing products.
Slovenian: Poleg tega morajo študijo o uporabi zdravila, v idealnem primeru na podlagi sekundarnih podatkov opazovanj iz obstoječih podatkovnih baz, izvesti tudi imetniki dovoljenj za promet z zdravili, ki vsebujejo kanagliflozin.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Slovenian: Zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2) se uporabljajo poleg diete in telesne vadbe pri bolnikih s sladkorno boleznijo tipa 2, bodisi samostojno bodisi v kombinaciji z drugimi zdravili za sladkorno bolezen.
English: • The PRAC therefore, was of the view that the risk of DKA should be minimised by its inclusion in the product information with a warning highlighting to healthcare professional and patients the possible atypical presentation of DKA to be considered in the occurrence of non-specific symptoms, together with the risk factors, and recommendations regarding treatment discontinuation.
Slovenian: • Zato je odbor PRAC menil, da je treba tveganje za DKA čim bolj zmanjšati in ga vključiti v informacije o zdravilu, z opozorilom, naj zdravstveni delavci in bolniki upoštevajo morebitno atipično sliko DKA pri pojavu nespecifičnih simptomov, skupaj z dejavniki tveganja in priporočili za prekinitev zdravljenja.
English: Planned and ongoing Drug Utilisation Studies (DUS) for dapagliflozin- and empagliflozincontaining products are expected to generate more information on the extent and nature of the offlabel use.
Slovenian: Pričakuje se, da bodo načrtovane in potekajoče študije o uporabi zdravil (DUS) za zdravila, ki vsebujejo dapagliflozin in empagliflozin, zagotovile več informacij o obsegu in naravi uporabe, ki ni v skladu z odobrenimi indikacijami.
English: Considering the above, the PRAC was of the view that DKA should be included in the product information of all SGLT2 inhibitors with the frequency rare.
Slovenian: Z upoštevanjem zgoraj navedenega je odbor PRAC menil, da je treba DKA vključiti v informacije o zdravilu za vse zaviralce SGLT2 s pogostnostjo „redko".
English: In a number of these reports, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
Slovenian: Pri številnih od teh poročil se je stanje kazalo z atipično sliko, z le zmerno povišanimi ravnmi glukoze v krvi.
English: The relatively long time-to-onset observed in clinical trials is suggestive of contributing factors triggering the development of DKA.
Slovenian: Sorazmerno dolg čas do pojava, ki so ga opazili v kliničnih preskušanjih, kaže, da k sprožitvi razvoja DKA prispevajo tudi drugi dejavniki.
English: Moreover, the MAHs should explore the feasibility of collecting plasma hormones in new or ongoing trials with the aim to identify patterns of hormone derangement that could further explain the mechanism of action of SGLT2 inhibitors in ketoacidosis.
Slovenian: Imetniki dovoljenj za promet z zdravili morajo v novih ali potekajočih preskušanjih tudi proučiti možnost odvzema plazemskih hormonov, da bi s tem določili vzorce hormonskih motenj, ki bi lahko nadalje pojasnili mehanizem delovanja zaviralcev SGLT2 pri ketoacidozi.
English: This can be partially buffered with the bicarbonate buffering system, but this system is quickly overwhelmed and other mechanisms must work to compensate for the acidosis.
Slovenian: To acidozo delno uravna bikarbonatni puferski sistem, vendar se ta hitro zasiti, zato morajo acidozo uravnavati drugi mehanizmi.
English: Forty-six cases of DKA were also reported in patients on SGLT2 inhibitors for T1DM, which is not currently an approved indication for these products.
Slovenian: O 46 primerih DKA so poročali tudi pri bolnikih, ki so prejemali zaviralce SGLT2 zaradi sladkorne bolezni tipa 1, kar trenutno ni odobrena indikacija za ta zdravila.
English: The atypical presentation of DKA cases in SGLT2 treated diabetes patients, combined with the otherwise non-specific symptoms presented by patients with DKA may delay the diagnosis and therefore lead to the development of more serious or life-threatening conditions.
Slovenian: Atipična slika primerov DKA pri bolnikih s sladkorno boleznijo, zdravljenih z zaviralci SGLT2, skupaj s sicer nespecifičnimi simptomi, ki se kažejo pri bolnikih z DKA, lahko prepreči pravočasno diagnosticiranje in zato privede do razvoja resnejših ali življenjsko nevarnih stanj.
English: This is not an approved indication for SGLT2 inhibitors containing products.
Slovenian: To ni odobrena indikacija za zdravila, ki vsebujejo zaviralce SGLT2.
English: When considering all the data submitted by the MAHs from clinical and non-clinical studies, postmarketing reports and in published literature, in relation to the risk of diabetic ketoacidosis (DKA) in association with SGLT2 inhibitors, the PRAC was of the view that a small excess risk could not be excluded in patients with T2DM.
Slovenian: Pri proučevanju vseh podatkov, ki so jih predložili imetniki dovoljenja za promet z zdravili iz kliničnih in predkliničnih študij, poročil iz obdobja trženja in objavljene literature v povezavi s tveganjem za diabetično ketoacidozo (DKA), povezano z zaviralci SGLT2, je odbor PRAC menil, da pri bolnikih s sladkorno boleznijo tipa 2 ni mogoče izključiti nekoliko povečanega tveganja.
English: The PRAC considered that this information should be included in the PI and, considering that the safety and efficacy of SGLT2 inhibitors have not been established in patients with T1DM, healthcare professionals should be reminded that these should not be used in this indication.
Slovenian: Odbor PRAC je menil, da je treba te informacije vključiti v informacije o zdravilu, in glede na to, da varnost in učinkovitost zaviralcev SGLT2 pri bolnikih s sladkorno boleznijo tipa 1 nista bili dokazani, je treba zdravstvene delavce opozoriti, da jih pri tej indikaciji ne smejo uporabljati.
English: In conclusion, the PRAC considered that the benefit-risk balance of SGLT2 inhibitors-containing products remained favourable, provided the proposed changes to the product information and the risk management plan are implemented.
Slovenian: Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zaviralce SGLT2, še naprej ugodno, pod pogojem, da se informacije o zdravilu in načrt za obvladovanje tveganja spremenijo, kot je predlagano.
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of DKA in association with SGLT2 inhibitors-containing products and in support of the efficacy of SGLT2 inhibitors-containing products.
Slovenian: • Odbor PRAC je proučil vse podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili v povezavi s tveganjem za DKA, povezano z zdravili, ki vsebujejo zaviralce SGLT2, in v podporo učinkovitosti zdravil, ki vsebujejo zaviralce SGLT2.
English: Atypical presentation of DKA in patients with type 2 diabetes could delay diagnosis and treatment.
Slovenian: Atipična slika DKA pri bolnikih s sladkorno boleznijo tipa 2 lahko prepreči pravočasno diagnosticiranje in zdravljenje.
English: This is not an approved indication for SGLT2 inhibitors containing products, nevertheless the PRAC considered that healthcare professionals should be warned of this risk and reminded that patients with T1DM should not be treated with SGLT2 inhibitors.
Slovenian: Čeprav to ni odobrena indikacija za zdravila, ki vsebujejo zaviralce SGLT2, je odbor PRAC menil, da je treba zdravstvene delavce opozoriti na to tveganje in jih opomniti, da bolnikom s sladkorno boleznijo tipa 1 ne smejo predpisati zdravljenja z zaviralci SGLT2.
English: Non-clinical mechanistic studies are already planned or on-going for dapagliflozin- and empagliflozin-containing products; such study is also required to be undertaken by the MAH of canagliflozin-containing products.
Slovenian: Za zdravila, ki vsebujejo dapagliflozin in empagliflozin, so neklinične študije mehanizma že načrtovane oziroma potekajo; tovrstno študijo morajo izvesti tudi imetniki dovoljenj za promet z zdravili, ki vsebujejo kanagliflozin.
English: Several postauthorisation safety studies are planned or ongoing in order to compare the incidence of DKA in SGLT2 inhibitors and other anti-hyperglycaemic agents.
Slovenian: Načrtuje ali izvaja se več študij varnosti v obdobju po izdaji dovoljenja za promet z zdravilom, namenjenih primerjavi pojavnosti DKA pri zaviralcih SGLT2 in drugih antihiperglikemičnih zdravilih.
English: In addition, the PRAC considered that “DKA with atypical presentation” should be added as an important identified risk to the Risk Management Plan (RMP) of those products.
Slovenian: Poleg tega je odbor PRAC menil, da je treba v načrt za obvladovanje tveganja (RMP) za ta zdravila kot pomembno znano tveganje vključiti „DKA z atipično sliko".
English: Further, restarting SGLT2 inhibitor medication in patients with previous DKA while on treatment is not recommended unless another clear precipitating factor is identified and resolved.
Slovenian: Ponovna uvedba zdravljenja z zaviralcem SGLT2 pri bolnikih, pri katerih se je DKA med zdravljenjem že pojavila, ni priporočljiva, razen če se ugotovi in odpravi drug očiten sprožilni dejavnik.
English: DKA typically occurs in T1DM patients with high blood glucose concentrations.
Slovenian: DKA se praviloma pojavi pri bolnikih s sladkorno boleznijo tipa 1 z visoko koncentracijo glukoze v krvi.
English: The PRAC, as a consequence, recommended the variation to the terms of the marketing authorisations for SGLT2 inhibitors-containing products.
Slovenian: Posledično je odbor PRAC priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo zaviralce SGLT2.
English: Limited data from clinical trials suggest that DKA occurs with common frequency in T1DM patients.
Slovenian: Omejeni podatki iz kliničnih preskušanj kažejo, da se DKA pri bolnikih s sladkorno boleznijo tipa 1 pojavlja s pogostnostjo „pogosto".
English: The PRAC considered that these should be included in the product information and physicians advised to consider the patient's history before initiating treatment with SGLT2 inhibitors.
Slovenian: Odbor PRAC je menil, da je treba te dejavnike vključiti v informacije o zdravilu in zdravnike obvestiti, naj pred uvedbo zdravljenja z zaviralci SGLT2 proučijo bolnikovo anamnezo.
English: One hundred and two serious and sometimes life-threatening cases of DKA suggestive of a causal association were identified in T2DM patients for the three active substances, raising thus a safety signal.
Slovenian: Za te tri zdravilne učinkovine so pri bolnikih s sladkorno boleznijo tipa 2 našli 102 resna in občasno življenjsko nevarna primera DKA, ki sta kazala na vzročno povezanost, kar je sprožilo varnostni signal.
English: • The PRAC concluded that a small excess risk of DKA associated with SGLT2 inhibitors treatment in patients with T2DM could not be excluded.
Slovenian: • Odbor PRAC je zaključil, da nekoliko povišanega tveganja za DKA, povezanega z zdravljenjem z zaviralci SGLT2, pri bolnikih s sladkorno boleznijo tipa 2 ni mogoče izključiti.
English: No subset of the population at increased risk could be identified from the analysis of cases reported in clinical studies.
Slovenian: Iz analize primerov, o katerih so poročali v kliničnih študijah, ni bilo mogoče določiti podskupine populacije s povečanim tveganjem.
English: Importantly, DKA with atypical presentation may occur in association with SGLT2 inhibitors.
Slovenian: Zlasti pomembno je, da se v povezavi z zaviralci SGLT2 lahko pojavi DKA z atipično sliko.
English: Patients should be advised to contact a doctor in order to be tested for ketoacidosis and to discontinue SGLT2 inhibitor treatment if DKA is suspected or diagnosed.
Slovenian: Bolnikom je treba svetovati, da se v primeru diagnoze DKA ali suma nanjo obrnejo na zdravnika, ki jih bo poslal na preiskave za ketoacidozo, in prekinejo zdravljenje z zaviralcem SGLT2.
English: The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with SGLT2 inhibitors treatment in patients with T1DM.
Slovenian: Odbor PRAC je nadalje menil, da je tveganje za DKA, vključno z atipično sliko, povezano tudi z zdravljenjem z zaviralci SGLT2 pri bolnikih s sladkorno boleznijo tipa 1.
English: However, cases reported with SLGT2 inhibitors occurred in patients with T2DM as well as T1DM.
Slovenian: Primeri, o katerih so poročali v povezavi z zaviralci SLGT2, pa so se pojavili tako pri bolnikih s sladkorno boleznijo tipa 2 kot pri bolnikih s sladkorno boleznijo tipa 1.
English: • The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with the use of SGLT2 inhibitors in patients with T1DM.
Slovenian: • Odbor PRAC je nadalje zaključil, da je tveganje za DKA, vključno z atipično sliko, povezano tudi z zdravljenjem z zaviralci SGLT2 pri bolnikih s sladkorno boleznijo tipa 1.
English: therefore the populations may not share the same baseline risk of DKA and careful consideration should be given to any direct incidence comparison.
Slovenian: Nadalje so v programih kliničnega razvoja zdravil uporabljali različna vključitvena in izključitvena merila, zato populacije nimajo enakega izhodiščnega tveganja za DKA in je treba skrbno proučiti neposredne primerjave pojavnosti.
English: In addition, the MAHs are required to clarify the mechanism behind SGLT2 inhibitors-induced DKA.
Slovenian: Poleg tega morajo imetniki dovoljenj za promet z zdravili pojasniti mehanizem, s katerim zaviralci SGLT2 povzročajo DKA.
English: Some of these effects were severe.
Slovenian: Nekateri neželeni učinki so bili hudi.
English: What measures are being taken to ensure the safe and effective use of Jevtana?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jevtana?
English: The full EPAR for Jevtana 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 Jevtana 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 Jevtana on 17 March 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Jevtana, veljavno po vsej Evropski uniji, izdala 17. marca 2011.
English: This is a summary of the European public assessment report (EPAR) for Jevtana.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jevtana.
English: What are the risks associated with Jevtana?
Slovenian: Kakšna tveganja so povezana z zdravilom Jevtana?
English: It is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient's weight and height).
Slovenian: Daje se vsake tri tedne kot enourna infuzija v odmerku 25 mg na kvadratni meter telesne površine (izračunane na podlagi bolnikove telesne mase in višine).
English: The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.
Slovenian: Povprečno skupno preživetje pri bolnikih, ki so jemali zdravilo Jevtana, je bilo 15,1 meseca v primerjavi z 12,7 meseca pri bolnikih, ki so jemali mitoksantron.
English: Jevtana cabazitaxel
Slovenian: Jevtana kabazitaksel
English: With their skeleton still in place, the cells cannot divide and they eventually die.
Slovenian: Ker ogrodje ostane nespremenjeno, se celice ne morejo deliti in sčasoma odmrejo.
English: It is given in combination with prednisone or prednisolone, taken daily throughout treatment.
Slovenian: Daje se v kombinaciji s prednizonom ali prednizolonom, ki se jemljeta vsak dan skozi celotno obdobje zdravljenja.
English: It decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi tega zdravila večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: It must not be given to patients whose blood neutrophil count is below 1,500/mm3, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine.
Slovenian: Ne smejo ga jemati bolniki, pri katerih je število nevtrofilcev v krvi nižje od 1 500/mm3, bolniki, ki imajo hudo okvaro jeter, ali osebe, ki so nedavno bile ali bodo cepljene proti rumeni mrzlici.
English: For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Jevtana preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Slovenian: Kabazitaksel deluje tako, da zavira sposobnost rakavih celic za razgradnjo njihovega notranjega „ogrodja“, ki jim omogoča, da se delijo in množijo.
English: The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Jevtana (opaženi pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), levkopenija (nizko število belih krvnih celic), nevtropenija (nizko število nevtrofilcev, vrste belih krvnih celic), trombocitopenija (nizko število trombocitov) in driska.
English: This is cancer that affects the prostate gland in men that produces the liquid in semen.
Slovenian: To je rak, ki prizadene prostato, žlezo pri moških, ki proizvaja semensko tekočino.
English: What benefits of Jevtana have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Jevtana izkazalo v študijah?
English: Before receiving Jevtana infusions, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting.
Slovenian: Pred infundiranjem zdravila Jevtana morajo bolniki najprej prejeti zdravila, ki preprečujejo alergijske reakcije, in zdravila, ki preprečujejo bruhanje.