FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefit has Glybera shown during the studies?
Slovenian: Kakšne koristi je zdravilo Glybera izkazalo med študijami?
English: Other information about Glybera
Slovenian: Druge informacije o zdravilu Glybera
English: There was also a reduction in the number of pancreatitis attacks in some patients, as well as fewer hospital admissions and stays in intensive care units.
Slovenian: Pri nekaterih je prišlo tudi do zmanjšanja števila napadov pankreatitisa ter zmanjšanja števila sprejemov v bolnišnico in obravnav na oddelkih za intenzivno nego.
English: Anticoagulant medicines, which can increase bleeding, must not be used from the week before Glybera treatment to one day after.
Slovenian: Zdravila za preprečevanje strjevanja krvi, ki lahko povečajo krvavitev, se ne smejo uporabljati vsaj teden dni pred zdravljenjem z zdravilom Glybera in še dan po njem.
English: The most common side effect reported with Glybera was pain in the legs following the injections, which occurred in a third of patients.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali pri uporabi zdravila Glybera, je bila bolečina v nogah po injiciranju, ki se je pojavila pri tretjini bolnikov.
English: The modified viral material used in Glybera does not cause infections and cannot make copies of itself.
Slovenian: Prilagojeni virusni material, ki ga uporabljajo za zdravilo Glybera, ne povzroča okužb in se ne morejo podvajati.
English: For more information about treatment with Glybera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Glybera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The full EPAR for Glybera 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 Glybera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information on the dose of Glybera to be given, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o odmerku zdravila Glybera, ki ga je treba dati bolniku, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: A risk management plan has been developed to ensure that Glybera is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Glybera je bil pripravljen načrt obvladovanja tveganj.
English: Other common side effects reported include headache, tiredness, hyperthermia (high body temperature), contusion (bruising) and increased levels of the enzyme creatine kinase in the blood (a measure of damage to muscle tissue).
Slovenian: Drugi pogosti neželeni učinki, o katerih so poročali, so glavobol, utrujenost, hipertermija (povišana telesna temperatura), kontuzija (podplutbe) in povišane ravni encima kreatin kinaze v krvi (merilo okvare mišičnih vlaken).
English: Given the small number of patients treated, these side effects do not provide a complete picture of the frequency and nature of the side effects of Glybera.
Slovenian: Glede na majhno število zdravljenih bolnikov, ti podatki ne omogočajo celovite slike pogostnosti in narave neželenih učinkov zdravila Glybera.
English: 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 Glybera.
Slovenian: 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.
English: Glybera is given as a single treatment involving multiple injections into the muscles of the upper and lower legs.
Slovenian: Zdravilo Glybera se daje kot enkratno zdravljenje, ki vključuje več injekcij v mišice zgornjega in spodnjega dela nog.
English: In addition, the company has put in place a restricted access programme to ensure that Glybera is used appropriately when the diagnosis is confirmed.
Slovenian: Poleg tega mora družba vzpostaviti program omejenega dostopa do zdravila Glybera, s čimer bo zagotovila, da se bo ob postavljeni diagnozi pravilno uporabljalo.
English: Although there were data for only a small number of patients, the results indicate that Glybera would be of benefit to those patients with severe or multiple pancreatitis attacks.
Slovenian: Čeprav so bili na voljo le podatki za manjše število bolnikov, rezultati kažejo, da bi zdravilo Glybera lahko pomagalo bolnikom z resnimi ali multiplimi napadi pankreatitisa.
English: Due to the multiple injections required, it is advisable to give it with a spinal or regional anaesthetic (medicines which numb certain parts of the body to block pain).
Slovenian: Zaradi velikega števila injiciranj se priporoča spinalna ali lokalna anestezija (zdravila, ki omrtvičijo določene dele telesa in tako ustavijo bolečino).
English: The company will also provide data from a registry to monitor the outcome of patients treated with Glybera, and will add a step to the manufacturing of the product to improve the safety profile.
Slovenian: Družba bo predložila tudi podatke iz registra za spremljanje izida pri bolnikih, zdravljenih z zdravilom Glybera, in dodala dodaten nadzor pri proizvodnji zdravila za izboljšanje njegovega varnostnega profila.
English: Patients with this disease need to be on a strict low-fat diet and are prone to recurring attacks of pancreatitis, which is a severe and life-threatening complication.
Slovenian: Bolniki s to boleznijo morajo imeti strogo dieto z majhnim vnosom maščob in so nagnjeni k ponavljajočim se napadom pankreatitisa, ki je resen in smrtno nevaren zaplet.
English: What information is still awaited for Glybera?
Slovenian: Katere informacije o zdravilu Glybera še pričakujemo?
English: One patient was diagnosed with pulmonary embolism (clots in blood vessels supplying the lungs) seven weeks after treatment.
Slovenian: Pri enem bolniku so sedem tednov po zdravljenju postavili diagnozo pljučne embolije (strdkov v krvnih žilah, ki oskrbujejo pljuča s krvjo).
English: Glybera is a type of advanced therapy medicine called a ‘gene therapy product'.
Slovenian: Zdravilo Glybera spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila za gensko zdravljenje“.
English: The data showed a reduction in blood fat levels after meals in some patients.
Slovenian: Podatki so pri nekaterih bolnikih pokazali znižanje ravni maščob v krvi po jedi.
English: What is the risk associated with Glybera?
Slovenian: Kakšna tveganja so povezana z zdravilom Glybera?
English: Glybera is only for patients whose disease has been confirmed by appropriate genetic testing and who have detectable levels of the lipoprotein lipase enzyme in their blood.
Slovenian: Zdravilo Glybera je namenjeno le tistim bolnikom, pri katerih je bila bolezen potrjena z ustreznimi genskimi preiskavami in ki imajo določljive ravni encima lipoproteinske lipaze v krvi.
English: Why has Glybera been approved?
Slovenian: Zakaj je bilo zdravilo Glybera odobreno?
English: Glybera should only be prescribed and given under the supervision of a doctor with expertise in treating lipoprotein lipase deficiency and in gene therapy.
Slovenian: Zdravilo Glybera je treba predpisati in uporabljati le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s pomanjkanjem lipoproteinske lipaze in uporabo genske terapije.
English: Lipoprotein lipase deficiency is a rare disease in which patients have a defect in the gene for lipoprotein lipase, an enzyme responsible for breaking down fats.
Slovenian: Pomanjkanje lipoproteinske lipaze je redka bolezen, pri kateri imajo bolniki okvaro gena za lipoproteinsko lipazo, tj. encima, katerega naloga je razgradnja maščob.
English: When injected into the muscles, it corrects the lipoprotein lipase deficiency by enabling the muscle cells to produce the enzyme.
Slovenian: Ko gen injicirajo v mišice, popravi pomanjkanje lipoproteinske lipaze tako, da mišičnim celicam omogoča tvorbo tega encima.
English: The active substance in Glybera, alipogene tiparvovec, is derived from a virus that has been modified so it can carry the lipoprotein lipase gene into the body's cells.
Slovenian: Zdravilno učinkovino v zdravilu Glybera, alipogentiparvovek, pridobivajo iz virusa, ki ga spremenijo tako, da lahko prenaša gen za lipoproteinsko lipazo v telesne celice.
English: Glybera is used to treat adults with lipoprotein lipase deficiency who have severe or multiple attacks of pancreatitis (inflammation of the pancreas) despite maintaining a low-fat diet.
Slovenian: Zdravilo Glybera se uporablja za zdravljenje odraslih bolnikov z diagnozo pomanjkanja lipoproteinske lipaze, ki imajo hude ali multiple napade pankreatitisa (vnetja trebušne slinavke) kljub omejevanju vnosa maščobe s hrano.
English: Glybera has been studied in 27 patients with lipoprotein lipase deficiency on a low-fat diet.
Slovenian: Zdravilo Glybera so proučevali pri 27 bolnikih s pomanjkanjem lipoproteinske lipaze, ki so imeli dieto z majhnim vnosom maščobe.
English: The company will also provide patients and healthcare professionals with educational materials, including information on how to administer Glybera and how to manage risks with the medicine.
Slovenian: Družba bo bolnikom in zdravstvenim delavcem zagotovila tudi izobraževalno gradivo z informacijami o dajanju tega zdravila ter o obvladovanju tveganj, povezanih z njim.
English: Glybera is a medicine that contains the active substance alipogene tiparvovec.
Slovenian: Glybera je zdravilo, ki vsebuje zdravilno učinkovino alipogentiparvovek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Glybera, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu z njim 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.
English: Glybera has been authorised under ‘exceptional circumstances' as it has not been possible to obtain complete information about the medicine, because of the rarity of the disease.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
English: For the full list of all side effects reported with Glybera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Gilenya, glejte navodilo za uporabo.
English: What is Glybera used for?
Slovenian: Za kaj se zdravilo Glybera uporablja?
English: How does Glybera work?
Slovenian: Kako zdravilo Glybera deluje?
English: How has Glybera been studied?
Slovenian: Kako je bilo zdravilo Glybera raziskano?
English: How is Glybera used?
Slovenian: Kako se zdravilo Glybera uporablja?
English: What is Glybera?
Slovenian: Kaj je zdravilo Glybera?
English: Unit-dose blister
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja
English: • QTc interval 500 msec.
Slovenian: • interval QTc 500 msec.
English: Continuous (real time) ECG monitoring is recommended.
Slovenian: Priporočeno je neprekinjeno spremljanje EKG (v realnem času).
English: • Information about the Fingolimod Pregnancy Exposure Registry
Slovenian: • informacije o Registru izpostavljenosti nosečnic fingolimodu
English: Concomitant treatment with immunosuppressant or immune-modulating medicines should be avoided.
Slovenian: Sočasnemu zdravljenju z imunosupresivnim ali imunomodulatornim zdravilom se je treba izogibati.
English: • New onset second degree or higher AV block.
Slovenian: • na novo prišlo do atrioventrikularnega bloka druge ali višje stopnje,
English: o That GILENYA is not recommended in patients with: o Second degree Mobitz Type II or higher AV block o Sick-sinus syndrome o Sino-atrial heart block o QTc prolongation >470 msec (females) or >450 msec (males) o Ischaemic cardiac disease including angina pectoris o Cerebrovascular disease o History of myocardial infarction o Congestive heart failure o History of cardiac arrest o Severe sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension
Slovenian: o Uporaba zdravila GILENYA ni priporočena pri bolnikih, ki imajo: o atrioventrikularni blok druge stopnje Mobitz tipa II ali atrioventrikularni blok višje stopnje o sindrom bolnega sinusnega vozla o sinuatrialni blok o podaljšanje intervala QTc na >470 msec (pri ženskah) ali >450 msec (pri moških) o ishemično bolezen srca, kar vključuje tudi angino pektoris o cerebrovaskularno bolezen o anamnezo miokardnega infarkta o kongestivno srčno popuščanje o anamnezo zastoja srca o hudo obliko apneje v spanju o anamnezo simptomatske bradikardije o anamnezo rekurentne sinkope o neurejeno hipertenzijo
English: The patient reminder card shall contain the following key messages:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
English: Patients may be monitored with a continuous ECG during the first 6 hours.
Slovenian: V prvih 6 urah je bolnik lahko spremljan z neprekinjenim EKG.
English: o Specific recommendations regarding vaccination for patients initiating or currently on GILENYA treatment.
Slovenian: o Specifična priporočila glede cepljenja za bolnike, ki začenjajo zdravljenje z zdravilom GILENYA ali se z njim že zdravijo.
English: The physician's checklist shall contain the following key messages:
Slovenian: Seznam previdnostnih ukrepov za zdravnika mora vsebovati naslednja ključna sporočila:
English: This should be repeated at suitable intervals.
Slovenian: Test nosečnosti je treba v ustreznih intervalih ponavljati.
English: o The need to report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of GILENYA.
Slovenian: o Pomembnost takojšnjega obveščanja lečečega zdravnika v primeru simptomov, ki kažejo na znižanje srčne frekvence (kot so omotičnost, vrtoglavica, slabost ali palpitacije) po prvem odmerjanju zdravila GILENYA.
English: • Physician's checklist prior to prescribing GILENYA
Slovenian: • seznam previdnostnih ukrepov, ki ga zdravnik potrebuje, preden predpiše zdravilo GILENYA
English: Suspension of treatment during serious infections should be considered.
Slovenian: V času resne okužbe je treba pretehtati možnost začasne prekinitve zdravljenja.
English: o GILENYA reduces peripheral blood lymphocyte counts.
Slovenian: o Zdravilo GILENYA znižuje število limfocitov v periferni krvi.
English: They will need an ECG at 6 hours and in some circumstances monitoring may involve an overnight stay.
Slovenian: Bolniku bo treba 6 ur po odmerjanju zdravila posneti EKG, v nekaterih primerih pa bo treba spremljanje podaljšati preko noči.
English: o The teratogenic risk of GILENYA: the importance of avoiding pregnancy when undergoing treatment with GILENYA and the need for a negative pregnancy test result prior to treatment initiation.
Slovenian: o Tveganje za teratogeno delovanje zdravila GILENYA: pomembnost preprečevanja zanositve v času zdravljenja z zdravilom GILENYA, pred začetkom zdravljenja pa je treba pridobiti negativen izvid testa nosečnosti.
English: o The need to provide patients with the patient reminder card.
Slovenian: o Zdravnik mora bolniku izročiti opozorilno kartico za bolnika.
English: The Member States shall ensure that, at launch and after launch, the MAH provides all physicians who intend to prescribe GILENYA with an updated physician information pack containing the following elements:
Slovenian: Država članica mora zagotoviti, da bo Imetnik dovoljenja za promet z zdravilom ob prihodu zdravila na trg in po njem vsem zdravnikom, za katere se pričakuje, da bodo predpisovali zdravilo GILENYA, priskrbel posodobljen komplet navodil za zdravnika, ki bo vseboval sledeče:
English: o GILENYA is not recommended in patients concomitantly taking Class Ia or Class III antiarrhythmic medicines.
Slovenian: o Uporaba zdravila GILENYA ni priporočena pri bolnikih, ki sočasno prejemajo antiaritmike razredov Ia in III.
English: If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to determine appropriate monitoring, at least overnight extended monitoring is recommended.
Slovenian: Če je pri teh bolnikih predvideno zdravljenje z zdravilom GILENYA, morajo pričakovane koristi presegati potencialna tveganja, poleg tega pa se je treba s kardiologom posvetovati glede ustreznega spremljanja bolnika, pri čemer je priporočeno spremljati bolnika najmanj preko noči.
English: o GILENYA is not recommended in patients concomitantly taking medicines which are known to decrease the heart rate.
Slovenian: o Uporaba zdravila GILENYA ni priporočena pri bolnikih, ki sočasno prejemajo zdravila, za katera vemo, da znižujejo srčno frekvenco.
English: o The need for a full ophthalmological assessment 3-4 months after starting GILENYA therapy for the early detection of visual impairment due to drug-induced macular oedema.
Slovenian: o 3-4 mesece po začetku zdravljenja z zdravilom GILENYA je treba opraviti celoten oftalmološki pregled za zgodnje odkrivanje okvare vida zaradi makularnega edema, ki ga povzročajo zdravila.
English: The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch in their territory.
Slovenian: Država članica se bo pred prihodom zdravila na trg države članice z Imetnikom dovoljenja za promet z zdravilom dogovorila za končno verzijo izobraževalnega gradiva.
English: Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients: o Requiring pharmacological intervention during monitoring at treatment initiation.
Slovenian: Spremljanje srčne frekvence v zdravstveni ustanovi je treba podaljšati najmanj preko noči in dokler ugotovljene motnje ne izzvenijo pri naslednjih bolnikih: o pri bolnikih, pri katerih je bilo treba v času spremljanja ob uvedbi zdravljenja farmakološko ukrepati, o če kadarkoli pride do atrioventrikularnega bloka tretje stopnje, o če je 6 ur po prejemu odmerka:
English: Until 6 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o Monitor the patient for 6 hours after the first dose of GILENYA has been administered for signs and symptoms of bradycardia, including hourly pulse and blood pressure checks.
Slovenian: V prvih 6 urah po prejemu prvega odmerka (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna) o Bolnika je treba 6 ur po prejemu prvega odmerka zdravila GILENYA spremljati glede znakov in simptomov bradikardije, kar vključuje merjenje frekvence pulza in krvnega tlaka vsako uro.
English: o The need for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Slovenian: o Jetrne teste je treba določati po 1, 3, 6, 9 in 12 mesecih zdravljenja z zdravilom GILENYA in občasno tudi kasneje.
English: o The need for a liver function test prior to treatment initiation and for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Slovenian: o Pomembnost določanja jetrnih testov pred začetkom zdravljenja, po 1, 3, 6, 9 in 12 mesecih zdravljenja z zdravilom GILENYA in občasno tudi kasneje.
English: o Perform an ECG at the end of the 6-hour monitoring period.
Slovenian: o Ob koncu 6-urnega obdobja spremljanja je treba bolniku posneti EKG.
English: o The need to advise women of child-bearing potential on the serious risk to the foetus and the need to practice effective contraception during treatment and for at least two months following discontinuation of treatment with GILENYA.
Slovenian: o Ženske v rodni dobi je treba opozoriti glede resnega tveganja za plod in glede uporabe učinkovite kontracepcijske metode v času zdravljenja in še najmanj dva meseca po prekinitvi zdravljenja z zdravilom GILENYA.
English: • Heart rate <45 bpm.
Slovenian: • srčna frekvenca nižja od 45 utripov na minuto,
English: If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to switch to non heart-rate-lowering therapy or, if not possible, to determine appropriate monitoring.
Slovenian: Če je pri teh bolnikih predvideno zdravljenje z zdravilom GILENYA, morajo pričakovane koristi presegati potencialna tveganja, s kardiologom pa se je treba posvetovati glede zamenjave navedenih zdravil za druga zdravila, ki ne znižujejo srčne frekvence.
English: o The signs and symptoms of infection and the need to report these immediately to the prescriber during and up to two months after treatment with GILENYA.
Slovenian: o Opis znakov in simptomov okužbe in pomembnost takojšnjega obveščanja lečečega zdravnika, če pride do njih v času zdravljenja in še najmanj dva meseca po prekinitvi zdravljenja z zdravilom GILENYA.
English: o That GILENYA is teratogenic so women with childbearing potential must: o Have a negative pregnancy test. o Be using effective contraception during and for at least two months following discontinuation of treatment with GILENYA.
Slovenian: o Zdravilo GILENYA je teratogeno, zato morajo ženske v rodni dobi: o imeti negativen izvid testa nosečnosti, o uporabljati učinkovito kontracepcijo v času zdravljenja in še najmanj dva meseca po prekinitvi zdravljenja z zdravilom GILENYA, o takoj sporočiti lečečemu zdravniku, če (namenoma ali nehote) zanosijo v času zdravljenja in še najmanj dva meseca po prekinitvi zdravljenja z zdravilom GILENYA.
English: o Recommendation for overnight monitoring after the first dose (or if the last dose of GILENYA was more than two weeks previously).
Slovenian: o Priporočila za spremljanje bolnika preko noči po prejemu prvega odmerka (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna).
English: o That their heart rate will need to be monitored for 6 or more hours after the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago), including hourly pulse and blood pressure checks.
Slovenian: o Bolnikovo srčno frekvenco bo treba spremljati 6 ur ali več po prvem odmerjanju zdravila GILENYA (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna), kar vključuje merjenje frekvence pulza in krvnega tlaka vsako uro.
English: >6 to 8 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose,
Slovenian: V obdobju od 6 do 8 ur po prejemu prvega odmerka (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna) o Če srčna frekvenca po 6 urah doseže najnižjo vrednost po prejemu prvega odmerka, je treba spremljanje podaljšati za najmanj 2 uri in do zvišanja srčne frekvence.
English: o Perform a liver function test prior to treatment initiation.
Slovenian: o Bolniku je treba pred začetkom zdravljenja določiti vrednost jetrnih testov.
English: o Monitoring requirements at treatment initiation Before first dose o Perform baseline ECG prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
Slovenian: o Zahtevano spremljanje bolnika ob uvedbi zdravljenja Pred prvim odmerjanjem o Bolniku je treba posneti izhodiščni EKG pred prejemom prvega odmerka zdravila GILENYA (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna).
English: o That they will have a baseline ECG and blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago).
Slovenian: o Bolniku bo treba posneti EKG in izmeriti krvni tlak pred prvim odmerjanjem zdravila GILENYA (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna).