FrancophonIA/ELRC3.0 huggingface dataset:
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADYNOVI.
Slovenian: Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom ADYNOVI, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: ADYNOVI Adults (18 years and older) N = 18 Dose: 45 ± 5 IU/kg
Slovenian: PK-parametri zdravilo ADYNOVI odrasli (stari 18 let in več) n = 18 Odmerek: 45 ± 5 i.e./kg zdravilo ADYNOVI mladostniki (12-<18 let) n = 8 Odmerek: 45 ± 5 i.e./kg zdravilo ADYNOVI pediatrični bolniki (6-<12 let) n = 17 Odmerek: 50 ± 1 0 i.e./kg zdravilo ADYNOVI pediatrični bolniki (< 6 let) n = 14 Odmerek: 50 ± 1 0 i.e./kg
English: A separate BAXJECT II Hi-Flow device is required to reconstitute each vial of ADYNOVI with the solvent.
Slovenian: Za rekonstitucijo vsake posamezne viale zdravila ADYNOVI z vehiklom potrebujete ločen pripomoček BAXJECT II Hi-Flow .
English: OUTER CARTON (BAXJECT II HI-FLOW DEVICE)
Slovenian: ŠKATLA (PRIPOMOČEK BAXJECT II HI-FLOW)
English: VIAL LABEL FOR THE POWDER (BAXJECT II HI-FLOW DEVICE)
Slovenian: NALEPKA NA VIALI S PRAŠKOM (PRIPOMOČEK BAXJECT II HI-FLOW)
English: Do not refrigerate after reconstitution.
Slovenian: Raztopine po pripravi ne shranjujte v hladilniku.
English: 1 powder vial and 1 vial with 5 ml solvent preassembled in BAXJECT III system.
Slovenian: Prašek in vehikel za raztopino za injiciranje 1 viala s praškom in 1 viala s 5 ml vehikla, sestavljeni v sistem BAXJECT III.
English: Nausea
Slovenian: Zaviralci
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection
Slovenian: ADYNOVI 250 i.e./2 ml prašek in vehikel za raztopino za injiciranje ADYNOVI 500 i.e./2 ml prašek in vehikel za raztopino za injiciranje ADYNOVI 1000 i.e./2 ml prašek in vehikel za raztopino za injiciranje
English: Calcium chloride dihydrate Tris(hydroxymethyl)aminomethane Polysorbate 80
Slovenian: Prašek manitol trehaloza dihidrat histidin glutation natrijev klorid kalcijev klorid dihidrat tris(hidroksimetil)aminometan polisorbat 80
English: ADYNOVI Adolescents (12-<18 years) N = 8 Dose: 45 ± 5 IU/kg
Slovenian: PK-parametri zdravilo ADYNOVI odrasli (stari 18 let in več) n = 18 Odmerek: 45 ± 5 i.e./kg zdravilo ADYNOVI mladostniki (12-<18 years) n = 8 Odmerek: 45 ± 5 i.e./kg zdravilo ADYNOVI pediatrični bolniki (6-<12 years) n = 17 Odmerek: 50 ± 10 i.e./kg zdravilo ADYNOVI pediatrični bolniki (< 6 let) n = 14 Odmerek: 50 ± 10 i.e./kg
English: Powder and solvent vials preassembled in BAXJECT III system.
Slovenian: Viala s praškom in viala z vehiklom, sestavljeni v sistem BAXJECT III.
English: The product may not be returned to refrigerated storage after storage at room temperature.
Slovenian: Če ste zdravilo hranili pri sobni temperaturi, ga ne smete več vrniti v hladilnik.
English: 1 vial: 2000 IU rurioctocog alfa pegol, 400 IU/ml after reconstitution.
Slovenian: 1 viala: 2000 i.e. rurioktokoga alfa pegola, 400 i.e./ml po rekonstituciji.
English: 1 powder vial and 1 vial with 2 ml solvent preassembled in BAXJECT III system.
Slovenian: Prašek in vehikel za raztopino za injiciranje 1 viala s praškom in 1 viala z 2 ml vehikla, sestavljeni v sistem BAXJECT III.
English: Therefore no experience regarding the use of ADYNOVI during preganancy and breast-feeding is available.
Slovenian: Hemofilija A se pri ženskah le redko pojavlja, zato ni izkušenj o uporabi zdravila ADYNOVI med nosečnostjo in dojenjem.
English: What ADYNOVI contains - The active substance is rurioctocog alfa pegol (pegylated human coagulation factor VIII
Slovenian: Kaj vsebuje zdravilo ADYNOVI - Učinkovina je rurioktokog alfa pegol (pegilirani humani koagulacijski faktor VIII, izdelan s tehnologijo rekombinantne DNA).
English: You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Slovenian: Obstaja majhno tveganje, da bi lahko pri vas nastopila anafilaktična reakcija (huda, nenadna alergijska reakcija) na zdravilo ADYNOVI, zato morate poznati zgodnje znake alergijskih reakcij, med katere sodijo izpuščaj, koprivnica, gnojni mehurčki, generalizirano srbenje, otekanje ustnic in jezika, težave z dihanjem, piskanje v pljučih, tiščanje v prsnem košu, splošno slabo počutje in omotica.
English: 1 vial: 250 IU rurioctocog alfa pegol, 125 IU/ml after reconstitution.
Slovenian: 1 viala: 250 i.e. rurioktokoga alfa pegola, 125 i.e./ml po rekonstituciji.
English: VIAL LABEL FOR THE SOLVENT (BAXJECT II HI-FLOW DEVICE)
Slovenian: NALEPKA NA VIALI Z VEHIKLOM (PRIPOMOČEK BAXJECT II HI-FLOW)
English: VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)
Slovenian: NALEPKA NA VIALI S PRAŠKOM (sistem BAXJECT III)
English: Sodium chloride
Slovenian: Žilne bolezni pordelost
English: Including tooth extraction.
Slovenian: Kirurški posegi Manjši vključno z izdrtjem zoba
English: 1 vial: 1000 IU rurioctocog alfa pegol, 200 IU/ml after reconstitution.
Slovenian: 1 viala: 1000 i.e. rurioktokoga alfa pegola, 200 i.e./ml po rekonstituciji.
English: 1 vial: 500 IU rurioctocog alfa pegol, 250 IU/ml after reconstitution.
Slovenian: 1 viala: 500 i.e. rurioktokoga alfa pegola, 250 i.e./ml po rekonstituciji.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Slovenian: ADYNOVI 2000 i.e./5 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 5 ml vehikla ustreza koncentraciji 400 i.e./ml.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
Slovenian: ADYNOVI 500 i.e./5 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 5 ml vehikla ustreza koncentraciji 100 i.e./ml.
English: 1 vial: 250 IU rurioctocog alfa pegol, 50 IU/ml after reconstitution.
Slovenian: 1 viala: 250 i.e. rurioktokoga alfa pegola, 50 i.e./ml po rekonstituciji.
English: BLISTER LABEL (BAXJECT III SYSTEM)
Slovenian: NALEPKA NA SESTAVU (sistem BAXJECT III)
English: 1 vial: 500 IU rurioctocog alfa pegol, 100 IU/ml after reconstitution.
Slovenian: 1 viala: 500 i.e. rurioktokoga alfa pegola, 100 i.e./ml po rekonstituciji.
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
Slovenian: ADYNOVI 500 i.e./2 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 2 ml vehikla ustreza koncentraciji 250 i.e./ml.
English: 1 vial: 1000 IU rurioctocog alfa pegol, 500 IU/ml after reconstitution.
Slovenian: 1 viala: 1000 i.e. rurioktokoga alfa pegola, 500 i.e./ml po rekonstituciji.
English: Connect the syringe to the BAXJECT II Hi-Flow device.
Slovenian: Na pripomoček BAXJECT II Hi-Flow privijte brizgo.
English: na c na c
Slovenian: c n.r.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 2000 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: ADYNOVI 2000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 2000 i.e./5 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 500 IU/ml after reconstitution with 2 ml solvent.
Slovenian: ADYNOVI 1000 i.e./2 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 2 ml vehikla ustreza koncentraciji 500 i.e./ml.
English: ASSEMBLY LABEL (BAXJECT III SYSTEM)
Slovenian: ŠKATLA (sistem BAXJECT III)
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent.
Slovenian: ADYNOVI 1000 i.e./5 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 5 ml vehikla ustreza koncentraciji 200 i.e./ml.
English: Life threatening haemorrhages.
Slovenian: Smrtno nevarne krvavitve
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 250 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 500 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: ADYNOVI 500 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 500 i.e./5 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 1000 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: ADYNOVI 1000 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 1000 i.e./2 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 250 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 125 IU/ml after reconstitution with 2 ml solvent.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA ADYNOVI 250 i.e./2 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 2 ml vehikla ustreza koncentraciji 125 i.e./ml.
English: ADYNOVI 500 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 500 i.e./2 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 2000 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: ADYNOVI 250 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 250 i.e./2 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 1000 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: ADYNOVI 250 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 250 i.e./5 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 1000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Slovenian: ADYNOVI 1000 i.e./5 ml prašek za injiciranje rurioktokog alfa pegol i.v.
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Slovenian: ADYNOVI 500 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol (pegilirani rekombinantni humani koagulacijski faktor VIII)
English: Posology
Slovenian: Zasnova
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA ADYNOVI 250 i.e./5 ml prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. humanega koagulacijskega faktorja VIII (rDNA), rurioktokoga alfa pegola, kar po rekonstituciji s 5 ml vehikla ustreza koncentraciji 50 i.e./ml.
English: OUTER CARTON (BAXJECT III SYSTEM)
Slovenian: NALEPKA NA PRETISNEM OMOTU (SISTEM BAXJECT III)
English: Connect the syringe to BAXJECT III.
Slovenian: Na pripomoček BAXJECT III privijte brizgo.
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 500 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 1000 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 500 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 250 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 1000 i.e. / 5 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol
Slovenian: ADYNOVI 250 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
English: VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)
Slovenian: NALEPKA NA VIALI Z VEHIKLOM (sistem BAXJECT III)
English: Powder: White to off-white friable powder.
Slovenian: Prašek: bel do belkast drobljiv prašek.
English: This means that it affects the activity of the immune system (the body's natural defences).
Slovenian: To pomeni, da vpliva na delovanje imunskega sistema (naravnega obrambnega mehanizma telesa).
English: Further information on Lenalidomide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Lenalidomide Accord so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lenalidomide Accord is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days.
Slovenian: Zdravilo Lenalidomide Accord se jemlje v ponavljajočih se 28-dnevnih ciklusih zdravljenja: bolnik vzame zdravilo enkrat na dan na določene dni v 28 dneh.
English: A lower dose should be used in patients who have moderate or more severe reduction in their kidney function.
Slovenian: Manjši odmerek se uporablja pri bolnikih z zmerno ali hudo oslabljenim delovanjem ledvic.
English: Depending on the day, the patient may take one or more medicines or may not take any medicines.
Slovenian: Bolnik mora odvisno od dneva v ciklusu vzeti eno ali več zdravil oziroma na nekatere dni ne vzame nobenega zdravila.
English: The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora nadzorovati zdravnik z izkušnjami z uporabo zdravil za zdravljenje raka.
English: The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine's use outside its approved uses.
Slovenian: Podjetje je v vsaki državi članici tudi vzpostavilo program preprečevanja nosečnosti in bo zbiralo podatke o morebitni uporabi zdravila za neodobrene indikacije.
English: It will also supply cards for patients to ensure that they are informed about appropriate safety measures to be taken by each patient.
Slovenian: Prav tako bo priskrbelo kartice za bolnike, s pomočjo katerih bo lahko vsak bolnik preveril, ali upošteva vse ustrezne varnostne ukrepe.
English: Lenalidomide Accord (lenalidomide)
Slovenian: Lenalidomide Accord (lenalidomid)
English: Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Lenalidomide Accord generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What measures are being taken to ensure the safe and effective use of Lenalidomide Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lenalidomide Accord?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Lenalidomide Accord primerljivo raven kakovosti in je bioekvivalentno z zdravilom Revlimid.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Revlimid, zato jih ni treba ponoviti za zdravilo Lenalidomide Accord.
English: For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Lenalidomide Accord glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.
Slovenian: Lenalidomid deluje na več načinov: preprečuje razvoj nenormalnih celic, preprečuje rast krvnih žil v tumorjih in spodbuja nekatere posebne celice imunskega sistema k napadanju nenormalnih celic.
English: Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Lenalidomide Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: • on its own, in adults who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer;
Slovenian: • samostojno pri odraslih, pri katerih je bila opravljena presaditev matičnih celic (postopek, pri katerem iz bolnikovega kostnega mozga odstranijo celice in jih nadomestijo z matičnimi celicami darovalca) za zaustavitev napredovanja raka;
English: The boxes containing Lenalidomide Accord capsules also bear a warning stating that lenalidomide can be harmful to the unborn child.
Slovenian: Škatle, ki vsebujejo kapsule zdravila Lenalidomide Accord, so tudi opremljene z opozorilom, da je lenalidomid lahko škodljiv za nerojene otroke.
English: • in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
Slovenian: • v kombinaciji z deksametazonom za zdravljenje odraslih, ki so se v preteklosti zaradi te bolezni zdravili vsaj enkrat.
English: An overview of Lenalidomide Accord and why it is authorised in the EU
Slovenian: Pregled zdravila Lenalidomide Accord in zakaj je odobreno v EU
English: As for every medicine, the company provided studies on the quality of Lenalidomide Accord.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Lenalidomide Accord.
English: Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells.
Slovenian: Lenalidomide Accord je zdravilo, ki se uporablja za zdravljenje diseminiranega plazmocitoma, tj. raka določene vrste belih krvnih celic, imenovanih plazmatke.
English: The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Slovenian: Podjetje, ki trži zdravilo Lenalidomide Accord, bo zdravstvenim delavcem priskrbelo dopis in izobraževalno gradivo, bolnikom pa knjižico, v katerih bo razloženo, da je zdravilo lahko škodljivo za nerojene otroke, in ki bodo vsebovali podrobnosti o varni uporabi zdravila.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lenalidomide Accord upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Revlimid.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Revlimid.
English: As for all medicines, data on the use of Lenalidomide Accord are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lenalidomide Accord stalno spremljajo.
English: The dose depends on the situation in which Lenalidomide Accord is used.
Slovenian: Odmerek je odvisen od okoliščin, zaradi katerih se zdravilo Lenalidomide Accord uporablja.
English: Lenalidomide Accord contains the active substance lenalidomide and is a ‘generic medicine'.
Slovenian: Zdravilo Lenalidomide Accord vsebuje učinkovino lenalidomid in je „generično zdravilo“.
English: What are the benefits and risks of Lenalidomide Accord?
Slovenian: Kakšne so koristi in tveganja zdravila Lenalidomide Accord?
English: What is Lenalidomide Accord and what is it used for?
Slovenian: Kaj je zdravilo Lenalidomide Accord in za kaj se uporablja?
English: Other information about Lenalidomide Accord
Slovenian: Druge informacije o zdravilu Lenalidomide Accord
English: The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulating agent.
Slovenian: Učinkovina v zdravilu Lenalidomide Accord, lenalidomid, je imunomodulator.