FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders rash, pruritus, erythema, hyperhidrosis erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion
Slovenian: Bolezni kože in podkožja izpuščaj, srbenje, eritem, hiperhidroza multiformni eritem, makularni izpuščaj, makulopapulozni izpuščaj, srbeč izpuščaj, urtikarija, alergijski dermatitis, generalizirano srbenje, eritematozni izpuščaj, generalizirani izpuščaj, ošpicam podoben izpuščaj,
English: CANCIDAS 70 mg powder for concentrate for solution for infusion 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with an orange aluminium band.
Slovenian: CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje 10 ml viala iz stekla tipa I s sivim zamaškom iz butilne gume in plastično zaporko z oranžnim aluminijastim obročkom.
English: Paediatric Patients: In adolescents (ages 12 to 17 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr was generally comparable to that seen in adults receiving caspofungin at 50 mg daily.
Slovenian: Pediatrični bolniki: Pri mladostnikih (starih od 12 do 17 let), ki so dobivali kaspofungin v odmerku 50 mg/m2 na dan (največ 70 mg na dan) je bila AUC0-24h kaspofungina v plazmi na splošno primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan.
English: Reconstitution of CANCIDAS
Slovenian: Priprava zdravila CANCIDAS
English: c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection.
Slovenian: c pripravljene raztopine zdravila CANCIDAS aseptično prenesite v intravensko vrečko (ali steklenico), ki vsebuje 250 ml 0,9 %, 0,45 % ali 0,225 % raztopine natrijevega klorida za injekcije ali raztopine Ringerjevega laktata.
English: Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Slovenian: Količino zdravila, ki ustreza izračunanemu uvajalnemu odmerku, potegnite iz viale (1. korak).
English: This infusion solution must be used within 24 hours if stored at or below 25°C or within 48 hours if stored refrigerated at 2 to 8°C
Slovenian: 24 urah, če je shranjena pri temperaturi 25 °C ali manj, ali v 48 urah, če je shranjena na hladnem pri temperaturi od 2 do 8 °C.
English: Glacial acetic acid Sodium hydroxide (to adjust the pH)
Slovenian: 6.1 Seznam pomožnih snovi saharoza manitol koncentrirana ocetna kislina (ledocet) natrijev hidroksid (za uravnavanje pH)
English: c. CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.
Slovenian: c. Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni na viali označeni odmerek (70 mg), če iz viale potegnete 10 ml.
English: General disorders and administration site conditions pyrexia, chills, infusion-site pruritus pain, catheter site pain, fatigue, feeling cold, feeling hot, infusion site erythema, infusion site induration, infusion site pain, infusion site swelling, injection site phlebitis, oedema peripheral, tenderness, chest discomfort, chest pain, face oedema, feeling of body temperature change, induration, infusion site extravasation,
Slovenian: Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura, mrzlica, srbenje na mestu infundiranja bolečina, bolečina na mestu vstavljenega katetra, utrujenost, občutek mraza, občutek vročine, eritem na mestu infundiranja, induracija na mestu infundiranja, bolečina na mestu infundiranja, oteklina na mestu infundiranja, flebitis na mestu injiciranja, periferni edem, občutljivost, nelagodje v prsnem košu, bolečina v prsnem košu, edem obraza, občutek spremembe telesne temperature, induracija, ekstravazacija na mestu infundiranja, draženje na mestu infundiranja, flebitis na mestu infundiranja, izpuščaj na mestu infundiranja, urtikarija na mestu infundiranja, eritem na mestu injiciranja, edem na mestu injiciranja, bolečina na mestu injiciranja, oteklina na mestu injiciranja, splošno slabo počutje, edem
English: lymphatic system disorders decreased, haematocrit decreased, white blood cell count decreased coagulopathy, leukopaenia, eosinophil count increased, platelet count decreased, platelet count increased, lymphocyte count decreased, white blood cell count increased, neutrophil count decreased
Slovenian: Bolezni krvi in limfatičnega sistema znižanje hemoglobina, znižanje hematokrita, zmanjšano število levkocitov anemija, trombocitopenija, motnje strjevanja krvi, levkopenija, povečano število eozinofilcev, zmanjšano število trombocitov, povečano število trombocitov, zmanjšano število limfocitov, povečano število levkocitov, zmanjšano število nevtrofilcev
English: What Cancidas contains
Slovenian: Kaj vsebuje zdravilo Cancidas
English: CANCIDAS for transfer to intravenous bag or bottle
Slovenian: Prostornina koncentrata zdravila CANCIDAS, ki ga je treba vbrizgati v infuzijsko vrečko ali steklenico
English: c. CANCIDAS is formulated to provide the full labeled vial dose (50 mg) when 10 ml is withdrawn from the vial.
Slovenian: c. Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni, na viali označeni odmerek (50 mg), če iz viale potegnete 10 ml.
English: The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, doubleblind study comparing caspofungin (50 mg/m
Slovenian: Prva študija je bila randomizirana, dvojno slepa študija z 82 bolniki, starimi od 2 do 17 let.
English: Cancidas contains sucrose
Slovenian: Zdravilo Cancidas vsebuje saharozo
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
Slovenian: CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 70 mg kaspofungina (v obliki acetata).
English: A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Slovenian: Odraslim bolnikom z zmerno jetrno okvaro je priporočljivo dnevni odmerek zmanjšati na 35 mg. Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro in pri pediatričnih bolnikih s katero koli stopnjo jetrne okvare nimamo.
English: Among patients with candidaemia, favourable response rates at the end of IV study therapy were comparable for caspofungin (72 % [66/92]) and amphotericin B (63 % [59/94]) in the primary efficacy analysis (MITT analysis) [% difference 10.0 (95.0 % CI -4.5, 24.5)].
Slovenian: Med bolniki s kandidemijo sta bila deleža ugodnega odziva na koncu intravenskega raziskovanega zdravljenja v analizi primarne učinkovitosti (analiza MITT) pri kaspofunginu (72 % [66/92]) in amfotericinu B (63 % [59/94]) podobna [% razlike
English: When co-administering inducers of metabolic enzymes, an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).
Slovenian: Pri sočasnem zdravljenju z induktorji presnovnih encimov moramo pri odraslih bolnikih razmisliti o povečanju dnevnega odmerka kaspofungina na 70 mg, po 70 mg uvajalnem odmerku (glejte poglavje 4.2).
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial contains 50 mg caspofungin (as acetate).
Slovenian: CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 50 mg kaspofungina (v obliki acetata).
English: In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg daily and to that in older children (2 to 11 years of age) receiving the 50 mg/m2 daily dose.
Slovenian: Pri malih otrocih (starih od 12 do 23 mesecev), ki so dobivali kaspofungin v odmerku 50 mg/m 2 na dan (največ 70 mg na dan), je bila AUC0-24h kaspofungina v plazmi po večkratnih odmerkih primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan, in kot pri starejših otrocih (starih od 2 do 11 let), ki so dobivali dnevni odmerek 50 mg/m
English: 35 mg for moderate hepatic impairment (from one 70 mg vial)
Slovenian: 35 mg pri zmerni jetrni okvari (iz ene viale po 70 mg)
English: Aseptically transfer this volume (ml)
Slovenian: To količino (ml)
English: Do not mix with diluents containing glucose, as CANCIDAS is not stable in diluents containing glucose.
Slovenian: Ne mešajte z vehikli, ki vsebujejo glukozo, ker zdravilo CANCIDAS v njih ni stabilno.
English: DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose.
Slovenian: NE UPORABLJAJTE VEHIKLOV, KI VSEBUJEJO GLUKOZO, ker zdravilo CANCIDAS v njih ni stabilno.
English: 35 mg for moderate hepatic impairment (from one 50 mg vial)
Slovenian: 35 mg pri zmerni jetrni okvari (iz ene viale po 50 mg)
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (70 mg vial)
Slovenian: NAVODILA ZA UPORABO PRI ODRASLIH BOLNIKIH (viala po 70 mg)
English: What Cancidas is
Slovenian: Kaj je zdravilo Cancidas
English: 35 mg for moderate hepatic impairment (from one 50 mg vial) at reduced volume
Slovenian: 35 mg pri zmerni jetrni okvari (iz ene viale po 50 mg) / zmanjšana prostornina infuzije
English: Cancidas 70 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 70 mg of caspofungin.
Slovenian: Cancidas 70 mg prašek za koncentrat za raztopino za infundiranje Ena viala zdravila Cancidas vsebuje 70 mg kaspofungina.
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (50 mg vial)
Slovenian: NAVODILA ZA UPORABO PRI ODRASLIH BOLNIKIH (viala po 50 mg)
English: CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion
Slovenian: CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Slovenian: Nedovzetnost pomeni, da po najmanj 7 dneh prejemanja terapevtskih odmerkov učinkovitega protiglivnega zdravila okužba še vedno napreduje ali se stanje ne izboljša.
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (50 mg vial)
Slovenian: NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH (viala po 50 mg)
English: In neonates and infants (<3 months) receiving caspofungin at 25 mg/m2 daily (corresponding mean daily dose of 2.1 mg/kg), caspofungin peak concentration (C1 hr) and caspofungin trough concentration (C24 hr) after multiple doses were comparable to that seen in adults receiving caspofungin at 50 mg daily.
Slovenian: Pri novorojenčkih in dojenčkih (starih <3 mesece), ki so dobivali kaspofungin v odmerku 25 mg/m (kar ustreza povprečnemu dnevnemu odmerku 2,1 mg/kg), sta bili največja koncentracija kaspofungina (C1 h) in koncentracija kaspofungina tik pred naslednjim odmerkom (C24 h) po večkratnih odmerkih podobni kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan. Prvi dan je bila C1 h pri teh novorojenčkih in dojenčkih primerljiva, C24 h pa zmerno večja (36 %) v primerjavi z odraslimi.
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (70 mg vial)
Slovenian: NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH (viala po 70 mg)
English: Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses.
Slovenian: Če je to iz zdravstvenih razlogov potrebno, lahko za 50 mg ali 35 mg dnevne odmerke pripravite manjšo prostornino infuzije - 100 ml. Raztopine ne uporabite, če je motna ali če je nastala oborina.
English: Cancidas 50 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 50 mg of caspofungin.
Slovenian: Cancidas 50 mg prašek za koncentrat za raztopino za infundiranje Ena viala zdravila Cancidas vsebuje 50 mg kaspofungina.
English: Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.
Slovenian: Če ste noseči ali dojite ali menite, da ste noseči, se posvetujte z zdravnikom, preden dobite to zdravilo.
English: • Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)
Slovenian: • spremembe nekaterih laboratorijskih izvidov krvi (vključno z motnjami strjevanja krvi,
English: Before reconstitution, the powder is a white to off-white-compact, powder.
Slovenian: prašek za koncentrat za raztopino za infundiranje Pred pripravo je prašek bel do skoraj bel kompakten prašek.
English: 50 mg/m2 and the 50 mg dose, respectively, while in one 6-month old child receiving the 50 mg/m dose, the AUC0-24 hr was somewhat higher.
Slovenian: Farmakokinetični podatki so pri enem 10-mesečnem otroku, ki je dobival 50 mg/m2 na dan, pokazali AUC0-24h v enakem območju, kot je bila pri starejših otrocih med uporabo 50 mg/m2 in odraslih med uporabo 50-mg odmerka, pri enem 6-mesečnem otroku, ki je dobival 50 mg/m2, pa je bila AUC0-24h nekoliko večja.
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin
Slovenian: CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje kaspofungin
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin
Slovenian: CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje kaspofungin
English: CANCIDAS 50 mg powder for concentrate for solution for infusion
Slovenian: CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje
English: CANCIDAS 70 mg powder for concentrate for solution for infusion
Slovenian: CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje
English: and 50 mg/m 2 daily in young children (3 to 11 months of age) can be considered (see section 5.2).
Slovenian: Malo podatkov nakazuje, da pride pri novorojenčkih in dojenčkih (starih manj kot 3 mesece) v poštev zdravljenje s kaspofunginom v odmerku 25 mg/m2 na dan, pri majhnih otrocih (starih od 3 do 11 mesecev) pa v odmerku 50 mg/m 2 na dan (glejte poglavje 5.2).
English: Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast.
Slovenian: glukana, ki je bistvena sestavina celične stene številnih filamentoznih gliv in kvasovk.
English: Very common
Slovenian: Ni priporočljivo
English: Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 50-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Slovenian: Priprava infuzije 50 mg/m za pediatrične bolnike, stare > 3 mesece (z uporabo viale po 50 mg) Dejanski dnevni vzdrževalni odmerek za pediatričnega bolnika določite na podlagi njegove telesne površine (izračunane, kot je prikazano zgoraj) po naslednji enačbi: Telesna površina (m2) X 50 mg/m2 = dnevni vzdrževalni odmerek
English: Development of in vitro resistance to caspofungin by Aspergillus species has been identified.
Slovenian: Pri Aspergillus sp. so in vitro ugotovili razvoj odpornosti proti kaspofunginu.
English: Empirical Therapy in Febrile, Neutropaenic Adult Patients: A total of 1,111 patients with persistent fever and neutropaenia were enrolled in a clinical study and treated with either caspofungin 50 mg once daily following a 70 mg loading dose or liposomal amphotericin B 3.0 mg/kg/day.
Slovenian: Empirično zdravljenje febrilnih, nevtropeničnih odraslih bolnikov: Klinična študija je zajela skupno 1.111 bolnikov s trdovratno zvišano telesno temperaturo in nevtropenijo.
English: • Chills, fever
Slovenian: • mrzlica, zvišana telesna temperatura
English: Class
Slovenian: Višina
English: Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 70-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Slovenian: Priprava infuzije 50 mg/m za pediatrične bolnike, stare >3 mesece (z uporabo viale po 70 mg) Dejanski dnevni vzdrževalni odmerek za pediatričnega bolnika določite na podlagi njegove telesne površine (izračunane, kot je prikazano zgoraj) po naslednji enačbi: Telesna površina (m2) X 50 mg/m2 = dnevni vzdrževalni odmerek
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Sočasna uporaba z induktorji presnovnih encimov
English: • Inflammation of the vein
Slovenian: • zvišana telesna temperatura
English: EU/1/16/1119/001 Zepatier
Slovenian: EU/1/16/1119/001
English: 50 mg / 100 mg
Slovenian: 50 mg/100 mg filmsko obložena tableta peroralna uporaba pretisni omot (alu/alu)
English: Oral use blister (alu/alu)
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja
English: Pack size
Slovenian: Zepatier
English: It is available as capsules (100 and 400 mg) and tablets (100 and 400 mg) and is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Slovenian: Na voljo je v obliki kapsul (100 in 400 mg) in tablet (100 in 400 mg) in se jemlje peroralno ob obroku z velikim kozarcem vode za zmanjšanje draženja želodca in črevesja.
English: What measures are being taken to ensure the safe and effective use of Imatinib Teva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Teva?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Teva on 8 January 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Imatinib Teva, veljavno po vsej Evropski uniji, izdala 8. januarja 2013.
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Slovenian: Uporablja se tudi pri odraslih in otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi);
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Teva have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Slovenian: Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.
English: The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Slovenian: Odmerek je odvisen od starosti bolnika, njegovega bolezenskega stanja in odziva na zdravljenje, vendar ne sme presegati 800 mg na dan. Za več informacij glejte navodilo za uporabo.
English: This means that Imatinib Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Glivec.
English: This is a summary of the European public assessment report (EPAR) for Imatinib Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imatinib Teva.
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin kinaze.
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Slovenian: Uporablja se tudi samostojno pri odraslih za zdravljenje Ph+ ALL, ki se je po predhodnih zdravljenjih ponovno pojavila ali se ne odziva na druga zdravljenja;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Teva has been shown to have comparable quality and to be bioequivalent to Glivec.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib Teva primerljivo raven kakovosti kot zdravilo Glivec ter da mu je biološko enakovredno.
English: Other information about Imatinib Teva
Slovenian: Druge informacije o zdravilu Imatinib Teva
English: By blocking these receptors, Imatinib Teva helps to control cell division.
Slovenian: Z zaviranjem teh receptorjev zdravilo Imatinib Teva pomaga pri nadzoru deljenja celic.
English: What are the benefits and risks of Imatinib Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Teva?
English: Because Imatinib Teva 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 Imatinib Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Slovenian: To pomeni, da so se nekateri geni prerazporedili in tvorijo poseben kromosom Philadephia.
English: The full EPAR for Imatinib Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about treatment with Imatinib Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Imatinib Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Imatinib Teva is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Slovenian: Zdravilo Imatinib Teva se uporablja za zdravljenje odraslih z (DFSP), ki ga ni mogoče odstraniti s kirurškim posegom ter pri odraslih, ki niso primerni za kirurški poseg po ponovnem pojavu raka po zaključenem zdravljenju ali pri razširitvi na druge dele telesa.
English: Imatinib Teva is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Slovenian: Zdravilo Imatinib Teva se uporablja za zdravljenje odraslih s HES ali CEL, ki imajo posebno preureditev dveh genov, imenovanih FIP1L1 in PDGFRα;
English: What is Imatinib Teva and what is it used for?
Slovenian: Kaj je zdravilo Imatinib Teva in za kaj se uporablja?
English: For practical information about using Imatinib Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Imatinib Teva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Because Imatinib Teva is a generic medicine, studies in patients have been limited to tests to determine that the tablets and capsules are bioequivalent to the reference medicine, Glivec.
Slovenian: Ker je zdravilo Imatinib Teva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali so tablete in kapsule biološko enakovredne referenčnemu zdravilu Glivec.
English: Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Glivec odtehtajo znana tveganja.