FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of CIAMBRA should be avoided during pregnancy.
Slovenian: Uporabi zdravila CIAMBRA med nosečnostjo se izogibamo.
English: ** In the pemetrexed /cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Slovenian: **V veji zdravljenja s pemetreksedom/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
English: If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive CIAMBRA.
Slovenian: Če imate ali ste imeli težave z ledvicami, se pogovorite s svojim zdravnikom ali bolnišničnim farmacevtom, ker morda ne boste mogli prejeti zdravila CIAMBRA.
English: Superiority p-value
Slovenian: Prednost p-vrednost
English: Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Slovenian: Zaradi gastrointestinalne toksičnosti pemetrekseda v kombinaciji s cisplatinom so opažali hudo dehidracijo.
English: 75 % of previous dose
Slovenian: 75% predhodnega odmerka 75% predhodnega odmerka
English: Treatment with CIAMBRA should be discontinued if a patient experiences any haematologic or nonhaematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Slovenian: Zdravljenje z zdravilom CIAMBRA je potrebno prekiniti, če bolnik izkusi kakršnokoli hematološko ali nehematološko toksičnost stopnje 3 ali 4 po 2 znižanjih odmerka ali nemudoma, če opazimo nevrološko toksičnost stopnje 3 ali 4.
English: What CIAMBRA is and what it is used for
Slovenian: Kaj je zdravilo CIAMBRA in za kaj ga uporabljamo
English: This medicinal product contains 54 mg sodium per vial , equivalent to 2,7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 54 mg natrija na vialo, kar je ekvivalentno 2,7% maksimalnega dnevnega vnosa 2 g natrija za odraslega, priporočenega s strani WHO.
English: Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after CIAMBRA treatment.
Slovenian: Kortikosteroidi: vaš zdravnik vam bo predpisal tablete steroidov (ustrezno 4 miligramom deksametazona dvakrat dnevno), ki jih boste morali jemati dan pred zdravljenjem z zdravilom CIAMBRA, na dan zdravljenja in na dan po zdravljenju z zdravilom CIAMBRA.
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤6 cycles: 3.3%, > 6cycles: 6.4%: p=0.046).
Slovenian: Znatno povečanje pojavnosti nevtropenije stopnje 3/4, ki je lahko povezano s preučevanim zdravilom, so opazili pri dolgotrajnejši izpostavljenosti pemetreksedu (≤ 6 ciklov: 3,3%, > 6 ciklov: 6,4%: p=0,046).
English: Progression free survival (months) Median
Slovenian: Preživetje brez napredovanja (meseci) Mediana
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
Slovenian: Obvestite svojega zdravnika, če se pojavi hud izpuščaj, srbenje ali mehurčki (Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza).
English: If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (may indicate a blood clot in the blood vessels of the lungs)
Slovenian: Če doživite nenadno težko dihanje, močno bolečino v prsih ali kašelj s krvavim izmečkom (lahko kaže na krvni strdek v krvnih žilah v pljučih).
English: When using CIAMBRA in combination with cisplatin:
Slovenian: Kadar uporabljamo zdravilo CIAMBRA v kombinaciji s cisplatinom:
English: Pancytopenia- combined low counts of white cells, red cells and platelets Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their CIAMBRA therapy.
Slovenian: Pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov Radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem, pred, med ali po zdravljenju z zdravilom CIAMBRA.
English: It is a white to almost white lyophilised powder.
Slovenian: Je bel do skoraj bel liofiliziran prašek.
English: NSCLC, maintenance treatment:
Slovenian: NSCLC, vzdrževalno zdravljenje:
English: Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/min is not recommended (see section 4.2).
Slovenian: Zato uporaba pemetrekseda pri bolnikih z očistkom kreatinina < 45 ml/min ni priporočena (glejte poglavje 4.2).
English: If you are concerned about any side effects, talk to your doctor.
Slovenian: Če ste zaradi katerega koli neželenega učinka zaskrbljeni, se pogovorite s svojim zdravnikom.
English: You will always receive CIAMBRA by infusion into one of your veins.
Slovenian: Zdravilo CIAMBRA boste vedno prejeli v obliki infuzije v veno.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of CIAMBRA has finished.
Slovenian: Cisplatin tudi dajemo v obliki infuzije v veno, približno 30 minut po zaključku infuzije zdravila CIAMBRA.
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for CIAMBRA used as a single agent or in combination with cisplatin.
Slovenian: Po okrevanju bolnike ponovno zdravimo z uporabo smernic v Preglednicah 1, 2 in 3, ki veljajo za zdravilo CIAMBRA, če ga uporabljamo kot edino zdravilo ali v kombinaciji s cisplatinom.
English: Unopened vial 3 years
Slovenian: 6.3 Rok uporabnosti Neodprta viala 3 leta
English: The reconstituted solution should be used immediately to prepare the infusion solution.
Slovenian: Rekonstituirano raztopino je potrebno uporabiti takoj za pripravo raztopine za infundiranje.
English: As a result, concomitant use of live attenuated vaccines is not recommended (see section 4.3 and 4.5).
Slovenian: Zato odsvetujemo uporabo živih oslabljenih cepiv (glejte poglavji 4.3 in 4.5).
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to pemetrexed plus cisplatin induction.
Slovenian: Izmed naključno izbranih bolnikov jih je 44,9% doseglo popoln/delen odziv in 51,9% jih je doseglo odziv stabilne bolezni na pemetreksed in indukcijsko zdravilo cisplatina.
English: There is no relevant use of CIAMBRA in the paediatric population.
Slovenian: Zdravilo CIAMBRA ni primerno za uporabo pri pediatrični populaciji.
English: CIAMBRA can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Slovenian: Zdravnik vam lahko predpiše zdravilo CIAMBRA, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
English: White to almost white lyophilised powder.
Slovenian: Bel do skoraj bel liofiliziran prašek.
English: If you start feeling chest pain or having a fast heart rate.
Slovenian: Če se pojavi bolečina v prsnem košu ali hitro bitje srca.
English: *** Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Slovenian: ***Skupna preglednica neželenih učinkov združuje rezultate študij vzdrževalnega zdravljenja samo s pemetreksedom JMEN (N=663) in nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N=539).
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), analogi folne kisline, ATC oznaka: L01BA04
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), CIAMBRA should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Slovenian: Če se pri bolnikih razvijejo nehematološke toksičnosti ≥ stopnje 3 (z izjemo nevrološke toksičnosti), moramo dajanje zdravila CIAMBRA prekiniti, dokler se vrednosti ne povrnejo na manjše ali enake, kot jih je imel bolnik pred zdravljenjem.
English: Preparation and administration precautions:
Slovenian: Previdnostni ukrepi pri pripravi in dajanju:
English: Therefore, caution should be made when administering higher doses of NSAIDs or aspirin, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Slovenian: Zato je pri dajanju visokih odmerkov NSAID ali acetilsalicilne kisline sočasno s pemetreksedom bolnikom z normalnim delovanjem ledvic (očistek kreatinina > 80 ml/min) potrebna previdnost.
English: For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji/redčenju zdravila glejte poglavje 6.3.
English: Creatinine clearance decreased**
Slovenian: Zelo pogosto Povišan kreatinin Znižan očistek**
English: CIAMBRA must only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.
Slovenian: Zdravilo CIAMBRA smemo dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije za zdravljenje raka.
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Slovenian: Učinkovitost pemetrekseda v primerjavi z docetakselom pri NSCLC - ITT populacija pemetreksed docetaksel
English: Abbreviation: CI = confidence interval * p-value refers to comparison between arms.
Slovenian: Okrajšava: IZ = interval zaupanja *p-vrednost se nanaša na primerjavo med vejami zdravljenja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE IN POT(I) UPORABE
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Slovenian: Okrajšave: IZ = interval zaupanja; ITT = namen zdraviti; N = velikost populacije.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of CIAMBRA and then approximately every 9 weeks (corresponding to 3 courses of CIAMBRA treatment).
Slovenian: V tednu pred dajanjem zdravila CIAMBRA boste prejeli tudi injekcijo vitamina B12 (1000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom CIAMBRA).
English: Other (N=252)
Slovenian: Drugo (N=252)
English: CIAMBRA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Slovenian: Zdravilo CIAMBRA je namenjena tudi zdravljenju bolnikov z napredovalim stadijem pljučnega raka, katerih bolezen se širi po tem, ko je bila že uporabljena druga začetna kemoterapija.
English: Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving treatment.
Slovenian: Zato morajo bolniki pred prejemanjem terapije in/ali po njej ustrezno hidrirati, prejeti morajo zadostno antiemetično zdravljenje.
English: Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n = 164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Slovenian: Klinično pomembne laboratorijske toksičnosti stopnje 3 in 4 so bile podobne pri integriranih rezultatih faze 2 treh študij pemetrekseda kot edine učinkovine (n = 164) in faze 3 študije pemetrekseda kot edine učinkovine, opisane zgoraj, z izjemo nevtropenije (12,8% oziroma 5,3%) in povišanja alaninske aminotransferaze (15,2% oziroma 1,9%).
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking CIAMBRA.
Slovenian: Dopolnjevanje vitaminov: vaš zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov), ki ga boste morali med prejemanjem zdravila CIAMBRA jemati enkrat dnevno.
English: Common side effects (may affect up to 1 in 10 people) Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) Alergijske reakcije: kožni izpuščaji / pekoč ali zbadajoč občutek Okužba vključno s sepso
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Slovenian: Bolniki morajo dnevno jemati peroralno folno kislino ali multivitaminski pripravek, ki vsebuje folno kislino (350 do 1000 mikrogramov).
English: A hospital pharmacist, nurse or doctor will have mixed the CIAMBRA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Slovenian: Bolnišnični farmacevt, medicinska sestra ali zdravnik bo prašek CIAMBRA, preden ga boste prejeli, zmešal z 9 mg/ml (0,9%) raztopino natrijevega klorida za injiciranje.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C or 15°C to 25°C.
Slovenian: Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik, in naj ne bi presegal 24 ur pri 2°C do 8°C ali 15°C do 25°C.
English: You must take at least 5 doses during the seven days before the first dose of CIAMBRA.
Slovenian: V sedmih dneh pred prvim odmerkom zdravila CIAMBRA morate vzeti vsaj 5 odmerkov.
English: If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal).
Slovenian: Če vam krvavijo dlesni, krvavite iz nosu ali ustne votline, ali se pojavi kakršnakoli krvavitev, ki se noče ustaviti, rdečkasto ali rožnato obarvan urin, nepričakovane podplutbe (ker imate lahko manj trombocitov, kot je normalno).
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Slovenian: Redkeje opaženi učinki so Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
English: If you have pain, redness, swelling or sores in your mouth.
Slovenian: Če imate bolečine, rdečino, oteklino ali razjede v ustni votlini.
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Slovenian: Okrajšave: IZ = interval zaupanja; RT = razmerje tveganja; ITT = namen zdraviti; n = velikost populacije.
English: CIAMBRA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Slovenian: Zdravilo CIAMBRA se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
English: Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pretreatment with folic acid and vitamin B12 was administered.
Slovenian: Poročali so o manjši toksičnosti in znižanju hematoloških in nehematoloških toksičnosti stopnje 3/4, kot je nevtropenija, febrilna nevtropenija ter okužba z nevtropenijo stopnje 3/4, kadar so pred zdravljenjem dajali folno kislino in vitamin B12.
English: There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 ml/min; therefore the use of pemetrexed is not recommended (see section 4.4).
Slovenian: O uporabi pemetrekseda pri bolnikih z očistkom kreatinina, nižjim od 45 ml/min, ni zadostnih podatkov, zato uporabe pemetrekseda ne priporočamo (glejte poglavje 4.4).
English: Concomitant administration of substances that are also tubularly secreted (e.g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Slovenian: Sočasno dajanje učinkovin, ki se tudi izločajo s tubulno sekrecijo (denimo probenecid, penicilin), lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: 75 % of previous dose (both CIAMBRA and cisplatin)
Slovenian: 75% predhodnega odmerka (obeh, zdravila CIAMBRA in cisplatina)
English: Cases of radiation recall have been reported in patients who received radiotherapy weeks or years previously.
Slovenian: Poročali so o kožni reakciji (“radiation recall”) pri bolnikih, ki so se zdravili z radioterapijo pred tedni ali leti.
English: Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Slovenian: Pred vsakim dajanjem kemoterapije je potrebno opraviti tudi teste biokemije seruma za vrednotenje ledvičnega in jetrnega delovanja.
English: Pemetrexed has a steady-state volume of distribution of9 l/m2.
Slovenian: Pemetreksed ima volumen porazdelitve v stanju dinamičnega ravnovesja 9 l/m2.
English: What you need to know before you use CIAMBRA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo CIAMBRA 3.
English: Common Pain Edema Renal Disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Slovenian: Bolezni sečil**** Okrajšave: ALT = alaninska aminotransferaza; AST = aspartatna aminotransferaza; CTCAE = običajni terminološki kriteriji za neželene učinke; NCI = nacionalni inštitut za rakava obolenja; SGOT
English: During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients' therapy to reduce toxicity.
Slovenian: Med študijo so bolnikom uvedli v terapijo nizke odmerke dopolnilne folne kisline in vitamin B12, za zmanjšanje toksičnosti.
English: If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with CIAMBRA.
Slovenian: Če ste imeli ali če boste imeli zdravljenje z obsevanjem, prosimo, povejte to svojemu zdravniku, saj ob jemanju zdravila CIAMBRA lahko pride do zgodnje ali pozne reakcije na obsevanje.
English: Patients with renal impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Slovenian: Bolniki z okvarjenim delovanjem ledvic (po standardni formuli Cockcrofta in Gaulta ali hitrost glomerularne filtracije, izmerjena z metodo Tc99m-DPTA serumskega očistka) Pemetreksed se primarno izloča nespremenjen preko ledvic.
English: After reconstitution (see section 6.6), each vial contains 25 mg/mL of pemetrexed.
Slovenian: Po rekonstituciji (glejte poglavje 6.6) vsebuje ena viala 25 mg/ml pemetrekseda.
English: Dose of CIAMBRA (mg/m
Slovenian: Odmerek zdravila CIAMBRA (mg/m2)
English: Each pack contains 1 vial.
Slovenian: Pakiranje po 1 vialo.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo in sicer kot osnovni »prosti natrij«.
English: Allergic reaction: if you develop skin rash / burning or prickling sensation, or fever.
Slovenian: Alergijska reakcija: če se pojavi izpuščaj / pekoč ali zbadajoč občutek, ali povišana telesna temperatura.
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Slovenian: V skladu z ostalimi pemetreksed študijami, so v študiji JMEN tudi opažali razliko v učinkovitosti glede na histologijo NSCLC.
English: Median overall survival in months (95% CI)
Slovenian: Mediana skupnega preživetja v mesecih (95% IZ)
English: What CIAMBRA looks like and contents of the pack
Slovenian: Izgled zdravila CIAMBRA in vsebina pakiranja
English: CIAMBRA 500 mgcontains 54 mg sodium (main component of cooking salt) in each vial.
Slovenian: Zdravilo CIAMBRA 500 mg vsebuje 54 mg natrija (glavna sestavina v kuharski soli) v eni viali.
English: If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal).
Slovenian: Če ste utrujeni, omotični, se hitro zadihate, ste bledi (ker imate morda manj hemoglobina, kot je normalno).
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling) Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving CIAMBRA usually in combination with another anticancer therapy.
Slovenian: Edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino) Nekateri bolniki so med prejemanjem zdravila CIAMBRA, običajno v kombinaciji z drugim zdravilom proti raku, doživeli srčno kap, možgansko kap ali "manjšo kap".
English: All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinumbased chemotherapy.
Slovenian: Vsi bolniki so imeli diagnozo nedrobnoceličnega pljučnega karcinoma IIIB ali IV. stopnje in so predhodno prejemali kemoterapijo na osnovi platine.
English: Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre treated with docetaxel (n = 41) and patients who did not receive previous docetaxel treatment (n =
Slovenian: Omejeni klinični podatki iz ločeno randomiziranih, kontroliranih preskušanj faze 3, nakazujejo, da so podatki o učinkovitosti (skupno preživetje, preživetje brez napredovanja) za pemetreksed podobni med bolniki, ki so bili predhodno zdravljeni z docetakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z docetakselom (n = 540).
English: Concomitant administration of nephrotoxic drugs (e.g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Slovenian: Sočasno dajanje nefrotoksičnih zdravil (denimo aminoglikozidov, diuretikov zanke, spojin platine, ciklosporina) lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
English: Adenocarcinoma (N=847)
Slovenian: Adenocarcinom (N=847)
English: Dose reductions for subsequent cycles are based on nadir ANC, platelet count and maximum non-haematologic toxicity seen from the previous cycle (see section 4.2).
Slovenian: Odmerke v naslednjih ciklusih nižamo na podlagi najnižjega ANC, števila trombocitov in največje nehematološke toksičnosti iz prejšnjega ciklusa (glejte poglavje 4.2).
English: Binding was not notably affected by varying degrees of renal impairment.
Slovenian: Na vezavo ni opazno vplivala različna stopnja okvare delovanja ledvic.
English: - The other ingredients are mannitol (E 421), hydrochloric acid (pH adjustment) and sodium hydroxide (pH adjustment) (see section 2, “Ciambra contains sodium”).
Slovenian: Druge sestavine zdravila so manitol (E421), klorovodikova kislina (prilagoditev pH) in natrijev hidroksid (prilagoditev pH) (glejte poglavje 2, »Zdravilo Ciambra vsebuje natrij«) .
English: CIAMBRA is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Slovenian: Zdravilo CIAMBRA dajemo v kombinaciji s cisplatinom, drugim zdravilom proti raku, za zdravljenje malignega plevralnega mezotelioma, vrste raka, ki prizadene vrhnjo plast pljuč, bolnikom, ki pred tem še niso prejemali kemoterapije.