FrancophonIA/ELRC3.0 huggingface dataset:
English: When prepared as directed, reconstituted and infusion solutions of ALIMTA contain no antimicrobial preservatives.
Slovenian: Rekonstituirane raztopine in raztopine za infundiranje Po pripravi, skladni z navodili, rekonstituirane raztopine in raztopine zdravila ALIMTA za infundiranje ne vsebujejo nobenih protimikrobnih konzervansov.
English: ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Slovenian: ALIMTA je v kombinaciji s cisplatinom indicirana kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: The following information is intended for medical or healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo, ravnanje z zdravilom in odlaganje.
English: The median OS for the overall population (n = 663) was 13.4 months for the ALIMTA arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI = 0.65-0.95, p = 0.01192).
Slovenian: Mediana skupnega preživetja za celotno populacijo (n = 663) je bila 13,4 mesece za skupino z zdravilom ALIMTA in 10,6 mesecev za skupino s placebom, razmerje tveganja = 0,79 (95 % CI: 0,65 do 0,95; p = 0,01192).
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo aritmijo in motorično nevropatijo.
English: *P-values <0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Slovenian: *P-vrednosti < 0,05 v primerjavi pemetreksed/cisplatin proti gemcitabin/cisplatin, z uporabo Fisherjevega Exact testa.
English: Fatigue (tiredness)
Slovenian: Utrujenost (izčrpanost) Kožni izpuščaji
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), ALIMTA 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),
English: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy and rash.
Slovenian: Poročani simptomi prevelikega odmerjanja vključujejo nevtropenijo, anemijo, trombocitopenijo, vnetje sluznic, senzorno polinevropatijo in izpuščaj.
English: Alkaline phosphatase, AST and ALT ≤ 5 times upper limit of normal is acceptable if liver has tumour involvement.
Slovenian: Če so jetra tumorsko prizadeta, so sprejemljive vrednosti alkalne fosfataze, AST in ALT ≤ 5-kratnik zgornje meje normalnih vrednosti.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA arm over the placebo arm (n = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001).
Slovenian: Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v skupini z zdravilom ALIMTA glede na skupino s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI: 0,490,73, p < 0,00001).
English: Children and adolescents There is no relevant use of ALIMTA in the paediatric population
Slovenian: Zdravilo Alimta ni primerno za uporabo pri pediatrični populaciji.
English: If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(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
English: Gemcitabine + cisplatin
Slovenian: ALIMTA + Cisplatin Gemcitabin + Cisplatin
English: ALIMTA 100 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 100 mg of pemetrexed.
Slovenian: ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I z gumijasto zaporko, ki vsebuje 100 mg pemetrekseda.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
Slovenian: Študija je dosegla svoj primarni ciljni učinek in dokazala statistično pomembno izboljšanje preživetja brez napredovanja bolezni v skupini, ki je prejemala zdravilo ALIMTA, v primerjavi s skupino, ki je prejemala placebo (n = 472, neodvisno pregledana populacija; mediano 3,9 meseca in 2,6 meseca) (razmerje tveganja=0,64, 95 % CI = 0,51-0,81, p = 0,0002).
English: For Precautions to be taken before handling or administering ALIMTA, see section 6.6.
Slovenian: Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila ALIMTA glejte poglavje 6.6.
English: **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Slovenian: **V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), alopecija mora biti poročana kot stopnja 1 ali 2.
English: ALIMTA 500 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 500 mg of pemetrexed.
Slovenian: ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I z gumijasto zaporko, ki vsebuje 500 mg pemetrekseda.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
English: Common Taste disturbance Eye disorders Common Conjunctivitis
Slovenian: Bolečina v prsnem košu Mišična oslabelost Konjunktivitis (vnetje očesa)
English: All Grades toxicity
Slovenian: Toksičnost vseh stopenj
English: From the start of ALIMTA plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the ALIMTA arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Slovenian: Od začetka indukcijskega zdravljenja prve izbire z zdravilom ALIMTA skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku ALIMTA in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95% % CI = 0,64-0,96).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/290/001
English: For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the ALIMTA arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Slovenian: Za bolnike z NSCLC , ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za skupino z zdravilom ALIMTA in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95% CI: 0,37-0,60, p = 0,00001).
English: Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy.
Slovenian: Nekateri bolniki so med prejemanjem zdravila ALIMTA, običajno v kombinaciji z drugim zdravilom proti raku, doživeli srčno kap, možgansko kap ali "manjšo kap".
English: EXP Read the leaflet for the shelf life of the reconstituted product.
Slovenian: EXP: Za informacije o roku uporabnosti pripravljenega zdravila preberite navodilo za uporabo.
English: ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Slovenian: ALIMTA 100 mg: Vsaka viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Slovenian: ***V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), motnje okusa in alopecija morata biti poročana kot stopnja 1 ali 2.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/290/002
English: Table 2 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b Dose of ALIMTA (mg/m2)
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov zdravila ALIMTA (kot edine učinkovine ali v kombinaciji) in cisplatina - Nehematološke toksičnostia, b
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 ALIMTA.
Slovenian: Če imate ali ste imeli težave z ledvicami, se pogovorite z zdravnikom ali bolnišničnim farmacevtom,
English: Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by glomerular filtration.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pemetreksed se izloča predvsem preko ledvic nespremenjen s tubulno sekrecijo in v manjšem obsegu z glomerulno filtracijo.
English: ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Talk to your doctor or hospital pharmacist before receiving ALIMTA.
Slovenian: Pred začetkom uporabe zdravila ALIMTA se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
English: ALIMTA at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Slovenian: 500 mg/m2 pri 64 bolnikih z malignim plevralnim mezoteliomom, ki predhodno še niso prejemali kemoterapije.
English: 8.3 months for patients treated with ALIMTA (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Slovenian: v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali metastatskim NSCLC po predhodni kemoterapiji, je pokazala mediano časa preživetja 8,3 mesece pri bolnikih, zdravljenih z zdravilom ALIMTA (Populacija z namenom zdraviti n = 283), in 7,9 mesecev pri bolnikih, zdravljenih z docetakselom (NZ n = 288).
English: Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Slovenian: Kolitis (vnetje sluznice debelega črevesa, ki ga lahko spremlja krvavitev iz črevesa ali danke) Intersticijska pljučnica (vnetje pljučnih mešičkov) Edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino)
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of ALIMTA plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the ALIMTA arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95% CI = 0.47-0.74).
Slovenian: Za naključno izbrane bolnike, merjeno od začetka zdravljenja z zdravilom ALIMTA in indukcijskim zdravljenjem prve izbire s cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala zdravilo ALIMTA, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59 95 % CI = 0,47-0,74).
English: ALIMTA 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Slovenian: ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation ALIMTA maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Slovenian: Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja z zdravilom ALIMTA v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: Constipation Common Dyspepsia
Slovenian: Zelo pogosto Diareja Bruhanje
English: Low haemoglobin level (anaemia) Low platelet count
Slovenian: Nizko število belih krvnih celic Nizka raven hemoglobina (anemija) Nizko število trombocitov Diareja
English: ALIMTA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Slovenian: ALIMTA 500 mg: Vsaka viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje AST, povišanje ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjuktivitis in znižanje očistka kreatinina.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the ALIMTA arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Slovenian: Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za skupino z zdravilom ALIMTA in 13,6 mesecev za skupino s placebom (razmerje tveganja = 0,71, 95% CI: 0,56-0,88, p = 0,002).
English: White to either light yellow or green-yellow lyophilised powder.
Slovenian: Bel do svetlorumen ali zelenorumen liofilizirani prašek.
English: ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion
Slovenian: ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje
English: Hypernatraemia - increased sodium in blood Inflammation of the skin, mainly of the lower limb with swelling, pain and redness
Slovenian: Vnetje kože, večinoma spodnjih okončin, z otekanjem, bolečino in pordelostjo
English: 95 % CI for median
Slovenian: Mediana (m) 95 % IZ za mediano
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: odpoved ledvic, okužbo, pireksijo, febrilno nevtropenijo, povišane AST, ALT in GGT, koprivnico in bolečino v prsnem košu.
English: Preparation and administration precautions
Slovenian: Previdnostni ukrepi pri pripravi in dajanju
English: ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the ALIMTA arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Slovenian: Mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 481) je bila 15,5 mesecev za skupino z zdravilom ALIMTA in 10,3 mesecev za skupino s placebom (razmerje tveganja = 0,70, 95% CI: 0,56-0,88, p = 0,002).
English: Rash Alopecia
Slovenian: Alopecija
English: ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section
Slovenian: ALIMTA je indicirana kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Common Leukocytes decreased
Slovenian: Pogosto Znižani levkociti
English: Breast-feeding must be discontinued during ALIMTA treatment.
Slovenian: Dojenje morate med zdravljenjem z zdravilom ALIMTA prekiniti.
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Slovenian: Občasno so v kliničnih študijah pemetrekseda, običajno ob sočasnem dajanju z drugo citotoksično učinkovino, poročali o resnih srčnožilnih in možganskožilnih dogodkih, vključno z miokardnim infarktom, angino pektoris, cerebrovaskularnim insultom in prehodnimi ishemičnimi atakami.
English: Nervous system disorders
Slovenian: Celotni sistemski očistek pemetrekseda je
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Slovenian: Ker ni podatkov o možnem medsebojnem delovanju pemetrekseda in NSAID-ov z daljšimi razpolovnimi časi, denimo, piroksikama ali rofekoksiba, moramo sočasno dajanje NSAID-ov s pemetreksedom pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic prekiniti vsaj za 5
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of ALIMTA plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with ALIMTA and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Slovenian: EMPHACIS, multicentrična, randomizirana, enojno slepa študija faze 3 zdravila ALIMTA skupaj s cisplatinom v primerjavi s cisplatinom pri bolnikih z malignim plevralnim mezoteliomom, ki v preteklosti še niso prejemali kemoterapije, je pokazala, da so imeli bolniki, zdravljeni z zdravilom
English: Women must use effective contraception during treatment with ALIMTA.
Slovenian: ALIMTA morajo ženske uporabljati učinkovito metodo kontracepcije.
English: CLASSIFICATION FOR SUPPLY
Slovenian: SEZNAM POMOŽNIH SNOVI
English: Treatment with ALIMTA should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Slovenian: 100 % predhodnega odmerka 50 % predhodnega odmerka a *Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) Zdravljenje z zdravilom ALIMTA moramo 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: SPECIAL STORAGE CONDITIONS
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE 10.
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with ALIMTA/ radiation therapy.
Slovenian: V kliničnih preskušanjih s pemetreksedom so občasno poročali o ezofagitisu/radiacijskem ezofagitisu.
English: Irritation of the skin and itching Chest pain
Slovenian: Odpoved ledvic Draženje kože in srbenje
English: NAME OF THE MEDICINAL PRODUCT ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: IME ZDRAVILA IN POT(I) UPORABE ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Slovenian: ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: NAME OF THE MEDICINAL PRODUCT ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: IME ZDRAVILA IN POT(I) UPORABE ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Videz parenteralnih zdravil je treba pred dajanjem vizualno pregledati, da ne vsebujejo trdnih delcev ali da nimajo spremenjene barve.
English: A multicentre, randomised, open label phase 3 study of ALIMTA versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of
Slovenian: Multicentrična, randomizirana, odprta študija faze 3 zdravila ALIMTA skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč
English: What ALIMTA looks like and contents of the pack ALIMTA is a powder for concentrate for solution for infusion in a vial.
Slovenian: ALIMTA je prašek za koncentrat za raztopino za infundiranje v viali.
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Slovenian: od 265 bolnikov, ki so jih naključno razporedili, da so prejemali eno učinkovino pemetreksed z dopolniloma folno kislino in vitaminom B12, ter pri 276 bolnikih, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, docetaksel.
English: Haemoglobin decreased
Slovenian: Znižani trombociti
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Slovenian: naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAID), denimo, ibuprofena in acetilsalicilne kisline (> 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: Docetaxel
Slovenian: Adenokarcinom
English: Common Vomiting Mucositis/ stomatitis
Slovenian: Pogosto Bruhanje Mukozitis/S tomatitis
English: Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased
Slovenian: Znižan hemoglobin 26,2 Znižani trombociti