FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for pemetrexed the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pemetrexed is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za pemetreksed odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo pemetreksed, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Treatment should be resumed according to the guidelines in Table 2.
Slovenian: Z zdravljenjem nadaljujemo skladno s smernicami v Preglednici
English: ALIMTA is a medicine used in the treatment of cancer.
Slovenian: ALIMTA je zdravilo, ki ga uporabljamo pri zdravljenju raka.
English: The 1 year and 2 year survival rates for patients on ALIMTA were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Slovenian: Stopnji preživetja pri 1 in pri 2 letih pri bolnikih, ki so prejemali zdravilo ALIMTA sta bili 58 % in 32 %, v primerjavi s 45 % in 21 % pri bolnikih, ki so prejemali placebo.
English: ** In the ALIMTA/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Slovenian: **V veji zdravljenja z zdravilom ALIMTA/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with ALIMTA.
Slovenian: Če ste bili nedavno cepljeni, prosimo, povejte to zdravniku saj lahko to ob jemanju zdravila ALIMTA povzroča škodljive učinke.
English: 2 rue du Colonel Lilly 67640 Fegersheim France
Slovenian: 2 rue du Colonel Lilly 67640 Fegersheim Francija
English: Concomitant use not recommended: Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): risk of systemic, possibly fatal, disease.
Slovenian: Odsvetovana sočasna uporaba: Živa oslabljena cepiva (razen proti rumeni mrzlici, za katero je sočasna uporaba kontraindicirana): tveganje za sistemsko, potencialno smrtno bolezen.
English: The ALIMTA maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Slovenian: Profila varnosti vzdrževalnega zdravljenja z zdravilom ALIMTA iz obeh študij, JMEN in PARAMOUNT, sta bila podobna.
English: Therefore patients should be cautioned against driving or operating machines if this event occurs.
Slovenian: Zato je treba bolnike opozoriti, da naj ne vozijo in upravljajo strojev, če se pojavi utrujenost.
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Slovenian: Odziv (n: ustrezen za odziv) Stopnja odzivnosti (%) (95 % IZ) Stabilna bolezen (%)
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Povejte zdravniku ali bolnišničnemu farmacevtu, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: In Vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter.
Slovenian: In vitro študije so pokazale, da se pemetreksed aktivno izloča z OAT3 (prenašalcem organskih anionov).
English: In the data from the originator product, 91 cases of cellulitis, 42 of dermatitis, 13 cases of dermo-hypodermitis, and 3 cases of pseudocellulitis were identified.
Slovenian: Na podlagi podatkov o originatorskem zdravilu so prepoznali 91 primerov celulitisa, 42 primerov dermatitisa, 13 primerov dermohipodermitisa in 3 primere psevdocelulitisa.
English: Reconstituted and Infusion Solutions: The product should be used immediately.
Slovenian: Rekonstituirane raztopine in raztopine za infundiranje: zdravilo moramo uporabiti nemudoma.
English: Time to treatment failure (TTTF - months) Median
Slovenian: Čas do neuspeha zdravljenja (Time to treatment failure, TTTF - meseci) Mediana
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu so dostopne na spletni strani Evropske agencije za zdravila EMA http://www.ema.europa.eu.
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Slovenian: Velika različnost med posamezniki v koagulacijskem statusu v času bolezni ter možnost medsebojnega delovanja med peroralnimi antikoagulacijskimi učinkovinami ter kemoterapijo proti raku zahtevata povečano pogostnost spremljanja INR (International Normalised Ratio), če se odločimo za zdravljenje bolnika s peroralnimi antikoagulacijskimi učinkovinami.
English: During a periodic regulatory review of the use of pemetrexed a number of cases describing pigmentation disorders has been described with a common frequency.
Slovenian: Med rednim regulatornim pregledom uporabe pemetrekseda so opisali številne primere motenj pigmentacije s pogosto pogostnostjo.
English: Other medicines and ALIMTA
Slovenian: Druga zdravila in zdravilo ALIMTA
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive ALIMTA.
Slovenian: Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje delovanja vaših ledvic in jeter ter oceno, ali imate dovolj krvnih celic za prejemanje zdravila ALIMTA.
English: Large cell (N=153)
Slovenian: Velike celice (N = 153)
English: SGOT (AST) elevation
Slovenian: SGOT (AST)
English: The dose of ALIMTA is 500 milligrams for every square metre of your body's surface area.
Slovenian: Odmerek zdravila ALIMTA je 500 miligramov za vsak kvadratni meter površine vašega telesa.
English: rue du Colonel Lilly F-67640 Fegersheim France
Slovenian: rue du Colonel Lilly F-67640, Fegersheim Francija
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C.
English: 75 % of previous dose (both ALIMTA and cisplatin)
Slovenian: 75 % predhodnega odmerka (obeh ALIMTE in cisplatina)
English: What ALIMTA is and what it is used for
Slovenian: Kaj je zdravilo ALIMTA in za kaj ga uporabljamo
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.
Slovenian: Če se vam okrog pljuč nabira tekočina, se bo zdravnik morda odločil tekočino pred dajanjem zdravila
English: This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
Slovenian: Ta odmerek lahko prilagodimo, ali zdravljenje odložimo, odvisno od vašega števila krvnih celic ter vašega splošnega stanja.
English: Prior chemotherapy did not include ALIMTA.
Slovenian: Predhodna kemoterapija ni vključevala zdravila ALIMTA.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3 times upper limit of normal.
Slovenian: Alkalna fosfataza (AF), aspartatna aminotransferaza (AST ali SGOT) in alaninska aminotransferaza (ALT ali SGPT) morajo biti ≤ 3-kratnik zgornje meje normalnih vrednosti.
English: Patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
Slovenian: Bolniki morajo prejeti tudi intramuskularno injekcijo vitamina B12 (1000 mikrogramov) v tednu pred prvim odmerkom pemetrekseda in enkrat vsake tri cikluse zatem.
English: 75 % of previous dose
Slovenian: 75 % predhodnega odmerka
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Slovenian: Predhodno zdravljenje z deksametazonom (ali drugim ustreznim kortikosteroidom) lahko zmanjša incidenco in resnost kožnih reakcij (glejte poglavje 4.2).
English: Hemoglobin decreased
Slovenian: Znižan hemoglobin
English: Concomitant use contraindicated: Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
Slovenian: Kontraindicirana sočasna uporaba: Cepivo proti rumeni mrzlici: tveganje za smrtno generalizirano bolezen po cepljenju (glejte poglavje 4.3).
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10-minute period.
Slovenian: Farmakokinetične lastnosti pemetrekseda po dajanju ene učinkovine so vrednotili pri 426 bolnikih z različnimi malignimi trdnimi tumorji v razponu odmerkov od 0,2 do 838 mg/m2, infundiranih v 10 minutah.
English: Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy.
Slovenian: Z zdravnikom se pogovorite o možnem tveganju pri prejemanju zdravila ALIMTA v času nosečnosti.
English: Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice).
Slovenian: Bolniki morajo prejeti zadostno antiemetično zdravljenje, pred in/ali po prejemanju cisplatina jih moramo tudi ustrezno hidrirati (glejte tudi Povzetek glavnih značilnosti zdravila cisplatina za posebne nasvete o odmerjanju).
English: It is a white to either light yellow or green-yellow lyophilised powder.
Slovenian: Je bel do bodisi svetlo rumen ali zeleno-rumen liofiliziran prašek.
English: a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Slovenian: aStatistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod 1,17645 mejo prednosti (p < 0,001).
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very rare (<1/10,000) and not known (cannot be estimated from available data).
Slovenian: < 1/100), redko (≥1/10.000 do < 1/1000), zelo redko (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Pemetrexed N = 265
Slovenian: Pemetreksed N = 265
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with ALIMTA, representing at least 10 total cycles of ALIMTA.
Slovenian: Skupno je 169 bolnikov (47,1 %) zaključilo ≥ 6 ciklov vzdrževalnega zdravljenja z zdravilom ALIMTA, kar predstavlja vsaj 10 polnih ciklov zdravila ALIMTA.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Slovenian: Izsledki študij in vitro s človeškimi jetrnimi mikrosomi so pokazali, da za pemetreksed ne pričakujemo, da bi povzročil klinično pomembno zaviranje presnovnega očistka zdravil, ki se presnavljajo s CYP3A, CYP2D6, CYP2C9 in CYP1A2.
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 glomerulne filtracije, izmerjena z metodo Tc99m-DPTA serumskega očistka)
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: Okrajšave: ALT = alaninska aminotransferaza; AST = aspartatna aminotransferaza; CTCAE = običajni terminološki kriteriji za neželene učinke; NCI = nacionalni inštitut za rakava obolenja; SGOT = serumska glutamat oksalocetna aminotransferaza; SGPT = serumska glutamat piruvična aminotransferaza.
English: The use of ALIMTA should be avoided during pregnancy.
Slovenian: Uporabi zdravila ALIMTA med nosečnostjo se izogibamo.
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for ALIMTA 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 ALIMTA, če jo uporabljamo kot edino učinkovino ali v kombinaciji s cisplatinom.
English: Kaplan Meier plots of overall survival by histology
Slovenian: Kaplan Meier-jeva grafa skupnega preživetja glede na histologijo
English: Anaphylactic shock (severe allergic reaction)
Slovenian: Hepatitis (vnetje jeter) Anafilaktični šok (huda alergijska reakcija)
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to ALIMTA 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 zdravilo ALIMTA in indukcijsko zdravilo cisplatina.
English: Diarrhoea without colostomy
Slovenian: Diareja brez kolostomije
English: Overall Survival
Slovenian: Skupno preživetje
English: 50 % of previous dose
Slovenian: 50 % predhodnega odmerka
English: If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist.
Slovenian: Če bi radi med zdravljenjem ali v 6 mesecih po zdravljenju spočeli otroka, se pogovorite z zdravnikom ali farmacevtom.
English: Frequency* Event**
Slovenian: Pogostnost* Dogodek**
English: OTHER SPECIAL WARNING(S), IF NECESSARY cytotoxic
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično
English: Efficacy of ALIMTA vs docetaxel in NSCLC - ITT population ALIMTA
Slovenian: Učinkovitost zdravila ALIMTA v primerjavi z docetakselom pri NSCLC - Populacija NZ ALIMTA
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za enkratno uporabo.
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: Men are advised not to father a child during and up to 6 months following treatment with ALIMTA and should therefore use effective contraception during treatment with ALIMTA and for up to 6 months afterwards.
Slovenian: Moškim odsvetujemo, da bi v času zdravljenja z zdravilom ALIMTA ter do 6 mesecev po zdravljenju s tem zdravilom spočeli otroka, zato naj v času zdravljenja z zdravilom ALIMTA ter do 6 mesecev po zdravljenju s tem zdravilom uporabljajo učinkovito kontracepcijo.
English: Loss of appetite
Slovenian: Slabost Izguba apetita
English: Upset stomach
Slovenian: Bolečina v trebuhu
English: Unopened vial This medicinal product does not require any special storage conditions.
Slovenian: Neodprta viala Za shranjevanje zdravila niso potrebna posebna navodila.
English: Common (may affect up to 1 in 10 people) Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Alergijske reakcije: kožni izpuščaji/pekoč ali zbadajoč občutek Okužba vključno s sepso
English: Thus, drainage of third space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Slovenian: Zato je pred zdravljenjem s pemetreskedom vredno premisliti o drenaži tekočine tretjega prostora, čeprav to morda ni potrebno.
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 ALIMTA 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 ALIMTA.
English: Dose for cisplatin (mg/m2)
Slovenian: Odmerek cisplatina (mg/m2)
English: What ALIMTA is and what it is used for What you need to know before you use ALIMTA How to use ALIMTA
Slovenian: Kaj je zdravilo ALIMTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ALIMTA Kako uporabljati zdravilo ALIMTA
English: 1 vial
Slovenian: 1 viala.
English: Pain, redness, swelling or sores in your mouth Nausea
Slovenian: Bolečina, rdečina, otekanje ali rane v vaših ustih
English: Preparation and administration precautions: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Slovenian: Previdnostni ukrepi pri pripravi in dajanju: Kot pri drugih potencialno toksičnih učinkovinah za zdravljenje raka je potrebna previdnost pri ravnanju z raztopinami pemetrekseda za infundiranje ter pripravi teh raztopin.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of ALIMTA has finished.
Slovenian: Cisplatin tudi dajemo v obliki infuzije v veno, približno 30 minut po zaključku infuzije zdravila ALIMTA.
English: Discard unused contents appropriately.
Slovenian: Neporabljeno vsebino ustrezno zavrzite.
English: NSCLC, maintenance treatment
Slovenian: NSCLC, vzdrževalno zdravljenje
English: Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.
Slovenian: Zaradi možnosti, da zdravljenje s pemetreksedom povzroči trajno neplodnost, naj se moški pred začetkom zdravljenja posvetujejo o shranjevanju sperme.
English: ALIMTA must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Slovenian: Zdravilo ALIMTA smemo dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije za zdravljenje raka.
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 poglavje 4.3 in 4.5).
English: ALIMTA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Slovenian: ALIMTA 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: The separation between the treatment arms was achieved by improvement in lung function in the ALIMTA/cisplatin arm and deterioration of lung function over time in the control arm.
Slovenian: Razlikovanje med vejama zdravljenja je bilo doseženo z izboljšanjem delovanja pljuč v veji zdravljenja z zdravilom ALIMTA/cisplatinom in poslabšanjem pljučnega delovanja s časom v kontrolni veji preskušanja.
English: Alimta 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 Alimta, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
English: Adenocarcinoma (N=847)
Slovenian: Adenokarcinom (N = 847)
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: Abbreviation: CI = confidence interval * p-value refers to comparison between arms.
Slovenian: Okrajšava: IZ = interval zaupanja *p-vrednost se nanaša na primerjavo med vejama zdravljenja.
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 ALIMTA.
Slovenian: Če ste imeli ali če boste imeli zdravljenje z obsevanjem, prosimo, povejte to zdravniku, saj ob jemanju zdravila ALIMTA lahko pride do zgodnje ali pozne reakcije na obsevanje.
English: Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/min is not recommended (see section 4.2).
Slovenian: Zato uporabe pemetrekseda pri bolnikih z očistkom kreatinina < 45 ml/min ne priporočamo (glejte poglavje 4.2).
English: Patients received a median of 5 cycles of maintenance treatment with ALIMTA and 3.5 cycles of placebo.
Slovenian: Bolniki so dobili povprečno 5 ciklov vzdrževalnega zdravljenja z zdravilom ALIMTA in 3,5 cikle placeba.
English: How to use ALIMTA
Slovenian: Kako uporabljati zdravilo ALIMTA
English: ALIMTA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Slovenian: ALIMTA se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
English: Non-inferiority p-value (HR) Progression free survival (months) Median
Slovenian: Prednostna p-vrednost (RT) Preživetje brez napredovanja (meseci) Mediana
English: An insufficient number of patients has been studied with creatinine clearance of below 45 ml/min.
Slovenian: Zadostnega števila bolnikov z očistkom kreatinina pod 45 ml/min niso preučili.
English: Manufacturer Lilly France S.A.S.
Slovenian: Izdelovalec Lilly France S.A.S.
English: Pemetrexed total systemic clearance is 91.8 ml/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/min).
Slovenian: 91,8 ml/min, razpolovni čas izločanja iz plazme je 3,5 ur pri bolnikih z normalnim ledvičnim delovanjem (očistek kreatinina 90 ml/min).
English: Dose of ALIMTA (mg/m2)
Slovenian: Odmerek ALIMTE (mg/m2)
English: Corticosteriods: 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 ALIMTA treatment.
Slovenian: Kortikosteroidi: zdravnik vam bo predpisal tablete steroidov (ustrezno 4 miligramom deksametazona dvakrat dnevno), ki jih boste morali jemati dan pred zdravljenjem z zdravilom ALIMTA, na dan zdravljenja in na dan po zdravljenju z zdravilom ALIMTA.
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Slovenian: Okrajšave: IZ = interval zaupanja; RT = razmerje tveganja; NZ = namen zdraviti; n = velikost populacije.
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).