natgillin/translations-raw huggingface dataset:
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.
Poremećaji bubrega često poremećaji bubrega**** Kratice: ALT = alanin aminotransferaza; AST = aspartat aminotransferaza; CTCAE = Zajednička terminologija za nuspojave; NCI = Nacionalni institut za rak; SGOT = serumska glutamat-oksaloctena aminotransferaza; SGPT = serumska glutamat piruvična aminotransferaza.
Reconstituted and infusion solution: The product should be used immediately.
Pripremljena otopina i otopina za infuziju: Lijek se mora odmah upotrijebiti.
How to store Pemetrexed Lilly Contents of the pack and other information
Kako čuvati Pemetrexed Lilly Sadržaj pakiranja i druge informacije
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).
Ukupni sistemski klirens pemetrekseda iznosi 91,8 ml/min, a poluvrijeme eliminacije iz plazme iznosi 3,5 sati u bolesnika s normalnom bubrežnom funkcijom (klirens kreatinina 90 ml/min).
When using Pemetrexed Lilly in combination with cisplatin:
Kad se Pemetrexed Lilly primjenjuje u kombinaciji s cisplatinom:
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).
Zabilježeno je značajno povećanje incidencije neutropenije stupnja 3/4, koja je mogla biti povezana s lijekom, pri duljoj izloženosti pemetreksedu (≤ 6 ciklusa: 3,3%, > 6 ciklusa: 6,4%; p = 0,046).
Frequency estimate: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from available data).
rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
It is a white to either light yellow or green-yellow lyophilised powder.
To je bijeli do svijetložuti ili zeleno-žuti liofilizirani prašak.
A total of 169 patients (47.1 %) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Ukupno je 169 (47,1%) bolesnika završilo ≥ 6 ciklusa terapije održavanja pemetreksedom, što znači da su primili najmanje 10 ciklusa pemetrekseda.
What Pemetrexed Lilly is and what it is used for
Što je Pemetrexed Lilly i za što se koristi
In a study conducted in beagle dog by intravenous bolus injection for 9 months, testicular findings (degeneration/necrosis of the seminiferous epithelium) have been observed.
U ispitivanju provedenom u pasa pasmine beagle, kojima su davane intravenske bolusne injekcije tijekom devet mjeseci, opažene su promjene na testisima (degeneracija/nekroza sjemenovodnog epitela).
This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.
Lijek je isključivo za jednokratnu primjenu; neiskorištenu otopinu valja zbrinuti sukladno lokalnim propisima.
You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Lilly.
Morate nastaviti uzimati folatnu kiselinu još najmanje 21 dan nakon posljednje doze lijeka Pemetrexed Lilly.
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Lilly.
Ako Vam se oko pluća nakupila tekućina, liječnik može odlučiti ukloniti tu tekućinu prije primjene lijeka Pemetrexed Lilly.
Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 mL/min is not recommended (see section 4.2).
Stoga se primjena pemetrekseda u bolesnika s klirensom kreatinina < 45 ml/min ne preporučuje (vidjeti dio 4.2).
For instructions on reconstitution and dilution of Pemetrexed Lilly before administration, see section 6.6.
Za upute o rekonstituciji i razrjeđivanju lijeka Pemetrexed Lilly prije primjene, vidjeti dio 6.6.
Dose of Pemetrexed Lilly (mg/m2)
Doza lijeka Pemetrexed Lilly (mg/m2)
75 % of previous dose (both Pemetrexed Lilly and cisplatin)
75% prethodne doze (i lijeka Pemetrexed Lilly i cisplatina)
Adjusted hazard ratio (HR) (95 % CI)
Prilagođeni omjer hazarda (HR) (95% CI)
Treatment with Pemetrexed Lilly 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.
Liječenje lijekom Pemetrexed Lilly mora se obustaviti ako se u bolesnika pojavi bilo kakva hematološka ili nehematološka toksičnost stupnja 3 ili 4 nakon dvaju sniženja doze, odnosno odmah ako se ustanovi neurotoksičnost stupnja 3 ili 4.
Pemetrexed Lilly should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Pemetrexed Lilly se mora primjenjivati u obliku intravenske infuzije u trajanju od 10 minuta prvog dana svakog 21-dnevnog ciklusa.
Therefore, caution should be made when administering higher doses of NSAIDs or acetylsalicylic acid, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 mL/min).
Stoga je nužan oprez pri istodobnoj primjeni pemetrekseda i viših doza NSAIL-a ili acetilsalicilatne kiseline u bolesnika s normalnom bubrežnom funkcijom (klirens kreatinina ≥ 80 ml/min).
What Pemetrexed Lilly looks like and contents of the pack Pemetrexed Lilly is a powder for concentrate for solution for infusion in a glass vial with rubber stopper.
Kako Pemetrexed Lilly izgleda i sadržaj pakiranja Pemetrexed Lilly je prašak za koncentrat za otopinu za infuziju u staklenoj bočici s gumenim čepom.
Pemetrexed + cisplatin Gemcitabine + cisplatin
Pemetreksed + cisplatin gemcitabin + cisplatin
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).
Nema dovoljno podataka o primjeni pemetrekseda u bolesnika s klirensom kreatinina manjim od 45 ml/min; stoga se u tih bolesnika ne preporučuje primjena pemetrekseda (vidjeti dio 4.4).
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 Pemetrexed Lilly.
Vitaminska nadoknada: liječnik će Vam propisati folatnu kiselinu (vitamin) koja se uzima kroz usta ili multivitaminski pripravak koji sadrži folatnu kiselinu (350 do 1000 mikrograma), koji morate uzimati jedanput na dan za vrijeme liječenja lijekom Pemetrexed Lilly.
For precautions to be taken before handling or administering Pemetrexed Lilly, see section 6.6.
Za mjere opreza koje treba poduzeti prije rukovanja lijekom ili primjene lijeka Pemetrexed Lilly, vidjeti dio 6.6.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Lilly.
Ako ste nedavno cijepljeni, obavijestite o tome svog liječnika jer to može izazvati štetne učinke uz primjenu lijeka Pemetrexed Lilly.
Other medicines and Pemetrexed Lilly
Drugi lijekovi i Pemetrexed Lilly
After reconstitution (see section 6.6), each vial contains 25 mg/mL of pemetrexed.
Nakon rekonstitucije (vidjeti dio 6.6), jedna bočica sadrži 25 mg/ml pemetrekseda.
DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
An insufficient number of patients has been studied with creatinine clearance of below 45 mL/min.
Nije ispitan dovoljan broj bolesnika s klirensom kreatinina manjim od 45 ml/min.
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 pre-treatment with folic acid and vitamin B12 was administered.
Manja toksičnost te smanjenje hematološke i nehematološke toksičnosti stupnja 3/4, poput neutropenije, febrilne neutropenije i infekcija praćenih neutropenijom stupnja 3/4 prijavljeni su kada je primijenjeno prethodno liječenje folatnom kiselinom i vitaminom B12.
- Pemetrexed Lilly 100 mg: 1 vial of 10ml - Pemetrexed Lilly 500 mg: 1 vial of 50ml
- Pemetrexid Lilly 100 mg: 1 bočica od 10 ml - Pemetrexid Lilly 500 mg: 1 bočica od 50 ml
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 Pemetrexed Lilly.
Vam se uzorak krvi kako bi se provjerilo jesu li Vam bubrežna ili jetrena funkcija dovoljno dobre i imate li dovoljno krvnih stanica da biste primili Pemetrexed Lilly.
When prepared as directed, reconstituted and infusion solutions of Pemetrexed Lilly contain no antimicrobial preservatives.
Kada se pripremaju prema uputama, rekonstituirana otopina i otopina za infuziju lijeka Pemetrexed Lilly ne sadrže antimikrobne konzervanse.
When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C to 8 °C).
Kada se pripreme prema uputama, pripremljena otopina pemetrekseda i otopina pemetrekseda za infuziju su fizički i kemijski stabilne 24 sata ako se čuvaju u hladnjaku (2°C - 8°C).
Adenocarcinoma (N = 847)
Adenokarcinom (N = 847)
Calculate the dose and the number of Pemetrexed Lilly vials needed.
Izračunajte dozu i potreban broj bočica lijeka Pemetrexed Lilly.
In patients with normal renal function (creatinine clearance > 80 mL/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
U bolesnika s normalnom funkcijom bubrega (klirens kreatinina ≥ 80 ml/min) visoke doze nesteroidnih protuupalnih lijekova (NSAIL, npr. ibuprofen > 1600 mg na dan) i više doze acetilsalicilatne kiseline (≥ 1,3 g na dan) mogu smanjiti eliminaciju pemetrekseda i, posljedično povećati pojavu nuspojava izazvanih pemetreksedom.
Pemetrexed*** (N = 800)
Pemetreksed*** (N = 800)
- If you have further questions, please ask your doctor or pharmacist.
- Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
Pemetrexed Lilly (pemetrexed) is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Pemetrexed Lilly (pemetreksed) je protutumorski lijek s višestrukim antifolatnim djelovanjem koji djeluje tako da prekida ključne metaboličke procese ovisne o folatima neophodne za umnažanje stanica.
Women must use effective contraception during treatment with Pemetrexed Lilly.
Žene moraju primjenjivati djelotvornu kontracepciju tijekom liječenja lijekom Pemetrexed Lilly.
Immune-mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Imunološki posredovana hemolitička anemija (razaranje crvenih krvnih stanica posredstvom protutijela)
Not known: frequency cannot be estimated from the available data Lower limb swelling with pain and redness Increased urine output
Nepoznate učestalosti: učestalost se ne može procijeniti iz dostupnih podataka Oticanje donjih udova praćeno boli i crvenilom
Driving and using machines Pemetrexed Lilly may make you feel tired.
Upravljanje vozilima i strojevima Pemetrexed Lilly može izazvati umor.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
The dose of Pemetrexed Lilly is 500 milligrams for every square metre of your body's surface area.
Kako se primjenjuje Pemetrexed Lilly Doza lijeka Pemetrexed Lilly je 500 miligrama po svakom kvadratnom metru Vaše površine tijela.
If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity),Pemetrexed Lilly should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Razvije li se u bolesnika nehematološka toksičnost stupnja ≥ 3 (osim neurotoksičnosti), primjena lijeka Pemetrexed Lilly mora se prekinuti dok se vrijednosti ne vrate na razinu prije liječenja ili nižu.
Extravasation should be managed by local standard practice as with other non-vesicants.
Ekstravazaciju treba zbrinuti sukladno standardnoj lokalnoj praksi kao za lijekove koji nisuvezikanti.
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 Pemetrexed Lilly.
Ako ste primali ili ćete primati terapiju zračenjem, obavijestite o tome svog liječnika jer se uz primjenu lijeka Pemetrexed Lilly mogu pojaviti rane ili kasne reakcije na zračenje.
It is unknown whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Nije poznato izlučuje li se pemetreksed u majčino mlijeko pa se mogu isključiti nuspojave na dojenče.
Pemetrexed Lilly is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Pemetrexed Lilly se također primjenjuje u kombinaciji s cisplatinom za početno liječenje bolesnika s uznapredovalim stadijem raka pluća.
Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Djelotvornost pemetrekseda u odnosu na docetaksel kod NSCLC - ITT populacija
Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Kratice: CI = interval pouzdanosti; HR = omjer rizika; ITT = populacija svih uključenih bolesnika; N = ukupan broj bolesnika.
A number of cases describing cellulitis, pseudocellulitis, dermatitis and dermo-hypodermitis have been reported with an unknown frequency.
Prijavljeno je više slučajeva celulitisa, pseudocelulitisa, dermatitisa te upale dermisa i hipodermisa, čija je učestalost bila nepoznata.
50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
50% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998)
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9 %) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Odgovarajući volumen rekonstituirane otopine pemetrekseda mora se dodatno razrijediti otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, do ukupnog volumena od 100 ml i primijeniti kao intravenska infuzija tijekom 10 minuta.
Fever or infection (common): if you have a temperature of 38 ºC or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common).
Morate se odmah javiti svom liječniku ako primijetite bilo što od sljedećeg: vrućicu ili infekciju (često): ako Vam je tjelesna temperatura 38°C ili viša, ako se znojite ili imate neke druge znakove infekcije (jer broj bijelih krvnih stanica može biti niži od normalnog,
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, odnosno zanemarive količine natrija.
Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94-1.15), and overall response rate was 30.6 % (95 % CI = 27.3-33.9) for pemetrexed plus cisplatin versus 28.2 % (95 % CI = 25.0-31.4) for gemcitabine plus cisplatin.
Preživljenje bez progresije bolesti (PFS) i stopa ukupnog odgovora bili su podjednaki između terapijskih skupina: medijan PFS-a iznosio je 4,8 mjeseci za pemetreksed i cisplatin u usporedbi s 5,1 mjeseci za gemcitabin i cisplatin (prilagođen omjer hazarda 1,04; 95% CI = 0,94 - 1,15), a stopa ukupnog odgovora bila je 30,6% (95% CI = 27,3 - 33,9) za pemetreksed i cisplatin u usporedbi s 28,2% (95% CI = 25,0 - 31,4) za gemcitabin i cisplatin.
** In the pemetrexed/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
** Skupina liječena kombinacijom pemetreksed/cisplatin, randomizirani i liječeni bolesnici (N = 225)
LIST OF EXCIPIENTS Mannitol, hydrochloric acid,sodium hydroxide
Manitol, kloridna kiselina, natrijev hidroksid.
Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4 % versus 28.9 %, p < 0.001), red blood cell transfusions (16.1 % versus 27.3 %, p < 0.001) and platelet transfusions (1.8 % versus 4.5 %, p = 0.002).
Bolesnici liječeni pemetreksedom i cisplatinom trebali su manje transfuzija (16,4% naspram 28,9%, p < 0,001), transfuzija eritrocita (16,1% naspram 27,3%, p < 0,001) i transfuzija trombocita (1,8% naspram 4,5%, p = 0,002).
Table 3 - Dose modification table for Pemetrexed Lilly (as single agent or in combination) and cisplatin - Neurotoxicity
Tablica 3 - Tablica za prilagodbu doze lijeka Pemetrexed Lilly (u monoterapiji ili u kombinaciji) i cisplatina - neurotoksičnost
Pemetrexed Lilly 100 mg contains less than 1 mmol (23 mg) sodium per vial, i.e. essentially ‘sodiumfree'.
Pemetrexed Lilly 100 mg sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
Patients also required lower administration of erythropoietin/darbopoietin (10.4 % versus 18.1 %, p < 0.001), G-CSF/GM-CSF (3.1 % versus 6.1 %, p = 0.004), and iron preparations (4.3 % versus 7.0 %, p = 0.021).
U tih je bolesnika također rjeđe trebalo primijeniti eritropoetin/darbepoetin (10,4% naspram 18,1%, p < 0,001), G-CSF/GM-CSF (3,1% naspram 6,1%, p = 0,004) i pripravke željeza (4,3% naspram 7,0%, p = 0,021).
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 Pemetrexed Lilly therapy.
Radijacijski pneumonitis (stvaranje ožiljaka na mjehurićima u plućima (alveolama) povezano s terapijom zračenjem) može se pojaviti u bolesnika koji su zračeni prije, tijekom ili nakon liječenja lijekom Pemetrexed Lilly.
A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Lilly powder with 9 mg/mL (0.9 %) sodium chloride solution for injection before it is given to you.
Prije primjene lijeka Pemetrexed Lilly bolnički ljekarnik, medicinska sestra ili liječnik će pomiješati Pemetrexed Lilly prašak s otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%).
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Lilly is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
U bolesnika koji se liječe zbog raka pluća nemalih stanica nakon prethodne kemoterapije preporučena doza lijeka Pemetrexed Lilly iznosi 500 mg/m2 tjelesne površine, a primjenjuje se u obliku intravenske infuzije tijekom 10 minuta, prvog dana svakog 21-dnevnog ciklusa.
Pemetrexed Lilly contains sodium
Pemetrexed Lilly sadrži natrij
Pemetrexed has a steady-state volume of distribution of 9 L/m2.
Volumen distribucije pemetrekseda u stanju dinamičke ravnoteže iznosi 9 l/m2.
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N = 663) and continuation pemetrexed maintenance (PARAMOUNT: N = 539) studies.
Tablica koja slijedi prikazuje učestalost i težinu nuspojava za koje se smatra da bi mogle biti povezane s ispitivanim lijekom, a koje su zabilježene u > 5% od 800 bolesnika randomiziranih da primaju samo pemetreksed i 402 bolesnika randomizirana da primaju placebo u ispitivanju monoterapije pemetreksedom kao terapije održavanja (JMEN: N = 663) i ispitivanja kontinuirane terapije održavanja pemetreksedom (PARAMOUNT: N =539).
Pemetrexed Lilly is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Pemetrexed Lilly se također primjenjuje u bolesnika s uznapredovalim rakom pluća u kojih je bolest napredovala nakon primjene neke druge početne kemoterapije.
Pemetrexed Lilly 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.
Pemetrexed Lilly se primjenjuje u kombinaciji s cisplatinom, još jednim protutumorskim lijekom, za liječenje zloćudnog pleuralnog mezotelioma, oblika raka koji zahvaća plućne ovojnice, u bolesnika koji prethodno nisu primali kemoterapiju.
Table 1 - Dose modification table for Pemetrexed Lilly (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500 /mm3 and nadir platelets ≥ 50,000 /mm3
Tablica 1 - Tablica za prilagodbu doze lijeka Pemetrexed Lilly (u monoterapiji ili u kombinaciji) i cisplatina - hematološka toksičnost Najniži ABN < 500 /mm3 i najniži broj trombocita ≥ 50 000 /mm3
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).
Bolesnici s blagim do umjerenim zatajenjem bubrega (klirens kreatinina od 45 do 79 ml/min) moraju izbjegavati uzimanje nesteroidnih protuupalnih lijekova (NSAIL-a) poput ibuprofena i acetilsalicilatne kiseline (> 1,3 g na dan) 2 dana prije, na sam dan i 2 dana nakon primjene pemetrekseda (vidjeti dio 4.5).
Nadir platelets < 50,000 /mm3 regardless of nadir ANC
Najniži broj trombocita < 50 000 /mm3 bez obzira na najniži ABN
After reconstitution, the solution contains 25 mg/mL of pemetrexed.
Nakon pripreme, otopina sadrži 25 mg/ml pemetrekseda.
Erythematous oedema mainly of the lower limbs has been reported with an unknown frequency.
Prijavljen je eritematozni edem, uglavnom donjih ekstremiteta, čija je učestalost nepoznata.
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Lilly and should therefore use effective contraception during treatment with Pemetrexed Lilly and for up to 6 months afterwards.
Muškarcima se savjetuje da ne začinju djecu tijekom liječenja i do 6 mjeseci nakon završetka liječenja lijekom Pemetrexed Lilly.
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received > 6 cycles of pemetrexed (N = 281).
Incidencija nuspojava ocijenjena je u bolesnika koji su primili ≤ 6 ciklusa pemetrekseda kao terapije održavanja (N = 519) te je uspoređena s bolesnicima koji su primili > 6 ciklusa pemetrekseda
There is no relevant use of Pemetrexed Lilly in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Pedijatrijska populacija Nije opravdana primjena lijeka Pemetrexed Lilly u pedijatrijskoj populaciji u indikaciji malignog pleuralnog mezotelioma i raka pluća nemalih stanica.