FrancophonIA/ELRC3.0 huggingface dataset:
English: CIAMBRA (pemetrexed) is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Slovenian: Zdravilo CIAMBRA (pemetreksed) je večtarčno protirakavo antifolatno zdravilo, ki deluje s porušenjem ključnih presnovnih procesov, odvisnih od folata, ki so nujni za podvajanje celic.
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm and platelets should be ≥ 100,000 cells/mm
Slovenian: Pred začetkom kateregakoli ciklusa kemoterapije morajo bolniki izpolnjevati naslednja merila: absolutno število nevtrofilcev (ANC) mora biti ≥ 1500 celic/mm3 ter število trombocitov ≥ 100.000 celic/mm3.
English: In the event of neurotoxicity, the recommended dose adjustment for CIAMBRA and cisplatin is documented in Table 3.
Slovenian: Priporočene prilagoditve odmerkov zdravila CIAMBRA in cisplatina v primeru nevrološke toksičnosti so navedene v Preglednici 3.
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Slovenian: Izmed 939 bolnikov, ki so bili zdravljeni s pemetreksedom in indukcijskim zdravilom cisplatina, je bilo naključno izbranih 539 bolnikov za vzdrževalno zdravljenje s pemetreksedom ali s placebom.
English: 95 % CI for HR Non-inferiority p-value (HR)
Slovenian: 95% IZ za RT Prednostna p-vrednost (RT)
English: Dose for cisplatin (mg/m
Slovenian: Odmerek cisplatina (mg/m2)
English: Nadir platelets <50,000 /mm regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000 /mm3 ne glede na najnižji ANC
English: HR (95 % CI)
Slovenian: RT (95% IZ)
English: CIAMBRA contains sodium
Slovenian: Zdravilo CIAMBRA vsebuje natrij
English: Pain, redness, swelling or sores in your mouth Nausea
Slovenian: Bolečina, rdečina, otekanje ali rane v vaših ustih Občutek siljenja na bruhanje
English: Adjusted hazard ratio (HR) (95% CI)
Slovenian: Prilagojeno razmerje tveganja (RT) (95% IZ)
English: Rare cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Slovenian: Poročali so o redkih primerih kožne reakcije (“radiation recall”), ki so se v preteklosti zdravili z radioterapijo (glejte poglavje 4.4).
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Slovenian: Raztopine pemetrekseda za infundiranje, pripravljene kot je navedeno zgoraj, so skladne s seti za dajanje in infuzijskimi vrečkami iz polivinilklorida in prevlečenimi s poliolefinom.
English: Chemical and physical in-use stability of the infusion solution of pemetrexed was demonstrated for 24 hours at 2°C-8°C or at 15°C-25°C.
Slovenian: Kemijska in fizikalna obstojnost za uporabo raztopine pemetrekseda za infundiranje je bila dokazana za 24 ur pri temperaturah 2°C - 8°C ali 15°C - 25°C.
English: 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).
Slovenian: Bolniki zdravljeni s pemetreksedom in cisplatinom so potrebovali manj transfuzij (16,4% proti 28,9%, p < 0,001), transfuzij rdečih krvničk (16,1% proti 27,3%, p < 0,001) in transfuzij krvnih ploščic (1,8% proti 4,5%, p = 0,002).
English: Common Vomiting Mucositis/ stomatitis
Slovenian: Bruhanje Mukozitis / stomatitis
English: CIAMBRA 100 mg contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo CIAMBRA 100 mg vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni »brez natrija« .
English: Method of administration For precautions to be taken before handling or administering CIAMBRA, see section 6.6.
Slovenian: Način uporabe Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila CIAMBRA glejte poglavje 6.6.
English: CIAMBRA in combination with cisplatin
Slovenian: Zdravilo CIAMBRA v kombinaciji s cisplatinom
English: 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 aspirin at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina > 80 ml/min) lahko visoki odmerki nesteroidnih protivnetnih zdravil (NSAID, denimo ibuprofen > 1600 mg dnevno) in acetilsalicilno kislino v visokih odmerkih (> 1,3 g dnevno) zmanjšajo izločanje pemetrekseda in tako lahko povečajo pojavnost neželenih učinkov pemetrekseda.
English: Uncommon side effects (may affect up to 1 in 100 people) Acute renal failure
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** Which is derived from the term “renal/genitourinary other”.
Slovenian: *Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti, razen izraza “znižan očistek kreatinina”.
English: 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).
Slovenian: Bolniki so potrebovali tudi nižje odmerjanje eritropoetin/darbopoetina (10,4% proti 18,1%, p < 0,001), G-CSF/GM-CSF (3,1% proti 6,1%, p = 0,004) in pripravkov z železom (4,3% proti 7,0%, p = 0,021).
English: Excipients: Mannitol (E 421), hydrochloric acid , sodium hydroxide (see package leaflet for further information).
Slovenian: Pomožne snovi: manitol (E 421), klorovodikova kislina , natrijev hidroksid (za nadaljnje informacije glejte navodilo za uporabo).
English: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Slovenian: Neželeni učinki, o katerih so pri uporabi pemetrekseda, tako v primeru monoterapije kot v kombinaciji z drugimi zdravili, najpogosteje poročali, so bili povezani z zavrtjem delovanja kostnega mozga, kar se je izrazilo kot anemija, nevtropenija, levkopenija, trombocitopenija; in z gastrointestinalno toksičnostjo, kar se je izrazilo kot anoreksija, slabost, bruhanje, diareja, zaprtje, faringitis, mukozitis in stomatitis.
English: Rash/ desquamation Common Pruritus Alopecia
Slovenian: Izpuščaj / luščenje Pogosto Pruritus Alopecija
English: You must continue taking the folic acid for 21 days after the last dose of CIAMBRA.
Slovenian: Po zadnjem odmerku zdravila CIAMBRA morate še 21 dni jemati folno kislino.
English: The pH of the reconstituted solution is between 6.6 and 7.8 The Osmolality of the reconstituted solution is 230-270 mOsmol/kg
Slovenian: Osmolalnost rekonstituirane raztopine je 230-270 mOsmol/kg.
English: Time to treatment failure (TTTF - months) Median
Slovenian: Čas do neuspeha napredovanja (TTTFmeseci)
English: Table 2 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov zdravila CIAMBRA (kot samostojno zdravilo ali v kombinaciji) in cisplatina - Nehematološke toksičnosti a, b
English: Table 3 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin - Neurotoxicity
Slovenian: Preglednica 3 - Preglednica za prilagajanje odmerkov zdravila CIAMBRA (kot samostojno zdravilo ali v kombinaciji) in cisplatina - Nevrotoksičnost
English: Gemcitabine/ cisplatin (N = 830)
Slovenian: Gemcitabin/ cisplatin (N = 830)
English: Each pack of CIAMBRA consists of one glass vial with rubber stopper and an aluminium seal with flip off cap, and it is covered with a shrink-wrapped plastic sleeve.
Slovenian: Eno pakiranje zdravila CIAMBRA vsebuje eno vialo iz stekla s klorobutilno gumijasto zaporko, viala je zatesnjena z aluminijasto snemno zaporko ter ovita s plastičnim filmom.
English: Breast-feeding must be discontinued during CIAMBRA treatment.
Slovenian: Dojenje morate med zdravljenjem z zdravilom CIAMBRA prekiniti.
English: CIAMBRA is a powder for concentrate for solution for infusion in a vial.
Slovenian: Zdravilo CIAMBRA je prašek za koncentrat za raztopino za infundiranje v viali.
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Slovenian: PARAMOUNT: Kaplan Meier graf preživetja brez napredovanja (PFS) in skupnega preživetja (OS) za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z NSCLC, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: 50% of previous dose (both CIAMBRA and cisplatin)
Slovenian: 75 % predhodnega odmerka (obeh, zdravila CIAMBRA in cisplatina)
English: 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.
Slovenian: Preživetje brez napredovanja (PBN) in celokupno razmerje odziva sta bila podobna med vejama zdravljenja: mediana PBN je bila 4,8 mesecev za pemetreksed skupaj s cisplatinom proti 5,1 mesecev za gemcitabin skupaj s cisplatinom (prilagojeno razmerje tveganja 1,04; 95% IZ 0,94-1,15) in celokupno razmerje odziva je bilo 30,6% (95% IZ 27,3-33,9) za pemetreksed skupaj s cisplatinom proti 28,2% (95% IZ 25,0-31,4) za gemcitabin skupaj s cisplatinom.
English: How to use CIAMBRA
Slovenian: Kako jemati zdravilo CIAMBRA
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Slovenian: Za namen te preglednice smo uporabili »cut off« 5% za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom in cisplatinom.
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 cells/mm and platelet count returns to ≥ 100,000 cells/mm3.
Slovenian: Pri bolnikih je med zdravljenjem potrebno biti pozoren na morebiten pojav mielosupresije, pemetrekseda pa bolnikom ne smemo dajati, dokler se absolutno število nevtrofilcev (ANC) ne povrne na ≥ 1500 celic/mm3 ter število trombocitov na ≥ 100.000 celic/mm3.
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Slovenian: Za namen te preglednice smo uporabili »cut off« 5% za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom.
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Slovenian: Multicentrična, randomizirana, odprta študija faze 3, kjer so preskušali pemetreksed 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 s pemetreksedom (ITT n = 283), in 7,9 mesecev pri bolnikih, zdravljenih z docetakselom (ITT n = 288).
English: There is no relevant use of CIAMBRA in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Slovenian: Pri pediatrični populaciji se zdravila CIAMBRA ne uporablja za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
English: Chemical and physical in-use stability of the infusion solution of pemetrexed was demonstrated for 24 hours at 2°C-8°C or 15-25°C.
Slovenian: Rekonstituirane raztopine in raztopine za infundiranje Kemijska in fizikalna obstojnost za uporabo raztopine pemetrekseda za infundiranje je bila dokazana za 24 ur pri temperaturah 2°C - 8°C ali 15°C - 25°C.
English: NSCLC, first-line treatment:
Slovenian: NSCLC, zdravljenje prvega izbora:
English: Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased
Slovenian: Znižan hemoglobin Znižani nevtrofilci / granulociti Znižani levkociti
English: Efficacy of pemetrexed plus cisplatin vs.cisplatin in malignant pleural mesothelioma Randomized and treated patients
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu Randomizirani in zdravljeni bolniki
English: DE Berlin-Chemie AG Tel: +49 (0) 30 67070
Slovenian: Tel: +420 267 199 333 DE Berlin-Chemie AG Tel: +49 (0) 30 67070
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI = 0.84-1.05).
Slovenian: Multicentrična, randomizirana, odprta študija faze 3 pemetrekseda 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 (NSCLC), je pokazala, da je pemetreksed skupaj s cisplatinom (ITT populacija n = 862) dosegla prvotno končno točko in pokazala podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (ITT n = 863) v skupnem preživetju (prilagojeno razmerje tveganja 0,94; 95% IZ = 0,84-1,05).
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 z daljšimi razpolovnimi časi, denimo piroksikama ali rofekoksiba, moramo sočasno dajanje NSAID s pemetreksedom pri bolnikih z blago do zmerno ledvično insuficienco prekiniti vsaj za 5 dni pred dajanjem pemetrekseda, na dan dajanja in še vsaj za 2 dni po dajanju pemetrekseda (glejte poglavje 4.4).
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: Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, o katerih so poročali pri >5% od 265 bolnikov, ki so jih naključno razporedili, da so prejemali le pemetreksed z dopolniloma folno kislino in vitaminom B12, ter pri 276 bolnikih, ki so jih naključno dodelili v skupino, ki je prejemala le docetaksel.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95% CI = 0 .61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56;
Slovenian: Analiza vpliva histologije NSCLC glede učinka zdravljenja na skupno preživetje je bila prednostna za pemetreksed proti docetakselu pri tistih, ki nimajo pretežno luskaste histologije (n = 399, 9,3 proti 8,0 mesecev, prilagojen RT = 0,78; 95% IZ = 0,61-1,00, p = 0,047) in je bila prednostna za docetaksel za luskasto celično histologijo karcinoma (n = 172, 6,2 proti 7,4 mesecev, prilagojen RT = 1,56; 95% IZ = 1,08-2,26, p = 0,018).
English: 100 % of previous dose
Slovenian: 100% predhodnega odmerka 100% predhodnega odmerka 100% predhodnega odmerka
English: CIAMBRA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section
Slovenian: Zdravilo CIAMBRA je indicirano kot monoterapija za zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega karcinoma, ki nima pretežno ploščatocelične histologije pri bolnikih, pri katerih bolezen ni napredovala neposredno po kemoterapiji na osnovi platine (glejte poglavje 5.1).
English: Women must use effective contraception during treatment with CIAMBRA.
Slovenian: Med zdravljenjem z zdravilom CIAMBRA morajo ženske uporabljati učinkovito metodo kontracepcije.
English: The recommended dose of CIAMBRA is 500 mg/m of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Priporočeni odmerek zdravila CIAMBRA je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: Rare side effects (may affect up to 1 in 1,000 people) Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) Radiacijski izpuščaj (kožni izpuščaj kot pri hudi sončni opeklini), ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena obsevanju, in sicer od nekaj dni do več let po obsevanju.. Bulozna stanja (bolezni s kožnimi mehurji), vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo
English: Squamous cell (N=473)
Slovenian: Luskaste celice (N=473)
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri < 1% bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo supraventrikularne aritmije.
English: Gemcitabine + cisplatin
Slovenian: Gemcitabin + cisplatin
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare
Slovenian: Imetnik dovoljenja za promet z zdravilom MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare
English: Frequency* Event**
Slovenian: Organski sistem Pogostnost Dogodek**
English: Frequency Event*
Slovenian: Organski sistem Pogostnost Dogodek*
English: 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.
Slovenian: Spodnja preglednica navaja pogostnost in resnost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5% od 800 bolnikov, ki so naključno prejemali pemetreksed kot edino zdravilo, in 402 bolnikov, ki so naključno prejemali placebo v študijah vzdrževalnega zdravljenja samo s pemetreksedom (JMEN: N=663) ter nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N=539).
English: NSCLC, second-line treatment:
Slovenian: NSCLC, zdravljenje drugega izbora:
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Slovenian: JMEN: Kaplan Meier graf preživetja brez napredovanja in skupnega preživetja za pemetreksed v primerjavi s placebom pri bolnikih z NSCL, ki nima pretežno ploščatocelične histologije:
English: In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy NSAIDs with long elimination half-lives should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Slovenian: Bolniki z blago do zmerno ledvično insuficienco, ki se lahko zdravijo s pemetreksedom, naj jemanje NSAID z dolgimi razpolovnimi časi izločanja prekinejo vsaj za 5 dni pred dajanjem pemetrekseda, na dan dajanja in še vsaj za 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: CIAMBRA should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Zdravilo CIAMBRA se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21-dnevnega ciklusa.
English: Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation treatment is frequent.
Slovenian: Medsebojna delovanja, ki so skupna vsem citostatikom Zaradi povečanega tveganja za trombozo pri bolnikih z rakom pogosto uporabljamo antikoagulacijsko zdravljenje.
English: What CIAMBRA contains
Slovenian: Kaj vsebuje zdravilo CIAMBRA
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 aspirin (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section
Slovenian: Bolniki z blago do zmerno ledvično insuficienco (očistek kreatinina od 45 do 79 ml/min) se morajo izogibati jemanju nesteroidnih protivnetnih zdravil (NSAID), kot je ibuprofen in acetilsalicilna kislina (> 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
Slovenian: Spodnja preglednica navaja pogostnost in resnost neželenih učinkov, o katerih so poročali pri > 5% 168 bolnikov z mezoteliomom, ki so jih naključno razporedili, da so prejemali cisplatin in pemetreksed, ter pri 163 bolnikov z mezoteliomom, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, cisplatin.