natgillin/translations-raw huggingface dataset:
- A description and timelines for the new study replacing APOLLO and designed to elucidate efficacy and safety in the elderly, including gastrointestinal cancer as a pre-specified endpoint.
RMP mora vključevati: - časovne roke za oddajo rezultatov študije APOLLO, - opis in časovni potek nove študije, ki bo nadomestila študijo APOLLO, in je zasnovana za oceno učinkovitosti in varnosti pri starejših, vključno z gastrointestinalnim rakom kot vnaprej določenim ciljem, - časovne poteke za oddajo dodatnih podatkov o pojavu kolorektalne hiperplazije v študiji ALTITUDE, - zavezo o oddaji končnega poročila študije o epidemiološki študiji ishemičnega kolitisa, - opis in časovni potek za novo opazovalno študijo glede incidence kolorektalne hiperplazije pri bolnikih, zdravljenih z alaskirenom.
Musculoskeletal and connective tissue disorders
Stenoza ledvične arterije
The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3,
Pri bolnikih s sladkorno boleznijo ali okvaro ledvic (GFR < 60 ml/min/1,73 m2) je sočasna uporaba aliskirena in zaviralcev angiotenzinskih receptorjev II ali zaviralcev ACE kontraindicirana, pri drugih bolnikih pa ni priporočena (glejte poglavja 4.3, 4.4 in 5.1).
Component of a multipack comprising 20 packs, each containing 14 tablets.
14 filmsko obloženih tablet del skupnega pakiranja z 20 škatlami po 14 tablet 49 filmsko obloženih tablet del skupnega pakiranja z 2 škatlama po 49 tablet
As for other medicinal products acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (eg.
Kot pri uporabi drugih zdravil, ki delujejo na sistem renin-angiotenzin, je potreba previdnost pri uporabi aliskirena pri bolnikih z drugimi boleznimi, zaradi katerih so bolj nagnjeni k slabšemu delovanju ledvic, kot so hipovolemija (na primer zaradi izgube krvi, hude ali dolgotrajne diareje, dolgotrajnega bruhanja in podobno), bolezni srca, jeter, sladkorna bolezen ali bolezen ledvic.
In hypertensive patients, once-daily administration of Riprazo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Znižanje krvnega tlaka je bilo odvisno od velikosti odmerka in se je ohranilo skozi celoten 24-urni interval odmerjanja (ohranjena koristnost učinka v zgodnjih jutranjih urah).
EU/2/08/088/004 Acticam 5 mg/ml solution for injection
EU/2/08/088/004 Acticam 5 mg/ml raztopina za injiciranje psi in mačke podkožno ali intravensko injekcijska viala (steklena)
N/A
Karenca
The use of gloves is recommended.
Priporoča se uporaba rokavic.
OTHER SPECIAL WARNING IF NECESSARY
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
You might have any of these symptoms and/or conditions.
Pojavi se lahko kateri koli od teh simptomov in/ali stanj.
Treatment may be delayed to allow sufficient time for recovery.
Zdravljenje se lahko odloži, da se omogoči zadosten čas za okrevanje.
This combination should be used with caution.
To kombinacijo se mora uporabljati previdno.
If necessary, creatinine clearance should be closely monitored.
Po potrebi se mora skrbno spremljati očistek kreatinina.
The pH of the reconstituted solution is between 6.6 and 7.8.
pH rekonstituirane raztopine je med 6,6 in 7,8.
* Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
*Definicija pogostnosti: zelo pogosti - ≥ 10 %; pogosti - > 5 % in < 10 %.
Event**
Dogodek*
There are many sorts of NSAIDs with different durations of activity.
Obstaja veliko vrst NSAIDs z različnimi trajanji delovanja.
Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Analize občutljivosti glavne končne točke učinkovitosti so ocenili tudi s protokolom kvalificirane (PK) populacije.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 July 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 22. 7. 2016
Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea.
Kakršna koli diareja, ki potrebuje hospitalizacijo (ne glede na stopnjo) ali diareja stopnje 3 ali 4
Treatment should be resumed according to the guidelines in Table 2.
Z zdravljenjem se nadaljuje skladno s smernicami v Preglednici 2.
In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
Do not use this medicine after the expiry date which is stated on the label and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
If you are pregnant, , think you may be pregnant or are planning to have a baby, tell your doctor.
Če ste noseči, menite, da bi lahko bili noseči ali nameravate zanositi, to povejte zdravniku.
Each pack consists of one vial.
Vsako pakiranje vsebuje eno vialo.
The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Učinek tekočine tretjega prostora, kot sta plevralni izliv ali ascites, na pemetreksed ni popolnoma opredeljen.
Further dilution is required.
Raztopino se mora še nadalje redčiti.
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).
Pogostnosti so določene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Odstotek bolnikov, ki so prejeli zdravljenje po študiji, je bil 64,3 % za pemetreksed in 71,7 % za placebo.
Fully supplemented patients
Bolniki s popolnim dopolnjevanjem
The recommended dose of cisplatin is 75 mg/m
Priporočeni odmerek cisplatina je 75 mg/m
If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Če niste prepričani, vprašajte zdravnika ali farmacevta, ali so katera od vaših zdravil NSAIDs.
The total bilirubin should be ≤ 1.5 times upper limit of normal.
Celotni bilirubin mora biti ≤ 1,5-kratnik zgornje meje normalnih vrednosti.
Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): risk of systemic, possibly fatal, disease.
Živa oslabljena cepiva (razen proti rumeni mrzlici, za katero je sočasna uporaba kontraindicirana): tveganje za sistemsko, potencialno smrtno bolezen.
Based on the planned date of your infusion of Pemetrexed Fresenius Kabi and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Na podlagi načrtovanega datuma vaše infuzije zdravila Pemetreksed Fresenius Kabi in/ali glede na delovanje vaših ledvic vam mora zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Mnogi bolniki, pri katerih so se le-ti pojavili, so imeli v osnovi dejavnike tveganja za razvoj ledvičnih dogodkov, vključno z dehidracijo ali že prej obstoječo hipertenzijo ali diabetesom.
Sienkiewicza 25, Kutno, 99-300, Poland
Sienkiewicza 25, Kutno, 99-300, Poljska ali
Reconstituted and infusion solutions: The product should be used immediately.
Rekonstituirane raztopine in raztopine za infundiranje: zdravilo je treba uporabiti takoj.
No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Ugotovili niso nobenih povezav med AST (SGOT), ALT (SGPT), ali celokupnim bilirubinom in farmakokinetiko pemetrekseda.
There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Podatkov o uporabi pemetrekseda pri nosečnicah ni, a za pemetreksed, kot tudi za druge antimetabolite, sumimo, da povzroča resne prirojene okvare, če se ga daje med nosečnostjo.
If concomitant administration of NSAIDs is necessary, patients should be monitored closely for toxicity, especially myelosuppression and gastrointestinal toxicity.
Če je sočasno dajanje NSAIDs potrebno, je pri bolnikih potrebno skrbno spremljati toksičnost, predvsem mieolosupresijo in gastrointestinalno toksičnost.
Polyglutamation is a time-and concentration-dependent process that occurs in tumour cells and, to a lesser extent, in normal tissues.
Poliglutamacija je proces, odvisen od časa in koncentracije, ki se dogaja v tumorskih celicah, in v manjšem obsegu v normalnih tkivih.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
Kasnejše injekcije vitamina B12 se lahko dajo isti dan kot pemetreksed.
Safety was assessed for patients who were randomised to receive pemetrexed (N=800).
Varnost je bila ocenjena pri bolnikih, ki so bili naključno izbrani za prejemanje pemetrekseda (N = 800).
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.
Bolniki morajo prejeti tudi intramuskularno injekcijo vitamina B12 (1000 mikrogramov) v tednu pred prvim odmerkom pemetrekseda in enkrat vsake tri cikle zatem.
75 % of previous dose 75 % of previous dose
75 % predhodnega odmerka 75 % predhodnega odmerka
At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
V času te končne analize preživetja je bilo živih ali ni bilo na voljo za nadaljnje spremljanje 28,7 % bolnikov v veji s pemetreksedom v primerjavi z 21,7 % v veji s placebom.
if you have recently received or are about to receive a vaccine against yellow fever.
• če ste bili nedavno cepljeni ali boste kmalu cepljeni proti rumeni mrzlici.
The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of PC versus GC.
Analiza učinkovitosti z uporabo PK populacije je skladna z analizo NZ populacije in podpira prednost PC proti GC.
Other medicines and Pemetrexed Fresenius Kabi Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Druga zdravila in zdravilo Pemetreksed Fresenius Kabi Obvestite zdravnika, če jemljete kakšna zdravila proti bolečinam ali vnetju (oteklinam), kot so zdravila, imenovana “nesteroidna protivnetna zdravila” (NSAIDs), vključno z zdravili, ki ste jih dobili brez recepta (kot je ibuprofen).
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 medicinal product metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
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.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če se zdravila, pripravljenega za uporabo, ne uporabi takoj, sta čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika, in naj bi ne presegala 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo redčenje opravljeno v kontroliranih in validiranih aseptičnih pogojih.
Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Statistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod 1,17645 mejo prednosti (p < 0,001).
To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see section 4.4).
Za zmanjšanje toksičnosti se mora bolnikom, ki jih zdravimo s pemetreksedom, dati tudi dopolnila vitaminov (glejte poglavje 4.4).
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 Fresenius Kabi.
Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje delovanja ledvic in jeter ter oceno, ali imate dovolj krvnih celic za prejemanje zdravila Pemetreksed Fresenius Kabi.
In clinical studies, patients with creatinine clearance of ≥ 45 ml/min required no dose adjustments other than those recommended for all patients.
V kliničnih študijah bolniki z očistkom kreatinina ≥ 45 ml/min niso potrebovali prilagajanja odmerkov, razen tistih prilagoditev, ki se priporočajo za vse bolnike.
Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, analogi folne kisline, oznaka ATC: L01BA04
Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for Pemetrexed Fresenius Kabi used as a single agent or in combination with cisplatin.
Po okrevanju bolnike ponovno zdravimo z uporabo smernic v Preglednicah 1, 2 in 3, ki veljajo za zdravilo Pemetreksed Fresenius Kabi, če ga uporabljamo kot edino učinkovino ali v kombinaciji s cisplatinom.
** In the pemetrexed /cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
** V veji zdravljenja s pemetreksedom/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
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/m infused over a 10-minute period.
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.
A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed
Skupno je 169 bolnikov (47,1 %) zaključilo ≥ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom, kar predstavlja vsaj 10 polnih ciklov pemetrekseda.
**** Combined term includes increased serum/blood creatinine, decreased glomerular filtration rate, renal failure and renal/genitourinary- other.
****Skupni izraz vključuje povišan kreatinin v serumu/krvi, znižano stopnjo glomerulne filtracije, ledvično odpoved in ledvice/sečila - drugo.
Pemetrexed N = 265
pemetreksed N = 265
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Nemčija
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).
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).
Common(may affect up to 1 in 10 people) Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Alergijske reakcije: kožni izpuščaj/pekoč ali zbadajoč občutek Okužba vključno s sepso
Patients received a median of 5 cycles of maintenance treatment with pemetrexed and 3.5 cycles of placebo.
Bolniki so dobili povprečno 5 ciklov vzdrževalnega zdravljenja s pemetreksedom in 3,5 cikla placeba.
No studies on the effects on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študije o vplivu na sposobnost vožnje in upravljanja strojev niso bile izvedene.
Pregnant women must avoid contact with cytostatic medicinal product.
Nosečnice se morajo izogibati stiku s citotoksičnimi zdravili.
Your doctor will discuss with you the potential risk of taking Pemetrexed Fresenius Kabi during pregnancy.
Z zdravnikom se pogovorite o možnem tveganju pri prejemanju zdravila Pemetreksed Fresenius Kabi v času nosečnosti.
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 oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
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.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Pemetrekseda se med nosečnostjo ne sme uporabljati, če to ni nujno potrebno, uporabiti pa se ga sme le po skrbni preučitvi potreb matere in tveganja za plod (glejte poglavje 4.4).
Pancytopenia-combined low counts of white cells, red cells and platelets
Pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov
All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
Vsi bolniki so prejemali študijsko terapijo kot začetno zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka in bolniki v obeh skupinah zdravljenja so prejemali popolno dopolnilo s folno kislino in vitaminom B12.
Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum non-haematologic toxicity from the preceding cycle of therapy.
Prilagajanja odmerkov na začetku naslednjega cikla naj temeljijo na najnižjih hematoloških vrednostih ali na največji nehematološki toksičnosti iz predhodnega cikla zdravljenja.
Intravenous use after reconstitution and dilution.
Intravenska uporaba po rekonstituciji in redčenju.
As a result, concomitant use of live attenuated vaccines is not recommended (see section 4.3 and 4.5).
Zato se odsvetuje uporabo živih oslabljenih cepiv (glejte poglavje 4.3 in 4.5).
Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter.
Spolno zrelim moškim se odsvetuje zaploditev otroka v času zdravljenja in še 6 mesecev zatem.
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).
Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N = 519) in jo primerjali z bolniki, ki so prejeli > 6 ciklov pemetrekseda (N = 281).
In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Študije in vitro so pokazale, da se pemetreksed vede kot večtarčni antifolat z zaviranjem timidilatne sintaze (TS - thymidylate synthase), dihidrofolatne reduktaze (DHFR - dihydrofolate reductase) in glicinamidne ribonukleotidne formiltransferaze (GARFT - glycinamide ribonucleotide formyltransferase), ki so ključni od folata odvisni encimi za de novo biosintezo timidinskih in purinskih nukleotidov.
Calculate the dose and the number of Pemetrexed Fresenius Kabi vials needed.
Izračunajte odmerek in število potrebnih vial zdravila Pemetreksed Fresenius Kabi.
Dose for cisplatin (mg/m
Odmerek cisplatina (mg/m
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Fresenius Kabi.
Če se vam okrog pljuč nabira tekočina, se bo zdravnik morda odločil tekočino pred dajanjem zdravila Pemetreksed Fresenius Kabi odstraniti.
Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/min is not recommended (see section 4.2).
Zato se uporabe pemetrekseda pri bolnikih z očistkom kreatinina < 45 ml/min ne priporoča (glejte poglavje 4.2).
A subgroup analysis was performed on patients who received folic acid and vitamin B12 supplementation during the entire course of study therapy (fully supplemented).
Analizo podskupin so opravili pri bolnikih, ki so prejemali dopolnilno folno kislino in vitamin B12 celoten čas trajanja zdravljenja v študiji (popolno dopolnjevanje).
The dose of Pemetrexed Fresenius Kabi is 500 milligrams for every square metre of your body's surface area.
Odmerek zdravila Pemetreksed Fresenius Kabi je 500 miligramov za vsak kvadratni meter površine vašega telesa.
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 Pemetrexed Fresenius Kabi.
Če imate ali ste imeli težave z ledvicami, se pogovorite z zdravnikom ali bolnišničnim farmacevtom, ker morda ne boste mogli prejeti zdravila Pemetreksed Fresenius Kabi.
Extravasation should be managed by local standard practice as with other nonvesicants.
Ob ekstravazaciji ukrepajte skladno z lokalno ustaljeno prakso kot pri drugih učinkovinah, ki niso mehurjevci.
*** Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
***Skupna preglednica neželenih učinkov združuje rezultate študij vzdrževalnega zdravljenja samo s pemetreksedom JMEN (N = 663) in nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N = 539).
These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Te razlike so bile verjetno posledica različnih populacij bolnikov, saj so v študijah faze 2 sodelovali bolniki, ki še niso prejemali kemoterapije, in tudi bolnice z rakom dojke, ki so v preteklosti prejemale kemoterapijo, s predhodno obstoječimi metastazami v jetrih in/ali nenormalnimi izhodiščnimi vrednostmi testov jetrnega delovanja.
Concomitant administration of substances that are also tubularly secreted (e.g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Sočasno dajanje snovi, ki se tudi izločajo s tubulno sekrecijo (npr. probenecid, penicilin), lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
Response (n: qualified for response) ▪ Response rate (%) (95% CI) ▪ Stable disease (%)
• RT (95 % IZ) Odziv (n: ustrezen za odziv) Stopnja odzivnosti (%) (95 % IZ) Stabilna bolezen (%)