FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common: Pain in extremity, arthralgia, myalgia Common: Muscular weakness, bone pain
Slovenian: Zelo pogosti: bolečina v udih, artralgija, mialgija Pogosti: mišična oslabelost, bolečine v kosteh
English: Uncommon: Drug hypersensitivity, hypersensitivity
Slovenian: Občasni: preobčutljivost na zdravila, preobčutljivost
English: The recommended dose of Pazenir in combination with gemcitabine is 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.
Slovenian: Priporočeni odmerek zdravila Abraxane v kombinaciji z gemcitabinom je 125 mg/m2, ki se daje intravensko 30 minut 1., 8. in 15. dan vsakega 28-dnevnega cikla.
English: Pazenir should not be administered until neutrophil counts recover to >1500 cells/mm3.
Slovenian: Zdravila Pazenir ni dovoljeno dajati, dokler število nevtrofilcev ne doseže vrednosti > 1.500 celic/mm3.
English: In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
Slovenian: V študiji z bolniki z napredovalimi čvrstimi tumorji so primerjali farmakokinetične lastnosti paklitaksela po intravenskem dajanju paklitaksela, vezanega na nanodelce humanega serumskega albumina, v odmerku 260 mg/m2 30 minut in lastnosti po injiciranju paklitaksela na bazi topila
English: a
Slovenian: IN
English: • Itching, dry skin, nail disorder
Slovenian: • srbenje, suha koža, bolezni nohtov
English: Pancreatic adenocarcinoma
Slovenian: Adenokarcinom trebušne slinavke
English: In addition, Pazenir is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin > 1.5 x ULN and AST ≤ 10 x
Slovenian: Poleg tega se zdravila Pazenir ne priporoča pri bolnikih z metastatskim adenokarcinomom trebušne slinavke, ki imajo zmerno do hudo okvaro jeter (celokupni bilirubin > 1,5 x ULN in AST ≤ 10 x ULN) (glejte poglavje 5.2).
English: Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving human serum albumin-paclitaxel nanoparticles.
Slovenian: Kardiotoksičnost Obstajajo redka poročila o kongestivnem srčnem popuščanju in motenem delovanju levega prekata pri posameznikih, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina.
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Slovenian: Od 514 bolnikov z nedrobnoceličnim pljučnim rakom v randomizirani študiji, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, v kombinaciji s karboplatinom, jih je bilo 31 % starih 65 let in več, 3,5 % pa jih je bilo starih 75 let in več.
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Slovenian: Od 421 bolnikov z adenokarcinomom trebušne slinavke v randomizirani študiji, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom, jih je bilo 41 % starih 65 let in več, 10 % pa 75 let in več.
English: Table 7: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine (N=421)
Slovenian: Preglednica 7: Neželeni učinki, o katerih so poročali s paklitakselu, vezanemu na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom (N = 421)
English: The usual dose for non-small cell lung cancer is 100 mg/m2 of body surface area given over a 30 minute period.
Slovenian: Običajni odmerek pri nedrobnoceličnem pljučnem raku je 100 mg/m2 telesne površine.
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine.
Slovenian: V preglednici 7 so navedeni neželeni učinki, ugotovljeni pri bolnikih z adenokarcinomom trebušne slinavke, zdravljenih s paklitakselom, vezanim na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom.
English: However chemical and physical in use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Slovenian: Vendar pa sta bili kemična in fizikalna stabilnost po rekonstituciji dokazani za 24 ur pri temperaturi 2 °C-8 °C, če je viala zaščitena pred svetlobo, in nato še za 4 ure pri temperaturi 15 °C-25 °C.
English: Very common: Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia
Slovenian: Zelo pogosti: periferna nevropatija, nevropatija, hipoestezija, parestezija
English: Uncommon: Increased blood pressure, increased weight, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium, increased bilirubin
Slovenian: Občasni: zvišan krvni tlak, zvečana telesna masa, zvišana laktat dehidrogenaza v krvi, zvišana vrednost kreatinina v krvi, zvišan krvni sladkor, zvišana vrednost fosforja v krvi, znižana vrednost kalija v krvi, zvišan bilirubin
English: Very common: Peripheral neuropathy2 Common: Dysgeusia, headache, dizziness
Slovenian: Zelo pogosti: periferna nevropatija2 Pogosti: disgevzija, glavobol, omotica
English: Grade 3-4
Slovenian: 3.-4. stopnje
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Slovenian: Sočasno dajanje paklitaksela in zdravil, ki znano inducirajo CYP2C8 oziroma CYP3A4 (npr. rifampicin, karbamazepin, fenitoin, efavirenz,
English: Rare: Cystoid macular oedema2
Slovenian: Občasni: cistoidni makularni edem
English: Breast cancer (human serum albumin-paclitaxel nanoparticles administered as monotherapy)
Slovenian: Rak dojk (paklitaksel, vezan na nanodelce humanega serumskega albumina, uporabljeno kot monoterapija)
English: 2 As reported in the post-marketing surveillance of human serum albumin-paclitaxel nanoparticles 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving human serum albumin-paclitaxel nanoparticlesmonotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Slovenian: 3 Pogostnost pnevmonitisa je izračunana na osnovi združenih podatkov pri 1.310 bolnikih v kliničnih preskušanjih, ki so prejemali monoterapijo s paklitakselom, vezanim na nanodelce humanega serumskega albumina, pri raku dojk in drugih indikacijah z uporabo SMQ MedDRA ‘intersticijska bolezen pljuč'.
English: Pazenir should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Slovenian: Zdravilo Pazenir se sme uporabljati pod nadzorom ustrezno usposobljenega onkologa v enotah,
English: Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Slovenian: Pogosti: tahikardija, aritmija, supraventrikularna tahikardija Redki: bradikardija, zastoj srca, moteno delovanje levega prekata,
English: Efficacy variable human serum albuminpaclitaxel nanoparticles (260 mg/m2)
Slovenian: Paklitaksel, vezan na nanodelce humanega serumskega albumina (260 mg/m2)
English: resume at next lower dose levela
Slovenian: Zmanjšajte na naslednjo nižjo raven odmerkova;
English: • medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
Slovenian: sakvinavir, indinavir, nelfinavir, efavirenz, nevirapin)
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
English: • Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
Slovenian: • bolečine v hrbtu, bolečine v kosteh • zmanjšana mišična koordinacija ali težave pri branju, zvečano ali zmanjšano solzenje, izguba trepalnic
English: Lung cancer
Slovenian: Pljučni rak
English: MedDRA = Medical Dictionary for Regulatory Activities; SMQ = Standardized MedDRA Query (a grouping of several MedDRA preferred terms to capture a medical concept).
Slovenian: MedDRA = medicinski slovar za regulativne aktivnosti; SMQ = standardizirana MedDRA poizvedba (Standardized MedDRA Query).
English: Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression.
Slovenian: Pri bolnikih z okvaro jeter lahko pride do večjega tveganja toksičnosti, še posebej zaradi mielosupresije.
English: HRA+G/G (95%Cl)
Slovenian: HRA+G/G (95-% IZ)a p-vrednostb
English: Survival, months (95% CI)
Slovenian: Mediana celokupnega preživetja, meseci (95-% IZ)
English: Uncommon: Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia
Slovenian: polidipsija, hiperglikemija, hipokalciemija, hipoglikemija, hiponatriemija
English: Unopened vials: Keep the container in the outer carton until use in order to protect from light.
Slovenian: Neodprte viale: vsebnik do uporabe shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Table 9 lists adverse reactions associated with the administration of human serum albuminpaclitaxel nanoparticles in combination with carboplatin.
Slovenian: V preglednici 9 so navedeni neželeni učinki, povezani z uporabo paklitaksela, vezanim na nanodelce humanega serumskega albumina, v kombinaciji s karboplatinom.
English: No toxicities occurred notably more frequently among patients at least 65 years of age who received human serum albumin-paclitaxel nanoparticles.
Slovenian: Pri bolnikih, ki so bili stari vsaj 65 let in so jemali paklitaksel, vezan na nanodelce humanega serumskega albumina, niso opazili pogostejše toksičnosti.
English: Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Slovenian: Občasni: hipotenzija, občutek perifernega mrazenja, ortostatska hipotenzija Redki: tromboza
English: Table 9: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with carboplatin (N = 514)
Slovenian: Preglednica 9: Neželeni učinki, o katerih so poročali pri paklitakselu, vezanem na nanodelce humanega serumskega albumina, v kombinaciji s karboplatinom (N = 514)
English: Return to the Day 1 dose levels and follow with WBC Growth Factors ORTreat with same doses as Day 8
Slovenian: Vrnite se na raven odmerkov 1. dne, nato dajte rastne faktorje belih krvnih celic ALI Zdravite z enakimi odmerki kot 8. dne
English: Common: Insomnia, depression, anxiety Uncommon: Restlessness
Slovenian: Pogosti: nespečnost, depresija, anksioznost Občasni: nemirnost
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression
Slovenian: Zelo pogosti: nevtropenija, anemija, levkopenija, trombocitopenija, limfopenija, supresija kostnega mozga
English: Pazenir dose (mg/m2)
Slovenian: Odmerek zdravila Pazenir (mg/m2)
English: No patients treated with human serum albumin-paclitaxel nanoparticles and carboplatin experienced Grade 4 peripheral neuropathy.
Slovenian: Noben bolnik, zdravljen s paklitakselom, vezanim na nanodelce humanega serumskega albumina, in karboplatinom, ni imel periferne nevropatije 4. stopnje.
English: Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Ena viala vsebuje 100 mg paklitaksela, vezanega na albuminske nanodelce.
English: Febrile neutropenia occurred in four patients on human serum albuminpaclitaxel nanoparticles.
Slovenian: Febrilna nevtropenija se je pojavila pri štirih bolnikih, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina.
English: For non-small cell lung cancer patients treated with paclitaxel and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
Slovenian: Pri bolnikih z nedrobnoceličnim pljučnim rakom, zdravljenih s paklitakselom in karboplatinom, je bil mediani čas do prvega pojava periferne nevropatije 3. stopnje, povezane z zdravljenjem, 121 dni,
English: GEM:
Slovenian: /GEM GEM
English: Arthralgia occurred in 32% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 6% of cases.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Artralgija se je pojavila pri 32 % bolnikov, ki so jemali paklitaksel, vezan na nanodelce humanega serumskega albumina, od tega je bilo 6 % hudih primerov.
English: • if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness;
Slovenian: • če začutite odrevenelost, mravljinčenje, zbadanje, občutljivost za dotik ali šibkost mišic; • če se pojavijo težave z dihanjem, kot sta zasoplost ali suh kašelj.
English: If Pazenir contacts mucous membranes, the membranes should be flushed thoroughly with water.
Slovenian: Če pride zdravilo Pazenir v stik s sluznico, le-to temeljito sperite z vodo.
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Slovenian: Občasni: produktiven kašelj, dispneja ob naporu, kongestija sinusov, plitvejši zvok dihanja, plevralni izliv, alergijski rinitis, hripavost, zamašitev nosu, suhost v nosu, piskanje v pljučih, emboli v pljučih, pljučna trombembolija
English: Stability of the reconstituted dispersion in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Slovenian: Stabilnost rekonstituirane disperzije v infuzijski vreči Kemična in fizikalna stabilnost sta bili po rekonstituciji dokazani za 24 ur pri temperaturi 2 °C-8 °C,
English: Population pharmacokinetic analysis included patients with normal renal function (n=65), and preexisting mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Slovenian: in s predobstoječo blago (n = 61), zmerno (n = 23) ali hudo (n = l) okvaro ledvic (po merilih osnutka smernic Ameriške agencije za hrano in zdravila (FDA) 2010).
English: The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Pazenir administration on Days 1, 8 and 15 of each 28-day cycle.
Slovenian: Sočasni priporočeni odmerek gemcitabina je 1.000 mg/m2, ki se daje intravensko 30 minut takoj po končanem dajanju zdravila Abraxane 1., 8. in 15. dan vsakega 28-dnevnega cikla.
English: Myalgia occurred in 24% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 7% of cases.
Slovenian: Mialgija se je pojavila pri 24 % bolnikov, ki so jemali paklitaksel, vezan na nanodelce humanega serumskega albumina, od tega je bilo 7 %
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, weight decreased
Slovenian: Pogosti: zvišana alanin-aminotransferaza, zvišana aspartataminotransferaza, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
English: Table 4: Dose reductions for haematologic toxicities in patients with non-small cell lung cancer Haematologic Toxicity
Slovenian: Preglednica 4: Zmanjšanje odmerka zaradi hematoloških toksičnosti pri bolnikih z nedrobnoceličnim pljučnim rakom
English: Pazenir 5 mg/ml powder for dispersion for infusion.
Slovenian: Pazenir 5 mg/ml prašek za disperzijo za infundiranje
English: Very common: Peripheral neuropathy1, dysgeusia, headache, dizziness Uncommon: VIIth nerve paralysis
Slovenian: Zelo pogosti: periferna nevropatija1, disgevzija, glavobol, omotica Občasni: paraliza obraznega živca
English: Table 6: Adverse reactions reported with human serum albumin-paclitaxel nanoparticlesmonotherapy at any dose in clinical studies
Slovenian: Preglednica 6: Neželeni dogodki, o katerih so poročali pri monoterapiji s paklitakselom, vezanim na nanodelce humanega serumskega albumina, v katerem koli odmerku v kliničnih študijah
English: No patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine had Grade 4 peripheral neuropathy.
Slovenian: Noben bolnik, zdravljen s paklitakselom, vezanim na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom, ni imel periferne nevropatije 4. stopnje.
English: If you are a woman of childbearing age, you should use effective contraception during and up to 1 month after receiving treatment with Pazenir.
Slovenian: Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo med zdravljenjem z zdravilom Pazenir in do 1 mesec po njem.
English: When it happens, hair loss is pronounced (over 50%) in the majority of patients)
Slovenian: Kadar pride do tega, je pri večini bolnikov izpadanje las izrazito
English: The usual dose for breast cancer is 260 mg/m of body surface area given over a 30 minute period.
Slovenian: Običajni odmerek pri raku dojk je 260 mg/m2 telesne površine.
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored human serum albuminpaclitaxel nanoparticles and carboplatin (p ≤ 0.002).
Slovenian: Z analizo večkrat izmerjenih spremenljivk so bile 3 od štirih podlestvic (periferna nevropatija, bolečina v rokah/nogah in sluh) v korist paklitakselu,
English: Thus patients receiving Pazenir should be vigilantly monitored by physicians for the occurrence of cardiac events.
Slovenian: Zaradi pojavljanja težav pri delovanju srca morajo biti bolniki, ki jemljejo zdravilo Pazenir, pod strogim nadzorom zdravnikov.
English: However, chemical and physical in use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, and protected from bright light.
Slovenian: Vendar pa sta bili kemična in fizikalna stabilnost po rekonstituciji dokazani za 24 ur pri 2 °C-8 °C, če je viala shranjena v originalni ovojnini in zaščiteno pred močno svetlobo.
English: Grade 3 mucositis or diarrhoea
Slovenian: mukozitis 3. stopnje ali driska
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8 °C when the vial is in the original carton, and protected from bright light.
Slovenian: Kemična in fizikalna stabilnost sta bili po rekonstituciji dokazani za 24 ur pri 2 °C- 8 °C, če je viala shranjena v originalni ovojnini in zaščitena pred močno svetlobo.
English: Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection
Slovenian: Pogosti: pljučnica, bronhitis, okužba zgornjih dihal, okužba sečil
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on human serum albuminpaclitaxel nanoparticleswith 10% being Grade 3, and no cases of Grade 4.
Slovenian: (večinoma senzorična nevropatija 1. ali 2. stopnje) so opazili pri 68 % bolnikov, ki so jemali paklitaksela, vezanega na nanodelce humanega serumskega albumina.
English: This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Slovenian: V to analizo so bili vključeni bolniki z normalnim delovanjem jeter (n = 130) in s predobstoječo blago (n = 8), zmerno
English: Cutaneous Toxicity:
Slovenian: Toksičnost za kožo:
English: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Slovenian: 15. dan ≥ 500 ali < 1.000 ALI ≥ 50.000 ali < 75.000
English: Very common: Dyspnoea, epistaxis, cough Common: Pneumonitis2, nasal congestion Uncommon: Dry throat, nasal dryness
Slovenian: Zelo pogosti: dispneja, epistaksa, kašelj Pogosti: pnevmonitis2, kongestija nosu Občasni: suho žrelo, suha nosna sluznica
English: Occurrence Dose of Pazenir (mg/m2)1
Slovenian: Pojavljanje Odmerek zdravila Pazenir (mg/m2)1
English: Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela
Slovenian: ANC ≥ 1.500; nadaljujte z naslednjo nižjo ravnijo odmerkaa
English: Uncommon: Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis
Slovenian: Občasni: draženje oči, očesna bolečina, nenormalen vid, zmanjšana ostrina vida,konjunktivitis, motnje vida, srbenje oči, keratitis
English: Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Slovenian: Pazenir 5 mg/ml prašek za disperzijo za infundiranje paklitaksel
English: Return to Day 1 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 1 doses
Slovenian: Vrnite se na raven odmerkov 1. dne, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za eno raven od odmerkov 1. dne
English: Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Slovenian: Občasni: hemolitični uremični sindrom
English: Pazenir is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1).
Slovenian: Zdravilo Pazenir je indicirano kot monoterapija pri raku dojk, skupaj z gemcitabinom pri adenokarcinomu trebušne slinavke ali skupaj s karboplatinom pri nedrobnoceličnem pljučnem raku
English: Uncommon: Mucosal inflammation, infusion site extravasation, infusion site inflammation, infusion site rash
Slovenian: Občasni: vnetje sluznic, ekstravazacija na mestu infuzije, vnetje na mestu infuzije, izpuščaj na mestu infuzije
English: Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
Slovenian: preživetja brez poslabšanja bolezni in preživetja za bolnike, ki so prejemali več kot prvo linijo zdravljenja.
English: Reduce 1 dose level and follow with WBC Growth Factors OR Reduce doses 2 dose levels from Day 1 doses
Slovenian: Zmanjšajte odmerke za eno raven, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za dve ravni od odmerkov 1. dne
English: Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion.
Slovenian: Paklitaksel se izloča večinoma s presnovo v jetrih in z izločanjem z žolčem.
English: The uncommon side effects may affect up to 1 in 100 people:
Slovenian: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
English: The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of human serum albumin-paclitaxel nanoparticles at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Slovenian: V kliničnih študijah je bila določena farmakokinetika celokupnega paklitaksela po 30-in 180-minutni infuziji paklitaksela, vezanega na nanodelce humanega serumskega albumina, pri odmerkih od 80 do
English: In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of human serum albumin-paclitaxel nanoparticles.
Slovenian: V okviru nadaljnjega spremljanja paklitaksela, vezanega na nanodelce humanega serumskega albumina, so pri nekaterih bolnikih, ki so predhodno jemali kapecitabin, poročali o palmarno-plantarni eritrodisesteziji.
English: • Increased liver function tests
Slovenian: • otekanje sluznic in mehkih tkiv • zvišani testi jetrne funkcije
English: Teva Pharma B.V. Swensweg 5
Slovenian: Teva Pharma B.V.
English: 100mg/20ml
Slovenian: 375 mg/m2.