FrancophonIA/ELRC3.0 huggingface dataset:
English: Human serum albumin-paclitaxel nanoparticles were administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle without any steroid premedication and without granulocyte colony stimulating factor prophylaxis.
Slovenian: Bolnikom (N = 521) so dajali paklitaksel, vezan na nanodelce humanega serumskega albumina, v obliki intravenske infuzije 30 minut v odmerku 100 mg/m2 1., 8. in 15. dan vsakega 21-dnevnega cikla brez kakršne koli steroidne premedikacije in brez profilakse z granulocitne kolonije spodbujajočim faktorjem.
English: 1st dose level reduction 2nd dose level reduction If additional dose reduction required
Slovenian: Celotni odmerek Prvo zmanjšanje ravni odmerka Drugo zmanjšanje ravni odmerka
English: For combination use of Pazenir and carboplatin, if Grade 3 or higher peripheral neuropathy develops, treatment should be withheld until improvement to Grade 0 or 1 followed by a dose reduction for all subsequent courses of Pazenir and carboplatin (see section 4.2).
Slovenian: Če se pri kombiniranem zdravljenju z zdravilom Pazenir in karboplatinom razvije periferna nevropatija 3. ali višje stopnje, je treba zdravljenje prekiniti do izboljšanja na 0. ali 1. stopnjo, nato pa zmanjšajte odmerek za vse naslednje cikle zdravila Pazenir in karboplatina (glejte poglavje 4.2).
English: Common: Interstitial pneumonitis3, dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea
Slovenian: Pogosti: intersticijski pnevmonitis3, dispneja, epistaksa, faringolaringealne bolečine, kašelj, rinitis, rinoreja
English: Very common: Dehydration, decreased appetite, hypokalaemia
Slovenian: Zelo pogosti: dehidracija, zmanjšan apetit, hipokaliemija
English: Solvent- based paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Slovenian: Paklitaksel na bazi topila so bolnikom (N = 531) dali v odmerku 200 mg/m2 v obliki intravenske infuzije, ki je tekla 3 ure, s standardno premedikacijo, takoj nato je sledil karboplatin intravensko v odmerku AUC = 6 mg•min/ml.
English: Pregnancy breast-feeding and fertility
Slovenian: Nosečnost, dojenje in plodnost
English: Some people may feel tired or dizzy after being given Pazenir.
Slovenian: Po uporabi zdravila Pazenir so lahko nekateri ljudje utrujeni ali omotični.
English: Pneumonitis occurred in 1% of patients when human serum albumin-paclitaxel nanoparticles was used as monotherapy and in 4% of patients when Pazenir was used in combination with gemcitabine.
Slovenian: Pnevmonitis se je pojavil pri 1 % bolnikov, pri katerih se je paklitaksel, vezan na nanodelce humanega serumskega albumina, uporabljalo kot monoterapija, in pri 4 % bolnikov, kadar se je zdravilo Pazenir uporabljalo skupaj z gemcitabinom.
English: Uncommon: Sepsis, oral candidiasis
Slovenian: Občasni: sepsa, oralna kandidoza
English: Medical or healthcare professionals
Slovenian: Zdravstveno osebje
English: The reconstituted dispersion in the intravenous drip may be stored for up to 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Slovenian: Rekonstituirana disperzija za intravensko dajanje z intravensko kanilo se lahko shranjuje do 24 ur pri temperaturi 2 °C-8 °C, če je viala zaščitena pred svetlobo, in nato še 4 ure pri temperaturi 15 °C
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Slovenian: Za bolnike s celokupnim bilirubinom > 5 x ULN ali za bolnike z metastatskim adenokarcinomom trebušne slinavke farmakokinetični podatki niso na voljo (glejte poglavje 4.2).
English: A higher median cumulative dose of gemcitabine was delivered in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Slovenian: V skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina/gemcitabinom je bil mediani kumulativni odmerek gemcitabina, ki ga je prejel bolnik, večji (11.400 mg/m2) kot v skupini z gemcitabinom (9.000 mg/m2).
English: Patients should not be retreated with subsequent cycles of Pazenir until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section 4.2).
Slovenian: Nadaljnjih ciklov zdravila Pazenir ne smete začeti, dokler se nevtrofilci ne vrnejo na vrednost > 1.500 celic/mm3, trombociti pa na vrednost > 100.000 celic/mm3 (glejte poglavje 4.2).
English: Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Slovenian: Antracikline je predhodno dobilo 77 % bolnikov.
English: Solvent-based paclitaxel(200 mg/m2 every 3 weeks)+ carboplatin (N=531)
Slovenian: Paklitaksel na bazi topila (200 mg/m2 vsake 3 tedne) + karboplatin (N = 531)
English: For patients ≥ 75 years of age in the human serum albumin-paclitaxel nanoparticles/gemcitabine and gemcitabine arms the survival Hazard Ratio (HR) was 1.08 (95% CI 0.653, 1.
Slovenian: Pri bolnikih, starih ≥ 75 let, je bilo razmerje tveganja (HR) za preživetje v skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina/gemcitabinom in v skupini z gemcitabinom 1,08 (95-% IZ 0,653; 1,797).
English: Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Slovenian: Pomožne snovi: raztopina humanega albumina (vsebuje natrij, natrijev kaprilat in N-acetil DL triptofanat).
English: Common: Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis
Slovenian: Pogosti: povečano solzenje, zamegljen vid, suho oko, keratokonjunktivitis sicca, madaroza
English: Peripheral neuropathy evaluated using the SMQ (broad scope).
Slovenian: 1 Periferna nevropatija ovrednotena z uporabo SMQ (razširjeni okvir).
English: The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Pazenir may result in the formation of proteinaceous strands.
Slovenian: brizge in infuzijske vreče) za rekonstituiranje in dajanje zdravila Pazenir, lahko povzroči nastajanje beljakovinskih vlaken.
English: Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Slovenian: Pogosti: periferna senzorična nevropatija, glavobol, disgevzija, omotičnost, periferna motorična nevropatija, ataksija, senzorične motnje, somnolenca
English: Hypersensitivity to the active substance or to any of the excipients listed in section Breast-feeding (see section 4.6).
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with human serum albumin-paclitaxel nanoparticles.
Slovenian: Obstajajo redka poročila o zmanjšani ostrini vida zaradi cistoidnega makularnega edema med zdravljenjem s paklitakselom, vezanim na nanodelce humanega serumskega albumina.
English: Beginning immediately after the end of human serum albumin-paclitaxel nanoparticles administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Slovenian: Takoj po končanem dajanju paklitaksela, vezanega na nanodelce humanega serumskega albumina, so bolnikom samo 1. dan vsakega 21-dnevnega cikla dali karboplatin intravensko v odmerku AUC = 6 mg•min/ml.
English: Discontinue Treatment
Slovenian: Ukinite zdravljenje
English: Uncommon: Dysuria, pollakiuria, haematuria, nocturia, polyuria, urinary incontinence
Slovenian: Občasni: disurija, polakisurija, hematurija, nokturija, poliurija, urinska inkontinenca
English: Reconstituted Pazenir dispersion is administered intravenously using an infusion set incorporating a 15 µm filter.
Slovenian: Rekonstituirana disperzija zdravila Pazenir se daje intravensko z infuzijskim setom, ki vključuje 15 µm filter.
English: Uncommon: Metastatic pain, tumour necrosis
Slovenian: Občasni: metastatske bolečine, nekroza tumorja
English: The very common side effects may affect more than 1 in 10 people:
Slovenian: Naslednji zelo pogosti neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov:
English: • Weakness and tiredness, fever
Slovenian: • šibkost in utrujenost, zvišana telesna temperatura
English: ULN) (see section 5.2).
Slovenian: in 5.2).
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Pazenir infusions.
Slovenian: Ni nujno, da pri pripravi ali dajanju infuzij zdravila Pazenir uporabljate specializirane vsebnike ali komplete za dajanje zdravila brez di(2-etilheksil)ftalata (DEHP).
English: Women of childbearing potential should use effective contraception during treatment 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 en mesec po zdravljenju.
English: The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Slovenian: (celokupni bilirubin > 1 do ≤ 1,5 x ULN) nima klinično pomembnega vpliva na farmakokinetiko paklitaksela.
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α-hydroxypaclitaxel; and to two minor metabolites, 3'-phydroxypaclitaxel and 6α-3'-p-dihydroxypaclitaxel.
Slovenian: Kot je navedeno v objavljeni literaturi, in vitro raziskave z mikrosomi humanih jeter in rezin tkiva kažejo, da se paklitaksel večinoma metabolizira v 6α-hidroksipaklitaksel in v dva manjša metabolita,
English: Common: Vision blurred
Slovenian: Pogosti: zamegljen vid
English: People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received paclitaxel attached to the human protein albumin with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.
Slovenian: (rak trebušne slinavke, ki se je razširil v druge dele telesa), ki so v kliničnem preskušanju prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, z gemcitabinom, so živeli dlje kot ljudje, ki so prejemali samo gemcitabin.
English: For Grade 3 sensory neuropathy, withhold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses.
Slovenian: Pri senzorični nevropatiji 3. stopnje prekinite zdravljenje, dokler se le-ta ne izboljša do 1. ali 2. stopnje, nato zmanjšajte odmerek za vsa nadaljnja zdravljenja.
English: Of the 229 patients in the randomized study who received human serum albumin-paclitaxel nanoparticles monotherapy for breast cancer, 13% were at least 65 years of age and < 2% were 75 years and older.
Slovenian: Od 229 bolnikov v randomizirani študiji, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, kot monoterapijo za raka dojk, jih je bilo 13 % starih vsaj 65 let in < 2 % jih je bilo starih 75 let in več.
English: Very common: Decreased appetite Common: Dehydration
Slovenian: Zelo pogosti: zmanjšan apetit Pogosti: dehidracija
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Slovenian: Pri bolnikih z metastatskim rakom dojk in bolnikih z nedrobnoceličnim pljučnim rakom in zmerno do hudo okvaro jeter (celokupni bilirubin > 1,5 do ≤ 5 x ULN in AST ≤ 10 x ULN) je priporočeno 20 %
English: Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Slovenian: Paklitaksel se je izkazal za genotoksičnega v in vivo okolju (mikronukleusni test pri miših), a ni kazal učinkov mutagenega delovanja v Ames testu ali pri preskušanju genetske mutacije na jajčnikih kitajskega hrčka
English: - Keep this leaflet.
Slovenian: Izogibajte se nastanku pene.
English: When reconstituted, Pazenir concentrate contains 4.2 mg of sodium per ml.
Slovenian: Po rekonstituciji vsebuje koncentrata zdravila Pazenir 4,2 mg natrija na ml.
English: • Acute kidney failure
Slovenian: • akutna odpoved ledvic
English: Common: Sepsis, pneumonia, oral candidiasis
Slovenian: Pogosti: sepsa, pljučnica, oralna kandidoza
English: Albumin (human) Sodium caprylate N-acetyl-DL-tryptophan Sodium chloride Hydrochloric acid Sodium hydroxide
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi albumin (humani) natrijev kaprilat N-acetil-DL triptofanat natrijev klorid klorovodikova kislina natrijev hidroksid
English: • Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst, decreased calcium in the blood, decreased sugar in the blood, decreased sodium in the blood
Slovenian: • znižana raven fosforja v krvi, zadrževanje tekočine, znižana raven albumina v krvi, povečana žeja, znižana raven kalcija v krvi, znižana raven krvnega sladkorja, znižana raven natrija v krvi
English: Pazenir is available in glass vials containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Zdravilo Pazenir je na voljo v steklenih vialah, ki vsebujejo 100 mg paklitaksela, vezanega na albuminske nanodelce.
English: Very common: Anorexia Common: Dehydration, decreased appetite, hypokalaemia
Slovenian: Zelo pogosti: anoreksija Pogosti: dehidracija, zmanjšan apetit, hipokaliemija
English: For patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days.
Slovenian: Periferna nevropatija Pri bolnikih, zdravljenih s paklitakselom, vezanim na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom, je bil mediani čas do prvega nastopa periferne nevropatije 3. stopnje 140 dni.
English: Patients who have baseline neutrophil counts <1500 cells/mm
Slovenian: Bolniki, ki imajo izhodiščno število nevtrofilcev < 1.500 celic/mm3.
English: Dose of Pazenir
Slovenian: Odmerek zdravila Pazenir
English: PA/pT (95.1% Cl)
Slovenian: HRA/T (95,1-% IZ)
English: There is limited experience of human serum albumin-paclitaxel nanoparticles/carboplatin use in patients 75 years or older.
Slovenian: Z uporabo paklitaksela, vezanega na nanodelce humanega serumskega albumina/karboplatina pri bolnikih, starih 75 let ali več, je malo izkušenj.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
Slovenian: O sepsi so poročali pri 5 % bolnikov z nevtropenijo ali brez nje, ki so prejemali paklitaksel, vezanega na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom med preskušanjem pri adenokarcinomu trebušne slinavke.
English: The following are the most common and clinically relevant adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/m2 human serum albumin-paclitaxel nanoparticlesonce every three weeks in the pivotal phase III clinical study.
Slovenian: Opis izbranih neželenih učinkov V nadaljevanju so opisani najpogostejši in klinično pomembni neželeni učinki pri 229 bolnikih z metastatskim rakom dojk, zdravljenih z 260 mg/m2 paklitaksela, vezanega na nanodelce humanega serumskega albumina, enkrat na tri tedne v ključni klinični študiji faze III.
English: If Pazenir dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Slovenian: Če pride disperzija zdravila Pazenir v stik s kožo, takoj sperite kožo in jo temeljito umijte z milnico in vodo.
English: Alopecia was observed in >80% of the patients treated with human serum albumin-paclitaxel nanoparticles.
Slovenian: Bolezni kože in podkožja Alopecijo so opazili pri > 80 % bolnikov, ki so jemali paklitaksel, vezan na nanodelce humanega serumskega albumina.
English: Progression-free Survival
Slovenian: Preživetje brez napredovanja bolezni
English: Non-small cell lung cancer (human serum albumin-paclitaxel nanoparticles administered in combination with carboplatin)
Slovenian: Nedrobnocelični pljučni rak (paklitaksel, vezan na nanodelce humanega serumskega albumina, uporabljen v kombinaciji s karboplatinom)
English: For febrile neutropenia, withhold Pazenir and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
Slovenian: Pazenir in gemcitabinom, dokler vročina ne izzveni in ni ANC ≥ 1.500 celic/mm3, nato nadaljujte zdravljenje z zmanjšano ravnijo odmerkov (glejte poglavje 4.2).
English: • Muscle weakness
Slovenian: • šibkost mišic
English: Table 6 lists adverse reactions associated with the administration of human serum albumin-paclitaxel nanoparticles to patients from studies in which human serum albumin-paclitaxel nanoparticles has been administered as monotherapy at any dose in any indication (N = 789).
Slovenian: Seznam neželenih učinkov v obliki preglednice Preglednica 6 navaja neželene učinke, ki so povezani z odmerjanjem paklitaksela, vezanega na nanodelce humanega serumskega albumina, bolnikom v študijah, pri katerih so s paklitaksel, vezan na nanodelce humanega serumskega albumina, dajali kot monoterapijo v katerem koli odmerku, pri kateri koli indikaciji (N = 789).
English: Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gammaglutamyltransferase, increased blood alkaline phosphatase
Slovenian: Pogosti: zmanjšana telesna masa, zvišana alanin-aminotransferaza, zvišana aspartat-aminotransferaza, znižana vrednost hematokrita, manjše število rdečih krvnih celic, zvišana telesna temperatura, zvišana gamaglutamiltransferaza, zvišana alkalna fosfataza v krvi
English: The key secondary endpoints were progression- free survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Slovenian: Ključna sekundarna cilja sta bila čas preživetja brez napredovanja bolezni (PFS - progression free survival) in stopnja celokupnega odziva (ORR - overall response rate), oba so ocenili z neodvisnim,
English: Uncommon: Breast pain
Slovenian: Občasni: bolečine v dojkah
English: The usual dose for advanced pancreatic cancer is 125 mg/m2 of body surface area given over a 30 minute period.
Slovenian: Običajni odmerek pri napredovalem raku trebušne slinavke je 125 mg/m2 telesne površine.
English: After reconstitution, each ml of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Po rekonstituciji vsebuje 1 ml disperzije 5 mg paklitaksela, vezanega na albuminske nanodelce.
English: Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer
Slovenian: Preglednica 5: Zmanjšanje odmerka zaradi hematoloških toksičnosti pri bolnikih z nedrobnoceličnim pljučnim rakom
English: Common: Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia
Slovenian: Pogosti: bolečine v trebuhu, abdominalna distenzija, bolečine v zgornjem predelu trebuha, dispepsija, gastroezofagealna refluksna bolezen, oralna hipoestezija
English: Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Pazenir, your doctor may wish to stop treatment or reduce the dose:
Slovenian: Posvetujte se z zdravnikom ali medicinsko sestro, če se vam pojavijo katere koli od spodaj navedenih težav, medtem ko vas zdravijo z zdravilom Pazenir.
English: Death or progression, n (%)
Slovenian: Število smrti (%)
English: Very common: Insomnia, depression Common: Anxiety
Slovenian: Zelo pogosti: nespečnost, depresija Pogosti: anksioznost
English: There was no evidence for accumulation of paclitaxel with multiple treatment courses.
Slovenian: Po več ponovitvah ciklusov zdravljenja ni bilo podatka o kopičenju paklitaksela.
English: Peripheral neuropathy
Slovenian: Periferno nevropatijo
English: Uncommon: Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness
Slovenian: Občasni: bolečine v steni prsnega koša, mišična šibkost, bolečine v vratu, bolečine v dimljah, mišični spazmi, mišično-skeletne bolečine, bolečine v bokih, neugodje v okončinah, mišična šibkost
English: • Reduction in the number of platelets in the blood
Slovenian: • znižanje števila trombocitov v krvi
English: There was no difference in ORR between the treatment arms in patients with non-squamous histology (N=602, 26% vs 25%, p=0.808).
Slovenian: (N = 602, 26 % proti 25 %, p = 0,808).
English: Uncommon: Hepatomegaly
Slovenian: Občasni: hepatomegalija
English: Very common: Fatigue, asthenia, pyrexia
Slovenian: Zelo pogosti: utrujenost, astenija, pireksija
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Pazenir over a minimum of 1 minute.
Slovenian: S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Pazenir vsaj 1 minuto.
English: Grade 4 cutaneous toxicity, diarrhoea, or mucositis
Slovenian: Ukinite zdravljenje kožna toksičnost, driska ali mukozitis
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Pazenir over a minimum of 1 minute.
Slovenian: S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo s 100 mg zdravila Pazenir vsaj 1 minuto.
English: Grades 1-4
Slovenian: 1.-4. stopnje
English: Human serum albumin-paclitaxel nanoparticles (100 mg/m2/week)+ carboplatin (N=521)
Slovenian: Paklitaksel, vezan na nanodelce humanega serumskega albumina (100 mg/m2/teden) + karboplatin (N = 521)
English: Very common: Weight decreased, alanine aminotransferase increased Common: Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased
Slovenian: Zelo pogosti: zmanjšana telesna masa, zvišana alanin-aminotransferaza Pogosti: zvišana aspartat-aminotransferaza, zvišan bilirubin v krvi, zvišan kreatinin v krvi
English: Pazenir should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Slovenian: Zdravilo Pazenir se sme uporabljati samo pod nadzorom ustrezno usposobljenega onkologa v enotah,
English: Uncommon: Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalised rash, dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face
Slovenian: Občasni: mehkost nohtne plošče, urtikarija, kožna bolečina, fotosenzitivna reakcija, motnje pigmentacije, srbeč izpuščaj, bolezni kože, hiperhidroza, onihomadeza, eritematozni izpuščaj, generaliziran izpuščaj, dermatitis, nočno potenje, makulopapulozni izpuščaj, vitiligo, hipotrihoza, neugoden občutek na nohtih, generaliziran pruritus, makulozni izpuščaj, papulozni izpuščaj, lezije kože, otekanje obraza
English: Occurrenc e
Slovenian: PRILOGA I
English: ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Slovenian: ≥ 500 ali < 1.000 ALI ≥ 50.000 ali < 75.000
English: The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Pazenir infusions.
Slovenian: Ni nujno, da pri pripravi ali dajanju infuzij zdravila Pazenir uporabljate specializirane vsebnike ali komplete za dajanje zdravila brez DEHP.