natgillin/translations-raw huggingface dataset:
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. 
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.
Myalgia occurred in 24% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 7% of cases. 
Mialgija se je pojavila pri 24 % bolnikov, ki so jemali paklitaksel, vezan na nanodelce humanega serumskega albumina, od tega je bilo 7 %
Common: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, weight decreased 
Pogosti: zvišana alanin-aminotransferaza, zvišana aspartataminotransferaza, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
Table 4: Dose reductions for haematologic toxicities in patients with non-small cell lung cancer Haematologic Toxicity 
Preglednica 4: Zmanjšanje odmerka zaradi hematoloških toksičnosti pri bolnikih z nedrobnoceličnim pljučnim rakom
Pazenir 5 mg/ml powder for dispersion for infusion. 
Pazenir 5 mg/ml prašek za disperzijo za infundiranje
Very common: Peripheral neuropathy1, dysgeusia, headache, dizziness Uncommon: VIIth nerve paralysis 
Zelo pogosti: periferna nevropatija1, disgevzija, glavobol, omotica Občasni: paraliza obraznega živca
Table 6: Adverse reactions reported with human serum albumin-paclitaxel nanoparticlesmonotherapy at any dose in clinical studies 
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
No patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine had Grade 4 peripheral neuropathy. 
Noben bolnik, zdravljen s paklitakselom, vezanim na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom, ni imel periferne nevropatije 4. stopnje.
If you are a woman of childbearing age, you should use effective contraception during and up to 1 month after receiving treatment with Pazenir. 
Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo med zdravljenjem z zdravilom Pazenir in do 1 mesec po njem.
When it happens, hair loss is pronounced (over 50%) in the majority of patients) 
Kadar pride do tega, je pri večini bolnikov izpadanje las izrazito
The usual dose for breast cancer is 260 mg/m of body surface area given over a 30 minute period. 
Običajni odmerek pri raku dojk je 260 mg/m2 telesne površine.
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). 
Z analizo večkrat izmerjenih spremenljivk so bile 3 od štirih podlestvic (periferna nevropatija, bolečina v rokah/nogah in sluh) v korist paklitakselu,
Thus patients receiving Pazenir should be vigilantly monitored by physicians for the occurrence of cardiac events. 
Zaradi pojavljanja težav pri delovanju srca morajo biti bolniki, ki jemljejo zdravilo Pazenir, pod strogim nadzorom zdravnikov.
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. 
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.
Grade 3 mucositis or diarrhoea 
mukozitis 3. stopnje ali driska
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. 
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.
Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection 
Pogosti: pljučnica, bronhitis, okužba zgornjih dihal, okužba sečil
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. 
(večinoma senzorična nevropatija 1. ali 2. stopnje) so opazili pri 68 % bolnikov, ki so jemali paklitaksela, vezanega na nanodelce humanega serumskega albumina.
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). 
V to analizo so bili vključeni bolniki z normalnim delovanjem jeter (n = 130) in s predobstoječo blago (n = 8), zmerno
Cutaneous Toxicity: 
Toksičnost za kožo:
Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000 
15. dan ≥ 500 ali < 1.000 ALI ≥ 50.000 ali < 75.000
Very common: Dyspnoea, epistaxis, cough Common: Pneumonitis2, nasal congestion Uncommon: Dry throat, nasal dryness 
Zelo pogosti: dispneja, epistaksa, kašelj Pogosti: pnevmonitis2, kongestija nosu Občasni: suho žrelo, suha nosna sluznica
Occurrence Dose of Pazenir (mg/m2)1 
Pojavljanje Odmerek zdravila Pazenir (mg/m2)1
Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela 
ANC ≥ 1.500; nadaljujte z naslednjo nižjo ravnijo odmerkaa
Uncommon: Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis 
Občasni: draženje oči, očesna bolečina, nenormalen vid, zmanjšana ostrina vida,konjunktivitis, motnje vida, srbenje oči, keratitis
Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel 
Pazenir 5 mg/ml prašek za disperzijo za infundiranje paklitaksel
Return to Day 1 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 1 doses 
Vrnite se na raven odmerkov 1. dne, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za eno raven od odmerkov 1. dne
Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome 
Občasni: hemolitični uremični sindrom
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). 
Zdravilo Pazenir je indicirano kot monoterapija pri raku dojk, skupaj z gemcitabinom pri adenokarcinomu trebušne slinavke ali skupaj s karboplatinom pri nedrobnoceličnem pljučnem raku
Uncommon: Mucosal inflammation, infusion site extravasation, infusion site inflammation, infusion site rash 
Občasni: vnetje sluznic, ekstravazacija na mestu infuzije, vnetje na mestu infuzije, izpuščaj na mestu infuzije
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. 
preživetja brez poslabšanja bolezni in preživetja za bolnike, ki so prejemali več kot prvo linijo zdravljenja.
Reduce 1 dose level and follow with WBC Growth Factors OR Reduce doses 2 dose levels from Day 1 doses 
Zmanjšajte odmerke za eno raven, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za dve ravni od odmerkov 1. dne
Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion. 
Paklitaksel se izloča večinoma s presnovo v jetrih in z izločanjem z žolčem.
The uncommon side effects may affect up to 1 in 100 people: 
Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
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. 
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
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. 
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.
• Increased liver function tests 
• otekanje sluznic in mehkih tkiv • zvišani testi jetrne funkcije
100mg/20ml 
375 mg/m2.
Very common: Alopecia, rash Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes 
Pogosti: motnje nohtov, srbenje, suha koža, eritem, obarvanje/razbarvanje nohtov, hiperpigmentacija kože, oniholiza, spremembe nohtov
Treat with Day 8 dose level and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses 
Zdravite z ravnijo odmerka 8. dne, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za eno raven od odmerkov 8. dne
Response rate [95% CI] (%) > 1st-line therapy 
Stopnja odziva [95-% IZ] (%)
Uncommon: Chest discomfort, abnormal gait, swelling, injection site reaction 
Občasni: nelagodje v prsnem košu, nenormalna hoja, otekanje, reakcija na mestu vboda
• Dry mouth, difficulty in swallowing 
• suha usta, oteženo požiranje
Non-small cell lung cancer A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. 
Pri 1.052 bolnikih z nedrobnoceličnim pljučnim rakom stadija IIIb/IV, ki prej še niso prejeli kemoterapije, so opravili multicentrično, randomizirano, odprto študijo.
• Decreased blood pressure when standing up, coldness in your hands and feet 
• bolečina na mestu tumorja, odmrtje tumorja • znižan krvni tlak v stoječem položaju, mrazenje v dlaneh in stopalih
Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis 
Zelo pogosti: slabost, driska, bruhanje, zaprtost, stomatitis
• Nausea, diarrhoea, constipation, sore mouth, loss of appetite 
• slabost, driska, zaprtost, razjede v ustih, izguba teka
• Pain in extremities 
• bolečine v udih
Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI) 
Smrt ali napredovanje bolezni, n (%) Mediana preživetja brez napredovanja bolezni, meseci (95-% IZ)
Talk to your doctor or nurse before using Pazenir 
Pred začetkom uporabe zdravila Pazenir se posvetujte z zdravnikom ali medicinsko sestro
(mg/m2)1 
(celice/mm3)
Breast cancer 
Rak trebušne slinavke
Pneumonitis has been reported at a rate of 4% with the use of human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine. 
Pnevmonitis se je pojavil pri 4 % bolnikov, kadar so bolniki prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, skupaj z gemcitabinom.
• Pazenir is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas. 
• Če imate metastatskega raka trebušne slinavke (pankreasa), se zdravilo Pazenir uporablja skupaj z zdravilom, ki se imenuje gemcitabin.
Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage 
Občasni: disfagija, flatulenca, glosodinija, suha usta, boleče dlesni, mehko blato, ezofagitis, bolečine v spodnjem delu trebuha, ulceracija ust, bolečine v ustih, rektalno krvavenje
Confirmed complete or partial overall reponse, n 95% Cl (%) 
potrjen popoln ali delen celokupen odziv, n (%) 95-% IZ (%) pA/pT (95,1-% IZ) p-vrednosta
Very common: Neutropenia, anaemia, thrombocytopenia Common: Pancytopenia 
Zelo pogosti: nevtropenija, anemija, trombocitopenija Pogosti: pancitopenija
There was a significant difference in overall response rate in the human serum albumin-paclitaxel nanoparticles/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS. 
V skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina/karboplatinom se je stopnja celokupnega odziva (ORR - Overall Response Rate) značilno razlikovala od kontrolne skupine pri bolnikih z nedrobnoceličnim pljučnim rakom s ploščatocelično histologijo (N = 450, 41 %
There were no clinically relevant pharmacokinetic interactions between human serum albumin-paclitaxel nanoparticlesand carboplatin. 
Med paklitakselom, vezanim na nanodelce humanega serumskega albumina, in karboplatinom ni bilo klinično pomembnih farmakokinetičnih interakcij.
Package leaflet: Information for the user Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel 
Navodilo za uporabo Pazenir 5 mg/ml prašek za disperzijo za infundiranje paklitaksel
Reduce to next lower dose levela; discontinue treatment if ADR persists 
ukinite zdravljenje, če neželeni učinek vztraja
• Low levels of potassium in the blood 
• znižana koncentracija kalija v krvi
Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G(95% Cl)a 
Celokupno preživetje število smrti, n (%) mediana celokupnega preživetja (95-% IZ) (meseci)
• Pain in the breast 
• bolečine v trebuhu
• Infection in the urinary tract 
• okužba sečil
Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Pazenir. 
Tako kot pri drugih potencialno toksičnih spojinah je treba tudi z zdravilom Pazenir previdno ravnati.
There was a statistically significant improvement in OS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates. 
celokupno zmanjšanje tveganja smrti je bilo 28 %, enoletno preživetje se je zvečalo za 59 %, dvoletno preživetje pa za 125 %.
Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR) 
Kratica: ANC = absolutno število nevtrofilcev (ANC=Absolute Neutrophil Count) Preglednica 3: Prilagajanje odmerka pri drugih neželenih učinkih zdravila pri bolnikih z adenokarcinomom trebušne slinavke
• Pain in a joint or joints 
• bolečine v sklepu ali sklepih
In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving human serum albumin-paclitaxel nanoparticles. 
Na splošno je bila pri bolnikih, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, pogostnost in resnost nevrotoksičnosti odvisna od odmerka.
• Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing - this means that they die. 
Deluje tako, da prepreči rakavim celicam, da bi se delile - to pomeni, da odmrejo.
This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as human serum albuminpaclitaxel nanoparticles 260 mg/m2 given as a 30 minute infusion without premedication (N = 229). 
To raziskavo so izvedli v več centrih pri bolnikih z metastatskim rakom dojk, ki so vsake 3 tedne prejemali paklitaksel kot samostojno zdravilo, ali kot paklitaksel na bazi topila v odmerku 175 mg/m2
Common: Vertigo Uncommon: Ear pain, tinnitus 
Občasni: bolečine v ušesih, tinitus
Delay of next cycle due to persistent neutropenia2 (Nadir 
ALI odložitev naslednjega cikla zaradi trdovratne nevtropenije2 (najmanjše ANC < 1.500/mm3)
However, a subsequent analysis in 981 patients receiving human serum albumin-paclitaxel nanoparticles monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years. 
Vendar je poznejša analiza pri 981 bolnikih, ki so prejemali monoterapijo s paklitakselom, vezanim na nanodelce humanega serumskega albumina, za metastatski rak dojk, od katerih je bilo 15 % starih 65 let in več,
Patients received a median treatment duration of 3.9 months in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment. 
Mediana trajanja zdravljenja v skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina/gemcitabinom je bila 3,9 meseca, v skupini z gemcitabinom pa 2,8 meseca.
There was a statistically significant improvement in PFS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS. 
Pri bolnikih, zdravljenih s paklitakselom, vezanim na nanodelce humanega serumskega albumina/gemcitabinom, v primerjavi s tistimi, ki so se zdravili samo z gemcitabinom, se je preživetje brez napredovanja bolezni statistično značilno izboljšalo, mediano preživetje brez napredovanja bolezni se je podaljšalo za 1,8 meseca.
Resume Pazenir at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2). 
Ko se periferna nevropatija izboljša na 0. ali 1. stopnjo, nadaljujte zdravljenje z zmanjšanim odmerkom zdravila Pazenir (glejte poglavje 4.2).
Teva Nederland B.V. (additional entity) Swensweg 5 
(dodatni subjekt) Swensweg 5
*Survival [95% CI] (weeks) > 1st-line therapy 
*Preživetje [95-% IZ] (tedni)
Reduce doses 1 dose level 
zmanjšanje odmerkov.
Nadir platelets <50,000/mm3 
Ukinite zdravljenje najmanjše število trombocitov < 50.000/mm3
First 
prvo drugo
Uncommon: Contusion Rare: Radiation recall phenomenon, radiation pneumonitis 
Redki: preobčutljivost predhodno obsevanih predelov, obsevalni pnevmonitis
Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenzalike illness, malaise, lethargy, hyperpyrexia 
Pogosti: periferni edem, vnetje sluznice, bolečine, okorelost, edem, šibkost, manjša zmogljivost, bolečine v prsih, gripi podobna bolezen, slabo počutje,
Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial Human serum albuminpaclitaxel nanoparticles (125 mg/m2)/ Gemcitabine 
Paklitaksel, vezan na nanodelce humanega serumskega albumina (125 mg/m2)/gemcitabin
resume at next lower dose levela aSee Table 1 for dose level reductions 
nadaljujte z naslednjo nižjo ravnijo odmerkaa a Za zmanjšanja ravni odmerka glejte preglednico 1.
Bone marrow suppression (primarily neutropenia) occurs frequently with human serum albuminpaclitaxel nanoparticles. 
Hematologija Pri paklitakselu, vezanem na nanodelce humanega serumskega albumina, pogosto pride do zavrtja delovanja kostnega mozga (večinoma nevtropenija).
• Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat 
plitvejši zvok dihanja, voda v pljučih, izguba glasu, krvni strdek v pljučih, suho žrelo • vetrovi, trebušni krči, bolečine ali razjede na dlesnih, krvavenje iz danke
Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of human serum albumin-paclitaxel nanoparticles. 
V obdobju spremljanja paklitaksela, vezanega na nanodelce humanega serumskega albumina, po začetku trženja so opazili paralizo kranialnih živcev, parezo glasilk in redke primere reakcij hude preobčutljivosti.
Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis 
Pogosti: okužbe, okužbe sečil, folikulitis, okužbe zgornjih dihal,
Very common: Diarrhoea, vomiting, nausea, constipation Common: Stomatitis, dyspepsia, abdominal pain, dysphagia 
Zelo pogosti: navzea, driska, bruhanje, zaprtost, bolečine v trebuhu, bolečina v zgornjem delu trebuha
There have been reports of tumour lysis syndrome during treatment with human serum albuminpaclitaxel nanoparticles. 
Med zdravljenjem s s paklitakselom, vezanim na nanodelce humanega serumskega albumina,
• Rash 
• modrice
MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Based on laboratory assessments: maximal degree of myelosuppression (treated population) 2 Peripheral neuropathy is evaluated using the SMQ neuropathy (broad scope) 3 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope) 
MedDRA = medicinski slovar za regulativne aktivnosti; SMQ = standardizirana MedDRA poizvedba (Standardized MedDRA
Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2 
kandidoza, sinusitis Občasni: oralna kandidoza, nazofaringitis, celulitis, herpes simpleks,
Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor 
Občasni: polinevropatija, arefleksija, diskinezija, hiporefleksija, nevralgija,
The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine at a dose of 1000 mg/m2 
421 bolnikih z metastatskim adenokarcinomom trebušne slinavke, zdravljenih s 125 mg/m2 paklitaksela, vezanega na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom v odmerku 1.000 mg/m2 1., 8. in 15. dan vsakega 28-dnevnega cikla v klinični študiji faze III.
If it contacts mucous membranes, the membranes should be flushed thoroughly with water. 
Če pride v stik s sluznico, le-to temeljito sperite z vodo.
Reconstituted Pazenir dispersion should be administered intravenously using an infusion set incorporating a 15 µm filter. 
Da se boste izognili dajanju teh vlaken, dajajte zdravilo Pazenir z infuzijskim sistemom, ki vključuje 15 µm filter.
In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving human serum albumin-paclitaxel nanoparticles in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy. 
ki so se končali s smrtjo v 30 dneh po zadnjem odmerku zdravila v kliničnem preskušanju, pri 4 %
Common: Pain in extremity, bone pain, back pain, muscle cramps, limb pain 
Pogosti: bolečine v udih, bolečine v kosteh, bolečine v hrbtu, mišični krči, bolečine v okončinah
The very rare side effects may affect up to 1 in 10,000 people: 
• motnja električnega prevodnega sistema srca (atrioventrikularni blok) Zelo redki neželeni učinki se lahko pojavijo pri največ 1 od 10.000 bolnikov:
Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicinal products known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure. 
CYP3A4 (npr. ketokonazol in drugi imidazolni antimikotiki, eritromicin, fluoksetin, gemfibrozil,
• Bruising 
fenitoin)
All formulations 
Vse formulacije
MUPS and capsules 
MUPS in kapsule
The MAH commits to update the dossier according to the various regulations and the EU Directive 2001/83/EC. 
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil dokumentacijo v skladu z različnimi uredbami in Direktivo EU 2001/83/ES.
CONDITIONS OF THE MARKETING AUTHORISATIONS 
DODATEK IV POGOJI DOVOLJENJ ZA PROMET Z ZDRAVILOM