FrancophonIA/ELRC3.0 huggingface dataset:
English: Paxene is a clear, colourless to slightly yellow, thickish solution that comes in vials containing 5 ml, 16.7 ml, 25 ml and 50 ml of concentrate.
Slovenian: Zdravilo Paxene je bistra, brezbarvna do rahlo rumena viskozna tekočina v vialah s po 5 ml, 16,7 ml, 25 ml in 50 ml koncentrata.
English: Severe peripheral neuropathy occurred in 3 % of patients treated with the recommended dose and schedule of Paxene.
Slovenian: Huda periferna nevropatija se je pojavila pri 3 % bolnikov, ki so prejemali priporočen odmerek zdravila Paxene po priporočenem razporedu.
English: The frequency of possible side-effects listed below is defined using the following convention: very common (affects more than 1 person in 10) common (affects 1 to 10 persons in 100) uncommon (affects 1 to 10 persons in 1,000)
Slovenian: Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (prizadenejo več kot 1 od 10 bolnikov)
English: • Yellowing of the skin and nails
Slovenian: • porumenelost kože in nohtov
English: The following is a recommended pre-medication regimen: dexamethasone (8 - 20 mg) given orally (12 and 6 hours) or intravenously (30 - 60 mins) prior to Paxene, chlorpheniramine 10 mg intravenously or an equivalent antihistamine 30 to 60 minutes before Paxene and cimetidine (300 mg) or ranitidine (50 mg) intravenously 30 to 60 minutes before Paxene.
Slovenian: Priporočena priprava na zdravljenje je naslednja: deksametazon (8-20 mg), ki ga dajemo peroralno (12 in 6 ur) ali intravensko (30-60 minut) pred zdravilom Paxene, 10 mg klorfeniramina ali temu ustreznega antihistaminika, ki ga dajemo intravensko 30 do 60 minut pred zdravilom Paxene, in cimetidin (300 mg) ali ranitidin (50 mg), ki ga dajemo intravensko 30 do 60 minut pred zdravilom Paxene.
English: This medicine contains approximately 50 % by volume of alcohol.
Slovenian: Zdravilo Paxene vsebuje približno 50 % alkohola glede na prostornino.
English: The other ingredients are polyoxyl castor oil, citric acid (anhydrous) and ethanol.
Slovenian: Pomožne snovi so makrogolglicerol ricinolat, citronska kislina (brezvodno) in etanol.
English: Common: dry mouth, mouth ulceration, melaena, dyspepsia
Slovenian: Pogosti: suha usta, rane v ustih, melena, dispepsija
English: Take special care with Paxene
Slovenian: Bodite posebno pozorni pri uporabi zdravila Paxene
English: In the first study, 332 patients with locally advanced or metastatic NSCLC were randomised to receive cisplatin (80 mg/m2) in combination with teniposide (100 mg/m2; n= 166), or cisplatin (80 mg/m2) and paclitaxel (175 mg/m2; n= 166).
Slovenian: V prvi študiji so naključno razporedili 332 bolnikov z lokalno napredovalim ali metastaziranim nedrobnoceličnim karcinomom pljuč tako, da so prejemali cisplatin (80 mg/m2) v kombinaciji s tenipozidom (100 mg/m2; n= 166), ali cisplatin (80 mg/m2) in paklitaksel (175 mg/m2; n= 166).
English: Carcinogenesis, mutagenesis, impairment of fertility 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 ima in vivo genotoksične učinke (mikronukleusni test pri miših), čeprav pri Amesovem testu ali analizi genskih mutacij z uporabo jajčnika kitajskega hrčka brez gena za hipoksantin-gvaninfosforibozil-transferazo (CHO/HGPRT) ni induciral mutagenosti.
English: The prepared solution may appear hazy.
Slovenian: Pripravljena raztopina je lahko motnega videza.
English: However, if treatment is to be continued, the dose of paclitaxel should be reduced for all subsequent courses of Paxene (see section 4.2).
Slovenian: Če zdravljenje nadaljujemo, pa je treba odmerek paklitaksela pri vseh nadaljnjih krogih zdravljenja z zdravilom Paxene zmanjšati (glejte poglavje 4.2).
English: • Dry mouth and mouth ulcers
Slovenian: • suha usta in razjede ust
English: • Advanced breast cancer when certain other treatments (standard anthracycline-containing therapy) have been tried but have not worked or when the patient is unsuitable for these treatments.
Slovenian: • napredovalega raka dojke, pri katerem so bile nekatere druge oblike zdravljenja (standardno zdravljenje z antraciklini) neuspešne, ali pri katerih tovrstno zdravljenje ni primerno
English: Efficacy of paclitaxel/cisplatin combination has been demonstrated in two randomised, controlled trials in patients with locally advanced or metastatic NSCLC.
Slovenian: Učinkovitost kombinacije paklitaksela in cisplatina so pokazali pri bolnikih z lokalno napredovalimi ali metastaziranimi nedrobnoceličnim karcinomom pljuč v dveh randomiziranih, nadzorovanih preskušanjih.
English: Women should be advised to use effective means of contraception to avoid becoming pregnant during therapy with Paxene and to inform the treating physician immediately should this occur.
Slovenian: Ženske naj med zdravljenjem z zdravilom Paxene za preprečevanje zanositve uporabljajo zanesljive oblike kontracepcije; če vseeno zanosijo, naj o tem takoj obvestijo svojega zdravnika.
English: • Brain disease
Slovenian: • bolezen možgan
English: Median survival for each paclitaxel-containing arm was not significantly different compared to etoposide/cisplatin (p= 0.097 and 0.090 for high-dose paclitaxel and low-dose paclitaxel, respectively).
Slovenian: Mediana preživetja v vseh skupinah, ki so prejemale paklitaksel, ni bila značilno različna od tistih, ki so prejemale etopozid/cisplatin (p= 0,097 za skupino, ki je prejemala velik odmerek paklitaksela, in 0,090 za skupino, ki je prejemala majhen odmerek paklitaksela).
English: Severe neuropathy and severe paraesthesia occurred in 3 % and 5 % of patients, respectively.
Slovenian: Huda nevropatija se je pojavila pri 3 %, huda parestezija pa pri 5 % bolnikov.
English: In NSCLC and ovarian cancer patients treated with paclitaxel over 3 hours followed by cisplatin, there is an apparent increase in the incidence of severe neurotoxicity.
Slovenian: Pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki so jih 3 ure zdravili s paklitakselom in nato s cisplatinom, je porast pogostosti hude nevrotoksičnosti očiten.
English: An in-line filter with a microporous membrane not greater than 0.22 µm should be attached to the intravenous tubing during infusion of Paxene (see section 6.6).
Slovenian: Na intravensko cevko mora biti med infundiranjem zdravila Paxene v sistem vgrajen filter z membrano z mikroporami, ki niso večje od 0,22 (glejte poglavje 6.6).
English: • Advanced ovarian cancer when certain other treatments (platinum-containing combination therapy without taxanes) have been tried but have not worked (as second-line treatment).
Slovenian: • napredovalim rakom jajčnika, pri katerem so bile nekatere druge oblike zdravljenja (s platino, ki ne vključuje taksanov) neuspešne, kot zdravljenje drugega izbora
English: Very rare*: bowel obstruction, bowel perforation, pseudomembranous colitis, ischemic colitis, mesenteric thrombosis, necrotising enterocolitis, oesophagitis, ascites, acute pancreatitis
Slovenian: Zelo redki*: obstrukcija črevesa, perforacija črevesa, psevdomembranski kolitis, ishemični kolitis, mezenterična tromboza, nekrotični enterokolitis, ezofagitis, ascites, akutni
English: Following an infusion of Paxene, the patients' performance at skilled tasks such as driving and operating machines may be impaired due to the alcohol content of Paxene (see section 4.4).
Slovenian: Ker zdravilo Paxene vsebuje alkohol, so lahko po infundiranju pri bolnikih zmanjšane sposobnosti izvajanja določenih spretnosti kot sta vožnja in upravljanje s stroji (glejte poglavje 4.4).
English: Although other dose regimens/combinations are under investigation, a combination regimen of Paxene and cisplatin is recommended.
Slovenian: Napredovali karcinom jajčnikov (zdravljenje prvega izbora) Čeprav druge režime odmerjanj in kombinacije še raziskujejo, se priporoča kombinacija zdravila Paxene in cisplatina.
English: Your continued treatment will depend on the results of your blood tests showing that it is safe to carry on with your treatment.
Slovenian: Nadaljevanje zdravljenja bo odvisno od rezultatov krvnih preiskav, ki bodo pokazale, ali je zdravljenje varno nadaljevati.
English: During treatment, you should tell the medical staff if you feel unwell.
Slovenian: Če se med zdravljenjem ne počutite dobro, o tem obvestite zdravstveno osebje.
English: There was no advantage in survival (9.5 vs. 9.9 months) or progression free survival (5.1 vs. 5.0 months) with cisplatin/paclitaxel vs cisplatin/tenoposide.
Slovenian: Pri primerjavi cisplatina/paklitaksela in cisplatina/tenopozida ni bilo prednosti pri preživetju (9,5 v primerjavi z 9,9 meseca) ali preživetja brez progresije (5,1 v primerjavi s 5,0 meseci).
English: In patients treated with paclitaxel severe conduction abnormalities are rare.
Slovenian: Pri bolnikih, ki se zdravijo s paklitakselom, so hude motnje prevodnosti redke.
English: Peripheral neuropathy was the cause of paclitaxel discontinuation in a few cases.
Slovenian: V nekaj primerih je bila periferna nevropatija razlog prekinitve zdravljenja s paklitakselom.
English: In the second study, 599 patients with stage IIIB or IV disease were randomised to receive cisplatin (75 mg/m2) and etoposide (100 mg/m2; n= 200), or cisplatin (75 mg/m2) and low-dose paclitaxel (135 mg/m2; n= 198), or cisplatin (75 mg/m2) and high-dose paclitaxel (250 mg/m2) with G-CSF (n= 201).
Slovenian: V drugi študiji so naključno razporedili 599 bolnikov s stopnjo bolezni IIIB ali IV tako, da so prejemali cisplatin (75 mg/m2) in etopozid (100 mg/m2; n= 200), ali cisplatin (75 mg/m2) ter majhne odmerke paklitaksela (135 mg/m2; n= 198) ali pa cisplatin (75 mg/m2) in velike odmerke paklitaksela (250 mg/m2) z G-CSF (n= 201).
English: Paxene is contraindicated during lactation.
Slovenian: Zdravilo Paxene je kontraindicirano v času dojenja.
English: Patients with impaired renal function:
Slovenian: Bolniki z zmanjšano ledvično funkcijo:
English: Paxene should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Slovenian: Paxene naj pripravijo in dajo samo osebe, ki so primerno izučene v postopanju s citostatični sredstvi.
English: The major elimination pathway is metabolism followed by biliary excretion; in six patients 39 % to 87 % of an intravenous dose (175 mg/m2) was excreted in faeces and, on average, only 10 % of the dose was excreted as unchanged paclitaxel.
Slovenian: Pri šestih bolnikih se je 39 % do 87 % intravenskega odmerka (175 mg/m2) izločilo z blatom, samo 10 % odmerka pa se je v povprečju izločilo v obliki nespremenjenega paklitaksela.
English: The terminal elimination half-life averaged 23.7 hours
Slovenian: Razpolovni čas popolne izločitve je bil v povprečju 23,7 ure (v intervalu 12 - 33).
English: Common: severe neuropathy (mainly peripheral), dizziness, nervousness, insomnia, depression, abnormal thinking, hypokinesia, abnormal gait, hypaesthesia, taste perversion,
Slovenian: Pogosti: huda nevropatija (večinoma periferna), omotičnost, živčnost, nespečnost, depresija, nenormalno razmišljanje, hipokinezija, nenormalna hoja, zmanjšana sposobnost čutenja,
English: Patients with baseline neutrophil counts < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS) should not receive paclitaxel.
Slovenian: Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3 (< 1.000 celic/mm3 pri AIDS-KS) ne smejo prejemati paklitaksela.
English: Patients with severe hepatic impairment should not be treated with paclitaxel.
Slovenian: Bolnikov s hudo jetrno okvaro ne smemo zdraviti s paklitakselom.
English: Metastatic ovarian cancer (second-line treatment)
Slovenian: Metastatski rak jajčnika (zdravljenje drugega izbora)
English: A single case of heart failure related to Paxene was seen in the AIDS-KS clinical study.
Slovenian: V klinični študiji pri bolnikih z AIDS-KS so opazili en sam primer srčnega popuščanja, ki je povezan z zdravilom Paxene.
English: Injection site reactions including reactions secondary to extravasation were usually mild and consisted of erythema, tenderness, skin discolouration, or swelling at the injection site but can result in cellulitis.
Slovenian: Reakcije na mestu injiciranja, vključno z reakcijami, ki so sekundarne za ekstravazacijo, so bile običajno blage in v obliki eritema, občutljivosti, spremembe barve kože ali otekline na mestu injiciranja, pa tudi celulitisa.
English: Patients with severe neutropenia (< 500 cells/mm3 for 7 days or more) during a course of paclitaxel or neutropenic sepsis should have their dose of paclitaxel reduced for subsequent courses of Paxene therapy (see section 4.2).
Slovenian: Pri bolnikih s hudo nevtropenijo (< 500 celic/mm3 in trajajočo 7 dni ali več) v času zdravljenja s paklitakselom ali z nevtropenično sepso je potrebno v naslednjih ciklih zdravljenja z zdravilom Paxene odmerek palitaksela zmanjšati (glejte poglavje 4.2).
English: The efficacy and safety of Paxene (175 mg/m² over 3 hours at 3-week intervals) in refractory metastatic breast cancer were investigated in 172 women in a multicentre, open-label Phase III trial.
Slovenian: Varnost in učinkovitost zdravila Paxene (175 mg/m² aplicirano v 3 urah vsake 3 tedne) pri neodzivnem metastatskem raku dojke so preučevali pri 172 ženskah v multicentričnem, odprtem preskušanju III. faze.
English: Bleeding episodes related to Paxene were reported in < 3% of patients and bleeding was localised.
Slovenian: O krvavitvah, povezanih z uporabo zdravila Paxene, so poročali pri manj kot 3 % bolnikov, krvavitve pa so bile lokalne.
English: AIDS-related Kaposi's sarcoma
Slovenian: Kaposijev sarkom, povezan z AIDS-om
English: • Nerve disorders including tingling sensation or pins and needles of the hands and feet
Slovenian: • motnje živčevja vključno s ščemenjem ali zbadanjem v dlaneh in stopalih
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Zdravila za parenteralno uporabo je potrebno pred uporabo vizualno pregledati na prisotnost delcev in spremembo barve.
English: • Localised swelling of the skin
Slovenian: • lokalna oteklina kože
English: Patients with impaired hepatic function:
Slovenian: Bolniki z zmanjšano jetrno funkcijo:
English: The usual dose of Paxene is 175 mg/m2 of body surface area, followed by cisplatin every three weeks.
Slovenian: Običajni odmerek zdravila Paxene je 175 mg/m2 telesne površine, nato pa cisplatin vsake tri tedne.
English: Neurotoxicity, mainly peripheral neuropathy, appeared to be more frequent and severe with a 175 mg/m2 3 hour infusion (85 % neurotoxicity, 15 % severe) than with a 135 mg/m2 24 hour infusion
Slovenian: Pri kombinaciji paklitaksela in cisplatina je bila nevrotoksičnost, večinoma periferna nevropatija, pogostejša in hujša pri 3-urni infuziji 175 mg/m2 (85 % nevrotoksičnost, 15 % huda) kot pri 24 urni infuziji 135 mg/m2 (25 % periferalna nevropatija, 3 % huda).
English: In the treatment of NSCLC and the first-line treatment of ovarian cancer, the administration of paclitaxel as a 3 hour infusion in combination with cisplatin resulted in a greater incidence of severe neurotoxicity than both single-agent paclitaxel and cyclophosphamide followed by cisplatin.
Slovenian: Pri zdravljenju nedrobnoceličnega karcinoma pljuč in pri zdravljenju prvega izbora raka jajčnikov je uporaba paklitaksela v obliki 3 urne infuzije v kombinaciji s cisplatinom povzročila večjo pogostost hude nevrotoksičnosti kot posamezna uporaba pklitaksela in ciklofosfamida, ki mu je sledil cisplatin.
English: Very common: neuropathy (mainly peripheral), paraesthesia, somnolence
Slovenian: Zelo pogosti: nevropatija (večinoma periferna), parestezija,
English: Two percent of patients had a platelet count nadir < 50,000 cells/mm3.
Slovenian: Pri dveh odstotkih bolnikov je bilo najnižje število trombocitov < 50.000 celic/mm3.
English: Uncommon: congestive heart failure, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction
Slovenian: asimptomatična ventrikularna tahikardija, tahikardija z bigeminijo, AV- blok in sinkopa, miokardni infarkt
English: The usual dose of Paxene is 175 mg/m2 of body surface area.
Slovenian: Običajen odmerek zdravila Paxene je 175 mg/m2 telesne površine.
English: What Paxene contains
Slovenian: Kaj vsebuje zdravilo Paxene
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
English: • Loss of hearing
Slovenian: • izguba sluha
English: You will be given Paxene every two weeks, as long as the results of your blood tests show that it is safe to carry on with your treatment.
Slovenian: Zdravilo Paxene boste prejeli vsaka dva tedna, dokler bodo rezultati krvnih preiskav kazali, da je varno nadaljevati z zdravljenjem.
English: Rare: pleural effusion, lung fibrosis Very rare*: cough, pulmonary hypertension
Slovenian: Pogosti: dispneja, epistaksa Redki: plevralni izliv, pljučna fibroza Zelo redki*: kašelj, pljučna hipertenzija
English: Paxene should be given before cisplatin when used in combination (see section 4.5).
Slovenian: Pri kombiniranem zdravljenju je bolnikom treba dati zdravilo Paxene pred cisplatinom (glejte poglavje 4.5).
English: Following an infusion of Paxene, the amount of alcohol may impair your ability to drive or use machines.
Slovenian: Po infundiranju zdravila Paxene bo vaša sposobnost vožnje in upravljanja s stroji morda zmanjšana.
English: You will be given Paxene every three weeks, as long as the results of your blood tests show that it is safe to carry on with your treatment.
Slovenian: Zdravilo Paxene boste prejeli vsake tri tedne, dokler bodo rezultati krvnih preiskav kazali, da je varno nadaljevati z zdravljenjem.
English: If Paxene solution comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
Slovenian: Če pride raztopina zdravila Paxene v stik s kožo, je potrebno le-to takoj dobro sprati z milom in vodo.
English: However, if treatment is to be continued in the event of moderate or severe reactions, the dose of paclitaxel should be reduced for subsequent courses of Paxene (see section 4.2).
Slovenian: Če je v primeru zmernih do hudih reakcij treba nadaljevati zdravljenje, je treba pri nadaljnjih krogih zdravljenja z zdravilom Paxene odmerek paklitaksela zmanjšati (glejte poglavje 4.2).
English: Baseline neutrophil count < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS).
Slovenian: Izhodiščno število nevtrofilcev < 1.500 celic/mm3 (< 1.000 celic/mm3 pri bolnikih z AIDS-KS).
English: CAUTION: dilution required
Slovenian: OPOZORILO: potrebno redčiti.
English: The efficacy and safety of Paxene (175 mg/m² over 3 hours repeated at 3-week intervals) in advanced metastatic ovarian cancer were investigated in 120 women in a multicentre, open-label extended Phase II trial.
Slovenian: Varnost in učinkovitost zdravila Paxene (175 mg/m² aplicirano v 3 urah vsake 3 tedne) pri napredovalem metastatskem raku jajčnika so preučevali pri 120 ženskah v multicentričnem, odprtem preskušanju II.
English: This leaflet was last approved in
Slovenian: Navodilo je bilo odobreno {datum}
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg/16.7 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 100 mg/16,7 ml
English: There were three septic episodes (2.8 %) during Paxene administration related to the medicinal product that proved fatal.
Slovenian: Med dajanjem zdravila Paxene je zaradi uporabe tega zdravila prišlo do treh usodnih septičnih epizod (2,8 %).
English: • Severe skin irritation, lesions and rash
Slovenian: • hudo draženje kože, rane in osip
English: AIDS-related Kaposi's sarcoma The recommended dose of Paxene is 100 mg/m2 administered as a 3-hour intravenous infusion every two weeks.
Slovenian: Kaposijev sarkom, povezan z AIDS-om Priporočeni odmerek zdravila Paxene je 100 mg/m2 in se daje v obliki 3 urne intravenske infuzije vsake dva tedna.
English: Common: mild injection site reactions (erythema, tenderness, skin discolouration or swelling, pain, extravasation, can result in cellulitis and skin ulceration), malaise, chest pain, chills, pyrexia
Slovenian: Pogosti: blage reakcije na mestu injiciranja (eritem, občutljivost, spremembe barve kože ali otekline, bolečine, ekstravazacija, pa tudi celulitis in rane na koži), neugodje, bolečine v prsnem košu, mrzlica, pireksija
English: Metastatic breast and ovarian cancer (second-line treatment) The recommended dose of Paxene is 175 mg/m2 administered as a 3-hour intravenous infusion every three weeks.
Slovenian: Metastatski karcinom dojke in jajčnika (zdravljenje druggega izbora) Priporočeni odmerek zdravila Paxene je 175 mg/m2 in se daje v obliki 3 urne intravenske infuzije vsake tri tedne.
English: Chemical, physical and microbial stability of unused, undiluted product remaining in the vial has been demonstrated for up to 28 days when stored below 25 °C.
Slovenian: Kemična, fizična in mikrobna stabilnost neuporabljenega, nerazredčenega zdravila v viali je bila dokazana za obdobje do 28 dni pri shranjevanju do 25 °C.
English: Paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Slovenian: Ker je paklitaksel citotoksično zdravilo za zdravljenje raka, je, tako kot pri drugih potencialno toksičnih snoveh, tudi pri ravnanju z zdravilom Paxene potrebna previdnost.
English: • Mild diarrhoea, constipation and stomach pain
Slovenian: • blaga driska, zaprtje in bolečine v trebuhu
English: Patients experiencing severe reactions should not be rechallenged with the product.
Slovenian: Bolnikov s hudimi reakcijami pri uporabi ne smemo več zdraviti z zdravilom.
English: The recommended dose of Paxene is 175 mg/m2 administered as a 3-hour intravenous infusion, followed by cisplatin at a dose of 80 mg/m2 every three weeks.
Slovenian: Priporočen odmerek 175 mg/m2 zdravila Paxene v obliki 3 urne intravenske infuzije, ki mu sledi cisplatin v odmerku 80 mg/m2 vsake tri tedne.
English: Patients were given a 3 hour infusion of Paxene 100 mg/m² administered every 14 days.
Slovenian: Bolniki so vsakih 14 dni prejeli 3-urno infuzijo zdravila Paxene 100 mg/m2.
English: Response rates strongly favoured the paclitaxel-containing arms [13 %, 30 % and 26 % for the etoposide/cisplatin, high-dose paclitaxel (p< 0.001 vs etoposide/cisplatin) and low-dose paclitaxel regimens (p= 0.003 vs etoposide/cisplatin), respectively].
Slovenian: Stopnje odzivnosti so bile bistveno boljše pri skupinah, ki so prejemale paklitaksel [13 % pri skupini, ki je prejemala etopozid/cisplatin, 30 % pri skupini, ki je prejemala velike odmerke paklitaksela (p < 0,001 v primerjavi s skupino, ki je prejemala etopozid/cisplatin), in 26 % pri skupini, ki je prejemala majhne odmerke paklitaksela (p= 0,003 v primerjavi s skupino, ki je prejemala etopozid/cisplatin)].
English: However, Grade 3 neurotoxicity was significantly more common in the high-dose paclitaxel arm vs. etoposide/cisplatin (40 % vs. 21 %).
Slovenian: Vendar je nevrotoksičnost 3. stopnje bila značilno pogostejša pri skupini, ki je prejemala velike odmerke paklitaksela (40 %), kot pri skupini, ki je prejemala etopozid/cisplatin (21 %).
English: A.
Slovenian: KS).
English: A greater proportion of paclitaxel-treated patients had improvements in short-term QoL.
Slovenian: Kratkoročna kakovost življenja se je izboljšala pri večjem deležu bolnikov, ki so prejemali paklitaksel.
English: If Paxene contacts mucous membranes, the membranes should be flushed thoroughly with water.
Slovenian: Če pride zdravilo Paxene v stik s sluznicami, je le-te potrebno dobro sprati z vodo.
English: Advanced ovarian cancer (first-line treatment)
Slovenian: Napredovali rak jajčnikov (zdravljenje prvega izbora)
English: Very common: asthenia, pain, oedema including peripheral
Slovenian: Zelo pogosti: astenija, bolečine, edem vključno z perifernim edemom in edemom lica
English: Severe hepatic impairment.
Slovenian: Hudo jetrno popuščanje.