FrancophonIA/ELRC3.0 huggingface dataset:
English: In eight published clinical trials (8 Phase III trials) including 4,735 patients with advanced ovarian cancer and in twelve published clinical trials (one large Phase II and eleven Phase III trials) including 4,315 NSCLC patients treated with paclitaxel and platinum-containing regimens, similar undesirable effects were observed compared to single-agent paclitaxel treatment.
Slovenian: V osmih objavljenih kliničnih preskušanjih (8 preskušanjih faze III), v katerih je sodelovalo 4 735 bolnis z napredovalim rakom jajčnikov, in v dvanajstih objavljenih kliničnih preskušanjih (eno veliko preskušanje faze II in enajst preskušanj faze III), v katerih je sodelovalo 4 315 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so jih zdravili s paklitakselom in pripravki, ki vsebujejo platino, so opazili podobne neželene učinke kot pri samostojnem zdravljenju s paklitakselom.
English: Several metabolites have been detected, but only three of them have been identified: 6 alpha-hydroxypaclitaxel, 3'-para-hydroxypaclitaxel and 6 alpha, 3'-para-dihydroxypaclitaxel.
Slovenian: Zaznali so več presnovkov, od katerih so identificirali le tri: 6 alfa-hidroksipaklitaksel, 3'-para-hidroksipaklitaksel in 6 alfa-3'-para-dihidroksipaklitaksel.
English: Also contains: polyoxyl castor oil, citric acid (anhydrous) and 49.7 % (v/v) ethanol.
Slovenian: Vsebuje tudi: makrogolglicerol ricinolat, citronsko kislino (brezvodno) in 49,7 % (v/v) etanola.
English: Formal clinical drug interaction studies have not been performed with Paxene.
Slovenian: Formalne klinične študije medsebojnega delovanja zdravila Paxene z drugimi zdravili niso bile izvedene.
English: • Disease in the oesophagus (the tube that carries food into your stomach)
Slovenian: • bolezen ezofagusa (cevka, po kateri pride hrana v želodec)
English: • Itching, red skin rash
Slovenian: • srbenje, rdeč kožni osip
English: Hypersensitivity to paclitaxel or to any of the excipients.
Slovenian: Preobčutljivost na paklitaksel ali katerokoli pomožno snov.
English: Paxene should be administered via an infusion control device (pump) using non-PVC tubing and connectors.
Slovenian: Zdravilo Paxene je treba dajati prek naprave za kontrolirano infundiranje (črpalke) s PVC ocevjem in konektorji.
English: rare (affects 1 to 10 persons in 10,000) very rare (affects less than 1 person in 10,000) not known (frequency cannot be estimated from the available data
Slovenian: pogosti (prizadenejo 1 do 10 od 100 bolnikov) občasni (prizadenejo 1 do 10 od 1.000 bolnikov) redki (prizadenejo 1 do 10 od 10.000 bolnikov) zelo redki (prizadenejo manj kot 1 od 10.000 bolnikov) neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: • Tell your doctor immediately if you develop severe or prolonged or bloody diarrhoea during or after treatment with Paxene.
Slovenian: • Takoj povejte svojemu zdravniku, če se je med ali po zdravljenju z zdravilom Paxene pri vas pojavila huda, dalj časa trajajoča ali krvava driska.
English: Hypotension, hypertension and bradycardia have been observed during administration of paclitaxel but patients are usually asymptomatic and do not require therapy.
Slovenian: Pri bolnikih so med zdravljenjem s paklitakselom opazili hipotenzijo, hipertenzijo in bradikardijo, vendar pa so bili bolniki običajno asimptomatski in niso potrebovali zdravljenja.
English: Paxene cannot be used in pregnancy, and women receiving Paxene must not breast-feed.
Slovenian: Zdravila Paxene se v času nosečnosti ne sme uporabljati; ženske, ki prejemajo zdravilo Paxene, ne smejo dojiti.
English: Very rare*: acute encephalopathy, autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension),
Slovenian: Zelo redki*: akutna encefalopatija, avtonomna nevropatija (ki povzroča paralitični ileus in ortostatsko hipotenzijo), krči.
English: Since paclitaxel is metabolised by cytochrome P450 isoenzymes CYP 3A4 and 2C8, caution should be exercised with other medicinal products known to inhibit (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals) or induce (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) these enzymes as they may affect the pharmacokinetics of paclitaxel.
Slovenian: Ker se paklitaksel presnavlja z izoencimoma citokromoma P450 CYP 3A4 in 2C8, je potrebna previdnost pri sočasni uporabi z zdravili, ki so znani zaviralci (npr. eritromicin, fluoksetin, gemfibrozil, antimikotiki imidazolskega tipa) ali induktorji (npr. rifampicin, karbamazepin, fenitoin, fenobarbital efavirenz, nevirapin) teh encimov in lahko vplivajo na farmakokinetiko paklitaksela.
English: The efficacy and safety of paclitaxel were evaluated in two major, randomised, controlled trials (vs. ciclophosphamide 750 mg/m2/ cisplatin 75 mg/m2).
Slovenian: Učinkovitost in varnost paklitaksela so ocenili v dveh večjih randomiziranih, nadzorovanih preskušanjih (v primerjavi s 750 mg/m2 ciklofosfamida/75 mg/m2 cisplatina).
English: • Mild allergic reactions including flushing and skin rash
Slovenian: • blage alergijske reakcije vključno z vročicami in kožnim osipom
English: When paclitaxel is given before cisplatin, the safety profile of paclitaxel is consistent with that reported for single-agent use.
Slovenian: Kadar paklitaksel dajemo pred cisplatinom, varnostni profil paklitaksela sovpada z varnostnim profilom, o katerem so poročali pri samostojnem zdravljenju.
English: The clinical response rate was 21.7 % (CI: 14.7 - 31.1 %), median time to progression was 4.1 months (CI: 3.3 - 4.9 months) and the median survival time was 13.4 months (CI: 11.5 - 15.0 months).
Slovenian: Klinični delež odgovorov je bil 21,7 % (CI: 14,7 - 31,1 %), mediana časa do napredovanja bolezni je bila 4,1 meseca (CI: 3,3 - 4,9 mesecev), mediana čas preživetja pa je bila 13,4 meseca (CI: 11,5 - 15,0 mesecev).
English: • are taking any other medicines prescribed by a physician for any condition (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenytoin, phenobarbital);
Slovenian: • jemljete katerokoli drugo zdravilo, ki vam ga je predpisal zdravnik za druge bolezni (npr. eritromicin, fluoksetin, gemfibrozil, antimikotiki imidazolskega tipa, rifampicin, karbamazepin, fenitoin, fenobarbital);
English: Rare*: motor neuropathy (with resultant minor distal
Slovenian: Redki*: motorična nevropatija (s posledično manjšo distalno šibkostjo)
English: The table below lists undesirable effects associated with the administration of single agent paclitaxel as a 3 hour infusion in the metastatic setting (286 patients treated in Paxene clinical studies and 812 patients treated in other paclitaxel clinical studies), and those reported in the postmarketing surveillance of paclitaxel*.
Slovenian: V spodnji tabeli so navedeni neželeni učinki, povezani z uporabo paklitaksela kot samostojnega zdravila v obliki 3 urne infuzije v metastatičnih pogojih (286 bolnikov, zdravljenih v kliničnih študijah z zdravilom Paxene, in 812 bolnikov, zdravljenih s paklitakselom v drugih kliničnih študijah), ter neželeni učinki, o katerih so poročali v postmarketinških raziskavah paklitaksela*.
English: Peripheral neuropathy can occur following the first course and can worsen with increasing exposure to paclitaxel.
Slovenian: Po prvem krogu zdravljenja se lahko pojavi periferna nevropatija, ki se s povečano izpostavljenostjo paklitakselu lahko poslabša.
English: Neuropathy occurred in 18 % of patients treated with Paxene.
Slovenian: Nevropatija se je pojavila pri 18 % bolnikov, ki so jih zdravili z zdravilom Paxene.
English: • Infections such as pneumonia
Slovenian: • okužbe kot je pljučnica
English: • Joint or muscle weakness, pain or loss of sensation in your legs
Slovenian: • oslabelost sklepov ali mišic, bolečina ali izguba občutka v nogah
English: • Changes in your skin and nails
Slovenian: • spremembe kože in nohtov
English: In order to minimise patient exposure to the plasticiser DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Paxene solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Slovenian: Da bi zmanjšali izpostavljenost bolnika mehčalcu DEHP [di-(2-etilheksil)ftalat], ki se sprošča iz PVC infuzijskih vrečk ali kompletov, je potrebno razredčene raztopine zdravila Paxene shranjevati v steklenicah ali plastenkah (polipropilen) ali pa v plastičnih vrečkah (polipropilen, poliolefin) ter jih dajati s pomočjo kompletov za aplikacijo iz polietilena.
English: Procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Slovenian: Potrebno je upoštevati postopke za ustrezno ravnanje in odlaganje citotoksičnih zdravil.
English: The frequency of undesirable effects listed below is defined using the following convention:
Slovenian: Spodaj navedeni neželeni učinki so opredeljeni po pogostosti po naslednji konvenciji:
English: • Temporary low white blood cell count, which may make you develop an infection
Slovenian: • začasna nizka raven levkocitov, zaradi katere se lahko razvije okužba
English: • Fits (convulsions, seizures)
Slovenian: • krči (konvulzije, epileptični napadi)
English: All patients must be pre-medicated with corticosteroids, antihistamines and H2 antagonists prior to Paxene.
Slovenian: Pred uporabo zdravila Paxene je treba vse bolnike predhodno zdraviti s kortikosteroidi, antihistaminiki in antagonisti H2.
English: When paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20 % decrease in paclitaxel clearance.
Slovenian: Kadar paklitaksel dajemo po cisplatinu, je pri bolnikih mielosupresija izrazitejša in pride do približno 20-odstotnega zmanjšanja očistka paklitaksela.
English: The clinical response rate was 18.5 %, median time to progression was 2.8 months (CI: 2.1 - 3.3 months) and the median survival time was 9.9 months (CI: 7.8 - 13.1 months).
Slovenian: Klinični delež odgovorov je bil 18,5 %, mediana časa do napredovanja bolezni je bila 2,8 meseca (CI: 2,1 - 3,3 meseca), mediana preživetja pa je bila 9,9 meseca (CI: 7,8 - 13,1 meseca).
English: The primary endpoint was best tumour response.
Slovenian: Primarna točka ocene učinkovitosti je bila boljša odzivnost tumorja.
English: Preparation for intravenous infusion
Slovenian: Priprava za intravensko infundiranje
English: Among patients (> 50 % on protease inhibitors) with normal baseline liver function, 28 %, 43 % and 44 % had elevations in bilirubin, alkaline phosphatase and AST (SGOT), respectively.
Slovenian: Med bolniki (> 50 % jih je prejemalo zaviralce proteaz) z normalno izhodiščno jetrno funkcijo, je 28 % bolnikov imelo povišan bilirubin, 43 % povišano alkalno fosfatazo in 44 % povišane vrednosti AST (SGOT).
English: Following intravenous administration, plasma concentrations decline in a biphasic or triphasic manner.
Slovenian: Po intravenski aplikaciji je padanje plazemskih koncentracij dvofazno ali trofazno.
English: Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
Slovenian: Zdravilo Paxene vsebuje polietoksilirano ricinusovo olje, ki lahko povzroči alergijsko reakcijo.
English: What Paxene is and what it is used for Before you use Paxene How to use Paxene
Slovenian: Kaj je zdravilo Paxene in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Paxene Kako uporabljati zdravilo Paxene Možni neželeni učinki
English: Paxene should not be used in pregnancy.
Slovenian: Zdravilo Paxene se pri nosečnicah ne sme uporabljati.
English: Male patients treated with Paxene are advised not to father a child during and up to six months after the treatment.
Slovenian: Moškim bolnikom, ki se zdravijo z zdravilom Paxene se priporoča, da ne splodijo otroka med zdravljenjem in do šest mesecev po zdravljenju.
English: • Pain in the bones and back, as well as leg cramps
Slovenian: • bolečine v kosteh in hrbtu ter krči v nogah
English: • Abnormal heart rhythm
Slovenian: • nenormalen srčni ritem
English: What Paxene looks like and contents of the pack
Slovenian: Izgled zdravila Paxene in vsebina pakiranja
English: Severe neutropenia (< 500 cells/mm3) occurred in 26 % of patients treated with Paxene during the entire treatment period.
Slovenian: Huda nevtropenija (< 500 celic/mm3) se je pojavila pri 26 % bolnikov, ki so jih ves čas zdravljenja zdravili z zdravilom Paxene.
English: Grade 2 or 3 peripheral neurotoxicity was observed more commonly with cisplatin/paclitaxel (29 % vs. 6 %).
Slovenian: Periferna nevrotoksičnost 2. in 3. stopnje je bila pri cisplatinu/paklitakselu pogostejša (29 % v primerjavi s 6 %).
English: The overall success rate (complete or partial response) after 15 cycles of treatment was 57 % (CI: 44 - 70 %) in liposomal anthracycline-resistant patients.
Slovenian: Skupna stopnja uspešnosti (popoln ali delni odziv) po 15 krogih zdravljenja pri bolnikih, odpornih proti liposomskim antraciklinom, je bila 57-odstotna (CI 44 - 70 %).
English: Thrombocytopenia was observed in 6 % of patients.
Slovenian: Trombocitopenijo so opazili pri 6 % bolnikov.
English: In the MBC and MOC studies a total of two patients experienced Grade 4 congestive heart failure.
Slovenian: V študijah pri bolnicah z MBC in MOC se je pri dveh bolnicah pojavilo kongestivno srčno popuščanje stopnje 4.
English: For use of cisplatin in treatment of advanced ovarian carcinoma and non-small cell lung carcinoma, please consult the cisplatin Summary of Product Characteristics for information.
Slovenian: Za uporabo cisplatina pri zdravljenju napredovalega karcinoma jajčnikov in nedrobnocličnega karcinoma pljuč glejte Povzetek glavnih značilnosti zdravila za cisplatin.
English: From a microbiological point of view, the diluted product should be used immediately.
Slovenian: Iz mikrobiološkega vidika je treba razredčeno zdravilo porabiti takoj.
English: • High blood pressure, blood clots and inflammation in the veins
Slovenian: • visok krvni pritisk, krvni strdki in vnetje ven
English: OTHER SPECIAL WARNING(S), IF NECESSARY CAUTION: dilution required For single use only.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA OPOZORILO: potrebno redčiti.
English: Use of filter devices which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.
Slovenian: Uporaba pripomočkov za filtriranje, ki imajo kratke cevke, prevlečene s PVC, na dotoku in odtoku ni povzročila pomembnega sproščanja DEHP.
English: Mild electrocardiogram changes have been observed during administration of paclitaxel.
Slovenian: Med dajanjem paklitaksela so opazili blage spremembe na elektrokardiogramu.
English: Patients should be closely monitored for the development of profound myelosuppression (see section 4.2).
Slovenian: Bolnike moramo natančno nadzorovati za razvoj izrazite mielosupresije (glejte poglavje 4.2).
English: Additionally ileus, effects on creatinine clearance, abnormal electrolytes (e.g. hyponatraemia, hypomagnesaemia), hyperglycaemia, cough and pneumonia occurred very rarely.
Slovenian: Poleg tega so se ileus, učinki na očistek kreatinina, nenormalne koncentracije elektrolitov (npr. hiponatremija, hipomagnezemija), hiperglikemija, kašelj in pljučnica pojavili zelo redko.
English: In vitro studies have shown that CYP 2C8 and 3A4 are involved in the formation of 6 alpha-hydroxypaclitaxel and 3'-para-dihydroxypaclitaxel, respectively.
Slovenian: Študije in vitro so pokazale, da pri tvorbi 6 alfa-hidroksipaklitaksela sodeluje CYP 2C8, pri tvorbi 3'-para-hidroksipaklitaksela pa CYP 3A4.
English: Neutropenia was present for > 7 days in 41 % and for 30 - 35 days in 8 % of patients.
Slovenian: Nevtropenijo je 41 % bolnikov imelo manj kot 7 dni, 8 % bolnikov pa 30-35 dni.
English: Severe cardiovascular events were observed more frequently in patients with NSCLC than breast or ovarian carcinoma.
Slovenian: Hude kardiovaskularne dogodke so pogosteje opazili pri bolnikih s nedrobnoceličnim karcinomom pljuč kot pri bolnicah s karcinomom dojke ali jajčnikov.
English: The following discussion refers to two major trials for the first-line chemotherapy of ovarian cancer (paclitaxel plus cisplatin: over 1,050 patients) and two Phase III trials for the treatment of advanced NSCLC (paclitaxel plus cisplatin: over 360 patients) (see section 5.1).
Slovenian: Naslednja razprava se nanaša na dve večji preskušanji zdravljenja prvega izbora raka jajčnikov s kemoterapijo (paklitaksel in cisplatin: več kot 1 050 bolnikov) in dve preskušanji faze III za zdravljenje napredovalega nedrobnoceličnega karcinoma pljuč (paklitaksel in cisplatin: več kot 360 bolnikov) (glejte poglavje 5.1).
English: Thrombocytopenia was observed in 50% of patients, and was severe (< 50,000 cells/mm3) in 9 %.
Slovenian: Trombocitopenijo so opazili pri 50 % bolnikov, pri 9 % teh bolnikov pa je bila huda (< 50.000 celic/mm3).
English: Very common: infection (including herpes simplex, oral candidiasis, pharyngitis, rhinitis) Common: flu syndrome
Slovenian: Zelo pogosti: infekcije (vključno z herpes simplex, oralno kandidiazo, faringitisom, rinitisom)
English: • Advanced AIDS-related Kaposi's sarcoma when certain other treatments (liposomal anthracyclines) have been tried but have not worked.
Slovenian: • napredovalega Kaposikevega sarkoma povezanega z AIDS-om, pri katerem so bile nekatere druge oblike predhodnega zdravljenja (antraciklini v obliki liposomov) neuspešne.
English: Preparation and administration precautions
Slovenian: Priprava zdravila in previdnost pri uporabi
English: Uncommon: severe infections, septic shock Rare*: pneumonia
Slovenian: Občasni: hude infekcije, septični šok Redki*: pljučnica
English: 6 alpha-hydroxypaclitaxel is the major component excreted in faeces.
Slovenian: 6 alfa-hidroksipaklitaksel je glavna spojina, ki se izloča z blatom.
English: Discard any unused contents according to standard practice for cytotoxic agents.
Slovenian: Neporabljeno zdravilo zavrzite v skladu s standardnimi postopki za citotoksične snovi.
English: Anaemia (Hb < 11 g/dL) was observed in 61 % of patients and was severe (Hb < 8 g/dL) in 10 %.
Slovenian: Anemijo (Hb < 11 g/dl) so opazili pri 61 % bolnikov, pri 10 % teh bolnikov pa je bila anemija huda (Hb < 8 g/dl).
English: Uncommon: (delayed) hypersensitivity, significant hypersensitivity reactions requiring therapy (e.g., hypotension, angioneurotic oedema, respiratory distress, generalised urticaria)
Slovenian: Občasni: (odložena) reakcija preobčutljivosti, značilne preobčutljivostne reakcije, ki terjajo zdravljenje (npr. hipotenzija, angionevrotični edem, respiratorna stiska, splošna urtikarija)
English: • If you experience an irregular heart beat, dizziness or faintness during treatment.
Slovenian: • Če med zdravljenjem opazite nepravilno bitje srca, vrtoglavice ali omedlevice.
English: Uncommon: changes in nail pigmentation or discolouration
Slovenian: Občasni: spremembe v pigmentaciji nohtov ali spremembe barve nohtnega ležišča
English: HOW TO USE PAXENE
Slovenian: KAKO UPORABLJATI ZDRAVILO PAXENE
English: Handling and disposa Procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Slovenian: Ravnanje in odlaganje Potrebno je upoštevati postopke za ustrezno ravnanje in odlaganje citotoksičnih zdravil.
English: Severe neutropenia (< 500 cells/mm3) occurred in 20 % and 39% of patients during the first course of treatment and the entire treatment period, respectively.
Slovenian: Huda nevtropenija (< 500 celic/mm3) se je v prvem krogu zdravljenja pojavila pri 20 % bolnikov, med celotnim zdravljenjem pa pri 39 % bolnikov.
English: Metastatic breast cancer
Slovenian: Metastatski rak dojke
English: With respect to progression free survival, highly statistically significant results were noted for the high-dose paclitaxel arm compared with etoposide/cisplatin (p= 0.007).
Slovenian: Pri preživetju brez progresije so pri skupini, ki je prejemala paklitaksel, v primerjavi s skupino, ki je prejemala etopozid/cisplatin, opazili statistično zelo značilne rezultate (p= 0,007).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, sta čas in pogoji shranjevanja pred uporabo odgovornost uporabnika; normalno naj bi zdravilo shranjevali največ 24 ur pri temperaturi 2 do 8 °C, razen če je bilo redčenje izvedeno v nadzorovanih in validiranih aseptičnih pogojih.
English: Others
Slovenian: Ostalo
English: The following undesirable effects relate to 107 AIDS-KS patients treated with 100 mg/m2 Paxene administered as a 3 hour infusion as second-line chemotherapy in a clinical study, and were considered possibly or probably related to Paxene.
Slovenian: Navedeni neželeni učinki se nanašajo na 107 bolnikov z AIDS-KS, pri katerih so v klinični študiji kot kemoterapijo drugega izbora uporabili 100 mg/m2 zdravila Paxene v obliki 3 urne infuzije, in za katere menijo, da so morebiti ali verjetno povezani z zdravilom Paxene.
English: Adequate contraceptive precautions should be used when receiving Paxene.
Slovenian: Med zdravljenjem z zdravilom Paxene je treba uporabljati ustrezno kontracepcijo.
English: • Severe allergic reactions (anaphylactic reaction) - you may experience localised itching and swelling of the hands, feet, ankles, face.
Slovenian: • hude alergijske reakcije (anafilaktična reakcija) - pojavi se lahko lokalno srbenje in oteklost rok, nog, gležnjev, obraza, ustnic, ust, jezika ali grla
English: Bone marrow suppression was the major dose-limiting toxicity of Paxene.
Slovenian: Supresija kostnega mozga je bila glavna oblika toksičnosti, ki omejuje velikost odmerka zdravila Paxene.
English: 30 mg/5 ml
Slovenian: DRUGI PODATKI 30 mg/5 ml
English: Paxene concentrate for solution for infusion must be diluted prior to infusion.
Slovenian: Zdravilo Paxene koncentrat za raztopino za infundiranje je treba pred uporabo razredčiti.
English: Paxene must be diluted under aseptic conditions prior to infusion.
Slovenian: Zdravilo Paxene je treba pred uporabo razredčiti v aseptičnih pogojih.
English: The usual dose of Paxene is 100 mg/m2 of body surface area.
Slovenian: Običajen odmerek zdravila Paxene je 100 mg/m2 telesne površine.
English: • Mild flaking of skin associated with dryness, rash and acne
Slovenian: • blaga luskavost kože, povezana s suho kožo, osipom in aknami
English: Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophil counts recover to ≥ 1,500 cells/mm3 (≥ 1,000 cells/mm3 for AIDS-KS patients) and platelets recover to a level of ≥ 100,000 cells/mm3 (≥ 75,000 cells/mm3 for AIDS-KS patients).
Slovenian: Bolniki ne smejo prejemati naslednjih krogov zdravljenja s pakliksatelom, dokler se število nevtrofilcev ne vrne na ≥ 1.500 celic/mm3 (≥ 1.000 celic/mm3 pri bolnikih z AIDS-KS) in dokler se število trombocitov ne vrne na raven ≥ 100.000 celic/mm3 (≥ 75.000 celic/mm3 pri bolnikih z AIDS
English: Patients with severe hepatic dysfunction should not be treated with paclitaxel.
Slovenian: Bolnikov s hudo jetrno disfunkcijo ne smemo zdraviti s paklitakselom.
English: One vial contains polyoxyl castor oil: 527 mg/ml and ethanol anhydrous; 49.7 v/v% For a full list of excipients, see section 6.1.
Slovenian: Ena viala vsebuje 527 mg/ml makrogolglicerol ricinolata in 49,7-odstotni v/v brezvodni etanol Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Pregnant staff should not handle Paxene.
Slovenian: Nosečnice ne smejo rokovati z zdravilom Paxene.
English: In the rare event of serious conduction abnormalities or arrhythmias, appropriate therapy and continuous cardiac monitoring is recommended during subsequent cycles of therapy.
Slovenian: V redkih primerih hudih anomalij prevodnosti ali aritmij, je potrebno začeti z ustreznim zdravljenjem, v naslednjih ciklih zdravljenja s paklitakselom pa je priporočljivo stalno kardiološko spremljanje bolnika.