FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited information to support treatment of this condition.
Slovenian: Omejeni podatki o učinkovitosti podpirajo to indikacijo
English: According to the duration of infusion, two dose regimes of Paxene are recommended: Paxene 175 mg/m2 administered as a 3-hour intravenous infusion, followed by cisplatin 75 mg/m2 every three weeks or Paxene 135 mg/m2 as a 24-hour infusion, followed by cisplatin 75 mg/m2 every three weeks.
Slovenian: Glede na trajanje infundiranja se priporočata dva režima odmerjanja zdravila Paxene: 175 mg/m2 zdravila Paxene, v obliki 3 urne intravenske infuzije, nato 75 mg/m2 cisplatina vsake tri tedne, ali 135 mg/m2 zdravila Paxene v obliki 24 urne infuzije ter nato 75 mg/m2 cisplatina vsake tri tedne.
English: NonPVC containing administration sets, such as those which are polyethylene-lined, should be used.
Slovenian: Uporabljati je potrebno komplete za aplikacijo, ki ne vsebujejo PVC in so npr. izdelani iz polietilena.
English: Advanced non-small cell lung cancer
Slovenian: Napredovali nedrobnocelični rak pljuč
English: Pharmacokinetic parameters of paclitaxel at 175 mg/m2 given over 3 hours in 13 patients with breast cancer were as follows: maximum concentration (Cmax) was 3,890 ng/ml, area under the plasma concentration vs. time curve (AUClast) was 14,090 ng/h/ml and clearance (CL) was 13.3 l/h/m2.
Slovenian: Farmakokinetični parametri paklitaksela pri odmerku 175 mg/m2, apliciranem v 3 urah 13 bolnicam z rakom dojke, so bili naslednji: največja koncentracija (Cmax) je bila 3.890 ng/ml, površina pod krivuljo plazemskih koncentracij v odvisnosti od časa (AUClast) je bila 14.090 ng/h/ml, očistek (CL) pa 13,3 l/h/m2.
English: • Dehydration, weight loss or weight gain
Slovenian: • dehidracija, znižanje ali zvišanje telesne mase
English: Patients who experience mucositis (Grade 2 or worse) during Paxene therapy should have their dose reduced by 25 % for subsequent courses of Paxene.
Slovenian: Bolnicam, pri katerih se med zdravljenjem z zdravilom Paxene pojavi vnetje sluznice (2. stopnje ali hujši), moramo v naslednjih krogih zdravljenja z zdravilom Paxene odmerek zmanjšati za 25 %.
English: Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
Slovenian: Pri pojavu prevelikega odmerjanja je potrebno bolnika natančno spremljati, zdravljenje pa mora biti usmerjeno predvsem k glavnim predvidenim oblikam toksičnosti in sicer supresiji kostnega mozga, vnetju sluznic in periferni nevropatiji.
English: No known antidote exists for Paxene overdose.
Slovenian: Za preveliko odmerjanje zdravila Paxene ni znanega antidota.
English: Medis, d.o.o Tel: + 386 1 589 69 00
Slovenian: Tel: + 386 1 589 69 00
English: • Severe infections such as pneumonia
Slovenian: • hude okužbe kot je pljučnica • huda anemija
English: Paxene 6 mg/ml concentrate for solution for infusion Paclitaxel
Slovenian: Paxene 6 mg/ml koncentrat za raztopino za infundiranje paklitaksel
English: Pharmacokinetic parameters of paclitaxel at 175 mg/m2 given over 3 hours in 5 patients with breast cancer and 3 patients with ovarian cancer were as follows: maximum concentration (Cmax) was 4,213 ng/ml, area under the plasma concentration vs. time curve (AUClast) was 12,603 ng·h/ml and clearance (CL) was 20.4 l/h/m2.
Slovenian: Farmakokinetični parametri paklitaksela pri odmerku 175 mg/m2, apliciranem v 3 urah 5 bolnicam z rakom dojke in 3 bolnicam z rakom jajčnika, so bili naslednji: največja koncentracija (Cmax) je bila 4.213 ng/ml, površina pod krivuljo plazemskih koncentracij v odvisnosti od časa (AUClast) je bila 12.603 ng·h/ml, očistek (CL) pa 20,4 l/h/m2.
English: Levels of the extractable plasticiser DEHP [di-(2-ethylhexyl)phthalate] increase with time and concentration when dilutions are prepared in PVC containers.
Slovenian: Če so razredčene raztopine pripravljene v vsebnikih iz PVC, koncentracije sproščenega mehčalca DEHP [di-(2-etilheksil)ftalat] naraščajo s časom in koncentracijo, zato uporaba plastičnih vsebnikov in kompletov za aplikacijo iz PVC ni priporočljiva.
English: Myelosuppression appeared to be less frequent and severe with paclitaxel as a 3 hour infusion followed by cisplatin compared with ciclophosphamide followed by cisplatin.
Slovenian: Mielosupresija je bila pri uporabi paklitaksela v obliki 3 urne infuzije, ki ji je sledil cisplatin, redkejša in manj huda kot pri ciklofosfamidu, ki mu je sledil cisplatin.
English: Four pack sizes are available: 30 mg/5 ml vial, 100 mg/16.7 ml vial, 150 mg/25 ml vial and 300 mg/50 ml vial packaged in a carton.
Slovenian: Na voljo so štiri velikosti pakiranja: škatlica 30 mg/5 ml vialo, 100 mg/16,7 ml vialo, 150 mg/25 ml in vialo 300 mg/50 ml zapakiranih v škatlo.
English: The active substance is paclitaxel 6 mg/ml (30 mg/5 ml, 100 mg/16.7 ml, 150 mg/25 ml or 300 mg/50 ml).
Slovenian: Zdravilna učinkovina je paklitaksel 6 mg/ml (30 mg/5 ml, 100 mg/16,7 ml, 150 mg/25 ml ali 300 mg/50 ml).
English: Very common: nausea, vomiting, diarrhoea, mucosal inflammation, constipation, stomatitis, abdominal pain
Slovenian: Zelo pogosti: slabost, bruhanje, diareja, vnetje sluznice, zaprtje, stomatitis, bolečine v trebuhu
English: You will be given this therapy as long as the results of your blood tests show that it is safe to carry on with your treatment.
Slovenian: To zdravljenje boste prejemali, dokler bodo rezultati krvnih preiskav kazali, da je nadaljevanje zdravljenja varno.
English: 4.4 Special warnings and special precautions for use Patients must be routinely premedicated with a corticosteroid, an antihistamine, and an H2-receptor antagonist prior to Paxene to prevent severe hypersensitivity reactions (see section 4.2).
Slovenian: Za preprečevanje hudih preobčutljivostnih reakcij je pri bolnikih pred uporabo zdravila Paxene, potrebno rutinsko izvajanje premedikacije s kortikosteroidom, z antihistaminikom in antagonistom receptorjev H2 (glejte poglavje 4.2)
English: • Experiencing pain while passing urine
Slovenian: • občutek bolečine med odvajanjem seča
English: Adequate data are not available to recommend dose alterations in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro ni na voljo ustreznih podatkov za priporočene prilagoditve odmerkov (glejte poglavji 4.4 in 5.2).
English: Patients who experience severe neutropenia (neutrophils < 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during Paxene therapy should have their dose reduced by 20 % (NSCLC and first-line treatment of ovarian cancer) or 25 % (MBC and MOC) for subsequent courses of Paxene.
Slovenian: Če se med zdravljenjem z zdravilom Paxene pri bolnicah pojavi huda periferna nevtropenija (število nevtrofilcev < 500 celic/mm3 in traja teden dni ali več), ali huda periferna nevropatija, je potrebno pri naslednjih ciklih zdravljenja odmerke zmanjšati za 20 % (pri pljučnem karcinomu ne-majhnih celic in prvem zdravljenju raka jajčnika) ali 25 % (MBC in MOC).
English: Common: vasodilatation (flushing) Uncommon: thrombophlebitis, hypertension, thrombosis Very rare*: shock
Slovenian: Zelo pogosti: hipotenzija Pogosti: vazodilatacija (vročinski oblivi) Občasni: tromboflebitis, hipertenzija, tromboza Zelo redki*: šok
English: The active substance of Paxene is paclitaxel.
Slovenian: Zdravilna učinkovina zdravila Paxene je paklitaksel.
English: When administered as a 3 hour infusion for the first-line chemotherapy of ovarian cancer, neurotoxicity, arthralgia/myalgia, and hypersensitivity were reported as more frequent and severe by patients treated with paclitaxel followed by cisplatin than patients treated with ciclophosphamide followed by cisplatin.
Slovenian: Pri uporabi v obliki 3 urne infuzije kot kemoterapija prvega izbora pri zdravljenju raka jajčnikov so pri bolnikih, ki so jih zdravili najprej s paklitakselom in nato s cisplatinom, poročali o pogostejši ter hujši nevrotoksičnosti, artralgiji/mialgiji in preobčutljivosti kot pri bolnikih, ki so jih zdravili s ciklofosfamidom in nato s cisplatinom.
English: Patients who experience severe neutropenia (neutrophils < 500 cells/mm3 for a week or longer), severe peripheral neuropathy or mucositis (Grade 3 or worse) during Paxene therapy should have their dose reduced by 25 % to 75 mg/m2 for subsequent courses of
Slovenian: Pri bolnikih, pri katerih med zdravljenjem z zdravilom Paxene nastopi huda nevtropenija (nevtrofilci < 500 celic/mm3 za teden ali več), huda periferna nevropatija ali vnetje sluznice (3. stopnje ali hujše), moramo odmerek v nadaljnjih krogih zdravljenja z zdravilom Paxene zmanjšati za 25 % na 75 mg/m2.
English: Do not store above 25 oC.
Slovenian: Shranjujte pri temperature do 25 ºC.
English: Advanced non-small cell lung carcinoma
Slovenian: Napredovali nedrobnocelični karcinom pljuč
English: When given as a longer infusion, increased myelosuppression may be seen in patients with moderate to severe hepatic impairment.
Slovenian: Pri bolnikih z zmerno do hudo jetrno okvaro lahko pri dajanju daljše infuzije opazimo zvečano mielosupresijo.
English: In the first trial, over 650 patients with stage IIb-c, III or IV primary ovarian cancer received a maximum of 9 treatment courses of paclitaxel (175 mg/m2
Slovenian: V prvem preskušanju je več kot 650 bolnic s primarnim rakom jajčnikov faze IIb-c, III ali IV prejelo največ 9 krogov zdravljenja s paklitakselom (175 mg/m2 v 3 urah) in nato cisplatin (75 mg/m2) ali kontrolo.
English: AIDS-related Kaposi's sarcoma Courses of Paxene should not be repeated until the neutrophil count is at least 1,000 cells/mm3 and the platelet count is at least 75,000 cells/mm3.
Slovenian: Postopkov zdravljenja z zdravilom Paxene ne smemo ponoviti, dokler ni število nevtrofilcev vsaj 1.000 celic/mm3, število trombocitov pa vsaj 75.000 celic/mm3.
English: België/Belgique/Belgien S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
Slovenian: België/Belgique/Belgien S.A. Mayne Pharma (Benelux) N.V.
English: Sensory symptoms have usually improved or resolved within months of paclitaxel discontinuation.
Slovenian: Po nekaj mesecih po prekinitvi zdravljenja s paklitakselom so se senzorični simptomi navadno izboljšali ali so izginili.
English: • Severe anaemia
Slovenian: Občasni: huda anemija
English: Paxene is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Slovenian: Ker je Paxene zdravilo z delovanjem na novotvorbe, je, tako kot pri drugih potencialno toksičnih snoveh, tudi pri ravnanju z njim potrebna previdnost.
English: Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before you receive treatment with Paxene.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo Pred začetkom zdravljenja z zdravilom Paxene povejte svojemu zdravniku, če ste noseči, mislite, da ste noseči ali če dojite.
English: AIDS-related Kaposi's sarcoma, the maximum concentrations ranged from 761 to 2,860 ng/ml (mean 1,530) and average area under the plasma concentration vs. time curve (AUC) was 5,619 ng/h/ml (range 2,609 - 9,428).
Slovenian: Po intravenskem odmerku 100 mg/m2, ki ga je s triurno infuzijo dobilo 19 bolnikov, ki imajo z aidsom povezan Kaposijev sarkom, se je največja koncentracija gibala v intervalu od 761 do 2860 ng/ml (kar pomeni 1530), povprečna površina pod koncentracijo plazme v primerjavi s časovno krivuljo (AUC) pa je bila 5619 ng h/ml (v intervalu 2609 - 9428).
English: Metastatic breast or ovarian cancer
Slovenian: Metastatski rak dojke ali jajčnika
English: • Pain and swelling might occur around the injection site
Slovenian: • okoli mesta injiciranja se lahko pojavijo bolečine in oteklina
English: Paxene should be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion, glucose 50 mg/ml (5%) solution for injection, or glucose 50 mg/ml (5%) in Ringer's solution for injection to a final concentration of 0.3 to 1.2 mg/ml.
Slovenian: Zdravilo Paxene je treba razredčiti do končne koncentracije 0,3 do 1,2 mg/ml v natrijevem kloridu 9 mg/ml (0,9 %) raztopini za infundiranje, glukozi 50 mg/ml (5 %) raztopini za injiciranje ali glukozi 50 mg/ml (5 %) v Ringerjevi raztopini za injiciranje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 100 mg/16.7 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI ZA PAXENE 100 mg/16,7 ml
English: • Increase in heart beat
Slovenian: • zvišan srčni utrip
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 30 mg/5 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 30 mg/5 ml
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 150 mg/25 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 150 mg/25 ml
English: The following adverse reactions relate to 166 MBC and 120 MOC patients treated with 175 mg/m2
Slovenian: Navedeni neželeni učinki se nanašajo na 166 bolnic z MBC in 120 bolnic z MOC, pri katerih so v dveh kliničnih študijah kot zdravljenje drugega izbora uporabili 175 mg/m2 zdravila Paxene v obliki 3
English: Very rare*: confusional state
Slovenian: Redki*: eritem
English: • Flu-like symptoms
Slovenian: • gripi podpbni simptomi
English: Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle.
Slovenian: Pri pripravi lahko raztopina postane motna, k čemur prispeva predvsem sestava topila.
English: • Abdominal pain caused by a build up of fluid in the abdomen (ascites), inflammation of the bowel, bowel obstruction, blood clots in the blood vessels to your bowel and perforation of your bowel wall
Slovenian: obstrukcija črevesja, krvni strdki v krvnih žilah do vašega črevesja in perforacija črevesne stene
English: • Feeling faint
Slovenian: • občutek omedlevanja
English: Very rare*: sensorineural hearing loss, vertigo
Slovenian: Pogosti: tinitus Zelo redki*: senzorinevralna izguba sluha, vrtoglavica
English: BATCH NUMBER Batch Number:
Slovenian: ŠTEVILKA SERIJE Serija:
English: Paediatric use:
Slovenian: Uporaba pri otrocih:
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Polyoxyl castor oil
Slovenian: 6.1 Seznam pomožnih snovi makrogolglicerol ricinolat citronska kislina (brezvodna) etanol
English: • Feeling or being sick
Slovenian: • občutek slabosti ali slabost
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 300 mg/50 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 300 mg/50 ml
English: Moderate to severe mucositis is uncommon with the recommended dose and schedule of Paxene.
Slovenian: Zmerna do huda oblika vnetja sluznice se pri priporočenih odmerkih in razporeditvi odmerkov zdravila Paxene pojavlja občasno.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (100 mg of paclitaxel in 16.7 ml)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 6 mg/ml paklitaksela (100 mg paklitaksela v 16,7 ml).
English: Increased neurotoxicity, arthralgia/myalgia but reduced myelosuppression were observed in advanced ovarian cancer patients administered 3 hour infusion paclitaxel/cisplatin as compared with patients who received ciclophosphamide/cisplatin.
Slovenian: Pri bolnicah z napredovalim rakom jajčnikov, ki so jim dajali 3 urno infuzijo paklitaksela/cisplatina, so v primerjavi z bolniki, ki so prejemali ciklofosfamid/cisplatin, opazili povečano nevrotoksičnost in artralgijo/mialgijo ter zmanjšano mielosupresijo.
English: Very common: arthralgia, myalgia Common: bone pain, leg cramps, myasthenia, back pain
Slovenian: Zelo pogosti: artralgija, mialgija Pogosti: bolečine v kosteh, krči v nogah, miastenija, bolečine v križu
English: Advanced breast cancer and ovarian cancer (second-line therapy)
Slovenian: Napredovali rak dojke in jajčnika (zdravljenje drugega izbora)
English: 20 ml clear glass (type I) vial fitted with a flip-off cap, containing 100 mg of concentrate.
Slovenian: 20 ml viala iz prozornega stekla (tip I) z dvižno zaporko, ki vsebuje 100 mg koncentrata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 150 mg/25 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI ZA PAXENE 150 mg/25 ml
English: Adequate data are not available to recommend dose alterations in patients with mild to moderate hepatic impairments (see section 4.2).
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro ni na voljo ustreznih podatkov za priporočene prilagoditve odmerkov (glejte poglavje 4.2).
English: The second major trial evaluated a maximum of 6 courses of either paclitaxel (135 mg/m² over 24 hours) followed by cisplatin (75 mg/m²) or control in over 400 patients with stage III/IV primary ovarian cancer, with a > 1 cm residual disease after staging laparotomy, or with distant metastases.
Slovenian: V drugem večjem preskušanju so pri več kot 400 bolnicah s primarnim rakom jajčnikov faze III/IV, z a > 1centimetrsko osnovno boleznijo po lapratomiji ali z oddaljenimi metastazami, ocenili do 6 krogov zdravljenja s paklitakselom (135 mg/m2 v 24 urah) in nato cisplatinom (75 mg/m2) ali kontrolo.
English: 5 ml clear glass (type I) vial fitted with a flip-off cap, containing 30 mg of concentrate.
Slovenian: 5 ml viala iz prozornega stekla (tip I) z dvižno zaporko, ki vsebuje 30 mg koncentrata.
English: Possible side effects 5 How to store Paxene Further information
Slovenian: Shranjevanje zdravila Paxene Dodatne informacije
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastialnega prostora
English: It is unknown whether paclitaxel is excreted in human milk.
Slovenian: Ni znano, ali se paklitaksel pri človeku izloča v mleko, zato je treba med zdravljenjem z zdravilom Paxene dojenje prekiniti.
English: Cardiac conduction abnormalities and arrhythmias
Slovenian: Motnje prevodnosti srca in aritmije
English: METHOD OF ADMINISTRATION Intravenous use Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite navodilo za uporabo.
English: NAME OF THE MEDICINAL PRODUCT Paxene 6 mg/ml concentrate for solution for infusion paclitaxel
Slovenian: IME ZDRAVILA Paxene 6 mg/ml koncentrat za raztopino za infundiranje
English: Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for 24 hours when stored below 25 ºC.
Slovenian: Po razredčitvi je bila kemična in fizična stabilnost v polipropilenskih infuzijskih vrečkah dokazana 24 ur pri shranjevanju do 25 ºC.
English: Additionally, in Paxene MBC and MOC studies tachycardia, palpitation and syncope were observed.
Slovenian: V študijah uporabe zdravila Paxene pri MBC in MOC so opazili tahikardijo, palpitacije in sinkope, zato je v prvih urah infundiranja zdravila Paxene priporočljivo pogosto spremljanje življenjskih funkcij.
English: Very common: hypotension
Slovenian: Zelo pogosti: huda nevtropenija,
English: 30 ml clear glass (type I) vial fitted with a flip-off cap, containing 150 mg of concentrate.
Slovenian: 30 ml viala iz prozornega stekla (tip I) z dvižno zaporko, ki vsebuje 150 mg koncentrata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 30 mg/5 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI ZA PAXENE 30 mg/5 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (30 mg of paclitaxel in 5 ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 6 mg/ml paklitaksela (30 mg paklitaksela v 5 ml).
English: EXPIRY DATE Use by:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 300 mg/50 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI ZA PAXENE 300 mg/50 ml
English: Luxembourg/Luxemburg S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
Slovenian: Luxembourg/Luxemburg S.A. Mayne Pharma (Benelux) N.V.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CAUTION: dilution required For single use only
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: Consequently, Paxene should be administered with caution in patients receiving protease inhibitors as concomitant therapy.
Slovenian: O medsebojnem delovanju z drugimi zaviralci proteaz ni na voljo dovolj podatkov, zato je pri bolnikih, ki se sočasno zdravijo z zaviralci proteaz, treba zdravilo Paxene dajati previdno.
English: Common: dyspnoea, epistaxis
Slovenian: Pogosti: disurija
English: Paxene administered as a 3-hour infusion as second-line chemotherapy in two clinical studies and were considered possibly or probably related to Paxene.
Slovenian: urne infuzije, in za katere menijo, da so morebiti ali verjetno povezani z zdravilom Paxene.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 6 mg/ml of paclitaxel (30 mg of paclitaxel in 5 ml or 100 mg of paclitaxel in 16.7 ml or 150 mg of paclitaxel in 25 ml or 300 mg of paclitaxel in 50 ml).
Slovenian: Ena viala vsebuje 6 mg/ml paklitaksela (30 mg paklitaksela na 5 ml, 100 mg paklitaksela na 16,7 ml, 150 mg paklitaksela na 25 ml ali 300 mg paklitaksela na 50 ml).
English: 50 ml clear glass (type I) vial fitted with a flip-off cap, containing 300 mg of concentrate.
Slovenian: 50 ml viala iz prozornega stekla (tip I) z dvižno zaporko, ki vsebuje 300 mg koncentrata.
English: • Nose bleeds
Slovenian: • bledica
English: Very rare side- effects are listed below:
Slovenian: Zelo redki neželeni učinki so našteti spodaj:
English: Tel: + 33 1 41 11 28 50
Slovenian: Mayne Pharma (France) SAS Tel: + 33 1 41 11 28 50
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (150 mg of paclitaxel in 25 ml)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 6 mg/ml paklitaksela (150 mg paklitaksela v 25 ml).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Paxene 6 mg/ml concentrate for solution for infusion paclitaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Paxene 6 mg/ml koncentrat za raztopino za infundiranje paklitaksel
English: Two doses of Paxene may be given: Paxene 175 mg/m2 of body surface area administrated as a 3 hour infusion into a vein, followed by another medicine, cisplatin, every three weeks; alternatively Paxene 135 mg/m2 given as a 24 hour infusion, followed by cisplatin, every three weeks.
Slovenian: 3 urne infuzije v veno in nato drugo zdravilo, cisplatin, vsake tri tedne; drugo odmerjanje je 135 mg/m2 zdravila Paxene v obliki 24 urne infuzije in nato vsake tri tedne cisplatin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (300 mg of paclitaxel in 50 ml)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 6 mg/ml paklitaksela (300 mg paklitaksela v 50 ml).
English: • Vision disturbances
Slovenian: • motnje vida
English: You should be able to drive and use machines between your treatments with Paxene, unless you feel tired or dizzy
Slovenian: Če ne občutite utrujenosti ali omotičnosti, bi lahko med dvema zdravljenjema z zdravilom Paxene vozili in upravljali s stroji.
English: • Discolouration of stool
Slovenian: • obarvano blato
English: • Reddening or flushing of your skin
Slovenian: • pordelost ali oblivanje obraza
English: Uncommon side-effects are listed below:
Slovenian: Občasni neželeni učinki so našteti spodaj:
English: Therefore, frequent complete blood counts should be performed on all patients during treatment.
Slovenian: Paklitaksel povzroča supresijo kostnega mozga, predvsem nevtropenijo, zato je med zdravljenjem pri vseh bolnikih potrebno pogosto kontrolirati celotno krvno sliko.
English: Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for at least 24 hours when stored below 25 °C.
Slovenian: Po redčenju se fizikalna in kemijska stabilnost v polipropilenskih infuzijskih vrečah ohrani 24 ur, če so shranjene pri temperaturi do 25 °C.
English: • Feeling dizzy
Slovenian: • trajna driska