FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Metastatisk bryst- og ovariekræft (andetvalgsbehandling) Den anbefalede dosis Paxene er 175 mg/m2 givet som en 3-timers intravenøs infusion hver tredje uge.
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.
Danish: Patienter, der oplever alvorlig neutropeni (neutrofile granulocytter < 500 celler/mm3 i en uge eller mere) eller alvorlig perifer neuropati under behandling med Paxene, bør få reduceret deres dosis med 20 % (NSCLC og førstevalgsbehandling af ovariekræft) eller 25 % (MBC og MOC) ved efterfølgende behandlinger med Paxene.
English: The terminal elimination half-life averaged 23.7 hours
Danish: Den terminale udskillelseshalveringstid var gennemsnitligt på 23,7 timer (variation 12 - 33).
English: • Itching, red skin rash
Danish: • Kløende, rødt hududslæt
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).
Danish: Aktivt stof: paclitaxel 6 mg/ml (30 mg/5 ml, 100 mg/16,7 ml, 150 mg/25 ml eller 300 mg/50 ml).
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.
Danish: Et hætteglas indeholder polyoxyl-ricinusolie: 527 mg/ml og vandfri ethanol; 49,7 v/v% Alle hjælpestoffer er anført under pkt.
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).
Danish: Patienter med alvorlig neutropeni (< 500 celler/mm3 i 7 dage eller mere) under et forløb med paclitaxel eller neutropeni-sepsis bør have deres dosis af paclitaxel nedsat i de efterfølgende behandlinger med Paxene (se pkt.
English: Paxene 6 mg/ml concentrate for solution for infusion Paclitaxel
Danish: Paxene 6 mg/ml koncentrat til infusionsvæske, opløsning paclitaxel
English: The incidence of Grade 4 neutropenia lasting 7 days or more was 22 %.
Danish: Neutropeni forsvandt efter 35 dage hos alle patienter, der blev fulgt op. Incidensen af grad 4 neutropeni varende 7 dage eller mere var 22 %.
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.
Danish: Den anbefalede dosis Paxene er 175 mg/m2 givet som en 3 timers intravenøs infusion efterfulgt af cisplatin i en dosis på 80 mg/m2 hver tredje uge.
English: Baseline neutrophil count < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS).
Danish: Neutrofiltælling på <1.500 celler/mm3 ved behandlingsstart (<1.000 celler/mm3 for aids-KS).
English: Patients with severe hepatic impairment should not be treated with paclitaxel.
Danish: Patienter med kraftig nedsat leverfunktion bør ikke behandles med paclitaxel.
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.
Danish: Paxene skal blandes op i natriumkloridopløsning til infusion 9 mg/ml (0,9 %), glukoseopløsning til injektion 50 mg/ml (5 %) eller glukose 50 mg/ml (5 %) i Ringer's opløsning til injektion til en endelig koncentration på 0,3 til 1,2 mg/ml.
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).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et indeholder 6 mg/ml paclitaxel (30 mg paclitaxel i 5 ml eller 100 mg paclitaxel i 16.7 ml eller 150 mg paclitaxel i 25 ml eller 300 mg paclitaxel i 50 ml).
English: • Severe skin irritation, lesions and rash
Danish: • Alvorlig hudirritation, læsioner og udslæt
English: Uncommon: congestive heart failure, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction
Danish: Almindelig: Takykardi, palpitation, bradykardi, synkope Ikke almindelig: Kongestiv hjerteinsufficiens, kardiomyopati, asymptomatisk ventrikulær takykardi, takykardi med bigemini, AV-blok og synkope, myokardieinfarkt
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.
Danish: I henhold til varigheden af infusionen anbefales to dosisregimer med Paxene: 175 mg/m2 Paxene givet som en 3 timers intravenøs infusion efterfulgt af 75 mg/m2 cisplatin ever tredje uge eller 135 mg/m2 Paxene som en 24 timers infusion efterfulgt af 75 mg/m2 cisplatin hver tredje uge.
English: Very common: nausea, vomiting, diarrhoea, mucosal inflammation, constipation, stomatitis, abdominal pain
Danish: Meget almindelig: Kvalme, opkastning, diarré, inflammation af mukosa, forstoppelse, stomatitis, mavesmerter
English: Advanced ovarian cancer (first-line treatment)
Danish: Avanceret ovariekræft (førstevalgsbehandling)
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.
Danish: Kemisk, fysisk og mikrobiel stabilitet af uanvendt, ikke opløst lægemiddel der forbliver i hætteglasset er påvist i op til 28 dage ved opbevaring under 25 °C.
English: Very rare*: bowel obstruction, bowel perforation, pseudomembranous colitis, ischemic colitis, mesenteric thrombosis, necrotising enterocolitis, oesophagitis, ascites, acute pancreatitis
Danish: Meget sjælden*: Tarmobstruktion, tarmperforation, pseudomembranøs colitis, iskæmisk colitis, mesenterisk trombose, nekrotiserende enterocolitis, øsofagitis, ascites,
English: Therefore, breast-feeding should be discontinued for the duration of Paxene therapy.
Danish: Amning bør derfor indstilles under behandling med Paxene.
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.
Danish: Farmakokinetiske parametre for paclitaxel ved 175 mg/m2 indgivet over 3 timer hos 13 patienter med brystkræft var som følger: højeste koncentrationer (Cmax) var 3.890 ng/ml, arealet under plasmakoncentrationen vs. tidskurven (AUC) var på 14.090 ng/t/ml og clearance (CL) var på 13,3 l/t/m2.
English: Very common: infection (including herpes simplex, oral candidiasis, pharyngitis, rhinitis) Common: flu syndrome
Danish: Meget almindelig: Infektion (inklusive herpes simplex, oral candidiasis, faryngitis, rhinitis) Almindelig:Influenzasyndrom Ikke almindelig: Kraftige infektioner, septisk shock Sjælden*: Pneumoni
English: BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om blindeskrift
English: Patients with impaired renal function:
Danish: Patienter med nedsat nyrefunktion:
English: Very common: alopecia
Danish: Almindelig: Dysuri
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.
Danish: Du vil få denne behandling, så længe resultaterne af dine blodprøver viser, at det er sikkert at fortsætte behandlingen.
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.
Danish: Farmakokinetiske parametre for paclitaxel ved 175 mg/m2 indgivet over 3 timer hos 5 patienter med brystkræft og hos 3 patienter med ovariekræft var som følger: højeste koncentrationer (Cmax) var 4.213 ng/ml, arealet under plasmakoncentrationen vs. tidskurven (AUC) var på 12.603 ng·t/ml og clearance (CL) var på 20,4 l/t/m2.
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)
Danish: Hyppigheden af bivirkninger anført nedenfor er defineret efter følgende konvention: meget almindelig (forekommer hos flere end 1 ud af 10 patienter) almindelig (forekommer hos mellem 1 og 10 ud af 100 patienter) ikke almindelig (forekommer hos mellem 1 og 10 ud af 1.000 patienter) sjælden (forekommer hos mellem 1 og 10 ud af 10.000 patienter) meget sjælden (forekommer hos færre end 1 ud af 10.000 patienter) ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data)
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
Danish: Patienter, der oplever alvorlig neutropeni (neutrofile granulocytter < 500 celler/mm3 i en uge eller mere), alvorlig perifer neuropati eller mucositis (grad 3 eller værre) under behandling med Paxene, bør få reduceret dosis med 25 % til 75 mg/m² ved efterfølgende behandlinger med Paxene.
English: Contact of the undiluted concentrate with plasticised PVC equipment or devices used to prepare solutions for infusion is not recommended.
Danish: Ufortyndet koncentrat bør ikke komme i kontakt med PVC-udstyr eller udstyr til forberedelse af opløsninger til infusion, der indeholder blødgjort PVC.
English: Pseudomembranous colitis has been rarely reported including cases in patients who have not been concomitantly treated with antibiotics.
Danish: Dette omfatter tilfælde hos patienter, der ikke samtidig er blevet behandlet med antibiotika.
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.
Danish: Behandling med Paxene bør ikke gentages, før antallet af neutrofile granulocytter er mindst 1.000 celler/mm3, og antallet af trombocytter er på mindst 75.000 celler/mm3.
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Danish: Som følge af det store alkoholindhold, kan Paxene ændre virkningen af andre lægemidler.
English: • Brain disease
Danish: • Hjernesygdom
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.
Danish: Du vil modtage Paxene-infusion hver tredje uge, så længe resultaterne af dine blodprøver viser, at det er sikkert at fortsætte behandlingen.
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.
Danish: Du vil modtage Paxene-infusion hver anden uge, så længe resultaterne af dine blodprøver viser, at det er sikkert at fortsætte behandlingen.
English: Paxene may alter the effect of other medicines because of its high alcohol content.
Danish: Som følge af det store alkoholindhold kan Paxene ændre virkningen af andre lægemidler.
English: Common: dry mouth, mouth ulceration, melaena, dyspepsia
Danish: Almindelig: Mundtørhed, mundulceration, melæna, dyspepsi
English: • Abnormal heart rhythm
Danish: • Unormal hjerterytme
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.
Danish: Der findes fire pakningsstørrelser: 30 mg/5 ml hætteglas, 100 mg/16,7 ml hætteglas, 150 mg/25 ml hætteglas og 300 mg/50 ml hætteglas pakket i en karton.
English: Very common: neuropathy (mainly peripheral), paraesthesia, somnolence
Danish: Meget almindelig: Neuropati (hovedsagelig perifer),
English: Medis, d.o.o Tel: + 386 1 589 69 00
Danish: Tel: + 386 1 589 6900
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.
Danish: To doseringer af Paxene kan gives: Paxene 175 mg/m2 kropsoverflade givet som en 3 timers infusion i en vene, efterfulgt af et andet lægemiddel, cisplatin, hver tredje uge; alternativt Paxene 135 mg/m2
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
Danish: I den første afprøvning fik over 650 patienter med stadium IIb-c, II eller IV primær ovariekræft et maksimum på 9 behandlingsforløb med paclitaxel (175 mg/m2 over 3 timer) efterfulgt af cisplatin (75 mg/m2) eller kontrol.
English: 6.6 Instructions for use, handling and disposal For single use only.
Danish: 6.6 Regler for destruktion og anden håndtering
English: België/Belgique/Belgien S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
Danish: België/Belgique/Belgien S.A. Mayne Pharma (Benelux) N.V.
English: Very common: arthralgia, myalgia Common: bone pain, leg cramps, myasthenia, back pain
Danish: Meget almindelig: Artralgi, myalgi Almindelig: Knoglesmerter, benkramper, myasteni, rygsmerter
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).
Danish: Efter en intravenøs dosis på 100 mg/m2 givet som en 3 timers infusion til 19 patienter med aids-relateret Kaposis sarkom varierede de højeste koncentrationer fra 761 til 2.860 ng/ml (gennemsnit 1.530) og gennemsnitsværdien for arealet under plasmakoncentrationen vs. tidskurven (AUC) var på 5.619 ng/t/ml (variation 2.609 - 9.428).
English: Very common: anorexia Uncommon: dehydration, weight loss and gain
Danish: Ikke almindelig: Dehydrering, vægttab og -forøgelse
English: Very common: asthenia, pain, oedema including peripheral
Danish: Meget almindelig: Asteni, smerter, ødemer, herunder perifere ødemer og ansigtsødemer
English: Very common side-effects are listed below:
Danish: Meget almindelige bivirkninger:
English: Rare: pleural effusion, lung fibrosis Very rare*: cough, pulmonary hypertension
Danish: Luftveje, thorax og mediastinum Almindelig: Dyspnø, epistaxis Sjælden: Pleural effusion, lungefibrose Meget sjælden*: Hosten, pulmonal hypertension
English: Very rare side- effects are listed below:
Danish: Meget sjældne bivirkninger:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 100 mg/16.7 ml
Danish: TEKST PÅ KARTON FOR PAXENE 100 mg/16.7 ml
English: Renal and urinary disorders General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: NAME OF THE MEDICINAL PRODUCT Paxene 6 mg/ml concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Paxene 6 mg/ml koncentrat til infusionsvæske, opløsning.
English: • Appearing and acting confused
Danish: • Forvirret adfærd
English: Cardiac conduction abnormalities and arrhythmias
Danish: Ledningsforstyrrelser i hjertet og arytmi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 150 mg/25 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEKST PÅ KARTON FOR PAXENE 150 mg/25 ml
English: The usual dose of Paxene is 175 mg/m2 of body surface area, followed by cisplatin every three weeks.
Danish: Avanceret ikke-småcellet lungekræft Den sædvanlige dosis paxene er 175 mg/m2 kropsoverflade, efterfulgt af cisplatin hver tredje uge.
English: Uncommon: severe elevation in bilirubin * As reported in post-marketing surveillance of paclitaxel.
Danish: * Indberettet ved overvågning af paclitaxel efter markedsføring.
English: BEFORE YOU USE PAXENE
Danish: Du må ikke få Paxene
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Paxene 6 mg/ml concentrate for solution for infusion paclitaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Paxene 6 mg/ml Koncentrat til infusionsvæske, opløsning paclitaxel
English: POSSIBLE SIDE EFFECTS
Danish: Bivirkninger).
English: Very common: severe neutropenia, severe leucopenia, thrombocytopenia, anaemia, myelosuppression Common: neutropenic fever Uncommon: severe anaemia Very rare*: acute myeloid leukaemia, myelodysplastic syndrome
Danish: Ikke almindelig: Alvorlig anæmi Meget sjælden*: Akut myeloid leukæmi, myelodysplastisk syndrom
English: The usual dose of Paxene is 100 mg/m2 of body surface area.
Danish: Aids-relateret Kaposis sarkom Den normale dosis Paxene er 100 mg pr m2 kropsoverflade.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (100 mg of paclitaxel in 16.7 ml)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 6 mg/ml paclitaxel (100 mg paclitaxel i 16.7 ml)
English: lips, mouth, tongue or throat
Danish: Knogler, led, muskler og bindevæv
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 30 mg/5 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEKST PÅ KARTON FOR PAXENE 30 mg/5 ml
English: Your concentrate for solution for infusion will be diluted and given slowly into a vein over about 3 hours unless otherwise stated.
Danish: Koncentratet til infusionsvæske, opløsning fortyndes og indgives langsomt i en åre i løbet af ca.
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
Danish: ekstravasation kan medføre cellulitis og hudulceration), utilpashed, brystsmerter, kulderystelser, pyrexi
English: 20 ml clear glass (type I) vial fitted with a flip-off cap, containing 100 mg of concentrate.
Danish: 20 ml klar glasflaske (type I) med vippelåg, indeholdende 100 mg koncentrat.
English: 5 ml clear glass (type I) vial fitted with a flip-off cap, containing 30 mg of concentrate.
Danish: 5 ml klar glasflaske (type I) med vippelåg, indeholdende 30 mg koncentrat.
English: • Severe anaemia
Danish: • Alvorlig blodmangel (anæmi)
English: Other in use storage times and conditions are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8 oC. Do not use Paxene if you notice any visible particles of discolouration of the solution.
Danish: Andre opbevaringstider og -forhold under brug er på brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 til 8 ºC.
English: 30 ml clear glass (type I) vial fitted with a flip-off cap, containing 150 mg of concentrate.
Danish: 30 ml klar glasflaske (type I) med vippelåg, indeholdende 150 mg koncentrat.
English: Very rare*: hepatic necrosis, hepatic encephalopathy
Danish: Meget sjælden*: levernekrose, leverencefalopati
English: Luxembourg/Luxemburg S.A. Mayne Pharma (Benelux) N.V. Tel: + 32 2 332 0315
Danish: Luxembourg/Luxemburg S.A. Mayne Pharma (Benelux) N.V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 300 mg/50 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE TEKST PÅ KARTON FOR PAXENE 300 mg/50 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (30 mg of paclitaxel in 5 ml).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 6 mg/ml paclitaxel (30 mg paclitaxel i 5 ml).
English: The usual dose of Paxene is 175 mg/m2 of body surface area.
Danish: Avanceret bryst- og ovariekræft (andetvalgsbehandling) Den normale dosis Paxene er 175 mg pr m2 kropsoverflade.
English: Rare side-effect are listed below:
Danish: Sjældne bivirkninger:
English: What Paxene is and what it is used for Before you use Paxene How to use Paxene
Danish: 1 Virkning og anvendelse 2 Det skal du vide om Paxene 3 Sådan bliver du behandlet med Paxene 4 Bivirkninger
English: Tel: + 33 1 41 11 28 50
Danish: Mayne Pharma (France) SAS Tel: + 33 1 41 11 28 50
English: 50 ml clear glass (type I) vial fitted with a flip-off cap, containing 300 mg of concentrate.
Danish: 50 ml klar glasflaske (type I) med vippelåg, indeholdende 300 mg koncentrat.
English: - This medicine has been prescribed for you personally and you should not pass it on to others.
Danish: - Lægen har ordineret Paxene til dig personligt.
English: • are taking any other medicines prescribed by a physician for any condition (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenytoin, phenobarbital);
Danish: • tager anden medicin, der er ordineret af en læge af andre grunde (f.eks. erythromycin, fluoxetin,
English: • Disease of the pancreas
Danish: • Sygdom i bugspytkirtlen
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.
Danish: Efter fortynding, har kemisk og fysisk stabilitet i polypropylene infusionsposer i brug vist sig i mindst 24 timer ved opbevaring under 25 °C.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (150 mg of paclitaxel in 25 ml)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 6 mg/ml paclitaxel (150 mg paclitaxel i 25 ml)
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.
Danish: Den anbefalede dosis Paxene er 100 mg/m2 givet som en 3-timers intravenøs infusion hver anden uge
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (300 mg of paclitaxel in 50 ml)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 6 mg/ml paclitaxel (300 mg paclitaxel i 50 ml)
English: Metastatic breast carcinoma, ovarian cancer and non-small cell lung carcinoma: Courses of Paxene should not be repeated until the neutrophil count is at least 1,500 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
Danish: Behandling med Paxene bør ikke gentages, før antallet af neutrofile granulocytter er mindst 1.500 celler/mm3, og antallet af trombocytter er på mindst 100.000 celler/mm3.
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
Danish: tarmobstruktion, blodpropper i blodkarrene til tarmen og perforation af tarmvæggen
English: Advanced breast cancer and ovarian cancer (second-line therapy)
Danish: ondt i halsen og svampeinfektion i munden (oral candidiasis)
English: - If you have further questions, please ask your doctor or your pharmacist.
Danish: - Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for at least 24 hours below 25 °C.
Danish: Efter fortynding har kemisk og fysisk stabilitet i polypropylen-infusionsposer i brug vist sig i mindst 24 timer ved opbevaring under 25 °C.
English: Excipients
Danish: Hæmatologi
English: Common side-effects are listed below:
Danish: Almindelige bivirkninger:
English: Take special care with Paxene
Danish: SÅDAN BLIVER DU BEHANDLET MED PAXENE
English: HOW TO USE PAXENE
Danish: DET SKAL DU VIDE OM PAXENE
English: • Discolouration of stool
Danish: • Misfarvet afføring
English: CAUTION: dilution required
Danish: FORSIGTIG: Fortynding før brug
English: • Increase in heart beat
Danish: • Forøgelse af hjerterytmen
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/113/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/113/004