FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter hvor alvorlige de er.
English: Adequate contraceptive precautions should be used when receiving Paxene.
Danish: Der skal bruges effektive antikonceptionsmidler, når der modtages behandling med Paxene.
English: • Pale skin
Danish: • Bleg hud
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).
Danish: Den kliniske responsfrekvens var 18,5 %, mediantiden for progression var 2,8 måneder (CI: 2,1 - 3,3 måneder), og medianoverlevelsestiden var 9,9 måneder (CI: 7,8 - 13,1 måneder).
English: • Nerve disorders including tingling sensation or pins and needles of the hands and feet
Danish: • Nervesygdomme inklusive en prikkende fornemmelse eller prikken og stikken i hænder og fødder
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).
Danish: Den kliniske responsfrekvens var 21,7 % (CI: 14,7 - 31,1 %), mediantiden for progression var 4,1 måneder (CI: 3,3 - 4,9 måneder), og medianoverlevelsestiden var 13,4 måneder (CI: 11,5 - 15,0 måneder).
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).
Danish: Hvis behandlingen imidlertid skal fortsætte i tilfælde af moderate eller alvorlige reaktioner, bør doseringen af paclitaxel nedsættes ved de efterfølgende behandlinger med Paxene (se pkt.
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).
Danish: Den følgende diskussion henviser til to større afprøvninger for førstevalgskemoterapi af ovariekræft (paclitaxel plus cisplatin: over 1050 patienter) og to fase III afprøvninger for behandling af fremskreden NSCLC (paclitaxel plus cisplatin: over 360 patienter) (se pkt.
English: Paxene should be administered through an in-line filter with a microporous membrane not greater than 0.22 µm.
Danish: Infusion af Paxene bør foregå gennem et inlinefilter med en mikroporøs membran på højst 0,22 µm.
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.
Danish: Paclitaxel har vist sig at være genotoksisk in vivo (micronucleustest på mus); men det inducerede ikke mutagenicitet i Ames-testen eller Chinese hamster ovary/hydoxantine-guanine phosphoribosyltransferase (CHO/HGPRT) genmutations-testen.
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.
Danish: Følgende er et anbefalet regimen for præ-medicinering: Dexamethason (8 - 20 mg), der gives oralt (12 og 6 timer) eller intravenøst (30 - 60 minutter) forud for Paxene, 10 mg klorfeniramin intravenøst eller en tilsvarende antihistamin 30 til 60 minutter inden Paxene og cimetidin (300 mg) eller ranitidin (50 mg) intravenøst 30 til 60 minutter inden Paxene.
English: Patients experiencing severe reactions should not be rechallenged with the product.
Danish: Patienter, der har udvist en alvorlig reaktion, bør ikke senere behandles med dette produkt.
English: Additionally ileus, effects on creatinine clearance, abnormal electrolytes (e.g. hyponatraemia, hypomagnesaemia), hyperglycaemia, cough and pneumonia occurred very rarely.
Danish: Herudover forekom ileus, virkninger på kreatinin clearance, abnorme elektrolytter (f.eks. hyponatriæmi, hypomagnesiæmi) hyperglykæmi, hosten og pneumoni meget sjældent.
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].
Danish: Responsrater var stærkt i favør af de paclitaxel-indeholdende arme [13 %, 30 % og 26 % for henholdsvis etoposid/cisplatin, højdosis paclitaxel (p<0.001 vs etoposid/cisplatin) og lavdosis paclitaxelregimer (p=0.003 vs. etoposid/cisplatin)].
English: • Flu-like symptoms
Danish: • Influenza-lignende symptomer
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).
Danish: Hvis behandlingen fortsættes, bør doseringen af paclitaxel nedsættes for alle efterfølgende forløb med Paxene (se pkt.
English: Further instructions for preparation for infusion
Danish: Yderligere information vedrørende klargøring til infusion
English: Paxene should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents (see section 6.6).
Danish: Paxene bør kun gives under opsyn af en kvalificeret specialist i onkologi på hospitalsafsnit, der er specialiserede i indgift af cytotoksiske stoffer (se pkt.
English: If Paxene solution comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
Danish: Hvis Paxene-opløsningen kommer i kontakt med huden, skal huden straks vaskes grundigt med sæbe og vand.
English: Hypersensitivity to paclitaxel or to any of the excipients.
Danish: Overfølsomhed over for paclitaxel eller over for et eller flere af hjælpestofferne.
English: Uncommon: (delayed) hypersensitivity, significant hypersensitivity reactions requiring therapy (e.g., hypotension, angioneurotic oedema, respiratory distress, generalised urticaria)
Danish: Ikke almindelig: (Forsinket) overfølsomhed, signifikante overfølsomhedsreaktioner, der kræver behandling (f.eks. hypotension, angioneurotisk ødem, respiratorydistress, generel urticaria)
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).
Danish: • avanceret ovariekræft, når visse andre behandlinger (platinholdig kombinationsterapi uden taxaner) har været anvendt uden resultat (som andetvalgsbehandling).
English: Pregnant staff should not handle Paxene.
Danish: Gravidt personale bør ikke håndtere Paxene.
English: Paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Danish: Paclitaxel er et cytotoksisk kræftlægemiddel, og som med andre potentielt toksiske præparater, bør der tages visse forholdsregler ved håndtering af Paxene.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Parenterale lægemidler skal inspiceres visuelt for partikeldannelse og misfarvning før brug, når opløsning og beholder tillader det.
English: Following an infusion of Paxene, the amount of alcohol may impair your ability to drive or use machines.
Danish: Efter en infusion med Paxene kan din evne til at køre eller betjene maskiner være påvirket pga. mængden af alkohol.
English: • Mild diarrhoea, constipation and stomach pain
Danish: • Mild diarré, forstoppelse og mavesmerter
English: Paxene is contraindicated during lactation.
Danish: Paxene er kontraindiceret under amning.
English: Use of filter devices such as those which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.
Danish: Brug af filterudstyr såsom filtre, der har kort indløbs- og udløbsrør i PVC har ikke resulteret i betydelig udlækning af DEHP.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Citric acid (anhydrous) Ethanol
Danish: Polyoxyl-ricinusolie Citronsyre (vandfri) Ethanol
English: Paxene concentrate for solution for infusion is used to treat:
Danish: Paxene-koncentrat til infusionsvæske, opløsning anvendes til behandling af:
English: Common: vasodilatation (flushing) Uncommon: thrombophlebitis, hypertension, thrombosis Very rare*: shock
Danish: Almindelig: Vasodilatation (rødme) Ikke almindelig: Tromboflebitis, hypertension, trombose Meget sjælden*: Shock
English: Uncommon: changes in nail pigmentation or discolouration
Danish: Ikke almindelig: Forandringer i neglepigmentering eller
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.
Danish: Paxene er en klar, farveløs til let gul, noget tyk opløsning, der leveres i hætteglas indeholdende 5 ml, 16,7 ml, 25 ml og 50 ml koncentrat.
English: However, Grade 3 neurotoxicity was significantly more common in the high-dose paclitaxel arm vs. etoposide/cisplatin (40 % vs. 21 %).
Danish: Grad 3 neurotoksicitet var imidlertid signifikant mere almindelig i højdosis paclitaxel armen vs etoposid/cisplatin (40 % vs 21 %).
English: • Yellowing of the skin and nails
Danish: • Gulfarvning af huden og negle
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).
Danish: Patienter bør ikke genbehandles med efterfølgende cyklusser med paclitaxel, før deres neutrofiltælling kommer tilbage på ≥ 1.500 celler/mm3 (≥ 1.000 celler/mm3 for aids-KS patienter) og leukocyttal når et niveau på ≥ 100.000 celler/mm3 (≥ 75.000 celler for aids-KS patienter).
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).
Danish: Et indbygget filter med en mikroporøs membran på ikke mere end 0,22 μm bør påsættes den intravenøse slange under infusion af Paxene (se pkt.
English: Please tell your doctor before you are given Paxene if you:
Danish: Før du modtager Paxene, skal du fortælle det til din læge, hvis du:
English: Adequate data are not available to recommend dose alterations in patients with mild to moderate hepatic impairments (see section 4.2).
Danish: Der findes ikke tilstrækkelige oplysninger til at anbefale ændringer i dosis for patienter med let til moderat nedsat leverfunktion (se pkt.
English: Consequently, Paxene should be administered with caution in patients receiving protease inhibitors as concomitant therapy.
Danish: Derfor bør Paxene gives med forsigtighed til patienter, der samtidig behandles med proteaseinhibitorer.
English: The other ingredients are polyoxyl castor oil, citric acid (anhydrous) and ethanol.
Danish: Øvrige indholdsstoffer: polyoxyl-ricinusolie, citronsyre (vandfri) og ethanol.
English: In patients treated with paclitaxel severe conduction abnormalities are rare.
Danish: For patienter, der behandles med paclitaxel, er alvorlige ledningsforstyrrelser sjældne.
English: Patients who experience mucositis (Grade 2 or worse) during Paxene therapy should have their dose reduced by 25 % for subsequent courses of Paxene.
Danish: Patienter, der oplever mucositis (grad 2 eller værre) under behandling med Paxene, bør have deres dosis nedsat med 25 % ved efterfølgende behandlinger med Paxene.
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).
Danish: Patienterne bør rutinemæssigt modtage præmedicinering med en kortikosteroid-, en antihistamin- og en H2-receptor antagonist forud for Paxene for at undgå alvorlige overfølsomhedsreaktioner (se pkt.
English: Severe neutropenia (< 500 cells/mm3) occurred in 26 % of patients treated with Paxene during the entire treatment period.
Danish: I hele behandlingsperioden opstod alvorlig neutropeni (<500 celler/mm3) hos 26 % af patienterne, behandlet med Paxene under hele behandlingsperioden.
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.
Danish: De følgende bivirkninger er i forbindelse med 107 aids-KS-patienter, der blev behandlet med 100 mg/m2 Paxene givet som en 3 timers infusion som andetvalgskemoterapi i en klinisk undersøgelse og blev betragtet som mulig eller sandsynlig relateret til Paxene.
English: • Mild flaking of skin associated with dryness, rash and acne
Danish: • Mild afskalning af hud, der forbindes med tørhed, udslæt og akne
English: Patients were given a 3 hour infusion of Paxene 100 mg/m² administered every 14 days.
Danish: Patienterne fik en 3 timers infusion af Paxene 100 mg/m2, som blev indgivet hver 14. dag.
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.
Danish: Den anden store afprøvning evaluerede et maksimum på 6 forløb med enten paclitaxel (135 mg/m2 over 24 timer) efterfulgt af cisplatin (75 mg/m2) eller kontrol hos over 400 patienter med stadium III/IV primær ovariekræft med en > 1 cm residual sygdom efter stadium laparotomi eller med fjerntliggende metastaser.
English: • Dry mouth and mouth ulcers
Danish: • Mundtørhed og mundsår
English: Use of filter devices which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.
Danish: Brug af filteranordninger med korte PVC-belagte ind- og udgangsslanger har ikke medført væsentlig udvaskning af DEHP.
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).
Danish: I den første undersøgelse blev 332 patienter med lokal fremskreden eller metastatisk NSCLC randomiseret til at få cisplatin (80 mg/m2) i kombination med teniposid (100 mg/m2; n = 166) eller cisplatin (80 mg/m2) og paclitaxel (175 mg/m²; n = 166).
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.
Danish: Myelosuppression synes at forekomme mindre og med mindre kraft med paclitaxel som en 3 timers infusion efterfulgt af cisplatin sammenlignet med cyklofosfamid efterfulgt af cisplatin.
English: Also contains: polyoxyl castor oil, citric acid (anhydrous) and 49.7 % (v/v) ethanol.
Danish: Indeholder også: Polyoxyl-ricinusolie, citronsyre (vandfri) og 49,7 % (v/v) ethanol.
English: • Joint or muscle weakness, pain or loss of sensation in your legs
Danish: • Led- eller muskelsvaghed, smerter eller føletab i benene
English: Your continued treatment will depend on the results of your blood tests showing that it is safe to carry on with your treatment.
Danish: Din fortsatte behandling vil afhænge af resultaterne af dine blodprøver, om det er sikkert at fortsætte med din behandling.
English: Common: severe neuropathy (mainly peripheral), dizziness, nervousness, insomnia, depression, abnormal thinking, hypokinesia, abnormal gait, hypaesthesia, taste perversion,
Danish: Almindelig: Alvorlig neuropati (hovedsagelig perifer), svimmelhed, nervøsitet, søvnløshed, depression, abnorm tankegang, hypokinesi, abnorm gangart, hypæstesi,
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.
Danish: Øget neurotoksicitet, arthralgi/myalgi, men nedsat myelosuppression blev set hos patienter med fremskreden ovariekræft, der fik givet 3 timers infusion af paclitaxel/cisplatin sammenlignet med patienter, der fil cyklofosfamid/cisplatin.
English: • Severe chest pains, irregular heart beat, feeling faint and heart attack
Danish: • Alvorlige brystsmerter, uregelmæssigt hjerteslag, mathedsfornemmelse og hjerteanfald
English: • Localised swelling of the skin
Danish: • Lokal hævelse på huden
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
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.
Danish: Ved administration som en 3 timers infusion som førstevalgskemoterapi af ovariekræft, blev der rapporteret neurotoksicitet, arthralgi/myalgi og overfølsomhed som oftere forekommende og kraftigere af patienter behandlet med paclitaxel efterfulgt af cisplatin end patienter behandlet med cyklofosfamid efterfult af cisplatin.
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.
Danish: Effekt og sikkerhed af Paxene (175 mg/m² over 3 timer i 3-ugers intervaller) ved refraktorisk metastatisk brystkræft blev undersøgt hos 172 kvinder i en åben fase III-multicenterundersøgelse.
English: NonPVC containing administration sets, such as those which are polyethylene-lined, should be used.
Danish: Man bør bruge infusionssæt, der ikke indeholder PVC, som f.eks. sæt, der er foret med polyethylen.
English: Keep the vial in the outer carton.
Danish: Opbevar hætteglasset i den ydre pakning.
English: This medicine contains approximately 50 % by volume of alcohol.
Danish: Vigtige oplysninger om nogle af de øvrige indholdsstoffer i Paxene Dette lægemiddel har en alkoholvolumen på ca. 50 %.
English: Common: transient skin change, dry skin, exfoliative dermatitis, pruritis, rash, acne, transient and mild nail
Danish: Almindelig: Kortvarige hudforandringer, tør hud, exfoliativ dermatitis, pruritus, udslæt, acne, forbigående og milde
English: Paxene concentrate for solution for infusion must be diluted prior to infusion.
Danish: Paxene-koncentrat til infusionsvæske, opløsning skal blandes umiddelbart før infusion.
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.
Danish: I behandlingen af NSCLC og førstevalgsbehandling af ovariekræft resulterede indgivelsen af paclitaxel som en 3 timers infusion i kombination med cisplatin i en større incidens af kraftig neurotoksicitet end både paclitaxel som enkeltmiddel og cyklofosfamid efterfulgt af cisplatin
English: If Paxene contacts mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis Paxene kommer i berøring med slimhinder, skylles slimhinderne grundigt med vand.
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
Danish: Neurotoksicitet, hovedsagelig perifer neuropati, sunes af forekomme oftere og alvorligere med en 175 mg/m2 3 timers infusion (85 % neurotoksicitet, 15 % alvorlig) end med en 135 mg/m2 24 timers infusion (25 % perifer neuropati, 3 % alvorlig), når paclitaxel blev kombineret med cisplatin.
English: METHOD OF ADMINISTRATION Intravenous use Read the package leaflet before use.
Danish: ANVENDELSESMÅDE Intravenøs brug Læs indlægssedlen inden brug.
English: • Experiencing pain while passing urine
Danish: • Smerter, når du lader vandet
English: There is no known specific treatment for extravasation reactions.
Danish: En specifik behandling af ekstravasation kendes p.t. ikke.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CAUTION: dilution required For single use only.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER FORSIGTIG: Fortynding før brug.
English: What Paxene contains
Danish: Paxene indeholder:
English: Very rare*: sensorineural hearing loss, vertigo
Danish: Almindelig: Tinnitus Meget sjælden*: Sensorisk-neuralt høretab, vertigo
English: Patients with severe hepatic dysfunction should not be treated with paclitaxel.
Danish: Patienter med svært nedsat leverfunktion bør ikke behandles med paclitaxel.
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).
Danish: I den anden undersøgelse blev 599 patienter med stadium IIIB eller IV sygdom randomiseret til at få cisplatin (75 mg/m2) og etoposid (100 mg/m2, n = 200) eller cisplatin (75mg/m2) og lavdosis paclitaxel (135 mg/m2; n= 198) eller cisplatin (75 mg/m2) og højdosis paclitaxel (250 mg/m2) med G-CSF (n = 201).
English: • Feeling agitated
Danish: • Føle sig foruroliget/ophidset
English: Since elimination of doxorubicin and its active metabolites may be reduced when paclitaxel and doxorubicin are used in combination, paclitaxel should be administered 24 hours after doxorubicin.
Danish: Paclitaxel bør administreres 24 timer efter doxorubicin, da eliminationen af doxorubicin og dens aktive metabolitter kan være nedsat når paclitaxel og doxorubicin anvendes i kombination.
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.
Danish: Effekt og sikkerhed af Paxene (175 mg/m² over 3 timer i 3-ugers intervaller) ved avanceret metastatisk ovariekræft blev undersøgt hos 120 kvinder i en åben udvidet fase II-multicenterundersøgelse.
English: Procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Danish: Fremgangsmåder for korrekt håndtering og bortskaffelse af cytostatika bør anvendes.
English: Patients with baseline neutrophil counts < 1,500 cells/mm3 (< 1,000 cells/mm3 for AIDS-KS) should not receive paclitaxel.
Danish: Patienter med neutrofiltælling på < 1.500 celler/mm3 før behandlingen (< 1.000 celler/mm3 for aids-KS) bør ikke få paclitaxel.
English: Patients with impaired hepatic function:
Danish: Patienter med nedsat leverfunktion:
English: Paxene is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Danish: Paxene er et cytostatikum, og som med andre potentielt toksiske forbindelser, skal man udvise forsigtighed under dets håndtering.
English: EXPIRY DATE Use by:
Danish: UDLØBSDATO Anvendes inden:
English: Metastatic breast or ovarian cancer
Danish: Metastatisk brystkræft / ovariekræft
English: • Infections - this may be associated with feeling hot (fever) or cold (chills), sore throat and fungal infection in the mouth (oral candidiasis)
Danish: • Infektioner - dette kan være forbundet med at føle sig varm (feber) eller kold (kulderystelser),