FrancophonIA/ELRC3.0 huggingface dataset:
English: Insufficient information is available on interactions with other protease inhibitors.
Danish: Der findes ikke tilstrækkelig oplysning om interaktioner med andre proteaseinhibitorer.
English: Other in-use storage times and conditions are the responsibility of the user.
Danish: Ansvaret for andre tider og forhold efter ibrugtagning påhviler brugeren.
English: Half to one hour before your infusion you will be given two different types of injection (an antihistamine and an H2 antagonist).
Danish: En halv til en time før din infusion giver man to forskellige typer antihistamin-indsprøjtninger (et antihistamin og en H2-antagonist).
English: Mild electrocardiogram changes have been observed during administration of paclitaxel.
Danish: Lette ændringer i elektrokardiogrammet er blevet observeret under administration af paclitaxel.
English: • Effects on the nerves controlling your muscles resulting in weakness in the arms and legs
Danish: • Påvirkninger af de nerver, der styrer dine muskler, hvilket resulterer i svaghed i arme og ben
English: - Keep this leaflet safe as you may need to read it again.
Danish: Du kan få brug for at læse den igen.
English: • Low blood pressure, which may make you feel light-headed upon standing
Danish: • Lavt blodtryk, der kan få dig til at føle dig ør, når du rejser dig op
English: • Balance problems
Danish: • Problemer med balancen
English: Twelve and then six hours before your infusion you will be given dexamethasone (a steroid), either as a tablet to swallow or as an injection.
Danish: Tolv og derefter seks timer før infusionen giver man dexamethason (et steroid) enten i tabletform til at sluge eller som en indsprøjtning.
English: Common: severe elevation in transaminases, severe elevation in alkaline phosphatase
Danish: Almindelig: Kraftig stigning i transaminaser, kraftig stigning i alkalisk fosfatase
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ikke ved over 25 °C.
English: MANUFACTURER'S BATCH NUMBER Batch Number:
Danish: FREMSTILLERENS BATCHNUMMER Batchnummer:
English: Neuropathy, primarily peripheral sensory neuropathy, occurs very commonly and is usually of mild to moderate intensity.
Danish: Neuropati, primært perifer sensorisk neuropati forekommer meget almindeligt og er sædvanligvis af mild til moderat intensitet.
English: It is generally believed that paclitaxel promotes the assembly of microtubules from tubulin dimer and prevents depolymerisation.
Danish: Man mener generelt, at paclitaxel fremmer tilstedeværelsen af microtubules, stammende fra tubulin dimer, og forhindrer depolymerisering.
English: The amounts (dose) of Paxene you will be given will be worked out depending on your body surface area in square meters (m2) and will also take into account the results of your blood tests and your medical condition.
Danish: Mængden (dosis) af Paxene, som du vil få, finder man frem til på grundlag af din kropsoverflade i kvadratmeter (m2) og af resultaterne af dine blodprøver og din medicinske tilstand.
English: • Tell your doctor immediately if you develop severe or prolonged or bloody diarrhoea during or after treatment with Paxene.
Danish: • Fortæl straks din læge, hvis du udvikler alvorlig, langvarig eller blodig diarré under eller efter behandling med Paxene.
English: Dispose of any remaining contents after first use.
Danish: Kasser eventuelt resterende indhold efter første brug.
English: Like all medicines, Paxene can cause side effects, although not everybody gets them.
Danish: Paxene kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Paclitaxel causes bone marrow suppression (particularly neutropenia).
Danish: Paclitaxel forårsager hæmning af knoglemarven (især neutropeni).
English: Paxene should not be used in pregnancy.
Danish: Paxene bør ikke anvendes under graviditet.
English: • Eating disorders including anorexia
Danish: • Spiseforstyrrelser, herunder anoreksi
English: • are taking ritonavir, nelfinavir, efavirenz, nevirapine (for the treatment of AIDS) or any other prescribed medicines for your condition;
Danish: • tager ritonavir, nelfinavir, efavirenz, nevirapin (til behandling af aids) eller noget andet ordineret lægemiddel for din tilstand;
English: Following intravenous administration, plasma concentrations decline in a biphasic or triphasic manner.
Danish: Efter en intravenøs behandling vil plasmakoncentrationerne falde bifasisk eller trifasisk.
English: Hypotension, hypertension and bradycardia have been observed during administration of paclitaxel but patients are usually asymptomatic and do not require therapy.
Danish: Hypotension, hypertension og bradykardi er observeret under behandling med paclitaxel, men patienterne er ofte asymptomatiske og kræver ikke behandling.
English: Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
Danish: Paxene indeholder polyoxyl-ricinusolie, som kan fremkalde en allergisk reaktion.
English: Pneumonitis in patients receiving concomitant radiotherapy and/or gemcitabine has been reported very rarely.
Danish: Pneumonitis hos patienter, der fik samtidig strålebehandling og/eller gemcitabene er meget sjældent rapporteret.
English: There were three septic episodes (2.8 %) during Paxene administration related to the medicinal product that proved fatal.
Danish: Der var tre septiske episoder (2,8 %) under indgivelse af Paxene relateret til lægemidlet, der viste sig at være fatale.
English: Concurrent, serious, uncontrolled infections.
Danish: Samtidige, ukontrollerede alvorlige infektiøse sygdomme.
English: In addition, paclitaxel induces bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Danish: Herudover inducerer paclitaxel bundter af microtubuli i hele celleforløbet og mange astere af microtubuli under mitosen.
English: A single case of heart failure related to Paxene was seen in the AIDS-KS clinical study.
Danish: Et enkelt tilfælde af hjertesvigt i forbindelse med Paxene er observeret i den kliniske aids-KS undersøgelse.
English: If you feel unwell between courses or after your treatment has finished, tell your doctor or pharmacist as soon as you can.
Danish: Hvis du bliver utilpas mellem infusionerne, eller efter endt behandling, skal du fortælle det til din læge eller sundhedspersonalet snarest muligt.
English: Paxene belongs to a group of medicines known as antineoplastic agents.
Danish: Paxene tilhører en gruppe af lægemidler, der kaldes antineoplastiske lægemidler.
English: Do not use Paxene after the expiry date, which is stated on the vial label and outer carton after “use by”.
Danish: Brug ikke Paxene efter den udløbsdato, der står angivet på hætteglassets etiket og pakningen efter "Anvendes inden".
English: Paediatric use:
Danish: Pædiatrisk anvendelse:
English: Therefore, paclitaxel is not recommended for paediatric use.
Danish: Derfor frarådes paclitaxel til pædiatrisk anvendelse.
English: This reaction should be considered in the differential diagnosis of cases of severe or persistent diarrhoea occurring during or shortly after treatment with paclitaxel.
Danish: Denne reaktion bør overvejes i differentialdiagnosen i tilfælde med svær eller vedvarende diarré, der opstår under eller lige efter behandling med paclitaxel.
English: Paxene cannot be used in pregnancy, and women receiving Paxene must not breast-feed.
Danish: Paxene kan ikke anvendes ved graviditet, og kvinder, der modtager behandling med Paxene, må ikke amme.
English: When paclitaxel is given before cisplatin, the safety profile of paclitaxel is consistent with that reported for single-agent use.
Danish: Når paclitaxel gives før cisplatin, er sikkerhedsprofilen for paclitaxel konsistent med den, der er rapporteret for enkeltmiddelbrug.
English: The exact mechanism of the antitumour activity of paclitaxel is not known.
Danish: Den nøjagtige mekanisme i paclitaxels tumorhæmmende aktivitet kendes ikke.
English: Arthralgia was reported in 32 % of all patients (5 % severe) and myalgia in 47 % (6 % severe).
Danish: Artralgi blev rapporteret hos 32 % af alle patienter (5 % alvorlig) og myalgi hos 47 % (6 % alvorlig).
English: Preparation and administration precautions
Danish: Forholdsregler ved forberedelse og administration
English: If you see another doctor or visit a hospital, remember to tell them what medicines you are taking.
Danish: Hvis du går til en anden læge eller indlægges på hospital, skal du fortælle om den medicin, du bruger.
English: From a microbiological point of view, the diluted product should be used immediately.
Danish: Set ud fra et mikrobiologisk synspunkt bør det opløste produkt anvendes øjeblikkeligt.
English: Where event incidence differed between Paxene and other paclitaxel clinical studies, the most frequent incidence is presented.
Danish: Hvor bivirkningsincidensen var forskellig mellem Paxene og andre paclitaxel kliniske undersøgelser, vises den oftest forekommende incidens.
English: Read all of this leaflet carefully before you start using this medicine:
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen.
English: Further data on the potential of drug interactions between paclitaxel and other CYP 3A4 substrates/inhibitors are limited.
Danish: Der er begrænsede yderligere oplysninger om de potentielle lægemiddelinteraktioner mellem paclitaxel og andre CYP 3A4-substrater/-hæmmere.
English: Paclitaxel, particularly in combination with radiation of the lung and/or gemcitabine, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis.
Danish: Paclitaxel kan, især i kombination med strålebehandling af lungerne og/eller gemcitabin, uden hensyn til deres kronologiske rækkefølge, medvirke til udvikling af interstitiel pneumonitis.
English: • Temporary low white blood cell count, which may make you develop an infection
Danish: • Midlertidigt lavt antal hvide blodlegemer, som kan medføre, at du får en infektion
English: • Pain and swelling might occur around the injection site
Danish: • Smerter og hævelse kan forekomme omkring injektionsstedet
English: When paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20 % decrease in paclitaxel clearance.
Danish: Når paclitaxel blev givet efter cisplatin, udviste patienterne en mere udtalt myelosuppression og et cirka 20 % fald i paclitaxel clearance.
English: A greater proportion of paclitaxel-treated patients had improvements in short-term QoL.
Danish: En større del af paclitaxelbehandlede patienter havde forbedringer i korttids livskvalitet.
English: Rare*: motor neuropathy (with resultant minor distal
Danish: Sjælden*: Motorisk neuropati (med resulterende mindre
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000; < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before you receive treatment with Paxene.
Danish: Fortæl din læge, hvis du er gravid, påtænker at blive gravid eller ammer, før du starter på behandling med Paxene.
English: • Loss of balance or staggering
Danish: • Tab af balance eller vaklen
English: Paxene should be administered via an infusion control device (pump) using non-PVC tubing and connectors.
Danish: Paxene bør administreres via en anordning til infusionskontrol (pumpe) ved anvendelse af ikke-PVCslanger og konnektorer.
English: If severe peripheral neuropathy occurs the benefit of continued treatment should be weighed against the risks.
Danish: Hvis alvorlige perifer neuropati skulle opstå, bør en fortsat behandling afvejes overfor risici.
English: In liposomal anthracycline-resistant patients, the response rates were comparable for patients who had never received a protease inhibitor (55.6 %) and those who received one at least 2 months prior to treatment with Paxene (60.9 %).
Danish: Hos liposomal anthracykliske-resistente patienter var responsraten sammenlignelig med patienter, der aldrig havde fået en proteasehæmmer (55,6 %) og de, der havde fået én mindst 2 måneder inden behandlingen med Paxene (60,9 %).
English: The efficacy and safety of Paxene were investigated in a single, non-comparative study in 107 patients with advanced KS, previously treated with systemic chemotherapy.
Danish: Effekt og sikker ved Paxene blev undersøgt i en enkelt ikke-sammenlignende undersøgelse hos 107 patienter med avanceret KS, som tidligere var blevet behandlet med systemisk kemoterapi.
English: Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
Danish: Behandlingen bør rettes mod de forventede vigtigste toksiske virkninger, som er hæmning af knoglemarv, mucositis og perifer neuropati.
English: • Acute leukaemia (blood cancer)
Danish: • Akut leukæmi (blodkræft)
English: Concurrent administration of ketoconazole, a known potent inhibitor of CYP 3A4, does not inhibit the elimination of paclitaxel in patients; thus, both medicinal products may be administered together without dosage adjustment.
Danish: Samtidig anvendelse af ketoconazole, en kendt, kraftig CYP 3A4-hæmmer, hæmmer ikke elimineringen af paclitaxel hos patienterne; derfor kan begge lægemidler indgives sammen uden justering af doseringen.
English: Since Paxene contains ethanol, consideration should be given to possible central nervous system and other effects.
Danish: Da Paxene indeholder ethanol, bør mulige virkninger på centralnervesystemet og andre virkninger tages i betragtning.
English: Peripheral neuropathy was the cause of paclitaxel discontinuation in a few cases.
Danish: Perifer neuropati var grunden til seponering af paclitaxel i et par enkelte tilfælde.
English: • Advanced ovarian cancer or remaining tumour (> 1 cm) after initial surgery, in combination with cisplatin as first-line treatment.
Danish: • avanceret ovariekræft eller tilbagebleven tumor (> 1 cm) efter indledende operation i kombination med cisplatin som førstevalgsbehandling.
English: Paclitaxel at low doses of 0.6 mg/kg/day was associated with low fertility and foetal toxicity in rats.
Danish: Paclitaxel i små doser på 0,6 mg/kg/dag medførte lav fertilitet og toksicitet på rottefostre.
English: Women should be advised to use effective means of contraception to avoid becoming pregnant during therapy with Paxene and to inform the treating physician immediately should this occur.
Danish: Kvindelige patienter bør oplyses om at anvende effektive antikonceptionsmidler for at undgå at blive gravide under behandling med Paxene og bør i tilfælde af graviditet straks oplyse deres behandlende læge herom.
English: All patients must be pre-medicated with corticosteroids, antihistamines and H2 antagonists prior to Paxene.
Danish: Alle patienter skal præ-medicineres med kortikosteroider, antihistaminer og H2 antagonister forud for Paxene.
English: You will only be given your infusion under medical supervision, and you will be checked regularly while you are having your infusion to see how you are reacting to it.
Danish: Infusionen foretages altid under lægetilsyn, og man undersøger dig regelmæssigt, mens den gives, for at se hvordan du reagerer over for medicinen.
English: Peripheral neuropathy can occur following the first course and can worsen with increasing exposure to paclitaxel.
Danish: Perifer neuropati kan forekomme efter det første forløb og kan forværres med øget eksponering over for paclitaxel.
English: The carcinogenic potential of paclitaxel has not been studied.
Danish: Paclitaxels carcinogene potentiale er ikke blevet undersøgt.
English: Animal studies showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Danish: Dyrestudier viste forskellige ikkereversible toksiske virkninger af paclitaxel på de mandlige kønsorganer i kliniske relevante dosisniveauer.
English: Thrombocytopenia was observed in 6 % of patients.
Danish: Trombocytopeni blev observeret hos 6 % af patienterne.
English: • Paxene is not recommended for use in children and adolescents under 18 years.
Danish: • Paxene anbefales ikke til børn og unge (under 18 år).
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.
Danish: Adskillige metabolitter er blevet sporet, men kun tre af dem er blevet identificeret: 6 alphahydroxypaclitaxel, 3'-para-hydroxypaclitaxel og 6 alpha, 3'-para-dihydroxypaclitaxel.
English: • Pain in the bones and back, as well as leg cramps
Danish: • Smerter i knogler og ryg, samt benkramper
English: Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Danish: Mindre symptomer såsom rødmen eller hudreaktioner kræver ikke en afbrydelse af behandlingen.
English: The overall success rate (complete or partial response) after 15 cycles of treatment was 57 % (CI: 44 - 70 %) in liposomal anthracycline-resistant patients.
Danish: Den samlede respons (fuldstændig eller delvis respons) efter 15 behandlingsforløb var 57 % (CI: 44 - 70 %) af liposomal anthracyklin-resistente patienter.
English: There was no advantage in survival (9.5 vs. 9.9 months) or progression free survival (5.1 vs. 5.0 months) with cisplatin/paclitaxel vs cisplatin/tenoposide.
Danish: Der var ingen fordel i overlevelse (9,5 vs 9,9 måneder) eller progressionfri overlevelse (5,1 vs 5,0 måneder) med cisplatin/paclitaxel vs cisplatin/tenoposid.
English: In the rare event of serious conduction abnormalities or arrhythmias, appropriate therapy and continuous cardiac monitoring is recommended during subsequent cycles of therapy.
Danish: I det sjældne tilfælde med alvorlige ledningsforstyrrelser eller arytmier, anbefales passende terapi og vedvarende kardiel observation ved de efterfølgende behandlingsforløb.
English: Neutropenic fever related to Paxene was reported in 14 % of patients.
Danish: Neutropenifeber relateret til Paxene blev rapporteret hos 14 % af patienterne.
English: This is a tumour that arises from blood vessels in the skin or internal organs and typically appears as flat or raised, purple to dark brown patches on the skin.
Danish: Det er en tumor, der opstår fra blodkar i huden eller i de indre organer, og som typisk fremtræder som flade eller let eleverede, violette til mørkebrune pletter på huden.
English: Paxene solutions should be prepared and stored in glass, polypropylene, or polyolefin containers.
Danish: Paxene-opløsninger bør klargøres og opbevares i beholdere af glas, polypropylen eller polyolefin.
English: • Low blood platelet counts that can cause unusual bleeding (e.g. nose bleeds) and unexplained bruising
Danish: • Lavt antal blodplader, der kan forårsage usædvanlig blødning (f.eks. næseblod) og uforklarlige blå mærker
English: When administered as part of a combination regimen with cisplatin, it is recommended that Paxene is given before cisplatin.
Danish: Når det gives som en del af en kombinationsbehandling med cisplatin, anbefales det, at Paxene gives før cisplatin.
English: • Problems with your lungs including swelling and fluid accumulation, which may cause breathing problems
Danish: • Problemer med dine lunger, herunder hævelse og væskeansamling, som kan give vejrtrækningsproblemer
English: Paxene should be given before cisplatin when used in combination (see section 4.5).
Danish: Paxene bør gives før cisplatin ved brug i kombination (se pkt.
English: However, severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angio-oedema or generalised urticaria require immediate discontinuation of paclitaxel and aggressive symptomatic therapy.
Danish: Alvorlige reaktioner såsom hypotension, der kræver behandling, dyspnø, der kræver bronchiedilatorer, angioødemer eller generel urticaria kræver imidlertid øjeblikkelig ophør af behandlingen med paclitaxel og intensiv symptomatisk behandling.
English: Your concentrate for solution for infusion will be kept in the pharmacy and they will prepare it, ready to be given by the doctor or nurse.
Danish: Koncentratet til infusionsvæske, opløsning vil blive opbevaret på apoteket, hvor man gør det klar til lægen eller sygeplejersken.
English: The frequency of undesirable effects listed below is defined using the following convention:
Danish: Nedenstående hyppighed af bivirkninger er defineret i henhold til følgende konvention:
English: Studies in patients with impaired renal function have not been performed and there are insufficient data to permit dose recommendations (see section 5.2).
Danish: Der er ikke gennemført undersøgelser hos patienter med nedsat nyrefunktion, og der findes ikke tilstrækkelige data til at anbefale dosis (se pkt.
English: Paxene should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Danish: Paxene må kun forberedes og administreres af personale, som er uddannet i håndteringen af cytotoksiske lægemidler.
English: • Advanced non-small cell lung cancer if potentially curative surgery and/or radiation therapy are not possible, in combination with cisplatin.
Danish: • avanceret ikke-småcellet lungekræft, hvis potentiel kurativ operation og/eller strålebehandling ikke er mulig, i kombination med cisplatin.
English: • Life-threatening allergic reaction (anaphylactic shock)
Danish: • Livstruende allergisk reaktion (anafylaktisk shock)
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.
Danish: In vitro-undersøgelser har påvist, at CYP2C8 og 3A4 er involveret i dannelsen af henholdsvis 6 alpha-hydroxypaclitaxel og 3'para-hydroxypaclitaxel.
English: Severe cardiovascular events were observed more frequently in patients with NSCLC than breast or ovarian carcinoma.
Danish: Alvorlige kardiovaskulære hændelser blev observeret oftere hos patienter med NSCLC end hos dem med bryst eller ovariekræft.
English: • If you experience an irregular heart beat, dizziness or faintness during treatment.
Danish: • Hvis du oplever uregelmæssigt hjerteslag, svimmelhed eller svaghed under behandlingen.
English: 6 alpha-hydroxypaclitaxel is the major component excreted in faeces.
Danish: 6 alpha-hydroxypaclitaxel var den overvejende udskilte komponent i fæces.
English: Very rare*: anaphylactic shock (including fatal hypersensitivity)
Danish: Meget sjælden*: Anafylaktisk shock (inklusive fatal overfølsomhed)
English: Paxene must be diluted under aseptic conditions prior to infusion.
Danish: Paxene skal fortyndes under aseptiske forhold før infusion.
English: There is no evidence that the toxicity of paclitaxel is increased when given as a 3 hour infusion to patients with mildly abnormal liver function.
Danish: Der er ingen tegn på, at toksiciteten for paclitaxel er øget, når det indgives som infusion over 3 timer til patienter med let unormal leverfunktion.
English: It is unknown whether paclitaxel is excreted in human milk.
Danish: Det er uvist, om paclitaxel udskilles i modermælken.
English: • If you previously had radiation treatment (radiotherapy) to your chest (see section 4: Possible side effects).
Danish: • Hvis du tidligere har fået strålebehandling (stråleterapi) på brystkassen (se pkt 4.
English: Efficacy of paclitaxel/cisplatin combination has been demonstrated in two randomised, controlled trials in patients with locally advanced or metastatic NSCLC.
Danish: Effekt af kombination af paclitaxel/cisplatin er blevet påvist i to randomiserede, kontrollerede afprøvninger hos patienter med lokal fremskreden eller metastatisk NSCLC.
English: • Persistent diarrhoea
Danish: • Vedvarende diarré
English: Paxene might also leak from the vein and cause an infection or ulceration of the surrounding skin.
Danish: Paxene kan også lække fra blodåren og forårsage en infektion eller et sår i huden omkring.