FrancophonIA/ELRC3.0 huggingface dataset:
English: Put the needle fully into the skin at an angle of about 45°, as shown in the picture.
Danish: Put kanylen helt ind i huden i en vinkel på omkring 45°, som vist på billedet.
English: Dose reduction and regular monitoring of the patient is required in such cases.
Danish: Reduktion af dosis og regelmæssig overvågning af patienter er påkrævet i sådanne tilfælde.
English: LITAK must not be mixed with other medicinal products.
Danish: LITAK må ikke blandes med andre lægemidler.
English: Adverse reactions that have been reported are listed in the table below by frequency category and system organ class.
Danish: Negative reaktioner, som er rapporteret, er angivet i tabellen nedenfor efter hyppighed og systemorganklasse.
English: Pregnant women must avoid contact with LITAK.
Danish: Gravide kvinder skal undgå kontakt med LITAK.
English: Patients less than 18 years of age.
Danish: Patienter under 18 år.
English: Your doctor will tell you how much LITAK you need and how often and when you have to inject yourself.
Danish: Deres læge fortæller Dem, hvor meget LITAK, De skal bruge, og hvor ofte og hvornår De skal have en indsprøjtning.
English: Less than a third of febrile events are associated with a documented infection.
Danish: Under en tredjedel af febertilfælde er forbundet med en dokumenteret infektion.
English: All patients were successfully treated with corticosteroids.
Danish: Alle patienter blev behandlet med kortikosteroider med succes.
English: Your doctor may decide that you should receive blood transfusions to improve your level of blood cells.
Danish: Deres læge beslutter måske, at De skal have blodtransfusioner for at forbedre niveauet af blodlegemer.
English: LITAK can be self-administered by the patient.
Danish: LITAK kan administreres af patienten selv.
English: Self-administration by the patient
Danish: Selvadministration af patienten
English: Before you inject LITAK, you must do the following:
Danish: Før du indsprøjter LITAK, skal du gøre det følgende:
English: Complications caused by cancer treatment due to break-down of cancer cells.
Danish: Komplikationer forårsaget af cancerbehandling på grund af nedbrydning af cancerceller.
English: Your must not use LITAK if you are pregnant.
Danish: De må ikke bruge LITAK, hvis De er gravid.
English: Draw the correct volume of LITAK into the syringe by pulling back the plunger (your doctor will inform you how many ml of LITAK you need to inject).
Danish: Træk den rigtige mængde LITAK ned i sprøjten ved at trække stemplet ud (din læge vil oplyse dig om hvor mange ml LITAK du skal indsprøjte).
English: The frequencies are defined as follows: 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: Hyppighederne er defineret således: Meget almindelige (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1.000), meget sjældne (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not inject a double dose to make up for a forgotten dose.
Danish: De må ikke indsprøjte en dobbeltdosis som erstatning for den glemte dosis.
English: From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt, medmindre åbningen forebygger risikoen for mikrobiologisk kontaminering, skal produktet bruges med det samme.
English: Experience with patients older than 65 years is limited.
Danish: Erfaring med patienter over 65 år er begrænset.
English: What should I do before I give myself a subcutaneous injection of LITAK?
Danish: Hvad skal jeg gøre før jeg giver mig selv en subkutan indsprøjtning med LITAK?
English: Treatment of nausea with antiemetics is usually not necessary.
Danish: Behandling af kvalme med antiemetika er normalt ikke nødvendigt.
English: At least 10 cases with acute autoimmune haemolytic anaemia have been reported.
Danish: Der er rapporteret mindst 10 tilfælde med akut autoimmun hæmolytisk anæmi.
English: Reduced function of organs due to high amounts of a specific substance produced by the body (a glycoprotein).
Danish: Nedsat organfunktion på grund af stor mængde af et specifikt stof produceret af kroppen (et glycoprotein).
English: The majority of deaths related to the medicinal product are due to infectious complications.
Danish: Størstedelen af lægemiddel-relaterede dødsfald skyldes komplikationer med infektioner.
English: Cell death occurs from energy depletion and apoptosis.
Danish: Celledød opstår af energiudtømmelse og apoptose.
English: The overall response rate was 97% with long-lasting remission, with 73% of patients staying in complete remission after four years follow-up time.
Danish: Den samlede responsrate var 97% med langvarig remission, hvor 73% af patienterne stadig havde komplet remission efter fire års opfølgningstid.
English: The peak risk is at 2 years after diagnosis with a median between 40 and 66 months.
Danish: Den største risiko findes 2 år efter diagnose med en median mellem 40 og 66 måneder.
English: Deviations from the posology indicated above are not advised.
Danish: Afvigelser fra den ovenfor angivne doseringer tilrådes ikke,
English: Find a comfortable, well-lit place and put everything you need where you can reach it.
Danish: Find et behageligt sted med god belysning og stil alt så du kan nå det.
English: Procedures for proper handling and disposal of antineoplastic medicinal products should be used.
Danish: Procedurer for korrekt håndtering og destruktion af antineoplastiske lægemidler skal anvendes.
English: This section contains information on how to give an injection of LITAK.
Danish: Dette afsnit indeholder information om, hvordan man giver en indsprøjtning med LITAK.
English: Your doctor may advise you about the possibility to store deep-frozen sperm (cryoconservation).
Danish: Deres læge kan måske rådgive Dem om muligheden for nedfrysning af sperma (kryokonservering).
English: Like all medicines, LITAK can cause side effects, although not everybody gets them.
Danish: LITAK kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Your doctor will calculate your dose according to your body weight and explain the treatment schedule in detail.
Danish: Deres læge vil udregne den dosis, De skal have, efter Deres legemsvægt og forklare behandlingsplanen i detaljer.
English: Concomitant use of other myelosuppressive medicinal products.
Danish: Samtidig brug af andre myelosuppressive lægemidler.
English: A complete recovery of T-helper cells and B-lymphocytes is delayed for up to 2 years.
Danish: En fuldstændig regeneration af T-hjælperceller og B-lymfocytter er forsinket i op til 2 år.
English: If severe toxicity occurs, the physician should consider delaying or discontinuing the therapy with the medicinal product until serious complications resolve.
Danish: Hvis der opstår alvorlig toksicitet, bør lægen overveje at udsætte eller afbryde behandlingen med lægemidlet indtil alvorlige komplikationer forsvinder.
English: Before and during treatment with LITAK, you will have regular blood tests to check whether it is safe for you to continue with your treatment.
Danish: Inden De starter på behandlingen med LITAK, og under selve behandlingen, vil De regelmæssigt få taget blodprøver for at kontrollere, om det er sikkert for Dem at fortsætte med behandlingen.
English: Patients should be instructed and trained appropriately.
Danish: Patienter skal have relevant instruktion og træning.
English: If you forget to use LITAK
Danish: Hvis De har glemt at bruge LITAK
English: Rejection response to blood transfusions.
Danish: Afstødningsrespons på blodtransfusioner.
English: Repeated occurrence of malignant (cancerous) disease cannot be excluded.
Danish: Det kan ikke udelukkes, at den ondartede (cancer)-sygdom kommer igen.
English: Carcinogenesis/mutagenesis
Danish: Carcinogenese/mutagenese
English: Treatment with these agents is associated with the occurrence of second malignancies.
Danish: Behandling med disse stoffer er forbundet med forekomst af sekundære maligniteter.
English: A daily oral dose of 100 mg of allopurinol is recommended for a period of 2 weeks.
Danish: En daglig oral dosis på 100 mg allopurinol anbefales for en periode på 2 uger.
English: Marketing Authorisation Holder and Manufacturer Lipomed GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller Lipomed GmbH
English: The use of haematopoietic growth factors neither improves the recovery of neutrophil counts nor decreases the incidence of fever.
Danish: Brugen af hæmatopoietiske vækstfaktorer hverken forbedrer regeneration af neutrofiltællinger eller nedsætter incidensen af feber.
English: For severity, please see text below the table.
Danish: Hvad angår sværhedsgrad, se teksten under tabellen.
English: LITAK is used to treat this disease.
Danish: LITAK anvendes til behandling af denne sygdom.
English: It is important that you do not try to give yourself the injection unless you have been instructed by your doctor or nurse.
Danish: Det er vigtigt, at De ikke prøver at give Dem selv en indsprøjtning, medmindre De er blevet instrueret i dette af Deres læge eller sygeplejerske.
English: Severe thrombocytopenias (< 50 x 10
Danish: Alvorlige trombocytopenier (< 50 x 10
English: If you want to father a child, please tell your doctor before treatment with LITAK is started.
Danish: Hvis De ønsker at blive far til et barn, skal De fortælle det til Deres læge, inden behandlingen med LITAK begynder.
English: You will find detailed instructions for injection at the end of this leaflet.
Danish: De finder en detaljeret vejledning i indsprøjtning til sidst i denne indlægsseddel.
English: Common: reversible, mostly mild increases in bilirubin and transaminases
Danish: Almindelige: reversible, oftest milde stigninger i bilirubin og transaminaser
English: Pull slightly on the plunger to check that no blood vessel has been punctured.
Danish: Træk lidt i stemplet for at kontrollere at der ikke er gået hul på et blodkar.
English: One third of these infections have to be considered as severe (e.g. septicaemia, pneumonia).
Danish: En tredjedel af disse infektioner skal betragtes som alvorlige (fx septikæmi, pneumoni).
English: It is unknown whether cladribine is excreted in human milk.
Danish: Det er ukendt, om cladribin udskilles i human mælk.
English: In the clinical trial using LITAK subcutaneously, 63 patients with hairy cell leukaemia (33 newly diagnosed patients and 30 patients with relapsed or progressive disease) were treated.
Danish: I den kliniske undersøgelse med subkutan anvendelse af LITAK blev 63 patienter med hårcelleleukæmi (33 nydiagnosticerede patienter og 30 patienter med recidiv eller progressiv sygdom) behandlet.
English: Serious allergic skin reaction (Stevens-Johnson syndrome or Lyell syndrome).
Danish: Alvorlig allergisk reaktion (Stevens-Johnson-syndrom eller Lyell-syndrom).
English: At this dose, severe limb anomalies were seen as well as a significant decrease in the mean foetal weight.
Danish: Ved denne dosis blev der iagttaget alvorlig anomalier på lemmer såvel som et signifikant fald i den gennemsnitlige fostervægt.
English: Inability of the heart to maintain adequate blood circulation.
Danish: Hjertet kan ikke opretholde tilstrækkelig blodcirkulation.
English: This slightly increased risk can be due to hairy cell leukaemia or to therapies used to treat the disease including LITAK.
Danish: Denne let forhøjede risiko kan skyldes hårcelleleukæmi eller behandlinger, som anvendes til behandling af sygdommen, inklusive LITAK.
English: In case of fever related to infections or agranulocytosis, an antibiotic treatment is indicated.
Danish: I tilfælde af feber, der er relateret til infektioner eller agranulocytose, er behandling med antibiotika indiceret.
English: Since patients with an active hairy cell leukaemia mostly present with low blood counts, especially low neutrophil counts, more than 90% of the cases have transient severe neutropenias (< 1.0 x 10
Danish: Da patienter med aktiv hårcelleleukæmi oftest har lave blodtællinger, især lave neutrofiltællinger, har mere end 90% af tilfældene kortvarige alvorlige neutropenier (< 1,0 x 10
English: Therapeutic risks and benefits should be carefully evaluated in patients with active or suspected infections.
Danish: Terapeutiske fordele og risici bør vurderes nøje hos patienter med aktive eller formodede infektioner.
English: Warnings and precautions Talk to your doctor or pharmacist before using LITAK.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før De bruger LITAK.
English: Clinical experience is very limited and safety of LITAK in these patients is not well established.
Danish: Klinisk erfaring er meget begrænset og sikkerheden ved brug af LITAK til disse patienter er ikke veletableret.
English: Plasma protein binding of cladribine is 25% on average, with a wide interindividual variation (5-50%).
Danish: Plasmaproteinbinding af cladribin udgør gennemsnitligt 25% med en bred interindividuel variation (5-50%).
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Danish: Hvis du ser blod i sprøjten, tag kanylen ud og stik den ind et andet sted.
English: Secondary malignancies are expected to occur in patients with hairy cell leukaemia.
Danish: Sekundære maligniteter forventes at forekomme hos patienter med hårcelleleukæmi.
English: The most suitable places to inject yourself are shown here: the top of your thighs and the abdomen, except for the area around the navel.
Danish: De bedste steder at foretage en indsprøjtning på sig selv er vist her: det øverste af lårene og bugen, undtaget området rundt om navlen.
English: LITAK has to be injected under your skin (subcutaneous injection), at about the same time each day.
Danish: LITAK skal indsprøjtes under huden (subkutan injektion) på nogenlunde samme tidspunkt hver dag.
English: Severe long-term lymphocytopenias have been reported rarely which, however, could not be associated with late infectious complications.
Danish: Alvorlige langvarige lymfocytopenier er sjældent rapporteret, men de kunne dog ikke sættes i forbindelse med sene komplikationer med infektioner.
English: The recovery of cytotoxic T-lymphocytes and natural killer cells occurs within 3 to 12 months.
Danish: Regeneration af cytotoksiske T-lymfocytter og naturlige dræberceller forekommer inden for 3 til 12 måneder.
English: Do not use LITAK - if you are allergic to cladribine or any of the other ingredients of LITAK (listed in section 6) - if you are pregnant or breast-feeding - if you are less than 18 years of age - if you have moderate to severe kidney or liver impairment - if you are using other medicines which affect the production of blood cells in the bone marrow
Danish: Brug ikke LITAK - hvis De er allergisk over for cladribin eller et af de øvrige indholdsstoffer i LITAK (angivet i punkt 6) - hvis De er gravid eller ammer - hvis De er under 18 år gammel, - hvis De har moderat til alvorligt nedsat nyre- eller leverfunktion - hvis De bruger anden medicin, som påvirker produktionen af hvide blodlegemer i knoglemarven
English: Cladribine is eliminated mainly by the kidneys.
Danish: Cladribin elimineres hovedsageligt af nyrerne.
English: Acute, irreversible neuro- and nephrotoxicity have been described in individual patients treated at a dose which was ≥ 4 times higher than the recommended regimen for hairy cell leukaemia.
Danish: Akut, irreversibel neuro- og nefrotoksicitet er beskrevet hos individuelle patienter, der er behandlet med en dosis, som var ≥ 4 gange højere end det anbefalede regime for hårcelleleukæmi.
English: Remove the red protective cap from the LITAK vial.
Danish: Fjern det røde beskyttelseslåg fra LITAK-hætteglasset.
English: Cytotoxic medicinal products should be handled with caution.
Danish: Cytotoksiske lægemidler skal omgås med forsigtighed.
English: In case of infections, antibiotic treatment should be initiated as required.
Danish: I tilfælde af infektioner skal behandling med antibiotika påbegyndes, hvis det er nødvendigt.
English: The effect on human fertility is unknown.
Danish: Virkningen på den humane fertilitet kendes ikke.
English: Inject the liquid slowly and evenly for approximately one minute, always keeping the skin pinched.
Danish: Sprøjt væsken langsomt og jævnt ind i løbet af cirka et minut, mens du holder huden trykket sammen.
English: To give yourself a subcutaneous injection, you will need:
Danish: For at give Dem selv en subkutan indsprøjtning skal De bruge følgende:
English: In case of pregnancy during therapy with cladribine, the woman should be informed about the potential hazard to the foetus.
Danish: I tilfælde af graviditet under behandling med cladribin skal kvinden informeres om den potentielle fare for fostret.
English: Pharmacotherapeutic group: Purine analogues, ATC code: L01BB04
Danish: Farmakoterapeutisk klassifikation: Purinanaloger, ATC-kode: L01BB04
English: Increased number of certain white blood cells (eosinophils).
Danish: Øget antal af hvide hvide blodlegemer (eosinofiler).
English: These were on average more severe than the infections manifested in 27% of all patients receiving a reduced dose of 0.5 mg/kg body weight per cycle.
Danish: Disse var i gennemsnit mere alvorlige end de infektioner, der var manifest hos 27 % af alle patienter, der modtager en reduceret dosis på 0,5 mg/kg legemsvægt pr. cyklus.
English: Pancytopenia is normally reversible and the intensity of bone marrow aplasia is dose-dependent.
Danish: Pancytopeni er normalt reversibelt, og intensiteten af knoglemarvsaplasi afhænger af dosis.
English: Intracellular concentration of cladribine exceeds its plasma concentration by 128 to 375 times.
Danish: Intracellulær koncentration af cladribin overstiger koncentration i plasma med 128 til 375 gange.
English: It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD).
Danish: Det anbefales at patienter som får cladribin, får bestrålede cellulære blodbestanddele/-produkter for at forebygge transfusionsrelateret graft-versus-host sygdom (Ta-GVHD).
English: If you had these symptoms prior to treatment with cladribine, tell your doctor about any change in these symptoms.
Danish: Hvis De havde disse symptomer før behandlingen med cladribin, skal De fortælle det til lægen, hvis De oplever en ændring af dem.
English: It affects the growth of malignant (cancerous) white blood cells which play a role in hairy cell leukaemia.
Danish: Det påvirker væksten af ondartede (kankrøse) hvide blodlegemer, som spiller en rolle ved hårcelleleukæmi.
English: On the basis of available data, no evaluation can be made of the carcinogenic risk of cladribine to humans.
Danish: På baggrund af tilgængelige data kan der ikke laves nogen vurdering af cladribins carcinogene risiko hos mennesker.
English: The mean volume of distribution of cladribine is 9.2 l/kg.
Danish: Middelvolumenet af fordeling af cladribin er 9,2 l/kg.
English: During the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required.
Danish: I den første måned efter behandling er myelosuppression yderst vigtig, og det kan blive nødvendigt med transfusioner af røde blodlegemer eller trombocytter.
English: Cladribine induces a severe and prolonged reduction of CD4+ and CD8+ T-lymphocytes.
Danish: Cladribin inducerer en alvorlig og forlænget reduktion af CD4+ og CD8+ T-lymfocytter.
English: In addition, the proper function of your liver and your kidneys will be checked.
Danish: Desuden vil det blive kontrolleret, om Deres lever og nyrer fungerer rigtigt.
English: In patients with a high tumour burden, prophylactic allopurinol therapy to control serum levels of uric acid, together with adequate or increased hydration, should be commenced 24 hours before the start of chemotherapy.
Danish: Hos patienter med en høj tumorbyrde skal profylaktisk behandling med allopurinol til kontrol af serumniveauer for urinsyre, sammen med adækvat eller forhøjet hydrering, påbegyndes 24 timer før starten af kemoterapi.
English: Cladribine is unlikely to cause alopecia; mild and transient alopecia for a few days was observed in 4/523 patients during the treatment, but could not clearly be associated with cladribine.
Danish: Cladribin forårsager sandsynligvis ikke alopecia (skaldethed); mild og kortvarig alopecia i et par dage blev observeret hos 4/523 patienter under behandling, men kunne ikke klart forbindes med cladribin.
English: For all patients treated with LITAK, periodic assessment of renal and hepatic function is advised as clinically indicated.
Danish: For alle patienter, der behandles med LITAK, tilrådes periodisk vurdering af nyre- og leverfunktionen som klinisk indiceret.
English: Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.
Danish: Behandling med LITAK skal igangsættes af en uddannet læge med erfaring i at behandle cancer med kemoterapi.
English: Paediatric population LITAK is contraindicated in patients less than 18 years of age (see section 4.3).
Danish: Pædiatrisk population LITAK er kontraindiceret hos patienter under 18 år (se pkt.
English: Inject straight away.
Danish: Injicer med det samme.
English: In case of an accumulation of the serum uric acid above the normal range, the dose of allopurinol may be increased to 300 mg/day.
Danish: I tilfælde med ophobning af serumurinsyre over det normale område kan dosis allopurinol øges til 300 mg/dag.
English: Therefore, patients treated with cladribine should be regularly monitored.
Danish: Derfor skal patienter som er blevet behandlet med cladribin, kontrolleres regelmæssigt.
English: The origin of febrile events should be investigated by appropriate laboratory and radiologic tests.
Danish: Årsagen til febertilfælde bør undersøges med relevante laboratorie- og røntgentest.
English: Low numbers of certain white blood cells (neutrophils and lymphocytes) and platelets in blood tests.
Danish: Lavt antal af visse hvide blodceller (neutrofiler og lymfocytter) og blodplader i blodprøver.
English: Following cladribine, the incidence of second malignancies ranges from 0% to 9.5% after a median observation period of 2.8 to 8.5 years.
Danish: Efter cladribin varierer forekomsten af sekundære maligniteter fra 0% til 9.5% efter en gennemsnitlig observationsperiode på 2,8 til 8,5 år.
English: Furthermore, CdATP inhibits ribonucleotide reductase, the enzyme responsible for the conversion of ribonucleotides into deoxyribonucleotides.
Danish: Desuden hæmmer CdATP reduktasen af ribonukleotid, det enzym, der er ansvarlig for omdannelsen af ribonukleotider til deoxyriboneukleotider.
English: You should not father a child during treatment and up to 6 months after treatment with LITAK.
Danish: De bør ikke blive far til et barn under behandlingen og op til 6 måneder efter behandling med LITAK.
English: You must not use LITAK with other medicines that affect the production of blood cells in the bone marrow (myelosuppression).
Danish: De må IKKE bruge LITAK sammen med andre lægemider, som påvirker produktionen af blodlegemer i knoglemarven (myelosuppression).
English: LITAK is a cytotoxic and should therefore be handled with caution.
Danish: LITAK er et celledræbende (cytotoksisk) middel og skal derfor håndteres med forsigtighed.
English: If someone else is injecting you, they can also use the outer surface of the upper arms or the buttocks.
Danish: Hvis andre foretager indsprøjtningen, kan de også bruge den ydre del af overarmene eller ballerne.
English: Lymphocytopenia lasting for several months and immunosuppression with an increased risk of infections are expected.
Danish: Lymfocytopeni, der varer i mange måneder, og immunsuppression med øget risiko for infektioner kan forventes.
English: If pregnancy occurs during your treatment, you must immediately inform your doctor.
Danish: Hvis De bliver gravid under behandlingen, skal De omgående kontakte Deres læge.