FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin rashes (2-31%) are mainly described in patients with other concomitantly administered medicinal products known to cause rash (antibiotics and/or allopurinol).
Danish: Hududslæt (2-31%) er hovedsageligt beskrevet hos patienter med andre samtidigt administrerede lægemidler, der vides at forårsage udslæt (antibiotika og/eller allopurinol).
English: Patients who have received an overdose of cladribine should be monitored haematologically for at least four weeks.
Danish: Patienter, der har fået en overdosis cladribin, bør overvåges hæmatologisk i mindst fire uger.
English: You may also receive an additional medicine containing the active substance allopurinol in order to reduce excess of uric acid.
Danish: De kan også få et supplerende lægemiddel, som indeholder det aktive stof allopurinol, for at nedsætte et forhøjet urinsyreniveau.
English: 10 ml type I glass vial with rubber stopper (bromobutyl) and flip-off aluminium cap.
Danish: 10 ml type I glas hætteglas med gummiprop (bromobutyl) og flip-off aluminiumslåg .
English: However, an in vitro study revealed cross-resistance between cladribine and nitrogen mustard (chlormethine); for cytarabine, one author has described an in vivo cross-reaction without loss of activity.
Danish: En in vitro undersøgelse har dog afsløret krydsresistens mellem cladribin og kvælstofsennepgas (klormetin); for cytarabin har en forfatter beskrevet en in vivo krydsreaktion uden aktivitetstab.
English: Always use LITAK as your doctor has told you.
Danish: Brug altid LITAK nøjagtigt efter lægens anvisning.
English: The risk requires assessment on a case-by-case basis (see section 4.4).
Danish: Risikoen gør, at der er behov for vurdering fra sag til sag (se pkt.
English: Forty percent of the patients who were treated with LITAK at a dose of 0.7 mg/kg body weight per cycle suffered from infections.
Danish: Fyrre procent af de patienter, der blev behandlet med LITAK ved en dosis på 0,7 mg/kg legemsvægt pr. cyklus, fik infektioner.
English: Long-term studies in animals to evaluate the carcinogenic potential of cladribine have not been conducted.
Danish: Langtidsundersøgelser af dyr for at vurdere cladribins carcinogene potentiale er ikke blevet udført.
English: Very common adverse reactions observed during the three most relevant clinical trials with cladribine in 279 patients treated for various indications and in 62 patients with hairy cell leukaemia (HCL) were myelosuppression, especially severe neutropenia (41% (113/279), HCL 98% (61/62)), severe thrombocytopenia (21% (58/279), HCL 50% (31/62)) and severe anaemia (14% (21/150), HCL 55% (34/62)), as well as severe immunosuppression/lymphopenia (63% (176/279), HCL 95% (59/62)), infections (39% (110/279), HCL 58% (36/62)) and fever (up to 64%).
Danish: Meget almindelige bivirkninger, som er iagttaget under de tre mest relevante kliniske forsøg med cladribin hos 279 patienter, som blev behandlet for forskellige indikationer, og hos 62 patienter med hårcelleleukæmi (HCL) var myelosuppression, specielt alvorlig neutropeni (41% (113/279), HCL 98% (61/62)), alvorlig trombocytopeni (21% (58/279), HCL 50% (31/62)) og alvorlig anæmi (14% (21/150), HCL 55% (34/62)), såvel som alvorlig immunsuppression/lymfopeni (63% (176/279), HCL 95% (59/62)), infektioner (39% (110/279), HCL 58% (36/62)) og feber (op til 64%).
English: Tell your doctor if you have or have had: - liver or kidney problems - infections if you suffer from an infection, this will be treated before you start using LITAK.
Danish: Fortæl det til lægen, hvis de har eller har haft: - lever- eller nyreproblemer infektioner hvis de lider af en infektion, skal den behandles, inden De begynder at bruge LITAK.
English: Like other nucleoside analogues, treatment with cladribine is associated with myelosuppression and profound and prolonged immunosuppression.
Danish: Ligesom andre nukleoside analoger, er behandling med cladribin forbundet med myelosuppression og udbredt og langvarig immunsuppression.
English: Increased heart rate, abnormal heart sound, low blood pressure, decreased blood supply to the heart muscle.
Danish: Øget hjerterytme, unormal hjertelyd, lavt blodtryk, nedsat blodforsyning til hjertemusklen.
English: LITAK should be injected into the tissue just under the skin (subcutaneous injection).
Danish: LITAK skal sprøjtes ind i vævet lige under huden (subkutan injektion).
English: if you notice any signs of infections (such as flu-like symptoms or fever) during or after treatment with LITAK, inform your doctor immediately.
Danish: hvis De opdager nogen tegn på infektion (som fx influenzalignende symptomer eller feber) under eller efter behandlingen med LITAK, skal De informere Deres læge med det samme.
English: Special handling precautions (see package leaflet)
Danish: Særlige forholdsregler ved håndtering (se indlægsseddel)
English: Reduced ossification was observed at 1.0 mg/kg/day.
Danish: Formindsket ossifikation blev iagttaget ved 1,0 mg/kg/dag.
English: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Germany
Danish: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Tyskland
English: Cladribine is contraindicated in pregnancy.
Danish: Cladribin er kontraindiceret under graviditeten.
English: Culture-negative fever following treatment with cladribine occurs in 10-40% of patients with hairy cell leukaemia and is rarely observed in patients with other neoplastic disorders.
Danish: Feber, hvor der er negativ dyrkning, efter behandling med cladribin forekommer hos 10-40% af patienter med hårcelleleukæmi og iagttages sjældent hos patienter med andre neoplastiske sygdomme.
English: The recommended daily dose is 0.14 mg per kg body weight for five consecutive days (single treatment course).
Danish: Den anbefalede daglige dosis er 0,14 mg pr. kg legemsvægt i fem på hinanden følgende dage (enkelt behandlingsforløb).
English: After injecting the liquid, remove the needle.
Danish: Efter at du har sprøjtet væsken ind, fjernes kanylen.
English: Low number of platelets, which can cause unusual bleeding (for example nose or skin bleeds).
Danish: Lavt antal blodplader, hvilket kan forårsage usædvanlige blødninger (for eksempel næseblod eller blødninger i huden).
English: The frequency of second malignancy following treatment with LITAK was 3.4% in all 232 hairy cell leukaemia patients treated, during a 10-year period.
Danish: Hyppigheden af sekundære maligniteter efter behandling med LITAK var 3,4% hos alle 232 patienter med hårcelleleukæmi, som blev behandlet i løbet af en 10-års periode.
English: Disinfect your skin by using an alcohol wipe, wait for the area to dry and pinch the skin between your thumb and forefinger, without squeezing it.
Danish: Desinficer huden med en renseserviet, vent på at området tørrer og tryk huden sammen med tommelfingeren og pegefingeren uden at klemme det.
English: If you feel drowsy, which may occur due to a low number of red blood cells caused by LITAK treatment, or dizzy, you should not drive or use machines.
Danish: Hvis De føler Dem døsig, hvilket kan ske på grund af et fald i antallet af røde blodlegemer på grund af behandlingen med LITAK, eller svimmel, bør De ikke føre motorkøretøj eller betjene maskiner.
English: Do not use LITAK after the expiry date which is stated on the vial label and the outer carton after EXP.
Danish: Brug ikke LITAK efter den udløbsdato, der står på etiketten på hætteglasset og den ydre karton efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Tiredness, chills, decreased appetite.
Danish: Træthed, kuldegysninger, nedsat appetit.
English: Eye inflammation.
Danish: Øjenbetændelse.
English: Increased resorptions, reduced live litter sizes, reduced foetal weights and increased foetal malformations of the head, trunk and appendages were seen at 3.0 mg/kg/day.
Danish: Forøgede resorptioner, formindsket kuldstørrelse, formindsket fostervægt og forøgede misdannelser af fostrets hoved, krop og vedhæng blev iagttaget ved 3,0 mg/kg/dag.
English: The cumulative frequencies of second malignancy are 5%, 10-12% and 13-14% following 5, 10 and 15 years respectively after diagnosis of hairy cell leukaemia.
Danish: Den kumulative hyppighed af sekundære maligniteter er 5%, 10 - 12% og 13-14% henholdsvis 5, 10 og 15 år efter diagnosen hårcelleleukæmi.
English: LITAK has a major effect on the ability to drive and use machines.
Danish: LITAK påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Gastrointestinal adverse reactions like nausea (5-28%), vomiting (1-13%), and diarrhoea (3-12%) as well as fatigue (2-48%), headache (1-23%), and decreased appetite (1-22%) have been reported during treatment with cladribine.
Danish: gastrointestinale bivirkninger som kvalme (5-28%), opkastning (1-13%) og diarré (3-12%) såvel som træthed (2-48%), hovedpine (1-23%) og nedsat appetit (1-22%) er rapporteret under behandling med cladribin.
English: Exposure to cladribine induces DNA fragmentation and cell death in various normal and leukaemic cells and cell lines at concentrations of 5 nM to 20 µM.
Danish: Udsættelse for cladribin forårsager dna-fragmentation og celledød i forskellige normale og leukæmiske celler og cellelinier ved koncentrationer på 5 nM til 20 µM.
English: LITAK contains the active substance cladribine.
Danish: LITAK indeholder det aktive stof cladribin.
English: An accumulation of active CdATP is observed predominantly in cells with a high dCK activity and a low deoxynucleotidase activity, particularly in lymphocytes and in other haematopoietic cells.
Danish: En ophobning af aktivt CdATP iagttages hovedsageligt i celler med en høj dCK aktivitet og en lav deoxynukleotidaseaktivitet, især i lymfocytter og i andre hæmatopoietiske celler.
English: The risk of severe myelotoxicity and long-lasting immunosuppression is increased in patients with a disease-related bone marrow infiltration or a previous myelosuppressive treatment.
Danish: Risikoen for alvorlig myelotoksicitet og langvarig immunsuppression er øget hos patienter med sygdomsrelateret knoglemarvsinfiltration eller en tidligere myelosuppressiv behandling.
English: LITAK is indicated for the treatment of hairy cell leukaemia.
Danish: LITAK er indiceret til behandling af hårcelleleukæmi
English: Due to the similar intracellular metabolism, cross-resistance with other nucleoside analogues, such as fludarabine or 2'-deoxycoformycin may occur.
Danish: På grund af lignende intracellulær metabolisme kan krydsresistens med andre nukleoside analoger, som fx fludarabin eller 2'-deoxycoformycin forekomme.
English: Paediatric use The use of LITAK in children has not been investigated (see section 4.2).
Danish: Pædiatrisk brug Brugen af LITAK til børn er ikke blevet undersøgt (se pkt.
English: Patients with symptoms of bone marrow depression should be treated with caution, since further suppression of bone marrow function should be anticipated.
Danish: Patienter med symptomer på knoglemarvsdepression bør behandles med forsigtighed, da yderligere suppression af knoglemarvsfunktionen bør påregnes.
English: Pharmacokinetic studies in humans showed that the plasma concentration curve of cladribine fits a 2or 3-compartment model with - and β-half-lives of on average 35 minutes and 6.7 hours, respectively.
Danish: Farmakokinetiske undersøgelser på mennesker har vist, at plasmakoncentrationskurven for cladribin passer til en 2- eller 3-kompartmentmodel med - og β-halveringstider på gennemsnitligt hhv. 35 minutter og 6,7 timer.
English: Fever of unknown origin frequently occurs in patients treated for hairy cell leukaemia and is manifested predominantly during the first 4 weeks of therapy.
Danish: Feber af ukendt oprindelse forekommer hyppigt hos patienter, der er behandlet for hårcelleleukæmi, og ses hovedsageligt manifest under de første 4 ugers behandling.
English: Very common: immunosuppression * Rare: graft-versus-host disease *
Danish: Meget almindelige: immunsuppression * Sjældne: graft-versus-host sygdom *
English: Forty-three percent of patients with hairy cell leukaemia experienced infectious complications at standard dose regimen.
Danish: 43 % af patienter med hårcelleleukæmi oplevede komplikationer med infektion ved standard dosisregime.
English: Non-haematologic tissues seem to be unaffected, explaining the low incidence of non-haematopoietic toxicity of cladribine
Danish: Ikke-hæmatologisk væv synes at være upåvirket, hvilket forklarer den lave forekomst af ikke-hæmatopoietisk toksicitet i cladribin.
English: Adverse reactions related to skin and subcutaneous tissue are mostly mild or moderate and transient, usually resolving within a cycle interval of 30 days.
Danish: Negative reaktioner som er forbundet med hud og subkutant væv er for det meste milde til moderate og kortvarige, og går sædvanligvis over i løbet af en cyklusperiode på 30 dage.
English: Abdominal pain and presence of excessive amount of gas in the stomach or bowels, mostly mild increases in liver laboratory values (bilirubin, transaminases) which will return to normal values once treatment is over.
Danish: Smerter i underlivet og store mængder luft i mave og tarme/indvolde, for det meste lette stigninger i laboratoriemålte leverværdier (bilirubin, transaminase), som falder til normale værdier, når behandlingen er afsluttet.
English: INSTRUCTIONS FOR INJECTION
Danish: VEJLEDNING I INDSPRØJTNING
English: Corticosteroids have been shown to enhance the risk for severe infections when used in combination with cladribine and should not be given concomitantly with cladribine.
Danish: Det er blevet vist at kortikosteroider øger risikoen for alvorlige infektioner, når det bruges i kombination med cladribin, og bør ikke gives samtidig med cladribin.
English: If you are injecting LITAK yourself, first you must receive adequate training by your doctor or nurse.
Danish: Hvis De selv indsprøjter LITAK, skal De først have tilstrækkelig instruktion af Deres læge eller sygeplejerske.
English: Due to a potential increase of haematological toxicity and bone marrow suppression, cladribine must not be used concomitantly with other myelosuppressive medicinal products.
Danish: På grund af en potentiel øgning af hæmatologisk toksicitet og knoglemarvssuppression, må cladribin ikke anvendes samtidig med andre myelosuppressive lægemidler.
English: Patients undergoing treatment with cladribine should be closely monitored for signs of haematologic and non-haematologic toxicities.
Danish: Patienter som gennemgår behandling med cladribin, bør overvåges nøje for tegn på hæmatologiske og ikke-hæmatologiske toksiciteter.
English: The highest incidence of second malignancy with LITAK was 6.5% after a median follow-up of 8.4 years.
Danish: Den højeste forekomst af sekundære maligniteter med LITAK var 6,5% efter en gennemsnitlig follow up på 8,4 år.
English: Do not put used syringes into the normal household garbage bin.
Danish: Undgå at smide brugte sprøjter i det almindelige husholdningsaffald.
English: LITAK should warm up to room temperature prior to administration.
Danish: LITAK skal opvarmes til stuetemperatur før administration.
English: Non-haematological adverse reactions are generally mild to moderate in severity.
Danish: Ikke-hæmatologiske bivirkninger er almindeligvis milde til moderate i sværhedsgrad.
English: Cladribine causes serious birth defects when administered during pregnancy.
Danish: Cladribin medfører alvorlige medfødte misdannelser, når det anvendes under graviditeten.
English: Immediate discontinuation of therapy, careful observation, and initiation of appropriate supportive measures (blood transfusions, dialysis, haemofiltration, anti-infectious therapy, etc.) are the indicated treatment of overdose of cladribine.
Danish: Omgående ophør af behandling, nøje overvågning og igangsættelse af relevante støtteforanstaltninger (blodtransfusioner, dialyse, hæmofiltration, antiinfektionsbehandling, osv.) er den indicerede behandling af en overdosis cladribin.
English: In particular, tell your doctor if you are using any medicines containing: - corticosteroids, commonly used to treat inflammation - antiviral agents, used to treat viral infections
Danish: De skal i særdeleshed fortælle det til Deres læge, hvis de bruger medicin, som indeholder: - kortikosteroider, som er almindelige ved behandling af betændelse - antivirale midler, som anvendes til behandling af virusinfektioner
English: Although anti-infective prophylaxis is not generally recommended, it may be beneficial for patients immunocompromised prior to therapy with cladribine or for patients with a pre-existing agranulocytosis.
Danish: Selvom anti-infektiv profylakse almindeligvis ikke anbefales, kan det være gavnligt for patienter som er blevet immunokompromitteret inden behandling med cladribin eller for patienter med en forudeksisterende agranulocytose.
English: Tell your doctor immediately if you have any of the following during or after treatment with LITAK: - any signs of infections (such as flu-like symptoms) - fever
Danish: Fortæl det straks til lægen, hvis De har en eller flere af følgende symptomer under eller efter behandling med LITAK: - tegn på infektioner (som fx influenzalignende symptomer) - feber
English: Effects on sternal ossification were seen at 1.5 and 3.0 mg/kg/day.
Danish: Virkninger på sternal ossifikation blev set ved 1,5 og 3,0 mg/kg/dag.
English: Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Danish: Vær sikker på at der ikke er noget luft i sprøjten; vend kanylen opad og tryk luften ud.
English: Cladribine is moderately acutely toxic to mice, with an LD50 of 150 mg/kg by intraperitoneal administration.
Danish: Cladribin er moderat akut toksisk for mus, med en LD50 på 150 mg/kg ved intraperitoneal indgivelse.
English: Sleepiness, numbness and tingling of the skin, feebleness, inactivity, disorder of peripheral nerves, confusion, impaired ability to coordinate movements.
Danish: Søvnløshed, følelsesløshed og prikken i huden, svækkelse, inaktivitet, lidelse i det perifere nervesystem, forvirring, nedsat evne til at koordinere bevægelser.
English: Uncommon: conjunctivitis Very rare: blepharitis
Danish: Ikke almindelige: conjunctivitis Meget sjældne: blefaritis
English: Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine.
Danish: Dyreforsøg og in vitro undersøgelser med humane cellerækker har påvist cladribins teratogene og mutagene virkning.
English: Sore throat.
Danish: Ondt i halsen.
English: In another study using a dose of 0.10 mg/kg body weight/day, the maximum plasma concentration Cmax after continuous intravenous infusion was 5.1 ng/ml (tmax: 12 hours) compared to 51 ng/ml after subcutaneous bolus injection (tmax: 25 minutes).
Danish: I en anden undersøgelse, hvor der blev brugt en dosis på 0,10 mg/kg legemsvægt/dag, var den maksimale plasmakoncentration Cmax efter uafbrudt intravenøs infusion 5,1 ng/ml (tmax: 12 timer) sammenlignet med 51 ng/ml efter subkutan bolusinjektion (tmax: 25 minutter).
English: In 7- to 14-day continuous intravenous infusion studies in cynomolgus monkeys, the target organs were the immune system ( 0.3 mg/kg/day), bone marrow, skin, mucous membranes, nervous system and testes ( 0.6 mg/kg/day) and kidneys ( 1 mg/kg/day).
Danish: I en 7 til 14-dages undersøgelse med kontinuerlig intravenøs infusion hos cynomolgus-aber, var målorganerne immunsystemet ( 0,3 mg/kg/dag), knoglemarv, hud, slimhinder, nervesystem og testikler ( 0,6 mg/kg/dag) og nyrer ( 1 mg/kg/dag).
English: Reduced kidney function.
Danish: Nedsat nyrefunktion.
English: If LITAK contacts the skin or eyes, rinse the involved surface immediately with copious amounts of water.
Danish: Hvis LITAK kommer i kontakt med huden eller øjnene, skal de berørte områder straks skylles med rigelige mængder vand.
English: Patients with active infection should be treated for the underlying condition prior to receiving therapy with cladribine.
Danish: Patienter med aktiv infektion bør behandles for den tilgrundliggende tilstand inden behandling med cladribin.
English: What you need to know before you use LITAK
Danish: Det skal De vide, før De begynder at bruge LITAK
English: After subcutaneous bolus injection of a 0.14 mg/kg cladribine dose, a Cmax of 91 ng/ml is reached on average after 20 minutes only.
Danish: Efter subkutan bolusinjektion af en dosis på 0,14 mg/kg cladribin nås Cmax på 91 ng/ml gennemsnitligt efter kun 20 minutter.
English: If you have any question with regard to giving the injection, please ask your doctor or nurse for help.
Danish: Hvis De har spørgsmål om indsprøjtningen, skal De bede lægen eller sygeplejersken om hjælp.
English: Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse reactions, such as myelo- and immunosuppression, long-lasting lymphocytopenia, and opportunistic infections.
Danish: Cladribin er et antineoplastisk og immunsuppressivt stof, der kan inducere betydelige uønskede, toksiske bivirkninger, som fx myelo- og immunsuppression, langvarig lymfocytopeni og opportunistiske infektioner.
English: Very common: infections * (e.g. pneumonia *, septicaemia *)
Danish: Meget almindelige: infektioner * (fx pneumoni *, septikæmi *)
English: The intracellular retention time of cladribine nucleotides in vivo is clearly prolonged as compared to the retention time in the plasma: Half-lives t1/2 of initially 15 hours and subsequently more than 30 hours were measured in leukaemic cells.
Danish: Den intracellulære retentionstid hos cladribinnukleotider in vivo forlænges tydeligt sammenlignet med retentionstider i plasmaet: Halveringstider t1/2 på indledningsvist 15 timer og efterfølgende mere end 30 timer blev målt i leukæmiske celler.
English: For single use only
Danish: Til engangsbrug
English: The recommended dose is directly withdrawn by a syringe and injected as a subcutaneous bolus injection without dilution.
Danish: Den anbefalede dosis trækkes op med en sprøjte og injiceres som en subkutan bolusinjektion uden fortynding.
English: Low number of red blood cells, which may result in anaemia, with symptoms such as tiredness and drowsiness.
Danish: Lavt antal røde blodlegemer, som kan medføre anæmi (blodmangel) med symptomer som træthed og døsighed.
English: The single substitution of hydrogen for chlorine at position 2 distinguishes cladribine from its natural counterpart 2'-deoxyadenosine and renders the molecule resistant to deamination by adenosine deaminase.
Danish: Den enkelte substitution af hydrogen med klorin ved position 2 adskiller cladribin fra dets naturlige modpart 2'-deoxyadenosin og gør molekylet resistent over for deaminering ved adenosin deaminase.
English: An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with cladribine.
Danish: En øget forekomst af opportunistiske infektioner forventes under, og i 6 måneder efter, behandlingen med cladribin.
English: An influence of cladribine on the activity of other antineoplastic agents has not been observed in vitro (e.g. doxorubicin, vincristine, cytarabine, cyclophosphamide) and in vivo.
Danish: Påvirkning af cladibrine på andre antineoplastiske stoffers aktivitet er ikke iagttaget in vitro (fx doxorubicin, vincristin, cytarabin, cyclofosfamid) og in vivo.
English: Unlike other nucleoside analogues, cladribine is toxic in rapidly proliferating cells as well as in resting cells.
Danish: Til forskel fra andre nukleosidanaloger er cladribin toksisk i hurtigt prolifererende celler såvel som i hvilende celler.
English: - fever
Danish: - feber
English: Pack size of 1 or 5 vials.
Danish: Pakningsstørrelser på 1 eller 5 hætteglas.
English: The renal excretion of unmetabolised cladribine occurs within 24 hours and accounts for 15% and 18% of the dose after 2-hour intravenous and subcutaneous administration, respectively.
Danish: Nyreekskretion af ikke-metaboliseret cladribin opstår inden for 24 timer og gør rede for hhv. 15% og 18% af dosis efter intravenøs indgivelse af to timers varighed og subkutan indgivelse.
English: Very common: decreased appetite Uncommon: cachexia
Danish: Meget almindelige: nedsat appetit Ikke almindelige: kakeksi