FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of action of cladribine is attributed to the incorporation of CdATP into DNA strands: the synthesis of new DNA in dividing cells is blocked and the DNA repair mechanism is inhibited, resulting in an accumulation of DNA strand breaks and a decrease of NAD (nicotinamide adenine dinucleotide) and ATP concentration, even in resting cells.
Danish: Handlingsmekanismen i cladribin skyldes inkorporeringen af CdATP i dna-strenge: Syntesen hos ny dna med celledeling blokeres, og dna-ophelingsmekanismen hæmmes, hvilket resulterer i en ophobning af dna-strengebrud og et fald i NAD- (nikotinamid adenin dinukleotid) og ATP-koncentration, selv i hvilende celler.
English: Be sure that the tip of the needle is in the solution.
Danish: Vær sikker på at spidsen af kanylen er nede i opløsningen.
English: Particular caution is advised and risks/benefits should be carefully evaluated if administration of cladribine is considered in patients with increased infection risk, manifested bone marrow failure or infiltration, myelosuppressive pre-treatments, as well as in patients with suspected or manifested renal and hepatic insufficiency.
Danish: Særlig forsigtighed tilrådes og risici/fordele bør nøje evalueres, hvis indgivelse af cladribin overvejes hos patienter med øget infektionsrisiko, manifest knoglemarvssvigt eller -infiltration, myelosuppressive forbehandlinger, såvel som hos patienter med formodet eller manifest nyre- og leverinsufficiens.
English: In rabbits, cladribine is teratogenic at doses of 3.0 mg/kg/day (given on gestation days 7-19).
Danish: Hos kaniner er cladribin teratogen ved doser på 3,0 mg/kg/dag (givet på gestationsdag 7-19).
English: Common: tachycardia, heart murmur, hypotension, epistaxis, myocardial ischemia *
Danish: Almindelige: takykardi, hjertemislyd, hypotension, epistaxis, myokardieiskæmi *
English: OUTER CARTON (1-VIAL PACK)
Danish: YDRE KARTON (PAKKE MED 1 HÆTTEGLAS)
English: The effects of cladribine on fertility have not been studied in animals.
Danish: Virkningen af cladribin på fertiliteten er ikke undersøgt i dyr.
English: The biexponential decline of the serum concentration of cladribine after subcutaneous bolus injection is comparable to elimination parameters after 2-hour intravenous infusion with an initial and terminal half-life of approximately 2 hours and 11 hours, respectively.
Danish: Det bieksponentielle fald i serumkoncentrationen af cladribin efter subkutan bolusinjektion kan sammenlignes med eliminationsparametre efter 2 timers intravenøs infusion med en initial og terminal halveringstid på hhv. ca. 2 timer og 11 timer.
English: In case certain adverse reactions with a potential impact on performance occur (e.g. dizziness, very common, or drowsiness, which may occur due to anaemia, which is very common), patients should be advised not to drive or use machines.
Danish: I tilfælde af at bivirkninger med potentiel påvirkning af evnen til at føre motorkøretøj eller betjene maskiner (fx svimmelhed, meget almindelig, eller døsighed, som kan forekomme på grund af anæmi, som er meget almindelig), bør patienter frarådes at føre motorkøretøj eller betjene maskiner.
English: Cladribine shows complete bioavailability after parenteral administration; the mean area under the plasma concentration versus time curve (AUC) is comparable after continuous or intermittent 2-hour intravenous infusion and after subcutaneous injection.
Danish: Cladribin viser fuldstændig biotilgængelighed efter parenteral indgivelse; middelområdet under plasmakoncentrationen kontra tidskurve (AUC) i plasma er sammenlignelig efter kontinuerlig eller intermitterende intravenøs infusion af 2 timers varighed og efter subkutan injektion.
English: Very rare side effects (may affect up to 1 in 10.000 people) Depression, epileptic attack.
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10,000 personer) Depression, epileptisk anfald.
English: Very common side effects (may affect more than 1 in 10 people) Infections.
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer) Infektioner.
English: What do I need for the injection?
Danish: Hvad skal jeg bruge til indsprøjtningen?
English: Uncommon side effects (may affect up to 1 in 100 people) Anaemia caused by destruction of red blood cells.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer) Anæmi, som skyldes destruktion af røde blodlegemer.
English: Do not use LITAK if you notice that the vial is damaged or that the solution is not clear or contains any particles.
Danish: Brug ikke LITAK, hvis hætteglasset er beskadiget, eller opløsningen ikke er klar eller indeholder partikler.
English: Cladribine is a cytostatic agent.
Danish: Cladribin er et cytostatisk middel.
English: If you use more LITAK than you should In case you inject an incorrect dose, tell your doctor immediately.
Danish: Hvis De har brugt for meget LITAK Hvis De indsprøjter en forkert dosis, skal De straks fortælle det til lægen.
English: If LITAK contacts the skin or mucous membranes, rinse the area immediately with copious amounts of water.
Danish: Hvis LITAK kommer i kontakt med hud eller slimhinder, skylles området straks med rigelige mængder vand.
English: Careful and regular monitoring of peripheral blood counts is essential during, and for 2 to 4 months following, treatment with cladribine to detect potential adverse reactions and consequent complications (anaemia, neutropenia, thrombocytopenia, infections, haemolysis or bleedings), and to survey haematologic recovery.
Danish: Grundig og regelmæssig overvågning af perifere blodtællinger er væsentlig under, og i 2 til 4 måneder efter, behandling med cladribin for at påvise potentielle bivirkninger og følgekomplikationer (anæmi, neutropeni, trombocytopeni, infektioner, hæmolyse eller blødninger), og for at vurdere hæmatologisk bedring.
English: Shortness of breath, swelling in lung tissue due to infection, inflammation of mouth and tongue.
Danish: Kortåndethed, hævet lungevæv på grund af infektion, betændelse i mund og tunge.
English: Therefore, simultaneous administration of nucleoside analogues with cladribine is not advisable.
Danish: Derfor tilrådes indgivelse af nukleoside analoger samtidig med cladribin ikke.
English: Rare: Cardiac failure, atrial fibrillation, cardiac decompensation
Danish: Sjældne: Hjerteinsufficiens, atrieflimren, hjertedekompensation
English: The use of disposable gloves and protective garments is recommended when handling and administering LITAK.
Danish: Brug af engangshandsker og beskyttelsestøj anbefales under håndtering og indgivelse af LITAK.
English: Very common severe complications, in some cases with fatal outcome, are opportunistic infections (e.g. Pneumocystis carinii, Toxoplasma gondii, listeria, candida, herpes viruses, cytomegalovirus and atypical mycobacteria).
Danish: Meget almindelige alvorlige komplikationer, i nogle tilfælde med fatalt resultat er opportunistiske infektioner (fx Pneumocystis carinii, Toxoplasmosa gondii, listeria, candida, herpesvirus, cytomegalovirus og atypiske mykobakterier).
English: The vials are for single use only.
Danish: Hætteglassene er kun til engangsbrug.
English: How to use LITAK
Danish: Sådan skal De bruge LITAK
English: There are no data on the use of LITAK in patients with renal or hepatic impairment.
Danish: Der er ingen data om brugen af LITAK til patienter med svækket nyre- eller leverfunktion.
English: The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days.
Danish: Den anbefalede dosis til hårcelleleukæmi er en enkelt kur med LITAK givet ved subkutan bolusinjektion med en daglig dosis på 0,14 mg/kg legemsvægt i fem på hinanden følgende dage.
English: Cladribine is teratogenic in mice (at doses of 1.5-3.0 mg/kg/day, given on gestation days 6-15).
Danish: Cladribin er teratogen hos mus (ved doser på 1,5-3,0 mg/kg/dag, givet på gestationsdag 6-15).
English: Rare serious adverse reactions
Danish: Sjældne alvorlige bivirkninger
English: LITAK should be inspected visually for particulate matter and discoloration prior to administration.
Danish: LITAK skal kontrolleres visuelt for partikler og misfarvning før administration.
English: You must not breast-feed while you are treated with LITAK and for at least six months after your last LITAK dose.
Danish: De må ikke amme, mens De får behandling med LITAK og i mindst seks måneder efter den sidste dosis LITAK.
English: Cladribine is a purine nucleoside analogue acting as an antimetabolite.
Danish: Cladribin er en purinnukleosidanalog, der virker som en antimetabolit.
English: Cladribine is a cytotoxic medicinal product, which is mutagenic to cultured mammalian cells.
Danish: Cladribin er et cytotoksisk lægemiddel, som er mutagen for dyrkede pattedyrceller.
English: - one sterile injection needle (e.g. 0.5 x 19 mm, 25 G x ¾''), - alcohol wipes,
Danish: - en steril kanyle (fx 0,5 x 19 mm, 25 G x ¾''), - renseservietter,
English: - one sterile syringe (e.g. 10 ml LUER syringe),
Danish: - en steril sprøjte (fx en 10 ml LUER-sprøjte),
English: Cladribine is incorporated into DNA strands and inhibits DNA synthesis and repair.
Danish: Cladribin inkorporeres i dna-strenge og hæmmer dna-syntese og -vedligeholdelse.
English: When LITAK is not self-administered by the patient, the use of disposable gloves and protective garments is recommended when handling and administering LITAK.
Danish: Når patienten ikke selv indsprøjter LITAK, anbefales det at bruge engangshandsker og beskyttende beklædning under håndtering og indgivelse af LITAK.
English: Blood counts
Danish: Blodtælling
English: Feeling sick, vomiting, constipation and diarrhoea.
Danish: Kvalme, opkastning, forstoppelse og diaré.
English: However, a toxicity study conducted with cynomolgus monkeys has shown that cladribine suppresses maturation of rapidly generating cells, including testicular cells.
Danish: En toksicitetsundersøgelse udført med cynomolgus-aber har vist, at cladribin undertrykker modning af hurtigt genererende celler, herunder testikelceller.
English: OUTER CARTON (5-VIAL PACK)
Danish: YDRE KARTON (PAKKE MED 5 HÆTTEGLAS)
English: Disturbances in speech and swallowing.
Danish: Besvær med at tale og synke.
English: No cytotoxic effect of cladribine could be observed in cell lines of solid tumours.
Danish: Der blev ikke set nogen cytotoksisk virkning i cellerækker hos massive tumorer.
English: Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function.
Danish: Ældre patienter skal behandles efter individuel vurdering og omhyggelig kontrol af blodtællinger og af nyre- og leverfunktionen.
English: Packs contain 1 or 5 vials, each with 5 ml of solution.
Danish: Pakninger indeholder 1 eller 5 hætteglas med hver 5 ml opløsning.
English: Sleeplessness, anxiety.
Danish: Søvnløshed, angst.
English: The cytotoxicity of cladribine is dose-dependent.
Danish: Cytotoksiciteten i cladribin er dosisafhængig.
English: Other medicines and LITAK
Danish: Brug af anden medicin sammen med LITAK
English: Do not use vials which are damaged, or if the solution is not clear or if it contains any particles.
Danish: Brug ikke hætteglasset med LITAK, hvis opløsningen er uklar eller indeholder partikler.
English: Skin reactions are mostly mild to moderate and usually resolve within a few days.
Danish: Hudreaktioner er som regel lette til moderate og forsvinder normalt i løbet af få dage.
English: Because of the potential for serious adverse reactions in nursing infants, lactation is contraindicated during treatment with cladribine and for 6 months after the last cladribine dose.
Danish: På grund af muligheden for alvorlige bivirkninger hos spædbørn, der ammes, er amning kontraindiceret under behandling med cladribin og i 6 måneder efter den sidste dosis cladribin.
English: Cladribine is a prodrug which is taken up rapidly in cells after parenteral administration, and is phosphorylated intracellularly to the active nucleotide 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by deoxycytidine kinase (dCK).
Danish: Cladribin er et pro-drug, som optages hurtigt i celler efter parenteral indgivelse, og det bliver fosforyleret intracellulært til det aktive nukleotid 2-klorodeoxyadenosin-5'-trifosfat (CdATP) ved deoxycytidinkinase (dCK).
English: In case you miss an injection of a dose, tell your doctor immediately.
Danish: Hvis de springer indsprøjtningen af en dosis over, skal De straks fortælle det til lægen.
English: Clean the rubber top of the vial with an alcohol wipe.
Danish: Rens hætteglassets gummitop med en renseserviet.
English: Further rare cases with fatal outcome, reported in association with LITAK chemotherapy, were second malignancy, cerebro- and cardiovascular infarctions, graft-versus-host disease caused by multiple transfusions of non-irradiated blood, as well as tumour lysis syndrome with hyperuricaemia, metabolic acidosis, and acute renal failure.
Danish: Yderligere sjældne tilfælde med dødelig udgang, som er rapporteret i forbindelse med LITAK-kemoterapi, var sekundær malignitet, cerebrale og kardiovaskulære infarkter, graft-versus-host sygdom forårsaget af adskillige transfusioner af ikke-bestrålet blod, såvel som tumorlysesyndrom med hyperurikæmi, metabolisk acidose og akut nyresvigt.
English: Rare side effects (may affect up to 1 in 1.000 people) Reduced liver function.
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1,000 personer) Nedsat leverfunktion.
English: Since interactions with medicinal products undergoing intracellular phosphorylation, such as antiviral agents, or with inhibitors of adenosine uptake may be expected, their concomitant use with cladribine is not recommended.
Danish: Da interaktion med lægemidler, som gennemgår intracellulær fosforylering, som fx antivirale stoffer, eller med hæmmere af adenosinoptagelse kan forventes, tilrådes samtidig brug af disse og cladribin ikke.
English: Remove the needle guard without touching the needle.
Danish: Fjern kanylens beskyttelseskappe uden at røre kanylen.
English: You must take adequate contraceptive precautions during therapy and for at least six months after your last LITAK dose.
Danish: De skal anvende passende antikonceptionsmidler under behandlingen og i mindst seks måneder efter den sidste dosis LITAK.
English: Pull the needle out of the vial.
Danish: Træk kanylen ud af hætteglasset.
English: Frequently observed symptoms of overdose are nausea, vomiting, diarrhoea, severe bone marrow depression (including anaemia, thrombocytopenia, leukopenia, and agranulocytosis), acute renal insufficiency, as well as irreversible neurologic toxicity (paraparesis/quadriparesis), Guillain-Barré syndrome, and Brown-Séquard syndrome.
Danish: Ofte observerede symptomer efter overdosis er kvalme, opkastning, diarré, alvolig knoglemarvsdepression (herunder anæmi, trombocytopeni, leukopeni og agranulocytose), akut nyresvigt såvel som irreversibel neurologisk toksicitet (paraparese/quadriparese), Guillain-Barré-syndrom og Brown-Séquard-syndrom.
English: Careful treatment is required in patients with known or suspected renal or hepatic impairment.
Danish: Forsigtig behandling er påkrævet hos patienter med kendt eller formodet nyre- eller leverinsufficiens.
English: Very common: nausea, vomiting, constipation, diarrhoea Common: gastrointestinal pain, flatulence Rare: ileus
Danish: Meget almindelige: kvalme, opkastning, obstipation, diarré Almindelige: gastrointestinal smerte, flatulens Sjældne: ileus
English: Dispose the puncture-proof container as instructed by your doctor, nurse or pharmacist.
Danish: Beholderen bortskaffes efter lægens, sygeplejersken eller apotekspersonalets instrukser.
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see section 4.4).
Danish: Mænd som behandles med cladribin bør frarådes at blive far til et barn i op til 6 måneder efter behandling og at søge rådgivning om nedfrysning af sperma inden behandlingen, fordi der er en mulighed for at behandling med cladribin kan lede til infertilitet (se pkt.
English: Remove the injection needle from the wrapping and place it firmly on the tip of the syringe.
Danish: Tag kanylen ud af indpakningen og sæt den godt fast på spidsen af sprøjten.
English: Very common: injection site reactions, fever, fatigue, chills, asthenia
Danish: Meget almindelige: reaktioner ved injektionsstedet, feber, træthed, kulderystelser, asteni
English: Very rare: cholecystitis
Danish: Meget sjældne: kolecystitis
English: Remove the syringe from the wrapping without touching the tip of the syringe.
Danish: Tag sprøjten ud af indpakningen uden at røre ved spidsen af sprøjten.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Parenterale lægemidler skal undersøges visuelt for partikelrester og misfarvning inden indgivelse.
English: Clinical experience is very limited and safety of LITAK in these patients is not well established (see sections 4.3 and 5.2).
Danish: Klinisk erfaring er meget begrænset og sikkerheden i forbindelse med brug af LITAK til disse patienter er ikke veletableret (se pkt.
English: Each ml of solution contains 2 mg of cladribine (2-CdA).
Danish: Hver ml opløsning indeholder 2 mg cladribin (2-CdA).
English: - one vial of LITAK (or two vials if you need to inject more than 5 ml).
Danish: - Et hætteglas LITAK (eller to hætteglas, hvis De skal indsprøjte mere end 5 ml), Brug ikke hætteglas, som er beskadigede.
English: Before injection, allow LITAK to warm up to room temperature.
Danish: Før indsprøjtning skal LITAK have lov til at opnå stuetemperatur.
English: Common side effects (may affect up to 1 in 10 people) Repeated occurrence of malignant (cancerous) disease.
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) Den ondartede (cancer-) sygdom opstår igen.
English: The prodrug cladribine is metabolised intracellularly, predominantly by deoxycytidine kinase, to 2-chlorodeoxyadenosine-5'-monophosphate, that is further phosphorylated to the diphosphate by nucleoside monophosphate kinase and to the active metabolite 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by nucleoside diphosphate kinase.
Danish: Cladribin er et prodrug, som metaboliseres intracellulært, hovedsageligt ved deoxycytidinkinase til 2-klorodeoxyadenosin-5'-monofosfat, som yderligere fosforyliseres til difosfat ved nukleosidmonofosfatkinase og til den aktive metabolit 2-klorodeoxyadenosin-5'-trifosfat (CdATP) ved nukleosiddifosfatkinase.
English: Serious adverse reactions like ileus, severe hepatic failure, renal failure, cardiac failure, atrial fibrillation, cardiac decompensation, apoplexy, neurological disturbances in speech and swallowing, tumour lysis syndrome with acute renal failure, transfusion-related graft-versus-host disease, Stevens-Johnson syndrome/Lyell syndrome (toxic epidermal necrolysis), haemolytic anaemia, hypereosinophilia (with erythematous skin rash, pruritus, and facial oedema) are rare.
Danish: Alvorlige bivirkninger som ileus, alvorlig leversvigt, nyresvigt, hjertesvigt, atrieflimren, hjertedekompensation, apopleksi, neurologiske forstyrrelser af tale og ved synken, tumorlysesyndrom med akut nyresvigt, transfusionsrelateret graft-versus-host sygdom, Stevens-Johnson-syndrom/Lyell-syndrom (toksisk epidermal nekrolyse), hæmolytisk anæmi, hypereosinofili (med erythematøst hududslæt, pruritus og ansigtsødem) er sjældne.
English: Where should I give my injection?
Danish: Hvor skal jeg give mig selv indsprøjtningen?
English: Very common: pancytopenia/myelosuppression *, neutropenia, thrombocytopenia, anemia, lymphopenia Uncommon: haemolytic anaemia * Rare: hypereosinophilia
Danish: Meget almindelige: pancytopeni/myelosuppression *, neutropeni, trombocytopeni, anæmi, lymfopeni Ikke almindelige: hæmolytisk anæmi * Sjældne: hypereosinofili
English: Do not remove the rubber stopper of the vial.
Danish: Undgå at fjerne hætteglassets gummiprop.
English: LITAK 2 mg/ml solution for injection cladribine
Danish: LITAK 2 mg/ml injektionsvæske, opløsning cladribin
English: LITAK is contraindicated in patients with moderate to severe renal impairment or with moderate to severe hepatic impairment (see section 4.3).
Danish: LITAK er kontraindiceret hos patienter med moderat til alvorlig nyresvækkelse eller med moderat til alvorlig leversvækkelse (se pkt.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen, hvis De tager anden medicin eller har gjort det for nylig.
English: Detailed instructions are contained in the Package Leaflet.
Danish: Indlægssedlen indeholder detaljerede instruktioner.
English: Avoid contact by pregnant women.
Danish: Undgå at gravide kommer i kontakt med midlet.
English: Moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or moderate to severe hepatic impairment (Child-Pugh score > 6) (see also section 4.4).
Danish: Patienter med moderat til alvorlig nyresvækkelse (kreatininclearance ≤ 50 ml/min) eller med moderat til alvorlig leversvækkelse (Child-Pugh-score > 6) (se også pkt.
English: LITAK 2 mg/ml solution for injection
Danish: LITAK 2 mg/ml injektionsvæske, opløsning
English: Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected to have adverse effects on human gametogenesis (see section 5.3).
Danish: Antineoplastiske stoffer som cladribin, som påvirker dna, rna og proteinsyntesen, kan forventes at have uønskede virkninger på den humane gametogenese (se pkt.
English: Return any portion of the contents remaining after use to your doctor or pharmacist for proper disposal.
Danish: Hvis der er noget tilbage, bør du aflevere det til din læge eller apotekspersonalet, så det kan blive bortskaffet på passende måde.
English: Very rare: lung embolism
Danish: Meget sjældne: lungeemboli
English: Very rare: amyloidosis
Danish: Meget sjældne: amyloidose
English: Very common: rash, localised exanthema, diaphoresis Common: pruritus, skin pain, erythema, urticaria Rare: Stevens-Johnson syndrome/Lyell syndrome
Danish: Meget almindelige: udslæt, lokalt eksantem, sveden Almindelige: pruritus, hudsmerte, erytem, urtikaria Sjælden: Stevens-Johnson-syndrom/Lyell-syndrom
English: Common: shortness of breath, pulmonary interstitial infiltrates mostly due to infectious aetiology, mucositis Uncommon: pharyngitis
Danish: Almindelige: kortåndethed, pulmonale interstitielle infiltrater, primært på grund af infektionsætiologi, mukositis
English: Abnormal heart rhythm.
Danish: Unormal hjerterytme.
English: Contains sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections
Danish: Indeholder natriumklorid, natriumhydroxid (til pH-justering), saltsyre (til pH-justering) og vand til injektionsvæsker
English: Skin eruption (rash), swelling, redness as well as soreness around the site of injection, sweating.
Danish: Hududslæt, hævelse, rødme samt ømhed omkring injektionsstedet, svedafsondring.
English: How do I prepare the injection?
Danish: Hvordan gør jeg en indsprøjtning klar?
English: Swelling in tissues (oedema), not feeling well, pain (muscle pain, joint pain, and bone pain).
Danish: Hævelser i vævet (ødemer), følelse af utilpashed, smerter (muskelsmerter, ledsmerter og knoglesmerter).
English: Each ml solution contains 2 mg cladribine.
Danish: Hver ml opløsning indeholder 2 mg cladribin.
English: Prevention of tumour lysis syndrome
Danish: Forebyggelse af tumorlysesyndrom
English: There are no studies available using cladribine in patients with renal or hepatic impairment (see also section 4.2 and section 4.4).
Danish: Der er ingen tilgængelige undersøgelser med cladribin hos patienter med nyre- eller leversvækkelse (se også pkt.
English: Inflammation of the gallbladder.
Danish: Betændelse i galdeblæren.