natgillin/translations-raw huggingface dataset:
Treatment with these agents is associated with the occurrence of second malignancies.
Zdravljenje s temi učinkovinami je povezano s pojavom sekundarnih malignomov.
In case of infections, antibiotic treatment should be initiated as required.
V primeru okužb je treba po potrebi uvesti antibiotično zdravljenje.
Clinical experience is very limited and safety of LITAK in these patients is not well established.
Klinične izkušnje so zelo omejene, varnost zdravila LITAK pri teh bolnikih ni zadostno ugotovljena.
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).
Potegnite pravilno prostornino zdravila LITAK v brizgo tako, da izvlečete bat (vaš zdravnik vam bo povedal, koliko ml zdravila LITAK si morate injicirati).
The effect on human fertility is unknown.
Učinek na plodnost pri človeku ni znan.
Concomitant use of other myelosuppressive medicinal products.
Sočasna uporaba drugih mielosupresivnih zdravil.
Pharmacotherapeutic group: Purine analogues, ATC code: L01BB04
Farmakoterapevtska skupina: analogi purinskih baz, oznaka ATC: L01BB04
In addition, the proper function of your liver and your kidneys will be checked.
Dodatno bodo preverjali pravilno delovanje vaših jeter in ledvic.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
LITAK must not be mixed with other medicinal products.
Zdravila LITAK ne smete mešati z drugimi zdravili.
LITAK has to be injected under your skin (subcutaneous injection), at about the same time each day.
Zdravilo LITAK je treba injicirati pod kožo (subkutano injiciranje), vsak dan ob približno enakem času.
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.
Tukaj so prikazana najbolj ustrezna mesta za injiciranje sebi: zgornji del stegen in trebuh, razen področja okrog popka.
If you forget to use LITAK
Če ste pozabili uporabiti zdravilo LITAK
One third of these infections have to be considered as severe (e.g. septicaemia, pneumonia).
Eno tretjino teh okužb so predstavljale hude okužbe (npr. septikemija, pljučnica).
Plasma protein binding of cladribine is 25% on average, with a wide interindividual variation (5-50%).
Plazemska vezava kladribina na beljakovine je povprečno 25 % s širokim razponom razlikovanja med posamezniki (5-50 %).
At least 10 cases with acute autoimmune haemolytic anaemia have been reported.
Poročali so o vsaj o 10 primerih akutne avtoimune hemolitične anemije.
Do not inject a double dose to make up for a forgotten dose.
Ne injicirajte si dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
What should I do before I give myself a subcutaneous injection of LITAK?
Kaj moram narediti, preden si podkožno injiciram zdravilo LITAK?
Long-term studies in animals to evaluate the carcinogenic potential of cladribine have not been conducted.
Dolgotrajnih študij pri živalih, da bi ovrednotili kancerogeni potencial kladribina, niso opravili.
It is unknown whether cladribine is excreted in human milk.
Ni znano, ali se kladribin izloča v materino mleko.
It is important that you do not try to give yourself the injection unless you have been instructed by your doctor or nurse.
Pomembno je, da si ne poskušate dati injekcije, razen če vas o tem ni poučil vaš zdravnik ali medicinska sestra.
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.
V kliničnih preskušanjih s podkožno uporabo zdravila LITAK so zdravili 63 bolnikov z dlakavocelično levkemijo (33 na novo diagnosticiranih bolnikov in 30 bolnikov s ponovitvijo ali napredovanjem bolezni).
Pregnant women must avoid contact with LITAK.
Nosečnice se morajo stiku z zdravilom LITAK izogniti.
On the basis of available data, no evaluation can be made of the carcinogenic risk of cladribine to humans.
Na podlagi razpoložljivih podatkov ni mogoče oceniti kancerogenega tveganja kladribina za človeka.
Clean the rubber top of the vial with an alcohol wipe.
Gumijasti vrh viale očistite z alkoholno blazinico.
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.
Izpostavljanje kladribinu povzroči fragmentacijo DNA in smrt celice v različnih normalnih in levkemičnih celicah ter celičnih linijah v koncentracijah od 5 nM do 20 µM.
LITAK is used to treat this disease.
Zdravilo LITAK se uporablja za zdravljenje te bolezni.
For severity, please see text below the table.
Za resnost glejte besedilo pod preglednico.
PML was reported 6 months to several years after treatment with cladribine.
O PML so poročali od šest mesecev do več let po zdravljenju s kladribinom.
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
Ker imajo bolniki ob odkritju aktivne dlakavocelične levkemije večinoma nizke koncentracije krvnih celic, posebno nevtrofilcev, ima več kot 90 % primerov prehodne hude nevtropenije (< 1,0 x 10
If you want to father a child, please tell your doctor before treatment with LITAK is started.
Če želite spočeti otroka, to povejte svojemu zdravniku pred začetkom zdravljenja z zdravilom LITAK.
Use a new syringe and injection needle for each injection.
Za vsako injiciranje uporabite novo brizgo in injekcijsko iglo.
Cell death occurs from energy depletion and apoptosis.
Do celične smrti pride zaradi pomanjkanja energije in apoptoze.
Therefore, patients treated with cladribine should be regularly monitored.
Torej je treba bolnike, zdravljene s kladribinom, redno spremljati.
Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.
Zdravljenje z zdravilom LITAK naj uvede usposobljeni zdravnik z izkušnjami pri kemoterapiji raka.
The mean volume of distribution of cladribine is 9.2 l/kg.
Povprečni volumen porazdelitve kladribina je 9,2 l/kg.
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
Ne uporabljajte zdravila LITAK - če ste alergični na kladribin ali katero koli sestavino zdravila LITAK (navedeno v poglavju 6), - če ste noseči ali dojite, - če ste mlajši od 18 let, - če imate zmerno do hudo okvarjeno delovanje ledvic ali jeter, - če jemljete druga zdravila, ki vplivajo na nastajanje krvnih celic v kostnem mozgu
Cladribine induces a severe and prolonged reduction of CD4+ and CD8+ T-lymphocytes.
Kladribin povzroči hudo in podaljšano znižanje koncentracij CD4+ in CD8+ T-limfocitov.
You may also receive an additional medicine containing the active substance allopurinol in order to reduce excess of uric acid.
Morda boste prejeli tudi dodatno zdravilo, ki vsebuje učinkovino alopurino, da se zmanjša presežek sečne kisline.
The risk requires assessment on a case-by-case basis (see section 4.4).
Tveganje zahteva oceno na podlagi posameznega primera (glejte poglavje 4.4).
Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine.
Študije na živalih ter in vitro študije s humanimi celičnimi linijami so pokazale teratogenost in mutagenost kladribina.
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.
Te so bile v povprečju hujše kot okužbe pri 27 % vseh bolnikov, ki so prejemali znižani odmerek 0,5 mg/kg telesne mase na cikel.
Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Zdravniki naj pri bolnikih z novimi ali poslabšanimi nevrološkimi, kognitivnimi ali vedenjskimi znaki ali simptomi razmislijo o diferencialni diagnostiki PML.
Like all medicines, LITAK can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo LITAK neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Self-administration by the patient
Samodajanje bolnika
You will find detailed instructions for injection at the end of this leaflet.
Podrobna navodila za injiciranje so na koncu teh navodil.
If you have any question with regard to giving the injection, please ask your doctor or nurse for help.
Če imate kakršna koli vprašanja v zvezi z dajanjem injekcije, prosimo, vprašajte svojega zdravnika ali medicinsko sestro za pomoč.
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.
Vendar pa je in vitro študija pokazala navzkrižno odpornost med kladribinom in nitroiperitom (klormetinom); za citarabin je en avtor opisal in vivo navzkrižno reakcijo brez izgube aktivnosti.
Common: reversible, mostly mild increases in bilirubin and transaminases
Pogosti: reverzibilna, večinoma blaga zvišanja vrednosti bilirubina in transaminaz
A complete recovery of T-helper cells and B-lymphocytes is delayed for up to 2 years.
Popolna poprava T celic-pomagalk in B-limfocitov je odložena do 2 leti.
Do not put used syringes into the normal household garbage bin.
Uporabljenih brizg ne odlagajte v običajni smetnjak za gospodinjske odpadke.
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.
Po kladribinu je pojavnost sekundarnih malignomov v razponu od 0 % do 9,5 % po medianem obdobju opazovanja 2,8 do 8,5 let.
Patients who have received an overdose of cladribine should be monitored haematologically for at least four weeks.
Bolnike, ki so prejeli preveliki odmerek kladribina, je treba hematološko spremljati vsaj štiri tedne.
Intracellular concentration of cladribine exceeds its plasma concentration by 128 to 375 times.
Znotrajcelična koncentracija kladribina presega njegovo plazemsko koncentracijo za 128- do 375-krat.
The recovery of cytotoxic T-lymphocytes and natural killer cells occurs within 3 to 12 months.
Popravljanje koncentracij citotoksičnih Tlimfocitov in naravnih celic ubijalk se pojavi v 3 do 12 mesecih.
Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Preverite, da v brizgi ni zraka: brizgo obrnite z iglo navzgor in iztisnite zrak ven.
- one sterile injection needle (e.g. 0.5 x 19 mm, 25 G x ¾''), - alcohol wipes,
- eno sterilno injekcijsko iglo (npr. 0,5 x 19 mm, 25 G x ¾''), - alkoholne blazinice,
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.
V primeru kopičenja serumske sečne kisline nad normalnim razponom lahko odmerek alopurinola zvišamo na 300 mg/dan.
Furthermore, CdATP inhibits ribonucleotide reductase, the enzyme responsible for the conversion of ribonucleotides into deoxyribonucleotides.
Poleg tega CdATP zavira ribonukleotidno reduktazo, encim, odgovoren za pretvorbo ribonukleotidov v deoksiribonukleotide.
It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD).
Priporočamo, da bolniki, ki prejemajo kladribin, dobivajo obsevane celične krvne sestavine/izdelke, da preprečimo s transfuzijo povezano graft-versus-host bolezen (Ta-GVHD-transfusion associated graftversus-host disease).
In case of fever related to infections or agranulocytosis, an antibiotic treatment is indicated.
V primeru zvišane telesne temperature, povezane z okužbami ali agranulocitozo, je indicirano antibiotično zdravljenje.
The use of haematopoietic growth factors neither improves the recovery of neutrophil counts nor decreases the incidence of fever.
Uporaba hematopoetskih rastnih faktorjev ne izboljša popravljanja koncentracij nevtrofilcev niti ne zniža pojavnosti zvišane telesne temperature.
This slightly increased risk can be due to hairy cell leukaemia or to therapies used to treat the disease including LITAK.
To rahlo zvišano tveganje je lahko posledica dlakavocelične levkemije ali terapij, s katerimi so bolezen zdravili, vključno z zdravilom LITAK.
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.
Kožo razkužite z uporabo alkoholne blazinice, počakajte, da se področje posuši, in s palcem in kazalcem naredite kožno gubo, ne da bi kožo stiskali.
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.
Če se počutite zaspane, kar se lahko zgodi zaradi nizkega števila rdečih krvnih celic kot posledica zdravljenja z zdravilom LITAK, ali omotične, ne vozite in ne upravljajte strojev.
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%).
Zelo pogosti neželeni učinki, opažani v treh najpomembnejših kliničnih preskušanjih s kladribinom pri 279 bolnikih, zdravljenih za različne indikacije, ter pri 62 bolnikih z dlakavocelično levkemijo (DCL), so bili mielosupresija, posebno huda nevtropenija (41 % (113/279), DCL 98 % (61/62)), huda trombocitopenija (21 % (58/279), DCL 50 % (31/62)) in huda anemija (14 % (21/150), DCL 55 % (34/62)), pa tudi huda imunosupresija/limfopenija (63 % (176/279), DCL 95 % (59/62)), okužbe (39 % (110/279), DCL 58 % (36/62)) ter zvišana telesna temperatura (do 64 %).
Adverse reactions that have been reported are listed in the table below by frequency category and system organ class.
Neželeni učinki, o katerih so poročali, so našteti v spodnji preglednici in razvrščeni po pogostnosti in organskih razredih.
Before injection, allow LITAK to warm up to room temperature.
Pred injekcijo pustite, da se zdravilo LITAK ogreje na sobno temperaturo.
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.
Kumulativne pogostnosti sekundarnih malignomov so 5 %, 10-12 % in 13-14 % po 5, 10 oziroma 15 letih po diagnozi dlakavocelične levkemije.
You must not use LITAK with other medicines that affect the production of blood cells in the bone marrow (myelosuppression).
Zdravila LITAK ne smete uporabljati z drugimi zdravili, ki vplivajo na nastajanje belih krvnih celic v kostnem mozgu (mielosupresija).
Skin rashes (2-31%) are mainly described in patients with other concomitantly administered medicinal products known to cause rash (antibiotics and/or allopurinol).
Kožne izpuščaje (2-31 %) opisujejo predvsem pri bolnikih, ki sočasno prejemajo druga zdravila, za katera je znano, da povzročajo izpuščaj (antibiotiki oziroma alopurinol).
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.
Pogostnost sekundarnih malignomov po zdravljenju z zdravilom LITAK je bila 3,4 % pri vseh 232 bolnikih z dlakavocelično levkemijo, zdravljenih v 10-letnem obdobju.
Remove the red protective cap from the LITAK vial.
Z viale zdravila LITAK snemite rdečo zaščitno zaporko.
However, a toxicity study conducted with cynomolgus monkeys has shown that cladribine suppresses maturation of rapidly generating cells, including testicular cells.
Vendar pa je študija toksičnosti pri opicah Cynomolgus pokazala, da kladribin zavira dozorevanje hitro nastajajočih celic, vključujoč testikularne celice.
if you notice any signs of infections (such as flu-like symptoms or fever) during or after treatment with LITAK, inform your doctor immediately.
če opazite kakršne koli znake okužbe (kot so gripi podobni simptomi ali zvišana telesna temperatura) med zdravljenjem z zdravilom LITAK ali po njem, morate o tem takoj obvestiti svojega zdravnika.
Pack size of 1 or 5 vials.
Velikost pakiranja je 1 ali 5 vial.
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.
Povejte svojemu zdravniku, če imate ali ste imeli: - težave z jetri ali ledvicami - okužbe če imate okužbo, jo je treba pozdraviti, preden začnete uporabljati zdravilo LITAK.
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.
V primeru, da se pojavijo nekateri neželeni učinki z možnim vplivom na sposobnost vožnje in upravljanja strojev (npr. zelo pogosta omotičnost ali zaspanost, ki se lahko pojavi zaradi anemije, kar je zelo pogosto), je treba bolnikom svetovati, naj ne vozijo in ne upravljajo strojev.
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.
Farmakokinetične študije pri človeku so pokazale, da krivulja plazemske koncentracije kladribina ustreza modelu z 2 ali 3 razdelki z - in β-razpolovnimi časi povprečno 35 minut oziroma 6,7 ur.
Clinical experience is very limited and safety of LITAK in these patients is not well established (see sections 4.3 and 5.2).
Klinične izkušnje so zelo omejene, varnost zdravila LITAK pri teh bolnikih ni zadostno ugotovljena (glejte poglavji 4.3 in 5.2).
A daily oral dose of 100 mg of allopurinol is recommended for a period of 2 weeks.
Priporočamo dnevni peroralni odmerek 100 mg alopurinola za obdobje 2 tednov.
Lymphocytopenia lasting for several months and immunosuppression with an increased risk of infections are expected.
Pričakujemo limfocitopenijo, trajajočo več mesecev, in imunosupresijo s povečanim tveganjem za okužbe.
The recommended daily dose is 0.14 mg per kg body weight for five consecutive days (single treatment course).
Priporočen dnevni odmerek je 0,14 mg na kg telesne mase na dan pet zaporednih dni (enkraten potek zdravljenja).
What LITAK is and what it is used for
Kaj je zdravilo LITAK in za kaj ga uporabljamo
Non-haematologic tissues seem to be unaffected, explaining the low incidence of non-haematopoietic toxicity of cladribine
Videti je, da nehematološka tkiva niso prizadeta, kar razlaga nizko pojavnost nehematopoetske toksičnosti kladribina.
Therapeutic risks and benefits should be carefully evaluated in patients with active or suspected infections.
Tveganja in koristi zdravljenja je treba skrbno ovrednotiti pri bolnikih z aktivnimi okužbami ali s sumom na okužbo.
For all patients treated with LITAK, periodic assessment of renal and hepatic function is advised as clinically indicated.
Za vse bolnike, zdravljene z zdravilom LITAK, se priporoča periodično ocenjevanje delovanja ledvic in jeter, kot je klinično indicirano.
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.
Za kortikosteroide so pokazali, da povečajo tveganje za hude okužbe, če jih uporabljamo v kombinaciji s kladribinom in jih ne smemo dajati sočasno s kladribinom.
Unlike other nucleoside analogues, cladribine is toxic in rapidly proliferating cells as well as in resting cells.
Za razliko od drugih nukleozidnih analogov je kladribin toksičen v hitro proliferirajočih kot tudi mirujočih celicah.
In case of pregnancy during therapy with cladribine, the woman should be informed about the potential hazard to the foetus.
V primeru zanositve v času zdravljenja s kladribinom moramo žensko obvestiti o možnem tveganju za plod.
The effects of cladribine on fertility have not been studied in animals.
Učinkov kladribina na plodnost pri živalih niso preučevali.
At this dose, severe limb anomalies were seen as well as a significant decrease in the mean foetal weight.
Pri tem odmerjanju so opažali hude anomalije okončin, pa tudi značilno znižanje povprečne telesne mase ploda.
If pregnancy occurs during your treatment, you must immediately inform your doctor.
Če zanosite med zdravljenjem, morate nemudoma obvestiti svojega zdravnika.
At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Če se kadar koli med zdravljenjem ali po njem pojavi kaj od naslednjega, o tem takoj obvestite zdravnika ali medicinsko sestro: zamegljen vid, izguba vida ali dvojni vid, težave pri govorjenju, oslabelost roke ali noge, sprememba načina hoje ali težave z ravnotežjem, dolgotrajna otrplost, zmanjšano zaznavanje ali izguba zaznavanja, izguba spomina ali zmedenost.
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
Zdravnika še zlasti obvestite, če uporabljate zdravila, ki vsebujejo: - kortikosteroide, ki se pogosto uporabljajo za zdravljenje vnetij - protivirusna zdravila, ki se uporabljajo za zdravljenje virustnih okužb
Progressive multifocal leukoencephalopathy (PML) Cases of PML, including fatal cases, have been reported with cladribine.
Progresivna multifokalna levkoencefalopatija (PML) Pri zdravljenju s kladribinom so poročali o primerih PML, vključno s primeri, ki so se končali s smrtjo.
Severe long-term lymphocytopenias have been reported rarely which, however, could not be associated with late infectious complications.
Poročali so o redkih hudih dolgotrajnih limfocitopenijah, ki pa jih ne moremo povezovati s poznimi zapleti zaradi okužbe.
If you are injecting LITAK yourself, first you must receive adequate training by your doctor or nurse.
Če si zdravilo LITAK injicirate sami, vas mora najprej ustrezno poučiti zdravnik ali medicinska sestra.
Patients with symptoms of bone marrow depression should be treated with caution, since further suppression of bone marrow function should be anticipated.
Bolnike s simptomi zavrtja delovanja kostnega mozga je treba zdraviti previdno, ker moramo predvideti nadaljnje zavrtje delovanja kostnega mozga.
Suggested evaluation for PML includes neurology consultation, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Predlagana diagnostika za PML vključuje nevrološko posvetovanje, magnetnoresonančno slikanje možganov in analizo cerebrospinalnega likvorja za DNA virusa JC (JCV) z verižno reakcijo s polimerazo (PCR-polymerase chain reaction) ali biopsijo možganov s preiskavo za JCV.
- a puncture-proof container for safe disposal of the used syringe.
- vsebnik, odporen proti vbodom, za varno odlaganje uporabljene brizge.
10 ml type I glass vial with rubber stopper (bromobutyl) and flip-off aluminium cap.
10 ml viala iz stekla tipa I z gumijastim zamaškom (bromobutil) in "flip-off" aluminijasto zaporko.