FrancophonIA/ELRC3.0 huggingface dataset:
English: Clynav is available as a solution for injection and can only be obtained with a prescription.
Slovenian: Zdravilo Clynav je na voljo v obliki raztopine za injiciranje, predpisovanje in izdaja zdravila pa je le na recept.
English: A main laboratory model study looked at the signs of pancreas disease in fish given Clynav compared with a dummy saline injection.
Slovenian: V glavni laboratorijski modelni študiji so preučevali znake bolezni trebušne slinavke pri ribah, ki so prejele zdravilo Clynav, v primerjavi z injekcijo fiziološke raztopine brez zdravilne učinkovine.
English: For practical information about using Clynav, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Clynav naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with Clynav, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Clynav naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Clynav contains as active substance a DNA plasmid (a small piece of DNA) containing the genetic code for making salmon pancreas disease virus proteins.
Slovenian: Zdravilo Clynav kot zdravilno učinkovino vsebuje plazmidno DNK (majhen del DNK), ki vsebuje genetski zapis za proizvodnjo beljakovin virusa bolezni trebušne slinavke pri lososu.
English: How does Clynav work?
Slovenian: Kako zdravilo Clynav deluje?
English: Clynav salmon pancreas disease vaccine (recombinant DNA plasmid)
Slovenian: Clynav cepivo za bolezen trebušne slinavke pri lososu (rekombinantna plazmidna DNK)
English: Clynav contains a DNA plasmid which, once injected into fish, will lead to the production of salmon pancreas disease virus (SPDV) proteins.
Slovenian: Zdravilo Clynav vsebuje plazmidno DNK, ki po injiciranju v ribo sproži nastajanje beljakovin virusa bolezni trebušne slinavke pri lososu (SPDV).
English: How is Clynav used?
Slovenian: Kako se zdravilo Clynav uporablja?
English: The fate of the remainder is unknown.
Slovenian: Usoda preostanka ni znana.
English: This means that the risk that you develop a malignant disease in the future is slightly higher than for healthy people.
Slovenian: To pomeni, da je tveganje, da se pri vas v prihodnje razvije maligna bolezen, nekoliko višje kot pri zdravih ljudeh.
English: Date of first authorisation: 14/04/2004 Date of last renewal: 27/03/2009
Slovenian: Datum prve odobritve: 14/04/2004 Datum zadnjega podaljšanja: 27/03/2009
English: Less than a third of febrile events are associated with a documented infection.
Slovenian: Manj kot tretjina febrilnih dogodkov je povezanih z dokumentirano okužbo.
English: Patients less than 18 years of age.
Slovenian: Bolniki mlajši od 18 let.
English: * see descriptive section below.
Slovenian: * glej opisno poglavje spodaj.
English: Your doctor may decide that you should receive blood transfusions to improve your level of blood cells.
Slovenian: Vaš zdravnik se bo morda odločil, da boste prejemali transfuzije krvi za izboljšanje ravni vaših krvnih celic.
English: Their frequency varies widely, ranging from 2% to 21%.
Slovenian: Njihova pogostnost je zelo različna, v razponu od 2 % do 21 %.
English: At present there exists no experience on possible long-term consequences of this immunosuppression.
Slovenian: Trenutno ni izkušenj v zvezi z možnimi dolgotrajnimi posledicami te imunosupresije.
English: Your doctor will tell you how much LITAK you need and how often and when you have to inject yourself.
Slovenian: Vaš zdravnik vam bo povedal, koliko zdravila LITAK potrebujete in kako pogosto in kdaj si ga morate sami injicirati.
English: Your doctor may advise you about the possibility to store deep-frozen sperm (cryoconservation).
Slovenian: Vaš zdravnik vam bo morda svetoval o možnosti shranjevanja globoko zmrznjene sperme (kriokonservacija).
English: All patients were successfully treated with corticosteroids.
Slovenian: Vse bolnike so uspešno zdravili s kortikosteroidi.
English: Inject straight away.
Slovenian: Takoj injicirajte.
English: Repeated occurrence of malignant (cancerous) disease cannot be excluded.
Slovenian: Ponavljajočega se pojava maligne (rakave) bolezni ni mogoče izključiti.
English: The majority of deaths related to the medicinal product are due to infectious complications.
Slovenian: Večina smrti, povezanih z zdravilom, je posledica zapletov zaradi okužbe.
English: The origin of febrile events should be investigated by appropriate laboratory and radiologic tests.
Slovenian: Izvor febrilnih dogodkov je treba raziskati z ustreznimi laboratorijskimi in radiološkimi preiskavami.
English: Experience with patients older than 65 years is limited.
Slovenian: Izkušnje pri bolnikih, starejših od 65 let, so omejene.
English: Put the needle fully into the skin at an angle of about 45°, as shown in the picture.
Slovenian: Iglo vbodite v kožo do konca pod kotom približno 45°, kot je prikazano na sliki.
English: Your doctor will calculate your dose according to your body weight and explain the treatment schedule in detail.
Slovenian: Vaš zdravnik bo izračunal vaš odmerek na podlagi vaše telesne mase in vam podrobno razložil časovni razpored zdravljenja.
English: Check you have the right volume.
Slovenian: Preverite, da imate pravo prostornino.
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).
Slovenian: Pogostnosti so določene kot sledi: zelo pogosti (> 1/10), pogosti (> 1/100 do < 1/10), občasni (> 1/1.000 do < 1/100), redki (> 1/10.000 do <1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Unless fatal, indications were that most or all of these effects would be slowly reversible upon cessation of exposure.
Slovenian: Če niso bili smrtni, je za večino ali vse od teh učinkov kazalo, da bodo po prenehanju izpostavljanja počasi reverzibilni.
English: Find a comfortable, well-lit place and put everything you need where you can reach it.
Slovenian: Poiščite udoben, dobro osvetljen prostor in si pripravite vse, kar potrebujete, tako da bo v dosegu roke.
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.
Slovenian: Pred zdravljenjem z zdravilom LITAK in med njim boste imeli redne preiskave krvi s katerimi bodo preverili ali je varno, da nadaljujete z vašim zdravljenjem.
English: Before you inject LITAK, you must do the following:
Slovenian: Pred injiciranjem zdravila LITAK morate narediti sledeče:
English: This section contains information on how to give an injection of LITAK.
Slovenian: To poglavje vsebuje podatke o tem, kako dati injekcijo zdravila LITAK.
English: Inject the liquid slowly and evenly for approximately one minute, always keeping the skin pinched.
Slovenian: Tekočino počasi in enakomerno injicirajte približno eno minuto, koža ves čas držite v kožni gubi.
English: Dose reduction and regular monitoring of the patient is required in such cases.
Slovenian: V takih primerih je potrebno znižanje odmerka in redno spremljanje bolnika.
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.
Slovenian: Celokupna stopnja odziva je bila 97 % z dolgotrajno remisijo, pri čemer je 73 % bolnikov doseglo popolno remisijo po štirih letih spremljanja.
English: Fatal outcome
Slovenian: Smrtni izid
English: Treatment of nausea with antiemetics is usually not necessary.
Slovenian: Zdravljenje slabosti z antiemetiki običajno ni potrebno.
English: (myelosuppression).
Slovenian: (mielosupresija).
English: The vials are for single use only.
Slovenian: Viale so namenjene samo enkratni uporabi.
English: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Germany
Slovenian: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Nemčija
English: Carcinogenesis/mutagenesis
Slovenian: Kancerogeneze/mutageneza
English: The peak risk is at 2 years after diagnosis with a median between 40 and 66 months.
Slovenian: Tveganje je najvišje po preteku 2 let od diagnoze z mediano med 40 in 66 meseci.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če ga ne uporabite takoj, je za čas in pogoje shranjevanja pripravljene raztopine odgovoren uporabnik.
English: If severe toxicity occurs, the physician should consider delaying or discontinuing the therapy with the medicinal product until serious complications resolve.
Slovenian: Če se pojavi huda toksičnost, naj zdravnik razmisli o odložitvi ali ukinitvi zdravljenja z zdravilom, dokler resni zapleti niso razrešeni.
English: Your must not use LITAK if you are pregnant.
Slovenian: Zdravila LITAK ne smete uporabljati, če ste noseči.
English: Other medicines and LITAK
Slovenian: Druga zdravila in zdravilo LITAK
English: Deviations from the posology indicated above are not advised.
Slovenian: Odstopanja od zgoraj navedenega odmerjanja niso priporočljiva.
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Slovenian: Če v brizgi zagledate kri, iglo izvlecite in jo vbodite drugam.
English: If you had these symptoms prior to treatment with cladribine, tell your doctor about any change in these symptoms.
Slovenian: Če ste imeli te simptome pred začetkom zdravljenja s kladribinom, o kakršni koli spremembi simptomov obvestite zdravnika.
English: Treatment with these agents is associated with the occurrence of second malignancies.
Slovenian: Zdravljenje s temi učinkovinami je povezano s pojavom sekundarnih malignomov.
English: In case of infections, antibiotic treatment should be initiated as required.
Slovenian: V primeru okužb je treba po potrebi uvesti antibiotično zdravljenje.
English: Clinical experience is very limited and safety of LITAK in these patients is not well established.
Slovenian: Klinične izkušnje so zelo omejene, varnost zdravila LITAK pri teh bolnikih ni zadostno ugotovljena.
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).
Slovenian: Potegnite pravilno prostornino zdravila LITAK v brizgo tako, da izvlečete bat (vaš zdravnik vam bo povedal, koliko ml zdravila LITAK si morate injicirati).
English: The effect on human fertility is unknown.
Slovenian: Učinek na plodnost pri človeku ni znan.
English: Concomitant use of other myelosuppressive medicinal products.
Slovenian: Sočasna uporaba drugih mielosupresivnih zdravil.
English: Pharmacotherapeutic group: Purine analogues, ATC code: L01BB04
Slovenian: Farmakoterapevtska skupina: analogi purinskih baz, oznaka ATC: L01BB04
English: In addition, the proper function of your liver and your kidneys will be checked.
Slovenian: Dodatno bodo preverjali pravilno delovanje vaših jeter in ledvic.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: LITAK must not be mixed with other medicinal products.
Slovenian: Zdravila LITAK ne smete mešati z drugimi zdravili.
English: LITAK has to be injected under your skin (subcutaneous injection), at about the same time each day.
Slovenian: Zdravilo LITAK je treba injicirati pod kožo (subkutano injiciranje), vsak dan ob približno enakem času.
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.
Slovenian: Tukaj so prikazana najbolj ustrezna mesta za injiciranje sebi: zgornji del stegen in trebuh, razen področja okrog popka.
English: If you forget to use LITAK
Slovenian: Če ste pozabili uporabiti zdravilo LITAK
English: One third of these infections have to be considered as severe (e.g. septicaemia, pneumonia).
Slovenian: Eno tretjino teh okužb so predstavljale hude okužbe (npr. septikemija, pljučnica).
English: Plasma protein binding of cladribine is 25% on average, with a wide interindividual variation (5-50%).
Slovenian: Plazemska vezava kladribina na beljakovine je povprečno 25 % s širokim razponom razlikovanja med posamezniki (5-50 %).
English: At least 10 cases with acute autoimmune haemolytic anaemia have been reported.
Slovenian: Poročali so o vsaj o 10 primerih akutne avtoimune hemolitične anemije.
English: Do not inject a double dose to make up for a forgotten dose.
Slovenian: Ne injicirajte si dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: What should I do before I give myself a subcutaneous injection of LITAK?
Slovenian: Kaj moram narediti, preden si podkožno injiciram zdravilo LITAK?
English: Long-term studies in animals to evaluate the carcinogenic potential of cladribine have not been conducted.
Slovenian: Dolgotrajnih študij pri živalih, da bi ovrednotili kancerogeni potencial kladribina, niso opravili.
English: It is unknown whether cladribine is excreted in human milk.
Slovenian: Ni znano, ali se kladribin izloča v materino mleko.
English: It is important that you do not try to give yourself the injection unless you have been instructed by your doctor or nurse.
Slovenian: Pomembno je, da si ne poskušate dati injekcije, razen če vas o tem ni poučil vaš zdravnik ali medicinska sestra.
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.
Slovenian: 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).
English: Pregnant women must avoid contact with LITAK.
Slovenian: Nosečnice se morajo stiku z zdravilom LITAK izogniti.
English: On the basis of available data, no evaluation can be made of the carcinogenic risk of cladribine to humans.
Slovenian: Na podlagi razpoložljivih podatkov ni mogoče oceniti kancerogenega tveganja kladribina za človeka.
English: Clean the rubber top of the vial with an alcohol wipe.
Slovenian: Gumijasti vrh viale očistite z alkoholno blazinico.
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.
Slovenian: 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.
English: LITAK is used to treat this disease.
Slovenian: Zdravilo LITAK se uporablja za zdravljenje te bolezni.
English: For severity, please see text below the table.
Slovenian: Za resnost glejte besedilo pod preglednico.
English: PML was reported 6 months to several years after treatment with cladribine.
Slovenian: O PML so poročali od šest mesecev do več let po zdravljenju s kladribinom.
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
Slovenian: 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
English: If you want to father a child, please tell your doctor before treatment with LITAK is started.
Slovenian: Če želite spočeti otroka, to povejte svojemu zdravniku pred začetkom zdravljenja z zdravilom LITAK.
English: Use a new syringe and injection needle for each injection.
Slovenian: Za vsako injiciranje uporabite novo brizgo in injekcijsko iglo.
English: Cell death occurs from energy depletion and apoptosis.
Slovenian: Do celične smrti pride zaradi pomanjkanja energije in apoptoze.
English: Therefore, patients treated with cladribine should be regularly monitored.
Slovenian: Torej je treba bolnike, zdravljene s kladribinom, redno spremljati.
English: Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.
Slovenian: Zdravljenje z zdravilom LITAK naj uvede usposobljeni zdravnik z izkušnjami pri kemoterapiji raka.
English: The mean volume of distribution of cladribine is 9.2 l/kg.
Slovenian: Povprečni volumen porazdelitve kladribina je 9,2 l/kg.
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
Slovenian: 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
English: Cladribine induces a severe and prolonged reduction of CD4+ and CD8+ T-lymphocytes.
Slovenian: Kladribin povzroči hudo in podaljšano znižanje koncentracij CD4+ in CD8+ T-limfocitov.
English: You may also receive an additional medicine containing the active substance allopurinol in order to reduce excess of uric acid.
Slovenian: Morda boste prejeli tudi dodatno zdravilo, ki vsebuje učinkovino alopurino, da se zmanjša presežek sečne kisline.
English: The risk requires assessment on a case-by-case basis (see section 4.4).
Slovenian: Tveganje zahteva oceno na podlagi posameznega primera (glejte poglavje 4.4).
English: Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine.
Slovenian: Študije na živalih ter in vitro študije s humanimi celičnimi linijami so pokazale teratogenost in mutagenost kladribina.
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.
Slovenian: 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.
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Slovenian: Zdravniki naj pri bolnikih z novimi ali poslabšanimi nevrološkimi, kognitivnimi ali vedenjskimi znaki ali simptomi razmislijo o diferencialni diagnostiki PML.
English: Like all medicines, LITAK can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo LITAK neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Self-administration by the patient
Slovenian: Samodajanje bolnika
English: You will find detailed instructions for injection at the end of this leaflet.
Slovenian: Podrobna navodila za injiciranje so na koncu teh navodil.
English: If you have any question with regard to giving the injection, please ask your doctor or nurse for help.
Slovenian: Če imate kakršna koli vprašanja v zvezi z dajanjem injekcije, prosimo, vprašajte svojega zdravnika ali medicinsko sestro za pomoč.
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.
Slovenian: 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.
English: Common: reversible, mostly mild increases in bilirubin and transaminases
Slovenian: Pogosti: reverzibilna, večinoma blaga zvišanja vrednosti bilirubina in transaminaz
English: A complete recovery of T-helper cells and B-lymphocytes is delayed for up to 2 years.
Slovenian: Popolna poprava T celic-pomagalk in B-limfocitov je odložena do 2 leti.
English: Do not put used syringes into the normal household garbage bin.
Slovenian: Uporabljenih brizg ne odlagajte v običajni smetnjak za gospodinjske odpadke.
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.
Slovenian: Po kladribinu je pojavnost sekundarnih malignomov v razponu od 0 % do 9,5 % po medianem obdobju opazovanja 2,8 do 8,5 let.
English: Patients who have received an overdose of cladribine should be monitored haematologically for at least four weeks.
Slovenian: Bolnike, ki so prejeli preveliki odmerek kladribina, je treba hematološko spremljati vsaj štiri tedne.
English: Intracellular concentration of cladribine exceeds its plasma concentration by 128 to 375 times.
Slovenian: Znotrajcelična koncentracija kladribina presega njegovo plazemsko koncentracijo za 128- do 375-krat.
English: The recovery of cytotoxic T-lymphocytes and natural killer cells occurs within 3 to 12 months.
Slovenian: Popravljanje koncentracij citotoksičnih Tlimfocitov in naravnih celic ubijalk se pojavi v 3 do 12 mesecih.
English: Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Slovenian: Preverite, da v brizgi ni zraka: brizgo obrnite z iglo navzgor in iztisnite zrak ven.
English: - one sterile injection needle (e.g. 0.5 x 19 mm, 25 G x ¾''), - alcohol wipes,
Slovenian: - eno sterilno injekcijsko iglo (npr. 0,5 x 19 mm, 25 G x ¾''), - alkoholne blazinice,
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.
Slovenian: V primeru kopičenja serumske sečne kisline nad normalnim razponom lahko odmerek alopurinola zvišamo na 300 mg/dan.
English: Furthermore, CdATP inhibits ribonucleotide reductase, the enzyme responsible for the conversion of ribonucleotides into deoxyribonucleotides.
Slovenian: Poleg tega CdATP zavira ribonukleotidno reduktazo, encim, odgovoren za pretvorbo ribonukleotidov v deoksiribonukleotide.
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).
Slovenian: 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).
English: In case of fever related to infections or agranulocytosis, an antibiotic treatment is indicated.
Slovenian: V primeru zvišane telesne temperature, povezane z okužbami ali agranulocitozo, je indicirano antibiotično zdravljenje.
English: The use of haematopoietic growth factors neither improves the recovery of neutrophil counts nor decreases the incidence of fever.
Slovenian: Uporaba hematopoetskih rastnih faktorjev ne izboljša popravljanja koncentracij nevtrofilcev niti ne zniža pojavnosti zvišane telesne temperature.
English: This slightly increased risk can be due to hairy cell leukaemia or to therapies used to treat the disease including LITAK.
Slovenian: To rahlo zvišano tveganje je lahko posledica dlakavocelične levkemije ali terapij, s katerimi so bolezen zdravili, vključno z zdravilom LITAK.
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.
Slovenian: Kožo razkužite z uporabo alkoholne blazinice, počakajte, da se področje posuši, in s palcem in kazalcem naredite kožno gubo, ne da bi kožo stiskali.