FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Clynav, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni VMP-a Clynav potražite u uputi o VMP-u.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clynav on
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Clynav na snazi u Europskoj uniji od 27/06/2017.
English: Check you have the right volume.
Croatian: Provjerite da imate ispravan volumen.
English: No specific antidote exists.
Croatian: Ne postoji specifični antidot.
English: Experience with patients older than 65 years is limited.
Croatian: Iskustvo s bolesnicima starijim od 65 godina je ograničeno.
English: Patients less than 18 years of age.
Croatian: Bolesnici mlađi od 18 godina.
English: At present there exists no experience on possible long-term consequences of this immunosuppression.
Croatian: Trenutno ne postoje iskustva o mogućim dugoročnim posljedicama ove imunosupresije.
English: This means that the risk that you develop a malignant disease in the future is slightly higher than for healthy people.
Croatian: To znači da je rizik od razvoja zloćudne bolesti u budućnosti kod Vas nešto veći nego kod zdravih ljudi.
English: Find a comfortable, well-lit place and put everything you need where you can reach it.
Croatian: Pronađite udobno, dobro osvijetljeno mjesto i stavite sve što Vam je potrebno na dohvat ruke.
English: Other medicines and LITAK
Croatian: Drugi lijekovi i LITAK
English: Do not inject a double dose to make up for a forgotten dose.
Croatian: Nemojte ubrizgati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: * see descriptive section below.
Croatian: * vidjeti opis dolje.
English: The following side effects may occur:
Croatian: Mogu nastati sljedeće nuspojave:
English: What LITAK is and what it is used for
Croatian: Što je LITAK i za što se koristi
English: Their frequency varies widely, ranging from 2% to 21%.
Croatian: Njihova učestalost znatno varira, u rasponu od 2% do 21%.
English: (myelosuppression).
Croatian: (mijelosupresija).
English: Always use LITAK as your doctor has told you.
Croatian: Uvijek primijenite LITAK točno onako kako Vam je rekao liječnik.
English: Your doctor will tell you how much LITAK you need and how often and when you have to inject yourself.
Croatian: Liječnik će Vam reći koliko Vam je lijeka LITAK potrebno i koliko često i kada si trebate ubrizgati lijek.
English: All patients were successfully treated with corticosteroids.
Croatian: Svi bolesnici uspješno su liječeni kortikosteroidima.
English: LITAK must not be mixed with other medicinal products.
Croatian: LITAK se ne smije miješati s drugim lijekovima.
English: Before you inject LITAK, you must do the following:
Croatian: Prije ubrizgavanja lijeka LITAK morate učiniti sljedeće:
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Croatian: Nositelj odobrenja mora obavijestiti Europsku komisiju o planovima za stavljanje u promet lijeka odobrenog ovom odlukom.
English: Treatment of nausea with antiemetics is usually not necessary.
Croatian: Liječenje mučnine antiemeticima obično nije potrebno.
English: The fate of the remainder is unknown.
Croatian: Sudbina ostatka lijeka nije poznata.
English: Put the needle fully into the skin at an angle of about 45°, as shown in the picture.
Croatian: Uvedite iglu u kožu pod kutem od 45ºC, kako je prikazano na slici.
English: Your doctor may advise you about the possibility to store deep-frozen sperm (cryoconservation).
Croatian: Liječnik Vam može dati savjet o mogućnosti pohranjivanja duboko zamrznute sperme (kriokonzervacija).
English: Less than a third of febrile events are associated with a documented infection.
Croatian: Manje od trećine slučajeva vrućice povezano je s dokumentiranom infekcijom.
English: The majority of deaths related to the medicinal product are due to infectious complications.
Croatian: Većina smrtnih slučajeva povezanih s ovim lijekom prouzročena je infekcijskim komplikacijama.
English: Your doctor will calculate your dose according to your body weight and explain the treatment schedule in detail.
Croatian: Liječnik će izračunati dozu prema Vašoj tjelesnoj težini i detaljno Vam objasniti plan liječenja.
English: The peak risk is at 2 years after diagnosis with a median between 40 and 66 months.
Croatian: Vršni rizik je 2 godine nakon dijagnoze s medijanom između 40 i 66 mjeseci.
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).
Croatian: Učestalost je definirana na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
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.
Croatian: Ukupna stopa odgovora bila je 97% s dugotrajnom remisijom, sa 73% bolesnika u kojih je kompletna remisija ostala nakon 4 godine praćenja.
English: LITAK is used to treat this disease.
Croatian: LITAK se koristi za liječenje ove bolesti.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate,ili ste nedavno uzeli bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: At least 10 cases with acute autoimmune haemolytic anaemia have been reported.
Croatian: Zabilježeno je najmanje 10 slučajeva s akutnom autoimunom hemolitičkom anemijom.
English: Deviations from the posology indicated above are not advised.
Croatian: Odstupanja od gore navedenog doziranja se ne preporučuju.
English: Fatal outcome
Croatian: Smrtni ishod
English: This section contains information on how to give an injection of LITAK.
Croatian: Ovaj dio sadrži informacije o načinu davanja injekcije lijeka LITAK.
English: If you had these symptoms prior to treatment with cladribine, tell your doctor about any change in these symptoms.
Croatian: Ako ste imali ove simptome prije početka liječenja kladribinom, obavijestite svog liječnika o svim promjenama tih simptoma.
English: One third of these infections have to be considered as severe (e.g. septicaemia, pneumonia).
Croatian: Trećina ovih infekcija trebaju se smatrati teškima (npr. septikemija, pneumonija).
English: Carcinogenesis/mutagenesis
Croatian: Kancerogeneza/mutageneza
English: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Germany
Croatian: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Njemačka
English: Warnings and precautions Talk to your doctor or pharmacist before using LITAK.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego primijenite LITAK.
English: LITAK has to be injected under your skin (subcutaneous injection), at about the same time each day.
Croatian: LITAK se mora ubrizgati pod kožu (potkožna injekcija) u približno isto vrijeme svaki dan.
English: Pharmacotherapeutic group: Purine analogues, ATC code: L01BB04
Croatian: Farmakoterapijska skupina: analog purina, ATK oznaka: L01BB04
English: A negative JCV PCR does not exclude PML.
Croatian: Negativni rezultat metode PCR na JCV ne isključuje PML.
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).
Croatian: Uvucite ispravan volumen lijeka LITAK u štrcaljku povlačenjem klipa (liječnik će Vam reći koliko ml lijeka LITAK trebate ubrizgati).
English: From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, osim ako način otvaranja lijeka ne nosi rizik od mikrobiološkog zagađenja, lijek se mora odmah primijeniti.
English: Repeated occurrence of malignant (cancerous) disease cannot be excluded.
Croatian: Ne može se isključiti ponovna pojava zloćudne bolesti (raka).
English: You will find detailed instructions for injection at the end of this leaflet.
Croatian: Detaljne upute za davanje injekcije nalaze se na kraju ove upute.
English: On the basis of available data, no evaluation can be made of the carcinogenic risk of cladribine to humans.
Croatian: Na temelju dostupnih podataka ne može se procijeniti kancerogeni rizik kladribina za ljude.
English: Like all medicines, LITAK can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, lijek LITAK može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Your doctor may decide that you should receive blood transfusions to improve your level of blood cells.
Croatian: Liječnik može odlučiti da morate primiti transfuziju krvi kako bi se popravio broj krvnih stanica.
English: Inject straight away.
Croatian: Odmah ubrizgajte.
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Croatian: Pojavi li se krv u štrcaljki, izvucite iglu i ponovno je uvedite u drugo mjesto.
English: Plasma protein binding of cladribine is 25% on average, with a wide interindividual variation (5-50%).
Croatian: Vezanje kladribina za proteine plazme je u prosjeku 25% s velikim interindividualnim razlikama (5-50%).
English: What should I do before I give myself a subcutaneous injection of LITAK?
Croatian: Što trebam učiniti prije davanja potkožne injekcije lijeka LITAK?
English: Severe thrombocytopenias (< 50 x 10
Croatian: Teška trombocitopenija (< 50 x 10
English: After injecting the liquid, remove the needle.
Croatian: Nakon ubrizgavanja tekućine uklonite iglu.
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
Croatian: Budući da bolesnici s aktivnom leukemijom vlasastih stanica uglavnom imaju nisku krvnu sliku, osobito nizak broj neutrofila, u više od 90% slučajeva javlja se prolazna teška neutropenija (< 1,0 x 10
English: Cell death occurs from energy depletion and apoptosis.
Croatian: Stanična smrt nastupa zbog nedostatka energije i apoptoze.
English: Pregnant women must avoid contact with LITAK.
Croatian: Trudnice moraju izbjegavati kontakt s lijekom LITAK.
English: Remove the red protective cap from the LITAK vial.
Croatian: Uklonite crvenu zaštitnu kapicu s bočice lijeka LITAK.
English: Inject the liquid slowly and evenly for approximately one minute, always keeping the skin pinched.
Croatian: Polagano i ravnomjerno ubrizgavajte tekućinu tijekom približno jedne minute, držeći kožu između prstiju.
English: The origin of febrile events should be investigated by appropriate laboratory and radiologic tests.
Croatian: Porijeklo vrućice treba istražiti pomoću odgovarajućih laboratorijskih i radioloških pretraga.
English: Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.
Croatian: Liječenje lijekom LITAK treba započeti kvalificirani liječnik s iskustvom u kemoterapiji tumora.
English: What LITAK is and what it is used for What you need to know before you use LITAK How to use LITAK
Croatian: Što je LITAK i za što se koristi Što morate znati prije nego počnete primjenjivati LITAK Kako primjenjivati LITAK
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.
Croatian: Prije i tijekom liječenja lijekom LITAK, redovito ćete raditi krvne pretrage radi provjere sigurnosti nastavka liječenja.
English: The mean volume of distribution of cladribine is 9.2 l/kg.
Croatian: Prosječni volumen distribucije kladribina je 9,2 l/kg.
English: Severe long-term lymphocytopenias have been reported rarely which, however, could not be associated with late infectious complications.
Croatian: Teška dugotrajna limfocitopenija rijetko je zabilježena, međutim, ne može se dovesti u vezu s kasnim infekcijskim komplikacijama.
English: In case of pregnancy during therapy with cladribine, the woman should be informed about the potential hazard to the foetus.
Croatian: U slučaju trudnoće tijekom liječenja kladribinom, žena mora biti informirana o mogućoj opasnosti za fetus.
English: If severe toxicity occurs, the physician should consider delaying or discontinuing the therapy with the medicinal product until serious complications resolve.
Croatian: U slučaju razvoja teške toksičnosti, liječnik treba razmotriti odgodu ili prekid liječenja ovim lijekom sve dok se ozbiljne komplikacije ne razriješe.
English: Dose reduction and regular monitoring of the patient is required in such cases.
Croatian: U takvim slučajevima potrebno je smanjenje doze i redovito praćenje bolesnika.
English: A complete recovery of T-helper cells and B-lymphocytes is delayed for up to 2 years.
Croatian: Potpuni oporavak pomagačkih T limfocita i B limfocita odgođen je do 2 godine.
English: Do not put used syringes into the normal household garbage bin.
Croatian: Ne bacajte upotrijebljene štrcaljke u običnu kantu za kućni otpad.
English: Therefore, patients treated with cladribine should be regularly monitored.
Croatian: Stoga bolesnike koji su liječeni kladribinom treba redovito nadzirati.
English: Clinical experience is very limited and safety of LITAK in these patients is not well established.
Croatian: Kliničko iskustvo je vrlo ograničeno i sigurnost primjene lijeka LITAK u ovih bolesnika nije dovoljno utvrđena.
English: At this dose, severe limb anomalies were seen as well as a significant decrease in the mean foetal weight.
Croatian: Kod ove doze viđene su teške anomalije udova kao i značajno smanjenje prosječne težine ploda.
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.
Croatian: U kliničkom ispitivanju potkožne primjene lijeka LITAK bilo je liječeno 63 bolesnika s leukemijom vlasastih stanica (33 novodijagnosticirana bolesnika i 30 bolesnika s relapsom ili progresivnom bolešću).
English: In addition, the proper function of your liver and your kidneys will be checked.
Croatian: Uz to će Vam provjeravati ispravnu funkciju jetre i bubrega.
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.
Croatian: Dezinficirajte kožu pomoću rupčića natopljenog alkoholom, pričekajte da se osuši i uštipnite kožu između palca i kažiprsta, bez stiskanja.
English: If you forget to use LITAK
Croatian: Ako ste zaboravili primijeniti LITAK
English: This slightly increased risk can be due to hairy cell leukaemia or to therapies used to treat the disease including LITAK.
Croatian: Taj donekle povećan rizik može biti posljedica leukemije vlasastih stanica ili lijekova koji se koriste za liječenje te bolesti, uključujući LITAK.
English: Unless fatal, indications were that most or all of these effects would be slowly reversible upon cessation of exposure.
Croatian: Ako nisu izazvali smrt, pokazalo se da su većina ili svi učinci bili reverzibilni nakon prestanka izlaganja lijeku.
English: Before injection, allow LITAK to warm up to room temperature.
Croatian: Prije ubrizgavanja neka se LITAK ugrije do sobne temperature.
English: If someone else is injecting you, they can also use the outer surface of the upper arms or the buttocks.
Croatian: Ako Vam netko drugi daje injekciju, može također koristiti vanjsku površinu nadlaktice ili stražnjicu.
English: What you need to know before you use LITAK
Croatian: Što morate znati prije nego počnete primjenjivati LITAK
English: 9/l) are observed in about 20% to 30% of all patients.
Croatian: 9/l) primijećena je u oko 20% do
English: If pregnancy occurs during your treatment, you must immediately inform your doctor.
Croatian: Ako tijekom liječenja nastupi trudnoća, odmah obavijestite liječnika.
English: INSTRUCTIONS FOR INJECTION
Croatian: UPUTE ZA DAVANJE INJEKCIJE
English: Patients should be instructed and trained appropriately.
Croatian: Bolesnici trebaju dobiti odgovarajuće upute i poduku.
English: Common: reversible, mostly mild increases in bilirubin and transaminases
Croatian: Često: reverzibilno i uglavnom blago povećanje bilirubina i transaminaza
English: If you want to father a child, please tell your doctor before treatment with LITAK is started.
Croatian: Želite li začeti dijete, recite to svome liječniku prije početka liječenja lijekom LITAK.
English: Use a new syringe and injection needle for each injection.
Croatian: Za svaku injekciju koristite novu štrcaljku i injekcijsku iglu.
English: Rare serious adverse reactions
Croatian: Rijetke ozbiljne nuspojave
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.
Croatian: U slučaju nakupljanja serumske mokraćne kiseline iznad raspona normalnih vrijednosti, doza alopurinola može se povećati na 300 mg/dan.
English: Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Croatian: Provjerite da u štrcaljki nije zaostao zrak: usmjerite iglu prema gore i istisnite zrak.
English: Prevention of tumour lysis syndrome
Croatian: Sprečavanje sindroma lize tumora
English: Concomitant use of other myelosuppressive medicinal products.
Croatian: Istovremena primjena drugih mijelosupresivnih lijekova.
English: Progressive multifocal leukoencephalopathy (PML) Cases of PML, including fatal cases, have been reported with cladribine.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Pri primjeni kladribina prijavljeni su slučajevi PML-a, uključujući slučajeve sa smrtnim ishodom.
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.
Croatian: Najprikladnija mjesta za davanje injekcije prikazana su na slici: vrh bedara i trbuha, osim područja oko pupka.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, korisnik je odgovoran za uvjete i vrijeme čuvanja.
English: Clean the rubber top of the vial with an alcohol wipe.
Croatian: Očistite gumeni vrh bočice pomoću rupčića natopljenog alkoholom.
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%).
Croatian: Vrlo česte nuspojave primijećene tijekom tri najvažnija klinička ispitivanja kladribina u 279 bolesnika liječenih u različitim indikacijama i 62 bolesnika s leukemijom vlasastih stanica (‘hairy cell leukaemia', HCL) bile su mijelosupresija, osobito teška neutropenija (41% (113/279), HCL 98% (61/62)), teška trombocitopenija (21% (58/279), HCL 50% (31/62)) i teška anemija (14% (21/150), HCL 55% (34/62)), kao i teška imunosupresija/limfopenija (63% (176/279), HCL 95% (59/62)), infekcije (39% (110/279), HCL 58% (36/62)) i vrućica (do 64%).
English: LITAK should be injected into the tissue just under the skin (subcutaneous injection).
Croatian: LITAK se ubrizgava u tkivo odmah ispod kože (potkožna injekcija).
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.
Croatian: Izloženost kladribinu izaziva fragmentaciju DNK i staničnu smrt u različitim normalnim i leukemijskim stanicama i staničnim linijama u koncentracijama od 5 nM do 20 μM.
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
Croatian: Osobito trebate reći liječniku ako uzimate neke od lijekova koji sadrže: - kortikosteroide, koji se obično koriste za liječenje upale - antivirusne lijekove, koji se koriste za liječenje virusnih infekcija.
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.
Croatian: Nuspojave vezane za kožu i potkožno tkivo su uglavnom blage ili umjerene i prolazne, obično prestaju tijekom intervala ciklusa od 30 dana.
English: The use of haematopoietic growth factors neither improves the recovery of neutrophil counts nor decreases the incidence of fever.
Croatian: Primjena hematopoetskih čimbenika rasta ne poboljšava niti oporavak broja neutrofila niti smanjuje incidenciju vrućice.
English: During the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required.
Croatian: Mijelosupresija je najizraženija tijekom prvog mjeseca nakon liječenja te mogu biti potrebne transfuzije crvenih krvnih stanica ili krvnih pločica.
English: It is important that you do not try to give yourself the injection unless you have been instructed by your doctor or nurse.
Croatian: Nemojte si sami pokušati dati injekciju osim ako ste dobili upute od liječnika ili medicinske sestre.
English: Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine.
Croatian: Ispitivanja na životinjama i ispitivanja in vitro na humanim staničnim linijama dokazala su teratogenost i mutagenost kladribina.
English: Store in a refrigerator (2°C-8°C).
Croatian: Čuvati u hladnjaku (2ºC-8ºC).
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
Croatian: Nemojte primjenjivati LITAK - ako ste alergični na kladribin ili neki drugi sastojak lijeka LITAK (naveden u dijelu 6.), - ako ste trudni ili dojite, - ako ste mlađi od 18 godina, - ako imate umjereno do teško oštećenje funkcije bubrega ili jetre, - ako uzimate druge lijekove koji utječu na stvaranje krvnih stanica u koštanoj srži
English: Cladribine is a purine nucleoside analogue acting as an antimetabolite.
Croatian: Kladribin je purinski nukleozidni analog koji djeluje kao antimetabolit.
English: Lymphocytopenia lasting for several months and immunosuppression with an increased risk of infections are expected.
Croatian: Očekuje se limfocitopenija u trajanju od nekoliko mjeseci i imunosupresija s povećanim rizikom od infekcija.
English: The vials are for single use only.
Croatian: Bočice su samo za jednokratnu uporabu.
English: Rare: Cardiac failure, atrial fibrillation, cardiac decompensation
Croatian: Rijetko: zatajenje srca, fibrilacija atrija, srčana dekompenzacija
English: PML was reported 6 months to several years after treatment with cladribine.
Croatian: Slučajevi PML-a prijavljeni su u razdoblju od šest mjeseci do nekoliko godina nakon liječenja kladribinom.
English: Pancytopenia is normally reversible and the intensity of bone marrow aplasia is dose-dependent.
Croatian: Pancitopenija je obično reverzibilna, a intenzitet aplazije koštane srži ovisi o dozi.