FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency will review any new information on this medicine every year and this package leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: Ceplene is available in pack sizes of 14 vials.
Croatian: Ceplene je dostupan u pakiranjima od 14 bočica.
English: Patients with all degrees of hepatic impairment may have tachycardia or hypotension for 30-60 minutes after Ceplene+IL-2 administration.
Croatian: Bolesnici sa svim stupnjevima oštećenja funkcije jetre mogu imati tahikardiju ili hipotenziju 30-60 minuta nakon primjene Ceplenea+IL-2.
English: Table 2: For treatment cycles 4-10 with Ceplene and IL-2, same as for Table 1 above, with the exception of number of cycles and duration of rest periods
Croatian: Tablica 2: Za 4. do 10. ciklus liječenja s Cepleneom i IL-2, isto kao i u gore navedenoj Tablici 1, s izuzetkom broja ciklusa i trajanja razdoblja odmora
English: Clearance of Ceplene is almost twice as high in females resulting in considerably lower systemic exposure than in males.
Croatian: Klirens Ceplenea je gotovo dvaput viši u žena što rezultira znatno nižom sustavnom izloženošću nego u muškaraca.
English: They are used for angina and heart beat disorders.
Croatian: Oni se koriste za anginu pektoris i poremećaje otkucaja srca.
English: Do not drive or use machines within one hour after receiving a Ceplene injection as it may reduce blood pressure causing dizziness, light-headedness and blurred vision.
Croatian: Ne upravljajte vozilima niti radite sa strojevima unutar sat vremena od primitka injekcije Ceplenea jer može sniziti krvni tlak i uzrokovati omaglicu, ošamućenost i zamagljen vid.
English: Also, if you are to have an operation or special X-ray investigation requiring an injection, first make sure that your doctor knows that you are receiving Ceplene.
Croatian: Također, ako ćete se podvrgavati operativnom zahvatu ili posebnoj pretrazi rendgenskim zrakama koje zahtijeva injekciju, prvo provjerite zna li Vaš liječnik da primate Ceplene.
English: If you want to stop taking Ceplene you should try to consult your doctor in advance.
Croatian: Ako želite prestati uzimati Ceplene, unaprijed se posavjetujte sa svojim liječnikom.
English: The mechanism by which Ceplene improves the anti-leukaemic function of lymphocytes in AML is not completely established; it is considered to be by inhibition of reactive oxygen species (ROS or ‘oxygen free radicals'), which are synthesised by monocytes/macrophages and granulocytes.
Croatian: Mehanizam kojim Ceplene poboljšava antileukemijsku funkciju limfocita u AML-u nije u potpunosti utvrđen; smatra se da djeluje inhibiranjem reaktivnih spojeva kisika (ROS ili “slobodni radikali kisika”), koji se sintetiziraju pomoću monocita/makrofaga i granulocita.
English: For patients experiencing grade 1 toxicity events
Croatian: Za bolesnike sa stupnjem toksičnosti 1
English: Push down the syringe plunger and inject one-tenth of a millilitre (0.1 mL) every minute, or more slowly if instructed to do so by your doctor.
Croatian: Klip štrcaljke gurnite prema dolje te svake minute ubrizgajte jednu desetinu mililitra (0,1 ml) ili sporije, ako Vam je takve upute dao Vaš liječnik.
English: Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, or syncope.
Croatian: Brzo supkutano injiciranje ili injiciranje u krvožilni prostor može rezultirati teškom hipotenzijom, tahikardijom ili sinkopom.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europe.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europe.eu.
English: Overall systemic exposure of Ceplene was greater in patients versus healthy subjects.
Croatian: Cjelokupna sustavna izloženost Cepleneu bila je veća kod bolesnika naspram zdravih ispitanika.
English: Since you will be using both IL-2 and Ceplene in a combined treatment, information about both dosages is provided:
Croatian: S obzirom da ćete u kombiniranom liječenju primjenjivati IL-2 i Ceplene, osigurane su informacije o oba doziranja:
English: It is not known whether Ceplene appears in breast milk.
Croatian: Nije poznato pojavljuje li se Ceplene u majčinu mlijeku.
English: Ceplene is indicated for use in adults.
Croatian: Ceplene je indiciran za primjenu kod odraslih.
English: You will start your treatment with Ceplene in the clinic under supervision of a doctor.
Croatian: Svoje liječenje Cepleneom započet ćete u klinici pod nadzorom liječnika.
English: The dispensing and storage directions in the section 6.6 are specific to aldesleukin.
Croatian: U dijelu 6.6 navedene su upute o izdavanju i uvjetima čuvanja specifične za aldesleukin.
English: If you notice a severe drop in blood pressure after use of Ceplene, please contact your physician immediately or at least prior to administration of further Ceplene injections.
Croatian: Ako primijetite jaki pad krvnog tlaka nakon primjenjivanja Ceplenea, molimo odmah se obratite svom liječniku ili barem prije primjene sljedeće injekcije Ceplenea.
English: Ceplene should not be injected into the same anatomic region as IL-2.
Croatian: Ceplene se ne smije injicirati u istu anatomsku regiju kao i IL-2.
English: The treatment with IL-2 and Ceplene lasts for 81 weeks and is cyclic.
Croatian: Liječenje s IL-2 i Cepleneom traje 81 tjedan i provodi se u ciklusima.
English: If you stop taking Ceplene
Croatian: Ako prestanete uzimati Ceplene
English: The solution must be clear and colourless.
Croatian: Otopina mora biti bistra i bezbojna.
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicine.
Croatian: To znači da zbog male učestalosti ove bolesti nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: • If you are receiving one of the following medicines: - Steroids such as prednisone and dexamethasone.
Croatian: • Ako uzimate jedan od sljedećih lijekova: - steroide poput prednizona i deksametazona.
English: Each 0.5 mL Ceplene dose is injected slowly, over 5-15 minutes.
Croatian: Svaka doza od 0,5 ml Ceplenea injicira se polagano, kroz 5-15 minuta.
English: • Any treatment for high blood pressure (for example thiazide diuretics [bendrofluazide], ACE inhibitors [captopril], calcium antagonists [nifedipine] and alpha-blockers [prazosin]).
Croatian: • bilo kakvo liječenje visokog krvnog tlaka (na primjer tiazidni diuretici [bendrofluazid], ACE inhibitori [kaptopril], antagonisti kalcija [nifedipin] i alfa-blokatori [prazosin]).
English: If significant hypotension or related symptoms are observed in subsequent treatment cycles, dose reduction should be initiated and if required, administered in hospital until responses to treatment allow for home administration.
Croatian: Ako se tijekom sljedećih ciklusa liječenja uoče znatna hipotenzija ili povezani simptomi mora se smanjiti doza te se po potrebi ona mora primijenjivati u bolnici dok odgovor na liječenje ne omogući primjenu kod kuće.
English: Plasma histamine concentrations were highly variable and were considerably higher in the groups of patients with moderate or severe hepatic impairment (medians 10 and 5 times the normal volunteers respectively).
Croatian: Koncentracije histamina u plazmi bile su vrlo varijabilne i znatno više u skupinama bolesnika s umjerenim ili teškim oštećenjem funkcije jetre (medijani 10, odnosno 5 puta viši u normalnih dobrovoljaca).
English: Always vary the site that you inject.
Croatian: Uvijek mijenjajte mjesto ubrizgavanja.
English: Ceplene must not be mixed with any other products and must not be diluted.
Croatian: Ceplene se ne smije miješati niti s jednim drugim lijekom i ne smije se razrjeđivati.
English: They are used to inhibit activity of the immune system (immunosuppressant) and to reduce inflammation.
Croatian: Oni se upotrebljavaju za inhibiranje aktivnosti imunološkog sustava (imunosupresivi) i smanjenje upale.
English: Should Ceplene related toxicities occur (such as hypotension, headache), the injection time can be increased from 5 minutes to a maximum duration of 15 minutes.
Croatian: Ako dođe do toksičnosti povezane s Cepleneom (poput hipotenzije, glavobolje), vrijeme injiciranja može se povećati s 5 minuta na maksimalno trajanje do 15 minuta.
English: Ceplene must be injected slowly in the layer of tissue just under the skin (subcutaneously), over a period of approximately 5 to 15 minutes.
Croatian: Ceplene se mora ubrizgavati polagano, u sloj tkiva odmah ispod kože (supkutano), tijekom razdoblja od približno 5 do 15 minuta.
English: Certain medicines used for an operation (for example neuromuscular blocking medicines and narcotic pain-killers) or dyes used for certain Xrays may interfere with this medicine.
Croatian: Određeni lijekovi korišteni za operativni zahvat (na primjer neuromuskularni blokatori i narkotici protiv boli) ili boje korištene za određene rendgenske zrake mogu utjecati na ovaj lijek.
English: The number of CR1 patients remaining leukaemia-free for 3 years was 40% after Ceplene+IL-2 versus 26% in patients not receiving this treatment (p=0.01).
Croatian: Broj CR1 bolesnika bez leukemije kroz 3 godine bio je 40% nakon primjene Ceplenea+IL-2 naspram 26% u bolesnika koji nisu primali ovo liječenje (p=0.01).
English: In female rats dosed before mating to gestation day 7, slightly reduced numbers of implantations and viable foetuses were found, but without any dose-response and within the range of historical control data.
Croatian: Kod ženki štakora kojima je doza davana prije parenja do 7. dana gestacije, pronađen je blago smanjen broj implantiranja i vitalnih fetusa, no bez bilo kakvog odgovora na dozu i unutar raspona prošlih kontrolnih podataka.
English: • Feeling of general discomfort or unease
Croatian: • opći osjećaj nelagode ili nemira
English: The randomised phase 3 trial (0201) compared Ceplene+IL-2 treatment to no treatment in 261 patients in first remission (CR1) and in another 59 patients in subsequent remission after relapse (CR>1).
Croatian: Randomizirano ispitivanje faze 3 (0201) usporedilo je liječenje Cepleneom+IL-2 s neliječenjem 261 bolesnika u prvoj remisiji (CR1) i 59 bolesnika u sljedećoj remisiji nakon relapsa (CR>1).
English: No clinical data are available on the effects of Ceplene on fertility.
Croatian: Nema dostupnih kliničkih podataka o učincima Ceplenea na plodnost.
English: Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself.
Croatian: Liječnik može odlučiti kako je pogodnije da si sami injicirate IL-2 i Ceplene.
English: • If you have received a stem cell transplant (a kind of bone marrow transplant) from a donor.
Croatian: • Ako su Vam presadili matične stanice (vrsta presađivanja koštane srži) od donora.
English: - IL-2 can be discontinued for 24 hours and then restarted at a 20% dose reduction level.
Croatian: Vrućica - primjena IL-2 može se prekinuti na 24 sata, a zatim ponovno početi smanjenjem razine doze od 20%.
English: In the peri-post natal development study, high doses of histamine dihydrochloride caused maternal toxicity, and the offspring showed toxicity during lactation (fewer live pups at day 21 compared to lactation at day 4) but not after weaning.
Croatian: U peripostnatalnim ispitivanjima razvoja, visoke doze histamin dihidroklorida uzrokovale su maternalnu toksičnost, a potomci su pokazali blagu toksičnost tijekom laktacije (manje žive mladunčadi 21. dana u usporedbi s 4. danom laktacije), no ne i nakon odbijanja od sise.
English: • The other ingredients are water for injections and sodium chloride, and it may also contain sodium hydroxide and/or hydrochloric acid for pH adjustment.
Croatian: • Drugi sastojci su voda za injekcije i natrijev klorid, a također može sadržavati natrijev hidroksid i/ili kloridnu kiselinu za podešavanje pH.
English: It has been noted that neuromuscular blocking agents, narcotic analgesics, and various contrast media can induce the release of endogenous histamine; therefore in patients undergoing diagnostic or surgical procedures, the additive effect of Ceplene treatment should be considered prior to the procedure (see section 4.4).
Croatian: Zapaženo je da neuromuskularni blokatori, narkotički analgetici i razna kontrastna sredstva mogu izazvati otpuštanje endogenog histamina; stoga se u bolesnika koji se podvrgavaju dijagnostičkim ili operativnim zahvatima prije postupka mora razmotriti aditivni učinak liječenja Cepleneom (vidjeti dio 4.4).
English: There are no significant effects of age or weight on the pharmacokinetic properties of histamine.
Croatian: Dob ili težina nemaju znatnog učinka na farmakokinetička svojstva histamina.
English: There have been 2 clinical studies to evaluate the use of Ceplene in the maintenance of remission in adult AML patients.
Croatian: Provedena su 2 klinička ispitivanja za procjenu primjene Ceplenea u održavanju remisije u odraslih bolesnika s AML.
English: Histamine concentrations and PK were highly variable across studies, as well as within the normal volunteer and patient groups.
Croatian: Koncentracije histamina i PK bile su vrlo varijabilne tijekom ispitivanja, kao i unutar skupina zdravih dobrovoljaca i bolesnika.
English: Study AML-1 was exploratory, enrolling 39 AML patients in remission to determine the dose and feasibility of Ceplene administered together with IL-2.
Croatian: Ispitivanje AML-1 bilo je istraživačko, obuhvaćalo je 39 bolesnika s AML u remisiji kako bi se odredila doza i izvedivost primjene Ceplena zajedno s IL-2.
English: H2 receptor antagonists with imidazole structures similar to histamine, e.g., cimetidine, systemic steroids and clonidine, must not be used during treatment with Ceplene (see section 4.3).
Croatian: Antagonisti H2 receptora s imidazolskim strukturama sličnim histaminu, npr. cimetidin, sistemski steroidi i klonidin, ne smiju se primjenjivati tijekom liječenja Cepleneom (vidjeti dio 4.3).
English: Hypotension (low blood pressure) may occur very commonly and may lead to light-headedness and fainting.
Croatian: Hipotenzija (nizak krvni tlak) može se pojaviti vrlo često i može dovesti do ošamućenosti i nesvjestice.
English: Injections should be preferably administered in a supervised setting in the presence of an adult family member, friend, or other care provider who is capable of responding appropriately should signs or symptoms of hypotension occur.
Croatian: Injiciranje se, po mogućnosti, mora izvršiti u nadziranom okruženju, u prisutnosti odraslog člana obitelji, prijatelja ili zdravstvenog djelatnika koji su sposobni reagirati na odgovarajući način u slučaju pojavljivanja znakova ili simptoma hipotenzije.
English: Side effects observed when Ceplene is used as described in this package leaflet:
Croatian: Uočene nuspojave kada se Ceplene uzima kao što je opisano u ovoj uputi o lijeku:
English: Animal studies showed reproductive toxicity but only at maternotoxic doses, and did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, no samo pri dozama toksičnim za majku te nisu ukazivala na izravne štetne učinke s obzirom na trudnoću, razvoj embrija/fetusa, porođaj ili postnatalni razvoj (vidjeti dio 5.3).
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Croatian: Važno je da si ne pokušavate sami dati injekciju, osim ako su Vas liječnik ili medicinska sestra u tome posebno obučili.
English: For both men and women using this treatment, an effective method of contraception must be used as it is important not to conceive a child while being treated with Ceplene and IL-2.
Croatian: I muškarci i žene koji primjenjuju ovo liječenje moraju primjenjivati učinkovitu metodu kontracepcije, jer je važno ne začeti dijete tijekom liječenja Cepleneom i IL-2.
English: This is to be returned to the pharmacist for disposal.
Croatian: Ona se mora vratiti ljekarniku zbog zbrinjavanja.
English: Ceplene with IL-2 will help your immune system attack any remaining cancer cells after a previous cancer treatment.
Croatian: Ceplene i IL-2 pomoći će Vašem imunološkom sustavu u borbi protiv preostalih stanica raka nakon prethodnog liječenja raka.
English: Treatment*
Croatian: Liječenje*
English: The first dose of Ceplene and IL-2 on day 1 of the initiation of the first cycle of treatment should be administered in the clinic under direct supervision by a physician.
Croatian: Prva doza Ceplenea i IL-2 na 1. dan pokretanja prvog ciklusa liječenja mora se primijeniti u klinici, pod izravnim nadzorom liječnika.
English: Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution.
Croatian: Bolesnike s prethodnom anamnezom autoimune bolesti (uključujući sistemski lupus, upalnu bolest crijeva, psorijazu i reumatoidni artritis) potrebno je oprezno liječiti.
English: Pinch up a section of the cleaned skin between your thumb and forefinger, without squeezing it. See Figure 5.
Croatian: 6. Dio očišćene kože primite između palca i kažiprsta, bez stiskanja.
English: Push the plunger of the syringe down to inject air into the vial.
Croatian: Klip štrcaljke gurnite prema dolje kako biste ubrizgali zrak u bočicu.
English: Ceplene/IL-2 is an immunotherapy which aims to induce immune-mediated destruction of residual myeloid leukaemic cells and thereby to prevent relapse of leukaemia.
Croatian: Ceplene/IL-2 je imunoterapija kojoj je cilj izazvati imunološki posredovano uništavanje rezidualnih stanica mijeloične leukemije i time spriječiti povratak leukemije.
English: Patient monitoring during subsequent treatment days or cycles should be performed as long as the patient continues to experience significant changes in vital signs during administration of Ceplene.
Croatian: Potrebno je nadzirati bolesnika tijekom sljedećih dana ili ciklusa liječenja dok god on i dalje ima znatno promijenjene vitalne znakove tijekom primjene Ceplenea.
English: PHARMACEUTICAL FORM Solution for injection.
Croatian: OBLIK Otopina za injekciju.
English: For Ceplene, no clinical data on exposed pregnancies are available.
Croatian: Za Ceplene nema dostupnih kliničkih podataka o izloženosti u trudnoći.
English: There may be a small amount of solution left in the vial.
Croatian: Mala količina otopine može ostati u bočici.
English: If you forget to take Ceplene
Croatian: Ako ste zaboravili uzeti Ceplene
English: The two medicines, IL-2 and Ceplene, are both injected twice a day, with a minimum of 6 hours between injections.
Croatian: Oba lijeka, IL-2 i Ceplene, ubrizgavaju se dvaput dnevno, s najmanje 6 sati razmaka između injekcija.
English: Beta-blockers and other anti-hypertensive agents should be used with caution during treatment with Ceplene.
Croatian: Beta-blokatori i drugi antihipertenzivi tijekom liječenja Cepleneom moraju se primjenjivati s oprezom.
English: The role of IL-2 is to promote the functions of NK cells and T cells by activating the anti-leukaemic properties of these cells and by expanding these cell populations by inducing cell cycle proliferation.
Croatian: Uloga IL-2 je potpomagati funkciju NK stanica i T stanica aktiviranjem antileukemijskih svojstava tih stanica i širenjem ove populacije stanica induciranjem proliferacije staničnog ciklusa.
English: If you have missed one of your doses in a day, contact your doctor or pharmacist.
Croatian: Ako ste u danu propustili jednu dozu, obratite se svojem liječniku ili ljekarniku.
English: A puncture-proof container so you can dispose of used syringes safely.
Croatian: • Neprobojni spremnik kako biste mogli sigurno ukloniti upotrijebljene štrcaljke.
English: • heart disease (for severe heart problems see above “Do not use Ceplene”),
Croatian: • bolest srca (za teške probleme sa srcem pogledajte gore navedeno
English: In subjects with severe renal impairment, there were decreases in systolic and diastolic blood pressure at plasma histamine concentrations which caused no appreciable decrease in blood pressure in other subjects.
Croatian: U ispitanika s teškim oštećenjem funkcije bubrega došlo je do sniženja sistoličkog i dijastoličkog krvnog tlaka pri koncentracijama histamina u plazmi koje nisu uzrokovale osjetno sniženje krvnog tlaka u drugih ispitanika.
English: Patients should be provided with capped polypropylene syringes and instructed to extract 0.5 mL of solution into the syringe.
Croatian: Bolesnicima treba osigurati polipropilenske štrcaljke sa zatvaračem i instruirati ih o vađenju 0,5 ml otopine u štrcaljku.
English: Alcohol wipe(s).
Croatian: • alkoholnu maramicu(e).
English: Medicines must not be disposed of via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: • Vomiting, pain in the upper belly (abdominal pain) and dry mouth
Croatian: • povraćanje, bol u gornjem dijelu trbuha (abdominalna bol) i suha usta
English: Dosing volumes based on patient weight are provided in Table 3 below.
Croatian: Volumeni koji se doziraju temeljeni na tjelesnoj težini bolesnika nalaze se u dolje navedenoj Tablici
English: Dispensing of dilute IL-2 (aldesleukin) for each patient
Croatian: Izdavanje razrijeđenog IL-2 (aldesleukina) za svakog bolesnika
English: Ceplene and IL-2 doses should be separated by 60 minutes, which should be maintained throughout treatment.
Croatian: Doze Ceplenea i IL-2 moraju se davati u razmaku od 60 minuta, što je potrebno održavati tijekom liječenja.
English: • Pain in limbs and back pain
Croatian: • bol u udovima i bol u leđima
English: Studies have shown chemical stability and sterility of diluted aldesleukin (dispensed in capped polypropylene tuberculin syringes) for up to three weeks when prepared in a controlled aseptic environment and stored under refrigeration at 2°C - 8°C.
Croatian: Ispitivanja su pokazala kemijsku stabilnost i sterilnost razrijeđenog aldesleukina (izdanog u polipropilenskim tuberkulinskim štrcaljkama sa zatvaračem) do tri tjedna, kada se priprema u kontroliranom sterilnom prostoru i čuva u hladnjaku na 2°C - 8°C.
English: Treatment-free (3 weeks) *see dose modification for provisions for the modification to dose and dosage schedule
Croatian: Bez liječenja (3 tjedna) *za odredbe o modifikaciji doze i rasporedu doziranja vidjeti modifikaciju doze.
English: • Loss of appetite (anorexia)
Croatian: • gubitak teka (anoreksija)
English: ROS are known to limit the anti-leukaemic effects of lymphocyte activators such as IL-2, by triggering dysfunction and death by apoptosis in NK cells and T cells.
Croatian: Poznato je da ROS-ovi ograničavaju antileukemijske učinke aktivatora limfocita poput IL-2, okidanjem disfunkcije i smrti apoptozom u NK stanicama i T stanicama.
English: Table 1: For treatment cycles 1-3 with Ceplene and IL-2
Croatian: Tablica 1: Za 1. do 3. ciklus liječenja s Ceplenom i IL-2
English: For patients experiencing grade 1-4 generalised toxic dermatitis -for grade 1 toxicity, the treatment should be delayed for 48 hours or until all symptoms have been resolved.
Croatian: Za bolesnike sa stupnjevima 1-4 generaliziranog toksičnog dermatitisa - za toksičnost stupnja 1, liječenje se mora odgoditi za 48 sati ili dok se simptomi ne povuku.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženosti dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: The role of Ceplene is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune-mediated destruction of residual leukaemic cells.
Croatian: Uloga Ceplenea je zaštititi limfocite, osobito NK stanice i T stanice, koje su odgovorne za imunološki posredovano uništavanje rezidualnih stanica leukemije.