FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious and sometimes fatal viral, bacterial, protozoan, and fungal infections, including those due to reactivation of latent infections, have been reported in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS. Progressive multifocal leukoencephalopathy (PML) has been reported in patients with B-CLL with or without treatment with alemtuzumab.
Croatian: U bolesnika koji ne boluju od multiple skleroze, a liječeni su alemtuzumabom u dozama većim ili učestalijim od doza koje se primjenjuju za liječenje multiple skleroze, primijećene su ozbiljne i ponekad smrtonosne infekcije virusima, bakterijama, protozoama i gljivicama, uključujući i one nastale uslijed reaktivacije latentnih infekcija.
English: • bleeding of gums
Croatian: • krvarenje iz rektuma
English: IV
Croatian: S
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba):
English: • If the patient shows clinical symptoms suggesting development of a serious adverse event associated with the infusion (myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage
Croatian: • Ako se u bolesnika javljaju klinički simptomi koji ukazuju na nastanak ozbiljnog štetnog događaja povezanog s infuzijom (ishemija miokarda,
English: % receiving ≥2 prior MS
Croatian: % bolesnika koji su prethodno primali ≥ 2 lijeka za multiplu sklerozu
English: Mean duration of prior MS
Croatian: Prosječno trajanje prethodnog liječenja multiple skleroze (≥ 1 lijeka)
English: • contusion
Croatian: Neutropenija
English: Women of childbearing potential should use effective contraceptive measures during treatment and for 4 months following a course of LEMTRADA treatment (see section 4.6).
Croatian: Žene reproduktivne dobi moraju primjenjivati djelotvorne kontracepcijske mjere tijekom liječenja i 4 mjeseca nakon svakog ciklusa liječenja lijekom
English: therapies
Croatian: Dojenje
English: Malignancy
Croatian: Citopenije
English: Dissection of the cervicocephalic arteries
Croatian: hemoragijski moždani udar, disekcija cervikocefaličnih arterija ili plućno alveolarno krvarenje)
English: Change from Baseline in EDSS at Year 23 (95% CI)
Croatian: Promjena u odnosu na početne vrijednosti EDSS-a u 2. godini3
English: Patients in clinical trials in MS had serum samples collected 1, 3, and 12 months after each treatment course for determination of antialemtuzumab antibodies.Approximately 85% of patients receiving LEMTRADA tested positive for antialemtuzumab antibodies during the study, with ≥90% of these patients testing positive also for antibodies that inhibited alemtuzumab binding in vitro.
Croatian: U kliničkim ispitivanjima multiple skleroze u bolesnika su 1, 3 i 12 mjeseci nakon svakog ciklusa liječenja, prikupljeni uzorci seruma radi utvrđivanja prisutnosti protutijela na alemtuzumab.
English: • rectal bleeding
Croatian: • kontuzija • relaps multiple skleroze
English: Read the package leaflet before use.
Croatian: Nemojte tresti bočicu prije uporabe.
English: During your treatment course and for 4 months afterwards, you may have LEMTRADA in your body.
Croatian: LEMTRADA se u tijelu može nalaziti tijekom ciklusa liječenja i do 4 mjeseca nakon njega.
English: To try to reduce infusion reactions, your doctor will give you other medicine(s) (see section 4 - infusion reactions).
Croatian: Kako bi pokušao umanjiti reakcije na infuziju, liječnik će Vam dati druge lijekove
English: reduction, p<0.0001) compared to IFNB-1a.
Croatian: u dozi od 12 mg (0,4%), u usporedbi s bolesnicima koji su primali IFNB-1a (0%).
English: 46.6% of the patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 received additional courses upon documented evidence of MS disease activity (relapse and/or MRI) and the treating physician's decision to retreat.
Croatian: 46,6% bolesnika početno liječenih lijekom LEMTRADA u dozi od 12 mg/dan u Ispitivanjima 1 i 2
English: Patients with other concomitant autoimmune diseases (besides MS).
Croatian: o istodobnim autoimunim bolestima osim multiple skleroze.
English: Date of first authorisation: 02 December 2015
Croatian: Datum prvog odobrenja: 2. prosinca 2015.
English: Get ready what you need
Croatian: Pripremite sve što Vam je potrebno
English: Symptoms can include:
Croatian: Simptomi mogu uključivati:
English: If you live in a region where these infections are common or if you are travelling to such a region:
Croatian: Ako živite u području u kojem su takve infekcije česte ili ako putujete u takvo područje:
English: The safety profile was similar to that seen in adults.
Croatian: Sigurnosni profil bio je sličan onome opaženome u odraslih.
English: Wait 30 minutes
Croatian: Pričekajte 30 minuta
English: Reconstitution should be carried out under aseptic conditions.
Croatian: Rekonstitucija se mora provoditi u aseptičkim uvjetima.
English: Find a comfortable, well-lit and clean surface.
Croatian: Pronađite udobnu, dobro osvijetljenu i čistu površinu.
English: • Wait 30 minutes (and no more than 8 hours) before use.
Croatian: • Pričekajte 30 minuta (ali ne više od 8 sati) prije primjene lijeka.
English: Administer once every four weeks.
Croatian: Primijenite jedanput svaka četiri tjedna.
English: • fever (high temperature)
Croatian: • vrućica (visoka temperatura)
English: Small air bubbles, however, are expected and acceptable.
Croatian: Međutim, mali mjehurići zraka su očekivana i prihvatljiva pojava.
English: • It is normal to see one or more air bubbles.
Croatian: • Normalno je da u otopini bude jedan ili više zračnih mjehurića.
English: Yellow indicator (becomes visible when the injection is complete)
Croatian: Žuti indikator (postaje vidljiv kada je injiciranje završeno)
English: Your injection may take up to 15 seconds to complete.
Croatian: Injekcija može potrajati do 15 sekundi.
English: Some people may have allergic or allergic-like reactions.
Croatian: Neke osobe mogu razviti alergijske reakcije ili reakcije nalik alergijskima.
English: PRESS HERE TO OPEN
Croatian: PRITISNITE OVDJE KAKO BISTE OTVORILI
English: Children less than 6 years old
Croatian: Djeca mlađa od 6 godina
English: The safety and efficacy of mepolizumab in children less than 6 years old have not yet been established.
Croatian: Sigurnost i djelotvornost mepolizumaba u djece mlađe od 6 godina nisu još ustanovljene.
English: Nucala is intended for long-term treatment.
Croatian: Nucala je namijenjena za dugoročno liječenje.
English: These reactions may occur for the first time after a long duration of treatment (see section 4.8).
Croatian: Te se reakcije mogu prvi puta pojaviti i nakon dugotrajnog liječenja (vidjeti dio 4.8).
English: If you do not notice that you have missed a dose until it is already time for your next dose, then just inject the next dose as planned.
Croatian: Ako primijetite da ste propustili dozu tek kad je već vrijeme za sljedeću, jednostavno injicirajte sljedeću dozu kako ste i planirali.
English: Slowly raise your thumb
Croatian: Polagano podignite palac
English: - if you are allergic to mepolizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na mepolizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: These reactions may be common (they can affect up to 1 in 10 people).
Croatian: Te reakcije mogu biti česte (mogu se javiti u do 1 na 10 osoba).
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: Dođe li do predoziranja, bolesnika treba liječiti potporno uz odgovarajući nadzor po potrebi.
English: The potential for harm to a human fetus is unknown.
Croatian: Potencijal za štetno djelovanje na ljudski plod nije poznat.
English: These events were all non-serious, mild to moderate in intensity and the majority resolved within a few days.
Croatian: Nijedan od tih događaja nije bio ozbiljan, svi su bili blage do umjerene težine i većina ih se povukla za nekoliko dana.
English: The potential for interactions with mepolizumab is therefore considered low.
Croatian: Stoga se smatra da je potencijal za interakcije s mepolizumabom nizak.
English: They usually occur within minutes to hours after the injection, but sometimes symptoms can start up to several days later.
Croatian: Obično nastupaju unutar nekoliko minuta do nekoliko sati nakon injekcije, no ponekad simptomi mogu početi i nekoliko dana kasnije.
English: Reconstitution is typically complete within 5 minutes after the sterile water has been added, but it may take additional time.
Croatian: Rekonstitucija će se obično dovršiti unutar 5 minuta nakon dodavanja sterilne vode, no može trajati i dulje.
English: • swelling of eyelids, face, lips, tongue or mouth
Croatian: • oticanje vjeđa, lica, usana, jezika ili usta
English: Tell your doctor or a nurse immediately if you get any of these symptoms.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koji od tih simptoma.
English: Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30°C.
Croatian: Kemijska i fizička stabilnost rekonstituiranog lijeka dokazana je tijekom 8 sati ako se čuva na temperaturi ispod 30°C.
English: Neutralising antibodies were detected in one adult subject.
Croatian: Neutralizirajuća protutijela otkrivena su u jednog odraslog ispitanika.
English: This dosing regimen is considered acceptable due to the wide therapeutic index of mepolizumab.
Croatian: Ovaj režim doziranja smatra se prihvatljivim zbog širokog terapijskog indeksa mepolizumaba.
English: For children aged 6-11 years, contact your doctor who will prescribe the recommended dose of Nucala which will be administered by a nurse or doctor.
Croatian: Za djecu u dobi od 6 do 11 godina obratite se svom liječniku, koji će propisati preporučenu dozu lijeka Nucala, koju će primijeniti medicinska sestra ili liječnik.
English: Nucala can reduce your number of asthma attacks, if you or your child are already using medicines such as high dose inhalers, but your asthma is not well controlled by these medicines.
Croatian: Nucala može smanjiti broj napadaja astme koje imate, ako Vi ili Vaše dijete već uzimate lijekove poput inhalatora s visokim dozama lijeka, ali Vam astma nije dobro kontrolirana tim lijekovima.
English: Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, ‘Possible side effects').
Croatian: Lijekovi ove vrste (monoklonska protutijela) mogu prouzročiti teške alergijske reakcije kada se injiciraju u tijelo (vidjeti dio 4. ‘Moguće nuspojave').
English: If you are pregnant, if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Check with your doctor if you think this applies to you.
Croatian: Provjerite sa svojim liječnikom ako mislite da se to odnosi na Vas.
English: Parasitic infections
Croatian: Parazitske infekcije
English: 1st “Click”
Croatian: Prvi ‘klik'
English: IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils.
Croatian: IL-5 je glavni citokin odgovoran za rast i diferencijaciju, regrutiranje, aktivaciju i preživljenje eozinofila.
English: Children aged 6 to 11 years old
Croatian: Djeca u dobi od 6 do 11 godina
English: - If you are not sure, hold the pen down for another 15 seconds to make sure the injection is complete.
Croatian: Ako niste sigurni, držite brizgalicu pritisnutom još 15 sekundi kako biste bili sigurni da je injekcija dovršena.
English: Nucala may weaken your resistance to infections caused by parasites.
Croatian: Nucala može oslabiti Vašu otpornost na infekcije koje uzrokuju paraziti.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, ako metoda rekonstitucije ne isključuje rizik od mikrobiološke kontaminacije, lijek se mora odmah primijeniti.
English: Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs.
Croatian: Neke osobe s teškom astmom imaju previše eozinofila (jedne vrste bijelih krvnih stanica) u krvi i plućima.
English: Local injection site reactions occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injections.
Croatian: Lokalne reakcije na mjestu injiciranja javljale su se uglavnom na početku liječenja i uz prve 3 injekcije, dok je uz sljedeće injekcije bilo manje prijava.
English: Dispose of it (see Step 9), and start again with a new pen.
Croatian: Bacite je (vidjeti 9. korak) i ponovite postupak koristeći novu brizgalicu.
English: 2nd “Click”
Croatian: Drugi 'klik'
English: Do not let the needle touch any surface.
Croatian: Nemojte dozvoliti da igla dotakne bilo kakvu površinu.
English: The comparison between mepolizumab and placebo was statistically significant (p=0.008).
Croatian: Usporedba između mepolizumaba i placeba bila je statistički značajna (p=0,008).
English: As a precautionary measure, it is preferable to avoid the use of Nucala during pregnancy.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu lijeka Nucala tijekom trudnoće.
English: Intravenous Mepolizumab
Croatian: Intravenski mepolizumab
English: Predefined categories included percent reductions ranging from 90-100% reduction, to no decrease in the prednisone dose from the end of the optimisation phase.
Croatian: Unaprijed određene kategorije uključivale su postotna smanjenja u rasponu od 90 - 100% smanjenja do nikakvog smanjenja doze prednizona od završetka faze optimizacije.
English: After a treatment interruption of 8 weeks, 30 of these patients, received mepolizumab for a further 52 weeks.
Croatian: Nakon privremenog prekida liječenja u trajanju od 8 tjedana, 30 od tih bolesnika primalo je mepolizumab tijekom dodatna 52 tjedna.
English: For examples of the associated manifestations reported and a description of the time to onset, see section 4.4.
Croatian: Za primjere oblika u kojima su se manifestirale i opis vremena do nastupa, vidjeti dio 4.4.
English: Talk to your doctor before using this medicine.
Croatian: Obratite se svom liječniku prije nego primite ovaj lijek.
English: If you are taking medicines called oral corticosteroids, Nucala can also help reduce the daily dose you need to control your asthma.
Croatian: Ako uzimate lijekove koji se zovu oralni kortikosteroidi, Nucala također može pomoći smanjiti dnevnu dozu tih lijekova potrebnu za kontrolu astme.
English: If you think you have injected too much Nucala, contact your doctor for advice.
Croatian: Ako mislite da ste injicirali previše lijeka Nucala, obratite se svom liječniku za savjet.
English: The absolute subcutaneous bioavailability appears complete compared to that observed in adults and adolescents of 76%.
Croatian: Apsolutna bioraspoloživost nakon supkutane primjene čini se potpunom u usporedbi s onom opaženom u odraslih i adolescenata (76%).
English: • You may notice a small drop of blood at the injection site.
Croatian: • Možda ćete primijetiti kapljicu krvi na mjestu injiciranja.
English: You may need to pull the needle cap quite firmly to remove it.
Croatian: Možda ćete morati prilično snažno povući zatvarač igle da biste ga skinuli.
English: • You should hear the 1st “click” to tell you your injection has started.
Croatian: • Trebali biste začuti prvi 'klik', koji označava početak injiciranja.
English: Call your doctor.
Croatian: javite se svom liječniku.
English: Check the medicine
Croatian: Provjerite lijek
English: However, mepolizumab was excreted into the milk of cynomolgous monkeys at concentrations of less than 0.5% of those detected in plasma.
Croatian: Međutim, mepolizumab se izlučio u mlijeko makaki majmuna u koncentracijama manjima od 0,5% onih pronađenih u plazmi.
English: There are no fertility data in humans.
Croatian: Nema podataka o plodnosti u ljudi.
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika.
English: The frequency of adverse reactions is defined using the following convention: 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
Croatian: Učestalost nuspojava definirana je 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: Contents of the pack and other information What Nucala contains
Croatian: Sadržaj pakiranja i druge informacije Što Nucala sadrži
English: Patients with preexisting helminth infections should be treated before starting therapy.
Croatian: Bolesnici s postojećim helmintijazama moraju se liječiti prije započinjanja terapije.
English: By blocking the action of this protein, it limits the production of more eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs.
Croatian: Blokiranjem djelovanja tog proteina ona ograničava proizvodnju novih eozinofila u koštanoj srži i smanjuje broj eozinofila u krvotoku i plućima.
English: This study did not include a littering or functional offspring assessment.
Croatian: Ovo ispitivanje nije obuhvatilo procjenu okota ni funkcionalnu procjenu mladunčadi.
English: Concentrations of mepolizumab were about 1.2-2.4 times higher in infants than in mothers for several months post partum and did not affect the immune system of the infants.
Croatian: Koncentracije mepolizumaba bile su približno 1,2 - 2,4 puta više u mladunčadi nego u majki tijekom nekoliko mjeseci nakon okota i nisu utjecale na imunosni sustav mladunčadi.
English: • Do not worry if you see a drop of liquid at the end of the needle.
Croatian: • Nemojte se zabrinuti ako vidite kapljicu tekućine na vrhu igle.
English: In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: • Take the carton out of the refrigerator.
Croatian: • Izvadite kutiju iz hladnjaka.
English: Seek medical attention immediately if you think you (or your child) may be having a reaction.
Croatian: • osip Odmah zatražite liječničku pomoć ako mislite da Vi (ili Vaše dijete) možda imate reakciju.
English: Do not use the pen if the yellow needle guard doesn't slide up as described.
Croatian: Nemojte upotrijebiti brizgalicu ako se žuti štitnik igle ne uvuče kao što je opisano.
English: If you may have had a similar reaction to any injection or medicine,
Croatian: Ako ste možda imali sličnu reakciju na bilo koju injekciju ili lijek,
English: If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Croatian: Ako se bolesnici zaraze tijekom liječenja lijekom Nucala i ne reagiraju na liječenje antihelminticima, potrebno je razmotriti privremeni prekid terapije.
English: The most common manifestations reported with these events included pain, erythema, swelling, itching, and burning sensation.
Croatian: Najčešće prijavljene manifestacije tih događaja uključivale su bol, eritem, oticanje, svrbež i žarenje.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Croatian: Daljnje zbrinjavanje treba se odvijati sukladno kliničkoj indikaciji ili preporukama nacionalnog centra za kontrolu otrovanja, ako postoje.
English: If you use more Nucala than you should
Croatian: Ako primijenite više lijeka Nucala nego što ste trebali
English: Do not expel any air bubbles from the syringe.
Croatian: Nemojte izbacivati mjehuriće zraka iz štrcaljke.
English: Any unused concentrate or solution remaining after 8 hours must be discarded.
Croatian: Neupotrijebljeni koncentrat ili otopinu preostalu nakon 8 sati mora se baciti.
English: MEA112997+MEA115588 <150 cells/µL
Croatian: MEA112997+MEA115588 <150 stanica/µl n
English: • Do not store it above 30°C.
Croatian: • Ne čuvati na temperaturi iznad 30°C.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Nucala therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je donijeti odluku o tome da li prekinuti dojenje ili prekinuti liječenje lijekom Nucala, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The side effects caused by Nucala are usually mild to moderate but can occasionally be serious.
Croatian: Nucala obično su blage do umjerene, no ponekad mogu biti ozbiljne.
English: You or your caregiver should inject the next dose of Nucala as soon as you remember.
Croatian: Vi ili Vaš njegovatelj trebate injicirati sljedeću dozu lijeka Nucala čim se sjetite.
English: In adults, adolescents and children, this magnitude of reduction was observed within 4 weeks of treatment.
Croatian: Ovakav opseg smanjenja u odraslih, adolescenata i djece opažen je unutar 4 tjedna liječenja.
English: Adults and adolescents aged 12 years and over
Croatian: Odrasli i adolescenti u dobi od 12 i više godina
English: Continue to hold down as you count to 5, then lift off
Croatian: Nastavite držati brizgalicu pritisnutom dok ne izbrojite do 5, a zatim je podignite
English: Following repeat subcutaneous administration every 4 weeks, there is approximately a two-fold accumulation at steady state.
Croatian: Nakon ponovljene supkutane primjene svaka 4 tjedna, zabilježena je približno dvostruka kumulacija u stanju dinamičke ravnoteže.
English: No children had detectable anti-mepolizumab antibodies during the long-term phase of the study.
Croatian: Nijedno dijete nije imalo mjerljive razine protutijela na mepolizumab tijekom dugoročne faze ispitivanja.
English: The mean number of exacerbations in the previous year was 3.6 and the mean predicted pre-bronchodilator FEV1 was 60%.
Croatian: Srednja vrijednost broja egzacerbacija u proteklih godinu dana bila je 3,6, a srednja vrijednost predviđenog FEV1 prije bronhodilatacije iznosila je 60%.
English: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom
Croatian: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT Ujedinjeno Kraljevstvo
English: Inspect and wait 30 minutes before use
Croatian: Pregledajte štrcaljku i pričekajte 30 minuta prije primjene
English: Do not inject within 5 cm of your navel (belly button).
Croatian: Nemojte injicirati unutar 5 cm od pupka.
English: Administration of Nucala to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Croatian: Nucala u trudnica treba razmotriti samo ako je očekivana korist za majku veća od svih mogućih rizika za plod.
English: The yellow needle guard will slide up into the pen.
Croatian: Žuti štitnik igle uvući će se u brizgalicu.
English: • Alcohol wipe (not included)
Croatian: • tupfer natopljen alkoholom (nije uključen u pakiranje)
English: Store in a refrigerator (2°C to 8°C).
Croatian: Čuvati u hladnjaku (2°C do 8°C).
English: • Gauze pad or cotton wool ball (not included) Do not perform the injection if you do not have all these.
Croatian: • gaza ili pamučna vata (nisu uključene u pakiranje) Nemojte injicirati lijek ako nemate sve navedeno.
English: In monkeys, mepolizumab had no effect on pregnancy or on embryonic/fetal and postnatal development (including immune function) of the offspring.
Croatian: U majmuna, mepolizumab nije utjecao na skotnost ženki kao ni na embriofetalni i postnatalni razvoj mladunčadi (uključujući imunosnu funkciju).