FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no developmental abnormalities were observed and reproductive performance of the first or second generations was not affected at any dose.
Croatian: Međutim, nisu se pokazale razvojne abnormalnosti i reproduktivna sposobnost prve ili druge generacije nije bila narušena ni pri kojoj dozi.
English: The patient will receive a carton containing 1 or 30 vials of Myalepta, depending on the pack size, which should be stored in a refrigerator until the day of use.
Croatian: Bolesnik će dobiti kutiju koja sadrži 1 ili 30 bočica lijeka Myalepta, ovisno o veličini pakiranja, i koja se mora čuvati u hladnjaku do dana uporabe.
English: You might also see smaller air bubbles in the syringe.
Croatian: Također se može dogoditi da vidite sitne zračne mjehuriće u štrcaljki.
English: • Do not try to prepare the medicine or inject yourself if you have not been trained.
Croatian: • Nemojte pokušati pripremiti lijek ili si ga sami ubrizgati ako niste primili upute za to.
English: • feeling very thirsty or hungry
Croatian: • izraziti osjećaj žeđi ili gladi
English: 28) Remove the syringe from the skin.
Croatian: 28) Izvucite štrcaljku iz kože.
English: • having a high temperature
Croatian: • visoka temperatura
English: • The glass ampoule should be at a 45 degree angle to the ground.
Croatian: • Staklena ampula mora biti pod kutom od 45 stupnjeva u odnosu na pod.
English: Signs of an allergic reaction can be seen in section 4 under “Allergic reactions”.
Croatian: Znakovi alergijske reakcije opisani su u dijelu 4. pod naslovom "Alergijske reakcije".
English: The most frequently occurring adverse reactions from the clinical studies were hypoglycaemia (14%) and weight decreased (17%).
Croatian: Najčešće nuspojave u kliničkim ispitivanjima bile su hipoglikemija (14%) i gubitak na težini (17%).
English: Increasing abnormalities of TG and HbA1c may be seen which may require a dose increase.
Croatian: Moguća je pojava povećanih abnormalnosti vrijednosti TG i HbA1c, što može zahtijevati povećanje doze.
English: Myalepta is available in packs containing 1 or 30 vials.
Croatian: Lijek Myalepta dostupan je u pakiranjima koja sadrže 1 ili 30 bočica.
English: Studies in animals have shown some evidence of reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama dala su određene dokaze o reproduktivnoj toksičnosti (vidjeti dio 5.3).
English: In particular, tell your doctor if you are taking any of the following medicines:
Croatian: Naročito obavijestite svog liječnika ako uzimate neki od sljedećih lijekova:
English: White lyophilised cake or powder.
Croatian: Bijeli liofilizirani kolačić ili prašak.
English: No effects on the distribution of subcutaneous fat are expected.
Croatian: Ne očekuju se učinci na raspodjelu potkožne masti.
English: Always use a new syringe.
Croatian: Uvijek upotrijebite novu štrcaljku.
English: EXP After reconstitution: use immediately.
Croatian: Nakon rekonstitucije: odmah upotrijebite.
English: 8) Check the amount of water for injection
Croatian: 8) Provjerite količinu vode za injekcije
English: Due to the number of patients with generalised and partial LD treated in clinical trials, it is not possible to detect with certainty, events which occur at a frequency of < 1%.
Croatian: Zbog broja bolesnika s generaliziranim i parcijalnim LD-om liječenih u kliničkim ispitivanjima nije moguće sa sigurnošću utvrditi događaje koji su se dogodili s učestalošću od < 1%.
English: Talk to your doctor if you are not sure.
Croatian: Razgovarajte s liječnikom ako niste sigurni.
English: Patients and carers should be advised to be aware of the signs and symptoms of hypoglycaemia.
Croatian: Bolesnike i njegovatelje treba uputiti da budu svjesni znakova i simptoma hipoglikemije.
English: Prolonged gestation resulted in the death of some females during parturition and lower survival of offspring within the immediate postnatal period.
Croatian: Produljena gestacija izazvala je smrt nekih ženki prilikom porođaja i nižu stopu preživljenja mladunčadi u neposrednom postnatalnom razdoblju.
English: • medicines which suppress the immune system (such as cyclosporine)
Croatian: • lijekove koji potiskuju imunosni sustav (npr. ciklosporin)
English: Clinical trials of metreleptin did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.
Croatian: Klinička ispitivanja metreleptina nisu uključivala dovoljan broj bolesnika u dobi od 65 godina i starijih da bi se moglo utvrditi odgovaraju li na lijek drukčije od mlađih bolesnika.
English: Mean change among the 5 patients < 6 years of age was 0.2%.
Croatian: Srednja vrijednost promjene među 5 bolesnika < 6 godina bila je 0,2%.
English: The clearance of metreleptin appears to be delayed in the presence of ADAs.
Croatian: Čini se da je klirens metreleptina odgođen u prisutnosti ADA.
English: Natural leptin is produced by fatty tissue and has many functions in the body including:
Croatian: Prirodni leptin je proizvod masnog tkiva koji ima brojne uloge u tijelu, uključujući:
English: Leptin is a cytokine and has the potential to alter the formation of cytochrome P450 (CYP450) enzymes.
Croatian: Leptin je citokin i ima potencijal za mijenjanje formiranja enzima citokroma P450 (CYP450).
English: Frequency not known*
Croatian: Nepoznata učestalost*
English: When dividing doses due to volume, doses can be administered one after the other at different injection sites.
Croatian: Kad se doza dijeli zbog volumena, doze se mogu primijeniti jedna za drugom na različitim mjestima injiciranja.
English: • If you inject other medicines, do not inject Myalepta in the same site as you have done for those other medicines.
Croatian: • Ako ubrizgavate druge lijekove, nemojte lijek Myalepta ubrizgavati na isto mjesto na koje ste ubrizgali te druge lijekove.
English: An example is given below for the different syringe sizes.
Croatian: U nastavku je prikazan primjer različitih veličina štrcaljki.
English: Step A: Setting up
Croatian: Korak A: Priprema
English: The effect of metreleptin on CYP450 enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted.
Croatian: Učinak metreleptina na enzime CYP450 može biti klinički značajan za supstrate CYP450 s uskim terapijskim indeksom, gdje se doza individualno prilagođava.
English: Frequencies are defined as 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 available data).
Croatian: (≥ 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: Though temporally associated, it is not possible to unequivocally confirm or deny a direct relation to metreleptin treatment based on the currently available body of evidence.
Croatian: Unatoč vremenskoj povezanosti nije moguće nedvosmisleno potvrditi ili negirati izravnu vezu s liječenjem metreleptinom na temelju trenutačno dostupnih dokaza.
English: The maximum tolerated dose may be less than the maximum daily dose, outlined in Table 1, as evidenced by excessive weight loss, even if metabolic response is incomplete.
Croatian: Najviša podnošljiva doza može biti manja od najviše dnevne doze navedene u Tablici 1, kako to pokazuje pretjerani gubitak težine, čak i ako je metabolički odgovor nepotpun.
English: Possible side effects with this medicine:
Croatian: Moguće nuspojave ovog lijeka:
English: Symptoms of high fat levels include:
Croatian: Simptomi visokih razina masti uključuju:
English: • medicines for sleep or anxiety called ‘benzodiazepines'
Croatian: • lijekove za spavanje ili za tjeskobu koji se nazivaju benzodiazepini
English: Do not inject into a muscle.
Croatian: Nemojte ubrizgavati u mišić.
English: Talk to your doctor, pharmacist or nurse before using Myalepta if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego što primijenite lijek Myalepta ako:
English: Visually inspect the vial containing the medicinal product.
Croatian: Vizualno provjerite bočicu koja sadrži lijek.
English: Data from clinical trials do not support safety and efficacy in patients with HIV-related LD.
Croatian: Podaci iz kliničkih ispitivanja ne govore u prilog sigurnosti i djelotvornosti u bolesnika s LD-om povezanim s HIV-om.
English: 26) Gently insert the needle into the skin at approximately a 45 degree angle to the body.
Croatian: 26) Nježno uvedite iglu u kožu približno pod kutom od 45 stupnjeva u odnosu na tijelo.
English: o Your pharmacist will give you the correct syringe for injecting.
Croatian: o Ljekarnik će Vam dati pravilnu štrcaljku za ubrizgavanje.
English: This leaflet was last revised in (month YYYY).
Croatian: Ova uputa je zadnji puta revidirana u {mjesec GGGG}.
English: Instructions for Use Before using Myalepta, you must first read Sections 1 - 6 of this package leaflet, and then read Section 7 Instructions for Use.
Croatian: Upute za uporabu Prije primjene lijeka Myalepta, najprije morate pročitati dijelove 1. do 6. ove upute o lijeku, a zatim pročitajte dio 7.
English: Dose adjustments should be made based on clinical response (see section 4.4).
Croatian: Doze je potrebno prilagoditi na temelju kliničkog odgovora (vidjeti dio 4.4).
English: Reductions in HbA1c and TG may not be seen in children as metabolic abnormalities may not be present at the start of treatment.
Croatian: Smanjenje HbA1c i TG-a ne mora se nužno manifestirati u djece jer metaboličke abnormalnosti ne moraju biti prisutne na početku liječenja.
English: These events included 1 episode in 1 patient of serious and severe appendicitis, 2 episodes in patients of serious and severe pneumonia, a single episode of serious and severe sepsis and non-serious severe gingivitis in 1 patient and 6 episodes of serious and severe sepsis or bacteraemia and 1 episode of non-serious severe ear infection in 1 patient.
Croatian: Ti su događaji uključili 1 epizodu teškog i ozbiljnog apendicitisa u 1 bolesnika, 2 epizode ozbiljne i teške pneumonije u bolesnika, jednu epizodu ozbiljne i teške sepse i ne-ozbiljnog teškog gingivitisa u 1 bolesnika i 6 epizoda ozbiljne i teške sepse ili bakteremije i 1 epizodu ne-ozbiljne teške infekcije uha u 1 bolesnika.
English: This will include for example instructions for handling possible ADRs.
Croatian: To, na primjer, uključuje upute za zbrinjavanje mogućih nuspojava.
English: Your doctor will change your dose of insulin or other medicines if needed.
Croatian: Liječnik će Vam po potrebi promijeniti dozu inzulina ili drugih lijekova.
English: • you have ever had inflammation of an organ called the pancreas (‘pancreatitis')
Croatian: • ste ikad imali upalu organa koji se naziva gušterača ("pankreatitis")
English: If this happens, do not drive or use any tools or machines.
Croatian: U tom slučaju nemojte upravljati vozilima ili raditi s alatima ili strojevima.
English: For instructions on administration, see section 4.2.
Croatian: Za upute za primjenu vidjeti dio 4.2.
English: Non-clinical data based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity reveal no risks additional to those attributed to an excess of the expected pharmacodynamic responses, such as loss of appetite and body weight.
Croatian: Neklinički podaci na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti ne ukazuje na rizike koji bi bili dodatni onima koji se pripisuju prekomjernim očekivanim farmakodinamičkim odgovorima, kao što su gubitak apetita i tjelesne težine.
English: Do not shake or vigorously mix.
Croatian: Nemojte tresti ili snažno miješati.
English: What Myalepta looks like and contents of the pack
Croatian: Kako Myalepta izgleda i sadržaj pakiranja
English: Actual amount of solution*
Croatian: Stvarna količina otopine*
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Myalepta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Myalepta, uzimajući u obzir korist od dojenja za dijete i korist od liječenja za ženu.
English: Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders.
Croatian: Liječenje treba započeti i pratiti zdravstveni radnik iskusan u dijagnosticiranju i zbrinjavanju metaboličkih poremećaja.
English: • with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Croatian: • s potvrđenim obiteljskim parcijalnim ili stečenim parcijalnim LD-om (Barraquer-Simons sindrom), u odraslih i djece u dobi od 12 i više godina u kojih standardna liječenja nisu postigla odgovarajuću metaboličku kontrolu.
English: • Until the powder dissolves and the liquid is clear.
Croatian: • Dok se prašak ne otopi i tekućina ne razbistri.
English: The cake of lyophilised powder should be intact and white in colour.
Croatian: Kolačić liofiliziranog praška mora biti netaknut i bijele boje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Myalepta in one or more subsets of the paediatric population in the treatment of lipodystrophy (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Myalepta u jednoj ili više podskupina pedijatrijske populacije za liječenje lipodistrofije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: In one post-marketing case, an infant was exposed to a 10-fold overdose of metreleptin for 8 months.
Croatian: U jednom slučaju nakon stavljanja lijeka u promet dojenče je bilo izloženo 10-erostrukom predoziranju metreleptinom tijekom 8 mjeseci.
English: Age, Gender, Race, Body Mass Index
Croatian: Dob, spol, rasa, indeks tjelesne mase
English: Multiple dosing regimens were explored during the NIH study, which led to the posology recommended in section 4.2.
Croatian: Tijekom NIH ispitivanja ispitivani su višestruki režimi doziranja, što je rezultiralo preporukama za doziranje u dijelu 4.2.
English: • A dose card on which the doctor can write for the patient the dose in mg, ml (and where appropriate units from a 0.3 ml U100 insulin syringe).
Croatian: • Karticu za doze na kojoj liječnik može bolesnicima ispisati dozu u mg, ml (odnosno, gdje je to primjereno, u odgovarajućim jedinicama inzulinske štrcaljke od 0,3 ml U100).
English: Gradually reducing your dose, and following a reduced fat diet may help to prevent this.
Croatian: Postupno smanjenje doze i pridržavanje dijete sa smanjenim udjelom masti mogu pomoći da se to spriječi.
English: • an increase in ‘HbA1c' in your blood, shown in tests
Croatian: • porast HbA1c u krvi, dokazan pretragama
English: The maximum daily dose in males and females is 10 mg or 2 mL injection volume
Croatian: Maksimalna dnevna doza u muškaraca i žena je 10 mg ili 2 ml volumena injekcije
English: No formal metabolism studies have been conducted.
Croatian: Nisu provedena formalna ispitivanja metabolizma.
English: Dose adjustments (injection volume)
Croatian: Prilagodbe doze (volumen injekcije)
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the information intended for patients in the package leaflet (section 7).
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6 i informacije namijenjene bolesnicima u uputi o lijeku (dio 7.).
English: If you want to use the same area of the body for each injection, do not use the same spot that you used for your last injection.
Croatian: Ako želite sve injekcije primijeniti na istom području tijela, nemojte ubrizgavati na istoj točki na kojoj ste ubrizgali prethodnu injekciju.
English: *Global post marketing experience
Croatian: *Globalno iskustvo nakon stavljanja lijeka u promet
English: Though not confirmed in clinical trials, neutralising antibodies could in theory affect the activity of endogenous leptin.
Croatian: Iako to nije potvrđeno u kliničkim ispitivanjima, neutralizirajuća protutijela teoretski mogu utjecati na aktivnost endogenog leptina.
English: • Women who could get pregnant should use effective contraception, including non-hormonal methods such as condoms, while using Myalepta.
Croatian: • Žene koje mogu zatrudnjeti moraju tijekom primjene lijeka Myalepta rabiti učinkovitu kontracepciju, uključujući nehormonalne metode kao što su kondomi.
English: Since it cannot be excluded that metreleptin may reduce exposure to substrates of CYP3A through enzyme induction, the efficacy of hormonal contraceptives may be reduced if co-administered with metreleptin.
Croatian: Budući da se ne može isključiti da metreleptin može smanjiti izloženost supstratima CYP3A putem indukcije enzima, djelotvornost hormonalnih kontraceptiva može se umanjiti ako se primjenjuju s metreleptinom.
English: • you have ever had a type of cancer called lymphoma
Croatian: • ste ikad bolovali od vrste raka koja se naziva limfom
English: Metreleptin exhibits no genotoxic potential and no proliferative or preneoplastic lesions were observed in mice or dogs following treatment up to 6 months.
Croatian: Metreleptin ne iskazuje genotoksički potencijal i nisu zamijećene proliferativne ili preneoplastičke lezije u miševa ili pasa nakon razdoblja liječenja od do 6 mjeseci.
English: 15) Mix the powder and water for injection
Croatian: 15) Pomiješajte prašak i vodu za injekcije
English: Your dose of Myalepta may change over time depending on how this medicine works for you.
Croatian: Vaša doza lijeka Myalepta može se s vremenom promijeniti ovisno o tome kako lijek kod Vas djeluje.
English: 13) Hold the vial at 45 degree angle to the table and slowly push the plunger all the way down with your thumb.
Croatian: 13) Držite bočicu pod kutom od 45 stupnjeva prema stolu i polako palcem potisnite klip skroz prema dolje.
English: Autoimmune disorders are associated with an increased risk of malignancies including lymphomas.
Croatian: Autoimuni poremećaji povezuju se s povećanim rizikom od maligniteta, uključujući limfome.
English: Non-clinical data indicate renal clearance is the major route of metreleptin elimination, with no apparent contribution of systemic metabolism or degradation.
Croatian: Pretklinički podaci govore da je bubrežni klirens glavni put eliminacije metreleptina, bez evidentnog doprinosa sistemnog metabolizma ili degradacije.
English: When small doses/volumes are prescribed (e.g. in children), the vials will remain almost completely filled with product after withdrawal of the required dose.
Croatian: Kad su propisane male doze/volumeni (npr. u djece), bočice će ostati gotovo pune lijeka nakon izvlačenja potrebne doze.
English: Important: Myalepta must be injected under the skin (‘subcutaneous').
Croatian: Važno: Myalepta se mora ubrizgavati pod kožu (supkutano).
English: Tell your doctor straight-away if you develop a high temperature, accompanied by increasing tiredness (see section 4).
Croatian: Odmah obavijestite svog liječnika ako dobijete visoku temperaturu praćenu pojačanim umorom (pogledajte dio 4.).
English: This card will also include pictures of the relevant syringe sizes on which the doctor can draw a line to indicate on the volume of water for injection to use for reconstitution and the volume of reconstituted solution to inject.
Croatian: Na kartici se također moraju nalaziti slike relevantnih veličina štrcaljki na kojima liječnik može crtom označiti volumen vode za injekcije koji treba upotrijebiti za rekonstituiranje i volumen rekonstituirane otopine koji treba ubrizgati.
English: • Move the vial gently in a circle (swirling motion)
Croatian: • Lagano vrtite bočicu u krug (kružni pokreti)
English: To remove the water for injection, break open the ampoule.
Croatian: Da biste izvadili vodu za injekcije, otvorite ampulu.
English: However, separate studies revealed that exposure of the mouse foetus to metreleptin was low (< 1%) after subcutaneous administration of metreleptin to pregnant mice.
Croatian: Međutim, zasebna ispitivanja pokazala su da je izloženost mišjeg fetusa metreleptinu bila niska (< 1%) nakon supkutane primjene metreleptina u skotnih ženki.
English: Never use remaining water for injection left over from a previous day's preparation of Myalepta solution.
Croatian: Nemojte nikad upotrijebiti vodu preostalu od pripreme otopine lijeka Myalepta prethodnog dana.
English: Anaphylactic reactions may follow immediately after administration of the medicine.
Croatian: Anafilaktičke reakcije mogu uslijediti odmah nakon primjene lijeka.
English: Specific clinical studies have not been conducted to assess the effect of age, gender, race, or body mass index on the pharmacokinetics of metreleptin in patients with lipodystrophy.
Croatian: Nisu provedena specifična klinička ispitivanja za ocjenu učinka dobi, spola, rase ili indeksa tjelesne mase na farmakokinetiku metreleptina u bolesnika s lipodistrofijom.
English: • who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy)
Croatian: • koji imaju naslijeđenu djelomičnu lipodistrofiju (naziva se i kongenitalnom ili obiteljskom lipodistrofijom)
English: Endogenous leptin is present in human milk.
Croatian: Endogeni leptin prisutan je u majčinu mlijeku.
English: Hypoglycaemia, deemed as related to metreleptin treatment, occurred in 14.2% of patients studied.
Croatian: Hipoglikemija, za koju se ocjenjuje da je povezana s liječenjem metreleptinom, javila se u 14,2% bolesnika.
English: Concomitant anti-diabetic and lipid-lowering dose regimens were not held constant during the study, but analyses showed no significant difference in efficacy between patients who had no increases or additions to their anti-diabetic or lipid-lowering treatments versus the overall study population.
Croatian: Istodobni režimi doziranja antidijabetika i lijekova za snižavanje razina lipida nisu održavani stalnima tijekom ispitivanja, no analize su pokazale da nema bitne razlike u djelotvornosti između bolesnika koji nisu imali povećanja ili dodavanja na svoju antidijabetičku terapiju ili terapiju za snižavanje razine lipida u odnosu na svekoliku ispitivanu populaciju.
English: If any of the above apply to you (or you are not sure), talk to your doctor before using Myalepta.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas (ili niste sigurni), razgovarajte sa svojim liječnikom prije nego primijenite lijek Myalepta.
English: The safety and efficacy of metreleptin in children aged 0 to 2 years with generalised LD and children aged 0 to 12 years with partial LD has not been established.
Croatian: Sigurnost i djelotvornost metreleptina u djece u dobi od 0 do 2 godine s generaliziranim LD-om i u djece u dobi od 0 do 12 godina s parcijalnim LD-om nisu još ustanovljene.
English: However, in published studies, leptin treatment of euleptinaemic prepubertal female mice has led to an earlier onset of puberty.
Croatian: Međutim, u objavljenim ispitivanjima je liječenje leptinom euleptinemičnih pretpubertetskih mišjih ženki izazvalo raniji ulazak u pubertet.
English: If you are not sure how much of the solution to inject, talk to your doctor or pharmacist before injecting.
Croatian: Ako niste sigurni koju količinu otopine trebate ubrizgati, prije ubrizgavanja razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Most of these patients (13 of 16) were able to stop insulin use within the first year of metreleptin.
Croatian: Većina od tih bolesnika (13 od 16) prestala je uzimati inzulin tijekom prve godine liječenja metreleptinom.
English: The plastic ampoule is a sealed container with a twist-off top.
Croatian: Plastična ampula je hermetički zatvoren spremnik s vrhom na odvrtanje (twist-off).