FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you see an air pocket or any air bubbles, follow the same instructions described in step 7 to remove the air from the syringe.
Croatian: • Ako vidite zračni džep ili zračni mjehurić, prema uputama opisanima u koraku 7 uklonite zrak iz štrcaljke.
English: The recommended daily dose of metreleptin is based on body weight as provided in Table 1.
Croatian: Preporučena dnevna doza metreleptina temelji se na tjelesnoj težini prema prikazu u Tablici 1.
English: If you use more Myalepta than you should
Croatian: Ako primijenite više lijeka Myalepta nego što ste trebali
English: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
Croatian: • s potvrđenim urođenim generaliziranim LD-om (Berardinelli-Seip sindrom) ili stečenim generaliziranim LD-om (Lawrence sindrom), u odraslih i djece u dobi od 2 i više godina
English: Other medicines and Myalepta
Croatian: Drugi lijekovi i Myalepta
English: There are limited data on the pharmacokinetics of metreleptin in patients with lipodystrophy and therefore no formal exposure-response analysis has been performed.
Croatian: Dostupni su ograničeni podaci o farmakokinetici metreleptina u bolesnika s lipodistrofijom te stoga nije obavljena formalna analiza odgovora na izloženost.
English: Talk to a doctor straight away if you notice any allergic reactions, including:
Croatian: Odmah razgovarajte s liječnikom ako opazite bilo kakvu alergijsku reakciju, uključujući:
English: Serious and/or severe infections that were temporally associated with > 80% blocking activity against metreleptin occurred in 5 generalised LD patients.
Croatian: Ozbiljne i/ili teške infekcije koje su bile vremenski povezane s > 80% blokirajuće aktivnosti protiv metreleptina pojavile su se u 5 bolesnika s generaliziranim LD-om.
English: Aegerion Pharmaceuticals Ltd. Royal Albert House Sheet Street, Windsor SL4 1BE
Croatian: Royal Albert House Sheet Street, Windsor SL4 1BE
English: Generally the majority of events could be managed by food intake with only relatively few modifications of anti-diabetic medicinal product dose occurring.
Croatian: Općenito, većinu slučajeva bilo je moguće riješiti prehranom uz samo relativno malo promjena doze antidijabetičkog lijeka.
English: Animal studies showed no adverse effects on male or female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala negativan učinak na plodnost u mužjaka ili ženki (vidjeti dio 5.3).
English: • You must remove an air pocket and air bubbles from the syringe to make sure you get the correct amount of sterile water in the syringe.
Croatian: • Morate ukloniti zračni džep i mjehuriće zraka iz štrcaljke kako biste bili sigurni da ćete u štrcaljki dobiti točnu količinu sterilne vode.
English: o If your dose is more than 5 mg, your doctor, nurse or pharmacist might tell you to give the dose as two separate injections.
Croatian: o Ako primjenjujete dozu veću od 5 mg, liječnik, medicinska sestra ili ljekarnik možda će Vam reći da dozu primijenite kao dvije odvojene injekcije.
English: Partial LD subgroup
Croatian: Podskupina s parcijalnim LD-om
English: Injection site reactions were reported in 3.4% of patients with LD treated with metreleptin.
Croatian: Reakcije na mjestu injiciranja prijavljene su u 3,4% bolesnika s LD-om liječenih metreleptinom.
English: Two-year carcinogenicity studies in rodents have not been conducted.
Croatian: Nisu provedena dvogodišnja ispitivanja karcinogenosti na glodavcima.
English: *Metreleptin is a recombinant human leptin analogue (produced in Escherichia coli cells by recombinant DNA technology to form recombinant methionyl-human leptin).
Croatian: *Metreleptin je rekombinantni analog humanog leptina (koji je proizveden u stanicama bakterije Escherichia coli uporabom tehnologije rekombinantne DNK kako bi se dobio rekombinantni metionil humani leptin).
English: Myalepta is an injection once a day under the skin (‘subcutaneous injection').
Croatian: Myalepta je injekcija koja se daje jedanput dnevno pod kožu (supkutana injekcija).
English: If you notice any of the symptoms referred to above and described further in section 4 of this leaflet, or you are not sure, talk to your doctor straight away.
Croatian: Ako primijetite neki od gore navedenih simptoma ili onih opisanih u dijelu 4. u nastavku ove upute, ili ako niste sigurni, odmah se obratite svom liječniku.
English: Myalepta might increase fertility in women with lipodystrophy (see section “Pregnancy, breast-feeding and fertility”).
Croatian: Myalepta može povećati plodnost u žena oboljelih od lipodistrofije (pogledajte dio "Trudnoća, dojenje i plodnost").
English: It is used in adults, adolescents and children 2 years or over:
Croatian: Lijek se primjenjuje u odraslih osoba, adolescenata i djece u dobi od 2 godine ili više:
English: • If there is medicine left in the syringe, you have not had your full dose.
Croatian: • Ako u štrcaljki preostane lijek, nećete primiti svoju punu dozu.
English: Patients were eligible for inclusion if they were > 6 months old, with a leptin level of < 12 ng/mL, and had at least 1 of the following 3 metabolic abnormalities:
Croatian: Bolesnici su bili podobni za uključivanje ako su bili stariji od 6 mjeseci, s razinom leptina < 12 ng/ml i imali najmanje jednu od sljedećih triju metaboličkih abnormalnosti:
English: Use new syringes each time.
Croatian: Svaki put upotrijebite novu štrcaljku.
English: Line up the top rim of the plunger with the line for the prescribed dose.
Croatian: Izravnajte gornji rub klipa s crticom za propisanu dozu.
English: In general, dose selection and modification for an elderly patient should be cautious, although no specific dose adjustment is recommended.
Croatian: U starijih bolesnika općenito treba biti oprezan s odabirom i promjenom doze, iako nema preporuka za neku određenu prilagodbu doze.
English: Decreased maternal body weight was observed from gestation throughout lactation at all doses and resulted in reduced weight of offspring at birth, which persisted into adulthood.
Croatian: Smanjenje tjelesne težine majke opaženo je od gestacije do laktacije pri svim dozama i rezultiralo je smanjenom težinom mladunčadi pri porođaju, što se nastavilo do odrasle dobi.
English: Total daily volume to be injected is 3.75 mg/5 = 0.75 mL.
Croatian: Ukupni dnevni volumen koji treba injicirati je 3,75 mg/5 = 0,75 ml.
English: The MAH shall ensure that in each Member State where Myalepta is marketed, all healthcare professionals and patients/carers who are expected to use Myalepta are provided with the following educational package:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet obvezan je osigurati da u svakoj državi članici u kojoj se Myalepta stavlja na tržište svi zdravstveni radnici i bolesnici/njegovatelji za koje se očekuje da će upotrebljavati lijek Myalepta dobiju sljedeći edukacijski komplet:
English: • feeling more irritable or more nervous
Croatian: • osjećaj pojačane razdražljivosti ili nervoze.
English: Doses exceeding 1 mL can be administered as two injections (the total daily dose divided equally) to minimise potential injection site discomfort due to injection volume.
Croatian: Doze iznad 1 ml mogu se primjenjivati u dvjema injekcijama (jednakomjerno raspoređena ukupna dnevna doza) kako bi se na najmanju mjeru svela moguća nelagoda na mjestu injekcije zbog volumena injekcije.
English: Use only with the solvent for reconstitution, syringes and needles, provided separately.
Croatian: Upotrijebite samo s otapalom za rekonstituciju, štrcaljkama i iglama koji su isporučeni odvojeno.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and supportive treatment initiated.
Croatian: U slučaju predoziranja potrebno je pažljivo pratiti bolesnike s obzirom na znakove ili simptome nuspojava i započeti suportivno liječenje.
English: There might be local regulations for this.
Croatian: Za njegovo zbrinjavanje u otpad možda postoje lokalni propisi.
English: • Inject all of the medicine.
Croatian: • Ubrizgajte cijelu količinu lijeka.
English: These will have been given to you by your doctor, nurse, or pharmacist.
Croatian: Njih će Vam dati liječnik, medicinska sestra ili ljekarnik.
English: Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
Croatian: Lijek Myalepta indiciran je kao dodatak dijeti kao nadomjesna terapija za liječenje komplikacija deficijencije leptina u bolesnika s lipodistrofijom (LD):
English: Therefore, an additional non-hormonal contraceptive method should be considered during treatment.
Croatian: Stoga tijekom liječenja treba razmotriti primjenu dodatne nehormonalne metode kontracepcije.
English: 29) Throw away the two used syringes and all caps, vials, or ampoules in the sharps disposal container straight away.
Croatian: 29) Dvije upotrijebljene štrcaljke i sve zatvarače, bočice ili ampule odmah odložite u spremnik za oštre predmete.
English: Additional training information
Croatian: Dodatni edukacijski materijali
English: In this case, prolonged overdose was associated with severe anorexia causing vitamin and zinc deficiencies, iron deficiency anaemia, protein calorie malnutrition, and poor weight gain, which resolved following supportive treatment and dose adjustment.
Croatian: U tom je slučaju produljeno predoziranje bilo povezano s teškom anoreksijom koja je prouzročila manjak vitamina i cinka, sideropeničnom anemijom, proteinsko-energetskom pothranjenosti i slabim dobivanjem na težini, što se riješilo nakon suportivnog liječenja i prilagodbe doze.
English: People with lipodystrophy can get a type of blood cancer called lymphoma, whether or not they are using Myalepta.
Croatian: Osobe koje boluju od lipodistrofije mogu oboljeti od vrste raka koja se naziva limfom, bez obzira koriste li lijek Myalepta ili ne.
English: If you use more Myalepta than you should, talk to your doctor or go to a hospital straight away.
Croatian: Ako primijenite više lijeka Myalepta nego što ste trebali, razgovarajte s liječnikom ili idite odmah u bolnicu.
English: For signs of low blood sugar levels, see section 4 under ‘Signs of high and low blood sugar'.
Croatian: Za znakove niske razine šećera u krvi pogledajte dio 4. pod "Znakovi visokog i niskog šećera u krvi".
English: Abrupt interruption and/or non-compliance with metreleptin dosing was suspected to have contributed to the occurrence of pancreatitis in 2 patients.
Croatian: Sumnja se da su nagli prekid i/ili nepridržavanje doziranja metreleptina pridonijeli nastanku pankreatitisa u 2 bolesnika.
English: In partial LD patients, assessment across age groups is limited, due to the small sample size.
Croatian: U bolesnika s parcijalnim LD-om procjena po dobnim skupinama ograničena je, zbog male veličine uzorka.
English: Signs of high blood sugar levels and high fat levels are listed in section 4 under “Signs of high and low blood sugar” and “Signs of high fat”.
Croatian: Znakovi visokih razina šećera i masti u krvi navedeni su u dijelu 4. pod "Znakovi visokog i niskog šećera u krvi" i "Znakovi povišene masnoće".
English: Myalepta can affect the way some other medicines work.
Croatian: Myalepta može utjecati na način kako djeluju neki drugi lijekovi.
English: • sharps disposal container (to safely dispose of the injection equipment afterwards)
Croatian: • spremnik za oštre predmete (za kasnije sigurno zbrinjavanje pribora za injekciju)
English: o Serious and severe infections secondary to the appearance of NAb may occur.
Croatian: o Navod o ozbiljnim i teškim infekcijama kao sekundarnim pojavama nastanka NAB-a.
English: These findings are considered to be related indirectly to metreleptin pharmacology, resulting in nutritional deprivation of treated animals, and also possibly, due to an inhibitory effect on spontaneous and oxytocin-induced contractions, as has been observed in strips of human myometrium exposed to leptin.
Croatian: Ovi se nalazi smatraju neizravno povezanima s farmakologijom metreleptina, zbog koje dolazi do nutritivne deprivacije liječenih životinja te također moguće zbog inhibitornog učinka na spontane kontrakcije i one inducirane oksitocinom, kako je bilo opaženo u trakama ljudskog miometrija izloženog leptinu.
English: A dose increment of 1.25 mg increases the daily dose to 3.75 mg.
Croatian: Povećanje doze za 1,25 mg povećava dnevnu dozu na 3,75 mg.
English: Before you begin self-administering this medicine at home, your doctor, nurse or pharmacist will train you how to prepare and inject Myalepta.
Croatian: Prije nego što počnete sami primjenjivati ovaj lijek kod kuće, liječnik, medicinska sestra ili ljekarnik uvježbat će s Vama pripremu i injiciranje lijeka Myalepta.
English: A blocking activity of the reaction between metreleptin and a recombinant leptin receptor has been observed in vitro in the blood of the majority of an extended set of patients (98 out of 102 patients or 96%) but the impact on the efficacy of metreleptin could not be clearly established.
Croatian: Blokirajuća aktivnost reakcije između metreleptina i receptora rekombinantnog leptina primijećena je in vitro u krvi većine proširene skupine bolesnika (98 od 102 bolesnika ili 96%), ali se utjecaj na djelotvornost metreleptina nije mogao jasno utvrditi.
English: • Do not recycle the syringes, caps, or sharps disposal container, or throw them into household waste.
Croatian: • Nemojte reciklirati štrcaljke, zatvarače ili spremnik za oštre predmete ili ih odlagati u kućanski otpad.
English: Healthcare professionals' educational material should contain:
Croatian: Edukacijski materijal za zdravstvene radnike mora sadržavati:
English: Take your time to carefully prepare and inject your medicine, which when including the period of the vial warming up after being taken out of the fridge, can be approximately 20 minutes in total.
Croatian: Odvojite vrijeme da pažljivo pripremite i ubrizgate lijek, za što Vam može trebati približno 20 minuta, računajući i vrijeme potrebno za zagrijavanje bočice nakon vađenja iz hladnjaka.
English: • a higher than normal desire for food or excessive eating
Croatian: • povećana želja za jelom ili prejedanje
English: The glass ampoule is a sealed container.
Croatian: Staklena ampula je hermetički zatvoren spremnik.
English: One serious and severe infection of appendicitis was temporally associated with blocking activity against metreleptin in a patient with partial LD who was not in the subgroup of partial LD patients.
Croatian: Jedna ozbiljna i teška infekcija apendicitisa bila je vremenski povezana s blokirajućom aktivnosti protiv metreleptina u jednog bolesnika s parcijalnim LD-om koji nije bio u podskupini bolesnika s parcijalnim LD-om.
English: An association between the development of a blocking activity against metreleptin and serious and severe infections cannot be excluded (see section 4.8).
Croatian: Ne može se isključiti povezanost između nastanka blokirajućeg djelovanja prema metreleptinu i ozbiljnih i teških infekcija (vidjeti dio 4.8).
English: ● Actual change from baseline in HbA1c at Month 12, and
Croatian: Stvarna promjena od početne vrijednosti HbA1c do 12. mjeseca i
English: How much to inject
Croatian: Koju količinu treba ubrizgati
English: Do not shake or vigorously agitate.
Croatian: Nemojte tresti ili snažno uzburkati.
English: If you need to inject 1 mL or more of Myalepta solution, your doctor might tell you to give the dose as two separate injections.
Croatian: Ako trebate ubrizgati 1 ml ili više otopine Myalepta, liječnik može odrediti da dozu primijenite kao dvije odvojene injekcije.
English: Consideration should also be given by the prescriber to have patients tested for the presence of neutralising antibodies.
Croatian: Propisivač također treba razmotriti testiranje bolesnika na prisutnost neutralizirajućih protutijela.
English: • The solution will take less than 5 minutes to become clear.
Croatian: • Otopini će trebati manje od 5 minuta da se razbistri.
English: • feeling more sleepy or confused
Croatian: • osjećaj veće pospanosti ili zbunjenosti
English: Arthralgia, Myalgia
Croatian: Artralgija, mialgija
English: Adverse reactions are classified by MedDRA System Organ Class and absolute frequency in Table 7.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti u Tablici 7.
English: The median fasting leptin concentration at baseline was 5.9 ng/mL (1.6-16.9) using the LINCO RIA test method.
Croatian: Medijan koncentracije leptina natašte na početku bio je 5,9 ng/ml (1,6-16,9) primjenom ispitne metode LINCO RIA.
English: If your syringe looks different or has different dose markings, talk to your doctor, nurse or pharmacist for more information.
Croatian: Ako vaša štrcaljka izgleda drukčije ili ima drukčije oznake za dozu, zatražite više informacija od liječnika, medicinske sestre ili ljekarnika.
English: Serious adverse reactions were reported in 2 patients, worsening hypertension and anaplastic large cell lymphoma.
Croatian: Ozbiljne nuspojave prijavljene su u 2 bolesnika, pogoršanje hipertenzije i anaplastični velikostanični limfom.
English: • To know how much medicine to inject (in mL), you divide your dose (in mg) by 5.
Croatian: • Da biste odredili koju količinu lijeka trebate ubrizgati (u ml), dozu (u mg) morate podijeliti s 5.
English: • or partial lipodystrophy has been caused by your body's response to something such as a viral illness (also called acquired lipodystrophy)
Croatian: • ili djelomičnu lipodistrofiju koja je izazvana odgovorom Vašeg tijela na neke utjecaje kao što su virusne bolesti (naziva se i stečenom lipodistrofijom)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, amino acids and derivatives, ATC code: A16AA07
Croatian: Farmakoterapijska skupina: ostali lijekovi za probavni sustav i metabolizam, aminokiseline i derivati, ATK oznaka: A16AA07
English: No studies with direct administration of metreleptin to juvenile animals have been conducted.
Croatian: Nisu provedena ispitivanja s izravnom primjenom metreleptina na mladim životinjama.
English: • Carefully push the plunger back up to force the air out of the syringe.
Croatian: • Pažljivo potisnite klip natrag kako biste istisnuli zrak iz štrcaljke.
English: • your body producing antibodies to metreleptin which may increase the risk of developing serious or severe infections.
Croatian: • tijelo proizvodi protutijela na metreleptin što može povećati rizik od nastanka ozbiljnih ili teških infekcija.
English: If a patient develops pancreatitis whilst being treated with metreleptin, it is advised that metreleptin be continued uninterrupted, as stopping treatment abruptly may exacerbate the condition.
Croatian: Ako bolesnik oboli od pankreatitisa tijekom liječenja metreleptinom, preporučljivo je nastaviti s primjenom metreleptina bez prekida, jer nagli prestanak liječenja može pogoršati stanje.
English: Step E: Choose and preparing where to inject
Croatian: Korak E: Odabir mjesta za ubadanje i priprema mjesta
English: In generalised LD patients, the overall incidence of adverse reactions was similar regardless of age.
Croatian: U bolesnika s generaliziranim LD-om, ukupna incidencija nuspojava bila je slična bez obzira na dob.
English: The mechanism for pancreatitis in these patients was presumed to be return of hypertriglyceridaemia and therefore increased risk of pancreatitis in the setting of discontinuation of effective therapy for hypertriglyceridaemia.
Croatian: Pretpostavlja se da je mehanizam nastanka pankreatitisa u ovih bolesnika bio povratak hipertrigliceridemije i stoga povećan rizik od pankreatitisa u uvjetima prekida učinkovitog liječenja hipertrigliceridemije.
English: • The needle is short in length, and all of the needle should go into the skin at a 45 degree angle.
Croatian: • Igla je kratka i treba ući u kožu cijelom duljinom pod kutom od 45 stupnjeva.
English: Myalepta reconstituted with water for injection is for single use only and should be administered immediately.
Croatian: Lijek Myalepta rekonstituiran vodom za injekcije namijenjen je isključivo za jednokratnu uporabu i treba se odmah primijeniti.
English: There are data to suggest metreleptin may increase fertility, due to effects on LH, with the consequent potential for unplanned pregnancy (see section 4.4).
Croatian: Plodnost Postoje podaci koji sugeriraju da metreleptin može povećati plodnost, zbog učinka na LH, s posljedičnim potencijalom za neplaniranu trudnoću (vidjeti dio 4.4).
English: • blood clot in your veins (deep vein thrombosis) - pain, swelling, warmth & redness, usually occurring in lower leg or thigh
Croatian: • krvni ugrušak u venama (tromboza dubokih vena) - bol, oticanje, vrućina i crvenilo, obično se pojavljuje u potkoljenici ili bedrima
English: Draft protocol to be submitted 3 months after notification of the European Commission decision.
Croatian: Nacrt protokola treba dostaviti 3 mjeseca nakon objave odluke Europske komisije.
English: These differences across age groups are likely related to differences in mean HbA1c at baseline, which was in the normal range for patients < 6 years (5.7%) and lower in patients ≥ 6 to < 12 years (6.4%) compared to the older age group (9.7%).
Croatian: Ove razlike po dobnim skupinama vjerojatno su povezane s razlikama u srednjoj vrijednosti HbA1c na početku, koji je bio u normalnom rasponu za bolesnike u dobi < 6 godina (5,7%) i niži u bolesnika u dobi ≥ 6 do < 12 godina (6,4%) u odnosu na stariju dobnu skupinu (9,7%).
English: Only the metabolic effects of metreleptin have been studied.
Croatian: Ispitivani su samo metabolički učinci metreleptina.
English: The median duration of metreleptin treatment was 4.2 years (range: 3.4 months-13.8 years).
Croatian: Medijan trajanja liječenja metreleptinom bio je 4,2 godine (raspon: 3,4 mjeseca-13,8 godina).
English: A causal relationship between lymphoma and Myalepta has not been established.
Croatian: Kauzalni odnos između limfoma i lijeka Myalepta nije utvrđen.
English: While being treated with Myalepta, your body might produce antibodies which may increase the risk of developing serious or severe infections.
Croatian: Tijekom liječenja lijekom Myalepta vaše tijelo može proizvesti protutijela, što može povećati rizik od nastanka ozbiljnih ili teških infekcija.
English: The glass vial will have a plastic cap that you should remove, revealing a rubber seal below.
Croatian: Staklena bočica ima plastični zatvarač koji trebate skinuti da se vidi gumeni čep koji se nalazi ispod njega.
English: The median duration of metreleptin treatment was 2.4 years (range: 6.7 months-14.0 years).
Croatian: Medijan trajanja liječenja metreleptinom bio je 2,4 godine (raspon: 6,7 mjeseci-14,0 godina).
English: Fasting TGs (mmol/L)
Croatian: TG natašte (mmol/l)
English: In order to further evaluate the long-term safety and effectiveness of Myalepta under normal conditions of clinical practice, the applicant should establish a registry including all patients with generalised or partial lipodystrophy treated with Myalepta according to an agreed protocol.
Croatian: Kako bi se dodatno evaluirale dugoročna sigurnost i učinkovitost lijeka Myalepta u normalnim uvjetima kliničke prakse, podnositelj zahtjeva obvezan je uspostaviti registar svih bolesnika s generaliziranom ili parcijalnom lipodistrofijom koji se liječe lijekom Myalepta u skladu s dogovorenim protokolom.
English: In clinical studies, hypoglycaemia has been managed with food/drink intake and by modifying the dose of anti-diabetic medicinal product.
Croatian: U kliničkim ispitivanjima hipoglikemija se zbrinjavala uzimanjem hrane/pića i promjenom doze antidijabetičkog lijeka.
English: • increase in fatty tissue
Croatian: • povećanje masnog tkiva
English: If you notice any of the symptoms above, or you are not sure, talk to your doctor straight away.
Croatian: Ako primijetite bilo koji od gornjih simptoma, ili ako niste sigurni, odmah se javite svom liječniku.
English: • Hold the bottom of the ampoule in one hand and the top of the ampoule in your other hand.
Croatian: • Prihvatite dno ampule jednom rukom, a vrh ampule drugom rukom.