FrancophonIA/ELRC3.0 huggingface dataset:
English: There are additional education training information and videos to help you understand how to use Myalepta correctly.
Croatian: Postoje dodatni edukacijski materijali i videozapisi koji će Vam pomoći u pravilnoj primjeni lijeka Myalepta.
English: In order to avoid medication errors including overdose, dose calculation and dose adjustment guidelines below should be followed.
Croatian: Radi izbjegavanja medikacijskih pogrešaka uključujući predoziranje, potrebno je pridržavati se smjernica za izračun i prilagodbu doze navedenih u nastavku.
English: Aegerion Pharmaceuticals B.V. Atrium Building 8th Floor
Croatian: Atrium Building 8th Floor
English: Converting dose from ‘mL' to ‘Units' when using the 0.3 mL syringe Weight of child
Croatian: Pretvaranje doze iz "ml" u "jedinice" prilikom uporabe štrcaljke od 0,3 ml Težina djeteta
English: The greater metreleptin exposure and longer t1/2 observed in the pregnant animals may be related to a reduced elimination capacity by binding to soluble leptin receptor found at higher levels in pregnant mice.
Croatian: Veća izloženost metreleptinu i dulji t1/2 koji su opaženi u skotnih životinja mogu biti povezani sa smanjenim kapacitetom eliminacije zbog vezivanja na topljivi leptinski receptor koji se u višim razinama nalazi u skotnih ženki miša.
English: o See the “Instructions for Use” to find out which syringe to use.
Croatian: o U "Uputama za uporabu" pronaći ćete koju štrcaljku trebate upotrijebiti.
English: While the impact of neutralising antibodies on efficacy has not been confirmed, consideration should be given by the prescriber to have patients tested for the presence of neutralising antibodies if there is significant loss of efficacy despite Myalepta administration.
Croatian: Iako utjecaj neutralizirajućih protutijela na djelotvornost nije potvrđen, propisivač mora razmotriti testiranje bolesnika na prisutnost neutralizirajućih protutijela ako dođe do značajnog smanjenja djelotvornosti unatoč primjeni lijeka Myalepta.
English: You should not stop using Myalepta unless your doctor tells you to.
Croatian: Ne smijete prestati s primjenom lijeka Myalepta dok Vam to liječnik ne kaže.
English: In a supportive trial in LD patients, the median Tmax was 4 hours (range: 2 to 6 hours; N = 5) following single-dose administration of metreleptin.
Croatian: U suportivnom ispitivanju u bolesnika s LD-om medijan Tmax bio je 4 sata (raspon: 2 do 6 sati; N=5) nakon primjene jedne doze metreleptina.
English: A total of 8 (24%) of the 34 patients with generalised LD who were receiving lipid-lowering therapies at baseline discontinued their use during metreleptin treatment.
Croatian: Ukupno 8 (24%) od 34 bolesnika s generaliziranim LD-om koji su na početku uzimali lijekove za snižavanje lipida prestalo ih je uzimati tijekom liječenja metreleptinom.
English: • Always keep the sharps disposal container out of reach of children.
Croatian: • Spremnik za oštre predmete uvijek držite izvan dohvata djece.
English: • How you connect the needle to the syringe will be depend on if you have been provided your water for injection in a plastic ampoule, a glass ampoule, or a glass vial (see below for specific instructions).
Croatian: • Kako ćete staviti iglu na štrcaljku ovisi o tome nalazi li se voda za injekcije koju ste dobili u plastičnoj ampuli, staklenoj ampuli ili staklenoj bočici (pogledajte posebne upute u nastavku).
English: Healthcare professionals should provide patients and carers with training on the reconstitution of the product and proper subcutaneous injection technique, so as to avoid intramuscular injection in patients with minimal subcutaneous adipose tissue.
Croatian: Zdravstveni radnici trebaju podučiti bolesnike i njegovatelje o rekonstituiranju lijeka i pravilnoj tehnici potkožnog injiciranja kako bi se izbjeglo intramuskularno injiciranje u bolesnika s minimalnim potkožnim adipoznim tkivom.
English: After IV administration, metreleptin clearance was shown to be 79.6 mL/kg/h in healthy volunteers.
Croatian: primjene, klirens metreleptina iznosio je 79,6 ml/kg/h u zdravih dobrovoljaca.
English: o Myalepta may increase fertility, due to effects on LH and thus the chances of unplanned pregnancy.
Croatian: o Myalepta može povećati plodnost zbog učinka na LH, s posljedičnim mogućnostima neplanirane trudnoće.
English: Women of childbearing potential should be advised that Myalepta may increase fertility and should be encouraged to use contraception.
Croatian: Žene koje mogu zatrudnjeti treba informirati da Myalepta može povećati plodnost i preporučiti im upotrebu kontracepcije.
English: • The vials may remain almost completely filled with product after withdrawal of the required dose.
Croatian: • Bočice mogu ostati gotovo pune lijeka nakon izvlačenja potrebne doze.
English: • low blood sugar (glucose)
Croatian: • niski šećer u krvi (glukoza)
English: Your doctor will monitor you for side effects.
Croatian: Liječnik će Vas nadzirati radi nuspojava.
English: - HCPs should provide training to patients on the correct technique.
Croatian: - Zdravstveni radnici moraju uputiti bolesnike u ispravnu tehniku.
English: You must use a clean syringe and needle for both injections.
Croatian: Za obje injekcije morate upotrijebiti čistu štrcaljku i iglu.
English: If you have injected less Myalepta than you should, talk to your doctor straight away.
Croatian: Ako primijenite manje lijeka Myalepta nego što ste trebali, odmah razgovarajte s liječnikom.
English: A causal relationship between the medicinal product treatment and the development and/or progression of lymphoma has not been established.
Croatian: Kauzalni odnos između liječenja lijekom i nastanka i/ili napredovanja limfoma nije utvrđen.
English: If a patient misses a dose, the dose should be administered as soon as the omission is noticed and the normal dosing schedule resumed the next day.
Croatian: Ako bolesnik propusti dozu, dozu je potrebno primijeniti čim se uoči propust, a sljedećeg dana potrebno je nastaviti s normalnim doziranjem.
English: Both had immunodeficiency and significant haematological abnormalities including severe bone marrow abnormalities before the start of treatment.
Croatian: Oboje su prije početka liječenja bili imunodeficijentni i imali značajne hematološke abnormalnosti, uključujući teške abnormalnosti koštane srži.
English: Dispose of any unused medicine.
Croatian: Zbrinite u otpad sav neiskorišteni lijek.
English: You may notice you develop a high temperature, accompanied by increasing tiredness
Croatian: Može se dogoditi da dobijete visoku temperaturu praćenu pojačanim umorom.
English: Initiating or adjusting lipid lowering medications may be required.
Croatian: Mogu biti potrebni uvođenje ili prilagodba doze lijekova za snižavanje razine lipida.
English: Metreleptin dose increases in adults and children based on incomplete clinical response can be considered after a minimum of 6 months of treatment, allowing for lowering concomitant insulin, oral anti-diabetic and/or lipid lowering medication.
Croatian: Povećanja doze metreleptina u odraslih i djece na temelju nepotpunog kliničkog odgovora mogu se razmotriti nakon minimalno 6 mjeseci liječenja, omogućavajući smanjivanje doze istodobno primijenjenog inzulina, oralnih antidijabetičkih lijekova i/ili smanjivanje doze lijeka koji snižava razinu lipida.
English: While being treated with Myalepta, you may get an allergic reaction.
Croatian: Tijekom liječenja lijekom Myalepta možete dobiti alergijsku reakciju.
English: Metreleptin works by copying the effects of leptin.
Croatian: Metreleptin djeluje tako što oponaša učinke leptina.
English: For all patients weighing more than 40 kg an incremental adjustment increase in daily dose would be 1.25 mg or 0.25 mL injection volume.
Croatian: Za sve bolesnike težine iznad 40 kg prilagodba povećanjem dnevne doze bila bi u koracima od 1,25 mg ili 0,25 ml volumena injekcije.
English: 2) Before preparing Myalepta solution, allow the powder vial to reach room temperature for about 10 minutes.
Croatian: 2) Prije pripreme otopine lijeka Myalepta ostavite bočicu s praškom da stoji oko 10 minuta kako bi dosegla sobnu temperaturu.
English: • One injection syringe with a much shorter needle for injecting the solution under your skin The size of this syringe will be chosen by your doctor, nurse or pharmacist for your dose of Myalepta.
Croatian: • jedna štrcaljka za injekciju s puno kraćom iglom za potkožno ubrizgavanje otopine Veličinu ove štrcaljke odabrat će Vaš liječnik, medicinska sestra ili ljekarnik, u skladu s Vašom dozom lijeka Myalepta.
English: Following reconstitution with water for injections, the medicinal product must be used immediately and cannot be stored for future use.
Croatian: Nakon rekonstitucije s vodom za injekcije lijek se mora odmah upotrijebiti i ne može se pohraniti za buduću uporabu.
English: Do not use this medicine after the expiry date which is stated on the vial and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji.
English: Your doctor or pharmacist will tell you how much of the solution to inject.
Croatian: Liječnik ili ljekarnik reći će Vam koju količinu otopine trebate ubrizgati.
English: Two of these patients were diagnosed with peripheral T-cell lymphoma while receiving the medicinal product.
Croatian: U dvoje od tih bolesnika dijagnosticiran je periferni T-stanični limfom tijekom primanja lijeka.
English: What Myalepta is and what it is used for
Croatian: Što je Myalepta i za što se koristi
English: Total daily volume to be injected is total dose in mg/5.
Croatian: Ukupni dnevni volumen koji treba injicirati je ukupna doza u mg/5.
English: The water for injection will come in either:
Croatian: Voda za injekcije nalazi se u:
English: o The need of compliance with treatment due to the risk of pancreatitis when medication is abruptly stopped.
Croatian: o Potrebno je naglasiti važnost discipline u liječenju zbog rizika od pankreatitisa ako se uzimanje lijeka naglo prekine.
English: Some medicines need to be monitored while you are using Myalepta since the dose of these medicines might need to be changed.
Croatian: Dok primjenjujete lijek Myalepta potrebno je pratiti neke druge lijekove jer možda treba promijeniti dozu tih lijekova.
English: Remove the needle and syringe from the vial and gently swirl the contents to reconstitute, until the liquid is clear.
Croatian: Izvadite iglu i štrcaljku iz bočice i lagano kružnim pokretima bočice promiješajte sadržaj kako bi se rekonstituirao, dok se tekućina ne razbistri.
English: Myalepta is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Myalepta tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: The Applicant should conduct this integrated analysis according to an agreed protocol including samples from all available historical samples from previous studies (NIH991265/20010769, FHA 101, NASH4 and obesity studies) with patients with GL/PL and samples obtained from patients that will be included in the efficacy and safety study in PL patients, the paediatric investigational plan (PIP) study and the patients registry.
Croatian: Podnositelj zahtjeva treba provesti ovu integralnu analizu u skladu s dogovorenim protokolom i uključiti uzorke iz svih dostupnih povijesnih uzoraka iz prethodnih ispitivanja (NIH991265/20010769, FHA 101, NASH4 i ispitivanja pretilosti) za bolesnike s GL-om/PL-om te uzorke prikupljene od bolesnika koji će biti uključeni u ispitivanje djelotvornosti i sigurnosti za bolesnike s PL-om, pedijatrijski plan ispitivanja (PIP) i registar bolesnika.
English: Actual body weight at initiation of treatment should always be used when calculating the dose.
Croatian: Za izračun doze uvijek treba koristiti stvarnu tjelesnu težinu u trenutku početka liječenja.
English: During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed.
Croatian: Tijekom postupnog smanjenja pratite razine triglicerida i po potrebi razmotrite uvođenje ili prilagodbu doze lijekova za snižavanje razine lipida.
English: In studies of healthy adult subjects, following intravenous administration of metreleptin, leptin volume of distribution (endogenous leptin and metreleptin) was approximately 4 to 5 times plasma volume; volumes (mean ± SD) were 370 ± 184 mL/kg, 398 ± 92 mL/kg, and 463 ± 116 mL/kg for 0.3, 1.0, and 3.0 mg/kg/day doses, respectively.
Croatian: U ispitivanjima provedenima na zdravim odraslim ispitanicima, nakon intravenske primjene metreleptina, volumen raspodjele leptina (endogenog leptina i metreleptina) iznosio je približno 4 do 5 puta više od volumena plazme; volumeni (srednja vrijednost ± SD) su bili 370 ± 184 ml/kg, 398 ± 92 ml/kg i 463 ± 116 ml/kg za doze od 0,3, 1,0 odnosno 3,0 mg/kg/dan.
English: • Clean the top of the vial with the alcohol wipe.
Croatian: • Očistite vrh bočice alkoholnom blazinicom.
English: What you need to know before you use Myalepta Do not use Myalepta if:
Croatian: Što morate znati prije nego počnete primjenjivati lijek Myalepta Nemojte primjenjivati lijek Myalepta ako:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Metreleptin may decrease insulin resistance in diabetic patients, resulting in hypoglycaemia in patients with LD and co-existing diabetes.
Croatian: Metreleptin može smanjiti inzulinsku rezistenciju u bolesnika s dijabetesom, što za posljedicu ima hipoglikemiju u bolesnika s LD-om i istodobnim dijabetesom.
English: • A sudden increase in the amount of triglyceride in your blood can make your pancreas inflamed (‘pancreatitis').
Croatian: • Nagli porast triglicerida u krvi može izazvati upalu gušterače (pankreatitis).
English: The reconstituted solution should be injected into the abdomen, thigh or upper arm tissue.
Croatian: Rekonstituiranu otopinu treba ubrizgati u abdomen, bedro ili nadlaktično tkivo.
English: • severe pain in your stomach (abdomen)
Croatian: • naglu oštru bol u trbuhu (abdomenu)
English: • blood pressure medicines called ‘calcium channel blockers'
Croatian: • statine za smanjenje kolesterola (npr. atorvastatin) • lijekove za krvni tlak koji se nazivaju "blokatori kalcijevih kanala"
English: Discontinuation in patients at risk for pancreatitis
Croatian: Obustava primjene lijeka u bolesnika s rizikom od pankreatitisa
English: • Do not dissolve another dose of Myalepta powder with any ampoule or vial containing unused remaining water for injection.
Croatian: • Nemojte otapati drugu dozu praška Myalepta bilo kojom ampulom ili bočicom koja sadrži neiskorištenu preostalu vodu za injekcije.
English: Of the 31 partial LD subgroup patients evaluated, 27 (87%) had familial partial LD and 4 (13%) had acquired partial LD.
Croatian: Od 31 procijenjena bolesnika iz podskupine s parcijalnim LD-om, 27 (87%) imalo je obiteljski parcijalni LD, a 4 bolesnika (13%) imala su stečeni parcijalni LD.
English: • The water for injection should go down the inside wall of the vial.
Croatian: • Voda za injekcije treba se slijevati niz unutarnju stijenku bočice.
English: Tell your doctor straight-away if you have any symptoms of an allergic reaction.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koje simptome alergijske reakcije.
English: • increased blood sugar (glucose)
Croatian: • povišeni šećer u krvi (glukoza)
English: 24) To inject under the skin, pinch the skin with one hand where you are going to inject.
Croatian: 24) Za ubrizgavanje pod kožu, palcem i kažiprstom jedne ruke uhvatite kožu u nabor na području primjene injekcije.
English: • The top rim of the plunger should line up with the black line on the syringe that matches the amount of Myalepta solution you are going to inject.
Croatian: • Gornji rub klipa treba se poravnati s crnom crticom na štrcaljki koja odgovara količini otopine Myalepta koju ćete ubrizgati.
English: Abortions, stillbirths and preterm deliveries have been reported in women exposed to metreleptin during pregnancy, though there is currently no evidence to suggest a causal relationship with the treatment.
Croatian: U žena koje su tijekom trudnoće bile izložene metreleptinu prijavljeni su pobačaji, mrtvorođenja i prijevremeni porođaji, iako trenutačno nema dokaza koji bi ukazivali na kauzalnu vezu s liječenjem.
English: Reproductive toxicity studies conducted in mice have revealed no adverse effects on mating, fertility or embryo-foetal development up to the maximum tested dose, approximately, 15-fold the maximum recommended clinical dose, based on body surface area of a 60 kg patient.
Croatian: Ispitivanja reproduktivne toksičnosti provedena na miševima nisu pokazala negativni učinak na parenje, plodnost ili embrio-fetalni razvoj do maksimalne ispitivane doze koja je iznosila približno 15-erostruko više od maksimalne preporučene kliničke doze, na temelju tjelesne površine bolesnika težine 60 kg.
English: 10) Make sure the vial of Myalepta powder has been out of the refrigerator for at least 10 minutes to reach room temperature.
Croatian: 10) Vodite računa da je bočica s praškom lijeka Myalepta stajala izvan hladnjaka najmanje 10 minuta kako bi dosegla sobnu temperaturu.
English: If clinical response is not seen after 6 months of treatment the physician should ensure that the patient is compliant with the administration technique, is receiving the correct dose and is adherent to diet.
Croatian: Ako se ne bilježi klinički odgovor nakon 6 mjeseci liječenja, liječnik treba provjeriti pridržava li se bolesnik ispravnog načina primjene lijeka te prima li bolesnik ispravnu dozu i pridržava li se dijete.
English: • swelling or bleeding under the skin (‘haemorrhage')
Croatian: • oticanje ili krvarenje pod kožom (hemoragija)
English: 16) To inject the Myalepta solution, you will use a new injection syringe, which will either be the 0.3 mL, 1.0 mL, or 2.5 mL syringe that was provided to you by your doctor, nurse or pharmacist.
Croatian: 16) Za ubrizgavanje otopine lijeka Myalepta upotrijebit ćete novu štrcaljku, a to će biti štrcaljka od 0,3 ml, 1,0 ml ili 2,5 ml koju su Vam dali liječnik, medicinska sestra ili ljekarnik.
English: If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks.
Croatian: Ako trebate prestati s primjenom lijeka Myalepta, liječnik će Vam postupno smanjivati dozu tijekom dva tjedna.
English: All patients had a history of pancreatitis and hypertriglyceridaemia.
Croatian: Svi su bolesnici u anamnezi imali pankreatitis i hipertrigliceridemiju.
English: Using the glass vial or plastic ampoule
Croatian: Ako upotrebljavate staklenu bočicu ili plastičnu ampulu
English: • pain below the ribs like heartburn or indigestion
Croatian: • bol ispod rebara poput žgaravice ili probavnih smetnji
English: Among the 39 patients with generalised LD who were receiving insulin at baseline, 16 (41%) were able to discontinue insulin use altogether after starting metreleptin.
Croatian: Među 39 bolesnika s generaliziranim LD-om koji su na početku primali inzulin, njih 16 (41%) potpuno je prestalo s uzimanjem inzulina nakon uvođenja metreleptina.
English: Overall, 51 (77%) patients were female, 31 (47%) were Caucasian, 11 (17%) Hispanic, and 16 (24%) Black.
Croatian: Sveukupno je bilo 51 (77%) ženskih bolesnika, 31 (47%) pripadnika bjelačke populacije, 11 (17%) hispanske i 16 (24%) crnačke populacije.
English: Weight decreased
Croatian: Smanjenje težine
English: Myalepta might increase fertility in women with lipodystrophy.
Croatian: Myalepta može povećati plodnost u žena s lipodistrofijom.
English: • very fast heartbeat
Croatian: • ubrzani otkucaji srca
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 patients but the impact on the efficacy of metreleptin could not be clearly established (see section 4.8).
Croatian: Blokirajuće djelovanje na reakciju između metreleptina i receptora rekombinantnog leptina primijećeno je in vitro u krvi u većine bolesnika, ali utjecaj na djelotvornost metreleptina nije jasno utvrđen (vidjeti dio 4.8).
English: This is to prevent your blood sugar from getting too low (‘hypo-glycaemia').
Croatian: Svrha toga je da se spriječi da Vam šećer u krvi bude prenizak (hipoglikemija).
English: o Ways to prevent the occurrence of medication errors - Myalepta is administered by SC injection and proper technique should be used to avoid intramuscular injection in patients with minimal SC tissue.
Croatian: o Načini za sprečavanje medikacijskih pogrešaka - Myalepta se primjenjuje supkutanom injekcijom i potrebno je primijeniti ispravnu tehniku kako bi se spriječilo intramuskularno ubrizgavanje u bolesnika s minimalnom količinom potkožnog tkiva.
English: • a plastic ampoule
Croatian: • plastičnoj ampuli,
English: Weight (kg) x 0.02 mg/kg = amount of dose adjustment in mg
Croatian: Težina (kg) x 0,02 mg/kg = količina prilagodbe doze u mg
English: The patient will also receive separately the solvent for reconstitution (i.e. water for injection), the syringes/needles for reconstitution, the syringes/needles for administration, the cleansing alcohol swabs, and a sharps disposal container.
Croatian: Bolesnik će također odvojeno dobiti otapalo za rekonstituciju (tj. vodu za injekcije), štrcaljke/igle za rekonstituciju, štrcaljke/igle za primjenu lijeka, jastučiće od vate natopljene alkoholom za čišćenje i spremnik za odlaganje oštrih predmeta.
English: • Sometimes, large spaces of air (air pockets) get caught inside the syringe.
Croatian: • Ponekad u štrcaljki zaostanu veliki prostori ispunjeni zrakom (zračni džepovi).
English: • alcohol wipes (to clean your skin where you will inject and to clean the tops of the vials)
Croatian: • alkoholne blazinice (za čišćenje kože na mjestu uboda i za čišćenje vrha bočice)
English: Your doctor, nurse or pharmacist will show you how to prepare and inject this medicine.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik pokazat će Vam kako trebate pripremiti lijek i ubrizgati ga.
English: • a container of water for injections for dissolving the Myalepta powder o The water for injections might come in glass or plastic ampoules, or glass vials with a rubber stopper.
Croatian: • spremnik s vodom za injekcije za otapanje praška Myalepta o Voda za injekcije može biti u staklenim ili plastičnim ampulama ili u staklenim bočicama s gumenim čepom.
English: You and your doctor will decide whether or not to continue breast-feeding while using this medicine.
Croatian: Vi i Vaš liječnik odlučit ćete hoćete li nastaviti s primjenom ovog lijeka dok dojite ili ne.
English: Upon initiation or discontinuation of metreleptin, in patients being treated with these types of agents, therapeutic monitoring of effect (e.g., warfarin), or drug concentrations (e.g. cyclosporin or theophylline) should be performed and the individual dose of the agent adjusted as needed.
Croatian: Nakon uvođenja ili ukidanja metreleptina, u bolesnika koji se liječe ovom vrstom lijekova potrebno je provoditi terapijsko praćenje učinka (npr. Za varfarin) ili koncentracije lijeka (npr. Za ciklosporin ili teofilin) i po potrebi prilagoditi individualnu dozu lijeka.
English: Neutralising antibodies
Croatian: Neutralizirajuća protutijela
English: What you need to know before you use Myalepta 3.
Croatian: Što morate znati prije nego počnete primjenjivati lijek Myalepta
English: In the generalised LD group, mean decreases from baseline in HbA1c were noted in all age groups ≥ 6 years; the mean decreases to Month 12/last observation carried forward LOCF were similar in the two older age groups (-1.1% and -2.6%).
Croatian: U skupini s generaliziranim LD-om srednje vrijednosti smanjenja HbA1c u odnosu na početnu vrijednost zabilježene su u svim dobnim skupinama od ≥ 6 godina; srednje vrijednosti smanjenja do 12. mjeseca/zadnje obavljeno opažanje (LOCF) bile su slične u dvije starije dobne skupine (-1,1% i -2,6%).