FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and supportive treatment initiated.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike pozorno spremljati glede znakov ali simptomov neželenih učinkov ter uvesti podporno zdravljenje.
English: The injection should be administered at the same time every day.
Slovenian: Zdravilo je treba injicirati vsak dan ob isti uri.
English: Using the glass vial or plastic ampoule
Slovenian: Uporaba steklene viale ali plastične ampule
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
Slovenian: • s potrjeno prirojeno generalizirano lipodistrofijo (LD) (Berardinelli-Seipov sindrom) ali pridobljeno generalizirano LD (Lawrenceov sindrom) pri odraslih in otrocih, starih 2 leti ali več;
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Myalepta , pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
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.
Slovenian: Ta kartica vsebuje tudi slike brizg ustreznih velikosti, na katerih lahko zdravnik nariše črto, ki označuje prostornino vode za injiciranje, ki je potrebna za rekonstitucijo, in prostornino rekonstituirane raztopine, ki jo je treba injicirati.
English: Two-year carcinogenicity studies in rodents have not been conducted.
Slovenian: Dvoletnih študije kancerogenosti pri glodavcih niso izvedli.
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.
Slovenian: Največji toleriran odmerek je lahko manjši od največjega dnevnega odmerka, navedenega v Preglednica 1, če prihaja do prekomerne izgube telesne teže, četudi metabolni odziv ni popoln.
English: • Metreleptin is similar to a human hormone called leptin.
Slovenian: • Metreleptin je podoben humanemu hormonu leptinu.
English: Based on clinical response (e.g. inadequate metabolic control) or other consideration (e.g. tolerability issues, excessive weight loss especially in paediatric patients), the dose may be decreased, or increased to the maximum dose listed in Table 1.
Slovenian: Na osnovi kliničnega odziva (npr. neustrezen nadzor presnove) ali drugih dejavnikov (npr. težave z intoleranco, prekomerna izguba telesne mase, predvsem pri pediatričnih bolnikih) je mogoče odmerek zmanjšati ali povečati do največjega odmerka, navedenega v Preglednica 1.
English: For instructions on administration, see section 4.2.
Slovenian: Za navodila o dajanju zdravila glejte poglavje 4.2.
English: • medicines for sleep or anxiety called ‘benzodiazepines'
Slovenian: • zdravila za spanje ali proti anksioznosti, imenovana "benzodiazepini".
English: Talk to a doctor straight away if you notice any allergic reactions, including:
Slovenian: Takoj se posvetujte z zdravnikom, če opazite katere koli alergijske reakcije, vključno z naslednjimi:
English: In clinical trials, antidrug antibodies (ADA) to metreleptin occurred very commonly (88%) in patients.
Slovenian: V kliničnih študijah so se protitelesa proti zdravilu (ADA - antidrug antibodies) na metreleptin pri bolnikih pojavila zelo pogosto (88 %).
English: The glass ampoule is a sealed container.
Slovenian: Steklena ampula je zatesnjen vsebnik.
English: Prior to launch of Myalepta in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Myalepta na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in drugimi vidiki programa.
English: - HCPs should provide training to patients on the correct technique.
Slovenian: - Zdravstveni delavci morajo bolnike usposobiti za uporabo pravilne tehnike.
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.
Slovenian: • s potrjeno familiarno parcialno LD ali pridobljeno parcialno LD (Barraquer-Simonsov sindrom)pri odraslih in otrocih, starih 12 let ali več, za katere standardno zdravljenje ni doseglo zadostne urejenosti presnove.
English: You and your doctor will decide whether or not to continue breast-feeding while using this medicine.
Slovenian: Skupaj z zdravnikom se boste odločili, ali boste med jemanjem tega zdravila nadaljevali z dojenjem ali ne.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Increasing abnormalities of TG and HbA1c may be seen which may require a dose increase.
Slovenian: Zaradi morebitnih opaženih nepravilnosti v TG in HBA1c bo morda treba povečati odmerek.
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.
Slovenian: Če po 6 mesecih zdravljenja klinični odziv ni opazen, se mora zdravnik prepričati, ali bolnik pravilno izvaja tehniko injiciranja in ali prejema pravilni odmerek ter upošteva dieto.
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.
Slovenian: Če opazite katere od simptomov, navedene zgoraj ali opisane v nadaljevanju v 4. poglavju tega navodila, oz. niste prepričani, se takoj posvetujte z zdravnikom.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Myalepta trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo to zdravilo uporabljali, prejeli naslednji paket izobraževalnih gradiv:
English: • who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy)
Slovenian: • s parcialno lipodistrofijo, ki je podedovana (imenovana tudi prirojena ali družinska lipodistrofija);
English: ● Fasting TG concentration > 2.26 mmol/L or postprandially elevated triglycerides
Slovenian: ● koncentracija TG na tešče > 2,26 mmol/L ali povišana raven trigliceridov po jedi
English: • your body producing antibodies to metreleptin which may increase the risk of developing serious or severe infections.
Slovenian: • vaše telo proizvaja protitelesa na metreleptin, zaradi česar lahko obstaja povečano tveganje pojava resnih ali hudih okužb.
English: In partial LD patients, assessment across age groups is limited, due to the small sample size.
Slovenian: Pri bolnikih s parcialno LD je zaradi majhne velikosti vzorca ocena po starostnih skupinah omejena.
English: • Do not touch the exposed needle on your syringe as it is sterile, and you may damage the needle or injure yourself.
Slovenian: • Ne dotikajte izpostavljene igle na vaši brizgi, ker je sterilna in lahko poškodujete iglo ali se poškodujete.
English: It is recommended that patients should use a different injection site each day when injecting in the same region.
Slovenian: Priporočeno je, da si bolnik vsak dan zdravilo injicira na drugo mesto, kadar si ga injicira na isti predel.
English: Partial LD subgroup
Slovenian: Podskupina s parcialno LD
English: Hence, the pharmacokinetics may be altered in patients with renal impairment.
Slovenian: Zato je lahko farmakokinetika pri bolnikih z okvaro ledvic spremenjena.
English: 30 vials
Slovenian: 30 vial
English: In order to ensure patients and carers understand the correct dose to be injected, the prescriber should prescribe the appropriate dose both in milligrams and the volume in millilitres.
Slovenian: Da bi bolniki in negovalci razumeli pravilni odmerek za injiciranje, mora zdravnik, ki zdravilo predpiše, določiti ustrezen odmerek tako v miligramih kot tudi v mililitrih.
English: - Access to further materials, including training videos in multiple languages that will demonstrate each step to in preparing and administering Myalepta via a website.
Slovenian: - Dostop do dodatnega gradiva preko spletne strani, vključno z videoposnetki za usposabljanje v več jezikih, ki prikazujejo pripravo in dajanja zdravila Myalepta po korakih.
English: Most events occurred during the initial 1-2 months of initiation of treatment.
Slovenian: 1-2 mesecih po začetku zdravljenja.
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).
Slovenian: • Kartico za odmerjanje, na katero zdravnik bolniku napiše odmerek v mg, ml (in po potrebi v enotah na 0,3 ml-insulinski brizgi U100).
English: For signs of low blood sugar levels, see section 4 under ‘Signs of high and low blood sugar'.
Slovenian: Za znake nizkih ravni krvnega sladkorja glejte 4. poglavje pod "Znaki za visok in nizek krvni sladkor".
English: Consideration should also be given by the prescriber to have patients tested for the presence of neutralising antibodies.
Slovenian: Zdravnik naj tudi presodi, ali naj bolniki opravijo test za prisotnost nevtralizirajočih protiteles.
English: • If there is medicine left in the syringe, you have not had your full dose.
Slovenian: • Če vam v brizgi ostane zdravilo, niste prejeli celotnega odmerka.
English: ● stomach area (abdomen), except for a 5 cm area directly around the belly button
Slovenian: • območje trebuha, razen v predelu 5 cm neposredno okrog popka;
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.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo nobenih dodatnih tveganj poleg tistih zaradi prekomernega pričakovanega farmakodinamičnega odziva, kot sta izguba teka in telesne teže.
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.
Slovenian: Če bolnik zboli za pankreatitisom med jemanjem metreleptina, se priporoča, da metreleptin uporablja še naprej, saj bi nenadna prekinitev zdravljenja lahko stanje še poslabšala.
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.
Slovenian: Za nadaljnjo oceno dolgoročne varnosti in učinkovitosti zdravila Myalepta pod običajnimi pogoji klinične prakse mora predlagatelj vzpostaviti register, ki bo vključeval vse bolnike z generalizirano ali parcialno lipodistrofijo, zdravljeno z zdravilom Myalepta, v skladu z dogovorjenim protokolom.
English: Low blood sugar with insulin or other anti-diabetic medicines
Slovenian: Nizek krvni sladkor z insulinom ali drugimi zdravili za sladkorno bolezen
English: An association between the development of a blocking activity against metreleptin and serious and severe infections cannot be excluded (see section 4.8).
Slovenian: Povezave med nastankom zaviralne aktivnosti proti metreleptinu ter resnimi in hudimi okužbami ni mogoče izključiti (glejte poglavje 4.8).
English: The recommended daily dose of metreleptin is based on body weight as provided in Table 1.
Slovenian: Priporočen dnevni odmerek metreleptina je odvisen od telesne mase, kot je določeno v preglednici 1.
English: • statins for reducing cholesterol (such as atorvastatin)
Slovenian: • statini za zniževanje holesterola (kot je atorvastatin);
English: Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders.
Slovenian: Zdravljenje mora predpisati in spremljati usposobljen zdravstveni delavec, ki ima izkušnje z diagnosticiranjem in zdravljenjem presnovnih motenj.
English: It is not known if metreleptin will pass into breast milk.
Slovenian: Ni namreč znano, ali metreleptin prehaja v materino mleko.
English: Patients and carers should be advised to be aware of the signs and symptoms of hypoglycaemia.
Slovenian: Bolnike in skrbnike je treba opomniti, da morajo biti pozorni na znake in simptome hipoglikemije.
English: If you are not sure how much of the solution to inject, talk to your doctor or pharmacist before injecting.
Slovenian: Če niste prepričani, koliko raztopine injicirati, se pred injiciranjem posvetujte z zdravnikom ali farmacevtom.
English: • If you inject other medicines, do not inject Myalepta in the same site as you have done for those other medicines.
Slovenian: • Pri injiciranju drugih zdravil pazite, da zdravila Myalepta ne injicirate na isto mesto kot ostala zdravila.
English: • sharps disposal container (to safely dispose of the injection equipment afterwards)
Slovenian: • vsebnik za odstranjevanje ostrih predmetov (za varno odstranjevanje opreme za injekcije po injiciranju).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, amino acids and derivatives, ATC code: A16AA07
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, aminokisline in njihovi derivati, oznaka ATC: A16AA07
English: To remove the water for injection, break open the ampoule at the break-point as shown in the picture above.
Slovenian: Da odstranite vodo za injekcije, odlomite vrh ampule na prelomni točki, kot je prikazano na zgornji sliki.
English: • Do not touch the area you have cleaned until you are injecting Myalepta.
Slovenian: • Ne dotikajte se očiščenega mesta, dokler ne injicirate zdravila Myalepta.
English: Step E: Choose and preparing where to inject
Slovenian: Korak E: Izbor in priprava mesta injiciranja
English: 21) If the syringe contains your correct dose amount of Myalepta solution, remove the needle from the vial.
Slovenian: 21) Če brizga vsebuje pravilno količino odmerka zdravila Myalepta, lahko odstranite iglo iz viale.
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).
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6 in informacije za bolnike v priloženih navodilih v priročniku za uporabo (7. poglavje).
English: In order to address the potential safety concerns and/or lack of efficacy related to immunogenicity of Myalepta, the applicant should submit an integrated analysis of immunogenicity measured according to validated assays.
Slovenian: Da bi upošteval potencialne varnostne zadržke in/ali pomanjkanje učinkovitosti v zvezi z imunogenostjo zdravila Myalepta, mora predlagatelj predložiti integrirano analizo imunogenosti, merjeno v skladu z validiranimi določitvami vsebnosti.
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.
Slovenian: Večja izpostavljenost metreleptinu in daljši t1/2, opažena pri brejih živalih, sta lahko povezana z zmanjšano sposobnostjo izločanja zaradi vezave na topnimi leptinskimi receptorji, ki so bili pri brejih miših prisotni v višjih ravneh.
English: This is to prevent your blood sugar from getting too low (‘hypo-glycaemia').
Slovenian: Tako namreč prepreči, da bi bil vaš krvni sladkor prenizek ("hipoglikemija").
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).
Slovenian: • Kako povezati iglo na brizgo je odvisno od tega, ali ste vodo za injekcije prejeli v plastični ampuli, stekleni ampuli ali stekleni viali (glejte specifična navodila spodaj).
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE ZA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: • a plastic ampoule
Slovenian: • plastični ampuli
English: Metreleptin mimics the physiological effects of leptin by binding to and activating the human leptin receptor, which belongs to the Class I cytokine family of receptors that signals through the JAK/STAT transduction pathway.
Slovenian: Metreleptin oponaša fiziološke učinke leptina, tako da se veže in aktivira receptor humanega leptina, ki pripada skupini citokinskih receptorjev I. razreda, kjer signalizacija poteka po transdukcijski poti JAK/STAT.
English: • you have ever had a type of cancer called lymphoma
Slovenian: • če ste že kdaj imeli raka, ki se imenuje limfom;
English: If metreleptin must be stopped for any reason, tapering of the dose over a two-week period is recommended in conjunction with a low fat diet, see section 4.2.
Slovenian: Če je treba iz kakršnega koli razloga prekiniti z uporabo metreleptina, se priporoča postopno zmanjšanje odmerka v obdobju dveh tednov, hkrati z dieto z nizko vsebnostjo maščob; glejte poglavje 4.2.
English: Reproductive toxicity studies have not included toxicokinetics analysis.
Slovenian: Študije vpliva na sposobnost razmnoževanja niso vključevale analize toksikokinetike.
English: In generalised LD patients, the overall incidence of adverse reactions was similar regardless of age.
Slovenian: Pri bolnikih z generalizirano LD je bila pogostost pojava neželenih učinkov podobna ne glede na starost.
English: Table 2 Dose calculation Weight and gender Starting dose calculation
Slovenian: Preglednica 2 Izračun odmerka Telesna masa in spol Izračun začetnega odmerka
English: Contents of the pack and other information What Myalepta contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Myalepta
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.
Slovenian: Mehanizem za pankreatitis pri teh bolnikih je domnevno povratek hipertrigliceridemije in posledično povečano tveganje za pankreatitis ob prekinitvi učinkovite terapije za hipertrigliceridemijo.
English: Serious adverse reactions were reported in 2 patients, worsening hypertension and anaplastic large cell lymphoma.
Slovenian: Resni neželeni učinki so bili poročani pri 2 bolnikih in sicer poslabšanje hipertenzije in anaplastični velikocelični limfom.
English: Following single subcutaneous doses of 0.01 to 0.3 mg/kg metreleptin in healthy adult subjects, the half-life was 3.8 to 4.7 hours.
Slovenian: Po enkratnih subkutanih odmerkih 0,01 do 0,3 mg/kg metreleptina pri zdravih odraslih osebah je bil razpolovni čas 3,8 do 4,7 ur.
English: Two of these patients were diagnosed with peripheral T-cell lymphoma while receiving the medicinal product.
Slovenian: Dva od teh bolnikov sta med prejemanjem zdravila dobila diagnozo perifernega T-celičnega limfoma.
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.
Slovenian: o Če je vaš odmerek večji kot 5 mg, vam bo zdravnik, medicinska sestra ali farmacevt morda naročil, da si ga dajte v dveh ločenih injekcijah.
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.
Slovenian: Eno resno in hudo vnetje slepiča je bilo časovno povezano z aktivnostjo blokiranja metreleptina pri bolniku s parcialno LD, ki pa ni bil v podskupini bolnikov s parcialno LD.
English: Non-clinical data indicate renal clearance is the major route of metreleptin elimination, with no apparent contribution of systemic metabolism or degradation.
Slovenian: Neklinični podatki kažejo, da je ledvični očistek glavna pot za izločanje metreleptina, pri čemer ni očitnih pokazateljev, da bi k izločanju prispeval tudi sistemski metabolizem ali razkroj.
English: 29) Throw away the two used syringes and all caps, vials, or ampoules in the sharps disposal container straight away.
Slovenian: 29) Rabljeni brizgi in vse pokrovčke, viale ali ampule takoj odstranite v vsebnik za odstre predmete.
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.
Slovenian: Ko so predpisani majhni odmerki/volumni (npr. pri otrocih), bodo po odvzemu potrebnega odmerka viale ostale skoraj popolnoma napolnjene z zdravilom.
English: However, no developmental abnormalities were observed and reproductive performance of the first or second generations was not affected at any dose.
Slovenian: Kljub temu pa niso bile opažene razvojne napake, prav tako pa noben odmerek ni vplival na razmnoževalno sposobnost prve ali druge generacije.
English: Dose adjustments should be made based on clinical response (see section 4.4).
Slovenian: V tem primeru so potrebne prilagoditve odmerka glede na klinični odziv (glejte poglavje 4.4).
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.
Slovenian: Med študijo niso konstantno izvajali hkratnih režimov odmerjanja zdravil za sladkorno bolezen in zniževanje lipidov, vendar študije niso pokazale znatne razlike v učinkovitosti pri bolnikih, katerim odmerkov zdravil za sladkorno bolezen ali zniževanje lipidov niso povečevali ali jih dodajali, v primerjavi s splošno populacijo v študiji.
English: Metreleptin works by copying the effects of leptin.
Slovenian: Metreleptin deluje tako, da posnema učinke leptina.
English: A causal relationship between the medicinal product treatment and the development and/or progression of lymphoma has not been established.
Slovenian: Povezanost med zdravljenjem z zdravilom in nastankom in/ali napredovanjem limfoma ni bila dokazana.
English: All events reported in clinical studies in patients with LD have been mild or moderate in severity and none have led to treatment discontinuation.
Slovenian: Vsi dogodki, poročani v kliničnih študijah pri bolnikih z LD, so bili blagi ali zmerni, in v nobenem primeru zdravljenja ni bilo treba prekiniti.
English: • Talk to your doctor, nurse or pharmacist about correct disposal of your sharps disposal container once it becomes full.
Slovenian: • Z zdravnikom, medicinsko sestro ali farmacevtom se posvetujte o pravilnem odstranjevanju vsebnika za ostre predmete, ko se ta napolni.