natgillin/translations-raw huggingface dataset:
• Do not touch the exposed needle on your syringe as it is sterile, and you may damage the needle or injure yourself.
• Ne dotikajte izpostavljene igle na vaši brizgi, ker je sterilna in lahko poškodujete iglo ali se poškodujete.
It is recommended that patients should use a different injection site each day when injecting in the same region.
Priporočeno je, da si bolnik vsak dan zdravilo injicira na drugo mesto, kadar si ga injicira na isti predel.
Partial LD subgroup
Podskupina s parcialno LD
Hence, the pharmacokinetics may be altered in patients with renal impairment.
Zato je lahko farmakokinetika pri bolnikih z okvaro ledvic spremenjena.
30 vials
30 vial
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.
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.
- Access to further materials, including training videos in multiple languages that will demonstrate each step to in preparing and administering Myalepta via a website.
- Dostop do dodatnega gradiva preko spletne strani, vključno z videoposnetki za usposabljanje v več jezikih, ki prikazujejo pripravo in dajanja zdravila Myalepta po korakih.
Most events occurred during the initial 1-2 months of initiation of treatment.
1-2 mesecih po začetku zdravljenja.
• 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).
• Kartico za odmerjanje, na katero zdravnik bolniku napiše odmerek v mg, ml (in po potrebi v enotah na 0,3 ml-insulinski brizgi U100).
For signs of low blood sugar levels, see section 4 under ‘Signs of high and low blood sugar'.
Za znake nizkih ravni krvnega sladkorja glejte 4. poglavje pod "Znaki za visok in nizek krvni sladkor".
Consideration should also be given by the prescriber to have patients tested for the presence of neutralising antibodies.
Zdravnik naj tudi presodi, ali naj bolniki opravijo test za prisotnost nevtralizirajočih protiteles.
• If there is medicine left in the syringe, you have not had your full dose.
• Če vam v brizgi ostane zdravilo, niste prejeli celotnega odmerka.
● stomach area (abdomen), except for a 5 cm area directly around the belly button
• območje trebuha, razen v predelu 5 cm neposredno okrog popka;
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.
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.
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.
Če bolnik zboli za pankreatitisom med jemanjem metreleptina, se priporoča, da metreleptin uporablja še naprej, saj bi nenadna prekinitev zdravljenja lahko stanje še poslabšala.
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.
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.
Low blood sugar with insulin or other anti-diabetic medicines
Nizek krvni sladkor z insulinom ali drugimi zdravili za sladkorno bolezen
An association between the development of a blocking activity against metreleptin and serious and severe infections cannot be excluded (see section 4.8).
Povezave med nastankom zaviralne aktivnosti proti metreleptinu ter resnimi in hudimi okužbami ni mogoče izključiti (glejte poglavje 4.8).
The recommended daily dose of metreleptin is based on body weight as provided in Table 1.
Priporočen dnevni odmerek metreleptina je odvisen od telesne mase, kot je določeno v preglednici 1.
• statins for reducing cholesterol (such as atorvastatin)
• statini za zniževanje holesterola (kot je atorvastatin);
Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders.
Zdravljenje mora predpisati in spremljati usposobljen zdravstveni delavec, ki ima izkušnje z diagnosticiranjem in zdravljenjem presnovnih motenj.
It is not known if metreleptin will pass into breast milk.
Ni namreč znano, ali metreleptin prehaja v materino mleko.
Patients and carers should be advised to be aware of the signs and symptoms of hypoglycaemia.
Bolnike in skrbnike je treba opomniti, da morajo biti pozorni na znake in simptome hipoglikemije.
If you are not sure how much of the solution to inject, talk to your doctor or pharmacist before injecting.
Če niste prepričani, koliko raztopine injicirati, se pred injiciranjem posvetujte z zdravnikom ali farmacevtom.
• If you inject other medicines, do not inject Myalepta in the same site as you have done for those other medicines.
• Pri injiciranju drugih zdravil pazite, da zdravila Myalepta ne injicirate na isto mesto kot ostala zdravila.
• sharps disposal container (to safely dispose of the injection equipment afterwards)
• vsebnik za odstranjevanje ostrih predmetov (za varno odstranjevanje opreme za injekcije po injiciranju).
Pharmacotherapeutic group: Other alimentary tract and metabolism products, amino acids and derivatives, ATC code: A16AA07
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, aminokisline in njihovi derivati, oznaka ATC: A16AA07
To remove the water for injection, break open the ampoule at the break-point as shown in the picture above.
Da odstranite vodo za injekcije, odlomite vrh ampule na prelomni točki, kot je prikazano na zgornji sliki.
• Do not touch the area you have cleaned until you are injecting Myalepta.
• Ne dotikajte se očiščenega mesta, dokler ne injicirate zdravila Myalepta.
Step E: Choose and preparing where to inject
Korak E: Izbor in priprava mesta injiciranja
21) If the syringe contains your correct dose amount of Myalepta solution, remove the needle from the vial.
21) Če brizga vsebuje pravilno količino odmerka zdravila Myalepta, lahko odstranite iglo iz viale.
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).
Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6 in informacije za bolnike v priloženih navodilih v priročniku za uporabo (7. poglavje).
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.
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.
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.
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.
This is to prevent your blood sugar from getting too low (‘hypo-glycaemia').
Tako namreč prepreči, da bi bil vaš krvni sladkor prenizek ("hipoglikemija").
• 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).
• 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).
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI POGOJI IN ZAHTEVE ZA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• a plastic ampoule
• plastični ampuli
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.
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.
• you have ever had a type of cancer called lymphoma
• če ste že kdaj imeli raka, ki se imenuje limfom;
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.
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.
Reproductive toxicity studies have not included toxicokinetics analysis.
Študije vpliva na sposobnost razmnoževanja niso vključevale analize toksikokinetike.
In generalised LD patients, the overall incidence of adverse reactions was similar regardless of age.
Pri bolnikih z generalizirano LD je bila pogostost pojava neželenih učinkov podobna ne glede na starost.
Table 2 Dose calculation Weight and gender Starting dose calculation
Preglednica 2 Izračun odmerka Telesna masa in spol Izračun začetnega odmerka
Contents of the pack and other information What Myalepta contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Myalepta
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.
Mehanizem za pankreatitis pri teh bolnikih je domnevno povratek hipertrigliceridemije in posledično povečano tveganje za pankreatitis ob prekinitvi učinkovite terapije za hipertrigliceridemijo.
Serious adverse reactions were reported in 2 patients, worsening hypertension and anaplastic large cell lymphoma.
Resni neželeni učinki so bili poročani pri 2 bolnikih in sicer poslabšanje hipertenzije in anaplastični velikocelični limfom.
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.
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.
Two of these patients were diagnosed with peripheral T-cell lymphoma while receiving the medicinal product.
Dva od teh bolnikov sta med prejemanjem zdravila dobila diagnozo perifernega T-celičnega limfoma.
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.
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.
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.
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.
Non-clinical data indicate renal clearance is the major route of metreleptin elimination, with no apparent contribution of systemic metabolism or degradation.
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.
29) Throw away the two used syringes and all caps, vials, or ampoules in the sharps disposal container straight away.
29) Rabljeni brizgi in vse pokrovčke, viale ali ampule takoj odstranite v vsebnik za odstre predmete.
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.
Ko so predpisani majhni odmerki/volumni (npr. pri otrocih), bodo po odvzemu potrebnega odmerka viale ostale skoraj popolnoma napolnjene z zdravilom.
However, no developmental abnormalities were observed and reproductive performance of the first or second generations was not affected at any dose.
Kljub temu pa niso bile opažene razvojne napake, prav tako pa noben odmerek ni vplival na razmnoževalno sposobnost prve ali druge generacije.
Dose adjustments should be made based on clinical response (see section 4.4).
V tem primeru so potrebne prilagoditve odmerka glede na klinični odziv (glejte poglavje 4.4).
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.
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.
Metreleptin works by copying the effects of leptin.
Metreleptin deluje tako, da posnema učinke leptina.
A causal relationship between the medicinal product treatment and the development and/or progression of lymphoma has not been established.
Povezanost med zdravljenjem z zdravilom in nastankom in/ali napredovanjem limfoma ni bila dokazana.
All events reported in clinical studies in patients with LD have been mild or moderate in severity and none have led to treatment discontinuation.
Vsi dogodki, poročani v kliničnih študijah pri bolnikih z LD, so bili blagi ali zmerni, in v nobenem primeru zdravljenja ni bilo treba prekiniti.
• Talk to your doctor, nurse or pharmacist about correct disposal of your sharps disposal container once it becomes full.
• Z zdravnikom, medicinsko sestro ali farmacevtom se posvetujte o pravilnem odstranjevanju vsebnika za ostre predmete, ko se ta napolni.
Metreleptin exhibits no genotoxic potential and no proliferative or preneoplastic lesions were observed in mice or dogs following treatment up to 6 months.
Metreleptin nima genotoksičnega potenciala, pri miših ali psih pa se po njegovem dajanju v trajanju do 6 mesecev niso pojavile proliferativne ali preneoplastične lezije.
• pain in the chest or back
• bolečina v prsnem košu ali hrbtu
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).
Aktivnost zaviranja reakcije med metreleptinom in receptorjem za rekombinantni leptin je bila ugotovljena in vitro v krvi večine bolnikov, vendar vpliva na učinkovitost metreleptina ni bilo mogoče jasno določiti (glejte poglavje 4.8).
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.
Predlagatelj mora to integrirano analizo izvesti v skladu z dogovorjenim protokolom, vključno z vzorci iz vseh razpoložljivih zgodovinskih vzorcev iz prejšnjih študij (NIH991265/20010769, FHA 101, NASH4 in študije debelosti) z bolniki z generalizirano/parcialno LD in vzorci, dobljenimi od bolnikov, ki bodo vključeni v študijo o učinkovitosti in varnosti pri bolnikih s parcialno LD, študijo iz načrta pediatričnih raziskav (PIP) in iz registra bolnikov.
• feeling more irritable or more nervous
• večja razdražljivost ali živčnost
Myalepta can affect the way some other medicines work.
Zdravilo Myalepta lahko vpliva na način delovanja drugih zdravil.
However, separate studies revealed that exposure of the mouse foetus to metreleptin was low (< 1%) after subcutaneous administration of metreleptin to pregnant mice.
Vendar pa so ločene študije pokazale, da je bila izpostavljenost mišjega ploda metreleptinu po subkutanem dajanju metreleptina breji miši nizka (< 1 %).
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%).
Te razlike med starostnimi skupinami so najverjetneje povezane z razlikami v povprečni izhodiščni ravni HbA1c, ki je bila pri bolnikih < 6 let v normalnem razponu (5,7 %) in pri bolnikih ≤ 6 do < 12 let (6,4 %) nižja v primerjavi s starejšo starostno skupino (9,7 %).
• The water for injection should go down the inside wall of the vial.
• Voda za injekcije bi morala steči po steni viale.
• Do not recycle the syringes, caps, or sharps disposal container, or throw them into household waste.
• Brizg, zapork ali vsebnika za ostre predmete ne reciklirajte ali jih mečite v gospodinjske odpadke.
Contact them if you are unclear about anything or if you need more information or help.
Če ste glede česar koli negotovi ali potrebujete več informacij ali pomoč, se obrnite nanje.
See section 3 “How much to inject” for more information.
Za več informacij glejte 3. poglavje "Koliko injicirati".
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”.
Znaki visokih ravni krvnega sladkorja in maščob so navedeni v 4. poglavju pod "Znaki za visok in nizek krvni sladkor" in "Znaki visokih ravni maščob v krvi".
● Actual change from baseline in HbA1c at Month 12, and
● dejanska sprememba v ravni HbA1c v 12. mesecu glede na izhodišče in
The median duration of metreleptin treatment was 4.2 years (range: 3.4 months-13.8 years).
Povprečno trajanje zdravljenja z metreleptinom je bilo 4,2 leti (razpon: 3,4 mesecev-13,8 let).
Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
Zdravilo Myalepta je indicirano kot dodatek prehrani kot nadomestna terapija za zdravljenje zapletov zaradi pomanjkanja leptina pri bolnikih s lipodistrofijo (LD):
In a pre- and postnatal development study in mice, metreleptin caused prolonged gestation and dystocia at all tested doses, starting at, approximately, a dose identical to the maximum recommended clinical dose, based on body surface area of a 60 kg patient.
V študiji pre- in ponatalnega razvoja pri miših je metreleptin povzročil daljšo gestacijo in distocijo pri vseh preizkušenih odmerkih, začenši s približno odmerkom, identičnim največjemu priporočenemu kliničnemu odmerku na osnovi telesne površine 60 kg težkega bolnika.
Do not give this medicine to children below the age of 2 years with generalised lipodystrophy, or below the age of 12 years with partial lipodystrophy.
Tega zdravila ne dajajte otrokom, mlajšim od 2 let, z generalizirano lipodistrofijo ali mlajšim od 12 let s parcialno lipodistrofijo.
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.
V podporni študiji pri bolnikih z LD je bil povprečni Tmax 4 ure (razpon: 2 do 6 ur; N=5) po enkratnem odmerku metreleptina.
Myalepta has minor influence on the ability to drive and use machines due to fatigue and dizziness.
Zdravilo Myalepta ima blag vpliv na sposobnost vožnje in upravljanja strojev zaradi utrujenosti in omotice.
The median fasting leptin concentration at baseline was 5.9 ng/mL (1.6-16.9) using the LINCO RIA test method.
Povprečna koncentracija leptina na tešče je bila ob izhodišču 5,9 ng/ml (1,6-16,9), določena je bila z uporabo testne metode LINCO RIA.
What you need to know before you use Myalepta Do not use Myalepta if:
Kaj morate vedeti, preden boste uporabili zdravilo Myalepta Ne uporabljajte zdravila Myalepta :
Healthcare professionals' educational material should contain:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati:
Not known (frequency cannot be estimated from the available data):
Morda boste opazili, da imate povišano temperaturo in ste vedno več utrujeni Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
Endogenous leptin is present in human milk.
V materinem mleku je prisoten endogeni leptin.
Women of childbearing potential should be advised that Myalepta may increase fertility and should be encouraged to use contraception.
Ženske v rodni dobi je treba obvestiti, da zdravilo Myalepta lahko poveča plodnost, zato naj uporabljajo kontracepcijo.
Animal studies showed no adverse effects on male or female fertility (see section 5.3).
Študije na živalih niso pokazale neželenih učinkov na plodnost pri samcih ali samicah (glejte poglavje 5.3).
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.
Zdravstveni delavci morajo bolnike in negovalce ustrezno poučiti o rekonstituciji zdravila in pravilni tehniki subkutanega injiciranja, da se pri bolnikih z minimalnim subkutanim adipoznim tkivom prepreči injiciranje v mišico.
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.
Bolnik bo prav tako posebej prejel topilo za rekonstitucijo (t. j. voda za injekcije), brizge/igle za rekonstitucijo, brizge/igle za dajanje zdravila, čistilne alkoholne krpice in vsebnik za odstranjevanje ostrih predmetov.
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).
Obstajajo podatki, ki kažejo, da lahko metreleptin poveča plodnost zaradi učinka na LH, zaradi česar obstaja možnost nenačrtovane nosečnosti (glejte poglavje 4.4).
The median duration of metreleptin treatment was 2.4 years (range: 6.7 months-14.0 years).
Povprečno trajanje zdravljenja z metreleptinom je bilo 2,4 leti (razpon: 6,7 mesecev-14,0 let).
No studies with direct administration of metreleptin to juvenile animals have been conducted.
Študije z neposrednim dajanjem metreleptina mladičem živali niso bile izvedene.
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.
Skupno 8 (24 %) od 34 bolnikov z generalizirano LD, ki je ob izhodišču prejemalo zdravila za znižanje lipidov, je z njimi med zdravljenjem z metreleptinom prenehalo.