natgillin/translations-raw huggingface dataset:
• feeling more sleepy 
• občutek večje zaspanosti
Initiating or adjusting lipid lowering medications may be required. 
Po potrebi je treba uvesti ali prilagoditi odmerek zdravila za zniževanje ravni lipidov.
For the 18 patients with baseline body weight less than or equal to 40 kg, the weighted average daily dose was 2.0 mg for males and 2.3 mg for females in the first year of treatment, and 2.5 mg for males and 3.2 mg for females over the entire study period. 
Pri 18 bolnikih z izhodiščno telesno težo manjšo ali enako 40 kg je bil utežen povprečni dnevni odmerek 2,0 mg za moške in 2,3 mg za ženske v prvem letu zdravljenja ter 2,5 mg za moške in 3,2 mg za ženske za celotno obdobje študije.
The reconstituted solution should be injected into the abdomen, thigh or upper arm tissue. 
Rekonstituirano raztopino je treba injicirati v tkivo na trebuhu, stegnu ali nadlahti.
Change from Baseline at Month 12 
Spremembe od osnove po 12 mesecih
This is the same as 0.05 mL. 
To je enako 0,05 ml.
Table 3 Required syringe for Myalepta reconstitution with water for injection Syringe 
Preglednica 3 Potrebna brizga za rekonstitucijo zdravila Myalepta z vodo za injekcije Brizga
Unused reconstituted solution should be discarded after use. 
Neporabljeno rekonstituirano raztopino je treba po uporabi zavreči.
If you use more Myalepta than you should, talk to your doctor or go to a hospital straight away. 
Če ste uporabili večji odmerek zdravila Myalepta, kot bi smeli Če ste vzeli večji odmerek zdravila Myalepta, kot bi smeli, se posvetujte s svojim zdravnikom ali pa takoj pojdite v bolnišnico.
o Responsibility of the prescribing physician to provide appropriate training to the patient/carer who will administer the treatment and that the first dose should be administered in the presence of a doctor or nurse. 
o Zdravnik, ki predpiše zdravilo Myalepta, je odgovoren za ustrezno usposabljanje bolnika/skrbnika, ki bo dajal zdravilo, in za dajanje prvega odmerka v prisotnosti zdravnika ali medicinske sestre.
• Without the needle attached, insert the 3 mL syringe tip into the top of the plastic ampoule as far as possible. 
• Brez pritrjene igle vstavite konico 3-mililitrske brizge čim dlje v vrh plastične ampule.
Remaining solution should be discarded after use. 
Ostanek raztopine je treba po uporabi zavreči.
Using the glass ampoule 
Uporaba steklene ampule
• Do not dissolve another dose of Myalepta powder with any ampoule or vial containing unused remaining water for injection. 
• Ne raztapljajte naslednjega odmerka praška zdravila Myalepta s katero koli ampulo ali vialo, v kateri je še ostanek vode za injekcije.
17) Insert the needle through the centre of the rubber bung, all the way into the vial containing the dissolved Myalepta solution. 
17) Iglo vstavite skozi sredino gumijastega čepa do konca v vialo, ki vsebuje raztopljeno raztopino zdravila Myalepta.
Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation (see section 4.4). 
Ob pojavu znakov in/ali simptomov pankreatitisa je treba izvesti ustrezen klinični pregled (glejte poglavje 4.4).
• Place the vial on a flat, hard surface. 
• Vialo postavite na trdno, ravno površino.
However, you may be at higher risk of getting a lymphoma when using the medicinal product. 
Vendar pa je tveganje, da zbolite za limfomom, večje, če jemljete to zdravilo.
Always use a new ampoule or vial of water for injection. 
uporabite novo ampulo ali vialo vode za injekcije.
• swelling or bleeding under the skin, where you injected 
• otekanje ali krvavitev pod kožo na mestu injiciranja
Myalepta is used to treat the complications of not having enough leptin in patients with lipodystrophy. 
Zdravila Myalepta se uporablja za zdravljenje zapletov, kadar bolniki z lipodistrofijo nimajo dovolj leptina.
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. 
16) Za injekcije raztopine zdravila Myalepta boste uporabili novo brizgo, ki bo ali 0,3-, 1,0- ali 2,5-mililitrska, dobili pa jo boste pri zdravniku, medicinski sestri ali farmacevtu.
With the needle still in the ampoule, pull the plunger up carefully. 
Z iglo še vedno v ampuli previdno povlecite bat navzgor.
The adverse reactions reported in generalised LD and this subgroup of partial LD patients are listed in Table 7. 
Neželeni učinki, poročani pri bolnikih z generalizirano LD in to podskupino s parcialno LD, so našteti v tabeli 7.
No formal metabolism studies have been conducted. 
Formalne študije presnove niso bile izvedene.
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. 
Čeprav vpliv nevtralizirajočih protiteles na učinkovitost ni bil potrjen, naj v primeru znatnega zmanjšanja učinkovitosti kljub uporabi zdravila Myalepta, zdravnik, ki predpiše zdravilo presodi, ali naj bolniki opravijo test za prisotnost nevtralizirajočih protiteles.
Closely monitor blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment. 
Pozorno spremljajte glukozo v krvi pri bolnikih, ki sočasno prejemajo insulin, predvsem pri tistih z visokimi odmerki, ali tistih, ki jemljejo insulinske sekretagoge oz. kombinacijo zdravil.
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. 
Zaviralna aktivnost reakcije med metreleptinom in receptorjem za rekombinantni leptin je bila ugotovljena in vitro v krvi večine bolnikov iz razširjenega nabora (98 od 102 bolnikov ali 96 %),
Excipients: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment) 
Pomožne snovi: glicin, saharoza, polisorbat 20, glutaminska kislina, natrijev hidroksid (za uravnavanje pH)
Cough, Dyspnoea Pleural effusion 
Kašelj, dispneja, plevralni izliv
• 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. 
• Zgornji rob bata se mora poravnati s črno črto na brizgi, ki ustreza količini raztopine zdravila
Unused reconstituted solution cannot be stored for later use. 
Neuporabljene razredčene raztopine ni dovoljeno hraniti za poznejšo uporabo.
6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 1 mL syringe. 
6) Ne glede na to, ali vodo za injekcije uporabljate iz viale ali ampule, morate vedno preveriti, ali imate v svoji 1-mililitrski brizgi zračne mehurčke ali zračne žepe.
o Non-compliance with or abrupt withdrawal of Myalepta may result in worsening of hypertriglyceridaemia and associated pancreatitis: - Risk factors include patients with a history of pancreatitis or severe hypertriglyceridaemia. 
Myalepta lahko povzroči poslabšanje hipertrigliceridemije in povezanega pankreatitisa: - Dejavniki tveganja vključujejo bolnike z anamnezo pankreatitisa ali hude hipertrigliceridemije.
Once insulin requirements have stabilised, dose adjustments of other anti-diabetics may also be needed in some patients to minimise the risk of hypoglycaemia. 
Ko se potrebna količina insulina stabilizira, bo pri nekaterih bolnikih treba prilagoditi tudi druge antidiabetike, da zmanjšate tveganje hipoglikemije.
The safety and efficacy of metreleptin in children aged 0 to 2 years with generalised LD and children aged 0 to 12 years with partial LD has not been established. 
Pediatrična populacija Varnost in učinkovitost metreleptina pri otrocih, starih 0 do 2 leti, z generalizirano LD, in otrocih,
6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 3 mL syringe. 
6) Ne glede na to, ali vodo za injekcije uporabljate iz viale ali ampule, morate vedno preveriti, ali imate v svoji 3-mililitrski brizgi zračne mehurčke ali zračne žepe.
Remove the needle cover. 
Odstranite pokrovček igle.
Myalepta is presented as a powder for solution for injection (powder for injection). 
Zdravilo Myalepta je na voljo kot prašek za raztopino za injiciranje (powder for injection).
In order to further investigate the effect of Myalepta on poor metabolic control once background therapy is maximized in patients with familial or acquired partial LD, the applicant should conduct an efficacy and safety study according to an agreed protocol. 
Myalepta na slabo presnovno urejenost, ko se pri bolnikih s familiarno ali pridobljeno parcialno LD osnovno zdravljenje maksimizira, mora predlagatelj izvesti študijo o učinkovitosti in varnosti v skladu z dogovorjenim protokolom.
Unplanned pregnancies may occur due to restoration of luteinizing hormone (LH) release, see section 
Nosečnost Zaradi obnove sproščanja luteinizirajočega hormona (LH) se lahko pojavi nenačrtovana nosečnost;
Remove the needle and syringe from the vial and gently swirl the contents to reconstitute, until the liquid is clear. 
Izvlecite iglo in brizgo iz viale in nežno vrtinčite vsebino, da se razredči in dobite prozorno tekočino.
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. 
Odmerke, ki presegajo 1 ml, je mogoče injicirati v dveh injekcijah (dnevni odmerek razdelite na enaka odmerka),
Dose adjustments in children without metabolic abnormalities should primarily be made according to weight change. 
Odmerke pri otrocih brez presnovnih nepravilnosti je treba prilagajati glede na spremembo telesne mase.
The Myalepta powder is dissolved by mixing it with water for injections to make the solution for injecting. 
Prašek zdravila Myalepta je treba raztopiti, tako da ga zmešate z vodo za injekcije in dobite raztopino za injiciranje.
• Do not remove the rubber seal. 
• Ne odstranite gumijastega tesnila.
Among 18 patients in the partial LD subgroup who had a baseline HbA1c level 8% or greater and data available at Month 12, the mean (SD) baseline HbA1c level was 9.9% (1.59) and the mean reduction in HbA1c at Month 12 was 1.3%. 
Med 18 bolniki v podskupini s parcialno LD, ki so imeli izhodiščno raven HbA1c 8-odstotno ali več in po 12 mesecih razpoložljive podatke, je bila povprečna (SD) izhodiščna raven HbA1c 9,9 % (1,59), povprečno odstotno zmanjšanje HbA1c po 12 mesecih pa je bilo 1,3-odstotno.
Weight (kg) x 0.02 mg/kg = amount of dose adjustment in mg 
Telesne masa (kg) x 0,02 mg/kg = volumen prilagoditve odmerka v mg
Remaining reconstituted product should be discarded after use. 
Ostanek rekonstituirane raztopine je treba po uporabi zavreči.
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. 
Na osnovi nepopolnega kliničnega odziva po najmanj 6 mesecih zdravljenja lahko poskusimo povečanje odmerkov metreleptina pri odraslih in otrocih, kar omogoča sočasno zniževanje insulina,
• pain below the ribs like heartburn or indigestion 
• bolečina pod rebri, kot zgaga ali slaba prebava
Acute pancreatitis associated with discontinuation of Myalepta 
Akutni pankreatitis zaradi prekinitve jemanja zdravila Myalepta
If you forget to use Myalepta 
Če ste pozabili uporabiti zdravilo Myalepta
Cases of T-cell lymphoma (see section 4.8) have been reported while using Myalepta in clinical studies. 
V kliničnih študijah so bili poročani primeri pojava T-celičnega limfoma (glejte poglavje 4.8) med uporabo zdravila Myalepta.
• Always keep the sharps disposal container out of reach of children. 
• Vsebnik za ostre predmete vedno hranite nedosegljiv otrokom.
• The solution will take less than 5 minutes to become clear. 
• Raztopina bo postala prozorna v manj kot 5 minutah.
• Each 0.05 mL is shown as a medium size line. 
• Vsakih 0,05 ml je prikazanih kot srednje velika črta.
Among the 4 patients in the partial LD subgroup between 12 and 18 years of age, mean change to Month 12/LOCF for HbA1c was -0.7% and for TGs was -55.1%. 
Med 4 bolniki v podskupini s parcialno LD, starimi med 12 in 18 let, je bila povprečna sprememba po 12 mesecih/LOCF v ravni HbA1c -0,7 % in v ravni TG -55,1 %.
• The 1 mL syringe and needle will be provided separately. 
• 1-mililitrska brizga in igla sta dostavljeni ločeno.
Fasting Triglycerides (mmol/L) 27 
Trigliceridi na tešče (mmol/l) 27 Povprečje (SD)
Symptoms of high fat levels include: 
Simptomi visokih ravni maščob v krvi vključujejo:
• Each 5 U is shown as a number with a big line. 
• Vsakih 5 U je prikazanih kot številka z veliko črto.
• This syringe shows the injection amount in mL, so you should inject the amount your doctor, nurse, or pharmacist has told you to. You do not need to convert the amount from mL to Units. 
• Ta brizga prikazuje količino za injiciranje v ml, zato morate injicirati količino, ki vam jo je predpisal zdravnik, medicinska sestra ali farmacevt.
31 gauge 8 mm needle 
premer 31G 8 mm igla
• 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. 
• stekleno vialo s praškom zdravila Myalepta; • vsebnik vode za injekcije, s katero boste raztopili prašek zdravila Myalepta o Voda za injekcije je lahko v steklenih ali plastičnih ampulah ali v steklenih vialah z gumijastim zamaškom.
An association between the development of neutralising antidrug antibodies and serious and severe infections cannot be excluded, and, continuation of Myalepta should be at the discretion of the prescriber. 
Ker oovezave med razvojem nevtralizirajočih protiteles proti zdravilu ter resnimi in hudimi okužbami ni mogoče izključiti, se mora o nadaljevanju zdravljenja z zdravilom Myalepta odločiti zdravnik, ki predpiše zdravilo.
No adverse reactions were reported in paediatric patients in the subgroup of partial LD patients. 
Pri pediatričnih bolnikih v podskupini bolnikov s parcialno LD o neželenih učinkih niso poročali.
Table 7 Adverse reactions reported with Myalepta in > 1 patient during clinical studies in generalised LD and the subgroup of partial LD patients and post-marketing experience System Organ Class 
Preglednica 7 Neželeni učinki, poročani pri zdravljenju z zdravilom Myalepta pri > 1 bolniku med kliničnimi študijami z bolniki z generalizirano LD in podskupino bolnikov s parcialno LD,
Table 9 Primary outcome results in study (NIH 991265/ 20010769) of evaluable patients in the partial LD subgroup treated with metreleptin at 12 months 
Preglednica 9 Primarni rezultati po 12 mesecih študije (NIH 991265/ 20010769) analiziranih bolnikov v podskupini s parcialno LD, zdravljenih z metreleptinom
This is the same as 0.01 mL. 
To je enako 0,01 ml.
Step F: Injecting Myalepta 
Korak F: Injekcije zdravila Myalepta
What Myalepta is and what it is used for 
Kaj je zdravilo Myalepta in za kaj ga uporabljamo
- Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation. 
- Ob pojavu znakov in/ali simptomov pankreatitisa je treba izvesti ustrezno klinično oceno.
Using the 2.5 mL syringe 
Uporaba 2,5-mililitrske brizge
• The vials may remain almost completely filled with product after withdrawal of the required dose. 
• Po odvzemu prepisanega odmerka lahko viale ostanejo skoraj popolnoma napolnjene z zdravilom.
o If your dose is more than 5 mg, you will use a 2.5 mL syringe. 
o Če je vaš odmerek več kot 5 mg, boste uporabili 2,5-mililitrsko brizgo.
• The needle should go all the way into the vial. 
• Iglo je treba vstaviti do konca v vialo.
The glass vial will have a plastic cap that you should remove, revealing a rubber seal below. 
Steklena viala bo imela plastični pokrovček, ki ga je treba odstraniti.
Using the 1 mL syringe 
Uporaba 1-mililitrske brizge
Abdominal pain upper, Diarrhoea, Pancreatitis, Vomiting 
Bolečine v zgornjem delu trebuha, driska, pankreatitis, bruhanje
• You will be given the 2.5 mL syringe to use if your daily dose is more than 5 mg up to 10 mg, which as a volume is greater than 1.0 mL of Myalepta solution. 
• 2,5-mililitrsko brizgo boste prejeli, če je vaš dnevni odmerek več kot 5 mg do 10 mg, kar je v prostornini več kot 1,0 ml raztopine Myalepta.
Step C: Dissolving Myalepta 
Korak C: Raztopitev zdravila Myalepta
Myalepta might increase fertility in women with lipodystrophy (see section “Pregnancy, breast-feeding and fertility”). 
Zdravilo Myalepta lahko poveča plodnost pri ženskah z lipodistrofijo (glejte poglavje "Nosečnost,
Insert the 1 mL syringe into the glass ampoule. 
Vstavite 1-mililitrsko brizgo v stekleno ampulo.
• pain in the chest 
• bolečina v prsnem košu
• sudden severe pain in your stomach (abdomen) 
• nenadna huda bolečina v trebuhu
• The 3 mL syringe and needle will be provided separately. 
• 3-mililitrska brizga in igla sta dostavljeni ločeno.
Step D: Filling the syringe with Myalepta for injection 
Korak D: Polnjenje brizge z zdravilom Myalepta za injekcije
A 4 to 5-fold increase in the t1/2 values was also observed in pregnant mice compared to non-pregnant mice. 
Pri brejih miših je bilo v primerjavi z nebrejimi mišmi prav tako opaziti 4- do 5-kratno podaljšanje t1/2.
o The requirement to perform regular follow-ups with the patient/carer to ensure continued correct and compliant Myalepta reconstitution and treatment. 
o Poskrbeti je treba za redno preverjanje dajanja zdravila s strani bolnika in/ali skrbnika, da se zagotovita nadaljnja pravilna in z navodili skladna rekonstitucija ter zdravljenje z zdravilom Myalepta.
Acute pancreatitis associated with discontinuation of metreleptin In clinical studies, 6 patients (4 with generalised LD and 2 with partial LD), experienced treatment-emergent pancreatitis. 
V kliničnih študijah se je pri 6 bolnikih (4 z generalizirano LD in 2 s parcialno LD) pojavil pankreatitis zaradi zdravljenja.
• Each 1 U is shown as a smaller line between the big lines. 
• Vsaka 1 U je prikazana kot manjša črta med velikimi črtami.
Tell your doctor straight-away if you develop a high temperature, accompanied by increasing tiredness (see section 4). 
Če imate visoko telesno temperaturo in občutek čedalje večje utrujenosti, se takoj posvetujte z zdravnikom (glejte poglavje 4).
• Each vial contains 11.3 milligrams of metreleptin. 
• Ena viala vsebuje 11,3 mg metreleptina.
4) Take the 1 mL syringe out of the plastic wrapper. 
4) Vzemite 1-mililitrsko brizgo iz plastičnega omota.
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. 
Vse od obdobja gestacije in tudi med dojenjem je bilo pri samicah opaziti zmanjšano telesno težo pri vseh odmerkih, posledica pa je bila manjša telesna masa mladičev ob skotitvi, ki je vztrajala vse do zrelosti.
Amount of mixed Myalepta solution to inject in ‘Unit' measurements on your 0.3 mL syringe 
Myalepta za injiciranje v "enotah" na vaši 0,3-mililitrski brizgi
For doses of: > 5 mg - 10 mg / > 1.0 mL volume daily 
Za odmerke: > 5 mg - 10 mg / > 1,0 ml dnevno
Reading the syringe 
Odčitavanje brizge
Example: A 15 kg patient is initiated at 0.06 mg/kg of Myalepta. 
Primer: bolnik, ki tehta15 kg, na začetku prejme 0,06 mg/kg zdravila Myalepta.
o If your dose is 1.5 mg or less, you will use a 0.3 mL syringe. 
o Če je vaš odmerek 1,5 mg ali manj, boste uporabili 0,3-mililitrsko brizgo.
Using the 0.3 mL syringe 
Uporaba 0,3-mililitrske brizge
If you stop using Myalepta 
Če ste prenehali uporabljati zdravilo Myalepta
Insert the 3 mL syringe into the glass ampoule. 
Vstavite 3-mililitrsko brizgo v stekleno ampulo.
The Guide/training material for healthcare professionals shall contain the following key elements: o Reminders on key prescribing information content, including indicated population, posology, warnings and precautions, and other safety- related information which is key to safe use of the product. 
o Opomnike o ključnih informacijah o predpisovanju, vključno s populacijo za katero je zdravilo indicirano, odmerjanjem, opozorili in previdnostnimi ukrepi ter ostalimi informacijami, povezanimi z varnostjo, ki so ključne za varno uporabo zdravila.
The reconstituted solution will take less than 5 minutes to become clear. 
Razredčena raztopina bo postala prozorna v manj kot 5 minutah.
What Myalepta is used for 
Za kaj se zdravilo Myalepta uporablja
Myalepta 11.3 mg powder for solution for injection Each vial contains 11.3 mg of metreleptin*. 
Myalepta 11,3 mg prašek za raztopino za injiciranje Ena viala vsebuje 11,3 mg metreleptina*.
How to stop using Myalepta 
Kako prenehati z uporabo zdravila Myalepta
Fasting TGs (mmol/L) 
TG na tešče (mmol/l) Povprečje (SD)
• blood clot in your veins (deep vein thrombosis) - pain, swelling, warmth & redness, usually occurring in lower leg or thigh 
• krvni strdek v venah (globoka venska tromboza) - bolečina, otekanje, toplota in rdečica,
Each vial contains 11.3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL) 
Ena viala vsebuje 11,3 mg metreleptina Po rekonstituciji en ml vsebuje 5 mg metreleptina (5 mg/ml).
Table 8 Primary outcome results in an open-label, single-arm study (NIH 991265/20010769) in evaluable patients with generalised LD treated with metreleptin at 12 months Parameter n 
Preglednica 8 Glavni rezultati v odprti študiji z enim krakom (NIH 991265/20010769) pri analiziranih bolnikih z generalizirano LD, zdravljenimi z metreleptinom, po 12 mesecih
• a feeling of general discomfort, uneasiness or pain (‘malaise') 
• občutek splošnega neudobja, neugodja ali bolečine • povišana raven maščob v krvi ("trigliceridi")
Myalepta 11.3 mg powder for solution for injection Type I glass vial (5 mL) with a bromobutyl rubber stopper and an aluminium seal/white plastic flip-off cap. 
Myalepta 11,3 mg prašek za raztopino za injiciranje Steklena viala tipa I (5 ml) z gumijastim zamaškom iz bromobutila ter aluminijastim tesnilom/belo plastično zaporko.
A higher accumulation is observed with higher ADA levels. 
je bilo opaženo večje kopičenje.
• Each vial contains 5.8 milligrams of metreleptin. 
• Ena viala vsebuje 5,8 mg metreleptina.
Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation. 
Ob pojavu znakov in/ali simptomov pankreatitisa je treba izvesti ustrezen klinični pregled.
Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment. 
Če opazite katere od naslednjih resnih neželenih učinkov, takoj obvestite zdravnika, saj boste morda potrebovali urgentno zdravljenje.
Among 24 patients with generalised LD who had a baseline TG level 5.65 mmol/l or greater and data available at Month 12, the mean (SD) baseline TG level was 31.7 mmol/l (33.68) and the mean percent reduction in triglycerides at Month 12 was 72%. 
Med 24 bolniki z generalizirano LD, ki so imeli izhodiščna raven TG 5,65 mmol/l ali več in so bili po 12 mesecih podatki zanje na voljo, je bila povprečna (SD) izhodiščna raven TG 31,7 mmol/l (33,68), povprečno odstotno zmanjšanje trigliceridov po 12 mesecih pa je bilo 72-odstotno.
4) Take the 3 mL syringe out of the plastic wrapper. 
4) Vzemite 3-mililitrsko brizgo iz plastičnega omota.
o Neutralising antibodies may develop on Myalepta therapy. 
o Pri uporabi zdravila Myalepta se lahko razvijejo nevtralizirajoča protitelesa.
25 kg patient is initiated at 0.06 mg/kg of Myalepta. 
Bolnik, ki tehta 25 kg, na začetku prejme 0,06 mg/kg zdravila Myalepta.
− A starting dose is 2.5 mg (0.5 mL of solution). 
− začetni odmerek je 2,5 mg (0,5 ml raztopine).
Consider dose increase before stopping treatment. 
Preden prekinete zdravljenje, poskusite s povečanjem odmerka.
Dose of Myalepta 
Odmerek zdravila Myalepta