FrancophonIA/ELRC3.0 huggingface dataset:
English: Example: A 15 kg patient is initiated at 0.06 mg/kg of Myalepta.
Slovenian: Primer: bolnik, ki tehta15 kg, na začetku prejme 0,06 mg/kg zdravila Myalepta.
English: o If your dose is 1.5 mg or less, you will use a 0.3 mL syringe.
Slovenian: o Če je vaš odmerek 1,5 mg ali manj, boste uporabili 0,3-mililitrsko brizgo.
English: Using the 0.3 mL syringe
Slovenian: Uporaba 0,3-mililitrske brizge
English: If you stop using Myalepta
Slovenian: Če ste prenehali uporabljati zdravilo Myalepta
English: Insert the 3 mL syringe into the glass ampoule.
Slovenian: Vstavite 3-mililitrsko brizgo v stekleno ampulo.
English: 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.
Slovenian: 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.
English: The reconstituted solution will take less than 5 minutes to become clear.
Slovenian: Razredčena raztopina bo postala prozorna v manj kot 5 minutah.
English: What Myalepta is used for
Slovenian: Za kaj se zdravilo Myalepta uporablja
English: Myalepta 11.3 mg powder for solution for injection Each vial contains 11.3 mg of metreleptin*.
Slovenian: Myalepta 11,3 mg prašek za raztopino za injiciranje Ena viala vsebuje 11,3 mg metreleptina*.
English: How to stop using Myalepta
Slovenian: Kako prenehati z uporabo zdravila Myalepta
English: Fasting TGs (mmol/L)
Slovenian: TG na tešče (mmol/l) Povprečje (SD)
English: • blood clot in your veins (deep vein thrombosis) - pain, swelling, warmth & redness, usually occurring in lower leg or thigh
Slovenian: • krvni strdek v venah (globoka venska tromboza) - bolečina, otekanje, toplota in rdečica,
English: Each vial contains 11.3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Slovenian: Ena viala vsebuje 11,3 mg metreleptina Po rekonstituciji en ml vsebuje 5 mg metreleptina (5 mg/ml).
English: 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
Slovenian: 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
English: • a feeling of general discomfort, uneasiness or pain (‘malaise')
Slovenian: • občutek splošnega neudobja, neugodja ali bolečine • povišana raven maščob v krvi ("trigliceridi")
English: 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.
Slovenian: 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.
English: A higher accumulation is observed with higher ADA levels.
Slovenian: je bilo opaženo večje kopičenje.
English: • Each vial contains 5.8 milligrams of metreleptin.
Slovenian: • Ena viala vsebuje 5,8 mg metreleptina.
English: Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation.
Slovenian: Ob pojavu znakov in/ali simptomov pankreatitisa je treba izvesti ustrezen klinični pregled.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Slovenian: Če opazite katere od naslednjih resnih neželenih učinkov, takoj obvestite zdravnika, saj boste morda potrebovali urgentno zdravljenje.
English: 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%.
Slovenian: 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.
English: 4) Take the 3 mL syringe out of the plastic wrapper.
Slovenian: 4) Vzemite 3-mililitrsko brizgo iz plastičnega omota.
English: o Neutralising antibodies may develop on Myalepta therapy.
Slovenian: o Pri uporabi zdravila Myalepta se lahko razvijejo nevtralizirajoča protitelesa.
English: 25 kg patient is initiated at 0.06 mg/kg of Myalepta.
Slovenian: Bolnik, ki tehta 25 kg, na začetku prejme 0,06 mg/kg zdravila Myalepta.
English: − A starting dose is 2.5 mg (0.5 mL of solution).
Slovenian: − začetni odmerek je 2,5 mg (0,5 ml raztopine).
English: Consider dose increase before stopping treatment.
Slovenian: Preden prekinete zdravljenje, poskusite s povečanjem odmerka.
English: Dose of Myalepta
Slovenian: Odmerek zdravila Myalepta
English: • Keeping the bottom of the ampoule still, gently twist the top of the ampoule until it is removed.
Slovenian: • Spodnji del ampule držite pri miru in z drugo roko nežno odvijajte vrh ampule, dokler se ta ne odstrani.
English: For females > 40 kg once daily dose
Slovenian: Za ženske > 40 kg enkratni dnevni odmerek
English: This medicine is for use in children aged 2 years and above, adolescents and adults with generalised lipodystrophy; it is also for use in children aged 12 years and above, adolescents and adults with partial lipodystrophy.
Slovenian: To zdravilo je primerno za otroke, stare 2 leti ali več, mladostnike in odrasle z generalizirano lipodistrofijo.
English: Metabolism and nutrition disorders Hypoglycaemia Decreased appetite Diabetes mellitus, Hyperphagia, Insulin resistance
Slovenian: Sladkorna bolezen, hiperfagija, odpornost na insulin
English: o For example, if you have been prescribed a 5 mg dose of Myalepta, 5 mg divided by 5 gives you 1 mL which is the amount you need to inject of the solution, using a 1 mL syringe.
Slovenian: • Da bi vedeli, koliko zdravila injicirati (v ml), svoj odmerek (v mg) delite s 5. o Če vam je zdravnik npr. predpisal 5 mg zdravila Myalepta, potem delite 5 mg s 5 in dobili boste 1 ml, ki je količina raztopine, ki jo morate injicirati z 1-mililitrsko brizgo.
English: This is because it is not known how metreleptin will affect your unborn baby.
Slovenian: Učinki metreleptina na nerojenega otroka namreč niso znani.
English: • swelling in your hands and feet
Slovenian: • otekanje dlani in stopal
English: This is mixed with the Myalepta powder to dissolve the powder to make the liquid medicine that you inject.
Slovenian: To pomešate s praškom zdravila Myalepta, da raztopite prašek v tekoče zdravilo,
English: 5) Withdraw 0.6 mL of water for injection into the 1 mL syringe.
Slovenian: 5) Izvlecite 0,6 ml vode za injekcije v 1-mililitrsko brizgo.
English: This will include for example instructions for handling possible ADRs.
Slovenian: To vključuje npr. navodila za ravnanje v primeru pojava neželenih učinkov.
English: - Tapering the dose over a two-week period is recommended in conjunction with a low fat diet. - Patients should be monitored during tapering.
Slovenian: - Priporoča se postopno zmanjšanje odmerka v obdobju dveh tednov, skupaj z dieto z nizko vsebnostjo maščob.
English: • Each 0.01 mL is shown as a smaller line.
Slovenian: • Vsakih 0,01 ml je prikazanih kot manjša črta.
English: Myalepta 5.8 mg powder for solution for injection Each vial contains 5.8 mg of metreleptin*.
Slovenian: Myalepta 5,8 mg prašek za raztopino za injiciranje Ena viala vsebuje 5,8 mg metreleptina*.
English: Serious and/or severe infections that were temporally associated with > 80% blocking activity against metreleptin occurred in 5 generalised LD patients.
Slovenian: Pri 5 bolnikih z generalizirano LD so se pojavile resne in/ali hude okužbe, ki so bile časovno povezane z > 80 % zaviralno aktivnostjo proti metreleptinu.
English: Individual patient once daily dose in mg = 5 mg Amount to inject once daily dose = 1 mL
Slovenian: Individualni enkratni dnevni odmerek za bolnika v mg = 5 mg Volumen za injiciranje enkratnega dnevnega odmerka = 1 ml
English: • Patients/carers educational material
Slovenian: • Izobraževalno gradivo za bolnike/skrbnike
English: With the needle still in the vial, turn the vial and syringe upside down.
Slovenian: Z iglo še vedno v viali obrnite vialo in brizgo na glavo.
English: Myalepta 5.8 mg powder for solution for injection EU/1/18/1276/005
Slovenian: Myalepta 5,8 mg prašek za raztopino za injiciranje EU/1/18/1276/005
English: Do not use this medicine if the solution is not clear, is coloured or has bits or lumps in it. Do not throw away any medicines via wastewater or household waste.
Slovenian: Ne uporabljajte tega zdravila, če raztopina ni prozorna, je obarvana ali vsebuje delce ali grude praška.
English: When starting therapy with Myalepta there is a risk of hypoglycaemia in patients who are on anti-diabetic medicinal products, in particular insulin or insulin secretagogues (see section 4.4).
Slovenian: Na začetku zdravljenja z zdravilom Myalepta pri bolnikih, ki prejemajo antidiabetike, predvsem insulin ali insulinske sekretagoge (glejte poglavje 4.4), obstaja nevarnost hipoglikemije.
English: Table 5 Conversion table for the 0.3 mL U100 insulin syringe Weight of child Dose of Myalepta
Slovenian: Preglednica 5 Pretvorbena preglednici za 0,3-mililitrsko insulinsko brizgo U100 Telesna masa otroka
English: In case of hypoglycaemic events of a non-severe nature, food intake management may be considered as an alternative to dose-adjustment of anti-diabetics according to the treating physician's opinion.
Slovenian: V primeru hipoglikemičnih dogodkov, ki niso hudi, lahko glede na mnenje lečečega zdravnika namesto prilagoditve odmerka antidiabetikov pride v poštev prilagoditev diete.
English: o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur:
Slovenian: o Pri bolnikih, ki hkrati jemljejo insulin in druga antidiabetike, se lahko pojavi hipoglikemija:
English: • Do not remove the needle guard.
Slovenian: • Ne odstranite varovala za iglo.
English: Myalepta 3 mg powder for solution for injection EU/1/18/1276/003
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje EU/1/18/1276/003
English: Individual patient once daily dose in mg = 2.5 mg Amount to inject once daily dose = 0.5 mL
Slovenian: Individualni enkratni dnevni odmerek za bolnika v mg = 2,5 mg Volumen za injiciranje enkratnega dnevnega odmerka = 0,5 ml
English: Table 6 Dose adjustment calculation Adjust dose as follows (if necessary)
Slovenian: Preglednica 6 Izračun prilagoditve odmerka
English: Among 45 patients with generalised LD who had a baseline HbA1c of 7% or greater and data available at Month 12, the mean (SD) baseline HbA1c was 9.6% (1.63) and the mean reduction in HbA1c at Month 12 was 2.8%.
Slovenian: Med 45 bolniki z generalizirano LD, ki so imeli izhodiščni HbA1c 7 % ali več in so bili po 12 mesecih podatki zanje na voljo, je bila povprečna (SD) izhodiščna vrednost HbA1c 9,6 % (1,63), povprečno zmanjšanje ravni HbA1c pa je bilo po 12 mesecih 2,8-odstotno.
English: Myalepta 11.3 mg powder for solution for injection EU/1/18/1276/001
Slovenian: Myalepta 11,3 mg prašek za raztopino za injiciranje EU/1/18/1276/001
English: Starting daily dose (injection volume)
Slovenian: Začetni dnevni odmerek (volumen injekcije)
English: After reconstitution, each mL contains 5 mg of metreleptin.
Slovenian: Po redčenju en ml vsebuje 5 mg metreleptina.
English: There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic medicinal products, in particular insulin or insulin secretagogues (e.g. sulphonylureas).
Slovenian: Hipoglikemija ob sočasni uporabi insulina in drugih antidiabetikov Pri bolnikih, ki se zdravijo z zdravilom Myalepta in hkrati jemljejo tudi antidiabetike, predvsem insulin ali insulinske sekretagoge (npr. sulfonilsečnine), obstaja tveganje hipoglikemije.
English: When properly mixed, the Myalepta solution should be clear and free of lumps of dry powder, bubbles or foam.
Slovenian: Ko je pravilno zmešana, je raztopina zdravila Myalepta prozorna in brez grud ali suhega praška,
English: For doses of: > 1.5 mg - 5 mg / 0.3 - 1.0 mL volume daily
Slovenian: Za odmerke: > 1,5 mg - 5 mg / 0,3 - 1,0 ml dnevno
English: 5) Withdraw 2.2 mL of water for injection into the 3 mL syringe.
Slovenian: 5) Izvlecite 2,2 ml vode za injekcije v 3-mililitrsko brizgo.
English: Step B: Filling the 1 mL syringe with 0.6 mL of water for injections
Slovenian: Korak B: Polnjenje 1-mililitrske brizge z 0,6 ml vode za injekcije
English: • Each 0.5 mL is shown as a number next to a big line.
Slovenian: • Vsakih 0,5 ml je prikazanih kot številka poleg velike črte.
English: Glass ampoule of water for injection
Slovenian: Steklena ampula vode za injekcije
English: Do not use the solution if discoloured or cloudy, or if particulate matter remains.
Slovenian: Raztopine ne uporabljajte, če je obarvana ali motna ali če so v njej delci.
English: Step B: Filling the 3 mL syringe with 2.2 mL of water for injections
Slovenian: Korak B: Polnjenje 3-mililitrske brizge z 2,2 ml vode za injekcije
English: Name and address of the manufacturer of the biological active substance Sandoz GmbH - BP Kundl
Slovenian: Sandoz GmbH - BP Kundl Biochemiestrasse 10 6250 Kundl
English: • Keeping the bottom of the ampoule still, snap the tip off.
Slovenian: • Spodnji del ampule držite na miru in odlomite konico.
English: Weight decreased
Slovenian: Zmanjšanje telesne teže
English: • fainting or feeling dizzy
Slovenian: • omedlevica ali občutek omotičnosti
English: • blood pressure medicines called ‘calcium channel blockers'
Slovenian: • zdravila za krvni tlak, imenovana "zaviralci kalcijevih kanalčkov"; • teofilin, ki se uporablja pri težavah s pljuči, kot je astma;
English: • swelling and reddening of the skin, hives
Slovenian: • otekanje in rdečica kože, koprivnica
English: Before opening the water for injection ampoule, prepare the 3 mL syringe by attaching the needle to it. Do not over-tighten the needle.
Slovenian: Preden odprete ampulo z vodo za injekcije, pripravite 3-mililitrsko brizgo tako, da nanjo pritrdite iglo.
English: o If your dose is more than 1.5 mg up to 5 mg, you will use a 1 mL syringe.
Slovenian: o Če je vaš odmerek več kot 1,5 mg in do največ 5 mg, boste uporabili 1,0-mililitrsko brizgo.
English: - Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of Myalepta treatment.
Slovenian: - V prvih 2 tednih zdravljenja z zdravilom Myalepta bo morda treba odmerek insulina zmanjšati tudi do 50 % ali več glede na potrebe ob začetku zdravljenja.
English: If your syringe looks different or has different dose markings, talk to your doctor, nurse or pharmacist for more information.
Slovenian: Če je vaša brizga videti drugače ali ima drugačne oznake za odmerke, se posvetujte z zdravnikom,
English: − A starting dose is 5 mg (1 mL of solution).
Slovenian: − začetni odmerek je 5 mg (1 ml raztopine).
English: Three cases of T-cell lymphoma have been reported while using metreleptin in clinical studies.
Slovenian: T-celični limfom V kliničnih študijah so bili poročani trije primeri pojava T-celičnega limfoma med uporabo metreleptina.
English: • Remove the needle cover.
Slovenian: • Odstranite pokrovček igle.
English: Glass vial of water for injection
Slovenian: Steklena viala vode za injekcije
English: Step B: Filling the 3 mL syringe with 1.1 mL of water for injections
Slovenian: Korak B: Polnjenje 3-mililitrske brizge z 1,1 ml vode za injekcije
English: • Healthcare professionals educational material
Slovenian: • Izobraževalno gradivo za zdravstvene delavce
English: After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Slovenian: Po raztopitvi vsebine viale v 0,6 mililitrih vode za injekcije en mililiter vsebuje 5 miligramov metreleptina.
English: How Myalepta works
Slovenian: Kako zdravilo Myalepta deluje
English: 5) Withdraw 1.1 mL of water for injection into the 3 mL syringe.
Slovenian: 5) Izvlecite 1,1 ml vode za injekcije v 3-mililitrsko brizgo.
English: The clearance of metreleptin appears to be delayed in the presence of ADAs.
Slovenian: Ob prisotnosti ADA je izločanje metreleptina potekalo počasneje.
English: • If there is less than 1.1 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 1.1 mL in the syringe.
Slovenian: • Če je v brizgi manj kot 1,1 ml vode za injekcije, v brizgo povlecite več vode za injekcije in ponavljajte koraka 6 in 7, dokler v brizgi ne bo 1,1 ml. 9) Ko imate v brizgi 1,1 ml vode za injekcije, odstranite brizgo iz viale ali ampule.
English: The weighted average daily dose (i.e., the average dose taking into account duration of treatment at different doses) for the 48 patients with baseline body weight greater than 40 kg was 2.6 mg for males and 5.2 mg for females during the first year of treatment, and 3.7 mg for males and 6.5 mg for females over the entire study period.
Slovenian: 48 bolnikov z izhodiščno telesno težo nad 40 kg je bil 2,6 mg za moške in 5,2 mg za ženske v prvem letu zdravljenja ter 3,7 mg za moške in 6,5 mg za ženske za celotno obdobje študije.
English: • Pull the plunger down to the 0.6 mL line to draw air into the syringe.
Slovenian: • Povlecite bat navzdol do črte za 0,6 ml, da potegnete zrak v brizgo.
English: While being treated with Myalepta, you may get an allergic reaction.
Slovenian: Med zdravljenjem z zdravilom Myalepta se lahko pojavijo alergijske reakcije.
English: • Each 0.1 mL is shown as a smaller line between the big lines.
Slovenian: • Vsakih 0,1 ml je prikazanih kot manjša črta med velikimi črtami.
English: 20) Check for air pockets and air bubbles.
Slovenian: 20) Preverite, ali so prisotni zračni žepi in zračni mehurčki.
English: Before opening the water for injection ampoule, prepare the 1 mL syringe by attaching the needle to it. Do not over-tighten the needle.
Slovenian: Preden odprete ampulo z vodo za injekcije, pripravite 1-mililitrsko brizgo tako, da nanjo pritrdite iglo.
English: • Pull the plunger down to the 1.1 mL line to draw air into the syringe.
Slovenian: • Povlecite bat navzdol do črte za 1,1 ml, da potegnete zrak v brizgo.
English: Large dose reductions of 50% or more of baseline insulin requirements may be needed in the initial phases of treatment.
Slovenian: V začetnih fazah zdravljenja bo morda treba odmerek insulina zmanjšati tudi do 50 % ali več glede na potrebe pred začetkom zdravljenja.
English: With the syringe still in the ampoule, turn the ampoule and syringe upside down.
Slovenian: Z brizgo še vedno v ampuli obrnite ampulo in brizgo na glavo.
English: • If there is less than 2.2 mL of water for injection in the syringe, draw more water for injection into the syringe and repeat the steps 6 and 7 until you have 2.2 mL in the syringe.
Slovenian: • Če je v brizgi manj kot 2,2 ml vode za injekcije, v brizgo povlecite več vode za injekcije in ponavljajte koraka 6 in 7, dokler v brizgi ne bo 2,2 ml. 9) Ko imate v brizgi 2,2 ml vode za injekcije, odstranite brizgo iz viale ali ampule.
English: How to use Myalepta
Slovenian: Kako uporabljati zdravilo Myalepta
English: - In case of hypoglycaemic events of a non-severe nature, food intake management may be considered as an alternative to dose adjustment of anti-diabetics.
Slovenian: - V primeru hipoglikemičnih dogodkov, ki niso hudi, lahko namesto prilagoditve odmerka antidiabetikov pride v poštev prilagoditev diete.
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.
Slovenian: Študije toksičnosti za razmnoževanje, izvedene na miših, niso pokazale nobenih neželenih učinkov na parjenje, plodnost ali razvoj zarodka do največjega preizkušenega odmerka, ki je bil pribl.
English: • Each 0.1 mL is shown as a number with a big line.
Slovenian: • Vsakih 0,1 ml je prikazanih kot številka z veliko črto.
English: • Each vial contains 3 milligrams of metreleptin.
Slovenian: • Ena viala vsebuje 3 mg metreleptina.
English: Attach the needle to the 1 mL syringe.
Slovenian: Pritrdite iglo na 1-mililitrsko brizgo.
English: o The risk of medication error: - 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 - The requirement to perform regular follow-ups with the patient/carer to ensure continued correct and compliant Myalepta reconstitution and treatment - Guidance on the appropriate syringe size ancillary administration set to prescribe according to the dosage of Myalepta and how to read the syringe volumes - How to access a video on line which shows step by step how to reconstitute, measure the correct dose and administer it subcutaneously o The association between LD and lymphoma and that the patient will be monitored during treatment.
Slovenian: - Napotki glede brizg ustrezne velikosti v kompletih s pomožnim materialom, ki se jih predpiše v skladu z odmerjanjem zdravila Myalepta, in kako odčitavati prostornino brizg - Kako dostopati do spletnega videoposnetka, ki po korakih prikazuje rekonstitucijo, pravilno odmerjanje in subkutano dajanje o Povezava med lipodistrofijo in limfomom, zaradi česar je treba bolnika spremljati med zdravljenjem.
English: Amount of mixed Myalepta solution
Slovenian: Količina zmešane raztopine zdravila Myalepta
English: • Guide for patients/carers
Slovenian: • Vodnik za bolnike/skrbnike
English: ‘Unit' measurement volume in 0.3 mL
Slovenian: "Enota" volumna za injiciranje v 0,3-mililitrski brizgi
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite kateri koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Table 1 Metreleptin recommended dose Baseline weight
Slovenian: Preglednica 1 Priporočen odmerek metreleptina Izhodiščna telesna masa
English: You must use a clean syringe and needle for both injections.
Slovenian: Za vsako injiciranje morate uporabiti čisto brizgo in iglo.
English: A separate case of anaplastic large cell lymphoma was reported in a paediatric patient receiving the medicinal product who did not have haematological abnormalities before treatment.
Slovenian: Pri pediatričnem bolniku, ki je prejemal zdravilo, vendar pred začetkom zdravljenja ni imel hematoloških motenj, je bil poročan ločen primer anaplastičnega velikoceličnega limfoma.
English: - Lymphoproliferative disorders, including lymphoma have been reported in patients with acquired generalised LD not treated with Myalepta.
Slovenian: - Pri bolnikih s pridobljeno generalizirano LD, ki se niso zdravili z zdravilom Myalepta so poročali o limfoproliferativnih boleznih, vključno z limfomi.
English: • Healthcare professionals training material
Slovenian: • Gradivo za usposabljanje zdravstvenih delavcev
English: Natural leptin is produced by fatty tissue and has many functions in the body including:
Slovenian: Naravni leptin proizvajajo maščobna tkiva in ima v telesu številne funkcije, vključno z naslednjimi: • nadzira občutek lakote in vaše ravni energije;
English: In patients with serious and severe infections, continuation of metreleptin should be at the discretion of the prescriber.
Slovenian: Pri bolnikih z resnimi in hudimi okužbami se mora lečeči zdravnik odločiti, ali naj bolnik nadaljuje z uporabo metreleptina ali ne, pri čemer je dobro.
English: • Pull the plunger down to the 2.2 mL line to draw air into the syringe.
Slovenian: • Povlecite bat navzdol do črte za 2,2 ml, da potegnete zrak v brizgo.