FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 148 patients with generalised and partial LD received metreleptin during clinical studies.
Slovenian: Povzetek varnostnega profila Med kliničnimi študijami je metreleptin prejelo skupno 148 bolnikov z generalizirano in parcialno LD.
English: Package leaflet: Information for the patient Myalepta 5.8 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Myalepta 5,8 mg prašek za injiciranje metreleptin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: • Do not attach the needle to the syringe.
Slovenian: • Ne pritrdite igle na brizgo.
English: Attach the needle to the 3 mL syringe.
Slovenian: Pritrdite iglo na 3-mililitrsko brizgo.
English: 19) Keeping the needle inside the vial, pull the plunger down.
Slovenian: 19) Z iglo v viali povlecite bat navzdol.
English: • If there is less than 0.6 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 0.6 mL in the syringe.
Slovenian: • Če je v brizgi manj kot 0,6 ml vode za injekcije, v brizgo povlecite več vode za injekcije in ponavljajte koraka 6 in 7, dokler v brizgi ne bo 0,6 ml. 9) Ko imate v brizgi 0,6 ml vode za injekcije, odstranite brizgo iz viale ali ampule.
English: o Hypersensitivity has been reported with Myalepta use including anaphylaxis, urticaria and generalised rash.
Slovenian: o Pri bolnikih, ki prejemajo zdravilo Myalepta, so poročali o primerih preobčutljivosti vključno z anafilaksijo, koprivnico in generaliziranim izpuščajem.
English: 18) With the needle in the vial, turn the vial and syringe upside down.
Slovenian: 18) Z iglo še vedno v viali obrnite vialo in brizgo na glavo.
English: • feeling more sleepy or confused
Slovenian: • občutek omotičnosti • občutek večje zaspanosti ali zmedenosti
English: Myalepta 5.8 mg powder for solution for injection Using a 3 mL syringe with a 21-gauge or smaller diameter needle, withdraw 1.1 mL of water for injection.
Slovenian: Myalepta 5,8 mg prašek za raztopino za injiciranje S 3-mililitrsko brizgo z iglo premerom 21 G ali manj izvlecite 1,1 ml vode za injekcije.
English: The weighted average daily dose (i.e., the average dose taking into account duration of treatment at different doses) for all 31 patients with baseline body weight greater than 40 kg was 7.0 mg during the first year of treatment, and 8.4 mg over the entire study period.
Slovenian: 31 bolnikov z izhodiščno telesno težo nad 40 kg je bil 7,0 mg v prvem letu zdravljenja ter 8,4 mg za celotno obdobje študije.
English: • bruising, reddening, itching or hives where the injection is given
Slovenian: • podplutbe, rdečica, srbenje ali izpuščaj na mestu injiciranja
English: Your doctor, nurse or pharmacist will give you ‘water for injection' with the medicine vial and syringes.
Slovenian: Zdravnik, medicinska sestra ali farmacevt vam bo skupaj z vialo z zdravilom in brizgami dal tudi
English: 21 gauge 40 mm needle Myalepta 11.3 mg powder for solution for injection 3.0 mL
Slovenian: 3,0 ml premer 21G 40 mm igla Myalepta 11,3 mg prašek za raztopino za injiciranje 3,0 ml premer 21G 40 mm igla
English: For males and females ≤ 40 kg once daily dose
Slovenian: Za moške in ženske ≥40 kg enkratni dnevni odmerek
English: • You must check for air pockets or air bubbles in your 3 mL syringe.
Slovenian: • Preverite, ali se v 3-mililitrski brizgi nahajajo zračni žepi ali zračni mehurčki.
English: Package leaflet: Information for the patient Myalepta 11.3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Myalepta 11,3 mg prašek za injiciranje metreleptin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic therapy.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Myalepta in jemljejo zdravila proti sladkorni bolezni, obstaja nevarnost hipoglikemije.
English: Limited clinical data exists in children less than 2 years old for generalised LD patients and less than 12 years old in partial LD patients.
Slovenian: Za otroke, mlajše od 2 let z generaliziranim LD, in mlajše od 12 let s parcialnim LD, je na voljo le malo kliničnih podatkov.
English: Weight (kg) x 0.06 mg/kg = Individual patient daily starting dose in mg Weight (kg) x 0.012 mL/kg = Individual patient daily starting volume to inject in mL
Slovenian: Telesna masa (kg) x 0,012 ml/kg = individualni dnevni začetni volumen za injiciranje za bolnika v ml
English: Package leaflet: Information for the patient Myalepta 3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Myalepta 3 mg prašek za injiciranje metreleptin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Symptoms of low blood sugar levels include:
Slovenian: Znaki visokega in nizkega krvnega sladkorja Simptomi nizkih ravni krvnega sladkorja vključujejo:
English: Myalepta 11.3 mg powder for solution for injection Using a 3 mL syringe with a 21-gauge or smaller diameter needle, withdraw 2.2 mL of water for injection.
Slovenian: Myalepta 11,3 mg prašek za raztopino za injiciranje S 3-mililitrsko brizgo z iglo premerom 21 G ali manj izvlecite 2,2 ml vode za injekcije.
English: Advice will be provided on symptoms of an allergic reaction and action to be taken in the event of such a reaction.
Slovenian: Podana naj bodo pojasnila o simptomih alergijskih reakcij in ukrepih pri pojavu le-teh. o Potreba po uporabi zdravila v skladu z navodili, zaradi tveganja pankreatitisa v primeru nenadne prekinitve uporabe.
English: Do not over-tighten the needle.
Slovenian: Pazite, da igle ne pritrdite premočno.
English: In 43 patients with hepatic data available, the mean changes at Month 12 in alanine aminotransferase, versus baseline (112.5 U/L) was -53.1 U/L, and aspartate aminotransferase versus baseline (75.3 U/L) was -23.8 U/L.
Slovenian: Pri 24 bolnikih z razpoložljivimi podatki o ledvicah je bila povprečna sprememba v stopnji izločanja beljakovin v primerjavi z izhodiščem (1675,7 mg/24 h) po 12 mesecih -906,1 mg/24 h. Pri 43 bolnikih z razpoložljivimi podatki o jetrih, je bila povprečna sprememba v ravni alanin-aminotransferaze v primerjavi z izhodiščem (112,5 U/l) po 12 mesecih -53,1 U/l, v ravni aspartat-aminotransferaze v primerjavi z izhodiščem (75,3 e./l) pa -23,8 e./l.
English: • severe pain in your stomach (abdomen)
Slovenian: • huda bolečina v trebuhu
English: After reconstitution with 1.1 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Slovenian: Po redčenju z 1,1 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
English: Do not use the solution if it is not clear or has bits or lumps in it.
Slovenian: Ne uporabljajte raztopine, če ni prozorna ali vsebuje delce ali grude praška.
English: • You must check for air pockets or air bubbles in your 1 mL syringe.
Slovenian: • Preverite, ali se v 1-mililitrski brizgi nahajajo zračni žepi ali zračni mehurčki.
English: • Each 0.5 U is shown as a small line between two 1 U lines.
Slovenian: • Vsakih 0,5 U je prikazanih kot majhna črtica med dvema črtama 1 U. To je enako 0,005 ml.
English: • Hold the ampoule so that the tip is facing up.
Slovenian: • Ampulo držite tako, da bo konica usmerjena navzgor.
English: After reconstitution with 2.2 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Slovenian: Po redčenju z 2,2 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
English: Menorrhagia
Slovenian: koprivnica
English: Tachycardia
Slovenian: Menoragija
English: Males and females ≤ 40 kg
Slovenian: Moški in ženske ≥ 40 kg
English: Myalepta 3 mg powder for solution for injection Using a 1 mL syringe with a 21-gauge or smaller diameter needle, withdraw 0.6 mL of water for injection.
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje Z 1-mililitrsko brizgo z iglo premera 21 G ali manj izvlecite 0,6 ml vode za injekcije.
English: o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur.
Slovenian: o Pri bolnikih, ki sočasno jemljejo insulin in druga zdravila za sladkorno bolezen, se lahko pojavi hipoglikemija.
English: Rotation of injection sites is recommended in patients co-administering insulin (or other subcutaneous medicinal products) and Myalepta.
Slovenian: - Pri bolnikih, ki sočasno prejemajo insulin (ali druga subkutana zdravila) in zdravilo
English: • chest infection
Slovenian: • okužbe v prstnem košu
English: You should not use Myalepta if you are pregnant or might become pregnant.
Slovenian: Če ste noseči ali bi lahko zanosili, ne uporabljajte zdravila Myalepta.
English: • swelling of your face, lips, tongue or throat
Slovenian: • otekanje obraza, ustnic, jezika ali v grla • bolečine v trebuhu, siljenje na bruhanje (navzea) in bruhanje
English: Both males and females > 40 kg
Slovenian: Moški in ženske > 40 kg
English: 0.156 mL 0.15 mL
Slovenian: 0,156 ml
English: After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Slovenian: Po redčenju z 0,6 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
English: Table 4 Required administration syringe per Myalepta dose Syringe
Slovenian: Preglednica 4 Potrebna brizga na odmerek zdravila Myalepta Brizga
English: • Move the vial gently in a circle (swirling motion)
Slovenian: • Pri tem nežno krožite z vialo (vrtite).
English: The individual patient dose = 0.9 mg. A dose increment of 0.02 mg/kg increases the daily dose to 0.08 mg/kg = 1.2 mg. Total daily volume to be injected is total dose in mg/5, in this case it is 1.2 mg/5 = 0.24 mL which equals 24 units on the 0.3 mL insulin syringe.
Slovenian: Skupni dnevni volumen za injiciranje je celotni odmerek v mg/5, ki je v tem primeru 1,2 mg/5 = 0,24 ml, kar je enako 24 enotam na 0,3-mililitrski insulinski brizgi.
English: • Insert the 3 mL syringe needle into the vial, through the rubber seal.
Slovenian: • Vstavite iglo 3-mililitrske brizge v vialo skozi gumijasto tesnilo.
English: After reconstitution, the solution must be administered immediately and cannot be stored for later use.
Slovenian: Po pripravi si morate raztopino injicirati takoj je ne smete hraniti za poznejšo uporabo.
English: • feeling sick (nausea) or being sick (vomiting)
Slovenian: • siljenje na bruhanje (navzea) in bruhanje • driska
English: - Monitoring of blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment is warranted.
Slovenian: - Pri bolnikih, ki sočasno prejemajo insulin, predvsem visoke odmerke, ali bolnikih, ki jemljejo insulinske sekretagoge in kombinacijo zdravil, je treba pozorno spremljati glukozo v krvi.
English: The once daily dose of Myalepta can be increased by increments as shown in Table 6 to a maximum daily dose.
Slovenian: *Opomba: Začetne odmerke in prirastke odmerka je treba zaokrožiti navzdol na najbližjih 0,01 ml Enkratni dnevni odmerek zdravila Myalepta se lahko povečuje v korakih, kot je prikazano v tabeli 6, do največjega dnevnega odmerka.
English: • One 1 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
Slovenian: • eno 1-mililitrsko brizgo z iglo premera 21G, dolgo 40 mm, za topljenje praška;
English: • Patients/carers training material The Guide/training material for patients/carers 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 za 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: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a blue plastic flip-off cap.
Slovenian: Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z modro plastično zaporko.
English: 12) Insert the needle of the 1 mL syringe containing the 0.6 mL of water for injection all the way into the Myalepta vial containing the powder.
Slovenian: 12) Vstavite iglo 1-mililitrske brizge, v kateri sta 0,6 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
English: Cases of T-cell lymphoma have been reported in clinical studies in patients taking Myalepta.
Slovenian: V kliničnih študijah so poročali o primerih pojava T-celičnega limfoma med uporabo zdravila Myalepta.
English: For doses of: ≤ 1.5 mg /≤ 0.3 mL volume daily
Slovenian: Za odmerke: ≥ 1,5 mg /≥ 0,3 ml dnevno
English: • Pull up until the top rim of the plunger lines up with the black 0.6 mL line.
Slovenian: • Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 0,6 ml.
English: • diabetes
Slovenian: • sladkorna bolezen
English: 21 gauge 40 mm needle
Slovenian: 40 mm igla
English: 0.168 mL 0.16 mL
Slovenian: 0,168 ml
English: 0.204 mL 0.20 mL
Slovenian: 0,204 ml
English: 12) Insert the needle of the 3 mL syringe containing the 2.2 mL of water for injection all the way into the Myalepta vial containing the powder.
Slovenian: 12) Vstavite iglo 3-mililitrske brizge, v kateri sta 2,2 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a white plastic flip-off cap.
Slovenian: Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z belo plastično zaporko.
English: 12) Insert the needle of the 3 mL syringe containing the 1.1 mL of water for injection all the way into the Myalepta vial containing the powder.
Slovenian: 12) Vstavite iglo 3-mililitrske brizge, v kateri sta 1,1 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
English: • One 3 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
Slovenian: • eno 3-mililitrsko brizgo z iglo premera 21G, dolgo 40 mm, za topljenje praška;
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a red plastic flip-off cap.
Slovenian: Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z rdečo plastično zaporko.
English: • Pull up until the top rim of the plunger lines up with the black 1.1 mL line.
Slovenian: • Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 1,1 ml.
English: • Insert the 1 mL syringe needle into the vial, through the rubber seal.
Slovenian: • Vstavite iglo 1-mililitrske brizge v vialo skozi gumijasto tesnilo.
English: • who have generalised lipodystrophy (the whole of your body does not have enough fatty tissue) It is used, when other treatments have been ineffective, in adults, and adolescents 12 years or over:
Slovenian: Uporablja se, če so bile druge oblike zdravljenja neučinkovite, pri odraslih in mladostnikih, starih 12 let ali več:
English: Myalepta 11.3 mg powder for injection metreleptin
Slovenian: Myalepta 11,3 mg prašek za raztopino za injiciranje metreleptin
English: *Global post marketing experience
Slovenian: in iz izkušenj po začetku trženja zdravila
English: 0.144 mL 0.14 mL
Slovenian: 0,144 ml
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje Steklena viala tipa I (3 ml) z gumijastim zamaškom iz klorobutila ter aluminijastim tesnilom/rdečo plastično zaporko.
English: 0.252 mL 0.25 mL
Slovenian: 0,252 ml
English: • going to the toilet to pass urine more often
Slovenian: • pogosteje odvajanje vode
English: Abrupt interruption and/or non-compliance with metreleptin dosing was suspected to have contributed to the occurrence of pancreatitis in 2 patients.
Slovenian: Obstaja možnost, da sta pri 2 bolnikih za pojav pankreatitisa bila odgovorna nenadna prekinitev in/ali nepravilno odmerjanje metreleptina.
English: - Rotation of injection sites is recommended in patients co administering insulin (or other SC medicinal products) and Myalepta.
Slovenian: Pri bolnikih, ki hkrati jemljejo insulin (ali druga subkutana zdravila) in zdravilo Myalepta, se priporoča rotacija mest injiciranja.
English: o Loss of efficacy, potentially due to neutralising antibodies, may occur in patients on Myalepta therapy.
Slovenian: o Pri bolnikih, ki se zdravijo z zdravilom Myalepta, lahko pride do zmanjšanja učinkovitosti, najverjetneje zaradi nevtralizirajočih protiteles.
English: Myalepta 5.8 mg powder for injection metreleptin
Slovenian: Myalepta 5,8 mg prašek za raztopino za injiciranje metreleptin
English: 0.132 mL 0.13 mL
Slovenian: 0,132 ml
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 0.288 mL 0.28 mL
Slovenian: 0,288 ml
English: Myalepta 3 mg powder for solution for injection 1.0 mL
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje 1,0 ml premer 21G
English: • Remove the needle guard.
Slovenian: • Odstranite varovalo za iglo.
English: When discontinuing Myalepta in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia), tapering of the dose over a two-week period is recommended in conjunction with a low-fat diet. During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed.
Slovenian: anamneza pankreatitisa, huda hipertrigliceridemija), se priporoča postopno zmanjšanje odmerka v obdobju dveh tednov, hkrati z dieto z malo maščobami.
English: Myalepta 3 mg powder for injection metreleptin
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje metreleptin
English: • Pull up until the top rim of the plunger lines up with the black 2.2 mL line.
Slovenian: • Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 2,2 ml.
English: Talk to your doctor, pharmacist or nurse before using Myalepta if:
Slovenian: Pred začetkom uporabe zdravila Myalepta se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: No formal pharmacokinetic studies were conducted in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter formalnih farmakokinetičnih študij niso izvedli.
English: 0.276 mL 0.27 mL
Slovenian: 0,276 ml
English: Rounded amount of solution
Slovenian: Zaokrožen volumen raztopine
English: 0.180 mL 0.18 mL
Slovenian: 0,180 ml
English: 0.192 mL 0.19 mL
Slovenian: 0,192 ml
English: 0.108 mL 0.10 mL
Slovenian: 0,108 ml
English: Myalepta 3 mg powder for solution for injection.
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue plastic flip-off cap.
Slovenian: Myalepta 5,8 mg prašek za raztopino za injiciranje Steklena viala tipa I (3 ml) z gumijastim zamaškom iz klorobutila ter aluminijastim tesnilom/modro plastično zaporko.
English: Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Slovenian: Po rekonstituciji en ml vsebuje 5 mg metreleptina (5 mg/ml).
English: 0.264 mL 0.26 mL
Slovenian: 0,264 ml
English: Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of treatment.
Slovenian: 2 tednih zdravljenja bo morda treba odmerek zmanjšati tudi do 50 % ali več glede na potrebe pred začetkom zdravljenja.
English: Myalepta 5.8 mg powder for solution for injection.
Slovenian: Myalepta 5,8 mg prašek za raztopino za injiciranje
English: 25 kg patient is initiated at 0.012 mL/kg = 0.3 mL of Myalepta solution to inject
Slovenian: Individualni odmerek za bolnika = 1,5 mg Bolnik, ki tehta 25 kg, na začetku prejme 0,012 ml/kg = 0,3 ml raztopine Myalepta za injiciranje
English: • You will be given the 1 mL syringe to use if your daily dose is more than 1.5 mg up to 5 mg,
Slovenian: • 1-mililitrsko brizgo boste prejeli, če je vaš dnevni odmerek več kot 1,5 mg do 5 mg, kar je v prostornini več kot 0,3 ml in do 1,0 ml raztopine Myalepta.
English: When properly mixed, the Myalepta reconstituted solution should be clear, colourless, and free of clumps or dry powder, bubbles or foam.
Slovenian: brezbarvna in brez grud ali suhega praška, zračnih mehurčkov ali pene.
English: Peak serum leptin (endogenous leptin and metreleptin) concentration (Cmax) occurred approximately 4.0 hours after subcutaneous administration of single doses ranging from 0.1 to 0.3 mg/kg in healthy adult subjects.
Slovenian: 4,0 ure po subkutanem odmerjanju enkratnih odmerkov od 0,1 do 0,3 mg/kg pri zdravih odraslih osebah.
English: 2.2 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Slovenian: Po raztopitvi vsebine viale v 2,2 mililitrih vode za injekcije en mililiter vsebuje 5 miligramov metreleptina.
English: 1.1 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Slovenian: Po raztopitvi vsebine viale v 1,1 mililitrih vode za injekcije en mililiter vsebuje 5 miligramov metreleptina.
English: 30 gauge 13 mm needle
Slovenian: 1,0 ml premer 30G 13 mm igla
English: 0.240 mL 0.24 mL
Slovenian: 0,240 ml
English: No formal pharmacokinetic studies were conducted in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic formalnih farmakokinetičnih študij niso izvedli .
English: Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 0.6 mL line.
Slovenian: • Vlecite ga navzdol, dokler ne bo zgornji rob bata poravnan s črno črto za 0,6 ml.
English: Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 1.1 mL line.
Slovenian: • Vlecite ga navzdol, dokler ne bo zgornji rob bata poravnan s črno črto za 1,1 ml.
English: Males and females ≤ 40 kg 0.06 mg/kg (0.012 mL/kg)
Slovenian: 0,06 mg/kg (0,012 ml/kg)
English: ● thigh
Slovenian: • kašelj • zasoplost
English: 0.216 mL 0.21 mL
Slovenian: 0,216 ml
English: This will include for example instructions for handling possible ADRs o Allergic reactions can occur with Myalepta use.
Slovenian: o Med zdravljenjem z zdravilom Myalepta se lahko pojavijo alergijske reakcije.
English: Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 2.2 mL line.
Slovenian: • Vlecite ga navzdol, dokler ne bo zgornji rob bata poravnan s črno črto za 2,2 ml.
English: Across two completed clinical studies (NIH 991265/20010769 and FHA101), there were 52 paediatric patients (4 in the subgroup of partial LD patients and 48 with generalised LD) enrolled and exposed to metreleptin.
Slovenian: 52 pediatričnih bolnikov (4 v podskupini bolnikov s parcialno LD in 48 z generalizirano LD), ki so bili izpostavljeni metreleptinu.
English: There was evidence of improvement in renal and hepatic function in patients with generalised LD treated with metreleptin.
Slovenian: Pri bolnikih z generalizirano LD, zdravljenih z metreleptinom, so bili vidni znaki izboljšanja v delovanju ledvic in jeter.
English: • One injection syringe with a much shorter needle for injecting the solution under your skin The size of this syringe will be chosen by your doctor, nurse or pharmacist for your dose of Myalepta.
Slovenian: Velikost te brizge izbere zdravnik, medicinska sestra ali farmacevt glede na vaš odmerek zdravila Myalepta.
English: Always use a new ampoule or vial of water for injection each time when preparing to dissolve Myalepta powder.
Slovenian: Vsakič, ko pripravljate prašek zdravila Myalepta za raztapljanje, uporabite novo ampulo ali vialo vode za injekcije.
English: How to store Myalepta
Slovenian: Shranjevanje zdravila Myalepta
English: Elderly
Slovenian: Tahikardija
English: • Do not over-tighten the needle.
Slovenian: • Pazite, da igle ne pritrdite premočno.
English: ● Presence of diabetes mellitus, or
Slovenian: ● sladkorna bolezen ali