natgillin/translations-raw huggingface dataset:
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.
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.
• Pull the plunger down to the 0.6 mL line to draw air into the syringe.
• Povlecite bat navzdol do črte za 0,6 ml, da potegnete zrak v brizgo.
While being treated with Myalepta, you may get an allergic reaction.
Med zdravljenjem z zdravilom Myalepta se lahko pojavijo alergijske reakcije.
• Each 0.1 mL is shown as a smaller line between the big lines.
• Vsakih 0,1 ml je prikazanih kot manjša črta med velikimi črtami.
20) Check for air pockets and air bubbles.
20) Preverite, ali so prisotni zračni žepi in zračni mehurčki.
Before opening the water for injection ampoule, prepare the 1 mL syringe by attaching the needle to it. Do not over-tighten the needle.
Preden odprete ampulo z vodo za injekcije, pripravite 1-mililitrsko brizgo tako, da nanjo pritrdite iglo.
• Pull the plunger down to the 1.1 mL line to draw air into the syringe.
• Povlecite bat navzdol do črte za 1,1 ml, da potegnete zrak v brizgo.
Large dose reductions of 50% or more of baseline insulin requirements may be needed in the initial phases of treatment.
V začetnih fazah zdravljenja bo morda treba odmerek insulina zmanjšati tudi do 50 % ali več glede na potrebe pred začetkom zdravljenja.
With the syringe still in the ampoule, turn the ampoule and syringe upside down.
Z brizgo še vedno v ampuli obrnite ampulo in brizgo na glavo.
• 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.
• 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.
How to use Myalepta
Kako uporabljati zdravilo Myalepta
- 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.
- V primeru hipoglikemičnih dogodkov, ki niso hudi, lahko namesto prilagoditve odmerka antidiabetikov pride v poštev prilagoditev diete.
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.
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.
• Each 0.1 mL is shown as a number with a big line.
• Vsakih 0,1 ml je prikazanih kot številka z veliko črto.
• Each vial contains 3 milligrams of metreleptin.
• Ena viala vsebuje 3 mg metreleptina.
Attach the needle to the 1 mL syringe.
Pritrdite iglo na 1-mililitrsko brizgo.
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.
- 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.
Amount of mixed Myalepta solution
Količina zmešane raztopine zdravila Myalepta
• Guide for patients/carers
• Vodnik za bolnike/skrbnike
‘Unit' measurement volume in 0.3 mL
"Enota" volumna za injiciranje v 0,3-mililitrski brizgi
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite kateri koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Table 1 Metreleptin recommended dose Baseline weight
Preglednica 1 Priporočen odmerek metreleptina Izhodiščna telesna masa
You must use a clean syringe and needle for both injections.
Za vsako injiciranje morate uporabiti čisto brizgo in iglo.
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.
Pri pediatričnem bolniku, ki je prejemal zdravilo, vendar pred začetkom zdravljenja ni imel hematoloških motenj, je bil poročan ločen primer anaplastičnega velikoceličnega limfoma.
- Lymphoproliferative disorders, including lymphoma have been reported in patients with acquired generalised LD not treated with Myalepta.
- Pri bolnikih s pridobljeno generalizirano LD, ki se niso zdravili z zdravilom Myalepta so poročali o limfoproliferativnih boleznih, vključno z limfomi.
• Healthcare professionals training material
• Gradivo za usposabljanje zdravstvenih delavcev
Natural leptin is produced by fatty tissue and has many functions in the body including:
Naravni leptin proizvajajo maščobna tkiva in ima v telesu številne funkcije, vključno z naslednjimi: • nadzira občutek lakote in vaše ravni energije;
In patients with serious and severe infections, continuation of metreleptin should be at the discretion of the prescriber.
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.
• Pull the plunger down to the 2.2 mL line to draw air into the syringe.
• Povlecite bat navzdol do črte za 2,2 ml, da potegnete zrak v brizgo.
A total of 148 patients with generalised and partial LD received metreleptin during clinical studies.
Povzetek varnostnega profila Med kliničnimi študijami je metreleptin prejelo skupno 148 bolnikov z generalizirano in parcialno LD.
Package leaflet: Information for the patient Myalepta 5.8 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Navodilo za uporabo Myalepta 5,8 mg prašek za injiciranje metreleptin Za to zdravilo se izvaja dodatno spremljanje varnosti.
• Do not attach the needle to the syringe.
• Ne pritrdite igle na brizgo.
Attach the needle to the 3 mL syringe.
Pritrdite iglo na 3-mililitrsko brizgo.
19) Keeping the needle inside the vial, pull the plunger down.
19) Z iglo v viali povlecite bat navzdol.
• 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.
• 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.
o Hypersensitivity has been reported with Myalepta use including anaphylaxis, urticaria and generalised rash.
o Pri bolnikih, ki prejemajo zdravilo Myalepta, so poročali o primerih preobčutljivosti vključno z anafilaksijo, koprivnico in generaliziranim izpuščajem.
18) With the needle in the vial, turn the vial and syringe upside down.
18) Z iglo še vedno v viali obrnite vialo in brizgo na glavo.
• feeling more sleepy or confused
• občutek omotičnosti • občutek večje zaspanosti ali zmedenosti
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.
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.
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.
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.
• bruising, reddening, itching or hives where the injection is given
• podplutbe, rdečica, srbenje ali izpuščaj na mestu injiciranja
Your doctor, nurse or pharmacist will give you ‘water for injection' with the medicine vial and syringes.
Zdravnik, medicinska sestra ali farmacevt vam bo skupaj z vialo z zdravilom in brizgami dal tudi
21 gauge 40 mm needle Myalepta 11.3 mg powder for solution for injection 3.0 mL
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
For males and females ≤ 40 kg once daily dose
Za moške in ženske ≥40 kg enkratni dnevni odmerek
• You must check for air pockets or air bubbles in your 3 mL syringe.
• Preverite, ali se v 3-mililitrski brizgi nahajajo zračni žepi ali zračni mehurčki.
Package leaflet: Information for the patient Myalepta 11.3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Navodilo za uporabo Myalepta 11,3 mg prašek za injiciranje metreleptin Za to zdravilo se izvaja dodatno spremljanje varnosti.
There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic therapy.
Pri bolnikih, ki se zdravijo z zdravilom Myalepta in jemljejo zdravila proti sladkorni bolezni, obstaja nevarnost hipoglikemije.
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.
Za otroke, mlajše od 2 let z generaliziranim LD, in mlajše od 12 let s parcialnim LD, je na voljo le malo kliničnih podatkov.
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
Telesna masa (kg) x 0,012 ml/kg = individualni dnevni začetni volumen za injiciranje za bolnika v ml
Package leaflet: Information for the patient Myalepta 3 mg powder for solution for injection metreleptin This medicine is subject to additional monitoring.
Navodilo za uporabo Myalepta 3 mg prašek za injiciranje metreleptin Za to zdravilo se izvaja dodatno spremljanje varnosti.
Symptoms of low blood sugar levels include:
Znaki visokega in nizkega krvnega sladkorja Simptomi nizkih ravni krvnega sladkorja vključujejo:
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.
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.
Advice will be provided on symptoms of an allergic reaction and action to be taken in the event of such a reaction.
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.
Do not over-tighten the needle.
Pazite, da igle ne pritrdite premočno.
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.
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.
• severe pain in your stomach (abdomen)
• huda bolečina v trebuhu
After reconstitution with 1.1 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Po redčenju z 1,1 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
Do not use the solution if it is not clear or has bits or lumps in it.
Ne uporabljajte raztopine, če ni prozorna ali vsebuje delce ali grude praška.
• You must check for air pockets or air bubbles in your 1 mL syringe.
• Preverite, ali se v 1-mililitrski brizgi nahajajo zračni žepi ali zračni mehurčki.
• Each 0.5 U is shown as a small line between two 1 U lines.
• Vsakih 0,5 U je prikazanih kot majhna črtica med dvema črtama 1 U. To je enako 0,005 ml.
• Hold the ampoule so that the tip is facing up.
• Ampulo držite tako, da bo konica usmerjena navzgor.
After reconstitution with 2.2 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Po redčenju z 2,2 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
Menorrhagia
koprivnica
Males and females ≤ 40 kg
Moški in ženske ≥ 40 kg
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.
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.
o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur.
o Pri bolnikih, ki sočasno jemljejo insulin in druga zdravila za sladkorno bolezen, se lahko pojavi hipoglikemija.
Rotation of injection sites is recommended in patients co-administering insulin (or other subcutaneous medicinal products) and Myalepta.
- Pri bolnikih, ki sočasno prejemajo insulin (ali druga subkutana zdravila) in zdravilo
• chest infection
• okužbe v prstnem košu
You should not use Myalepta if you are pregnant or might become pregnant.
Če ste noseči ali bi lahko zanosili, ne uporabljajte zdravila Myalepta.
• swelling of your face, lips, tongue or throat
• otekanje obraza, ustnic, jezika ali v grla • bolečine v trebuhu, siljenje na bruhanje (navzea) in bruhanje
Both males and females > 40 kg
Moški in ženske > 40 kg
After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Po redčenju z 0,6 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
Table 4 Required administration syringe per Myalepta dose Syringe
Preglednica 4 Potrebna brizga na odmerek zdravila Myalepta Brizga
• Move the vial gently in a circle (swirling motion)
• Pri tem nežno krožite z vialo (vrtite).
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.
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.
• Insert the 3 mL syringe needle into the vial, through the rubber seal.
• Vstavite iglo 3-mililitrske brizge v vialo skozi gumijasto tesnilo.
After reconstitution, the solution must be administered immediately and cannot be stored for later use.
Po pripravi si morate raztopino injicirati takoj je ne smete hraniti za poznejšo uporabo.
• feeling sick (nausea) or being sick (vomiting)
• siljenje na bruhanje (navzea) in bruhanje • driska
- Monitoring of blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment is warranted.
- 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.
The once daily dose of Myalepta can be increased by increments as shown in Table 6 to a maximum daily dose.
*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.
• One 1 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
• eno 1-mililitrsko brizgo z iglo premera 21G, dolgo 40 mm, za topljenje praška;
• 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.
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.
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.
Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z modro plastično zaporko.
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.
12) Vstavite iglo 1-mililitrske brizge, v kateri sta 0,6 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
Cases of T-cell lymphoma have been reported in clinical studies in patients taking Myalepta.
V kliničnih študijah so poročali o primerih pojava T-celičnega limfoma med uporabo zdravila Myalepta.
For doses of: ≤ 1.5 mg /≤ 0.3 mL volume daily
Za odmerke: ≥ 1,5 mg /≥ 0,3 ml dnevno
• Pull up until the top rim of the plunger lines up with the black 0.6 mL line.
• Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 0,6 ml.
• diabetes
• sladkorna bolezen
21 gauge 40 mm needle
40 mm igla
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.
12) Vstavite iglo 3-mililitrske brizge, v kateri sta 2,2 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
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.
Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z belo plastično zaporko.
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.
12) Vstavite iglo 3-mililitrske brizge, v kateri sta 1,1 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
• One 3 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder
• eno 3-mililitrsko brizgo z iglo premera 21G, dolgo 40 mm, za topljenje praška;
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.
Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z rdečo plastično zaporko.
• Pull up until the top rim of the plunger lines up with the black 1.1 mL line.
• Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 1,1 ml.
• Insert the 1 mL syringe needle into the vial, through the rubber seal.
• Vstavite iglo 1-mililitrske brizge v vialo skozi gumijasto tesnilo.
• 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:
Uporablja se, če so bile druge oblike zdravljenja neučinkovite, pri odraslih in mladostnikih, starih 12 let ali več:
Myalepta 11.3 mg powder for injection metreleptin
Myalepta 11,3 mg prašek za raztopino za injiciranje metreleptin
*Global post marketing experience
in iz izkušenj po začetku trženja zdravila
Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
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.
• going to the toilet to pass urine more often
• pogosteje odvajanje vode
Abrupt interruption and/or non-compliance with metreleptin dosing was suspected to have contributed to the occurrence of pancreatitis in 2 patients.
Obstaja možnost, da sta pri 2 bolnikih za pojav pankreatitisa bila odgovorna nenadna prekinitev in/ali nepravilno odmerjanje metreleptina.
- Rotation of injection sites is recommended in patients co administering insulin (or other SC medicinal products) and Myalepta.
Pri bolnikih, ki hkrati jemljejo insulin (ali druga subkutana zdravila) in zdravilo Myalepta, se priporoča rotacija mest injiciranja.
o Loss of efficacy, potentially due to neutralising antibodies, may occur in patients on Myalepta therapy.
o Pri bolnikih, ki se zdravijo z zdravilom Myalepta, lahko pride do zmanjšanja učinkovitosti, najverjetneje zaradi nevtralizirajočih protiteles.
Myalepta 5.8 mg powder for injection metreleptin
Myalepta 5,8 mg prašek za raztopino za injiciranje metreleptin
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Myalepta 3 mg powder for solution for injection 1.0 mL
Myalepta 3 mg prašek za raztopino za injiciranje 1,0 ml premer 21G
• Remove the needle guard.
• Odstranite varovalo za iglo.
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.
anamneza pankreatitisa, huda hipertrigliceridemija), se priporoča postopno zmanjšanje odmerka v obdobju dveh tednov, hkrati z dieto z malo maščobami.
Myalepta 3 mg powder for injection metreleptin
Myalepta 3 mg prašek za raztopino za injiciranje metreleptin
• Pull up until the top rim of the plunger lines up with the black 2.2 mL line.
• Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 2,2 ml.
Talk to your doctor, pharmacist or nurse before using Myalepta if:
Pred začetkom uporabe zdravila Myalepta se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
No formal pharmacokinetic studies were conducted in patients with hepatic impairment.
Pri bolnikih z okvaro jeter formalnih farmakokinetičnih študij niso izvedli.
Rounded amount of solution
Zaokrožen volumen raztopine
Myalepta 3 mg powder for solution for injection.
Myalepta 3 mg prašek za raztopino za injiciranje
Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue plastic flip-off cap.
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.
Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Po rekonstituciji en ml vsebuje 5 mg metreleptina (5 mg/ml).
Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of treatment.
2 tednih zdravljenja bo morda treba odmerek zmanjšati tudi do 50 % ali več glede na potrebe pred začetkom zdravljenja.
Myalepta 5.8 mg powder for solution for injection.
Myalepta 5,8 mg prašek za raztopino za injiciranje