natgillin/translations-raw huggingface dataset:
• Keeping the bottom of the ampoule still, gently twist the top of the ampoule until it is removed. 
• Spodnji del ampule držite pri miru in z drugo roko nežno odvijajte vrh ampule, dokler se ta ne odstrani.
For females > 40 kg once daily dose 
Za ženske > 40 kg enkratni dnevni odmerek
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. 
To zdravilo je primerno za otroke, stare 2 leti ali več, mladostnike in odrasle z generalizirano lipodistrofijo.
Metabolism and nutrition disorders Hypoglycaemia Decreased appetite Diabetes mellitus, Hyperphagia, Insulin resistance 
Sladkorna bolezen, hiperfagija, odpornost na insulin
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. 
• 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.
This is because it is not known how metreleptin will affect your unborn baby. 
Učinki metreleptina na nerojenega otroka namreč niso znani.
• swelling in your hands and feet 
• otekanje dlani in stopal
This is mixed with the Myalepta powder to dissolve the powder to make the liquid medicine that you inject. 
To pomešate s praškom zdravila Myalepta, da raztopite prašek v tekoče zdravilo,
5) Withdraw 0.6 mL of water for injection into the 1 mL syringe. 
5) Izvlecite 0,6 ml vode za injekcije v 1-mililitrsko brizgo.
This will include for example instructions for handling possible ADRs. 
To vključuje npr. navodila za ravnanje v primeru pojava neželenih učinkov.
- Tapering the dose over a two-week period is recommended in conjunction with a low fat diet. - Patients should be monitored during tapering. 
- Priporoča se postopno zmanjšanje odmerka v obdobju dveh tednov, skupaj z dieto z nizko vsebnostjo maščob.
• Each 0.01 mL is shown as a smaller line. 
• Vsakih 0,01 ml je prikazanih kot manjša črta.
Myalepta 5.8 mg powder for solution for injection Each vial contains 5.8 mg of metreleptin*. 
Myalepta 5,8 mg prašek za raztopino za injiciranje Ena viala vsebuje 5,8 mg metreleptina*.
Serious and/or severe infections that were temporally associated with > 80% blocking activity against metreleptin occurred in 5 generalised LD patients. 
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.
Individual patient once daily dose in mg = 5 mg Amount to inject once daily dose = 1 mL 
Individualni enkratni dnevni odmerek za bolnika v mg = 5 mg Volumen za injiciranje enkratnega dnevnega odmerka = 1 ml
• Patients/carers educational material 
• Izobraževalno gradivo za bolnike/skrbnike
With the needle still in the vial, turn the vial and syringe upside down. 
Z iglo še vedno v viali obrnite vialo in brizgo na glavo.
Myalepta 5.8 mg powder for solution for injection EU/1/18/1276/005 
Myalepta 5,8 mg prašek za raztopino za injiciranje EU/1/18/1276/005
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. 
Ne uporabljajte tega zdravila, če raztopina ni prozorna, je obarvana ali vsebuje delce ali grude praška.
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). 
Na začetku zdravljenja z zdravilom Myalepta pri bolnikih, ki prejemajo antidiabetike, predvsem insulin ali insulinske sekretagoge (glejte poglavje 4.4), obstaja nevarnost hipoglikemije.
Table 5 Conversion table for the 0.3 mL U100 insulin syringe Weight of child Dose of Myalepta 
Preglednica 5 Pretvorbena preglednici za 0,3-mililitrsko insulinsko brizgo U100 Telesna masa otroka
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. 
V primeru hipoglikemičnih dogodkov, ki niso hudi, lahko glede na mnenje lečečega zdravnika namesto prilagoditve odmerka antidiabetikov pride v poštev prilagoditev diete.
o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur: 
o Pri bolnikih, ki hkrati jemljejo insulin in druga antidiabetike, se lahko pojavi hipoglikemija:
• Do not remove the needle guard. 
• Ne odstranite varovala za iglo.
Myalepta 3 mg powder for solution for injection EU/1/18/1276/003 
Myalepta 3 mg prašek za raztopino za injiciranje EU/1/18/1276/003
Individual patient once daily dose in mg = 2.5 mg Amount to inject once daily dose = 0.5 mL 
Individualni enkratni dnevni odmerek za bolnika v mg = 2,5 mg Volumen za injiciranje enkratnega dnevnega odmerka = 0,5 ml
Table 6 Dose adjustment calculation Adjust dose as follows (if necessary) 
Preglednica 6 Izračun prilagoditve odmerka
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%. 
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.
Myalepta 11.3 mg powder for solution for injection EU/1/18/1276/001 
Myalepta 11,3 mg prašek za raztopino za injiciranje EU/1/18/1276/001
Starting daily dose (injection volume) 
Začetni dnevni odmerek (volumen injekcije)
After reconstitution, each mL contains 5 mg of metreleptin. 
Po redčenju en ml vsebuje 5 mg metreleptina.
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). 
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.
When properly mixed, the Myalepta solution should be clear and free of lumps of dry powder, bubbles or foam. 
Ko je pravilno zmešana, je raztopina zdravila Myalepta prozorna in brez grud ali suhega praška,
For doses of: > 1.5 mg - 5 mg / 0.3 - 1.0 mL volume daily 
Za odmerke: > 1,5 mg - 5 mg / 0,3 - 1,0 ml dnevno
5) Withdraw 2.2 mL of water for injection into the 3 mL syringe. 
5) Izvlecite 2,2 ml vode za injekcije v 3-mililitrsko brizgo.
Step B: Filling the 1 mL syringe with 0.6 mL of water for injections 
Korak B: Polnjenje 1-mililitrske brizge z 0,6 ml vode za injekcije
• Each 0.5 mL is shown as a number next to a big line. 
• Vsakih 0,5 ml je prikazanih kot številka poleg velike črte.
Glass ampoule of water for injection 
Steklena ampula vode za injekcije
Do not use the solution if discoloured or cloudy, or if particulate matter remains. 
Raztopine ne uporabljajte, če je obarvana ali motna ali če so v njej delci.
Step B: Filling the 3 mL syringe with 2.2 mL of water for injections 
Korak B: Polnjenje 3-mililitrske brizge z 2,2 ml vode za injekcije
• Keeping the bottom of the ampoule still, snap the tip off. 
• Spodnji del ampule držite na miru in odlomite konico.
Weight decreased 
Zmanjšanje telesne teže
• fainting or feeling dizzy 
• omedlevica ali občutek omotičnosti
• blood pressure medicines called ‘calcium channel blockers' 
• zdravila za krvni tlak, imenovana "zaviralci kalcijevih kanalčkov"; • teofilin, ki se uporablja pri težavah s pljuči, kot je astma;
• swelling and reddening of the skin, hives 
• otekanje in rdečica kože, koprivnica
Before opening the water for injection ampoule, prepare the 3 mL syringe by attaching the needle to it. Do not over-tighten the needle. 
Preden odprete ampulo z vodo za injekcije, pripravite 3-mililitrsko brizgo tako, da nanjo pritrdite iglo.
o If your dose is more than 1.5 mg up to 5 mg, you will use a 1 mL syringe. 
o Če je vaš odmerek več kot 1,5 mg in do največ 5 mg, boste uporabili 1,0-mililitrsko brizgo.
- Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of Myalepta treatment. 
- 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.
If your syringe looks different or has different dose markings, talk to your doctor, nurse or pharmacist for more information. 
Če je vaša brizga videti drugače ali ima drugačne oznake za odmerke, se posvetujte z zdravnikom,
− A starting dose is 5 mg (1 mL of solution). 
− začetni odmerek je 5 mg (1 ml raztopine).
Three cases of T-cell lymphoma have been reported while using metreleptin in clinical studies. 
T-celični limfom V kliničnih študijah so bili poročani trije primeri pojava T-celičnega limfoma med uporabo metreleptina.
• Remove the needle cover. 
• Odstranite pokrovček igle.
Glass vial of water for injection 
Steklena viala vode za injekcije
Step B: Filling the 3 mL syringe with 1.1 mL of water for injections 
Korak B: Polnjenje 3-mililitrske brizge z 1,1 ml vode za injekcije
• Healthcare professionals educational material 
• Izobraževalno gradivo za zdravstvene delavce
After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin. 
Po raztopitvi vsebine viale v 0,6 mililitrih vode za injekcije en mililiter vsebuje 5 miligramov metreleptina.
How Myalepta works 
Kako zdravilo Myalepta deluje
5) Withdraw 1.1 mL of water for injection into the 3 mL syringe. 
5) Izvlecite 1,1 ml vode za injekcije v 3-mililitrsko brizgo.
The clearance of metreleptin appears to be delayed in the presence of ADAs. 
Ob prisotnosti ADA je izločanje metreleptina potekalo počasneje.
• 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. 
• 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.
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