natgillin/translations-raw huggingface dataset:
These findings are considered to be related indirectly to metreleptin pharmacology, resulting in nutritional deprivation of treated animals, and also possibly, due to an inhibitory effect on spontaneous and oxytocin-induced contractions, as has been observed in strips of human myometrium exposed to leptin.
Ta odkritja se smatrajo kot posredno povezana s farmakologijo metreleptina, ki povzroča podhranjenost živali, ki prejemajo zdravilo, zelo verjetno pa so tudi posledica zaviralnega učinka na spontane in z oksitocinom sprožene popadke, kot je bilo mogoče opaziti v trakovih miometrija pri ljudeh, izpostavljenih leptinu.
Myalepta is an injection once a day under the skin (‘subcutaneous injection').
Zdravilo Myalepta je injekcija, ki si jo je treba enkrat dnevno dati pod kožo ("subkutana injekcija").
What Myalepta is and what it is used for 2.
Kaj je zdravilo Myalepta in za kaj ga uporabljamo 2.
• Clean the top of the vial with the alcohol wipe.
• Vrh viale očistite z alkoholnim robčkom.
Total daily volume to be injected is 3.75 mg/5 = 0.75 mL.
Skupni dnevni volumen za injiciranje je 3,75 mg/5 = 0,75 ml.
Your doctor, nurse or pharmacist should provide you separately with the appropriate syringes and needles, wipes and water for injections to enable you to prepare and inject Myalepta.
Zdravnik, medicinska sestra ali farmacevt vam mora posebej dati ustrezne brizge in igle, alkoholne zložence in vodo za injekcije, da si boste lahko sami pripravili in injicirali zdravilo Myalepta.
For patients weighing less than 40 kg, actual body weight at initiation of therapy should be used to calculate dose; of these, in patients weighing less than or equal to 25 kg, refer to Table 5 for the starting dose.
Pri bolnikih, ki tehtajo manj kot 40 kg, je treba za izračun odmerka uporabiti dejansko telesno težo na začetku zdravljenja; pri bolnikih, ki tehtajo 25 kg ali manj, za začetni odmerek glejte Preglednica 5.
Only the metabolic effects of metreleptin have been studied.
Preučeni so bili samo učinki metreleptina na presnovo.
Abortions, stillbirths and preterm deliveries have been reported in women exposed to metreleptin during pregnancy, though there is currently no evidence to suggest a causal relationship with the treatment.
Pri ženskah, ki so bile med nosečnostjo izpostavljene metreleptinu, so bili poročani primeri splavov, mrtvorojenosti in predčasnih porodov, čeprav trenutno ni nobenih dokazov za vzročno povezanost teh dogodkov z zdravljenjem.
Use only with the solvent for reconstitution, syringes and needles, provided separately.
Uporabljajte samo s topilom za rekonstitucijo, brizgami in iglami, ki so na voljo ločeno.
In this case, prolonged overdose was associated with severe anorexia causing vitamin and zinc deficiencies, iron deficiency anaemia, protein calorie malnutrition, and poor weight gain, which resolved following supportive treatment and dose adjustment.
V tem primeru je zaradi dolgotrajnega prevelikega odmerjanja prišlo do hude anoreksije, posledica česar so bili pomanjkanje vitaminov in cinka, slabokrvnost zaradi pomanjkanja železa, podhranjenost z vidika kalorij iz beljakovin ter slabo pridobivanje teže.
Upon initiation or discontinuation of metreleptin, in patients being treated with these types of agents, therapeutic monitoring of effect (e.g., warfarin), or drug concentrations (e.g. cyclosporin or theophylline) should be performed and the individual dose of the agent adjusted as needed.
Po začetku ali prekinitvi uporabe metreleptina je treba pri bolnikih, ki se zdravijo s tovrstnimi učinkovinami, spremljati učinek (npr. varfarin) ali koncentracije zdravila (npr. ciklosporin ali teofilin) ter po potrebi prilagoditi posamezni odmerek učinkovine.
LD patients with a blocking activity against metreleptin and concurrent infections responded to standard of care treatment (see section 4.4).
Bolniki z LD, ki so imeli zaviralno aktivnost proti metreleptinu in hkratne okužbe, so se odzvali na standardno zdravljenje (glejte poglavje 4.4).
o To know how much solution to inject (in Units), divide your dose (in mg) by 5, and then times it by 100.
o Da bi vedeli, koliko raztopine injicirati (v enotah), svoj odmerek (v mg) delite s 5 in ga nato pomnožite s 100.
• Use the alcohol swab to clean the break point on the ampoule.
• Z alkoholnim zložencem očistite prelomno točko na ampuli.
This unused water for injection should be disposed of in your sharps container.
To neporabljeno vodo za injekcije je treba zavreči v vsebnik za ostre predmete.
Do not stop using Myalepta without talking to your doctor.
Zdravila Myalepta ne prenehajte jemati, brez da bi se posvetovali z zdravnikom.
It can be administered any time of the day without regard to the timing of meals.
Zdravilo je mogoče injicirati kadar koli čez dan, ne glede na obroke.
Additionally, adverse reactions from post-marketing sources are also presented.
Poleg tega so predstavljeni tudi neželeni učinki iz virov po začetku trženja zdravila.
Overall, 30 (97%) patients were female, 26 (84%) were Caucasian, 2 (7%) Hispanic, and 0 Black.
Skupno je bilo 30 (97 %) bolnikov žensk, 26 (84 %) jih je bilo belcev, 2 (7 %) Hispanca in 0 črncev.
A subgroup of partial LD patients is analysed for whom TG ≥ 5.65 mmol/l and/or HbA1c ≥ 6.5% at baseline.
Analizirana je podskupina bolnikov s parcialno LD, za katere je osnovna raven TG ≥ 5,65 mmol/l in/ali HbA1c ≥ 6,5 %.
• being clumsy and dropping things
• nerodnost in padanje stvari iz rok
• low blood sugar (glucose)
• nizek krvni sladkor (glukoza)
These will have been given to you by your doctor, nurse, or pharmacist.
Tega boste prejeli od zdravnika, medicinske sestre ali farmacevta.
Metreleptin may decrease insulin resistance in diabetic patients, resulting in hypoglycaemia in patients with LD and co-existing diabetes.
Metreleptin lahko zmanjša odpornost na insulin pri diabetikih, kar lahko pri bolnikih z LD in sočasno sladkorno boleznijo vodi do hipoglikemije.
Your doctor or pharmacist will tell you how much of the solution to inject.
Zdravnik ali farmacevt vam bo povedal, koliko raztopine injicirati.
11) Remove the plastic cap from the vial of Myalepta powder.
11) Odstranite plastično zaporko z viale s praškom zdravila Myalepta.
• swelling or bleeding under the skin (‘haemorrhage')
• otekanje ali krvavitev pod kožo ("krvavitev")
Place the vial on a hard, flat surface.
Vialo postavite na trdo, plosko površino.
While being treated with Myalepta, your body might produce antibodies which may increase the risk of developing serious or severe infections.
Pri zdravljenju z zdravilom Myalepta vaše telo lahko proizvaja protitelesa, zaradi česar lahko obstaja povečano tveganje za pojav resnih in hudih okužb.
To remove the water for injection, break open the ampoule.
Za odstranite vodo za injekcije, odlomite pokrovček ampule.
If you need to inject 1 mL or more of Myalepta solution, your doctor might tell you to give the dose as two separate injections.
Če morate injicirati 1 ml raztopine Myalepta ali več, vam bo zdravnik morda rekel, da si odmerek injicirate v dveh ločenih injekcijah.
• Carefully push the plunger back up to force the air out of the syringe.
• Previdno potisnite bat nazaj navzgor, da iztisnete zrak iz brizge.
15) Mix the powder and water for injection
15) Zmešajte prašek in vodo za injekcije.
Remove the vial from the refrigerator and allow the vial to warm for 10 minutes to reach room temperature (20 °C-25 °C) prior to reconstitution.
Vzemite vialo iz hladilnika in počakajte 10 minut, da se segreje na sobno temperaturo (20 °C
Once insulin requirements have stabilised, dose adjustments of other anti-diabetic therapies may also be needed in some patients to minimise the risk of hypoglycaemia (see section 4.4 and 4.8).
Ko se potrebna količina insulina stabilizira, bo pri nekaterih bolnikih treba prilagoditi tudi druge antidiabetike, da zmanjšate tveganje za hipoglikemijo (glejte poglavji 4.4 in 4.8).
Among the 39 patients with generalised LD who were receiving insulin at baseline, 16 (41%) were able to discontinue insulin use altogether after starting metreleptin.
Med 39 bolniki z generalizirano LD, ki so ob izhodišču prejemali insulin, jih je lahko 16 (41 %) po začetku jemanja metreleptina povsem opustilo jemanje insulina.
The syringe will now be facing up.
Brizga bo sedaj usmerjena navzgor.
A causal relationship between lymphoma and Myalepta has not been established.
Vzročna povezanost med limfomom in zdravilom Myalepta ni bila dokazana.
Line up the top rim of the plunger with the line for the prescribed dose.
Poravnajte zgornji rob bata s črto za predpisan odmerek.
• A sudden increase in the amount of triglyceride in your blood can make your pancreas inflamed (‘pancreatitis').
• Nenadno povišanje količine trigliceridov v vaši krvi lahko povzroči vnetje trebušne slinavke
It is unknown whether metreleptin or its metabolites are excreted in human milk.
Ni znano, ali se metreleptin ali njegovi presnovki izločajo v materino mleko.
Instructions for Use Before using Myalepta, you must first read Sections 1 - 6 of this package leaflet, and then read Section 7 Instructions for Use.
Navodila za uporabo Pred uporabo zdravila Myalepta morate najprej prebrati poglavja 1-6 tega navodila, nato pa poglavje 7 -" Priročnik za uporabo".
Both had immunodeficiency and significant haematological abnormalities including severe bone marrow abnormalities before the start of treatment.
Oba bolnika sta pred začetkom zdravljenja že imela imunsko pomanjkljivost in hude hematološke motnje, vključno s hudimi motnjami kostnega mozga.
Autoimmune disorders are associated with an increased risk of malignancies including lymphomas.
Le-te pa so povezane s povečanim tveganjem malignomov, vključno z limfomi.
Studies in animals have shown some evidence of reproductive toxicity (see section 5.3).
Študije na živalih so pokazale določen škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• The needle should go as far into the ampoule as possible.
• Iglo je treba vstaviti čim dlje v ampulo.
Dispose of any unused medicine.
Morebitno neporabljeno zdravilo zavrzite.
• The active substance is metreleptin.
• Učinkovina je metreleptin.
Total daily volume to be injected is total dose in mg/5.
Skupni dnevni volumen za injiciranje je celotni odmerek v mg/5.
10) Make sure the vial of Myalepta powder has been out of the refrigerator for at least 10 minutes to reach room temperature.
10) Prepričajte se, da je viala s praškom zdravila Myalepta vsaj 10 minut zunaj hladilnika na sobni temperaturi.
Converting dose from ‘mL' to ‘Units' when using the 0.3 mL syringe Weight of child
Pretvarjanje odmerka iz "ml" v "enote" pri uporabi 0,3-mililitrske brizge Telesna masa otroka
If you have injected less Myalepta than you should, talk to your doctor straight away.
Če ste injicirali manjši odmerek zdravila Myalepta, kot bi morali, se takoj posvetujte z zdravnikom.
In clinical trials (Studies NIH 991265/20010769 and FHA101), the rate of ADAs for generalised LD and the partial LD patients studied and with data available were 88% (65 out of 74 patients).
V kliničnih študijah (študije NIH 991265/20010769 in FHA101) je incidenca ADA pri bolnikih z generalizirano in parcialno LD, za katere so bili na voljo podatki, znašala 88 % (65 od 74 bolnikov).
• blood-thinning medicines (such as warfarin or phenprocoumon)
• zdravila proti strjevanju krvi (kot je varfarin ali fenprokumon);
Push the plunger all the way down.
Bat potisnite čisto navzdol.
Though temporally associated, it is not possible to unequivocally confirm or deny a direct relation to metreleptin treatment based on the currently available body of evidence.
Čeprav je časovno povezano, na podlagi trenutno razpoložljivega dokaznega gradiva ni mogoče nedvoumno potrditi ali zavrniti neposredne povezave z zdravljenjem z metrelepinom.
• To help with injecting Myalepta solution using the small 0.3 mL syringe, the last column in the table below shows the ‘Unit' measurement on the syringe that relates to the different potential doses of the medicine prescribed by your doctor, nurse, or pharmacist.
• Za pomoč pri injiciranju raztopine zdravila Myalepta z majhno 0,3-mililitrsko brizgo je v zadnjem stolpcu spodnje preglednice prikazana merska "enota" na brizgi, ki ustreza različnim potencialnim odmerkom zdravila, ki vam jih predpiše zdravnik, medicinska sestra ali farmacevt.
During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed.
V tem času spremljajte ravni trigliceridov in po potrebi uvedite ali prilagodite odmerek zdravila za zniževanje ravni lipidov.
• Do not remove the needle from the vial.
• Ne odstranite igle iz viale.
Myalepta has minor influence on the ability to drive and use machines.
Zdravilo Myalepta ima blag vpliv na sposobnost vožnje in upravljanja strojev.
• alcohol wipes (to clean your skin where you will inject and to clean the tops of the vials)
• alkoholne zložence (za čiščenje kože na mestu injiciranja ter za čiščenje vrha vial);
White lyophilised cake or powder.
Bela liofilizirana pogača ali prašek.
• sweating more than normal
• potenje bolj kot običajno
See section 2 “How to stop using Myalepta” for more information.
Za več informacij glejte 2. poglavje "Kako prenehati z uporabo zdravila Myalepta".
You should not stop using Myalepta unless your doctor tells you to.
Z jemanjem zdravila Myalepta ne prenehajte, razen če vam to naroči zdravnik.
Before you begin self-administering this medicine at home, your doctor, nurse or pharmacist will train you how to prepare and inject Myalepta.
Preden si začnete zdravilo sami dajati doma, vas mora zdravnik, medicinska sestra ali farmacevt poučiti o pripravi in injiciranju zdravila Myalepta.
Following reconstitution with water for injections, the medicinal product must be used immediately and cannot be stored for future use.
Po redčenju z vodo za injiciranje je treba zdravilo uporabiti takoj in se ga ne sme shraniti za poznejšo uporabo.
Of the 31 partial LD subgroup patients evaluated, 27 (87%) had familial partial LD and 4 (13%) had acquired partial LD.
Med 31 analiziranimi bolniki iz podskupine s parcialno LD jih je 27 (87 %) imelo familiarno parcialno LD in 4 (13 %) pridobljeno parcialno LD.
• high blood sugar levels
• povišane ravni krvnega sladkorja
Myalepta reconstituted with water for injection is for single use only and should be administered immediately.
Zdravilo Myalepta, razredčeno z vodo za injiciranje, je predvideno samo za enkratno uporabo in ga je treba vzeti takoj.
o Ways to prevent the occurrence of medication errors - Myalepta is administered by SC injection and proper technique should be used to avoid intramuscular injection in patients with minimal SC tissue.
o Načini preprečevanja napak pri uporabi zdravila - Zdravilo Myalepta se daje s subkutano injekcijo, zato je treba uporabiti primerno tehniko, da se pri bolnikih z minimalnim subkutanim tkivom prepreči intramuskularno injiciranje.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Morebitno neporabljeno zdravilo ali odpadni material je treba zavreči v skladu z lokalnimi predpisi.
If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks.
Če morate prenehati z jemanjem zdravila Myalepta, vam bo zdravnik postopoma zmanjševal odmerek v obdobju dveh tednov.
Overall, 51 (77%) patients were female, 31 (47%) were Caucasian, 11 (17%) Hispanic, and 16 (24%) Black.
Skupno je bilo 51 (77 %) bolnikov žensk, 31 (47 %) jih je bilo belcev, 11 (17 %) Hispancev in 16 (24 %) črncev.
• If you are female and weigh more than 40 kg:
• Če ste ženska in tehtate več kot 40 kg:
Blood glucose abnormal, Blood triglycerides increased, Drug specific antibody present, Glycosylated haemoglobin increased, Weight increased
Nenormalna raven glukoze v krvi, povečani trigliceridi v krvi, prisotnost za zdravilo specifičnih protiteles, povečan glikoziliran hemoglobin, povečanje telesne teže
If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks before stopping it altogether.
Če morate prenehati z uporabo zdravila Myalepta, vam bo zdravnik postopoma zmanjševal odmerek v obdobju dveh tednov, preden boste zdravilo povsem prenehali uporabljati.
If any of the above apply to you (or you are not sure), talk to your doctor before using Myalepta.
Če jemljete katero od zgornjih zdravil (ali ste negotovi), se pred uporabo zdravila Myalepta posvetujte z zdravnikom.
In the generalised LD group, mean decreases from baseline in HbA1c were noted in all age groups ≥ 6 years; the mean decreases to Month 12/last observation carried forward LOCF were similar in the two older age groups (-1.1% and -2.6%).
V skupini z generalizirano LD je bilo pri vseh starostnih skupinah ≤ 6 let zabeleženo povprečno zmanjšanje od izhodiščne ravni HbA1c; povprečna zmanjšanja po 12 mesecih/zadnjem izvedenem spremljanju (LOCF - last observation carried forward) so bila podobna pri obeh starejših starostnih skupinah (-1,1 % in -2,6 %).
Talk to a doctor straight away if you notice any signs of an inflamed pancreas, including:
Takoj se posvetujte z zdravnikom, če opazite katere koli znake vnete trebušne slinavke, vključno z naslednjimi:
The AUC exposure of pregnant mice was approximately 2 to 3 times greater than observed in non-pregnant mice after 10 mg/kg subcutaneous administration of metreleptin.
Izpostavljenost na podlagi AUC pri brejih miših je bila približno 2- do 3-krat večja kot pri nebrejih miših po 10 mg/kg subkutanega prejemanja metreleptina.
Specific clinical studies have not been conducted to assess the effect of age, gender, race, or body mass index on the pharmacokinetics of metreleptin in patients with lipodystrophy.
Starost, spol, rasa, indeks telesne mase Specifičnih kliničnih študij za oceno učinka starosti, spola, rase ali indeksa telesne mase na farmakokinetiko metreleptina pri bolnikih z lipodistrofijo niso izvedli.
• having a high temperature
• povišana telesna temperatura
If a patient misses a dose, the dose should be administered as soon as the omission is noticed and the normal dosing schedule resumed the next day.
Če bolnik izpusti odmerek, ga mora vzeti takoj, ko to opazi, ter naslednji dan nadaljevati z normalnim odmerjanjem.
• Remove the syringe from the plastic ampoule.
• Odstranite brizgo iz plastične ampule.
o See the “Instructions for Use” to find out which syringe to use.
o V "priročniku za uporabo" je navedeno, katero brizgo uporabiti.
Your doctor, nurse or pharmacist will show you how to prepare and inject this medicine.
Zdravnik, medicinska sestra ali farmacevt vam bo pokazal, kako zdravilo pripraviti in ga injicirati.
Tell your doctor straight-away if you have any symptoms of an allergic reaction.
Svojega zdravnika takoj obvestite o morebitnih simptomih alergijske reakcije.
• increased blood sugar (glucose)
• povišan krvni sladkor (glukoza)
All reports of hypoglycaemia in patients with generalised LD and in the subgroup of partial LD patients, have been mild in nature with no pattern of onset or clinical sequelae.
Vsi pojavi hipoglikemije pri bolnikih z generalizirano LD in v podskupini bolnikov s parcialno LD so bili blage narave in brez vzorca nastanka ali kliničnih posledic.
A dose increment of 1.25 mg increases the daily dose to 3.75 mg.
povečanjem v koraku po 1,25 mg se dnevni odmerek poveča na 3,75 mg.
However, in published studies, leptin treatment of euleptinaemic prepubertal female mice has led to an earlier onset of puberty.
Vendar pa je pri objavljenih študijah dajanje metreleptina predpubertetnim mišjim samicam vodilo do zgodnejšega začetka pubertete.
● Fasting insulin concentration > 30 μU/mL, or
● koncentracija insulina na tešče > 30 μ e./ml ali
- Guidance in the educational materials on: The size of syringes and needles to prescribe Prescribing the dose in both mg and ml and, where a 0.3 mL U100 insulin syringe is used, informing patients on the dose in "units" on the syringe to inject The prescribing of ampoule/vial sizes volumes of water for injection in appropriate volumes to reduce the risk of re-use Pharmacists will be guided in the educational materials on the ancillary items that need to be dispensed to patients including appropriate sized reconstitution and administration syringes and needles, appropriate sized vials/ampoules of water for injection, alcohol swabs and a sharps bin plus how to access Aegerion reconstitution and administration kits containing all of the above items except the water for injection and sharps bin.
Predpisovanju odmerka v mg in ml ter, v primeru uporabe 0,3 ml-insulinske brizge U100, o obveščanju bolnikov o odmerku v »enotah« na brizgi za injiciranje Predpisovanju ampul/vial z vodo za injekcije z ustreznim volumnom, da se zmanjša tveganje ponovne uporabe zdravila V izobraževalnem gradivu dobijo farmacevti napotke o pomožnem materialu, ki ga je treba izdati bolnikom, vključno z ustrezno velikostjo brizg in iglel za rekonstitucijo in dajanje zdravila, ustrezno velikostjo viala/ampula vodo za injekcije z ustreznim volumnom, alkoholnimi blazinicami in vsebnikom za ostre predmete, ter napotke o zagotovitvi kompletov za rekonstitucijo in dajanje podjetja Aegerion, ki vsebujejo ves omenjeni material, razen vode za injekcije in vsebnika za ostre predmete.
In studies of healthy adult subjects, following intravenous administration of metreleptin, leptin volume of distribution (endogenous leptin and metreleptin) was approximately 4 to 5 times plasma volume; volumes (mean ± SD) were 370 ± 184 mL/kg, 398 ± 92 mL/kg, and 463 ± 116 mL/kg for 0.3, 1.0, and 3.0 mg/kg/day doses, respectively.
Pri študijah z zdravimi odraslimi osebami je bil po intravenskem odmerjanju metreleptina porazdelitveni volumen leptina (endogeni leptin in metreleptin) približno 4- do 5-krat večji od volumna plazme; volumni (povprečni ± SD) so bili 370 ± 184 ml/kg, 398 ± 92 ml/kg in 463 ± 116 ml/kg za 0,3, 1,0 oz. 3,0 mg/kg/dnevni odmerek.
The maximum daily dose in males and females is 10 mg or 2 mL injection volume
Največji dnevni odmerek pri moških in ženskah je 10 mg ali 2 ml injiciranega volumna.
• If you are male and weigh more than 40 kg:
• Če ste moški in tehtate več kot 40 kg:
• The needle should be facing down.
• Igla mora biti usmerjena navzdol.
• All of the water for injection should be injected into the vial.
• V vialo je treba injicirati vso vodo za injekcije.
Insert the needle into the vial containing the lyophilized powder, through the centre of the stopper and direct the stream of solvent to the wall of the vial to avoid excessive foaming.
Iglo vstavite v vialo z liofiliziranim praškom skozi sredino zamaška in usmerite curek topila ob steno viale, da preprečite prekomerno penjenje.
o Myalepta may increase fertility, due to effects on LH and thus the chances of unplanned pregnancy.
o Zdravilo Myalepta lahko poveča plodnost zaradi učinka na LH, zaradi česar obstaja možnost nenačrtovane nosečnosti.
Metreleptin has not been studied in patients with impaired renal or hepatic function.
Metreleptin ni bil preučen pri bolnikih z okvarami ledvic ali jeter.
● Percent change from baseline in fasting serum TGs at Month 12
● odstotna sprememba v ravneh TG v serumu na tešče v 12. mesecu glede na izhodišče.
• fluid in your lungs - difficulty breathing or cough
• tekočina v pljučih - oteženo dihanje ali kašelj
• Do not move the plunger.
• Ne premikajte bata.
Adverse reactions are classified by MedDRA System Organ Class and absolute frequency in Table 7.
Neželeni učinki so razvrščeni v Preglednica 7 glede na organske sisteme MedDRA in absolutno pogostost.
• muscle pain (‘myalgia')
• bolečine v mišicah ("mialgija")
The median age at baseline was 38 years (range: 15-64 years), with 5 (16%) patients being less than 18 years of age.
Povprečna starost je bila 38 let (razpon: 15-64 let), od tega je bilo 5 (16 %) bolnikov mlajših od 18 let.
The cake of lyophilised powder should be intact and white in colour.
Pogača iz liofiliziranega praška mora biti intaktna in bele barve.
o The 0.3 mL syringe will show the injection amount in ‘Unit' instead of ‘mL'.
o Na 0,3-mililitrski brizgi bo količina za injiciranje prikazana v "enoti" namesto v "ml".
The importance of tapering the dose of Myalepta over two weeks if it is to be discontinued.
Pomembnost postopnega zmanjšanja odmerka zdravila Myalepta v obdobju dveh tednov v primeru prenehanja jemanja zdravila.