FrancophonIA/ELRC3.0 huggingface dataset:
English: Metreleptin exhibits no genotoxic potential and no proliferative or preneoplastic lesions were observed in mice or dogs following treatment up to 6 months.
Slovenian: Metreleptin nima genotoksičnega potenciala, pri miših ali psih pa se po njegovem dajanju v trajanju do 6 mesecev niso pojavile proliferativne ali preneoplastične lezije.
English: • pain in the chest or back
Slovenian: • bolečina v prsnem košu ali hrbtu
English: A blocking activity of the reaction between metreleptin and a recombinant leptin receptor has been observed in vitro in the blood of the majority of patients but the impact on the efficacy of metreleptin could not be clearly established (see section 4.8).
Slovenian: Aktivnost zaviranja reakcije med metreleptinom in receptorjem za rekombinantni leptin je bila ugotovljena in vitro v krvi večine bolnikov, vendar vpliva na učinkovitost metreleptina ni bilo mogoče jasno določiti (glejte poglavje 4.8).
English: The Applicant should conduct this integrated analysis according to an agreed protocol including samples from all available historical samples from previous studies (NIH991265/20010769, FHA 101, NASH4 and obesity studies) with patients with GL/PL and samples obtained from patients that will be included in the efficacy and safety study in PL patients, the paediatric investigational plan (PIP) study and the patients registry.
Slovenian: Predlagatelj mora to integrirano analizo izvesti v skladu z dogovorjenim protokolom, vključno z vzorci iz vseh razpoložljivih zgodovinskih vzorcev iz prejšnjih študij (NIH991265/20010769, FHA 101, NASH4 in študije debelosti) z bolniki z generalizirano/parcialno LD in vzorci, dobljenimi od bolnikov, ki bodo vključeni v študijo o učinkovitosti in varnosti pri bolnikih s parcialno LD, študijo iz načrta pediatričnih raziskav (PIP) in iz registra bolnikov.
English: • feeling more irritable or more nervous
Slovenian: • večja razdražljivost ali živčnost
English: Myalepta can affect the way some other medicines work.
Slovenian: Zdravilo Myalepta lahko vpliva na način delovanja drugih zdravil.
English: However, separate studies revealed that exposure of the mouse foetus to metreleptin was low (< 1%) after subcutaneous administration of metreleptin to pregnant mice.
Slovenian: Vendar pa so ločene študije pokazale, da je bila izpostavljenost mišjega ploda metreleptinu po subkutanem dajanju metreleptina breji miši nizka (< 1 %).
English: These differences across age groups are likely related to differences in mean HbA1c at baseline, which was in the normal range for patients < 6 years (5.7%) and lower in patients ≥ 6 to < 12 years (6.4%) compared to the older age group (9.7%).
Slovenian: Te razlike med starostnimi skupinami so najverjetneje povezane z razlikami v povprečni izhodiščni ravni HbA1c, ki je bila pri bolnikih < 6 let v normalnem razponu (5,7 %) in pri bolnikih ≤ 6 do < 12 let (6,4 %) nižja v primerjavi s starejšo starostno skupino (9,7 %).
English: • The water for injection should go down the inside wall of the vial.
Slovenian: • Voda za injekcije bi morala steči po steni viale.
English: • Do not recycle the syringes, caps, or sharps disposal container, or throw them into household waste.
Slovenian: • Brizg, zapork ali vsebnika za ostre predmete ne reciklirajte ali jih mečite v gospodinjske odpadke.
English: Contact them if you are unclear about anything or if you need more information or help.
Slovenian: Če ste glede česar koli negotovi ali potrebujete več informacij ali pomoč, se obrnite nanje.
English: See section 3 “How much to inject” for more information.
Slovenian: Za več informacij glejte 3. poglavje "Koliko injicirati".
English: Signs of high blood sugar levels and high fat levels are listed in section 4 under “Signs of high and low blood sugar” and “Signs of high fat”.
Slovenian: Znaki visokih ravni krvnega sladkorja in maščob so navedeni v 4. poglavju pod "Znaki za visok in nizek krvni sladkor" in "Znaki visokih ravni maščob v krvi".
English: ● Actual change from baseline in HbA1c at Month 12, and
Slovenian: ● dejanska sprememba v ravni HbA1c v 12. mesecu glede na izhodišče in
English: The median duration of metreleptin treatment was 4.2 years (range: 3.4 months-13.8 years).
Slovenian: Povprečno trajanje zdravljenja z metreleptinom je bilo 4,2 leti (razpon: 3,4 mesecev-13,8 let).
English: Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
Slovenian: Zdravilo Myalepta je indicirano kot dodatek prehrani kot nadomestna terapija za zdravljenje zapletov zaradi pomanjkanja leptina pri bolnikih s lipodistrofijo (LD):
English: In a pre- and postnatal development study in mice, metreleptin caused prolonged gestation and dystocia at all tested doses, starting at, approximately, a dose identical to the maximum recommended clinical dose, based on body surface area of a 60 kg patient.
Slovenian: V študiji pre- in ponatalnega razvoja pri miših je metreleptin povzročil daljšo gestacijo in distocijo pri vseh preizkušenih odmerkih, začenši s približno odmerkom, identičnim največjemu priporočenemu kliničnemu odmerku na osnovi telesne površine 60 kg težkega bolnika.
English: Do not give this medicine to children below the age of 2 years with generalised lipodystrophy, or below the age of 12 years with partial lipodystrophy.
Slovenian: Tega zdravila ne dajajte otrokom, mlajšim od 2 let, z generalizirano lipodistrofijo ali mlajšim od 12 let s parcialno lipodistrofijo.
English: In a supportive trial in LD patients, the median Tmax was 4 hours (range: 2 to 6 hours; N = 5) following single-dose administration of metreleptin.
Slovenian: V podporni študiji pri bolnikih z LD je bil povprečni Tmax 4 ure (razpon: 2 do 6 ur; N=5) po enkratnem odmerku metreleptina.
English: Myalepta has minor influence on the ability to drive and use machines due to fatigue and dizziness.
Slovenian: Zdravilo Myalepta ima blag vpliv na sposobnost vožnje in upravljanja strojev zaradi utrujenosti in omotice.
English: The median fasting leptin concentration at baseline was 5.9 ng/mL (1.6-16.9) using the LINCO RIA test method.
Slovenian: Povprečna koncentracija leptina na tešče je bila ob izhodišču 5,9 ng/ml (1,6-16,9), določena je bila z uporabo testne metode LINCO RIA.
English: What you need to know before you use Myalepta Do not use Myalepta if:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Myalepta Ne uporabljajte zdravila Myalepta :
English: Healthcare professionals' educational material should contain:
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vsebovati:
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Morda boste opazili, da imate povišano temperaturo in ste vedno več utrujeni Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: Endogenous leptin is present in human milk.
Slovenian: V materinem mleku je prisoten endogeni leptin.
English: Women of childbearing potential should be advised that Myalepta may increase fertility and should be encouraged to use contraception.
Slovenian: Ženske v rodni dobi je treba obvestiti, da zdravilo Myalepta lahko poveča plodnost, zato naj uporabljajo kontracepcijo.
English: Animal studies showed no adverse effects on male or female fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale neželenih učinkov na plodnost pri samcih ali samicah (glejte poglavje 5.3).
English: Healthcare professionals should provide patients and carers with training on the reconstitution of the product and proper subcutaneous injection technique, so as to avoid intramuscular injection in patients with minimal subcutaneous adipose tissue.
Slovenian: Zdravstveni delavci morajo bolnike in negovalce ustrezno poučiti o rekonstituciji zdravila in pravilni tehniki subkutanega injiciranja, da se pri bolnikih z minimalnim subkutanim adipoznim tkivom prepreči injiciranje v mišico.
English: The patient will also receive separately the solvent for reconstitution (i.e. water for injection), the syringes/needles for reconstitution, the syringes/needles for administration, the cleansing alcohol swabs, and a sharps disposal container.
Slovenian: Bolnik bo prav tako posebej prejel topilo za rekonstitucijo (t. j. voda za injekcije), brizge/igle za rekonstitucijo, brizge/igle za dajanje zdravila, čistilne alkoholne krpice in vsebnik za odstranjevanje ostrih predmetov.
English: There are data to suggest metreleptin may increase fertility, due to effects on LH, with the consequent potential for unplanned pregnancy (see section 4.4).
Slovenian: Obstajajo podatki, ki kažejo, da lahko metreleptin poveča plodnost zaradi učinka na LH, zaradi česar obstaja možnost nenačrtovane nosečnosti (glejte poglavje 4.4).
English: The median duration of metreleptin treatment was 2.4 years (range: 6.7 months-14.0 years).
Slovenian: Povprečno trajanje zdravljenja z metreleptinom je bilo 2,4 leti (razpon: 6,7 mesecev-14,0 let).
English: No studies with direct administration of metreleptin to juvenile animals have been conducted.
Slovenian: Študije z neposrednim dajanjem metreleptina mladičem živali niso bile izvedene.
English: A total of 8 (24%) of the 34 patients with generalised LD who were receiving lipid-lowering therapies at baseline discontinued their use during metreleptin treatment.
Slovenian: Skupno 8 (24 %) od 34 bolnikov z generalizirano LD, ki je ob izhodišču prejemalo zdravila za znižanje lipidov, je z njimi med zdravljenjem z metreleptinom prenehalo.
English: 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.
Slovenian: 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.
English: Myalepta is an injection once a day under the skin (‘subcutaneous injection').
Slovenian: Zdravilo Myalepta je injekcija, ki si jo je treba enkrat dnevno dati pod kožo ("subkutana injekcija").
English: What Myalepta is and what it is used for 2.
Slovenian: Kaj je zdravilo Myalepta in za kaj ga uporabljamo 2.
English: • Clean the top of the vial with the alcohol wipe.
Slovenian: • Vrh viale očistite z alkoholnim robčkom.
English: Total daily volume to be injected is 3.75 mg/5 = 0.75 mL.
Slovenian: Skupni dnevni volumen za injiciranje je 3,75 mg/5 = 0,75 ml.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Only the metabolic effects of metreleptin have been studied.
Slovenian: Preučeni so bili samo učinki metreleptina na presnovo.
English: 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.
Slovenian: 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.
English: Use only with the solvent for reconstitution, syringes and needles, provided separately.
Slovenian: Uporabljajte samo s topilom za rekonstitucijo, brizgami in iglami, ki so na voljo ločeno.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: LD patients with a blocking activity against metreleptin and concurrent infections responded to standard of care treatment (see section 4.4).
Slovenian: Bolniki z LD, ki so imeli zaviralno aktivnost proti metreleptinu in hkratne okužbe, so se odzvali na standardno zdravljenje (glejte poglavje 4.4).
English: o To know how much solution to inject (in Units), divide your dose (in mg) by 5, and then times it by 100.
Slovenian: o Da bi vedeli, koliko raztopine injicirati (v enotah), svoj odmerek (v mg) delite s 5 in ga nato pomnožite s 100.
English: • Use the alcohol swab to clean the break point on the ampoule.
Slovenian: • Z alkoholnim zložencem očistite prelomno točko na ampuli.
English: This unused water for injection should be disposed of in your sharps container.
Slovenian: To neporabljeno vodo za injekcije je treba zavreči v vsebnik za ostre predmete.
English: Do not stop using Myalepta without talking to your doctor.
Slovenian: Zdravila Myalepta ne prenehajte jemati, brez da bi se posvetovali z zdravnikom.
English: It can be administered any time of the day without regard to the timing of meals.
Slovenian: Zdravilo je mogoče injicirati kadar koli čez dan, ne glede na obroke.
English: Additionally, adverse reactions from post-marketing sources are also presented.
Slovenian: Poleg tega so predstavljeni tudi neželeni učinki iz virov po začetku trženja zdravila.
English: Overall, 30 (97%) patients were female, 26 (84%) were Caucasian, 2 (7%) Hispanic, and 0 Black.
Slovenian: Skupno je bilo 30 (97 %) bolnikov žensk, 26 (84 %) jih je bilo belcev, 2 (7 %) Hispanca in 0 črncev.
English: A subgroup of partial LD patients is analysed for whom TG ≥ 5.65 mmol/l and/or HbA1c ≥ 6.5% at baseline.
Slovenian: Analizirana je podskupina bolnikov s parcialno LD, za katere je osnovna raven TG ≥ 5,65 mmol/l in/ali HbA1c ≥ 6,5 %.
English: • being clumsy and dropping things
Slovenian: • nerodnost in padanje stvari iz rok
English: Aegerion Pharmaceuticals B.V. Atrium Building 8th Floor
Slovenian: Atrium Building 8th Floor
English: • low blood sugar (glucose)
Slovenian: • nizek krvni sladkor (glukoza)
English: These will have been given to you by your doctor, nurse, or pharmacist.
Slovenian: Tega boste prejeli od zdravnika, medicinske sestre ali farmacevta.
English: Metreleptin may decrease insulin resistance in diabetic patients, resulting in hypoglycaemia in patients with LD and co-existing diabetes.
Slovenian: Metreleptin lahko zmanjša odpornost na insulin pri diabetikih, kar lahko pri bolnikih z LD in sočasno sladkorno boleznijo vodi do hipoglikemije.
English: Your doctor or pharmacist will tell you how much of the solution to inject.
Slovenian: Zdravnik ali farmacevt vam bo povedal, koliko raztopine injicirati.
English: 11) Remove the plastic cap from the vial of Myalepta powder.
Slovenian: 11) Odstranite plastično zaporko z viale s praškom zdravila Myalepta.
English: • swelling or bleeding under the skin (‘haemorrhage')
Slovenian: • otekanje ali krvavitev pod kožo ("krvavitev")
English: Place the vial on a hard, flat surface.
Slovenian: Vialo postavite na trdo, plosko površino.
English: While being treated with Myalepta, your body might produce antibodies which may increase the risk of developing serious or severe infections.
Slovenian: Pri zdravljenju z zdravilom Myalepta vaše telo lahko proizvaja protitelesa, zaradi česar lahko obstaja povečano tveganje za pojav resnih in hudih okužb.
English: To remove the water for injection, break open the ampoule.
Slovenian: Za odstranite vodo za injekcije, odlomite pokrovček ampule.
English: 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.
Slovenian: Če morate injicirati 1 ml raztopine Myalepta ali več, vam bo zdravnik morda rekel, da si odmerek injicirate v dveh ločenih injekcijah.
English: • Carefully push the plunger back up to force the air out of the syringe.
Slovenian: • Previdno potisnite bat nazaj navzgor, da iztisnete zrak iz brizge.
English: 15) Mix the powder and water for injection
Slovenian: 15) Zmešajte prašek in vodo za injekcije.
English: 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.
Slovenian: Vzemite vialo iz hladilnika in počakajte 10 minut, da se segreje na sobno temperaturo (20 °C
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The syringe will now be facing up.
Slovenian: Brizga bo sedaj usmerjena navzgor.
English: A causal relationship between lymphoma and Myalepta has not been established.
Slovenian: Vzročna povezanost med limfomom in zdravilom Myalepta ni bila dokazana.
English: Line up the top rim of the plunger with the line for the prescribed dose.
Slovenian: Poravnajte zgornji rob bata s črto za predpisan odmerek.
English: • A sudden increase in the amount of triglyceride in your blood can make your pancreas inflamed (‘pancreatitis').
Slovenian: • Nenadno povišanje količine trigliceridov v vaši krvi lahko povzroči vnetje trebušne slinavke
English: It is unknown whether metreleptin or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se metreleptin ali njegovi presnovki izločajo v materino mleko.
English: 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.
Slovenian: Navodila za uporabo Pred uporabo zdravila Myalepta morate najprej prebrati poglavja 1-6 tega navodila, nato pa poglavje 7 -" Priročnik za uporabo".
English: Both had immunodeficiency and significant haematological abnormalities including severe bone marrow abnormalities before the start of treatment.
Slovenian: Oba bolnika sta pred začetkom zdravljenja že imela imunsko pomanjkljivost in hude hematološke motnje, vključno s hudimi motnjami kostnega mozga.
English: Autoimmune disorders are associated with an increased risk of malignancies including lymphomas.
Slovenian: Le-te pa so povezane s povečanim tveganjem malignomov, vključno z limfomi.
English: Studies in animals have shown some evidence of reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale določen škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • The needle should go as far into the ampoule as possible.
Slovenian: • Iglo je treba vstaviti čim dlje v ampulo.
English: Dispose of any unused medicine.
Slovenian: Morebitno neporabljeno zdravilo zavrzite.
English: • The active substance is metreleptin.
Slovenian: • Učinkovina je metreleptin.
English: Total daily volume to be injected is total dose in mg/5.
Slovenian: Skupni dnevni volumen za injiciranje je celotni odmerek v mg/5.
English: 10) Make sure the vial of Myalepta powder has been out of the refrigerator for at least 10 minutes to reach room temperature.
Slovenian: 10) Prepričajte se, da je viala s praškom zdravila Myalepta vsaj 10 minut zunaj hladilnika na sobni temperaturi.
English: Converting dose from ‘mL' to ‘Units' when using the 0.3 mL syringe Weight of child
Slovenian: Pretvarjanje odmerka iz "ml" v "enote" pri uporabi 0,3-mililitrske brizge Telesna masa otroka
English: If you have injected less Myalepta than you should, talk to your doctor straight away.
Slovenian: Če ste injicirali manjši odmerek zdravila Myalepta, kot bi morali, se takoj posvetujte z zdravnikom.
English: 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).
Slovenian: 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).
English: • blood-thinning medicines (such as warfarin or phenprocoumon)
Slovenian: • zdravila proti strjevanju krvi (kot je varfarin ali fenprokumon);
English: Push the plunger all the way down.
Slovenian: Bat potisnite čisto navzdol.
English: 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.
Slovenian: Čeprav je časovno povezano, na podlagi trenutno razpoložljivega dokaznega gradiva ni mogoče nedvoumno potrditi ali zavrniti neposredne povezave z zdravljenjem z metrelepinom.
English: • 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.
Slovenian: • 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.
English: During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed.
Slovenian: V tem času spremljajte ravni trigliceridov in po potrebi uvedite ali prilagodite odmerek zdravila za zniževanje ravni lipidov.
English: • Do not remove the needle from the vial.
Slovenian: • Ne odstranite igle iz viale.
English: Myalepta has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Myalepta ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • alcohol wipes (to clean your skin where you will inject and to clean the tops of the vials)
Slovenian: • alkoholne zložence (za čiščenje kože na mestu injiciranja ter za čiščenje vrha vial);
English: White lyophilised cake or powder.
Slovenian: Bela liofilizirana pogača ali prašek.
English: • sweating more than normal
Slovenian: • potenje bolj kot običajno
English: See section 2 “How to stop using Myalepta” for more information.
Slovenian: Za več informacij glejte 2. poglavje "Kako prenehati z uporabo zdravila Myalepta".
English: You should not stop using Myalepta unless your doctor tells you to.
Slovenian: Z jemanjem zdravila Myalepta ne prenehajte, razen če vam to naroči zdravnik.