FrancophonIA/ELRC3.0 huggingface dataset:
English: To indicate and to substantiate where necessary, any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Slovenian: 2. prikazati in po potrebi utemeljiti vse razlike med zdravilom Solacyl 100 % prašek in referenčnim zdravilom, ki bi lahko upravičile različne zaključke o učinkovitosti zdravil.
English: On the basis of the grounds for referral CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Slovenian: Na podlagi vzrokov za napotitveni postopek je CVMP obravnaval razlike med zdravilom Solacyl 100 % prašek in referenčnim zdravilom, ki bi lahko upravičile različne zaključke o učinkovitosti zdravil.
English: Solacyl powder for oral solution powder
Slovenian: Solacyl 100 % prašek za peroralno raztopino prašek teleta in prašiči peroralno
English: Date of first authorisation: 20 December 2012 Date of latest renewal: 18 September 2017
Slovenian: Datum prve odobritve: 20. december 2012 Datum zadnjega podaljšanja: 18. september 2017
English: Do not stop taking them when your bladder condition improves.
Slovenian: Ne prenehajte jih jemati, ko se vam stanje izboljša.
English: 95% Confidence Interval
Slovenian: 95 % interval zaupanja
English: Treatment for overdose should be symptomatic and supportive.
Slovenian: Zdravljenje prevelikega odmerjanja mora biti simptomatsko in podporno.
English: PC: {number} SN: {number} NN:
Slovenian: PC: {številka} SN: {številka} NN: {številka}
English: Therefore, after reviewing all data, confusional state should be included in section 4.8 of the SmPC with frequency unknown.
Slovenian: Po pregledu vseh podatkov bi bilo zato treba stanje zmedenosti vključiti v poglavje 4.8 SmPC s pogostnostjo neznana.
English: If it is less than 6 hours before your next scheduled dose, skip the dose and continue to take your medicine at the usual time.
Slovenian: Če je do naslednjega odmerka manj kot 6 ur, preskočite izpuščeni odmerek in nadaljujte z jemanje zdravila ob običajnem času.
English: It is likely that this medicine passes into your breast milk.
Slovenian: To zdravilo verjetno prehaja v materino mleko.
English: - if you have kidney or liver problems.
Slovenian: - če imate težave z ledvicami ali jetri.
English: Tell your doctor about the medicines that you take.
Slovenian: Povejte zdravniku, katera zdravila jemljete.
English: Results for QTcF and QTcIf were consistent with QTcI.
Slovenian: Rezultati za QTcF in QTcIf so se skladali z rezultati za QTcI.
English: If you forget to take your medicine, take the missed dose as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo, vzemite pozabljeni odmerek, takoj ko se spomnite.
English: Cumulatively and according to the summary tabulations, confusional state was the most frequently serious Psychiatric disorder reported (37 serious reports, 18.5% of the serious psychiatric disorder reported.
Slovenian: Kumulativno in glede na tabelarične povzetke je bilo "stanje zmedenosti" najpogosteje poročana resna psihiatrična motnja (37 poročil o resnih primerih, 18,5 % resnih psihiatričnih motenj, o katerih so poročali).
English: Betmiga may affect the way other medicines work, and other medicines may affect how this medicine works.
Slovenian: Zdravilo Betmiga lahko vpliva na delovanje drugih zdravil in druga zdravila lahko vplivajo na delovanje tega zdravila.
English: Do not stop treatment with Betmiga early if you do not see an immediate effect.
Slovenian: Zdravljenja z zdravilom Betmiga ne prenehajte zgodaj, če ne opazite takojšnjega učinka.
English: Genotoxicity and carcinogenicity studies have shown no genotoxic or carcinogenic potential in vivo.
Slovenian: Študije genotoksičnosti in kancerogenosti in vivo niso pokazale genotoksičnega ali kancerogenega potenciala.
English: 3 years Shelf life after first opening of the bottle: 6 months
Slovenian: 3 leta Rok uporabnosti po prvem odprtju plastenke: 6 mesecev
English: Your bladder might need some time to adapt.
Slovenian: Sečni mehur lahko potrebuje nekaj časa za prilagoditev.
English: A randomized, active controlled, long term study demonstrated that efficacy was maintained throughout a 1-year treatment period.
Slovenian: Randomizirana dolgoročna študija, kontrolirana z zdravilno učinkovino, je pokazala, da se je učinkovitost ohranila med 1-letnim obdobjem zdravljenja.
English: Adults (including elderly patients) The recommended dose is 50 mg once daily
Slovenian: Odrasli (vključno s starejšimi bolniki) Priporočeni odmerek je 50 mg enkrat na dan.
English: In the phase 3 studies, mirabegron was administered with or without food and demonstrated both safety and efficacy.
Slovenian: V študijah 3. faze je bil mirabegron uporabljen tako s hrano kot brez nje in dokazali so, da je varen in učinkovit.
English: The Cmax and AUC are approximately 40% to 50% higher in females than in males.
Slovenian: Cmax in AUC sta približno 40 % do 50 % večja pri ženskah kot pri moških.
English: Effect on QT interval
Slovenian: Vpliv na interval QT
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be established from the available data).
Slovenian: (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: The safety and efficacy of mirabegron in children below 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost mirabegrona pri otrocih do 18. leta starosti še nista bili dokazani.
English: It may be taken with or without food.
Slovenian: Vzame se jo lahko s hrano ali brez nje.
English: Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect.
Slovenian: Koncentracijo digoksina v serumu je treba spremljati in jo uporabiti za titriranje odmerka digoksina, da bi dosegli želeni klinični učinek.
English: Tell your doctor right away if you are unable to empty your bladder.
Slovenian: Takoj obvestite zdravnika, če ne morete izprazniti sečnega mehurja.
English: These may be signs of severely elevated blood pressure.
Slovenian: Ti so lahko znak močno zvišanega krvnega tlaka.
English: In one study, 495 patients received an active control (tolterodine prolonged release formulation).
Slovenian: V eni študiji je 495 bolnikov prejemalo kontrolno zdravilno učinkovino (tolterodin v obliki s podaljšanim sproščanjem).
English: CI: Confidence Interval
Slovenian: IZ: interval zaupanja
English: If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 mg tablet by mouth once daily.
Slovenian: Če imate težave z ledvicami ali jetri, vam bo zdravnik morda moral zmanjšati odmerek na eno 25-mg tableto, ki jo zaužijete enkrat na dan.
English: The tablet is to be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed.
Slovenian: Tableto je treba vzeti s tekočino, jo celo pogoltniti in se je ne sme zgristi, prelomiti ali zdrobiti.
English: These metabolites are not pharmacologically active.
Slovenian: Ta presnovka nista farmakološko aktivna.
English: The observed embryofetal toxicity occurred at doses associated with maternal toxicity.
Slovenian: Embriofetalno toksičnost so opazili pri odmerkih, ki so bili povezani s toksičnostjo za mater.
English: Gender No dose adjustment is necessary according to gender.
Slovenian: Spol Prilagoditev odmerka glede na spol ni potrebna.
English: Not known side effects (frequency cannot be estimated from the available data)
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: From the 138 cases identified, none was considered as an index case by the MAH and only 55 cases were classified as informative.
Slovenian: ugotovljenih primerov ni nobenega opredelil kot indeksni primer in le 55 primerov je bilo opredeljenih kot informativnih.
English: This is an uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, immediately stop taking the medicine and seek urgent medical advice.
Slovenian: Ta neželeni učinek se pojavlja občasno (pojavi se lahko pri največ 1 od 100 bolnikov), a če se pojavi, takoj nehajte jemati to zdravilo in poiščite nujno zdravniško pomoč.
English: Tell your doctor or pharmacist if you are taking, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: There is no information to suggest that this medicine affects your ability to drive or use machines.
Slovenian: Ni informacij, ki bi kazale, da to zdravilo vpliva na sposobnost upravljanja vozil in strojev.
English: Table 3: Co-primary and selected secondary efficacy endpoints at end of treatment for studies 046, 047 and 074
Slovenian: Preglednica 3: Soprimarna opazovana dogodka in izbrani sekundarni končni dogodki učinkovitosti na koncu zdravljenja za študije 046, 047 in 074
English: Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B.
Slovenian: Blaga: Child-Pugh A; zmerna: Child-Pugh B.
English: A single 400 mg dose of moxifloxacin was used as a positive control.
Slovenian: Kot pozitivna kontrola je bil uporabljen en 400-mg odmerek moksifloksacina.
English: Gender differences in Cmax and AUC are attributed to differences in body weight and bioavailability.
Slovenian: Razlike Cmax in AUC med spoloma so posledica razlik v telesni masi in biološki uporabnosti.
English: Betmiga 50 mg once daily was effective at the first measured time point of week 4, and efficacy was maintained throughout the 12-week treatment period.
Slovenian: Zdravilo Betmiga 50 mg enkrat na dan je bilo učinkovito ob prvem času merjenja 4. teden in je ostalo učinkovito med celotnim 12-tedenskim obdobjem zdravljenja.
English: Changes in pulse rate and blood pressure are reversible upon discontinuation of treatment.
Slovenian: Spremembe srčne frekvence in krvnega tlaka so po prenehanju zdravljenja reverzibilne.
English: You should continue taking your tablets.
Slovenian: Tablete jemljite še naprej.
English: However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown.
Slovenian: Ker bolniki z anamnezo podaljšanja intervala QT ali bolniki, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QT, niso bili vključeni v te študije, učinek mirabegrona pri teh bolnikih ni znan.
English: The most serious side effects may include irregular heart beat (atrial fibrillation).
Slovenian: Med najresnejšimi neželenimi učinki je lahko neredno bitje srca (atrijska fibrilacija).
English: Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients.
Slovenian: Krvni tlak je potrebno izmeriti pred začetkom zdravljenja in periodično med zdravljenjem z mirabegronom, zlasti pri bolnikih s hipertenzijo.
English: The study population consisted of approximately 48% antimuscarinic treatment naïve patients as well as approximately 52% patients previously treated with antimuscarinic medicinal products.
Slovenian: Študijska populacija je obsegala približno 48 % oseb, ki predhodno niso prejemale antimuskarinskih zdravil, in približno 52 % oseb, predhodno že zdravljenih z antimuskarinskimi zdravili.
English: This medicinal product is not recommended during pregnancy.
Slovenian: Uporaba tega zdravila med nosečnostjo ni priporočljiva.
English: Do not crush.
Slovenian: Ne je zdrobiti.
English: Renal clearance (CLR) is approximately 13 L/h, which corresponds to nearly 25% of CLtot.
Slovenian: Ledvični očistek (CLR) je približno 13 l/h in pomeni skoraj 25 % CLtot.
English: Most adverse reactions were mild to moderate in severity.
Slovenian: Večina neželenih učinkov je bila blagih do zmernih.
English: Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Slovenian: Alu-Alu pretisni omoti v škatlah, ki vsebujejo 10, 20, 30, 50, 60, 90, 100 ali 200 tablet.
English: Treatment satisfaction - visual analogue scale (FAS) (Secondary)
Slovenian: Zadovoljstvo z zdravljenjem - vizualna analogna skala (FAS) (sekundarni)
English: Mirabegron did not induce CYP1A2 or CYP3A.
Slovenian: Prav tako ni induciral CYP1A2 ali CYP3A.
English: In a monkey model, mirabegron showed decreased voiding frequency.
Slovenian: V opičjem modelu je mirabegron zmanjšal pogostnost praznjenja.
English: Mirabegron can increase blood pressure.
Slovenian: Mirabegron lahko povzroči povišanje krvnega tlaka.
English: If the blood level is out of range, your doctor may adjust the dose of digoxin.
Slovenian: Če je koncentracija v krvi zunaj ustreznega razpona, vam bo zdravnik morda prilagodil odmerek digoksina.
English: Tachycardia Palpitation Atrial fibrillation
Slovenian: Srčne bolezni tahikardija palpitacije atrijska fibrilacija
English: Tolterodine ER 4 mg
Slovenian: Tolterodin ER 4 mg
English: Iron oxide yellow (E172)
Slovenian: rdeči železov oksid (E172)
English: Betmiga has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Betmiga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: The Cmax and AUC of mirabegron and its metabolites following multiple oral doses in elderly volunteers (≥ 65 years) were similar to those in younger volunteers (18-45 years).
Slovenian: Cmax in AUC mirabegrona in njegovih presnovkov sta bili po večkratnih peroralnih odmerkih pri starejših prostovoljcih (≥ 65 let) podobni kot pri mlajših (18-45 let).
English: The terminal elimination half-life (t1/2) is approximately 50 hours.
Slovenian: (t1/2) je približno 50 ur.
English: Substances that are inducers of CYP3A or P-gp decrease the plasma concentrations of mirabegron.
Slovenian: Snovi, ki inducirajo CYP3A ali P-gp, zmanjšajo koncentracijo mirabegrona v plazmi.
English: For patients who are initiating a combination of mirabegron and digoxin, the lowest dose for digoxin should be prescribed initially.
Slovenian: Bolnikom, ki začenjajo s sočasno uporabo mirabegrona in digoksina, je treba uvodoma predpisati najmanjši odmerek digoksina.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: What you need to know before you take Betmiga Do not take Betmiga:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Betmiga Ne jemljite zdravila Betmiga:
English: On the basis of the scientific conclusions for mirabegron the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mirabegron is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za mirabegron odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(a), ki vsebuje(jo) mirabegron nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to
Slovenian: Pogostnost neželenih učinkov je opredeljena na naslednji način: zelo pogosti (≥ 1/10), pogosti
English: In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events.
Slovenian: V treh 12-tedenskih dvojno slepih, s placebom kontroliranih študijah 3. faze je 88 % bolnikov dokončalo zdravljenje s tem zdravilom; 4 % bolnikov so zdravljenje prekinili zaradi neželenih učinkov.
English: Total body clearance (CLtot) from plasma is approximately 57 L/h.
Slovenian: Izločanje Celotni telesni očistek (CLtot) iz plazme je približno 57 l/h.
English: Mirabegron is excreted in the milk of rodents and therefore is predicted to be present in human milk (see section 5.3).
Slovenian: Mirabegron se pri glodalcih izloča v mleku, zato je mogoče predvidevati, da je v materinem mleku prisoten tudi pri človeku (glejte poglavje 5.3).
English: Renal elimination of mirabegron is primarily through active tubular secretion along with glomerular filtration.
Slovenian: Izločanje mirabegrona skozi ledvice poteka predvsem z aktivno tubularno sekrecijo, obenem z glomerularno filtracijo.
English: During the urine storage phase, when urine accumulates in the bladder, sympathetic nerve stimulation predominates.
Slovenian: Med fazo shranjevanja urina, ko se urin nabira v mehurju, prevladuje simpatična živčna stimulacija.
English: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Slovenian: Simptomatsko zdravljenje urgentne mikcije, večje pogostnosti mikcij in/ali urgentne inkontinence, ki se lahko pojavijo pri odraslih bolnikih s sindromom prekomerno aktivnega sečnega mehurja (PASM).
English: Mirabegron is a potent and selective beta 3-adrenoceptor agonist.
Slovenian: Mirabegron je močan in selektiven agonist adrenergičnih receptorjev beta 3.
English: Study 046
Slovenian: Študija 046
English: The bottle may not be available in your country.
Slovenian: Pakiranje v plastenki ni nujno na voljo v vaši državi.
English: Stopping treatment may result in recurrence of symptoms of overactive bladder.
Slovenian: Posledica prenehanja zdravljenja je lahko ponovitev simptomov prekomerno aktivnega sečnega mehurja.
English: Dose-adjustment is not recommended.
Slovenian: Prilagoditev odmerka ni priporočljiva.
English: They recovered in a short time after mirabegron discontinuation.
Slovenian: Okrevali so v kratkem času po prenehanju uporabe mirabegrona.
English: Following the administration of 160 mg 14C-mirabegron to healthy volunteers, approximately 55% of the radiolabel was recovered in the urine and 34% in the faeces.
Slovenian: Po uporabi 160 mg 14C-mirabegrona pri zdravih prostovoljcih se je približno 55 % radioaktivnosti pojavilo v urinu in 34 % v blatu.
English: Your doctor may need to reduce your dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections).
Slovenian: Zdravnik vam bo morda moral zmanjšati odmerek ali vam bo povedal, da ne smete jemati zdravila Betmiga, še posebej če jemljete druga zdravila, kot so itrakonazol, ketokonazol (glivične okužbe), ritonavir (HIV/AIDS) ali klaritromicin (bakterijske okužbe).
English: Do not stop taking Betmiga without talking to your doctor first, as your overactive bladder symptoms may come back.
Slovenian: Ne prenehajte jemati zdravila Betmiga, ne da bi se prej posvetovali z zdravnikom, kajti simptomi prekomerno aktivnega sečnega mehurja se vam lahko ponovijo.
English: Female (72%) and male (28%) patients with a mean age of 59 years (range 1895 years) were included.
Slovenian: Študije so zajele bolnice (72 %) in bolnike (28 %) s povprečno starostjo 59 let (razpon: od 18 do 95 let).
English: Mirabegron is extensively distributed.
Slovenian: Mirabegron se izdatno porazdeli.
English: Contents of the pack and other information What Betmiga contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Betmiga
English: Therefore beta 3-adrenoceptor stimulation should not interfere with the voiding process.
Slovenian: Zato stimulacija adrenergičnih receptorjev beta 3 ne bi smela motiti praznjenja.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7)
English: Pharmacokinetic studies performed with radio-labelled mirabegron have shown that the parent compound and/or its metabolites are excreted in the milk of rats at levels that were approximately 1.7-fold higher than plasma levels at 4 hours post administration (see section 4.6).
Slovenian: Farmakokinetične študije z radioaktivno označenim mirabegronom so pokazale, da se matična spojina in/ali njeni presnovki izločajo v mleku podgan v koncentraciji, ki je približno 1,7-krat večja od koncentracije v plazmi 4 ure po uporabi (glejte poglavje 4.6).
English: The volume of distribution at steady state (Vss) is approximately 1670 L. Mirabegron is bound (approximately 71%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je približno 1670 l. Mirabegron je (približno 71 %) vezan na beljakovine v človeški plazmi in ima zmerno afiniteto za albumin in alfa-1-kisli glikoprotein.
English: Other medicines and Betmiga
Slovenian: Druga zdravila in zdravilo Betmiga
English: Most of patients are elderly patients according to the information included in the EVDAs but there are also non-elderly patients.
Slovenian: Glede na informacije, vključene v EVDAS, je bila večina bolnikov starejših.
English: Mirabegron is a weak inhibitor of P-gp.
Slovenian: Mirabegron je šibek zaviralec P-gp.
English: After first opening of the bottle, the tablets can be stored for 6 months.
Slovenian: Po prvem odprtju plastenke morate tablete porabiti v roku 6 mesecev.
English: The cardiovascular malformations observed in the rabbit were shown to be mediated via activation of the beta 1-adrenoceptor.
Slovenian: Kardiovaskularne malformacije, ki so jih opazili pri kuncih so bile posredovane preko aktivacije adrenergičnih receptorjev beta 1.
English: During the urine voiding phase, the bladder is predominantly under parasympathetic nervous system control.
Slovenian: Med fazo praznjenja urina je mehur pretežno pod nadzorom parasimpatičnega živčevja.
English: The effect of mirabegron on human fertility has not been established.
Slovenian: Vpliv mirabegrona na plodnost pri človeku ni ugotovljen.
English: Mean difference from placebo† -
Slovenian: Povprečna razlika od placeba† -
English: Unchanged mirabegron accounted for 45% of the urinary radioactivity, indicating the presence of metabolites.
Slovenian: Na račun nespremenjenega mirabegrona je šlo 45 % radioaktivnosti v urinu; to kaže na prisotnost presnovkov.
English: The effect of co-administered medicinal products on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of other medicinal products was studied in single and multiple dose studies.
Slovenian: Vpliv sočasne uporabe zdravil na farmakokinetiko mirabegrona in vpliv mirabegrona na farmakokinetiko sočasno uporabljenih zdravil so raziskali v študijah enkratnega in večkratnih odmerkov.
English: In vitro erythrocyte concentrations of 14C-mirabegron were about 2-fold higher than in plasma.
Slovenian: In vitro je bila koncentracija 14C-mirabegrona v eritrocitih približno 2-krat večja kot v plazmi.
English: Symptoms of overdose may include a forceful beating of the heart, an increased pulse rate or an increased blood pressure.
Slovenian: Med simptomi prevelikega odmerjanja so lahko močno bitje srca, hitrejši srčni utrip ali zvišan krvni tlak.
English: Mean Cmax and AUC increased more than dose proportionally over the dose range.
Slovenian: Povprečna Cmax in AUC sta se v razponu odmerkov povečali več kot sorazmerno odmerku.
English: Steady state concentrations are achieved within 7 days of once daily dosing with mirabegron.
Slovenian: Koncentracija v stanju dinamičnega ravnovesja je dosežena v 7 dneh uporabe mirabegrona enkrat na dan.
English: Study 074
Slovenian: Študija 074
English: What Betmiga is and what it is used for
Slovenian: Kaj je zdravilo Betmiga in za kaj ga uporabljamo