FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking the tablet just after food will lower the risk of an upset stomach.
Slovenian: Jemanje tablete takoj po hrani bo zmanjšalo možnost želodčnih težav.
English: Do not take Zomarist - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Zomarist - če ste alergični na vildagliptin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The clinical relevance of this decrease is unknown.
Slovenian: Klinični pomen tega vpliva ni znan.
English: This is so that signs of increased liver enzymes can be detected as early as possible.
Slovenian: To je potrebno za čimprejšnje odkrivanje znakov zvišanih vrednosti jetrnih encimov.
English: Insulin helps to lower the level of sugar in the blood, especially after meals.
Slovenian: Insulin pomaga zniževati koncentracijo sladkorja v krvi, posebno po obrokih.
English: A slow increase in the dose may also improve gastrointestinal tolerability.
Slovenian: Tudi počasno zviševanje odmerka lahko izboljša gastrointestinalno prenosljivost zdravila.
English: If no adequate strength of Zomarist is available, individual monocomponents should be used instead of the fixed dose combination.
Slovenian: Če ni na voljo ustrezna jakost zdravila Zomarist, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
English: If you have to go to a doctor or hospital, take the pack and this leaflet with you.
Slovenian: Če morate k zdravniku oziroma v bolnišnico, vzemite škatlo zdravil in ta navodila s seboj.
English: To prevent them, it is recommended that metformin be taken in 2 daily doses during or after meals.
Slovenian: Za preprečevanje teh učinkov je priporočeno jemanje metformina v 2 odmerkih dnevno in sicer med obrokom ali takoj po njem.
English: Gastrointestinal adverse reactions occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Slovenian: Do gastrointestinalnih neželenih učinkov pride najpogosteje na začetku zdravljenja in v večini primerov spontano izzvenijo.
English: If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.
Slovenian: Če ste vildagliptin že jemali, pa ste ga morali prenehati zaradi bolezni jeter, ne smete jemati tega zdravila.
English: Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma.
Slovenian: Ketoacidoza je stanje, pri katerem se snovi, imenovane ketonska telesa, kopičijo v krvi, kar lahko povzroči diabetično predkomo.
English: Plasma protein binding is negligible.
Slovenian: Obseg vezave na plazemske proteine je zanemarljiv.
English: Your doctor will discuss with you the potential risk of taking Zomarist during pregnancy.
Slovenian: Zdravnik vam bo pojasnil možna tveganja zaradi jemanja zdravila Zomarist med nosečnostjo.
English: They were reversible despite continued treatment and were not associated with histopathological abnormalities.
Slovenian: Ti so bili reverzibilni kljub nadaljevanju zdravljenja in jih niso spremljale histopatološke nepravilnosti.
English: These were consistently located on the extremities (hands, feet, ears and tail).
Slovenian: Te spremembe so dosledno opažali na udih (rokah, stopalih, uhljih in repu).
English: Food slightly delays the time to peak plasma concentration to 2.5 hours, but does not alter the overall exposure (AUC).
Slovenian: Hrana nekoliko podaljša čas do najvišje plazemske koncentracije na 2,5 ure, ne spremeni pa celotne izpostavljenosti zdravilu (AUC).
English: Food does not affect the extent and rate of absorption of vildagliptin from Zomarist.
Slovenian: Hrana ne vpliva na obseg in hitrost absorpcije vildagliptina iz zdravila Zomarist.
English: There are no adequate data from the use of Zomarist in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila Zomarist pri nosečnicah.
English: What you need to know before you take Zomarist
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zomarist
English: Not all pack sizes and tablet strengths may be available in your country.
Slovenian: V vaši državi morda niso na voljo vse velikosti pakiranj in jakosti tablet.
English: The substance metformin works by helping the body to make better use of insulin.
Slovenian: Učinkovina metformin deluje tako, da pomaga organizmu bolje izrabiti insulin.
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Slovenian: C označenega vildagliptina se je približno 85 % odmerka izločilo z urinom, 15 % odmerka pa so našli v blatu.
English: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter.
Slovenian: GFR je treba oceniti pred uvedbo zdravljenja z zdravili, ki vsebujejo metformin, nato pa vsaj enkrat letno.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist.
Slovenian: Naslednje trditve opisujejo farmakokinetične lastnosti posameznih učinkovin zdravila Zomarist.
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Slovenian: GFR je treba oceniti pred uvedbo zdravljenja, nato pa v rednih presledkih (glejte poglavje 4.2).
English: If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Slovenian: Če ste pozabili vzeti tableto, jo vzemite z naslednjim obrokom, razen če je že čas, da vzamete naslednjo tableto.
English: Use of vildagliptin has beenassociated with a risk of developing of acute pancreatitis.
Slovenian: Uporabo vildagliptina povezujejo s tveganjem za razvoj akutnega pankreatitisa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin in combination with metformin in all subsets of the paediatric population with type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z vildagliptinom v kombinaciji z metforminom za vse podskupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Patients should be informed of the characteristic symptom of acute pancreatitis.
Slovenian: Bolnike je potrebno obvestiti o značilnem simptomu akutnega pankreatitisa.
English: Ethnic group: Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Slovenian: Etnična pripadnost: Podatki omejenega obsega nakazujejo, da rasna pripadnost nima pomembnega vpliva na farmakokinetiko vildagliptina.
English: Metformin must be discontinuedat the time of surgery under general, spinal or epidural anaesthesia.
Slovenian: Uporabo metformina je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
English: Since this product has been marketed, the following side effects have also been reported:
Slovenian: Odkar je zdravilo na trgu, so poročali tudi o naslednjem neželenem učinku
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Slovenian: Priporočamo vam, da se držite navodil za nego kože in stopal, kot vam jih priporoča vaš zdravnik ali medicinska sestra.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA PRI SKUPNEM PAKIRANJU (BREZ "BLUE BOX" PODATKOV)
English: During treatment with Zomarist, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Slovenian: Med zdravljenjem z zdravilom Zomarist bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Slovenian: Po peroralnem odmerjanju je neabsorbirani delež v blatu znašal 20-30 %.
English: Continue to follow any advice about diet that your doctor has given you.
Slovenian: Še naprej se držite diete, ki vam jo je priporočil zdravnik.
English: Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of sugar in your blood.
Slovenian: Zdravnik vam lahko predpiše, da jemljete to zdravilo samostojno ali pa skupaj z določenimi drugimi zdravili, ki znižujejo raven sladkorja v krvi.
English: Metformin is contraindicated.
Slovenian: Metformin je kontraindiciran.
English: All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.
Slovenian: Vsi simptomi in nenormalni laboratorijski izvidi so izzveneli brez zdravljenja po prekinitvi jemanja preiskovanega zdravila.
English: Other medicines and Zomarist
Slovenian: Druga zdravila in zdravilo Zomarist
English: The safety and efficacy of Zomarist in children and adolescents (< 18 years) have not been established.
Slovenian: Varnost in učinkovitost zdravila Zomarist pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
English: The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the longterm benefit of intensive blood glucose control in type 2 diabetes.
Slovenian: V prospektivni randomizirani študiji UKPDS (UK Prospective Diabetes Study - Britanska prospektivna študija diabetesa) so ugotovili dolgoročno koristnost intenzivnega uravnavanja koncentracije glukoze pri diabetesu tipa 2.
English: Your doctor will tell you exactly the dose of Zomarist to take.
Slovenian: Zdravnik vam bo natančno povedal, kolikšen odmerek zdravila Zomarist morate jemati.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Slovenian: Bolnik mora biti o tem poučen, koncentracijo glukoze v krvi pa je treba meriti pogosteje, še posebno na začetku zdravljenja.
English: Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
Slovenian: Zato ni verjetno, da bi vildagliptin vplival na presnovni očistek sočasno uporabljanih zdravil, ki se presnavljajo z encimi CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 ali CYP 3A4/5.
English: Do not stop taking Zomarist unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Zomarist, če vam tega ne naroči zdravnik.
English: Three other subjects experienced oedema of the feet, with paraesthesia in two cases.
Slovenian: Pri treh drugih osebah je prišlo do otekanja stopal, v dveh primerih s parestezijo.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Slovenian: V kontroliranih kliničnih preskušanjih najvišje koncentracije metformina v plazmi (Cmax) niso presegale 4 µg/ml niti pri najvišjih odmerkih.
English: In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
Slovenian: In vitro študije so pokazale, da vildagliptin ne zavira/inducira encimov CYP 450.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Slovenian: Diagnostični laboratorijski izvidi so zmanjšan pH krvi (< 7,35), zvišane ravni laktata v plazmi (> 5 mmol/l) in povečana anionska vrzel ter razmerje laktat/piruvat.
English: Findings were only observed in association with maternal toxicity at ≥ 150 mg/kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.
Slovenian: Učinke so opažali samo v povezavi s toksičnostjo za mater pri odmerkih ≥ 150 mg/kg, vključevali pa so prehodno zmanjšanje telesne mase in zmanjšano motorično aktivnost v F1 generaciji.
English: The following statements reflect the information available on the individual active substances.
Slovenian: Naslednje trditve odražajo podatke, ki so na voljo za obe posamezni zdravilni učinkovini.
English: Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Slovenian: Glukokortikoidi, beta-2 agonisti in diuretiki imajo intrinzično hiperglikemično aktivnost.
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Slovenian: Domnevajo, da je farmakokinetika absorpcije metformina nelinearna.
English: Sulphonylureas are known to cause hypoglycaemia.
Slovenian: Znano je, da sulfoniluree povzročajo hipoglikemijo.
English: Information on the likely symptoms of overdose with vildagliptin was taken from a rising dose tolerability study in healthy subjects given vildagliptin for 10 days.
Slovenian: Podatki o verjetnih simptomih prevelikega odmerjanja vildagliptina temeljijo na študiji prenašanja naraščajočih odmerkov, izvedeni na zdravih osebah, ki so prejemale vildagliptin 10 dni.
English: Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Slovenian: Ker vildagliptin ni niti substrat encimov citokroma P (CYP) 450 niti ne zavira ali inducira encimov CYP 450, ni verjetno, da bi prišlo do interakcij z učinkovinami, ki so substrati, zaviralci ali induktorji teh encimov.
English: No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose.
Slovenian: Povezave med neželenimi učinki in starostjo, etnično pripadnostjo, trajanjem zdravljenja ali velikostjo dnevnega odmerka niso ugotovili.
English: Taking Zomarist with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Slovenian: Jemanje zdravila Zomarist s hrano ali takoj po njej lahko ublaži gastrointestinalne simptome, ki so povezani z jemanjem metformina (glejte tudi poglavje 5.2).
English: Combination with a sulphonylurea
Slovenian: Kombinacija s sulfonilureo
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z "BLUE BOX" PODATKI)
English: These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.
Slovenian: Ta zvišanja vrednosti aminotransferaz so bila večinoma asimptomatska, neprogresivne narave in niso bila povezana s holestazo ali z ikterusom.
English: Should these occur, you should promptly consult your doctor.
Slovenian: Če pride do teh sprememb, takoj obvestite svojega zdravnika.
English: Diabetic skin lesions are a common complication of diabetes.
Slovenian: Diabetične spremembe na koži so pogost diabetični zaplet.
English: A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
Slovenian: V študiji na zdravih prostovoljcih se je pokazalo, da je uporaba cimetidina v odmerku 400 mg dvakrat na dan povečala sistemsko izpostavljenost metforminu (AUC) za 50 %.
English: You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Zomarist.
Slovenian: Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Zomarist.
English: The following data are findings from studies performed with vildagliptin or metformin individually.
Slovenian: Naslednji podatki so izsledki študij, ki so jih izvajali ločeno z vildagliptinom ali metforminom.
English: No new toxicities associated with the combination were identified.
Slovenian: Pri tem niso ugotovili nobenega novega toksičnega vpliva, povezanega s kombinacijo učinkovin.
English: Biotransformation Metformin is excreted unchanged in the urine.
Slovenian: Biotransformacija Metformin se izloča z urinom v nespremenjeni obliki.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD08
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, kombinacije peroralnih antidiabetikov, oznaka ATC: A10BD08
English: 10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 60 filmsko obloženih tablet 120 filmsko obloženih tablet 180 filmsko obloženih tablet 360 filmsko obloženih tablet
English: Zomarist is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Slovenian: Zdravilo Zomarist ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin, in se ga ne sme uporabljati pri bolnikih z diabetesom tipa 1.
English: The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution.
Slovenian: Povprečen volumen porazdelitve vildagliptina v stanju dinamičnega ravnovesja po intravenski aplikaciji (Vss) je 71 litrov, kar kaže ne ekstravaskularno porazdelitev.
English: - Do not use Zomarist if you are pregnant or breast-feeding (see also “Do not take Zomarist”).
Slovenian: - Če ste noseči ali dojite, ne smete uporabljati zdravila Zomarist (glejte tudi “Ne jemljite zdravila Zomarist”).
English: Your doctor will test your blood and urine for sugar regularly.
Slovenian: Poleg tega vam bo zdravnik redno pregledoval vsebnost sladkorja v krvi in urinu.
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Slovenian: Ledvični očistek metformina je > 400 ml/min, kar nakazuje, da se metformin izloča z glomerulno filtracijo in tubulno sekrecijo.
English: The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Slovenian: Cmax vildagliptina in površina pod krivuljo časovne porazdelitve koncentracij v plazmi (AUC) sta se v okviru terapevtskih odmerkov povečevali približno sorazmerno z velikostjo odmerka.
English: Zomarist may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Zomarist lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
English: This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.
Slovenian: Dokazano je bilo, da to zdravilo znižuje koncentracijo sladkorja v krvi in tako pomaga preprečevati zaplete sladkorne bolezni.
English: If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Zomarist, kot bi smeli Če ste vzeli preveč tablet zdravila Zomarist ali če kdo drug vzame vaše tablete, se takoj obrnite na zdravnika ali farmacevta.
English: 60 film-coated tablets.
Slovenian: 60 filmsko obloženih tablet.
English: Renal impairment: In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Slovenian: Okvara ledvic: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic je bila izpostavljenost vildagliptinu večja (Cmax 8-66 %; AUC 32-134 %), celotni telesni očistek pa je bil manjši v primerjavi z osebami z normalnim delovanjem ledvic.
English: However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can.
Slovenian: Vendar pa vildagliptina ni mogoče odstraniti s hemodializo, je pa mogoče s hemodializo odstraniti njegov glavni presnovek (LAY 151).
English: Vildagliptin Information regarding overdose with vildagliptin is limited.
Slovenian: Podatki o prevelikem odmerjanju vildagliptina so omejeni.
English: Studies in animals have shown excretion of both metformin and vildagliptin in milk.
Slovenian: Študije na živalih kažejo na izločanje metformina in vildagliptina v mleko.
English: If you have reduced kidney function, your doctor may prescribe a lower dose.
Slovenian: Če imate zmanjšano delovanje ledvic, vam bo zdravnik morda predpisal nižji odmerek.
English: If you forget to take Zomarist
Slovenian: Če ste pozabili vzeti zdravilo Zomarist
English: You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:
Slovenian: Prenehajte jemati zdravilo Zomarist in takoj obiščite zdravnika, če se pri vas pojavijo naslednji neželeni učinki:
English: - Do not store above 30C.
Slovenian: - Shranjujte pri temperaturi do 30 C.
English: Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes.
Slovenian: Po aplikaciji odmerka 850 mg je bila najvišja koncentracija v plazmi 40 % nižja, AUC manjša za 25 %, čas do najvišje koncentracije v plazmi pa daljši za 35 minut.
English: The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
Slovenian: Ocenjeno je, da zvišana incidenca teh tumorjev pri miših ne predstavlja pomembnega tveganja za ljudi glede na to, da vildagliptin in njegov glavni presnovek nista genotoksična, da je do tumorjev prišlo le pri eni živalski vrsti in glede na visoka razmerja med izpostavljenostmi, pri katerih so tumorje opažali.
English: Another two-year carcinogenicity study was conducted in mice at oral doses up to 1000 mg/kg.
Slovenian: Drugo dvoletno študijo karcinogenosti so opravili na miših s peroralnimi odmerki do 1.000 mg/kg.
English: Embryofoetal toxicity was evaluated in rats and rabbits.
Slovenian: Toksičnost za zarodek in plod so ocenjevali pri podganah in kuncih.
English: Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood.
Slovenian: Obe učinkovini, vildagliptin in metformin, pomagata uravnavati koncentracijo sladkorja v krvi.
English: **Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported.
Slovenian: **Poročali so o posameznih primerih nenormalnih vrednosti jetrnih testov ali hepatitisa, ki so izzveneli po ukinitvi metformina.
English: Driving and using machines If you feel dizzy while taking Zomarist, do not drive or use any tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste med jemanjem zdravila Zomarist omotični, ne vozite avtomobila in ne upravljajte z orodji in stroji.
English: Vildagliptin has a low potential for interactions with co-administered medicinal products.
Slovenian: Vildagliptin ima le majhno možnost medsebojnega delovanja z drugimi sočasno uporabljenimi zdravili.
English: Stop taking Zomarist for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Slovenian: Za kratek čas prenehajte jemati zdravilo Zomarist, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
English: Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions.
Slovenian: Poleg tega so v obdobju trženja zdravila poročali o mehurčastih in eksfoliacijskih kožnih spremembah.