FrancophonIA/ELRC3.0 huggingface dataset:
English: 17 December 2009 EMA/830685/2009 EMEA/H/C/1020
Slovenian: 17. december 2009 EMEA/830685/2009 EMEA/H/C/1020
English: Idiopathic means that the disease has no obvious cause.
Slovenian: Idiopatsko pomeni, da bolezen nima nikakršnega očitnega vzroka.
English: The 210 patients who completed the first 12 weeks were also offered the opportunity to continue treatment in an extension study.
Slovenian: Prav tako so 210 bolnikom, ki so zaključili prvih 12 tednov zdravljenja, ponudili možnost nadaljevanja zdravljenja v podaljšku študije.
English: The company had also provided results on studies involving patients with Parkinson's disease.
Slovenian: Družba je prav tako priložila rezultate študij, ki so vključevale bolnike s Parkinsonovo boleznijo.
English: The effects of Nenad were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Nenad so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: There were also problems with the patches not sticking well enough to the skin.
Slovenian: Prav tako so se pojavljale težave, ker se obliž ni dovolj dobro prilepil na kožo.
English: What is Nenad?
Slovenian: Kaj je zdravilo Nenad?
English: Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Slovenian: Sindrom nemirnih nog je motnja, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da prepreči neprijetne, boleče ali nenavadne občutke v telesu, najpogosteje ponoči.
English: The company presented results of one main study of 309 patients with moderate-to-severe restless legs syndrome.
Slovenian: Družba je predložila rezultate ene glavne študije, ki je vključevala 309 bolnikov z zmernim do hudim sindromom nemirnih nog.
English: On 30 November 2009, Axxonis Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Nenad, for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults.
Slovenian: Družba Axxonis Pharma AG je dne 30. novembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Nenad, namenjenim zdravljenju znakov in simptomov zmernega do hudega idiopatskega sindroma nemirnih nog pri odraslih.
English: The Committee was also concerned that a large proportion of patients in the study stopped treatment with Nenad because of skin irritation, making the patch unsuitable for long-term use.
Slovenian: Odbor je prav tako izrazil zaskrbljenost nad tem, da je velik delež bolnikov v študiji prekinil zdravljenje z zdravilom Nenad zaradi draženja kože, zaradi česar je obliž neprimeren za dolgotrajno uporabo.
English: What documentation did the company present to support its application to the Agency?
Slovenian: Katero dokumentacijo je družba predložila Evropski agenciji za zdravila v podporo svoji vlogi?
English: Since restless legs syndrome is often a lifelong disease, long-term data were considered essential.
Slovenian: Ker je sindrom nemirnih nog pogosto doživljenjska bolezen, so podatki o dolgotrajnih učinkih bistveni.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Nenad?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Nenad?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Nenad be refused.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in priporočil zavrnitev dovoljenja za promet z zdravilom Nenad.
English: This means that it imitates the action of dopamine, a messenger substance in the parts of the brain that control movement and co ordination.
Slovenian: To pomeni, da posnema delovanje dopamina, sporočilne snovi v delih možganov, ki nadzorujejo gibanje in koordinacijo.
English: What was Nenad expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Nenad uporabljalo?
English: The patients were given Nenad, ropinirole (another medicine for restless legs syndrome) or placebo (a dummy medicine).
Slovenian: Bolniki so prejeli zdravilo Nenad, ropinirol (drugo zdravilo za sindrom nemirnih nog) ali placebo (zdravilo brez zdravilne učinkovine).
English: The active substance in Nenad, lisuride, is a dopamine agonist.
Slovenian: Zdravilna učinkovina zdravila Nenad, lizurid, je agonist dopamina.
English: The CHMP noted that, while the short-term effectiveness of Nenad for the treatment of restless legs syndrome had been shown, there was not enough evidence to demonstrate its long-term effectiveness.
Slovenian: CHMP je upošteval, da kljub temu, da so bili kratkoročni učinki zdravila Nenad za zdravljenje sindroma nemirnih nog dokazani, ni bilo zadostnih dokazov za njegovo dolgotrajno učinkovitost.
English: However, during the CHMP evaluation, the company withdrew its application for Nenad to be used for this disease.
Slovenian: Vendar pa je med postopkom ocenjevanja CHMP družba umaknila vlogo za zdravilo Nenad za uporabo pri tej bolezni.
English: However, the syndrome is thought to be caused by problems in the way dopamine works in the brain, which was expected to be corrected by lisuride.
Slovenian: Vendar pa se domneva, da sindrom nastane zaradi motenj delovanja dopamina v možganih, ki naj bi se odpravile z lizuridom.
English: The company withdrew before the European Commission had issued a decision on this opinion.
Slovenian: Družba je podala zahtevek za umik, še preden je Evropska komisija odobrila dovoljenje.
English: The company informed the CHMP that there are no consequences for patients using Nenad in clinical trials or compassionate use programmes.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki jemljejo zdravilo Nenad v kliničnih preskušanjih ali programih sočutne uporabe.
English: Nenad was expected to be used in adults with moderate-to-severe idiopathic restless legs syndrome.
Slovenian: Zdravilo Nenad naj bi se uporabljalo pri odraslih z zmernim do hudim idiopatskim sindromom nemirnih nog.
English: The way lisuride was expected to work in restless legs syndrome is not fully understood.
Slovenian: Način delovanja lizurida pri simptomu nemirnih nog ni popolnoma znan.
English: Nenad is a transdermal patch (patch that delivers a medicine across the skin) that contains the active substance lisuride.
Slovenian: Zdravilo Nenad je transdermalni obliž (obliž, ki dovaja zdravilo skozi kožo), ki vsebuje zdravilno učinkovino lizurid.
English: How was Nenad expected to work?
Slovenian: Kako naj bi zdravilo Nenad delovalo?
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Nenad in the treatment of restless legs syndrome did not outweigh its risks.
Slovenian: CHMP je menil, da koristi zdravila Nenad pri zdravljenju sindroma nemirnih nog ne odtehtajo z njim povezanih tveganj.
English: The main measure of effectiveness was the change in the rating of the
Slovenian: Glavno merilo učinkovitosti je bila sprememba ocene bolnikovih simptomov po 12 tednih glede na mednarodno ocenjevalno lestvico
English: patients' symptoms after 12 weeks using the International Restless Legs Syndrome rating scale (IRLS) score.
Slovenian: sindroma nemirnih nog (IRLS).
English: Date of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013
Slovenian: Datum prve odobritve: 19. november 2008 Datum zadnjega podaljšanja: 28. november 2013
English: (type A) and magnesium stearate.
Slovenian: (tipa A) in magnezijev stearat.
English: Your doctor will tell you exactly how many tablets of Xiliarx to take.
Slovenian: Zdravnik vam bo natančno povedal, koliko tablet zdravila Xiliarx morate jemati.
English: EU/1/08/486/001 7 tablets EU/1/08/486/002 14 tablets EU/1/08/486/003 28 tablets EU/1/08/486/004 30 tablets EU/1/08/486/005 56 tablets EU/1/08/486/006 60 tablets EU/1/08/486/007 90 tablets EU/1/08/486/008 112 tablets EU/1/08/486/009 180 tablets EU/1/08/486/010 336 tablets
Slovenian: EU/1/08/486/001 7 tablet EU/1/08/486/002 14 tablet EU/1/08/486/003 28 tablet EU/1/08/486/004 30 tablet EU/1/08/486/005 56 tablet EU/1/08/486/006 60 tablet EU/1/08/486/007 90 tablet EU/1/08/486/008 112 tablet EU/1/08/486/009 180 tablet EU/1/08/486/010 336 tablet
English: EU/1/08/486/011 336 tablets (3 packs of 112)
Slovenian: EU/1/08/486/011 336 tablet (3 pakiranja po 112 tablet)
English: How to take Xiliarx • Swallow the tablets whole with some water.
Slovenian: Kako jemati zdravilo Xiliarx - Tablete pogoltnite cele z malo vode.
English: Xiliarx is not a substitute for insulin in insulin-requiring patients.
Slovenian: Zdravilo Xiliarx ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin.
English: Xiliarx should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Xiliarx se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: If you think you may be allergic to vildagliptin or any of the other ingredients of Xiliarx, do not take this medicine and talk to your doctor.
Slovenian: Če menite, da bi lahko bili alergični na vildagliptin ali katerokoli sestavino zdravila Xiliarx, ne jemljite tega zdravila in se posvetujte z zdravnikom.
English: The amount of Xiliarx people have to take varies depending on their condition.
Slovenian: Koliko zdravila Xiliarx morajo ljudje jemati, je odvisno od njihovega stanja.
English: Your doctor will prescribe Xiliarx either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Slovenian: Zdravnik vam bo predpisal zdravilo Xiliarx bodisi za samostojno uporabo ali skupaj z določenimi drugimi zdravili, ki jih že jemljete, če ta zdravila do zdaj niso bila dovolj učinkovita za urejanje sladkorne bolezni.
English: The active substance of Xiliarx, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Slovenian: Zdravilna učinkovina zdravila Xiliarx, vildagliptin, sodi v skupino zdravil, ki se imenujejo “peroralni antidiabetiki”.
English: It is not known if Xiliarx passes into breast milk.
Slovenian: Ni znano, ali zdravilo Xiliarx prehaja v materino mleko.
English: What Xiliarx is and what it is used for
Slovenian: Kaj je zdravilo Xiliarx in za kaj ga uporabljamo
English: Your doctor may wish to alter your dose of Xiliarx if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids(generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Slovenian: Zdravnik vam bo morda svetoval spremembo odmerka zdravila Xiliarx, če jemljete druga zdravila kot so - tiazidi ali drugi diuretiki (imenovani tudi tablete za odvajanje vode) - kortikosteroidi (običajno se jih uporablja za zdravljenje vnetij) - hormoni ščitnice - nekatera zdravila, ki vplivajo na živčevje.
English: The safety and efficacy of Xiliarx in children and adolescents (< 18 years) have not been established.
Slovenian: Varnost in učinkovitost zdravila Xiliarx pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
English: Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Xiliarx for 10 days.
Slovenian: Podatki o verjetnih simptomih prevelikega odmerjanja temeljijo na študiji prenašanja naraščajočih odmerkov, izvedeni na zdravih osebah, ki so prejemale zdravilo Xiliarx 10 dni.
English: Do not stop taking Xiliarx unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Xiliarix, če vam tega ne naroči zdravnik.
English: No studies on the effect on human fertility have been conducted for Xiliarx (see section 5.3).
Slovenian: Študij o vplivu zdravila Xiliarx na plodnost pri ljudeh niso izvajali (glejte poglavje 5.3).
English: Driving and using machines If you feel dizzy while taking Xiliarx, do not drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste med jemanjem zdravila Xiliarx omotični, ne vozite in ne upravljajte strojev.
English: What you need to know before you take Xiliarx
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xiliarx
English: Xiliarx contains lactose (milk sugar).
Slovenian: Zdravilo Xiliarx vsebuje laktozo (mlečni sladkor).
English: Oral use Xiliarx can be administered with or without a meal (see also section 5.2).
Slovenian: Zdravilo Xiliarx se lahko jemlje z obrokom ali brez njega (glejte tudi poglavje 5.2).
English: • Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
Slovenian: • bolezen jeter (hepatitis) (redko); simptomi vključujejo rumeno kožo in oči, slabost, izgubo apetita ali temno obarvan urin, kar lahko kaže na bolezen jeter (hepatitis) ;
English: Following withdrawal of treatment with Xiliarx and LFT normalisation, treatment with Xiliarx should not be reinitiated.
Slovenian: Po prekinitvi zdravljenja z zdravilom Xiliarx in normalizaciji vrednosti jetrnih testov se zdravljenja z zdravilom Xiliarx ne sme ponovno uvesti.
English: Other medicines and Xiliarx
Slovenian: Druga zdravila in zdravilo Xiliarx
English: Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Xiliarx therapy is recommended.
Slovenian: Če zvišanje AST ali ALT na ali nad 3-kratno zgornjo mejo normalnih vrednosti vztraja, je priporočena prekinitev zdravljenja z zdravilom Xiliarx.
English: Xiliarx is used to treat adult patients with type 2 diabetes.
Slovenian: Zdravilo Xiliarx se uporablja za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2.
English: • Do not use any Xiliarx pack that is damaged or shows signs of tampering.
Slovenian: • Škatle zdravila Xiliarx ne uporabljajte, če je poškodovana ali opazite, da je bila že odprta.
English: What Xiliarx is and what it is used for What you need to know before you take Xiliarx How to take Xiliarx
Slovenian: Kaj je zdravilo Xiliarx in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xiliarx Kako jemati zdravilo Xiliarx Možni neželeni učinki
English: Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Slovenian: Tablete Xiliarx 50 mg so na voljo v pakiranjih po 7, 14, 28, 30, 56, 60, 90, 112, 180 ali 336 tablet in v skupnem pakiranju, ki obsega 3 škatle, od katerih vsaka vsebuje 112 tablet.
English: Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Slovenian: Zdravila Xiliarx ne smejo uporabljati bolniki z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST) nad 3-kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavji 4.4 in 5.2).
English: Some symptoms need immediate medical attention: You should stop taking Xiliarx and see your doctor immediately if you experience the following side effects:
Slovenian: Pri nekaterih simptomih je potrebna takojšnja zdravniška pomoč: V primeru, da pride do naslednjih neželenih učinkov, morate prenehati jemati zdravilo Xiliarx in takoj obiskati zdravnika:
English: If you take too many Xiliarx tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Xiliarx, kot bi smeli Če ste vzeli preveč tablet zdravila Xiliarx ali če je kdo drug vzel vaše zdravilo, se takoj obrnite na zdravnika.
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Xiliarx is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic ali s končno ledvično odpovedjo (ESRD - end-stage renal disease) je priporočeni odmerek zdravila Xiliarx 50 mg enkrat na dan (glejte tudi poglavja 4.4, 5.1 in
English: A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo.
Slovenian: Rezultati kliničnega preskušanja vildagliptina pri bolnikih iz funkcijskih razredov I-III po klasifikaciji Newyorškega združenja za srce (New York Heart Association, NYHA) so pokazali, da zdravljenje z vildagliptinom v primerjavi s placebom ni povzročalo spremembe funkcije levega prekata ali poslabšanja že prej prisotnega kongestivnega popuščanja srca.
English: Table 7 Post-marketing adverse reactions
Slovenian: Obdobje trženja Preglednica 7 Neželeni učinki v obdobju trženja
English: Children and adolescents The use of Xiliarx in children and adolescents up to 18 years of age is not recommended.
Slovenian: Otroci in mladostniki Pri otrocih in mladostnikih do 18. leta starosti uporaba zdravila Xiliarx ni priporočena.
English: Liver function should be monitored during treatment with Xiliarx at three-month intervals during the first year and periodically thereafter.
Slovenian: Delovanje jeter je treba v prvem letu zdravljenja z zdravilom Xiliarx spremljati vsake 3 mesece in občasno tudi kasneje.
English: Liver function tests should be performed prior to the initiation of treatment with Xiliarx in order to know the patient's baseline value.
Slovenian: Pred začetkom zdravljenja z zdravilom Xiliarx je treba opraviti pregled jetrnih testov za določitev bolnikovih izhodiščnih vrednosti.
English: If you forget to take Xiliarx
Slovenian: Če ste pozabili vzeti zdravilo Xiliarx
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Xiliarx.
Slovenian: Bolniki, pri katerih pride do ikterusa ali drugih znakov, ki nakazujejo moteno delovanje jeter, morajo prekiniti zdravljenje z zdravilom Xiliarx.
English: What Xiliarx looks like and contents of the pack Xiliarx 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Slovenian: Tablete Xiliarx 50 mg so okrogle, ploščate, bele do svetlo rumenkaste barve, z napisom “NVR” na eni strani in “FB” na drugi.
English: • if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Xiliarx - če ste alergični na vildagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The elimination halflife after oral administration is approximately 3 hours.
Slovenian: Po peroralni aplikaciji je razpolovni čas izločanja približno 3 ure.
English: Due to lack of human data, Xiliarx should not be used during pregnancy.
Slovenian: Zaradi nezadostnih podatkov o uporabi med nosečnostjo pri ljudeh zdravila Xiliarx ne smete uporabljati pri nosečnicah.
English: Xiliarx 50 mg tablets
Slovenian: Xiliarx 50 mg tablete
English: Xiliarx 50 mg tablets vildagliptin
Slovenian: Xiliarx 50 mg tablete vildagliptin
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Xiliarx alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
Slovenian: • 100 mg na dan, ki ga vzamete v odmerkih 50 mg zjutraj in 50 mg zvečer, če jemljete zdravilo Xiliarx samostojno ali skupaj z drugim zdravilom, ki se imenuje metformin ali glitazon, v kombinaciji z metforminom in sulfonilureo ali z insulinom, - 50 mg na dan zjutraj, če imate zmerno ali hudo ledvično bolezen ali ste na dializnem zdravljenju.
English: Xiliarx should not be used during breast-feeding.
Slovenian: Zdravila Xiliarx se med dojenjem ne sme uporabljati.
English: • Take Xiliarx every day for as long as your doctor tells you.
Slovenian: Kako dolgo jemati zdravilo Xiliarx - Zdravilo Xiliarx jemljite vsak dan, dokler vam tako priporoča zdravnik.
English: If you stop taking Xiliarx
Slovenian: Če ste prenehali jemati zdravilo Xiliarix
English: • Uncommon: Constipation
Slovenian: • pogosti: omotičnost
English: • The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate
Slovenian: - Druge sestavine zdravila so brezvodna laktoza, mikrokristalna celuloza, natrijev škrobni glikolat
English: Overall, vildagliptin improved glycaemic control when given as monotherapy or when used in combination with metformin, a sulphonylurea, and a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 8).
Slovenian: V celoti je vildagliptin bodisi v monoterapiji bodisi v kombinaciji z metforminom, s sulfonilureo ali s tiazolidindionom izboljšal urejenost glukoze v krvi, kar se je pokazalo kot klinično pomembno znižanje vrednosti HbA1c od izhodišča do časa opazovanja v študiji (glejte preglednico 6).
English: • 50 mg daily taken as one dose in the morning if you are taking Xiliarx with another medicine called a sulphonylurea.
Slovenian: Običajni odmerek zdravila Xiliarx je: - 50 mg na dan, ki ga vzamete v enem odmerku zjutraj, če jemljete zdravilo Xiliarx skupaj z drugim zdravilom, ki se imenuje sulfonilurea
English: How Xiliarx works
Slovenian: Kako zdravilo Xiliarx deluje
English: Some patients have had the following side effects while taking Xiliarx and insulin (with or without metformin):
Slovenian: Pri nekaterih bolnikih je med jemanjem zdravila Xiliarx in uporabo insulina (z metforminom ali brez njega) prišlo do naslednjih neželenih učinkov:
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Xiliarx 100 mg daily were 1.4 and 2.7 kg, respectively.
Slovenian: V študiji s pioglitazonom in dodanim zdravilom je prišlo do povečanja telesne mase in sicer pri placebu za 1,4 kg, pri zdravilu Xiliarx v odmerku 100 mg dnevno pa za 2,7 kg.
English: If a dose of Xiliarx is missed, it should be taken as soon as the patient remembers.
Slovenian: Če bolnik izpusti odmerek zdravila Xiliarx, naj ga vzame takoj, ko se spomni.
English: Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2).
Slovenian: Zdravilo Xiliarx se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3-kratno zgornjo mejo normalnih vrednosti (glejte tudi poglavji 4.2 in 5.2).
English: Xiliarx is not recommended for use in children and adolescents under (< 18 years).
Slovenian: Uporaba zdravila Xiliarx pri otrocih in mladostnikih (< 18 let) ni priporočljiva.
English: A test to determine your liver function will be performed before the start of Xiliarx treatment, at threemonth intervals for the first year and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Xiliarx boste opravili preiskavo delovanja jeter, med zdravljenjem pa boste v prvem letu opravljali kontrolne preiskave na tri mesece in kasneje v rednih časovnih intervalih.
English: Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Slovenian: Vildagliptin je indiciran tudi za uporabo v kombinaciji z insulinom (z metforminom ali brez njega) pri bolnikih, pri katerih diabetesa ni mogoče ustrezno urediti z dieto, telesno vadbo in insulinom v stabilnem odmerku
English: • Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating
Slovenian: • pogosti: omotičnost, tremor, šibkost, nizka koncentracija glukoze v krvi, čezmerno znojenje