natgillin/translations-raw huggingface dataset:
If you have questions about how long to take this medicine, talk to your doctor.
Če vas zanima, kako dolgo morate jemati to zdravilo, se pogovorite s svojim zdravnikom.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Pogostnosti so definirane kot: zelo pogosti (≥1/10), pogosti (≥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), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Not all pack sizes may be marketed in your country.
V vaši državi morda niso na voljo vse velikosti pakiranj.
Since this product has been marketed, the following side effects have also been reported:
Odkar je zdravilo na trgu, so poročali tudi o naslednjih neželenih učinkih:
Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Sladkorna bolezen tipa 2 se razvije v primeru, ko organizem ne tvori dovolj insulina, ali pa če insulin, ki ga organizem tvori, ne deluje tako, kot bi moral.
EU/1/08/485/001 7 tablets EU/1/08/485/002 14 tablets EU/1/08/485/003 28 tablets EU/1/08/485/004 30 tablets EU/1/08/485/005 56 tablets EU/1/08/485/006 60 tablets EU/1/08/485/007 90 tablets EU/1/08/485/008 112 tablets EU/1/08/485/009 180 tablets EU/1/08/485/010 336 tablets
EU/1/08/485/001 7 tablet EU/1/08/485/002 14 tablet EU/1/08/485/003 28 tablet EU/1/08/485/004 30 tablet EU/1/08/485/005 56 tablet EU/1/08/485/006 60 tablet EU/1/08/485/007 90 tablet EU/1/08/485/008 112 tablet EU/1/08/485/009 180 tablet EU/1/08/485/010 336 tablet
If you need to see a doctor or go to the hospital, take the pack with you.
Če morate k zdravniku oziroma v bolnišnico, vzemite škatlo zdravil s seboj.
It is used when diabetes cannot be controlled by diet and exercise alone.
Uporablja se takrat, ko sladkorne bolezni ni mogoče urediti samo z dieto in telesno vadbo.
EU/1/08/485/011 336 tablets (3 packs of 112)
EU/1/08/485/011 336 tablet (3 pakiranja po 112 tablet)
What Jalra is and what it is used for
Kaj je zdravilo Jalra in za kaj ga uporabljamo
The amount of Jalra people have to take varies depending on their condition.
Koliko zdravila Jalra morajo ljudje jemati, je odvisno od njihovega stanja.
Rare cases of hepatic dysfunction (including hepatitis) have been reported.
Poročali so o redkih primerih motenega delovanja jeter (vključno s hepatitisom).
Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.
Čeprav boste začeli jemati zdravilo za sladkorno bolezen, je zelo pomembno, da se še naprej držite diete in/ali telesne vadbe, kakor vam priporoča zdravnik.
LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment.
Koncentracije presnovka LAY151 so bile približno 2-3-krat višje kot pri bolnikih s hudo okvaro ledvic.
Use of vildagliptin has been associated with a risk of developing acute pancreatitis.
Uporabo vildagliptina povezujejo s tveganjem za razvoj akutnega pankreatitisa.
There are no adequate data from the use of vildagliptin in pregnant women.
Ni zadostnih podatkov o uporabi vildagliptina pri nosečnicah.
Multipack: 336 (3 packs of 112) tablets.
Skupno pakiranje: 336 tablet (3 pakiranja po 112 tablet).
Digoxin (Pgp substrate), warfarin (CYP2C9 substrate)
Digoksin (substrat P-glikoproteina), varfarin (substrat CYP2C9)
If it is almost time for your next dose, skip the dose you missed.
Če je že skoraj čas za naslednji odmerek, izpustite pozabljeni odmerek.
Jalra is not a substitute for insulin in insulin-requiring patients.
Zdravilo Jalra ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin.
If you think you may be allergic to vildagliptin or any of the other ingredients of Jalra, do not take this medicine and talk to your doctor.
Če menite, da bi lahko bili alergični na vildagliptin ali katerokoli sestavino zdravila Jalra, ne jemljite tega zdravila in se posvetujte z zdravnikom.
Other medicines and Jalra
Druga zdravila in zdravilo Jalra
The maximum change (increase or decrease) in the exposure to vildagliptin is ~30%, which is not considered to be clinically relevant.
Največja razlika (povečanje ali zmanjšanje) izpostavljenosti vildagliptinu je bila približno 30 %, kar ocenjujejo za klinično nepomembno.
Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Zdravila Jalra se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin in all subsets of the paediatric population with type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z vildagliptinom za vse podskupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH02
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, zaviralci dipeptidil peptidaze 4 (DPP4), oznaka ATC: A10BH02
Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product.
Od teh bolnikov jih je 2.264 prejemalo vildagliptin kot monoterapijo, 1.520 bolnikov pa je prejemalo vildagliptin v kombinaciji z drugim zdravilom.
Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals.
Insulin je snov, ki pomaga zniževati koncentracijo sladkorja v krvi, posebno po obrokih.
Do not stop taking Jalra unless your doctor tells you to.
Ne prenehajte jemati zdravila Jalra, če vam tega ne naroči zdravnik.
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:
Vildagliptin je indiciran za zdravljenje sladkorne bolezni tipa 2 pri odraslih:
If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.
Če ste že jemali vildagliptin, pa ste ga morali prenehati zaradi bolezni jeter, ne smete jemati tega zdravila.
Animal studies have shown excretion of vildagliptin in milk.
Študije so pokazale, da se pri živalih vildagliptin izloča v mleko.
C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
C označenega vildagliptina se je približno 85 % odmerka izločilo z urinom, 15 % odmerka pa so našli v blatu.
What you need to know before you take Jalra
Kaj morate vedeti, preden boste vzeli zdravilo Jalra
Your doctor will prescribe Jalra 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.
Zdravnik vam bo predpisal zdravilo Jalra 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.
* p< 0.05 for comparison versus placebo
* p< 0,05 za primerjavo s placebom
Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Jalra for 10 days.
Podatki o verjetnih simptomih prevelikega odmerjanja temeljijo na študiji prenašanja naraščajočih odmerkov, izvedeni na zdravih osebah, ki so prejemale zdravilo Jalra 10 dni.
It is not known if Jalra passes into breast milk.
Ni znano, ali zdravilo Jalra prehaja v materino mleko.
• Do not use this medicine after the expiry date which is stated on the blister and the carton after
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake “EXP”.
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.
Ker vildagliptin ni niti substrat encimov citokrom 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.
Monotherapy placebo controlled studies
Študije z monoterapijo, kontrolirane s placebom
Your doctor may wish to alter your dose of Jalra 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.
Zdravnik vam bo morda svetoval spremembo odmerka zdravila Jalra, 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.
Information regarding overdose with vildagliptin is limited.
Podatki o prevelikem odmerjanju vildagliptina so omejeni.
How to take Jalra • Swallow the tablets whole with some water.
Kako jemati zdravilo Jalra - Tablete pogoltnite cele z malo vode.
The active substance of Jalra, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Zdravilna učinkovina zdravila Jalra, vildagliptin, sodi v skupino zdravil, ki se imenujejo “peroralni antidiabetiki”.
The safety and efficacy of Jalra in children and adolescents (< 18 years) have not been established.
Varnost in učinkovitost zdravila Jalra pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
In vitro data in human kidney microsomes suggest that the kidney may be one of the major organs contributing to the hydrolysis of vildagliptin to its major inactive metabolite, LAY151.
In vitro podatki, pridobljeni na mikrosomih človeških ledvic, nakazujejo, da bi bile ledvice lahko eden pomembnejših organov za hidrolizo vildagliptina v njegov glavni neaktivni metabolit LAY 151.
Liver enzyme monitoring
Spremljanje jetrnih encimov
Oral use Jalra can be administered with or without a meal (see also section 5.2).
Zdravilo Jalra se lahko jemlje z obrokom ali brez njega (glejte tudi poglavje 5.2).
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.
Ocenjeno je, da zvišana incidenca teh tumorjev pri miših ne predstavlja pomembnega tveganja za ljudi glede na to, da vildagliptin in njegov glavni metabolit nista genotoksična, da je do tumorjev prišlo le pri eni živalski vrsti in glede na visoka razmerja med izpostavljenostmi, pri katerih so tumorje opažali.
Excipient with known effect: Each tablet contains 47.82 mg lactose (anhydrous).
Pomožne snovi z znanim učinkom: Ena tableta vsebuje 47,82 mg laktoze (brezvodne).
No dose adjustments are necessary in elderly patients (see also sections 5.1 and 5.2).
Za starejše bolnike prilagajanje odmerkov ni potrebno (glejte tudi poglavji 5.1 in 5.2).
There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients.
Iz kliničnih preskušanj ni nobenih izkušenj z uporabo vildagliptina pri bolnikih iz funkcijskega razreda IV po klasifikaciji NYHA, zato uporaba pri teh bolnikih ni priporočena.
Limited data from patients with end stage renal disease (ESRD) indicate that vildagliptin exposure is similar to that in patients with severe renal impairment.
Maloštevilni podatki bolnikov s končno ledvično odpovedjo (ESRD) kažejo, da je pri njih izpostavljenost vildagliptinu podobna kot pri bolnikih s hudo okvaro ledvic.
Three other subjects experienced oedema of the feet, with paraesthesia in two cases.
Pri treh drugih osebah je prišlo do otekanja stopal, v dveh primerih s parestezijami.
Diabetic skin lesions are a common complication of diabetes.
Diabetične spremembe na koži so pogost zaplet pri sladkorni bolezni.
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets
7 tablet 14 tablet 28 tablet 30 tablet 56 tablet 60 tablet 90 tablet 112 tablet 180 tablet 336 tablet
Embryo-foetal toxicity was evaluated in rats and rabbits.
Toksičnost za zarodek in plod so ocenjevali pri podganah in kuncih.
Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3-4 hour haemodialysis session starting 4 hours post dose).
Vildagliptin se je s hemodializo izločil le v majhni meri (samo 3 % v 3-4 urah hemodialize z začetkom 4 ure po odmerjanju).
The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the glucuronide (BQS867) and the amide hydrolysis products (4% of dose).
Glavni metabolit (LAY 151) nima farmakološkega učinka in nastane s hidrolizo ciano skupine ter predstavlja 57 % odmerka, sledijo pa mu glukuronid (BQS867) in produkti hidrolize amida (4 % odmerka).
Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor.
Vildagliptin iz skupine spodbujevalcev Langerhansovih otočkov je močan in selektiven zaviralec DPP-4.
Vildagliptin has a low potential for interactions with co-administered medicinal products.
Vildagliptin ima le majhno možnost medsebojnega delovanja s sočasno uporabljenimi zdravili.
• Store in the original package in order to protect from moisture.
• Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
It can also develop if the body produces too much glucagon.
Sladkorna bolezen se razvije tudi v primeru, ko organizem tvori preveč glukagona.
The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Varnost in učinkovitost vildagliptina v trotirnem zdravljenju v kombinaciji z metforminom in tiazolidindionom ni bila ugotovljena.
Another two-year carcinogenicity study was conducted in mice at oral doses up to 1,000 mg/kg.
Drugo dvoletno študijo karcinogenosti so opravili na miših s peroralnimi odmerki do 1.000 mg/kg.
Jalra 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Tablete Jalra 50 mg so okrogle, ploščate, bele do svetlo rumenkaste barve, z napisom “NVR” na eni strani in “FB” na drugi.
Ethnic group Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Podatki omejenega obsega nakazujejo, da rasna pripadnost nima pomembnega vpliva na farmakokinetiko vildagliptina.
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Zato je v okviru rutinske oskrbe sladkornih bolnikov priporočeno opazovanje kože glede kožnih sprememb kot so mehurčast izpuščaj ali razjede na koži.
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.
Cmax vildagliptina in AUC (površina pod krivuljo časovne porazdelitve koncentracij v plazmi) sta se v okviru terapevtskih odmerkov povečevali približno sorazmerno z velikostjo odmerka.
How Jalra works
Kako zdravilo Jalra deluje
• Do not use any Jalra pack that is damaged or shows signs of tampering.
• Škatle zdravila Jalra ne uporabljajte, če je poškodovana ali opazite, da je bila že odprta.
The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations.
Neželeni učinki v teh preskušanjih so bili večinoma blagi in prehodne narave, zdravljenja zaradi njih ni bilo treba prekinjati.
* p< 0.05 for comparison versus placebo + comparator
* p< 0,05 za primerjavo s placebom + primerjalnim zdravilom
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
• bolezen jeter (hepatitis) (redko); simptomi vključujejo rumeno kožo in oči, slabost, izgubo apetita ali temno obarvan urin, kar lahko kaže na bolezen jeter (hepatitis) );
What Jalra is and what it is used for What you need to know before you take Jalra How to take Jalra
Kaj je zdravilo Jalra in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Jalra Kako jemati zdravilo Jalra Možni neželeni učinki
Some symptoms need immediate medical attention: You should stop taking Jalra and see your doctor immediately if you experience the following side effects:
Pri nekaterih simptomih je potrebna takojšnja zdravniška pomoč: V primeru, da pride do naslednjih neželenih učinkov, morate prenehati jemati zdravilo Jalra in takoj obiskati zdravnika:
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal.
Bolnikom, pri katerih pride do zvišanja vrednosti aminotransferaz, je treba za potrditev opraviti še drugo preiskavo delovanja jeter, nato pa jih je treba spremljati s pogostimi pregledi jetrnih testov, dokler se nenormalni izvid(i) ne normalizira(jo).
Study 2301: Vildagliptin 50 mg twice daily (N=90) Study 2384: Vildagliptin 50 mg twice daily (N=79)
študija 2301: vildagliptin 50 mg dvakrat dnevno (N=90) študija 2384: vildagliptin 50 mg dvakrat dnevno (N=79)
If you forget to take Jalra
Če ste pozabili vzeti zdravilo Jalra
• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.
• angioedem (redko: pojavi se lahko pri največ 1 od 1.000 bolnikov); simptomi vključujejo otečen obraz, jezik ali grlo in žrelo, oteženo požiranje, oteženo dihanje, nenaden izbruh izpuščaja ali koprivnice, kar lahko kaže na reakcijo, imenovano “angioedem”;
Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
Bolniki, pri katerih prihaja do neželenega učinka v obliki omotičnosti, naj se izogibajo vožnji ali upravljanju s stroji.
Combination with pioglitazone, metformin and glyburide
Kombinacija s pioglitazonom, metforminom in gliburidom
Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive (see section 5.1).
Kliničnih izkušenj pri bolnikih iz funkcijskega razreda III po klasifikaciji NYHA, ki so prejemali vildagliptin, je še vedno malo, rezultati pa niso prepričljivi (glejte poglavje 5.1).
• Common: Dizziness
• pogosti: omotičnost
Children and adolescents The use of Jalra in children and adolescents up to 18 years of age is not recommended.
Otroci in mladostniki Pri otrocih in mladostnikih do 18. leta starosti uporaba zdravila Jalra ni priporočena.
Jalra is used to treat adult patients with type 2 diabetes.
Zdravilo Jalra se uporablja za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2.
Driving and using machines If you feel dizzy while taking Jalra, do not drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Če ste med jemanjem zdravila Jalra omotični, ne vozite in ne upravljajte strojev.
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels.
Pri 600 mg je pri eni osebi prišlo do otekanja rok in stopal ter zvišanja koncentracij kreatin-kinaze (CK), aspartataminotransferaze (AST), C-reaktivnega proteina (CRP) in mioglobina.
A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor).
O večjem deležu primerov so poročali ob jemanju vildagliptina v kombinaciji z zaviralcem angiotenzinske konvertaze (zaviralcem ACE).
Mean baseline HbA1c (%)
Povprečna izhodiščna vrednost HbA1c (%)
Jalra 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.
Tablete Jalra 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.
Following oral administration in the fasting state, vildagliptin is rapidly absorbed, with peak plasma concentrations observed at 1.7 hours.
Po peroralni aplikaciji na tešče se vildagliptin hitro absorbira in doseže najvišje koncentracije v plazmi po 1,7 ure.
The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Uporaba vildagliptina povzroči hitro in popolno zaviranje delovanja DPP-4, kar povzroča zvišanje endogenih koncentracij hormonov inkretinov GLP-1 (glukagonu podoben peptid 1; glucagon-like peptide 1) in GIP (od glukoze odvisni insulinotropni polipeptid; glucose-dependent insulinotropic polypeptide) na tešče in po obroku.
Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
V kliničnih študijah niso opažali zvišane incidence kožnih sprememb, vendar je pri bolnikih s kožnimi obolenji kot zapletom sladkorne bolezni obseg izkušenj omejen.
Results from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions.
Rezultati študij s temi peroralnimi antidiabetiki niso pokazali nobenih klinično pomembnih farmakokinetičnih interakcij.
Jalra contains lactose (milk sugar).
Zdravilo Jalra vsebuje laktozo Zdravilo Jalra vsebuje laktozo (mlečni sladkor).
At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels.
Pri 400 mg je v treh primerih prišlo do bolečin v mišicah in v posameznih primerih do blage in prehodne parestezije, povišane telesne temperature, edemov in prehodnega zvišanja koncentracije lipaz.
If you take too many Jalra tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Če ste vzeli večji odmerek zdravila Jalra, kot bi smeli Če ste vzeli preveč tablet zdravila Jalra ali če je kdo drug vzel vaše zdravilo, se takoj obrnite na zdravnika.
Patients treated with vildagliptin reported significantly lower incidences of gastrointestinal adverse reactions versus those treated with metformin.
Pri bolnikih, ki so prejemali vildagliptin, so poročali o pomembno nižji incidenci gastrointestinalnih neželenih učinkov v primerjavi s tistimi, ki so prejemali metformin.
Jalra 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).
Zdravila Jalra 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).
Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Jalra therapy is recommended.
Če zvišanje AST ali ALT na ali nad 3-kratno zgornjo mejo normalnih vrednosti vztraja, je priporočena prekinitev zdravljenja z zdravilom Jalra.
If you stop taking Jalra
Če ste prenehali jemati zdravilo Jalra
Decreased blood glucose
nizka koncentracija glukoze v krvi