FrancophonIA/ELRC3.0 huggingface dataset:
English: Amprenavir: Cmax ↓ 35% Amprenavir: AUC ↓ 18% Amprenavir: Cmin (C12h) ↔
Slovenian: (Telzir 1400 mg enkratni amprenavir: Cmax 35% amprenavir: AUC  18% amprenavir: Cmin (C12h) 
English: Caution is warranted and close monitoring is recommended when this combination is given in integrase inhibitorresistant patients.
Slovenian: Če je ta kombinacija uporabljena pri bolnikih, ki so odporni proti zaviralcem integraze je potrebna previdnost in skrbno spremljanje.
English: Read the package leaflet before use Shake bottle vigorously before use
Slovenian: Pred uporabo plastenko dobro pretresite.
English: Amprenavir in addition is also an inhibitor of the CYP3A4 enzyme, although to a lesser extent than ritonavir.
Slovenian: Čeprav v manjšem obsegu kot ritonavir je tudi amprenavir zaviralec encima CYP3A4.
English: Atazanavir: Cmax ↓ 24%* Atazanavir: AUC ↓ 22%* Atazanavir: Cmin↔* *compared to atazanavir/ ritonavir 300 mg/ 100 mg once daily
Slovenian: 300 mg enkrat dnevno atazanavir: Cmax  24%* atazanavir: AUC 22%* atazanavir: Cmin
English: Atazanavir: Cmax ↓ 24%* Atazanavir: AUC↓ 22%* Atazanavir: Cmin↔* *compared to atazanavir/ ritonavir 300 mg/ 100 mg once daily
Slovenian: 300 mg enkrat dnevno atazanavir: Cmax  24%* atazanavir: AUC 22%*atazanavir: Cmin
English: Telzir tablet can be taken with or without food.
Slovenian: Lahko se jih jemlje s hrano ali brez.
English: When antineoplastic agents agents:
Slovenian: flutikazon propionat: 
English: Abacavir
Slovenian: Raztopina
English: BENZODIAZEPINES Midazolam
Slovenian: BENZODIAZEPINI
English: Paroxetine: Cmax ↓ 51% Paroxetine: AUC ↓55%
Slovenian: 20 mg enkrat dnevno paroksetin: Cmax  51% paroksetin: AUC  55%
English: 90 x 1 tablets (unit dose)
Slovenian: 90 x 1 tableta (enoodmerni pretisni omot)
English: 32.27 g
Slovenian: prašek: 32,27 g 1 steklenica
English: Solution for injection Intravenous use vial (glass)
Slovenian: Intravenska uporaba viala (steklo)
English: Content (concentration)
Slovenian: Stična Ovojnina Vsebina (koncentracija)
English: Powder for oral suspension bottle (glass)
Slovenian: 1 viala prašek za peroralno suspenzijo peroralna uporaba Steklenica (steklo)
English: 1 vial
Slovenian: Pot uporabe
English: Immediate Packaging
Slovenian: Velikost pakiranja raztopina za injiciranje
English: Package size
Slovenian: Velikost pakiranja o č
English: This summary was last updated in 2-2013.
Slovenian: Povzetek je bil nazadnje posodobljen 2-2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adasuve on 20 February 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Adasuve, veljavno po vsej Evropski uniji, odobrila dne 20. februarja 2013.
English: The full EPAR for Adasuve can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Adasuve je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe use of Adasuve?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Adasuve?
English: Its action on receptors for other neurotransmitters may also play a role.
Slovenian: Pomembno je lahko tudi njegovo delovanje na receptorje drugih nevrotransmiterjev.
English: A fall in PEC score indicates an improvement in symptoms.
Slovenian: Znižanje rezultata PEC pomeni izboljšanje simptomov.
English: Regarding its safety, most side effects are comparable to those of other antipsychotic medicines.
Slovenian: Kar zadeva varnost zdravila je večina neželenih učinkov primerljiva z neželenimi učinki drugih antipsihotikov.
English: The PEC score at the beginning of the study for these groups of patients was between 17 and 18.
Slovenian: Rezultat PEC je pri teh skupinah bolnikov v začetku študije znašal med 17 in 18.
English: Other information about Adasuve
Slovenian: Druge informacije o zdravilu Adasuve
English: Adasuve has been studied in two main studies.
Slovenian: Zdravilo Adasuve so preučevali v dveh glavnih študijah.
English: Agitation is a known complication of both mental illnesses.
Slovenian: Agitacija je znan zaplet pri obeh duševnih motnjah.
English: This is a summary of the European public assessment report (EPAR) for Adasuve.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Adasuve.
English: One study involved 344 patients with schizophrenia and the second study involved 314 patients with bipolar disorder.
Slovenian: V eno študijo je bilo vključenih 344 bolnikov s shizofrenijo, v drugo pa 314 bolnikov z bipolarno motnjo.
English: The potential risk of bronchospasm is considered manageable and has been adequately addressed through risk minimisation measures.
Slovenian: Potencialno tveganje bronhospazma je obvladljivo in je bilo primerno zajeto v ukrepih za zmanjšanje tveganja.
English: The effects of Adasuve were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Adasuve so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Adasuve should only be used in a hospital under the supervision of a healthcare professional.
Slovenian: Zdravilo Adasuve se lahko uporablja samo v bolnišnici pod nadzorom zdravstvenega delavca.
English: The company that makes Adasuve must ensure that all healthcare professionals who are expected to use Adasuve receive an information pack containing key information on how to use the medicine as well as important safety information.
Slovenian: Družba, ki izdeluje zdravilo Adasuve, mora zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi zdravilo uporabljali, prejeli informacijski paket s ključnimi informacijami o uporabi zdravila in pomembnimi varnostnimi informacijami.
English: For more information about treatment with Adasuve, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Adasuve preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Since these neurotransmitters are involved in agitation in schizophrenia and bipolar disorder, loxapine helps to normalise the activity of the brain, reducing agitation.
Slovenian: Ker ti nevrotransmiterji sodelujejo pri agitaciji pri shizofreniji in bipolarni motnji, loksapin pomaga normalizirati aktivnost možganov in zmanjša agitacijo.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: S tem prekine signale, ki jih med možganskimi celicami prenašajo „nevrotransmiterji“, kemične snovi, ki omogočajo komunikacijo med celicami.
English: If considered necessary the doctor may prescribe a second dose of 9.1 mg after two hours.
Slovenian: Po potrebi lahko zdravnik po dveh urah predpiše drugi 9,1-miligramski odmerek.
English: Loxapine works mainly by blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Slovenian: Loksapin večinoma blokira receptorje za nevrotransmiterje 5hidroksitriptamina (imenovanega tudi serotonin) in dopamin.
English: What benefit has Adasuve shown during the studies?
Slovenian: Kakšne koristi je zdravilo Adasuve izkazalo med študijami?
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Slovenian: Shizofrenija je duševna bolezen, ki ima vrsto simptomov, vključno z neorganiziranim mišljenjem in govorom, halucinacijami (bolnik vidi ali sliši stvari, ki jih ni), sumničavostjo ter blodnjami (zmotnimi prepričanji).
English: The CHMP concluded that the benefits of Adasuve outweigh its risks and recommended that it be granted marketing authorisation.
Slovenian: Odbor CHMP je zaključil, da so koristi zdravila Adasuve večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Bipolar disorder is a mental illness with alternating periods of high mood and depression.
Slovenian: Bipolarna motnja je duševna bolezen, pri kateri se izmenjujejo obdobja privzdignjenega razpoloženja in depresije.
English: It is available as an inhalation powder in a portable inhaler device for single use (4.5 mg and 9.1 mg).
Slovenian: Na voljo je v obliki praška za inhaliranje v prenosnem inhalatorju za enkratno uporabo (4,5 mg in 9,1 mg).
English: The main measure of effectiveness was the change in the patients' symptoms two hours after giving a dose of loxapine, assessed using a standard scale of agitation in patients with schizophrenia and bipolar disorder (positive and negative symptom scale, excited component: PEC score).
Slovenian: Glavno merilo učinkovitosti je bila sprememba bolnikovih simptomov dve uri po dajanju odmerka loksapina, ki so jo ocenili na podlagi standardne ocenjevalne lestvice agitacije pri bolnikih s shizofrenijo in bipolarno motnjo (lestvica pozitivnih in negativnih simptomov, komponenta razburjenosti: rezultat PEC).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adasuve.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Adasuve, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It must also not be used in patients with symptoms such as wheezing and shortness of breath or who have lung conditions such as asthma or chronic obstructive pulmonary disease.
Slovenian: Zdravilo se prav tako ne sme uporabljati pri bolniki s simptomi, kot so sopenje in kratka sapa, ali pri bolnikih s težavami s pljuči, kot so astma ali kronična obstruktivna pljučna bolezen.
English: Treatment with Adasuve is started with the inhalation of a single dose of 9.1 mg.
Slovenian: Zdravljenje z zdravilom Adasuve se začne z inhaliranjem enkratnega, 9,1-miligramskega odmerka.
English: A lower dose of 4.5 mg may be prescribed if the patient did not tolerate the initial dose of 9.1 mg or if a lower dose is considered more appropriate.
Slovenian: Mogoče je dati nižji, 4,5miligramski odmerek, če bolnik ni dobro prenašal začetnega, 9,1-miligramskega odmerka ali če se zdravnik odloči, da je nižji odmerek primernejši.
English: What is the risk associated with Adasuve?
Slovenian: Kakšna tveganja so povezana z zdravilom Adasuve?
English: Adasuve must not be used in people who are hypersensitive (allergic) to loxapine or any of the other ingredients.
Slovenian: Zdravila Adasuve ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) loksapin ali katero koli drugo sestavino zdravila.
English: In studies in agitated patients, bronchospasm was reported as an uncommon but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short acting beta-agonist.
Slovenian: V študijah z agitiranimi bolniki so o bronhospazmu poročali kot o občasnem, a resnem neželenem učinku, medtem ko so pri bolnikih z aktivno boleznijo dihalnih poti o bronhospazmu pogosto poročali in je ta večkrat zahteval zdravljenje s kratkotrajno delujočimi agonisti beta.
English: In the brain, it attaches to and blocks several different receptors on the surface of nerve cells.
Slovenian: Loksapin deluje tako, da se veže na več različnih receptorjev na površini živčnih celic in blokira njihovo delovanje.
English: The most common side effects with Adasuve are dysgeusia (taste disturbances), sedation or somnolence (sleepiness) and dizziness.
Slovenian: Najpogostejši neželeni učinki zdravila Adasuve so bili disgevzija (motnje okušanja), sedacija ali somnolenca (zaspanost) in omotičnost.
English: The CHMP noted that the administration of Adasuve is non-invasive.
Slovenian: Odbor CHMP je tudi navedel, da je dajanje zdravila Adasuve neinvazivno.
English: Adasuve was more effective than placebo at controlling agitation.
Slovenian: Zdravilo Adasuve je bilo učinkovitejše pri obvladovanju agitacije kot placebo.
English: Patients should be observed for signs of shortness of breath for one hour after each dose.
Slovenian: Bolnike je prvo uro po vsakem odmerku treba opazovati za znake kratke sape.
English: Adasuve loxapine
Slovenian: Adasuve loksapin
English: Why has Adasuve been approved?
Slovenian: Zakaj je bilo zdravilo Adasuve odobreno?
English: Both studies compared 4.5 mg and 9.1 mg of Adasuve with placebo (a dummy treatment).
Slovenian: Obe študiji sta primerjali odmerka zdravila Adasuve 4,5 mg in 9,1 mg s placebom (zdravilom brez zdravilne učinkovine).
English: Adasuve is a medicine that contains the active substance loxapine.
Slovenian: Adasuve je zdravilo, ki vsebuje zdravilno učinkovino loksapin.
English: The active substance in Adasuve, loxapine, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina v zdravilu Adasuve, loksapin, je antipsihotik.
English: For the full list of all side effects reported with Adasuve, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Adasuve, glejte navodilo za uporabo.
English: In the study in patients with schizophrenia, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.0 points and patients taking 9.1 mg had an average fall of 8.7 points.
Slovenian: V študiji pri bolnikih s shizofrenijo so pri bolnikih, ki so prejemali 4,5 mg zdravila Adasuve, zabeležili povprečno znižanje rezultata PEC za 8,0 točk, pri bolnikih, ki so prejemali odmerek 9,1 mg, pa povprečno znižanje za 8,7 točk.
English: Adasuve is used to rapidly control mild to moderate agitation in adults with schizophrenia or bipolar disorder.
Slovenian: Zdravilo Adasuve se uporablja za hitro obvladanje blage do zmerne agitacije pri odraslih bolnikih s shizofrenijo ali bipolarno motnjo.
English: In the study in patients with bipolar disorder, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.2 points, and patients taking 9.1 mg had an average fall of 9.2 points.
Slovenian: V študiji pri bolnikih z bipolarno motnjo so pri bolnikih, ki so prejemali 4,5 mg zdravila Adasuve, zabeležili povprečno znižanje rezultata PEC za 8,2 točke, pri bolnikih, ki so prejemali odmerek 9,1 mg, pa povprečno znižanje za 9,2 točke.
English: The CHMP concluded that Adasuve has been demonstrated to rapidly control (within minutes) mild to moderate agitation in patients with schizophrenia or bipolar disorder who are cooperative with using an inhaler.
Slovenian: Odbor CHMP je zaključil, da se je pokazalo, da je mogoče z zdravilom Adasuve hitro obvladati (v nekaj minutah) blago do zmerno agitacijo pri bolnikih s shizofrenijo ali z bipolarno motnjo, ki so pripravljeni uporabiti inhalator.
English: Information on how to use the inhaler can be found in the package leaflet.
Slovenian: Za informacije o uporabi inhalatorja glejte navodila za uporabo.
English: This compared with a fall of 4.7 points in patients taking placebo.
Slovenian: Pri bolnikih, ki so prejemali placebo, je bila ta vrednost 4,7 točk.
English: How has Adasuve been studied?
Slovenian: Kako je bilo zdravilo Adasuve raziskano?
English: This compared with a fall of 5.8 points in patients taking placebo.
Slovenian: Pri bolnikih, ki so prejemali placebo, je bila ta vrednost 5,8 točk.
English: An airway-opening medicine called a short-acting beta agonist should also be available for the treatment of patients who develop bronchospasm (excessive and prolonged contraction of the airway muscles).
Slovenian: Za zdravljenje bolnikov, pri katerih se razvije bronhospazem (pretirano in dolgotrajno krčenje mišic v dihalnih poteh), mora biti na voljo tudi zdravilo za odpiranje dihalnih poti, imenovano kratkotrajno delujoči agonist beta.
English: How is Adasuve used?
Slovenian: Kako se zdravilo Adasuve uporablja?
English: What is Adasuve used for?
Slovenian: Za kaj se zdravilo Adasuve uporablja?
English: What is Adasuve?
Slovenian: Kaj je zdravilo Adasuve?
English: How does Adasuve work?
Slovenian: Kako zdravilo Adasuve deluje?
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product
Slovenian: Pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila
English: • The risk of bladder cancer risk and relevant risk minimisation advice.
Slovenian: • Tveganju za raka sečnega mehurja in ustreznim nasvetom za zmanjšanje tega tveganja.
English: Medical attention may be needed.
Slovenian: Morda bo potrebna zdravniška pomoč.
English: These changes are, however, not considered to be clinically relevant.
Slovenian: Vendar te spremembe ne veljajo za klinično pomembne.
English: You may have to take this treatment over a long period of time.
Slovenian: Morda boste morali jemati to zdravilo dolgo časa.
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: 23 julij 2012
English: Then take your next dose at the usual time.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: 112 tablets.
Slovenian: 112 tablet.
English: A double dose should not be taken on the same day.
Slovenian: Na isti dan ne sme vzeti dvojnega odmerka zdravila.
English: How much to take and when
Slovenian: Koliko zdravila vzeti in kdaj ga jemati
English: Your doctor will tell you exactly how many tablets of Jalra to take.
Slovenian: Zdravnik vam bo natančno povedal, koliko tablet zdravila Jalra morate jemati.
English: Characteristics in specific groups of patients
Slovenian: Značilnosti pri specifičnih skupinah bolnikov
English: • Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Slovenian: - Zdravnik vas bo redno pregledoval in preverjal, ali zdravljenje dosega pričakovan učinek.
English: Additional information on special populations Elderly (≥ 65 years)
Slovenian: Drugi podatki o posebnih skupinah bolnikov Starejši bolniki (≥ 65 let)
English: In the event of an overdose, supportive management is recommended.
Slovenian: V primeru zaužitja prevelikega odmerka je priporočeno podporno zdravljenje.
English: Doses higher than 100 mg are not recommended.
Slovenian: Odmerki nad 100 mg niso priporočljivi.
English: No data are available (see also section 5.1).
Slovenian: Podatkov ni na voljo (glejte tudi poglavje 5.1).
English: The maximum daily dose is 100 mg.
Slovenian: Najvišji dnevni odmerek je 100 mg.
English: If you forget to take a dose of this medicine, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti odmerek tega zdravila, ga vzemite takoj, ko se spomnite.
English: If you have questions about how long to take this medicine, talk to your doctor.
Slovenian: Če vas zanima, kako dolgo morate jemati to zdravilo, se pogovorite s svojim zdravnikom.
English: 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).
Slovenian: 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).
English: Not all pack sizes may be marketed in your country.
Slovenian: V vaši državi morda niso na voljo vse velikosti pakiranj.
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 naslednjih neželenih učinkih:
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: If you need to see a doctor or go to the hospital, take the pack with you.
Slovenian: Če morate k zdravniku oziroma v bolnišnico, vzemite škatlo zdravil s seboj.
English: It is used when diabetes cannot be controlled by diet and exercise alone.
Slovenian: Uporablja se takrat, ko sladkorne bolezni ni mogoče urediti samo z dieto in telesno vadbo.
English: EU/1/08/485/011 336 tablets (3 packs of 112)
Slovenian: EU/1/08/485/011 336 tablet (3 pakiranja po 112 tablet)
English: What Jalra is and what it is used for
Slovenian: Kaj je zdravilo Jalra in za kaj ga uporabljamo
English: The amount of Jalra people have to take varies depending on their condition.
Slovenian: Koliko zdravila Jalra morajo ljudje jemati, je odvisno od njihovega stanja.
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported.
Slovenian: Poročali so o redkih primerih motenega delovanja jeter (vključno s hepatitisom).
English: 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.
Slovenian: 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.
English: LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment.
Slovenian: Koncentracije presnovka LAY151 so bile približno 2-3-krat višje kot pri bolnikih s hudo okvaro ledvic.
English: Use of vildagliptin has been associated with a risk of developing acute pancreatitis.
Slovenian: Uporabo vildagliptina povezujejo s tveganjem za razvoj akutnega pankreatitisa.
English: There are no adequate data from the use of vildagliptin in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi vildagliptina pri nosečnicah.
English: Multipack: 336 (3 packs of 112) tablets.
Slovenian: Skupno pakiranje: 336 tablet (3 pakiranja po 112 tablet).
English: Digoxin (Pgp substrate), warfarin (CYP2C9 substrate)
Slovenian: Digoksin (substrat P-glikoproteina), varfarin (substrat CYP2C9)
English: If it is almost time for your next dose, skip the dose you missed.
Slovenian: Če je že skoraj čas za naslednji odmerek, izpustite pozabljeni odmerek.
English: Jalra is not a substitute for insulin in insulin-requiring patients.
Slovenian: Zdravilo Jalra ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin.
English: 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.
Slovenian: Če menite, da bi lahko bili alergični na vildagliptin ali katerokoli sestavino zdravila Jalra, ne jemljite tega zdravila in se posvetujte z zdravnikom.
English: Other medicines and Jalra
Slovenian: Druga zdravila in zdravilo Jalra
English: The maximum change (increase or decrease) in the exposure to vildagliptin is ~30%, which is not considered to be clinically relevant.
Slovenian: Največja razlika (povečanje ali zmanjšanje) izpostavljenosti vildagliptinu je bila približno 30 %, kar ocenjujejo za klinično nepomembno.
English: Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Jalra se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.