FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Pioglitazone Krka, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Slovenian: Zdravilna učinkovina zdravila Pioglitazone Krka, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
English: What are the benefits and risks of Pioglitazone Krka?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pioglitazone Krka?
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 Pioglitazone Krka.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pioglitazone Krka, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Pioglitazone Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pioglitazone Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Pioglitazone Krka is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Slovenian: Zdravilo Pioglitazone Krka se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Krka.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pioglitazone Krka.
English: Because Pioglitazone Krka is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Slovenian: Ker je zdravilo Pioglitazone Krka generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
English: Pioglitazone Krka should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Slovenian: Zdravilo Pioglitazone Krka se ne sme uporabljati pri bolnikih na dializi (tehniki čiščenja krvi, uporabljeni pri bolnikih z obolenjem ledvic).
English: Pioglitazone Krka is a ‘generic medicine'.
Slovenian: Zdravilo Pioglitazone Krka je generično zdravilo.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Krka has been shown to have comparable quality and to be bioequivalent to Actos.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone Krka primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
English: Pioglitazone Krka is a medicine that contains the active substance pioglitazone.
Slovenian: Pioglitazone Krka je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
English: Pioglitazone Krka can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Slovenian: Zdravilo Pioglitazone Krka se lahko uporablja tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z insulinom samim in za katere metformin ni primeren.
English: Pioglitazone Krka can also be used with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Slovenian: Zdravilo Pioglitazone Krka se lahko uporablja tudi s sulfonilsečnino (drugo zdravilo proti sladkorni bolezni), če metformin ni primeren (dvojno zdravljenje).
English: The Committee recommended that Pioglitazone Krka be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Pioglitazone Krka odobri dovoljenje za promet.
English: Other information about Pioglitazone Krka
Slovenian: Druge informacije o zdravilu Pioglitazone Krka
English: Pioglitazone Krka is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Slovenian: Zdravilo Pioglitazone Krka se uporablja samostojno pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primerno.
English: Why has Pioglitazone Krka been approved?
Slovenian: Zakaj je bilo zdravilo Pioglitazone Krka odobreno?
English: How has Pioglitazone Krka been studied?
Slovenian: Kako je bilo zdravilo Pioglitazone Krka raziskano?
English: What is Pioglitazone Krka used for?
Slovenian: Za kaj se zdravilo Pioglitazone Krka uporablja?
English: How is Pioglitazone Krka used?
Slovenian: Kako se zdravilo Pioglitazone Krka uporablja?
English: How does Pioglitazone Krka work?
Slovenian: Kako zdravilo Pioglitazone Krka deluje?
English: What is Pioglitazone Krka?
Slovenian: Kaj je zdravilo Pioglitazone Krka?
English: In the MRP United Kingdom is the Reference Member State (RMS) and Austria, Belgium, Finland, France, Germany, Italy, Ireland, Luxembourg, Portugal, Spain and Sweden are Concerned Member States (CMS).
Slovenian: V postopku medsebojnega priznavanja je bilo Združeno kraljestvo referenčna država članica, medtem ko so bile Avstrija, Belgija, Finska, Francija, Nemčija, Italija, Irska, Luksemburg, Portugalska, Španija in Švedska zadevne države članice.
English: VIANI EVOHALER and associated names (See Annex I)
Slovenian: VIANI EVOHALER in z njim povezana imena (glejte Dodatek I)
English: In several EU Member States Viani Evohaler and associated names are approved through the Mutual Recognition Procedure (MRP).
Slovenian: V številnih državah članicah EU je bilo zdravilo Viani Evohaler in z njim povezana imena odobreno s postopkom medsebojnega priznavanja (MRP).
English: Viani Evohaler and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Slovenian: Zdravilo Viani Evohaler in z njim povezana imena (glejte Dodatek I), ki vsebuje salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β-agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), je indicirano za običajno zdravljenje astme, kadar je uporaba kombiniranega zdravila (dolgo delujočega beta-2-agonista in inhalacijskega kortikosteroida) ustrezna: pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in »po potrebi« z inhalacijskim kratko delujočim beta-2-agonistom ni mogoče doseči zadostnega nadzora bolezni, ali pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta-2-agonistom vzpostaviti zadosten nadzor bolezni.
English: It is available as a solution for injection which should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Slovenian: Na voljo je v obliki raztopine za injiciranje, ki jo mora injicirati zdravstveni delavec približno 30 minut pred začetkom kemoterapije.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Hospira has been shown to be comparable to Aloxi.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Palonosetron Hospira primerljivo z zdravilom Aloxi.
English: The full EPAR for Palonosetron Hospira 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 Palonosetron Hospira je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, the recommended dose is 250 micrograms, injected into a vein over 30 seconds.
Slovenian: Priporočeni odmerek pri odraslih je 250 mikrogramov, ki se 30 sekund injicira v veno.
English: This is a summary of the European public assessment report (EPAR) for Palonosetron Hospira.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Palonosetron Hospira.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Slovenian: To pomeni, da kemični snovi v telesu, imenovani 5-hidroksitriptamin (5HT, znani tudi kot serotonin), prepreči vezavo na receptorje 5HT3 v črevesju.
English: It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Slovenian: Uporablja se pri odraslih in otrocih, starejših od enega meseca, pri kemoterapiji z zdravili, ki povzročajo bodisi močno slabost in bruhanje (kot je cisplatin) bodisi zmerno (kot so ciklofosfamid, doksorubicin ali karboplatin).
English: The Committee recommended that Palonosetron Hospira be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Palonosetron Hospira odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Palonosetron Hospira?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Palonosetron Hospira?
English: Because Palonosetron Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Palonosetron Hospira generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: A risk management plan has been developed to ensure that Palonosetron Hospira is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Palonosetron Hospira je bil pripravljen načrt obvladovanja tveganj.
English: The company provided data from the published literature on palonosetron.
Slovenian: Družba je predstavila podatke o palonosetronu iz objavljene literature.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Palonosetron Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: This means that Palonosetron Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aloxi.
English: What are the benefits and risks of Palonosetron Hospira?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Palonosetron Hospira?
English: It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect.
Slovenian: Za povečanje učinkovitosti se mu lahko doda kortikosteroid (drugo vrsta zdravila, ki se lahko uporablja za preprečevanje slabosti in bruhanja).
English: For more information about treatment with Palonosetron Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Palonosetron Hospira preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Palonosetron Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Palonosetron Hospira naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: By blocking these receptors, Palonosetron Hospira prevents the nausea and vomiting that often happen after chemotherapy.
Slovenian: Zdravilo Palonosetron Hospira z zaviranjem teh receptorjev prepreči slabost in bruhanje, ki se pogosto pojavita po kemoterapiji.
English: Other information about Palonosetron Hospira
Slovenian: Druge informacije o zdravilu Palonosetron Hospira
English: Palonosetron Hospira is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Slovenian: Zdravilo Palonosetron Hospira se uporablja za preprečevanje navzeje (slabosti) in bruhanja, ki ju povzroča kemoterapija (zdravila za zdravljenje raka).
English: What is Palonosetron Hospira and what is it used for?
Slovenian: Kaj je zdravilo Palonosetron Hospira in za kaj se uporablja?
English: Therefore, the CHMP's view was that, as for Aloxi, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Aloxi odtehtajo znana tveganja.
English: The active substance in Palonosetron Hospira, palonosetron, is a ‘5HT3 antagonist'.
Slovenian: Zdravilna učinkovina zdravila Palonosetron Hospira, palonosetron, je „antagonist 5HT3“.
English: Palonosetron Hospira is a ‘generic medicine'.
Slovenian: Zdravilo Palonosetron Hospira je „generično zdravilo“.
English: Palonosetron Hospira should only be given before chemotherapy and can only be obtained with a prescription.
Slovenian: Zdravilo Palonosetron Hospira se daje samo pred kemoterapijo, izdaja pa je le na recept.
English: It is not intended to provide practical advice on how to use Palonosetron Hospira.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Palonosetron Hospira approved?
Slovenian: Zakaj je bilo zdravilo Palonosetron Hospira odobreno?
English: the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Slovenian: Pri otrocih se raztopina v odmerku 20 mikrogramov na kilogram telesne mase 15 minut daje z infundiranjem (kapalno infuzijo) v veno.
English: No additional studies were needed as Palonosetron Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
Slovenian: Ker je zdravilo Palonosetron Hospira generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Aloxi, niso bile potrebne nobene dodatne študije.
English: How is Palonosetron Hospira used?
Slovenian: Kako se zdravilo Palonosetron Hospira uporablja?
English: Palonosetron Hospira contains the active substance palonosetron.
Slovenian: Zdravilo Palonosetron Hospira vsebuje zdravilno učinkovino palonosetron.
English: How has Palonosetron Hospira been studied?
Slovenian: Kako je bilo zdravilo Palonosetron Hospira raziskano?
English: Date of first authorisation: 10 January 2008 Date of latest renewal: 20 September 2012
Slovenian: Datum prve odobritve: 10. januar 2008 Datum zadnjega podaljšanja: 20. september 2012
English: STOP taking TESAVEL and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: Zdravilo TESAVEL takoj PRENEHAJTE jemati in se posvetujte z zdravnikom, če opazite katerega koli od naslednjih resnih neželenih učinkov:
English: TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila TESAVEL se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: What TESAVEL is and what it is used for
Slovenian: Kaj je zdravilo TESAVEL in za kaj ga uporabljamo
English: If you take more TESAVEL than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila TESAVEL, kot bi smeli Če ste vzeli večji odmerek tega zdravila od predpisanega, se takoj posvetujte z zdravnikom.
English: Other medicines and TESAVEL
Slovenian: Druga zdravila in zdravilo TESAVEL
English: Your doctor may ask you to stop TESAVEL.
Slovenian: Zdravnik vam bo morda naročil, da prenehate z jemanjem zdravila TESAVEL.
English: Do not take TESAVEL - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila TESAVEL - če ste alergični na sitagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: What you need to know before you take TESAVEL
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo TESAVEL
English: Due to lack of human data, TESAVEL should not be used during pregnancy.
Slovenian: Zaradi pomanjkanja podatkov pri ljudeh se zdravila TESAVEL med nosečnostjo ne sme jemati.
English: For adult patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control:
Slovenian: Pri odraslih bolnikih s sladkorno boleznijo tipa 2 je zdravilo TESAVEL indicirano za izboljšanje urejenosti glikemije:
English: What TESAVEL is and what it is used for What you need to know before you take TESAVEL How to take TESAVEL
Slovenian: Kaj je zdravilo TESAVEL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo TESAVEL Kako jemati zdravilo TESAVEL Možni neželeni učinki
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of TESAVEL and periodically thereafter.
Slovenian: Ker prilagoditev odmerka temelji na ledvični funkciji, pred začetkom zdravljenja z zdravilom TESAVEL in periodično tekom zdravljenja priporočamo oceno ledvične funkcije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with TESAVEL in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom TESAVEL za vse skupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and TESAVEL administered concomitantly.
Slovenian: Pri uporabi v kombinaciji z metforminom in/ali agonistom PPAR je treba odmerek metformina in/ali agonista PPAR ohraniti in zdravilo TESAVEL uporabljati sočasno.
English: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 ljudi): nizek krvni sladkor Pogosti: zaprtje
English: If you forget to take TESAVEL
Slovenian: Če ste pozabili vzeti zdravilo TESAVEL
English: If you stop taking TESAVEL
Slovenian: Če ste prenehali jemati zdravilo TESAVEL
English: 5 How to store TESAVEL Contents of the pack and other information
Slovenian: Shranjevanje zdravila TESAVEL Vsebina pakiranja in dodatne informacije
English: The usual recommended dose is: one 100mg film-coated tablet once a day by mouth
Slovenian: Običajni priporočeni odmerek je: - ena 100 mg filmsko obložena tableta, - enkrat na dan,
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, TESAVEL may be administered with or without food.
Slovenian: Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo TESAVEL lahko jemlje s hrano ali brez nje.
English: TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Slovenian: Zdravilo TESAVEL je indicirano tudi kot dodatno zdravljenje k insulinu (z metforminom ali brez), če z dieto in s telesno aktivnostjo ter stabilnim odmerkom insulina urejenost glikemije ni zadostna.
English: TESAVEL has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo TESAVEL nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: It is important to stay on the diet and exercise recommended by your doctor while taking TESAVEL.
Slovenian: Med jemanjem zdravila TESAVEL je pomembno, da se držite diete in telesne aktivnosti, ki vam ju je priporočil zdravnik.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Slovenian: Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V kliničnih preskušanjih zdravila TESAVEL kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (tj. metforminom in/ali agonistom PPAR), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
English: If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers.
Slovenian: Če bolnik izpusti odmerek zdravila TESAVEL, ga mora vzeti takoj, ko se spomni.
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily.
Slovenian: Pri bolnikih s hudo ledvično okvaro (GFR ≥ 15 do < 30 ml/min) ali bolnikih s končno ledvično odpovedjo (ESRD - end-stage renal disease) (GFR < 15 ml/min), vključno s tistimi, ki potrebujejo hemodializo ali peritonealno dializo, je odmerek zdravila TESAVEL 25 mg enkrat na dan.
English: What TESAVEL looks like and contents of the pack
Slovenian: Izgled zdravila TESAVEL in vsebina pakiranja
English: When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Pri uporabi zdravila TESAVEL v kombinaciji s sulfonilsečnino ali z insulinom lahko po potrebi zmanjšate odmerek sulfonilsečnine ali insulina, da se tako zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.4).
English: How to take TESAVEL
Slovenian: Kako jemati zdravilo TESAVEL
English: TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Slovenian: Pri bolnikih s hudo jetrno okvaro uporaba zdravila TESAVEL ni raziskana, zato je potrebna previdnost (glejte poglavje 5.2).
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
Slovenian: Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je odmerek zdravila TESAVEL 50 mg enkrat na dan.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL (see section 4).
Slovenian: Pri bolnikih, ki so prejemali zdravilo TESAVEL, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
English: Method of administration TESAVEL can be taken with or without food.
Slovenian: Način uporabe Zdravilo TESAVEL lahko bolnik jemlje skupaj s hrano ali brez nje.
English: What TESAVEL contains
Slovenian: Kaj vsebuje zdravilo TESAVEL
English: TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Slovenian: Zdravilo TESAVEL spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP-4).