natgillin/translations-raw huggingface dataset:
Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide 
Lojuxta 30 mg trde kapsule Lojuxta 40 mg trde kapsule Lojuxta 60 mg trde kapsule lomitapid
Blood alkaline phosphatase increased Blood potassium decreased Carotene decreased International normalised ratio abnormal 
Pogosti povečano mednarodno umerjeno razmerje, povišana raven alkalne fosfataze v krvi, znižana raven kalija v krvi, znižana raven karotena, nenormalno mednarodno umerjeno razmerje, nenormalne preiskave delovanja jeter,
Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules lomitapide 
Navodilo za uporabo Lojuxta 5 mg trde kapsule Lojuxta 10 mg trde kapsule Lojuxta 20 mg trde kapsule lomitapid
You should contact your doctor before you stop taking this medicine. 
Preden prenehate jemati to zdravilo, se posvetujte z zdravnikom.
Hepatobiliary disorders 
Hepatotoksična zdravila
Grapefruit juice must be omitted from the diet while patients are treated with Lojuxta. 
Med zdravljenjem z zdravilom Lojuxta je treba sok grenivke izločiti iz prehrane.
• The capsule shell for the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172). 
• Ovojnica kapsul 5 mg in 10 mg vsebuje želatino, titanov oksid (E 171) in rdeči železov oksid
Very-low-density lipoprotein cholesterol (VLDL-C) (mg/dL) 
Lipoproteinski holesterol zelo majhne gostote (VLDL-C) (mg/dl)
Lojuxta contains lactose. 
Zdravilo Lojuxta vsebuje laktozo.
• Advice on escalating Lojuxta dose gradually to improve tolerability of the medicine; 
kot je vnetna črevesna bolezen ali malabsorpcija; • Nasvet glede postopnega večanja odmerka zdravila Lojuxta, da se izboljša prenašanje zdravila;
Abdominal pain upper Abdominal distension Abdominal pain Vomiting 
bolečina v trebuhu, bolečina v zgornjem delu trebuha,
Excipient with known effect Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4). 
Ena trda kapsula vsebuje 389,68 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
Excipient with known effect Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4). 
Ena trda kapsula vsebuje 259,79 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
• inflammation of the stomach and intestine that causes diarrhoea and vomiting 
• vnetje želodca in črevesa, ki povzroča drisko ter bruhanje, • regurgitacija (vračanje hrane iz želodca),
gamma-GT, serum albumin (liver injury); high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK-18 Fragment, NashTest (liver inflammation); 
C-reaktivni protein z veliko občutljivostjo (hs-CRP), hitrost sedimentacije eritrocitov (ESR), fragment citokeratina-18 (CK-18), preiskava za NASH (vnetje jeter); izboljšana preiskava za jetrno fibrozo (ELF), Fibrometer, razmerje AST/ALT, rezultat Fib-4, Fibrotest (jetrna fibroza).
How to store Lojuxta 
Shranjevanje zdravila Lojuxta
• The capsule shell for the 20 mg capsule contains gelatin and titanium dioxide (E171). 
• Ovojnica kapsul 20 mg vsebuje želatino in titanov oksid (E 171).
Muscle aches and pains (myalgia) or weakness 
Lahko se pojavita tudi bolečina v mišicah (mialgija) ali šibkost v mišicah (miopatija).
• Compliance with the supplementation regimen should be verified at regular scheduled appointments and the importance emphasised. 
• Pomembnost nadomeščanja maščobnih kislin in liposolubilnih vitaminov; • Bolnikovo upoštevanje režima nadomeščanja je treba preverjati pri rednih načrtovanih obiskih.
Just take your normal dose at the usual time the next day. 
Če ste pozabili vzeti zdravilo Lojuxta Vzemite normalni odmerek ob običajnem času naslednji dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Blood bilirubin increased Gamma-glutamyltransferase increased Neutrophil percentage increased Protein urine 
Občasni zmanjšana telesna masa, povišana raven bilirubina v krvi, povišana raven gamaglutamiltransferaze,
Lomitapide is a “lipid-modifying agent” which works by blocking the action of “microsomal triglyceride transfer protein.” This protein is located within the liver and the gut cells, where it is involved in assembling fatty substances into larger particles that are then released into the blood stream. 
Ta protein je v jetrih in celicah črevesa, kjer je vključen v sestavljanje maščobnih snovi v večje dele, ki se nato sprostijo v krvni obtok.
• Contraindication for use in patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption; 
• Podatki o kontraindikacijah pri bolnikih z zmerno ali hudo potrjeno jetrno okvaro/boleznijo,
Abdominal pain lower Frequent bowel movements 
Presnovne in prehranske motnje Pogosti zmanjšan tek
Haematemesis 
Dojenje
Omega-6 Linoleic acid 
Linolna kislina
Fatigue Asthenia 
Pogosti utrujenost
Warnings and precautions Talk to your doctor or pharmacist before taking Lojuxta if you: 
Pred začetkom jemanja zdravila Lojuxta se posvetujte z zdravnikom ali farmacevtom:
The use of St. John's Wort should be avoided with Lojuxta. 
Uporabi šentjanževke v kombinaciji z zdravilom Lojuxta se je treba izogibati.
Due date 
Dnevna količina
Excipient with known effect Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4). 
Ena trda kapsula vsebuje 194,84 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
STATEMENT OF ACTIVE SUBSTANCE(S) 
ZDRAVILA E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
E. 
INR).
Lojuxta 20 mg: each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide. 
Lojuxta 20 mg: ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 20 mg lomitapida.
• Patient Alert Cards 
• kartice z opozorili za bolnika
• if you take any of these medicines that affect the way lomitapide is broken down in the body: o itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections) ; o telithromycin, clarithromycin, erythromycin (for bacterial infections); o indinavir, nelfinavir, saquinavir (for HIV infection) ; o diltiazem, verapamil (for high blood pressure, or angina), and dronedarone (to regulate heart rhythm). 
o telitromicin, klaritromicin, eritromicin (za zdravljenje bakterijskih okužb), o indinavir, nelfinavir, sakvinavir (za zdravljenje okužbe z virusom HIV); o diltiazem, verapamil (za zdravljenje visokega krvnega tlaka ali angine) in dronedaron
• High sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK18 Fragment, NashTest (liver inflammation) 
• vsaj en označevalec iz vsake od naslednjih kategorij: • C-reaktivni protein z veliko občutljivostjo (hs-CRP), hitrost sedimentacije eritrocitov
This medicinal product has been authorised under ‘exceptional circumstances'. 
DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Dehydration Increased appetite 
Neznana pogostnost dehidracija
Lojuxta 10 mg hard capsules 
Lojuxta 10 mg trde kapsule
Excipient with known effect Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4). 
Ena trda kapsula vsebuje 140,23 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
• Lojuxta 5 mg is an orange cap/orange body hard capsule with “5 mg” printed on the body and “A733“ printed on the cap in black ink. 
• Zdravilo Lojuxta 5 mg je trda kapsula z oranžnim pokrovčkom/oranžnim telesom s črnima oznakama „5 mg“ na telesu in „A733“ na pokrovčku.
Lojuxta 60 mg hard capsules 
Lojuxta 60 mg trde kapsule
Excipient with known effect Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4). 
Ena trda kapsula vsebuje 70,12 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
Lojuxta 20 mg hard capsules 
Lojuxta 20 mg trde kapsule
Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide. 
Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 20 mg lomitapida.
• paracetamol - to treat pain 
• paracetamol - za zdravljenje bolečine, • zdravila za zdravljenje cistične fibroze (npr. ivakaftor),
Lojuxta 5 mg: each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. 
Lojuxta 5 mg: ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 5 mg lomitapida.
Frequent bowel movements Gastric dilatation Gastric disorder 
Občasni suha usta, trdo blato, gastroezofagealni refluks,
Excipient with known effect Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4). 
Ena trda kapsula vsebuje 129,89 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. 
Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 5 mg lomitapida.
Bile acid sequestrants Lomitapide has not been tested for interaction with bile acid sequestrants (resins such as colesevelam and cholestyramine). 
Medsebojnega delovanja lomitapida in snovi, ki vežejo žolčno kislino (smol, kot sta kolesevelam in holestiramin),
Lomitapide Observational Worldwide Evaluation Registry Information about the existence and importance of the registry aiming to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide. 
Podatki o obstoju in pomembnosti registra, ki je namenjen sistematičnemu zbiranju podatkov o varnost ter učinkovitosti izidov pri bolnikih, zdravljenih z lomitapidom.
Lojuxta 30 mg hard capsules 
Lojuxta 30 mg trde kapsule
Nervous system disorders 
želodčna motnja,
Lojuxta 5 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. 
Lojuxta 5 mg trde kapsule Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 5 mg lomitapida.
• To evaluate the occurrence of the following in patients treated with lomitapide: 
• če jemljete kakršna koli zdravila, ki vplivajo na način razgradnje lomitapida v telesu:
Abdominal discomfort Dyspepsia 
Neznana pogostnost alopecija
• burping 
• mehur,
Lojuxta 40 mg hard capsules 
Lojuxta 40 mg trde kapsule
Inhibitors of CYP3A4 When lomitapide 60 mg was co-administered with ketoconazole 200 mg twice daily, a strong inhibitor of 
Ko se je lomitapid 60 mg dajal skupaj s ketokonazolom
• medicines to treat gout (e.g. colchicine) 
• zdravila za zdravljenje protina (npr. kolhicin),
• Repeat tests weekly and withhold dosing if there are signs of abnormal liver function (increase in bilirubin or INR), if aminotransferase levels rise above 5x ULN, or if aminotransferase levels do not fall below 3x ULN within approximately 4 weeks. 
• Preiskave ponavljajte vsak teden in prekinite odmerjanje, če so prisotni znaki nenormalnega jetrnega delovanja (povečana vrednost bilirubina ali
Lojuxta 60 mg: each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide. 
Lojuxta 60 mg: ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 60 mg lomitapida.
Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules 
Lojuxta 5 mg trde kapsule Lojuxta 10 mg trde kapsule Lojuxta 20 mg trde kapsule Lojuxta 30 mg trde kapsule Lojuxta 40 mg trde kapsule Lojuxta 60 mg trde kapsule
Hepatic impairment 
Občasni vrtoglavica
Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide 
Lojuxta 5 mg trde kapsule Lojuxta 10 mg trde kapsule Lojuxta 20 mg trde kapsule Lojuxta 30 mg trde kapsule Lojuxta 40 mg trde kapsule Lojuxta 60 mg trde kapsule lomitapid
Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide. 
Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 60 mg lomitapida.
No dose adjustments are required when co-administered with Lojuxta. 
Kadar se ta zdravila uporabljajo sočasno z zdravilom Lojuxta, prilagajanje odmerka ni potrebno.
Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide. 
Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 30 mg lomitapida.
The capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap. 
Kapsula je trda kapsula z belim pokrovčkom/belim telesom, velika 19,4 mm, s črnima oznakama „20 mg“ na telesu in „A733“ na pokrovčku.
The capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap. 
Kapsula je trda kapsula z oranžnim pokrovčkom/oranžnim telesom, velika 19,4 mm, s črnima oznakama „5 mg“ na telesu in „A733“ na pokrovčku.
Lojuxta 5 mg hard capsules 
trda kapsula Lojuxta 5 mg trde kapsule
Gastroenteritis Gastrointestinal infection Influenza 
Občasni gastroenteritis, okužba prebavil, gripa, nazofaringitis, sinuzitis
• The capsule shell for the 60 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172). 
• Ovojnica kapsul 60 mg vsebuje želatino, titanov oksid (E 171) in rumeni železov oksid (E 172).
Ear and labyrinth disorders 
Ušesne bolezni, vključno z motnjami labirinta
Lojuxta 30 mg: each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide. 
Lojuxta 30 mg: ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 30 mg lomitapida.
Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide. 
Lojuxta 10 mg: ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 10 mg lomitapida.
• Lojuxta 10 mg is an orange cap/white body hard capsule with “10 mg” printed on the body and “A733“ printed on the cap in black ink. 
• Zdravilo Lojuxta 10 mg je trda kapsula z oranžnim pokrovčkom/belim telesom s črnima oznakama „10 mg“ na telesu in „A733“ na pokrovčku.
• Lojuxta 60 mg is a yellow cap/yellow body hard capsule with “60 mg” printed on the body and “A733” printed on the cap in black ink. 
• Zdravilo Lojuxta 60 mg je trda kapsula z rumenim pokrovčkom/rumenim telesom s črnima oznakama „60 mg“ na telesu in „A733“ na pokrovčku.
Nasopharyngitis Sinusitis 
Občasni hematurija
The capsule is an orange cap/yellow body hard capsule of 21.6 mm, printed with black ink imprinted with “30 mg” on body and “A733” on cap. 
Kapsula je trda kapsula z oranžnim pokrovčkom/rumenim telesom, velika 21,6 mm, s črnima oznakama „30 mg“ na telesu in „A733“ na pokrovčku.
• Lojuxta 30 mg is an orange cap/yellow body hard capsule with “30 mg” printed on the body and “A733” printed on the cap in black ink. 
• Zdravilo Lojuxta 30 mg je trda kapsula z oranžnim pokrovčkom/rumenim telesom s črnima oznakama „30 mg“ na telesu in „A733“ na pokrovčku.
Gastrooeosophageal reflux disease Abdominal tenderness Epigastric discomfort Gastric dilatation 
gastrektazija, hematemeza, krvavitev iz spodnjih prebavil, refluksni ezofagitis
The clinical studies supporting the safety and efficacy of lomitapide in HoFH would have been unlikely to detect this adverse outcome given their size and duration. 
Glede na velikost in trajanje kliničnih študij, ki podpirajo varnost in učinkovitost lomitapida pri homozigotni družinski hiperholesterolemiji (HoFH),
• Lojuxta 40 mg is a yellow cap/white body hard capsule with “40 mg” printed on the body and “A733” printed on the cap in black ink. 
• Zdravilo Lojuxta 40 mg je trda kapsula z rumenim pokrovčkom/belim telesom s črnima oznakama „40 mg“ na telesu in „A733“ na pokrovčku.
Lojuxta 40 mg: each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide. 
Lojuxta 40 mg: ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 40 mg lomitapida.
Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide. 
Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 40 mg lomitapida.
Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide. 
Ena trda kapsula vsebuje lomitapidijev mesilat, v količini, ki ustreza 10 mg lomitapida.
• The capsule shell for the 40 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172). 
• Ovojnica kapsul 40 mg vsebuje želatino, titanov oksid (E 171) in rumeni železov oksid (E 172).
The capsule is a yellow cap/yellow body hard capsule of 23.4 mm, printed with black ink imprinted with “60 mg” on body and “A733” on cap. 
Kapsula je trda kapsula z rumenim pokrovčkom/rumenim telesom, velika 23,4 mm, s črnima oznakama „60 mg“ na telesu in „A733“ na pokrovčku.
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) 
rdeči železov oksid (E 172) Lojuxta 20 mg trde kapsule želatina titanov dioksid (E 171)
Concomitant use of HMG-CoA reductase inhibitors (‘statins') 
Sočasna uporaba zaviralcev reduktaze HMG-CoA (statinov) Lomitapid poveča koncentracijo statinov v plazmi.
The capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap. 
Kapsula je trda kapsula z oranžnim pokrovčkom/belim telesom, velika 19,4 mm, s črnima oznakama „10 mg“ na telesu in „A733“ na pokrovčku.
The capsule is a yellow cap/white body hard capsule of 23.4 mm, printed with black ink imprinted with “40 mg” on body and “A733” on cap. 
Kapsula je trda kapsula z rumenim pokrovčkom/belim telesom, velika 23,4 mm, s črnima oznakama „40 mg“ na telesu in „A733“ na pokrovčku.
The dose of lomitapide was escalated from 5 mg to an individually determined maximum tolerated dose up to 60 mg. After Week 26, patients remained on lomitapide to determine the effects of longer-term treatment and were allowed to change background lipid-lowering therapies. 
Po 26. tednu so bolniki nadaljevali z jemanjem lomitapida, s čimer so želeli ugotoviti učinke dolgotrajnega zdravljenja.
Table 4 lists all adverse reactions for subjects who received lomitapide monotherapy (N=291) treated in Phase 2 studies in subjects with elevated LDL-C (N=462). 
(N = 291) v študijah 2. faze, ki so vključevale bolnike s povečano koncentracijo holesterola LDL
• Patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption. 
• bolniki s potrjeno pomembno ali kronično črevesno boleznijo, kot je vnetna črevesna bolezen ali malabsorpcija; • sočasna uporaba > 40 mg simvastatina (glejte poglavje 4.5);
Hard, capsule. 
Ovojnica kapsule
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
Pred uporabo preberite priloženo navodilo!
There was no evidence of embryofoetal toxicity in rabbits at 3 times the maximum recommended human dose (MRHD) of 60 mg based on body surface area. 
Dokazov o toksičnosti za zarodek in plod pri kuncih, pri katerih je bil odmerek 3-krat večji od največjega priporočenega odmerka pri človeku, 60 mg, na podlagi telesne površine, ni. Toksičnost za zarodek in plod so opazili pri kuncih pri ≥ 6,5-kratnem največjem priporočenem odmerku pri človeku, vendar brez toksičnosti za mater.
Diarrhoea Nausea Flatulence 
Bolezni jeter, žolčnika in žolčevodov
(E172) and yellow iron oxide (E172). 
rumeni železov oksid (E 172)
• Not to take Lojuxta if patient has liver problems, or unexplained abnormal liver tests; 
Brošura za bolnike mora vsebovati naslednje ključne elemente: • Ne jemljite zdravila Lojuxta, če imate težave z jetri ali nenormalne rezultate preiskav jetrnega delovanja; • Informacije, da lahko zdravilo Lojuxta povzroči težave z jetri;
The dose of Lojuxta should be taken 12 hours apart from any other concomitant weak CYP3A4 inhibitors. 
Odmerek zdravila Lojuxta je treba vzeti z 12-urnim zamikom glede na sočasno uporabo drugih šibkih
Diarrhoea 
Bolezni živčevja
• medicines to treat and prevent blood clots (e.g. cilostazol, ticagrelor) 
• zdravila za zdravljenje in preprečevanje krvnih strdkov (npr. cilostazol, tikagrelor), • zdravila za zdravljenje angine - bolečine v prsnem košu, ki jo povzroča srce (npr. ranolazin),
Grapefruit juice is a moderate inhibitor of CYP3A4 and is expected to substantially increase exposure to lomitapide. 
CYP3A4, zato se pričakuje, da bo pomembno povečal izpostavljenost lomitapidu.
• flatulence (wind) 
• vetrovi,
When the dose of lomitapide was taken 12 hours apart from atorvastatin, 
Pri uporabi odmerka lomitapida z 12-urnim zamikom glede na uporabo atorvastatina niso opazili klinično pomembnega povečanja izpostavljenosti lomitapidu.
Abdominal pain Abdominal pain upper Flatulence 
Zelo pogosti diareja, navzea, flatulenca
CYP3A4, lomitapide AUC increased approximately 27-fold and Cmax increased approximately 15-fold. 
200 mg dvakrat na dan, se je vrednost AUC lomitapida povečala za približno 27-krat,
Exercise additional caution if administering more than 1 weak CYP3A4 inhibitor with Lojuxta. 
Pri sočasni uporabi šibkega zaviralca CYP3A4 in zdravila Lojuxta je potrebna posebna previdnost.
Decreased appetite 
distenzija trebuha,
This summary was last updated in 01-2017. 
Povzetek je bil nazadnje posodobljen 01-2017.
On average, patients in the study were followed up for 3.1 years. 
V povprečju so bolnike v študiji spremljali 3,1 leta.
Supportive evidence was provided from a further six studies. 
Podporni dokazi so bili zagotovljeni v šestih nadaljnjih študijah.
The European Commission granted a marketing authorisation valid throughout the European Union for Jardiance on 22 May 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Jardiance, veljavno po vsej Evropski uniji, izdala 22. maja 2014.
The recommended starting dose is 10 mg once a day, which can be increased if necessary to 25 mg daily in suitable patients. 
Priporočeni začetni odmerek je 10 mg enkrat na dan, ki se lahko po potrebi poveča na 25 mg dnevno pri bolnikih, ki so za to primerni.
What measures are being taken to ensure the safe and effective use of Jardiance? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jardiance?
Regarding safety, overall the side effects were considered manageable. 
Kar zadeva celokupno varnost, so se neželeni učinki šteli za obvladljive.
In those receiving Jardiance, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo. 
Pri bolnikih, ki so prejemali zdravilo Jardiance, so se kardiovaskularni dogodki pojavili pri 10,5 % (490 od 4 687) bolnikov v primerjavi z 12,1 % (282 od 2 333) bolnikov, ki so prejemali placebo.
This is a summary of the European public assessment report (EPAR) for Jardiance. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jardiance.
Other information about Jardiance 
Druge informacije o zdravilu Jardiance
The full EPAR and risk management plan summary for Jardiance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Jardiance sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This leads to high levels of glucose in the blood. 
To vodi do visokih ravni glukoze v krvi.
The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. 
Glavno merilo učinkovitosti je bil pojav enega od treh glavnih kardiovaskularnih dogodkov: kapi, srčnega napada ali smrti zaradi kardiovaskularne bolezni.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Jardiance's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Jardiance večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients. 
Koristen učinek zdravila Jardiance na glukozo v krvi so zabeležili v štirih glavnih študijah, v katerih je sodelovalo več kot 2 700 bolnikov.
Some of these were continuations of the main studies, and suggested that the benefits of the medicine continued with longer therapy. 
Nekatere od njih so bile nadaljevanje glavnih študij, v njih pa so zabeležili, da so se koristi zdravila ohranile z daljšim zdravljenjem.