FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Estonian: Pärast 26. nädalat jätkasid patsiendid lomitapiidi kasutamist, et teha kindlaks pikaajalise ravi toime, kusjuures oli lubatud muuta teisi samaaegselt kasutatavaid vere lipiidisisaldust vähendavaid ravimeid.
English: Muscle aches and pains (myalgia) or weakness
Estonian: Pearinglus, peavalu, migreen
English: Consequently, this would reduce the effect of lomitapide.
Estonian: Seetõttu nõrgeneb arvatavasti lomitapiidi toime.
English: Lojuxta 10 mg hard capsules
Estonian: Lojuxta 10 mg kõvakapslid
English: • Information that Lojuxta was teratogenic in non-clinical studies and should not be taken during pregnancy or by patients trying to get pregnant;
Estonian: • Teave, et lomitapiid oli mittekliinilistes uuringutes teratogeenne ja et see on vastunäidustatud naistele, kes on rasedad või soovivad rasestuda.
English: Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Estonian: Iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 20 mg lomitapiidile.
English: Lojuxta 20 mg hard capsules
Estonian: Lojuxta 20 mg kõvakapslid
English: Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Estonian: Iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 5 mg lomitapiidile.
English: Excipient with known effect Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).
Estonian: Iga kõvakapsel sisaldab 129,89 mg laktoosi (laktoosmonohüdraadina) (vt lõik 4.4).
English: Hard, capsule.
Estonian: Kapsli kest
English: • Lojuxta 20 mg is a white cap/white body hard capsule with “20 mg” printed on the body and “A733” printed on the cap in black ink.
Estonian: • Lojuxta 20 mg on valge kapslikaane ja valge kapslikehaga kõvakapsel; kapslikehale on musta tindiga trükitud „20 mg” ja kapslikaanele „A733”.
English: The medicinal product is contraindicated in patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests.
Estonian: Lojuxta on vastunäidustatud mõõduka või raske maksafunktsiooni kahjustusega patsientidele, sealhulgas patsientidele, kelle maksafunktsiooni testide tulemused teadmata põhjusel püsivalt normist kõrvale kalduvad.
English: • medicines to treat cystic fybrosis (e.g. ivacaftor)
Estonian: • tsüstilise fibroosi ravimid (nt ivakaftoor);
English: Very-low-density lipoprotein cholesterol (VLDL-C) (mg/dL)
Estonian: Väga väikese tihedusega lipoproteiini kolesterool (VLDL-kolesterool) (mg/dl)
English: Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Estonian: Lojuxta 10 mg: iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 10 mg lomitapiidile.
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules lomitapide
Estonian: Lojuxta 5 mg kõvakapslid Lojuxta 10 mg kõvakapslid Lojuxta 20 mg kõvakapslid Lomitapiid
English: Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Estonian: Iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 60 mg lomitapiidile.
English: • medicines to treat low blood sodium level (e.g. tolvaptan)
Estonian: • vere väikese naatriumisisalduse ravimid (nt tolvaptaan);
English: Lojuxta 60 mg hard capsules
Estonian: Lojuxta 60 mg kõvakapslid
English: • The capsule shell for the 60 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Estonian: • 60 mg kapslite kest sisaldab želatiini, titaandioksiidi (E171) ja kollast raudoksiidi (E172).
English: Lojuxta 60 mg: each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Estonian: Lojuxta 60 mg: üks kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 60 mg lomitapiidile.
English: • medicines to treat anxiety disorders and depression (e.g. alprazolam, fluoxetine, fluvoxamine)
Estonian: • ärevushäirete ja depressiooni korral kasutatavad ravimid (nt alprasolaam, fluoksetiin,
English: 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.
Estonian: Annusel, mis ületas maksimaalse soovitatava annuse inimestel (60 mg) kehapindala alusel 3 korda, ei olnud lomitapiid küülikutel embrüotoksiline.
English: • The capsule shell for the 40 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Estonian: • 40 mg kapslite kest sisaldab želatiini, titaandioksiidi (E171) ja kollast raudoksiidi (E172).
English: • 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.
Estonian: • Lojuxta 60 mg on kollase kapslikaane ja kollase kapslikehaga kõvakapsel; kapslikehale on musta tindiga trükitud „60 mg” ja kapslikaanele „A733”.
English: Lojuxta 20 mg hard capsules Gelatin
Estonian: Lojuxta 20 mg kõvakapslid Želatiin
English: Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Estonian: Iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 30 mg lomitapiidile.
English: International normalised ratio increased
Estonian: Maksa rasvasisalduse protsendi maksimaalne absoluutne suurenemine
English: Lojuxta 30 mg hard capsules
Estonian: Lojuxta 30 mg kõvakapslid
English: 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.
Estonian: Oranži kapslikaane ja oranži kapslikehaga 19,4 mm pikkune kõvakapsel; kapslikehale on musta tindiga trükitud „5 mg” ja kapslikaanele „A733”.
English: gamma-GT, serum albumin (liver injury); high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK-18 Fragment, NashTest (liver inflammation);
Estonian: - gamma-GT ja seerumi albumiini sisalduse määramine, et kindlaks teha võimalik maksakahjustus; vähemalt üks marker järgmistest kategooriatest: kõrgtundlik C-reaktiivne valk (hs-CRP), erütrotsüütide settereaktsioon (ESR), CK-18 fragment, NashTest (maksapõletik); täiendatud maksafibroosi (ELF) paneel, fibromeeter, AST/ALT suhe, Fib-4 skoor, Fibrotest (maksafibroos).
English: • indigestion
Estonian: • röhitsemine;
English: Myalgia
Estonian: Hematuuria
English: Lojuxta 30 mg: each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Estonian: Lojuxta 30 mg: üks kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 30 mg lomitapiidile.
English: Lojuxta 40 mg: each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Estonian: Lojuxta 40 mg: üks kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 40 mg lomitapiidile.
English: Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Estonian: Iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 10 mg lomitapiidile.
English: See package leaflet for further information.
Estonian: Lisateabe saamiseks lugege pakendi infolehte.
English: Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Estonian: Iga kõvakapsel sisaldab lomitapiidmesilaati koguses, mis vastab 40 mg lomitapiidile.
English: Co-administration of a CYP3A4 inducer is expected to reduce the effect of lomitapide.
Estonian: CYP3A4 indutseerija samaaegne manustamine nõrgendab arvatavasti lomitapiidi toimet.
English: − The need to take daily dietary supplements (i.e. 400 IU vitamin E, approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day).
Estonian: • Nõuanded patsientidele järgmiste küsimuste osas: - vajadus järgida rasvavaest dieeti (rasvadest saadakse alla 20% ööpäevasest energiakogusest); - ravimi võtmise aeg (Lojuxtat tuleb võtta tühja kõhuga vähemalt 2 tundi pärast õhtusööki); - vajadus kasutada ravi ajal toidulisandeid, mis sisaldavad ööpäevases annuses 400 RÜ E-vitamiini ja ligikaudu 200 mg linoolhapet, 110 mg eikosapentaeenhapet (EPA), 210 mg alfa-linoleenhapet (ALA) ja 80 mg dokosaheksaeenhapet (DHA).
English: • medicines to treat and prevent blood clots (e.g. dabigatran etexilate)
Estonian: • ravimid, mida kasutatakse trombide raviks ja ärahoidmiseks (nt dabigatraaneteksilaat);
English: Haematemesis
Estonian: Müalgia
English: 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.
Estonian: Valge kapslikaane ja valge kapslikehaga 19,4 mm pikkune kõvakapsel; kapslikehale on musta tindiga trükitud „20 mg” ja kapslikaanele „A733”.
English: • 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.
Estonian: • Lojuxta 30 mg on oranži kapslikaane ja kollase kapslikehaga kõvakapsel; kapslikehale on musta tindiga trükitud „30 mg” ja kapslikaanele „A733”.
English: • 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.
Estonian: • Lojuxta 10 mg on oranži kapslikaane ja valge kapslikehaga kõvakapsel; kapslikehale on musta tindiga trükitud „10 mg” ja kapslikaanele „A733”.
English: • 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.
Estonian: • Lojuxta 40 mg on kollase kapslikaane ja valge kapslikehaga kõvakapsel; kapslikehale on musta tindiga trükitud „40 mg” ja kapslikaanele „A733”.
English: Blood bilirubin increased Gamma-glutamyltransferase increased Neutrophil percentage increased Protein urine
Estonian: Kehakaalu langus, vere bilirubiinisisalduse suurenemine, gamma-glutamüültransferaasi sisalduse suurenemine, neutrofiilide arvu protsentuaalne suurenemine, proteinuuria, protrombiiniaja pikenemine, kopsufunktsiooni normist kõrvalekalle, vere valgeliblede arvu suurenemine
English: Lojuxta 40 mg hard capsules
Estonian: Lojuxta 40 mg kõvakapslid
English: Hepatic impairment
Estonian: Rasked kõrvaltoimed
English: • weight loss
Estonian: • kõhupuhitus;
English: 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
Estonian: Lojuxta 5 mg kõvakapslid Lojuxta 10 mg kõvakapslid Lojuxta 20 mg kõvakapslid Lojuxta 30 mg kõvakapslid Lojuxta 40 mg kõvakapslid Lojuxta 60 mg kõvakapslid
English: Lojuxta 30 mg hard capsules Gelatin
Estonian: Lojuxta 30 mg kõvakapslid Želatiin
English: Grapefruit juice must be omitted from the diet while patients are treated with Lojuxta.
Estonian: Ravi ajal Lojuxtaga tuleb greipfruudimahl menüüst välja jätta.
English: 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.
Estonian: Nimetatud valku leidub maksa- ja soolerakkudes, kus see osaleb rasvaühendite kokkupanemises suuremateks rasvaosakesteks, mis seejärel satuvad vereringesse.
English: Nasopharyngitis Sinusitis
Estonian: Sapphapete sekvestrandid
English: Recommendation concerning co-administration with Lojuxta no clinically meaningful increase in lomitapide exposure was observed.
Estonian: Lomitapiidi ja atorvastatiini annuse vahele 12 tunni jätmisel lomitapiidi kontsentratsiooni kliiniliselt olulist tõusu ei täheldatud.
English: • medicines to treat urinary incontinence (e.g. propiverine)
Estonian: • kusepidamatuse ravimid (nt propiveriin);
English: 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.
Estonian: Ooranži kapslikaane ja valge kapslikehaga 19,4 mm pikkune kõvakapsel; kapslikehale on musta tindiga trükitud „10 mg” ja kapslikaanele „A733”.
English: • muscle spasms
Estonian: • lihasvalu;
English: Nausea
Estonian: Suukaudne
English: 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.
Estonian: Kollase kapslikaane ja kollase kapslikehaga19,4 mm pikkune kõvakapsel; kapslikehale on musta tindiga trükitud „60 mg” ja kapslikaanele „A733
English: The dose of Lojuxta should be taken 12 hours apart from any other concomitant weak CYP3A4 inhibitors.
Estonian: Lojuxta ja muu samaaegselt kasutatava nõrga CYP3A4 inhibiitori annuste vahele tuleb jätta 12 tundi.
English: 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.
Estonian: Oranži kapslikaane ja kollase kapslikehaga 19,4 mm pikkune kõvakapsel; kapslikehale on musta tindiga trükitud „30 mg” ja kapslikaanele „A733”.
English: • muscle pain
Estonian: • silma turse;
English: Entire trial weeks 0-78 N (%)
Estonian: Kogu uuring 0…78.
English: Adverse reaction
Estonian: Seedetrakti häired
English: Eructation
Estonian: Imetamine
English: Renal insufficiency
Estonian: Maksapuudulikkus
English: • feeling of incomplete defaecation (bowel movement), urgent need to defaecate
Estonian: • mittetäieliku defekatsiooni (roojamise) tunne, roojapidamatus;
English: • nausea and vomiting (feeling or being sick)
Estonian: • iiveldus ja oksendamine;
English: 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.
Estonian: Kollase kapslikaane ja valge kapslikehaga 19,4 mm pikkune kõvakapsel; kapslikehale on musta tindiga trükitud „40 mg” ja kapslikaanele „A733”.
English: Pulmonary histiocytosis was observed in rodents.
Estonian: Närilistel on täheldatud kopsude histiotsütoosi.
English: ALT
Estonian: Eakad
English: Diarrhoea
Estonian: Neerupuudulikkus
English: In ferrets, lomitapide was both maternally toxic and teratogenic at <1 times the MRHD.
Estonian: Tuhkrutel avaldas lomitapiid annuse korral, mis oli väiksem kui soovitatav maksimaalne annus inimesel, nii toksilist toimet emasloomadele kui ka teratogeenset toimet.
English: Hepatobiliary disorders
Estonian: Hepatotoksilised ained
English: • paracetamol - to treat pain
Estonian: • paratsetamool (valuvaigisti);
English: The dose of Lojuxta should be administered 12 hours apart from any other weak CYP3A4 inhibitor.
Estonian: Lojuxta samaaegsel kasutamisel muu nõrga CYP3A4 inhibiitoriga tuleb jätta selle ja Lojuxta annuse vahele 12 tundi.
English: On average, patients in the study were followed up for 3.1 years.
Estonian: Uuringus osalenud patsiente jälgiti keskmiselt 3,1 aastat.
English: This summary was last updated in 01-2017.
Estonian: Kokkuvõtte viimane uuendus: 01-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jardiance on 22 May 2014.
Estonian: Euroopa Komisjon andis Jardiance müügiloa, mis kehtib kogu Euroopa Liidus, 22. mail 2014.
English: What measures are being taken to ensure the safe and effective use of Jardiance?
Estonian: Mis meetmed võetakse, et tagada Jardiance ohutu ja efektiivne kasutamine?
English: Supportive evidence was provided from a further six studies.
Estonian: Esitati ka kuuest lisauuringust pärinevaid toetavaid tõendeid.
English: Other information about Jardiance
Estonian: Muu teave Jardiance kohta
English: 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.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Jardiance kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Jardiance empagliflozin
Estonian: Jardiance empagliflosiin
English: The recommended starting dose is 10 mg once a day, which can be increased if necessary to 25 mg daily in suitable patients.
Estonian: Soovitatav algannus on 10 mg üks kord ööpäevas, mida tohib vajaduse korral sobivatel patsientidel suurendada 25 mg-ni ööpäevas.
English: Why is Jardiance approved?
Estonian: Miks Jardiance heaks kiideti?
English: 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.
Estonian: Jardiance rühmas esines kardiovaskulaarseid juhte 10,5%-l (490 patsienti 4687st) ning platseeborühmas 12,1%-l (282 patsienti 2333st).
English: This is a summary of the European public assessment report (EPAR) for Jardiance.
Estonian: See on ravimi Jardiance Euroopa avaliku hindamisaruande kokkuvõte.
English: What is Jardiance and what is it used for?
Estonian: Mis on Jardiance ja milleks seda kasutatakse?
English: 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.
Estonian: Inimravimite komitee otsustas, et Jardiance kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Jardiance contains the active substance empagliflozin.
Estonian: Jardiance sisaldab toimeainena empagliflosiini.
English: It is not intended to provide practical advice on how to use Jardiance.
Estonian: Hindamisaruandes ei anta Jardiance kasutamise praktilisi nõuandeid.
English: All the studies showed a modest but clinically meaningful decrease in HbA1c with Jardiance compared with placebo: in the study investigating use of Jardiance without other medicines, the reduction in HbA1c was 0.74% more than placebo with the 10 mg dose and 0.85% more than placebo with the 25 mg dose.
Estonian: Kõigist uuringutest ilmnes HbA1c sisalduse tagasihoidlik, kuid kliiniliselt oluline vähenemine Jardiance kasutamisel võrreldes platseeboga: uuringus, kus kasutati Jardiancet ainuravimina, vähenes HbA1c sisaldus 10 mg annusega 0,74% rohkem kui platseeboga ning 25 mg annusega 0,85% rohkem kui platseeboga.
English: A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients.
Estonian: Jardiance soodsat toimet vere glükoosisisaldusele tõendasid rohkem kui 2700 patsiendil korraldatud neli põhiuuringut.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jardiance have been included in the summary of product characteristics and the package leaflet.
Estonian: Jardiance ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What are the risks associated with Jardiance?
Estonian: Mis riskid Jardiancega kaasnevad?
English: There was also supportive evidence suggesting benefit when the medicine was combined with insulin.
Estonian: Tõendid toetasid ka ravimi kasulikkust koos insuliiniga kasutamisel.
English: Another main study showed that adding Jardiance to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects.
Estonian: Ühest põhiuuringust selgus, et Jardiance lisamine tavapärasele ravile vähendab kardiovaskulaarseid (südant ja veresooni mõjutavaid) kõrvalnähte.
English: When blood sugar levels decrease, HbA1C levels also decrease.
Estonian: Vere glükoosisisalduse vähenedes väheneb ka HbA1c sisaldus.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Estonian: II tüüpi diabeet on haigus, mille korral organismis ei teki vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: Jardiance was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Estonian: Jardiance vähendas ka kardiovaskulaarsete juhtude esinemissagedust II tüüpi diabeediga patsientidel, kellel juba oli kardiovaskulaarne haigus.
English: This leads to high levels of glucose in the blood.
Estonian: See põhjustab vere suure glükoosisisalduse.
English: Because Jardiance relies on the working of the kidneys for its effect, treatment with this medicine is not recommended in patients with moderately or severely impaired kidney function.
Estonian: Et Jardiance toime sõltub neerude talitlusest, ei soovitata seda ravimit mõõduka või raske neerutalitluse häirega patsientidele.
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Estonian: Efektiivsuse põhinäitaja oli kolme põhilise kardiovaskulaarse juhu (südameinfarkti, insuldi või kardiovaskulaarsest haigusest tingitud surma) esinemine.
English: Some of these were continuations of the main studies, and suggested that the benefits of the medicine continued with longer therapy.
Estonian: Mõned neist olid põhiuuringute jätkuuuringud, mis näitasid, et Jardiance on kasulik ka pikema ravi korral.
English: How does Jardiance work?
Estonian: Kuidas Jardiance toimib?
English: For the full list of all side effects and restrictions with Jardiance, see the package leaflet.
Estonian: Jardiance kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: It can also be used as an ‘add-on' to other diabetes medicines.
Estonian: Seda tohib kasutada ka lisaks muudele diabeediravimitele.
English: If Jardiance is used in combination with insulin or sulphonylureas (medicines that make the body produce insulin), the doses of these may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Estonian: Kui Jardiancet kasutatakse koos insuliini või sulfonüüluurearavimiga (organismis insuliini tekkimist soodustavad ravimid), võib olla vaja vähendada nende ravimite annust, et vähendada hüpoglükeemia (vere normaalsest väiksema glükoosisisalduse) riski.
English: In addition, the results indicated that Jardiance treatment was associated with a beneficial fall in body weight and blood pressure.
Estonian: Lisaks näitasid tulemused, et Jardiance raviga kaasnevad kehakaalu ja vererõhu kasulik vähenemine.
English: For practical information about using Jardiance, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Jardiance kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Jardiance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Jardiancega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar) when the medicine is taken with a sulphonylurea or insulin.
Estonian: Jardiance kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on hüpoglükeemia (vere normaalsest väiksem glükoosisisaldus), kui ravimit võetakse koos sulfonüüluurearavimiga või insuliiniga.
English: Jardiance is available as tablets (10 and 25 mg) and can only be obtained with a prescription.
Estonian: Jardiance on retseptiravim ja seda turustatakse tablettidena (10 ja 25 mg).
English: Regarding safety, overall the side effects were considered manageable.
Estonian: Ohutuse seisukohast olid ravimi kõrvalnähud ohjatavad.
English: Jardiance is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not satisfactorily controlled.
Estonian: Jardiance on diabeediravim ning seda kasutatakse koos dieedi ja füüsilise treeninguga II tüüpi diabeediga (suhkurtõvega) täiskasvanutel, kelle haigus ei ole rahuldavalt reguleeritud.