FrancophonIA/ELRC3.0 huggingface dataset:
English: The median duration of follow-up was 28.75 months in the panobinostat + bortezomib + dexamethasone arm and 29.04 months in the placebo + bortezomib + dexamethasone arm.
Estonian: 28,75 kuud ja platseebo + bortesomiib + deksametasooni rühmas 29,04 kuud.
English: 33.3% patients in the panobinostat + bortezomib + dexamethasone arm and 10.3% patients in the placebo + bortezomib + dexamethasone arm received platelet transfusions during treatment.
Estonian: Trombotsüütide transfusioone tehti 33,3%-le panobinostaat + bortesomiib + deksametasooni rühma ja 10,3%-le platseebo + bortesomiib + deksametasooni rühma patsiendile.
English: Modification of bortezomib starting dose
Estonian: Bortesomiibi algannuse muutmine
English: Bortezomib may be started at 1.3 mg/m2 once weekly on days 1 and 8, and dexamethasone at 20 mg on days 1 and 8.
Estonian: Panobinostaadi algannus võib olla 15 mg ja kui esimeses tsüklis talutakse seda hästi, võib annust teises tsüklis suurendada 20 mg-ni. Bortesomiibi algannus võib olla 1,3 mg/m2 üks kord nädalas 1. ja 8. ravipäeval ja deksametasooni annus 20 mg 1. ja 8. ravipäeval.
English: Very common Pancytopenia, thrombocytopenia, anaemia, leukopenia, neutropenia, lymphopenia
Estonian: Pantsütopeenia, trombotsütopeenia, aneemia, leukopeenia, neutropeenia, lümfopeenia
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Estonian: magneesiumstearaat, mannitool, mikrokristalliline tselluloos, eelželatiniseeritud tärklis, želatiin, titaandioksiid (E171), briljantsinine FCF (E133), kollane raudoksiid (E172), must raudoksiid (E172), propüleenglükool (E1520), šellak.
English: EU/1/15/1023/007 6 capsules EU/1/15/1023/008 12 capsules EU/1/15/1023/009 24 capsules
Estonian: EU/1/15/1023/001 6 kapslit EU/1/15/1023/002 12 kapslit EU/1/15/1023/003 24 kapslit
English: Conjunctival haemorrhage
Estonian: Vererakkude hulga langus
English: Respiratory failure, rales, wheezing, epistaxis
Estonian: Hingamispuudulikkus, räginad, vilisev hingamine, ninaverejooks
English: Bortezomib dose on recovery to grade 2 neutropenia
Estonian: Bortesomiibi annus pärast neutropeenia taastumist 2. raskusastmeni
English: Fluid and electrolyte blood levels, especially potassium, magnesium and phosphate, should be monitored periodically during therapy and corrected as clinically indicated to prevent potential dehydration and electrolyte disturbances (see section 4.2).
Estonian: Dehüdratsiooni ja elektrolüütide häirete tekkimise ennetamiseks tuleb ravi ajal perioodiliselt jälgida vedeliku tasakaalu ja elektrolüütide, eriti kaaliumi, magneesiumi ja fosfori sisaldust veres ja korrigeerida vastavalt kliinilisele näidustusele (vt lõik 4.2).
English: CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, mostly commonly involving gastrointestinal haemorrhage.
Estonian: ja 4. raskusastme verejooksust teatati 4,2%-l patsientidest, kõige sagedamini oli tegu seedetrakti verejooksuga.
English: Table 1 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 1-8)
Estonian: Tabel 1 Soovitatav annustamisskeem Farydak'i võtmiseks kombinatsioonis bortesomiibi ja deksametasooniga (tsüklid 1...8)
English: EU/1/15/1023/001 6 capsules
Estonian: EU/1/15/1023/007 6 kapslit
English: Strong inducers are expected to have greater effects, and may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided.
Estonian: Tugevatel indutseerijatel eeldatakse olevat tugevam toime ja need võivad panobinostaadi efektiivsust vähendada - seetõttu tuleb vältida tugevatoimeliste CYP3A4 indutseerijate, sealhulgas, aga mitte ainult, karbamasepiini,
English: Table 2 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 9-16).
Estonian: Tabel 2 Soovitatav annustamisskeem Farydak'i võtmiseks kombinatsioonis bortesomiibi ja deksametasooniga (tsüklid 9…16).
English: o How to use the compliance card: this section provides a general overview on how to use the compliance card. o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card. o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit.
Estonian: o Kuidas kasutada ravimit vastavalt retseptile: selles osas esitatakse juhised ravijärgimuse kaardi täitmiseks.
English: Clinical judgement on how to continue the treatment should be exercised when a patient experiences an adverse drug reaction.
Estonian: Ravimi kõrvaltoimete tekkides tuleb teha kliiniline otsus, kuidas ravi jätkata.
English: In this subset of patients (N=147), the median duration of treatment was 4.5 months in the panobinostat + bortezomib + dexamethasone arm and 4.8 months in the placebo + bortezomib + dexamethasone arm.
Estonian: Selles patsientide alarühmas (N=147) oli ravi mediaankestus panobinostaat + bortesomiib +
English: QT syndrome.
Estonian: mida kutsutakse pikenenud QT sündroomiks.
English: Panobinostat dose on recovery to grade 2 thrombocytopenia
Estonian: Panobinostaadi annus pärast trombotsütopeeni a taastumist 2. raskusastmeni
English: Colitis, haematemesis, gastrointestinal pain
Estonian: Koliit, veriokse, seedetrakti valu
English: Agents that are predicted to decrease panobinostat concentrations
Estonian: Ained, mis võivad vähendada panobinostaadi kontsentratsiooni
English: * Based on NCI-CTEP classification
Estonian: ULN = normi ülemine piir *Vastavalt NCI-CTEP (National Cancer Institute Cancer Therapy Evaluation Program) klassifikatsioonile
English: Discontinuation due to adverse events, regardless of causality, was observed in 36.2% of patients.
Estonian: 36,2% patsientidest katkestas ravi kõrvaltoimete tõttu, põhjuslikkust arvestamata.
English: ECG (electrocardiogram) abnormalities have been reported in patients treated with panobinostat + bortezomib + dexamethasone, mainly involving ST-T depression (21.7%) and T wave changes (39.6%).
Estonian: kõrvalekalletest, peamiselt oli tegu ST-T depressiooniga (21,7%) ja T-saki muutustega (39,6%).
English: Kaplan Meier medians PAN+BTZ+Dex: 12.48 months PBO+BTZ+Dex: 4.70 months
Estonian: 95% CI [0,31; 0,72] Log-rank p-väärtus=0,0003 Kaplan Meieri mediaanid PAN+BTZ+Dex: 12,48 kuud PBO+BTZ+Dex: 4,70 kuud
English: Prolongation of QT interval
Estonian: QT-intervalli pikenemine
English: • flatulence
Estonian: Unetus
English: Platelets <50 x 109/l with bleeding
Estonian: 3. raskusaste Trombotsüüte <50 x 109/l veritsusega
English: Table 1 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 1-8)
Estonian: Tabel 1 Soovitatav panobinostaadi annustamisgraafik kombinatsioonis bortesomiibi ja deksametasooniga (tsüklid 1…8)
English: Farydak 20 mg capsules panobinostat
Estonian: Farydak 20 mg kapslid panobinostatum
English: Bortezomib dose on recovery to grade 2 thrombocytopenia
Estonian: Bortesomiibi annus pärast trombotsütopeenia taastumist ≤ 2. raskusastmeni
English: Microcrystalline cellulose Pregelatinised starch (maize)
Estonian: Eelželatiniseeritud tärklis (mais)
English: Consider dose escalation up to 15 mg in subsequent cycles based on patient tolerability.
Estonian: Vähendage panobinostaadi annust esimeses ravitsüklis 10 mg-ni. Kaaluge järgnevates tsüklites annuse suurendamist 15 mg-ni vastavalt sellele, kuidas patsient ravi talub.
English: Farydak 15 mg capsules panobinostat
Estonian: Farydak 15 mg kapslid panobinostatum
English: Gastrointestinal haemorrhage, haematochezia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence
Estonian: Seedetrakti verejooks, veriroe, gastriit, keiliit, pingetunne kõhus, suukuivus, puhitus
English: Adverse drug reactions are listed according to system organ classes in MedDRA.
Estonian: Kõrvaltoimed on loetletud MedDRA
English: Table 2 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 9-16)
Estonian: Tabel 2 Soovitatav panobinostaadi annustamisgraafik kombinatsioonis bortesomiibi ja deksametasooniga (tsüklid 9…16)
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat.
Estonian: Üks kõvakapsel sisaldab veevaba panobinostaatlaktaati, mis vastab 20 mg-le panobinostaadile.
English: Hepatic dysfunction, primarily mild transient elevations in aminotransferases and total bilirubin, has been reported in patients during treatment with panobinostat.
Estonian: Panobinostaadiga ravi ajal on patsientidel registreeritud maksafunktsiooni häireid, peamiselt aminotransferaaside aktiivsuse ja üldbilirubiini kerget mööduva iseloomuga tõusu.
English: SGOT (AST) levels
Estonian: Bilirubiinisisaldus SGOT (ASAT) väärtus
English: - For men taking Farydak
Estonian: - Mehed, kes võtavad Farydak'i
English: Farydak 10 mg capsules panobinostat
Estonian: Farydak 10 mg kapslid panobinostatum
English: Farydak 10 mg hard capsules are light green opaque capsules (15.6-16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Estonian: Farydak 10 mg kõvakapslid on helerohelised läbipaistmatud kapslid (15,6...16,2 mm), mis sisaldavad valget kuni peaaegu valget pulbrit, kapsli kaanele on märgitud musta tindiga radiaalselt „LBH 10 mg“ ja kapsli kehale musta tindiga kaks radiaalset joont, blistrites.
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat.
Estonian: Üks kõvakapsel sisaldab veevaba panobinostaatlaktaati, mis vastab 15 mg-le panobinostaadile.
English: • feeling thirsty, low urine output, weight loss, dry flushed skin, irritability (signs of dehydration)
Estonian: • joogijanu, uriinierituse vähenemine, kehakaalu langus, kuiv õhetav nahk, ärevus
English: Farydak 20 mg hard capsules are red opaque capsules (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Estonian: Farydak 20 mg kõvakapslid on punased läbipaistmatud kapslid (19,1...19,7 mm), mis sisaldavad valget kuni peaaegu valget pulbrit, kapsli kaanele on märgitud musta tindiga radiaalselt „LBH 20 mg“ ja kapsli kehale musta tindiga kaks radiaalset joont, blistrites.
English: On-treatment deaths not due to the study indication (multiple myeloma) were reported in 6.8% of panobinostat + bortezomib + dexamethasone-treated patients versus 3.2% of placebo + bortezomib + dexamethasone-treated patients.
Estonian: 6,8%-l panobinostaat + bortesomiib + deksametasooni rühma patsiendil versus 3,2%-l platseebo + bortesomiib + deksametasooni rühma patsiendil teatati uuringu näidustusest (hulgimüeloom) sõltumatust surmast ravi ajal.
English: In the overall patient population PFS based on the full analysis set (FAS) was statistically significantly different between the treatment arms (stratified Log-rank test p<0.0001, with an estimated 37% risk reduction in the panobinostat + bortezomib + dexamethasone arm compared to the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.63 (95% CI: 0.52, 0.76)).
Estonian: 37% panobinostaat + bortesomiib + deksametasooni rühmas võrreldes platseebo + bortesomiib + deksametasooni rühmaga (riskisuhe: 0,63 (95% CI: 0,52; 0,76)).
English: Neutropenia was frequently reported on the basis of laboratory findings determined during the study (all grades: 75%).
Estonian: Neutropeenia Kliiniliste uuringute käigus teatati laborianalüüside tulemuste põhjal sageli neutropeenia juhtudest
English: • abdominal pain, diarrhoea, swelling or bloating of the abdomen (signs of inflamed stomach lining)
Estonian: • kõhuvalu, kõhulahtisus, kõhupaistetus või puhitus (maolimaskestapõletiku nähud)
English: - medicines used to treat breast cancer, such as tamoxifen.
Estonian: - ravimid, mida kasutatakse rinnavähi raviks, tamoksifeen.
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat.
Estonian: Üks kõvakapsel sisaldab veevaba panobinostaatlaktaati, mis vastab 10 mg-le panobinostaadile.
English: Farydak 15 mg hard capsules are orange opaque capsules (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Estonian: Farydak 15 mg kõvakapslid on oranžid läbipaistmatud kapslid (19,1...19,7 mm), mis sisaldavad valget kuni peaaegu valget pulbrit, kapsli kaanele on märgitud musta tindiga radiaalselt „LBH 15 mg“ ja kapsli kehale musta tindiga kaks radiaalset joont, blistrites.
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Estonian: magneesiumstearaat, mannitol, mikrokristalliline tselluloos, eelželatiniseeritud tärklis, želatiin, titaandioksiid (E171), punane raudoksiid (E172), must raudoksiid (E172), propüleenglükool
English: Haemorrhage intracranial, syncope, tremor, dysgeusia
Estonian: Intrakraniaalne hemorraagia, minestus, treemor,
English: Psychiatric disorders
Estonian: Psühhiaatrilised häired Väga sage
English: Gastrointestinal toxicity is very common in patients treated with panobinostat.
Estonian: Panobinostaatravi ajal esineb väga sageli seedetrakti toksilisust.
English: Infections and infestations Very common Upper respiratory tract infection, pneumonia
Estonian: Ülemiste hingamisteede infektsioon, pneumoonia
English: • increased blood level of uric acid
Estonian: • vere kusihappesisalduse suurenemine
English: Orange opaque hard gelatin capsule (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on cap and two radial bands in black ink on body.
Estonian: Oranž läbipaistmatu želatiinist kõvakapsel (19,1...19,7 mm), mis sisaldab valget kuni peaaegu valget pulbrit, kapsli kaanele on märgitud musta tindiga radiaalselt „LBH 15 mg“ ja kapsli kehale musta tindiga kaks radiaalset joont.
English: Red opaque hard gelatin capsule (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on cap and two radial bands in black ink on body.
Estonian: Punane läbipaistmatu želatiinist kõvakapsel (19,1...19,7 mm), mis sisaldab valget kuni peaaegu valget pulbrit, kapsli kaanele on märgitud musta tindiga radiaalselt „LBH 20 mg“ ja kapsli kehale musta tindiga kaks radiaalset joont.
English: Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided (see section 4.5).
Estonian: Tugevad indutseerijad võivad vähendada panobinostaadi efektiivsust, seetõttu tuleb vältida panobinostaadi ja tugevate CYP3A4 indutseerijate, sealhulgas, kuid mitte ainult, karbamasepiini,
English: Light green opaque hard gelatin capsule (15.6-16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on cap and two radial bands in black ink on body.
Estonian: Heleroheline läbipaistmatu želatiinist kõvakapsel (15,6...16,2 mm), mis sisaldab valget kuni peaaegu valget pulbrit, kapsli kaanele on märgitud musta tindiga radiaalselt „LBH 10 mg“ ja kapsli kehale musta tindiga kaks radiaalset joont.
English: Agents whose plasma exposure can be decreased by panobinostat
Estonian: Ravimid, mille plasmakontsentratsiooni võib panobinostaat vähendada Hormonaalsed rasestumisvastased vahendid
English: • feeling tired, itching, yellowing of the skin and whites of the eyes, nausea or vomiting, loss of appetite, pain on the right side of your stomach, dark or brown urine, bleeding or bruising more easily than normal (signs of a liver problem)
Estonian: söögiisu kadumine, valu paremas kõhupooles, tume või pruun uriin, veritsuste ja verevalumite kergem tekkimine (maksaprobleemi nähud)
English: Farydak 20 mg hard capsules
Estonian: Farydak 20 mg kõvakapslid
English: Plasma exposure of panobinostat is not altered in cancer patients with mild to severe renal impairment.
Estonian: Kerge kuni raske neerukahjustusega vähihaigetel ei ole panobinostaadi plasmakontsentratsioon muutunud.
English: Farydak 10 mg hard capsules
Estonian: Farydak 10 mg kõvakapslid
English: Farydak 15 mg hard capsules
Estonian: Farydak 15 mg kõvakapslid
English: Fertility
Estonian: Želatiin
English: Blood electrolytes
Estonian: Elektrolüüdid veres
English: The median OS was 40.3 months in the panobinostat + bortezomib + dexamethasone arm and 35.8 months in the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.94 (95% CI: 0.78, 1.14)).
Estonian: deksametasooni rühmas 35,8 kuud (riskisuhe: 0,94 (95% CI: 0,78; 1,14)).
English: Shock haemorrhagic
Estonian: Hemorraagiline šokk
English: Renal and urinary disorders
Estonian: Panobinostaadi renaalne kliirens
English: Patients with mild hepatic impairment should be started on panobinostat at a reduced dose of 15 mg during the first treatment cycle.
Estonian: Esimese ravitsükli ajal tuleb kerge maksakahjustusega patsientidel ravi alustada panobinostaadi vähendatud annusega 15 mg. Annuse suurendamist 15 mg-lt 20 mg-le tuleb kaaluda arvestates patsiendi taluvust.
English: A dose escalation from 15 mg to 20 mg may be considered based on patient tolerability.
Estonian: 20 mg-ni arvestates patsiendi taluvust.
English: None
Estonian: Ei muudeta
English: Hormonal contraceptives
Estonian: Trombotsütopeenia
English: Farydak 10 mg hard capsules Gelatin
Estonian: Kapsli kest Farydak 10 mg kõvakapslid
English: Special populations
Estonian: Liigeste turse
English: • clicking, rattling or crackling noise made by the lungs when breathing
Estonian: • hingamisel kopsudest tuleb klõpsuv, korisev või ragisev hääl
English: Nervous system disorders Very common Dizziness, headache Common
Estonian: Närvisüsteemi häired Väga sage
English: Gastrointestinal toxicity, primarily diarrhoea, nausea and vomiting, is among the most frequently reported adverse reactions.
Estonian: Kõige sagedamini teatatud kõrvaltoimete hulka kuulus seedetrakti toksilisus, peamiselt kõhulahtisus, iiveldus ja oksendamine.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: Results showed that:
Estonian: Uuringute tulemused näitasid järgmist:
English: This summary was last updated in 06-2017.
Estonian: Kokkuvõtte viimane uuendus: 06-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onglyza on 1 October 2009.
Estonian: Euroopa Komisjon andis Onglyza müügiloa, mis kehtib kogu Euroopa Liidus, 1. oktoobril 2009.
English: The recommended dose is 5 mg once a day.
Estonian: Soovitatav annus on 5 mg üks kord ööpäevas.
English: What measures are being taken to ensure the safe and effective use of Onglyza?
Estonian: Mis meetmed võetakse, et tagada Onglyza ohutu ja efektiivne kasutamine?
English: Regarding safety, Onglyza is generally well tolerated.
Estonian: Ohutuse seisukohast on ravi Onglyzaga üldiselt hästi talutav.
English: The full EPAR for Onglyza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Onglyza kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Medicine Agency therefore decided that Onglyza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Onglyza kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about Onglyza
Estonian: Muu teave Onglyza kohta
English: This is a summary of the European public assessment report (EPAR) for Onglyza.
Estonian: See on ravimi Onglyza Euroopa avaliku hindamisaruande kokkuvõte.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onglyza have been included in the summary of product characteristics and the package leaflet.
Estonian: Onglyza ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What is Onglyza and what is it used for?
Estonian: Mis on Onglyza ja milleks seda kasutatakse?
English: Adding dapagliflozin to metformin reduced HbA1c levels by 1.2 percentage points.
Estonian: Dapagliflosiini lisamisel metformiinile vähenes HbA1c sisaldus 1,2 protsendi võrra.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Estonian: Need hormoonid vabanevad pärast sööki ning stimuleerivad kõhunäärmes insuliini teket.
English: Onglyza saxagliptin
Estonian: Onglyza saksagliptiin
English: Why is Onglyza approved?
Estonian: Miks Onglyza heaks kiideti?
English: However, the results were not considered to be clinically relevant and the company withdrew its application for the use of saxagliptin as an initial combination medicine in previously untreated patients.
Estonian: Uuringu tulemusi ei peetud aga kliiniliselt asjakohaseks ning ettevõte võttis tagasi avalduse, milles oli taotlenud saksagliptiini kasutamist esialgsesse kombinatsiooni kuuluva ravimina varem ravimata patsientidel.
English: What are the risks associated with Onglyza?
Estonian: Mis riskid Onglyzaga kaasnevad?
English: In type 2 diabetes, the pancreas does not make enough insulin to control the level of glucose in the blood or the body is unable to use insulin effectively.
Estonian: II tüüpi diabeet on haigus, mille korral kõhunäärmes ei teki vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: If used in combination with a sulphonylurea (medicines that make the body produce insulin) or insulin, the dose of these medicines may need to be reduced to avoid hypoglycaemia (low blood sugar levels).
Estonian: Kui Onglyzat võetakse koos sulfonüüluurearavimi (organismis insuliini tekkimist soodustav ravim) või insuliiniga, võib olla vaja vähendada nende ravimite annuseid, et ennetada hüpoglükeemiat (vere liiga väike glükoosisisaldus).
English: It is not intended to provide practical advice on how to use Onglyza.
Estonian: Hindamisaruandes ei anta Onglyza kasutamise praktilisi nõuandeid.
English: It is used either on its own in patients who cannot take metformin (another diabetes medicine) or as ‘add-on' to other diabetes medicines, including insulin.
Estonian: Seda kasutatakse ainuravimina patsientidel, kellele metformiin (teine diabeediravim) ei sobi, ja muude diabeediravimite, sh insuliini lisaravimina.
English: Onglyza contains the active substance saxagliptin.
Estonian: Onglyza sisaldab toimeainena saksagliptiini.
English: HbA1c levels were on average around 9% at the start of the study.
Estonian: Uuringu algul oli patsientide HbA1c sisaldus keskmiselt ligikaudu 9%.
English: Onglyza must not be used in people who are hypersensitive (allergic) to saxagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 inhibitor.
Estonian: Onglyzat ei tohi kasutada inimesed, kes on saksagliptiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised) või kel on esinenud raskeid allergilisi reaktsioone dipeptidüülpeptidaas-4 (DPP-4) inhibiitorite suhtes.
English: A further study compared saxagliptin with metformin in patients who had not previously received substantial treatment with diabetes medicines.
Estonian: Lisauuringus võrreldi saksagliptiini ja metformiini kasutamist patsientidel, keda ei olnud varem diabeediravimitega ravitud.