FrancophonIA/ELRC3.0 huggingface dataset:
English: improvement; ADA = adalimumab; CDAI = Clinical Disease Activity Index; CR = Clinical Remission; CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints; IR = inadequate responder; LDA = Low Disease Activity; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicity controlled p≤0.001upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g nominal p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001upadacitinib vs adalimumab comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison j nominal p<0.05 upadacitinib vs adalimumab comparison k nominal p≤0.01 upadacitinib vs placebo or MTX comparison l nominal p<0.05 upadacitinib vs MTX comparison
Estonian: kliinilise haiguse aktiivsuse indeks; CR = kliiniline remissioon; CRP = C-reaktiivne valk; DAS28 = haiguse aktiivsuse skoor 28 liigest; IR = ebaadekvaatne vastus; LDA = haiguse madal aktiivsus; MTX = metotreksaat; PBO = platseebo; UPA= upadatsitiniib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e Varieeruvuse kontroll p ≤ 0,001 upadatsitiniib vs. platseebo või MTX-i võrdlus f Varieeruvuse kontroll p ≤ 0,01 upadatsitiniib vs. platseebo või MTX-i võrdlus g Nominaalne p ≤ 0,001 upadatsitiniib vs. platseebo või MTX-i võrdlus h Nominaalne p ≤ 0,001 upadatsitiniib vs. adalimumabi võrdlus i Nominaalne p ≤ 0,01 upadatsitiniib vs. adalimumabi võrdlus j Nominaalne p < 0,05 upadatsitiniib vs. adalimumabi võrdlus k Nominaalne p ≤ 0,01 upadatsitiniib vs. platseebo või MTX-i võrdlus l Nominaalne p<0.05 upadatisiniib vs MTX-võrdlus
English: Table 5: Radiographic changes
Estonian: Radiograafilised muutused
English: Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.
Estonian: Ravi upadatsitiniibiga seostati maksaensüümi aktiivsuse sagedasema tõusuga võrreldes platseeboga.
English: ACR50 (% of patients)
Estonian: ACR50 (patsientide protsent)
English: Potential for other medicinal products to affect the pharmacokinetics of upadacitinib
Estonian: Teiste ravimite potentsiaalne mõju upadatsitiniibi farmakokineetikale
English: Inhibition of progression of structural joint damage was assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score, at weeks 24/26 and week 48 in SELECT-EARLY and SELECT-COMPARE.
Estonian: Struktuurse liigesekahjustuse progressiooni pärssimist hinnati modifitseeritud Sharpi koguskoori (mTSS) ja selle komponentidega ning erosiooniskoori ja liigespilu ahenemise skooriga 24./26.
English: • Primary endpoint: clinical remission (DAS28-CRP) at week 12
Estonian: • Esmane tulemusnäitaja: kliiniline remissioon (DAS28-CRP) 12. nädalal
English: In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with upadacitinib 15 mg, compared to 1.9% and 0.9%, respectively, of patients treated with MTX.
Estonian: nädalani ALAT ja ASAT taseme tõuse ≥ 3 korra üle ULN-i vähemalt ühel mõõtmisel vastavalt 0,8%-l ja 0,4%-l 15 mg upadatsitiniibiga ravitud patsientidest, võrreldes 1,9% ja 0,9%-ga MTX-iga ravitud patsientidel.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of 49 tablets (for the 98 pack)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 49 tableti karp (98 tableti pakendis)
English: Upadacitinib plasma exposures are proportional to dose over the therapeutic dose range.
Estonian: Terapeutilise annustamise vahemikus on upadatsitiniibi plasmakontsentratsioon proportsionaalne ravimi annusega.
English: Cases of bacterial meningitis have been reported in patients receiving upadacitinib.
Estonian: Upadatsitiniibi saavatel patsientidel on esinenud baktermeningiiti.
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with upadacitinib 15 mg, compared to 1.5% and 0.7%, respectively, of patients treated with placebo.
Estonian: nädalani alaniini transaminaasi (ALAT) ja aspartaadi transaminaasi (ASAT) taseme tõuse ≥ 3 korra üle normi ülemise piiri (ULN) vähemalt ühel mõõtmisel vastavalt 2,1%-l ja 1,5%-l 15 mg upadatsitiniibiga ravitud patsientidest, võrreldes 1,5% ja 0,7%-ga platseeboga ravitud patsientidel.
English: Consider the risks and benefits of treatment prior to initiating upadacitinib in patients:
Estonian: Enne ravi alustamist upadatsitiniibiga kaaluge raviga kaasnevaid riske ja kasutegureid järgmistel patsientidel:
English: How to store RINVOQ
Estonian: Kuidas RINVOQ'i säilitada
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Estonian: Suurenenud nahavähiriskiga patsientidele on soovitatav teha naha perioodiline läbivaatus.
English: Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Estonian: Enne ravi alustamist upadatsitiniibiga patsientidel, kelle haigusloos esineb eelnevalt ravimata latentne TB või kellel on TB infektsiooni riskitegurid, tuleb kaaluda tuberkuloosivastast ravi.
English: The risks and benefits of upadacitinib treatment should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing upadacitinib therapy in patients who develop a malignancy.
Estonian: Enne upadatsitiniibiga ravi alustamist kaaluge riski/kasu suhet patsientidel, kellel on varem diagnoositud pahaloomuline kasvaja (v.a edukalt ravitud mittemelanoomne nahavähk) samuti upadatsitiniibiga ravi jätkamist patsientidel, kellel ravi ajal diagnoositakse pahaloomuline kasvaja.
English: QR code to be included For more information and support on taking RINVOQ go to www.rinvoq.eu
Estonian: Lisateavet ja abi RINVOQ võtmise kohta leiate aadressil www.rinvoq.eu.
English: The overall longterm rate of opportunistic infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 0.6 events per 100 patient-years.
Estonian: Üldine pikaajaline oportunistlike infektsioonide esinemissagedus 15 mg upadatsitiniibi ravirühmas kõigis viies III faasi kliinilises uuringus oli 0,6 juhtumit 100 patsiendiaasta kohta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for 84 tablet multipack (with Blue Box)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 84 tableti mitmikpakendi karp (sinise raamiga)
English: 15 38g 15 45g,h
Estonian: 15 38g 15 45g, h 29 12 34g
English: Patients should be screened for tuberculosis (TB) before starting upadacitinib therapy.
Estonian: Enne ravi alustamist upadatsitiniibiga tuleb patsientidele teha tuberkuloosi (TB) sõeluuring.
English: • cold sores (herpes simplex)
Estonian: • ohatised (herpesviirusnakkus)
English: This is because some medicines may reduce how well RINVOQ works or may increase the risk of getting side effects.
Estonian: Mõni ravim võib vähendada RINVOQ'i toimet või suurendada kõrvaltoimete tekkeriski.
English: No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.
Estonian: Koosmanustamisel upadatsitiniibiga ei ole CYP3A substraatide ega rosuvastatiini või atorvastatiini annuse kohaldamine vajalik.
English: • medicines to treat fungal infections (such as itraconazole, posaconazole or voriconazole)
Estonian: • ravimeid seeninfektsioonide raviks (nt itrakonasool, posakonasool või vorikonasool)
English: Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
Estonian: Enne ravi alustamist ja ravi ajal upadatsitiniibiga tuleb teha viirushepatiidi sõeluuring ning jälgida viiruse reaktiveerumise suhtes.
English: • HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and placebo groups, respectively
Estonian: • HDL-i kolesterool ≥ 1,03 mmol/L (40 mg/dl): 89% ja 61%, vastavalt 15 mg upadatsitiniibi rühmas ja platseeborühmas
English: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, posaconazole, voriconazole, and clarithromycin).
Estonian: Tugevate CYP3A4 inhibiitoritega (nt ketokonasool, itrakonasool, posakonasool, vorikonasool ja klaritromütsiin) koosmanustamisel upadatsitiniibi kontsentratsioon suureneb.
English: • Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively
Estonian: • Triglütseriidid ≥ 2,26 mmol/l (200 mg/dl): 25% ja 15%, vastavalt 15 mg upadatsitiniibi rühmas ja platseeborühmas
English: The use of upadacitinib has not been studied in subjects with end stage renal disease.
Estonian: Upadatsitiniibi kasutamist lõppstaadiumis neerukahjustusega patsientidel ei ole uuritud.
English: • Language for HCPs to inform patients of the importance of the PAC
Estonian: • Selgitatakse tervishoiutöötajatele, kuidas rääkida patsiendile patsiendi teabekaardi tähtsusest.
English: In clinical trials, upadacitinib was administered without regard to meals (see section 4.2).
Estonian: Kliinilistes uuringutes manustati upadatsitiniibi söögiaegadest sõltumatult (vt lõik 4.2).
English: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.
Estonian: Üks toimeainet prolongeeritult vabastav tablett sisaldab upadatsitiniibi hemihüdraati, mis vastab 15 mg upadatsitiniibile.
English: 49 prolonged-release tablets.
Estonian: 49 toimeainet prolongeeritult vabastavat tabletti.
English: • Language to advise patients and their HCPs about the risk of live vaccinations when given during upadacitinib therapy o Description of targeted risks for awareness by the patient and for HCPs involved in their care including:
Estonian: • selgitatakse patsientidele ja tervishoiutöötajatele riske, mis kaasnevad elusvaktsiinide manustamisega ravi ajal upadatsitiniibiga; o sihtriskide kirjeldus, et parandada patsiendi ja tema ravis osalevate tervishoiutöötajate teadlikkust, sh järgmine teave:
English: Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that observed with upadacitinib 30 mg QD.
Estonian: III faasi uuringutes oli upadatsitiniibi annuse 15 mg üks kord ööpäevas efektiivsus üldiselt sarnane upadatsitiniibi annusega 30 mg üks kord ööpäevas.
English: • increased levels of cholesterol (a type of fat in the blood) as shown in tests
Estonian: • kolesterooli (rasva tüüp veres) kõrgem tase, mida näitavad analüüsid
English: Table 4: Response and remission
Estonian: Ravivastus ja remissioon
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, increases in CPK values were observed.
Estonian: Platseebokontrolliga uuringutes, kus kasutati taustaravimina DMARD-e, täheldati kuni 12./14.
English: • A patient alert card
Estonian: • patsiendi teabekaart.
English: Treatment group MTX
Estonian: Ravirühm MTX
English: In placebo-controlled clinical studies with background DMARDs, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg group was 27.4% compared to 20.9% in the placebo group.
Estonian: Platseebokontrolliga kliinilistes uuringutes, kus kasutati taustaravimina DMARD-e, oli infektsioonide esinemissagedus 12/14 nädala jooksul upadatsitiniibi annusega 15 mg ravitud rühmas 27,4%, võrreldes 20,9%-ga platseeborühmas.
English: 98 prolonged-release tablets.
Estonian: 98 toimeainet prolongeeritult vabastavat tabletti.
English: • increased levels of triglycerides (a type of fat in the blood) as shown in tests
Estonian: • triglütseriidide (rasva tüüp veres) kõrgem tase, mida näitavad analüüsid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 98 tableti karp
English: • infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus
Estonian: • kopsuinfektsioon (pneumoonia), mis võib põhjustada õhupuudust, palavikku ja limaga köha Ülaltoodud kõrvaltoimed esinevad aeg-ajalt (võivad esineda kuni 1 inimesel 100-st).
English: Evaluate at baseline and thereafter according to routine patient management.
Estonian: Hinnake maksaensüüme ravi alguses ja seejärel rutiinse raviplaani järgi.
English: ACR Response
Estonian: ACR-i ravivastus
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
Estonian: JAK-inhibiitoreid, sh upadatsitiniibi, saavatel patsientidel on teatatud süvaveenitromboosi (Deep venous thrombosis, DVT) ja kopsuemboolia (Pulmonary embolism, PE) juhtumitest.
English: Malignancies were observed in clinical studies of upadacitinib.
Estonian: Kliinilistes uuringutes upadatsinitiibiga täheldati pahaloomuliste kasvajate esinemist.
English: • LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and placebo groups, respectively
Estonian: • LDL-i kolesterool ≥ 3,36 mmol/L (130 mg/dl): 42% ja 19%, vastavalt 15 mg upadatsitiniibi rühmas ja platseeborühmas
English: In methotrexate (MTX)-controlled studies, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 19.5% compared to 24.0% in the MTX group.
Estonian: Metotreksaadi (MTX) kontrolliga uuringutes oli infektsioonide esinemissagedus 12/14 nädala jooksul 15 mg upadatsitiniibi monoravi rühmas 19,5%, võrreldes 24,0%-ga MTX-i rühmas.
English: Intrinsic factors
Estonian: Püsitegurid
English: 28 prolonged-release tablets.
Estonian: 28 toimeainet prolongeeritult vabastavat tabletti.
English: • Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and placebo groups, respectively
Estonian: • Üldkolesterool ≥ 5,17 mmol/l (200 mg/dl): 62% ja 31%, vastavalt 15 mg upadatsitiniibi rühmas ja platseeborühmas
English: In MTX-controlled studies, there were no cases of opportunistic infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group and 0.2% in the MTX group.
Estonian: MTX-i kontrolliga uuringutes ei esinenud oportunistlikke infektsioone 12/14 nädala jooksul 15 mg upadatsitiniibi monoravi rühmas, MTX-i rühmas oli esinemissagedus 0,2%.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun. PC
Estonian: E T K N R L P PC
English: In placebo-controlled clinical studies with background DMARDs, the frequency of opportunistic infections over 12/14 weeks in the upadacitinib 15 mg group was 0.5% compared to 0.3% in the placebo group.
Estonian: Platseebokontrolliga kliinilistes uuringutes, kus kasutati taustaravimina DMARD-e, oli oportunistlike infektsioonide esinemissagedus 12/14 nädala jooksul 15 mg upadatsitiniibiga ravitud rühmas 0,5%, võrreldes 0,3%-ga platseeborühmas.
English: Oral use
Estonian: Oraalne kandidiaas
English: Upadacitinib should be used with caution in patients with severe renal impairment.
Estonian: Raske neerukahjustusega patsientidel tuleb upadatsitiniibi kasutada ettevaatlikult.
English: In placebo-controlled clinical studies with background DMARDs, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg group was 1.2% compared to 0.6% in the placebo group.
Estonian: Platseebokontrolliga kliinilistes uuringutes, kus kasutati taustaravimina DMARD-e, oli tõsiste infektsioonide esinemissagedus 12/14 nädala jooksul 15 mg upadatsitiniibiga ravitud rühmas 1,2%, võrreldes 0,6%-ga platseeborühmas.
English: Each prolonged-release tablet contains 15 mg of upadacitinib (as upadacitinib hemihydrate).
Estonian: Üks toimeainet prolongeeritult vabastav tablett sisaldab 15 mg upadatsitiniibi (upadatsitiniibi hemihüdraadina).
English: In a clinical study, coadministration of upadacitinib after multiple doses of rifampicin (strong CYP3A inducer) resulted in approximately 50% and 60% decreases in upadacitinib Cmax and AUC, respectively.
Estonian: Ühes kliinilises uuringus vähenes upadatsitiniibi Cmax ja AUC vastavalt ligikaudu 50% ja 60% pärast rifampitsiini (tugeva
English: What RINVOQ is and what it is used for 2.
Estonian: 1. Mis ravim on RINVOQ ja milleks seda kasutatakse 2. Mida on vaja teada enne RINVOQ'i võtmist 3.
English: 29 14 43e
Estonian: 14 45e, h 29 14 43e
English: Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Estonian: Kõrge DVT/PE tekkeriskiga patsientidel tuleb upadatsitiniibi kasutada ettevaatlikult.
English: Table 3: Clinical trials summary Study name Population (n) Treatment arms
Estonian: Kliiniliste uuringute kokkuvõte Uuringu nimetus
English: In MTX-controlled studies, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 0.6% compared to 0.4% in the MTX group.
Estonian: MTX-i kontrolliga uuringutes oli tõsiste infektsioonide esinemissagedus 12/14 nädala jooksul 15 mg upadatsitiniibi monoravi rühmas 0,6%, võrreldes 0,4%ga MTX-i rühmas.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
Estonian: Farmakoloogilise ohutuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: Hepatic transaminase elevations
Estonian: Maksa transaminaaside tõus
English: Hypercholesterolaemia Hypertriglyceridaemia
Estonian: Hüperkolesteroleemia Hüperglütserideemia
English: Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with upadacitinib.
Estonian: Ravi ajal ja pärast ravi upadatsitiniibiga tuleb patsiente hoolikalt jälgida infektsiooni nähtude ning sümptomite suhtes.
English: Immunosuppressive medicinal products
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: AbbVie Logistics B.V Zuiderzeelaan 53
Estonian: AbbVie Logistics B.V.
English: 30 prolonged-release tablets
Estonian: 30 toimeainet prolongeeritult vabastavat tabletti.
English: Malignancy
Estonian: Monoravi
English: Abbreviations: ADA = adalimumab; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a All placebo data at week 48 derived using linear extrapolation b SELECT-EARLY c SELECT-COMPARE
Estonian: Lühendid: ADA = adalimumab; IR = ebaadekvaatne vastus; MTX = metotreksaat; PBO = platseebo; UPA= upadatsitiniib a Kõik andmed platseebo kohta 48. nädalal on saadud lineaarse ekstrapoleerimisega b SELECT-EARLY c SELECT-COMPARE d Progresseerumise puudumine on mTSS-i muutus ≤ 0 e Nominaalne p ≤ 0,001 upadatsitiniib vs. platseebo või MTX-i võrdlus f Varieeruvuse kontroll p ≤ 0,01 upadatsitiniib vs. platseebo või MTX-i võrdlus g Varieeruvuse kontroll p ≤ 0,001 upadatsitiniib vs. platseebo või MTX-i võrdlus
English: • medicines to treat seizures or fits (such as phenytoin)
Estonian: • ravimeid krambihoogude raviks (nt fenütoiin)
English: Important to open
Estonian: Pakend tuleb avada.
English: • shingles or painful skin rash with blisters (herpes zoster)
Estonian: • vöötohatis või valulik villiline lööve
English: 30 prolonged-release tablets 90 prolonged-release tablets
Estonian: 90 toimeainet prolongeeritult vabastavat tabletti.
English: o Language on the risk of VTE during treatment with upadacitinib o Language on need for discontinuation of upadacitinib, evaluation, and appropriate treatment for VTE if clinical features of deep venous thrombosis or pulmonary embolism develop
Estonian: • VTE risk o näited riskiteguritest, mis suurendavad patsiendi VTE riski ning mille korral on vajalik ettevaatus upadatsitiniibi kasutamisel; o selgitatakse VTE riski ravi ajal upadatsitiniibiga o selgitatakse vajadust katkestada upadatsitiniibi võtmine, hinnata seisundit ja alustada sobivat VTE ravi, kui tekivad süvaveenitromboosi või kopsuembolismi kliinilised tunnused.
English: Talk to your doctor if you notice any of the following side effects: Very common (may affect more than 1 in 10 people)
Estonian: Väga sage (võib esineda rohkem kui 1 inimesel 10-st) • kurgu- ja ninainfektsioonid
English: On background csDMARDs
Estonian: Taustaravimina csDMARD-d
English: Non-melanoma skin cancer
Estonian: Mittemelanoomne nahavähk
English: Special populations
Estonian: Ravirühmad
English: How to puncture the foil
Estonian: Fooliumi purustamine
English: • A reminder to use contraception, that upadacitinib is contraindicated during pregnancy, and to notify their HCPs if they become pregnant while taking upadacitinib o Description of signs/symptoms of deep venous thrombosis or pulmonary embolism which the patient needs to be aware of, so that they can seek attention from an HCP.
Estonian: • meeldetuletus patsiendile kasutada rasestumisvastast vahendit; et upadatsitiniib on raseduse ajal vastunäidustatud; ning vajadus teavitada tervishoiutöötajaid, kui patsient rasestub upadatsitiniibi võtmise ajal.
English: 1 vial + 1 pre-filled syringe powder: 450 IU; solvent: 0.75 ml (600 IU/ml)
Estonian: 1 viaal + 1 süstel pulber: 450 RÜ; lahusti: 0,75 ml (600 RÜ/ml)
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Estonian: pulber: viaal (klaas); lahusti: viaal (klaas)
English: Lorviqua (lorlatinib)
Estonian: Lorviqua (lorlatiniib)
English: What measures are being taken to ensure the safe and effective use of Lorviqua?
Estonian: Mis meetmed võetakse, et tagada Lorviqua ohutu ja efektiivne kasutamine?
English: Lorviqua is available as tablets (25 and 100 mg) and the recommended dose is 100 mg once a day.
Estonian: Ravimit Lorviqua turustatakse tablettidena (25 ja 100 mg) ning soovituslik algannus on 100 mg üks kord ööpäevas.
English: The European Medicines Agency therefore decided that Lorviqua's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Lorviqua kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: If certain side effects develop the doctor may reduce the dose or interrupt treatment temporarily.
Estonian: Teatud kõrvalnähtude tekkimisel võib arst annust vähendada või ravi ajutiselt katkestada.
English: As for all medicines, data on the use of Lorviqua are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Lorviqua kasutamise kohta pidevat järelevalvet.
English: Lorviqua must not be used together with medicines known as ‘strong CYP3A4/5 inducers' because the combined medicines could have an effect on the liver.
Estonian: Lorviquat ei tohi kasutada koos ravimitega, mis on teadaolevalt tugevad CYP3A4/5-induktorid, sest koos kasutatuna võivad need ravimid kahjustada maksa.
English: In this study Lorviqua was not compared with any other treatment or placebo (a dummy treatment).
Estonian: Selles uuringus ei võrreldud Lorviquat ühegi muu ravimi ega platseeboga (näiv ravim).
English: It works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer cells.
Estonian: See toimib ALK aktiivsust blokeerides, vähendades sellega vähirakkude kasvu ja levikut.
English: The most common side effects with Lorviqua (which may affect more than 1 in 5 people) are hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), oedema (build-up of fluid), peripheral neuropathy (nerve damage in the hands and feet), problems with thinking, learning and memory, tiredness, weight gain and effects on mood.
Estonian: Lorviqua kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 5st) on hüperkolesteroleemia (vere suur kolesteroolisisaldus), hüpertriglütseriideemia (vere suur triglütseriidide (teatud rasvad) sisaldus), ödeem (turse teke), perifeerne neuropaatia (käte ja jalgade närvikahjustused), mõtlemis-, õppevõime- ja mäluprobleemid, väsimus, kaalutõus ja meeleoluhäired.
English: What is Lorviqua and what is it used for?
Estonian: Mis on Lorviqua ja milleks seda kasutatakse?