FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies.
Estonian: IMBRUVICA kliinilistes uuringutes on ravi saanud kerge või mõõduka neerukahjustusega patsiendid.
English: Non-melanoma skin cancers were reported more frequently in patients treated with IMBRUVICA than in patients treated with comparators in pooled comparative randomised phase 3 studies.
Estonian: Võrdlusravimiga randomiseeritud III faasi koonduuringutes teatati mittemelanoom nahavähist IMBRUVICA'ga ravitud patsientidel sagedamini kui võrdlusravimit kasutanud patsientidel.
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Estonian: Teadaolevat toimet omav abiaine Üks 140 mg õhukese polümeerikattega tablett sisaldab 28 mg laktoosmonohüdraati.
English: The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Estonian: IMBRUVICA ohutust ja efektiivsust eelnevalt ravi mittesaanud KLL/VLL (krooniline lümfotsüütleukeemia/väikerakuline lümfotsütaarne lümfoom) patsientidel hinnati ka ühes randomiseeritud mitmekeskuselises avatud III faasi uuringus (PCYC-1130-CA), kus kasutati IMBRUVICA't kombinatsioonis obinutuzumabiga versus kloorambutsiili kombinatsioonis obinutuzumabiga.
English: Co-administration of grapefruit juice, containing CYP3A4 inhibitors, in eight healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by approximately 4- and 2-fold, respectively.
Estonian: Kaheksale tervele uuritavale manustati samaaegselt greibimahla, mis sisaldab CYP3A4 inhibiitoreid; see suurendas ibrutiniibi plasmakontsentratsiooni järgnevalt: Cmax suurenes ligikaudu 4 korda ja AUC 2 korda.
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA
Estonian: Ühe sõltumatu järelvalvekomitee poolt vastavalt IWCLL kriteeriumitele hinnatud progressioonivaba elulemuse osas ilmnes IMBRUVICA rühma patsientidel statistiliselt oluline 78% surma või haiguse progresseerumise riski vähenemine.
English: Treatment-emergent grade 3 or 4 cytopenias (neutropenia, thrombocytopenia and anaemia) were reported in patients treated with IMBRUVICA.
Estonian: IMBRUVICA'ga ravitud patsientidel on registreeritud raviaegset 3. või 4. raskusastme tsütopeeniat (neutropeeniat, trombotsütopeeniat ja aneemiat).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Estonian: ÜMBRIS - 560 MG TABLETID (28 päeva)
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Estonian: Uuritavate mediaanvanus oli 63 aastat (vahemikus 44 kuni 86 aastat), 76% olid meessoost ja 95% olid europiidsest rassist.
English: Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Estonian: Patsiendid (n=150) randomiseeriti 1:1 saama kas IMBRUVICA't 420 mg ööpäevas või platseebot kombinatsioonis rituksimabiga kuni haiguse progressioonini või vastuvõetamatu toksilisuseni.
English: Tumour lysis syndrome has been reported with IMBRUVICA therapy.
Estonian: Ravi korral IMBRUVICA'ga on teatatud tuumori lüüsi sündroomist.
English: The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatment-naïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA).
Estonian: IMBRUVICA ohutust ja efektiivsust WM ravis hinnati ka ühes randomiseeritud mitmekeskuselises topeltpimedas III faasi uuringus eelnevalt ravimata või eelnevalt ravi saanud WM patsientidel, kus võrreldi IMBRUVICA kombinatsiooni rituksimabiga versus platseebo kombinatsiooni rituksimabiga (PCYC-1127-CA).
English: Uncommon Angioedema Panniculitis
Estonian: Angioödeem Pannikuliit*
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Estonian: ÜMBRIS - 560 MG TABLETID (30 päeva)
English: No specific studies have been conducted to date in subjects with impaired renal function.
Estonian: Neerufunktsiooni häiretega patsientidega ei ole senini spetsiifilisi uuringuid läbi viidud.
English: IMBRUVICA 560 mg film-coated tablets Macrogol
Estonian: IMBRUVICA 560 mg õhukese polümeerikattega tabletid Makrogool
English: The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
Estonian: IMBRUVICA ohutust ja efektiivsust varem ravitud KLL-iga patsientidel uuriti veel randomiseeritud mitmekeskuselises topeltpimedas III faasi uuringus, kus võrreldi IMBRUVICA't koos rituksimabiga versus platseebo koos rituksimabiga (uuring CLL3001).
English: atazanavir, or fosamprenavir
Estonian: • seljavalu või liigesevalu
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Estonian: Joonis 8: Kaplan-Meieri kõver PFS kohta (ravikavatsuslik populatsioon) uuringus PCYC1127-CA
English: At baseline, 45% had advanced clinical stage (Rai Stage III or IV), 35% of patients had at least one tumor ≥5 cm, 39% with baseline anemia, 23% with baseline thrombocytopenia, 65% had elevated β2 microglobulin >3500 mcg/L, 47% had a CrCL <60 mL/min, 20% of patients presented with del11q, 6% of patients presented with del17p/tumor protein 53 (TP53) mutation, and 44% of patients presented with unmutated immunoglobulin heavy chain variable region (IGHV).
Estonian: Temsiroliimus patsientidest oli vähemalt üks ≥ 5 cm kasvaja, 39%-l oli ravieelselt aneemia, 23%- oli ravieelselt trombotsütopeenia, 65%-l oli β2 mikroglobuliini tase tõusnud > 3500 mikrogrammi/l, 47%-l oli CrCL < 60 ml/min, 20%-l patsientidest esines del11q, 6%-l patsientidest esines del17p/kasvajavalk 53 (TP53) mutatsioon ning 44%-l patsientidest esines muteerumata immunoglobluliini raske ahela varieeruv piirkond (immunoglobulin heavy chain variable region, IGHV).
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Estonian: Joonis 5: Kaplan-Meieri kõver PFS kohta (ravikavatsuslik populatsioon) uuringus PCYC1130-CA
English: The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Estonian: MRL korral on soovitatav raviannus 560 mg (neli kapslit) üks kord ööpäevas.
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg (one capsule) for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Estonian: Kui kasu kaalub riski üles ja CYP3A4 tugevat inhibiitorit peab tingimata kasutama, siis vähendada IMBRUVICA annust 140 mg-ni (üks kapsel) inhibiitori kasutamise ajaks või katkestada ajutiselt ravi IMBRUVICA'ga (7 päevaks või lühemaks ajaks) Jälgida patsienti hoolikalt toksilisuse nähtude suhtes ja pidada kinni soovitustest annuse modifitseerimiseks vastavalt vajadusele (vt lõigud 4.2 ja 4.4).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Estonian: ÜMBRIS - 420 MG TABLETID (30 päeva)
English: IMBRUVICA 280 mg film-coated tablets Macrogol
Estonian: IMBRUVICA 280 mg õhukese polümeerikattega tabletid Makrogool
English: • medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
Estonian: • antibiootikumideks nimetatavad ravimid, mida kasutakse bakteriaalsete nakkuste raviks klaritromütsiin, telitromütsiin, tsiprofloksatsiin, erütromütsiin või rifampitsiin
English: At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Estonian: Ravieelselt oli seerumi IgM mediaanne väärtus 3,2 g/dl (vahemik 0,6...8,3 g/dl), 63% patsientidest olid aneemilised (hemoglobiin ≤11 g/dl või 6,8 mmol/l) ning MYD88
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Estonian: Tabel 8: PFS analüüs alarühmades (Uuring PCYC-1112-CA) Riskitiheduste suhe
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Estonian: EU/1/14/945/001 (90 kõvakapslit) EU/1/14/945/002 (120 kõvakapslit)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Estonian: ÜMBRIS - 420 MG TABLETID (28 päeva)
English: IMBRUVICA 140 mg film-coated tablets and IMBRUVICA 420 mg film-coated tablets Macrogol
Estonian: IMBRUVICA 140 mg õhukese polümeerikattega tabletid ja IMBRUVICA 420 mg õhukese polümeerikattega tabletid
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Estonian: Tabel 4: Efektiivsustulemused uuringus PCYC-1115-CA Tulemusnäitaja
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Estonian: IMBRUVICA 560 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 560 mg ibrutiniibi.
English: Each hard capsule contains 140 mg of ibrutinib.
Estonian: Üks kõvakapsel sisaldab 140 mg ibrutiniibi.
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Estonian: Kui kasu kaalub riski üles ja CYP3A4 tugevat inhibiitorit peab tingimata kasutama, siis vähendada IMBRUVICA annust 140 mg-ni inhibiitori kasutamise ajaks või katkestada ajutiselt ravi IMBRUVICA'ga (7 päevaks või lühemaks ajaks) Jälgida patsienti hoolikalt toksilisuse nähtude suhtes ja pidada kinni soovitustest annuse modifitseerimiseks vastavalt vajadusele (vt lõigud 4.2 ja 4.4).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
Estonian: ÜMBRIS - 280 MG TABLETID (28 päeva)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
Estonian: ÜMBRIS - 280 MG TABLETID (30 päeva)
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Estonian: 28 õhukese polümeerikattega tabletti 30 õhukese polümeerikattega tabletti
English: IMBRUVICA 140 mg hard capsules ibrutinib
Estonian: IMBRUVICA 140 mg kapslid ibrutinibum
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioral signs or symptoms.
Estonian: Uute või halvenevate neuroloogiliste, kognitiivsete või käitumuslike nähtude või sümptomitega patsientide diferentsiaaldiagnoosis peavad arstid arvestama võimaliku PML-ga. PML kahtlusel tuleb patsiendi seisundit vastavalt diagnostiliselt hinnata ning ravi tuleb katkestada kuni PML välistamiseni.
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Estonian: IMBRUVICA 280 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 280 mg ibrutiniibi.
English: IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Estonian: IMBRUVICA 420 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 420 mg ibrutiniibi.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Estonian: IMBRUVICA 420 mg tabletid ibrutinibum
English: • If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.
Estonian: • Kui te ei ole kindel, millal järgmist annust võtta, siis pidage nõu oma arsti, apteekri või meditsiiniõega.
English: Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Estonian: IMBRUVICA 280 mg õhukese polümeerikattega tabletid Lillad ovaalsed tabletid (pikkus 15 mm ja laius 7 mm), mille ühel küljel on pimetrükk „ibr“ ja teisel küljel „280“.
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Estonian: IMBRUVICA 420 mg õhukese polümeerikattega tabletid Kollakasrohelised kuni rohelised ovaalsed tabletid (pikkus 17,5 mm ja laius 7,4 mm), mille ühel küljel on pimetrükk „ibr“ ja teisel küljel „420“.
English: The recommended dose for the treatment of MCL is 560 mg once daily.
Estonian: MRL korral on soovitatav raviannus 560 mg üks kord ööpäevas.
English: Drug-drug interactions
Estonian: Ravimite omavahelised koostoimed
English: Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), written with “ibr” on one side and “560” on the other side.
Estonian: IMBRUVICA 560 mg õhukese polümeerikattega tabletid Kollased kuni oranžid ovaalsed tabletid (pikkus 19 mm ja laius 8,1 mm), mille ühel küljel on pimetrükk „ibr“ ja teisel küljel „560“.
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Estonian: Joonis 6: Kaplan-Meieri kõver PFS kohta (ravikavatsuslik (ITT) populatsioon) uuringus PCYC-1112- CA
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Estonian: Imbruvica 140 mg
English: 120 hard capsules
Estonian: 90 kõvakapslit 120 kõvakapslit
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Estonian: IMBRUVICA 560 mg tabletid ibrutinibum
English: Lymphocytosis was not observed in patients with WM treated with IMBRUVICA.
Estonian: Patsientidel, kes said ravi IMBRUVICA'ga WM-i tõttu, lümfotsütoosi ei täheldatud.
English: HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Estonian: HR = riskitiheduste suhe; CI = usaldusintervall; ORR = üldine ravivastuse määr; OS = üldine elulemus; PFS = progressioonivaba elulemus; PR = osaline ravivastus
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Estonian: Kasutamisel koos mõõdukate CYP3A4 inhibiitoritega tuleb ibrutiniibi annust vähendada 280 mg-ni üks kord ööpäevas.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
Estonian: ÜMBRIS - 140 MG TABLETID (28 päeva)
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. A lower Cmax was observed in fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days (see section 5.2).
Estonian: Vabatahtlikel, kellele pärast 40 mg omeprasooli võtmist üks kord ööpäevas 5 päeva jooksul manustati tühja kõhuga ühekordne annus 560 mg ibrutiniibi, täheldati madalamat Cmax väärtust (vt lõik 5.2).
English: NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated.
Estonian: NE = ei ole hinnatav; HR = riskitiheduste suhe; CI = usaldusintervall; ORR = üldine ravivastuse määr; PFS = progressioonivaba elulemus
English: Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Estonian: Joonis 3: Kaplan-Meieri kõver OS kohta (ravikavatsuslik populatsioon) uuringus PCYC-1115-CA
English: Cardiac arrhythmia
Estonian: Südamearütmia
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Estonian: Kasutamisel koos mõõdukate CYP3A4 inhibiitoritega tuleb ibrutiniibi annust vähendada 280 mg-ni (kaks kapslit) üks kord ööpäevas.
English: The Kaplan-Meier curve for PFS is shown in Figure 6.
Estonian: Kaplan-Meieri kõver progressioonivaba elulemuse kohta on esitatud joonisel 6.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
Estonian: ÜMBRIS - 140 MG TABLETID (30 päeva)
English: • fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath - these could be signs of an infection (viral, bacterial or fungal).
Estonian: • palavik, külmavärinad, valud kehas, väsimustunne, külmetuse või gripi sümptomid, õhupuudus
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Estonian: IMBRUVICA 280 mg tabletid ibrutinibum
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Estonian: IMBRUVICA 140 mg tabletid ibrutinibum
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Estonian: 14 õhukese polümeerikattega tabletti
English: Ventricular tachyarrhythmia
Estonian: kloorambutsiil riski N
English: Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
Estonian: IMBRUVICA'ga ravitud patsientidel on registreeritud kodade virvendusarütmiat, kodade laperdust ja ventrikulaarse tahhüarütmia juhtusid.
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Estonian: Joonis 2: Kaplan-Meieri kõver PFS kohta (ravikavatsuslik populatsioon) uuringus PCYC-1115-CA
English: • medicines called statins to treat high cholesterol - rosuvastatin
Estonian: • ravimid, mida nimetatakse statiinideks ja kasutatakse suure kolesteroolisisalduse vähendamiseks
English: Rare
Estonian: KÕBLIKKUSAEG
English: Cerebrovascular accidents
Estonian: Tserebrovaskulaarne atakk
English: The most common grade 3/4 adverse reactions (≥5%) were neutropenia, pneumonia, and thrombocytopenia.
Estonian: astme kõrvaltoimed olid neutropeenia, pneumoonia ja trombotsütopeenia.
English: The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Estonian: Täieliku ravivastuse (CR) määr IWCLL kriteeriumite alusel oli 16,2% IMBRUVICA harus, võrreldes 3,0%-ga kloorambutsiili harus.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
Estonian: IMBRUVICA 140 mg õhukese polümeerikattega tabletid Üks õhukese polümeerikattega tablett sisaldab 140 mg ibrutiniibi.
English: IMBRUVICA 140 mg film-coated tablets
Estonian: BLISTER - 140 MG TABLETID
English: Cerebrovascular accident a, #
Estonian: Tserebrovaskulaarne atakk a, #
English: Urticaria
Estonian: Liigesevalu
English: A randomised, multicenter, open-label phase 3 study (PCYC-1115-CA) of IMBRUVICA versus chlorambucil was conducted in patients with treatment-naïve CLL who were 65 years of age or older.
Estonian: 65-aastastel ja vanematel ravi mitte saanud KLL patsientidel viidi läbi randomiseeritud mitmekeskuseline avatud III faasi uuring (PCYC-1115-CA), milles võrreldi IMBRUVICA't ja kloorambutsiili.
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Estonian: Ravivastuse määr (CR, VGPR, PR)
English: Petechiae
Estonian: Pearinglus
English: Lymphocytosis
Estonian: kloorambutsiil:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Estonian: PUDELI SILT - 140 MG KAPSLID
English: Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation.
Estonian: Kasutamisel koos teiste trombotsüütide agregatsiooni agonistidega ei leitud ibrutiniibil olulist pärssivat toimet trombotsüütide agregatsioonile.
English: Onychoclasis
Estonian: Trükitint
English: Very common Haemorrhage Bruising Hypertension
Estonian: Verevalumid* Hüpertensioon*
English: Metabolism
Estonian: Pneumoonia*
English: Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
Estonian: Mittemelanoom nahavähk* Basaalrakuline kartsinoom Lamerakuline kartsinoom
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Estonian: EU/1/14/945/011 (28 tabletti) EU/1/14/945/005 (30 tabletti)
English: ORR including PR with lymphocytosis d (%)
Estonian: ORR, sealhulgas osaline ravivastus koos lümfotsütoosiga d
English: Progression-free survival (PFS) was assessed by IRC according to IWCLL criteria indicated a 77% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. With a median follow-up time on study of 31 months, the median PFS was not reached in the IMBRUVICA+obinutuzumab arm and was 19 months in the chlorambucil+obinutuzumab arm. Efficacy results for Study PCYC-1130-CA are shown in Table 5 and the Kaplan-Meier curve for PFS is shown in Figure 5.
Estonian: Uuringu mediaanse jälgimisaja 31 kuu jooksul ei saavutatud PFS mediaani IMBRUVICA+obinutuzumabi harus ja see oli 19 kuud kloorambutsiili+obinutuzumabi harus.
English: Do not take extra doses to make up the missed dose.
Estonian: Ärge võtke kahekordset annust, kui annus jäi eelmisel korral võtmata.
English: EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Estonian: EU/1/14/945/009 (28 tabletti) EU/1/14/945/010 (30 tabletti)
English: IMBRUVICA 560 mg film-coated tablets
Estonian: KARP - 560 MG TABLETID
English: How to store IMBRUVICA
Estonian: Kuidas IMBRUVICA't säilitada
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Estonian: EU/1/14/945/007 (28 tabletti) EU/1/14/945/008 (30 tabletti)
English: IMBRUVICA 420 mg film-coated tablets
Estonian: BLISTER - 420 MG TABLETID
English: The Kaplan-Meier landmark estimate for OS at 48-months was 85.5% in the IMBRUVICA arm.
Estonian: Kaplan-Meieri OS hetkehinnang 48. kuul oli IMBRUVICA harus
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Estonian: EU/1/14/945/012 (28 tabletti) EU/1/14/945/006 (30 tabletti)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Estonian: VÄLINE PAPPKARP - 140 MG KAPSLID
English: Monitor patients for the appearance of non-melanoma skin cancer.
Estonian: Patsiente tuleb jälgida mittemelanoom nahavähi tekke suhtes.
English: CI=confidence interval; HR=hazard ratio; ORR=overall response rate; OS=overall survival; PFS=progression-free survival IRC evaluated.
Estonian: CI = usaldusintervall; HR = riskitiheduste suhe; ORR = üldine ravivastuse määr; OS = üldine elulemus; PFS = progressioonivaba elulemus
English: Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172)
Estonian: IMBRUVICA 280 mg tabletid sisaldavad ka musta raudoksiidi (E172) ja punast raudoksiidi (E172);
English: Progression free survival (PFS) as assessed by IRC according to International Workshop on CLL (IWCLL) criteria indicated an 84% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1115-CA are shown in Table 4 and the Kaplan-Meier curves for PFS and OS are shown in Figures 2 and 3, respectively.
Estonian: Sõltumatu järelevalvekomitee (IRC) hinnangust progressioonivabale elulemusele (PFS), mis tugines kroonilise lümfotsüütleukeemia rahvusvahelise töörühma (International Workshop on CLL, IWCLL) kriteeriumitele, selgus 84%-line, statistiliselt oluline surma või progressiooni riski vähenemine IMBRUVICA raviharus.
English: Musculoskeletal pain
Estonian: Mittemelanoom nahavähk
English: Use as directed by your physician.
Estonian: Võtke seda ravimit nii, nagu arst on teile selgitanud.
English: IMBRUVICA 280 mg film-coated tablets
Estonian: BLISTER - 280 MG TABLETID
English: Cytopenias
Estonian: • nahapunetus
English: The dose of ibrutinib should be reduced to 140 mg once daily or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Estonian: Kasutamisel koos tugevate CYP3A4 inhibiitoritega tuleb ibrutiniibi annust vähendada 140 mg-ni üks kord ööpäevas või katkestada ravi kuni 7 päevaks.
English: Very common Arthralgia Muscle spasms Musculoskeletal pain
Estonian: Lihasspasmid Lihaste ja luustiku valu*