FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Icelandic: Hver 280 mg filmuhúðuð tafla inniheldur 56 mg laktósamónóhýdrat.
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Icelandic: Verkunarniðurstöður í rannsókn PCYC-1115-CA Endapunktur
English: Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side.
Icelandic: Gulgrænar til grænar kringlóttar töflur (9 mm), með ígreyptu „ibr“ á annarri hliðinni og „140“ á hinni hliðinni.
English: The median time since diagnosis was 42 months, and median number of prior treatments was 3 (range: 1 to 5 treatments), including 35% with prior high-dose chemotherapy, 43% with prior bortezomib, 24% with prior lenalidomide, and 11% with prior autologous or allogeneic stem cell transplant.
Icelandic: Fjörutíu og tveir mánuðir (miðgildi) voru frá sjúkdómsgreiningu og fyrri meðferðir voru 3 (miðgildi) (á bilinu 1 til 5 meðferðir) þ.á m. höfðu 35% fengið háskammta krabbameinslyfjameðferð, 43% meðferð með bortezomibi, 24% meðferð með lenalidomidi og 11% höfðu fengið samgena eða ósamgena stofnfrumuígræðslu.
English: CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response.
Icelandic: CI=öryggisbil; HR=hættuhlutfall; CR=full svörun; PR=hlutasvörun.
English: IMBRUVICA contains sodium
Icelandic: IMBRUVICA inniheldur natríum
English: The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment.
Icelandic: Við lokagreininguna höfðu 133 (67,9%) af 196 þátttakendum sem upphaflega var slembiraðað í ofatumumab meðferðarhópinn skipt yfir í ibrutinib meðferð.
English: The Kaplan-Meier curve for PFS is shown in Figure 6.
Icelandic: Kaplan-Meier graf fyrir lifun án versnunar sjúkdóms er sýnt á mynd 6.
English: Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 months Follow-up
Icelandic: Kaplan-Meier graf fyrir lifun án versnunar sjúkdóms (þýði samkvæmt meðferðaráætlun (ITT)) í rannsókn PCYC-1112-CA í lokagreiningu með 65 mánaða eftirfylgni
English: NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated.
Icelandic: NE = ekki hægt að meta; HR = hættuhlutfall; CI = öryggisbil; ORR = heildarsvörunartíðni Metið af IRC.
English: The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Icelandic: Skammt af ibrutinibi skal minnka í 140 mg (eitt hylki) einu sinni á sólarhring eða gera hlé á meðferð í allt að 7 daga við samhliðanotkun með öflugum CYP3A4-hemlum.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Icelandic: VASI 560 MG TAFLA (30 dagar)
English: If these toxicities persist or recur following two dose reductions, discontinue the medicinal product.
Icelandic: Hætta skal meðferð með lyfinu ef eiturverkanir eru viðvarandi eða koma aftur eftir tvær skammtaminnkanir.
English: • acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
Icelandic: • acetýlsalicýlsýra og bólgueyðandi verkjalyf sem ekki eru sterar, svo sem ibuprofen eða naproxen
English: At a supratherapeutic dose of 1,680 mg, ibrutinib did not prolong the QTc interval to any clinically relevant extent.
Icelandic: Lenging á QTc bili fyrir tilstilli ibrutinibs kom ekki fram svo nokkru nemi klínískt við 1.680 mg, sem er stærri skammtur en meðferðarskammtur.
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule).
Icelandic: Hjá sjúklingum með meðalskerta lifrarstarfsemi (Child-Pugh flokkun B) er ráðlagður skammtur 140 mg (eitt hylki) einu sinni á sólarhring.
English: 120 hard capsules
Icelandic: 90 hörð hylki 120 hörð hylki
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Icelandic: Miðgildi aldurs var 63 ára (á bilinu 44 til 86 ára), 76% voru karlar og 95% voru hvítir.
English: How to take IMBRUVICA
Icelandic: Hvernig nota á IMBRUVICA
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 arm.
Icelandic: Lifun án versnunar sjúkdóms sem var metin af óháðri eftirlitsnefnd (IRC) samkvæmt IWCLL viðmiði bendir til 78% tölfræðilega marktækt minni hættu á dauðsfalli eða versnun hjá sjúklingum í IMBRUVICA hópnum.
English: Mild inducers may be used concomitantly with IMBRUVICA, however, patients should be monitored for potential lack of efficacy.
Icelandic: Nota má væga virkja samhliða IMBRUVICA en fylgjast skal með sjúklingum m.t.t. skorts á verkun.
English: The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg (three capsules) once daily (for details of the combination regimen, see section 5.1).
Icelandic: Langvinnt eitilfrumuhvítblæði (CLL) og Waldenström risaglóbúlínblæði (WM) Ráðlagður skammtur við meðferð á CLL, annaðhvort sem einlyfjameðferð eða í samsettri meðferð, er 420 mg (þrjú hylki) einu sinni á sólarhring (sjá frekari upplýsingar um samsetta meðferð í kafla 5.1).
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Icelandic: Miðgildi aldurs var 69 ár (á bilinu 36 til 89 ár), 66% voru karlar og 79% voru hvítir.
English: To minimise the potential for an interaction in the GI tract, oral narrow therapeutic range, P-gp or BCRP substrates such as digoxin or methotrexate should be taken at least 6 hours before or after IMBRUVICA.
Icelandic: P-gp eða BCRP sem ætluð eru til inntöku og eru með þröngt meðferðarbil, svo sem digoxín eða metotrexat, a.m.k. 6 klst. fyrir eða eftir IMBRUVICA.
English: These may be signs and symptoms of stroke.
Icelandic: Þetta geta verið einkenni um heilaslag.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Icelandic: VASI 560 MG TAFLA (28 dagar)
English: The updated Kaplan-Meier curve for PFS is shown in Figure 4.
Icelandic: Kaplan-Meier graf fyrir lifun án versnunar sjúkdóms er sýnt á mynd 4.
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).
Icelandic: Við upphaf voru 45% með langt genginn sjúkdóm (Rai stig III eða IV), 35% sjúklinga voru með a.m.k. eitt æxli ≥ 5 cm, 39% voru með blóðleysi við upphaf, 23% voru með blóðflagnafæð við upphaf, 65% hafði hækkað β2 míkróglóbúlin > 3500 míkróg/l, 47% var með kreatínínúthreinsun < 60 ml/mín., 20% sjúklinga var með 11q úrfellingu, 6% sjúklinga var með 17p úrfellingu/æxlisprótein 53 (TP53) stökkbreytingu og hjá 44% sjúklinga var breytilegt svæði þungakeðju ónæmisglóbúlína (IGHV) án stökkbreytinga.
English: In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken.
Icelandic: Hjá sjúklingum sem fá gáttatif meðan á IMBRUVICA meðferð stendur skal meta vandlega hættuna á segarekssjúkdómi í bláæðum.
English: The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Icelandic: Möttulfrumu eitlaæxli (MCL) Ráðlagður skammtur við meðferð á MCL er 560 mg (fjögur hylki) einu sinni á sólarhring.
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.
Icelandic: Gular til appelsínugular ílangar töflur (19 mm langar og 8,1 mm breiðar), merktar með „ibr“ á annarri hliðinni og „560“ á hinni hliðinni.
English: Median duration of overall response, months (range)
Icelandic: Lengd heildarsvörunar (miðgildi), mánuðir (á bili)
English: IMBRUVICA 420 mg film-coated tablets
Icelandic: IMBRUVICA 420 mg filmuhúðaðar töflur
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fram hjá allt að 1 af hverjum 10 einstaklingum)
English: Mild CYP3A4 inhibitors
Icelandic: Vægir CYP3A4-hemlar
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.
Icelandic: Gulgrænar til grænar ílangar töflur (17,5 mm langar og 7,4 mm breiðar), merktar með „ibr“ á annarri hliðinni og „420“ á hinni hliðinni.
English: If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Icelandic: Ef eiturverkanir koma aftur fram skal minnka skammt sem gefinn er einu sinni á sólarhring um 140 mg.
English: In pregnant rats, ibrutinib at a dose of 80 mg/kg/day was associated with increased post-implantation loss and increased visceral (heart and major vessels) malformations and skeletal variations with an exposure margin 14 times the AUC found in patients at a daily dose of 560 mg. At a dose of ≥40 mg/kg/day, ibrutinib was associated with decreased foetal weights (AUC ratio of ≥5.6 as compared to daily dose of 560 mg in patients).
Icelandic: 80 mg/kg/sólarhring auknum missi fangs og aukinni vansköpun innyfla (hjarta og stórra æða) og beinabreytingum þar sem útsetning var 14 föld AUC-útsetning hjá sjúklingum við daglega skammta sem nema 560 mg.
English: Use of preparations containing St. John's Wort is contraindicated in patients treated with IMBRUVICA.
Icelandic: Ekki skal nota lyf sem innihalda jóhannesarjurt hjá sjúklingum sem fá meðferð með IMBRUVICA.
English: IMBRUVICA 280 mg film-coated tablets
Icelandic: IMBRUVICA 280 mg filmuhúðaðar töflur
English: Co-administration of ketoconazole, a very strong CYP3A4 inhibitor, in 18 fasted healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by 29- and 24-fold, respectively.
Icelandic: Hjá 18 fastandi, heilbrigðum þátttakendum jók samhliða gjöf ketaconazols, sem er mjög öflugur CYP3A4-hemill, útsetningu fyrir ibrutinibi (Cmax og AUC) 29-sinnum og 24-sinnum, í þeirri röð.
English: • medicines called calcium channel blockers for high blood pressure or chest pain - diltiazem or verapamil
Icelandic: lyf sem nefnast kalsíumgangalokar, við háum blóðþrýstingi eða brjóstverk, - diltiazem eða verapamil
English: No specific studies have been conducted to date in subjects with impaired renal function.
Icelandic: Fram að þessu hafa engar sértækar rannsóknir verið gerðar hjá sjúklingum með skerta nýrnastarfsemi.
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.
Icelandic: Skammt af ibrutinibi skal minnka í 140 mg einu sinni á sólarhring eða gera hlé á meðferð í allt að 7 daga við samhliðanotkun með öflugum CYP3A4-hemlum.
English: IMBRUVICA 560 mg film-coated tablets
Icelandic: IMBRUVICA 560 mg filmuhúðaðar töflur
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Icelandic: EU/1/14/945/001 (90 hörð hylki) EU/1/14/945/002 (120 hörð hylki)
English: Infections
Icelandic: svimatilfinning
English: Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women.
Icelandic: Samkvæmt því sem komið hefur fram hjá dýrum getur IMBRUVICA valdið skaða fyrir fóstur þegar það er gefið á meðgöngu.
English: If you stop taking IMBRUVICA
Icelandic: Ef hætt er að nota IMBRUVICA
English: Moderate CYP3A4 inhibitors
Icelandic: Meðalöflugir CYP3A4-helmar
English: Population pharmacokinetics data indicated that gender does not significantly influence ibrutinib clearance from the circulation.
Icelandic: Rannsóknir á lyfjahvörfum benda til að kyn hafi ekki marktæk áhrif á úthreinsun ibrutinibs úr blóðrásinni.
English: Supplements such as fish oil and vitamin E preparations should be avoided.
Icelandic: Forðast á fæðubótarefni eins og lýsi (fiskiolíu) og vörur með E-vítamíni.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
Icelandic: VASI 280 MG TAFLA (30 dagar)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Icelandic: IMBRUVICA 420 mg töflur ibrutinib
English: IMBRUVICA+Obinutuzumab N=113
Icelandic: IMBRUVICA+obinutuzumab
English: If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Icelandic: Ef grunur er um ágenga fjölhreiðra innlyksuheilabólgu skal grípa til viðeigandi greiningarmats og fresta meðferð þar til búið er að útiloka ágenga fjölhreiðra innlyksuheilabólgu.
English: The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Icelandic: Miðgildi aldurs var 68 ár (á bilinu 34 til 88 ár), 74% voru karlar og 87% voru hvítir.
English: Monitor patients for the appearance of non-melanoma skin cancer.
Icelandic: Fylgjast skal með sjúklingum með tilliti til þess að fram komi húðkrabbamein sem ekki er sortuæxli.
English: IMBRUVICA 140 mg film-coated tablets
Icelandic: IMBRUVICA 140 mg filmuhúðaðar töflur
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Icelandic: Hjá sjúklingum með vægt skerta lifrarstarfsemi (Child-Pugh flokkun A) er ráðlagður skammtur 280 mg einu sinni á sólarhring.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
Icelandic: VASI 280 MG TAFLA (28 dagar)
English: Janssen-Cilag, S.A. Tel: +34 91 722 81 00 contacto@its.jnj.com
Icelandic: +34 91 722 81 00 contacto@its.jnj.com
English: Second restart at 420 mg daily restart at 280 mg daily
Icelandic: Hefja aftur með 420 mg á sólarhring
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Icelandic: VASI 420 MG TAFLA (30 dagar)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Icelandic: IMBRUVICA 560 mg töflur ibrutinib
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Icelandic: Skammt af ibrutinibi skal minnka í 280 mg einu sinni á sólarhring við samhliðanotkun með meðalöflugum CYP3A4-hemlum.
English: Administer IMBRUVICA to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity.
Icelandic: IMBRUVICA ef ávinningurinn vegur þyngra en áhættan og fylgjast skal vandlega með þeim m.t.t. eiturverkana.
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Icelandic: Imbruvica 140 mg
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.
Icelandic: IMBRUVICA hjá sjúklingum með CLL/SLL sem höfðu ekki fengið meðferð áður í slembaðri, fjölsetra, opinni 3. stigs rannsókn (PCYC-1130-CA) með IMBRUVICA í samsettri meðferð með obinutuzumabi samanborið við chlorambucil í samsettri meðferð með obinutuzumabi.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Icelandic: 28 filmuhúðaðar töflur
English: Ibrutinib is metabolised primarily by CYP3A4 to produce a dihydrodiol metabolite with an inhibitory activity towards BTK approximately 15 times lower than that of ibrutinib.
Icelandic: Ibrutinib umbrotnar aðallega fyrir tilstilli CYP3A4 og myndar dihydrodiól umbrotsefni sem hefur u.þ.b.
English: Febrile neutropenia Leukocytosis Lymphocytosis
Icelandic: Mjög sjaldgæfar Heilkenni hvítkornastöðu (Leukostasis syndrome)
English: No dose adjustment is required in combination with mild inhibitors.
Icelandic: Ekki er þörf á skammtaaðlögun við samhliða notkun vægra hemla.
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Icelandic: Skammt af ibrutinibi skal minnka í 280 mg (tvö hylki) einu sinni á sólarhring við samhliðanotkun með meðalöflugum CYP3A4-hemlum.
English: C]-ibrutinib in healthy subjects, approximately
Icelandic: C]-ibrutinibi hjá heilbrigðum þátttakendum hafði u.þ.b.
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.
Icelandic: Fjólubláar ílangar töflur (15 mm langar og 7 mm breiðar), merktar með „ibr“ á annarri hliðinni og „280“ á hinni hliðinni.
English: Day 1, and 500 mg/m2 Cycles 2 through 6, Day 1.
Icelandic: 30 mínútum í lotu 1 á degi 2 og 3 og í lotum 2-6 á degi 1 og 2 í allt að 6 lotur.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Icelandic: VASI 420 MG TAFLA (28 dagar)
English: • allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)
Icelandic: • ofnæmisviðbrögð, sem geta stundum verið alvarleg, geta verið þroti í andliti, vörum, munni,
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Icelandic: IMBRUVICA 280 mg töflur ibrutinib
English: Third restart at 280 mg daily restart at 140 mg daily
Icelandic: Hefja aftur með 140 mg á sólarhring
English: Table 5: Efficacy results in Study PCYC-1130-CA
Icelandic: PCYC-1130-CA
English: Cases of cerebrovascular accident, transient ischaemic attack and ischaemic stroke including fatalities have been reported with the use of ibrutinib, with and without concomitant atrial fibrillation and/or hypertension.
Icelandic: Greint hefur verið frá tilvikum heilaslags (heilablóðfall), skammvinnrar heilablóðþurrðar og blóðþurrðarslags þ.m.t. dauðsföllum við notkun ibrutinibs, hvort sem gáttatif og/eða háþrýstingur er til staðar eða ekki.
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561 lv@its.jnj.com
Icelandic: Tel: +371 678 93561 lv@its.jnj.com
English: Polyvinyl alcohol
Icelandic: Pólývínýlalkóhól
English: Also tell your doctor if you take any of the following medicines - The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:
Icelandic: - Þau geta haft áhrif á IMBRUVICA og IMBRUVICA getur haft áhrif á eftirtalin lyf ef þau eru tekin samhliða:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
Icelandic: VASI 140 MG TAFLA (30 dagar)
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Icelandic: Kaplan-Meier graf fyrir heildarlifun (þýði samkvæmt meðferðaráætlun (ITT)) í rannsókn PCYC-1115-CA
English: Urticaria
Icelandic: Aukaverkanir
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
Icelandic: VASI 140 MG TAFLA (28 dagar)
English: These include minor bleeding events such as contusion, epistaxis, and petechiae; and major bleeding events, some fatal, including gastrointestinal bleeding, intracranial haemorrhage, and haematuria.
Icelandic: Þ.m.t.minniháttar blæðingar svo sem mar, blóðnasir og depilblæðingar og svæsnar blæðingar, sumar banvænar svo sem blæðing frá meltingarvegi, blæðing innan höfuðkúpu og blóðmiga.
English: arm.
Icelandic: Hjarta
English: The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg once daily (for details of the combination regimen, see section 5.1).
Icelandic: Langvinnt eitilfrumuhvítblæði (CLL) og Waldenström risaglóbúlínblæði (WM) Ráðlagður skammtur við meðferð á CLL, annaðhvort sem einlyfjameðferð eða í samsettri meðferð, er 420 mg einu sinni á sólarhring (sjá frekari upplýsingar um samsetta meðferð í kafla 5.1).
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Icelandic: Rautt járnoxíð (E172) Gult járnoxíð (E172)
English: p-value associated with response rate was <0.0001.
Icelandic: % Lifandi án versnunar p<0,0001
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.
Icelandic: IMBRUVICA 420 mg daglega eða lyfleysu ásamt rituximabi fram að sjúkdómsversnun eða óásættanlegum eiturverkunum.
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
Icelandic: Hjá sjúklingum með meðalskerta lifrarstarfsemi (Child-Pugh flokkun B) er ráðlagður skammtur 140 mg einu sinni á sólarhring.
English: CLL
Icelandic: Sundl
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Icelandic: Hver filmuhúðuð tafla inniheldur 280 mg ibrutinib.
English: Bleeding-related events
Icelandic: Tilvik tengd blæðingum
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Icelandic: Hver filmuhúðuð tafla inniheldur 560 mg ibrutinib.
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Icelandic: 14 filmuhúðaðar töflur
English: Cerebrovascular accidents
Icelandic: N Hættuhlutfall
English: Janssen-Cilag AS Tlf: +47 24 12 65 00 jacno@its.jnj.com
Icelandic: +47 24 12 65 00 jacno@its.jnj.com
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.
Icelandic: Við langtímaeftirfylgni fengu síðan alls 73 þátttakendur (54,9%) sem upphaflega var slembiraðað í chlorambucil hópinn ibrutinib sem víxlmeðferð.
English: Women should avoid becoming pregnant while taking IMBRUVICA and for up to 3 months after ending treatment.
Icelandic: IMBRUVICA er notað og í allt að 3 mánuði eftir að meðferð lýkur.
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
Icelandic: +45 4594 8282 jacdk@its.jnj.com
English: IMBRUVICA 140 mg hard capsules ibrutinib
Icelandic: IMBRUVICA 140 mg hörð hylki ibrutinib
English: Infections and infestations Very common Pneumonia Upper respiratory tract infection Skin infection
Icelandic: Lungnabólga* Sýking í efri öndunarvegi Sýking í húð*
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
Icelandic: Leitaðu ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingi ef eitthvað af þessu á við (eða ef þú ert ekki viss) áður en þú notar IMBRUVICA.
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Icelandic: Kaplan-Meier graf fyrir lifun án versnunar sjúkdóms (þýði samkvæmt meðferðaráætlun (ITT)) í rannsókn PCYC-1112- CA
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Icelandic: IMBRUVICA 140 mg filmuhúðaðar töflur ibrutinib
English: No clinical data are available on this interaction.
Icelandic: Klínísk gögn um þessa milliverkun eru ekki fyrirliggjandi.
English: Monitor patients for pulmonary symptoms indicative of ILD.
Icelandic: Fylgjast skal með sjúklingum með tilliti til einkenna frá lungum sem bent gætu til millivefjalungnasjúkdóms.
English: Do not get pregnant while you are taking this medicine.
Icelandic: Látið lækninn tafarlaust vita ef þungun verður. • Ekki á að hafa barn á brjósti á meðan lyfið er notað.
English: MCL
Icelandic: P-gildi
English: Unchanged ibrutinib accounted for approximately 1% of the radiolabeled excretion product in faeces and none in urine.
Icelandic: 1% af geislamerkta efninu sem skildist út með hægðum og ekkert í þvagi.
English: IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Icelandic: Hver filmuhúðuð tafla inniheldur 420 mg ibrutinib.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Icelandic: IMBRUVICA 140 mg töflur ibrutinib