FrancophonIA/ELRC3.0 huggingface dataset:
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Biopoin 3,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Biopoin 4,000
English: The haemoglobin values in your blood should not exceed a value of 12 g/dl (7.45 mmol/l).
Maltese: Il-livelli tal-emoglobina fid-demm tiegħek m'għandhomx jaqbżu valur ta' 12 g/dl (7.45 mmol/l).
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Maltese: Il-konċentrazzjoni mmirata tal-emoglobina f‘tnejn mill-istudji kienet >13 g/dl; fit-tlett studji l-oħra din kienet 12-14 g/dl.
English: Misuse
Maltese: LOTT
English: Patients on haemodialysis will usually receive the injection at the end of dialysis via an arterio-venous fistula.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: In patients with a poor haemoglobin response to epoetin theta, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Maltese: F'pazjenti b'rispons batut tal-emoglobina għal epoetin theta, spegazzjonijiet alternattivi għarrispons batut għandhom jiġu kkunsidrati (ara sezzjonijiet 4.4 u 5.1).
English: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 micrograms) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 2,000 unità internazzjonali (IU) (16.7 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 4,000 IU (33.3 mikrogrammi) epoetin theta f'kull ml.
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: Biopoin 30,000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 1 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: Open the needle bag at the flaps (see picture 1).
Maltese: Iftaħ il-borża tal-labra mill-flaps (ara stampa 1).
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: Biopoin 3,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: 4 pre-filled syringes with safety needle containing 1 ml.
Maltese: 4 siringi mimlija għal-lest ta' 1 ml b'labra tas-sigurtà.
English: EU/1/09/565/023 1 pre-filled syringe EU/1/09/565/024 1 pre-filled syringe with safety device EU/1/09/565/025 4 pre-filled syringes EU/1/09/565/026 4 pre-filled syringes with safety device EU/1/09/565/027 6 pre-filled syringes EU/1/09/565/028 6 pre-filled syringes with safety device EU/1/09/565/040 1 pre-filled syringe with safety needle EU/1/09/565/041 4 pre-filled syringes with safety needle EU/1/09/565/042 6 pre-filled syringes with safety needle
Maltese: EU/1/09/565/040 1 siringa mimlija b'labra tas-sigurtà EU/1/09/565/041 4 siringi mimlija b'labra tas-sigurtà EU/1/09/565/042 6 siringi mimlija b'labra tas-sigurtà
English: If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin value exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%.
Maltese: Jekk ikun hemm żieda fl-emoglobina ta' aktar minn 2 g/dl (1.24 mmol/l) fuq perjodu ta' erba' ġimgħat jew jekk il-livell tal-emoglobina jkun aktar minn 12 g/dl (7.45 mmol/l), id-doża għandha titnaqqas b'25 sa 50%.
English: Not known in cancer patients (frequency cannot be estimated from the available data) - Thromboembolic events, e.g. increase in blood clots.
Maltese: Mhux magħruf f'pazjenti bil-kanċer (ma tistax tittieħed stima mid-data disponibbli) - Episodji tromboemboliċi, eż. żieda fin-numru ta' trombożi.
English: 6 pre-filled syringes containing 1 ml.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 1 siringa mimlija għal-lest ta' 1 ml.
English: It is unlikely to be serious.
Maltese: Probabbli ma tkunx xi ħaġa serja.
English: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 micrograms) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 3,000 unità internazzjonali (IU) (25 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 6,000 IU (50 mikrogrammi) epoetin theta f'kull ml.
English: EU/1/09/565/007 6 pre-filled syringes
Maltese: EU/1/09/565/007 6 siringi mimlija għal-lest
English: Subcutaneous administration
Maltese: TAL-PRODOTT MEDIĊINALI
English: During the studies, mortality was lower in the epoetin theta group (6.9%) compared to placebo (10.3%).
Maltese: Waqt dawn l-istudji, il-mortalita' kienet inqas fil-grupp ta epoetin theta (6.9%)
English: 4 pre-filled syringes containing 1 ml.
Maltese: 4 siringi mimlija għal-lest ta' 1 ml.
English: Biopoin 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml..
Maltese: IU/0.5 ml: Siringa waħda mimlija għal-lest fiha 5,000 unità internazzjonali (IU) (41.7 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 10,000
English: 6 pre-filled syringes with safety needle containing 0.5 ml.
Maltese: 6 siringi mimlija għal-lest ta' 0.5 ml b'labra tas-sigurtà.
English: Biopoin 10,000 IU/1 ml: One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 10,000 unità internazzjonali (IU) (83.3 mikrogrammi) epoetin theta f' 1 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 10,000
English: Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 2,000 international units (IU) (16.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 2,000 unità internazzjonali (IU) (16.7 µg) epoetin theta f'0.5 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 4,000 IU (33.3 µg) epoetin theta f'kull ml.
English: Confirm visually that the needle is fully engaged in the safety shield under the lock (see picture 15).
Maltese: Ikkonferma viżwalment li l-labra tkun daħlet kompletament ġol-protezzjoni tas-sigurtà taħt is sokor (ara stampa 15).
English: 6 pre-filled syringes with safety needle containing 1 ml.
Maltese: 6 siringi mimlija għal-lest ta' 1 ml b'labra tas-sigurtà.
English: Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response.
Maltese: Infezzjonijiet li jitfaċċaw minn żmien għal ieħor, episodji ta' infjammazjoni jew trawma, telf ta' demm okkult, emoliżi, tossiċità severa ta' aluminju, mard ematoloġiku moħbi, jew fibrożi fil-mudullun jistgħu wkoll jikkompromettu r-rispons eritropojetiku.
English: Not known in patients with chronic renal failure (frequency cannot be estimated from the available data) - Cases of a condition called pure red cell aplasia (PRCA) have been reported.
Maltese: Mhux magħruf f'pazjenti b'insuffiċjenza renali kronika (ma tistax tittieħed stima tal-frekwenza mid data disponibbli)
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).
Maltese: Johnson (SJS) u nekrolisi epidermali tossika (TEN), li jistgħu jkunu ta' periklu għall-ħajja jew fatali b'rabta ma' kura b'epoetin (ara s-sezzjoni 4.4).
English: Due to limited experience, the efficacy and safety of epoetin theta could not be assessed in patients with impaired liver function or homozygous sickle cell anaemia.
Maltese: Popolazzjonijiet speċjali Minħabba esperjenza limitata, l-effikaċja u s-sigurtà ta' epoetin theta ma setgħux ikunu evalwati f'pazjenti b'indeboliment fil-funzjoni tal-fwied jew f'pazjenti b'anemija omożigotika tat-tip sickle cell.
English: Check the expiry date on the pre-filled syringe label (EXP).
Maltese: Ehmeż il-labra mas-siringa (ara stampa 3).
English: How to store Biopoin
Maltese: X'fih Biopoin
English: A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment if haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below.
Maltese: Livell sostnut tal-emoglobina ta' aktar minn 12 g/dl (7.45 mmol/l) għandu jiġi evitat; gwida għall-aġġustament xieraq tad-doża meta jiġu osservati valuri tal-emoglobina li jaqbżu 12 g/dl (7.45 mmol/l) hija deskritta aktar il-quddiem.
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 10,000 unità internazzjonali (IU) (83.3 µg) epoetin theta f'1 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 10,000
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl [6.21 mmol/l]).
Maltese: Fi provi kliniċi, riskju ogħla ta' mewt u każijiet kardjovaskulari serji kienu osservati meta ġew mogħtija epoetins sabiex jintlaħaq livell ta' emoglobina li hu ogħla minn 12 g/dl (7.5 mmol/l).
English: EU/1/09/565/009 6 pre-filled syringes
Maltese: EU/1/09/565/009 6 siringi mimlija għal-lest
English: EU/1/09/565/001 6 pre-filled syringes
Maltese: EU/1/09/565/001 6 siringi mimlija għal-lest
English: Remember
Maltese: JIS
English: EU/1/09/565/004
Maltese: EU/1/09/565/003 EU/1/09/565/004
English: In cancer patients receiving chemotherapy, after repeated subcutaneous administration of 20,000 IU epoetin theta once-weekly, the terminal half-life is 29 hours after the first dose and 28 hours in steady state.
Maltese: IU epetin theta, darba fil-ġimgħa, f'pazjenti b'kanċer li kienu qed jirċievu kimoterapija, il-half-life terminali hi 29 siegħa wara l-ewwel doża u 28 siegħa fis-stat fiss.
English: Check again to make sure the correct dose of Biopoin is in the syringe.
Maltese: Erġa iċċekkja li hemm id-doża korretta ta' Biopoin fis-siringa.
English: 6 pre-filled syringes containing 0.5 ml.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest ta' 0.5 ml.
English: In both studies, treatment with epoetin theta resulted in a significant haemoglobin response (p < 0.001), defined as an increase in haemoglobin of ≥ 2 g/dl without transfusion, and a significant reduction in transfusion requirements (p < 0.05) in comparison to placebo.
Maltese: Fiż-żewġ studji, kura b'epoetin theta wassal għal rispons tal-emoglobina sinifikanti(p < 0.001), definit bħala żieda fl-emoglobina ta' ≥ 2 g/dl mingħajr trasfużjoni, u tnaqqis sinifikanti fil-ħtieġa ta' trasfużjonijiet (p < 0.05) meta kkumparat ma' plaċebo.
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided.
Maltese: Żieda fl-emoglobina ta' aktar minn 2g/dl (1.24 mmol/l) fuq perjodu ta' erba' ġimgħat trid tiġi evitata.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Maltese: ma ġew osservati l-ebda sintomi ta' avvelenament.
English: OTHER
Maltese: IV
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 3,000 international units (IU) (25 µg) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 3,000 unità internazzjonali (IU) (25 µg) epoetin theta f'0.5 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 6,000 IU (50 µg) epoetin theta f'kull ml. Biopoin 4,000
English: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 5,000 unità internazzjonali (IU) (41.7 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 10,000
English: EU/1/09/565/005 6 pre-filled syringes
Maltese: EU/1/09/565/005 6 siringi mimlija għal-lest
English: EU/1/09/565/003 6 pre-filled syringes
Maltese: EU/1/09/565/003 6 siringi mimlija għal-lest
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 409 cancer patients receiving chemotherapy were included in two prospective, randomised double-blind, placebo-controlled studies.
Maltese: 409 pazjent b'kanċer li kienu qed jirċievu kimoterapija ġew inklużi f'żewġ studji prospettivi,
English: Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 4,000 international units (IU) (33.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 4,000 unità internazzjonali (IU) (33.3 µg) epoetin theta f'0.5 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 8,000 IU (66.7 µg) epoetin theta f'kull ml. Biopoin 5,000
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: 0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: 1 pre-filled syringe with safety needle containing 1 ml.
Maltese: 1 siringa mimlija għal-lest ta' 1 ml b'labra tas-sigurtà.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Maltese: Biopoin 1,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Pooled post-hoc analyses of clinical studies of epoetins have been performed in chronic renal failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
Maltese: Twettqu analiżijiet post-hoc miġbura ta' studji kliniċi dwar epoetins f'pazjenti b'insuffiċjenza renali kronika (fuq id-dijaliżi, mhux fuq id-dijaliżi, f'pazjenti dijabetiċi u mhux dijabetiċi).
English: ORR (%) p-value p<0.0001
Maltese: ORR (%) Valur p p < 0.0001
English: CLL and WM
Maltese: CLL u WM
English: p<0.005 for OS.
Maltese: p < 0.005 għal OS.
English: Loc. Borgo S. Michele, 04100 Latina,
Maltese: Borgo S. Michele, 04100 Latina,
English: a (CR+PR) P-value
Maltese: a (CR +PR) Valur p
English: • The active substance is ibrutinib.
Maltese: • Is-sustanza attiva hi ibrutinib.
English: Rai stage 0/I/II
Maltese: 0/I/II
English: Overall Response Rate (CR, VGPR, PR, MR)
Maltese: Rata ta' Rispons Totali (CR, VGPR, PR, MR)
English: ciprofloxacin, erythromycin or rifampicin
Maltese: telithromycin, ciprofloxacin, erythromycin jew rifampin
English: Per IRC.
Maltese: Skont IRC.
English: Black iron oxide (E172) Propylene glycol (E1520)
Maltese: Iron oxide iswed (E172) Propylene glycol (E1520)
English: България „Джонсън & Джонсън България” ЕООД Тел.
Maltese: Джонсън България” ЕООД
English: Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4 (CYP3A4).
Maltese: Ibrutinib huwa mmetabolizzat primarjament mill-enzima 3A4 taċ-ċitokroma P450 (CYP3A4).
English: Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Maltese: Qalba tal-pillola Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
English: ECOG per CRF
Maltese: ECOG għal kull CRF
English: • acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
Maltese: • acetyl salicylic acid u mediċini kontra l-infjammazzjoni mhux sterojdi (NSAIDs - non-steroidal anti-inflammatories) bħal ibuprofen jew naproxen
English: All PRs achieved; p<0.0001 for ORR.
Maltese: Il-PRs kollha miksuba; p < 0.0001 għal ORR.
English: Mantle cell lymphoma (MCL)
Maltese: Limfoma taċ-ċellula mantle (MCL)
English: The dihydrodiol metabolite of ibrutinib is a weak inhibitor toward CYP2B6, CYP2C8, CYP2C9, and CYP2D6.
Maltese: Il-metabolit dihydrodiol ta' ibrutinib huwa impeditur għal CYP2B6, CYP2C8, CYP2C9, u CYP2D6.
English: The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 6% (year 1-2), 8% (year 2-3), 9% (year 3-4), and 9% (year 4-5).
Maltese: Il-prevalenza ta' pressjoni għolja ta' Grad 3 jew aktar kien 4% (sena 0-1), 6% (sena 1-2), 8% (sena 2-3), 9% (sena 3-4), u 9% (sena 4-5).
English: 120 capsules
Maltese: 90 kapsula 120 kapsula
English: Date of latest renewal: 25 June 2019
Maltese: Data tal-aħħar tiġdid: 25 ta' Ġunju 2019
English: ≥5 cm
Maltese: ≥ 5 ċm
English: Not known Stevens-Johnson syndrome
Maltese: Mhux magħruf Sindrome ta' Stevens-Johnson
English: Median DOR (CR+PR) (months)
Maltese: Medjan ta' DOR (CR+PR) (xhur)
English: • medicines for depression - nefazodon
Maltese: • mediċini għad-despressjoni - nefazodone
English: ORR was assessed according to the 2008 IWCLL criteria by investigators and IRC.
Maltese: ORR ġie stmat skont il-kriterji IWCLL tal-2008 minn investigaturi u IRC.
English: Final Analysis at 65-month follow-up
Maltese: Analizi finali fil-65 xahar ta' segwitu
English: Ibrutinib is an in vitro inhibitor of P-gp and BCRP (see section 4.5).
Maltese: Ibrutinib huwa inibitur ta' P-gp u BCRP in vitro (ara sezzjoni 4.5).
English: Capsule content Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate (E487)
Maltese: Kontenut tal-kapsula Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate (E487)
English: Involvement of CYP2D6 in the metabolism of ibrutinib appears to be minimal.
Maltese: L-involviment ta' CYP2D6 fil-metaboliżmu ta' ibrutinib jidher li huwa minimu.
English: There are limited data on the effects of IMBRUVICA overdose.
Maltese: Hemm data limitata dwar l-effetti ta' doża eċċessiva ta' IMBRUVICA.
English: Manufacturer Janssen Pharmaceutica NV Turnhoutseweg 30
Maltese: Janssen Pharmaceutica NV Turnhoutseweg 30
English: IMBRUVICA contains sodium
Maltese: IMBRUVICA fih sodium
English: 8.1 months HR=0.215 [95% CI: 0.146; 0.317]
Maltese: 8.1 xhur HR = 0.215 [95% CI: 0.146; 0.317]
English: • Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see section 2 “IMBRUVICA contains lactose”), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).
Maltese: • Qalba tal-pillola: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, (ara sezzjoni 2 “IMBRUVICA fih lactose”), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).
English: The first dose of obinutuzumab was divided between day 1 (100 mg) and day 2 (900 mg).
Maltese: Lewwel doża ta' obinutuzumab inqasmet bejn jum 1 (100 mg) u jum 2 (900 mg).
English: IMBRUVICA contains lactose (a type of sugar).
Maltese: IMBRUVICA fih lactose (tip ta' zokkor).
English: Monitor patients for pulmonary symptoms indicative of ILD.
Maltese: Immonitorja l-pazjenti għal sintomi fil-pulmuni li jindikaw ILD.
English: Intolerance to excipients
Maltese: Intolleranza għall-eċċipjenti
English: The apparent volume of distribution at steady state (Vd, ss/F) was approximately 10,000 L.
Maltese: Il-volum apparenti ta' distribuzzjoni fl-istat fiss (Vd, ss/F) kien madwar 10,000 L.
English: Placebo+R N=75
Maltese: Plaċebo+R N=75
English: The overall response rate per IRC observed in the monotherapy arm was 87% (0% CR, 29% VGPR, 42% PR, 16% MR).
Maltese: Ir-rata ta' rispons totali skont l-IRC osservata fil-grupp ta' monoterapija kienet 87% (0% CR, 29% VGPR, 42% PR, 16% MR).
English: ORR including PR with lymphocytosis d (%)
Maltese: ORR inkluż PR b'limfoċitosi
English: The median number of prior treatments was 4 (range, 1 to 7 treatments).
Maltese: In-numru medjan ta' trattamenti preċedenti kien ta' 4 (firxa, trattament 1 sa 7 trattamenti).
English: • medicines for HIV infection - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,
Maltese: • mediċini għal infezzjonijiet bl-HIV - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir,
English: Placebo+BR N=289
Maltese: Plaċebo + BR N = 289
English: Ibrutinib exposure increases with doses up to 840 mg.
Maltese: L-esponiment għal ibrutinib jiżdied b'dożi sa 840 mg.
English: The dihydrodiol metabolite and other metabolites are P-gp substrates.
Maltese: Il-metabolit dihydrodiol u metaboliti oħra huma sustrati ta' P-gp.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE27.
Maltese: Sustanzi antineoplastiċi, impedituri tal-proteina kinase, Kodiċi ATC:
English: The steady state AUC observed in patients at 560 mg is (mean ± standard deviation) 953 ± 705 ng h/mL.
Maltese: LAUC fl-istat fiss osservata f'pazjenti b'doża ta' 560 mg hija (medja ± devjazzjoni standard) 953 ± 705 ng siegħa/mL.
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Maltese: Figura 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
English: The BCR pathway is implicated in the pathogenesis of several B-cell malignancies, including MCL, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and CLL.
Maltese: Ir-rotta BCR hija implikata fil-patoġenesi ta' diversi tumuri malinni taċ-ċellula-B, inkluż MCL, limfoma taċ-ċellula B kbira mifruxa (DLBCLdiffuse large B-cell lymphoma), limfoma follikulari, u CLL.
English: PFS Median PFS (95% CI), (months)
Maltese: PFS PFS medjana (95% CI), (xhur)