FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to progression (TTP) based on investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210).
Maltese: Iż-żmien medjan għall-progressjoni (TTP, time to progression) ibbażat fuq il-marda progressiva (PD, progressive disease) iddeterminata mill investigatur kien ta' 7.5 xhur fil-grupp ta' epoetin alfa flimkien ma' SOC u ta' 7.5 xhur fil-grupp ta' SOC (HR 1.099, CI 95%: 0.998, 1.210).
English: Other medicines and Binocrit
Maltese: Mediċini oħra u Binocrit
English: What Binocrit contains - The active substance is: epoetin alfa (for quantity see the table below).
Maltese: Is-sustanza attiva hi: epoetin alfa (għall-kwantità ara t-tabella hawn taħt).
English: The mean volume of distribution was 49.3 mL/kg after intravenous doses of 50 and 100 IU/kg in healthy subjects.
Maltese: Il-volum medju tad-distribuzzjoni kien ta' 49.3 mL/g wara dożi ġol-vini ta' 50 u 100 IU/kg f'individwi b'saħħithom.
English: Patients treated with epoetin alfa were also able to predeposit significantly more units of blood (epoetin alfa 300 IU/kg = 4.4 units; epoetin alfa 600 IU/kg = 4.7 units) than placebo-treated patients (2.9 units).
Maltese: Il-pazjenti kkurati b'epoetin alfa kienu wkoll kapaċi jagħmlu predepożitu ta' ferm aktar unitajiet ta' demm (epoetin alfa 300 IU/kg = 4.4 unitajiet; epoetin alfa 600
English: Binocrit is not approved in the management of anaemia associated with hepatitis C.
Maltese: Binocrit mhuwiex approvat fl-immaniġġjar ta' anemija marbuta ma' epatite Ċ.
English: Binocrit is a biosimilar medicinal product.
Maltese: Binocrit hu prodott mediċinali bijosimili.
English: Moreover, in patients with a baseline haemoglobin of > 13 g/dL (> 8.1 mmol/L), the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Maltese: f'pazjenti b'emoglobina fil-linja bażi ta' > 13 g/dL (> 8.1 mmol/L), il-possibbiltà li l-kura b'epoetin alfa tista' tiġi assoċjata ma' riskju miżjud ta' avvenimenti trombotiċi /avvenimenti vaskulari, ta' wara l-operazzjoni, ma tistax tiġi eskluża.
English: Randomised
Maltese: Pożoloġija
English: A pre-filled syringe of 0.6 mL contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 0.6 mL fiha 6,000 unità internazzjonali (IU) li jikkorrispondu għal 50.4 mikrogrammi ta' epoetin alfa.
English: - in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
Maltese: (CRF): - f'adulti u fi tfal li jkollhom minn sena sa 18-il sena fuq l-emodijalisi u f'pazjenti adulti fuq dijalisi peritonali (ara sezzjoni 4.4).
English: Do not shake Binocrit syringes.
Maltese: Ħu doża waħda biss ta' Binocrit minn kull siringa.
English: In patients with a poor haemoglobin response to Binocrit, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Maltese: F'pazjenti b'rispons batut tal-emoglobina għal Binocrit, għandhom jiġu kkunsidrati spegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.4 u 5.1).
English: 1 pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 1 mL fiha 2,000 unità internazzjonali (IU) li jikkorrispondu għal 16.8 mikrogrammi ta' epoetin alfa.
English: INFORMATION IN BRAILLE Binocrit 8,000 IU/0.8 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 8,000
English: Do not administer Binocrit by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Maltese: Tagħtix Binocrit permezz ta' infużjoni ġol-vini jew flimkien ma' soluzzjonijiet oħrajn ta' prodotti mediċinali (jekk jogħġbok irreferi għal sezzjoni 6.6 għal informazzjoni addizzjonali).
English: How to use Binocrit
Maltese: Binocrit.
English: If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute Binocrit therapy at a dose 25% below the previous dose.
Maltese: Jekk l-emoglobina taqbeż 13 g/dL (8.1 mmol/L), waqqaf it-terapija sakemm il-livell jinżel taħt 12 g/dL (7.5 mmol/L), u mbagħad erġa' ibda t-terapija b'Binocrit f'doża li tkun 25% taħt id-doża ta' qabel.
English: INFORMATION IN BRAILLE Binocrit 9,000 IU/0.9 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 9,000
English: • unusual tiredness,
Maltese: • Reazzjoni allerġika severa tista' tinkludi:
English: Binocrit is used to treat symptomatic anaemia caused by kidney disease:
Maltese: Binocrit huwa indikat fit-trattament tal-anemija sintomatika (konċentrazzjoni ta' emoglobina ta'
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq issit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: INFORMATION IN BRAILLE Binocrit 7,000 IU/0.7 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 7,000
English: Binocrit is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Maltese: Binocrit huwa indikat għall-kura ta' anemija sintomatika assoċjata ma' insuffiċjenza renali kronika
English: INFORMATION IN BRAILLE Binocrit 6,000 IU/0.6 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 6,000
English: If Binocrit is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Maltese: Jekk Binocrit jiġi injettat taħt il-ġilda (b'mod subkutaneju), l-ammont injettat fi kwalunkwe post normalment ma jkunx iktar minn millilitru (1 mL) f'injezzjoni waħda.
English: Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe
Maltese: Binocrit 8,000 IU/0.8 mL injezzjoni Epoetin alfa
English: Binocrit is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Maltese: limfoma malinna jew majeloma multipla, u li jkunu f'riskju ta' trasfużjoni kif evalwat mill-istat ġenerali tal-pazjent (eż. status kardjovaskulari, anemija diġà eżistenti fil-bidu tal-kimoterapija) għal kura ta' anemija u tnaqqis tal-ħtiġijiet ta' trasfużjoni.
English: Adult patients with low- or intermediate-1-risk MDS
Maltese: Pazjenti adulti b'riskju baxx jew intermedju 1 ta' MDS
English: Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled syringe
Maltese: Binocrit 7,000 IU/0.7 mL injezzjoni Epoetin alfa
English: INFORMATION IN BRAILLE Binocrit 5,000 IU/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 5,000
English: Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe
Maltese: Binocrit 3,000 IU/0.3 mL injezzjoni Epoetin alfa
English: Store and transport refrigerated (2°C-8°C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2°C sa 8°C).
English: Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each syringe contains 0.8 mL of solution for injection.
Maltese: Binocrit 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.8 mL ta' soluzzjoni għall-injezzjoni.
English: Epoetin alfa is not approved in the management of anaemia associated with hepatitis C.
Maltese: Epoetin alfa mhuwiex approvat għall-immaniġġjar ta' anemija marbuta ma'
English: Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per mL
Maltese: Binocrit 40,000 IU/1 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull mL ta' soluzzjoni fih 40,000 IU ta' epoetin alfa* li jikkorrispondu għal 336.0 mikrogrammi f'kull mL
English: Tell your doctor or nurse immediately if you think too much Binocrit has been injected.
Maltese: Għid lit-tabib jew lill-infermier tiegħek immedjatament jekk taħseb li ġie injettat iżżejjed Binocrit.
English: Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Each syringe contains 0.7 mL of solution for injection.
Maltese: Binocrit 7,000 IU/0.7 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.7 mL ta' soluzzjoni għall-injezzjoni.
English: Binocrit should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Maltese: Binocrit għandu jingħata sabiex iżid l-emoglobina għal livell ta' mhux iktar minn 11 g/dL (6.8 mmol/L).
English: Following subcutaneous injection, serum levels of epoetin alfa reach a peak between 12 and 18 hours post-dose.
Maltese: Wara injezzjoni taħt il-ġilda, il-livelli ta' epoetin alfa fis-serum jilħqu l-massimu bejn 12 u 18-il siegħa wara d-doża.
English: Binocrit may be given by injection:
Maltese: Binocrit jista' jingħata permezz ta' injezzjoni:
English: In that stratum, 20/40 (50%) subjects without prior transfusions demonstrated erythroid response during the first 24 weeks, compared with 7/31 (22.6%) subjects with prior transfusions (two subjects with prior transfusion reached primary endpoint based on reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline).
Maltese: F'dak l-istrat 20/40 (50%) tal-individwi mingħajr trasfużjonijiet preċedenti wrew rispons tal-eritojde matul l-ewwel 24 ġimgħa, meta mqabbel ma' 7/31 (22.6%) tal-individwi bi trasfużjonijiet preċedenti (żewġ individwi bi trasfużjonijiet preċedenti laħqu l-punt ta' tmiem primarju abbażi ta' tnaqqis talunitajiet RBC trasfużi b'numru assolut ta' mill-inqas 4 unitajiet kull 8 ġimgħat meta mqabbel mat
English: Key baseline characteristics for the < 200 mU/mL stratum are shown in the table below.
Maltese: Il-karatteristiċi fil-linja bażi għall-istrat ta' < 200 mU/mL jintwerew fit-tabella t'hawn taħt.
English: • If you do not respond adequately to Binocrit, your doctor will check your dose and will inform you if you need to change doses of Binocrit.
Maltese: • ma tistax tieħu mediċini li jraqqu d-demm Binocrit jista' ma jkunx adattat għalik.
English: The therapeutic margin of epoetin alfa is very wide.
Maltese: Il-marġini terapewtiku ta' epoetin alfa huwa wiesa' ħafna.
English: In paediatric patients the recommended haemoglobin concentration range is between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Maltese: 11 g/dL (5.9 sa 6.8 mmol/L).
English: The recommended starting dose is Binocrit 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Maltese: Id-doża tal-bidu rakkomandata hija ta' Binocrit 450 IU/kg (id-doża totali massima hija ta' 40,000 IU)
English: Package leaflet: Information for the patient Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Binocrit 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Binocrit 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Binocrit 10,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: - sopravivenza totali mqassra u żieda fl-imwiet attribwiti għall-progressjoni tal-marda wara 4 xhur f'pazjenti b'kanċer metastatiku tas-sider li jkunu qed jirċievu kimoterapija meta jingħata biex jinkiseb livell ta' konċentrazzjoni ta' emoglobina ta' 12 sa14 g/dL (7.5 sa 8.7 mmol/L), - żieda fir-riskju ta' mewt meta jingħata biex jinkiseb livell ta' konċentrazzjoni ta' emoglobina ta'
English: INFORMATION IN BRAILLE Binocrit 4,000 IU/0.4 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 4,000
English: Binocrit contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: EU/1/07/410/005 EU/1/07/410/006 EU/1/07/410/031 EU/1/07/410/032
Maltese: EU/1/07/410/006 EU/1/07/410/031 EU/1/07/410/032
English: INFORMATION IN BRAILLE Binocrit 10,000 IU/1 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 10,000
English: INFORMATION IN BRAILLE Binocrit 3,000 IU/0.3 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 3,000
English: Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Binocrit 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Binocrit 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Binocrit 10,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: IU/0.6 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Binocrit 7,000 IU/0.7 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Binocrit 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Binocrit 9,000
English: INFORMATION IN BRAILLE Binocrit 20,000 IU/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 20,000
English: INFORMATION IN BRAILLE Binocrit 40,000 IU/1 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 40,000
English: Baseline Characteristics for Subjects with sEPO < 200 mU/mL at Screening
Maltese: Karatteristiċi fil-Linja Bażi għall-Pazjenti b'sEPO < 200 mU/mL fl-Eżami Randomised
English: Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Maltese: [Hb] bejn 10 u 13 g/dL [6.2 u 8.1 mmol/L], li m'għandhomx defiċjenza ta' ħadid), jekk il-proċeduri li jiffrankaw id-demm ma jkunux disponibbli jew ikunu insuffiċjenti meta operazzjoni skedata maġġuri tkun teħtieġ volum kbir ta' demm (4 jew iktar unitajiet ta' demm għan-nisa jew 5 jew iktar unitajiet għall-irġiel).
English: Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe
Maltese: Binocrit 1,000 IU/0.5 mL injezzjoni Epoetin alfa
English: Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: Binocrit 40,000 IU/1 mL injezzjoni Epoetin alfa
English: For patients on peritoneal dialysis Binocrit may be given twice a week.
Maltese: Għal pazjenti fuq dijalisi peritoneali, Binocrit jista' jingħata darbtejn fil-ġimgħa.
English: EU/1/07/410/015 EU/1/07/410/016 EU/1/07/410/045 EU/1/07/410/046
Maltese: EU/1/07/410/016 EU/1/07/410/045
English: INFORMATION IN BRAILLE Binocrit 2,000 IU/1 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 2,000
English: 1 pre-filled syringe of 0.5 mL 6 pre-filled syringes of 0.5 mL 1 pre-filled syringe of 0.5 mL with a needle safety guard 6 pre-filled syringes of 0.5 mL with a needle safety guard
Maltese: Siringa mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.5 mL bi protezzjoni tas-sigurtà tal-labra
English: 1 pre-filled syringe of 0.5 mL contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest ta' 0.5 mL fiha 20,000 unità internazzjonali (IU) li jikkorrispondu għal 168.0 mikrogrammi ta' epoetin alfa.
English: How to store Binocrit
Maltese: X'fih Binocrit
English: Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Binocrit 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.3 mL ta' soluzzjoni għall-injezzjoni.
English: Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: Binocrit 2,000 IU/1 mL injezzjoni Epoetin alfa
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Maltese: Sintomi ta' anemija u l-konsegwenzi tagħha jistgħu jvarjaw skont l-età, is-sess, u l-gravità totali tal marda; hemm bżonn ta' evalwazzjoni ta' tabib tal-kors kliniku u tal-kundizzjoni tal-pazjent individwali.
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Binocrit 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Maltese: Kura ta' pazjenti kirurġiċi adulti fi programm ta' predonazzjoni awtologa Pazjenti li għandhom anemija ħafifa (ematokrit ta' 33 sa 39%) li jeħtieġu predepożitu ta' ≥ 4 unitajiet ta' demm, għandhom jiġu kkurati b'Binocrit b'doża ta' 600
English: Side effects from an overdose of Binocrit are unlikely.
Maltese: Effetti sekondarji minn doża eċċessiva ta' Binocrit mhumiex mistennija.
English: Binocrit is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
Maltese: ≤ 10 g/dL) f'adulti b'riskju baxx jew intermedju 1 ta' sindromi majelodisplastiċi primarji (MDS,
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin levels within the desired concentration range between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Maltese: Għandu jsir aġġustament xieraq fid-dożaġġ sabiex il-livelli tal-emoglobina jinżammu fil-medda tal konċentrazzjoni mixtieqa bejn 9.5 g/dL u 11 g/dL (5.9 sa 6.8 mmol/L).
English: Amount of epoetin alfa
Maltese: IU/1 mL injezzjoni Epoetin alfa
English: Epoetin alfa was administered at 75 IU/kg/week intravenously in 2 or 3 divided doses post-dialysis, titrated by 75 IU/kg/week at intervals of 4 weeks (up to a maximum of 300 IU/kg/week), to achieve a 1 g/dL/month increase in haemoglobin.
Maltese: Epoetin alfa ngħata f'doża ta' 75 IU/kg/ġimgħa ġol-vini fi 2 jew 3 dożi maqsuma wara d-dijalisi, ittitrat b'75 IU/kg/ġimgħa f'intervalli ta' 4 ġimgħat (sa massimu ta' 300
English: INFORMATION IN BRAILLE Binocrit 1,000 IU/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 1,000
English: Phlebotomy may be performed if excessively high haemoglobin levels occur.
Maltese: Tista' titwettaq flebotomija jekk iseħħu livelli għoljin iżżejjed ta' emoglobina.
English: • Hives.
Maltese: MDS.
English: - Uncontrolled hypertension.
Maltese: - Pressjoni għolja mhux ikkontrollata.
English: All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
Maltese: Il-kawżi l-oħrajn kollha ta' anemija (defiċjenza ta' ħadid, folate jew ta' vitamina B12, avvelenament bl aluminju, infezzjoni jew infjammazzjoni, telf ta' demm, emolisi u fibrożi tal-mudullun ta' kwalunkwe oriġini) għandhom jiġu kkunsidrati u kkurati qabel ma tinbeda t-terapija b'epoetin alfa, u meta tiddeċiedi biex iżżid id-doża.
English: • Only use Binocrit if it has been stored correctly - see section 5, How to store Binocrit.
Maltese: • Uża Binocrit biss jekk ikun inħażen b'mod korrett - ara sezzjoni 5, Kif taħżen Binocrit.
English: Binocrit is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion.
Maltese: Binocrit jintuża biex tiġi kkurata anemija f'adulti li jkunu qed jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla (kanċer tal-mudullun) li jista' jkollhom bżonn ta' trasfużjoni tad-demm.
English: If the haemoglobin is rising by more than 2 g/dL (1.25 mmol/L) per month, or if the sustained haemoglobin exceeds 12 g/dL (7.5 mmol/L) reduce the Binocrit dose by 25%.
Maltese: Jekk lemoglobina tkun qed tiżdied b'iktar minn 2 g/dL (1.25 mmol/L) kull xahar, jew jekk il-livell sostnut ta' emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Binocrit b'25%.
English: EU/1/07/410/013 EU/1/07/410/014 EU/1/07/410/041 EU/1/07/410/042
Maltese: EU/1/07/410/021 EU/1/07/410/022 EU/1/07/410/047
English: INFORMATION IN BRAILLE Binocrit 30,000 IU/0.75 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Binocrit 30,000
English: In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40,000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Maltese: Il-pressjoni tad-demm, fil-pazjenti kollha li jkunu qegħdin jirċievu epoetin alfa, għandha tiġi mmonitorjata mill-qrib u kkontrollata kif meħtieġ.
English: Binocrit is prescribed to stimulate your bone marrow to produce more red blood cells.
Maltese: Binocrit huwa prodott sterili iżda mhux ippreservat u jintuża darba biss.
English: If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Binocrit dose by about 25 to 50%.
Maltese: Jekk il-konċentrazzjoni tal-emoglobina tkun qed tiżdied b'iktar minn 2 g/dL (1.25 mmol/L) kull xahar, jew jekk il-livell tal-konċentrazzjoni tal-emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Binocrit b'madwar 25 sa 50%.
English: Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe Each syringe contains 1 mL of solution for injection.
Maltese: Binocrit 2,000 IU/1 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 1 mL ta' soluzzjoni għall-injezzjoni.
English: Each graduation ring corresponds to a volume of 0.1 mL.
Maltese: Kull ċirku ggradat jikkorrispondi għal volum ta' 0.1 mL.
English: Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Binocrit 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: The desired haemoglobin concentration range was 9.6 to 11.2 g/dL.
Maltese: 9.6 sa 11.2 g/dL.
English: 1 pre-filled syringe of 1 mL contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa.
Maltese: Siringa mimlija għal-lest ta' 1 mL fiha 10,000 unità internazzjonali (IU) li jikkorrispondu għal 84.
English: If the haemoglobin level reaches 15 g/dL (9.38 mmol/L), or higher, during the preoperative period, administration of Binocrit should be stopped and further dosages should not be administered.
Maltese: Jekk il-livell tal-emoglobina jilħaq il-15 g/dL (9.38 mmol/L), jew ogħla, matul il-perjodu ta' qabel l operazzjoni, l-għoti ta' Binocrit għandu jitwaqqaf u ma għandhomx jingħataw aktar dożaġġi.