FrancophonIA/ELRC3.0 huggingface dataset:
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe EU/1/07/432/007
Maltese: Silapo 4 000 IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/007
English: if you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Maltese: jekk tkun ser tagħmel operazzjoni ortopedika maġġuri mhux obbligatorja (bħal operazzjoni talġenbejn jew tal-irkoppa), u inti:
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe EU/1/07/432/005
Maltese: Silapo 3 000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/005
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.8 ml soluzzjoni għall-injezzjoni għandha 8 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Adult surgery patients in an autologous predonation programme.
Maltese: Pazjenti adulti li kellhom il-kirurġija f'programm ta' pre-donazzjoni awtologa
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: Kien hemm rapporti ta' reazzjonijiet avversi serji tal-ġilda (SCARs) fosthom is-sindrome ta' StevensJohnson (SJS) u nekroliżi epidermali tossika (TEN), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' kura b'epoetini (ara s-sezzjoni 4.4).
English: These include: iron, folate, or Vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
Maltese: B12; intossikazzjoni bl-aluminju; infezzjonijiet interkurrenti; episodji ta' infjammazzjoni jew trawmatiċi; telf ta' demm moħbi; emolisi, fibrożi tal-muddullun ta' kwalunkwe oriġini.
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/432/015
Maltese: Silapo 10 000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/015
English: Phlebotomy may be performed if excessively high haemoglobin levels occur.
Maltese: Il-flebotomija tista' issir jekk ikun hemm livelli għoljin tal-emoglobina.
English: Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Maltese: b'kunsiderazzjoni għal medda mmirata għall-emoglobina ta' bejn 10 g/dl (6.2 mmol/l) sa 12 g/dl (7.5 mmol/l)
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: Silapo 40 000 IU/1 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: Treatment of adult patients with low- or intermediate-1-risk MDS
Maltese: Trattament ta' pazjenti adulti b'MDS b'riskju baxx- jew intermedju-1
English: Silapo should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl (6.2 mmol/l).
Maltese: Silapo jista' jingħata taħt il-ġilda lil pazjenti b'anemija (eż. konċentrazzjoni tal-emoglobina ≤ 10 g/dl (6.2 mmol/l).
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Silapo 4 000 IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.4 ml soluzzjoni għall-injezzjoni fiha 4 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: IU/0.75 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.75 ml soluzzjoni għall-injezzjoni fiha 30 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: • Fits
Maltese: Fax:
English: Measurement of erythropoietin following multiple dose intravenous administration revealed a half-life of approximately 4 hours in healthy volunteers and a somewhat more prolonged half-life of approximately 5 hours in renal failure patients.
Maltese: Il-kejl ta' l- eritropojetin wara dożi multipli amministrati ġol-vini juru half-life ta' bejn wieħed u ieħor 4 sigħat f'voluntiera b'saħħithom u half-life kemm xejn aktar twila f'pazjenti b'insuffiċjenza renali, ta' bejn wieħed u ieħor 5 sigħat.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/432/013
Maltese: IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/013
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%) individwu mingħajr trasfużjonijiet preċedenti wrew reazzjoni għall-eritrojdi matul l-ewwel 24 ġimgħa, meta mqabbla ma' 7/31 (22.6%) individwu bi trasfużjonijiet preċedenti (żewġ individwi bi trasfużjoni preċedenti laħqu punt aħħari primarju bbażat fuq it-tnaqqis tal-unitajiet ta' RBC trasfużi minn numru assolut ta' mill-inqas 4 unitajiet kull 8 ġimgħat meta mqabbla mat-8 ġimgħat qabel il-linja bażika).
English: Patients scheduled for major elective orthopaedic surgery should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease.
Maltese: Pazjenti skedati għal operazzjoni ortopedika maġġuri mhux obbligatorja għandhom jirċievu profilassi antitrombotika adegwata, għax avvenimenti trombotiċi u vaskulari jistgħu jseħħu f'pazjenti kirurġiċi, speċjalment f'dawk b'mard kardjovaskulari diġà eżistenti.
English: Pyrexia
Maltese: • Rimettar
English: Silapo should be withheld when the haemoglobin concentration exceeds 12 g/dl (7.5 mmol/l).
Maltese: Silapo għandu jitrażżan meta l-konċentrazzjoni tal-emoglobina taqbeż 12 g/dl (7.5 mmol/l).
English: Excipient with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.30 mg phenylalanine.
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: Silapo 10 000 IU/1 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: After administration of erythropoietin, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the
Maltese: Wara l-amministrazzjoni tal-eritropojetin, in-numru tal-eritroċiti, il-valuri tal-Hb u l-għadd ta' retikuloċiti jiżdiedu, wkoll bħar-rata inkorporata tal
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Silapo 40 000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'1 ml soluzzjoni għall-injezzjoni fiha 40 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Silapo 3 000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.9 ml soluzzjoni għall-injezzjoni fiha 3 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: The injections can then be given by a doctor, trained nurse or other health care professional.
Maltese: L-injezzjonijiet b'Silapo jistgħu imbagħad jingħataw minn tabib, infermiera mħarrġa jew professjonist ieħor.
English: Excipient with known effect Each pre-filled syringe contains 0.25 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.25 mg phenylalanine.
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: Silapo 4 000 IU/0.4 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: Epoetin alfa
Maltese: Kriżi ipertensiva
English: The maximum dosage should not exceed 150 IU/kg 3 times per week, 240 IU/kg (up to a maximum of 20 000 IU) once weekly or 480 IU/kg (up to a maximum of 40 000 IU) once every 2 weeks.
Maltese: IU) darba fil-ġimgħa jew 480 IU/kg (sa massimu ta' 40 000 IU) darba kull ġimagħtejn.
English: Use in adult patients with myelodysplastic syndrome
Maltese: L-użu f'pazjenti adulti b'sindrome majelodisplastika
English: Excipient with known effect Each pre-filled syringe contains 0.45 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.45 mg phenylalanine.
English: Serum electrolytes should be monitored in chronic renal failure patients.
Maltese: L-elettroliti fis-serum għandhom jiġu mmoniterjati f'pazjenti b' insuffiċjenza renali kronika.
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.75 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.75 ml soluzzjoni għall-injezzjoni għandha 30 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/432/011
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/011
English: Hypertension, Venous and arterial thromboses
Maltese: Pressjoni għolja, Trombożi fl-arterji u fil-vini
English: Serum electrolytes (substances in your blood) should be monitored in chronic renal failure patients.
Maltese: L-elettroliti fis-serum (sustanzi f'demmek) għandhom jiġu osservati f'pazjenti b' insuffiċjenza renali kronika.
English: Cases of antibody-mediated PRCA have been very rarely reported in chronic renal failure patients with erythropoietin administered by the subcutaneous route.
Maltese: Każijiet ta' PRCA ġejjin minn antikorpi huma rari ħafna f'pazjenti b' insuffiċjenza renali kronika bl-erythropojetin amministrat minn taħt il-ġilda.
English: • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l),
Maltese: • tnaqqis fis-sopravivenza globali u żieda fl-imwiet attribwiti għal firxa tal-marda fi żmien 4 xhur f'pazjenti b'kanċer metastatiku tas-sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta' emoglobina ta' 12-14 g/dl (7.5 - 8.7 mmol/l),
English: The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Maltese: IU/kg) fuq l-esponiment għal trasfużjoni ta' demm alloġeniku, ġie evalwat fi prova klinika double-blind, ikkontrollata bi plaċebo, li saret fuq pazjenti adulti li ma kellhomx defiċjenza ta' ħadid, skedati għal operazzjoni maġġuri elettiva tal-ġenbejn jew tal-irkoppa.
English: In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Maltese: Fl-indikazzjoni "żieda fil-ġabra ta' demm awtologiku": infart mijokardjali jew puplesija fix-xahar ta' qabel jibda' it-trattament, anġina pectoris instabbli, żieda fir-risku ta' trombosi fil-vini profondi bħal ma hija storja personali ta' mard tromboemboliku venuż.
English: The safety and efficacy of epoetin zeta in paediatrics have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' epoetin zeta f'pazjenti pedjatriċi ma ġewx determinati s'issa.
English: • High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).
Maltese: • Livelli għolja ta' potassju fid-demm li jista' jikkaġuna ritmu abnormali tal-qalb (dan hu effett sekondarju komuni ħafna f'pazjenti fuq dijalisi).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: Silapo 1 000 IU/0.3 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: • Severe allergic reaction that may include: o a swollen face, lips, mouth, tongue or throat o difficulty swallowing or breathing o itchy rash (hives)
Maltese: • Reazzjoni allerġika severa li tista' tinkludi: o wiċċ, xofftejn, ħlaq, ilsien jew griżmejn minfuħin o diffikultà biex tibla' jew tieħu n-nifs o raxx bil-ħakk (ħorrieqija)
English: If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin has increased ≥ 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40 000 cells/µl the dose should remain at 300 IU/kg 3 times per week.
Maltese: Jekk wara 4 ġimgħat oħra ta' terapija ta' 300 IU/kg 3 darbiet fil-ġimgħa, l-emoglobina żdiedet ≥ 1 g/dl (0.62 mmol/l) jew l-għadd tar-retikoloċiti żdied ≥ 40 000 ċellula/µl id-doża għanda tibqa' ta' 300
English: Baseline Characteristics for Subjects with sEPO<200 mU/ml at Screening Randomised
Maltese: Karatteristiċi tal-linja bażika għas-Suġġetti b' sEPO <200 mU/ml fl-Iskrinjar Parteċipanti magħżula b'mod każwali Epoetin alfa
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/432/009
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/009
English: Excipient with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.40 mg phenylalanine.
English: Hamster Ovary (CHO) cell line).
Maltese: fil-linja taċ-ċellula fil-CHO).
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Silapo 4 000 IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.4 ml soluzzjoni għall-injezzjoni għandha 4 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: In controlled clinical studies, use of epoetin alfa and other ESAs have shown:
Maltese: Jekk qed tirċievi emodijalisi:
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.5 ml soluzzjoni għall-injezzjoni fiha 5 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.5 ml soluzzjoni għall-injezzjoni fiha 20 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.6 ml soluzzjoni għall-injezzjoni fiha 6 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Maintenance phase: Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Maltese: Hb bejn l-10 u t-12 g/dl (6.2-7.5 mmol/l).
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: Silapo 3 000 IU/0.9 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Silapo 10 000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'1 ml soluzzjoni għall-injezzjoni fiha 10 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Common in dialysis
Maltese: Komuni fid-dijalisi
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Silapo 40 000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'1 ml soluzzjoni għall-injezzjoni għandha 40 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Excipient with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.50 mg phenylalanine.
English: If the haemoglobin increase is < 1 g/dl (< 0.62 mmol/l) and the reticulocyte count has increased < 40 000 cells/µl above baseline, increase the dose to 300 IU/kg 3 times per week.
Maltese: 62 mmol/l) u l-għadd tar-retikoloċiti żdied < 40 000 ċellula/µl 'il fuq mil-inja bażi, żid id-doża għal 300 IU/kg 3 darbiet fil-ġimgħa.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe EU/1/07/432/018
Maltese: IU/0.75 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/018
English: These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Maltese: Dawn ir-rapporti huma bbażati fuq sejbiet in vitro minn kampjuni ta' tumur uman, iżda huma ta' sinjifikanza mhix ċerta fis-sitwazzjoni klinika.
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Silapo 3 000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.9 ml soluzzjoni għall-injezzjoni għandha 3 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
Maltese: Għandha tingħata attenzjoni għal uġigħ ta' ras qawwi f'daqqa li jixbah lillemigranja, bħala sinjal possibbli ta' twissija.
English: Pure red cell aplasia Thrombocythemia
Maltese: Is-siringa hija issa lesta biex tintuża.
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.3 ml soluzzjoni għall-injezzjoni fiha 1 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
Maltese: Jista' jkun hemm żieda moderata, li tiddependi mid-doża, fl-għadd tal-plejtlits fil-limiti normali matul it-trattament bl-eritropojetin.
English: Erythroid response was defined according to International Working Group (IWG) 2006 criteria as a haemoglobin increase ≥1.5 g/dl from baseline or a 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, and a response duration of at least 8 weeks.
Maltese: Ir-reazzjoni għall-eritrojdi kienet definita skont il-kriterji tal-Grupp ta' Ħidma Internazzjonali (IWG) 2006 bħala żieda fl-emoglobina ≥1.5 g/dl mil-linja bażika jew tnaqqis tal-unitajiet RBC trasfużi minn numru assolut ta' mill-inqas 4 unitajiet kull 8 ġimgħat meta mqabbla mat-8 ġimgħat ta' qabel il-linja bażika, u tul ta' reazzjoni ta' mill-inqas 8 ġimgħat.
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.
Maltese: Kien hemm rapporti ta' reazzjonijiet avversi serji tal-ġilda (SCARs) fosthom is-sindrome ta' StevensJohnson (SJS) u nekroliżi epidermali tossika (TEN), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' kura b'epoetini.
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: IU/0.75 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Silapo is used to provide adequate control of the symptoms of anaemiawhilst maintaininga haemoglobin concentrationbelowor at 12g/dl(7.5mmol/l).
Maltese: Pazjenti għandhom jiġu mmonitorati mill-qrib sabiex jiġi żgurat li tingħata biss l-anqas doża effettiva approvata ta' Silapo sabiex ikun hemm kontroll adegwat għas-sintomi ta' l-anemija filwaqt li lkonċentrazzjoni tal-emoglobina tinżamm taħt jew sa 12g/dl (7.5 mmol/l).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.6 ml soluzzjoni għall-injezzjoni għandha 6 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: In patients with chronic renal failure and clinically evident ischaemic heart disease or congestive heart failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration.
Maltese: F'pazjenti b'nuqqas renali kroniku u l-mard tal-qalb iskematiku kliniku jew insuffiċjenza kongestiva fil-qalb, iż-żamma tal-livell tal-emoglobona m'għandhiex taqbeż il-limitu ta' fuq tal-mira tal-koncentrazzjoni tal-emoglobina.
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see sections 4.2 and 4.4).
Maltese: Kienet osservata tendenza li jiżdiedu l-estimi ta' riskju għal kwalunkwe kawża ta' mewt, episodji kardjovaskulari u ċerebrovaskulari assoċjati ma' dożi għoljin ta' ESA komulattivi indipendenti middijabete jew il-qagħda tad-dijaliżi (ara sezzjonijiet 4.2 u 4.4).