FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, an increased risk of death and serious cardiovascular events was observed when ESAs were administered to achieve a haemoglobin concentration level of greater than 12 g/dL (7.5 mmol/L).
Maltese: Fil-provi kliniċi, ġie osservat riskju miżjud ta' mewt u avvenimenti kardjovaskulari serji meta l-ESAs ingħataw biex jinkiseb livell ta' konċentrazzjoni tal-emoglobina ta' aktar minn 12 g/dL (7.5 mmol/L).
English: Excipients with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.40 mg phenylalanine.
English: • Place the plastic catcher of the needle-trap against a hard, stable surface and with one hand pivot the syringe barrel upward against the needle forcing the needle into the catcher where it locks in place (an audible 'click” is heard when the needle is locked in the catcher).
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: Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/431/011 1 pre-filled syringe EU/1/07/431/012 6 pre-filled syringes EU/1/07/431/036 1 pre-filled syringe with needle guard EU/1/07/431/037 6 pre-filled syringes with needle guard EU/1/07/431/064 1 pre-filled syringe with needle-trap EU/1/07/431/065 6 pre-filled syringes with needle-trap
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/011 siringa 1 mimlija għal-lest EU/1/07/431/012 6 siringi mimlija għal-lest EU/1/07/431/036 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/037 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/064 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/065 6 siringi mimlija għal-lest b'tarka għal-labra
English: The most frequently occurring adverse drug reactions observed in clinical trials of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Maltese: Ir-reazzjonijiet avversi tal-mediċina li jseħħu bl-aktar mod frekwenti li ġew osservati fil-provi kliniċi ta' epoetin alfa huma dijarea, dardir, rimettar, deni u uġigħ ta' ras.
English: A sustained haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided; guidance for appropriate dose adjustment for when haemoglobin concentrations exceed 12 g/dL (7.5 mmol/L) are described below.
Maltese: Konċentrazzjoni sostnuta ta' emoglobina ta' aktar minn 12 g/dL (7.5 mmol/lL għandha tiġi evitata; gwida għal aġġustament tad-doża għal meta lkonċentrazzjonijiet tal-emoglobina jaqbżu 12 g/dL (7.5 mmol/L) huma deskritti hawn isfel.
English: If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range of between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L) is achieved (this should be done in steps of at least four weeks).
Maltese: IU/kg (3 darbiet fil-ġimgħa) sakemm tinkiseb ilmedda tal-konċentrazzjoni mixtieqa tal-emoglobina ta' bejn 9.5 g/dL sa 11 g/dL (5.9 sa 6.8 mmol/L) (dan għandu jsir fi stadji ta' mill-inqas erba' ġimgħat).
English: Retacrit 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: Retacrit 1,000 IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.3 ml soluzzjoni għall-injezzjoni għandha 1,000 unit internazzjonali (IU) epoetin zeta* (erythropoietin uman rikombinat).
English: • Symptoms of pure red cell aplasia (PRCA)
Maltese: • Sintomi ta' aplasija pura taċ-ċelloli ħomor (PRCA - pure rec cell aplasia)
English: Excipients with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.30 mg phenylalanine.
English: 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.4 ml soluzzjoni għall-injezzjoni li fiha 4,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Maltese: Żewġ provi oħra iżgħar, każwali bil-plaċebo bħala kontroll urew titjib sinifikanti fil-parametri tal-kwalità tal-ħajja fuq l-iskala EORTC-QLQ-C30 jew CLAS, rispettivament.
English: Retacrit 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 għal-lest b'0.5 ml soluzzjoni għall-injezzjoni għandha 5,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: Each pre-filled syringe contains 0.8 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 0.8 ml soluzzjoni.
English: The recommended maintenance dose is between 25 IU/kg and 50 IU/kg, 2 times per week in 2 equal injections.
Maltese: Id-doża ta' manteniment rakkomandata hija bejn il-25 IU/kg u l-50 IU/kg, darbtejn fil-ġimgħa f'żewġ injezzjonijiet ugwali.
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: In 5 small, open label, uncontrolled studies (number of patients ranged from 9-22, total N=72), Epoetin alfa has been administered subcutaneously in children at starting doses of 100 IU/kg/week to 150 IU/kg/week with the possibility to increase up to 300 IU/kg/week.
Maltese: F'5 studji żgħar, open-label, mhux ikkontrollati (in-numru ta' pazjenti varja minn 9-22, total N=72), Epoetin alfa ngħata taħt il-ġilda fit-tfal f'dożi talbidu ta' 100
English: Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Maltese: F'dawn il-pazjenti huma rrakkomandati reviżjoni tax-xant bikrija u profilassi ta' trombożi permezz tal-għoti ta' pereżempju acetylsalicylic acid.
English: • If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
Maltese: • Jekk ikun hemm bżonn mediku li jitnaqqas iż-żmien qabel l-operazzjoni tiegħek, inti ser tingħata doża ta' kuljum ta' 300 IU/kg sa għaxart ijiem qabel l-operazzjoni, dakinhar tal-operazzjoni u għal erbat ijiem immedjatament wara.
English: In the double-blind study, patients were treated with epoetin alfa 600 IU/kg or placebo intravenously once daily every 3 to 4 days over 3 weeks (total 6 doses).
Maltese: IU/kg jew plaċebo ġol-vini darba kuljum kull 3 sa 4 ijiem matul 3 ġimgħat (total ta' 6 dożi).
English: Retacrit 40 000 IU
Maltese: Retacrit 40,000
English: Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva, li jinkludu każijiet ta' raxx (li jinkludu urtikarja), reazzjonijiet anafilattiċi, u edema anġjonewrotika (ara sezzjoni 4.4).
English: Hypertension, Venous and arterial thrombosis
Maltese: Pressjoni għolja, Trombożi fl-arterji u filvini
English: Rare: may affect up to 1 in 1 000 people.
Maltese: Rari: jistgħu jaffettwaw sa 1 f'kull 1,000 persuna.
English: 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.9 ml soluzzjoni għall-injezzjoni li fiha 3,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Erythropoietins exhibit a dose-related effect on haematological parameters which is independent of route of administration.
Maltese: L-eritropoetini juru effett relatat mad-doża fuq il-parametri ematoloġiċi li huwa indipendenti minn imnejn jingħataw.
English: Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure.
Maltese: Jista' jkollok uġigħ fis-sider, qtugħ ta' nifs, u nefħa bluġigħ u ħmura ġeneralment fir-riġel bħala sintomi.
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/431/003 1 pre-filled syringe EU/1/07/431/004 6 pre-filled syringes EU/1/07/431/028 1 pre-filled syringe with needle guard EU/1/07/431/029 6 pre-filled syringes with needle guard EU/1/07/431/056 1 pre-filled syringe with needle-trap EU/1/07/431/057 6 pre-filled syringes with needle-trap
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/003 siringa 1 mimlija għal-lest EU/1/07/431/004 6 siringi mimlija għal-lest EU/1/07/431/028 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/029 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/056 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/057 6 siringi mimlija għal-lest b'tarka għal-labra
English: Treatment of symptomatic anaemia in paediatric chronic renal failure patients on haemodialysis
Maltese: Trattament ta' anemija sintomatika f'pazjenti pedjatriċi b'falliment kroniku tal-kliewi fuq emodijalisi
English: 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.5 ml soluzzjoni għall-injezzjoni li fiha 5,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'0.6 ml soluzzjoni għall-injezzjoni għandha 2,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'1 ml soluzzjoni għall-injezzjoni fiha li 10,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Excipients with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Maltese: Eċċipjenti b'effett magħruf Kull siringa mimlija għal-lest fiha 0.50 mg phenylalanine.
English: Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/431/009 1 pre-filled syringe EU/1/07/431/010 6 pre-filled syringes EU/1/07/431/034 1 pre-filled syringe with needle guard EU/1/07/431/035 6 pre-filled syringes with needle guard EU/1/07/431/062 1 pre-filled syringe with needle-trap EU/1/07/431/063 6 pre-filled syringes with needle-trap
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/009 siringa 1 mimlija għal-lest EU/1/07/431/010 6 siringi mimlija għal-lest EU/1/07/431/034 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/035 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/062 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/063 6 siringi mimlija għal-lest b'tarka għal-labra
English: Further pharmacodynamic studies explored 40 000 IU once weekly versus 150 IU/kg 3 times per week.
Maltese: IU darba fil-ġimgħa kontra 150 IU/kg 3 darbiet filġimgħa.
English: 1 pre-filled syringe without needle guard containing 0.9 ml solution for injection 6 pre-filled syringes without needle guard containing 0.9 ml solution for injection 1 pre-filled syringe with needle guard containing 0.9 ml solution for injection 6 pre-filled syringes with needle guard containing 0.9 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.9 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.9 ml solution for injection
Maltese: 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.9 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.9 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.9 ml ta' soluzzjoni għall-injezzjoni
English: Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija għal-lest b'1.0 ml soluzzjoni għall-injezzjoni għandha 10,000 unità internazzjonali (IU) ta' epoetin zeta* (erythropoietin uman rikombinat).
English: Adult haemodialysis patients
Maltese: Operazzjoni ortopedika elettiva maġġuri
English: 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.3 ml soluzzjoni għall-injezzjoni li fiha 1,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: 1 pre-filled syringe without needle guard containing 1 ml solution for injection 4 pre-filled syringes without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle guard containing 1 ml solution for injection 4 pre-filled syringes with needle guard containing 1 ml solution for injection 6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle-trap containing 1 ml solution for injection 4 pre-filled syringes with needle-trap containing 1 ml solution for injection 6 pre-filled syringes with needle-trap containing 1 ml solution for injection
Maltese: 4 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'1.0 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'1.0 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'1 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'1 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'1 ml ta' soluzzjoni għall-injezzjoni
English: 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.6 ml soluzzjoni għall-injezzjoni li fiha 6,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
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 Retacrit dose by about 25 to 50%.
Maltese: Jekk il-konċentrazzjoni tal-emoglobina qed tiżdied b'aktar minn 2 g/dL (1.25 mmol/L) fix-xahar, jew jekk il-livell tal-konċentrazzjoni tal-emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Retacrit b'madwar 25 sa 50%.
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Maltese: Pazjenti b'anemija ħafifa (ematokrit ta' 33 sa 39%) li għandhom bzonn depozitu minn qabel ta' ≥ 4 unitajiet ta' demm għandhom jiġu ttratati b'Retacrit 600
English: Pure red cell aplasia Thrombocythemia
Maltese: • dan l-aħħar kellek attakk tal-qalb jew puplesija
English: Each pre-filled syringe contains 0.9 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 0.9 ml soluzzjoni.
English: Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe EU/1/07/431/007 1 pre-filled syringe EU/1/07/431/008 6 pre-filled syringes EU/1/07/431/032 1 pre-filled syringe with needle guard EU/1/07/431/033 6 pre-filled syringes with needle guard EU/1/07/431/060 1 pre-filled syringe with needle-trap EU/1/07/431/061 6 pre-filled syringes with needle-trap
Maltese: IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/07/431/007 siringa 1 mimlija għal-lest EU/1/07/431/008 6 siringi mimlija għal-lest EU/1/07/431/032 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/033 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/060 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/061 6 siringi mimlija għal-lest b'tarka għal-labra
English: Each pack contains 1, 4 or 6 pre-filled syringes.
Maltese: Kull pakett għandu 1, 4 jew 6 siringi mimlija għal-lest.
English: If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L) is achieved (this should be done in steps of at least four weeks).
Maltese: Jekk ikun neċessarju, żid jew naqqas id-doża b'25 IU/kg (3 darbiet fil-ġimgħa) sakemm tinkiseb ilmedda tal-konċentrazzjoni mixtieqa tal-emoglobina bejn 10 g/dL sa 12 g/dL (6.2 sa 7.5 mmol/L) (dan għandu jsir fi stadji ta' mill-inqas erba' ġimgħat).
English: • increased risk of death when administered to achieve a haemoglobin concentration level of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Maltese: • żieda fir-riskju ta' mewt meta jingħata biex jinkiseb livell tal-konċentrazzjoni tal-emoglobina ta' 12 g/dL (7.5 mmol/L) f'pazjenti b'marda malinna attiva li la qegħdin jirċievu l-kimoterapija u lanqas terapija bir-radjazzjoni.
English: If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin concentration 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, ilkonċentrazzjoni tal-emoglobina żdiedet ≥ 1 g/dL (≥0.62 mmol/L) jew l-għadd tar-retikoloċiti żdied ≥40,000 ċelluli/µl, id-doża għanda tibqa' ta' 300 IU/kg 3 darbiet fil-ġimgħa.
English: These patients responded to epoetin alfa therapy in a manner similar to that observed in patients on dialysis.
Maltese: Dawn il-pazjenti rrispondew għal terapija b'epoetin alfa b'mod simili għal dak osservat f'pazjenti fuq dijalisi.
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 zeta, and when deciding to increase the dose.
Maltese: Il-kawżi l-oħra kollha ta' anemija (defiċjenza fil-ħadid, folate jew Vitamina B12, intossikazzjoni blaluminju, infezzjoni jew infjammazzjoni, telf ta' demm, emolisi u fibrożi tal-mudullun ta' kwalunkwe oriġini) għandhom jiġu evalwati u kkurati qabel ma tinbeda t-terapija b'epoetin zeta, u meta jiġi deċiż li tiżdied id-doża.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Retacrit 2 000 IU
Maltese: Retacrit 2,000
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 l-aġġustament xieraq tad-doża sabiex jinżammu l-livelli tal-emoglobina fil-medda talkonċentrazzjoni mixtieqa bejn 9.5 g/dL sa 11 g/dL (5.9 sa 6.8 mmol/L).
English: 1 pre-filled syringe without needle guard containing 0.3 ml solution for injection 6 pre-filled syringes without needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle guard containing 0.3 ml solution for injection 6 pre-filled syringes with needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.3 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.3 ml solution for injection
Maltese: 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.3 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.3 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.3 ml ta' soluzzjoni għall-injezzjoni
English: Serum electrolytes should be monitored in chronic renal failure patients.
Maltese: Lelettroliti fis-serum għandhom jiġu mmonitorjati f'pazjenti b'falliment kroniku tal-kliewi.
English: EU/1/07/431/003 EU/1/07/431/004 EU/1/07/431/028 EU/1/07/431/029 EU/1/07/431/056 EU/1/07/431/057
Maltese: EU/1/07/431/028 EU/1/07/431/029 EU/1/07/431/056
English: • You will usually continue Retacrit treatment for one month after the end of chemotherapy.
Maltese: • Normalment ser tkompli t-trattament b'Retacrit għal xahar wara tmiem il-kimoterapija.
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/431/001 1 pre-filled syringe EU/1/07/431/002 6 pre-filled syringes EU/1/07/431/026 1 pre-filled syringe with needle guard EU/1/07/431/027 6 pre-filled syringes with needle guard EU/1/07/431/054 1 pre-filled syringe with needle-trap EU/1/07/431/055 6 pre-filled syringes with needle-trap
Maltese: EU/1/07/431/002 6 siringi mimlija għal-lest EU/1/07/431/026 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/027 6 siringi mimlija għal-lest b'tarka għal-labra EU/1/07/431/054 siringa 1 mimlija għal-lest b'tarka għal-labra EU/1/07/431/055 6 siringi mimlija għal-lest b'tarka għal-labra
English: 1 pre-filled syringe without needle guard containing 0.4 ml solution for injection 6 pre-filled syringes without needle guard containing 0.4 ml solution for injection 1 pre-filled syringe with needle guard containing 0.4 ml solution for injection 6 pre-filled syringes with needle guard containing 0.4 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.4 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.4 ml solution for injection
Maltese: 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.4 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.4 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.4 ml ta' soluzzjoni għall-injezzjoni
English: Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: Retacrit 1,000 IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Retacrit 2,000
English: EU/1/07/431/015 EU/1/07/431/016 EU/1/07/431/040 EU/1/07/431/041 EU/1/07/431/068 EU/1/07/431/069
Maltese: EU/1/07/431/041 EU/1/07/431/068 EU/1/07/431/069
English: 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: Siringa waħda mimlija minn qabel b'0.6 ml soluzzjoni għall-injezzjoni li fiha 2,000 unità internazzjonali (IU) ta' epoetin zeta (rikombinant uman eritroptejin).
English: Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe epoetin zeta
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel epoetin zeta