FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains up to 0.5 mg phenylalanine in each dosage unit.
Maltese: Din il-mediċina fiha sa 0.5 mg phenylalanine f'kull doża.
English: 1 pre-filled syringe contains 20 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 20 000 IU Epoetin zeta
English: At the start of your therapy, Silapo is injected by medical or nursing staff.
Maltese: Fil-bidu tat-terapija tiegħek, Silapo jista' jiġi injettat min staff mediku jew infermiera.
English: Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
Maltese: B'mod alternattiv, l-injezzjoni tista' tingħata fit-tmiem tas-sessjoni tad-dijalisi permezz ta' tubi tal-labra fistla, segwit minn 10 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) biex tlaħlaħ it-tubi u tassigura injezzjoni sodisfaċenti tal-prodott fiċ-ċirkolazzjoni.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Maltese: Dawn l-istudji wrew mortalità eċċessiva konsistenti statistikament sinifikanti u bla spjegazzjoni f'pazjenti li għandhom anemija assoċjata ma diversi kansers komuni li rċevew eritropojetin rikombinanti uman meta mqabbel ma' kontrolli.
English: Anaphylactic reaction
Maltese: • Reazzjoni allerġika
English: Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Maltese: Pazjenti li għal xi raġuni ma jistgħux jirċievu profilassi antitrombotika adegwata.
English: Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).
Maltese: Żewġ individwi kellhom fatturi ta' riskju sinifikanti (fibrillazzjoni atrijali, insuffiċjenza tal-qalb u tromboflebite).
English: Silapo should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤10 g/dl (6.2 mmol/l)).
Maltese: Silapo għandu jingħata lil pazjenti b'anemija sintomatika (eż. konċentrazzjoni tal-emoglobina ≤10 g/dl (6.2 mmol/l)).
English: Adult patients with low- or intermediate-1-risk MDS
Maltese: Pazjenti adulti b'MDS b'riskju baxx- jew intermedju-1
English: Respiratory tract congestion
Maltese: Edema anġjonewtrotika
English: If the solution is given into a vein, it should be injected over 1-5 minutes.
Maltese: Jekk is-soluzzjoni għandha tingħata ġo vina, għandha tiġi injettata fuq perijodu ta' bejn 1-5 minuti.
English: Anti-erythropoeitin antibody positive
Maltese: Antikorp anti-eritropoetina pożittiva rari
English: Patients scheduled for major elective orthopaedic surgery
Maltese: Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
English: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva
English: No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Maltese: Ma teżistix evidenza li tindika interazzjoni bejn epoetin alfa u G-CSF jew GM-CSF fir-rigward ta' ddifferenzjar ematoloġiku jew il-proliferazzjoni ta' kampjuni ta' bijopsiji tat-tumuri in vitro.
English: At a rate of rise in haemoglobin of > 2 g/dl (> 1.25 mmol/l) per month the Silapo dose should be reduced by about 25-50%.
Maltese: F'rata ta' żieda fl-emoglobina ta' >2 g/dl (> 1.25 mmol/l) fix-xahar id-doża ta' 'Silapo għanda tonqos b'xi 25-50%.
English: Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Maltese: L-eritropojetin ma wera l-ebda tibdil fit-testijiet mutaġenetiċi fil-kultura taċ-ċelluli batterjali u mammiferi u studji mikronukleji in vivo fi-ġrieden.
English: 1 pre-filled syringe contains 6 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 6 000 IU Epoetin zeta
English: The recommended total weekly dose is between 75 and 300 IU/kg.
Maltese: Id-doża rrakkomandata fil-ġimgħa hija ta' bejn il-75 u t-300 IU/kg.
English: The percentage of subjects who were transfused in the epoetin alfa group decreased from 51.8% in the 8 weeks prior to baseline to 24.7% between weeks 16 and 24, compared to the placebo group which had an increase in transfusion rate from 48.9% to 54.1% over the same time periods.
Maltese: Il-perċentwali ta' individwi li ngħataw trasfużjoni fil-grupp tal-epoetin alfa naqas minn 51.8% fl-ewwel 8 ġimgħat qabel il-linja bażi għal 24.7% bejn is-16 u l-24 ġimgħa, meta mqabbla malgrupp tal-plaċebo li kellu żieda minn 48.9% għal 54.1% fir-rata ta' trasfużjoni fuq l-istess perjodi ta' żmien.
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Maltese: Fl-istudju bit-tikketta tingħaraf ma kien hemm ebda differenza fis-sopravivenza globali fost pazjenti trattati b'eritropojetin rikombinanti uman u l-kontrolli.
English: Treatment of adult patients scheduled for major elective orthopaedic surgery In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of > 10 to ≤ 13 g/dl, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Maltese: F'pazjenti skedati għal operazzjoni ortopedika maġġuri elettiva b'emoglobina qabel il-kura ta' > 10 sa ≤ 13 g/dl, intwera li epoetin alfa jnaqqas ir-riskju li jiġu riċevuti trasfużjonijiet alloġeniċi u jħaffef lirkupru eritrojdi (żieda fil-livelli tal-emoglobina, livelli ta' ematokrit, u l-għadd ta' retikuloċiti.
English: As with other haematopoietic growth factors, erythropoietin has shown in vitro stimulating properties on human endothelial cells.
Maltese: Bħall-fatturi oħra ta' tkabbir ematopojetiku, l-eritropojetin wera in vitro propretajiet stimulanti fuq ċelluli endoteljali.
English: Adult surgery patients in an autologous predonation programme
Maltese: Pazjenti kirurġiċi f'programmi predonazzjoni awtologi
English: 1 pre-filled syringe contains 30 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 30 000 IU Epoetin zeta
English: Key baseline characteristics for the <200 mU/ml stratum are shown in the table below.
Maltese: Il-karatteristiċi bażiċi ewlenin għall-istrat < 200 mU/ml huma murija fit-tabella hawn taħt.
English: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l),
Maltese: • żmien imqassar għal progressjoni tat-tumur fil-pazjenti b'kanċer tar-ras u ta' l-għonq avvanzat li qed jirċievu terapija ta' radjazzjoni meta jingħata biex jintaħaq livell ta' emoglobina ta' aktar minn 14 g/dl (8.7 mmol/l).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In a randomised, double-blind, placebo-controlled study of 4 038 CRF patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dl, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dl or placebo (see section 4.4).
Maltese: Fi studju double-blind, ikkontrollat bi plaċebo li sar fuq 4 038 pazjent b'falliment kroniku tal-kliewi magħżula b'mod każwali li mhumiex fuq dijalisi b'dijabete ta' tip 2 u livelli ta' emoglobina ta' ≤ 11 g/dl, il-pazjenti rċevew trattament jew b'darbepoetin alfa sabiex jintlaħqu livelli ta' emoglobina ta' 13 g/dl jew plaċebo (ara sezzjoni 4.4).
English: 1 pre-filled syringe contains 40 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 40 000 IU Epoetin zeta
English: Do not use Silapo if you are allergic to erythropoietins or any of the other ingredients of this medicine (listed in section 6) if you have developed Pure Red Cell Aplasia (PRCA; reduced or stopped production of red blood cells) following treatment with any erythropoietin if you have high blood pressure, which is not properly controlled with blood pressure-lowering medicines if you cannot be given medicines to thin blood for the prevention of blood clots if you are donating your own blood before surgery, and:
Maltese: Tużax Silapo jekk int allerġiku għall-eritropojetini jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6) jekk żviluppajt Pure Red Cell Aplasia (PRCA; in-nuqqas ta' ċelluli żgħar tad-demm ħomor) wara trattament b'kwalunkwe eritropojetin jekk għandek pressjoni għolja, li m'hijiex ikkontrollata kif suppost bi prodotti li jnaqqsu lpressjoni jekk ma tistax tingħata mediċini li jraqqu d-demm għall-prevenzjoni tat-tagħqid tad-demm jekk qed tagħti d-demm tiegħek stess qabel il-kirurġija, u:
English: Treatment of anaemia and reduction of transfusion requirements in adult patients 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).
Maltese: Trattament ta' anemija u nuqqas ta' bżonnijiet ta' trasfużjoni f'pazjenti adulti li qegħdin jirċievu l-kimoterapija għal tumuri solidi, limfoma malinn jew myeloma multiplu, u f'riskju ta' trasfużjoni kif assessjat mill-istatus ġenerali tal-pazjent (e.g. status kardjovaskulari, anemija preeżistenti fil-bidu tal-kimoterapija).
English: In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: iron supplementation, e.g. 200-300 mg/day orally (100-200 mg/day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ml oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose transferrin saturation is below 20%.
Maltese: Supplementazzjoni bil-ħadid, e.g. 200-300 mg/jum b'mod orali (100-200 mg/jum għall-pazjenti pedjatriċi) huwa rrakomandat għall-pazjenti li għandhom insuffiċjenza renali kronika li l-livelli tas-serum ferritin tagħhom huma taħt il-100 ng/ml sostituzzjoni ta-ħadid orali ta' 200-300 mg/jum huwa rrakomandat għall-pazjenti kollha bil-kanċer li s-saturazzjoni tat-transferrin tagħhom huwa taħt l-20% Għal pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri, għandu jingħata suppliment ta' ħadid (ħadid elementali 200 mg/jum b'mod orali) matul il-kors tat-terapija b'epoetin zeta.
English: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
Maltese: Trattament għal anemija sintomatika assoċjata ma' falliment renali kroniku (CRF) f'pazjenti adulti u tfal: o Trattament għal anemija assoċjata ma' falliment renali kroniku f'pazjenti adulti u tfal fuq emodijalisi u pazjenti adulti fuq dijalisi peritoneali (Ara sezzjoni 4.4). o Trattament għal anemija severa li ġejja mill-kliewi akkumpanjata minn sintomi kliniċi f'pazjenti adulti b'insuffiċjenza tal-kliewi li għad mhux ikollhom dijalisi (Ara sezzjoni 4.4).
English: Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Maltese: L-eritropojetin hija glikoproteina li tistimola, bħala fattur mitosi-stimulanti u ormon differenzjat, il-formazzjoni ta' eritroċiti minn prekursuri tal-kompartiment taċ-ċellula mhux differenzjata.
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Silapo 8 000 IU/0.8 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Silapo 10 000 UI/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Silapo 20 000
English: In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Maltese: F'pazjenti li juru nuqqas f'daqqa ta' effikaċja, li tidher permezz ta' nuqqas fl-emoglobina (1-2 g/dl per month) b'żieda ta' bżonn ta' trasfużjonijiet, l-għadd tar-retikuloċiti għandu jittieħed u kawżi tipiċi ta' nuqqas ta' rispons (eż defiċjenza fil-ħadid, folate jew il-Vitamina B12, intossikament bl-alumilju, infezzjoni jew infjammazzjoni, telf ta' demm, u emolisi) għandhom jiġu investigati.
English: Pure Red Cell Aplasia (PRCA) has been reported very rarely after months to years of subcutaneous treatment with other products containing erythropoietins and may not be ruled out with Silapo.
Maltese: Il-Pure Red Cell Aplasia (PRCA) ġiet irraportata rarament wara xhur sa snin ta' trattament mogħti taħt il-ġilda bi prodotti oħra li għandhom l-eritropojetini u ma tistax tiġi eskluża b'Silapo.
English: • Cough
Maltese: • Sogħla
English: 1 pre-filled syringe contains 10 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 10 000 IU Epoetin zeta
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Maltese: Il-meta-analiżi jindika wkoll b'mod konsistenti żieda sinifikanti ta' riskju relattiv għal każijiet tromboembolitiċi f'pazjenti bil-kanċer li qed jirċievu ertropojetin rikombinanti uman (ara sezzjoni 4.4).
English: Major elective orthopaedic surgery
Maltese: • Emorraġiji ċerebrali
English: Adult cancer patients with symptomatic anaemia receiving chemotherapy
Maltese: Pazjenti adulti morda bil-kanċer b'anemija sintomatika li jkunu qegħdin jirċievu kimoterapija
English: The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Maltese: Id-data klinika provduta tagħti x'tifhem li dawk il-pazjenti li l-emoglobina inizjali tagħhom hija baxxa ħafna (< 6.8 g/dl jew < 4.25 mmol/l) jista' jkun li jkollhom bżonn dożi ta' manteniment ogħla minn dawk li l-emoglobina inizjali tagħhom hija ogħla minn > 6.8 g/dl jew> 4.25 mmol/l).
English: Your doctor should try to keep your haemoglobin levels between 10 and 12g/dl.
Maltese: It-tabib tiegħek ser iżomm il-konċentrazzjoni tal-emoglobina bejn 10 u 12 g/dl.
English: Epoetin zeta is identical in its amino acid sequence and similar in carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Maltese: L-Epoetin zeta huwa identiku fis-sekwenza tal-aċidi aminiċi tiegħu u l-kompozizzjoni ta' karboidrati hija simili għall-eritropojetin indiġinu uman li ġie iżolat mill-urina ta' pazjenti anemiċi.
English: Hyperkalaemia has been observed in isolated cases.
Maltese: L-iperkalemija ġiet osservata f'kazijiet iżolati.
English: A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
Maltese: Studju multiċentrali li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bilplaċebo, vvaluta l-effikaċja u s-sigurtà ta' epoetin alfa f'individwi adulti anemiċi b'MDS b'riskju baxx- jew intermedju-1.
English: - The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese
Maltese: - Is-sustanza attiva hi l-epoetin zeta (magħmul permezz tat-teknoloġija tar-rikombinant DNA
English: Excipient with known effect Each pre-filled syringe contains 0.38 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.38 mg phenylalanine.
English: Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Maltese: Phenylalanine jista' jkun ta' ħsara għal pazjenti bil-fenilketonurja (phenylketonuria, PKU), disturb ġenetiku rari fejn il-phenylalanine jakkumula għaliex il-ġisem ma jistax ineħħih sewwa.
English: 150 IU/kg 3x/week or 450 IU/kg once weekly for 4 weeks
Maltese: IU/kg 3x/ġimgħa jew 450 IU/kg darba fil-ġimgħa għal 4 ġimgħat
English: Median
Maltese: Medjan
English: Moreover, in patients with a baseline haemoglobin of > 13 g/dl, the possibility that epoetin zeta treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Maltese: F'pazjenti fl-emoglobina fil-linja bażi ta' > 13 g/dl, il-possibbiltà li t-trattament b'Silapo jista' jkun assoċjat ma' żieda fir-riskju ta' episodji trombotiċi/vaskulari ma tistax tkun eskluża.
English: Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms Addressed in the subsection below and/or in section 4.4
Maltese: Jinkludu każijiet arterjali u venużi, fatali u mhux fatali, bħal każijiet ta' trombożi tal-veni fondi, emboli pulmonari, trombożi retinali, trombożi arterjali (li jinkludi infart mijokardjali), inċidenti ċerebrovaskulari (li jinkludu infart ċerebrali u emorraġija ċerebrali), attakki iskemiċi għaddiena u trombożi tax-xant (li jinkludi tagħmir tad-dijalisi) u trombożi fi ħdan anewriżmi b'xant arterjovenuż.
English: Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/kg body weight 2 times weekly for 3 weeks prior to surgery.
Maltese: Pazjenti b'anemija ħafifa (ematokrit ta' 33-39%) li għandhom bzonn depozitu minn qabel ta' ≥ 4 unitajiet ta' demm għandhom jiġu ttratati b'Silapo b'doża ta' 600
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 fiha 8 000 unit internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: 1 pre-filled syringe contains 1 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 1 000 IU Epoetin zeta
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodju'.
English: The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Maltese: Ir-rispons eritropoietiku osservat fiż-żewġ gruppi ta' kura, irriżulta f'rati simili ta' trasfużjoni (16% filgrupp ta' 600
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: Il-differenza tal-emoglobina għandha tiġi indirizzata permezz tal-ġestjoni tad-doża, b'konsidrazzjoni għal medda mixtieqa għall-emoglobina ta' bejn 10 g/dl (6.2 mmol/l) sa 12 g/dl (7.5 mmol/l).
English: The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/dl or < 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or > 5 mmol/l).
Maltese: Id-data klinika tagħti x'tifhem li dawk il-pazjenti li l-emoglobina inizjali tagħhom hija baxxa ħafna (<6 g/dl jew < 3.75 mmol/l) jista' jkun li jkollhom bżonn dożi ta' manteniment ogħla minn dawk li l-anemija inizjali tagħhom hija anqas severa (Hb > 8 g/dl jew > 5 mmol/l).
English: 1 pre-filled syringe contains 4 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 4 000 IU Epoetin zeta
English: 1 pre-filled syringe contains 2 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 2 000 IU Epoetin zeta
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: Silapo 8 000 IU/0.8 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: If haemoglobin level exceeds 12 g/dl (7.5 mmol/l), discontinue therapy until it falls to 12 g/dl (7.5 mmol/l) or lower and then reinstitute Silapo therapy at a dose 25% below the previous dose.
Maltese: Jekk il-livell tal-emoglobina jaqbeż it-12 g/dl (7.5 mmol/l), it-terapija għanda tieqaf sakemm tinżel għal 12 g/dl (7.5 mmol/l) jew inqas u mbgħad erġa' agħti t-terapija tas-Silapo f'doża ta' 25% anqas mid-doża ta' qabel.
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Silapo 3 000 IU/0.9 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Silapo 4 000 IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Silapo 5 000
English: Hyperkalaemia
Maltese: STADAPHARM
English: Data from clinical studies with Silapo are in line with the safety profile of other authorised erythropoietins.
Maltese: Data minn studji kliniċi b'Silapo huma simili fil-profil tas-sigurtà ma' erythropojetini awtorizzati oħra.
English: Fe-incorporation rate.
Maltese: Żieda fl-inkorporazzjoni tal
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Maltese: Kien hemm rapporti ta' reazzjonijiet serji tal-ġilda fosthom is-sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN) b'rabta ma' kura b'epoetini.
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/432/019
Maltese: Silapo 40 000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/019
English: Dose (IU/kg given 3 times per week)
Maltese: Doża (UI/kg mogħtija 3 darbiet fil-ġimgħa)
English: • you have unstable angina pectoris (new or increasing chest pain)
Maltese: • għandek anġina pectoris (uġigħ fis-sider li ma kellekx qabel jew żieda fl- uġigħ fis-sider)
English: 1 pre-filled syringe contains 3 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 3 000 IU Epoetin zeta
English: Cough
Maltese: Medja
English: Excipient with known effect Each pre-filled syringe contains 0.20 mg phenylalanine.
Maltese: Eċċipjent b'effett magħruf Kull siringa mimlija minn qabel fiha 0.20 mg phenylalanine.