FrancophonIA/ELRC3.0 huggingface dataset:
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Maltese: F'erba' studji kkontrollati bil-plaċebo il-proporzjonijiet ta' periklu għall-għejxien globali varjaw bejn 1.25 u 2.47 favur dawk li rċevew il-kontroll.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakket u informazzjoni oħra
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Maltese: Meta-analiżi tad-data dwar sopravivenza globali pproduċiet estimu tal-punt talproporzjon ta' periklu ta' 1.06 favur il-kontrolli (CI ta' 95%: 1.00, 1.12, 53 prova u 13,933 pazjent) u għall-pazjenti bil-kanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu ta' sopravivenza globali kien ta' 1.04 (CI ta' 95%: 0.97, 1.11; 38 prova u 10,441 pazjent).
English: Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%).
Maltese: Inqas pazjenti b'mod sinifikanti rċevew trasfużjonijiet ta' RBC fil-grupp epoetin alfa flimkien ma' SOC (5.8% kontra 11.4%); madankollu, aktar pazjenti b'mod sinifikanti kellhom avvenimenti vaskulari trombotiċi fil-grupp epoetin alfa flimkien ma' SOC (2.8% kontra 1.4%).
English: Rash/erythemac
Maltese: Raxx/ħmurac
English: Strokeb
Maltese: Puplesijab
English: Oedemad
Maltese: Edimad
English: Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Maltese: Darbepoetin alfa huwa magħmul b'teknoloġija ġenetika fiċ-Ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO-K1 - Chinese Hamster Ovary K1 Cells).
English: At the time haemoglobin ≥ 10.0 g/dL was first achieved, the mean (SD) weightadjusted dose was 0.48 (0.24) mcg/kg (range: 0.0 to 1.7 mcg/kg) weekly for the once weekly group and 0.76 (0.21) mcg/kg (range: 0.3 to 1.5 mcg/kg) biweekly for the once every two week group.
Maltese: 0 g/dL għall-ewwel darba, id-doża medja (SD) aġġustata għall-piż kienet 0.48 (0.24) mcg/kg (medda: 0.0 sa 1.7 mcg/kg) kull ġimgħa għall-grupp ta' darba kull ġimgħa u 0.76 (0.21) mcg/kg (medda: 0.3 sa 1.5 mcg/kg) darbtejn fil-ġimgħa għall-grupp ta' darba kull ġimagħtejn.
English: Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Maltese: Darbepoetin alfa jistimula l-eritropoesi bl-istess mekkaniżmu tal-ormon endoġenu.
English: • Shortness of breath (allergic bronchospasm)
Maltese: • Qtugħ ta' nifs (bronkospażmu allerġiku)
English: In an European observational registry study which enrolled 319 paediatric patients with chronic kidney disease (13 (4.1%) patients < 1 year of age, 83 (26.0%) patients 1-< 6 years of age, 90 (28.2%) patients 6-< 12 years of age, and 133 (41.7%) patients ≥ 12 years of age) receiving darbepoetin alfa, mean haemoglobin concentrations ranging between 11.3 and 11.5 g/dL and mean weight-adjusted darbepoetin alfa doses remained relatively constant (between 2.31 mcg/kg month and 2.67 mcg/kg month) over the study period for the entire study population.
Maltese: Fi studju Ewropew ta' reġistru ta' osservazzjoni li rreġistra 319-il pazjent pedjatriku b'marda kronika tal-kliewi (13 (4.1%) tal-pazjenti ta' età < sena, 83 (26.0%) tal-pazjenti ta' età minn sena sa < 6 snin, 90 (28.2%) tal-pazjenti ta' età minn 6 sa < 12-il sena, u 133 (41.7%) tal-pazjenti ta' età ≥ 12-il sena) li kienu qed jirċievu darbepoetin alfa, konċentrazzjonijiet medji tal-emoglobina li jvarjaw bejn 11.3 u 11.5 g/dL u dożi medji ta' darbepoetin alfa aġġustati għall-piż baqgħu relattivament kostanti (bejn 2.31 mcg/kg kull xahar u 2.67 mcg/kg kull xahar) matul il-perjodu ta' studju għall-popolazzjoni kollha tal-istudju.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Maltese: Meta-analiżi tindika wkoll b'mod konsistenti żieda sinnifikanti fir-riskju relattiv ta' avvenimenti tromboemboliċi f'pazjenti bilkanċer li jirċievu eritropoetina rikombinanti uman (ara sezzjoni 4.4).
English: c Thromboembolic events adverse reaction includes PT embolism arterial, thrombophlebitis, thrombosis, venous thrombosis limb.
Maltese: c Ir-reazzjoni avversa avvenimenti tromboemboliċi tinkludi PT emboliżmu arterjali, tromboflebite, trombożi,
English: In a phase 1 pharmacokinetic study, following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the paediatric patients.
Maltese: Fi studju farmakokinetiku ta' fażi I, wara għoti ġol-vina, ġiet osservata differenza ta' madwar 25% flerja taħt il-kurva minn ħin 0 sal-infinità (AUC[0-∞] - area under the curve from time 0 to infinity) bejn pazjenti tfal u pazjenti adulti; madankollu, din id-differenza kienet anqas minn darbtejn il-firxa f'AUC[0-∞] osservata f'pazjenti tfal.
English: Bioavailability is 37% with subcutaneous administration.
Maltese: Il-biodisponibilità hija ta' 37% b'għoti taħt il-ġilda.
English: During the evaluation period (weeks 29-33), the mean (95% CI) weekly equivalent dose was 0.20 (0.17, 0.24) mcg/kg in the once every two week arm and 0.27 (0.23, 0.32) mcg/kg in the once monthly arm.
Maltese: Waqt il-perjodu ta' evalwazzjoni (ġimgħat 29-33) id-doża medja (CI ta' 95%) ekwivalenti fil-ġimgħa kienet ta' 0.20 (0.17, 0.24) mcg/kg fil-grupp ta' darba kull ġimagħtejn u 0.27 (0.23, 0.32) mcg/kg fil-grupp ta' darba kull xahar.
English: Adverse reactions were determined based on pooled data from eight randomised, double-blind,
Maltese: Reazzjonijiet avversi ġew determinati abbażi ta' data miġbura minn tmien studji, randomised,
English: Rash/erythemae
Maltese: Raxx/ħmurae
English: Finger grips Syringe label Syringe barrel
Maltese: Tikketta tas-siringa Kanna tas-Siringa
English: The results showed non-inferiority for the primary endpoint of overall survival with a median survival for darbepoetin alfa versus placebo of 9.5 and 9.3 months, respectively (stratified HR 0.92; 95% CI: 0.831.01).
Maltese: Ir-riżultati wrew nuqqas ta' inferjorità għall-punt finali primarju ta' sopravivenza globali b'sopravivenza medjana għal darbepoetin alfa kontra plaċebo ta' 9.5 u 9.3 xhur, rispettivament (HR stratifikat 0.92; CI ta' 95 %: 0.83-1.01).
English: The vial contains either 25, 40, 60, 100, 200 or 300 micrograms of darbepoetin alfa.
Maltese: Il-kunjett fih 25, 40, 60, 100, 200 jew 300 mikrogramma ta' darbepoetin alfa.
English: • Tell your doctor if you have an allergy to latex.
Maltese: • Għid lit-tabib tiegħek jekk għandek allerġija għal-latex.
English: Step 1: Prepare
Maltese: Pakkett ta' 1
English: EPO-ANE-3010, a randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Maltese: EPO-ANE-3010, studju randomised, open-label, multiċentriku twettaq f'2,098 mara b'anemija b'kanċer metastatiku fis-sider, li rċevew kimoterapija tal-ewwel linja jew tat-tieni linja.
English: Pharmacotherapeutic group: Anti-anaemic preparations, other anti-anaemic preparations, ATC Code: B03XA02.
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet kontra l-anemija, preparazzjonijiet oħra kontra lanemija.
English: • Serious allergic reactions which may include:
Maltese: • Reazzjonijiet allerġiċi serji li jistgħu jinkludu:
English: In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
Maltese: F'dan l-istudju, il-half-life terminali (SD) medja kienet 74 (SD 27) siegħa.
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 (see section 4.4).
Maltese: Ġew irrappurtati reazzjonijiet avversi severi tal-ġilda (SCARs - severe cutaneous adverse reactions) inkluż is-sindrome ta' Stevens-Johnson (SJS - Stevens-Johnson syndrome) u nekrolisi tossika talepidermide (TEN - toxic epidermal necrolysis), li jistgħu jkunu ta' periklu għall-ħajja jew fatali (ara sezzjoni 4.4).
English: Aranesp 10 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 15 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 20 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 30 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 40 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 50 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 60 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 80 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 100 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 130 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 150 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 300 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 500 micrograms solution for injection in pre-filled pen (SureClick) darbepoetin alfa
Maltese: Aranesp 10 mikrogrammi soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 15-il mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 20 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 30 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 50 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 80 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 130 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 150 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Aranesp 500 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) darbepoetin alfa
English: Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and
Maltese: Sors: jinkludi 8 studji randomised, double-blind, ikkontrollati bi plaċebo (980291-skeda 1 u 2, 980297, 990114,
English: Amgen S.r.l Tel: +39 02 6241121
Maltese: Tel: +39 02 6241121
English: b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, pulmonary embolism, as well as thrombosis in device from SOC product issues.
Maltese: b Ir-reazzjonijiet avversi avvenimenti tromboemboliċi jinkludu PT emboliżmu, trombożi, trombożi tal-vini profondi, trombożi tal-vini jugulari, trombożi venuża, trombożi arterjali, trombożi tal-vina pelvika, emboliżmu periferali, emboliżmu pulmonari kif ukoll trombożi fl-apparat minn kwistjonijiet tal-SOC tal-prodott.
English: There have been reports of serious hypersensitivity reactions including anaphylactic reaction, angioedema, allergic bronchospasm, skin rash and urticaria associated with darbepoetin alfa.
Maltese: Kien hemm rapporti ta' reazzjonijiet ta' sensittività eċċessiva serji inkluż reazzjoni anafilattika, anġjoedima, bronkospażmu allerġiku, raxx tal-ġilda u urtikarja assoċjati ma' darbepoetin alfa.
English: In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).
Maltese: Fil-każ ta' poliċitemija, Aranesp għandu jitwaqqaf temporanjament (ara sezzjoni 4.2 ).
English: • an observed 9% increase in risk for PD or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
Maltese: • żieda osservata fir-riskju ta' 9% għal PD jew mewt fil-grupp ta' epoetin alfa flimkien ma' SOC minn analiżi primarja u żieda fir-riskju ta' 15% li ma tistax tiġi eliminata b'mod statistiku f'pazjenti b'kanċer metastastiku fis-sider li kienu qed jirċievu kimoterapija meta ngħata biex tintlaħaq mira ta' konċentrazzjoni ta' emoglobina ta' 10 sa 12 g/dL (6.2 sa 7.5 mmol/L).
English: Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies
Maltese: Pazjenti b'tumuri solidi (eż., tumuri fil-pulmun, fis-sider, fil-kolon, fl-ovarji) u tumuri limfojdi malinni (eż., limfoma, mijeloma multipla) ħadu sehem fl-istudji kliniċi.
English: It may harm them,
Maltese: DAĦĦAL il-labra ġol-ġilda.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 130 µg injection
Maltese: Aranesp 130 µg injezzjoni
English: • Store the pre-filled pen in the refrigerator (2ºC - 8ºC).
Maltese: • Aħżen il-pinna mimlija għal-lest fi friġġ (2ºC - 8ºC).
English: These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 mcg/kg weekly and 3 to 9 mcg/kg every two weeks).
Maltese: Dawn ilparametri kienu konsistenti ma' farmakokinetika lineari mad-doża fuq firxa wiesa' ta' dożi (0.5 sa 8 mcg/kg kull ġimgħa u 3 sa 9 mcg/kg kull ġimagħtejn).
English: The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
Maltese: Il-half-life terminali ta' darbepoetin alfa hija 21 siegħa (SD 7.5) meta mogħti ġol-vina.
English: Aranesp contains sodium
Maltese: Aranesp fih is-sodium
English: The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Maltese: Is-sustanza attiva ta' Aranesp hija darbepoetin alfa li hija magħmula permezz ta' teknoloġija ġenetika fiċ-Ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO-K1 - Chinese Hamster Ovary K1 Cells).
English: Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Maltese: N-linked, filwaqt li l-ormon endoġenu u l-eritropoetini rikombinanti umani (r-HuEPO - recombinant human erythropoietin) għandhom tlieta.
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: Il-ħin medjan għall-progressjoni (TTP) ibbażat fuq il-marda progressiva determinata mill-investigatur (PD) kien ta' 7.5 xhur fil-grupp ta' epoetin alfa flimkien ma' SOC u 7.5 xhur fil-grupp tal-SOC (HR 1.099, CI ta' 95 %: 0.998, 1.210).
English: Where the same sampling duration was used, observed pharmacokinetic data and population pharmacokinetic modelling demonstrated that the pharmacokinetics of darbepoetin alfa was similar for paediatric and adult patients with CRF.
Maltese: Fejn intuża l-istess tul ta' teħid ta' kampjuni, data farmakokinetika u mudellar farmakokinetiku tal-popolazzjoni osservati wrew li l-farmakokinetika ta' darbepoetin alfa kienet simili għall-pazjenti adulti u pazjenti tfal li għandhom CRF.
English: Haemoglobin concentrations were corrected to ≥ 10 g/dL in > 98% (p < 0.001) of paediatric patients administered darbepoetin alfa once weekly and 84% (p = 0.293) once every two weeks.
Maltese: Il-konċentrazzjonijiet talemoglobina ġew ikkoreġuti għal ≥ 10 g/dL f'> 98% (p < 0.001) tal-pazjenti pedjatriċi mogħtija darbepoetin alfa darba fil-ġimgħa u f'84% (p = 0.293) mogħtija darbepoetin alfa darba kull ġimagħtejn.
English: • Allergic reactions
Maltese: • Reazzjonijiet allerġiċi
English: Source: includes 8 randomised, double-blind, placebo-controlled studies (980291-schedule 1 and 2, 980297, 990114, 20000161, 20010145, 20030232, and 20070782) a Hypersensitivity events includes all events under the hypersensitivity SMQ.
Maltese: Sors: Jinkludi 5 studji, randomised, double-blind, ikkontrollati b'mod attiv, (970200, 970235, 980117, 980202, u 980211) minbarra r-reazzjoni avversa ta' puplesija li ġiet identifikata bħala reazzjoni avversa fl-istudju TREAT (studju 20010184).
English: In clinical studies, an increased risk of death, serious cardiovascular or cerebrovascular events including stroke, and vascular access thrombosis was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dL (7.5 mmol/L).
Maltese: Fi studji kliniċi, żieda fir-riskju ta' mewt, avvenimenti kardjovaskulari jew ċerebrovaskulari serji inkluż puplesija, u trombożi ta' aċċess vaskulari kienu osservati meta ESAs ingħataw biex jimmiraw għal emoglobina ta' aktar minn 12 g/dL (7.5 mmol/L).
English: In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001).
Maltese: Fi studju prospettiv, randomised, double-blind, ikkontrollat bil-plaċebo, li sar fuq 344 pazjent anemiku b'tumuri malinni limfoproliferattivi li kienu qed jirċievu kimoterapija, kien hemm tnaqqis sinifikanti fil-ħtiġijiet ta' trasfużjoni u titjib fir-rispons tal-emoglobina (p < 0.001).
English: The primary efficacy endpoint [change in haemoglobin between baseline and the evaluation period (week 21-28)] was comparable between the two groups.
Maltese: Il-punt finali primarju tal-effikaċja [bidla fl-emoglobina bejn il-linja bażi u l-perjodu ta' evalwazzjoni (ġimgħa 21-28)] kien komparabbli bejn iż-żewġ gruppi.
English: OTHER Amgen Europe B.V.
Maltese: OĦRAJN Amgen Europe B.V.
English: There have been reports, from post-marketing experience, of serious hypersensitivity reactions including anaphylactic reaction, angioedema, allergic bronchospasm, skin rash and urticaria associated with darbepoetin alfa.
Maltese: Kien hemm rapporti, minn esperjenza ta' wara t-tqegħid fis-suq, ta' reazzjonijiet ta' sensittività eċċessiva serji inkluż reazzjoni anafilattika, anġjoedima, bronkospażmu allerġiku, raxx tal-ġilda u urtikarja assoċjati ma' darbepoetin alfa.
English: Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater in vivo activity.
Maltese: Minħabba l-kontenut akbar ta' karboidrati, darbepoetin alfa għandu half-life terminali itwal minn r-HuEPO, u għalhekk għandu attività in vivo akbar.
English: • non-inferiority of darbepoetin alfa to placebo for overall survival and progression free survival in patients with advanced stage non-small cell lung cancer receiving chemotherapy when administered to a target haemoglobin of 12 g/dL (7.5 mmol/L) (see section 5.1).
Maltese: • nuqqas ta' inferjorità ta' darbepoetin alfa għal plaċebo għal sopravivenza globali u sopravivenza mingħajr progressjoni f'pazjenti b'kanċer tal-pulmun mhux taċ-ċellula żgħira fi stadju avvanzat meta ngħata biex tintlaħaq mira ta' emoglobina ta' 12 g/dL (7.5 mmol/L) (ara sezzjoni 5.1).
English: At the final analysis, 1,653 deaths were reported.
Maltese: Fl-analiżi finali, ġew irrappurtati 1,653 każ ta' mewt.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Maltese: Epoetins mhumiex approvati fl-immaniġġjar ta' anemija assoċjata ma' epatite Ċ.
English: Leave the pre-filled syringe at room temperature for approximately 30 minutes.
Maltese: Ħalli s-siringa mimlija għal-lest f'temperatura ambjentali għal bejn wieħed u ieħor 30 minuta.
English: Convulsions have been reported in patients receiving darbepoetin alfa (see section 4.4).
Maltese: Konvulżjonijiet kienu irrappurtati f'pazjenti li kienu qed jirċievu darbepoetin alfa (ara sezzjoni 4.4).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Maltese: Il-farmakokinetika ta' darbepoetin alfa ġiet studjata klinikament f'pazjenti b'insuffiċjenza renali kronika wara għoti ġol-vina u taħt il-ġilda.
English: Aranesp 10 micrograms solution for injection in pre-filled syringe Aranesp 15 micrograms solution for injection in pre-filled syringe Aranesp 20 micrograms solution for injection in pre-filled syringe Aranesp 30 micrograms solution for injection in pre-filled syringe Aranesp 40 micrograms solution for injection in pre-filled syringe Aranesp 50 micrograms solution for injection in pre-filled syringe Aranesp 60 micrograms solution for injection in pre-filled syringe Aranesp 80 micrograms solution for injection in pre-filled syringe Aranesp 100 micrograms solution for injection in pre-filled syringe Aranesp 130 micrograms solution for injection in pre-filled syringe Aranesp 150 micrograms solution for injection in pre-filled syringe Aranesp 300 micrograms solution for injection in pre-filled syringe Aranesp 500 micrograms solution for injection in pre-filled syringe darbepoetin alfa
Maltese: Aranesp 10 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 15-il mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 20 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 30 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 50 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 80 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 130 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 150 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Aranesp 500 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest darbepoetin alfa
English: • Your thigh
Maltese: • tqila;
English: - Your doctor should try to keep your haemoglobin between 10 and 12 g/dL.
Maltese: - It-tabib tiegħek għandu jipprova jżomm l-emoglobina tiegħek bejn 10 u 12 g/dL.
English: c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations.
Maltese: e Ir-reazzjoni avversa raxx tinkludi PT raxx, raxx pruritiku, raxx ġeneralizzat, rash papulari, ħmura, raxx bil qxur, raxx makulopapulari, raxx vesikulari kif ukoll raxx pustulari minn SOC
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Maltese: Każijiet kienu rrappurtati f'pazjenti bl-epatite Ċ ittrattati b'interferon u ribavirin, meta jintużaw epoetins fl-istess waqt.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 150 µg injection
Maltese: Aranesp 150 µg injezzjoni
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or whose transferrin saturation is below 20%.
Maltese: Terapija supplementari bil-ħadid hija rakkomandata għall-pazjenti kollha b'valuri ta' ferritin fis-serum taħt 100 mcg/L jew li għandhom saturazzjoni ta' transferrin taħt 20%.