FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional study in 27 patients was used to show that Exelon capsules and oral solution produced similar levels of the active substance in the blood.
Maltese: Intuża studju ieħor fuq 27 pazjent biex juri li l-kapsuli u s-soluzzjoni orali Exelon ipproduċew livelli simili tas-sustanza attiva fid-demm.
English: Exelon is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Exelon jintuża fit-trattament ta' pazjenti b'dimenzja tat-tip Alzheimer minn ħafifa għal moderatament gravi, li hija tip ta' disturb tal-moħħ progressiv li jolqot gradwalment il-memorja, l-abilità intellettwali u l-imġiba.
English: Exelon capsules have also been studied in 541 patients with dementia due to Parkinson's disease.
Maltese: Il-kapsuli Exelon ġew studjati fuq 541 pazjent b'dimenzja kkaġunata mill-marda ta' Parkinson.
English: What is Exelon?
Maltese: X'inhu Exelon?
English: Why has Exelon been approved?
Maltese: Għaliex ġie approvat Exelon?
English: The CHMP concluded that Exelon has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Maltese: Is-CHMP ikkonkluda li Exelon għandu effikaċja modesta fit-trattament tas-sintomi tad-dimenzja ta' Alzheimer, minkejja li dan tabilħaqq iġib benefiċċju importanti lil uħud mill-pazjenti.
English: Exelon has been studied in mild to moderately severe Alzheimer's disease.
Maltese: Exelon ġie studjat fil-marda ta' Alzheimer minn ħafifa għal moderatament gravi.
English: Exelon was more effective than placebo at controlling symptoms.
Maltese: Irriżulta li Exelon kien aktar effikaċi mill-plaċebo fil-kontroll tas-sintomi.
English: The patients with dementia due to Parkinson's disease taking Exelon capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Maltese: Il-pazjenti b'dimenzja kkaġunata mill-marda ta' Parkinson li ġew ittrattati bil-kapsuli Exelon urew titjib fis-sintomi konjittivi ta' 2.1 punti apparagun mat-taħżin ta' 0.7 punti irreġistrat fil-pazjenti li ħadu plaċebo, minn valur inizjali ta' 24 punt.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Exelon's benefits did not outweigh its risks.
Maltese: Għall-ewwel ilKumitat ikkonkluda li għat-trattament tad-dimenzja kkaġunata mill-marda ta' Parkinson, il-benefiċċji ta' Exelon ma kinux ogħla mir-riskji tiegħu.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Maltese: Ir-rivastigmina taħdem billi timblokka l-enzimi li jkissru laċetilkolina: l-aċetilkolinesterażi u l-butirilkolinesterażi.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Maltese: Fil-pazjenti b'dimenzja tat-tip Alzheimer jew b'dimenzja kkaġunata mill-marda ta' Parkinson ċerti ċelluli nervużi tal-moħħ imutu, u dan jikkawża livelli baxxi tan-newrotrażmettitur aċetilkolina (sustanza kimika li tippermetti ċċelluli nervużi jikkomunikaw ma' xulxin).
English: Exelon must also not be used in patients who are suspected to have had in the past a severe allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
Maltese: Exelon ma għandux jintuża minn pazjenti li dwarhom ikun hemm suspett li fl-imgħoddi seta' kellhom reazzjonijiet allerġiċi severi msejħa ‘dermatite allerġika tal-kuntatt' għall-istikk Exelon.
English: In the three studies of Exelon capsules in patients with Alzheimer's dementia, patients taking doses of Exelon between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Maltese: Fit-tliet studji li saru fuq ilkapsuli Exelon fil-pazjenti bid-dimenzja ta' Alzheimer, il-pazjenti li ħadu dożi ta' Exelon ta' bejn 6 u 9 mg kuljum kellhom żieda medja ta' 0.2 punti fis-sintomi konjittivi, mill-valur inizjali ta' 22.9 punti talbidu tal-istudju; aktar ma jkun baxx il-punteġġ, aħjar ikun ir-riżultat li tilħaq it-terapija.
English: See the summary of product characteristics (also part of the EPAR) for detailed information.
Maltese: Ara s-sommarju tal-karatteristiċi tal-prodott (ukoll parti mill-EPAR) għal informazzjoni dettaljata.
English: By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
Maltese: Billi jimblokka dawn l-enzimi, Exelon jippermetti żieda fil-livelli tal-aċetilkolina fil-moħħ, u għaldaqstant jgħin fit-tnaqqis tas-sintomi taddimenzja tat-tip Alzheimer u tad-dimenzja kkaġunata mill-marda ta' Parkinson.
English: How has Exelon been studied?
Maltese: Kif ġie studjat Exelon?
English: What is the risk associated with Exelon?
Maltese: X'inhu r-riskju assoċjat ma' Exelon?
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi f'żewġ oqsma prinċipali: konjittiv (il-ħila tal-ħsieb, tat-tagħlim u tal-ftakir) u globali (taħlita ta' bosta oqsma fosthom il-funzjonament ġenerali, is-sintomi konjittivi, l-imġiba u l-kapaċità li jsiru l-attivitajiet ta' kuljum).
English: Other information about Exelon
Maltese: Aktar tagħrif dwar Exelon
English: The types of side effects seen with Exelon depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Maltese: It-tipi ta' effetti sekondarji osservati bl-użu ta' Exelon jiddependu mit-tip ta' dimenzja li tkun qed tiġi ttrattata u minn jekk ikunx qed jintużaw il-kapsuli, is-soluzzjoni orali jew l-istikk transdermiku.
English: Date of last renewal: 19 May 2006
Maltese: Data ta' l-aħħar tiġdid: 19 Mejju 2006
English: 4817 ZK Breda
Maltese: NL-4817 ZK Breda
English: Placental transfer was minimal.
Maltese: Ittrasferiment mill-plaċenta kien minimu.
English: Thromboembolic Events
Maltese: Avvenimenti tromboemboliċi
English: Amgen Europe B.V. Minervum 7061
Maltese: Il-Manifattur Amgen Europe B.V. Minervum 7061
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Maltese: Riskju relattiv għola ta' avveniment thromboemboliċi (RR 1.67, 95% CI: 1.35, 2.06, 35 studju u 6769 pazjent) ġew osservati f' pazjenti kkurati b' eritropoetin uman rikombinanti.
English: Click
Maltese: KLIK
English: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6 Juncos, PR 00777-4060
Maltese: PO Box 4060, Road 31 km 24.6
English: Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 patients who received r-HuEPO.
Maltese: Tagħrif ippreżentat minn studji kkontrollati inkludew 1357 pazjenti, 766 li ngħataw Nespo u 591 pazjent li ngħataw r-HuEPO.
English: • alcohol wipes or similar.
Maltese: • msielaħ ta' l-alkoħol jew simili;
English: Italy
Maltese: MALTI
English: In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
Maltese: Fil-każ ta' poliċitemija, Nespo għandu jitwaqqaf temporanjament (ara sezzjoni 4.2 ).
English: Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
Maltese: Reazzjonijiet avversi ġew determinati fuq l-informazzjoni li nġabret minn sebgħa studji, randomised, double-blind, kkontrollati bi plaċebo ta' Nespo b' total ta' 2112-il pazjent (Nespo 1200, plaċebo 912).
English: Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies (e.g., lymphoma, multiple myeloma) were enrolled in the clinical studies.
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: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA)
English: Very Common (≥ 1/10)
Maltese: Komuni ħafna (≥1/10)
English: Do not shake.
Maltese: Nespo jiġi f' kunjetti.
English: IV/SC 1 ml
Maltese: IV/SC
English: Nespo (SureClick) comes in a pre-filled pen that contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of the active substance darbepoetin alfa.
Maltese: Nespo (SureClick) jiġi ġo pinna mimlija għal-lest li fiha 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 jew 500 mikrogramma tas-sustanza attiva darbepoetin alfa.
English: Nespo comes in a pre-filled syringe that contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of the active substance darbepoetin alfa.
Maltese: Nespo jiġi ġo siringa mimlija għal-lest li fiha 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 jew 500 mikrogramma tas-sustanza attiva darbepoetin alfa.
English: Nespo 10 micrograms solution for injection in a pre-filled syringe Nespo 15 micrograms solution for injection in a pre-filled syringe Nespo 20 micrograms solution for injection in a pre-filled syringe Nespo 30 micrograms solution for injection in a pre-filled syringe Nespo 40 micrograms solution for injection in a pre-filled syringe Nespo 50 micrograms solution for injection in a pre-filled syringe Nespo 60 micrograms solution for injection in a pre-filled syringe Nespo 80 micrograms solution for injection in a pre-filled syringe Nespo 100 micrograms solution for injection in a pre-filled syringe Nespo 130 micrograms solution for injection in a pre-filled syringe Nespo 150 micrograms solution for injection in a pre-filled syringe Nespo 300 micrograms solution for injection in a pre-filled syringe Nespo 500 micrograms solution for injection in a pre-filled syringe
Maltese: Nespo 10 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 15-il mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 20 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 30 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 40 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 50 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 60 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 80 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 100 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 130 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 150 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 300 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Nespo 500 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest
English: Leave the pre-filled syringe at room temperature for approximately 30 minutes.
Maltese: Ħalliha toqgħod f' temperatura ambjentali għal bejn wieħed u ieħor 30 minuta.
English: • Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria.
Maltese: • Reazzjonijiet allerġiċi, inklużi reazzjonijiet anafilattiċi, anġioedema, raxx tal-ġilda u urtikarja.
English: Common (≥ 1/100 to
Maltese: Komuni (> 1/100 to < 1/10)
English: • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Maltese: • Aplażja pura taċ-ċelluli ħomor (PRCA) - (anemija, għeja mhux tas-soltu, nuqqas ta' enerġija)
English: Nespo comes in a vial that contains either 15, 25, 40 or 60 micrograms of the active substance darbepoetin alfa.
Maltese: Nespo jiġi ġo kunjett ta' 15-il, 25, 40 jew 60 mikrogramma tas-sustanza attiva darbepoetin alfa.
English: Nespo works in exactly the same way as the natural hormone erythropoietin.
Maltese: Nespo jaħdem eżattament fl-istess mod bħall-ormon naturali eritropojetina.
English: Thromboembolic events, including pulmonary embolism
Maltese: Komuni (> 1/100 to < 1/10) Avvenimenti tromboemboliċi, inkluż emboliżmu pulmonari
English: Clinical Trial Experience
Maltese: Jekk klinikament
English: In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis.
Maltese: Fil-grupp ta' Nespo, 83% kienu fuq dijaliżi u 17% ma kienux fuq
English: • 2.25 micrograms (once weekly) of Nespo per kilogram of your body weight.
Maltese: • 2.25 mikrogrammi (darba fil-ġimgħa) ta' Nespo għal kull kilogramma tal-piż ta' ġismek.
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-placebo r-ratio ta' periklu ta' l-għejxien kien bejn 1.25 u 2.47 favur dawk li rċevew ilkontroll.
English: Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Maltese: Nespo fih ukoll sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 u ilma għall-injezzjoni.
English: Appropriate dose titration between 500 μg, 300 μg, and 150 μg should be considered.
Maltese: Aġġustament xieraq fid-doża ta' bejn 500 μg, 300 μg, u 150 μg għandu jiġi
English: In clinical studies, minimal accumulation was observed with either route of administration.
Maltese: Fl-istudji kliniċi, akkumulazzjoni minima ġiet osservata fiż-żewġ modi ta' teħid.
English: Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with recombinant erythropoietic proteins, including darbepoetin alfa.
Maltese: Aplażja pura ta' ċelluli ħomor ikkawżata minn anitkorpi anti-eritropojetin newtralizzanti ġiet irrappurtata b'assoċazzjoni ma' kura bi proteini rikombinanti eritropojetiċi, inkluża darbepoetin alfa.
English: Clearance of darbepoetin alfa is 1.9 ml/hr/kg (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/kg).
Maltese: Il-clearance ta' darbepoetin alfa hija ta' 1.9 ml/siegħa/kg (SD 0.56) u l-volum ta' distribuzzjoni (Vss) huwa bejn wieħed u ieħor l-istess bħall-volum tal-plażma (50 ml/kg).
English: • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy) Convulsions (fits and seizures) have been reported in patients treated with Nespo.
Maltese: • Aplażja pura taċ-ċelluli ħomor (PRCA) - (anemija, għeja mhux tas-soltu, nuqqas ta' enerġija) Konvulżjonijiet (aċċessjonijiet jew puplesiji) ġew rrappurtati f' pazjenti kkurati b'Nespo.
English: In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
Maltese: Fi studju prospettiv, randomised double-blind, ikkontrollat bil-plaċebo, li sar fuq 314-il pazjent b'kanċer fil-pulmun li kienu qed jirċievu kimoterapija li fiha l-platinum, kien hemm tnaqqis sinifikattiv fil-ħtiġijiet ta' trasfużjoni (p < 0.001).
English: A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 µg/kg darbepoetin alfa administered SC every 3 weeks in combination with chemotherapy was conducted which allowed for full characterisation of the terminal half-life.
Maltese: Sar studju farmakokinetiku f' pazjenti b' anemija kkawżata mill-kimoterapija, dawn ngħataw 6.75 µg/kg darbepoetin alfa taħt il-ġilda darba kull tliet ġimgħat flimkien mal-kimoterapija, b' hekk saret karatterizazzjoni kompleta tal-half-life terminali.
English: The active substance of Nespo is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Maltese: Is-sustanza attiva ta' Nespo hija darbepoetin alfa li hija magħmula b'teknoloġija ġenetika fiċĊelluli Ovarji tal-Ħamster Ċiniż (CHO-K1).
English: Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed.
Maltese: Ġie osservat ukoll titjib fl-għeja li ġie mkejjel bil-kejl Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue).
English: • convulsions (fits or seizures);
Maltese: • konvulżjonijiet (aċċessjonijiet jew puplesiji);
English: In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
Maltese: Fi studji qabel l-użu kliniku, intwera li l-clearance renali hija minima (sa 2% il-clearance totali), u ma teffettwax il-half life fis-serum.
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 fit-tul ta' ħajja u żjieda fl-imwiet attribwiti ma' progressjoni tal-mard f' 4 xhur f' pazjenti b' kanċer metastastiku fis-sider, li qed jirċievu l-kimoterapija, meta ngħatalhom biex jintlaħaq targit ta' emoglobina ta' 12-14 g/dl (7.5 - 8.7 mmol/l)
English: Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Maltese: Darbepoetin alfa tistimola l-eritropojeżi bl-istess mekkaniżmu ta' l-ormon endoġenu.
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'tumur malinn limfoproliferiku li kienu qed jirċievu kimoterapija, kien hemm tnaqqis sinifikattiv filħtiġijiet ta' trasfużjoni u titjib fir-rispons ta' l-emoglobina (p < 0.001).
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: Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80
Maltese: Nespo fih ukoll sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride,
English: SureClick x1
Maltese: Tħawwadx.
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 għandha half-life terminali itwal minn r-HuEPO, u għalhekk għandha attività in vivo akbar.
English: In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
Maltese: Fi studji kliniċi kkontrollati, l-użu ta' Nespo u aġenti li jistimolaw l-eritropojesi (ESAs) wera:
English: In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.
Maltese: Meta jkun hemm insuffiċjenza tal-kliewi, il-kilwa ma tipproduċix biżżejjed mill-ormon naturali eritropojetina li ta' spiss tikkawża anemija.
English: Pharmacotherapeutic group: Anti-anaemic ATC Code: B03XA02.
Maltese: Anti-anemiku Kodiċi ATC:
English: Rotate injection site:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: In clinical studies, an increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Maltese: Fi studji kliniċi, riskju għola ta' mewt, avvenimenti kardjovaskulari serji u trombożi ta'aċċess vaskulari ġew osservati meta aġenti li jistimolaw l-eritropojesi (ESAs) ġew mogħtija biex jintlaħaq targit ta' lemoglobina ta' aktar minn 12g/dl (7.5 mmol/l).
English: Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Maltese: Sensittività eċċessiva għal darbepoetin alfa, r-HuEPO jew għal xi sustanzi mhux attivi.
English: • high blood pressure which is being controlled with medicines prescribed by your doctor;
Maltese: • pressjoni għolja li mhix qed tiġi kkurata b'mediċini oħra mogħtija mit-tabib tiegħek;
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: Varjazzjoni fl-emoglobina għandha tiġi ndirizzata permezz ta' immaniġjar tad-doża, b' kunsiderazzjoni għat-targit ta' l-emoglobina ta' 10g/dl (6.2 mmol/l) għal 12 g/dl (7.5mmol/l).
English: In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
Maltese: F' dan l-istudju, il-half-life terminali (SD) kienet 74 (SD 27) siegħa .
English: Nespo 20 µg injection Darbepoetin alfa SC
Maltese: Nespo 20 µg injezzjoni Darbepoetin alfa SC
English: These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/kg weekly and 3 to 9 µg/kg every two weeks).
Maltese: Dawn ilparametri kienu konsistenti ma' farmakokinetiċi tad-doża linjari fuq medda wiesa' ta' dożi (0.5 sa 8 μg/kg kull ġimgħa u 3 sa 9 μg/kg kull ġimagħtejn).
English: • 0.45 micrograms once weekly
Maltese: • 0.45 mikrogrammi (darba fil-ġimgħa).
English: Bioavailability is 37% with subcutaneous administration.
Maltese: Il-biodisponibilità fil-ġisem hija ta' 37% bl-għoti taħt il-ġilda.
English: Following subcutaneous administration of 2.25 µg/kg to adult cancer patients a mean peak concentration of 10.6 ng/ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours (SD 19.7).
Maltese: 6 ng/ml (SD 5.9) ta' darbepoetin alfa ntlaħqet f' ħin medju ta' 91 siegħa (SD 19.7).
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Maltese: Il-konċentrazzjoni targit ta' l-emoglobina f' żewġ studji kienet > 13 g/dl; fit-tlitt studji l-oħra kienet 12-14 g/dl.
English: BLISTERED PRE-FILLED SYRINGE LABEL
Maltese: Inċidenza fis-suġġett
English: However, there is potential for an interaction with drugs that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Maltese: Madankollu, jista' jkun hemm potenzjal għal interazzjoni ma' mediċini li jeħlu b'mod qawwi maċċelluli ħomor tad-demm eżempju, cyclosporin, tacrolimus.
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 l-għoti ġol-vina u taħt il-ġilda.
English: Hypertension
Maltese: FARMAKOLOĠIKU
English: The Nespo (SureClick) pre-filled pen delivers the complete dose of each presentation.
Maltese: Il-pinna mimlija għal-lest b' Nespo (SureClick) tagħti d-doza kompleta li msemmija fuq il-pakkett.
English: Nespo 130 µg injection Darbepoetin alfa
Maltese: Nespo 130 µg injezzjoni Darbepoetin alfa
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-eritropojetina umana rikombinanti (r-HuEPO) għandhom tlieta.
English: Keep this leaflet.
Maltese: Fażi ta' korrezzjoni
English: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.
Maltese: Kura ta' l-anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (CRF) f' pazjenti adulti u
English: Nespo 500 µg injection Darbepoetin alfa
Maltese: Nespo 500 µg injezzjoni Darbepoetin alfa
English: For excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1..
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8167 patients).
Maltese: 99, 1.18; 42 studji u 8167 pazjenti).