FrancophonIA/ELRC3.0 huggingface dataset:
English: Nespo 150 µg injection Darbepoetin alfa
Maltese: Nespo 150 µg injezzjoni Darbepoetin alfa
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1 (20 April 2007) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazjoni (MAH) għat-Tqegħid fuq is-Suq jikkommetti ruħu li jwettaq l-istudji u l-attivitajiet miżjuda ta' farmakoviġilanza kif dettaljat fil-Pjan ta' Famakoviġilanza, kif miftiehem fil-verżjoni 1 (20 ta' April 2007) tal-Pjan ta' Mmaniġġjar ta' Riskju (RMP) ippresentata f'Modulu 1.8.2. ta' l-Applikazzjoni għal l-Awtorizzazjoni għat-Tqegħid fis-Suq u kull tiġdid sussegwenti ta' lRMP kif miftiehem mis-CHMP.
English: Nespo 80 µg injection Darbepoetin alfa
Maltese: Nespo 80 µg injezzjoni Darbepoetin alfa
English: Nespo 15 µg injection Darbepoetin alfa
Maltese: Nespo 15 µg injezzjoni Darbepoetin alfa
English: Subject Incidence
Maltese: EFFETTI
English: Nespo 300 µg injection Darbepoetin alfa
Maltese: Nespo 300 µg injezzjoni Darbepoetin alfa
English: Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Maltese: Darbepoetin alfa hija magħmula b'teknoloġija ġenetika fiċ-Ċelluli Ovarji tal-Ħamster Ċiniż (CHO
English: ∅ Do not twist the grey needle cap
Maltese: Pazjenti tfal li għandhom insuffiċjenza renali kronika
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), ESAs are not indicated for use in this patient population.
Maltese: • tnaqqis fil-ħin għal progress ta' tumur f'pazjenti b'kanċer avvanzat fir-ras u fl-għonq li qed jirċievu kura bir-raġġi meta mogħti biex tintlaħaq emoglobina ta' aktar minn 14 g/dl (8.7 mmol/l), l-użu ta' ESAs mhux indikat f' din il-popolazzjoni ta' pazjenti.
English: These measures will help to protect the environment.
Maltese: Nespo ma ġiex ittestjat f'nisa tqal.
English: Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Maltese: L-inċidenza ta' effetti mhux mixtieqa meqjusa bħala relatati mal-kura b'Nespo fi studji kliniċi kontrollati huma dawn:
English: Treatment with Nespo should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.1 mmol/l).
Maltese: Il-kura b' Nespo għandha titwaqqaf temporanjament jekk il-livell ta' l-emoglobina jaqbeż it-13g/dl (8.1mmol/l).
English: Nespo 30 µg injection Darbepoetin alfa
Maltese: Nespo 30 µg injezzjoni Darbepoetin alfa
English: Nespo 10 µg injection Darbepoetin alfa
Maltese: Nespo 10 µg injezzjoni Darbepoetin alfa
English: Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/kg, the terminal half-life was 73 hours (SD 24).
Maltese: Wara l-għoti ta' darbepoetin alfa darba fix-xahar, b' dożi taħt il-ġilda li jvarjaw bejn 0.6 u 2.1 µg/kg, il-half-life terminali kienet ta' 73 siegħa (SD 24).
English: Disposing of used syringes
Maltese: Meta tuża mediċini oħra
English: For the purpose of ambulatory use, Nespo may be removed from storage once for a maximum single period of seven days at room temperature (up to 25°C).
Maltese: Għall-iskop ta' l-użu ambulatorju, Nespo jista' jitneħħa mill-friġġ darba għal perijodu wieħed ta' massimu ta' sebgħat ijiem f' temperatura ambjentali (sa 25°C).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 25 micrograms of darbepoetin alfa in 1 ml (25 µg/ml).
Maltese: Kull kunjett fih 25 mikrogramma ta' darbepoetin alfa f' 1 ml (25 µg/ml).
English: Nespo is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.
Maltese: Nespo tintuża biex tikkura l-anemija sintomatika f'pazjenti adulti bil-kanċer li għandhom tumuri malinni mhux majelojdi u li qed jirċievu l-kimoterapija.
English: 1 ml
Maltese: Nespo 100 µg
English: Nespo 50 µg injection Darbepoetin alfa
Maltese: Nespo 50 µg injezzjoni Darbepoetin alfa
English: Paediatric patients with chronic renal failure
Maltese: Pazjenti b' insuffiċjenza renali kronika
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Maltese: Kura ta' l-anemija sintomatika f' pazjenti adulti u f' pazjenti tfal li għandhom insuffiċjenza renali
English: In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/dl (7.5 mmol/l), the dosage adaptation described in section 4.2 should be closely respected, in order to minimise the potential risk of thromboembolic events.
Maltese: Jekk il-livell ta' l-emoglobina jaqbeż it-12 g/dl (7.5 mmol/l) f' pazjenti b'tumuri solidi jew limfoproliferattivi, l-addattament tad-doża kif deskritt f'sezzjoni 4.2 għandu jiġi rispettat b'attenzjoni, sabiex jitnaqqas ir-riskju potenzjali ta' episodji tromboemboliċi.
English: EXP.:
Maltese: Ftakar:
English: Nespo 40 µg injection Darbepoetin alfa
Maltese: Nespo 40 µg injezzjoni Darbepoetin alfa
English: Nespo 20 µg injection Darbepoetin alfa
Maltese: Nespo 20 µg injezzjoni Darbepoetin alfa
English: Nespo 100 µg injection Darbepoetin alfa
Maltese: Nespo 100 µg injezzjoni Darbepoetin alfa
English: What Nespo contains
Maltese: QABEL MA TUŻA NESPO
English: Nespo should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl (6.2 mmol/l)) in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l).
Maltese: Nespo għandu jingħata taħt il-ġilda lil pazjenti b' anemija (eżempju: konċentrazzjoni ta' emoglobina ≤10 g/dl (6.2 mmol/l) sa biex l-emoglobina tiżdied b' mhux aktar minn 12g/dl (7.5 mmol/l).
English: The initial weekly dose of Nespo (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 200.
Maltese: Id-doża tal-bidu ta' Nespo ta' kull ġimgħa (μg/ġimgħa) tista' tiġi ddeterminata billi tiddividi d-doża totali fil-ġimgħa ta' r-HuEPO (IU/ġimgħa) b' 200.
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 eċċess ta' mortalità statistikament sinnifikanti mhux spejgat f' pazjenti li għandhom anemija assoċjata ma' varji tipi ta' kanċer komuni li rċevew eritropoeitin rikombinanti uman meta mqabbla mal-kontrolli.
English: Nespo did not reveal any genotoxic potential nor did it have any effect on the proliferation of nonhaematological cells in vitro or in vivo.
Maltese: Nespo ma wera l-ebda potenzjal ġenotossiku u ma kellu l-ebda effett fuq il-proliferazzjoni ta' ċelluli mhux ematoloġiċi in vitro jew in vivo.
English: Nespo 60 µg injection Darbepoetin alfa
Maltese: Nespo 60 µg injezzjoni Darbepoetin alfa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 60 micrograms of darbepoetin alfa in 1 ml (60 µg/ml).
Maltese: Kull kunjett fih 60 mikrogramma ta' darbepoetin alfa f' 1 ml (60 µg/ml).
English: Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF who were either receiving or not receiving dialysis determined pharmacokinetic profiles for sampling periods up to 1 week (168 hours) after a single subcutaneous or intravenous dose.
Maltese: Valutazzjoni ta' farmokinetika ta' darbepoetin alfa f' pazjenti tfal (3 sa 16-il sena) li għandhom CRF li kienu qed jirċievu jew li ma kienux qed jirċievu dijalisi ddetermina profili farmakokinetiċi għal sampling ta' perijodi sa ġimgħa (168 siegħa) wara doża waħda taħt il-ġilda jew ġol-vina.
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 open-label ma kien hemm l-ebda differenza fl-għejxien bejn pazjenti li ġew kkurati b' eritropoetina rikombinanti umana u dawk li rċevew kontroll.
English: Nespo should be used with caution in patients with epilepsy.
Maltese: Nespo għandu jintuża b' attenzjoni f' pazjenti li għandhom epilessija.
English: Nespo is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children.
Maltese: Nespo jintuża biex jikkura l-anemija sintomatika li hija assoċjata ma' insuffiċjenza renali kronika (insuffiċjenza tal-kliewi) f' adulti u fi tfal.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Nespo 15 micrograms solution for injection in a vial Nespo 25 micrograms solution for injection in a vial Nespo 40 micrograms solution for injection in a vial Nespo 60 micrograms solution for injection in a vial darbepoetin alfa Please read this leaflet carefully before you start using this medicine.
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Nespo 15-il mikrogramma soluzzjoni għall-injezzjoni ġo kunjett Nespo 25 mikrogramma soluzzjoni għall-injezzjoni ġo kunjett Nespo 40 mikrogramma soluzzjoni għall-injezzjoni ġo kunjett Nespo 60 mikrogramma soluzzjoni għall-injezzjoni ġo kunjett darbepoetin alfa Aqra sew dan il-fuljett kollu qabel tibda tuża din il-mediċina.
English: Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
Maltese: Infezzjonijiet li jitfaċċaw minn żmien għal ieħor, episodji ta' infjammazjoni jew trawma, telf ta' demm (li ma jidhirx waqt eżami mediku), emoliżi, tossiċità severa ta' aluminju, mard ematoloġiku moħbi, jew fibrożi fil-mudullun jistgħu wkoll jikkompromettu r-rispons eritropojetiku.
English: • a new Nespo pre-filled syringe; and
Maltese: • siringa mimlija għal-lest b'Nespo ġdida; u
English: Avoid areas with scars or stretch marks.
Maltese: Evita siti b' marki ta' ġrieħi u stretch marks.
English: In order to correct your anaemia, your initial dose will be • 500 micrograms once every three weeks (6.75 micrograms of Nespo per kilogram of your body
Maltese: Sabiex tiġi korretta l-anemija tiegħek, id-doża tal-bidu tiegħek tkun ta' • 500 mikrogramma darba kull tliet ġimgħat (6.75 mikrogrammi ta' Nespo għal kull kilogramma
English: 0.3 ml
Maltese: B03XA02.
English: Each 0.3 ml pre-filled syringe contains30 micrograms darbepoetin alfa (100 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.3 ml fiha 30 mikrogramma darbepoetin alfa (100 mikrogramma/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 40 micrograms of darbepoetin alfa in 1 ml (40 µg/ml).
Maltese: Kull kunjett fih 40 mikrogramma ta' darbepoetin alfa f' 1 ml (40 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 ml pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/ml).
Maltese: Kull siringa mimlija għal-lest ta' 0.4 ml fiha 10 mikrogrammi darbepoetin alfa (25 mikrogramma/ml).
English: Poorly controlled hypertension.
Maltese: GĦAMLA KWALITATTIVA
English: Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
Maltese: Minħabba kontenut ogħla ta' karboidrati f' darbepoetin alfa, il-livell ta' darbepoetin alfa fiċċirkolazzjoni jibqa' 'l fuq mill-konċentrazzjoni stimolatorja minima għall-eritropojeżi għal żmien itwal mid-doża molari ekwivalenti ta' r-HuEPO.
English: Your normal dialysis routine will not affect the ability of Nespo to treat your anaemia.
Maltese: Ir-rutina normali ta' dijalisi tiegħek mhix se teffettwa l-kapaċità ta' Nespo biex tikkuralek l-anemija.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 ml pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.3 ml fiha 60 mikrogramma darbepoetin alfa (200 mikrogramma/ml).
English: EU/1/01/184/005 1 pack EU/1/01/184/006 4 pack
Maltese: EU/1/01/184/006 Pakkett Folja ta' 4 EU/1/01/184/035
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 ml pre-filled pen contains 10 micrograms darbepoetin alfa (25 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.4 ml fiha 10 mikrogrammi darbepoetin alfa (25 mikrogramma/ml).
English: Nespo 10 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 15 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 20 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 30 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 40 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 50 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 60 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 80 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 100 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 130 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 150 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 300 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 500 micrograms solution for injection in a pre-filled pen (SureClick)
Maltese: Nespo 150 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick) Nespo 300 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest (SureClick)
English: • High blood pressure (hypertension) • Fluid retention (oedema)
Maltese: • Biċċiet ta' demm magħqud (trombożi)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 25 micrograms darbepoetin alfa.
Maltese: Kull kunjett ta' 1 ml fih 25 mikrogramma darbepoetin alfa.
English: Very rare (seen in less than 1 in 10,000 people)
Maltese: Rari ħafna (seħħew f' anqas minn persuna waħda f'kull 10,000 persuna)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 ml pre-filled pen contains 80 micrograms darbepoetin alfa (200 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.4 ml fiha 80 mikrogramma darbepoetin alfa (200 mikrogramma/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 micrograms of darbepoetin alfa in 1 ml (15 µg/ml).
Maltese: Kull kunjett fih 15-il mikrogramma ta' darbepoetin alfa f' 1 ml (15 µg/ml).
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or whose transferrin saturation is below 20%.
Maltese: Kura supplementari bil-ħadid hija rakkomandata għall-pazjenti kollha b' livelli ta' ferritin fis-serum taħt 100 μg/l jew li għandhom saturazzjoni ta' transferrin taħt 20%.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 ml (40 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 15-il mikrogramma ta' darbepoetin alfa f' 0.375 ml (40 µg/ml).
English: Serious allergic reactions which may include:
Maltese: Reazzjonijiet allerġiċi serji li jistgħu jinkludu:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 ml pre-filled pen contains 20 micrograms darbepoetin alfa (40 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.5 ml fiha 20 mikrogramma darbepoetin alfa (40 mikrogramma/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 ml pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.4 ml fiha 40 mikrogramma darbepoetin alfa (100 mikrogramma/ml).
English: EU/1/01/184/031 1 pack EU/1/01/184/032 4 pack
Maltese: EU/1/01/184/032 Pakkett Folja ta' 4 EU/1/01/184/044
English: If the bone marrow is consistent with PRCA, testing for anti-erythropoietin antibodies should be performed.
Maltese: Jekk il-mudullun hu konsistenti ma' aplażja pura ta' ċelluli ħomor (PRCA), għandhom jsiru testijiet għal anitkorpi anti-eritropojetiċi.
English: 9 Unlocked
Maltese: Tqala u treddigħ
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 ml (40 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 15-il mikrogramma ta' darbepoetin alfa f' 0.375 ml (40 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 ml pre-filled pen contains 50 micrograms darbepoetin alfa (100 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 0.5 ml fiha 50 mikrogramma darbepoetin alfa (100 mikrogramma/ml).
English: 0.65 ml
Maltese: Nespo 500 µg
English: Nespo 60 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Maltese: Nespo 60 mikrogramma soluzzjoni għall-injezzjoni ġo kunjett Darbepoetin alfa
English: X Locked
Maltese: X'fih Nespo
English: Count slowly to 15 seconds for injection to end.
Maltese: Għodd bil-mod sa 15-il sekonda sa kemm tispiċċa l-injezzjoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 ml (200 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 130 mikrogramma ta' darbepoetin alfa f' 0.65 ml (200 µg/ml).
English: To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2.
Maltese: Biex tevita li tgħawweġ il-labra, aqla' bil-mod l-għatu minn mal-labra mingħajr ma ddawwar jew tgħawweġ kif muri fi stampi 1 u 2.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib sa biex jiġi assigurat li tintuża l-anqas doża ta' Nespo approvata biex jiġi pprovdut kontroll fuq is-sintomi ta' l-anemija.
English: EU/1/01/184/017 1 pack EU/1/01/184/018 4 pack
Maltese: EU/1/01/184/018 Pakkett Folja ta' 4 EU/1/01/184/041
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/ml).
Maltese: Kull siringa mimlija għal-lest fiha 500 mikrogramma ta' darbepoetin alfa f' 1 ml (500 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.5 ml pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/ml).
Maltese: Kull siringa mimlija għal-lest ta' 0.5 ml fiha 20 mikrogramma darbepoetin alfa (40 mikrogramma/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml pre-filled pen contains 500 micrograms darbepoetin alfa (500 micrograms/ml).
Maltese: Kull pinna mimlija għal-lest ta' 1 ml fiha 500 mikrogramma darbepoetin alfa (500 mikrogramma/ml).
English: Patients should be monitored closely, if the haemoglobin exceeds 12 g/dl (7.5 mmol/l), the dose should be reduced by approximately 25 to 50%.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib, jekk l-emoglobina taqbeż it-12g/dl (7.5mmol/l), iddoża għandha titnaqqas b'bejn wieħed u ieħor 25 u 50%.
English: If the rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50%.
Maltese: Jekk l-emoglobina tgħola b' aktar minn 2 g/dl (1.25 mmol/l) f' erba' ġimgħat, id-doża trid titnaqqas b' bejn 25% u 50%.
English: EU/1/01/184/070 4 Pack Blister
Maltese: EU/1/01/184/057 - 4 pack
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Maltese: Sintomi u problemi ta' anemija jistgħu jvarjaw skond l-età, is-sess, u l-piż ta' mard fuq kollox; evalwazzjoni minn tabib ta' l-istat kliniku u l-kundizzjoni tal-pazjent huma neċessarji.
English: • Your doctor should try to keep your haemoglobin between 10 and 12 g/dl.
Maltese: • It-tabib tiegħek għandu jipprova jżommlok l-emoglobina tiegħek bejn 10 u 12 g/dl.
English: The vials are made from type 1 glass with fluoropolymer coated rubber stoppers.
Maltese: Il-kunjetti huma magħmula minn ħġieġ Tip I b' tappijiet tal-lastiku b' rita ta' fluoropolymer.
English: • Sudden life-threatening allergic reactions (anaphylaxis)
Maltese: • Reazzjonijiet allerġiċi f'daqqa li jistgħu jkunu ta' periklu għal ħajja (anafilassi)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 ml (200 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 80 mikrogramma ta' darbepoetin alfa f' 0.4 ml (200 µg/ml).
English: CLIC
Maltese: SC
English: The recommended initial dose is 500 μg (6.75 μg/kg) given once every three weeks, or once weekly dosing can be given at 2.25 μg/kg body weight.
Maltese: Id-doża rakkomandata fil-bidu hija ta' 500 μg (6.75 μg/kg) mogħtija darba kull tliet ġimgħat, jew 2.25 μg/kg piż tal-ġisem mogħtija darba fil-ġimgħa .
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 ml pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/ml).
Maltese: Kull siringa mimlija għal-lest fiha 150 mikrogramma ta' darbepoetin alfa f' 0.3 ml (500 µg/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml vial 60 micrograms darbepoetin alfa.
Maltese: Kull kunjett ta' 1 ml fih 60 mikrogramma darbepoetin alfa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 ml (200 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 100 mikrogramma ta' darbepoetin alfa f' 0.5 ml (200 µg/ml).
English: Nespo is a sterile but unpreserved product.
Maltese: Nespo hija soluzzjoni sterili iżda mhux ppreservata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 ml (500 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 300 mikrogramma ta' darbepoetin alfa f' 0.6 ml (500 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 ml (200 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 60 mikrogramma ta' darbepoetin alfa f' 0.3 ml (200 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 ml (100 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 40 mikrogramma ta' darbepoetin alfa f' 0.4 ml (100 µg/ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 130 micrograms of darbepoetin alfa in 0.65 ml (200 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 130 mikrogramma ta' darbepoetin alfa f' 0.65 ml (200 µg/ml).
English: Manufacturer:
Maltese: MANIFATTURI
English: Nespo 500 micrograms solution for injection in a pre-filled syringe Darbepoetin alfa
Maltese: Nespo 500 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 10 mikrogrammi ta' darbepoetin alfa f' 0.4 ml (25 µg/ml).
English: EU/1/01/184/015 1 pack EU/1/01/184/016 4 pack
Maltese: EU/1/01/184/016 Pakkett Folja ta' 4 EU/1/01/184/040
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 500 micrograms of darbepoetin alfa in 1 ml (500 µg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 500 mikrogramma ta' darbepoetin alfa f' 1 ml (500 µg/ml).
English: A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided.
Maltese: Għandhom jiġu evitati żjidiet fl-emoglobina ta' aktar minn 2g/dl (1.25 mmol/l) fuq perijodu ta' erba' ġimgħat.
English: The safety and effectiveness of once every three weeks dosing of Nespo therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Maltese: Is-sigurtà u l-effikaċja ta' ddożar ta' Nespo darba kull tliet ġimgħat biex titnaqqas il-ħtieġa ta' trasfużjonijiet ta' ċelluli ħomor tad-demm f' pazjenti li kienu qed jirċievu l-kimoterapija ġew assessjati fi studju randomized, double-blind, multi-nazzjonali.