FrancophonIA/ELRC3.0 huggingface dataset:
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 sinifikanti fil-ħtiġijiet ta' trasfużjoni (p < 0.001).
English: In a randomised, double-blind, placebo-controlled study (TREAT) 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 (with darbepoetin alfa rescue at haemoglobin less than 9 g/dL).
Maltese: Fi studju randomised, double-blind, ikkontrollat bil-plaċebo (TREAT) ta' 4,038 pazjent b'CRF mhux fuq dijalisi b'dijabete tat-tip 2 u b'livelli ta' emoglobina ≤ 11 g/dL, il-pazjenti rċevew trattament b'darbepoetin alfa għal-livelli mmirati ta' emoglobina ta' 13 g/dL jew plaċebo (b'salvataġġ b'darbepoetin alfa meta l-livell ta' emoglobina ikun inqas minn 9 g/dL).
English: Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with ESAs, including Aranesp.
Maltese: Aplasija pura taċ-ċelluli ħomor ikkawżata minn anitkorpi newtralizzanti anti-eritropoetin ġiet irrappurtata f'assoċjazzjoni ma' ESAs, inkluż Aranesp.
English: In clinical studies, minimal accumulation was observed with either route of administration.
Maltese: Fi studji kliniċi, akkumulazzjoni minima ġiet osservata biż-żewġ rotot ta' għoti.
English: Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC alone group (HR 1.07, 95% CI: 0.97, 1.18).
Maltese: Ilmedjan tas-sopravivenza globali fil-grupp ta' epoetin alfa flimkien ma' SOC kien ta' 17.8 xhur meta mqabbel ma' 18-il xahar fil-grupp ta' SOC waħdu (HR 1.07, CI ta' 95 %: 0.97, 1.18).
English: Stroke was reported as common in CRF patients in TREAT (see section 5.1).
Maltese: Puplesija kienet irrappurtata bħala komuni f'pazjenti b'CRF fi TREAT (ara sezzjoni 5.1).
English: INFORMATION IN BRAILLE Aranesp 130 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 130 siringa
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-kliewi ma tipproduċux biżżejjed ormon naturali eritropoetina li ta' spiss jista' jikkawża anemija.
English: It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Maltese: Huwa normali li tara taqtira likwidu fit-tarf tal-labra jew fuq il-protezzjoni tas-sigurtà s-safra.
English: Stroke was identified as an adverse reaction in an additional clinical study (TREAT, see section 5.1).
Maltese: Puplesija kienet identifikata bħala reazzjoni avversa fi studju kliniku ieħor (TREAT, ara sezzjoni 5.1).
English: Check the expiry date on the pre-filled syringe label (EXP).
Maltese: Iċċekkja d-data ta' meta tiskadi fuq it-tikketta tas-siringa mimlija għal-lest (EXP).
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see sections 4.2 and 4.4).
Maltese: Ġiet osservata xejra lejn stimi ta' żieda fir-riskju għal mortalità kkawżata minn kull kawża, każijiet kardjovaskulari u ċerebrovaskulari assoċjati ma dożi kumulattivi ogħla ta' ESA indipendentement mill-istat ta' dijabete jew dijalisi (ara sezzjonijiet 4.2 u 4.4).
English: HR 1.05, 95% CI (0.94, 1.17)), or all-cause mortality or end stage renal disease (ESRD) (darbepoetin alfa vs placebo; HR 1.06, 95% CI (0.95, 1.19)).
Maltese: L-istudju ma laħaq l-ebda għan ewlieni li juri tnaqqis fir-riskju ta' mortalità minn kull kawża jew morbidità kardjovaskulari (darbepoetin alfa vs plaċebo; HR 1.05, CI ta' 95% (0.94, 1.17)), jew mortalità minn kull kawża jew marda tal-kliewi tal-aħħar stadju (ESRD - end stage renal disease) (darbepoetin alfa vs placebo;
English: - Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Maltese: - Ġew irrappurtati reazzjonijiet serji tal-ġilda inkluż is-sindrome ta' Stevens-Johnson (SJSStevens-Johnson syndrome) u nekrolisi tossika tal-epidermide (TEN - toxic epidermal necrolysis) f'assoċjazzjoni ma' trattament b'epoetin.
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 u konsistenti f'pazjenti li għandhom anemija assoċjata ma' diversi tipi ta' kanċer komuni li rċevew eritropoetina rikombinanti umana meta mqabbla mal-kontrolli.
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 flgħeja kif imkejjel permezz tal-iskala Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue).
English: In a randomised, double-blind, placebo-controlled phase 3 study 2,549 adult patients with anaemia receiving chemotherapy for the treatment of advanced stage non-small cell lung cancer (NSCLC), were randomised 2:1 to darbepoetin alfa or placebo and treated to a maximum Hb of 12 g/dL.
Maltese: Fi studju randomised, double-blind, ikkontrollat bi plaċebo tal-fażi 3, 2,549 pazjent adult b'anemija li kienu qed jirċievu l-kimoterapija għat-trattament tal-kanċer tal-pulmun mhux taċ-ċellula żgħira fi stadju avvanzat (NSCLC), ġew randomised 2:1 għal darbepoetin alfa jew plaċebo u trattati għal Hb massima ta' 12 g/dL.
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: It-tneħħija ta' darbepoetin alfa hija ta' 1.9 mL/siegħa/kg (SD 0.56) u lvolum ta' distribuzzjoni (Vss) huwa bejn wieħed u ieħor l-istess bħall-volum tal-plażma (50 mL/kg).
English: Syringe label Used syringe barrel
Maltese: Molla protetiva tallabra użata
English: INFORMATION IN BRAILLE Aranesp 130 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 130 pinna
English: Following subcutaneous administration of 2.25 mcg/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: Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using the “Rule of three”.
Maltese: Skont il-Linja Gwida tas-Sommarju talKaratteristiċi tal-Prodott (Reviżjoni 2, Settembru 2009), il-frekwenza ta' reazzjonijiet avversi identifikati flambjent ta' wara t-tqegħid fis-suq ġiet determinata bl-użu tar-“Regola ta' tlieta”.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aranesp 200 mcg injection
Maltese: U MNEJN GĦANDU JINGĦATA Aranesp 200 mcg injezzjoni
English: • Fluid retention (oedema)
Maltese: • Żamma ta' fluwidu (edima)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aranesp 25 mcg injection
Maltese: U MNEJN GĦANDU JINGĦATA Aranesp 25 mcg injezzjoni
English: NAME OF THE MEDICINAL PRODUCT Aranesp 80 µg injection
Maltese: Aranesp 80 µg injezzjoni
English: Treatment of paediatric patients younger than 1 year of age has not been studied in randomised clinical trials (see section 5.1).
Maltese: It-trattament ta' pazjenti pedjatriċi b'età inqas minn sena għadha ma ġietx studjata fi provi kliniċi randomised (ara sezzjoni 5.1).
English: The reported risk of thrombotic vascular events (TVEs) should be carefully weighed against the benefits to be derived from treatment with darbepoetin alfa particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g., deep venous thrombosis, pulmonary embolism, and cerebral vascular accident).
Maltese: Ir-riskju rrappurtat ta' avvenimenti vaskulari trombotiċi (TVEs) għandu jiġi ppeżat b'attenzjoni kontra l-benefiċċji li għandhom jinkisbu minn trattament b'darbepoetin alfa b'mod partikolari f'pazjenti b'fatturi ta' riskju eżistenti minn qabel għal TVE, inklużi l-obeżità u storja preċedenti ta' TVEs (eż. trombożi fil-vina fonda, emboliżmu pulmonari, u aċċident vaskulari ċerebrali).
English: • Convulsions (fits and seizures)
Maltese: • Konvulżjonijiet (aċċessjonijiet u attakki ta' puplesija)
English: • 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or
Maltese: • 500 mikrogramma darba kull tliet ġimgħat (6.75 mikrogramma ta' Aranesp għal kull kilogramma ta' piż tal-ġisem tiegħek) jew
English: Aranesp 25 micrograms solution for injection in vial Each vial contains 25 micrograms of darbepoetin alfa in 1 mL (25 mcg/mL).
Maltese: Aranesp 25 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 25 mikrogramma ta' darbepoetin alfa f'1 mL (25 mcg/mL).
English: Stretch method
Maltese: Il-metodu tal-qarsa
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 in association with epoetin treatment.
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARs - severe cutaneous adverse reactions) inkluż issindrome ta' Stevens-Johnson (SJS - Stevens-Johnson syndrome) u nekrolisi tossika tal-epidermide (TEN - toxic epidermal necrolysis), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, ġew irrappurtati f'assoċjazzjoni ma' trattament b'epoetin.
English: b Stroke events includes PT haemorrhagic stroke, ischaemic stroke, cerebrovascular accident, and stroke in evolution.
Maltese: b L-avvenimenti ta' puplesija jinkludu PT puplesija emorraġika, puplesija iskemika, aċċident ċerebrovaskulari, u puplesija fl-evoluzzjoni.
English: Treatment with Aranesp should be temporarily discontinued if haemoglobin levels exceed 13 g/dL (8.1 mmol/L).
Maltese: It-trattament b'Aranesp għandu jitwaqqaf temporanjament jekk il-livelli tal-emoglobina jaqbżu it-13 g/dL (8.1 mmol/L).
English: A risk to the suckling child cannot be excluded.
Maltese: Riskju għat-tarbija li qed terda' ma jistax jiġi eskluż.
English: INFORMATION IN BRAILLE Aranesp 150 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 150 siringa
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' sopravivenza globali u żieda fl-imwiet attribwiti għal progressjoni tal-marda wara 4 xhur f'pazjenti b'kanċer metastastiku fis-sider li kienu qed jirċievu kimoterapija, meta ngħata biex tintlaħaq mira ta' emoglobina ta' 12-14 g/dL (7.5-8.7 mmol/L).
English: However, there is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Maltese: Madankollu, jista' jkun hemm potenzjal ta' interazzjoni ma' sustanzi li jeħlu b'mod qawwi maċċelluli ħomor tad-demm eż. cyclosporin, tacrolimus.
English: INFORMATION IN BRAILLE Aranesp 150 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 150 pinna
English: • Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Maltese: • Ġie rrappurtat raxx serju tal-ġilda inkluż is-sindrome ta' Stevens-Johnson u nekrolisi tossika talepidermide f'assoċjazzjoni ma' trattament b'epoetin.
English: AMQ e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema.
Maltese: aċċess vaskulari fid-dijalisi e Ir-reazzjoni avversa raxx/ħmura tinkludi PT raxx, raxx pruritiku, raxx makulari, raxx ġeneralizzat, ħmura.
English: Adult patients with chronic renal failure
Maltese: Pazjenti adulti li għandhom insuffiċjenza renali kronika
English: • Alcohol wipes
Maltese: Labra użata
English: NAME OF THE MEDICINAL PRODUCT Aranesp 20 µg injection
Maltese: Aranesp 20 µg injezzjoni
English: INFORMATION IN BRAILLE Aranesp 500 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 500 siringa
English: Thromboembolic eventsc
Maltese: Kif taħżen Aranesp
English: INFORMATION IN BRAILLE Aranesp 80 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 80 pinna
English: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Maltese: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 mikrogramma soluzzjoni għallinjezzjoni ġo pinna mimlija għal-lest
English: Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial Aranesp is administered either subcutaneously or intravenously as described in the posology.
Maltese: Aranesp 25, 40, 60, 100, 200, 300 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Aranesp jingħata taħt il-ġilda jew fil-vini kif deskritt fil-pożoloġija.
English: Darbepoetin alfa did not reveal any genotoxic potential nor did it have any effect on the proliferation of non-haematological cells in vitro or in vivo.
Maltese: Darbepoetin alfa 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: NAME OF THE MEDICINAL PRODUCT Aranesp 300 µg injection
Maltese: Aranesp 300 µg injezzjoni
English: INFORMATION IN BRAILLE Aranesp 80 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 80 siringa
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Maltese: B IMBOTTA l-planġer bil-mod u bi presjoni konstanti sakemm tħoss jew tisma' “tfaqqiħa”.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 60 µg injection
Maltese: Aranesp 60 µg injezzjoni
English: NAME OF THE MEDICINAL PRODUCT Aranesp 50 µg injection
Maltese: Aranesp 50 µg injezzjoni
English: NAME OF THE MEDICINAL PRODUCT Aranesp 15 µg injection
Maltese: Aranesp 15 µg injezzjoni
English: NAME OF THE MEDICINAL PRODUCT Aranesp 40 µg injection
Maltese: Aranesp 40 µg injezzjoni
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2
English: INFORMATION IN BRAILLE Aranesp 300 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 300 siringa
English: INFORMATION IN BRAILLE Aranesp 20 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 20 pinna
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 globali bejn pazjenti li ġew ittrattati b'eritropoetina rikombinanti umana u dawk li rċevew kontroll.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 100 µg injection
Maltese: Aranesp 100 µg injezzjoni
English: INFORMATION IN BRAILLE Aranesp 20 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 20 siringa
English: • increased risk of death when administered to target a haemoglobin of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Maltese: • żieda fir-riskju ta' mewt meta ngħata biex tintlaħaq mira ta' emoglobina ta' 12 g/dL (7.5 mmol/L) f'pazjenti b'tumur malinn attiv li ma kinux qed jirċievu la kimoterapija u lanqas terapija ta' radjazzjoni.
English: Aranesp 200 micrograms solution for injection in vial Each vial contains 200 micrograms of darbepoetin alfa in 1 mL (200 mcg/mL).
Maltese: Aranesp 200 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 200 mikrogramma ta' darbepoetin alfa f'1 mL (200 mcg/mL).
English: Amgen Biotechnologia Sp. z o.o.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: Paediatric population with chronic renal failure
Maltese: Pazjenti b'insuffiċjenza renali kronika
English: • Cotton ball or gauze pad
Maltese: Soluzzjoni ċara u bla kulur
English: In a randomised clinical study 114 paediatric patients aged 2 to 18 with chronic kidney disease receiving or not receiving dialysis who were anaemic (haemoglobin < 10.0 g/dL) and not being treated with an ESA were administered darbepoetin alfa weekly (n = 58) or once every two weeks (n = 56) for the correction of anaemia.
Maltese: Fi studju kliniku randomised 114-il pazjent pedjatriku ta' età minn 2 sa 18-il sena b'marda kronika talkliewi li kienu qed jirċievu dijalisi jew li ma kienux qed jirċievu dijalisi, li kienu anemiċi (emoglobina < 10.
English: Aranesp 60 micrograms solution for injection in vial.
Maltese: Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni f'kunjett.
English: EU/1/01/185/032 4 Pack Blister
Maltese: EU/1/01/185/032 pakkett folja ta' 4
English: Aranesp 25 micrograms solution for injection in vial.
Maltese: Aranesp 25 mikrogramma soluzzjoni għall-injezzjoni f'kunjett.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aranesp 300 mcg injection
Maltese: U MNEJN GĦANDU JINGĦATA Aranesp 300 mcg injezzjoni
English: INFORMATION IN BRAILLE Aranesp 500 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 500 pinna
English: INFORMATION IN BRAILLE Aranesp 100 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 100 pinna
English: Sodium phosphate dibasic
Maltese: Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80
English: The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
Maltese: Is-siringa mimlija għal-lest fiha 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 jew 500 mikrogramma ta' darbepoetin alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 25 micrograms darbepoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 1 mL fih 25 mikrogramma darbepoetin alfa.
English: INFORMATION IN BRAILLE Aranesp 40 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 40 pinna
English: INFORMATION IN BRAILLE Aranesp 10 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 10 siringa
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: Aranesp għandu jingħata taħt il-ġilda lil pazjenti b'anemija (eż. konċentrazzjoni ta' emoglobina ≤ 10 g/dL (6.2 mmol/L) sabiex l-emoglobina tiżdied għal mhux aktar minn 12 g/dL (7.5 mmol/L).
English: INFORMATION IN BRAILLE Aranesp 50 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 50 pinna
English: Skin and subcutaneous tissue disorders
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: NAME OF THE MEDICINAL PRODUCT Aranesp 10 µg injection
Maltese: Aranesp 10 µg injezzjoni
English: Aranesp 200 micrograms solution for injection vial EU/1/01/185/108 1 Pack
Maltese: Aranesp 200 mikrogramma soluzzjoni għall-injezzjoni f'kunjett EU/1/01/185/108 Pakkett ta' 1
English: Paediatric chronic renal failure population
Maltese: Jekk għandek insuffiċjenza renali kronika
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 60 micrograms darbepoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 1 mL fih 60 mikrogramma darbepoetin alfa.
English: Marketing Authorisation Holder Amgen Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqeghid fis-Suq Amgen Europe B.V.
English: • 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.
Maltese: • 2.25 mikrogramma (darba fil-ġimgħa) ta' Aranesp għal kull kilogramma ta' piż tal-ġisem tiegħek.
English: INFORMATION IN BRAILLE Aranesp 50 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 50 siringa
English: INFORMATION IN BRAILLE Aranesp 100 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 100 siringa
English: Cases of severe hypertension have been observed following overdose with Aranesp (see section 4.4).
Maltese: Każijiet ta' pressjoni għolja severa kienu osservati wara doża eċċessiva b'Aranesp (ara sezzjoni 4.4).
English: Aranesp 300 micrograms solution for injection in vial Each vial contains 300 micrograms of darbepoetin alfa in 1 mL (300 mcg/mL).
Maltese: Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 300 mikrogramma ta' darbepoetin alfa f'1 mL (300 mcg/mL).
English: INFORMATION IN BRAILLE Aranesp 60 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 60 siringa
English: Aranesp 300 micrograms solution for injection in vial.
Maltese: Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni f'kunjett.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/071
Maltese: FIS-SUQ EU/1/01/185/071
English: Aranesp 25 micrograms solution for injection vial EU/1/01/185/100 1 Pack
Maltese: Aranesp 25 mikrogramma soluzzjoni għall-injezzjoni f'kunjett EU/1/01/185/100
English: Aranesp 40 micrograms solution for injection vial EU/1/01/185/102 1 Pack
Maltese: Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni f'kunjett EU/1/01/185/102 Pakkett ta' 1
English: INFORMATION IN BRAILLE Aranesp 300 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 300 pinna
English: INFORMATION IN BRAILLE Aranesp 30 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 30 pinna
English: Aranesp 15 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Maltese: Aranesp 15-il mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 15-il mikrogramma ta' darbepoetin alfa f'0.375 mL (40 mcg/mL).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/033
Maltese: FIS-SUQ EU/1/01/185/033
English: In a clinical study in 124 paediatric patients with chronic kidney disease receiving or not receiving dialysis aged 1 to 18, patients that were stable on epoetin alfa were randomised to receive either darbepoetin alfa administered once weekly (subcutaneously or intravenously) using a dose conversion ratio of 238:1 or to continue with epoetin alfa therapy at the current dose, schedule, and route of administration.
Maltese: Fi studju kliniku f'124 pazjent pedjatriku b'marda kronika tal-kliewi li kienu qed jirċievu dijalisi, jew li ma kienux qed jirċievu dijalisi, ta' età minn sena sa 18-il sena, pazjenti li kienu stabbli fuq epoetin alfa kienu randomised biex jirċievu darbepoetin alfa mogħti darba fil-ġimgħa (taħt il-ġilda jew filvina) bl-użu ta' proporzjon ta' konverżjoni tad-doża ta' 238: 1 jew biex ikomplu b'terapija b'epoetin alfa bid-doża, skeda, u rotta ta' għoti kurrenti.
English: EU/1/01/185/111 4 Pack
Maltese: EU/1/01/185/111 Pakkett ta' 4
English: INFORMATION IN BRAILLE Aranesp 15 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 15 pinna
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Maltese: Tnaqqis paradossali fl-emoglobina u żvilupp ta' anemija severa assoċjata ma' għadd baxx ta' retikuloċiti għandhom iwasslu għal twaqqif tat-trattament b'epoetin u għal testijiet għall-antikorpi anti-eritropoetin.
English: More severe cases have been observed with long-acting epoetins.
Maltese: Tnejn mill-istudji rreġistraw pazjenti li kien qed jiġu ttrattati bilkimoterapija.
English: Aranesp 60 micrograms solution for injection in vial Each vial contains 60 micrograms of darbepoetin alfa in 1 mL (60 mcg/mL).
Maltese: Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 60 mikrogramma ta' darbepoetin alfa f'1 mL (60 mcg/mL).
English: Solution for injection (injection) in pre-filled pen (SureClick).
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni) ġo pinna mimlija għal-lest (SureClick).