FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 200 micrograms darbepoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 1 mL fih 200 mikrogramma darbepoetin alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/043
Maltese: FIS-SUQ EU/1/01/185/043
English: Dialysis vascular access thrombosisd
Maltese: Aplasija pura taċ-ċelluli ħomor
English: INFORMATION IN BRAILLE Aranesp 40 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 40 siringa
English: Aranesp 80 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL).
Maltese: Aranesp 80 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 80 mikrogramma ta' darbepoetin alfa f'0.4 mL (200 mcg/mL).
English: Aranesp 25 micrograms solution for injection in vial Aranesp 40 micrograms solution for injection in vial Aranesp 60 micrograms solution for injection in vial Aranesp 100 micrograms solution for injection in vial Aranesp 200 micrograms solution for injection in vial Aranesp 300 micrograms solution for injection in vial darbepoetin alfa
Maltese: Aranesp 25 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Aranesp 200 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni f'kunjett darbepoetin alfa
English: Aranesp 60 micrograms solution for injection vial EU/1/01/185/104 1 Pack
Maltese: Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni f'kunjett EU/1/01/185/104
English: INFORMATION IN BRAILLE Aranesp 10 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 10 pinna
English: EU/1/01/185/062 - 4 pack
Maltese: EU/1/01/185/062 - Pakkett ta' 4
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/036
Maltese: FIS-SUQ EU/1/01/185/036
English: INFORMATION IN BRAILLE Aranesp 60 pen
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 60 pinna
English: Convulsions were common in the placebo groups.
Maltese: Konvulżjonijiet kienu komuni fil-gruppi tal-plaċebo.
English: Aranesp 150 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL).
Maltese: Aranesp 150 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 150 mikrogramma ta' darbepoetin alfa f'0.3 mL (500 mcg/mL).
English: Aranesp 100 micrograms solution for injection vial EU/1/01/185/106 1 Pack
Maltese: Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni f'kunjett EU/1/01/185/106 Pakkett ta' 1
English: INFORMATION IN BRAILLE Aranesp 30 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 30 siringa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 30 µg injection
Maltese: Aranesp 30 µg injezzjoni
English: EU/1/01/185/101 4 pack
Maltese: EU/1/01/185/101 Pakkett ta' 4
English: Treatment of symptomatic chemotherapy-induced anaemia in cancer patients
Maltese: Trattament ta' anemija sintomatika kkawżata minn kimoterapija f'pazjenti bil-kanċer
English: Aranesp 40 micrograms solution for injection in vial Each vial contains 40 micrograms of darbepoetin alfa in 1 mL (40 mcg/mL).
Maltese: Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 40 mikrogramma ta' darbepoetin alfa f'1 mL (40 mcg/mL).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/034
Maltese: FIS-SUQ EU/1/01/185/034
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/042
Maltese: FIS-SUQ EU/1/01/185/042
English: Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 mcg/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 minn 0.6 sa 2.1 mcg/kg, il-half-life terminali kienet ta' 73 siegħa (SD 24).
English: EU/1/01/185/014 4 Pack Blister
Maltese: EU/1/01/185/014 pakkett folja ta' 4
English: INFORMATION IN BRAILLE Aranesp 15 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Aranesp 15 siringa
English: Aranesp 100 micrograms solution for injection in vial Each vial contains 100 micrograms of darbepoetin alfa in 1 mL (100 mcg/mL).
Maltese: Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 100 mikrogramma ta' darbepoetin alfa f'1 mL (100 mcg/mL).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/044
Maltese: FIS-SUQ EU/1/01/185/044
English: Aranesp 15 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.42 mg of sodium in 0.375 mL.
Maltese: Aranesp 15-il mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 1.42 mg ta' sodium f'0.375 mL.
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 mmirata tal-emoglobina f'żewġ studji kienet > 13 g/dL; fit-tliet studji l-oħra din kienet 12-14 g/dL.
English: • The expiry date printed on the label has passed the last day of the month shown.
Maltese: • Id-data ta' meta tiskadi stampata fuq it-tikketta għaddiet l-aħħar ġurnata tax-xahar muri.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 300 micrograms darbepoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 1 mL fih 300 mikrogramma darbepoetin alfa.
English: Aranesp 200 micrograms solution for injection in vial.
Maltese: Aranesp 200 mikrogramma soluzzjoni għall-injezzjoni f'kunjett.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/038
Maltese: FIS-SUQ EU/1/01/185/038
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/035
Maltese: FIS-SUQ EU/1/01/185/035
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/037
Maltese: FIS-SUQ EU/1/01/185/037
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/039
Maltese: FIS-SUQ EU/1/01/185/039
English: Aranesp 130 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL).
Maltese: Aranesp 130 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 130 mikrogramma ta' darbepoetin alfa f'0.65 mL (200 mcg/mL).
English: EU/1/01/185/022 4 Pack Blister
Maltese: EU/1/01/185/022 pakkett folja ta' 4
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 40 micrograms darbepoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 1 mL fih 40 mikrogramma darbepoetin alfa.
English: EU/1/01/185/058 - 4 pack
Maltese: EU/1/01/185/058 - Pakkett ta' 4
English: Other medicines and Aranesp
Maltese: Mediċini oħra u Aranesp
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/040
Maltese: FIS-SUQ EU/1/01/185/040
English: Aranesp 15 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Maltese: Aranesp 15-il mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 15-il mikrogramma ta' darbepoetin alfa f'0.375 mL (40 mcg/mL).
English: • 0.75 micrograms once every two weeks, or
Maltese: • 0.75 mikrogramma darba kull ġimagħtejn, jew
English: Aranesp 150 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL).
Maltese: Aranesp 150 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 150 mikrogramma ta' darbepoetin alfa f'0.3 mL (500 mcg/mL).
English: EU/1/01/185/057 - 4 pack
Maltese: EU/1/01/185/057 - Pakkett ta' 4
English: If clinically indicated, phlebotomy may be performed.
Maltese: Jekk klinikament indikat , tista' ssir flebotomija.
English: In patients with a poor haemoglobin response to Aranesp, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Maltese: F'pazjenti li għandhom rispons batut tal-emoglobina għal Aranesp, għandhom jiġu kkunsidrati spjegazzjonijiet alternattivi għar-rispons batut (ara sezzjonijiet 4.4 u 5.1).
English: NAME OF THE MEDICINAL PRODUCT Aranesp 500 µg injection
Maltese: Aranesp 500 µg injezzjoni
English: Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL).
Maltese: Aranesp 80 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 80 mikrogramma ta' darbepoetin alfa f'0.4 mL (200 mcg/mL).
English: In all paediatric CRF studies, there were no additional adverse reactions identified for paediatric patients compared to those previously reported for adult patients (see section 5.1).
Maltese: Fl-istudji kollha dwar CRF fit-tfal ma kien hemm l-ebda reazzjonijiet avversi addizzjonali identifikati għall-pazjenti pedjatriċi meta mqabbla ma' dawk li kienu rrappurtati qabel għall-pazjenti adulti (ara sezzjoni 5.1).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 100 micrograms darbepoetin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 1 mL fih 100 mikrogramma darbepoetin alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull siringa mimlija għal-lest ta' 0.4 mL fiha 10 mikrogrammi darbepoetin alfa (25 mikrogramma/mL).
English: Aranesp 60 micrograms solution for injection pre-filled syringe EU/1/01/185/013 1 Pack Blister
Maltese: Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest EU/1/01/185/013 Pakkett b'Folja ta' 1
English: EU/1/01/185/020 4 Pack Blister
Maltese: EU/1/01/185/020 pakkett folja ta' 4
English: EU/1/01/185/107 4 Pack
Maltese: EU/1/01/185/107 Pakkett ta' 4
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 sa progressjoni tat-tumur f'pazjenti b'kanċer avanzat fir-ras u fl-għonq li kienu qed jirċievu terapija ta' radjazzjoni meta ngħata biex tintlaħaq emoglobina ta' aktar minn 14 g/dL (8.7 mmol/L), ESAs mhux indikati għall-użu f'din il-popolazzjoni ta' pazjenti.
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-valur tal-emoglobina jaqbeż it-12 g/dL (7.5 mmol/L), f'pazjenti b'tumuri malinni solidi jew limfoproliferattivi, l-adattament tad-doża deskritt fis-sezzjoni 4.2 għandu jiġi rispettat b'attenzjoni, sabiex jitnaqqas ir-riskju potenzjali ta' episodji tromboemboliċi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/072 1 pack
Maltese: FIS-SUQ EU/1/01/185/072 - Pakkett ta' 1
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled pen contains 10 micrograms darbepoetin alfa (25 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pinna mimlija għal-lest ta' 0.4 mL fiha 10 mikrogramma ta' darbepoetin alfa (25 mikrogramma/mL).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 mL pre-filled pen contains 15 micrograms darbepoetin alfa (40 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pinna mimlija għal-lest ta' 0.375 mL fiha 15-il mikrogramma darbepoetin alfa (40 mikrogramma/mL).
English: Aranesp 300 micrograms solution for injection vial EU/1/01/185/110 1 Pack
Maltese: Aranesp 300 mikrogramma soluzzjoni għall-injezzjoni f'kunjett EU/1/01/185/110
English: The frequency is estimated from clinical trial data as uncommon.
Maltese: Il-frekwenza hija stmata minn data minn provi kliniċi bħala mhux komuni.
English: Leave the pre-filled pen at room temperature for at least 30 minutes before injecting.
Maltese: Ħalli l-pinna mimlija għal-lest fit-temperatura tal-kamra għal mill-inqas 30 minuta qabel ma tinjetta.
English: Aranesp 20 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL).
Maltese: Aranesp 20 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 20 mikrogramma ta' darbepoetin alfa f'0.5 mL (40 mcg/mL).
English: Aranesp 100 micrograms solution for injection in vial.
Maltese: Aranesp 100 mikrogramma soluzzjoni għall-injezzjoni f'kunjett.
English: EU/1/01/185/059 - 4 pack
Maltese: EU/1/01/185/059 - Pakkett ta' 4
English: Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL).
Maltese: Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 40 mikrogramma ta' darbepoetin alfa f'0.4 mL (100 mcg/mL).
English: Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children.
Maltese: Aranesp jintuża biex jittratta anemija sintomatika li hija assoċjata ma' insuffiċjenza renali kronika (insuffiċjenza tal-kliewi) f'adulti u fi tfal.
English: Aranesp 60 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL).
Maltese: Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 60 mikrogramma ta' darbepoetin alfa f'0.3 mL (200 mcg/mL).
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Maltese: trombożi u komplikazzjonijiet relatati bejn dawk li rċevew eritropoetina rikombinanti umana u dawk fil-grupp ta' kontroll.
English: Aranesp 25 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Maltese: Aranesp 25 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 3.79 mg ta' sodium.
English: Aranesp 200 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Maltese: Aranesp 200 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 3.79 mg ta' sodium.
English: Aranesp 30 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL).
Maltese: Aranesp 30 mikrogramma soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 30 mikrogramma ta' darbepoetin alfa f'0.3 mL (100 mcg/mL).
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins.
Maltese: Użu taħt il-ġilda huwa ppreferut f'pazjenti li mhux qegħdin fuq dijalisi tad-demm sabiex jiġi evitat titqib tal-vini periferali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/102 1 pack
Maltese: FIS-SUQ EU/1/01/185/102 Pakkett ta' 1
English: EU/1/01/185/073 - 4 pack
Maltese: EU/1/01/185/073 - Pakkett ta' 4
English: A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 mcg/kg darbepoetin alfa administered SC every
Maltese: Sar studju farmakokinetiku f'pazjenti b'anemija kkawżata mill-kimoterapija ttrattati b'6.75 mcg/kg darbepoetin alfa mogħti SC darba kull tliet ġimgħat flimkien ma' kimoterapija li ppermetta karatterizzazzjoni kompluta talhalf-life terminali.
English: In CRF patients on haemodialysis, events of vascular access thrombosis (such as vascular access complication, arteriovenous fistula thrombosis, graft thrombosis, shunt thrombosis, arteriovenous fistula site complication, etc.) have been reported in post-marketing data.
Maltese: F'pazjenti b'CRF fuq emodijalisi, avvenimenti ta' trombożi ta' aċċess vaskulari (bħal kumplikazzjoni fl-aċċess vaskulari, trombożi fil-fistula bejn l-arterja u l-vina, trombożi fil-parti trapjantata, trombożi fix-shunt, kumplikazzjoni fis-sit tal-fistula bejn l-arterja u l-vina, eċċ.) ġew irrappurtati fid-data ta' wara t-tqegħid fis-suq.
English: Aranesp 10 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL).
Maltese: Aranesp 10 mikrogrammi soluzzjoni għall-injezzjoni ġo pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 10 mikrogrammi ta' darbepoetin alfa f'0.4 mL (25 mcg/mL).
English: Aranesp 60 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Maltese: Aranesp 60 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 3.79 mg ta' sodium.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.65 mL pre-filled pen contains 130 micrograms darbepoetin alfa (200 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pinna mimlija għal-lest ta' 0.65 mL fiha 130 mikrogramma darbepoetin alfa (200 mikrogramma/mL).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 mL pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull siringa mimlija għal-lest ta' 0.375 mL fiha 15-il mikrogramma darbepoetin alfa (40 mikrogramma/mL).
English: Please tell your doctor if you are suffering or have suffered from: - high blood pressure which is being controlled with medicines prescribed by your doctor; - sickle cell anaemia; - epileptic fits (seizures); - convulsions (fits or seizures); - liver disease; - significant lack of response to medicines used to treat anaemia; - an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or - hepatitis C.
Maltese: Jekk jogħġbok għid lit-tabib tiegħek jekk qed tbati jew jekk batejt minn: - pressjoni għolja li qed tiġi ttrattata b'mediċini preskritti mit-tabib tiegħek; - anemija tat-tip sickle cell; - attakki ta' epilessija (aċċessjonijiet); - konvulżjonijiet (aċċessjonijiet jew puplesiji); - mard tal-fwied; - nuqqas sinifikanti ta' rispons għal mediċini wżati biex jittrattaw l-anemija; - allerġija għall-latex (l-għatu tal-labra tal-siringa mimlija għal-lest fih sustanza mnissla mill latex); jew - epatite Ċ
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/041
Maltese: FIS-SUQ EU/1/01/185/041
English: EU/1/01/185/018 4 Pack Blister
Maltese: EU/1/01/185/018 pakkett folja ta' 4
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull siringa mimlija għal-lest ta' 0.3 mL fiha 30 mikrogramma ta' darbepoetin alfa (100 mikrogramma/mL).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aranesp 40 mcg injection
Maltese: U MNEJN GĦANDU JINGĦATA Aranesp 40 mcg injezzjoni
English: Injecting Aranesp yourself
Maltese: X'fih Aranesp
English: Aranesp 40 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Maltese: Aranesp 40 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Kull kunjett fih 3.79 mg ta' sodium.
English: EU/1/01/185/067 - 4 pack
Maltese: EU/1/01/185/067 - Pakkett ta' 4
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aranesp 100 mcg injection
Maltese: U MNEJN GĦANDU JINGĦATA Aranesp 100 mcg injezzjoni
English: Aranesp 200 micrograms solution for injection in vial 1 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover.
Maltese: Aranesp 200 mikrogramma soluzzjoni għall-injezzjoni f'kunjett Soluzzjoni għall-injezzjoni ta' 1 mL (200 mcg/mL darbepoetin alfa) f'kunjett magħmul minn ħġieġ tip 1 b'tap magħmul minn fluoropolymer u lastku laminat u siġill tal-aluminju b'għatu flip-off. Daqs tal-pakkett ta' kunjett wieħed jew 4 kunjetti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 80 micrograms darbepoetin alfa (200 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull siringa mimlija għal-lest ta' 0.4 mL fiha 80 mikrogramma ta' darbepoetin alfa (200 mikrogramma/mL).
English: At the time of clinical data cutoff, the median progression free survival (PFS) per investigator assessment of disease progression was 7.4 months in each arm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met.
Maltese: mewt ta' epoetin alfa flimkien ma' standard ta' kura (SOC) kif imqabbel ma' SOC waħdu. Fil-ħin talwaqfien tad-data klinika, il-medjan ta' sopravivenza mingħajr progressjoni (PFS) għal kull stima talinvestigatur tal-progressjoni tal-marda kien ta' 7.4 xhur f'kull grupp (HR 1.09, CI ta' 95 %: 0.99, 1.20), li jindika li l-objettiv tal-istudju ma ntlaħaqx.
English: Aranesp 10 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL).
Maltese: Aranesp 10 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 10 mikrogrammi ta' darbepoetin alfa f'0.4 mL (25 mcg/mL).
English: Aranesp 15 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.42 mg of sodium in 0.375 mL.
Maltese: Aranesp 15-il mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 1.42 mg ta' sodium f'0.375 mL.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 15 micrograms solution for injection in pre-filled syringe Darbepoetin alfa
Maltese: Aranesp, 15-il mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Darbepoetin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.3 mL pre-filled pen contains 30 micrograms darbepoetin alfa (100 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pinna mimlija għal-lest ta' 0.3 mL fiha 30 mikrogramma darbepoetin alfa (100 mikrogramma/mL).
English: Aranesp 20 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL).
Maltese: Aranesp 20 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 20 mikrogramma ta' darbepoetin alfa f'0.5 mL (40 mcg/mL).
English: EU/1/01/185/066 - 4 pack
Maltese: EU/1/01/185/066 - Pakkett ta' 4
English: Hypertension
Maltese: Pożoloġija
English: Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL).
Maltese: Aranesp 500 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 500 mikrogramma ta' darbepoetin alfa f'1 mL (500 mcg/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-12 g/dL (7.5 mmol/L), id-doża għandha titnaqqas b'bejn wieħed u ieħor 25 sa 50%.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.4 mL pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull siringa mimlija għal-lest ta' 0.4 mL fiha 40 mikrogramma darbepoetin alfa (100 mikrogramma/mL).
English: EU/1/01/185/103 4 Pack
Maltese: EU/1/01/185/103 Pakkett ta' 4
English: EU/1/01/185/041 1 Pack Unblistered EU/1/01/185/090 1 blister pack with needle guard EU/1/01/185/091 4 blister pack with needle guard Aranesp 130 micrograms solution for injection pre-filled syringe EU/1/01/185/069 1 Pack Blister
Maltese: EU/1/01/185/090 pakkett tal-folja b'għatu ta' protezzjoni tal-labra ta' 1 EU/1/01/185/091 pakkett tal-folja b'għatu ta' protezzjoni tal-labra ta' 4 Aranesp 130 mikrogramma soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest EU/1/01/185/069 Pakkett b'Folja ta' 1
English: How do I prepare my Aranesp injection?
Maltese: Kif nipprepara l-injezzjoni ta' Aranesp?
English: You can use:
Maltese: Ftakar: