FrancophonIA/ELRC3.0 huggingface dataset:
English: Embryo-foetal development studies were conducted with doses between 0.2- and 2-fold (rats) and between 1- and 4-fold (rabbits) the proposed therapeutic maintenance dose of 100 mg/day.
Maltese: Studji fl-iżvilupp ta' l-embriju u tal-fetu saru minn dożi bejn 0.2- u 2- il darba (fil-firien) jew bejn 1- u 4-il darba (fil-fniek), id-doża terapewtika proposta ta' manutenzjoni ta' 100 mg.
English: Tel: + 385 1 3908 777
Maltese: Pfizer Croatia d.o.o. Tel: +385 1 3908 777
English: Rash, pruritus
Maltese: Dijarea, dardir
English: Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25ºC.
Maltese: L-istabbilità kimika u fiżika effettiva tas-soluzzjoni għal infużjoni ġiet murija għal 48 siegħa f' temperatura ta' 25
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: L-istudji dwar l-interazzjoni twettqu biss fuq l-adulti.
English: 3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients.
Maltese: 3 fi 22 pazjent jew ikklassifikati mill-investigatur bħala newtropeniċi fil-linja bażi f'13-il pazjent.
English: Table of Adverse Reactions System Organ
Maltese: Klassi talOrgani tasSistema
English: ECALTA should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL.
Maltese: ECALTA għandu jiġi rikostitwit bl-ilma għall-injezzjonijiet għal konċentrazzjoni ta' 3.33 mg/ml u suċċessivament dilwit għal konċentrazzjoni ta' 0.77 mg/ml.
English: Treatment was administered for at least 14 and not more than 42 days.
Maltese: Il-kura ngħatat għal mill-anqas 14-il ġurnata u mhux aktar minn 42 ġurnata.
English: The in vitro activity of anidulafungin against Candida species is not uniform.
Maltese: L-attività in vitro tal-anidulafungin kontra l-ispeċi ta' Candida mhijiex uniformi.
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) was assessed in 35 adult neutropenic patients defined as absolute neutrophil count ≤ 500 cells/mm
Maltese: L-effikaċja ta' anidulafungin (loading dose ta' 200 mg ġol-vina segwita minn 100 mg ġol-vina kuljum) ġiet ivvalutata f'35 pazjent newtropeniku adult definita bħala l-għadd assolut ta' newtrofili ≤ 500 ċellola/mm
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC.
Maltese: L-istabbilità kimika u fiżika effettiva tas-soluzzjoni rikostitwita ġiet murija għal 24 siegħa f'temperatura ta' 25
English: The infusion solution may be stored at 25°C (room temperature) for 48 hours or stored frozen for at least 72 hours, and should be administered at 25C (room temperature) within 48 hours.
Maltese: Is-soluzzjoni għall-infużjoni tista' tinżamm f'temperatura ta' 25 oC (temperatura normali) għal 48 siegħa jew tinħażen fil-friża għal ta' l-anqas 72 siegħa, u tkun amministrata f'temperatura ta' 25 oC (temperatura normali) fi żmien 48 siegħa.
English: Do not use ECALTA - if you are allergic to anidulafungin, other echinocandins (e.g.caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).
Maltese: - jekk inti allerġiku/a għal anidulafungin, echinocandins oħra, (eż. caspofungin acetate) jew sustanzi oħra ta' din il-mediċina (elenkati f'sezzjoni 6).
English: Administration of anidulafungin to rats did not indicate any effects on reproduction, including male and female fertility.
Maltese: L-amministrazzjoni ta' anidulafungin lill-firien ma indikat l-ebda effett fuq ir-riproduzzjoni, inkluża lfertilità tar-raġel u tal-mara.
English: In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred.
Maltese: F'ċerti pazjenti b'kondizzjonijiet mediċi serji preżenti li kienu qegħdin jirċievu diversi mediċini konkomitanti flimkien ma' anidulafungin, seħħew anormalitajiet epatiċi klinikament sinifikanti.
English: Dilution and infusion
Maltese: Dilwizzjoni u infużjoni
English: The successful global response rate at End of Intravenous Treatment and End of All Treatment were both 7/13 (53.8%) in the 13 patients with neutropenia assessed by investigators at baseline.
Maltese: Ir-rata ta' rispons globali ta' suċċess fit-Tmiem tat-Trattament ġol-Vina kif ukoll fit-Tmiem tat-Trattament Kollu kienet 7/13 (53.8%) fit-13-il pazjent b'newtropenja vvalutati mill-investigaturi fil-linja bażi.
English: Pack size of 1 vial.
Maltese: Pakkett ta' Barra
English: In clinically stable patients, a switch to oral azole therapy was permitted after at least 10 days of study treatment.
Maltese: F'pazjenti klinikament stabbli, il-bidla għal terapija ta' azole orali kienet permessa wara mill-inqas 10 ġranet ta' trattament ta' studju.
English: Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.
Maltese: Każijiet iżolati ta' disfunzjoni epatika sinifikanti, epatite, u insuffiċjenza tal-fwied ma kienux komuni fil-provi kliniċi.
English: Candidaemia and other forms of Invasive Candidiasis The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, doubleblind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Maltese: Is-sigurtà u l-effikaċja ta' anidulafungin ġew evalwati fi studju pivitali multiċentri, multinazzjonali, magħmul b'għażla każwali, double-blind, ta' Fażi 3 fuq pazjenti primarjament mhux newtropeniċi,b'candidemia u numru limitat ta' pazjenti b'infezzjoni ta' Candida f'tessuti ta' taħt ilġilda, jew b'mard li jikkawża axxessi.
English: Infusion volume
Maltese: U KWANTITATTIVA
English: Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL.
Maltese: Irrikostitwixxi b'mod asettiku kull kunjett fi 30mL ilma għall-injezzjonijiet biex jipprovdi konċentrazzjoni ta' 3.33 mg/mL.
English: Overall study mortality Mortality during study therapy Mortality attributed to Candida infection
Maltese: Mortalità matul it-terapija ta' studju Mortalità attribwita għal infezzjoni b'Candida 2/127 (1.6%)
English: Hepatobiliary tract
Maltese: Soluzzjoni rikostitwita
English: How to store ECALTA
Maltese: X'fih ECALTA
English: Steady state was achieved on the first day after a loading dose (twice the maintenance dose), and steady state Cmax and AUCss increase in a dose-proportional manner.
Maltese: Stat fiss inkiseb fl-ewwel jum wara loading dose (doża ta' manutenzjoni doppja), u lCmax u l-AUCss fissi jiżdiedu b'mod proporzjonali mad-doża.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għal kondizzjonijiet tal-ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Reconstituted solution
Maltese: MANIFATTUR RESPONSABBLI
English: The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established.
Maltese: Il-kompatibilità ta' ECALTA rikostitwit ma' sustanzi, addittivi, jew mediċini għal ġol-vina għajr 9 mg/mL (0.9%) sodium chloride għal infużjoni jew 50 mg/mL (5%) glukożju għal infużjoni ma ġietx stabbilita.
English: Plasma concentrations of anidulafungin in healthy men and women were similar.
Maltese: Il-konċentrazzjonijiet fil-plasma ta' anidulafungin f'irġiel u nisa b'saħħithom kienu simili.
English: For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Maltese: Għal anidulafungin, ma kienx hemm effetti fuq il-fertilità fi studji li saru fuq ġrieden maskili u femminili (ara sezzjoni 5.3).
English: Infusion site pain
Maltese: Uġigħ filpost talinfużjoni
English: Flushing, hot flush
Maltese: Volum totali ta' linfużjoni
English: Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.
Maltese: Il-konċentrazzjonijiet ta' anidulafungin waqgħu taħt il-limiti l'aktar baxxi ta' kwantifikazzjoni 6 ijiem wara d-doża.
English: Twenty one (16.3%) had concomitant candidemia.
Maltese: Wieħed u għoxrin (16.3%) kellhom candidemia konkomitanti.
English: 30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.
Maltese: Kunjett ta' 30 mL magħmul minn ħġieġ tat-Tip 1 bi stopper tal-lastku (gomma butyl b'kisja ta' polimer minn ġewwa fuq is-superfiċje li tmiss mal-prodott u b'kisja ta' lubrikant fuq is-superfiċje ta' fuq għal manifattura faċilitata, jew alternattivament gomma bromobutyl ma' lubrikant) u siġill ta' laluminju b'għatu flip-off.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I : Sommarju tal- Karatteristiċi talProdott, sezzjoni 4.2).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: Disturbi talFwied u talMarrara
English: ECALTA must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose for infusion.
Maltese: ECALTA jrid jiġi rikostitwit f'ilma għall-injezzjonijiet) u wara jiġi dilwit BISS b'9 mg/mL (0.9%) sodium chloride soluzzjoni għall-injezzjoni jew 50 mg/mL (5%) glukożju għal infużjoni.
English: Total infusion volume
Maltese: Informazzjoni għall-utent
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, jew għal xi eċċipjenti elenkati f'sezzjoni 6.1. Sensittività eċċessiva għal prodotti mediċinali oħra tal-klassi echinocandin.
English: Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Maltese: Anqas minn 1% tad-doża radjuattiva amministrata kienet imneħħija fl-awrina, li jindika tneħħija mill-kliewi negliġibbli.
English: Serious side effects - tell your doctor or another healthcare professional immediately should any of the following occur: - Convulsion (seizure) - Flushing - Rash, pruritis (itching) - Hot flush - Hives - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
Maltese: - Konvulżjoni (aċċessjoni) - Fwawar - Raxx, prurite (ħakk) - Ħmura fil-wiċċ bil-fwawar - Urtikarja (ħorriqija) - Kontrazzjoni f'daqqa tal-muskoli madwar il-passaġġi tal-arja li jirriżulta fi tħarħir jew sogħla - Diffikultà biex tieħu n-nifs
English: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Maltese: M'hemmx informazzjoni biżżejjed li ssostni doża ta' 100mg għal iktar minn 35 ġurnata.
English: In vitro and in vivo genotoxicity studies with anidulafungin provided no evidence of genotoxic potential.
Maltese: L-istudji in vitro u in vivo tal-ġenotossiċità b'anidulafungin ma pprovdew ebda evidenza ta' potenzjal ġenotossiku.
English: 6 Week Follow-up Calculated as anidulafungin minus fluconazole With or without concurrent candidaemia c
Maltese: 6 Ġimgħat ta' Kontinwazzjoni a Ikkalkulata bħala anidulafungin tnaqqas fluconazole b
English: Excursions for 96 hours up to 25ºC are permitted, and the powder can be returned to refrigerated storage.
Maltese: Il-prodott jista' jkun espost sa 96 siegħa għal temperatura sa 25 oC.
English: ECALTA must not be administered as a bolus injection.
Maltese: ECALTA m'għandux jingħata bħala injezzjoni bolus.
English: Infusion solution
Maltese: Soluzzjoni għal infużjoni
English: A standardized technique for testing the susceptibility of Candida species to anidulafungin as well as the respective interpretative breakpoints has been established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Maltese: Teknika standardizzata għall-ittestjar tas-suxxettibbiltà tal-ispeċi ta' Candida għal anidulafungin kif ukoll il-punti kritiċi interpretattivi rispettivi ġew stabbiliti mill-Kumitat Ewropew dwar it-Testijiet tasSuxxettibbiltà (EUCAST).
English: Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study.
Maltese: Pazjenti b'endokardite, ostjomajelite jew meninġite b'Candida, jew dawk b'infezzjoni minħabba C. krusei, kienu speċifikament esklużi mill-istudju.
English: Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4).
Maltese: ħmura tal-wiċċ, ħmura tal-wiċċ bil-fwawar, u urtikarja (avvenimenti mhux komuni), b'sommarju f'Tabella 1 (ara sezzjoni 4.4).
English: Dilution requirements for ECALTA administration
Maltese: Disturbi tadDemm u tasSistema Limfatika
English: What ECALTA looks like and contents of the pack
Maltese: Id-dehra ta' ECALTA u l-kontenut tal-pakkett:
English: The RMP should reflect the following additional risk minimisation measures to address the important identified risk of medication errors resulting in overdose: - educational material(s) for healthcare professionals developed in accordance with the key elements agreed; - the agreed patient card.
Maltese: L-RMP għandu jirrifletti l-miżuri addizzjonali li ġejjin għallminimizzazzjoni tar-riskju, biex jiġi indirizzat ir-riskju ta' importanza identifikat ta' żbalji fil-medikazzjoni li jirriżultaw f'doża eċċessiva: - materjal(i) edukattiv(i) għall-professjonisti fil-qasam tal-kura tassaħħa, żviluppat(i) skont l-elementi ewlenin maqbula; - il-kard tal-pazjent maqbula.
English: Methotrexate-containing products for oral use with at least one indication requiring once weekly dosing Each MAH should operate a risk management system to be described in a risk management plan (RMP) which shall be submitted to the relevant Competent Authorities.
Maltese: Prodotti li fihom Methotrexate għall-użu orali b'tal-inqas indikazzjoni waħda li tkun teħtieġ dożaġġ darba fil-ġimgħa Kull MAH għandu jopera sistema ta' ġestjoni tar-riskju li għandha tiġi deskritta fi pjan tal-ġestjoni tar-riskju (RMP) li għandu jiġi ppreżentat lill-Awtoritajiet Kompetenti rilevanti.
English: All methotrexate-containing products Each MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Maltese: Il-prodotti kollha li fihom methotrexate Kull MAH għandu jimplimenta l-kwestjonarji ta' segwitu mmirati maqbula għall-iżbalji fil-medikazzjoni kollha li jirriżultaw f'doża eċċessiva.
English: Then disconnect the syringe (with needle) from the device.
Maltese: NeoRecormon inti stess (ara l-istruzzjonijiet fit-tmiem ta' dan il-fuljett).
English: See section 5.1
Maltese: Ara sezzjoni 5.1
English: EU/1/97/031/ 025-026 EU/1/97/031/029-030 EU/1/97/031/031-032 EU/1/97/031/033-034 EU/1/97/031/035-036 EU/1/97/031/037-038 EU/1/97/031/041-042 EU/1/97/031/043-044 EU/1/97/031/045-046
Maltese: EU/1/97/031/035 - 036 EU/1/97/031/037 - 038 EU/1/97/031/041 - 042 EU/1/97/031/043 - 044
English: · Anaemia in premature infants
Maltese: • Anemija fi trabi prematuri
English: L-Glutamic acid, L-Phenylalanine.
Maltese: Glutamic acid, u L-Phenylalanine.
English: An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95 % CI: 1.13, 2.31).
Maltese: Żieda fir-riskju relattiv ta' episodji tromboembolitiċi kienet osservata fil-popolazzjoni globali (RR 1.62, 95 % CI: 1.13, 2.31).
English: Roche (Hellas) A.E.
Maltese: Roche (Hellas)A.
English: Prevention of anaemia of prematurity
Maltese: Prevenzjoni ta' anemija ta' prematurità
English: IV/SC use
Maltese: Użu IV/SC
English: NeoRecormon Multidose 50,000 IU 5000 IU/ ml
Maltese: NeoRecormon Multidose 50,000 IU 5000
English: Solvent: 10 ml ampoule (type I glass).
Maltese: Solvent: ampulla ta' 10 ml (ħġieġ tip I).
English: Analysis of the individual components of the composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), stroke 1.92 (1.38, 2.68), congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
Maltese: Analiżi talkomponenti ndividwali tal-punti finali komposti uriet l-HR li ġejjin (CI ta' 95%): mewt 1.05 (0.92, 1.21), puplesija 1.92 (1.38, 2.68), insuffiċjenza konġestiva tal-qalb (CHF - congestive heart failure) 0.89 (0.74, 1.08), infart mijokardijaku (MI - myocardial infarction) 0.96 (0.75, 1.23), dħul l-isptar minħabba iskemija mijokardijaka 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
English: · The active substance is epoetin beta.
Maltese: • Is-sustanza attiva hi epoetin beta.
English: Roche Pharma AG Emil-Barell-Strasse 1
Maltese: Emil-Barell-Strasse 1
English: Phenylalanine (up to 5.0 mg/vial) Sodium (less than 1 mmol per dose) Benzyl alcohol (up to 40 mg per multidose solvent ampoule)
Maltese: Phenylalanine (sa 5.0 mg/kunjett) Sodju (inqas minn 1 mmol kull doża) Benzyl alcohol (sa 40 mg kull ampulla multidose bis-solvent)
English: 0.6 ml
Maltese: INDIVIDWALI 0.6 ml
English: - Intravenous administration:
Maltese: - Amministrazzjoni ġol-vini:
English: Pharmacotherapeutic group: antianemic, ATC code: B03XA01
Maltese: Kategorija farmakoterapewtika: anti-anemiku, Kodiċi ATC:
English: 5000 IU/ ml 500 IU 1000 IU 1500 IU 2000 IU 2500 IU 3000 IU 3500 IU 4000 IU 4500 IU 5000 IU 0.1 ml 0.2 ml 0.3 ml 0.4 ml 0.5 ml 0.6 ml 0.7 ml 0.8 ml 0.9 ml
Maltese: IU 0.1 ml 0.2 ml 0.3 ml 0.4 ml 0.5 ml 0.6 ml 0.7 ml 0.8 ml 0.9 ml 1.0 ml
English: Shunt thrombosis Thrombocytosis
Maltese: Trombożi fix-shunt Tromboċitożi
English: Administering the intravenous injection Preparing for injection: follow steps 1 to 8
Maltese: Preparazzjoni għall-injezzjoni: segwi passi 1 sa 8.
English: a) Correcting the anaemia
Maltese: a) Korrezzjoni ta' l-anemija
English: Thromboembolic event
Maltese: Avveniment trombo embolitiku
English: NeoRecormon contains phenylalanine, benzyl alcohol and sodium This medicine contains phenylalanine.
Maltese: NeoRecormon fih phenylalanine, benzyl alcohol u sodium Din il-mediċina fiha phenylalanine.
English: 0.3 ml
Maltese: INDIVIDWALI 0.3 ml
English: NeoRecormon Multidose contains up to 5.0 mg phenylalanine/vial as an excipient.
Maltese: NeoRecormon Multidose fih sa 5.0 mg ta' phenylalanine/kunjett bħala sustanza mhux attiva.
English: One pre-filled syringe contains either 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml solution.
Maltese: Siringa mimlija għal-lest waħda fiha 500, 1000, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 jew 30,000 IU (unitajiet internazzjonali) epoetin beta f'0.3 ml jew 0.6 ml ta' soluzzjoni.
English: Benzyl alcohol, Benzalkonium chloride, Water for injections.
Maltese: Benzyl alcohol, Benzalkonium chloride, Ilma għall-injezzjonijiet.
English: Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
Maltese: Esperimenti fuq l-annimali wrew li epoetin beta ma jżidx il-mijelotossiċità ta' prodotti mediċinali ċitostatiċi bħal etoposide, cisplatin, cyclophosphamide, u fluorouracil.
English: After the injection: follow steps 17 to 19.
Maltese: Wara l-injezzjoni segwi passi 17 sa 19.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Reazzjonijiet avversi huma elenkati skont il-klassi tas-sistemi u tal-organi MedDRA u l-kategorija talfrekwenza.
English: Date of the last renewal: 16 July 2007
Maltese: Data tal-aħħar tiġdid: 16 ta' Lulju 2007
English: BATCH NUMBER Lot
Maltese: NUMRU TAL- LOT Lott
English: · Risk Management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42 % as compared with intravenous administration.
Maltese: Il-biodisponibiltà ta' epoetin beta wara amministrazzjoni taħt il-ġilda hija bejn 23 u 42 % meta mqabbel ma' amministrazzjoni ġol-vina.
English: 10 Prepare the syringe and needle: follow steps 11 to 14.
Maltese: Ipprepara s-siringa u l-labra: segwi passi 11 sa 14.
English: Treatment with NeoRecormon should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.1 mmol/l).
Maltese: Kura b'NeoRecormon għandha titwaqqaf temporanjament jekk il-livelli ta' l-emoglobina jaqbżu 13 g/dl (8.1 mmol/l).
English: One vial contains 50,000 international units (IU) corresponding to 415 micrograms epoetin beta* (recombinant human erythropoietin).
Maltese: Kunjett wieħed fih 50,000 unita internazzjonali (IU) li jikkorrispondu għal 415 mikrogrammi epoetin beta* (eritropoetin rikombinanti uman).
English: One ml solution for injection contains 33,333 IU epoetin beta.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 33,333 IU epoetin beta.
English: In patients with baseline haemoglobin ≤ 10 g/dl (n=899), the hazard ratio point estimate for survival was 0.98 (95 % CI 0.68 to 1.40).
Maltese: F'pazjenti b'emoglobina fil-linja bażi ≤ 10 g/dl (n=899), l-estimu tal-punt tal-proporzjon ta' periklu għas-sopravivenza kien 0.98 (95 % CI 0.68 sa 1.40).
English: [units]
Maltese: Minn qabel [unitajiet]
English: One ml solution for injection contains 13,333 IU epoetin beta.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 13,333 IU epoetin beta.
English: 18 Move the safety shield forward 90°, away from the syringe barrel (A).
Maltese: 18 Mexxi l-protezzjoni tas-sigurtà 90° 'il quddiem, 'il bogħod mill-bittija tas-siringa (A).
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: Varjabilità ta' l-emoglobina għandha tiġi rranġata permezz ta' mmaniġġjar tad-doża, b'kunsiderazzjoni għall-firxa mmirata ta' l-emoglobina ta' 10 g/dl (6.2 mmol/l) sa 12 g/dl (7.5 mmol/l).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 16 July 1997
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Lulju 1997
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Maltese: Il-kategoriji tal-frekwenza huma definiti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: One ml solution for injection contains 16,667 IU epoetin beta.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 16,667 IU epoetin beta.
English: Premature infants A fall in serum ferritin values is very common (see section 4.4).
Maltese: Trabi prematuri Tnaqqis fil-valuri ta' ferritin fis-serum huwa komuni ħafna (ara sezzjoni 4.4).
English: Treatment with NeoRecormon is normally a long-term therapy.
Maltese: Kura b'NeoRecormon normalment hija terapija fit-tul.
English: Pure red cell aplasia (PRCA)
Maltese: Aplasja pura taċ-ċelluli ħomor (PRCA - Pure red cell aplasia)
English: This multidose preparation can be used for several patients.
Maltese: Din il-preparazzjoni ta' doża multipla tista' tintuża għal diversi pazjenti.
English: Pregnancy, breast-feeding and fertilty
Maltese: Tqala, treddigħ u fertilità
English: 1.0 ml
Maltese: IU/1 ml
English: Store at +2°C to +8°C
Maltese: Aħżen f'temperatura ta' +2°C sa +8°C Dejjem segwi teknika asettika
English: An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
Maltese: 3H-thymidine f'ċelluli eritrojdi b'nukleu tal-milsa in vitro (kultura ta' ċelluli tal-milsa tal-ġrieden) wara inkubazzjoni b'epoetin beta.
English: NeoRecormon 500 IU
Maltese: NeoRecormon 500