FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for one month at 2°C - 8°C.
Maltese: Stabilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita kienet demostrata għal xahar f'temperatura ta' 2°C - 8°C.
English: L-Isoleucine,
Maltese: L-Leucine, L-Isoleucine,
English: One vial contains 50,000 IU (international units) epoetin beta.
Maltese: Kunjett wieħed fih 50,000 IU (unitajiet internazzjonali) epoetin beta.
English: Haemoglobin concentration
Maltese: Konċentrazzjoni tal-emoglobina
English: (2) Place a 26G needle onto an appropriate single-use syringe (max.1 ml).
Maltese: (2) Qiegħed labra 26G fuq siringa xierqa li tintuża darba biss (massimu 1 ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 50,000 IU epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 50,000 IU epoetin beta.
English: 2 years.
Maltese: IU 2000
English: · Symptomatic anaemia caused by chronic kidney disease
Maltese: • Anemija sintomatika kkawżata minn marda kronika tal-kliewi
English: NeoRecormon is provided in the following pack-sizes:
Maltese: NeoRecormon huwa pprovdut fid-daqsijiet tal-pakkett li ġejjin:
English: (10) Before and after reconstitution NeoRecormon Multidose must be stored at +2° to +8°C (refrigerator).
Maltese: (10) Kemm qabel u kemm wara r-rikostituzzjoni, NeoRecormon Multidose għandu jinżamm taħt temperatura ta' bejn +2° u +8°C (fil-friġġ).
English: Traceability of NeoRecormon
Maltese: Traċċabilità ta' NeoRecormon
English: · Treating symptomatic anaemia caused by chronic kidney disease (renal anaemia) in patients on dialysis, or not yet on dialysis.
Maltese: • Kura ta' anemija sintomatika kkawżata minn mard kroniku tal-kliewi (anemija renali) f'pazjenti fuq id-dijalisi, jew li għad mhux fuq id-dijalisi.
English: 10 Prepare the syringe and needle: follow steps 11 to 14 15 Insert the needle into the vein.
Maltese: Ipprepara s-siringa u l-labra: segwi passi 11 sa 14. 15 Daħħal il-labra ġol-vina.
English: 1 ampoule contains solvent (benzyl alcohol and benzalkonium chloride in water for injections).
Maltese: Ampulla waħda fiha solvent (benzyl alcohol u benzalkonium chloride f'ilma għall-injezzjonijiet).
English: (7) Hold the OPC (One-Point-Cut) ampoule with the blue point upwards.
Maltese: (7) Żomm l-ampulla OPC (One-Point-Cut) bil-marka l-blu tħares ‘il fuq.
English: One ml solution for injection contains 6667 IU epoetin beta.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 6667 IU epoetin beta.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Maltese: Fl-erba' studji kkontrollati bil-plaċebo il-proporzjonijiet ta' periklu għas-sopravivenza globali varjaw bejn 1.25 u 2.47 favur il-kontrolli.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Maltese: periklu ta' 1.06 favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13,933 pazjent) u għall-pazjenti bilkanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu tas-sopravivenza globali kien 1.04 (95% CI: 0.97, 1.11; 38 prova u 10,441 pazjent).
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Maltese: Epoetins mhux approvati fl-immaniġġjar ta' anemija assoċjata ma' epatite Ċ.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: · Adults with symptomatic anaemia receiving chemotherapy for cancer
Maltese: • Adulti b'anemija sintomatika li qed jingħataw kimoterapija għall-kanċer
English: - In the solvent: benzyl alcohol and benzalkonium chloride as preservatives and water for injections.
Maltese: • Fis-solvent: benzyl alcohol u benzalkonium chloride bħala preservattivi u ilma għallinjezzjonijiet.
English: · Store in a refrigerator (2°C - 8°C).
Maltese: • Aħżen fi friġġ (2°C - 8°C).
English: Lyophilisate
Maltese: Pożoloġija
English: The initial dosage is 3 x 40 IU/kg per week.
Maltese: Id-doża tal-bidu hi 3 × 40 IU/kg fil-ġimgħa.
English: Phenylalanine (up to 0.3 mg/syringe)
Maltese: Phenylalanine (sa 0.3 mg/siringa) Sodju (inqas minn 1 mmol/siringa)
English: NeoRecormon has not shown evidence of impaired fertility in animals.
Maltese: NeoRecormon ma wera l-ebda evidenza ta' indeboliment fil-fertilità fl-annimali.
English: NeoRecormon in reconstituted multidose solution contains benzyl alcohol which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Maltese: NeoRecormon f'soluzzjoni multidose rikostitwita fih benzyl alcohol li jista' jikkawża reazzjonijiet tossiċi u anafilaktojdi fi trabi u tfal ta' età sa 3 snin.
English: In a randomised, double-blind, placebo-controlled study of 4,038 chronic renal failure 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 (see section 4.4).
Maltese: Fi studju randomised, double-blind, ikkontrollat bil-plaċebo ta' 4,038 pazjent b'insuffiċjenza kronika tal-kliewi li ma kinux fuq dijalisi, b'dijabete tat-tip 2 u b'livelli ta' emoglobina ≤ 11 g/dL, il-pazjenti rċevew kura b'darbepoetin alfa biex jintlaħqu livelli ta' emoglobina ta' 13 g/dL jew plaċebo (ara sezzjoni 4.4).
English: blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] (body weight ³ 45 kg)
Maltese: Riserva ta' ċelluli ħomor endoġeni = volum tad-demm [ml] × (PCV - 33) ÷ 100 Nisa: volum tad-demm [ml] = 41 [ml/kg] × piż tal-ġisem [kg] + 1200 [ml] Irġiel: volum tad-demm [ml] = 44 [ml/kg] × piż tal-ġisem [kg] + 1600 [ml] (piż tal-ġisem ≥ 45 kg)
English: Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Maltese: Epoetin beta huwa magħmul minn teknoloġija ġenetika speċjalizzata u jaħdem eżatt l-istess bħall-ormon naturali eritropoetin.
English: Men:
Maltese: Importanti:
English: NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection Epoetin beta
Maltese: NeoRecormon Multidose 50,000 IU lajofiliżat u solvent għal soluzzjoni għall-injezzjoni Epoetin beta
English: Analogous results have been found in animal experiments in uraemic and normal rats.
Maltese: Riżultati jixxibħu nkisbu minn esperimenti fl-annimali f'firien normali u uremiċi.
English: It is unlikely to be serious.
Maltese: Mhux probabbli li tkun xi ħaġa serja.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Maltese: Meta-analiżi ndikat ukoll b'mod konsistenti żieda sinifikanti fir-riskju relattiv ta' avvenimenti tromboembolitiċi f'pazjenti bil-kanċer li kienu qed jirċievu eritropoetin rikombinanti uman (ara sezzjoni 4.4).
English: Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa, reported an incidence of stroke as common.
Maltese: Dejta minn prova klinika kkontrollata b'epoetin alfa jew darbepoetin alfa, irrappurtat l-inċidenza ta' puplesija bħala komuni.
English: (8.7 mmol/l), - 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), - 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: 14 g/dl (8.7 mmol/l), - sopravivenza globali mqassra u żieda fl-imwiet attribwiti lill-progressjoni tal-marda wara 4 xhur f'pazjenti b'kanċer metastatiku tas-sider li kienu qed jirċievu kimoterapija meta mogħti biex tintlaħaq emoglobina ta' 12-14 g/dl (7.5-8.7 mmol/l), - żieda fir-riskju ta' mewt meta mogħti biex tintlaħaq emoglobina ta' 12 g/dl (7.5 mmol/l)
English: One ml solution for injection contains 1667 IU epoetin beta.
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fiha 1667 IU epoetin beta.
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 mortalità eċċessiva statistikament sinifikanti u konsistenti mhux spjegata f'pazjenti li għandhom anemija assoċjata ma' deversi kanċers komuni li rċevew eritropoetin rikombinanti uman meta mqabbel mal-kontrolli.
English: One ml solution for injection contains 50,000 IU epoetin beta.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 50,000 IU epoetin beta.
English: Note: Each carton contains either 1 syringe/1 needle, 4 syringes/4 needles or 6 syringes/6 needles.
Maltese: Nota: Kull kaxxa ta' NeoRecormon fiha siringa waħda/labra waħda, 4 siringi/4 labriet jew 6 siringi/6 labriet.
English: After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Maltese: Wara lamministrazzjoni ta' epoetin beta, in-numru ta' eritroċiti, il-valuri tal-Hb u l-għadd ta' retikuloċiti żdiedu, flimkien mar-rata ta' inkorporazzjoni ta' 59Fe.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and
Maltese: Meta-analiżi tat-tagħrif globali tas-sopravivenza pproduċiet estimu tal-punt tal-proporzjon ta' periklu ta' 1.06 favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13,933 pazjent) u għall-pazjenti bilkanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu tas-sopravivenza globali kien 1.04 (95% CI: 0.97, 1.11; 38 prova u 10,441 pazjent).
English: In clinical trials, an increased risk of death and serious cardiovascular events or cerebrovascular events including stroke was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Maltese: Fi provi kliniċi, kienet osservata żieda fir-riskju ta' mewt u ta' episodji kardjovaskulari serji jew avvenimenti kardjovaskulari inkluż puplesija meta sustanzi li jistimolaw l-eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta' aktar minn 12 g/dl (7.5 mmol/l).
English: · in infants or young children up to 3 years, since NeoRecormon Multidose solvent contains benzyl alcohol as a preservative
Maltese: • fi trabi jew tfal żgħar ta' età sa 3 snin, minħabba li s-solvent ta' NeoRecormon Multidose fih benzyl alkoħol bħala preservattiv.
English: · Injection needle(s) (27G or 30G (depending on the prescribed strengths of the medicine) with safety shield (used for priming, setting the dose and injecting the medicine).
Maltese: • Labra/Labar tal-Injezzjoni 27G jew 30G b'tarka tas-sigurtà (użata biex tipprajma, tissettja d-doża u tinjetta l-mediċina).
English: Packs of 1 vial containing 50,000 IU epoetin beta, 1 ampoule containing 10 ml solvent, 1 reconstitution and withdrawal device, 1 needle (21G2, stainless steel) and 1 disposable syringe (polypropylene and polyethylene).
Maltese: Pakketti ta' kunjett wieħed li fih 50,000 IU epoetin beta, ampulla waħda li fiha 10 ml ta' solvent, apparat wieħed għar-rikostituzzjoni u biex tiġbed, labra waħda (21G2, azzar li ma jissaddadx), u siringa waħda li tintuża darba u tintrema (polypropylene u polyethylene).
English: NeoRecormon dosing
Maltese: Tużax NeoRecormon
English: The initial weekly dose is 30,000 IU.
Maltese: IU u 30,000 IU:
English: In some patients, a fall in serum iron parameters is observed (see section 4.4).
Maltese: F'xi pazjenti, huwa osservat tnaqqis fil-parametri ta' ħadid fis-serum (ara sezzjoni 4.4).
English: Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
Maltese: Ikteb id-data tar-rikostituzzjoni u d'data meta tiskadi fuq it-tikketta (tiskadi wara xahar mir-rikostituzzjoni).
English: INFORMATION IN BRAILLE neorecormon 2000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 2000
English: In patients with a poor haemoglobin response to NeoRecormon, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Maltese: F'pazjenti b'rispons ta' emoglobina batut għal NeoRecormon, għandhom jiġu kkunsidrati spjegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.4 u 5.1).
English: ·Do not inject into a muscle.
Maltese: • Tinjettax ġo muskolu.
English: PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
Maltese: PRCA ikkawżata minn antikorpi newtralizzanti kontra l-eritropoetin, kienet irrappurtata f'assoċjazzjoni ma' terapija b'eritropoetin, inkluż NeoRecormon.
English: If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), the dose should be reduced by approximately 25 to 50 %.
Maltese: Jekk l-emoglobina taqbeż 12 g/dl (7.5 mmol/l), id-doża għandha titnaqqas b'madwar 25 sa 50 %.
English: Anaemic patients with chronic renal failure
Maltese: Pazjenti anemiċi b'insuffiċjenza kronika tal-kliewi
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updatespublished on the European medicines web-portal
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: A tendency towards increased risk estimates for allcause 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: Kienet osservata tendenza lejn żieda fl-istimi ta' riskju ta' mortalità minn kull kawża, u avvenimenti kardjovaskulari u ċerebrovaskulari assoċjati ma' dożi kumulattivi ta' ESA ogħla indipendenti mill-istat ta' dijabete jew ta' dijaliżi (ara sezzjonijiet 4.2 u 4.4).
English: Tabulated list of adverse reactions
Maltese: Reazzjoni avversa Frekwenza
English: Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine,
Maltese: Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine,
English: INFORMATION IN BRAILLE neorecormon 20.000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 20,000
English: It acts as a mitosis stimulating factor and differentiation hormone Epoetin beta, the active substance of NeoRecormon, is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anaemic patients.
Maltese: Epoetin beta, is-sustanza attiva ta' NeoRecormon, hija identika fl-amino acids u l-karboidrati tagħha, għall-eritropoetin li kien iżolat mill-urina ta' pazjenti anemiċi.
English: Do not misuse NeoRecormon:
Maltese: Tużax NeoRecormon:
English: · Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions.
Maltese: • Kellem tabib immedjatament jekk ikollok uġigħ ta' ras, speċjalment uġigħ ta' ras f'daqqa, li ttektek u li tixbaħ lill-emigranja, konfużjoni, disturbi fil-kliem, mixi mhux stabbli, aċċessjoni jew konvulżjoni.
English: NeoRecormon 30,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 30,000 international units (IU) corresponding to 250 micrograms epoetin beta* (recombinant human erythropoietin).
Maltese: NeoRecormon 30,000 IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest b'0.6 ml ta' soluzzjoni għall-injezzjoni fiha 30,000 unità internazzjonali (IU - international units) li jikkorrispondu għal 250 mikrogramma epoetin beta* (eritropoetin rikombinanti uman).
English: Hypertension Hypertensive crisis
Maltese: GĦAMLA KWALITATTIVA
English: INFORMATION IN BRAILLE neorecormon 30.000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 30,000 IU
English: This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull siringa, i.e. essenzjalment “mingħajr sodium”.
English: · Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 34 weeks).
Maltese: • Prevenzjoni ta' anemija fi trabi prematuri (b'piż bejn 750 u 1500 g u li twieldu qabel l34 ġimgħa).
English: Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms), see section 4.4.
Maltese: Tista' sseħħ shunt thrombosis speċjalment f'pazjenti li għandhom tendenza għal ipotensjoni jew dawk li għandhom kumplikazzjonijiet fil-fistulae arterjovenużi (eż. stenożi, anewriżmi), ara sezzjoni 4.4.
English: NeoRecormon contains phenylalanine and sodium This medicine contains phenylalanine.
Maltese: NeoRecormon fih phenylalanine u sodium
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti (elenkati fissezzjoni 6.1).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: (3) Disinfect the rubber seal with alcohol.
Maltese: (3) Iddiżinfetta s-sigill tal-lasktu bl-alkoħol.
English: Chronic renal failure
Maltese: Insuffiċjenza kronika tal-kliewi
English: NeoRecormon contains up to 40 mg benzyl alcohol as a preservative per solvent ampoule and must therefore not be given to infants or young children up to three years old.
Maltese: NeoRecormon multidose fih sa 40 mg benzyl alcohol bħala preservattiv f'kull ampulla bis-solvent u għalhekk m'għandux jingħata lil trabi jew tfal żgħar ta' età sa tliet snin.
English: INFORMATION IN BRAILLE neorecormon 4000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 4000 IU
English: Its use in this indication must be balanced against the reported increased risk of thromboembolic events.
Maltese: L-użu tiegħu f'din l-indikazzjoni għandu jkun meqjus skond iż-żieda fir-riskju rrappurtat ta' avvenimenti tromboembolitiċi.
English: 6 pre-filled syringes (0.3 ml) and 6 needles (30G1/2)
Maltese: 6 siringi mimlija għal-lest (0.3 ml) u 6 labriet (30G1/2)
English: The terminal half-life is higher than after intravenous administration, with an average of 13 - 28 hours.
Maltese: Il-half-life terminali hija ogħla minn dik wara amministrazzjoni ġol-vini, b'medja ta' 13 -28 siegħa.
English: · Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed during erythropoietin therapy, including in isolated cases during therapy with NeoRecormon.
Maltese: • Aplasija pura taċ-ċelloli l-ħomor (PRCA) ikkawżata minn antikorpi newtrallizzanti kienet osservata waqt terapija b'eritropoetin, inkluż każijiet iżolati waqt terapijab'NeoRecormon.
English: NeoRecormon 4000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin).
Maltese: NeoRecormon 4000 IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest b'0.3 ml ta' soluzzjoni għall-injezzjoni fiha 4000 unità internazzjonali (IU - international units) li jikkorrispondu għal 33.2 mikrogrammi epoetin beta* (eritropoetin rikombinanti uman).
English: Inject the NeoRecormon solution.
Maltese: Injetta s-soluzzjoni ta' NeoRecormon.
English: Serious skin reaction including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Maltese: Kien hemm rapporti ta' reazzjonijiet serji tal-ġilda fosthom is-sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN) b'rabta ma' kura b'epoetini.
English: INFORMATION IN BRAILLE neorecormon 3000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 3000 IU
English: NeoRecormon 20,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 20,000 international units (IU) corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin).
Maltese: IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest b'0.6 ml ta' soluzzjoni għall-injezzjoni fiha 20,000 unità internazzjonali (IU - international units) li jikkorrispondu għal 166 mikrogramma epoetin beta* (eritropoetin rikombinanti uman).
English: haemoglobin concentration ≤ 10g/dl (6.2 mmol/l).
Maltese: NeoRecormon għandu jingħata taħt il-ġilda lill-pazjenti b'anemija (e.ż. konċentrazzjoni ta' lemoglobina ≤ 10g/dl (6.2 mmol/l)).
English: NeoRecormon 3000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin).
Maltese: NeoRecormon 3000 IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest b'0.3 ml ta' soluzzjoni għall-injezzjoni fiha 3000 unità internazzjonali (IU - international units) li jikkorrispondu għal 24.9 mikrogrammi epoetin beta* (eritropoetin rikombinanti uman).
English: Serum potassium and phosphate levels should be monitored regularly during therapy with NeoRecormon.
Maltese: Livelli tal-potassju u l-fosfat fis-serum għandhom ikunu issorveljati regolarment waqt terapija b'NeoRecormon.
English: INFORMATION IN BRAILLE neorecormon 6000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 6000
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, i.e. essenzjalment “mingħajr sodium”.
English: One ampoule contains 10 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Maltese: Ampulla waħda fiha 10 ml solvent (ilma għall-injezzjonijiet bl-alkoħol benżiliku u klorur talbenżalkonju bħala preservattivi).
English: Adverse reactions are listed in Table 1 below.
Maltese: Lista ta' reazzjonijiet avversi f'tabella
English: If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
Maltese: Jekk wara 8 ġimgħat ta' terapija il-valur ta' emoglobina ma żdiedx b'mill-inqas 1 g/dl (0.62 mmol/l), hemm probabbilta' li l-pazjent mhux se jirrispondi u l-kura għandha titwaqqaf.
English: NeoRecormon 5000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) corresponding to 41.5 micrograms epoetin beta* (recombinant human erythropoietin).
Maltese: IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest b'0.3 ml ta' soluzzjoni għall-injezzjoni fiha 5000 unità internazzjonali (IU - international units) li jikkorrispondu għal 41.5 mikrogrammi epoetin beta* (eritropoetin rikombinanti uman).
English: · Do not use NeoRecormon after the expiry date which is stated on the carton and label.
Maltese: • Tużax NeoRecormon wara d-data ta' meta jiskadi li tidher fuq il-kartuna.