FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2)
Maltese: 4 siringi mimlija għal-lest (0.6 ml) u 4 labriet (27G1/2)
English: NeoRecormon is indicated for:
Maltese: Tużax NeoRecormon ħażin:
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 ta' l-emoglobina fi tnejn mill-istudji kienet >13 g/dl; fittliet studji li jibqa' din kienet 12-14 g/dl.
English: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in cancer patients System organ class
Maltese: Tabella 2: Reazzjonijiet avversi attribwiti lill-kura b'NeoRecormon fi provi kliniċi kkontrollati f'pazjenti bil-kanċer Klassi tas-sistemi u talorgani
English: NeoRecormon 6000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) corresponding to 49.8 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 6000 unità internazzjonali (IU - international units) li jikkorrispondu għal 49.8 mikrogrammi epoetin beta* (eritropoetin rikombinanti uman).
English: Each pre-filled syringe contains 0.6 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 0.6 ml ta' soluzzjoni.
English: NeoRecormon pre-filled syringe Instructions for Use
Maltese: NeoRecormon siringa mimlija għal-lest Istruzzjonijiet dwar l-Użu
English: · Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Maltese: • Kien hemm rapporti ta' raxxijiet serji tal-ġilda fosthom is-sindrome ta' Stevens-Johnson u nekroliżi epidermali tossika b'rabta ma' kura b'epoetini.
English: NeoRecormon 10,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) corresponding to 83 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 10,000 unità internazzjonali (IU - international units) li jikkorrispondu għal 83 mikrogramma epoetin beta* (eritropoetin rikombinanti uman).
English: Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Maltese: Tista' sseħħ ukoll kriżi ipertensiva b'sintomi bħal ta' enċefalopatija (e.ż. uġigħ ta' ras u konfużjoni, disturbi motorji tas-sensi - bħal problemi biex wieħed jitkellem jew diffikultà fil-mixi - sa anki attakki ta' puplesija tonokloniċi) f'pazjenti ndividwali li ssoltu jkollhom pressjoni normali jew baxxa (ara sezzjoni 4.4).
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.
Maltese: Użu taħt il-ġilda huwa preferibbli f'pazjenti li mhux qed jirċievu emodijalisi biex jiġi evitat it-titqib ta' vini periferali.
English: NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/syringe as an excipient.
Maltese: NeoRecormon f'siringa mimlija għal-lest jista' jkun fih sa 0.3 mg ta' phenylalanine/siringa bħala sustanza mhux attiva.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046
Maltese: FIS-SUQ EU/1/97/031/046
English: Particularly at beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses.
Maltese: Speċjalment fil-bidu tat-terapija, hija rakkomandata sorveljanza regolari tal-pressjoni tad-demm, inkluż bejn dijalisi u ieħor.
English: - Subcutaneous administration:
Maltese: Twissijiet u prekawzjonijiet:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032
Maltese: FIS-SUQ EU/1/97/031/032
English: NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 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 2000 unità internazzjonali (IU - international units) li jikkorrispondu għal 16.6 mikrogrammi epoetin beta* (eritropoetin rikombinanti uman).
English: An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95 % CI 0.87, 1.46).
Maltese: Meta-analiżi bbażata fuq tagħrif tal-pazjent individwali, li nkludiet tagħrif mit-12-il studju kliniku kkontrollat kollha, magħmula b'NeoRecormon f'pazjenti anemiċi bil-kanċer (n=2301), uriet estimu globali tal-punt tal-proporzjon ta' periklu għas-sopravivenza ta' 1.13 favur il-kontrolli (95 % CI 0.87, 1.46).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION NeoRecormon 500 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 500 international units (IU) corresponding to 4.15 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 soluzzjoni għall-injezzjoni li fiha 500 unità internazzjonali (IU) li jikkorrespondu għal 4.15-il mikrogramma epoetin beta* (eritropoetin rikombinanti uman).
English: NeoRecormon 500 IU NeoRecormon 2000 IU NeoRecormon 3000 IU NeoRecormon 4000 IU NeoRecormon 5000 IU NeoRecormon 6000 IU NeoRecormon 10,000 IU NeoRecormon 20,000 IU NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Maltese: IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest NeoRecormon 3000 IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest NeoRecormon 4000 IU soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest NeoRecormon 5000
English: Other medicines and NeoRecormon
Maltese: Mediċini oħra u NeoRecormon
English: 1 vial contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
Maltese: Kunjett wieħed fih: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, u L-Phenylalanine.
English: · Keep your unused syringe(s) in the original carton and store in a refrigerator at 2˚C to 8˚C.
Maltese: • Is-soluzzjoni rikostitwita tista' tinżamm għal xagħar fi friġġ f'temperatura ta' bejn 2°C - 8°C.
English: NeoRecormon 500 IU, NeoRecormon 2000 IU, NeoRecormon 3000 IU, NeoRecormon 4000 IU, NeoRecormon 5000 IU and NeoRecormon 6000 IU solution for injection in pre-filled syringe
Maltese: IU NeoRecormon 3000 IU NeoRecormon 4000 IU NeoRecormon 5000
English: 6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2)
Maltese: 6 siringi mimlija għal-lest (0.3 ml) u 6 labriet (27G1/2)
English: MARKETING AUTHORISATION NUMBER EU/1/97/031/019
Maltese: FIS-SUQ EU/1/97/031/031
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 10 ml solvent for NeoRecormon Multidose 50,000 IU epoetin beta (water for injections, benzyl alcohol, benzalkonium chloride)
Maltese: epoetin beta (ilma għall-injezzjonijiet, benzyl alcohol, benzalkonium chloride)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/042
Maltese: FIS-SUQ EU/1/97/031/042
English: NeoRecormon 30,000 IU 1 prefilled syringe with one needle (27G1/2) or 4 pre-filled syringes with 4 needles (27G1/2).
Maltese: Siringa mimlija għal-lest waħda b'labra waħda (27G1/2) jew 4 siringi mimlija għal-lest b'4 labriet (27G1/2).
English: 6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2)
Maltese: 6 siringi mimlija għal-lest (0.6 ml) u 6 labriet (27G1/2)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038
Maltese: FIS-SUQ EU/1/97/031/038
English: A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided.
Maltese: Żieda fl-emoglobina ta' aktar minn 2 g/dl (1.25 mmol/l) fuq perjodu ta' erba' ġimgħat għandha tiġi evitata.
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 (see section 4.8).
Maltese: Kien hemm rapporti ta' reazzjonijiet avversi serji tal-ġilda (SCARs - severe cutaneous adverse reactions) fosthom is-sindrome ta' Stevens-Johnson (SJS - Stevens-Johnson syndrome) u nekroliżi epidermali tossika (TEN - toxic epidermal necrolysis), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' kura b'epoetini (ara sezzjoni 4.8).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/034
Maltese: FIS-SUQ EU/1/97/031/034
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Maltese: Każijiet kienu irrapportati f'pazjenti b'epatite Ċ ikkurati b'interferon u ribavirin, meta epoetins kienu wżati fl-istess waqt.
English: * produced in Chinese Hamster Ovary cells (CHO) by recombinant DNA technology
Maltese: * magħmul f'ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO) permezz ta' teknoloġija rikombinanti tad-DNA.
English: NeoRecormon Multidose is a lyophilisate and solvent for solution for injection.
Maltese: NeoRecormon Multidose hu lajofiliżat u solvent għal soluzzjoni għall-injezzjoni.
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), - 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: Il-pazjenti għandhom jiġu sorveljati mill-viċin sabiex jiġi assigurat li tiġi wżata l-inqas doża effettiva approvata ta' NeoRecormon biex jiġi pprovdut kontoll adegwat tas-sintomi ta' l-anemija waqt li lkonċentrazzjoni tal-emoglobina tinżamm taħt jew f'livell ta' 12g/dl (7.45 mmol/l).
English: INFORMATION IN BRAILLE neorecormon 10.000 IU
Maltese: INFORMAZZJONI BIL-BRAILLE neorecormon 10,000
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 fissopravivenza globali bejn pazjenti kkurati b'eritropoetin rikombinanti uman u l-kontrolli.
English: These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8).
Maltese: Dawn l-antikorpi ntwerew li jirreaġixxu mal-proteini eritopoetiċi kollha, u pazjenti ssuspettati jew ikkonfermati li għandhom antikorpi newtralizzanti kontra leritropoetin m'għandhomx jinqalbu għal NeoRecormon (ara sezzjoni 4.8).
English: - Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy.
Maltese: • Kura ta' anemija b'sintomi relatati f'pazjenti adulti bil-kanċer li qed jirċievu kimoterapija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043
Maltese: FIS-SUQ EU/1/97/031/043
English: Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (see section 4.4).
Maltese: Uġigħ ta' ras u pressjoni għolja relatati ma' kura b'epoetin beta li jistgħu jiġu kkontrollati b'mediċini, huma komuni (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/026
Maltese: FIS-SUQ EU/1/97/031/026
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection
Maltese: NeoRecormon Multidose 50,000 IU lajofiliżat u solvent għal soluzzjoni għall-injezzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/045
Maltese: FIS-SUQ EU/1/97/031/045
English: Rarely, epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site reactions may occur.
Maltese: Rarament, reazzjonijiet tal-ġilda relatati ma' kura b'epoetin beta, bħal raxx, ħakk, urtikarja jew reazzjonijiet fis-sit ta' l-injezzjoni jistgħu jiġru.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/037
Maltese: FIS-SUQ EU/1/97/031/037
English: Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume corresponds to one to two times the plasma volume.
Maltese: Investigazzjonijiet farmakokinetiċi f'voluntieraf'saħħithom u pazjenti uremiċi juru li l-half-life ta' epoetin beta mogħti ġol-vini hu ta' bejn 4 u 12-il siegħa u li l-volum ta' distribuzzjoni jikkorispondi għal darba sa darbtejn il-volum tal-plażma.
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Maltese: Is-sintomi u r-riżultat ta' l-anemija jistgħu jvarjaw bl-età, sess u effett globali tal-marda; valutazzjoni ta' tabib tal-progressjoni u l-kundizzjoni klinika tal-pazjent individwali hija neċessarja.
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 antierythropoietin antibody testing.
Maltese: Tnaqqis paradossali fl-emoglobina u żvilupp ta' anemija severa assoċjata ma' għadd baxx ta' retikuloċiti għandhom iwasslu għal waqfien tal-kura b'epoetin u għal testijiet għall-antikorpi kontra eritropoetin.
English: On those occasions where the patient's PCV allows blood donation, i.e. PCV ³ 33 %, NeoRecormon is administered at the end of blood donation.
Maltese: F'dawk id-drabi fejn il-PCV tal pazjent jippermetti d-donazzjoni tad-demm, jiġifieri PCV ≥ 33 %, NeoRecormon jingħata fl-aħħartad-donazzjoni.
English: NeoRecormon 2000 IU solution for injection in pre-filled syringe NeoRecormon 3000 IU solution for injection in pre-filled syringe NeoRecormon 4000 IU solution for injection in pre-filled syringe NeoRecormon 5000 IU solution for injection in pre-filled syringe NeoRecormon 6000 IU solution for injection in pre-filled syringe NeoRecormon 10,000 IU solution for injection in pre-filled syringe NeoRecormon 20,000 IU solution for injection in pre-filled syringe NeoRecormon 30,000 IU solution for injection in pre-filled syringe
Maltese: Iġbed is-soluzzjoni ta' NeoRecormon ġos-siringa, neħħi l-arja mis-siringa għal gol-kunjett u rranġa l-ammont ta' soluzzjoni ta' NeoRecormon fis-siringa skond id-doża preskritta.
English: Based on results from clinical trials including 1725 patients approximately 8 % of patients treated with NeoRecormon are expected to experience adverse reactions.
Maltese: Skond ir-riżultati miksubin minn provi kliniċi li nkludew 1725 pazjent, madwar 8 % tal-pazjenti kkurati b'NeoRecormon huma mistennija li jkollhom esperjenza ta' reazzjonijiet avversi.
English: Lyophilisate: Vial (type I glass) with a stopper (teflonised rubber).
Maltese: Kunjett (ħġieġ tip I) b'tapp (lasktu teflonizzat).
English: The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs).
Maltese: L-effikaċja bijoloġika ta' epoetin beta kienet murija wara li ngħatat taħt il-ġilda u ġol-vini lil diversi annimali in vivo li ntużaw bħala mudell (firien normali u uremiċi, ġrieden poliċitemiċi, klieb).
English: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in CKD patients System organ class
Maltese: Tabella 1: Reazzjonijiet avversi attribwiti lill-kura b'NeoRecormon fi provi kliniċi kkontrollati f'pazjenti b'CKD Klassi tas-sistemi u talorgani
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/044
Maltese: FIS-SUQ EU/1/97/031/044
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 (see section 4.4)
Maltese: Kien hemm rapporti ta' reazzjonijiet avversi serji tal-ġilda (SCARs) fosthom is-sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, b'rabta ma' kura b'epoetini (ara sezzjoni 4.4)
English: 1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections.
Maltese: Siringa waħda fiha: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, LThreonine, L-Glutamic acid, L-Phenylalanine, u ilma għall-injezzjonijiet.
English: - The active substance is epoetin beta.
Maltese: IU injezzjoni epoetin beta
English: · 1 dry sterile pad.
Maltese: • Iċċekkja l-likwidu fis-siringa.
English: · Very rarely (may affect up to 1 in 10,000 people) a severe form of allergic reaction has occurred, especially just after an injection.
Maltese: • Rari ħafna (tista' taffettwa sa persuna waħda minn kull 10,000) dehret forma severa ta' reazzjoni allerġika, speċjalment eżatt wara l-injezzjoni.
English: For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular: - only patients with a PCV ³ 33 % (haemoglobin ³ 11 g/dl [6.83 mmol/l]) should donate; - special care should be taken with patients below 50 kg weight; - the single volume drawn should not exceed approx. 12 % of the patient's estimated blood volume.
Maltese: Biex NeoRecormon jintuża fuq pazjenti li jkunu fi programm fejn jingħataw id-demm tagħhom stess, għandhom jiġu kkunsidrati l-linji gwida uffiċjali dwar il-prinċipji tad-donazzjoni tad-demm, partikolarment: - jistgħu jagħtu d-demm biss pazjenti b'PCV ≥ 33 % (emoglobina ≥ 11 g/dl [6.83 mmol/l]; - kura speċjali trid tingħata lil pazjenti li jiżnu inqas minn 50 kg; - il-volum meħud f'darba m'għandux jaqbeż bejn wieħed u ieħor 12 % ta' dak li hu stmat li hu il volum tad-demm tal-pazjent.
English: In patients treated with NeoRecormon, this incidence is 7 % compared to 4 % in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
Maltese: F'pazjenti kkurati b'NeoRecormon, din l-inċidenza hija ta' 7 % meta mqabbla ma' 4 % fil-kontrolli; din mhix assoċjata ma' żieda fil-mortalità b'kawża trombo-embolitika meta mqabbla mal-kontrolli.
English: NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10,000 IU and 20,000IU 1 prefilled syringe with one needle (27G1/2) or 6 pre-filled syringes with 6 needles (27G1/2).
Maltese: IU u 20,000IU Siringa waħda mimlija għal-lest b'labra waħda (27G1/2) jew 6 siringi mimlija għal-lest b'6 labriet (27G1/2).
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Maltese: IU NeoRecormon 30,000 IU Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin beta
English: 17 There may be a little bleeding at the injection site.
Maltese: 17 Jista' jkun hemm ftit fsada fis-sit tal-injezzjoni.
English: Hypertension
Maltese: Lajofiliżat
English: Your doctor might prescribe acetylsalicylic acid or modify the shunt.
Maltese: It-tabib tiegħek jista' jippreskrivi acetylsalicylic acid jew jimmodifika x-shunt.
English: A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.
Maltese: Studju dwar riskju ta' kanċer b'eritropoetin omologu fil-ġrieden ma żvelax sinjali ta' potenzjal proliferattiv jew tumuroġeniku.
English: This regresses during the course of continued therapy.
Maltese: Din tonqos tul il-kors tat-terapija.
English: Talk to your doctor before taking NeoRecormon · if your baby needs treatment with NeoRecormon, your baby will be carefully monitored for any potential effects on the eye. · if your anaemia does not improve with epoetin treatment · if you are low in certain B vitamins (folic acid or vitamin B12) · if you have very high levels of aluminium in your blood · if your blood platelet count is high · if you have chronic liver disease · if you have epilepsy · if you have developed anti-erythropoietin antibodies and pure red cell aplasia (reduced or stopped production of red blood cells) during prior exposure to any erythropoietic substance.
Maltese: F'każijiet iżolati kienet irrappurata aplasja pura taċ-ċelluli ħomor (PRCA) ikkawżata minn antikorpi newtralizzanti kontra l-eritropoetin, f'assoċjazzjoni ma' terapija b'NeoRecormon.
English: · Periodic Safety Update Reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/041
Maltese: FIS-SUQ EU/1/97/031/041
English: Talk to your doctor before using NeoRecormon · if your anaemia does not improve with epoetin treatment · if you are low in certain B vitamins (folic acid or vitamin B12) · if you have very high levels of aluminium in your blood · if your blood platelet count is high · if you have chronic liver disease · if you have epilepsy · if you have developed anti-erythropoietin antibodies and pure red cell aplasia (reduced or stopped production of red blood cells) during prior exposure to any erythropoietic substance.
Maltese: F'każijiet rari ħafna, ffurmaw antikorpi newtralizzanti kontra l-eritropoetin b'aplasja pura taċ-ċelluli ħomor (PRCA) u anki mingħajrha waqt terapija b'rHuEPO.
English: If you have phenylketonuria, talk to your doctor about your treatment with NeoRecormon.
Maltese: Ir-riżultati kliniċi miksubin s'issa ma jurux li hemm interazzjoni ta' NeoRecormon ma' prodotti mediċinali oħra.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 2000 IU injection epoetin beta
Maltese: Il-kura b'NeoRecormon hija maqsuma f'żewġ stadji:
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: · Rarely (may affect up to 1 in 1,000 people), allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred.
Maltese: • Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) dehru allerġiji jew reazzjonijiet tal-ġilda, bħal raxx jew urtikarja, ħakk jew reazzjonijiet madwar is-sit ta' linjezzjoni.
English: After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.
Maltese: Wara l-bidu tat-terapija, it-tabib tiegħek se j¿omm il-livell ta' l-emoglobina tiegħek bejn 10 u 12 g/dL.
English: NeoRecormon is indicated for: - Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients.
Maltese: - Kura ta' anemija sintomatika assoċjata ma' insuffiċjenza kronika tal-kliewi f'pazjenti adulti u pedjatriċi.