FrancophonIA/ELRC3.0 huggingface dataset:
English: PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including with epoetin theta.
Maltese: PRCA ikkawżata minn anitkorpi anti-eritropojetin newtralizzanti ġiet irrappurtata waqt terapija eritropojetika, li tinkludi b'epoetin theta .
English: EU/1/09/573/025 EU/1/09/573/026 EU/1/09/573/027 EU/1/09/573/028 EU/1/09/573/040 EU/1/09/573/041 EU/1/09/573/042
Maltese: EU/1/09/573/026 EU/1/09/573/027 EU/1/09/573/028 EU/1/09/573/040
English: During the studies, mortality was lower in the epoetin theta group (6.9%) compared to placebo (10.3%).
Maltese: Waqt dawn l-istudji, il-mortalita' kienet inqas fil-grupp ta epoetin theta (6.9%) ikkumparat mal-plaċebo (10.
English: Eporatio 10,000 IU/1 ml, Eporatio 20,000 IU/1 ml and Eporatio 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution.
Maltese: IU/1 ml u Eporatio 30,000 IU/1 ml: Kull siringa mimlija għal-lest fiha 1 ml soluzzjoni.
English: In controlled clinical studies, use of epoetins has shown: - shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin level in excess of 14 g/dl (8.69 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 value of 12-14 g/dl (7.45-8.69 mmol/l), - increased risk of death when administered to target a haemoglobin value of 12 g/dl (7.45 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Maltese: - f'sopravivenza globali mqassra u żieda fl-imwiet attribwiti għall-progressjoni tal-marda wara 4 xhur f'pazjenti b'kanċer metastatiku tas-sider li jkunu qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta' emoglobina ta' 12 - 14 g/dl (7.45 - 8.69 mmol/l), - f'żieda fir-riskju ta' mewt meta jingħata biex jintlaħaq livell ta' emoglobina ta' 12 g/dl (7.45 mmol/l) f'pazjenti b'mard malinn attiv li ma jkunux qed jirċievu la kimoterapija u lanqas terapija bir-radjazzjoni.
English: Adverse reactions listed below in table 1 are classified according to System Organ Class.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt f'tabella 1 huma kklassifikati skond is-Sistema talKlassifika tal-Organi.
English: Eporatio 30,000 IU/1 ml injection Epoetin theta
Maltese: Eporatio 30,000 IU/1 ml injezzjoni Epoetin theta
English: Packs of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Maltese: Pakketti li fihom 1, 4 u 6 siringi mimlija għal-lest; 1, 4 u 6 siringi mimlija għal-lest b'labra tas-sigurtà jew 1, 4 u 6 siringi mimlija għal-lest bi protezzjoni għas-sigurtà tal-labra.
English: Eporatio contains sodium
Maltese: Eporatio fih is-sodium
English: Eporatio 1,000 IU/0.5 ml injection Epoetin theta
Maltese: Eporatio 1,000 IU/0.5 ml injezzjoni Epoetin theta
English: The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy.
Maltese: Ġenerali Il-farmakokinetika ta' epoetin theta ġiet studjata f'voluntiera f'saħħithom, f'pazjenti b'insuffiċjenza renali kronika u f'pazjenti b'kanċer li kienu qed jirċievu kimoterapija.
English: Common (may affect up to 1 in 10 people) - Headache; - High blood pressure; - Flu-like symptoms, such as fever, chills, feeling of weakness, tiredness; - Skin reactions, such as rash, itching or reactions around the injection site.
Maltese: - Uġigħ ta' ras; - Pressjoni għolja tad-demm; - Sintomi jixbhu lill-influwenza bħal deni, dehxiet, sensazzjoni ta' dgħjufija, għeja ; - Reazzjonijiet fil-ġilda bħal ħakk, urtikarja jew reazzjonijiet fis-sit tal-injezzjoni.
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-hazard ratios għas-sopravivenza globali varjaw bejn 1.25 u2.47 favur il-kontrolli.
English: Eporatio 3,000 IU/0.5 ml injection Epoetin theta
Maltese: Eporatio 3,000 IU/0.5 ml injezzjoni Epoetin theta
English: Eporatio contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Maltese: Eporatio fih is-sustanza attiva epoetin theta, li hija kważi identika għall-eritropojetin, ormon naturali magħmul f'ġismek.
English: Eporatio 30,000 IU/1 ml: One pre-filled syringe contains 30,000 international units (IU)
Maltese: IU/1 ml: Siringa waħda mimlija għal-lest fiha 10,000 unità internazzjonali (IU)
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 30,000 international units (IU) (250 µg) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 µg) epoetin theta per ml.
Maltese: Eporatio 30,000 IU/1 ml: Siringa waħda mimlija għal-lest fiha 30,000 unità internazzjonali (IU) (250 mikrogrammi) epoetin theta f' 1 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 30,000 IU (250 mikrogrammi) f'kull ml.
English: 6 pre-filled syringes containing 0.5 ml.
Maltese: 6 siringi mimlija għal-lest ta' 0.5 ml.
English: Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Maltese: disturbi fil-kliem, mixi mhux stabbli) u komplikazzjonijiet relatati magħha (aċċessjonijiet, attakki ta' puplesija) li wkol jistgħu jiġru f'pazjenti li ssoltu jkollhom pressjoni normali jew baxxa (Ara sezzjoni 4.4).
English: *See subsection “Description of selected adverse reactions” below
Maltese: *Ara sottosezzjoni “Deskrizzjoni tar-reazzjonijiet avversi magħżula” hawn taħt Deskrizzjoni tar-reazzjonijiet avversi magħżula
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl [6.21 mmol/l]).
Maltese: Epoetin theta għandu jingħata minn taħt il-ġilda lil pazjenti b'anemija (eż. livell tal-emoglobina ≤ 10 g/dl [6.21 mmol/l]).
English: Approximately 9% of patients can be expected to experience an adverse reaction.
Maltese: Madwar 9% tal-pazjenti huma mistennija li jkollhom reazzjonijiet avversi.
English: Average bioavailability of epoetin theta after subcutaneous administration is approximately 31% compared with intravenous administration.
Maltese: Il-biodisponibiltà medja ta' epoetin theta wara amministrazzjoni minn taħt il-ġilda hija madwar 31%
English: Eporatio 20,000 IU/1 ml: One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 international units (IU) (166.7 micrograms) per ml.
Maltese: IU/1 ml: Siringa waħda mimlija għal-lest fiha 20,000 unità internazzjonali (IU) (166.7 mikrogrammi) epoetin theta f' 1 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 20,000
English: Eporatio 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 international units (IU) (33.3 micrograms) per ml.
Maltese: IU/0.5 ml: Siringa waħda mimlija għal-lest fiha 2,000 unità internazzjonali (IU) (16.7 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 4,000 IU (33.3 mikrogrammi) f'kull ml.
English: Eporatio 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 international units (IU) (50 micrograms) per ml.
Maltese: Eporatio 3,000 IU/0.5 ml: Siringa waħda mimlija għal-lest fiha 3,000 unità internazzjonali (IU) (25 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 6,000 IU (50 mikrogrammi) f'kull ml.
English: Eporatio is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Maltese: Eporatio jintuża għal kura ta'anemija sintomatika (pereżempju għeja, dgħufija u qtugħ ta' nifs).
English: Eporatio 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 international units (IU) (66.7 micrograms) per ml.
Maltese: IU/0.5 ml: Siringa waħda mimlija għal-lest fiha 4,000 unità internazzjonali (IU) (33.3 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 8,000 IU (66.7 mikrogrammi) f'kull ml.
English: The terminal half-life is higher than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin theta.
Maltese: b'medja ta' 25 siegħa wara doża waħda u 34 siegħa fis-stat fiss wara dożi ripetuti tlett darbiet fil ġimgħa, mingħajr ebda akkumulazzjoni ta' epoetin theta.
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Eporatio 3,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Eporatio 4,000
English: - Serious skin rashes:
Maltese: epoetins rriżulta:
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 1,000 international units (IU) (8.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per ml.
Maltese: Eporatio 1,000 IU/0.5 ml: Siringa waħda mimlija għal-lest fiha 1,000 unità internazzjonali (IU) (8.3 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 2,000
English: 6 pre-filled syringes containing 1 ml.
Maltese: 6 siringi mimlija għal-lest ta' 1 ml.
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 20,000 international units (IU) (166.7 µg) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 20,000 unità internazzjonali (IU) (166.7 µg) epoetin theta f'1 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 20,000
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: Eporatio 30,000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 1 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 micrograms) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 20,000 unità internazzjonali (IU) (166.7 mikrogrammi) epoetin theta f' 1 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 20,000
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Maltese: IL-PRODOTT MEDIĊINALI Eporatio 1,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 5,000 international units (IU) (41.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Maltese: IU/0.5 ml: Siringa waħda mimlija għal-lest fiha 5,000 unità internazzjonali (IU) (41.7 mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 10,000
English: EU/1/09/573/011 1 pre-filled syringe EU/1/09/573/012 1 pre-filled syringe with safety device EU/1/09/573/013 4 pre-filled syringes EU/1/09/573/014 4 pre-filled syringes with safety device EU/1/09/573/015 6 pre-filled syringes EU/1/09/573/016 6 pre-filled syringes with safety device EU/1/09/573/034 1 pre-filled syringe with safety needle EU/1/09/573/035 4 pre-filled syringes with safety needle EU/1/09/573/036 6 pre-filled syringes with safety needle
Maltese: EU/1/09/573/034 1 siringa mimlija għal-lest b'labra tas-sigurtà EU/1/09/573/035 4 siringi mimlija għal-lest b'labra tas-sigurtà EU/1/09/573/036 6 siringi mimlija għal-lest b'labra tas-sigurtà
English: In patients with a poor haemoglobin response to epoetin theta, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Maltese: F'pazjenti b'rispons batut tal-emoglobina għal epoetin theta, spegazzjonijiet alternattivi għar rispons batut għandhom jiġu kkunsidrati (ara sezzjonijiet 4.4 u 5.1).
English: EU/1/09/573/017 1 pre-filled syringe EU/1/09/573/018 1 pre-filled syringe with safety device EU/1/09/573/019 4 pre-filled syringes EU/1/09/573/020 4 pre-filled syringes with safety device EU/1/09/573/021 6 pre-filled syringes EU/1/09/573/022 6 pre-filled syringes with safety device EU/1/09/573/037 1 pre-filled syringe with safety needle EU/1/09/573/038 4 pre-filled syringes with safety needle EU/1/09/573/039 6 pre-filled syringes with safety needle
Maltese: EU/1/09/573/017 EU/1/09/573/018 EU/1/09/573/019 EU/1/09/573/020 EU/1/09/573/021 EU/1/09/573/022 EU/1/09/573/037 EU/1/09/573/038 EU/1/09/573/039
English: EU/1/09/573/023 1 pre-filled syringe EU/1/09/573/024 1 pre-filled syringe with safety device EU/1/09/573/025 4 pre-filled syringes EU/1/09/573/026 4 pre-filled syringes with safety device EU/1/09/573/027 6 pre-filled syringes EU/1/09/573/028 6 pre-filled syringes with safety device EU/1/09/573/040 1 pre-filled syringe with safety needle EU/1/09/573/041 4 pre-filled syringes with safety needle EU/1/09/573/042 6 pre-filled syringes with safety needle
Maltese: EU/1/09/573/040 1 siringa mimlija għal-lest b'labra tas-sigurtà EU/1/09/573/041 4 siringi mimlija għal-lest b'labra tas-sigurtà EU/1/09/573/042 6 siringi mimlija għal-lest b'labra tas-sigurtà
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: Eporatio 3,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 10,000 unità internazzjonali (IU) (83.3 mikrogrammi) epoetin theta f' 1 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 10,000
English: Date of latest renewal: 11 September 2014.
Maltese: Data tal-ewwel awtorizzazzjoni: 29/10/2009 Data tal-aħħar tiġdid: 11/09/2014
English: EU/1/09/573/001 6 pre-filled syringes
Maltese: EU/1/09/573/001 6 siringi mimlija għal-lest
English: EU/1/09/573/009 6 pre-filled syringes
Maltese: EU/1/09/573/009 6 siringi mimlija għal-lest
English: Eporatio 1,000 IU/0.5 ml, Eporatio 2,000 IU/0.5 ml, Eporatio 3,000 IU/0.5 ml, Eporatio 4,000 IU/0.5 ml and Eporatio 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Maltese: IU/0.5 ml, Eporatio 3,000 IU/0.5 ml, Eporatio 4,000
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 3,000 international units (IU) (25 µg) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 3,000 unità internazzjonali (IU) (25 µg) epoetin theta f'0.5 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 6,000 IU (50 µg) epoetin theta f'kull ml. Eporatio 4,000
English: Eporatio 20,000 IU/1 ml
Maltese: IU/1 ml, Eporatio 20,000
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 10,000 unità internazzjonali (IU) (83.3 µg) epoetin theta f'1 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 10,000
English: EU/1/09/573/007 6 pre-filled syringes
Maltese: EU/1/09/573/007 6 siringi mimlija għal-lest
English: EU/1/09/573/004
Maltese: EU/1/09/573/003 EU/1/09/573/004
English: In these two studies, 180 haemodialysis patients and 193 patients not undergoing dialysis were switched from maintenance phase treatment with epoetin beta to treatment with epoetin theta for a period of six months showing stable haemoglobin values and a similar safety profile as epoetin beta.
Maltese: sitt xhur, u wrew valuri ta' emoglobina stabbli u profil ta' sigurta' simili għal dak b'epoetin beta.
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 4,000 international units (IU) (33.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 4,000 unità internazzjonali (IU) (33.3 µg) epoetin theta f'0.5 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 8,000 IU (66.7 µg) epoetin theta f'kull ml. Eporatio 5,000
English: EU/1/09/573/005 6 pre-filled syringes
Maltese: EU/1/09/573/005 6 siringi mimlija għal-lest
English: Two randomised controlled studies were conducted in 270 haemodialysis patients and 288 patients not yet undergoing dialysis, who were on stable treatment with epoetin beta.
Maltese: Żewġ studji randomised u kkontrollati twettqu fuq 270 pazjent fuq id-dijaliżi tad-demm u 288 pazjent għadhom mhux fuq id-dijaliżi, li kienu stabbli fuq kura b'epoetin beta.
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: 1 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: The therapeutic margin of epoetin theta is very wide.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: Pregnancy and breast-feeding
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 2,000 international units (IU) (16.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 2,000 unità internazzjonali (IU) (16.7 µg) epoetin theta f'0.5 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 4,000 IU (33.3 µg) epoetin theta f'kull ml. Eporatio 3,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Eporatio 1,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: EU/1/09/573/003 6 pre-filled syringes
Maltese: EU/1/09/573/003 6 siringi mimlija għal-lest
English: 1 pre-filled syringe containing 1 ml.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 1 siringa mimlija għal-lest ta' 1 ml.
English: - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Maltese: - Kura tal-anemija sintomatika f'pazjenti adulti b'kanċer li għandhom tumuri malinni mhux majelojdi u li qed jirċievu kimoterapija.
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Maltese: Eporatio 3,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Eporatio 4,000
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Maltese: 0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieg tip I), b'għatu tat-tarf (lastku tal-bromobutyl) u tap tal-planġer (lasktu tal-chlorobutyl teflonizzat) u labra tal-injezzjoni (azzar li ma jissaddadx) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà (labra tassigurtà) jew labra tal-injezzjoni (azzar li ma jissaddadx) bi protezzjoni għas-sigurtà tal-labra.
English: Following subcutaneous injection of 40 IU/kg body weight epoetin theta at three different sites (upper arm, abdomen, thigh) in healthy volunteers, similar plasma level profiles were observed.
Maltese: Ġew irrapurtati sintomi li jixbħu lill-influwenza,bħal deni, dehxiet, u kundizzjonijiet ta' astenja.
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Maltese: Anemija sintomatika f' pazjenti b'kanċer li għandhom tumuri malinni mhux majelojdi u li qed jirċievu kimoterapija
English: In the event of polycythaemia, epoetin theta should be temporarily withheld.
Maltese: IU/kg piż tal-ġisem, epoetin theta f'tlett siti differenti