FrancophonIA/ELRC3.0 huggingface dataset:
English: - Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients listed in section 6.1.
Maltese: - Ipersensittività għas-sustanza attiva, epoetins oħrajn u d-derivattivi tagħhom jew għal kwalunkwe eċċipjent elenkat fit-taqsima 6.1.
English: The syringe has a scale on the syringe barrel.
Maltese: Hemm skala fuq it-tubu tas-siringa.
English: Symptomatic anaemia associated chronic renal failure Data from correction phase studies in 284 chronic renal failure patients show that the haemoglobin response rates (defined as haemoglobin levels above 11 g/dl at two consecutive measurements) in the epoetin theta group (88.4% and 89.4% in studies in patients on dialysis and not yet undergoing dialysis, respectively) were comparable to epoetin beta (86.2% and 81.0%, respectively).
Maltese: Anemija sintomatika assoċjata ma' insuffiċjenza renali kronika Tagħrif miġbur minn studji waqt il-fażi ta' korrezzjoni f'284 pazjent b'insuffiċjenza renali kronika juri li r-rata ta'rispons tal-emoglobina (definita b'livell ta' emoglobina ‘l fuq minn 11 g/dl, mkejjel darbtejn wara xulxin) fil-grupp ta'epoetin theta (88.4% u 89.4% f'studji b'pazjenti li qed jirċievu dijaliżi u dawk li mhumiex qed jirċievu dijaliżi rispettivament) kien simili għal dawk ta' epoetin beta (86.2% u 81.
English: EU/1/09/565/025 EU/1/09/565/026 EU/1/09/565/027 EU/1/09/565/028 EU/1/09/565/040 EU/1/09/565/041 EU/1/09/565/042
Maltese: EU/1/09/565/026 EU/1/09/565/027 EU/1/09/565/028 EU/1/09/565/040
English: Table 1: Adverse reactions System organ class
Maltese: Tabella 1: 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% meta mqabbla ma' amministrazzjoni minn ġol-vina.
English: The first study was conducted in 186 anaemic patients with non-myeloid malignancies (55% with haematological malignancies and 45% with solid tumours) receiving non-platinum chemotherapy.
Maltese: L-ewwel studju sar f'186 pazjent anemiku b'tumuri malinni mhux majelojdi (55% b'tumuri ematoloġiċi u 45% b'tumuri solidi) u li kienu qed jirċievu kimoterapija mhux bil-platinum.
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: The safety and efficacy of Biopoin in children and adolescents aged up to 17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Biopoin fit-tfal u l-adolexxenti sa età ta' 17-il sena ma ġewx stabbiliti.
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: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10 persuni) - 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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Contents of the pack and other information 7.
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative epoetin doses independent of the diabetes or dialysis status was observed (see sections 4.2 and section 4.4).
Maltese: Ġiet osservata tendenza lejn stimi ta' żieda fir-riskju għal mortalità mill-kawżi kollha, avvenimenti kardjovaskulari u ċerebrovaskulari assoċjati ma' dożi kumulattivi ogħla ta' epoetin b'mod indipendenti mill-istat ta' dijabete jew dijaliżi (ara sezzjonijiet 4.2 u 4.4).
English: Date of first authorisation: 23 October 2009.
Maltese: Data tal-ewwel awtorizzazzjoni: 23/10/2009
English: Date of latest renewal: 26 August 2014.
Maltese: Data tal-aħħar tiġdid: 26/08/2014
English: Frequency groupings are defined according to the following convention:
Maltese: Il-frekwenza tal-effetti mhux mixtieqa hija definita bl-użu tal-konvenzjoni li ġejja:
English: Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO-K1) by recombinant DNA technology.
Maltese: Ovarji tal-Ħamster Ċiniż (CHO-K1).
English: Biopoin contains sodium
Maltese: Biopoin fih is-sodium
English: Other medicines and Biopoin
Maltese: Mediċini oħra u Biopoin
English: Shunt thrombosis*
Maltese: Trombożi fix-xant*
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar l-immaniġġjar tal-prodott mediċinali qabel jingħata, ara t-taqsima 6.6.
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Maltese: Il-varjabilità tal-emoglobina trid tiġi indirizzata permezz tal-immaniġġjar tad-doża, b'konsiderazzjoni għall-mira ta' medda tal emoglobina ta' 10 g/dl (6.21 mmol/l) sa 12 g/dl (7.45 mmol/l).
English: Anaemia caused by chronic renal failure
Maltese: Anemija assoċjata ma' insuffiċjenza renali kronika
English: Symptomatic anaemia associated with chronic renal failure
Maltese: Anemija sintomatika assoċjata ma' insuffiċjenza renali kronika
English: The initial dose is 20,000 IU.
Maltese: Id-doża tal bidu hija ta' 20,000
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 tindika wkoll b'mod konsistenti, żieda sinifikanti tar-riskju relattiv ta' avvenimenti tromboemboliċi f'pazjenti bil-kanċer li jkunu qed jirċievu eritropojetin uman rikombinanti (ara sezzjoni 4.4).
English: The recommended dose is…
Maltese: Id-doża rakkomandata hija…
English: SC IV
Maltese: SC
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Maltese: Epoetins mhumiex approvati għall-immaniġġjar ta' anemija marbuta ma' epatite Ċ.
English: Biopoin 30,000 IU/1 ml injection Epoetin theta
Maltese: Biopoin 30,000 IU/1 ml injezzjoni Epoetin theta
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: Il-half-life terminali hi għola meta mqabbla mal-amministrazzjoni ġol vina, b'medja ta' 25 siegħa wara doża waħda u 34 siegħa fis-stat fiss wara dożi ripetuti tlett darbiet filġimgħa, mingħajr ebda akkumulazzjoni ta' epoetin theta.
English: Biopoin 10,000 IU/1 ml, Biopoin 20,000 IU/1 ml and Biopoin 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution.
Maltese: IU/1 ml u Biopoin 30,000 IU/1 ml: Kull siringa mimlija għal-lest fiha 1 ml soluzzjoni.
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Maltese: Saret ukoll analiżi sistematika li nvolviet aktar minn 9,000 pazjent bil-kanċer li pparteċipaw f'57 studji kliniċi.
English: If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the haemoglobin level.
Maltese: Jekk ikun hemm poliċitemija severa, metodi konvenzjonali (flebotomija) jistgħu jkunu indikati biex jitnaqqas l-livell tal-emoglobina.
English: Push the safety shield towards the needle (see picture 12).
Maltese: Imbotta l-protezzjoni tas-sigurtà lejn il-labra (ara stampa 12).
English: Pure red cell aplasia (PRCA)*
Maltese: Aplażja taċ-ċelluli l ħomor tad-demm pura (PRCA)*
English: Biopoin 1,000 IU/0.5 ml injection Epoetin theta
Maltese: Biopoin 1,000 IU/0.5 ml injezzjoni Epoetin theta
English: *See subsection “Description of selected adverse reactions” below
Maltese: *Ara sottosezzjoni “Deskrizzjoni tar-reazzjonijiet avversi magħżula” hawn taħt
English: Biopoin 3,000 IU/0.5 ml injection Epoetin theta
Maltese: Biopoin 3,000 IU/0.5 ml injezzjoni Epoetin theta
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U
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: Pakkett li fih 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: Skin reactions*
Maltese: Reazzjonijiet fil-ġilda*
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR
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: 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: Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Maltese: L-eritropojetin uman huwa ormon glikoprotejiku endoġenu li huwa r-regolatur ewlieni tal-eritropojeżi permezz tal-interazzjoni speċifika mar-riċettur tal-eritropojetin fuq iċ-ċelluli eritrojdi proġenituri fil mudullun.
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: 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: Biopoin contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Maltese: Biopoin fih is-sustanza attiva epoetin theta, li hija kważi identika għall-eritropojetin, ormon naturali magħmul f'ġismek.
English: - Uncontrolled hypertension.
Maltese: Klassifika tal-Organi.
English: Solution for injection (injection).
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni)
English: The pharmacokinetics of epoetin theta are independent of age or gender.
Maltese: Il-farmakokinetika ta' epoetin theta mhiex dipendenti fuq l-eta' jew il-ġeneru tal-pazjent.
English: Treatment with epoetin theta should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.07 mmol/l).
Maltese: Il-kura b'epoetin theta għandha tiġi temporanjament imwaqqfa jekk il-livell tal-emoglobina jaqbeż it-13 g/dl (8.07 mmol/l).
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.
Maltese: Kien hemm rapporti ta' reazzjonijiet serji tal-ġilda fosthom is-sindrome ta' Stevens-Johnson (SJS) u nekrolisi epidermali tossika (TEN) b'rabta ma' kura b'epoetin.
English: Biopoin 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: Biopoin 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: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Maltese: Kienu rrappurtati każijiet f'pazjenti b'epatite Ċ ikkurati b'interferon u ribavirin, meta epoetins jintużaw fl-istess ħin.
English: The second study was conducted in 223 patients with various solid tumours receiving platinum-containing chemotherapy.
Maltese: It-tieni studju sar f'223 pazjent b'diversi tumuri solidi li kienu qed jirċievu kimoterapija bil-platinum.
English: In the clinical studies, pre-dialysis patients were treated once-weekly with epoetin theta, 174 patients in the maintenance phase study and 111 patients in the long-term study.
Maltese: Fi studji kliniċi, pazjenti li għadhom ma kienux fuq d-dijaliżi rċevew kura ta' darba fil-ġimgħa b'epoetin theta, 174 pazjent fl-istudju ta' waqt il-fażi ta' manteniment u 111 pazjent fl-istudju fit-tul.
English: Information for injecting yourself”).
Maltese: Informazzjoni dwar kif tinjetta lilek innifsek”).
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: IU/kg piż tal-ġisem, epoetin theta f'tlett siti differenti (fid-dirgħajn, fl-addome, fil-koxxa) f'voluntiera f'saħħithom, il-profili tal-livelli fil-plażma osservati kienu jixxibħu.
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 updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini.
English: In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients and 289 patients not yet undergoing dialysis.
Maltese: F'żewġ studji fit-tul, l-effikaċja ta'epoetin theta ġiet evalwata f'124 pazjent fuq id-dijaliżi u 289 pazjent għad mhux fuq id-dijaliżi.
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 fis-sopravivenza globali bejn pazjenti kkurati b'eritropojetin rikombinanti uman u l-kontrolli.
English: Biopoin 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: 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: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%.
Maltese: Ġenerali Kura supplementari bil-ħadid hija rakkomandata għall-pazjenti kollha b' livelli ta' ferritin fis-serum taħt 100 μg/l jew li għandhom saturazzjoni ta' transferrin taħt 20%.
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 li kienet statistikament sinifikanti u konsistenti, u mhux spjegata, f'pazjenti b'anemija assoċjata ma' diversi kanċers komuni li rċevew eritropojetin rikombinanti uman meta mqabbla mal-kontrolli.
English: Biopoin 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: EU/1/09/565/017 1 pre-filled syringe EU/1/09/565/018 1 pre-filled syringe with safety device EU/1/09/565/019 4 pre-filled syringes EU/1/09/565/020 4 pre-filled syringes with safety device EU/1/09/565/021 6 pre-filled syringes EU/1/09/565/022 6 pre-filled syringes with safety device EU/1/09/565/037 1 pre-filled syringe with safety needle EU/1/09/565/038 4 pre-filled syringes with safety needle EU/1/09/565/039 6 pre-filled syringes with safety needle
Maltese: EU/1/09/565/037 1 siringa mimlija għal-lest b'labra tas-sigurtà EU/1/09/565/038 4 siringi mimlija għal-lest b'labra tas-sigurtà EU/1/09/565/039 6 siringi mimlija għal-lest b'labra tas-sigurtà
English: One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 micrograms) epoetin theta per ml.
Maltese: 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) epoetin theta f'kull ml.
English: Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported (not known, frequency cannot be estimated from the available data).
Maltese: Rejazzjonijiet allerġiċi bħal raxx tal-ġilda, nefhiet f'partijiet tal-ġilda b'urtikarja, u rejazzjonijiet allerġiċi qawwijin b' debbulizza, pressjoni baxxa, qtugħ ta' nifs u nefħa fil-wiċċ ġew irrapurtati (mhux magħruf, ma tistax tittieħed stima mid-data disponibbli).
English: Hypertension
Maltese: Artralġja
English: Symptomatic anaemia associated with chronic renal failure 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 u l-konsegwenzi tal-anemija jistgħu jvarjaw skond l-età, ilġeneru u l-effett globali tal-marda; evalwazzjoni mit-tabib tal-kors kliniku u l-kundizzjoni individwali tal-pazjent hi meħtieġa.
English: In patients with chronic renal failure undergoing haemodialysis, the elimination half-life of epoetin theta is 6 hours after single dosing and 4 hours in steady state after repeated intravenous administration of 40 IU/kg body weight epoetin theta three times weekly.
Maltese: F'pazjenti b'insuffiċjenza renali kronika fuq emodijaliżi, il-half-life ta' eliminazzjoni ta' epoetin theta hi 6 sieħat wara doża waħda u 4 siegħat fis-stat fiss wara l-amministrazzjoni ripetuta minn ġol vina ta'40
English: Disposing of used syringes
Maltese: Rimi ta'siringi użati
English: Biopoin 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: Biopoin 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: EU/1/09/565/011 1 pre-filled syringe EU/1/09/565/012 1 pre-filled syringe with safety device EU/1/09/565/013 4 pre-filled syringes EU/1/09/565/014 4 pre-filled syringes with safety device EU/1/09/565/015 6 pre-filled syringes EU/1/09/565/016 6 pre-filled syringes with safety device EU/1/09/565/034 1 pre-filled syringe with safety needle EU/1/09/565/035 4 pre-filled syringes with safety needle EU/1/09/565/036 6 pre-filled syringes with safety needle
Maltese: EU/1/09/565/034 1 siringa mimlija għal-lest b'labra tas-sigurtà EU/1/09/565/035 4 siringi mimlija għal-lest b'labra tas-sigurtà EU/1/09/565/036 6 siringi mimlija għal-lest b'labra tas-sigurtà
English: Check the appearance of Biopoin.
Maltese: Iċċekja id-dehra ta' Biopoin.
English: Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see section 4.4).
Maltese: puplesija) li wkol jistgħu jiġru f'pazjenti li ssoltu jkollhom pressjoni normali jew baxxa (Ara sezzjoni 4.4).
English: 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 IU (66.7 micrograms) epoetin theta per ml.
Maltese: Siringa waħda mimlija għal-lest fiha 4,000 unità internazzjonali (IU) (33.3mikrogrammi) epoetin theta f' 0.5 ml soluzzjoni għall-injezzjoni li jikkorrespondu għal 8,000 IU (66.7 mikrogrammi) epoetin theta f'kull ml.
English: Intravenous administration
Maltese: Amministrazzjoni ġol vina
English: Anaemia in cancer patients
Maltese: a) Korrezzjoni tal-anemija
English: Biopoin 1,000 IU/0.5 ml, Biopoin 2,000 IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000 IU/0.5 ml and Biopoin 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Maltese: IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000
English: Biopoin 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: Siringa waħda mimlija għal-lest fiha 30,000 unità internazzjonali (IU) (250 µg) epoetin theta f'1 ml soluzzjoni għall-injezzjoni li jikkorrispondu għal 30,000 IU (250 µg) epoetin theta f'kull ml.
English: Biopoin 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: Biopoin 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: 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 nekrolisi epidermali tossika b'rabta ma' kura b'epoetin.
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