FrancophonIA/ELRC3.0 huggingface dataset:
English: Ingelvac PCV Flex is a vaccine used to protect pigs from two weeks of age against porcine circovirus type 2 (PCV2).
Maltese: Ingelvac PCV Flex huwa vaċċin li jintuża biex jipproteġi lill-ħnieżer minn età ta' ġimagħtejn kontra ċircovirus tal-ħnieżer ta' tip 2 (PCV2).
English: Why is Ingelvac PCV Flex approved?
Maltese: Għaliex ġie approvatIngelvac PCV Flex?
English: What are the risks associated with Ingelvac PCV Flex?
Maltese: X'inhuma r-riskji assoċjati ma' Ingelvac PCV Flex?
English: For the full list of restrictions and all side effects reported with Ingelvac PCV Flex, see the package leaflet.
Maltese: Għal-lista sħiħa ta᾿ restrizzjonijiet u tal-effetti sekondarji kollha rrappurtati b᾿ Ingelvac PCV Flex, ara l-fuljett ta᾿ tagħrif.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac PCV FLEX's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta᾿ Ingelvac PCV Flex huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: How is Ingelvac PCV Flex used?
Maltese: Kif jaħdem Ingelvac PCV Flex?
English: How does Ingelvac PCV Flex work?
Maltese: Kif jintuża Ingelvac PCV Flex?
English: The vaccine starts to be effective 2 weeks after vaccination and protection lasts for 17 weeks.
Maltese: Il-vaċċin jibda jkun effettiv ġimagħtejn wara t-tilqima u l-protezzjoni ddum għal 17-il ġimgħa.
English: Content
Maltese: Il-pakkett
English: Medicinal Product no longer authorised
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Numru ta' l_EU Isem iventat Qawwa
English: Package size
Maltese: Kontenut Daqs tal-pakkett
English: MedDRA System Organ Classification (SOC)
Maltese: Klassifikazzjoni tal-Organi tas-Sistema(SOC)
English: D-25436 Uetersen Germany
Maltese: D-25436 Uetersen Il-Ġermanja
English: This usually takes between 15 and 30 minutes.
Maltese: Dan normalment jieħu bejn 15 u 30 minuta.
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 20 December 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 18 Diċembru 2007 Data tal-aħħar tiġdid: 20 Diċembru 2012
English: The apparent molecular weight of erythropoietin is 32 000-40 000 Dalton.
Maltese: Il-massa molekulari apparenti ta' eritropojetin hija ta' 32 000-40 000 Dalton.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZJONI BIL-BRAILLE
English: Usual maintenance dose
Maltese: Doża ta' manteniment normali
English: Weight (kg)
Maltese: Piż (kg)
English: 6.1 List of Excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: Porphyria acute
Maltese: Porfirja akuta
English: 4.3 Contraindications
Maltese: 4.3 Kontra-indikazzjonjiet
English: Target Hb (10 - 12 g/dl)
Maltese: Hb mixtieq (10-12 g/dl)
English: Surgery patients
Maltese: Pazjenti kirurġiċi
English: D-61118 Bad Vilbel Germany
Maltese: D-61118 Bad Vilbel Il-Ġermanja
English: Screening sEPO <200 mU/ml (N) Haemoglobin (g/l)
Maltese: Total (N) sEPO fl-iskrinjar <200 mU/ml (N) Emoglobina (g/l)
English: STADAPHARM GmbH Stadastraße 2-18
Maltese: GmbH Stadastraße 2-18
English: Contains phenylalanine, see leaflet for further information.
Maltese: Fih il-phenylalanine, ara l-fuljett għal aktar informazzjoni.
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6 769 patients) was observed in patients treated with recombinant human erythropoietin.
Maltese: Riskju relattiv ogħla ta' każijiet tromboembolitiċi (RR 1.67, 95% CI: 1.35, 2.06, 35 prova u 6 769 pazjent) kien osservat f'pazjenti fuq eritropojetin rikombinanti uman.
English: Silapo contains phenylalanine
Maltese: Silapo fih phenylalanine
English: The solution contains 3 333 IU Epoetin zeta per ml.
Maltese: Is-soluzzjoni fiha 3 333 IU Epoetin zeta kull ml.
English: Sixteen percent of epoetin alfa 300 IU/kg, 23% of epoetin alfa 100 IU/kg and 45% of placebo-treated patients required transfusion.
Maltese: Sittax fil-mija ta' epoetin alfa 300 IU/kg, 23% ta' epoetin alfa 100 IU/kg, u 45% tal-pazjenti kkurati bi plaċebo kienu jeħtieġu trasfużjoni.
English: Silapo is a biosimilar medicinal product.
Maltese: Silapo huwa prodott mediċinali bijoloġiku simili.
English: Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Total (N)
Maltese: NUMRU(I)
English: Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
Maltese: Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH).
English: Silapo contains sodium
Maltese: Silapo fih sodium
English: congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
Maltese: L-analiżi tal-komponenti individwali tal-punti aħħarin komposti wera l-HR (95% CI) li ġej: mewt 1.05 (0.92, 1.21), puplesija (1.38, 2.68), falliment tal-qalb konġestiv (CHF) 0.89 (0.74, 1.08), infart mijokardjali (MI) 0.96 (0.75, 1.23), teħid l-isptar minħabba iskemija mijokardjali 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.87).
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 the 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: Meta-analiżi tat-tagħrif tas-sopravivenza globali rriżulta fi stima ta' punt ta' proporzjon ta' riskju relattiv ta' 1.06 a favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13 933 pazjent) u għal pazjenti li jirċievu kimoterapija, il-proporzjon ta' riskju relattiv ta' sopravivenza globali kien ta' 1.04 (95% CI: 0.97, 1.11; 38 prova u 10 441 pazjent).
English: Silapo therapy is usually started under medical supervision.
Maltese: It-terapija b'Silapo normalmment tibda taħt superviżjoni medika.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8 167 patients).
Maltese: Meta-analiżi ta' l-informazzjoni dwar is-sopravivenza globali tat stima ta' punt ta' proporzjon ta' periklu ta' 1.08 favur il-kontrolli (-95% CI: 0.99, 1.18; 42 prova u 8 167 pazjent).
English: Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects.
Maltese: Minn total ta' 3 417-il individwu f'25 studju każwali bi plaċebo jew kura standard bħala kontroll, double-blinded, il-profil tas-sikurezza globali ta' epoetin alfa kien valutat f'2 094 individwu anemiku.
English: This is given three times a week, injected into a vein (over 1-5 minutes).
Maltese: Din tingħata tliet darbiet fil-ġimgħa, injettata f'vina (għal 1-5 minuti).
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2C - 8C).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu.
English: • have severe disorders of the veins and arteries
Maltese: • għandek disturbi severi tal-vini u tal-arterji
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dl, > 10 to ≤ 13 g/dl and > 13 g/dl).
Maltese: Il-pazjenti ġew stratifikati skont l-emoglobina tagħhom fil-linja bażi (≤ 10 g/dl, > 10 sa ≤ 13 g/dl u > 13 g/dl).
English: Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01
Maltese: Kategorija farmakoterapewtika: preparazzjonijiet antianemiċi oħrajn, eritropojetin Kodiċi ATC:
English: Drug ineffective
Maltese: Mediċina ineffettiva
English: Frequency estimate: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000), not known (frequency cannot be estimated from the available data).
Maltese: Komuni ħafna (>1/10); Komuni (>1/100 sa <1/10); Mhux komuni (>1/1 000 sa <1/100); Rari (>1/10 000 sa <1/1 000); Rari ħafna (<1/10 000), Mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli).
English: The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Maltese: L-effikaċja bijoloġika tal-eritropojetin intweriet f'diversi mudelli ta' l-annimali in vivo (ġrieden normali u anemiċi, ġrieden polycythaemic).
English: A systematic review has also been performed involving more than 9 000 cancer patients participating in 57 clinical trials.
Maltese: Reviżjoni sistematika ġiet mwettqa wkoll fuq aktar minn 9 000 pazjent bil- kanċer li kienu qed jipparteċipaw f'57 prova klinika.
English: 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with erythropoietin.
Maltese: 3H-thymidine fiċ-celluli eritrojdi nukleati tal-milsa instab in vitro (kultura ta' cellula tal-milsa tal-ġurdien) wara inkubazzjoni bl-eritropojetin.
English: Median time from baseline to first transfusion was statistically significantly longer in the epoetin alfa group compared to placebo (49 vs. 37 days; p=0.046).
Maltese: Iż-żmien medjan mil-linja bażika sal-ewwel trasfużjoni kien statistikament itwal b'mod sinifikanti filgrupp tal-epoetin alfa meta mqabbel mal-plaċebo (49 vs. 37 jum; p=0.046).
English: In two large, open-label studies, 2 697 cancer patients receiving non-platinum chemotherapy were included, 1 895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
Maltese: F'żewġ studji kbar bit-tikketti miftuħa (open label), 2 697 pazjent tal-kanċer li qegħdin jirċievu kimoterapija mhux tal-platinu ġew inklużi, 1 895 b'tumuri solidi (683 tas-sider, 260 tal-pulmun, 174 ġinekoloġiku, 300 gastro-intestinali, u 478 tipi oħra ta' tumri) u 802 b'kankri mallinni emotalogiċi.
English: Adverse Reaction (Preferred Term Level)
Maltese: Reazzjoni Avversa (Livell tat-Terminu Preferut)
English: The solution contains 40 000 IU Epoetin zeta per ml.
Maltese: Is-soluzzjoni fiha 40 000 IU Epoetin zeta kull ml.
English: 95% CI for Mean Prior Transfusions
Maltese: 95% CI għall-Medja Qabel it-Trasfużjonijiet
English: An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Maltese: Inċidenza akbar ta' episodji trombotiċi vaskulari (ara sezzjoni 4.4 u sezzjoni 4.8 - Ġenerali) kienet osservata f'pazjenti li kienu qed jirċievu mediċini eritropojetiċi.
English: Reticulocyte count increase ≥ 40 000/μl or Hb increase ≥ 1 g/dl
Maltese: Żieda fl-għadd ta' retikuloċiti ≥ 40 000/μl jew żieda fl-Hb ≥ 1 g/d
English: After 4 weeks of treatment the time to first transfusion was further increased in the epoetin alfa group (142 vs. 50 days, p=0.007).
Maltese: Wara 4 ġimgħat ta' trattament, iż-żmien sal-ewwel trasfużjoni kompla jiżdied fil-grupp tal-epoetin alfa (142 vs. 50 jum, p=0.007).
English: The recommended starting dose of Silapo is 450 IU/kg (maximum total dose is 40 000 IU).
Maltese: Id-doża inizjali rakkomandata ta' Silapo hija 450 IU/kg (doża totali massima hija 40 000
English: Reticulocyte count increase < 40 000/μl and Hb increase < 1 g/dl
Maltese: Żieda fl-għadd ta' retikuloċiti < 40 000/μl u żieda fl-Hb < 1 g/dl
English: *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Maltese: *Magħmul mit-teknoloġija rikombinanti DNA tal-linja ċellulari fl-Ovarju tal-Hamster Ċiniż (CHO).
English: 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast,
Maltese: 721 pazjent tal-kanċer li qegħdin jirċievu kimoterapija mhux tal-platinu ġew inklużi fi tliet studji plaċebo-kontrollati, 389 pazjent b' kankri ematoloġiċi mallinni (221 myeloma multipla, 144 non-Hodgkin's lymphoma, u 24 kankri mallinni ematoloġici oħra) u 332 b'tumuri solidi (172 tas-sider, 64 ġinekoloġiku, 23 tal-pulmun, 22 prostata, 21 gastro-intestinali, u 30 tip ieħor ta' tumuri).
English: The solution contains 10 000 IU Epoetin zeta per ml.
Maltese: Is-soluzzjoni fiha 10 000 IU Epoetin zeta kull ml.
English: ANNEX II
Maltese: ANNEX
English: Thrombotic/vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents.
Maltese: Episodji trombotiċi/vaskulari, bħal iskemija mijokardijaka, infart mijokardijaku, inċidenti ċerebrovaskulari (emorraġija ċerebrali u infart ċerebrali), attakki iskemiċi temporanji, trombożi tal-vini profonda, trombożi arterjali, emboli pulmonari, anewriżmi, trombożi fir-retina, u tagħqid ta' demm f'kilwa artifiċjali kienu rrappurtati f'pazjenti li kienu qed jirċievu sustanzi eritropojetiċi.
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Maltese: - Trattament għal anemija sintomatika f'pazjenti adulti u tfal b'falliment renali kroniku.
English: The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
Maltese: Il-parti magħmula mill-proteina tikkontribwixxi xi 58% tal-massa totali u tikkonsisti minn 165 aċidi aminiċi.
English: Epoetin alfa 300 IU/kg significantly reduced the risk of allogeneic transfusion in patients with a pretreatment haemoglobin of > 10 to ≤ 13 g/dl.
Maltese: Epoetin alfa 300 IU/kg naqqas b'mod sinifikanti r-riskju ta' trasfużjoni alloġeneika f'pazjenti b'emoglobina ta' qabel il-kura ta' > 10 sa ≤ 13 g/dl.
English: The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Maltese: Il-konċentrazzjoni tal-emoglobina mixtieqa għandha tkun ta' bejn 10 u 12 g/dl (6.2-7.5 mmol/l) ħlief f'pazjenti tfal fejn il-konċentrazzjoni tal-emoglobina għandha tkun bejn 9.5 u 11 g/dl (5.9-6.8 mmol/l).
English: Adult patients on peritoneal dialysis
Maltese: Pazjenti adulti fuq dijalisi peritonjali
English: Congenital, familial and genetic disorders
Maltese: Disturbi konġenitali, familjali u ġenetiċi
English: Overdose of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Maltese: Dosaġġ eċċessiv ta' eritropojetin jista' jipproduċi effetti li huma estensjonjiet tal-effetti farmakologiċi tal-ormon.
English: Epoetin zeta is a copy of the human protein erythropoietin and acts in the same way.
Maltese: Epoetin zeta hi kopja talproteina umana erythropoietin u taġixxi bl-istess mod.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Maltese: Ġew rapportati każijiet f'pazjenti b'epatite Ċ trattati b'interferon u ribavirin, meta epoetini jintużaw fl-istess ħin.
English: Convulsion
Maltese: Konvulżjoni
English: The recommended starting dose of Silapo is 50 IU/kg (International Units per kilogram).
Maltese: IU/kg (Units Intenazzjonali kull kilogramma).
English: Tabulated list of adverse reactions
Maltese: Lista ttabulata ta' reazzjonijiet avversi
English: In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Maltese: Fi prova prospettiva, randomised, double-blind , plaċebo-kontrollata magħmula fi 375 pazjent anemiċi b'kankri mallinni varji mhux myeloid li qed jirċievu l-kimoterapija mhux tal-platinu, kien hemm tnaqqis sinjifikanti ta' sequelae relatati ma' l-anemija (eż. l-għejja, nuqqas ta' enerġija, u nuqqas ta' attività), kif imkejjel mill-istrumenti u skali li ġejjin:
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Maltese: Ma' dawn kien hemm 228 individwu b'CRF trattati b'epoetin alfa f'4 studji b'falliment kroniku tal-kliewi (2 studji ta' qabel il-dijalisi [N = 131 individwu espost b'CRF] u 2 fuq dijalisi [N = 97 individwu espost]; 1 404 individwi esposti għall-kanċer f'16-il studju ta' anemija minħabba kimoterapija; 147 individwu espost f'2 studji għal donazzjoni tad-demm awtologi; 213-il individwu espost fi studju 1 fil-perijodu perikirurġiku u 102 individwi esposti f'żewġ studji
English: In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4).
Maltese: Fil-maġġoranza ta' dawn il-pazjenti, kienu osservati antikorpi għall-eritropojetini (ara sezzjoni 4.3 u 4.4).
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 bi plaċebo bħala kontroll il-proporzjonijiet ta' ħsara għal sopravivenza globali kienet tvarja bejn 1.25 u 2.47 favur il-kontrolli.
English: Angioneurotic oedema
Maltese: Injezzjoni taħt il-ġilda
English: SYRINGE LABELS
Maltese: TAS-SIRINGA
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Maltese: Fl-istudju multiċentrali li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bil-plaċebo, 4 (4.7%)individwi esperjenzaw TVEs (mewt għal għarrieda, puplesija iskemika, emboliżmu u flebite).
English: ≤2 RBC Units ˃2 and ≤4 RBC Units ˃4 RBC Units No one subject did not have sEPO data in the ≥200 mU/ml stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Maltese: RBC Unitajiet Le individwu wieħed ma kellux data dwar l-sEPO fl-istrat ≥200 mU/ml kien hemm 13-il individwu fil-grupp ta' epoetin alfa u 6 individwi fil-grupp tal-plaċebo
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Maltese: Artralġja, Uġigħ fl-għadam, Mijalġja, Uġigħ fl-estremitajiet
English: Maintenance phase: Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level: Hb between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Maltese: Hb bejn id-9.5 u l-11 g/dl (5.9-6.8 mmol/l).
English: There is no evidence to indicate that treatment with erythropoietin alters the metabolism of other medicinal products.
Maltese: Ma teżistix evidenza li tindika li t-trattament bl-eritropojetin ibiddel il-metaboliżmu ta' prodotti mediċinali oħra.
English: Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ≤10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).
Maltese: Silapo jista' jintuża biex tiżdied il-konċentrazzjoni tal-emoglobina f'anemija sintomatika (konċentrazzjoni tal-emoglobina ta' ≤10 g/dl) fl-adulti b'sindromi majelodisplastiċi (MDS) primarji b'riskju baxx jew intermedju-1 li għandhom eritropojetin baxx fis-serum (<200 mU/ml).
English: Treatment of adult patients scheduled for major elective orthopaedic surgery
Maltese: Trattament ta' pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri
English: Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Maltese: Sirdat, Mard bħal tal-Influwenza, Reazzjoni fis-sit tal-injezzjoni, Edema periferika
English: Silapo 20 000 IU
Maltese: Silapo 20 000
English: Haemoglobin concentration
Maltese: Konċentrazzjoni ta' emoglobina
English: Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Maltese: Indipendentament mit-trattament bl-eritropojetin, episodji trombotiċi u vaskulari jistgħu jseħħu f'pazjenti kirurġiċi b'mard kardjovaskulari wara flebotomija ripetuta.
English: An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
Maltese: Prova open-label, tat-tip grupp parallel, li saret fuq individwi adulti li ma kellhomx defiċjenza ta' ħadid, b'emoglobina ta' qabel il-kura ta' ≥ 10 sa ≤ 13 g/dl, li kienu skedati għal operazzjoni ortopedika maġġuri tal-ġenbejn jew tal-irkoppa, qabbel epoetin alfa 300 IU/kg mogħti taħt il-ġilda kuljum għal 10 ijiem qabel l-operazzjoni, fil-jum tal-operazzjoni, u għal erbat ijiem wara l-operazzjoni, ma' epoetin alfa 600
English: Do not use Silapo if:
Maltese: Tużax Silapo jekk:
English: The following maintenance doses were observed in clinical trials after 6 months of treatment.
Maltese: Id-dożi ta' manteniment li ġejjin ġew osservati fi provi kliniċi wara 6 xhur ta' trattament.
English: There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
Maltese: Hemm rapporti konflittwali fil-letteratura dwar jekk l-eritropojetin jistax ikollu rwol ewlieni bħala proliferatur ta' tumuri.
English: Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p<0.001).
Maltese: Ir-reazzjoni għall-eritrojdi matul l-ewwel 24 ġimgħa tal-istudju ntweriet minn 27/85 (31.8%) individwu fil-grupp tal-epoetin alfa meta mqabbla ma' 2/45 (4.4%) individwu fil-grupp tal-plaċebo (p<0.
English: Do not to stop the treatment without consultation of your doctor.
Maltese: Qatt m'għandek twaqqaf it-trattament mingħajr ma tikkonsulta lit-tabib tiegħek.
English: 1 pre-filled syringe contains 8 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 8 000 IU Epoetin zeta
English: Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Maltese: Eritroblastopenja medjata mill-antikorpi (PRCA) ġiet irrappurtata wara perijodu ta' minn xhur sa snin ta' kura b'epoetin alfa.
English: From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dl) was twice than that observed in the 300 IU/kg daily group (0.73 g/dl).
Maltese: IU/kg kull ġimgħa (1.44 g/dl) kienet id-doppju minn dik osservata fil-grupp ta' 300 IU/kg ta' kuljum (0.73 g/dl).
English: 1 pre-filled syringe contains 5 000 IU Epoetin zeta
Maltese: Injezzjoni tas-Silapo 5 000 IU Epoetin zeta