FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies showed that Abilify is effective at treating symptoms of schizophrenia using standard rating scales (such as the Positive and Negative Syndrome Scale, PANSS).
Maltese: Studji wrew li Abilify huwa effettiv fil-kura ta' sintomi ta' skiżofrenja bl-użu ta' skali ta' klassifikazzjoni standard (bħall-Iskala tas-Sindromu Pożittiv u Negattiv (the Positive and Negative Syndrome Scale), PANSS).
English: This is a summary of the European public assessment report (EPAR) for Abilify.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Abilify.
English: Other information about Abilify
Maltese: Informazzjoni oħra dwar Abilify
English: With regard to safety, the medicine has side effects comparable to those of other antipsychotics.
Maltese: Fir-rigward tas-sigurtà, il-mediċina għandha effetti sekondarji komparabbli ma' dawk ta' antipsikotiċi oħrajn.
English: Why is Abilify approved?
Maltese: Għaliex ġie approvat Abilify?
English: In studies of 1,203 adults, Abilify was more effective than placebo (a dummy treatment) at reducing symptoms.
Maltese: Fi studji fuq 1,203 adulti, Abilify kien iktar effettiv minn plaċebo (kura finta) fit-tnaqqis tas-sintomi.
English: Studies in bipolar I disorder showed that Abilify is effective at treating manic episodes using standard measurements such as the Young-Mania Rating Scale (YMRS) scale.
Maltese: Studji b'disturb bipolari I wrew li Abilify kien effettiv fil-kura ta' episodji ta' manija bl-użu ta' kejl standard bħall-iskala Young-Mania Rating Scale (YMRS).
English: Abilify is an antipsychotic medicine for patients with schizophrenia and bipolar I disorder.
Maltese: Abilify huwa mediċina antipsikotika għall-pazjenti li jbatu bl-iskiżofrenja u bid-disturb bipolari I.
English: In 4 out of 5 studies in 1,900 adults, Abilify was more effective than placebo at reducing manic symptoms, with two of these studies showing that Abilify has a similar effect to haloperidol and to lithium.
Maltese: F'4 minn 5 studji fuq 1,900 adult, Abilify kien iktar effettiv minn plaċebo fit-tnaqqis ta' sintomi ta' manija, bi tnejn minn dawn l-istudji juru li Abilify għandu effett simili għal haloperidol u għal litju.
English: In another adult study, Abilify was as effective as haloperidol, another antipsychotic medicine, in preventing symptoms from returning over 1 year.
Maltese: Fi studju ieħor fuq adulti, Abilify kien effettiv daqs haloperidol, mediċina antipsikotika oħra, filprevenzjoni ta' sintomi milli jirritornaw tul sena.
English: A study in 544 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify over 24 hours was greater than with placebo and similar to that with haloperidol.
Maltese: Studju fuq 544 pazjent ikkurati b'injezzjoni għal aġitazzjoni u mġiba b'disturbi wera li t-titjib b'Abilify tul 24 siegħa kien ikbar minn dak bil-plaċebo u simili għal dak b'haloperidol.
English: Abilify has also been studied in 302 adolescents aged between 13 and 17, with results showing Abilify to be more effective than placebo.
Maltese: Abilify kien studjat ukoll fi 302 adoloxxenti ta' bejn it-13 u s-17-il sena, fejn ir-riżultati wrew li Abilify kien iktar effettiv minn plaċebo.
English: Finally, a study in 291 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify was greater after 2 hours than with placebo and similar to that with lorazepam (another medicine for treating agitation).
Maltese: Fl-aħħar nett, studju fuq 291 pazjent ikkurati b'injezzjoni għal aġitazzjoni u mġiba b'disturbi wera li ttitjib b'Abilify, wara sagħtejn, kien ikbar minn dak bil-plaċebo u simili għal dak b'lorazepam (mediċina oħra għall-kura ta' aġitazzjoni).
English: The side effects are similar in adolescents, but sleepiness, extrapyramidal disorder, akathisia and tiredness are very common in this group (in more than 1 in 10 adolescents).
Maltese: L-effetti sekondarji huma simili f'adoloxxenti, iżda ħedla tan-ngħas, disturbi ekstrapiramidali, akatisja u għeja huma komuni ħafna f'dan il-grupp (f'aktar minn adoloxxent wieħed minn kull 10).
English: In schizophrenia, a mental illness with symptoms such as delusions, disorganised speech, and hallucinations (hearing or seeing things that are not there), Abilify is used to treat patients from the age of 15 years.
Maltese: Fl-iskiżofrenja, marda mentali bis-sintomi bħal delużjonijiet, diskors disorganizzat, u alluċinazzjonijiet (is-smigħ u d-dehra ta' affarijiet li mhumiex hemm), Abilify jintuża għall-kura ta' pazjenti mill-età ta' 15-il sena.
English: It can also be used for up to 12 weeks to treat manic episodes in adolescents from the age of 13 years.
Maltese: Jista' jintuża wkoll sa 12-il ġimgħa għall-kura ta' episodji ta' manija f'adoloxxenti mill-età ta' 13-il sena.
English: Studies comparing Abilify to placebo or other medicines (such as haloperidol and lithium) show that Abilify is effective at reducing symptoms of schizophrenia and at treating and preventing high moods in patients with bipolar I disorder.
Maltese: Studji li qabblu Abilify ma' plaċebo jew mediċini oħrajn (bħal haloperidol u litju) urew li Abilify kien effettiv fit-tnaqqis ta' sintomi ta' skiżofrenja u fil-kura u fil-prevenzjoni ta' burdati għolja f'pazjenti b'disturb bipolari I.
English: What is the risk associated with Abilify?
Maltese: X'inhu r-riskju assoċjat ma' Abilify?
English: How does Abilify work?
Maltese: Kif jintuża Abilify?
English: A study in 296 children and adolescents showed that Abilify was more effective than placebo at reducing the manic symptoms in patients aged 13 years and older.
Maltese: Studju fuq 296 tifel u tifla u adoloxxenti wera li Abilify kien iktar effettiv minn plaċebo fit-tnaqqis tassintomi ta' manija f'pazjenti ta' 13-il sena u ikbar.
English: Other studies showed that Abilify was more effective than placebo at preventing manic episodes in previously treated adults for up to 74 weeks, and when it was used as an add-on to existing treatment.
Maltese: Studji oħrajn urew li Abilify kien iktar effettiv minn plaċebo biex jipprevjeni episodji ta' manija f'adulti li kienu preċedentement ikkurati sa 74 ġimgħa, u meta ntuża bħala terapija addizzjonali mal-kura eżistenti.
English: In bipolar I disorder, Abilify is used in adults to treat manic episodes (periods of abnormally high mood) and to prevent new ones in those who have responded to the medicine in the past.
Maltese: Fid-disturb bipolari I, Abilify jintuża f'adulti għall-kura ta' episodji ta' manija (perjodi ta' burdata għolja anormali) u għall-prevenzjoni ta' oħrajn ġodda f'dawk li rrispondew għall-mediċina fl-imgħoddi.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: EPAR summary for the public octocog alfa
Maltese: Sommarju tal-EPAR għall-pubbliku octocog alfa
English: The full EPAR for Helixate NexGen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Maltese: Octocog alfa tiġi prodotta permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': hija magħmula minn ċelloli li ġiet introdotta fihom ġene (DNA) li tagħmilhom kapaċi jipproduċuha.
English: The active substance in Helixate NexGen, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Maltese: Is-sustanza attiva f'Helixate NexGen, l-octocog alfa (il-fattur koagulattiv VIII uman), huwa sustanza li tgħin id-demm jagħqad.
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Maltese: Dan jikkonsisti fissustanza attiva octocog alfa (fattur tal-koagulazzjoni VIII fil-bniedem).
English: Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Maltese: Reazzjonijiet ta' ipersensittività assoċjati mal-ġilda (ħakk, ħorriqija u raxx) jistgħu jseħħu b'mod komuni (bejn pazjent u 10 pazjenti f'100) iżda reazzjoni allerġika severa hija rari (bejn wieħed u 10 pazjenti f'10,000).
English: Helixate NexGen given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Maltese: Helixate NexGen mogħti b'injezzjoni fil-vina ġie studjat f'66 pazjent li kienu rċevew kura qabel bilfattur tal-koagulazzjoni VIII uman rikombinanti u f'61 tifel u tifla li ma kinux.
English: Helixate NexGen is similar to another medicine that was previously authorised in the EU called Helixate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Maltese: Helixate NexGen huwa simili għal mediċina oħra li kienet approvata fl-UE, imsejħa Helixate, iżda tiġi ppreparata b'mod differenti sabiex ma jkunx hemm proteini ġejjin mill-bniedem f'din il-mediċina.
English: Why is Helixate NexGen approved?
Maltese: Għaliex ġie approvat Helixate NexGen?
English: The European Commission granted a marketing authorisation valid throughout the EU for Helixate NexGen on 4 August 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Helixate NexGen fl-4 ta' Awwissu 2000.
English: The data provided on immune tolerance induction in patients with inhibitors showed, that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Maltese: Id-data pprovduta dwar l-istimulazzjoni ta' tolleranza immunitarja fil-pazjenti wriet li xi pazjenti jibbenefikaw mid-doża għolja u l-inibitur jista' jiġi eliminat.
English: Helixate NexGen as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Maltese: Helixate NexGen ġie studjat ukoll bħala infużjoni kontinwa fi 15-il pazjent b'emofilja A li saritilhom operazzjoni maġġuri.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems such as bleeding in the joints, muscles and internal organs.
Maltese: Pazjenti bl-emofilja A jkollhom nuqqas tal-fattur VIII, u dan jikkaġuna problemi ta' koagulazzjoni tad-demm bħal tnixxija ta' demm fil-ġogi, muskoli jew organi interni.
English: In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Helixate NexGen into a vein.
Maltese: Fil-pazjenti li ngħataw kura qabel, globalment, 95% tal-fsid irrispondew għal injezzjoni waħda jew tnejn fil-vina ta' Helixate NexGen. Fil-pazjenti li ma rċevewx kura qabel, madwar 90% tal-episodji ta' fsada rrispondew għallkura b'1 jew 2 injezzjonijiet fil-vina.
English: Helixate NexGen is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Maltese: Helixate NexGen jintuża biex jikkoreġi d-defiċjenza tal-fattur VIII billi jissostitwixxi l-fattur VIII nieqes, u jippermetti kontroll temporanju tad-disturb tal-fsada.
English: What are the risks associated with Helixate NexGen?
Maltese: X'inhuma r-riskji assoċjati ma' Helixate NexGen?
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm ukoll riskju li bil-mediċini ta' fattur VIII ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra fattur VIII, li jikkawżaw li l-mediċina tieqaf tkun effettiva u dan jirriżulta f'telf tal-kontroll tal-fsada.
English: Other information about Helixate NexGen
Maltese: Kif jintuża Helixate NexGen?
English: The dose and duration of treatment depend on whether Helixate NexGen is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Maltese: Id-doża u t-tul tal-kura jiddependu fuq jekk Helixate NexGen jintużax għallkura jew għall-prevenzjoni ta' fsada waqt kirurġija, kif ukoll fuq il-livelli tal-fattur VIII tal-pazjent, isseverità tal-emofilja, il-firxa u l-post tal-fsada u l-kundizzjoni u l-piż tal-ġisem tal-pazjent.
English: How does Helixate NexGen work?
Maltese: Kif jaħdem Helixate NexGen?
English: The Agency concluded that Helixate NexGen has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Maltese: L-Aġenzija kkonkludiet li Helixate NexGen intwera li kien effettiv fil-kura u fil-prevenzjoni ta' fsada f'pazjenti bl-emofilja A u li għandu profil ta' sigurtà aċċettabbli.
English: Helixate NexGen given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Maltese: Saru studji fuq Helixate NexGen mogħti b' doża għolja biex isir magħruf jekk huwiex effettiv fit-tneħħija tal-antikorpi kontra l-fattur VIII mid-demm (proċess magħruf bħala stimulazzjoni ta' tolleranza immunitarja) sabiex il-kura bil-fattur VIII tibqa' effettiva.
English: Helixate NexGen is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Maltese: Helixate NexGen jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni jew infużjoni (dripp) ġo vina.
English: Helixate NexGen is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Maltese: Helixate NexGen huwa mediċina li tintuża għall-kura u l-prevenzjoni ta' fsada f'pazjenti ta' kull età b'emofilja A (disturb ta' fsada li jintiret ikkawżat minn nuqqas ta' fattur VIII).
English: Stopping bleeding was assessed as ‘excellent' in all 15 patients.
Maltese: It-twaqqif tal-fsada ġiet evalwata bħala 'eċċellenti' fil-15-il pazjent kollha.
English: Oral suspension Oral use bottle (glass)
Maltese: Użu orali flixkun (ħġieġ)
English: Route of Administration
Maltese: Sospensjoni orali
English: 420 mg Concentrate for solution for infusion
Maltese: 420 mg Konċentrat għal soluzzjoni għallinfujoni
English: Intravenous use Vial (glass) 30 mg/ml
Maltese: 30 mg/ml
English: Content
Maltese: Isem
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes
Maltese: 4 siringi mimlija għal-lest
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 1 pre-filled syringe
Maltese: 1 siringa mimlija għal-lest waħda
English: Ref.: EMEA/464033/2009 EMEA/H/C/546/II/24
Maltese: Londra, 23 ta' Lulju 2009 Dok. ta' Ref.: EMEA/464033/2009 EMEA/H/C/546/II/24
English: It is available as capsules.
Maltese: Jiġi f'forma ta' kapsuli.
English: What is Lyrica?
Maltese: X'inhu Lyrica?
English: The active substance in Lyrica, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva f'Lyrica, pregabalin, hija simili fl-istruttura għall-aċidu butriku talgamma-amino (GABA) ‘newrotrasmettitur' tal-ġisem stess, iżda għandu effetti bijoloġiċi differenti ħafna.
English: Lyrica is a medicine that contains the active substance pregabalin.
Maltese: Lyrica huwa mediċina li fiha s-sustanza attiva pregabalin.
English: Four of the studies compared the short-term effects of Lyrica at doses between 150 and 600 mg per day with those of placebo (a dummy treatment) in a total of 2,757 patients.
Maltese: Erba' mill-istudji qabblu l-effetti fuq żmien qasir ta' Lyrica b'dożi ta' bejn 150 u 600 mg kuljum ma' dawk tal-plaċebo (trattament finta) f'total ta' 2,757 pazjent.
English: Lyrica has been authorised since July 2004.
Maltese: Lyrica ilu awtorizzat minn Lulju 2004.
English: On 23 April 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Lyrica.
Maltese: Fit-23 ta' April 2009, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrikmanda r-rifjut ta' emenda fl-awtorizzazzjoni għat-tqegħid fis-suq għallprodott mediċinali Lyrica.
English: • neuropathic pain (pain due to nerve damage);
Maltese: • uġigħ newropatiku (uġigħ dovut għal ħsara fin-nervituri);
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturb tal-ansjetà ġeneralizzat (ansjetà jew nervożiżmu fit-tul dwar ħwejjeġ ta' kuljum).
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 23 July 2009.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, isCHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fit-23 ta' Lulju 2009.
English: This is expected to reduce the symptoms of fibromyalgia, such as pain.
Maltese: Dan huwa mistenni li jnaqqas is-sintomi ta' fibromjalġija, bħall-uġigħ.
English: The fifth study compared the long-term effects of Lyrica with those of placebo in 566 patients who had responded to an initial six weeks of treatment with Lyrica.
Maltese: Il-ħames studju qabbel l-effetti fuq żmien twil ta' Lyrica ma' dawk tal-plaċebo f'566 pazjent li kienu rreaġixxew għal trattament inizjali ta' sitt ġimgħat b'Lyrica.
English: At that point in time, the CHMP was of the opinion that the benefits of Lyrica in the treatment of fibromyalgia did not outweigh its risks.
Maltese: F'dak il-mument, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Lyrica fit-trattament ta' fibromjalġja ma kinux akbar mir-riskji.
English: The change concerned an extension of indication to add the treatment of fibromyalgia.
Maltese: L-emenda kienet tikkonċerna estensjoni tal-indikazzjoni biex jiżdied ittrattament ta' fibromjalġija.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Lyrica in Europe for fibromyalgia.
Maltese: Il-kumpanija infurmat lis-CHMP li attwalment m'hemm ebda prova klinika li qiegħda ssir b'Lyrica flEwropa għall-fibromjalġija.
English: The company presented the results of five main studies involving over 3,000 adults with fibromyalgia.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' ħames studji ewlenin li kienu jinvolvu aktar minn 3,000 adult b'fibromjalġja.
English: What was Lyrica expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Lyrica?
English: Lyrica was also expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Maltese: Lyrica kien ukoll mistenni li jintuża għat-trattament tal-adulti b'fibromjalġija, marda li tikkawża wġigħ fit-tul u mxerred u reazzjonijiet ta' wġigħ meta wieħed jintmess.
English: • epilepsy in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Maltese: • epilessija f'pazjenti li jkollhom kollassi parzjali (attakki tal-epilessija li jibdew f'parti speċifika tal-moħħ) li ma jistgħux jiġu kkontrollati bit-trattament attwali tagħhom;
English: How is Lyrica expected to work?
Maltese: Kif huwa mistenni li jaħdem Lyrica?
English: The full European Public Assessment Report (EPAR) for Lyrica is available here.
Maltese: Ir-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) sħiħ għal Lyrica jista' jinsab hawnhekk.
English: What is happening for Lyrica for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder?
Maltese: X'qiegħed jiġri għal Lyrica għat-trattament tal-uġigħ newropatiku, tal-epilessija u tad-disturb tal-ansjetà ġeneralizzat?
English: Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Maltese: Il-fibromjalġija tista' tikkawża wkoll sintomi oħra bħal sensibbiltà, ebusija, għeja, ansjetà u bidliet fil-mod kif pazjent jorqod, kif iħoss u kif jaħseb.
English: What are the consequences of the refusal for patients in clinical trials with Lyrica?
Maltese: X'inhuma l-konsegwenzi tar-rifjut għal dawk il-pazjenti li huma involuti fi provi kliniċi b'Lyrica?
English: There are no consequences on the use of Lyrica in the authorised indications, for which the balance of benefits and risks remains unchanged.
Maltese: M'hemm ebda konsegwenza fuq l-użu ta' Lyrica għall-indikazzjonijiet awtorizzati, li għalihom, ilbilanċ tal-benefiċċji u tar-riskji jibqa' mhux mibdul.
English: Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica pregabalin
Maltese: Mistoqsijiet u tweġibiet dwar ir-rakkomandazzjoni għar-rifjut ta' emenda flawtorizzazzjoni għat-tqegħid fis-suq għal Lyrica pregabalin
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride
Maltese: 6.1 Lista ta' eċċipjenti Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride
English: Binocrit contains sodium
Maltese: Binocrit fih sodium
English: 10, A-6250 Kundl, Austria
Maltese: 10, A-6250
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: proporzjon ta' periklu ta' 1.06 favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13,933 pazjent) u għall-pazjenti bil-kanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu ta' sopravivenza totali kien ta' 1.04 (95% CI: 0.97, 1.11; 38 prova u 10,441 pazjenti).
English: Do not use Binocrit:
Maltese: Tużax Binocrit:
English: Further pharmacodynamic studies explored 40,000 IU once weekly versus 150 IU/kg 3 times per week.
Maltese: Studji addizzjonali farmakodinamiċi esploraw doża ta' 40,000 IU darba fil-ġimgħa kontra 150 IU/kg
English: • Symptoms of pure red cell aplasia (PRCA)
Maltese: • Sintomi ta' aplasija pura taċ-ċelluli ħomor (PRCA)
English: Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Maltese: Is-sustanzi mhux attivi l-oħra huma: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (għal aġġustament tal-pH), sodium hydroxide (għal aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: The mean CL/F for the 150 IU/kg, 3 times-per-week and 40,000 IU, once-weekly regimens in the anaemic cancer subjects were 45.8 and 11.3 mL/h/kg, respectively.
Maltese: IU/kg 3 darbiet kull ġimgħa u 40,000 IU darba fil-ġimgħa f'individwi anemiċi bilkanċer, kienet ta' 45.8 u 11.3 mL/h/kg, rispettivament.
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