FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Maltese: Ibbażat fuq l-informazzjoni miġbura minn analiżi ta' provi kkontrollati bil-plaċebo, li kienu jinkludu total ta' 1,923 pazjent fuq pramipexole u 1,354 pazjent fuq il-plaċebo, ir-reazzjonijiet avversi għallmediċina kienu rrappurtati b'mod frekwenti għaż-żewġ gruppi. 63% tal-pazjenti fuq pramipexole u 52% tal-pazjenti fuq il-plaċebo, irrappurtaw mill-anqas reazzjoni avversa waħda għall-mediċina.
English: General disorders and administration site conditions fatigue peripheral oedema
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata għeja edema periferali
English: • tachycardia (increased heart rate)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Maltese: Minħabba li l-antikolinerġiċi huma eliminati primarjament permezz tal-bijotrasformazzjoni, ilpotenzjal għal interazzjoni hu limitat, għalkemm interazzjoni mal-antikolinerġiċi ma ġietx investigata.
English: Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the up titration of Pramipexole Accord.
Maltese: Jekk qed tieħu levodopa, hu rrakkomandat li d-doża ta' levodopa titnaqqas meta tibda l-kura bi Pramipexole Accord.
English: 1 dose (0.5 ml) contains approximately: Human Papillomavirusa Type 6 L1 proteinb,c aHuman Papillomavirus = HPV bL1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Maltese: b,c a Papillomavirus Uman = HPV b L1 proteina fis-sura ta' partikuli qishom virus prodotti fiċ-ċelluli tal-moffa (Saccharomyces cerevisiae CANADE 3C-5 (Speċi 1895)) minn teknoloġija DNA rikombinanti c adsorbit fuq amorphous aluminium hydroxyphosphate sulphate adjuvant (225 mikrogramma Al)
English: Content (concentratio n)
Maltese: Kontenut (konċentrazzjoni
English: 1 vial
Maltese: 10 kunjetti
English: 1 pre-filled syringe + 2 needles
Maltese: 1 siringa mimlija għal-lest + 2 labriet
English: 1 pre-filled syringe
Maltese: Proteina tip 16 L1
English: 1 pre-filled syringe + 1 needle
Maltese: 10 siringi mimlijin għal-lest + 10 labriet
English: It is available as 250 mg sachets, each containing 12.5 mg imiquimod (5%).
Maltese: Hija tiġi bħala qratas ta' 250 mg, kull wieħed ikun fih 12.5 mg ta' imiquimod (5%).
English: This summary was last updated in 09-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi:09-2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ALDARA EPAR summary for the public
Maltese: RAPPORT TAL-VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) ALDARA Sommarju ta' l-EPAR għall-pubbliku
English: The marketing authorisation was renewed on 18 September 2003 and on 18 September 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-18 ta' Settembru 2003 u fit-18 ta' Settembru 2008.
English: Aldara is a cream containing the active substance imiquimod.
Maltese: Aldara hija ingwent li fih is-sustanza attiva imiquimod.
English: • Aldara has also been studied in patients with actinic keratoses in two studies involving a total of 505 patients.
Maltese: • Aldara ġiet ukoll studjata f'pazjenti b'keratożi aktinika f'żewġ studji li involvew total ta' 505 pazjenti.
English: The active substance in Aldara cream, imiquimod, is an immune response modifier.
Maltese: Is-sustanza attiva fl-ingwent Aldara, imiquimod, hija modifikatur tar-reazzjoni immunitarja.
English: The marketing authorisation holder is Meda AB.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq huwa Meda AB.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara's benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu tal-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' ALDARA huma akbar mir-riskji tagħha għall-kura ta' felul tal-ġenitali esterni u perianali (condylomata acuminata), karċinomi żgħar taċ-ċellola bażali u keratożi aktinika mhux iperkeratotika, mhux ipertrofika f'pazjenti adulti immunokompetenti meta għażliet ta' kuri topikali oħra mhux indikati jew anqas addattati.
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport tal-Valutazzjoni Pubblika Ewropew (EPAR).
English: • warts on the genitals and around the anus;
Maltese: • Felul fuq il-ġenitali u madwar l-anus;
English: • In the treatment of genital warts, the total clearance rate across the four main studies was 15 to 52% in the Aldara-treated patients, compared with 3 to 18% in the placebo-treated patients.
Maltese: • Fil-kura ta' felul ġenitali, ir-rata ta' eliminazzjoni totali fl-erba' studji ewlenin kienet 15 sa 52% f'pazjenti ikkurati b'Aldara meta mqabbla ma' 3 sa 18% f'pazjenti ikkurati bil-plaċebo.
English: • In actinic keratoses, complete clearance after one or two courses of treatment was seen in 54 and 55% of Aldara-treated patients in the two studies, compared with 15 and 2% in the placebo-treated patients.
Maltese: • F'keratożi aktinika, eliminazzjoni kompluta wara kors wieħed jew tnejn ta' kura dehru f'54 u 55% ta' pazjenti ikkurati b'Aldara fiż-żewġ studji, meta mqabbla ma' 15 u 2% fil-pazjenti ikkurati bi plaċebo.
English: • For genital warts, Aldara is applied three times a week for up to 16 weeks.
Maltese: • Għal felul ġenitali, Aldara hija applikata tliet darbiet fil-ġimgħa sa 16-il ġimgħa.
English: What is Aldara?
Maltese: Kif taħdem Aldara?
English: • small basal cell carcinomas (slow-growing types of skin cancer);
Maltese: • Karċinomi żgħar taċ-ċellola bażali (tipi ta' kanċer tal-ġilda li jikbru bil-mod);
English: Why has Aldara been approved?
Maltese: Għaliex ġiet approvata Aldara?
English: When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon.
Maltese: Meta imiquimod huwa applikat fuq il-ġilda, huwa jaħdem lokalment fuq is-sistema immunitarja biex iqanqal il-ħelsien ta' ċitokini, inklużi interferon.
English: • Aldara has been studied in 923 patients with genital warts in four main studies lasting 16 weeks.
Maltese: • Aldara ġiet studjata f'923 pazjent b'felul ġenitali f'erba' studji ewlenin li damu 16-il ġimgħa.
English: There were no differences between the two dose frequencies.
Maltese: Ma kien hemm l-ebda differenza bejn il-frekwenzi taż-żewġ dożaġġi.
English: • When the results of the two studies in basal cell carcinoma were looked at together, total clearance was seen in 66 to 80% of Aldara-treated patients compared with 0 to 3% in the placebo group.
Maltese: • Meta saret ħarsa lejn ir-riżultati taż-żewġ studji flimkien f'karċinoma taċ-ċellola bażali, eliminazzjoni totali dehret f'66 sa 80% ta' pazjenti ikkurati b'Aldara meta mqabbla ma' 0 sa 3% fil-grupp tal-plaċebo.
English: The most common side effect with Aldara (seen in more that 1 patient in 10) is a reaction at the site of application of the cream (pain or itching).
Maltese: L-aktar effett sekondarju komuni b'Aldara (deher f'aktar minn pazjent 1 f'10) hija reazzjoni fis-sit ta' l-applikazzjoni ta' l-ingwent (uġigħ jew ħakk).
English: How has Aldara been studied?
Maltese: Kif ġiet studjata Aldara?
English: In all studies, Aldara was more effective than placebo.
Maltese: Fl-istudji kollha, Aldara kienet aktar effettiva minn plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aldara on 18 September 1998.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aldara fit-18 ta' Settembru 1998.
English: Other information about Aldara:
Maltese: Tagħrif ieħor dwar Aldara:
English: The main measure of effectiveness was the number of patients with total clearance of treated warts.
Maltese: Ilkejl ewlieni ta' l-effikaċja kien in-numru ta' pazjenti b'eliminazzjoni totali tal-felul ikkurati.
English: What is the risk associated with Aldara?
Maltese: X'inhu r-riskju assoċjat ma' Aldara?
English: • actinic keratoses of the face and scalp (precancerous, abnormal skin growths that develop after too much exposure to sunlight), in patients whose immune system is working normally.
Maltese: • Keratożi aktinika tal-wiċċ u l-qurriegħa (żviluppi mhux normali tal-ġilda li jseħħ qabel ifeġġ kanċer u li jiżviluppa wara esponiment żejjed għad-dawl tax-xemx), f'pazjenti li s-sistema immunitarja tagħhom qed taħdem sewwa.
English: • Aldara has also been studied in 724 patients with small basal cell carcinomas in two studies where patients were treated for six weeks, and used Aldara or placebo either five times a week or every day.
Maltese: • Aldara ġiet ukoll studjata f'724 pazjent b'karċinomi żgħar taċ-ċellola bażali f'żewġ studji fejn ilpazjenti kienu ikkurati għal sitt ġimgħat, u użaw Aldara jew plaċebo jew ħames darbiet fil-ġimgħa jew kuljum.
English: For the full list of all side effects reported with Aldara, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha irrapportati b'Aldara, ara l-Fuljett ta' Tagħrif.
English: The doctor then takes blood samples 45, 60 and 90 minutes later to see how much growth hormone the body has produced.
Maltese: It-tabib imbagħad jieħu kampjuni tad-demm 45, 60 u 90 minuta wara biex jara kemm il-ġisem ipproduċa ormoni li jinkoraġġixxu t-tkabbir.
English: Further information on Macimorelin Aeterna Zentaris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
Maltese: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
English: Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with Macimorelin Aeterna Zentaris; 74% of people who tested positive with ITT also tested positive with Macimorelin Aeterna Zentaris.
Maltese: B'mod ġenerali, 94 % tal-persuni li ttestjaw negattivi għad-defiċjenza fl-ormoni li jinkoraġġixxu ttkabbir b'ITT ittestjaw negattivi wkoll b'Macimorelin Aeterna Zentaris, 74 % tal-persuni li ttestjaw pożittivi b'ITT ittestjaw pożittivi wkoll b'Macimorelin Aeterna Zentaris.
English: Macimorelin Aeterna Zentaris contains the active substance macimorelin.
Maltese: Macimorelin Aeterna Zentaris fih is-sustanza attiva macimorelin.
English: Macimorelin Aeterna Zentaris gave a similar number of negative test results for growth hormone deficiency as a comparator test; however, it gives fewer positive test results than the comparator.
Maltese: Macimorelin Aeterna Zentaris ta numru ta' riżultati negattivi għat-test tad-defiċjenza fl-ormoni li jinkoraġġixxu t-tkabbir li huwa simili għal dak tat-test komparatur; madankollu, jagħti inqas riżultati pożittivi għat-test mill-komparatur.
English: The most common side effects with Macimorelin Aeterna Zentaris (which may affect up to 1 in 10 people) are a bitter or metallic taste, tiredness, headache, nausea (feeling sick), dizziness, diarrhoea and feeling hot. Macimorelin Aeterna Zentaris may also cause a change in heart rhythm.
Maltese: L-effetti sekondarji l-aktar komuni b'Macimorelin Aeterna Zentaris (li jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni) huma togħma mora jew metallika, għeja, uġigħ ta' ras, nawżja (tħossok imdardar), sturdament, dijarrea u sħana. Macimorelin Aeterna Zentaris jista' jikkawża wkoll bidla firritmu tal-qalb.
English: The study involved 166 adults who had either a high, intermediate or low likelihood of having growth hormone deficiency, or who were confirmed not to have growth hormone deficiency.
Maltese: L-istudju involva 166 adult li kellhom probabbiltà għolja, intermedja jew baxxa li jkollhom defiċjenza flormoni li jinkoraġġixxu t-tkabbir, jew li kienu kkonfermati li ma kellhomx defiċjenza fl-ormoni li jinkoraġġixxu t-tkabbir.
English: Other information about Macimorelin Aeterna Zentaris
Maltese: Informazzjoni oħra dwar Macimorelin Aeterna Zentaris
English: Macimorelin Aeterna Zentaris was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.
Maltese: Macimorelin Aeterna Zentaris tqabbel ma' test ieħor li normalment jintuża għad-dijanjożi taddefiċjenza fl-ormoni li jinkoraġġixxu t-tkabbir, imsejjaħ test tat-tolleranza tal-insulina (ITT), fi studju ewlieni wieħed.
English: On the whole, Macimorelin Aeterna Zentaris has fewer side effects than the comparator test, which temporarily lowers the level of sugar in the blood.
Maltese: B'mod ġenerali, Macimorelin Aeterna Zentaris għandu inqas effetti sekondarji mit-test komparatur, li temporanjament ibaxxi l-livelli taz-zokkor fid-demm.
English: How does Macimorelin Aeterna Zentaris work?
Maltese: Macimorelin Aeterna Zentaris?
English: As for all medicines, data on the use of Macimorelin Aeterna Zentaris are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Macimorelin Aeterna Zentaris hija ssorveljata kontinwament.
English: The active substance in Macimorelin Aeterna Zentaris, macimorelin, stimulates the release of growth hormone into the blood by activating receptors (targets) found on cells in the pituitary gland, a gland located at the base of the brain.
Maltese: Is-sustanza attiva f'Macimorelin Aeterna Zentaris, il-macimorelin, tistimula r-rilaxx tal-ormoni li jinkoraġġixxu t-tkabbir fid-demm billi tattiva r-riċetturi (miri) li jinsabu fuq iċ-ċelloli fil-glandola pitwitarja, glandola li tinsab fil-bażi tal-moħħ.
English: Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone.
Maltese: Macimorelin Aeterna Zentaris huwa mediċina li tintuża biex tittestja l-abbiltà tal-ġisem li jipproduċi lormoni li jinkoraġġixxu t-tkabbir.
English: For the full list of side effects and restrictions with Macimorelin Aeterna Zentaris, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Macimorelin Aeterna Zentaris, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Macimorelin Aeterna Zentaris?
Maltese: X'inhuma r-riskji assoċjati ma' Macimorelin Aeterna Zentaris?
English: EMA therefore decided that Macimorelin Aeterna Zentaris's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-EMA ddeċidiet li l-benefiċċji ta' Macimorelin Aeterna Zentaris huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: The recommended dose is 0.5 mg per kg body weight which the patient should take once.
Maltese: Id-doża rakkomandata hija 0.5 mg għal kull kg tal-piż tal-ġisem li l-pazjent għandu jieħu darba.
English: Among them, 140 were tested with both Macimorelin Aeterna Zentaris and ITT.
Maltese: Fosthom, 140 kienu ttestjati b'kemm Macimorelin Aeterna Zentaris kif ukoll b'ITT.
English: 30 minutes
Maltese: 30 minuta
English: “click”
Maltese: “klikk”
English: 15 seconds
Maltese: 15-il sekonda
English: Date of latest renewal: 19 May 2006
Maltese: Data tal-aħħar tiġdid: 19 ta' Mejju 2006
English: Placental transfer was minimal.
Maltese: It-trasferiment mill-plaċenta kien minimu.
English: Aranesp 40 µg injection Darbepoetin alfa IV/SC
Maltese: Aranesp 40 µg injezzjoni Darbepoetin alfa IV/SC
English: • A demonstration device
Maltese: • Apparat ta' dimostrazzjoni
English: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6 Juncos, PR 00777-4060
Maltese: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6
English: Thromboembolic eventsb, including pulmonary embolism
Maltese: Avvenimenti tromboemboliċib, inkluż emboliżmu pulmonari
English: Pharmacodynamic effects
Maltese: Effetti Farmakodinamiċi
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 miżjud ta' avveniment thromboemboliċi (RR 1.67, CI ta' 95%: 1.35, 2.06; 35 prova u 6,769 pazjent) kien osservat f'pazjenti ttrattati b'eritropoetina rikombinanti uman.
English: Equipment:
Maltese: Apparat:
English: SJS/TEN, erythema multiforme, blistering, skin exfoliation
Maltese: SJS/TEN, eritema multiforme, infafet, tqaxxir tal-ġilda
English: Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
Maltese: Data ppreżentata minn studji kkontrollati tinkludi 1,357 pazjenti, 766 li ngħataw Aranesp u 591 pazjent li ngħataw r-HuEPO.
English: Syringe safety guard
Maltese: Gwardja protetiva tassiringa
English: Analysis of the individual components of the composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), stroke 1.92 (1.38, 2.68), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
Maltese: Analiżi tal-komponenti ndividwali tal-punti finali komposti wriet lHR (CI ta' 95%) li ġejjin: mewt 1.05 (0.92, 1.21), insuffiċjenza konġestiva tal-qalb (CHF) 0.89 (0.74, 1.08), infart mijokardijaku (MI - myocardial infarction) 0.96 (0.75, 1.23 ), puplesija 1.92 (1.38, 2.68), dħul l-isptar għall-iskemija mijokardijaka 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
English: MedDRA system organ class
Maltese: Klassi tas-sistemi u tal-organi ta' MedDRA
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100, < 1/10); mhux komuni (≥ 1/1,000, < 1/100); rari (≥ 1/10,000, < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima minn data disponibbli).
English: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients (see section 4.2).
Maltese: Trattament ta' anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (CRF - chronic renal failure) f'pazjenti adulti u tfal (ara sezzjoni 4.2).
English: • High blood pressure (hypertension)
Maltese: • Pressjoni għolja (ipertensjoni)
English: • Hives (urticaria)
Maltese: • Ħorriqija (urtikarja)
English: Uncommon1
Maltese: Mhux komuni1
English: The secondary endpoint of progression free survival was 4.8 and 4.3 months, respectively (stratified HR 0.95; 95% CI: 0.87-1.04), ruling out the pre-defined 15% risk increase.
Maltese: Il-punt finali sekondarju ta' sopravivenza mingħajr progressjoni kien ta' 4.8 u 4.3 xhur, rispettivament (HR stratifikat 0.95; CI ta' 95 %: 0.87-1.04), bleliminazzjoni taż-żieda fir-riskju predefinita ta' 15%.
English: • alcohol wipes or similar.
Maltese: • imsielaħ bl-alkoħol jew simili.
English: Appropriate dose titration between 500 mcg, 300 mcg, and 150 mcg should be considered.
Maltese: Titrazzjoni xierqa fid-doża bejn 500 mcg, 300 mcg, u 150 mcg għandha tiġi kkunsidrata.
English: • Stroke
Maltese: • Stikk
English: The mean haemoglobin at week 28 for r-HuEPO and darbepoetin alfa was 11.1 (SD 1.4) g/dL and 11.1 (SD 1.1) g/dL, respectively.
Maltese: L-emoglobina medja f'ġimgħa 28 għal r-HuEPO u darbepoetin alfa kienet 11.1 (SD 1.4) g/dL u 11.1 (SD 1.1) g/dL, rispettivament.
English: placebo-controlled studies of Aranesp with a total of 4,630 patients (Aranesp 2,888, placebo 1,742).
Maltese: double-blind, ikkontrollati bi plaċebo ta' Aranesp b'total ta' 4,630 pazjent (Aranesp 2,888,
English: - The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by genetechnology).
Maltese: - Is-sustanza attiva hi darbepoetin alfa , r-HuEPO (erythropoietin magħmul permezz ta' teknoloġija ġenetika).
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 tad-data globali ta' għejxien pproduċiet stima ta' punt ta' proporzjon ta' periklu ta' 1.08 favur il-kontrolli (CI ta' 95%: 0.99, 1.18; 42 prova u 8,167 pazjent).
English: • 0.45 micrograms once weekly.
Maltese: • 0.45 mikrogramma darba fil-ġimgħa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8 June 2001
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta' Ġunju 2001
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Maltese: Trattament ta' anemija sintomatika f'pazjenti adulti u tfal li għandhom insuffiċjenza renali kronika
English: The mean haemoglobin for r-HuEPO and darbepoetin alfa at baseline was 11.1 (SD 0.7) g/dL and 11.3 (SD 0.6) g/dL, respectively.
Maltese: L-emoglobina medja għal r-HuEPO u darbepoetin alfa fil-linja bażi kienet 11.1 (SD 0.7) g/dL u 11.3 (SD 0.6) g/dL, rispettivament.
English: Aranesp works in exactly the same way as the natural hormone erythropoietin.
Maltese: Aranesp jaħdem eżattament bl-istess mod bħall-ormon naturali eritropoetina.
English: Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Maltese: Sustanzi mhux attivi: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 u ilma għall-injezzjoni.
English: 2 Frequency cannot be estimated from the available data.
Maltese: 2 Il-frekwenza ma' tistax tiġi stmata mid-data disponibbli.
English: This will make the injection more comfortable.
Maltese: Infezzjonijiet u Infestazzjonijiet.
English: Patients with CRF experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower haemoglobin levels (13.5 g/dL (8.4 mmol/L) versus 11.3 g/dL (7.1 mmol/L); 14 g/dL (8.7 mmol/L) versus 10 g/dL (6.2 mmol/L) in two clinical studies.
Maltese: Pazjenti b'CRF kellhom riskji akbar ta' mewt u avvenimenti kardjovaskulari serji meta mogħtija ESAs biex jiġu mmirati livelli ta' emoglobina ogħla kontra dawk aktar baxxi (13.5 g/dL (8.4 mmol/L) kontra 11.3 g/dL (7.1 mmol/L); 14 g/dL (8.7 mmol/L) kontra 10 g/dL (6.2 mmol/L)) f'żewġ studji kliniċi.
English: Not known: frequency cannot be estimated from available data • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Maltese: • Aplasija pura taċ-ċelluli ħomor (PRCA - pure red cell aplasia) - (anemija, għeja mhux tas soltu, nuqqas ta' enerġija)
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Maltese: Twettqet ukoll analiżi sistemika li nkludiet aktar minn 9,000 pazjent bil-kancer li pparteċipaw f'57 prova klinika.
English: Identified adverse reactions associated with Aranesp are hypertension, stroke, thromboembolic events, convulsions, allergic reactions, rash/erythema and pure red cell aplasia (PRCA); see section 4.4.
Maltese: Reazzjonijiet avversi identifikati bħala assoċjati ma' Aranesp huma pressjoni għolja, puplesija, avvenimenti tromboemboliċi, konvulżjonijiet, reazzjonijiet allerġiċi, raxx/eritema u aplasija pura taċċelluli ħomor (PRCA - pure red cell aplasia); ara sezzjoni 4.4.
English: In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
Maltese: Fil-grupp ta' Aranesp, 83% kienu fuq dijalisi u 17% ma kinux fuq dijalisi.
English: 1 Adverse reactions identified in the post-marketing environment.
Maltese: 1 Reazzjonijiet avversi identifikati fl-ambjent ta' wara t-tqegħid fis-suq.
English: The median TTP based on IRCdetermined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI: 0.924, 1.156).
Maltese: It-TTP medjan ibbażat fuq PD determinata mill-IRC kien ta' 8.0 xhur fil-grupp ta' epoetin alfa flimkien ma' SOC u 8.3 xhur fil-grupp tal-SOC (HR 1.033, CI ta' 95 %: 0.924, 1.156).