FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for PritorPlus 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 Għal aktar informazzjoni rigward il-kura bi PritorPlus, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: PritorPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: PritorPlus huwa mediċina li fiha żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: PritorPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Maltese: PritorPlus ma għandux jintuża lanqas minn persuni li jkollhom problemi gravi fil-fwied, fil-kliewi jew problemi biljari, livelli wisq baxxi ta' potassju fid-demm jew livelli għoljin wisq ta' kalċju fid-demm.
English: Other information about PritorPlus
Maltese: II. Anġjotensina
English: The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Maltese: Id-doża ta' PritorPlus li għandha tintuża tiddependi mid-doża ta' telmisartan li l-pazjent kien qiegħed jieħu qabel: pazjenti li kienu qegħdin jieħdu 40 mg telmisartan għandhom jieħdu l-pilloli ta' 40/12.5 mg, u pazjenti li kienu qed jingħataw 80 mg telmisartan għandhom jieħdu l-pilloli ta' 80/12.5
English: How has PritorPlus been studied?
Maltese: Kif ġie studjat PritorPlus?
English: What is the risk associated with PritorPlus?
Maltese: X'inhu r-risku assoċjat ma' PritorPlus?
English: The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet.
Maltese: Il-pilloli ta' 80/25 mg jintużaw minn pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata permezz ta' pilloli ta' 80/12.5
English: The CHMP decided that PritorPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: PritorPlus jintuża minn pazjenti li jkollhom ipertensjoni essenzjali (pressjoni tad-demm għolja), li ma tkunx ikkontrollata b'mod adegwat bit-telmisartan biss. ‘Essenzjali' tfisser li l-ipertensjoni ma jkollhiex kawża evidenti.
English: PritorPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Maltese: PritorPlus kien aktar effettiv fit-tnaqqis tal-pressjoni tad-demm dijastolika mit-telmisartan waħdu u mill-plaċebo.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, PritorPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Maltese: F'pazjenti bid-dijabete tat-tip 2 jew f'pazjenti b'indeboliment renali moderat jew sever, PritorPlus m'għandux jintuża flimkien ma' mediċini li fihom aliskiren (li jintużaw ukoll biex jikkuraw l-ipertensjoni essenzjali).
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to PritorPlus.
Maltese: Fil-pazjenti li ma kinux ikkontrollati bil-pilloli ta' 80/12.5 mg, il-fatt li qalbu għall-pilloli ta' 80/25 mg kien aktar effettiv fit-tnaqqis tal-pressjoni tad-demm dijastolika milli meta baqgħu jieħdu doża aktar baxxa.
English: EMA/31239/2016 EMEA/H/C/000305
Maltese: EMA/31239/2016 EMA/H/C/000305
English: The full EPAR for Visudyne can be found 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: The most common side effects with Visudyne (seen in between 1 and 10 patients in 100) are hypercholesteraemia (high blood cholesterol levels), hypersensitivity (allergic reactions), severely reduced visual acuity (very unclear vision), visual impairment (such as unclear vision, blurred fuzzy vision or flashes of light), defects in the visual field (such as small areas of reduced vision, grey or dark haloes, and black spots), dyspnoea (shortness of breath), nausea (feeling sick), photosensitivity reactions (sunburn-like reactions following exposure to light), reactions at the injection site (pain, swelling, inflammation and leakage of fluid from the veins), asthenia (weakness), infusion-related pain (mainly chest and back pain), syncope (fainting), headache and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Visudyne (li dehru f'bejn wieħed u għaxar pazjenti minn kull mija) huma iperkolesteremija (livelli għolja ta' kolesterol fid-demm), ipersensittività (reazzjonijiet allerġiċi), akutezza viżwali ridotta serjament (vista mċajpra ħafna), nuqqas tal-vista (bħal vista mċajpra, sfukata, imħawda jew b'leħħiet ta' dawl), difetti fiż-żona tal-vista (bħal żoni żgħar ta' viżjoni ridotta, dwawar griżi jew skuri u tikek suwed), dispnea (qtugħ ta' nifs), nawżja (tħossok ma tiflaħx), reazzjonijiet ta' fotosensittività (ħruq fil-partijiet tal-ġilda esposti għad-dawl), reazzjonijiet fejn tingħata l-injezzjoni (uġigħ, nefħa u ħruġ ta' fluwidu mill-vini), astenja (dgħufija),uġigħ relatat mal-infużjoni (l-aktar uġigħ fis-sider u fid-dahar), sinkope (ħass ħażin), uġigħ ta' ras u sturdament.
English: This document is a summary of the European Public Assessment Report (EPAR) for Visudyne.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR) għal Visudyne.
English: Why has Visudyne been approved?
Maltese: Għaliex ġie approvat Visudyne?
English: In the two studies of wet AMD, 61% of the patients receiving Visudyne had responded to treatment after a year (246 out of 402), compared with 46% of those receiving placebo (96 out of 207).
Maltese: Fiż-żewġ studji ta' AMD imxarrba 61% tal-pazjenti li rċevewu Visudyne kienu rrispondew għall-kura wara sena (246 minn 402), imqabbla ma' 46% ta' dawk li rċevew plaċebo (96 minn 207).
English: Visudyne is a medicine that contains the active substance verteporfin.
Maltese: Visudyne hija mediċina li fiha s-sustanza attiva verteporfin.
English: • the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
Maltese: • bil-forma ‘mxarrba' ta' deġenerazzjoni makulari relatata mal-età (AMD), marda li taffettwa l-parti ċentrali tar-retina (msejħa l-makula) fil-parti ta' wara tal-għajn.
English: The active substance in Visudyne, verteporfin, is a photosensitising agent (a substance that changes when exposed to light).
Maltese: Is-sustanza attiva f'Visudyne, il-verteporfin, hija aġent fotosensitizzanti (sustanza li tinbidel meta esposta għad-dawl).
English: Visudyne was more effective than placebo in the studies of AMD and pathologic myopia.
Maltese: Visudyne kien iktar effettiv mill-plaċebo fl-istudji tal-AMD u mijopija patoloġika.
English: In the study of pathologic myopia, 86% of the patients receiving Visudyne had responded after a year (70 out of 81), compared with 67% of those receiving placebo (26 out of 39).
Maltese: Fl-istudju tal-mijopija patoloġika, wara sena,86% tal-pazjenti li rċevew Visudyne kienu rrispondew wara sena (70 minn 81), imqabbla ma' 67% ta' dawk li rċevew plaċebo (26 minn 39).
English: Visudyne has also been compared with placebo in ‘occult' subfoveal choroidal neovascularisation (when the blood vessels affected are not well defined on the scan), in a two-year study involving 339 patients.
Maltese: Visudyne tqabbel ukoll ma' plaċebo f'neovaskularizzazzjoni koroidali taħt il-fovea ‘okkulta' (meta l-vini affettwati ma jkunux definiti sew fuq l-isken), fi studju ta' sentejn li involva 339 pazjent.
English: It is used in ‘photodynamic therapy', a method of treatment that uses light (generally from a laser) to activate a photosensitising agent.
Maltese: Tintuża fit-‘terapija fotodinamika', metodu ta' kura li tuża d-dawl (ġeneralment minn lejżer) biex tattiva aġent fotosensitizzanti.
English: Visudyne has been compared with placebo (a dummy treatment) in two studies involving a total of 609 AMD patients with classic subfoveal neovascularisation, and in one study involving 120 patients with neovascularisation caused by pathologic myopia.
Maltese: Visudyne ġie mqabbel mal-plaċebo (kura finta) f'żewġ studji li damu sentejn u li fihom ħadu sehem 609 pazjenti b'AMD neovaskulari klassiċi ta' taħt il-fovea u fi studju wieħed li jinvolvi n-neovaskulirizzazzjoni kkawżata minn mijopija patoloġika.
English: • choroidal neovascularisation caused by pathologic myopia (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Maltese: • in-neovaskularizzazzjoni koroidali kkawżata minn mijopija patoloġika (tip ta' problema gravi bilviżta tal-bogħod li fiha l-ballun tal-għajn ikompli jikber u jitwal iktar milli suppost).
English: Visudyne is used to treat adults with:
Maltese: Visudyne jintuża fil-kura ta' adulti:
English: Other information about Visudyne:
Maltese: Aktar tagħrif dwar Visudyne:
English: What is Visudyne?
Maltese: Kif jaħdem Visudyne?
English: Visudyne is used when the neovascularisation is ‘predominantly classic' (when the blood vessels affected are well defined on an eye scan) and subfoveal (occurs in the area under the fovea - the central area of the macula);
Maltese: Visudyne jintuża meta n-neovaskularizzazzjoni tkun ‘predominantament klassika' (meta l-arterji u vini affettwati jkunu definiti sew fi sken tal-għajn) u taħt il-fovea (li sseħħ fil-parti ta' taħt il-fovea - il-parti ċentrali tal-makula);
English: When the laser light is shone into the eye, verteporfin is activated and generates toxic oxygen molecules which block blood vessels, damage and even kill cells.
Maltese: Meta d-dawl tal-lejżer jixgħel ġol-għajn, il-verteporfin tiġi attivata u tiġġenera molekuli tossiċi tal-ossiġnu li jimblokkaw l-vini, jagħmlu l-ħsara u joqtlu ċ-ċelloli.
English: The CHMP decided that Visudyne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li Visudyne għandu iktar benefiċċji milli riskji u rrakkomanda li dan jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: This was followed by a confirmatory study in a further 364 patients that was carried out at the request of the CHMP.
Maltese: Dan kien segwit bi studju konfermatorju ta' 364 pazjent ieħor li sar fuq talba tas-CHMP.
English: What is the risk associated with Visudyne?
Maltese: X'inhu r-riskju assoċjat ma' Visudyne?
English: For the full list of restrictions and side effects reported with Visudyne, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Visudyne, ara l-fuljett ta' tagħrif.
English: It is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Jinstab bħala trab li jiġi magħmul f'soluzzjoni għal infużjoni (dripp) għal ġol-vina.
English: First, the patient receives Visudyne as an infusion into a vein lasting 10 minutes.
Maltese: L-ewwel, il-pazjent jingħata Visudyne bħala infużjoni ġo vina fuq perjodu ta' 10 minuti.
English: The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling.
Maltese: Il-forma mxarrba ta' AMD hija kkawżata minn neovaskularizzazzjoni koroidali (it-tkabbir anormali ta' vini taħt il-makula), li jistgħu jnixxu l-fluwidu u d-demm u jikkawżaw nefħa.
English: Visudyne must not be used in patients with porphyria (an inability to break down chemicals called porphyrins) or in patients with severe liver disease.
Maltese: Visudyne ma għandux jintuża fil-pazjenti bil-porfirija (inabilità li jkissru kimiċi magħrufa bħala porphyrins) jew fil-pazjenti b'mard sever fil-fwied.
English: SYSTEM ORGAN CLASS
Maltese: SISTEMA TALKLASSIFIKA TAL-ORGANI
English: Rienso contains ethanol and sodium
Maltese: Rienso fih ethanol u sodium
English: Responders (%)
Maltese: Hgb (%)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 June 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Ġunju 2012
English: See SmPC Section 4.9 for
Maltese: Ara sezzjoni 4.9
English: Available in packs sizes of 1, 2, 6 or 10 vials.
Maltese: Disponibbli f'daqsijiet tal-pakkett ta' kunjett 1, 2, 6 jew 10 kunjetti.
English: Rienso is available in packs sizes of 1, 2, 6 or 10 vials.
Maltese: Rienso huwa disponibbli f'daqsijiet tal-pakkett ta' kunjett 1, 2, 6 jew 10 kunjetti.
English: COMMON (≥ 1/100 to
Maltese: KOMUNI (≥1/100 sa <1/10)
English: Rienso will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.
Maltese: Rienso mhux se jinterferixxi ma' X-ray, tomografija kompjuterizzata (CT), tomografija b'emissjoni ta' pożitroni (PET), tomografija kompjuterizzata b'emissjoni ta' foton wieħed (SPECT), ultrasound jew immaġini b'mediċina nukleari.
English: 31 October 2016
Maltese: 31 ta' Ottubru 2016
English: Rate of infusion had no influence on Rienso PK parameters.
Maltese: Ir-rata ta' infużjoni ma kellha lebda influwenza fuq il-parametri PK ta' Rienso.
English: Chemical and physical in-use stability has been demonstrated for 96 hours at 25 °C.
Maltese: Stabilità kimika u fiżika waqt l-użu ntweriet għal 96 siegħa f'temperatura ta' 25 °C.
English: Baseline ferritin (mean ± SD, ng/ml)
Maltese: Ferritin fil-linja bażi (medja ± SD, ng/ml)
English: 510 mg iron/17 ml
Maltese: 510 mg ħadid / 17 ml
English: Oral Iron n = 116
Maltese: Ħadid orali n = 116
English: Ethanol and sodium content
Maltese: Kontenut ta' ethanol u sodium
English: Oral Iron n = 77
Maltese: Ħadid orali n = 77
English: RARE (≥ 1/10,000 to
Maltese: RARI (>1/10,000 sa
English: 48 months
Maltese: 48 xahar.
English: It includes iron oxide particles with an iron oxide core surrounded by a polyglucose sorbitol-carboxymethylether shell.
Maltese: Dan jinkludi partiċelli ta' iron oxide b'qalba ta' iron oxide mdawra b'qoxra ta' polyglucose sorbitol-carboxymethylether.
English: Rienso 30 mg/ml solution for infusion.
Maltese: Rienso 30 mg/ml soluzzjoni għall-infużjoni.
English: 17 ml of solution in a vial (type I glass) with a stopper (chlorobutyl rubber) and an aluminium crimp-on seal.
Maltese: 17 ml ta' soluzzjoni f'kunjett (ħġieġ tip I) b'tapp (lastku chlorobutyl) u siġill 'crimp-on' tal-aluminju.
English: UNCOMMON (≥ 1/1,000 to
Maltese: MHUX KOMUNI (≥1/1,000 sa
English: Black to reddish brown solution Osmolality: 270-330 mosm/kg pH: 6.5 to 8.0
Maltese: Soluzzjoni ta' lewn iswed għall-dak kannella jagħti fl-aħmar Osmolarità: 270-330 mosm/kg pH: 6.5 sa 8.0
English: Rienso has not been specifically studied in patients with hepatic impairment; clinical experience is limited to 8 patients.
Maltese: Rienso ma ġiex studjat speċifikament f'pazjenti b'indeboliment tal-fwied; esperjenza klinika hija limitata għal 8 pazjenti.
English: Iron as ferumoxytol
Maltese: Ħadid bħala ferumoxytol
English: Rienso should be administered as an infusion in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose for at least 15 minutes (see sections 6.3 and 6.6).
Maltese: Rienso għandu jingħata bħala infużjoni f'50-250 ml ta' 0.9% sodium chloride sterili jew 5% glucose sterili għal mill-inqas 15-il minuta (ara sezzjonijiet 6.3 u 6.6).
English: Oral Iron n = 76
Maltese: Ħadid orali n = 76
English: Volume of distribution (Vd) was consistent with plasma volume, and the mean maximum observed plasma concentration (Cmax) and terminal half-life (t1/2) values increased with dose.
Maltese: Il-volum ta' distribuzzjoni (Vd) kien konsistenti mal-volum tal-plażma, u lvaluri medji tal-konċentrazzjoni massima osservata fil-plażma (Cmax) u tal-half-life terminali (t1/2) żdiedu mad-doża.
English: C-labelled product to lactating rats 10-11 days post-parturition, which peaked at 8 to 24 hours post-administration.
Maltese: C lill-firien li kienu qed ireddgħu 10-11-il jum wara l-ħlas, li laħqet massimu fi żmien 8 sa 24 siegħa wara l-għoti.
English: Hgb = haemoglobin; TSAT = transferrin saturation; SD = standard deviation
Maltese: TSAT = saturazzjoni ta' transferrin; SD = devjazzjoni stàndard
English: Other medicines and Rienso
Maltese: Mediċini oħra u Rienso
English: Dry mouth Dyspepsia Glossodynia
Maltese: Ħalq xott Dispepsja Glossodinja
English: 2 × 510 mg iron (2 vials)
Maltese: 2 x 510 mg ħadid (2 kunjetti) 2 x 510 mg ħadid (2 kunjetti)
English: Interference with Serological Testing
Maltese: Interferenza ma' Testijiet Seroloġiċi
English: *Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting (see sections 4.3 and 4.4).
Maltese: *Reazzjonijiet ta' sensittività eċċessiva fatali u ta' periklu għall-ħajja kienu osservati b'Rienso flambjent ta' wara t-tqegħid fis-suq (ara sezzjonijiet 4.3 u 4.4).
English: - The other ingredients are mannitol, Polyglucose-sorbitol carboxymethylether (PSC), Sodium hydroxide (for pH adjustment, Hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma mannitol, Polyglucose-sorbitol carboxymethylether (PSC), Sodium hydroxide (għall-aġġustament tal-pH, Hydrochloric acid (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: Baseline Hgb (mean ± SD, g/dl)
Maltese: Hgb fil-linja bażi (medja ± SD, g/dl)
English: Bronchospasm Cough
Maltese: Bronkospażmu Sogħla
English: Name and address of the manufacturer responsible for batch release Takeda Italia S.p.A.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Takeda Italia S.p.A.
English: - 17 ml solution for infusion contains 510 mg of iron as ferumoxytol.
Maltese: - 17 ml ta' soluzzjoni għall-infużjoni fiha 510 mg ta' ħadid bħala ferumoxytol.
English: In the Rienso and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at Baseline.
Maltese: Fil-gruppi ta' Rienso u ta' ħadid orali, 36% u 43% tal-pazjenti, rispettivament, kienu qed jirċievu ESAs fil-Linja Bażi.
English: The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Maltese: Id-dijanjosi ta' defiċjenza ta' ħadid għandha tkun ibbażata fuq testijiet xierqa tal-laboratorju (ara sezzjoni 4.2).
English: Rienso 30 mg/ml solution for infusion Iron as ferumoxytol
Maltese: Rienso 30 mg/ml soluzzjoni għall-infużjoni Ħadid bħala ferumoxytol
English: Baseline TSAT (mean ± SD, %)
Maltese: TSAT fil-linja bażi (medja ± SD, %)
English: • Patients with any known history of drug allergy including hypersensitivity to other parenteral iron products
Maltese: • Pazjenti bi kwalunkwe storja medika magħrufa ta' allerġija għall-mediċina inkluż sensittività eċċessiva għal prodotti oħrajn li fihom ħadid parenterali.
English: Rienso is an iron preparation, containing the active substance ferumoxytol, which is given by infusion into a vein.
Maltese: Rienso huwa preparazzjoni tal-ħadid li fiha s-sustanza attiva, ferumoxytol, li tingħata permezz ta' infużjoni fil-vina.
English: Baseline at Day 35 (mean ± SD, ng/ml) * p≤0.001 for main efficacy endpoint
Maltese: Bidla fil-Ferritin millinja bażi f'Jum 35 (medja ± SD, ng/ml) * p≤0.001 għall-punt finali maġġuri tal-effikaċja Hgb = emoglobina;
English: In Study 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races.
Maltese: Fi Studju 3, l-età medja tal-pazjenti kienet ta' 60 sena (firxa, 24 sa 87); 43% kienu nisa; 34% kienu Kawkasi, 59% kienu Suwed, u 7% kienu ta' razez oħra.
English: In Study 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races.
Maltese: Fi Studju 2, l-età medja tal-pazjenti kienet ta' 65 sena (firxa, 31 sa 96); 61% kienu nisa; 58% kienu Kawkasi, 35% kienu Suwed, u 7% kienu ta' razez oħra.
English: Rienso was administered as two 510 mg intravenous injections (separated by 2 to 8 days) and oral iron (ferrous fumarate) was administered at a total daily dose of 200 mg elemental iron for 21 days.
Maltese: Rienso ingħata bħala żewġ injezzjonijiet ta' 510 mg filvini (separati b'jumejn sa 8 ijiem) u ħadid orali (ferrous fumarate) ingħata bħala doża totali ta' kuljum ta' 200 mg ħadid elementali għal 21 ġurnata.
English: • Anaemia not caused by iron deficiency
Maltese: • Anemija mhux ikkawżata minn defiċjenza ta' ħadid.
English: In rabbits administration of Rienso during organogenesis induced decreased foetal weights and external and/or soft tissue malformations (malrotated or flexed fore- and malrotated hindlimbs, internal hydrocephaly, absent brains, cleft palate and microglossia) at the high dose of 45.3 mg Fe/kg/day (HED of 14.6 mg Fe/kg/day), a dose which induced only minimal maternal toxicity.
Maltese: Fil-fniek l-għoti ta' Rienso matul l-organoġenesi wassal għal tnaqqis fil-piż tal-feti u malformazzjonijiet esterni u/jew fit-tessut artab (riġlejn ta' quddiem imdawwra ħażin jew iddrittati u riġlejn ta' wara mdawwra ħażin, idroċefalija interna, imħuħ nieqsa, palat mixquq u ilsien żgħir), f'doża għolja ta' 45.3 mg Fe/kg/kuljum (HED ta' 14.6 mg Fe/kg/kuljum), doża li wasslet biss tossiċità minima fl-omm.
English: The Cmax and time of maximum concentration (tmax) were 206 mcg/ml and 0.32 hr, respectively.
Maltese: Is-Cmax u l-ħin tal-konċentrazzjoni massima (tmax) kienu ta' 206 mcg/ml u 0.
English: • Hypersensitivity to the active substance, to Rienso or any of its excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għal Rienso jew għal kwalunkwe wieћed mill eċċipjenti elenkati fis-sezzjoni 6.1.
English: In female pups of the mid and high dose groups of 30 mg Fe/kg/day and 60 mg Fe/kg/day respectively (HED of 4.8 mg Fe/kg/day and
Maltese: Filfrieħ femminili tal-gruppi ta' doża medja u għolja ta' 30 mg Fe/kg/kuljum u 60 mg Fe/kg/kuljum rispettivament (HED ta' 4.8 mg Fe/kg/kuljum u 9.7 mg Fe/kg/kuljum, rispettivament) maturazzjoni sesswali kienet ittardjata u f'xi nisa kien innutat tfixkil taċ-ċiklu oestrus.
English: In the Rienso and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at Baseline.
Maltese: Fil-gruppi ta' Rienso u ta' ħadid orali, 42% u 44% tal-pazjenti, rispettivament, kienu qed jirċievu sustanzi li jistimulaw l-eritropoesi (ESAs) filLinja
English: For dilution instructions, please see section 4.2.
Maltese: Għal struzzjonijiet dwar id-dilwizzjoni, jekk jogħġbok ara sezzjoni 4.2.
English: Cumulatively 21 cases of hypersensitivity (8 serious, 13 non-serious) have been reported during clinical trials.
Maltese: B'kollox kienu rrappurtati 21 każ ta' sensittività eċċessiva (8 serji, 13 mhux serji) matul il-provi kliniċi.
English: Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
Maltese: Rienso huwa indikat għall-kura ġol-vini ta' anemija kkawżata minn defiċjenza ta' ħadid f'pazjenti adulti b'mard kroniku tal-kliewi (CKD).
English: In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Rienso and placebo.
Maltese: Fi prova cross-over, ikkontrollata bil-plaċebo, 713-il pazjent b'CKD irċevew doża waħda ta' 510 mg ta' Rienso u plaċebo.
English: The most frequently reported adverse reactions were gastrointestinal symptoms (diarrhoea, constipation, nausea and vomiting), headache, dizziness and hypotension, all occurring in less than 2.5% of patients.
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti kienu sintomi gastro-intestinali (dijarea, stitikezza, tqalligħ u rimettar), uġigħ ta' ras, sturdament u pressjoni baxxa, li kollha jseħħu f'inqas minn 2.5% tal-pazjenti.