FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents Rienso should not be given to children and adolescents under 18 years old.
Maltese: Tfal u adolexxenti Rienso m'għandux jingħata lil tfal u adolexxenti b'età inqas minn 18-il sena.
English: The use of Rienso is contraindicated in cases of:
Maltese: L-użu ta' Rienso huwa kontra-indikat f'każijiet ta':
English: Available pharmacokinetic data in animals have shown excretion of Rienso in milk (see section 5.3).
Maltese: Dejta farmakokinetika disponibbli fl-annimali wriet li kien hemm eliminazzjoni ta' Rienso fil-ħalib tas-sider (ara sezzjoni 5.3).
English: In clinical trials involving 1562 subjects with CKD, adverse reactions were seen in 7.9% of patients who received Rienso, of which 0.2% were considered serious.
Maltese: Fi provi kliniċi li kienu jinvolvu 1562 pazjent b'CKD, reazzjonijiet avversi kienu osservati f'7.9% tal-pazjenti li rċevew Rienso, li minnhom 0.2% kienu kkunsidrati serji.
English: Rienso exhibited dose-dependent, capacity-limited elimination from plasma with a half life of approximately 16 hours in humans.
Maltese: Rienso wera eliminazzjoni dipendenti mid-doża, b'kapaċità limitata mill-plażma b'half life ta' madwar 16-il siegħa fil-bnedmin.
English: Dehydration Gout
Maltese: Deidrazzjoni Gotta
English: • Information regarding the increased risk of serious including fatal hypersensitivity reactions: contraindications, special patient populations (e.g. pregnant women, elderly), warnings, symptoms of hypersensitivity reactions, monitoring by health care professionals during 30 minutes after administration, warning on late onset of allergic reactions.
Maltese: • Informazzjoni dwar riskju akbar ta' reazzjonijiet ta' sensittività eċċessiva serji inkluż dawk fatali: kontraindikazzjonijiet, popolazzjonijiet speċjali ta' pazjenti (eż. nisa tqal, anzjani), twissijiet, sintomi ta' reazzjonijiet ta' sensittività eċċessiva, monitoraġġ minn professjonisti filkura tas-saħħa għal 30 minuta wara l-għoti, twissija dwar bidu tard ta' reazzjonijiet ta' allerġija.
English: • Healthcare professional checklist • Patient alert card
Maltese: • Lista ta' kontroll għall-professjonisti fil-kura tas-saħħa • Kartuna ta' twissija għall-pazjent
English: In Study 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races.
Maltese: Fi Studju 1, l-età medja tal-pazjenti kienet ta' 66 sena (firxa, 23 sa 95); 60% kienu nisa; 65% kienu Kawkasi, 32% kienu Suwed, u 2% kienu ta' razez oħra.
English: The safety and efficacy of Rienso in children and adolescents below the age of 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Rienso fi tfal u adolexxenti b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: The safety and efficacy of Rienso (cumulative dose of 1.02 grams) for the treatment of iron deficiency in CKD patients with IDA were assessed in three randomized, open-label, controlled clinical studies (Studies 1, 2 and 3).
Maltese: Is-sigurtà u effikaċja ta' Rienso (doża kumulattiva ta' 1.02 grammi) għall-kura ta' defiċjenza ta' ħadid f'pazjenti b'CKD b'IDA kienu evalwati fi tliet studji kliniċi kazwali, tat-tip open-label u kkontrollati (Studji 1, 2 u 3).
English: The estimated values of CL and Vd following two 510 mg doses of Rienso administered intravenously within 24 hours were 69.1 ml/hr and 3.3 l, respectively.
Maltese: Il-valuri stmati ta' CL u Vd wara żewġ dożi ta' 510 mg ta' Rienso mogħtija fil-vini fi żmien 24 siegħa kienu ta' 69.1 ml/siegħa u 3.3 L, rispettivament.
English: No adverse effects on fertility or general reproductive performance were noted in rats given IV Rienso at doses up to 18 mg Fe/kg/day (Human Equivalent Dose of 2.9 mg Fe/kg/day).
Maltese: Ma kienux osservati effetti avversi fuq il-fertilità jew fuq il-prestazzjoni riproduttiva ġenerali fil-firien mogħtija Rienso IV f'dożi sa 18 mg Fe/kg/kuljum (Doża Ekwivalenti għall-Bniedem ta' 2.9 mg Fe/kg/kuljum).
English: • Administer Rienso as an infusion as follows: o 510 mg (one vial) diluted in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose, administered for at least 15 minutes (concentration of 2-8 mg iron per ml).
Maltese: • Agħti Rienso bħala infużjoni kif ġej: o 510 mg (kunjett wieħed) dilwit f'50-250 ml ta' 0.9% sodium chloride sterili jew 5% glucose sterili, mogħti għal mill-inqas 15-il minuta (konċentrazzjoni ta' 2-8 mg ħadid
English: Tachycardia/Arrhythmia, Cardiac arrest Cardio-respiratory arrest Myocardial infarction Cyanosis
Maltese: Waqfien kardijakurespiratorju Infart mijokardijaku Ċjanożi
English: Cumulatively, since the granting of the marketing authorisation up to the data lockpoint (DLP) of the current PSUR, a total of 527 reported post-marketing cases of hypersensitivity reactions of which more than 50 % were serious including life threatening allergic reactions (264 serious, 263 non-serious).
Maltese: B'kollox, minn meta ingħatat l-awtorizzazzjoni għat-tqegħid fis-suq sal-punt meta waqfet tinġabar id-dejta (DLP - data lock-point) tal-PSUR attwali, kienu rrappurtati total ta' 527 każ ta' reazzjonijiet ta' sensittività eċċessiva wara t-tqegħid fis-suq li minnhom aktar minn 50% kienu serji inkluż reazzjonijiet allerġiċi ta' periklu għall-ħajja (264 serji, 263 mhux serji).
English: No gender differences in Rienso PK parameters were observed.
Maltese: Ma kienux osservati differenzi bejn is-sessi filparametri PK ta' Rienso.
English: Study 3 CKD on Haemodialysis
Maltese: Studju 3 CKD b'emodijalisi
English: Rienso is a colloidal iron-carbohydrate complex.
Maltese: Rienso huwa kumpless kollojdali ta' ħadid-karboidrat.
English: 5.2 Pharmacokinetic Properties
Maltese: .2 Tagħrif farmakokinetiku
English: Therefore Rienso should not be administered to children and adolescents below the age of 18 years (see section 5.1).
Maltese: Għalhekk Rienso m'għandux jingħata lit-tfal u adolexxenti b'età inqas minn 18-il sena (ara sezzjoni 5.1).
English: In a 4 week repeated dose toxicity study in rats after a recovery of 26 weeks hepatic changes (focal or multifocal haemorrhage, hemorrhagic necrosis, chronic inflammation, and/or bile duct hyperplasia) were seen in the female animals (the cumulative HED of the dose groups compares to a safety multiple of 5.1 and 10.5 to the cumulative human therapeutic dose (2 x 510 mg Fe) in a 60 kg human).
Maltese: F'studju ta' erba gimgħat ta' tossiċità minn dożi ripetuti fil-firien wara lirkupru ta' 26 ġimgħa, bidliet epatiċi (emorraġija fokali jew multifokali, nekrożi emorraġika, infjammazzjoni kronika, u / jew iperplażja tal-kanal tal-bili) dehru fl-annimali femminili (il-HED kumulattiv ta' l-gruppi tad-doża jitqabbel ma' sigurtà multipla ta' 5.1 u 10.5 tal-doża terapewtika kumulattiva tal-bniedem (2 x 510 mg Fe) fi bniedem ta' 60 kg).
English: After the DLP of the present PSUR, 6 additional fatal cases of hypersensitivity reactions with ferumoxytol have been reported.
Maltese: Wara d-DLP tal-PSUR preżenti, kienu irrappurtati 6 każijiet fatali oħra ta' reazzjonijiet ta' sensittività eċċessiva b'ferumoxytol.
English: The MAH shall conduct a study to investigate the mechanism of hypersensitivity associated with the exposure to ferumoxytol, according to a protocol agreed by the CHMP.
Maltese: L-MAH għandu jwettaq studju biex jinvestiga lmekkaniżmu ta' sensittività eċċessiva assoċjata ma' esponiment għal ferumoxytol, skont protokoll miftiehem mas-CHMP.
English: Serious hypersensitivity or hypotensive reactions are uncommon (less than 1 case per 100 patients) and were reported in 0.2% (3/1562) of subjects with CKD who received Rienso during the clinical studies.
Maltese: Sensittività eċċessiva jew reazzjonijiet ipotensivi serji mhumiex komuni (inqas minn każ wieħed f'kull 100 pazjent) u kienu rrappurtati f'0.2% (3/1562) ta' individwi b'CKD li rċevew Rienso matul l-istudji kliniċi.
English: All six fatal hypersensitivity cases were reported in the US and involved elderly patients (> 65 years of age) with co-morbidities.
Maltese: Is-sitt każijiet fatali ta' sensittività eċċessiva kollha kienu rrappurtati fl-Istati Uniti u kienu jinvolvu pazjenti anzjani (età ta' > 65 sena) b'ko-morbiditajiet.
English: Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution.
Maltese: Faċilitajiet għal risuxxitazzjoni kardjo respiratorja u tagħmir għall-immaniġġjar ta' reazzjonijiet anafilattiċi/anafilattojdi akuti għandu jkun disponibbli, li jinkludi soluzzjoni ta' 1:1000 adrenaline li tista' tiġi injettata.
English: Common side effects (may affect up to 1 in 10 people): - bleeding, swelling, bruising, pain, rash, irritation or warmth at infusion/injection site
Maltese: Effetti sekondarji komuni ( jista' jaffettwaw sa' 1 f'kull 10 persuni) - fsada, nefħa, tbenġil, uġigħ, raxx, irritazzjoni jew sħana fis-sit tal-infużjoni/injezzjoni
English: Table 2 presents all adverse experiences observed during the clinical studies in which 1562 subjects with CKD received two injections of 510 mg of Rienso separated by an interval of 2 to 8 days and post-marketing experience.
Maltese: Tabella 2 tippreżenta esperjenzi avversi kollha osservati waqt l-istudji kliniċi fejn 1562 individwu b'CKD irċevew żewġ injezzjonijiet ta' 510 mg ta' Rienso separati b'intervall minn jumejn sa 8 ijiem u l-esperjenza ta' wara t-tqegħid fis-suq.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 510 mg/17 ml
Maltese: INDIVIDWALI 510 mg/17 ml
English: • Administer a single vial as an infusion.
Maltese: • Għati kunjett wieħed bħala infużjoni.
English: • Rienso must only be mixed with sterile sodium chloride 9 mg/ml (0.9%) or sterile 5% glucose up to a final concentration of 2-8 mg iron per ml.
Maltese: • Rienso għandu jitħallat biss ma' sodium chloride 9 mg/ml (0.9%) sterili jew 5% glucose sterili sa konċentrazzjoni finali ta' 2-8 mg ħadid f'kull ml.
English: Interference with Magnetic Resonance Imaging (MRI) No spontaneous post-marketing reports of MRI interference have been received to date.
Maltese: Interferenza f'Immaġini b'Reżonanza Manjetika (MRI - Magnetic Resonance Imaging) Sal-lum ma wasal l-ebda rapport spontanju ta' wara t-tqegħid fis-suq ta' interferenza fl-MRI.
English: Haemodialysis patients:
Maltese: Kategorija farmakoterapewtika:
English: Rare side effects (may affect up to 1 in 1,000 people): - burning, prickling, numbness or tingling sensation of skin - dehydration - upset stomach/indigestion - nose bleed - dry mouth - burning or tingling sensation of tongue/mouth - increased tearing - blurred vision - gout - abnormal blood tests (decreased glucose, elevated potassium, abnormal liver function, elevated type of white blood cell i.e. eosinophilia)
Maltese: Effetti sekondarji rari (jista' jaffettwaw sa'1 f'kull 1,000 persuna): - ħruq, sensazzjoni ta' qris, tnemnim jew sensazzjoni ta' tingiż fil-ġilda - deidratazzjoni - stonku mdardar/indiġestjoni - fsada mill-imnieħer - ħalq xott - sensazzjoni ta' ħruq jew tingiż fl-ilsien/ħalq - żjieda fid-dmugħ - vista mċajpra - gotta - testijiet tad-demm mhux normali (glucose imnaqqas, potassium elevat, funzjoni tal-fwied mhux normali, tip ta' ċellula bajda tad-demm elevata i.e. esinofilja)
English: Clinical presentation has included anaphylactic type reactions presenting with cardiac arrest/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness (see section 4.8).
Maltese: Preżentazzjoni klinika kienet tinkludi reazzjonijiet tat-tip anafilattiċi li jippreżentaw b'waqfien tal-qalb/waqfien kardjorespiratorju, pressjoni baxxa klinikament sinifikanti, sinkope, u nuqqas ta' rispons (ara sezzjoni 4.8).
English: How to store Rienso
Maltese: X'fih Rienso
English: Following completion of the controlled phase of each of the Phase 3 trials, patients who were iron deficient and anaemic could be optionally retreated and receive two additional 510 mg intravenous injections of Rienso for a total cumulative dose of 2.04 g. Overall, 69 patients received a total cumulative dose of 2.04 g. Adverse reactions following this repeat Rienso dosing were similar in character and frequency to those observed following the first two intravenous injections.
Maltese: Wara li tlestiet il-fażi kkontrollata ta' kull wieħed mill-provi ta' Fażi 3, il-pazjenti li kellhom defiċjenza ta' ħadid u kienu anemiċi setgħu jiġu kkurati mill-ġdid b'mod mhux obbligatorju u jirċievu żewġ injezzjonijiet addizzjonali fil-vini ta' 510 mg ta' Rienso għal doża kumulattiva totali ta' 2.04 g. Globalment, 69 pazjent irċevew doża kumulattiva totali ta' 2.04 g.
English: Immunologic Disease or Infection
Maltese: Disturbi fissistema immuni
English: - The active substance is iron as ferumoxytol 30 mg/ml.
Maltese: - Is-sustanza attiva hi ħadid bħala ferumoxytol 30 mg/ml. - 1 ml ta' soluzzjoni għall-infużjoni fiha 30 mg ta' ħadid bħala ferumoxytol.
English: Rienso must only be mixed with sterile sodium chloride 9 mg/ml (0.9%) or sterile 5% glucose up to a final concentration of 2-8 mg iron per ml.
Maltese: Rienso għandu jitħallat biss ma' sodium chloride 9 mg/ml (0.9%) sterili jew 5% glucose sterili sa konċentrazzjoni finali ta' 2-8 mg ħadid f'kull ml.
English: This includes the Baseline and mean change to Day 35 in haemoglobin (Hgb, g/dl), transferrin saturation (TSAT, %) and ferritin (ng/ml) as well as the proportion of subjects who were Hgb Responders at Day 35 (defined as proportion of subjects with an increase in Hgb of at least 1.0 g/dl) in each treatment group for Studies 1, 2, and 3.
Maltese: Ir-riżultati prinċipali tal-effikaċja f'Jum 35 mill-fażi kkontrollata ta' kull studju huma murija f'Tabella 3. Dan jinkludi il-bidla mil-linja bażi u l-bidla medja sa Jum 35 fl-emoglobina (Hgb, g/dl), saturazzjoni ta' transferrin (TSAT,%) u ferritin (ng/ml) kif ukoll il-proporzjon ta' individwi li Rrispondew għal Hgb f'Jum 35 (definit bħala proporzjon ta' individwi b'żjieda f'Hgb ta' mill-inqas 1.0 g/dl) f'kull grupp ta' kura għall-Istudji 1, 2, u 3.
English: Baseline at Day 35 (mean ± SD, %)
Maltese: Bidla fl-TSAT millinja bażi f'Jum 35 (medja ± SD, %)
English: ≤ 50 kg Body Weight
Maltese: ≤50 kg ta' Piż tal-Ġisem >50 kg ta' Piż tal-Ġisem
English: However, the MAH acknowledges that Rostoker and Cohen recommend a minimum of 6 months between ferumoxytol's administration, which they base on the study with 6 healthy volunteers published by Storey et al.
Maltese: Madankollu l-MAH jirrikonoxxi li Rostoker u Cohen jirrakkomandaw minimu ta' 6 xhur wara l-għoti ta' ferumoxytol, li huma jibbażaw fuq l-istudju b'6 voluntiera f'saħħithom ippubblikat minn Storey et al.
English: Summary of Efficacy Endpoints at Day 35 (Intent to Treat Population)
Maltese: Tabella 3: Sommarju tal-Punti Finali tal-Effikaċja f'Jum 35 (Popolazzjoni b'Intenzjoni li tiġi Kkurata)
English: It should be noted that 28 out of the 35 fatal cases of hypersensitivity reactions occurred in elderly patients (> 65 years of age).
Maltese: Wieħed għandu jinnota li 28 minn 35 każ fatali ta' reazzjonijiet ta' sensittività eċċessiva seħħew f'pazjenti anzjani (età ta' > 65 sena).
English: Table 1: Recommended Dosing Table for Rienso Administration Total Amount of Rienso to Administer mg of Iron (Number of vials)
Maltese: Tabella 1: Tabella ta' dożaġġ irrakkomandat għall-għoti ta' Rienso
English: Studies 1 and 2 enrolled patients with non-dialysis dependent CKD and Study 3 enrolled patients who were undergoing haemodialysis.
Maltese: Studji 1 u 2 irreġistraw pazjenti b'CKD mhux dipendenti fuq dijalisi u Studju 3 irreġistra pazjenti li kienu jagħmlu l-emodijalisi.
English: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.
Maltese: Dan il-prodott mediċinali fih ammonti żgħir ta' ethanol (alkoħol), inqas minn 100 mg f'kull kunjett ta' 17 ml.
English: Retrospective observational data from three large haemodialysis clinics in the US over a 1 year period included the treatment of over 8,600 patients with more than 33,300 administered doses of Rienso; nearly 50% of patients received repeat dosing with 4 or more doses.
Maltese: Dejta ta' osservazzjoni retrospettiva minn tliet kliniki kbar tal-emodijalisi fl-Istati Uniti fuq perijodu ta' sena kienet tinkludi l-kura ta' aktar minn 8600 pazjent b'aktar minn 33300 doża mogħtija ta' Rienso; kważi 50% tal-pazjenti rċevew dożaġġ ripetut b'4 dożi jew aktar.
English: Considering the cumulative number of reported cases of hypersensitivity reactions (serious, nonserious) including 35 fatal cases, the PRAC considered new additional risk minimisation measures in addition to the ones already implemented as part of the previous PSUR, and recommended that a warning on the severity of the outcome of hypersensitivity reactions in patients over 65 or with comorbidities should be added in section 4.4 of the SmPC.
Maltese: B'konsiderazzjoni tan-numru kumulattiv ta' każijiet ta' reazzjonijiet ta' sensittività eċċessiva irrappurtati (serji, mhux serji) inkluż 35 każ fatali, il-PRAC ikkunsidra miżuri addizzjonali ġodda ta' minimizzazzjoni tar-riskju minbarra dawk diġà implimentati bħala parti mill-PSUR preċedenti, u rrakkomanda li twissija dwar is-severità tar-riżultat ta' reazzjonijiet ta' sensittività eċċessiva f'pazjenti ta' aktar minn 65 jew b'ko-morbiditajiet tiġi miżjuda fis-sezzjoni 4.4 tal-SmPC.
English: Laryngeal oedema Pharyngeal oedema Respiratory arrest Respiratory failure Throat irritation Throat tightness Wheezing
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Hypersensitivity reactions
Maltese: Sensittività
English: Condition
Maltese: LISTA
English: This medicine contains less than 23 mg sodium per 17 ml vial, i.e., it is essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 23 mg ta' sodium f'kull kunjett ta' 17 ml, jiġifieri, huwa essenzjalment “mingħajr sodium”.
English: Rienso must not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or ferritin is greater than 800 ng/ml (see section 4.2).
Maltese: Rienso m'għandux jingħata lillpazjenti jekk l-emoglobina tagħhom tkun aktar minn 12 g/dl, is-Saturazzjoni ta' Transferrin fis-serum (TSAT) tkun aktar minn 50% jew ferritin ikun aktar minn 800 ng/ml (ara sezzjoni 4.2).
English: Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting.
Maltese: Reazzjonijiet ta' sensittività eċċessiva fatali u ta' periklu għall-ħajja kienu osservati b'Rienso flambjent ta' wara t-tqegħid fis-suq.
English: The shell isolates the bioactive iron from plasma components until the iron-carbohydrate complex enter reticuloendothelial system macrophages of the liver, spleen and bone marrow.
Maltese: Il-qoxra tiżola l-ħadid bijoattiv minn komponenti tal-plażma sakemm il-kumpless ta' ħadid-karboidrat jidħol fil-makrofaġi tas-sistema retikuloendoteljali tal-fwied, milsa u mudullun.
English: During the post-marketing phase, several patients received an overdose of Rienso ranging from 1 g in 1 day to 2.5 g over 21 days.
Maltese: Matul ilfażi ta' wara t-tqegħid fis-suq, diversi pazjenti rċevew doża eċċessiva ta' Rienso li varjat minn 1 g f'ġurnata għal 2.5 g fuq perijodu ta' 21 ġurnata.
English: Rienso-treated patients included hypotension, infusion site swelling, increased serum ferritin levels, chest pain, diarrhoea, dizziness, ecchymosis, pruritis, chronic renal failure and urticaria.
Maltese: Fi provi kliniċi, reazzjonijiet avversi li wasslu għal twaqqif tal-kura u li seħħew f' ≥2 pazjenti kkurati b'Rienso kienu jinkludu pressjoni baxxa, nefħa fis-sit tal-infużjoni, żjieda fil-livelli ta' ferritin fisserum, uġigħ fis-sider, dijarea, sturdament, ekimożi, ħakk, insuffiċjenza renali kronika u urtikarja.
English: Rienso should not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or Ferritin is greater than 800 ng/ml (see section 4.4).
Maltese: Rienso m'għandux jingħata lill-pazjenti jekk l-emoglobina tagħhom tkun aktar minn 12 g/dl, isSaturazzjoni ta' Transferrin fis-serum (TSAT) ikun aktar minn 50% jew Ferritin ikun aktar minn 800 ng/ml (ara sezzjoni 4.4).
English: Sodium hydroxide (for pH adjustment) Hydrocholric acid (for pH adjustment)
Maltese: Ilma għall-injezzjonijiet Sodium hydroxide (għall-aġġustament tal-pH) Hydrocholric acid (għall-aġġustament tal-pH)
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Ilma għall-Injezzjonijiet Sodium hydroxide (għall-aġġustament tal-pH) Hydrocholric acid (għall-aġġustament tal-pH)
English: Limited clinical study data is available regarding re-treatment with Rienso and no clinical study data is available for repeated long term use.
Maltese: Dejta limitata minn studji kliniċi hija disponibbli dwar trattament mill-ġdid b'Rienso u l-ebda dejta minn studju kliniku hija disponibbli għall-użu ripetut fit-tul.
English: Study 2 Non-dialysis CKD
Maltese: Studju 2 CKD mingħajr dijalisi
English: Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Maltese: Il-pazjenti għandhom jiġu immonitorjati b'attenzjoni għal sinjali u sintomi ta' reazzjonijiet ta' sensittività eċċessiva inkluż monitoraġġ tal-pressjoni u l-polz matul u għal mill-inqas 30 minuta wara kull infużjoni ta' Rienso.
English: Elderly patients (> 65 years of age) or patients with multiple co-morbidities who experience a serious hypersensitivity reaction may have more severe outcomes.
Maltese: Pazjenti anzjani (età ta' > 65 sena) jew pazjenti li għandhom ko-morbiditajiet multipli li jkollhom reazzjoni ta' sensittività eċċessiva serja jista' jkollhom riżultati aktar severi.
English: You will be carefully observed during the infusion and for at least 30 minutes after each infusion by your doctor or nurse.
Maltese: Inti se tiġi osservat b'attenzjoni waqt l-infużjoni u għal mill-inqas 30 minuta wara kull infużjoni mittabib jew l-infermier tiegħek.
English: The effect on vascular MR imaging lasts approximately 1-2 days while tissue diagnostic imaging may be affected for up to 6 months.
Maltese: MR vaskulari idum madwar jum sa jumejn filwaqt li immaġini dijanjostiċi tattessut jistgħu jiġu affettwati sa 6 xhur.
English: Therefore the MAH proposed as part of this PSUR to amend the current warning in section 4.4 of the SmPC to reflect that interference with MRI can occur up to 6 months after administration of ferumoxytoll which was agreed by the PRAC.
Maltese: Għalhekk bħala parti minn dan il-PSUR l-MAH jipproponi li tiġi emendatait-twissija kurrenti fis-sezzjoni 4.4 tal-SmPC biex tirrifletti li interferenza fl-MRI tista' sseħħ sa 6 xhur wara l-għoti ta' ferumoxytol li kien miftiehem mill-PRAC.
English: If you are on haemodialysis, you may receive Rienso via infusion over 15 minutes during a dialysis session.
Maltese: Jekk qed tagħmel emodijalisi, tista' tirċievi Rienso permezz ta' infużjoni fuq medda ta' 15-il minuta waqt sessjoni ta' dijalisi.
English: Rienso has not been tested in pregnant women.
Maltese: Rienso ma jitneħħiex b'emodijalisi.
English: During this PSUR covering period, 45 new cases of hypersensitivity reactions have been reported: 24 serious including one fatal case already reported as part of the previous PSUR as late-breaking information and 21 non-serious cases.
Maltese: Matul dan il-perjodu kopert mill-PSUR, kienu rrappurtati 45 każ ġdid ta' reazzjonijiet ta' sensittività eċċessiva: 24 każ serju inkluż każ fatali wieħed li ġà kien irrappurtat bħala parti mill-PSUR preċedenti bħala informazzjoni kritika ttardjata, u 21 każ mhux serju.
English: 1 ml contains 30 mg of iron.
Maltese: U KWANTITATTIVA 1 ml ta' soluzzjoni fiha 30 mg ta' ħadid bħala ferumoxytol.
English: Marketing authorisation holder: Takeda Pharma A/S Dybendal Alle 10
Maltese: Takeda Pharma A/S