FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4: Summary of results on iron homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND)
Maltese: Istudju 304 (CKD 5D) u fil-Ġimgħa 12 fl-Istudju 204 (CKD ND)
English: The non clinical programme was based on 7 repeat dose toxicology studies in rats and dogs.
Maltese: Il-programm mhux kliniku kien ibbażat fuq studji tossikoloġiċi b'7 dożi ripetuti fil-firien u fil-klieb.
English: Experience from clinical studies in patients with hepatic impairment is limited.
Maltese: L-esperjenza minn studji kliniċi fuq pazjenti b'indeboliment epatiku hija limitata.
English: 4.4 Special warnings and precautions for use
Maltese: 4.3 Kontraindikazzjonijiet
English: severe abdominal pain or constipation (uncommon)
Maltese: Ipromellożu (hypromellose)
English: Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side.
Maltese: Il-pilloli Fexeric miksijin b'rita huma lewn il-ħawħ, b'forma ovali, imnaqqxin b'“KX52” fuq naħa waħda.
English: The dose of phosphate binder was titrated as needed to maintain serum phosphorus levels between 3.5 and 5.5 mg/dl, to a maximum of 12 g/day.
Maltese: Id-doża tal-aġent li jingħaqad mal-fosfat ġiet ittitrata skont il-ħtieġa biex il-livelli tal-fosfru fis-serum jinżammu bejn 3.5 u 5.5 mg/dl, għal massimu ta' 12 g/kuljum.
English: Fexeric should be temporarily discontinued if serum ferritin
Maltese: Proporzjon b'ferritin
English: Temporarily discontinue Fexeric if the serum phosphorus is < 3 mg/dl and resume at a lower dose once the serum phosphorus has returned to the target range.
Maltese: Waqqaf Fexeric temporanjament jekk il-fosfru fis-serum jkun ta' < 3 mg/dl u erġa' ibda f'doża aktar baxxa ladarba l-fosfru fis-serum ikun reġa' lura għall-medda fil-mira.
English: Data on primary and secondary pharmacodynamics, safety pharmacology and pharmacokinetics of Fexeric were derived from the repeat dose toxicology studies, and did not reveal safety concerns for humans.
Maltese: Data dwar il-farmakodinamika primarja u sekondarja, is-sigurtà farmakoloġika u l-farmakokinetika ta'
English: The dose can be increased or decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week intervals as needed to maintain serum phosphorus at recommended target levels up to a maximum of 12 g (12 tablets) per day.
Maltese: Id-doża tista' tiżdied jew titnaqqas b'1 sa 2 g (pillola 1 sa 2) kuljum f'intervalli ta' ġimagħtejn- sa 4- ġimgħat skont kif ikun meħtieġ biex il-fosfru fis-serum jinżamm f'livelli rakkomandati fil-mira sa massimu ta' 12 g (12-il pillola) kuljum.
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of
Maltese: Kull pillola miksija b'rita fiha 1 g ta' kumpless ta' koordinazzjoni taċ-ċitrat ferriku (ekwivalenti għal
English: Uncommon side effects (may affect up to 1 in 100 people): changes in iron blood test results decreased or increased appetite indigestion, flatulence inflammation of stomach lining, ulcer of mucosal lining of the stomach or the first part of the bowel reflux of stomach juices in the oesophagus abnormal stools, irregularity in bowel movement shortness of breath, wheezing, abnormal breath sounds
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): bidliet fir-riżultati tat-testijiet tal-ħadid fid-demm tnaqqis jew żieda fl-aptit indiġestjoni, gass fl-istonku infjammazzjoni tal-kisja tal-istonku, ulċera tal-kisja mukosali tal-istonku jew fl-ewwel parti tal-musrana rifluss tal-meraq tal-istonku fl-esofagu ippurgar anomalu, ippurgar irregolari livelli baxxi ta' fosfru fis-serum ħalq xott disturbi fit-togħma uġigħ ta' ras sturdament livelli baxxi ta' potassju fis-serum inkontinenza raxx fil-ġilda, ħakk palpitazzjonijiet qtugħ ta' nifs, tħarħir, ħsejjes anomali man-nifs uġigħ għatx bronkite ħsara fil-muskoli żieda fil-piż fluwidu fil-pulmun pressjoni għolja ħafna tad-demm
English: Decreased appetite, hyperkalaemia, hypophosphataemia, increased appetite Dizziness, headache Palpitations, dyspnoea Malignant hypertension
Maltese: Tnaqqis fl-aptit, iperkalemija, iperfosfatemija,
English: Your doctor will monitor the phosphorus levels regularly.
Maltese: It-tabib tiegħek ser jissorvelja l-livelli ta' fosfru b'mod regolari.
English: The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness.
Maltese: Issintomi ta' doża eċċessiva akuta ta' ħadid jinkludu rimettar, dijarea, uġigħ addominali, irritabbiltà, u ħedla.
English: Effects on phosphorus homeostasis
Maltese: Disturbi renali u fis-sistema urinarja
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia
Maltese: - valproic acid: mediċina għall-kura ta' epilessija u ta' disturbi mentali
English: During the overall 52-week active-controlled period, the decrease in serum phosphorus (approximately 2.0 mg/dl following up to a 2 week washout period) and the percentage of patients who achieved and maintained serum phosphorus ≤ 5.5 mg/dl (approximately 62%) were comparable in both the Fexeric and the active control groups (Table 3).
Maltese: Matul il-perjodu kollu ta' 52- ġimgħa b'kontroll attiv, it tnaqqis fil-fosfru fis-serum (ta' madwar 2.0 mg/dl wara perjodu ta' tneħħija ta' ġimagħtejn) u lperċentwal ta' pazjenti li laħqu u li żammew il-fosfru fis-serum ≤ 5.5 mg/dl (madwar 62%) kienu komparabbli kemm fil-grupp ta' Fexeric kif ukoll f'dak tal-kontroll attiv (Tabella 3).
English: In the pivotal non-dialysis study 204, a total of 148 CKD ND patients with hyperphosphatemia and iron deficiency anaemia received treatment with study drug; there were 141 patients in the intent-totreat population (Fexeric: 72 patients; Placebo: 69 patients).
Maltese: b'iperfosfatimija u b'anemija b'defiċjenza tal-ħadid, irċevew kura bil-mediċina tal-istudju; kien hemm 141 pazjent fil-popolazzjoni b'intenzjoni li jiġu kkurati (Fexeric:
English: In the pivotal non-dialysis study 204 CKD ND patients treated with Fexeric had a significant increase in serum TSAT, ferritin and haemoglobin levels compared to the placebo group after 12 weeks of treatment (p< 0.001 for treatment difference for each parameter) (Table 4).
Maltese: Fl-istudju 204 mhux pivotali fuq pazjenti li ma kinux fuq dijalisi, il-pazjenti b'CKD ND li ngħataw kura b'Fexeric kellhom żieda sinifikanti fil-livelli ta' TSAT, ta' ferritin u ta' emoglobina fis-serum meta mqabbla mal-grupp tal-plaċebo wara 12-il ġimgħa ta' kura (p<0.
English: Abnormal breath sounds, increased serum ferritin, increased transferrin saturation, increased weight
Maltese: Ħsejjes anomali man-nifs, żieda fil-ferritin fis serum, żieda fis-saturazzjoni ta' transferrin, żieda fil-piż
English: During the subsequent 4-week placebo-controlled period, the serum phosphorus levels remained stable in patients receiving Fexeric (mean decrease of 0.24 mg/dl), whereas patients receiving placebo had a mean increase of 1.79 mg/dl (p < 0.0001 for treatment difference).
Maltese: Matul il-perjodu sussegwenti ta' 4- ġimgħat ikkontrollat bi plaċebo, il-livelli tal-fosfru fis-serum baqgħu stabbli filpazjenti li kienu qed jirċievu Fexeric (tnaqqis medju ta' 0.24 mg/dl), filwaqt li l-pazjenti li kienu rċevew plaċebo kellhom żieda medja ta' 1.79 mg/dl (p<0.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħra fuq Fexeric
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: Muscle injury
Maltese: Indeboliment epatiku
English: Also contains sunset yellow FCF (E110), Allura Red AC (E129), see the package leaflet for futher
Maltese: Fih ukoll sunset yellow FCF (E110), Allura Red AC (E129), għal aktar informazzjoni ara l-fuljett ta'
English: The ability of Fexeric to control serum phosphorus in CKD patients was principally evaluated in one long-term, pivotal Phase III trial (Study 304) in CKD 5D patients, and in one pivotal Phase II, 12 week, placebo-controlled trial (Study 204) in CKD ND patients with anaemia.
Maltese: Il-kapaċità ta' Fexeric li jikkontrolla l-fosfru fis-serum f'pazjenti b'CKD kienet prinċipalment ivvalutata fi prova pivotali fit-tul tal-Fażi III (Studju 304) f'pazjenti b'CKD 5D, u fi prova pivotali,
English: Results from subgroup analyses in the pivotal clinical study in dialysis patients show that the concomitant use of frequently co-prescribed medications in CKD patients (fluoroquinolones, tetracyclines, proton pump inhibitors, thyroid hormones, sertraline, Vitamin D, warfarin, acetylsalicylic acid) do not affect the efficacy of Fexeric with respect to its ability to lower serum
Maltese: tetraċiklini, inibituri tal-pompa tal-proton, ormoni tat-tirojde, sertraline, Vitamina D, warfarina, aċidu aċetilsaliċiliku) ma jaffettwax l-effikaċja ta' Fexeric fir-rigward tal-kapaċità tiegħu li jnaqqas il-fosfru fis-serum.
English: You may need to read it again.
Maltese: ebda data ma hi disponibbli.
English: Since iron-based preparations are known to reduce the absorption of levothyroxine (thyroxine), physicians should consider monitoring suitable markers or clinical signs of efficacy if these medicinal products are concomitantly administered with Fexeric.
Maltese: Peress li preparazzjonijiet abbażi tal-ħadid huma magħrufa li jnaqqsu l-assorbiment ta' levothyroxine (thyroxine), it-tobba għandhom jikkunsidraw il-monitoraġġ ta' markaturi xierqa jew ta' sinjali kliniċi ta' effikaċja jekk dawn il-prodotti mediċinali jingħataw flimkien ma' Fexeric.
English: This blood test may be part of your routine tests for your
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: It is not known whether ferric citrate coordination complex/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk il-kumpless ta' koordinazzjoni taċ-ċitrat ferriku /metaboliti tiegħu jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: The following side effects have been reported with Fexeric in dialysis patients: Very common side effects (may affect more than 1 in 10 people):
Maltese: Ġew irrapportati l-effetti sekondarji li ġejjin b'Fexeric f'pazjenti fuq dijalisi: Effetti sekondarji komuni ħafna ( jistgħu jaffetwaw aktar minn persuna 1 minn kull 10):
English: CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day.
Maltese: Pazjenti b'CKD li ma jkunux fuq dijalisi jeħtieġu d-doża tal-bidu l-aktar baxxa, 3 g (3 pilloli) kuljum.
English: Ferritin change from baseline at Week 52 (mean ± SD, ng/ml)
Maltese: (medja ± SD, ng/ml)
English: Monitoring blood levels of these medicines may also be considered: - ciprofloxacin, doxycycline, cefdinir: medicines to treat bacterial infections - valproic acid: a medicine to treat epilepsy and mental disorders - sertraline: a medicine to treat depression - methotrexate: a medicine to treat rheumatoid arthritis, cancer and the skin disease, psoriasis - alendronate: a medicine to treat decreased bone mass and density - levodopa: a medicine to treat Parkinson's disease - levothyroxine: a medicine to treat thyroid hormone deficiency
Maltese: Għalkemm il-potenzjal ta' interazzjonijiet ma' prodotti mediċinali jidher baxx, fil-każ ta' kura konkomitanti bi prodotti b'tieqa terapewtika dejqa, l-effett kliniku/avvenimenti avversi għandhom jiġu ssorveljati malli jinbeda jew mal-aġġustament tad-doża ta' Fexeric jew tal-prodott konkomitanti.
English: - Keep this leaflet.
Maltese: Testijiet ta' monitoraġġ
English: <Active substance name (INN)> is a linear GdCA.
Maltese: <Isem is-sustanza attiva (INN)> huwa GdCA lineari.
English: Dynamic imaging:
Maltese: Immaġini dinamika:
English: • Assessment of myocardial perfusion
Maltese: • Valutazzjoni tal-perfużjoni mijokardijaka
English: Package leaflet
Maltese: Doża Rakkomandata
English: between 40 and 120 minutes following the injection, depending on the individual imaging needs.
Maltese: bejn 40 u 120 minuta wara l-injezzjoni, skont il-ħtiġijiet ta' immaġini individwali.
English: Immediately following bolus injection.
Maltese: Immedjatament wara injezzjoni bolus.
English: Liver, kidneys, urinary tract , adrenal glands
Maltese: Fwied, kliewi, passaġġ tal-awrina, glandoli adrenali
English: Intravenous gadoteric acid, gadobutrol, gadoteridol Summary of product characteristics
Maltese: Gadoteric acid, gadobutrol, gadoteridol fil-vini
English: Target organ
Maltese: Organu immirat
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min /1.73 m2).
Maltese: Kien hemm rapporti ta' fibrożi sistemika nefroġenika (NSF - nephrogenic systemic fibrosis) assoċjata mal-użu ta' xi sustanzi ta' kuntrast li fihom gadolinium f'pazjenti b'indeboliment renali sever (GFR< 30mL/min /1.73 m2) akut jew kroniku.
English: Brain and Spine up to 60 minutes after the administration.
Maltese: Moħħ u sinsla sa 60 minuta wara l-għoti.
English: Breast
Maltese: Sider
English: • Magnetic Resonance Angiography (MRA) for the assessment of stenoses, occlusions and collaterals in adults and children (above the age of 2 years).
Maltese: • Angjografija b'Reżonanza Manjetika (MRA - Magneti Resonance Angiography) għall-valutazzjoni ta' stenosi, okklużjonijiet u kollaterali f'adulti u tfal (b'età ta' aktar minn sentejn ).
English: • Assessment of cardiac masses or myocardial viability
Maltese: • Valutazzjoni tal-massa kardijaka jew vijabilità mijokardijaka
English: The recommended dose of <active substance name (INN)> in adult patients and children is 0.05 mmol/kg body weight (0.1 mL/kg of the 0.5 M solution).
Maltese: Id-doża rakkomandata ta' <Isem is-sustanza attiva (INN)> f'pazjenti adulti u tfal hija 0.05 mmol/kg ta' piż tal-ġisem (0.1 mL/kg ta' soluzzjoni ta' 0.5 M).
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott sussegwentement tista' tiġi aġġornata mill-awtoritajiet kompetenti talIstat Membru, flimkien mal-Istat Membru ta' referenza, skont il-proċeduri stabbiliti fil-Kapitolu 4 tatTitolu III tad-Direttiva 2001/83/KE.
English: Head and neck region, thoracic space (including the heart and female breast), abdomen (gastrointestinal tract including pancreas), pelvis (prostate, bladder and uterus) and musculoskeletal system
Maltese: Reġjun tar-ras u tal-għonq, spazju toraċiku (inklużi lqalb u s-sider femminili), addome (apparat gastrointestinali inkluż il-frixa), pelvi (prostata, bużżieqa tal-awrina u l-utru) u sistema muskoluskeletrika
English: • MR imaging of the whole body in adults and children (above the age of 2 years) including head and neck region, thoracic space (including the heart and female breast), abdomen (pancreas and liver), abdomen (gastrointestinal tract), retroperitoneal space (kidney, adrenal glands), pelvis (prostate, bladder and uterus) and musculoskeletal system where it facilitates identification of abnormal structures or lesions and helps in differentiating normal from pathological tissues (see sections 4.2 and
Maltese: MR tal-ġisem kollu f'adulti u tfal (ta' aktar minn sentejn) inkluż ir-reġjun tar-ras u talgħonq, spazju toraċiku (inkluż il-qalb u s-sider femminili), addome (frixa u fwied), addome (passaġġ gastrointestinali), spazju retroperitoneali (kliewi, glandoli adrenali), pelvi (prostata, bużżieqa tal-awrina u l-utru) u sistema muskoluskeletrika fejn dan jiffaċilita l-identifikazzjoni ta' strutturi anormali jew leżjonijiet u jgħin fid-diffrenzjar ta' tessuti normali minn dawk patoloġiċi (ara sezzjonijiet 4.2 u 5.1).
English: Intravenous gadobenic acid (restriction of the indication - all references to other indications should be removed across the Product Information)
Maltese: Gadobenic acid fil-vini (restrizzjoni tal-indikazzjoni - ir-referenzi kollha għal indikazzjonijiet oħra għandhom jitneħħew mill-Informazzjoni dwar il-Prodott kollha)
English: 0.05 mmol/kg body weight (0.1 mL/kg of the 0.5 M solution)
Maltese: 0.05 mmol/kg ta' piż tal-ġisem (0.1 mL/kg ta' soluzzjoni ta' 0.5 M)
English: T1-weighted sequences to be acquired as either dynamic or static delayed imaging.
Maltese: Sekwenzi bl-użu ta' T1 li għandhom jiġu akkwistati bħala immaġni dinamiċi jew statiċi ttardjati.
English: Intravenous gadoxetic acid
Maltese: Gadoteric acid ġol-ġogi
English: 0.1 mmol/kg body weight (0.2 mL/kg of the 0.5 M solution)
Maltese: 0.1 mmol/kg ta' piż tal-ġisem (0.2 mL/kg ta' soluzzjoni ta' 0.5 M)
English: Intra-articular gadopentetic acid
Maltese: Gadopentetic acid ġol-ġogi
English: A T1-weighted, gradient-echo sequence with a time resolution of 2 minutes or less should be acquired before contrast injection and repeated several times over a period of 5 to 8 min after a rapid intravenous contrast bolus injection.
Maltese: Sekwenza ta' gradient echo bl-użu ta' T1 b'riżoluzzjoni tal-ħin ta' 2 minuti jew inqas għandha tinkiseb qabel l-injezzjoni tal-kuntrast u għandha tiġi ripetuta diversi drabi fuq perjodu ta' 5 sa 8 minuti wara injezzjoni mgħaġgla ta' bolus ta' kuntrast ġolvini.
English: Cardiac MRI
Maltese: MRI tal-qalb
English: Signal intensity increases and non-clinical data show that gadolinium is released from linear GdCAs.
Maltese: Żidiet fl-intensità tas-sinjal u dejta mhux klinika juru li gadolinium jinħeles minn GdCAs lineari.
English: Brain and spine
Maltese: Moħħ u sinsla
English: With the linear GdCAs this can cause dose-dependent increases in T1-weighted signal intensity in the brain, particularly in the dentate nucleus, globus pallidus, and thalamus.
Maltese: B'GdCAs lineari dan jista' jikkawża żidiet dipendenti mid-doża fl-intensità tas-sinjal bl-użu ta' T1 fil-moħħ, b'mod partikolari fin-nukleu dentat, globus pallidus, u t-talamu.
English: • part for healthcare professionals: Post-contrast imaging acquisition:
Maltese: • parti għall-professjonisti tal-kura tas-saħħa:
English: MRI of brain/spine: 0.2 ml per kilogram of body weight MRI of arteries: 0.2 ml per kilogram of body weight MRI of the liver, the kidney, urinary tract or adrenal glands: 0.1 ml per kilogram of body weight
Maltese: 0.2 mL kull kilogramma ta' piż tal-ġisem MRI tal-arterji: 0.2 mL kull kilogramma ta' piż tal-ġisem
English: Two separate injections of 0.05 mmol/kg body weight (each corresponding to 0.1 mL/kg of the 0.5 M solution) during rest and stress imaging.
Maltese: Żewġ injezzjonijiet separati ta' 0.05 mmol/kg ta' piż talġisem (kull waħda tikkorrispondi għal 0.1 mL/kg ta' soluzzjoni ta' 0.5 M) waqt immagini waqt mistrieħ u taħt stress.
English: Magnetic resonance angiography
Maltese: Anġjografija b'Reżonanza Manjetika
English: If use of <Product name> cannot be avoided, the dose should not exceed 0.1 mmol/kg body weight when used for MR of the brain and spine, MR-angiography breast MRI or whole body MRI and should not exceed 0.05 mmol/kg body weight when used for MR of the liver, kidneys, urinary tract or adrenal glands.
Maltese: Jekk l-użu ta' <Isem tal-Prodott> ma jistax jiġi evitat, id-doża m'għandhiex taqbeż 0.1 mmol/kg ta' piż tal-ġisem meta jintuża għal MR tal-moħħ u tas-sinsla, anġjografija MR, MRI tas-sider jew MRI talġisem kollu u m'għandhiex taqbeż 0.05 mmol/kg ta' piż tal-ġisem. meta jintuża għall-MR tal-fwied, kliewi, passaġġ tal-awrina jew glandoli adrenali.
English: Because of the lack of information on repeated administration, <Product name> injections should not be repeated unless the interval between injections is at least 7 days.
Maltese: Minħabba n-nuqqas ta' informazzjoni dwar għoti ripetut, injezzjonijiet ta' <Isem tal-prodott> m'għandhomx jiġu ripetuti sakemm l-intervall bejn l-injezzjonijiet ma jkunx mill-inqas 7 ijiem.
English: MRA immediately after the administration, with scan delay calculated on the basis of test bolus or automatic bolus detection technique.
Maltese: MRA immedjatament wara l-għoti, b'ittardjar tal-iskan ikkalkulat abbażi ta' teknika ta' sejba b'bolus test jew awtomatiku.
English: After intravenous administration of <active substance name (INN)> gadolinium can be retained in the brain and in other tissues of the body (bones, liver, kidneys, skin) and can cause dose-dependent increases in T1-weighted signal intensity in the brain , particularly in the dentate nucleus, globus pallidus, and thalamus.
Maltese: Wara għoti ġol-vini ta' <isem is-sustanza attiva (INN)> gadolinium jista' jinżamm fil-moħħ u f'tessuti oħra tal-ġisem (għadam, fwied, kliewi, ġilda) u jista' jikkawża żidiet li jiddependu mid-doża fl-intensità tas-sinjal bl-użu ta' T1 fil-moħħ, b'mod partikolari fin-nukleu dentat, globus pallidus, u t-talamu.
English: Section 4.1 Therapeutic indications <Product name> is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI).
Maltese: Sezzjoni 4.1 Indikazzjonijiet terapewtiċi <Isem tal-prodott> għandu jintuża biss meta l-informazzjoni dijanjostika hija essenzjali u mhux disponibbli b'immaġini ta' reżonanza manjetika (MRI - magnetic resonance imaging) mhux imsaħħa.
English: • Specific applications in the heart include measurement of myocardial perfusion under pharmacological stress conditions and viability diagnostics ("delayed enhancement").
Maltese: • Applikazzjonijiet speċifiċi fil-qalb jinkludu kejl tal-perfużjoni tal-mijokardju taħt kondizzjonijiet ta' tensjoni farmakoloġika u d-dijanjostiċi tal-vijabilità ("dewmien fit-titjib").
English: Annex III Amendments to relevant sections of the product information
Maltese: Anness III Emendi għas-sezzjonijiet rilevanti tal-informazzjoni dwar ilprodott
English: Clinical consequences are unknown.
Maltese: Ilkonsegwenzi kliniċi mhumiex magħrufa.
English: Dynamic
Maltese: Fwied
English: The possible diagnostic advantages of using <active substance name (INN)> in patients who will require repeated scans should be weighed against the potential for deposition of gadolinium in the brain and other tissues.
Maltese: Il-vantaġġi dijanjostiċi possibbli tal-użu ta' <isem is-sustanza attiva (INN)> f'pazjenti li jkunu jeħtieġu skans ripetuti għandhom jintiżnu kontra l-potenzjal ta' depożitu ta' gadolinium fil-moħħ u f'tessuti oħra.
English: immediately after the administration, with scan delay calculated on the basis of test bolus or automatic bolus detection technique.
Maltese: immedjatament wara l-għoti, b'ittardjar tal-iskan ikkalkulat abbażi ta' teknika ta' sejba b'bolus test jew awtomatiku.
English: 0.1 mmol/kg body weight, administered as a single bolus of 0.2 mL/kg of the 0.5 M solution.
Maltese: 0.1 mmol/kg ta' piż tal-ġisem, mogħti bħala bolus wieħed ta' 0.2 mL/kg ta' soluzzjoni ta' 0.5 M.
English: <Product name> is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: of the liver in adults and children (above the age of 2 years)
Maltese: <Isem tal-prodott> huwa sustanza ta' kuntrast paramanjetiku għall-użu f'immaġini ta' reżonanza manjetika (MRI - magnetic resonance imaging) dijanjostika indikata għal: tal-fwied f'adulti u tfal (b'età ta' aktar minn sentejn)
English: The recommended dose is:
Maltese: Id-doża rakkomandata hija:
English: MRI of the breast, heart or other body areas: 0.2 ml per kilogram of body weight
Maltese: MRI tas-sider, qalb jew partijiet oħra tal-ġisem: 0.2 mL kull kilogramma ta' piż tal-ġisem
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY
Maltese: Località Marino del Tronto 63100 Ascoli Piceno (AP) L-ITALJA
English: • Hematocrit >25%
Maltese: • Ematokrit > 25%
English: Date of last renewal: 31/07/2014
Maltese: Data tal-aħħar tiġdid: 31/07/2014