FrancophonIA/ELRC3.0 huggingface dataset:
English: Published data demonstrate markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment (see Section 4.2).
Maltese: Data ppubblikata turi b'mod ċar, livelli ta' melatonina endoġena elevati sew matul il-ġurnata minħabba eliminazzjoni mnaqqsa f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.2).
English: The maximum daily dose that you/your child will receive is 10 mg (two 5-mg tablets).
Maltese: Id-doża massima ta' kuljum li se tingħataw int jew it-tifel/tifla tiegħek hija 10 mg (żewġ pilloli ta' 5 mg).
English: This finding is compatible with the short half-life of melatonin in humans.
Maltese: Din is-sejba hija kompatibbli mal-half-life tal-melatonina fil-bnedmin.
English: • Low levels of white blood cells (neutropenia)
Maltese: • Numru baxx ta' ċelluli tad-demm bojod (newtropenija)
English: How to store Slenyto
Maltese: X'fih Slenyto
English: Data with 2 mg prolonged release melatonin tablets and data with 1 mg and 5 mg mini-tablets indicate that there is no accumulation of melatonin after repeated dosing.
Maltese: Data b'pilloli tal-melatonina ta' 2 mg li jerħu l-mediċina bil-mod u data b'pilloli żgħar ta' 1 mg u 5 mg tindika li wara dożaġġ ripetut ma hemm l-ebda akkumulazzjoni ta' melatonina.
English: The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.
Maltese: F'kull każ ma nstabet l-ebda interazzjoni farmakokinetika klinikament sinifikanti.
English: The most frequently reported adverse reactions with Slenyto in clinical studies were somnolence, fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100-1:10 children.
Maltese: Bidliet mhux mistennija fl-imġiba, bħal agressjoni, jistgħu jkunu komuni (u jaffettwaw bejn persuna 1 minn 100 sa persuna 1 minn 10).
English: The recommended starting dose is 2 mg of Slenyto.
Maltese: Id-doża tal-bidu rakkomandata hija ta' 2 mg Slenyto.
English: Slenyto is for use in the treatment of insomnia.
Maltese: Slenyto jintuża fit-trattament tal-insomnja.
English: Drowsiness
Maltese: Pożoloġija
English: After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen.
Maltese: Wara talanqas 3 xhur ta' trattament, it-tabib għandu jevalwa l-effett tat-trattament u jqis li jwaqqaf it-trattament jekk ma jidher l-ebda effett ta' trattament klinikament rilevanti.
English: Slenyto 1 mg prolonged-release tablet
Maltese: Slenyto 1 mg pilloli li jerħu l-mediċina bil-mod
English: Slenyto is for oral use.
Maltese: Slenyto huwa għal użu orali.
English: The improvements in total sleep time (TST), sleep latency (SL) and duration of uninterrupted sleep (LSE; longest sleep episode) seen in the double blind-phase were maintained throughout the 39 weeks' follow up period.
Maltese: It-titjib fil-ħin ta' rqad totali (TST), il-latenza tal-irqad (SL) u t-tul ta' rqad mingħajr interruzzjoni (LSE; episodju tal-itwal raqda) li deher fil-fażi double-blind inżamm matul il-perjodu ta' segwitu ta' 39 ġimgħa.
English: Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 or 8-MOP), which increases melatonin levels by inhibiting its metabolism.
Maltese: Għandha tiġi eżerċitata kawtela fil-pazjenti li jkunu qed jirċievu 5- jew 8-methoxypsoralen (5 jew 8MOP), li żżid il-livelli ta' melatonin billi tinibixxi l-metaboliżmu tiegħu.
English: INFORMATION IN BRAILLE Slenyto 1 mg (only applicable for outer carton, not applicable for bottle label)
Maltese: INFORMAZZJONI BIL-BRAILLE Slenyto ta' 1 mg (applikabbli biss għall-kartuna ta' barra, mhx applikabbli għat-tikketta tal-flixkun)
English: The dose can be repeated.
Maltese: Id-doża tista' tiġi ripetuta.
English: This summary was last updated in 07-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 07-2017.
English: The full EPAR for SonoVue can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal SonoVue jinstab fis-website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports tal-Aġenzija.
English: SonoVue is used in:
Maltese: SonoVue jintuża:
English: Side-effects were generally minor.
Maltese: L-effetti sekondarji kienu ġeneralment minuri.
English: The medicine contains the active substance sulphur hexafluoride (a gas).
Maltese: Din il-mediċina fiha s-sustanza attiva eżafluworur tal-kubrit (gass).
English: Other information about SonoVue
Maltese: Informazzjoni oħra dwar SonoVue
English: This is a summary of the European public assessment report (EPAR) for SonoVue.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal SonoVue.
English: SonoVue sulphur hexafluoride
Maltese: SonoVue eżafluworur tal-kubrit
English: The European Commission granted a marketing authorisation valid throughout the European Union for SonoVue on 26 March 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal SonoVue fis-26 ta' Marzu 2001.
English: • echocardiography (a diagnostic test where an image of the heart is obtained).
Maltese: • fl-ekukardjografija (test dijanjostiku għall-akkwist ta' immaġni tal-qalb).
English: Why is SonoVue approved?
Maltese: Għaliex ġie approvat SonoVue?
English: SonoVue must not be injected into a vein in patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs).
Maltese: SonoVue m'għandux jiġi injettat ġo vina f'pazjenti li jafu li għandhom shunts mil-lemin għax-xellug (moviment anormali tad-demm fil-qalb), pressjoni għolja pulmonari severa (pressjoni tad-demm għolja fl-arterja pulmonari, il-vażu li jwassal mill-qalb għall-pulmun), iperpressjoni mhux ikkontrollata (pressjoni tad-demm għolja) jew sindrome tal-qtugħ ta' nifs fl-adulti (akkumulazzjoni severa tal-fluwidi fiż-żewġ pulmuni).
English: In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the ‘gold standard', such as angiography (X-rays of blood vessels).
Maltese: F'dawn l-istudji, SonoVue ma tqabbilx ma' xi mediċina oħra, iżda r-riżultati tat-test b'SonoVue tqabblu mal-“ogħla standard” (“gold standard”), bħall-anġjografija (raġġi X tal-vażi).
English: For use in Doppler scans, a further 3 main studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels.
Maltese: Għal użu fi skens Doppler, 3 studji ewlenin oħra involvew 361 pazjent li kienu qed jiġu ttestjati għallanormalitajiet f'vażi kbar, u 217-il pazjent li kienu qed jiġu ttestjati għall-anormalitajiet f'vażi iżgħar.
English: For use in echocardiography, SonoVue was investigated in 3 main studies.
Maltese: Għal użu fl-ekukardjografija, SonoVue ġie investigat fi 3 studji ewlenin.
English: Pooled analysis of the studies suggested that SonoVue identified children with vesicoureteral reflux in 89% of cases, and correctly distinguished patients who did not have the condition in 81% of cases.
Maltese: Analiżi miġbura tal-istudji ssuġġeriet li SonoVue identifika tfal b'rifluss veżikureterali f'89 % tal-każijiet, u b'mod korrett iddistingwa pazjenti li ma kellhomx il-kondizzjoni f'81 % tal-każijiet.
English: • Doppler (a diagnostic test that measures the speed of blood flow).
Maltese: • f'Doppler (test dijanjostiku li jkejjel il-veloċità tal-fluss tad-demm).
English: Ultrasound with SonoVue was compared with the standard method using X-rays with an X-ray contrast agent.
Maltese: L-ultrasound b'SonoVue tqabbel mal-metodu standard bl-użu ta' raġġi X ma' aġent ta' kuntrast tar-raġġi X.
English: What are the risks associated with SonoVue?
Maltese: X'inhuma r-riskji assoċjati ma' SonoVue?
English: SonoVue is a medicine for diagnostic use only.
Maltese: SonoVue huwa mediċina għal użu dijanjostiku biss.
English: The company also presented results from the literature of 4 main studies involving over 500 children given SonoVue before ultrasound scans of the bladder to detect vesicoureteral reflux.
Maltese: Il-kumpanija ppreżentat ukoll riżultati mil-letteratura ta' 4 studji ewlenin li involvew ‘il fuq minn 500 wild li ngħataw SonoVue qabel skens tal-ultrasound tal-bużżieqa tal-awrina sabiex jiġi identifikat rifluss veżikureterali.
English: • ultrasound scans of the bladder and urinary tract in children and adolescents to detect vesicoureteral reflux, a condition in which urine flows backward from the bladder to the kidneys, leading to scarring and kidney infections.
Maltese: • fi skens tal-ultrasound tal-bużżieqa tal-awrina u fl-apparat tal-awrina fit-tfal u fl-adolexxenti sabiex jiġi identifikat rifluss veżikureterali, kondizzjoni li fiha l-awrina timxi lura mill-bużżieqa tal-awrina għall-kliewi, li twassal għal ċikatriċi u infezzjonijiet fil-kliewi.
English: When made up into a solution, SonoVue contains sulphur hexafluoride gas as ‘microbubbles' in suspension in a liquid.
Maltese: Meta jsir soluzzjoni, SonoVue fih il-gass eżafluworur tal-kubrit bħala “mikro-bżieżaq” f'sospensjoni f'likwidu.
English: The most common side effects when SonoVue is injected into a vein (seen in up to 1 in 100 patients) are headache, nausea (feeling sick) and reactions at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni meta SonoVue jiġi injettat ġo vina (li dehru f'sa pazjent 1 minn kull 100) huma wġigħ ta' ras, nawżja (tħossok ma tiflaħx) u reazzjonijiet fis-sit tal-injezzjoni.
English: Using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys).
Maltese: L-użu ta' SonoVue sabiex jitkejjel il-fluss tad-demm f'vażi kbar tejjeb il-kwalità tal-isken fit-testijiet tal-arterji ċerebrali (fir-ras), tal-karotidi (fl-għonq) u talvina portali (li twassal għall-fwied), iżda mhux tal-arterji renali (li jwasslu għall-kliewi).
English: SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.
Maltese: SonoVue kien aktar effettiv mill-komparatur u mill-plaċebo fit-titjib taċ-ċarezza tal-immaġni miksuba tal-ventriklu taxxellug u l-bordura tal-ventriklu tax-xellug.
English: However, this was not observed in the pancreas, kidney, ovary or prostate gland.
Maltese: Madankollu, dan ma ġiex osservat fil-frixa, fil-kliewi, fl-ovarji jew fil-glandola tal-prostata.
English: These involved a total of 317 patients, and compared SonoVue with another contrast agent and placebo (a dummy treatment).
Maltese: Dawn involvew total ta' 317-il pazjent, u qabblu SonoVue ma' aġent ta' kuntrast ieħor u mal-plaċebo (kura finta).
English: The active substance in SonoVue, sulphur hexafluoride, is a gas that is not soluble in body fluids or water.
Maltese: Is-sustanza attiva f'SonoVue, l-eżafluworur tal-kubrit, hija gass li ma jinħallx fil-fluwidi tal-ġisem jew fl-ilma.
English: When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles.
Maltese: Meta SonoVue jsir f'sospensjoni, il-gass jinqabad ġewwa bżieżaq żgħar msejħin mikrobżieżaq.
English: SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability to create an echo.
Maltese: Il-kejl ewlieni tal-effikaċja kien kemm kienu ċari l-immaġnijiet miksubin fit-test.
English: When used with ultrasound of the heart or for measuring blood flow, SonoVue is injected intravenously (into a vein) before the test is carried out, as a 2 or 2.4 ml dose depending on which test is being carried out.
Maltese: Meta jintuża ma' ultrasound tal-qalb jew biex jitkejjel il-fluss tad-demm, SonoVue jiġi injettat ġol-vini (ġo vina) qabel ma jsir it-test, bħala doża ta' 2 jew 2.4 ml skont it-test li jkun qed isir.
English: SonoVue can be used in adults for Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions (areas of disease) in the breast or liver;
Maltese: SonoVue jista' jintuża fl-adulti għat-testijiet Doppler għal vażi kbar, bħal dawk fir-ras, dawk li jwasslu għar-ras jew il-vina ewlenija sal-fwied, jew għal vażi iżgħar bħal dawk f'leżjonijiet (partijiet tal-mard) fis-sider jew filfwied;
English: SonoVue has been shown to be effective in improving ultrasound scans of the heart in adults and the bladder in children, and in measurements of blood flow.
Maltese: SonoVue intwera li huwa effettiv biex itejjeb l-iskens tal-ultrasound tal-qalb fl-adulti u tal-bużżieqa talawrina fit-tfal, u fil-kejl tal-fluss tad-demm.
English: • deficiency in the enzyme NADPH reductase.
Maltese: • nuqqas fl-enzima NADPH riduttażi.
English: The full EPAR for Methylthioninium chloride Proveblue 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: • glucose-6-phosphate dehydrogenase deficiency (G6PD),
Maltese: • nuqqas ta' nuqqas ta' deidroġenażi fosfat-6 tal-glukożju (G6PD),
English: The dose in children aged three months or less is 0.3 to 0.5 mg/kg.
Maltese: Id-doża fit-tfal li għandhom tliet xhur jew inqas hija ta' 0.3 sa 0.5 mg/kg.
English: The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.
Maltese: Il-mediċina ta' referenza għall-Klorur tal-metiltijoninju Proveblue hija Injezzjoni tal-Klorur tal-Metiltijoninju USP 1% w/v.
English: This means that it is similar to a reference medicine, containing the same active substance but in a different concentration.
Maltese: Dan ifisser li hija simili għal mediċina ta' referenza, li fiha l-istess sustanza attiva iżda f'konċentrazzjoni differenti.
English: The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles'), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine), sweating and pain at the site of injection or in a limb.
Maltese: L-effetti sekondarji l-aktar komuni bil-klorur tal-metiltijoninju huma sturdament, parestesija (sensazzjonijiet rari bħal 'pinnijiet u labar') disgweżja (disturbi fit-togħma), nawżja (tħossok ma tiflaħx), skulurazzjoni tal-ġilda, chromaturia (kolorazzjoni anormali tal-awrina), għaraq u wġigħ fis-sit tal-injezzjoni jew fid-dirgħajn u r-riġlejn.
English: Methylthioninium chloride Proveblue is available as a solution for injection (5 mg/ml), which is injected slowly into a vein over a period of five minutes.
Maltese: Il-klorur tal-metiltijoninju Proveblue huwa disponibbli bħala soluzzjoni għal injezzjoni (5 mg/ml), li jiġi injettat bil-mod f'vina fuq perjodu ta' ħames minuti.
English: Methylthioninium chloride Proveblue is a ‘hybrid medicine'.
Maltese: Il-klorur tal-metiltijoninju Proveblue huwa ‘mediċina ibrida'.
English: Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.
Maltese: Is-sustanzi li jistgħu jikkawżaw metemoglobinemija jinkludu ċerti antibijotiċi, anestetiċi lokali, nitrati fl-ilma tax-xorb u fil-pestiċidi.
English: The usual dose for adults and children aged above three months is 1 to 2 mg per kilogram (kg) body weight.
Maltese: Id-doża normali għall-adulti u għat-tfal li għandhom aktar minn tliet xhur hija ta' 1 jew 2 mg għal kull (kg) tal-piż tal-ġisem.
English: This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Klorur talmetiltijoninju Proveblue.
English: Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by the use of certain medicines or chemicals.
Maltese: Il-klorur tal-metiltijoninju Proveblue jintuża fl-adulti u fit-tfal ta' kull età bħala antidotu biex jikkura sintomi ta' metemoglobinemija kkawżati mill-użu ta' ċerti mediċini jew kimiki.
English: Methylthioninium chloride Proveblue methylthioninium chloride
Maltese: Klorur tal-metiltijoninju Proveblue klorur tal-metiltijoninju
English: The European Commission granted a marketing authorisation valid throughout the European Union for Methylthioninium chloride Proveblue on 6 May 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għall-Klorur tal-metiltijoninju Proveblue valida fl-Unjoni Ewropea kollha fis-6 ta' Mejju 2011.
English: The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue), helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin.
Maltese: Is-sustanza attiva fil-Klorur tal-metiltijoninju Proveblue, (imsejħa wkoll metelen blu) tgħin biex tgħaġġel il-konverżjoni tal-emoglobina anormali lura għall-emoglobina normali.
English: Methylthioninium chloride Proveblue contains the active substance methylthioninium chloride.
Maltese: Il-klorur tal-metiltijoninju Proveblue fih is-sustanza attiva tal-klorur tal-metiltijoninju.
English: Other information about Methylthioninium chloride Proveblue
Maltese: Informazzjoni oħra dwar il-Klorur tal-metiltijoninju Proveblue
English: What are the risks associated with Methylthioninium chloride Proveblue?
Maltese: X'inhuma r-riskji assoċjati mal-Klorur tal-metiltijoninju Proveblue?
English: Methylthioninium chloride Proveblue must not be used in people who are hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (the group to which methylthioninium chloride belongs).
Maltese: Il-Klorur tal-metiltijoninju Proveblue ma għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għall-klorur tal-metiltijoninju, jew għal xi wieħed mill-kuluri thiazine (il-grupp li minnu jagħmel parti lklorur tal-metiltijoninju).
English: The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.
Maltese: Imbagħad, l-elettroni jiġu ttrasferti lejn l-atomi tal-ħadid fl-emoglobina anormali, u taqlibhom fil-forma ferruża normali.
English: • methaemoglobinaemia caused by chlorate poisoning,
Maltese: • metemoglobinemija kkawżata minn avvelenament bil-klorat,
English: Why is Methylthioninium chloride Proveblue approved?
Maltese: Għaliex ġie approvat il-Klorur tal-metiltijoninju Proveblue?
English: Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on its use from the published literature, which confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.
Maltese: Minħabba li l-klorur tal-metiltijoninju kien jintuża fl-Unjoni Ewropea għal diversi deċennji biex jikkura lmetemoglobinemija, il-kumpanija ppreżentat data dwar l-użu tiegħu minn letteratura ppubblikata, li kkonfermat li l-klorur tal-metiltijoninju huwa effettiv fil-kura tal-metemoglobinemija li ġiet ikkawżata minn esponiment għal mediċina jew għal kimika fl-adulti u t-tfal.
English: The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia.
Maltese: Il-Kumitat ikkonkluda li l-esperjenza twila bis-sustanza attiva, klorur tal-metiltijoninju, turi li huwa effettiv fil-kura ta' metemoglobinemija.
English: How is Methylthioninium chloride Proveblue used?
Maltese: Kif jintuża l-Klorur tal-metiltijoninju Proveblue?
English: • methaemoglobinaemia caused by nitrite during treatment of cyanide poisoning,
Maltese: • metemoglobinemija kkawżata minn nitrit matul il-kura tal-avvelenament biċ-ċjanur,
English: • Known serious hypersensitivity to other parenteral iron products.
Maltese: • Sensittività eċċessiva serja magħrufa għal prodotti oħrajn li fihom ħadid parenterali.
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 għallimmaniġġjar ta' reazzjonijiet anafilattiċi/anafilattojdi akuti għandu jkun disponibbli, li jinkludi soluzzjoni ta' 1:1000 adrenaline li tista' tiġi injettata.
English: 4.6 Fertility, pregnancy and lactation [the wording below should be inserted in the relevant section]
Maltese: .6 Fertilità, tqala u treddigħ [il-kitba t'hawn taħt għandha tiddaħħal fis-sezzjoni rilevanti]
English: • Hypersensitivity to the active substance, to {invented name} or any of its excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għal {isem ivvintat} jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: The patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection (see section 4.4).
Maltese: Il-pazjent għandu jiġi osservat għal effetti avversi għal mill-inqas 30 minuta wara kull injezzjoni ta' {isem ivvintat} (ara sezzjoni 4.4).
English: You will be observed for at least 30 minutes by your doctor or nurse after each administration.
Maltese: Inti se tiġi osservat għal mill-inqas 30 minuta mit-tabib jew l-infermier tiegħek wara kull għoti.
English: Possible side effects [the wording below should be inserted in the relevant section]
Maltese: Effetti sekondarji possibbli [il-kitba t'hawn taħt għandha tiddaħħal fis-sezzjoni rilevanti]
English: There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Maltese: Hemm ukoll riskju miżjud ta' reazzjonijiet ta' sensittività eċċessiva għal kumplessi ta' ħadid parenterali f'pazjenti b'kundizzjonijiet immuni jew infjammatorji (eż. lupus erythematosus sistemiku, artrite rewmatojde).
English: Each patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection.
Maltese: Kull pazjent għandu jiġi osservat għal effetti avversi għal mill-inqas 30 minuta wara kull injezzjoni ta' {isem ivvintat}.
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: Wara d-deċiżjoni tal-Kummissjoni, l-awtoritajiet kompetenti fl-Istati Membri, flimkien mal-Istat Membru ta' referenza, jaġġornaw l-informazzjoni dwar il-prodott skont il-proċeduri stabbiliti filKapitolu 4 tat-Titolu III tad-Direttiva 2001/83/EC
English: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Maltese: Preparazzjonijiet li fihom ħadid li jingħataw b'mod parenterali jistgħu jikkawżaw reazzjonijiet ta' sensittività eċċessiva li jinkludu reazzjonijiet anafilattiċi/anafilattojdi serji u potenzjalment fatali.
English: [All references to the recommendation for an initial test dose before the administration of the first dose to a new patient should be removed in section 4.2 and in any other sections of the SmPC where applicable.
Maltese: [Ir-referenzi kollha għar-rakkomandazzjoni għal doża test inizjali qabel l-għoti tal-ewwel doża lil pazjent ġdid għandhom jitneħħew f'sezzjoni 4.2 u fi kwalunkwe sezzjonijiet oħrajn tal-SmPC fejn applikabbli.