FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.
Maltese: Kawtela għandha tittieħed f'pazjenti b'mard pulmonari klinikament sinifikanti, inkluż fibrożi pulmonari mxerrda tal-interstizju u mard kroniku sever ta' mblokk tal-pulmuni, billi ma twettqux studji fuq dawn il-pazjenti.
English: What Luminity looks like and contents of the pack
Maltese: Id-Dehra ta' Luminity u l-kontenuti tal-pakkett
English: The full EPAR for Fulvestrant Mylan 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: Fulvestrant Mylan is a ‘generic medicine'.
Maltese: Fulvestrant Mylan huwa ‘mediċina ġenerika'.
English: The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen.
Maltese: Is-sustanza attiva f'Fulvestrant Mylan, fulvestrant, hija antiestroġenu.
English: Fulvestrant Mylan contains the active substance fulvestrant.
Maltese: Fulvestrant Mylan fih is-sustanza attiva fulvestrant.
English: Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.
Maltese: Fulvestrant Mylan huwa mediċina antiestroġena użata għall-kura tal-kanċer tas-sider avvanzat jew metastatiku (kanċer li jkun infirex għal partijiet oħra tal-ġisem) f'nisa li jkunu qabżu l-menopawża b'tip ta' kanċer tas-sider magħruf bħala ‘kanċer pożittiv għar-riċettur tal-estroġenu' li ma jkunux ingħataw kura ormonali qabel, jew li l-kanċer tagħhom kien reġa' tfaċċa wara kura b'antiestroġenu ieħor.
English: Other information about Fulvestrant Mylan
Maltese: Informazzjoni oħra dwar Fulvestrant
English: Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg).
Maltese: Fulvestrant Mylan jista' jinkiseb biss b'riċetta ta' tabib u huwa disponibbli bħala soluzzjoni għall injezzjoni f'siringi mimlijin għal-lest (250 mg).
English: The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose.
Maltese: Id-doża rakkomandata hija 500 mg mogħtija darba fixxahar, b'doża addizzjonali ta' 500 mg mogħtija ġimagħtejn wara l-ewwel doża.
English: This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fulvestrant
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan.
Maltese: Diġà saru l-istudji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Faslodex, u m'hemmx għalfejn jiġu ripetuti għal Fulvestrant
English: This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Faslodex.
Maltese: Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħall-'mediċina ta' referenza' li hija diġà awtorizzata fl-Unjoni Ewropea (EU) blisem ta' Faslodex.
English: Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Mylan huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Agency recommended that Fulvestrant Mylan be approved for use in the EU.
Maltese: Mylan ikun approvat għall-użu fl-UE.
English: There was no need for ‘bioequivalence' studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Mylan jiġix assorbit b'mod simili għall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: Immediate Packaging
Maltese: Dags talpakkett
English: Solution for injection Subcutaneous use pre-filled syringe 1 pre-filled syringe
Maltese: Soluzzjoni għall-injezzjoni Użu għal taħt il-ġilda Siringa mimlija għal-lest 28 siringa mimlija għal-lest
English: Fresenius Kabi España, S.A.U.
Maltese: Fresenius Kabi España, S.
English: • Deficiency in NADPH (nicotinamide adenine dinucleotide phosphate) reductase.
Maltese: • Defiċjenza fl-NADPH (nicotinamide adenine dinucleotide phosphate) reductase.
English: Phototoxicity / Photosensitivity
Maltese: Fototossiċità / Fotosensittività
English: Reproductive Toxicology
Maltese: Tossikoloġija riproduttiva
English: Methaemoglobinaemia,
Maltese: Metemoglobinemija,
English: Pierrel S.p.A. s.s. Appia 7 bis, 46/48 - 81043 Capua, Italy
Maltese: Pierrel S.p.A. s.s. Appia 7 bis, 46/48, 81043 Capua, Italja
English: System organ class
Maltese: Sistema tal klassifika tal organi
English: Pierrel S.p.A. s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italy
Maltese: Pierrel S.p.A. s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italja
English: Summary of the safety profile
Maltese: Sommarju tal- profil tas-sigurtà
English: These include SSRIs (selective serotonin reuptake inhibitors), bupropion, buspirone, clomipramine, mirtazapine, and venlafaxine.
Maltese: Dawn jinkludu SSRIs (selective serotonin reuptake inhibitors), bupropion, buspirone, clomipramine, mirtazapine, u venlafaxine.
English: Methylthioninium chloride is an in vitro inhibitor of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5.
Maltese: Methylthioninium chloride huwa impeditur in vitro ta' CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 u 3A4/5.
English: • Monoamine oxidase inhibitors
Maltese: • impedituri ta' monoamine oxidase
English: 22 rue Marc Donadille, 13013 Marseille, France
Maltese: 22 rue Marc Donadille, 13013 Marseille, Franza
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta ' reazzjonijiet avversi
English: Serotonin Syndrome with concomitant use of serotonergic drugs (see section 4.4 and section 4.5).
Maltese: Sindrome tas-Serotonin b'użu konkomitanti ta' mediċini serotonerġiċi (ara sezzjoni 4.4 u sezzjoni 4.5)
English: Methylthioninium chloride is a substrate of P-glycoprotein (P-gp).
Maltese: Methylthioninium chloride huwa sottostrat ta' P-glycoprotein (P-gp).
English: PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, France
Maltese: Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, Franza
English: Failure to respond to methylthioninium chloride suggests cytochrome b5 reductase deficiency, glucose6- phosphate dehydrogenase deficiency or sulfhaemoglobinemia.
Maltese: Nuqqas ta' reazzjoni għal methylthioninium chloride jissuġġerixxi defiċjenza taċ-ċitokromju b5 reductase, defiċjenza tal-glucose-6- phosphate dehydrogenase jew sulfhaemoglobinemia.
English: • Patients with Glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of haemolytic anaemia
Maltese: • Pazjenti b'defiċjenza ta' Glucose-6-phosphate dehydrogenase (G6PD) minħabba r-riskju ta'
English: Chromaturia (blue-green)
Maltese: Kromaturja (blu - ħadrani)
English: Haemolytic anaemia
Maltese: anemija emolitika
English: Methylthioninium chloride is an in vitro inducer of CYP1A2.
Maltese: Methylthioninium chloride huwa induttur in vitro ta' CYP1A2.
English: Lower doses (<1 mg/kg) may be needed.
Maltese: Jistgħu jkunu meħtieġa dożi iżgħar (<1 mg/kg).
English: The clinical consequences of increases plasma concentration of co-administered drugs which are sensitive CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A substrates cannot be ruled out.
Maltese: Il-konsegwenzi kliniċi ta' żjieda fil-konċentrazzjoni ta' plażma ta' mediċini amministrati fl-istess waqt li huma sottostrati sensittivi ta' CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 u 3A ma jistax jiġi eskluż.
English: 5 ampoules of 2 ml 20 ampoules of 2 ml 10 mg/2 ml
Maltese: 5 fjali ta' 2 ml 20 fjali ta' 2 ml 10 mg/2 ml
English: Methylthioninium chloride is a potent inhibitor of the transporters OCT2, MATE1 and MATE2-K.
Maltese: Methylthioninium chloride huwa impeditur qawwi tat-trasportaturi OCT, MATE1 u MATE2-K.
English: The administration of large intravenous doses (≥ 7 mg/kg) of Methylthioninium chloride Proveblue to individuals without methaemoglobinaemia induces nausea and vomiting, chest tightness, chest pain, tachycardia, apprehension, severe sweating, tremor, mydriasis, blue-green staining of the urine, blue staining of the skin and mucous membranes, abdominal pain, dizziness, paraesthesia, headache, confusion, hypertension, mild methaemoglobinaemia (up to 7%) and electrocardiogram changes (T wave flattening or inversion).
Maltese: L-għoti ta' dożi kbar minn ġol-vini (≥ 7 mg/kg) ta' Methylthioninium chloride Proveblue lil individwi mingħajr metemoglobinemija jikkawża nawżja u rimettar, għafis fis-sider, uġigħ fis-sider, takikardija, biża', għaraq eċċessiv, rogħda, midrijażi, awrina blu jew ħadranija, kulur blu fil-ġilda u fil-membrani mukużi, uġigħ fl-addome, sturdament, parestesija, uġigħ ta' ras, konfużjoni, pressjoni għolja, metemoglobinemija ħafifa (sa 7%) u bidliet fl-elettrokardjogramma (l-iċċattjar jew il-qlib tat-T wave).
English: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois France
Maltese: 52, Rue Marcel et Jacques Gaucher 94120
English: It must be injected very slowly over a period of 5 minutes.
Maltese: Għandu jiġi injettat bil-mod ħafna fuq perjodu ta' 5 minuti.
English: Musculoskeletal and connective tissue disorder
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: Avoid concomitant use of methylthioninium chloride with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (see section 4.5).
Maltese: Evita l-użu fl-istess waqt ta' methylthioninium chloride ma' impedituri silettivi għat-teħid mill-ġdid ta' serotonin (SSRIs - selective serotonin reuptake inhibitors), impedituri għat-teħid mill-ġdid ta' serotonin u norepinephrine (SNRIs- serotonin and norepinephrine reuptake inhibitors), u impedituri ta' monoamine oxidase (ara sezzjoni 4.5)
English: fluvoxamine, paroxetine, sertraline and zimelidine
Maltese: SSRIs) bħal citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline u zimelidine
English: Ελλάδα a VIPharma International AE Τηλ: + 30-210-6194170
Maltese: Τηλ: + 30-210-6194170
English: Cenexi 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France
Maltese: Cenexi 52, Rue Marcel et Jacques Gaucher, 94120
English: Provepharm SAS Teл.
Maltese: Sewqan u tħaddim ta' magni
English: Methylthioninium chloride Proveblue is not an in vitro inducer of CYP2B6 and CYP3A4.
Maltese: Methylthioninium chloride Proveblue mhux induttur in vitro ta' CYP2B6 u CYP3A4.
English: Individuals with methaemoglobinaemia
Maltese: Individwi b'metemoglobinemija
English: The estimated terminal half-life of methylthioninium chloride after intravenous administration is 26.7h.
Maltese: Il-half-life terminali ta' methylthioninium chloride wara l-għoti minn ġol-vini hija stmata li hija 26.7 sigħat.
English: Methylthioninium chloride Proveblue is an in vitro inhibitor of P-gp.
Maltese: Methylthioninium chloride Proveblue huwa impeditur in vitro ta' P-gp.
English: Methylthioninium chloride Proveblue has been observed to stain tissues selectively.
Maltese: Methylthioninium chloride Proveblue ġie osservat li jtebba' t-tessuti b'mod selettiv.
English: Solution for injection (injection) Clear dark blue solution with a pH value between 3.0 and 4.5 Osmolality is usually between 10 and 15 mOsm/kg.
Maltese: L-osmolalità hija normalment bejn 10 u 15 mOsm/kg.
English: Methylthioninium chloride Proveblue is not an in vitro substrate for BCRP or OCT2 and is not an in vitro inhibitor of BCRP, OAT1 or OAT3.
Maltese: Methylthioninium chloride Proveblue mhux sottostrat in vitro għal BRCP jew OCT2 u mhux impeditur in vitro ta' BRCP, OAT1 jew OAT3.
English: In the case of aniline- or dapsone-induced methaemaglobinaemia, the maximum recommended cumulative dose for the course of treatment is 4 mg/kg (see section 4.4).
Maltese: Fil-każ ta' metemoglobinemija indotta mill-anilina jew mid-dapsone, id-doża kumulattiva massima rakkomandata għall-kors tal-kura hija ta' 4 mg/kg (ara sezzjoni 4.4).
English: Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016
Maltese: Data tal-ewwel awtorizzazzjoni : 6 ta 'Mejju 2011
English: Electrocardiogram (ECG) and blood pressure should be monitored during and after treatment with Methylthioninium chloride Proveblue as hypotension and cardiac arrhythmia are potential adverse reactions (see section 4.8).
Maltese: L elettrokardjogramma (ECG) u l-pressjoni tad-demm għandhom jiġu ssorveljati waqt u wara l-kura b'Methylthioninium chloride Proveblue minħabba li pressjoni baxxa u arritmija kardijaka huma effetti sekondarji potenzjali (ara sezzjoni 4.8).
English: For instructions on handling and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq il-maniġġar u id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes.
Maltese: Id-doża rakkomandata hija ta' 0.3 sa 0.5 mg/kg piż tal-ġisem, jiġifieri 0.06 sa 0.1 ml/kg, fuq perjodu ta' 5 minuti.
English: What Methylthioninium chloride Proveblue contains - The active substance is methylthioninium chloride.
Maltese: X'fih Methylthioninium chloride Proveblue - Is-sustanza attiva hija methylthioninium chloride.
English: Haemolytic anaemia has also been reported in case of severe overdose (20-30 mg/kg) in infants and adults with methaemoglobinaemia caused by aniline or chlorates.
Maltese: L-anemija emolitika ġiet irrapportata ukoll f'każ ta' doża eċċessiva severa (20-30 mg/kg) fi trabi u f'adulti b'metemoglobinemija kkawżata mill-anilina jew mill-klorati.
English: In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin.
Maltese: In vivo, f'konċentrazzjoni baxxa, methylthioninium chloride iħaffef il-konverżjoni ta' metemoglobina f'emoglobina.
English: Laboratoires ETHYPHARM Tel: + 33 1 41 12 65 63
Maltese: Tel: + 33 1 41 12 65 63
English: Monitoring tests You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
Maltese: Testijiet ta' sorveljanza Isirulek testijiet ta' sorveljanza waqt u wara t-trattament b'Methylthioninium chloride Proveblue.
English: Methylthioninium chloride Proveblue 5 mg/ml injection methylthioninium chloride
Maltese: Methylthioninium chloride Proveblue 5 mg/ml injezzjoni methylthioninium chloride
English: Pharmacotherapeutic group: All other therapeutic products, antidotes, ATC code: V03AB17
Maltese: Il-prodotti terapewtiċi l-oħrajn kollha, antidoti, Kodiċi ATC:
English: An equivocal evidence of carcinogenic activity was observed in female mice.
Maltese: Evidenza ekwivoka ta' attività karċinoġenika ġiet osservata fil-ġrieden nisa.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Adverse reactions, seen at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were moderate regenerative anaemia associated with increased mean platelet count and fibrinogen levels, a minimal increase in mean total bilirubin blood values and an increased incidence of moderate urine bilirubin levels.
Maltese: Ir-reazzjonijiet avversi, li dehru f'livelli ta' espożizzjoni simili għal-livelli ta' espożizzjoni kliniċi u b'rilevanza possibbli għall-użu kliniku kienu anemija reġenerattiva moderata assoċjata ma' żieda filmedja tal-għadd ta' plejtlits u fil-livelli tal-fibrinoġen, żieda minima fil-medja tal-valuri totali talbilirubina fid-demm u inċidenza akbar ta' livelli moderati ta' bilirubina fl-awrina.
English: A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg) may be given after one hour in case of persistence or recurrence of symptoms.
Maltese: Doża ripetuta (0.3 sa 0.5 mg/kg piż tal-ġisem, jiġifieri 0.06-0.1 ml/kg) tista' tingħata wara siegħa f'każ ta' sintomi persistenti jew rikorrenti.
English: Hyperbilirubinaemia
Maltese: Uġigħ fl-estremitajiet
English: Methylthioninium chloride was mutagenic in gene mutation assays in bacteria and mouse lymphoma cells but not in vivo mouse micronucleus assay when administered intravenously at 62 mg/kg.
Maltese: Methylthioninium chloride kien mutaġeniku fl-analiżi ta' mutazzjoni ġenetika fil-batterji u fiċ-ċelloli tal-limfoma tal-ġrieden iżda mhux f'analiżi in vivo tal-mikronukleu tal-ġrieden meta ngħata minn ġolvini f'doża ta' 62 mg/kg.
English: Methylthioninium chloride may cause a cutaneous photosensitivity reaction when exposed to strong light sources, such as phototherapy, those found in operating theatres or locally from illuminating devices such as pulse oximeters.
Maltese: Methylthioninium chloride jista' jikkaġuna reazzjoni fotosensittiva tal-ġilda meta jkun espost għal sorsi qawwija ta' dawl, bħal fototerapija, dawk li jinsabu fis-swali tal-operazzjoni jew lokalment minn tagħmir illuminanti bħal ossimetri tal-polz.
English: Not known (frequency cannot be estimated from the available data): - serotonin syndrome when Methylthioninium chloride Proveblue has been taken with certain medicines to treat depression or anxiety, see section 2 - decreased haemoglobin (protein in red blood cells that carry oxygen in the blood) levels may be reported during blood tests - reduction in red blood cells which may turn your skin pale and make you breathless and weak - local tissue damage at the injection site - jaundice (yellowing of the skin and eyes) - this has only been reported in infants - problems with speech - high or low blood pressure - agitation - lack of oxygen - irregular heartbeat, including an abnormally slow or fast beating of the heart - severe allergic reactions (so called anaphylactic reaction which may cause your throat or face to swell, difficulty breathing or a severe rash) - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood) - shortness of breath - confusion - shaking - hives - fever - rapid breathing - dilated pupils - discoloured stools.
Maltese: - ħsara lit-tessut lokali fis-sit tal-injezzjoni - suffejra (il-ġilda u u l-għajnejn jisfaru) - din ġiet rapportata biss fi trabi - problemi fit-tħaddid - pressjoni għolja jew baxxa - aġitazzjoni - nuqqas t'ossiġenu - qalb tħabbat b'mod irregolari, li jinkludi qalb li tħabbat b'mod abnormali bil-mod jew bil-qawwi - reazzjonijiet allerġiċi severi (dawk magħrufa bħala reazzjonijiet anafilattiċi li jistgħu jikkaġunaw lil griżmejk jew li wiċċek jintefaħ, jikkaġunaw diffikultà biex tieħu n-nifs jew ikollok raxx sever) - żieda fl-metaemoglobina (għamla abnormali ta' emoglobina fid-demm) - nuqqas ta' nifs - konfużjoni - rogħda - ħorrieqija - deni - nifs mgħaġġel - mimmi mwassa' - ippurgar skolorat.
English: • Common side effects (may affect up to 1 in 10 people): - stomach pain - chest pain - headache - anxiety - injection site pain - vomiting
Maltese: • Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 f'10) - uġigħ fl-estremitajiet - sturdament - għorieq - tibdil fil-kulur tal-ġilda.
English: Methylthioninium chloride Proveblue must be injected very slowly over a period of 5 minutes to prevent high local concentrations of the compound from producing additional methaemoglobin.
Maltese: Methylthioninium chloride Proveblue għandu jiġi injettat bil-mod ħafna fuq perjodu ta' 5 minuti sabiex jiġi evitat li konċentrazzjonijiet lokali għoljin tal-kompost jipproduċu aktar metemoglobina.
English: The most commonly reported adverse reactions observed during clinical trials are dizziness, paraesthesia, dysgeusia, nausea, skin discoloration, chromaturia, sweating, injection site pain and pain in extremity.
Maltese: L-aktar reazzjonijiet avversi komuni osservati waqt il-provi kliniċi huma sturdament, parestesija, Disturbi fit-togħma, dardir, tibdil fil-kulur tal-ġilda, kromaturja, għorieq, uġigħ fis-sit tal-injezzjoni u uġigħ fl-estremitajiet.
English: Its use in parathyroid surgery (not indicated) has induced adverse CNS effects when administered concomitantly with serotonergic medicinal products (see section 4.5).
Maltese: L-użu tiegħu filkirurġija tal-paratirojde (mhux indikat) ikkawża effetti avversi fuq is-CNS meta ngħata fl-istess ħin ma' mediċini serotonerġiċi (ara sezzjoni 4.5).
English: Tel: +33 (0)4 91 08 69 30
Maltese: Provepharm SAS Teл.: + 33 (0)4 91 08 69 30
English: It must especially not be mixed with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Maltese: Għandu jiġi dilwit ma' soluzzjoni għal injezzjoni ta' sodium chloride 9 mg/ml (0.9%) għaliex intwera li l-klorur inaqqas is-solubbiltà ta' methylthioninium chloride.
English: Methylthioninium chloride Proveblue is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Maltese: Methylthioninium chloride Proveblue huwa ipotoniku u jista' jkun dilwit f'soluzzjoni għal injezzjoni ta' 50 ml glukożju 50 mg/ml (5%) sabiex ikun evitat uġigħ lokali, b'mod partikolari fil-popolazzjoni pedjatrika.
English: • Hypersensitivity to the active substance, or to any other thiazine dyes
Maltese: • Sensittività eċċessiva għas-sustanza attiva, jew għal xi kulur thiazine ieħor
English: How to store Methylthioninium chloride Proveblue
Maltese: Kif taħżen Methylthioninium chloride Proveblue
English: The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes.
Maltese: Id-doża normali hija 1 sa 2 mg għal kull kilogramma tal-piż tal-ġisem tiegħek, jiġifieri 0.2 sa 0.4 ml għal kull kilogramma mogħtija fuq perjodu ta' 5 minuti.
English: Tel.: + 48 694 775 205
Maltese: AB Pharm Sp. z o.o. Tel. + 48 694 775 205
English: Each 2 ml ampoule contains 10 mg methylthioninium chloride.
Maltese: Kull fjala ta' 2 ml fiha 10 mg methylthioninium chloride.
English: After opening or dilution: From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product must be used immediately.
Maltese: Minn perspettiva mikrobijoloġika, sakemm il-metodu ta' ftuħ/ dilwizzjoni jipprekludi r-riskju ta' kontaminazzjoni mikrobjali, il-prodott għandu jintuża minnufih.
English: Faeces discoloration (blue-green)
Maltese: Bidla fil-kulur tal-ipppurgar (bluħadrani)
English: Methylthioninium chloride (also called methylene blue) belongs to a group of medicines called antidotes.
Maltese: Il-methylthioninium chloride (li jissejjaħ ukoll methylene blue) jagħmel parti minn grupp ta' mediċini li jissejħu antidoti.
English: Methylthioninium chloride may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs.
Maltese: Methylthioninium chloride jista' jikkaġuna sindrome serotonerġiku serju jew fatali meta jintuża f'kombinazzjoni ma' mediċini serotonerġiċi.
English: Patients treated with methylthioninium chloride in combination with serotonergic drugs should be monitored for the emergence of serotonin syndrome.
Maltese: Pazjenti trattati b'methylthioninium chloride f'kombinazzjoni ma' mediċini serotonerġiċi għandhom jiġu monitorati għall-iżvilupp tas-sindrome ta' serotonin.