FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Methylthioniniumchlorid var mutagen i genmutationsundersøgelsen i bakterier og lymfomceller fra mus, men ikke i in vivo micronucleusundersøgelser på mus, når der administreres 62 mg/kg intravenøst.
English: Extreme caution should be exercised when administering to newborns and infants below the age of 3 months due to lower concentrations of NADPH-methaemoglobin reductase necessary for reducing methaemoglobin to haemoglobin, making these infants more susceptible to methaemoglobinaemia produced by high doses of methylthioninium chloride.
Danish: Der bør udvises den yderste forsigtighed ved indgivelse til nyfødte og spædbørn under 3 måneder på grund af de lavere koncentrationer af NADPH-methæmoglobinreduktase, der er nødvendig for at reducere methæmoglobin til hæmoglobin, hvilket gør disse spædbørn mere udsatte for methæmoglobinæmi fremkaldt af høje doser af methylthioniniumchlorid.
English: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois France
Danish: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois Frankrig
English: Due to a lack of available data on whether methylthioninium chloride passes into human breast milk, breast-feeding should be discontinued for up to 8 days after treatment with this medicine.
Danish: På grund af manglende data om, hvorvidt methylthioniniumchlorid udskilles i modermælk, bør amning afbrydes i op til 8 dage efter behandling med dette lægemiddel.
English: The use of Methylthioninium chloride Proveblue during pregnancy is not recommended unless it is clearly necessary, for example in a life-threatening situation.
Danish: Det anbefales ikke at bruge Methylthioniniumchlorid Proveblue under graviditeten, medmindre det er absolut nødvendigt, f.eks. i en livstruende situation.
English: The excretion of methylthioninium chloride in milk has not been studied in animals.
Danish: Udskillelse af methylthioniniumchlorid i human mælk er ikke blevet undersøgt hos dyr.
English: • Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine,
Danish: • selektive serotoningenoptagelseshæmmere (SSRI) såsom citalopram, escitalopram, fluoxetin,
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.
Danish: De bivirkninger, der ses ved eksponeringsniveauer svarende til kliniske eksponeringsniveauer og uden mulig relevans for klinisk anvendelse, var moderat regenerativ anæmi i tilknytning til en højere median for patienternes trombocyttal og fibrinogenniveauer, en minimal stigning i medianen for de samlede bilirubinværdier i blodet og en øget forekomst af moderate bilirubinniveauer i urinen.
English: In patients with aniline-induced methaemoglobinaemia, repeated doses of methylthioninium chloride may be required.
Danish: Hos patienter med methæmoglobinæmi fremkaldt af anilin kan gentagne doser af methylthioniniumchlorid være nødvendige.
English: These include SSRIs (selective serotonin reuptake inhibitors), bupropion, buspirone, clomipramine, mirtazapine, and venlafaxine.
Danish: Disse omfatter selektive serotoningenoptagelseshæmmere (SSRI), bupropion, buspiron, clomipramin, mirtazapin og venlafaxin.
English: The maximum recommended cumulative dose for the course of treatment is 7 mg/kg and should not be exceeded, since Methylthioninium chloride administered above the maximum dose may cause methaemoglobinaemia in susceptible patients.
Danish: Den maksimale anbefalede kumulative dosis for behandlingsforløbet er 7 mg/kg og bør ikke overskrides, da methylthioniniumchlorid administreret over den maksimale dosis kan forårsage methæmoglobinæmi hos særligt modtagelige patienter.
English: Based on kinetic data, breast-feeding should be discontinued for up to 8 days after treatment with Methylthioninium chloride Proveblue.
Danish: Baseret på kinetiske data bør amning afbrydes i op til 8 dage efter behandling med Methylthioniniumchlorid Proveblue.
English: Methylthioninium chloride may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs.
Danish: Methylthioniniumchlorid kan forårsage alvorligt eller fatalt serotonergt syndrom, når det anvendes i kombination med serotonerge lægemidler.
English: Like all medicines, Methylthioninium chloride Proveblue can cause side effects, although not everybody gets them.
Danish: Methylthioniniumchlorid Proveblue kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Methylthioninium chloride is a substrate of P-glycoprotein (P-gp).
Danish: Methylthioniniumchlorid er et substrat af P-glykoprotein (P-gp).
English: Monitoring tests You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
Danish: Du vil blive udsat for monitoreringstest under og efter behandlingen med Methylthioniniumchlorid Proveblue.
English: Haemodialysis may be used in patients with severe haemolysis.
Danish: Hæmodialyse kan anvendes hos patienter med svær hæmolyse.
English: Skin discoloration (blue)
Danish: Misfarvning af huden (blå)
English: Methylthioninium chloride Proveblue can exacerbate dapsone-induced haemolytic anemia because of the formation of the dapsone reactive metabolite hydroxylamine which oxidises haemoglobin.
Danish: Methylthioniniumchlorid Proveblue kan forværre hæmolytisk anæmi fremkaldt af dapson på grund af dannelsen af den dapsonreaktive metabolit hydroxylamin, som oxiderer hæmoglobin.
English: Do not drive or use any tools or machines as methylthioninium chloride has moderate influence on the ability to drive and use machines.
Danish: Kør ikke bil og lad være med at arbejde med værktøj eller maskiner, da methylthioniniumchlorid i moderat grad påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Confusional state
Danish: Konfusionstilstand
English: Inject very slowly over a period of 5 minutes.
Danish: Indgives meget langsomt over et tidsrum på 5 minutter.
English: Individuals without methaemoglobinaemia
Danish: Personer uden methæmoglobinæmi
English: The administration of methylthioninium chloride Proveblue has the potential to transiently increase or decrease the clearance of drugs that are primarily metabolized by these enzymes.
Danish: Administration af methylthioniniumchlorid Proveblue kan potentielt medføre en forbigående forøgelse eller reduktion i eliminationen af lægemidler, der primært metaboliseres via disse enzymer.
English: Methylthioninium chloride should be avoided in patients receiving medicinal products that enhance serotonergic transmission because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Danish: Methylthioniniumchlorid bør undgås hos patienter, som modtager lægemidler, der forstærker serotonerg transmission fordi der er en risiko for alvorlige CNS-reaktioner, herunder potentielt fatalt serotoninsyndrom.
English: It is recommended not to exceed a cumulative dose for the course of treatment of 4 mg/kg in patients with dapsone-induced methaemoglobinaemia.
Danish: Det anbefales, at en kumulativ dosis for hele behandlingsforløbet på 4 mg/kg ikke overskrides hos patienter med methæmoglobinæmi fremkaldt af dapson.
English: In vitro, methylthioninium chloride has been shown to reduce motility of human sperm in a dose dependant manner.
Danish: In vitro har methylthioniniumchlorid vist sig at nedbringe motiliteten af menneskets sæd på en dosisafhængig måde.
English: Patients treated with methylthioninium chloride in combination with serotonergic drugs should be monitored for the emergence of serotonin syndrome.
Danish: Patienter, der bliver behandlet med methylthioniniumchlorid i kombination med serotonerge lægemidler, bør monitoreres for fremkomst af serotoninsyndrom.
English: Pierrel S.p.A. s.s. Appia 7 bis, 46/48 - 81043 Capua, Italy
Danish: s.s. Appia 7 bis, 46/48, 81043 Capua, Italien
English: • mirtazapine
Danish: • mirtazapin
English: • Deficiency in NADPH (nicotinamide adenine dinucleotide phosphate) reductase.
Danish: • NADPH (nicotinamidadenindinucleotidphosphat)-reduktasemangel.
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).
Danish: Elektrokardiogram (EKG) og blodtryk bør overvåges under og efter behandling med Methylthioniniumchlorid Proveblue, da hypotension og hjertearytmi er potentielle bivirkninger (se pkt.
English: Caution should be exercised in the course of treatment with methylthioninium chloride as this may exacerbate Heinz body formation and haemolytic anaemia.
Danish: Der bør udvises forsigtighed under behandlingen med methylthioniniumchlorid, da det kan forstærke dannelsen af Heinz body anæmi og hæmolytisk anæmi.
English: Pierrel S.p.A. s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italy
Danish: s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italien
English: Infants 3 months old or younger and newborn infants:
Danish: Spædbørn på 3 måneder eller derunder og nyfødte:
English: • Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning
Danish: • Patienter med nitritinduceret methæmoglobinæmi fremkaldt under behandling af cyanidforgiftning
English: Your skin may turn blue blue or green urine numbness and tingling abnormal taste in mouth nausea
Danish: Din hud kan blive blå - blå eller grøn urin - følelsesløshed og snurren - usædvanlig smag i munden - kvalme
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på den fremstiller , der er ansvarlig for batchfrigivelse
English: Methylthioninium chloride Proveblue should not be used during pregnancy unless clearly necessary, e.g. in life-threatening methaemoglobinaemia.
Danish: Methylthioniniumchlorid Proveblue bør ikke anvendes under graviditeten, medmindre det er absolut nødvendigt, f.eks. ved livstruende methæmoglobinæmi.
English: If symptoms of serotonin syndrome occur, discontinue use of methylthioninium chloride, and initiate supportive treatment.
Danish: Hvis der opstår symptomer på serotoninsyndrom, skal methylthioniniumchlorid seponeres, og der skal iværksættes understøttende behandling.
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.
Danish: De kliniske konsekvenser af øgede plasmakoncentrationer af samtidigt administrerede lægemidler, som er følsomme CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19-, CYP2D6- og CYP3A-substrater kan ikke udelukkes.
English: Methylthioninium chloride has moderate influence on the ability to drive and use machines.
Danish: Methylthioniniumchlorid påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Cumulative doses of Methylthioninium chloride may lead to dyspnoea and tachypnoea, presumably related to reduced oxygen availability caused by methaemoglobinaemia, chest pain, tremor, cyanosis and haemolytic anaemia.
Danish: Kumulative doser af methylthioniniumchlorid kan føre til dyspnø og takypnø, antageligt som følge af nedsat ilttilgængelighed forårsaget af methæmoglobinæmi, brystsmerter, tremor, cyanose og hæmolytisk anæmi.
English: Failure to respond to methylthioninium chloride suggests cytochrome b5 reductase deficiency, glucose6- phosphate dehydrogenase deficiency or sulfhaemoglobinemia.
Danish: Manglende reaktion på methylthioniniumchlorid tyder på cytochrom b5 reduktasemangel, glukose-6phosphatdehydrogenasemangel eller sulfhæmoglobinæmi.
English: In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin.
Danish: In vivo ved lave koncentrationer fremskynder methylthioniniumchlorid omdannelsen af methæmoglobin til hæmoglobin.
English: • Patients with methaemoglobinaemia due to chlorate poisoning
Danish: • Patienter med methæmoglobinæmi som følge af chloratforgiftning
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).
Danish: Indgivelse af store intravenøse doser (≥ 7 mg/kg) af Methylthioniniumchlorid Proveblue til personer uden methæmoglobinæmi forårsager kvalme og opkastninger, strammen omkring brystet, brystsmerter, takykardi, ængstelse, svær svedproduktion, tremor, mydriasis, blågrønfarvning af urinen, blåfarvning af huden og slimhinderne, mavesmerter, svimmelhed, paræstesi, hovedpine, forvirring, hypertension, mild methæmoglobinæmi (op til 7 %) og ændringer i elektrokardiogrammer (T-bølge udfladning eller inversion).
English: It is unknown whether methylthioninium chloride is excreted in human breast milk.
Danish: Det vides ikke, om methylthioniniumchlorid udskilles i human mælk.
English: - if you suffer from hyperglycaemia or diabetes mellitus, as these conditions may be worsened by the glucose solution used for the dilution of the medicine - your urine and stools may turn a blue-green colour; and skin may possibly turn a blue colour when you are treated with Methylthioninium chloride Proveblue.
Danish: 3) - Hvis du lider af hyperglycæmi eller diabetes mellitus, da disse lidelser kan forværres af glukoseopløsningen, der anvendes til opløsning af lægemidlet - Din urin og afføring kan blive blågrøn, og din hud kan blive blåfarvet, når du behandles med Methylthioniniumchlorid Proveblue.
English: Its use in parathyroid surgery (not indicated) has induced adverse CNS effects when administered concomitantly with serotonergic medicinal products (see section 4.5).
Danish: Brugen heraf ved kirurgi i biskjoldbruskkirtlen (ikke indiceret) har medført bivirkninger på centralnervesystemet, når det indgives samtidig med serotonerge lægemidler (se pkt.
English: Methylthioninium chloride should be used with caution in patients with moderate to severe renal disease since there is limited data available and methylthioninium chloride is predominantly renally eliminated.
Danish: Methylthioniniumchlorid bør anvendes med forsigtighed hos patienter med moderat til svær nyresygdom, da der foreligger begrænsede data, og methylthioniniumchlorid udskilles hovedsageligt via nyrerne.
English: The administration of methylthioninium chloride Proveblue has the potential to transiently increase the exposure of drugs primarily cleared by renal transport involving the OCT2/MATE pathway, including cimetidine, metformin and acyclovir.
Danish: Administration af methylthioniniumchlorid kan potentielt medføre en forbigående forøgelse af eksponeringen for lægemidler, der primært elimineres ved renal transport via OCT2/MATE, herunder cimetidin, metformin og aciclovir.
English: If the intravenous use of methylthioninium chloride cannot be avoided in patients treated with serotonergic medicinal products, the lowest possible dose should be chosen and the patient observed closely for central nervous system (CNS) effects for up to 4 hours after administration (see sections 4.4 and 4.8).
Danish: Hvis en intravenøs anvendelse af methylthioniniumchlorid ikke kan undgås hos patienter i behandling med serotonerge lægemidler, bør der vælges den lavest mulige dosis, og patienten skal observeres nøje for virkninger på centralnervesystemet (CNS) i op til 4 timer efter indgivelsen (se pkt.
English: In cases of suspected methaemoglobinaemia, it is advisable to check the oxygen saturation by cooximetry when available since pulse oximetry may provide a false estimation of oxygen saturation during administration of methylthioninium chloride.
Danish: I tilfælde af formodede om methæmoglobinæmi tilrådes det at kontrollere iltmætningen ved hjælp af cooximetri, når det er muligt, da pulsoximetri kan give et falsk billede af iltmætningen under indgivelsen af methylthioniniumchlorid.
English: Methylthioninium chloride is a potent inhibitor of the transporters OCT2, MATE1 and MATE2-K.
Danish: Methylthioniniumchlorid er en potent hæmmer af transportproteinerne OCT2, MATE1 og MATE2-K.
English: Solution for injection 5 ampoules of 10 ml
Danish: Injektionsvæske, opløsning 5 ampuller à 10 ml
English: Anaesthesiologists should be vigilant for methaemoglobinaemia in patients receiving dapsone therapy and for BIS (Bispectral Index) interference with Methylthioninium chloride Proveblue administration.
Danish: Anæstesiologer skal være meget opmærksomme på methæmoglobinæmi hos patienter i dapsonbehandling og på interferens mellem BIS-behandling (Bispectral Index) og indgivelse af Methylthioniniumchlorid Proveblue.
English: If your blood disorder has been caused by aniline or dapsone, total cumulative dose should not exceed 4 mg/kg (see section 2).
Danish: Hvis din blodlidelse er forårsaget af anilin eller dapson, bør den samlede kumulative dosis ikke overskride 4 mg/kg (jf. pkt.
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.
Danish: De hyppigst indberettede bivirkninger under kliniske forsøg er svimmelhed, paræstesi, dysgeusia, kvalme, misfarvning af huden, farvet urin, øget svedtendens, smerter på injektionsstedet og ekstremitetssmerter.
English: You should not be given this medicine after the expiry date which is printed on the carton and the ampoule labels after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og mærkaterne på ampullen efter Exp. Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
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.
Danish: Methylthioniniumchlorid Proveblue er ikke et substrat for BCRP eller OCT2 in vitro og hæmmer ikke BCRP, OAT1 eller OAT3 in vitro.
English: The clinical consequences are considered likely to be minimal due to the transient and single dose use that normally occurs in the emergency setting.
Danish: Det vurderes, at de kliniske konsekvenser sandsynligvis er minimale, idet den normale brug i forbindelse med nødsituationer er kortvarig og består af enkeltdoser.
English: If you are given more Methylthioninium chloride Proveblue than you should As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions: - feeling sick, - stomach pain, - chest pain, - dizziness, - headache, - sweating, - confusion, - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood), - high blood pressure, - shortness of breath, - abnormally fast beating of the heart, - tremor, - skin discolouration.
Danish: Hvis du har fået for meget Methylthioniniumchlorid Proveblue Da du får dette lægemiddel, mens du er på hospitalet, er det usandsynligt, at du vil få for meget eller for lidt, men fortæl det til din læge, hvis du oplever en af nedenstående bivirkninger: - kvalme - mavesmerter - brystsmerter - svimmelhed - hovedpine - svedtendens - forvirring - en stigning i methæmoglobinniveauet (en unormal form for hæmoglobin i blodet) - højt blodtryk - stakåndethed - unormalt hurtig puls - rysten - misfarvning af huden.
English: • Very common side effects (may affect more than 1 in 10 people) pain in extremity dizziness sweating skin discolouration.
Danish: • Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 behandlede) - smerter i arme eller ben - svimmelhed - øget svedtendens - misfarvning af huden.
English: Other medicines and Methylthioninium chloride Proveblue Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Methylthioniniumchlorid Proveblue Fortæl det altid til lægen, på apotekspersonalet eller til sundhedspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: Hyperbilirubinaemia has been observed in infants after administration of 20 mg/kg methylthioninium chloride.
Danish: Hyperbilirubinæmi er blevet observeret hos spædbørn efter indgivelse af 20 mg/kg methylthioniniumchlorid.
English: The clinical consequences of the inhibition are not known.
Danish: De kliniske konsekvenser af denne hæmning er ukendte.
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).
Danish: I tilfælde af methæmoglobinæmi fremkaldt af anilin eller dapson er den anbefalede maksimale, kumulative dosis for hele behandlingsforløbet 4 mg/kg (se pkt.
English: Do not use Methylthioninium chloride Proveblue if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present.
Danish: Methylthioniniumchlorid Proveblue må ikke anvendes, hvis opløsningen er misfarvet, uklar, grumset, eller hvis der er bundfald eller partikler i den.
English: What Methylthioninium chloride Proveblue contains - The active substance is methylthioninium chloride.
Danish: Methylthioniniumchlorid Proveblue indeholder: - Aktivt stof: methylthioniniumchlorid.
English: Local tissue necrosis at the injection site Not known Injection site pain
Danish: Lokal nekrose af vævet på injektionsstedet
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.
Danish: • Ikke kendt (hyppigheden kan ikke fastsættes ud fra de tilgængelige data): - serotoninsyndrom, når Methylthioniniumchlorid Proveblue er blevet taget sammen med visse lægemidler til behandling af depression eller angst, se afsnit 2 - nedsat hæmoglobin (protein i de røde blodlegemer, som transporterer ilt i blodet) kan ses i forbindelse med blodprøver - fald i antallet af røde blodlegemer, hvilket kan forårsage bleg hud, stakåndethed og svaghed - lokal vævsskade på injektionsstedet - gulsot (gulfarvning af hud og øjne) - dette er kun set hos spædbørn - taleproblemer - højt eller lavt blodtryk - uro - iltmangel - uregelmæssigt hjerteslag, herunder abnormt langsomt eller hurtigt hjerteslag - alvorlige allergiske reaktioner (såkaldte anafylaktiske reaktioner, som kan forårsage hævelse af svælg eller ansigt, vejrtrækningsbesvær eller alvorligt udslæt) - stigning i methæmoglobin (en abnorm form for hæmoglobin i blodet) - stakåndethed - forvirring - rysten - nældefeber - feber - hurtig vejrtrækning - udvidede pupiller - misfarvet afføring.
English: • buspirone
Danish: • buspiron