natgillin/translations-raw huggingface dataset:
Din hud kan blive blå - reduktion i antallet af røde blodlegemer, som kan gøre din hud bleg og gøre dig stakåndet og svag - gulsot (gulfarvning af huden og øjnene), dette er kun indberettet hos spædbørn.
Your skin may turn blue - reduction in red blood cells which may turn your skin pale and make you breathless and weak, - jaundice (yellowing of the skin and eyes), this has only been reported in infants.
Ampuller af type I-glas.
Type I glass ampoules.
Patienter med hyperglycæmi eller diabetes mellitus
Patients with hyperglycaemia or diabetes mellitus
Fotosensitivitet
Photosensitivity
Methylthioniniumchlorid Proveblue er indiceret til voksne, børn og unge (fra 0 til 17 år).
Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).
Virkningen af methylthioniniumchlorid ved behandling af methæmoglobinæmi i den pædiatriske population blev påvist i to retrospektive undersøgelser og en åben randomiseret klinisk undersøgelse.
The efficacy of methylthioninium chloride for the treatment of methaemoglobinaemia in peadiatric population was demonstrated in two retrospective studies and one open randomised clinical trial.
Methylthioniniumchlorid Proveblue gives til dig eller dit barn (0-17 år) til behandling af problemer med dit blod som følge af eksponering for visse lægemidler eller kemiske stoffer, der kan forårsage en sygdom kaldet methæmoglobinæmi.
Methylthioninium chloride Proveblue will be given to you or your child (0-17 years old) to treat problems with your blood resulting from exposure to some medicines or chemicals that can cause a disease called methaemoglobinaemia.
Akut symptomatisk behandling af methæmoglobinæmi fremkaldt af lægemidler og kemiske stoffer.
Acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia.
Methylthioniniumchlorid (også kaldet methylenblåt) tilhører en gruppe af lægemidler kaldet modgifte.
Methylthioninium chloride (also called methylene blue) belongs to a group of medicines called antidotes.
• clomipramin
• clomipramine
• Patienter med glukose-6-phosphatdehydrogenasemangel (G6PD) på grund af risikoen for hæmolytisk anæmi
• Patients with Glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of haemolytic anaemia
Den kan være grøn eller blå - øget følsomhed over for lys i huden (lysfølsomhed).
They may appear green or blue - increased sensitivity of your skin to light (photosensitivity)
Bivirkningerne er de samme hos voksne og børn med undtagelse af gulsot, som kun er indberettet for spædbørn.
These effects are the same in adults and children except jaundice which has only been reported in infants.
Bivirkningerne er de samme som hos voksne (med undtagelse af hyperbilirubinæmi, der kun er indberettet for spædbørn).
Adverse reactions are the same as in adults (except hyperbilirubinaemia, reported in infants only).
Den anslåede halveringstid for methylthioniniumchlorid efter intravenøs indgivelse er 26,7 timer.
The estimated terminal half-life of methylthioninium chloride after intravenous administration is 26.7h.
De kliniske konsekvenser vurderes imidlertid at være minimale, idet methylthioniniumchlorid Proveblue ofte kun anvendes én gang og i akutte nødsituationer.
The clinical consequences are however considered minimal since methylthioninium chloride Proveblue is used often only once and in an acute emergency setting.
Hæmolytisk anæmi er også blevet indberettet i tilfælde af alvorlig overdosis (20-30 mg/kg) hos spædbørn og voksne med methæmoglobinæmi forårsaget af anilin eller chlorater.
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.
Evnen til at føre motorkøretøj kan blive påvirket som følge af forvirring, svimmelhed og muligvis synsforstyrrelser.
Indeed, driving can be affected due to confusional state, dizziness and possibly eye disturbances.
Exp. Lægemidlet skal anvendes umiddelbart efter åbning eller fortynding.
EXP The medicine must be used immediately after opening or dilution.
Læs indlægssedlen inden brug Kun til intravenøs anvendelse Til langsom intravenøs injektion
Intravenous use only For slow intravenous injection
Der er ingen eller utilstrækkelige data fra anvendelse af methylthioniniumchlorid til gravide kvinder.
There are no adequate data from the use of methylthioninium chloride in pregnant women.
Det skal indgives meget langsomt over et tidsrum på 5 minutter.
It must be injected very slowly over a period of 5 minutes.
Rådgiv patienterne om, at de skal tage forholdsregler, der beskytter mod lys, eftersom der kan opstå fotosensitivitet efter administration af methylthioniniumchlorid.
Advise patients to take protective measures against exposure to light, because photosensitivity may occur after administration of methylthioninium chloride.
Methylthioniniumchlorid Proveblue skal injiceres meget langsomt over et tidsrum på 5 minutter for at forhindre, at høje lokale koncentrationer af stoffet producerer yderligere methæmoglobin.
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.
• Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): - mavesmerter - brystsmerter - hovedpine - angst - smerter på injektionsstedet - opkastning
• Common side effects (may affect up to 1 in 10 people): - stomach pain - chest pain - headache - anxiety - injection site pain - vomiting
Hvis en intravenøs anvendelse af Methylthioniniumchlorid ikke kan undgås, skal du have den lavest mulige dosis, og du skal observeres nøje i op til 4 timer efter administrationen.
However, if the intravenous use of methylthioninium chloride cannot be avoided, you should be administered the lowest possible dose and observed closely for up to 4 hours after administration.
Methæmoglobinæmi,
Methaemoglobinaemia,
De i nedenstående tabel opstillede bivirkninger optræder hos voksne, børn og unge (fra 0 år og op til 17 år) efter intravenøs indgivelse.
The adverse reactions listed in the table below occur in adults, children and adolescents (aged 0 to 17 years old) after intravenous administration.
Yderligere oplysninger om, hvordan Methylthioniniumchlorid Proveblue kan indgives, findes i punkt 3 i indlægssedlen.
Additional information on how Methylthioninium chloride Proveblue can be given is provided in section 3 of the Package Leaflet.
Intravenøs injektion af methylthioniniumchlorid har lejlighedsvis forårsaget hypotension og hjertearytmi, og sådanne lidelser kan ved sjældne lejligheder være dødelige.
Intravenous injection of methylthioninium chloride has occasionally caused hypotension and cardiac arrhythmias, and such disorders might prove fatal on rare occasions.
Stoffet giver urin og afføring en blågrøn farve og huden en blå farve, der kan hindre diagnosticering af cyanose.
It imparts a blue-green colour to urine, faeces and a blue colour to skin which may hinder a diagnosis of cyanosis.
Du bør ikke få Methylthioniniumchlorid samtidig med, at du tager visse lægemidler mod depression eller angst, som påvirker et kemikalie i hjernen kaldet serotonin.
You should not be given methylthioninium chloride at the same time you are taking certain medicines to treat depression or anxiety which affect a brain chemical called serotonin.
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.
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.
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.
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.
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois Frankrig
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois France
På grund af manglende data om, hvorvidt methylthioniniumchlorid udskilles i modermælk, bør amning afbrydes i op til 8 dage efter behandling med dette lægemiddel.
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.
Det anbefales ikke at bruge Methylthioniniumchlorid Proveblue under graviditeten, medmindre det er absolut nødvendigt, f.eks. i en livstruende situation.
The use of Methylthioninium chloride Proveblue during pregnancy is not recommended unless it is clearly necessary, for example in a life-threatening situation.
Udskillelse af methylthioniniumchlorid i human mælk er ikke blevet undersøgt hos dyr.
The excretion of methylthioninium chloride in milk has not been studied in animals.
• selektive serotoningenoptagelseshæmmere (SSRI) såsom citalopram, escitalopram, fluoxetin,
• Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine,
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.
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.
Hos patienter med methæmoglobinæmi fremkaldt af anilin kan gentagne doser af methylthioniniumchlorid være nødvendige.
In patients with aniline-induced methaemoglobinaemia, repeated doses of methylthioninium chloride may be required.
Disse omfatter selektive serotoningenoptagelseshæmmere (SSRI), bupropion, buspiron, clomipramin, mirtazapin og venlafaxin.
These include SSRIs (selective serotonin reuptake inhibitors), bupropion, buspirone, clomipramine, mirtazapine, and venlafaxine.
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.
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.
Baseret på kinetiske data bør amning afbrydes i op til 8 dage efter behandling med Methylthioniniumchlorid Proveblue.
Based on kinetic data, breast-feeding should be discontinued for up to 8 days after treatment with Methylthioninium chloride Proveblue.
Methylthioniniumchlorid kan forårsage alvorligt eller fatalt serotonergt syndrom, når det anvendes i kombination med serotonerge lægemidler.
Methylthioninium chloride may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs.
Methylthioniniumchlorid Proveblue kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Methylthioninium chloride Proveblue can cause side effects, although not everybody gets them.
Methylthioniniumchlorid er et substrat af P-glykoprotein (P-gp).
Methylthioninium chloride is a substrate of P-glycoprotein (P-gp).
Du vil blive udsat for monitoreringstest under og efter behandlingen med Methylthioniniumchlorid Proveblue.
Monitoring tests You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
Hæmodialyse kan anvendes hos patienter med svær hæmolyse.
Haemodialysis may be used in patients with severe haemolysis.
Misfarvning af huden (blå)
Skin discoloration (blue)
Methylthioniniumchlorid Proveblue kan forværre hæmolytisk anæmi fremkaldt af dapson på grund af dannelsen af den dapsonreaktive metabolit hydroxylamin, som oxiderer hæmoglobin.
Methylthioninium chloride Proveblue can exacerbate dapsone-induced haemolytic anemia because of the formation of the dapsone reactive metabolite hydroxylamine which oxidises haemoglobin.
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.
Do not drive or use any tools or machines as methylthioninium chloride has moderate influence on the ability to drive and use machines.
Konfusionstilstand
Confusional state
Indgives meget langsomt over et tidsrum på 5 minutter.
Inject very slowly over a period of 5 minutes.
Personer uden methæmoglobinæmi
Individuals without methaemoglobinaemia
Administration af methylthioniniumchlorid Proveblue kan potentielt medføre en forbigående forøgelse eller reduktion i eliminationen af lægemidler, der primært metaboliseres via disse enzymer.
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.
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.
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.
Det anbefales, at en kumulativ dosis for hele behandlingsforløbet på 4 mg/kg ikke overskrides hos patienter med methæmoglobinæmi fremkaldt af dapson.
It is recommended not to exceed a cumulative dose for the course of treatment of 4 mg/kg in patients with dapsone-induced methaemoglobinaemia.
In vitro har methylthioniniumchlorid vist sig at nedbringe motiliteten af menneskets sæd på en dosisafhængig måde.
In vitro, methylthioninium chloride has been shown to reduce motility of human sperm in a dose dependant manner.
Patienter, der bliver behandlet med methylthioniniumchlorid i kombination med serotonerge lægemidler, bør monitoreres for fremkomst af serotoninsyndrom.
Patients treated with methylthioninium chloride in combination with serotonergic drugs should be monitored for the emergence of serotonin syndrome.
s.s. Appia 7 bis, 46/48, 81043 Capua, Italien
Pierrel S.p.A. s.s. Appia 7 bis, 46/48 - 81043 Capua, Italy
• mirtazapin
• mirtazapine
• NADPH (nicotinamidadenindinucleotidphosphat)-reduktasemangel.
• Deficiency in NADPH (nicotinamide adenine dinucleotide phosphate) reductase.
Elektrokardiogram (EKG) og blodtryk bør overvåges under og efter behandling med Methylthioniniumchlorid Proveblue, da hypotension og hjertearytmi er potentielle bivirkninger (se pkt.
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).
Der bør udvises forsigtighed under behandlingen med methylthioniniumchlorid, da det kan forstærke dannelsen af Heinz body anæmi og hæmolytisk anæmi.
Caution should be exercised in the course of treatment with methylthioninium chloride as this may exacerbate Heinz body formation and haemolytic anaemia.
s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italien
Pierrel S.p.A. s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italy
Spædbørn på 3 måneder eller derunder og nyfødte:
Infants 3 months old or younger and newborn infants:
• Patienter med nitritinduceret methæmoglobinæmi fremkaldt under behandling af cyanidforgiftning
• Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning
Din hud kan blive blå - blå eller grøn urin - følelsesløshed og snurren - usædvanlig smag i munden - kvalme
Your skin may turn blue blue or green urine numbness and tingling abnormal taste in mouth nausea
Navn og adresse på den fremstiller , der er ansvarlig for batchfrigivelse
Name and address of the manufacturers responsible for batch release
Methylthioniniumchlorid Proveblue bør ikke anvendes under graviditeten, medmindre det er absolut nødvendigt, f.eks. ved livstruende methæmoglobinæmi.
Methylthioninium chloride Proveblue should not be used during pregnancy unless clearly necessary, e.g. in life-threatening methaemoglobinaemia.
Hvis der opstår symptomer på serotoninsyndrom, skal methylthioniniumchlorid seponeres, og der skal iværksættes understøttende behandling.
If symptoms of serotonin syndrome occur, discontinue use of methylthioninium chloride, and initiate supportive treatment.
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.
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.
Methylthioniniumchlorid påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
Methylthioninium chloride has moderate influence on the ability to drive and use machines.
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.
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.
Manglende reaktion på methylthioniniumchlorid tyder på cytochrom b5 reduktasemangel, glukose-6phosphatdehydrogenasemangel eller sulfhæmoglobinæmi.
Failure to respond to methylthioninium chloride suggests cytochrome b5 reductase deficiency, glucose6- phosphate dehydrogenase deficiency or sulfhaemoglobinemia.
In vivo ved lave koncentrationer fremskynder methylthioniniumchlorid omdannelsen af methæmoglobin til hæmoglobin.
In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin.
• Patienter med methæmoglobinæmi som følge af chloratforgiftning
• Patients with methaemoglobinaemia due to chlorate poisoning
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).
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).
Det vides ikke, om methylthioniniumchlorid udskilles i human mælk.
It is unknown whether methylthioninium chloride is excreted in human breast milk.
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.
- 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.
Brugen heraf ved kirurgi i biskjoldbruskkirtlen (ikke indiceret) har medført bivirkninger på centralnervesystemet, når det indgives samtidig med serotonerge lægemidler (se pkt.
Its use in parathyroid surgery (not indicated) has induced adverse CNS effects when administered concomitantly with serotonergic medicinal products (see section 4.5).
Methylthioniniumchlorid bør anvendes med forsigtighed hos patienter med moderat til svær nyresygdom, da der foreligger begrænsede data, og methylthioniniumchlorid udskilles hovedsageligt via nyrerne.
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.
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.
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.
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.
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).
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.
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.
Methylthioniniumchlorid er en potent hæmmer af transportproteinerne OCT2, MATE1 og MATE2-K.
Methylthioninium chloride is a potent inhibitor of the transporters OCT2, MATE1 and MATE2-K.
Injektionsvæske, opløsning 5 ampuller à 10 ml
Solution for injection 5 ampoules of 10 ml
Anæstesiologer skal være meget opmærksomme på methæmoglobinæmi hos patienter i dapsonbehandling og på interferens mellem BIS-behandling (Bispectral Index) og indgivelse af Methylthioniniumchlorid Proveblue.
Anaesthesiologists should be vigilant for methaemoglobinaemia in patients receiving dapsone therapy and for BIS (Bispectral Index) interference with Methylthioninium chloride Proveblue administration.
Hvis din blodlidelse er forårsaget af anilin eller dapson, bør den samlede kumulative dosis ikke overskride 4 mg/kg (jf. pkt.
If your blood disorder has been caused by aniline or dapsone, total cumulative dose should not exceed 4 mg/kg (see section 2).