FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Uporaba zdravila Metiltioninijev klorid Proveblue lahko prehodno poveča ali zmanjša očistek zdravil, ki se primarno presnavljajo s temi encimi.
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.
Slovenian: V primerih suma na methemoglobinemijo je priporočljivo preveriti nasičenost s kisikom s COoksimetrijo, če je na razpolago, saj lahko pulzna oksimetrija med dajanjem metiltioninijevega klorida da napačne ocene nasičenosti s kisikom.
English: Based on kinetic data, breast-feeding should be discontinued for up to 8 days after treatment with Methylthioninium chloride Proveblue.
Slovenian: Na podlagi kinetičnih podatkov je treba dojenje prekiniti za 8 dni po zdravljenju z zdravilom Metiltioninijev klorid Proveblue.
English: In patients with aniline-induced methaemoglobinaemia, repeated doses of methylthioninium chloride may be required.
Slovenian: Pri bolnikih z methemoglobinemijo, povzročeno z anilinom, bodo morda potrebni ponavljajoči odmerki metiltioninijevega klorida.
English: Like all medicines, Methylthioninium chloride Proveblue can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Metiltioninijev klorid Proveblue neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Slovenian: Kumulativni odmerki metiltioninijevega klorida lahko povzročijo dispnejo in tahipnejo, ki sta domnevno povezani z zmanjšano razpoložljivostjo kisika zaradi methemoglobinemije, bolečine v prsih, tresenje, cianozo in hemolitično anemijo.
English: Marketing Authorisation Holder Provepharm SAS
Slovenian: Imetnik dovoljenja za promet z zdravilom Provepharm SAS
English: Methylthioninium chloride is an in vitro inhibitor of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5.
Slovenian: Metiltioninijev klorid je in vitro zaviralec CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 in 3A4/5.
English: Patients treated with methylthioninium chloride in combination with serotonergic drugs should be monitored for the emergence of serotonin syndrome.
Slovenian: Bolnike, ki se zdravijo z metiltioninijevim kloridom v kombinaciji s serotonergičnimi zdravili, je treba spremljati glede pojava serotoninskega sindroma.
English: Individuals without methaemoglobinaemia
Slovenian: Osebe brez methemoglobinemije
English: What Methylthioninium chloride Proveblue is and what it is used for What you need to know before you are given Methylthioninium chloride Proveblue How Methylthioninium chloride Proveblue is given Possible side effects
Slovenian: Kaj je zdravilo Metiltioninijev klorid Proveblue in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Metiltioninijev klorid Proveblue Kako uporabljati zdravilo Metiltioninijev klorid Proveblue Možni neželeni učinki
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).
Slovenian: Dajanje velikih intravenskih odmerkov (≥ 7 mg/kg) zdravila Metiltioninijev klorid Proveblue osebam brez methemoglobinemije povzroči siljenje na bruhanje in bruhanje, stiskanje v prsih, bolečine v prsih, tahikardijo, strah, močno potenje, tresenje, midriazo, modrozeleno obarvanost urina, modro obarvanost kože in sluznic, bolečine v trebuhu, omotico, parestezije, glavobol, zmedenost, hipertenzijo, blago methemoglobinemijo (do 7 %) in spremembe elektrokardiograma (ploski valovi T ali inverzija).
English: Preparation for intravenous administration
Slovenian: Priprava za intravensko uporabo
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.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue je treba uporabljati s previdnostjo pri bolnikih z zmerno do hudo boleznijo ledvic, saj je na voljo malo podatkov in se metiltioninijev klorid izloča predvsem skozi ledvice.
English: What Methylthioninium chloride Proveblue looks like and contents of the pack Methylthioninium chloride Proveblue is a clear dark blue solution for injection (injection) and is supplied in clear glass ampoules.
Slovenian: Izgled zdravila Metiltioninijev klorid Proveblue in vsebina pakiranja Zdravilo Metiltioninijev klorid Proveblue je bistra temnomodra raztopina za injiciranje (injekcija) in je pakirana v prozorne steklene ampule.
English: Anaesthesiologists should be vigilant for methaemoglobinaemia in patients receiving dapsone therapy and for BIS (Bispectral Index) interference with Methylthioninium chloride Proveblue administration.
Slovenian: Anesteziologi morajo biti pozorni na methemoglobinemijo pri bolnikih, zdravljenih z dapsonom, in na interferenco BIS (bispektralni indeks) pri dajanju zdravila Metiltioninijev klorid Proveblue.
English: Cenexi 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France
Slovenian: Cenexi 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, Francija
English: Methylthioninium chloride Proveblue can exacerbate dapsone-induced haemolytic anemia because of the formation of the dapsone reactive metabolite hydroxylamine which oxidises haemoglobin.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue lahko poslabša hemolitično anemijo, povzročeno z dapsonom, zaradi nastanka reaktivnega presnovka dapsona hidroksilamina, ki oksidira hemoglobin.
English: Solution for injection 5 ampoules of 10 ml
Slovenian: raztopina za injiciranje 5 ampul po 10 ml
English: For single use only Any solution remaining in the opened ampoules must be discarded.
Slovenian: Raztopino, ki ostane v odprtih ampulah, je treba zavreči.
English: • Patients with methaemoglobinaemia due to chlorate poisoning
Slovenian: • Bolniki z methemoglobinemijo zaradi zastrupitve s kloratom.
English: Warnings and precautions Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue - if you have moderate or severe renal disease; lower doses (< 1 mg/kg) may be needed - if your blood disorder has been caused by a chemical called aniline, which is contained in dyes; lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3 of this package leaflet) - if your blood disorder has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3)
Slovenian: Pred začetkom uporabe zdravila Metiltioninijev klorid Proveblue se posvetujte z zdravnikom ali medicinsko sestro - če imate zmerno ali hudo bolezen ledvic; morda bodo potrebni nižji odmerki (< 1 mg/kg) - če je vašo bolezen krvi povzročila kemikalija, imenovana anilin, ki jo vsebujejo barvila; morda bodo potrebni nižji odmerki in skupni odmerek ne sme preseči 4 mg/kg (glejte poglavje 3 teh navodil za uporabo) - če je vašo bolezen krvi povzročilo zdravilo, imenovano dapson (uporablja se za zdravljenje gobavosti in drugih kožnih bolezni); morda bodo potrebni nižji odmerki in skupni odmerek ne sme preseči 4 mg/kg (glejte poglavje 3)
English: Type I glass ampoules.
Slovenian: Steklene ampule tipa I.
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.
Slovenian: Uporaba zdravila Metiltioninijev klorid Proveblue lahko prehodno poveča izpostavljenost zdravilom, ki se v glavnem izločajo prek ledvičnega prenosa po poti OCT2/MATE, vključno s cimetidinom, metforminom in aciklovirjem.
English: • buspirone
Slovenian: • buspiron
English: What Methylthioninium chloride Proveblue is and what it is used for
Slovenian: Kaj je zdravilo Metiltioninijev klorid Proveblue in za kaj ga uporabljamo
English: Failure to respond to methylthioninium chloride suggests cytochrome b5 reductase deficiency, glucose6- phosphate dehydrogenase deficiency or sulfhaemoglobinemia.
Slovenian: Neodzivanje na metiltioninijev klorid kaže na pomanjkanje citokrom-b5-reduktaze, pomanjkanje glukoza-6-fosfat-dehidrogenaze ali sulfhemoglobinemijo.
English: If diluted in glucose 50 mg/ml (5%) solution for injection, methylthioninium chloride must be used with caution in patients with hyperglycaemia or diabetes mellitus, as these conditions may be exacerbated by the glucose solution.
Slovenian: Če se metiltioninijev klorid uporablja razredčen v raztopini glukoze 50 mg/ml (5 %) za injiciranje, ga je treba s previdnostjo uporabljati pri bolnikih s hiperglikemijo ali diabetesom mellitusom, saj lahko raztopina glukoze poslabša ta stanja.
English: Methylthioninium chloride Proveblue should not be used during pregnancy unless clearly necessary, e.g. in life-threatening methaemoglobinaemia.
Slovenian: Zdravila Metiltioninijev klorid Proveblue se ne sme uporabljati med nosečnostjo, če ni to nujno potrebno, tj. pri življenjsko nevarni methemoglobinemiji.
English: You must not be given Methylthioninium chloride Proveblue: - if you are allergic to methylthioninium chloride or other thiazine dyes - if your body does not produce enough of the enzyme G6PD (glucose-6-phosphate dehydrogenase) - if your body does not produce enough of the enzyme NADPH (nicotinamide adenine dinucleotide phosphate) reductase - if your blood disorder has been caused by nitrite during treatment of cyanide poisoning - if your blood disorder has been caused by chlorate poisoning.
Slovenian: Ne uporabljajte zdravila Metiltioninijev klorid Proveblue: - če ste alergični na metiltioninijev klorid ali druga tiazinska barvila - če vaše telo ne proizvaja dovolj encima G6PD (glukoza-6-fosfat-dehidrogenaza) - če vaše telo ne proizvaja dovolj encima NADPH (nikotinamid adenin dinukleotid fosfat)
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.
Slovenian: Med kliničnimi preskušanji so najpogosteje poročali o naslednjih neželenih učinkih: omotica, parestezija, disgevzija, navzea, obarvanje kože, kromaturija, čezmerno znojenje, bolečina na mestu injiciranja in bolečina v udu.
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.
Slovenian: Če ste prejeli večji odmerek zdravila Metiltioninijev klorid Proveblue, kot bi smeli Ker boste to zdravilo prejeli v bolnišnici, ni verjetno, da ga boste prejeli preveč ali premalo, vendar pa obvestite svojega zdravnika, če opazite enega od naslednjih neželenih učinkov: - siljenje na bruhanje, - bolečine v želodcu, - bolečine v prsih, - omotico, - glavobol, - potenje, - zmedenost, - zvišanje ravni methemoglobina (nenormalne oblike hemoglobina v krvi), - povišan krvni tlak, - zadihanost, - nenormalno hitro bitje srca, - tresenje, - obarvanje kože.
English: Methylthioninium chloride may cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, lights in operating rooms and pulse oximeters.
Slovenian: Metiltioninijev klorid lahko povzroči fotosenzitivnostno reakcijo kože (reakcijo, podobno sončni opeklini) pri izpostavljenosti močnim virom svetlobe, npr. pri svetlobni terapiji, lučeh v operacijskih dvoranah in pulznih oksimetrih.
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.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue ni in vitro substrat BCRP ali OCT2 in ni in vitro zaviralec BCRP, OAT1 ali OAT3.
English: 5 ampoules of 2 ml 20 ampoules of 2 ml 10 mg/2 ml
Slovenian: 5 ampul po 2 ml 20 ampul po 2 ml 10 mg/2 ml
English: How to store Methylthioninium chloride Proveblue Contents of the pack and other information
Slovenian: Shranjevanje zdravila Metiltioninijev klorid Proveblue Vsebina pakiranja in dodatne informacije
English: Intravenous use only For slow intravenous injection
Slovenian: Za počasno intravensko injiciranje.
English: When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening.
Slovenian: Pri uporabi v kombinaciji s temi zdravili lahko metiltioninijev klorid povzroči serotoninski sindrom, ki je lahko tudi smrtno nevaren.
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.
Slovenian: Metiltioninijevemu kloridu se je treba izogniti pri bolnikih, ki prejemajo zdravila, ki povečujejo serotonergični prenos, zaradi potenciala za hude učinke na osrednji živčni sistem, vključno s serotoninskim sindromom, ki lahko ima smrten izid .
English: Do not use Methylthioninium chloride Proveblue if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present.
Slovenian: Zdravila Metiltioninijev klorid Proveblue ne uporabljajte, če je raztopina spremenjene barve, motna, gosta ali vsebuje precipitat ali delce.
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.
Slovenian: Zlasti se ga ne sme mešati z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, ker je bilo dokazano, da kloridni ioni zmanjšajo topnost metiltioninijevega klorida.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema methemoglobinemija,
English: • Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning
Slovenian: • Bolniki z methemoglobinemijo, povzročeno z nitritom med zdravljenjem zastrupitve s cianidom.
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).
Slovenian: Med zdravljenjem z zdravilom Metiltioninijev klorid Proveblue in po njem sta potrebna ektrokardiogram (EKG) nadzor in nadzor krvnega tlaka, saj sta hipotenzija in srčna aritmija možna neželena učinka (glejte poglavje 4.8).
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.
Slovenian: • Neznana pogostnost (pogosnosti iz razpoložljivih podatkov ni mogoče oceniti) - serotoninski sindrom, ko se je zdravilo Metiltioninijev klorid Proveblue jemalo z določenimi zdravili za zdravljenje depresije ali anksioznosti; glejte poglavje 2 - testi krvi lahko pokažejo znižanje ravni hemoglobina (beljakovine v rdečih krvnih celicah, ki prenaša kisik v krvi) - zmanjšanje števila rdečih krvnih celic, zaradi česar lahko vaša koža postane bleda ter ste zasopli in slabotni - poškodba tkiva na mestu injiciranja - zlatenica (porumenelost kože in oči) - o njej so poročali samo pri dojenčkih - težave pri govorjenju - visok ali nizek krvni tlak - vznemirjenost - pomanjkanje kisika - nepravilno bitje srca, vključno z nenormalno počasnim ali hitrim bitjem srca - hude alergijske reakcije (tako imenovana anafilaktična reakcija, ki lahko povzroči otekanje grla ali obraza, težave pri dihanju ali hude izpuščaje) - zvišanje ravni methemoglobina (nenormalne oblike hemoglobina v krvi) - zadihanost - zmedenost - tresenje - koprivnica - zvišana telesna temperatura - hitro dihanje - razširjene zenice - obarvano blato.
English: Hyperbilirubinaemia has been observed in infants after administration of 20 mg/kg methylthioninium chloride.
Slovenian: Hiperbilirubinemija je bila opažena pri dojenčkih po aplikaciji 20 mg/kg metiltioninijevega klorida.
English: Caution should be exercised in the course of treatment with methylthioninium chloride as this may exacerbate Heinz body formation and haemolytic anaemia.
Slovenian: Med zdravljenjem z metiltioninijevim kloridom je potrebna previdnost, saj lahko ta poslabša nastajanje Heinzovih telesc in hemolitično anemijo.
English: An equivocal evidence of carcinogenic activity was observed in female mice.
Slovenian: Nezanesljiv dokaz kancerogene aktivnosti je bil opažen pri samicah miši.
English: It must not be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Slovenian: Ne sme se ga redčiti z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, ker je bilo dokazano, da kloridni ioni zmanjšajo topnost metiltioninijevega klorida.
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.
Slovenian: raztopina za injiciranje (injekcija) Bistra temnomodra raztopina s pH vrednostjo med 3,0 in 4,5.
English: What you need to know before you are given Methylthioninium chloride Proveblue
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Metiltioninijev klorid Proveblue
English: Individuals with methaemoglobinaemia
Slovenian: Osebe z methemoglobinemijo
English: Methylthioninium chloride Proveblue is not an in vitro inducer of CYP2B6 and CYP3A4.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue ni in vitro induktor CYP2B6 in CYP3A4.
English: Please refer to section 4.4 for important safety information.
Slovenian: Za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4.
English: A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range.
Slovenian: Ponovni odmerek (1 do 2 mg/kg telesne mase, tj. 0,2-0,4 ml/kg telesne mase) se lahko aplicira eno uro po prvem odmerku v primeru perzistentnih ali ponavljajočih se simptomov ali če ravni methemoglobina ostanejo znatno višje od običajnih kliničnih vrednosti.
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.
Slovenian: Metiltioninijev klorid lahko povzroči fotosenzitivnostno reakcijo kože pri izpostavljenosti močnim virom svetlobe, ki se uporabljajo npr. pri fototerapiji in v operacijskih dvoranah, ali lokalnim virom svetlobe iz pripomočkov, ki oddajajo svetlobo, kot je npr. pulzni oksimeter.
English: It is unknown whether methylthioninium chloride is excreted in human breast milk.
Slovenian: Ni podatkov o tem, ali se metiltioninijev klorid izloča v materino mleko.
English: • venlafaxine
Slovenian: • venlafaksin
English: Your skin may turn blue blue or green urine numbness and tingling abnormal taste in mouth nausea
Slovenian: - moder ali zelen urin - odrevenelost in mravljinčenje - nenormalen okus v ustih - siljenje na bruhanje
English: A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range (see section 4.4 for important safety information).
Slovenian: Ponovni odmerek (0,3 do 0,5 mg/kg telesne mase, tj. 0,06-0,1 ml/kg telesne mase) se lahko aplicira eno uro po prvem odmerku v primeru trdovratnih ali ponavljajočih se simptomov ali če ravni methemoglobina ostanejo znatno višje od običajnih kliničnih vrednosti (za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4).
English: Skin discoloration (blue)
Slovenian: Bolezni sečil kromaturija (modrozeleno)
English: Methylthioninium chloride is an in vitro inducer of CYP1A2.
Slovenian: Metiltioninijev klorid je in vitro induktor CYP1A2.
English: Death occurred in 2 infants after administration of 20 mg/kg methylthioninium chloride.
Slovenian: Pri 2 dojenčkih je nastopila smrt po aplikaciji 20 mg/kg metiltioninijevega klorida.
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.
Slovenian: Ponovni odmerek (0,3 do 0,5 mg/kg telesne mase, tj. 0,06-0,1 ml/kg) se lahko da eno uro po prvem odmerku v primeru trdovratnih ali ponavljajočih se simptomov.
English: 22 rue Marc Donadille, 13013 Marseille, France
Slovenian: 22 rue Marc Donadille, 13013 Marseille, Francija
English: In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin.
Slovenian: Metiltioninijev klorid in vivo v nizkih koncentracijah pospeši pretvorbo methemoglobina v hemoglobin.
English: In vitro, methylthioninium chloride has been shown to reduce motility of human sperm in a dose dependant manner.
Slovenian: Študija in vitro je pokazala, da metiltioninijev klorid v odvisnosti od odmerka zmanjša gibljivost človeškega semena.
English: What Methylthioninium chloride Proveblue contains - The active substance is methylthioninium chloride.
Slovenian: Kaj vsebuje zdravilo Metiltioninijev klorid Proveblue - Učinkovina je metiltioninijev klorid.
English: This medicine may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in children.
Slovenian: To zdravilo se lahko razredči v 50 ml raztopine glukoze 50 mg/ml (5 %) za injiciranje, da se izognemo lokalni bolečini, zlasti pri otrocih.
English: Methylthioninium chloride may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs.
Slovenian: Metiltioninijev klorid lahko pri uporabi v kombinaciji s serotonergičnimi zdravili povzroči hud ali smrten serotoninski sindrom.
English: Each box contains a tray with 20 ampoules of 2 ml.
Slovenian: Ena škatla vsebuje podstavek s 20 ampulami po 2 ml.