natgillin/translations-raw huggingface dataset:
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. 
Posebna previdnost je potrebna pri dajanju novorojenčkom in dojenčkom, mlajšim od 3 mesecev, zaradi manjših koncentracij NADPH-methemoglobin reduktaze, ki je potrebna za pretvorbo methemoglobina v hemoglobin, zaradi česar so ti dojenčki dovzetnejši za methemoglobinemijo, ki jo povzročijo visoki odmerki metiltioninijevega klorida.
These include SSRIs (selective serotonin reuptake inhibitors), bupropion, buspirone, clomipramine, mirtazapine, and venlafaxine. 
Ta zdravila vključujejo SSRI (selektivne zaviralce ponovnega privzema serotonina), bupropion, buspiron, klomipramin, mirtazapin in venlafaksin.
If you have any doubts about whether this medicine should be given to you, consult your doctor. 
Če imate kakršne koli pomisleke glede tega, ali smete prejeti to zdravilo, se posvetujte z zdravnikom.
The use of Methylthioninium chloride Proveblue during pregnancy is not recommended unless it is clearly necessary, for example in a life-threatening situation. 
Uporaba zdravila Metiltioninijev klorid Proveblue med nosečnostjo ni priporočena, če ni to nujno potrebno, tj. pri življenjsko nevarnem stanju.
- 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. 
- če imate hiperglikemijo ali sladkorno bolezen, saj lahko ti bolezni poslabša raztopina glukoze, ki se uporablja za redčenje zdravila - vaš urin in vaše blato se lahko obarvata modrozeleno; koža se lahko pri zdravljenju z zdravilom Metiltioninijev klorid Proveblue obarva modro.
If your blood disorder has been caused by aniline or dapsone, total cumulative dose should not exceed 4 mg/kg (see section 2). 
Če je vašo bolezen krvi povzročil anilin ali dapson, skupni odmerek ne sme preseči 4 mg/kg (glejte poglavje 2).
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). 
Če se intravenski uporabi metiltioninijevega klorida pri bolnikih, zdravljenih s serotonergičnimi zdravili, ni mogoče izogniti, je treba izbrati najnižji odmerek in bolnika do 4 ure po aplikaciji skrbno spremljati glede učinkov na osrednje živčevje (glejte poglavji 4.4 in 4.8).
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. 
Metiltioninijevega klorida ne smete prejemati sočasno z določenimi zdravili za zdravljenje depresije ali tesnobe, ki vplivajo na kemikalijo v možganih, imenovano serotonin.
If symptoms of serotonin syndrome occur, discontinue use of methylthioninium chloride, and initiate supportive treatment. 
Če se pojavijo znaki serotoninskega sindroma, prenehajte z uporabo metiltioninijevega klorida in uvedite podporno zdravljenje.
• Hypersensitivity to the active substance, or to any other thiazine dyes 
• Preobčutljivost na učinkovino (učinkovine) ali katerokoli tiazinsko barvilo.
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. 
Ni mogoče izključiti kliničnih posledic povečanja plazemske koncentracije sočasno uporabljenih učinkovin, ki so občutljivi substrati CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 in 3A.
The adverse reactions listed in the table below occur in adults, children and adolescents (aged 0 to 17 years old) after intravenous administration. 
Neželeni učinki, navedeni v spodnji preglednici, poročani pri odraslih, otrocih in mladostnikih (v starosti od 0 do 17 let) po intravenski uporabi.
Advise patients to take protective measures against exposure to light, because photosensitivity may occur after administration of methylthioninium chloride. 
Bolnikom svetujte, naj se zaščitijo pred izpostavljenostjo svetlobi, saj se lahko po dajanju metiltioninijevega klorida pojavi fotosenzitivnost.
Pierrel S.p.A. s.s. Appia 7 bis, 46/48 - 81043 Capua, Italy 
s.s. Appia 7 bis, 46/48, 81043 Capua, Italija
For instructions on handling and dilution of the medicinal product before administration, see section 6.6. 
Za navodila za ravnanje z zdravilom in redčenje pred uporabo glejte poglavje 6.6.
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. 
- zmanjšanje števila rdečih krvnih celic, zaradi česar lahko vaša koža postane bleda ter ste zasopli in slabotni, - zlatenico (porumenelost kože in oči), o čemer so poročali samo pri dojenčkih.
• Very common side effects (may affect more than 1 in 10 people) pain in extremity dizziness sweating skin discolouration. 
• Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - bolečina v okončini - omotica - čezmerno potenje - obarvanje kože.
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). 
Izogibajte se sočasni uporabi metiltioninijevega klorida s selektivnimi zaviralci ponovnega privzema serotonina (SSRI), zaviralci ponovnega privzema serotonina in noradrenalina (SNRI) in zaviralci monoaminooksidaze (glejte poglavje 4.5).
Pierrel S.p.A. s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italy 
s.s. Appia 7 bis, 46/48 IT-81043 Capua (CE) Italija
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. 
Metiltioninijev klorid je bil mutagen pri preskušanju genske mutacije bakterij in limfomskih celic miši, vendar ne pri preskušanju mikronukleusa miši in vivo pri intravenski uporabi 62 mg/kg.
Methylthioninium chloride is a substrate of P-glycoprotein (P-gp). 
Metiltioninijev klorid je substrat P-glikoproteina (P-gp).
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). 
V primeru methemoglobinemije, povzročene z anilinom ali dapsonom, je največji priporočeni kumulativni odmerek za celotno zdravljenje 4 mg/kg (glejte poglavje 4.4).
Additional information on how Methylthioninium chloride Proveblue can be given is provided in section 3 of the Package Leaflet. 
Dodatne informacije o tem, kako uporabljati zdravilo Metiltioninijev klorid Proveblue, so navedene v poglavju 3 navodil za uporabo.
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. 
Največji priporočeni kumulativni odmerek v celotnem zdravljenju je 7 mg/kg in se ga ne sme preseči, saj lahko metiltioninijev klorid v količini, ki je večja od največjega odmerka, pri dovzetnih bolnikih povzroči methemoglobinemijo.
• Monoamine oxidase inhibitors 
• zaviralce monoaminooksidaze
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois France 
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois Francija
Some evidence of carcinogenic activity of methylthioniniul chloride has been shown in male mice and male rats. 
Obstaja nekaj dokazov o kancerogeni aktivnosti metiltioninijevega klorida pri samcih miši in podgan.
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. 
Uporaba zdravila Metiltioninijev klorid Proveblue lahko prehodno poveča ali zmanjša očistek zdravil, ki se primarno presnavljajo s temi encimi.
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. 
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.
Based on kinetic data, breast-feeding should be discontinued for up to 8 days after treatment with Methylthioninium chloride Proveblue. 
Na podlagi kinetičnih podatkov je treba dojenje prekiniti za 8 dni po zdravljenju z zdravilom Metiltioninijev klorid Proveblue.
In patients with aniline-induced methaemoglobinaemia, repeated doses of methylthioninium chloride may be required. 
Pri bolnikih z methemoglobinemijo, povzročeno z anilinom, bodo morda potrebni ponavljajoči odmerki metiltioninijevega klorida.
Like all medicines, Methylthioninium chloride Proveblue can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Metiltioninijev klorid Proveblue neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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. 
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.
Marketing Authorisation Holder Provepharm SAS 
Imetnik dovoljenja za promet z zdravilom Provepharm SAS
Methylthioninium chloride is an in vitro inhibitor of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5. 
Metiltioninijev klorid je in vitro zaviralec CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 in 3A4/5.
Patients treated with methylthioninium chloride in combination with serotonergic drugs should be monitored for the emergence of serotonin syndrome. 
Bolnike, ki se zdravijo z metiltioninijevim kloridom v kombinaciji s serotonergičnimi zdravili, je treba spremljati glede pojava serotoninskega sindroma.
Individuals without methaemoglobinaemia 
Osebe brez methemoglobinemije
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 
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
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). 
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).
Preparation for intravenous administration 
Priprava za intravensko uporabo
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. 
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.
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. 
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.
Anaesthesiologists should be vigilant for methaemoglobinaemia in patients receiving dapsone therapy and for BIS (Bispectral Index) interference with Methylthioninium chloride Proveblue administration. 
Anesteziologi morajo biti pozorni na methemoglobinemijo pri bolnikih, zdravljenih z dapsonom, in na interferenco BIS (bispektralni indeks) pri dajanju zdravila Metiltioninijev klorid Proveblue.
Cenexi 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France 
Cenexi 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, Francija
Methylthioninium chloride Proveblue can exacerbate dapsone-induced haemolytic anemia because of the formation of the dapsone reactive metabolite hydroxylamine which oxidises haemoglobin. 
Zdravilo Metiltioninijev klorid Proveblue lahko poslabša hemolitično anemijo, povzročeno z dapsonom, zaradi nastanka reaktivnega presnovka dapsona hidroksilamina, ki oksidira hemoglobin.
Solution for injection 5 ampoules of 10 ml 
raztopina za injiciranje 5 ampul po 10 ml
For single use only Any solution remaining in the opened ampoules must be discarded. 
Raztopino, ki ostane v odprtih ampulah, je treba zavreči.
• Patients with methaemoglobinaemia due to chlorate poisoning 
• Bolniki z methemoglobinemijo zaradi zastrupitve s kloratom.
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) 
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)
Type I glass ampoules. 
Steklene ampule tipa I.
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. 
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.
What Methylthioninium chloride Proveblue is and what it is used for 
Kaj je zdravilo Metiltioninijev klorid Proveblue in za kaj ga uporabljamo
Failure to respond to methylthioninium chloride suggests cytochrome b5 reductase deficiency, glucose6- phosphate dehydrogenase deficiency or sulfhaemoglobinemia. 
Neodzivanje na metiltioninijev klorid kaže na pomanjkanje citokrom-b5-reduktaze, pomanjkanje glukoza-6-fosfat-dehidrogenaze ali sulfhemoglobinemijo.
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. 
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.
Methylthioninium chloride Proveblue should not be used during pregnancy unless clearly necessary, e.g. in life-threatening methaemoglobinaemia. 
Zdravila Metiltioninijev klorid Proveblue se ne sme uporabljati med nosečnostjo, če ni to nujno potrebno, tj. pri življenjsko nevarni methemoglobinemiji.
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. 
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)
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. 
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.
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. 
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.
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. 
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.
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. 
Zdravilo Metiltioninijev klorid Proveblue ni in vitro substrat BCRP ali OCT2 in ni in vitro zaviralec BCRP, OAT1 ali OAT3.
5 ampoules of 2 ml 20 ampoules of 2 ml 10 mg/2 ml 
5 ampul po 2 ml 20 ampul po 2 ml 10 mg/2 ml
How to store Methylthioninium chloride Proveblue Contents of the pack and other information 
Shranjevanje zdravila Metiltioninijev klorid Proveblue Vsebina pakiranja in dodatne informacije
Intravenous use only For slow intravenous injection 
Za počasno intravensko injiciranje.
When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening. 
Pri uporabi v kombinaciji s temi zdravili lahko metiltioninijev klorid povzroči serotoninski sindrom, ki je lahko tudi smrtno nevaren.
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. 
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 .
Do not use Methylthioninium chloride Proveblue if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present. 
Zdravila Metiltioninijev klorid Proveblue ne uporabljajte, če je raztopina spremenjene barve, motna, gosta ali vsebuje precipitat ali delce.
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. 
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.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema methemoglobinemija,
• Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning 
• Bolniki z methemoglobinemijo, povzročeno z nitritom med zdravljenjem zastrupitve s cianidom.
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). 
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).