natgillin/translations-raw huggingface dataset:
Luminity has not been specifically studied in patients with renal impairment. 
Pri bolnikih z okvaro ledvic uporabe zdravila Luminity niso posebej proučevali.
Driving and using machines 
Način uporabe in postopek mehanske aktivacije
The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose. 
Priporočeni odmerek je 500 mg enkrat na mesec ter dodaten 500-miligramski odmerek, ki se da dva tedna po začetnem odmerku.
The full EPAR for Fulvestrant Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fulvestrant Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen. 
Fulvestrant Mylan je antiestrogensko zdravilo, ki se uporablja za zdravljenje napredovalega ali metastatskega raka dojke (raka, ki se je razširil na druge dele telesa) pri ženskah po menopavzi z vrsto raka dojke, imenovano „rak s pozitivnimi estrogenskimi receptorji“, ki se pred tem niso hormonsko zdravile ali pri katerih se je rak po zdravljenju z drugim antiestrogenom ponovil.
This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fulvestrant Mylan.
The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Fulvestrant Mylan primerljivo z zdravilom Faslodex.
Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Fulvestrant Mylan generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What measures are being taken to ensure the safe and effective use of Fulvestrant Mylan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fulvestrant Mylan?
The dose is given as two injections, each given into the muscle of one buttock over one to two minutes. 
Odmerek se daje z dvema injekcijama v mišico, po eno injekcijo v vsako stran zadnjice, v trajanju ene do dveh minut.
This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Faslodex. 
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Faslodex.
As for every medicine, the company provided studies on the quality of Fulvestrant Mylan. 
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Fulvestrant Mylan.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan. 
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Faslodex, zato jih za zdravilo Fulvestrant Mylan ni treba ponoviti.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulvestrant Mylan have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fulvestrant Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Fulvestrant Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Fulvestrant Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Fulvestrant Mylan 
Druge informacije o zdravilu Fulvestrant Mylan
The Agency recommended that Fulvestrant Mylan be approved for use in the EU. 
Priporočila je, da se zdravilo Fulvestrant Mylan odobri za uporabo v EU.
Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg). 
Predpisovanje in izdaja zdravila je le na recept, na voljo pa je v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah (250 mg).
What are the benefits and risks of Fulvestrant Mylan? 
Kakšne so koristi in tveganja, povezani z zdravilom Fulvestrant Mylan?
Fulvestrant Mylan is a ‘generic medicine'. 
Zdravilo Fulvestrant Mylan je „generično zdravilo“.
This is because the composition of Fulvestrant Mylan is the same as the reference medicine and when given by injection into the muscle, the active substance in both products is expected to be absorbed in the same way. 
Razlog za to je dejstvo, da je sestava zdravila Fulvestrant Mylan enaka kot pri referenčnem zdravilu, zato se pričakuje, da se zdravilna učinkovina v obeh zdravilih pri injiciranju v mišico enako absorbira.
The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen. 
Zdravilna učinkovina v zdravilu Fulvestrant Mylan, fulvestrant, je antiestrogen.
There was no need for ‘bioequivalence' studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Fulvestrant Mylan absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
For practical information about using Fulvestrant Mylan, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Fulvestrant Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Fulvestrant Mylan. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Therefore, the Agency's view was that, as for Faslodex, the benefit outweighs the identified risk. 
Zato je menila, da njegove koristi enako kot pri zdravilu Faslodex odtehtajo znana tveganja.
What is Fulvestrant Mylan and what is it used for? 
Kaj je zdravilo Fulvestrant Mylan in za kaj se uporablja?
Why is Fulvestrant Mylan approved? 
Zakaj je bilo zdravilo Fulvestrant Mylan odobreno?
Fulvestrant Mylan contains the active substance fulvestrant. 
Zdravilo Fulvestrant Mylan vsebuje zdravilno učinkovino fulvestrant.
How has Fulvestrant Mylan been studied? 
Kako je bilo zdravilo Fulvestrant Mylan raziskano?
How is Fulvestrant Mylan used? 
Kako se zdravilo Fulvestrant Mylan uporablja?
How does Fulvestrant Mylan work? 
Kako zdravilo Fulvestrant Mylan deluje?
Solution for injection Subcutaneous use pre-filled syringe 1 pre-filled syringe 
1 napolnjena injekcijska brizga
Such medicines include: 
Takšna zdravila vključujejo:
Case reports of efficacy are also available in literature. 
Posamezna poročila o učinkovitosti so opisana tudi v literaturi.
The frequencies are not known (cannot be estimated from the available data). 
Pogostnost ni znana (iz razpoložljivih podatkov je ni mogoče oceniti).
Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016 
Datum prve odobritve: 6 maj 2011 Datum zadnjega podaljšanja: 8 februar 2016
This discolouration is expected and will disappear after the treatment has ended 
To obarvanje je pričakovano in bo izginilo po končanem zdravljenju
Use immediately on opening. 
Uporabite takoj po odprtju.
When indicated, the frequency is based on a very small sample size. 
Kjer je tako navedeno, pogostnost temelji na zelo majhni velikosti vzorca.
Lower doses (<1 mg/kg) may be needed. 
Morda bodo potrebni nižji odmerki (<1 mg/kg).
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6.
Alternative treatment options should be considered. 
Proučiti je treba druge možnosti zdravljenja.
A second dose may be given after one hour if required. 
Po preteku ene ure se lahko da drugi odmerek, če je potrebno.
The clinical consequence is not known. 
Klinične posledice niso znane.
In rats, increased resorption rates have been observed. 
Pri podganah so bile opažene povečane stopnje resorpcije.
These features resolve generally within 2-12 hours of the injection. 
Ta stanja na splošno izzvenijo v 2-12 urah po injiciranju.
It is also well absorbed by the oral route. 
Tudi po peroralni poti se dobro absorbira.
The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. 
Zdravnik ali medicinska sestra bosta preverila, da datum izteka roka uporabnosti ni pretekel, preden vam bosta dala injekcijo.
Usually, treatment should not exceed one day. 
Zdravljenje običajno ne sme trajati dlje kot en dan.
This medicine will help your haemoglobin return to normal and restore the transport of oxygen in the blood. 
To zdravilo bo pripomoglo, da vaš hemoglobin spet postane normalen, in bo ponovno vzpostavilo prenos kisika v krvi.
Treatment does not usually exceed one day. 
Zdravljenje običajno ne traja dlje kot en dan.
They may appear green or blue - increased sensitivity of your skin to light (photosensitivity) 
Videti je zeleno ali modro - povečana občutljivost vaše kože na svetlobo (fotosenzitivnost)
The patient should be maintained under observation, the methaemoglobin level should be monitored and appropriate supportive measures taken as necessary. 
Bolnika je treba opazovati, spremljati je treba raven methemoglobina in po potrebi uporabiti ustrezne podporne ukrepe.
It must not be administered by subcutaneous or intrathecal injection. 
Ne sme se ga injicirati podkožno ali intratekalno.
No dose adjustment is necessary. 
Starejši Prilagoditev odmerka ni potrebna.
However, the risk is limited as the medicinal product is intended for acute administration only in emergency situations at hospital. 
Vendar pa je tveganje omejeno, saj je zdravilo namenjeno za akutno uporabo samo v nujnih primerih v bolnišnici.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte se z zdravnikom, preden vzamete to zdravilo.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če se zdravila ne uporabi takoj, je za čas shranjevanja in pogoje med uporabo odgovoren uporabnik.
Infants 3 months old or younger 
Otroci, stari 3 mesece ali mlajši
• Deficiency in NADPH (nicotinamide adenine dinucleotide phosphate) reductase. 
• Pomanjkanje NADPH (nikotinamid adenin dinukleotid fosfat) reduktaze.
Too limited data are available to support a continuous infusion dose recommendation. 
Za priporočanje odmerka za kontinuirano infuzijo ni na voljo dovolj podatkov.
Before any administration, it is recommended to inspect the parenteral solutions to verify that they are free of particles. 
Pred dajanjem je priporočljivo pregledati parenteralne raztopine, da bi se prepričali, da ne vsebujejo delcev.
Indeed, driving can be affected due to confusional state, dizziness and possibly eye disturbances. 
Na vožnjo lahko vpliva zaradi stanja zmedenosti, omotice in morebitnih motenj vida.
Keep the ampoule in the original package in order to protect from light. 
Ampulo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
One-month repeated dose toxicity in dogs showed no macroscopic toxic effects. 
Toksičnost pri enomesečnih ponavljajočih se odmerkih pri psih ni pokazala makroskopskih toksičnih učinkov.
Protective measures against exposure to light should be taken. 
Treba se je zaščiti pred izpostavljenostjo svetlobi.
Infants above 3 months, children and adolescents: Same posology as for adults. 
Dojenčki, starejši od 3 mesecev, otroci in mladostniki: enako odmerjanje kot za odrasle.
In rats and rabbits, teratogenic effects have been reported, with foetal and maternal toxicity. 
Pri podganah in kuncih so poročali o teratogenih učinkih s toksičnostjo za plod in mater.
Both infants had complex medical circumstances and methylthioninium chloride was only partially responsible. 
Pri obeh dojenčkih so bile zdravstvene okoliščine zapletene in je bil metiltioninijev klorid samo delno odgovoren.
The medicine must be used immediately after opening or dilution. 
Zdravilo je treba uporabiti takoj po odprtju ali razredčenju.
• Patients with Glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of haemolytic anaemia 
• Bolniki s pomanjkanjem glukoza-6-fosfat-dehidrogenaze (G6PD) zaradi tveganja hemolitične anemije.
After opening or dilution: From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product must be used immediately. 
Po odprtju ali redčenju: Z mikrobiološkega vidika je treba zdravilo uporabiti takoj, če način odpiranja/redčenja ne preprečuje tveganja mikrobne kontaminacije.
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. 
Druga zdravila in zdravilo Metiltioninijev klorid Proveblue Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
The majority of the dose is excreted in the urine, usually in the form of leucomethylthioninium chloride. 
Večina odmerka se izloči z urinom, običajno v obliki levkometiltioninijevega klorida.
There is no experience in patients with severe hepatic impairment. 
Pri bolnikih s hudo jetrno okvaro ni izkušenj.
If any of the above applies to you, please consult your doctor. 
Če karkoli od zgoraj navedenega velja za vas, se posvetujte z zdravnikom.
The maximum recommended cumulative dose for the course of treatment is 7 mg/kg. 
Najvišji priporočljivi skupni odmerek za celotno zdravljenje je 7 mg/kg.
These effects are the same in adults and children except jaundice which has only been reported in infants. 
Ti neželeni učinki so enaki pri odraslih in otrocih, razen zlatenice, o kateri so poročali samo pri dojenčkih.
The clinical consequences are considered likely to be minimal due to the transient and single dose use that normally occurs in the emergency setting. 
Smatra se, da so klinične posledice verjetno minimalne zaradi prehodnega in enkratnega odmerka, ki se običajno uporabi v nujnih okoliščinah.
Methylthioninium chloride (also called methylene blue) belongs to a group of medicines called antidotes. 
Metiltioninijev klorid (imenovan tudi metilensko modro) spada v skupino zdravil, imenovanih antidoti.
Pharmacotherapeutic group: All other therapeutic products, antidotes, ATC code: V03AB17 
Farmakoterapevtska skupina: druga nerazvrščena zdravila za zdravljenje različnih bolezni, antidoti, oznaka ATC: V03AB17
Reported in infants only 
Samo pri dojenčkih
Lower doses should therefore be considered and total cumulative dose should not exceed 4 mg/kg. 
Zato je treba uporabiti nižje odmerke, kumulativni odmerek pa ne sme preseči 4 mg/kg.
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. 
Zaradi pomanjkanja razpoložljivih podatkov o tem, ali metiltioninijev klorid prehaja v materino mleko, je treba dojenje prekiniti za 8 dni po zdravljenju s tem zdravilom.
Inject very slowly over a period of 5 minutes. 
Injicirajte zelo počasi v obdobju 5 minut.
Intravenous injection of methylthioninium chloride has occasionally caused hypotension and cardiac arrhythmias, and such disorders might prove fatal on rare occasions. 
Intravenska injekcija metiltioninijevega klorida je občasno povzročila hipotenzijo in srčne aritmije, takšne motnje pa so lahko v redkih primerih smrtne.
In methaemoglobinaemia, your blood contains too much methaemoglobin (an abnormal form of haemoglobin that is not able to transport oxygen around your body effectively). 
Pri methemoglobinemiji vaša kri vsebuje preveč methemoglobina (nenormalne oblike hemoglobina, ki ne more učinkovito prenašati kisika po telesu).
Your doctor will inject this medicine into a vein (intravenously) slowly over a period of 5 minutes. 
Vaš zdravnik bo to zdravilo počasi v obdobju 5 minut vbrizgal v veno (intravensko).
It has also been shown to inhibit the growth of cultured two-cell mouse embryos and the production of progesterone in cultured human luteal cells. 
Pokazalo se je tudi, da zavira rast vzgojenih dvoceličnih zarodkov miši in proizvodnjo progesterona pri vzgojenih lutealnih celicah človeka.
Patients with hyperglycaemia or diabetes mellitus 
Bolniki s hiperglikemijo ali diabetesom mellitusom
fluvoxamine, paroxetine, sertraline and zimelidine 
fluoksetin, fluvoksamin, paroksetin, sertralin in zimelidin
The estimated terminal half-life of methylthioninium chloride after intravenous administration is 26.7h. 
Ocenjeni končni razpolovni čas metiltioninijevega klorida po intravenski aplikaciji je 26,7 ur.
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. 
Zdravilo Metiltioninijev klorid Proveblue boste vi ali vaš otrok (0-17 let starosti) prejeli za zdravljenje problemov s krvjo, ki so posledica izpostavljenosti nekaterim zdravilom ali kemikalijam, ki lahko povzročijo bolezen, imenovano methemoglobinemija.
Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old). 
Zdravilo Metiltioninijev klorid Proveblue je indicirano pri odraslih, otrocih in mladostnikih (starih 0 do 17 let).
Adverse reactions are the same as in adults (except hyperbilirubinaemia, reported in infants only). 
Neželeni učinki so enaki kot pri odraslih (razen hiperbilirubinemije, o kateri so poročali samo pri dojenčkih).
It must be injected very slowly over a period of 5 minutes. 
Injicirati ga je treba zelo počasi v obdobju 5 minut.
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. 
O hemolitični anemiji so poročali tudi v primeru znatno prevelikega odmerjanja (20-30 mg/kg) pri dojenčkih in odraslih z methemoglobinemijo, povzročeno z anilinom ali klorati.
There are no adequate data from the use of methylthioninium chloride in pregnant women. 
Ni zadostnih podatkov o uporabi metiltioninijevega klorida pri nosečnicah.
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. 
Učinkovitost metiltioninijevega klorida za zdravljenje methemoglobinemije pri pediatrični populaciji je bila dokazana v dveh retrospektivnih študijah in enem odprtem, randomiziranem kliničnem preskušanju.
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. 
Zdravilo Metiltioninijev klorid Proveblue je treba injicirati zelo počasi v obdobju 5 minut, da bi preprečili, da visoke lokalne koncentracije spojine povzročijo nastanek dodatnega methemoglobina.
Methylthioninium chloride has moderate influence on the ability to drive and use machines. 
Metiltioninijev klorid ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Haemodialysis may be used in patients with severe haemolysis. 
Hemodializo se lahko uporabi pri bolnikih s hudo hemolizo.
It imparts a blue-green colour to urine, faeces and a blue colour to skin which may hinder a diagnosis of cyanosis. 
Povzroči modrozeleno obarvanje urina, blata in modro obarvanje kože, ki lahko ovira diagnosticiranje cianoze.
Special care must be taken with Methylthioninium chloride Proveblue: - in newborns and infants 3 months old or younger, lower doses are recommended (see section 3 of this package leaflet). 
Bodite posebno pozorni pri uporabi zdravila Metiltioninijev klorid Proveblue: - pri novorojenčkih in dojenčkih, starih 3 mesece ali mlajših, se priporoča nižje odmerke (glejte poglavje 3 teh navodil za uporabo).
The excretion of methylthioninium chloride in milk has not been studied in animals. 
Izločanje metiltioninijevega klorida v mleko pri živalih ni bilo proučeno.
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. 
Če se intravenski uporabi metiltioninijevega klorida ni mogoče izogniti, morate prejeti najnižji možni odmerek in vas je treba do 4 ure po prejemu skrbno spremljati.
The clinical consequences are however considered minimal since methylthioninium chloride Proveblue is used often only once and in an acute emergency setting. 
Vendar pa se smatra, da so klinične posledice minimalne, saj se zdravilo Metiltioninijev klorid Proveblue pogosto uporabi le enkrat in to v okoliščinah akutne nujnosti.
• Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, 
• selektivne zaviralce ponovnega privzema serotonina (SSRI), kot so citalopram, escitalopram,
• Common side effects (may affect up to 1 in 10 people): - stomach pain - chest pain - headache - anxiety - injection site pain - vomiting 
• Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - bolečine v želodcu - bolečine v prsih - glavobol - tesnoba - bolečina na mestu injiciranja - bruhanje
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. 
Neželeni učinki, ugotovljeni pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti in z morebitno relevantnostjo za klinično uporabo, so bili zmerna regenerativna anemija, povezana s povečanjem povprečnega števila trombocitov in ravni fibrinogena, majhno povečanje povprečnih vrednosti bilirubina v krvi in povečanje pogostnosti zmernih ravni bilirubina v urinu.
Do not drive or use any tools or machines as methylthioninium chloride has moderate influence on the ability to drive and use machines. 
Ne vozite avtomobila in ne upravljajte z orodji ali stroji, ker ima metiltioninijev klorid zmeren vpliv na sposobnost upravljanja vozil in strojev.
Acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia. 
Akutno simptomatsko zdravljenje methemoglobinemije, povzročene z zdravili in kemikalijami.