FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.
Danish: Dosen gives som to injektioner, en i hver af sædemusklerne over ét til to minutter.
English: This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fulvestrant Mylan.
English: 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.
Danish: Fulvestrant Mylan er et antiøstrogent middel til behandling af fremskreden eller metastatisk brystkræft (kræft, der har spredt sig til andre dele af kroppen) hos kvinder efter overgangsalderen med en type brystkræft kaldet "østrogenreceptor-positiv kræft", der ikke tidligere har fået hormonbehandling, eller hvis kræft er vendt efter behandling med et andet antiøstrogent middel.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Fulvestrant Mylan er sammenligneligt med Faslodex.
English: Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells.
Danish: De fleste typer brystkræft stimuleres til at vokse, når hormonet østrogen binder til mål (receptorer) på kræftcellerne.
English: As for every medicine, the company provided studies on the quality of Fulvestrant Mylan.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Fulvestrant Mylan.
English: It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall.
Danish: Det blokerer receptorerne for østrogen på cellerne og medfører et fald i antallet af østrogenreceptorer.
English: 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.
Danish: Det betyder, at Fulvestrant Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Faslodex.
English: Fulvestrant Mylan is a ‘generic medicine'.
Danish: Fulvestrant Mylan er et "generisk lægemiddel".
English: The Agency recommended that Fulvestrant Mylan be approved for use in the EU.
Danish: Agenturet anbefalede, at Fulvestrant Mylan godkendes til anvendelse i EU.
English: 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.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Faslodex, og det er ikke nødvendigt at gentage disse for Fulvestrant Mylan.
English: 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.
Danish: Dette skyldes, at sammensætningen af Fulvestrant Mylan er den samme som referencelægemidlets, og når det indgives ved injektion i musklen, forventes det aktive stof i begge lægemidler at blive absorberet på samme måde.
English: 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.
Danish: Der var ikke behov for "bioækvivalensundersøgelser" af, om Fulvestrant Mylan absorberes på samme måde som referencelægemidlet for at producere den samme mængde af det aktive stof i blodet.
English: As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.
Danish: Dette medfører, at kræftcellerne ikke stimuleres af østrogen, og dermed reduceres væksten af tumoren.
English: Fulvestrant Mylan contains the active substance fulvestrant.
Danish: Fulvestrant Mylan indeholder det aktive stof fulvestrant.
English: Other information about Fulvestrant Mylan
Danish: Andre oplysninger om Fulvestrant Mylan
English: The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen.
Danish: Det aktive stof i Fulvestrant Mylan, fulvestrant, er et antiøstrogen.
English: What measures are being taken to ensure the safe and effective use of Fulvestrant Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fulvestrant Mylan?
English: What are the benefits and risks of Fulvestrant Mylan?
Danish: Hvilke fordele og risici er der forbundet med Fulvestrant Mylan?
English: For more information about treatment with Fulvestrant Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fulvestrant Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Fulvestrant Mylan er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg).
Danish: Fulvestrant Mylan udleveres kun efter recept og fås som en injektionsvæske, opløsning, i fyldte sprøjter (250 mg).
English: Therefore, the Agency's view was that, as for Faslodex, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Faslodex.
English: It is not intended to provide practical advice on how to use Fulvestrant Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Fulvestrant Mylan bør anvendes.
English: What is Fulvestrant Mylan and what is it used for?
Danish: Hvad er Fulvestrant Mylan, og hvad anvendes det til?
English: For practical information about using Fulvestrant Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Fulvestrant Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Fulvestrant Mylan approved?
Danish: Hvorfor blev Fulvestrant Mylan godkendt?
English: 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.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fulvestrant Mylan.
English: How has Fulvestrant Mylan been studied?
Danish: Hvordan blev Fulvestrant Mylan undersøgt?
English: How is Fulvestrant Mylan used?
Danish: Hvordan anvendes Fulvestrant Mylan?
English: How does Fulvestrant Mylan work?
Danish: Hvordan virker Fulvestrant Mylan?
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn)
English: Solution for injection Subcutaneous use pre-filled syringe 1 pre-filled syringe
Danish: Fyldt injektionssprøjte 1 fyldt injektionssprøjte
English: It is also well absorbed by the oral route.
Danish: Det absorberes også godt ad oral vej.
English: The frequencies are not known (cannot be estimated from the available data).
Danish: Hyppigheden er ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Alternative treatment options should be considered.
Danish: Alternative behandlingsmuligheder bør overvejes.
English: Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016
Danish: Dato for første markedsføringstilladelse: 6 maj 2011 Dato for seneste fornyelse: 8 februar 2016
English: A second dose may be given after one hour if required.
Danish: Om nødvendigt kan der gives endnu en dosis efter en time.
English: Lower doses (<1 mg/kg) may be needed.
Danish: Der kan være behov for lavere doser (<1 mg/kg).
English: In rats, increased resorption rates have been observed.
Danish: I rotter er der observeret øgede resorptionsrater.
English: Case reports of efficacy are also available in literature.
Danish: Case-rapporter om virkningen findes også i litteraturen.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis lægemidlet ikke anvendes omgående, er opbevaringstid- og forhold brugerens ansvar.
English: These features resolve generally within 2-12 hours of the injection.
Danish: Disse symptomer forsvinder normalt i løbet af 2 til 12 timer efter injektionen.
English: One-month repeated dose toxicity in dogs showed no macroscopic toxic effects.
Danish: Toksicitet ved gentagen dosis i en måned hos hunde viste ingen makroskopiske toksiske virkninger.
English: Preparation for intravenous administration
Danish: Forberedelse til intravenøs administration
English: No dose adjustment is necessary.
Danish: Dosisjustering er ikke påkrævet.
English: This discolouration is expected and will disappear after the treatment has ended
Danish: Misfarvningen er forventelig og vil forsvinde efter behandlingens ophør.
English: When indicated, the frequency is based on a very small sample size.
Danish: Når hyppigheden er angivet, er den baseret på en meget lille stikprøvestørrelse.
English: Usually, treatment should not exceed one day.
Danish: Behandlingen bør normalt ikke vare mere end en dag.
English: This medicine will help your haemoglobin return to normal and restore the transport of oxygen in the blood.
Danish: Dette lægemiddel vil hjælpe dit hæmoglobin til at vende til normalen og genoprette transporten af ilt i blodet.
English: Phototoxicity / Photosensitivity
Danish: Fototoksicitet/fotosensitivitet
English: The patient should be maintained under observation, the methaemoglobin level should be monitored and appropriate supportive measures taken as necessary.
Danish: Patienten bør holdes under observation, methæmoglobinniveauet bør kontrolleres, og der bør træffes passende understøttende foranstaltninger efter behov.
English: Pharmacotherapeutic group: All other therapeutic products, antidotes, ATC code: V03AB17
Danish: Farmakoterapeutisk klassifikation: Alle andre behandlingsprodukter, modgifte, ATC-kode: V03AB17
English: Treatment does not usually exceed one day.
Danish: Behandlingen varer normalt ikke mere end en dag.
English: Before any administration, it is recommended to inspect the parenteral solutions to verify that they are free of particles.
Danish: Det anbefales, at de parenterale opløsninger kontrolleres før indgivelse for at sikre, at de er fri for partikler.
English: • Hypersensitivity to the active substance, or to any other thiazine dyes
Danish: • Overfølsomhed over for det aktive stof eller over for andre thiazinfarvestoffer
English: The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you.
Danish: Lægen eller sundhedspersonalet kontrollerer, at udløbsdatoen på mærkaten ikke er overskredet, før du får injektionen.
English: Reported in infants only
Danish: Kun indberettet for spædbørn
English: In rats and rabbits, teratogenic effects have been reported, with foetal and maternal toxicity.
Danish: I rotter og kaniner er der indberettet teratogene virkninger med føtal og maternel toksicitet.
English: However, the risk is limited as the medicinal product is intended for acute administration only in emergency situations at hospital.
Danish: Risikoen er dog begrænset, da lægemidlet er beregnet til akut indgivelse i nødsituationer på hospitaler.
English: Your doctor will inject this medicine into a vein (intravenously) slowly over a period of 5 minutes.
Danish: Lægen injicerer dette lægemiddel i en vene (intravenøst) langsomt over et tidsrum på 5 minutter.
English: Too limited data are available to support a continuous infusion dose recommendation.
Danish: Der foreligger ikke tilstrækkelige data til støtte for en anbefaling om en løbende infusionsdosis.
English: For instructions on handling and dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om håndtering og fortynding af lægemidlet før administration, se pkt.
English: Protective measures against exposure to light should be taken.
Danish: Der skal tages forholdsregler, der beskytter mod lys.
English: It must not be administered by subcutaneous or intrathecal injection.
Danish: Det må ikke indgives ved subkutan eller intratekal injektion.
English: Keep the ampoule in the original package in order to protect from light.
Danish: Ampullen opbevares i den originale yderpakning for at beskytte mod lys.
English: Both infants had complex medical circumstances and methylthioninium chloride was only partially responsible.
Danish: Begge spædbørn havde komplekse medicinske lidelser, og methylthioniniumchlorid var kun delvis ansvarlig.
English: The majority of the dose is excreted in the urine, usually in the form of leucomethylthioninium chloride.
Danish: Størstedelen af dosen udskilles via urinen, normalt i form af leucomethylthioniniumchlorid.
English: Infants above 3 months, children and adolescents: Same posology as for adults.
Danish: Spædbørn over 3 måneder, børn og unge: Samme dosering som for voksne.
English: Adults, children above 3 months and elderly
Danish: Voksne, børn over 3 måneder og ældre
English: 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.
Danish: Efter åbning eller fortynding: Fra et mikrobiologisk synspunkt skal produktet anvendes omgående, medmindre åbningsmetoden/fortyndingsmetoden udelukker risikoen for mikrobiel kontamination.
English: Lower doses should therefore be considered and total cumulative dose should not exceed 4 mg/kg.
Danish: Lavere doser bør derfor overvejes, og den samlede kumulative dosis bør ikke overstige 4 mg/kg.
English: The medicine must be used immediately after opening or dilution.
Danish: Lægemidlet skal anvendes umiddelbart efter åbning eller opløsning.
English: The clinical consequence is not known.
Danish: Den kliniske konsekvens er ukendt.
English: Repeated dose toxicity
Danish: Toksicitet ved gentagen dosis
English: fluvoxamine, paroxetine, sertraline and zimelidine
Danish: fluvoxamin, paroxetin, sertralin og zimelidin
English: In methaemoglobinaemia, your blood contains too much methaemoglobin (an abnormal form of haemoglobin that is not able to transport oxygen around your body effectively).
Danish: Ved methæmoglobinæmi indeholder dit blod for meget methæmoglobin (en unormal form af hæmoglobin, der ikke kan transportere ilt rundt i din krop effektivt).
English: 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.
Danish: Det har også vist sig at hæmme væksten af dyrkede tocellede museembryoer og produktionen af progesteron i dyrkede luteale menneskeceller.
English: For single use only Any solution remaining in the opened ampoules must be discarded.
Danish: Kun til engangsbrug Eventuel resterende opløsning i ampullerne skal kasseres.
English: Marketing Authorisation Holder Provepharm SAS
Danish: Indehaver af markedsføringstilladelsen Provepharm SAS
English: The maximum recommended cumulative dose for the course of treatment is 7 mg/kg.
Danish: Den maksimale anbefalede kumulative dosis for hele behandlingsforløbet er på 7 mg/kg.
English: 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.
Danish: 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.
English: Type I glass ampoules.
Danish: Ampuller af type I-glas.
English: Patients with hyperglycaemia or diabetes mellitus
Danish: Patienter med hyperglycæmi eller diabetes mellitus
English: Photosensitivity
Danish: Fotosensitivitet
English: Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).
Danish: Methylthioniniumchlorid Proveblue er indiceret til voksne, børn og unge (fra 0 til 17 år).
English: 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.
Danish: Virkningen af methylthioniniumchlorid ved behandling af methæmoglobinæmi i den pædiatriske population blev påvist i to retrospektive undersøgelser og en åben randomiseret klinisk undersøgelse.
English: 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.
Danish: 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.
English: Acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia.
Danish: Akut symptomatisk behandling af methæmoglobinæmi fremkaldt af lægemidler og kemiske stoffer.
English: Methylthioninium chloride (also called methylene blue) belongs to a group of medicines called antidotes.
Danish: Methylthioniniumchlorid (også kaldet methylenblåt) tilhører en gruppe af lægemidler kaldet modgifte.
English: • clomipramine
Danish: • clomipramin
English: • Patients with Glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of haemolytic anaemia
Danish: • Patienter med glukose-6-phosphatdehydrogenasemangel (G6PD) på grund af risikoen for hæmolytisk anæmi
English: They may appear green or blue - increased sensitivity of your skin to light (photosensitivity)
Danish: Den kan være grøn eller blå - øget følsomhed over for lys i huden (lysfølsomhed).
English: These effects are the same in adults and children except jaundice which has only been reported in infants.
Danish: Bivirkningerne er de samme hos voksne og børn med undtagelse af gulsot, som kun er indberettet for spædbørn.
English: Adverse reactions are the same as in adults (except hyperbilirubinaemia, reported in infants only).
Danish: Bivirkningerne er de samme som hos voksne (med undtagelse af hyperbilirubinæmi, der kun er indberettet for spædbørn).
English: The estimated terminal half-life of methylthioninium chloride after intravenous administration is 26.7h.
Danish: Den anslåede halveringstid for methylthioniniumchlorid efter intravenøs indgivelse er 26,7 timer.
English: The clinical consequences are however considered minimal since methylthioninium chloride Proveblue is used often only once and in an acute emergency setting.
Danish: De kliniske konsekvenser vurderes imidlertid at være minimale, idet methylthioniniumchlorid Proveblue ofte kun anvendes én gang og i akutte nødsituationer.
English: 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.
Danish: 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.
English: Indeed, driving can be affected due to confusional state, dizziness and possibly eye disturbances.
Danish: Evnen til at føre motorkøretøj kan blive påvirket som følge af forvirring, svimmelhed og muligvis synsforstyrrelser.
English: EXP The medicine must be used immediately after opening or dilution.
Danish: Exp. Lægemidlet skal anvendes umiddelbart efter åbning eller fortynding.
English: Intravenous use only For slow intravenous injection
Danish: Læs indlægssedlen inden brug Kun til intravenøs anvendelse Til langsom intravenøs injektion
English: There are no adequate data from the use of methylthioninium chloride in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af methylthioniniumchlorid til gravide kvinder.
English: • venlafaxine
Danish: • venlafaxin
English: It must be injected very slowly over a period of 5 minutes.
Danish: Det skal indgives meget langsomt over et tidsrum på 5 minutter.
English: Advise patients to take protective measures against exposure to light, because photosensitivity may occur after administration of methylthioninium chloride.
Danish: Rådgiv patienterne om, at de skal tage forholdsregler, der beskytter mod lys, eftersom der kan opstå fotosensitivitet efter administration af methylthioniniumchlorid.
English: 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.
Danish: Methylthioniniumchlorid Proveblue skal injiceres meget langsomt over et tidsrum på 5 minutter for at forhindre, at høje lokale koncentrationer af stoffet producerer yderligere methæmoglobin.
English: • Common side effects (may affect up to 1 in 10 people): - stomach pain - chest pain - headache - anxiety - injection site pain - vomiting
Danish: • Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): - mavesmerter - brystsmerter - hovedpine - angst - smerter på injektionsstedet - opkastning
English: 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.
Danish: 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.
English: Methaemoglobinaemia,
Danish: Methæmoglobinæmi,
English: The adverse reactions listed in the table below occur in adults, children and adolescents (aged 0 to 17 years old) after intravenous administration.
Danish: De i nedenstående tabel opstillede bivirkninger optræder hos voksne, børn og unge (fra 0 år og op til 17 år) efter intravenøs indgivelse.
English: Additional information on how Methylthioninium chloride Proveblue can be given is provided in section 3 of the Package Leaflet.
Danish: Yderligere oplysninger om, hvordan Methylthioniniumchlorid Proveblue kan indgives, findes i punkt 3 i indlægssedlen.
English: Intravenous injection of methylthioninium chloride has occasionally caused hypotension and cardiac arrhythmias, and such disorders might prove fatal on rare occasions.
Danish: Intravenøs injektion af methylthioniniumchlorid har lejlighedsvis forårsaget hypotension og hjertearytmi, og sådanne lidelser kan ved sjældne lejligheder være dødelige.
English: It imparts a blue-green colour to urine, faeces and a blue colour to skin which may hinder a diagnosis of cyanosis.
Danish: Stoffet giver urin og afføring en blågrøn farve og huden en blå farve, der kan hindre diagnosticering af cyanose.
English: 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.
Danish: Du bør ikke få Methylthioniniumchlorid samtidig med, at du tager visse lægemidler mod depression eller angst, som påvirker et kemikalie i hjernen kaldet serotonin.