FrancophonIA/ELRC3.0 huggingface dataset:
English: • Under direct visualisation, the tip of the subretinal injection cannula is placed in contact with the retinal surface.
Danish: • Spidsen af kanylen til subretinal injektion anbringes i kontakt med den retinale overflade under direkte visualisering.
English: • After vitrectomy is completed, Luxturna is administered by subretinal injection using a commercially available subretinal injection cannula introduced via pars plana.
Danish: • Når vitrektomien er gennemført, administreres Luxturna ved subretinal injektion med en almindelig kanyle til subretinal injektion, der indføres via pars plana.
English: What Luxturna looks like and contents of the pack Luxturna is a clear, colourless concentrate for solution for subretinal injection, supplied in a clear plastic vial.
Danish: Luxturna er et klart, farveløst koncentrat til opløsning til indsprøjtning under nethinden, som leveres i et gennemsigtigt hætteglas af plast.
English: The MAH shall ensure that in each Member State (MS) where LUXTURNA is marketed, the product is distributed through treatment centres where qualified staff (i.e. vitreoretinal surgeons and pharmacists) have participated in the mandatory educational program about use of the product and pharmacy training, in order to ensure LUXTURNA correct use so as to minimise the risks associated with its administration and/or the administration procedure (increased intraocular pressure, retinal tear, macular disorders, cataract, intraocular inflammation and/or infection related to the procedure and retinal detachment, third party transmission).
Danish: Dette skal sikre, at LUXTURNA anvendes korrekt for at mindske de risici, som er associeret med administrationen og/eller administrationsproceduren (forhøjet intraokulært tryk, retinal rift, sygdomme i macula, katarakt, intraokulær inflammation og/eller infektion relateret til proceduren og retinaløsning, overførsel til tredje part).
English: Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into a sterile 1 mL syringe.
Danish: Sprøjterne til injektion klargøres ved at trække 0,8 ml fortyndet opløsning op i en steril 1 ml sprøjte.
English: Transfer 2.7 mL of solvent taken from the two thawed vials and dispense into a sterile 10 mL empty glass vial using a 3 mL syringe.
Danish: Overfør 2,7 ml solvens fra de to optøede hætteglas, og dispenser dem til et sterilt, tomt 10 ml hætteglas med en 3 ml sprøjte.
English: If particulates, cloudiness, or discoloration are visible, the single-dose vial must not be used.
Danish: Hvis der ses partikler, uklarheder eller misfarvning, må enkeltdosis-hætteglasset ikke anvendes.
English: Gently invert the thawed solvent vials five times to mix the contents.
Danish: Vend forsigtigt hætteglassene med optøet solvens på hovedet fem gange for at blande indholdet.
English: If particulates, cloudiness, or discoloration are visible, the product must not be used.
Danish: Hvis der ses partikler, uklarheder eller misfarvning, må produktet ikke anvendes.
English: Thaw one single-dose vial of concentrate and two single-use vials of solvent at room temperature.
Danish: Optø ét enkeltdosishætteglas med koncentrat og to engangshætteglas med solvens ved stuetemperatur.
English: Nausea, vomiting, abdominal pain upper, lip pain Skin and subcutaneous disorders Common
Danish: Kvalme, opkastning, smerter i øverste del af abdomen, læbesmerter
English: For dilution, transfer 0.3 mL of thawed concentrate into a 1 mL syringe and add it to the 10 mL sterile vial containing the solvent.
Danish: Til fortynding overføres 0,3 ml optøet koncentrat til en 1 ml sprøjte og tilsættes til det sterile 10 ml hætteglas, som indeholder solvenset.
English: Y3
Danish: Å3
English: Transfer 2.7 mL of the solvent taken from the two thawed vials and dispense into a sterile 10 mL glass vial using a 3 mL syringe.
Danish: Overfør 2,7 ml af solvenset fra de to optøede hætteglas, og dispenser dem til et sterilt 10 ml hætteglas med en 3 ml sprøjte.
English: vector genomes/mL concentrate and solvent for solution for injection voretigene neparvovec
Danish: vektorgenomer/ml koncentrat og solvens til injektionsvæske, opløsning voretigen neparvovec
English: Y2
Danish: Å2
English: For dilution, draw 0.3 mL of thawed concentrate into a 1 mL syringe and add it to the 10 mL sterile vial containing the solvent.
Danish: Til fortynding trækkes 0,3 ml optøet koncentrat op i en 1 ml sprøjte og tilsættes til det sterile 10 ml hætteglas, som indeholder solvenset.
English: The other ingredients of the concentrate are sodium chloride (see end of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate dihydrate (for pH adjustment), poloxamer 188 and water for injections.
Danish: Øvrige indholdsstoffer af koncentratet er natriumchlorid (se slutningen af punkt 2), natriumdihydrogenphosphatmonohydrat (til justering af pH-værdi), dinatriumhydrogenphosphatdihydrat (til justering af pH-værdi), poloxamer 188 og vand til injektionsvæsker.
English: vector genomes/mL concentrate for solution for injection voretigene neparvovec
Danish: vektorgenomer/ml koncentrat til injektionsvæske, opløsning voretigen neparvovec
English: • Tell your doctor if you have signs of an eye infection or eye inflammation, for example if you have eye redness, sensitivity to light, eye swelling or eye pain.
Danish: • Fortæl det til lægen, hvis du har tegn på øjeninfektion eller øjenbetændelse.
English: • Redness of the eye
Danish: • Øjensmerter
English: In 13/29 (45%) subjects receiving bilateral administrations, Luxturna vector DNA sequences were detected in tear samples; most of these subjects were negative after the day 1 post-injection visit, however, four of these subjects had positive tear samples beyond the first day, one subject up to day 14 post-second eye injection.
Danish: De fleste af disse forsøgsdeltagere blev testet negative efter besøget 1 dag efter injektion, men fire af disse forsøgsdeltagere havde positive tåreprøver efter den første dag, og én forsøgsdeltager op til 14 dage efter injektion i det andet øje.
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Luxturna.
Danish: Kontakt lægen, før du får Luxturna, hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl.
English: Thaw one single-dose vial of concentrate and two vials of solvent at room temperature.
Danish: Optø ét enkeltdosishætteglas med koncentrat og to hætteglas med solvens ved stuetemperatur.
English: The solvent contains sodium chloride (see end of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate dihydrate (for pH adjustment), poloxamer 188 and water for injections.
Danish: Solvenset indeholder natriumchlorid (se slutningen af punkt 2), natriumdihydrogenphosphatmonohydrat (til justering af pH-værdi), dinatriumhydrogenphosphatdihydrat (til justering af pH-værdi), poloxamer 188 og vand til injektionsvæsker.
English: Concentrate and solvent for solution for injection
Danish: Koncentrat og solvens til injektionsvæske, opløsning
English: vector genomes/mL concentrate and solvent for solution for injection
Danish: vektorgenomer/ml koncentrat og solvens til injektionsvæske, opløsning
English: This ability depends on the subject's visual acuity, visual field and the extent of nyctalopia (decreased ability to perceive and/or see in dim light), each of which are functions specifically affected by the retinal disease associated with RPE65 mutations.
Danish: Denne evne afhænger af forsøgsdeltagerens synsstyrke, synsfelt og omfanget af nyktalopi (nedsat evne til at opfatte og/eller se under svage lysforhold).
English: Starting 3 days prior to the administration of Luxturna to the first eye, it is recommended that an immunomodulatory regimen is initiated following the schedule below (Table 1).
Danish: Det anbefales, at der indledes et immunmodulerende regime 3 dage før administration af Luxturna i det første øje.
English: Ask your doctor whether you should stop breast-feeding after receiving Luxturna.
Danish: Det er ukendt, om det udskilles i modermælk Spørg din læge om du skal stoppe med at amme efter at du har fået Luxtuna.
English: Gently invert the vials five times to mix the contents.
Danish: Vend forsigtigt hætteglassene på hovedet fem gange for at blande indholdet.
English: Each dose of diluted solution contains 1.5 x 10
Danish: En dosis fortyndet opløsning indeholder 1,5 x 10
English: vg voretigene neparvovec in each eye. Each dose will be delivered into the subretinal space in a total volume of 0.3 mL.
Danish: Hver dosis administreres til det subretinale rum med et samlet volumen på 0,3 ml.
English: Gently invert the vial at least five times for proper mixing.
Danish: Vend forsigtigt hætteglasset på hovedet mindst fem gange for at blande indholdet.
English: • Deposits under the retina
Danish: • Aflejringer under nethinden.
English: Concentrate and solvent for solution for injection.
Danish: Koncentrat og solvens til injektionsvæske, opløsning.
English: - Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec.
Danish: - Der skal bæres personligt sikkerhedsudtyr (herunder laboratoriekittel, beskyttelsesbriller og handsker) under klargøring eller administration af voretigen neparvovec.
English: Patients may resume swimming and strenuous activity, after a minimum of one to two weeks, on the advice of their healthcare professional.
Danish: Kanyle til subretinal injektion Anbefalet injektionsområde svømning og anstrengende fysisk aktivitet efter mindst en til to uger, alt efter øjenlægens anbefaling.
English: How Luxturna is given to you
Danish: Sådan vil du få Luxturna
English: Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec (see section 6.6).
Danish: Der skal bæres personligt sikkerhedsudstyr (herunder kittel, beskyttelsesbriller og handsker) under klargøring eller administration af voretigen neparvovec (se pkt.
English: • Nausea (feeling sick), vomiting, abdominal (belly) pain, lip pain
Danish: • Kvalme, opkastning, mavesmerter, læbesmerter
English: If it does occur, your doctor will treat the symptoms as necessary.
Danish: Hvis det sker, vil lægen behandle symptomerne på passende vis. Fortæl det til lægen eller sygeplejersken, hvis du får synsproblemer.
English: • Breakdown of the surgical wound
Danish: • Nedbrydning af operationssåret.
English: • Break in the retina
Danish: Trokar til vitrektomi
English: Rash, swelling face
Danish: Udslæt, hævelse af ansigtet
English: Adverse reactions
Danish: • Nethindeløsning
English: Hepatic and renal impairment
Danish: Hud og subkutane væv Almindelig
English: Date of first authorisation: 26 February 2015
Danish: Dato for første markedsføringstilladelse: 26. februar 2015
English: *post-marketing experience
Danish: *post-marketing erfaring
English: Currently, no formal carcinogenicity data are available.
Danish: Der findes ikke for øjeblikket nogen tilgængelige formelle carcinogenitetsdata.
English: • if you are not on dialysis
Danish: • Hvis du ikke er i dialyse
English: This effect is observed after 2 weeks is maintained with long-term treatment.
Danish: Denne virkning blev observeret efter 2 uger og opretholdt ved langtidsbehandling.
English: Changing treatment:
Danish: Skift af behandling:
English: This was not confirmed in a dog study or in clinical trials.
Danish: Dette blev ikke bekræftet ved studier på hunde eller ved kliniske studier.
English: Tablets must be swallowed whole.
Danish: Tabletterne skal sluges hele.
English: The recommended starting dose of Tasermity for adults and the elderly (> 65 years) is one or two tablets with each meal 3 times a day.
Danish: Den anbefalede startdosis af Tasermity for voksne og ældre personer (> 65 år) er en eller to tabletter sammen med hvert måltid 3 gange dagligt.
English: • if you have low levels of phosphate in your blood (your doctor will check this for you).
Danish: • Hvis du har lavt fosfatindhold i blodet (din læge vil måle det for dig)
English: Additional treatments: Due to either your kidney condition or your dialysis treatment you may:
Danish: Yderligere behandling: På grund af enten din nyresygdom eller dialysebehandlingen kan du:
English: Uncommon Very Rare
Danish: Ikke almindelig Meget sjælden Ikke kendt
English: ATC code: V03AE02.
Danish: ATC-kode: V03A E02.
English: If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal.
Danish: Hvis du er kommet til at springe en dosis over, udelades denne dosis, og den næste dosis tages på det normale tidspunkt i forbindelse med et måltid.
English: Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter.
Danish: Serumphosphat bør testes hver anden eller tredje uge, indtil der er opnået et stabilt serumphosphatniveau, og derefter jævnligt.
English: Your doctor will check for interactions between Tasermity and other medicines on a regular basis.
Danish: Lægen vil jævnligt kontrollere for interaktioner mellem Tasermity og anden medicin.
English: Triglycerides, HDL cholesterol and albumin did not change.
Danish: Triglycerider, HDL-kolesterol og albumin forandredes ikke.
English: • have a low amount of vitamin D in your blood.
Danish: • have et lavt indhold af D-vitamin i blodet.
English: Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal products.
Danish: Tættere monitorering af TSH-niveauer anbefales derfor hos patienter, der får begge lægemidler.
English: In clinical trials mean total and LDL cholesterol declined by 15-31%.
Danish: Ved kliniske studier blev middel total og LDL kolesterol reduceret med 15-31 %.
English: • develop a low or high level of calcium in your blood.
Danish: • udvikle et nedsat eller forhøjet calciumniveau i blodet.
English: The dose range may vary between 1 and 5 tablets of 800 mg per meal.
Danish: Doseringsområdet kan variere mellem 1 og 5 tabletter af 800 mg pr. måltid.
English: • if you have symptoms of delayed emptying of stomach contents such as feeling of fullness,
Danish: • Hvis du har symptomer på forsinket tømning af maveindholdet, såsom følelse af mæthed,
English: Do not crush, chew or break into pieces prior to administration.
Danish: Må ikke knuses, tygges eller brækkes i stykker inden administration.
English: This risk can be reduced by careful adherence to sterile techniques during bag changes.
Danish: Denne risiko kan reduceres ved omhyggelig overholdelse af sterile teknikker under poseskift.
English: • Tasermity should not be taken at the same time as ciprofloxacin (an antibiotic).
Danish: • Tasermity må ikke tages samtidig med ciprofloxacin (et antibiotikum).
English: Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, the Netherlands
Danish: Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, Holland
English: Each bottle contains 180 film-coated tablets.
Danish: Hver flaske indeholder 180 filmovertrukne tabletter.
English: It contains multiple amines separated by one carbon from the polymer backbone.
Danish: Den indeholder adskillige aminer adskilt af en kulstofamin af polymerstammen.
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Danish: 37 Hollands Road Haverhill Suffolk CB9 8PU Storbritannien.
English: However, in vitro and in vivo studies have indicated that sevelamer does not have genotoxic potential.
Danish: Dog har in vitro og in vivo studier antydet, at sevelamer ikke har noget genotoksisk potentiale.
English: Closer monitoring of serum bicarbonate levels is therefore recommended.
Danish: Derfor anbefales en nøje monitorering af bicarbonatniveau i serum.
English: Therefore your doctor may monitor the levels of TSH in your blood more closely.
Danish: Derfor vil lægen muligvis holde nærmere øje med TSH-niveauerne i dit blod.
English: Sevelamer hydrochloride must be taken three times per day with meals.
Danish: Sevelamerhydrochlorid skal tages tre gange dagligt i forbindelse med måltider.
English: The following side effects have been reported in patients taking Tasermity: Very common (may affect more than 1 in 10 people): nausea, vomiting
Danish: Følgende bivirkninger er rapporteret hos patienter, der tager Tasermity: Meget almindelig (kan påvirke flere end 1 ud af 10 personer): kvalme, opkastning
English: Tasermity contains sevelamer as the active ingredient.
Danish: Tasermity indeholder sevelamer som er det aktive stof.
English: • if you are allergic to sevelamer or to any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for sevelamer eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Since Tasermity does not contain calcium your doctor might prescribe additional calcium tablets.
Danish: Da Tasermity ikke indeholder calcium, kan lægen ordinere supplerende calciumtabletter.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Indberetningsfrekvensen klassificeres som meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Sevelamer hydrochloride is not absorbed and may affect the bioavailability of other medicinal products.
Danish: Sevelamerhydrochlorid absorberes ikke, men kan påvirke biotilgængeligheden af andre lægemidler.
English: Hypersensitivity*
Danish: Overfølsomhed *
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer hydrochloride.
Danish: Den gennemsnitlige, faktiske daglige dosis i den kroniske fase i et klinisk studie over 1 år var 7 g sevelamerhydrochlorid.
English: In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats).
Danish: I reproduktionsstudier var der intet tegn på, at sevelamer medførte fosterdødelighed, foster-toksicitet eller teratogenitet ved de testede doser (op til 1 g/kg/dag hos kaniner og op til 4,5 g/kg/dag hos rotter).
English: However, the causality of the sevelamer crystals in initiating such disorders has not been demonstrated.
Danish: Kausaliten mellem sevelamer krystaller og initiering af sådanne lidelser er dog ikke blevet påvist.
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer hydrochloride treatment.
Danish: Der er i øjeblikket utilstrækkelige data til at udelukke muligheden for folatmangel ved langtidsbehandling med sevelamerhydrochlorid.
English: 1411 DD Naarden The Netherlands
Danish: 1411 DD Naarden Holland
English: The recommended starting dose of sevelamer hydrochloride is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Danish: Den anbefalede startdosis af sevelamerhydrochlorid er 2,4 g eller 4,8 g dagligt baseret på klinisk behov og serumphosphatniveau.
English: Pharmacotherapeutic group: Treatment of hyperphosphatemia.
Danish: Farmakoterapeutisk klassifikation: Behandling af hyperphosphatæmi.
English: The effects may be secondary to vitamin D and/or vitamin K depletion at these high doses.
Danish: Virkningerne kan være en følge af mangel på D-vitamin og/eller K-vitamin ved disse høje doser.
English: Consequently, sevelamer hydrochloride should not be taken simultaneously with ciprofloxacin.
Danish: Derfor bør sevelamerhydrochlorid ikke tages samtidig med ciprofloxacin.
English: Dialysis Interaction studies have not been conducted in patients on dialysis.
Danish: Dialyse Der er ikke gennemført interaktionsstudier hos patienter i dialyse.
English: Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.
Danish: Øget serumfosfat kan også medføre hudkløe, røde øjne og smerter i eller brud på knogler.
English: As data on the chronic use of sevelamer hydrochloride for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2).
Danish: Da der ikke foreligger data om kronisk anvendelse af sevelamerhydrochlorid i over et år, kan potentiel absorption og akkumulation af sevelamer under langvarig kronisk behandling ikke helt udelukkes (se pkt.
English: If you forget to take Tasermity
Danish: Hvis du har glemt at tage Tasermity
English: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis, …) associated with the presence of sevelamer crystals have been reported in literature.
Danish: Tilfælde af alvorlige inflammatoriske sygdomme i forskellige dele af mave-tarmkanalen (herunder alvorlige komplikationer såsom blødning, perforation, ulceration, nekrose, colitis, ...) forbundet med tilstedeværelsen af sevelamer krystaller er blevet rapporteret i litteraturen.
English: Efficacy and safety of sevelamer hydrochloride has not been studied in patients with:
Danish: Sevelamerhydrochlorids sikkerhed og virkning er ikke undersøgt hos patienter med:
English: It cannot be excluded that sevelamer hydrochloride can bind fat-soluble vitamins contained in ingested food.
Danish: Det kan ikke udelukkes, at sevelamerhydrochlorid kan binde fedtopløselige vitaminer i indtaget mad.
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Danish: De hyppigst forekommende bivirkninger (≥ 5 % af patienterne) var alle i systemorganklassen mavetarm-kanalen.
English: When you switch from another phosphate binder to Tasermity, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Tasermity may decrease the levels of bicarbonate.
Danish: Ved skift fra en anden fosfatbinder til Tasermity vil lægen måske overveje at overvåge bicarbonatniveauet i dit blod nøjere, fordi Tasermity kan reducere bicarbonatniveauerne.
English: Pack size: 1 bottle of 180 tablets
Danish: Pakningsstørrelse: 1 flaske med 180 tabletter
English: Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities.
Danish: Mange af disse tilfælde har involveret patienter med andre lidelser, bl.a. synkeforstyrrelser eller esophagus-abnormiteter.
English: Tasermity should only be given to pregnant or breast-feeding women if clearly needed.
Danish: Tasermity må kun gives til gravide eller ammende kvinder, hvis der er et klart behov.
English: Tasermity contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Danish: Tasermity indeholder sevelamer, en ikke-absorberet phosphatbindende poly (allylaminhydrochlorid) polymer, der er fri for metal og calcium.
English: • In certain people taking levothyroxine (a thyroid hormone) and Tasermity, increased levels of thyroid stimulating hormone (TSH, a substance in your blood which helps control your body's chemical functions) may very rarely be observed.
Danish: • Hos visse personer, der tager levothyroxin (et thyroideahormon) og Tasermity, kan forhøjede niveauer af thyroidea stimulerende hormon (TSH, et stof i blodet, som medvirker til at kontrollere kroppens kemiske funktion) forekomme i yderst sjældne tilfælde.