FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid sticky eyes in the morning, the patient should be advised to apply the last drop of the day at least 30 minutes before going to bed.
Danish: For at undgå at øjenlågene er klistret sammen om morgenen, skal patienten rådes til ikke at dryppe øjnene senere end 30 minutter før sengetid.
English: - The other ingredients are benzalkonium chloride (see section 2 under ‘Cystadrops contains benzalkonium chloride'), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid and water for injections.
Danish: - Øvrige indholdsstoffer: benzalkoniumchlorid (se afsnit 2 under "Cystadrops indeholder benzalkoniumchlorid"), natriumedetat, carmellosenatrium, citronsyremonohydrat, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: Carmellose sodium Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Carmellosenatrium Citronsyremonohydrat Natriumhydroxid (til justering af pH) Saltsyre (til justering af pH) Vand til injektionsvæsker
English: Benzalkonium chloride Disodium edetate
Danish: Benzalkoniumchlorid Natriumedetat
English: The patient should be advised to follow the instructions below for opening of the vial and attachement of the dropper applicator:
Danish: Patienten skal informeres om at følge nedenstående anvisninger i åbning af flasken og påsætning af dråbetælleren:
English: • discomfort where the drops have been instilled (mainly sticky eyes and sticky eyelashes),
Danish: • gener på det sted, dråberne er dryppet i (hovedsageligt sammenklistrede øjenlåg og vipper),
English: • Immediately before using a vial for the first time, write the date of opening in the space provided on the carton box.
Danish: • Umiddelbart inden du bruger en flaske første gang, skal du skrive den dato, du åbner flasken, i det dertil beregnede felt på kartonæsken.
English: The accumulation of corneal cystine crystals increases if Cystadrops is discontinued.
Danish: Ophobningen af cystinkrystaller i hornhinden øges, hvis Cystadrops seponeres.
English: Cysteamine reduces corneal cystine crystal accumulation acting as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides.
Danish: Cysteamin reducerer ophobning af cystinkrystaller i hornhinden, idet det depleterer cystin ved at konvertere cystin til cystein og cystein-cysteaminblandede disulfider.
English: The patient should be told to discard the dropper bottle after 7 days of use.
Danish: Patienten skal informeres om, at pipetteflasken skal kasseres 7 dage efter åbning.
English: Other medicines and Cystadrops Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Cystadrops Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Cystadrops contains benzalkonium chloride
Danish: Cystadrops indeholder benzalkoniumchlorid
English: If you stop using Cystadrops
Danish: Hvis du holder op med at bruge Cystadrops
English: If you stop using Cystadrops, cystine crystals accumulation in the eye (cornea) may increase and lead to increased sensitity to light (photophobia), corneal deterioration (keratopathy) and loss of vision.
Danish: Hvis du holder op med at bruge Cystadrops, kan ophobningen af cystinkrystaller i hornhinden vokse og medføre øget følsomhed for lys (fotofobi), nedbrydning af hornhinden (keratopati) og synstab.
English: Before opening:
Danish: Inden åbning:
English: • 1 dropper applicator.
Danish: • 1 dråbetæller.
English: The drop will go in here (picture 6).
Danish: Her skal dråben placeres (billede 6).
English: Benzalkonium chloride is known to discolour soft contact lenses.
Danish: Benzalkoniumchlorid er kendt for at misfarve bløde kontaktlinser.
English: Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Danish: Cystadrops er indiceret til behandling af aflejringer af cystinkrystaller i hornhinden hos voksne og børn over 2 år med cystinose.
English: In case of concomitant therapy with other topical ocular medicinal products, an interval of ten minutes should be allowed between successive applications.
Danish: I tilfælde af samtidig behandling med andre topikale okulære lægemidler skal der gå 10 minutter mellem anvendelse af hvert præparat.
English: It is used to reduce the quantity of cystine crystals in the surface of the eye (cornea) in adults and children from 2 years of age with cystinosis.
Danish: Øjendråberne anvendes til at nedsætte mængden af cystinkrystaller på øjets overflade (hornhinden) hos voksne og børn fra 2 år med cystinose.
English: Cysteamine excretion in human's milk is unknown.
Danish: Det er ukendt, om cysteamin udskilles i human mælk.
English: • Unscrew the small white cap from the dropper.
Danish: • Skru den lille, hvide hætte af dråbetælleren.
English: If you forget to use Cystadrops
Danish: Hvis du har glemt at bruge Cystadrops
English: Preclinical data on oral cysteamine:
Danish: Prækliniske data for oralt cysteamin
English: • Cystadrops can be used for up to 7 days from the time of opening.
Danish: • Cystadrops må bruges i op til 7 dage efter, flasken er blevet åbnet.
English: • The recommended dose is 1 drop in each eye, 4 times a day during waking hours.
Danish: • Den anbefalede dosis er 1 dråbe i hvert øje 4 gange dagligt i dagtimerne (mens du er vågen).
English: Accumulation of crystals in the eye can lead to increased sensitivity to light (photophobia), corneal deterioration (keratopathy) and loss of vision .
Danish: Ophobning af krystaller i øjnene kan medføre øget følsomhed for lys (fotofobi), nedbrydning af hornhinden (keratopati) og synstab.
English: Cystadrops can be used for up to 7 days from the time of opening.
Danish: Cystadrops må bruges i op til 7 dage efter, flasken blevet åbnet.
English: To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the dropper bottle.
Danish: For at forebygge kontaminering af dråbetælleren og øjendråberne skal der udvises forsigtighed for at undgå, at pipetteflaskens dråbetæller berører øjenlåg, øjenomgivelser og andre overflader.
English: After first opening:
Danish: Efter åbning:
English: Cystadrops is an eye drops solution that contains the active substance cysteamine (also known as mercaptamine).
Danish: Om Cystadrops Cystadrops er øjendråber, der indeholder det aktive stof cysteamin (kaldes også mercaptamin).
English: • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Danish: • Dråbetælleren må ikke røre ved dit øje, øjenlåg, øjenomgivelserne eller andre overflader.
English: 5 mL solution in a 10 mL amber glass vial closed by a bromobutyl stopper and sealed with an aluminium tear-off cap. A PVC dropper applicator with HDPE closure is packed separately and included in each carton box.
Danish: 5 ml opløsning i en 10 ml ravfarvet glasflaske, lukket med brombutylprop og forseglet med en aluminiumshætte.
English: What you need to know before you use Cystadrops
Danish: Det skal du vide, før du begynder at bruge Cystadrops
English: • irritation of eyelid
Danish: • irritation i øjenlåg
English: What Cystadrops contains - The active substance is cysteamine (mercaptamine), as hydrochloride.
Danish: Cystadrops indeholder: - Aktivt stof: cysteamin (mercaptamin) som hydrochlorid.
English: A trend towards a lower IVCM total score in Cystadrops arm was observed at day 30.
Danish: Der blev på dag 30 observeret en udvikling mod en lavere total IVCM-score i Cystadrops-armen.
English: Genotoxicity studies have been performed: induction of chromosome aberrations in cultured eukaryotic cell lines has been reported and specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
Danish: Specifikke studier med cysteamin viste ingen mutagen effekt i Ames' test og ingen klastogen effekt i mikronukleustesten hos mus.
English: Benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.
Danish: Benzalkoniumchlorid kan irritere øjnene, og man ved, at det kan misfarve bløde kontaktlinser.
English: Each mL contains mercaptamine hydrochloride equivalent to 3.8 mg mercaptamine (cysteamine).
Danish: En ml indeholder mercaptaminhydrochlorid svarende til 3,8 mg mercaptamin (cysteamin).
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Danish: Hvis patienten får tågesyn efter drypning, skal han/hun vente med at føre motorkøretøj eller betjene maskiner, indtil synet er klart igen.
English: Human pharmacokinetic assessment following ocular administration of Cystadrops was not performed.
Danish: Cystadrops' farmakokinetik er ikke undersøgt efter administration i øjnene hos mennesker.
English: Benzalkonium chloride (see leaflet for further information), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid, water for injections.
Danish: Benzalkoniumchlorid (se indlægssedlen), natriumedetat, carmellosenatrium, citronsyremonohydrat, natriumhydroxid, saltsyre, vand til injektionsvæsker.
English: A mean decrease in corneal cystine crystal deposits of 30%, in comparison with baseline, was maintained over time with a median dosing regimen of 3 drops/eye/day (range 1-3 drops) for 7 of the 8 patients.
Danish: Ved en mediandosis på 3 dråber/øje/dag (1-3 dråber) blev der hos 7 af de 8 patienter over tid opretholdt en gennemsnitlig reduktion i aflejring af cystinkrystaller i hornhinden på 30 % sammenlignet med baseline.
English: Viscous, clear solution.
Danish: En tyktflydende, klar opløsning.
English: Each mL contains 3.8 mg of cysteamine (mercaptamine), as hydrochloride.
Danish: En ml indeholder 3,8 mg cysteamin (mercaptamin) som hydrochlorid.
English: The recommended dose is one drop in each eye, 4 times a day during waking hours.
Danish: Den anbefalede dosis er en dråbe i hvert øje 4 gange dagligt i dagtimerne (i patientens vågenperiode).
English: To use the eye drops, please follow the instructions below carefully.
Danish: Følg nøje nedenstående anvisninger i brug af øjendråberne.
English: The effect on pregnancy of untreated cystinosis is also unknown.
Danish: Det vides heller ikke, i hvilket omfang ubehandlet cystinose måtte indvirke på graviditet.
English: One mL of eye drops solution contains 3.8 mg of cysteamine.
Danish: En ml øjendråber, opløsning, indeholder 3,8 mg cysteamin.
English: Only use the drops in your eyes (ocular use).
Danish: Dråberne må kun anvendes i øjnene.
English: • eye redness, eye itching, eye irritation (burning)
Danish: • røde øjne, øjenkløe, irritation i øjnene (svie)
English: However it should be considered that the recommended daily dose of cysteamine applied as eye drops is no more than approximately 0.4% of the highest recommended daily oral dose of cysteamine in any age group.
Danish: Det skal imidlertid tages i betragtning, at det for alle aldersgrupper gælder, at den anbefalede daglige okulære dosis af cysteamin kun er ca. 0,4 % af den højeste anbefalede daglige dosis af oral cysteamin.
English: What Cystadrops looks like and contents of the pack Cystadrops is a clear and viscous eye drops solution.
Danish: Udseende og pakningsstørrelser Cystadrops er klare og tyktflydende øjendråber (opløsning).
English: Use a new vial.
Danish: Tag en ny flaske i brug.
English: Posology
Danish: KARTONÆSKE
English: Check with your doctor or pharmacist if you are not sure.
Danish: Tal med lægen eller apotekspersonalet, hvis du er bekymret.
English: • 1 amber glass vial containing 5 mL of eye drops solution,
Danish: • 1 ravfarvet glasflaske med 5 ml øjendråber
English: • Discard 7 days after opening.
Danish: • Kasser flasken 7 dage efter åbning.
English: Although no effects during pregnancy and breast-feeding are anticipated, since systemic exposure to cysteamine is negligible, precautions should be taken with concomitant treatment with oral cysteamine.
Danish: Der skal tages forholdsregler ved samtidig behandling med oralt cysteamin, selvom der ikke forventes nogen indvirkning på graviditet eller amning, fordi den systemiske eksponering for cysteamin er ubetydelig.
English: • Hold the dropper bottle, pointing down, between your thumb and fingers.
Danish: • Hold pipetteflasken med fingrene, flasken skal vende nedad.
English: • Remove the grey stopper (picture 3) from the vial.
Danish: • Fjern den grå prop fra flasken (billede 3).
English: The most common adverse reactions are eye pain, ocular hyperaemia, eye pruritus, lacrimation increased, blurred vision or eye irritation.
Danish: De hyppigste bivirkninger er øjensmerter, okulær hyperæmi, øjenkløe, tåreflåd, tågesyn og øjenirritation.
English: • Write down the date you opened the vial in the space on the carton.
Danish: • Skriv datoen, hvor du åbner flasken, i feltet på kartonæsken.
English: Each mL of eye drops solution contains 0.1 mg of benzalkonium chloride.
Danish: Hjælpestof, som behandleren skal være opmærksom på: En ml øjendråber, opløsning, indeholder 0,1 mg benzalkoniumchlorid.
English: Very common : instillation site discomfort (mainly sticky eyes and sticky eyelashes)
Danish: Meget almindelig: gener på inddrypningsstedet (hovedsageligt sammenklistrede øjenlåg og vipper) Almindelig: smerter på inddrypningsstedet
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Before the first admnistration, in order to facilitate the administration, the patient should be told to bring back Cystadrops at room temperature.
Danish: Inden første administration skal patienten informeres om at lade Cystadrops få stuetemperatur for at lette administrationen.
English: Step 3: Using the eye drops
Danish: Trin 3: Sådan bruger du øjendråberne
English: Very common : eye pain, vision blurred, eye irritation, ocular hyperaemia, eye pruritus, lacrimation increased, deposit eye
Danish: Meget almindelig: øjensmerter, tågesyn, øjenirritation, okulær hyperæmi, øjenkløe, tåreflåd, aflejringer i øjnene
English: Common : abnormal sensation in eye, dry eye, foreign body sensation in eye, eyelid oedema, eyelid irritation, visual impairment, hordeolum
Danish: Almindelig: unormale fornemmelser i øjnene, tørre øjne, fornemmelse af fremmedlegeme i øjnene, øjenlågsødem, øjenlågsirritation, nedsat syn, bygkorn
English: How to use Cystadrops
Danish: Sådan skal du bruge Cystadrops
English: The recommended total daily ocular dose of cysteamine is no more than approximately 0.4% of the highest recommended dose of oral cysteamine in any age group.
Danish: For alle aldersgrupper gælder, at den anbefalede totale dagsdosis af cysteamin til okulær anvendelse kun er ca. 0,4 % af den højeste anbefalede orale dosis cysteamin.
English: After first opening: keep the dropper bottle tightly closed in the outer carton in order to protect from light.
Danish: Efter anbrud: Opbevar pipetteflasken tæt lukket til i den ydre karton for at beskytte mod lys.
English: Cystadrops 3.8 mg/mL eye drops solution cysteamine
Danish: Cystadrops 3,8 mg/ml øjendråber, opløsning cysteamin
English: Recordati
Danish: Øjne
English: Cystadrops 3.8 mg/mL eye drops solution
Danish: Cystadrops 3,8 mg/ml øjendråber, opløsning
English: Eye drops solution.
Danish: Øjendråber, opløsning.
English: Therefore contact with soft contact lenses is to be avoided for15 minutes after having applied the eye drops.
Danish: Derfor skal du fjerne bløde kontaktlinser, inden du drypper øjnene, og først sætte dem på plads igen 15 minutter efter, at du har dryppet øjnene.
English: Cystadrops 3.8 mg/mL eye drops solution cysteamine (mercaptamine)
Danish: Cystadrops 3,8 mg/ml øjendråber, opløsning cysteamin (mercaptamin)
English: However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), women taking oral cysteamine should not breast-feed.
Danish: På grund af resultater fra dyrestudier med diegivende hunner og nyfødte (se pkt.
English: Recordati Rare Diseases Immeuble "Le Wilson" 70, avenue du Général de Gaulle FR-92800 Puteaux France
Danish: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Frankrig
English: If the patient misses an instillation, the patient should be told to continue the treatment with the next instillation.
Danish: Patienten skal informeres om at fortsætte behandlingen med næste drypning, hvis han/hun glemmer en dosis.
English: After first opening, the patient should be told to keep the dropper bottle at room temperature.
Danish: Patienten skal informeres om at opbevare pipetteflasken ved stuetemperatur, når den først er åbnet.
English: • Keep the dropper bottle tightly closed in the outer carton in order to protect from light.
Danish: • Opbevar pipetteflasken tæt tillukket i den ydre karton for at beskytte mod lys.
English: • To avoid potential irritation, remove excess medicine around the eye with a moist tissue
Danish: • Fjern overskydende medicin med en fugtig serviet (billede 8) for at undgå mulig irritation.
English: Keep the dropper bottle tightly closed in the outer carton in order to protect from light.
Danish: Opbevar pipetteflasken tæt tillukket i den ydre karton for at beskytte mod lys.
English: • Bring the dropper bottle tip close to the eye. Use the mirror if it helps.
Danish: Brug spejlet, hvis det hjælper.
English: Opened on:
Danish: Anbrudt den:
English: Discard 7 days after first opening.
Danish: Kasseres 7 dage efter anbrud.
English: Since the recommended total daily dose of cysteamine base is no more than approximately 0.4% of the highest recommended oral dose of cysteamine base in any age group, no interactions with orally administered medicinal products are anticipated.
Danish: Der forventes ingen interaktioner med oralt administrerede lægemidler, eftersom det for alle aldersgrupper gælder, at den anbefalede totale dagsdosis af cysteaminbase kun er ca. 0,4 % af den højeste anbefalede orale dosis cysteaminbase.
English: VIAL LABEL
Danish: FLASKEETIKET
English: • To avoid sticky eyes in the morning, it is recommended to apply the last drop of the day at least 30
Danish: • Det anbefales, at du kommer den sidste dråbe i øjnene mindst 30 minutter før sengetid for at undgå, at dine øjenlåg er klistret sammen om morgenen.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar flasken i den ydre karton for at beskytte mod lys.
English: • Take the dropper out of its sachet, without touching the end intended to be attached to the vial, attach it (picture 4) to the vial and do not remove it.
Danish: Sæt dråbetælleren på flasken (billede 4) og tag den ikke af igen.
English: • Keep the vial in the outer carton in order to protect from light.
Danish: • Opbevar pipetteflasken i den ydre karton for at beskytte mod lys.
English: • Take the dropper out of its sachet, without touching the end intended to be attached to the vial, and attach it (picture 4) to the vial.
Danish: • Tag dråbetælleren ud af posen uden at berøre den ende, der skal sættes på flasken.
English: • visual impairement
Danish: • nedsat syn
English: If you use more Cystadrops than you should
Danish: Hvis du brugt for meget Cystadrops
English: • stye
Danish: • tågesyn
English: • Cystadrops must be brought back at room temperature before the first administration.
Danish: • Inden du anvender Cystadrops første gang, skal øjendråberne have stuetemperatur.
English: It must then be removed by a doctor or nurse.
Danish: Det skal så fjernes af en læge eller en sygeplejerske.
English: Medicinal product no longer authorise©EMEA 2008
Danish: Lægemidlet er ikke længere autoriseret til sal©EMEA 2008
English: It is a well-known substance, which has been used to control pain for many years.
Danish: Det er et velkendt stof, som kan anvendes til smertekontrol i mange år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for IONSYS to Janssen-Cilag International NV on 24 January 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for IONSYS til Janssen-Cilag International NV den 24. januar 2006.
English: The system will stop working 24 hours after the first dose or after 80 doses have been delivered.
Danish: Systemet holder op med at virke efter 24 timer efter første dosis eller efter at have afgivet 80 doser.
English: Four main studies were performed in about 800 patients after an operation.
Danish: Omkring 800 patienter deltog i fire hovedundersøgelser efter en operation.
English: IONSYS can be used up to six times in one hour, but for no more than 80 doses within a 24-hour period.
Danish: IONSYS kan anvendes op til seks gange i timen, men må ikke overstige 80 doser inden for en periode på 24 timer.
English: It is given using a system that is operated by the patient.
Danish: Det gives ved hjælp af et system, som styres af patienten.
English: The effects of IONSYS were first tested in experimental models before being studied in humans.
Danish: Virkningerne af IONSYS blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Other information about IONSYS:
Danish: Andre oplysninger om IONSYS:
English: The Committee recommended that IONSYS be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for IONSYS.
English: However, the risk with IONSYS is low, as the medicine is for short-term use.
Danish: Risikoen i forbindelse med IONSYS er dog lav, da lægemidlet er beregnet til korttidsbrug.
English: These studies measured the number of patients who stopped treatment because they were not getting enough pain relief.
Danish: Disse undersøgelser målte antallet af patienter, der stoppede behandlingen, fordi de ikke fik tilstrækkelig smertelindring.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IONSYS EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) IONSYS EPAR - sammendrag for offentligheden
English: IONSYS must only be used in hospital, and it must not be used in patients who have respiratory problems (such as breathing difficulties), or heart, liver or kidney problems.
Danish: IONSYS må kun anvendes på hospitaler og må ikke anvendes til patienter med åndedrætsproblemer (såsom vejrtrækningsvanskeligheder) eller med hjerte-, lever- eller nyreproblemer.
English: A doctor or a nurse applies the transdermal system to the patient's skin on the chest or upper arm.
Danish: En læge eller en sygeplejerske sætter transdermalt systemet fast på patientens hud (på brystet eller overarmen).
English: The company that makes IONSYS will monitor the key safety risks associated with IONSYS such as overdose, abuse, addiction or misuse, and will provide an educational plan for patients, doctors and healthcare providers, aimed at minimising the risk and supporting the safe and effective use of the medicine.
Danish: Firmaet, som fremstiller IONSYS, skal overvåge de vigtigste sikkerhedsrisici i forbindelse med IONSYS, f.eks. overdosering, misbrug, afhængighed eller forkert anvendelse, og fremlægge en uddannelsesplan for patienter, læger og fagfolk inden for sundhedssektoren, som tager sigte på at minimere risiciene og styrke sikker og effektiv anvendelse af lægemidlet.
English: IONSYS is given to the patient after an operation.
Danish: IONSYS gives til patienten efter en operation.
English: Fentanyl, the active substance in IONSYS, can be abused.
Danish: Fentanyl, det aktive stof i IONSYS, kan misbruges.
English: The most common side effects with IONSYS (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache and erythema (redness of the skin) at the site of application.
Danish: De hyppigste bivirkninger af IONSYS (som ses hos flere end 1 ud af 10 patienter) er kvalme, opkast, hovedpine og erytem (rødme af huden) på påføringsstedet.