FrancophonIA/ELRC3.0 huggingface dataset:
English: The treatment should not be stopped.
Danish: Behandlingen må ikke stoppes.
English: Each box contains:
Danish: Hver æske indeholder:
English: • Repeat the step 3 for the other eye.
Danish: • Gentag trin 3 for det andet øje.
English: 19 patients were under 6 years old, 21 between 6 and 12 years old and 29 between 12 and 18 years old.
Danish: 19 patienter var under 6 år, 21 var mellem 6 og 12 år, og 29 var mellem 12 og 18 år.
English: OCT-1 study
Danish: OCT-1-studiet
English: The majority of these adverse reactions are transient and most are mild or moderate.
Danish: De fleste af disse bivirkninger er forbigående, og de fleste er lette eller moderate.
English: You can usually carry on taking the drops, unless the effects are serious.
Danish: Du kan normalt fortsætte med at bruge dråberne, medmindre bivirkningerne er alvorlige.
English: Date of first authorisation: 19 January 2017 10.
Danish: Dato for første markedsføringstilladelse: 19 januar 2017
English: The following side effects were reported:
Danish: Følgende bivirkninger er rapporteret:
English: None of the patients discontinued treatment over the 5 year follow-up.
Danish: Ingen af patienterne afbrød behandlingen i løbet af den 5 år lange opfølgningsperiode.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), 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: Hyppigheden defineres 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: Do not stop using Cystadrops without speaking to your doctor.
Danish: Du må ikke holde op med at bruge Cystadrops uden at tale med din læge.
English: 15 patients were exposed to Cystadrops.
Danish: 15 patienter blev eksponeret for Cystadrops.
English: Therefore, oral cysteamine should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
Danish: Derfor bør oralt cysteamin ikke anvendes under graviditet, især ikke i første trimester, medmindre det er strengt nødvendigt.
English: The efficacy and safety results are similar in both paediatric and adult populations.
Danish: Resultaterne for virkning og sikkerhed er de samme i den pædiatriske og voksne population.
English: Cystadrops must be used every day for the medicine to work properly.
Danish: Cystadrops skal bruges hver dag, for at medicinen virker korrekt.
English: The IVCM total score was the primary efficacy endpoint.
Danish: Den totale IVCM-score var det primære effektmål.
English: Therefore talk to your doctor before stopping this treatment.
Danish: Du skal derfor tale med din læge, inden du stopper behandlingen.
English: At this dose, weight gain and survival of the offspring during lactation was also reduced.
Danish: Ved denne dosis var vægtstigning og overlevelse hos afkommet i dieperioden også reduceret.
English: If a drop misses your eye Try again.
Danish: Hvis en dråbe ikke kommer ind i øjet Prøv igen.
English: It will facilitate the use of the drops.
Danish: Det gør anvendelse af dråberne lettere.
English: • Make sure that you do not lose the small white cap (picture 5) that comes on the top of the dropper.
Danish: • Sørg for, at du ikke mister den lille hvide hætte (billede 5), der sidder på spidsen af dråbetælleren.
English: Step 1: Before using a vial for the first time
Danish: Trin 1: Inden du bruger en flaske første gang
English: • pain where the drops have been instilled
Danish: • smerter på det sted, dråberne er dryppet i
English: Reported adverse reactions are listed below, by system organ class and by frequency (by patient).
Danish: De rapporterede bivirkninger er anført nedenfor i henhold til systemorganklasse og hyppighed (pr. patient).
English: • Do not refrigerate.
Danish: • Må ikke nedfryses.
English: You may find that your vision is blurred for a few minutes just after using Cystadrops.
Danish: Dit syn kan være sløret i et par minutter, lige efter du har brugt Cystadrops.
English: Clinical data on safety and efficacy were collected during the 2 clinical trials (OCT-1 and CHOC studies).
Danish: Kliniske data for sikkerhed og virkning blev indsamlet under de 2 kliniske forsøg (OCT-1 og CHOC).
English: The consequence of this for the clinical use of the drug is unknown.
Danish: Konsekvensen af dette for den kliniske anvendelse er ukendt.
English: Frequency, type and severity of adverse reactions in children are the same as in adults.
Danish: Bivirkningernes hyppighed, type og sværhedsgrad hos børn er de samme som hos voksne.
English: Those instructions are also available as an animated movie on www.cystadrops.net ‘QR code to be included'
Danish: Du kan også se disse instruktioner i en animeret film på www.cystadrops.net ‘QR-code skal inkluderes'
English: 69 paediatric patients were followed through clinical trials and the French NPU programme.
Danish: 69 pædiatriske patienter blev fulgt i kliniske forsøg og det franske NPU-program.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer)
English: The recommended interval between each instillation is 4 hours.
Danish: Det anbefalede interval mellem 2 drypninger er 4 timer.
English: This study assessed the safety and efficacy of Cystadrops during 5 years.
Danish: Dette studie vurderede sikkerheden og virkningen af Cystadrops over 5 år.
English: Dose adaptation was performed following ocular examination.
Danish: Dosis blev justeret efter øjenundersøgelser.
English: Temporary (in average less than 1 minute) blurred vision or other visual disturbances may affect the ability to drive or use machines.
Danish: Midlertidigt (gennemsnitligt under 1 minut) tågesyn eller anden synsforstyrrelse kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Before first opening: store in a refrigerator.
Danish: Inden anbrud: Opbevares i køleskab.
English: The mean IVCM total score was calculated for 11 patients.
Danish: Den gennemsnitlige, totale IVCM-score blev beregnet for 11 patienter.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The mean decrease by 40% in the Cystadrops arm was confirmed at day 90.
Danish: En gennemsnitlig reduktion på 40 % i Cystadrops-armen blev bekræftet på dag 90.
English: Each carton box contains 1 vial and 1 dropper applicator.
Danish: Hver kartonæske indeholder 1 flaske og 1 dråbetæller.
English: In total 15 paediatric patients were exposed to Cystadrops whereof 3 subjects (including one 2 year and one 3 year old subject) being less than 6 years of age.
Danish: I alt blev 15 pædiatriske patienter eksponeret for Cystadrops, hvoraf de 3 (herunder en 2-årig og en 3årig) var under 6 år.
English: • Get the dropper bottle and a mirror.
Danish: • Tag pipetteflasken og et spejl.
English: Take special care not to touch the tip of the dropper with your fingers.
Danish: Vær ekstra forsigtig med ikke at røre ved spidsen af dråbetælleren med dine fingre.
English: If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.
Danish: Hvis graviditet konstateres eller planlægges, skal behandlingen nøje genovervejes, og patienten skal informeres om den mulige teratogene risiko ved cysteamin.
English: If you wear soft contact lenses
Danish: Hvis du går med bløde kontaktlinser
English: Wait for your next scheduled application and then continue with your regular routine.
Danish: Vent indtil næste planlagte drypning og fortsæt så, som du plejer.
English: Experimental administration of the drug causes depletion of somatostatin in several animal species.
Danish: Eksperimentel administration af lægemidlet medfører somatostatindepletering hos flere dyrearter.
English: Similarly to other topically administered ocular products, systemic absorption is likely to occur.
Danish: Ligesom for andre lokalt administrerede øjenpræparater vil der sandsynligvis forekomme systemisk absorption.
English: • abnormal sensation in eye, a feeling of something in the eye
Danish: • unormal fornemmelse i øjnene, følelse af at have noget i øjet
English: Systemic exposure of cysteamine following ocular administration is therefore lower than following oral administration.
Danish: Den systemiske eksponering for cysteamin efter administration i øjnene er derfor lavere end efter oral administration.
English: Do not use Cystadrops If you are allergic to cysteamine or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Cystadrops hvis du er allergisk over for cysteamin eller et af de øvrige indholdsstoffer i Cystadrops (angivet i afsnit 6).
English: Pregnancy and breast-feeding Even if the level of Cystadrops in the blood is negligible, precautions should be taken.
Danish: Graviditet og amning Selvom indholdet af Cystadrops i blodet er ubetydeligt, bør der træffes forholdsregler.
English: No carcinogenic studies have been conducted with cysteamine.
Danish: Der er ikke udført karcinogenicitetsstudier med cysteamin.
English: If you use Cystadrops with another eye medicine Ensure that there is at least a 10 minute gap between using Cystadrops and the other eye medicine.
Danish: Hvis du bruger Cystadrops sammen med et andet lægemiddel til øjnene Sørg for, at der går mindst 10 minutter mellem brug af Cystadrops og det andet lægemiddel.
English: Belgique/België/Belgien
Danish: Belgique/België/Belgien Recordati
English: There are no adequate data from the use of cysteamine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af cysteamin til gravide kvinder.
English: • You must throw away the dropper bottle 7 days after you first opened it even if it is not empty.
Danish: • Du skal kassere pipetteflasken 7 dage efter åbning, også selvom den ikke er tom.
English: After 30 days of treatment and at a median frequency of 4 instillations per day, an average 30% decrease in the IVCM total score was observed.
Danish: Efter 30 dages behandling med mediant 4 drypninger pr. dag sås der en gennemsnitlig reduktion på 30 % i den totale IVCM-score.
English: This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/m2/day.
Danish: Dette svarer til 0,6 g/m2/dag hos rotter, hvilket er under halvdelen af den anbefalede kliniske vedligeholdelsesdosis af cysteamin (1,30 g/m2/dag).
English: • The recommended interval between each application is 4 hours (for example, you can have your eye drops at 8.00 am, 12.00 am, 4.00 pm and 8.00 pm).
Danish: • Det anbefales, at der går 4 timer mellem hver drypning (du kan f.eks. bruge øjendråberne kl. 8.00,
English: Warnings and precautions Talk to your doctor or pharmacist before using Cystadrops.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du bruger Cystadrops.
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Danish: Der sås nedsat fertilitet hos rotter ved 375 mg/kg/dag, en dosis ved hvilken vægtstigning blev hæmmet.
English: • After using Cystadrops, press a finger into the corner of your eye by the nose (picture 7), then gently massage your upper eyelid to spread the eye drops over the eye.
Danish: • Når du har brugt Cystadrops, skal du sætte en finger mod øjenkrogen ind mod næsen (billede 7) og forsigtigt massere dit øverste øjenlåg for at sprede øjendråberne over øjet.
English: • Store in a refrigerator (2°C - 8°C).
Danish: • Opbevares i køleskab (2 °C-8 °C).
English: Cystadrops may have a minor influence on the ability to drive and use machines.
Danish: Cystadrops påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: What is cystinosis
Danish: Hvad er cystinose
English: Do not drive or use machines until your vision is clear.
Danish: Du må ikke køre motorkøretøj eller betjene maskiner, hvis du ikke kan se klart.
English: Pull down your eyelid with a clean finger, until there is a “pocket” between the eyelid and your eye.
Danish: Træk ned i nederste øjenlåg med en ren finger, indtil der dannes en lomme mellem øjenlåget og øjet.
English: High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Danish: Høje doser cysteamin, administreret enten oralt eller parenteralt, forårsager ulcus duodeni hos rotter og mus, men ikke hos aber.
English: This study was a randomised, controlled trial to assess the efficacy and the safety profile of Cystadrops following a period of 90 days of treatment at a dose regimen of 4 drops/eye/day.
Danish: Dette studie var et randomiseret kontrolleret stufie til vurdering af Cystadrops' virkning og sikkerhedsprofil efter 90 dages behandling med en dosis på 4 dråber/øje/dag.
English: If you put too many drops in your eyes, rinse your eyes out, preferably with saline solution (or if not available with warm water).
Danish: Hvis du kommer for mange dråber i øjnene, skal du skylle øjnene - helst med saltvand (hvis du ikke har saltvand, skal du bruge varmt vand).
English: Treatment with Cystadrops should be initiated under the supervision of a physician experienced in the management of cystinosis.
Danish: Behandling med Cystadrops skal indledes under supervision af en læge med erfaring i behandling af cystinose.
English: Cystinosis is a rare hereditary disease in which the body is unable to remove excess cystine (an amino acid), causing cystine crystals to accumulate in various organs (such as kidney and eyes).
Danish: Cystinose er en sjælden arvelig sygdom, hvor kroppen ikke er i stand til at fjerne overskud af cystin (en aminosyre), hvilket forårsager, at der ophobes cystinkrystaller i forskellige organer (f.eks. nyrerne og øjnene).
English: Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Danish: Reproduktionsstudier viste embryo-/føtotoksisk effekt (resorption og tab efter implantation) hos rotter ved dosisniveauer på 100 mg/kg/dag og hos kaniner, der fik cysteamin 50 mg/kg/dag.
English: No data on the effect of cysteamine on human fertility are available.
Danish: Der er ingen data om cysteamins indvirkning på human fertilitet.
English: After first opening: 7 days.
Danish: Efter anbrud: 7 dage.
English: CHOC study
Danish: CHOC-studiet
English: • Keep Cystadrops at room temperature (it will facilitate the use of the dropper).
Danish: • Opbevar Cystadrops ved stuetemperatur (det gør det lettere at bruge dråbetælleren).
English: • Remove the green protective cap (picture 1).
Danish: • Fjern den grønne beskyttelseshætte (billede 1).
English: • Wash your hands carefully in order to avoid microbiological contamination of the content in the vial.
Danish: • Vask hænderne grundigt for at undgå mikrobiel kontaminering af flaskens indhold.
English: Patients should be instructed to remove contact lenses prior to the administration of the eye drops and wait at least 15 minutes before re-inserting contact lenses.
Danish: Patienten skal informeres om at tage kontaktlinserne ud inden administration af øjendråberne og vente mindst 15 minutter, før kontaktlinserne sættes i igen.
English: Pharmacotherapeutic group: Ophtalmologicals, other ophtalmologicals, ATC code: S01XA21.
Danish: Farmakoterapeutisk klassifikation: Oftalmologiske lægemidler, andre oftalmologiske lægemidler, ATC-kode: S01XA21.
English: Step 4: Storing the eye drops after use
Danish: Trin 4: Opbevaring af øjendråberne efter brug
English: • Remove the metal seal (picture 2).
Danish: • Fjern metalforseglingen (billede 2).
English: • Replace the small white cap on the dropper immediately after use.
Danish: • Sæt den lille hvide hætte på dråbetælleren igen straks efter brug.
English: Administration of cysteamine in neonate rats induced cataracts.
Danish: Administration af cysteamin til nyfødte rotter inducerede katarakt.
English: vial vial dropper dropper small white cap turn and push to attach small white cap
Danish: flaske flaske dråbetæller dråbetæller lille hvid hætte drej og pres for at påsætte lille hvid hætte
English: The efficacy was assessed with In-Vivo Confocal Microscopy total score (IVCM score) by quantifying the cystine crystals in the 7 layers of the cornea.
Danish: Virkningen blev vurderet som total score ved in vivo konfokal mikroskopi (IVCM-score) med kvantificering af cystinkrystaller i hornhindens 7 lag.
English: • Check the opening date that you wrote down on the carton box.
Danish: • Tjek den dato, du skrev på kartonæsken.
English: Single doses of the drug inhibit prolactin secretion in animals.
Danish: Enkeltdoser af lægemidlet hæmmer prolaktinsekretionen hos dyr.
English: Move firmly the dropper bottle up and down to facilitate the filing of the dropper.
Danish: Ryst pipetteflasken op og ned for at fylde dråbetælleren.
English: The dose should not exceed 4 drops a day in each eye.
Danish: Dosis må ikke overstige 4 dråber pr. øje pr. dag.
English: Two clinical trials were performed with Cystadrops: a single arm clinical trial on 8 children and adults (OCT-1 study) and a randomised, multi-centre, open label, active controlled phase III clinical trial (CHOC study) conducted on 32 patients.
Danish: Der er udført to kliniske forsøg med Cystadrops: Et klinisk forsøg med én behandlingsarm og 8 børn og voksne (OCT-1-studiet) og et randomiseret åbent klinisk multicenterforsøg (CHOC-studiet) udført med 32 patienter.
English: medicine deposit on the eyelashes, around the eyes
Danish: medicinrester på øjenvipperne og rundt om øjnene
English: Cystadrops contains benzalkonium chloride which may cause eye irritation.
Danish: Cystadrops indeholder benzalkoniumchlorid, som kan irritere øjnene.
English: The dose could be decreased progressively (to a minimum total daily dose of 1 drop in each eye) depending on the results of ophthalmic examination (such as, corneal cystine crystal deposits, photophobia).
Danish: Dosis kan nedsættes progressivt (til en daglig minimumsdosis på 1 dråbe i hvert øje), afhængigt af øjenundersøgelsernes resultater (f.eks. aflejringer af cystinkrystaller i hornhinden, fotofobi).
English: • Do not touch the opening of the vial after removing the grey stopper.
Danish: • Rør ikke ved flaskens åbning, når du har taget den grå prop af.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cystadrops in one or more subsets of the paediatric population in the treatment of corneal cystine crystal deposits in cystinosis patients (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Cystadrops i en eller flere undergrupper af den pædiatriske population ved behandling af aflejringer af cystinkrystaller i hornhinden hos cystinose-patienter (se pkt.
English: The safety and efficacy of Cystadrops in children aged less than 2 years has not been established.
Danish: Cystadrops' sikkerhed og virkning hos børn under 2 år er ikke klarlagt.
English: remove remove remove metal seal vial green protective cap grey stopper
Danish: fjern fjern fjern metalforsegling flaske grøn beskyttelseshætte grå prop
English: Benzalkonium chloride, which is commonly used as a preservative in ophtalmic products, has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Danish: Det er også rapporteret, at benzalkoniumchlorid, der hyppigt anvendes som konserveringsmiddel i øjenpræparater, har forårsaget punktat keratopati og/eller toksisk ulcerativ keratopati.
English: Systemic exposure following ocular administration is anticipated to be low.
Danish: Det forventes, at den systemiske eksponering vil være lav efter administration i øjnene.
English: Step 2: Before using the eye drops
Danish: Trin 2: Inden du bruger øjendråberne
English: Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Danish: Der er beskrevet teratogen effekt hos rotter, hvis cysteamin administreres i en dosis på 100 mg/kg/dag under organogenesen.
English: What you need to know before you use Cystadrops 3.
Danish: Det skal du vide, før du begynder at bruge Cystadrops 3.
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet, herunder teratogen effekt (se pkt.
English: How to use Cystadrops 4.
Danish: Sådan skal du bruge Cystadrops 4.
English: Superiority of Cystadrops was demonstrated compared to the control arm (cysteamine hydrochloride 0.10%) p<0.001 95% CI (2.11; 5.58).
Danish: Cystadrops superioritet blev påvist ved sammenligning med kontrolarmen (cysteaminhydrochlorid 0,10 %), p<0,001; 95 % KI (2,11; 5,58).
English: Overdose is unlikely to occur with ocular administration.
Danish: Det er ikke sandsynligt, at der sker overdosering ved administration i øjnene.
English: High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Danish: Høje doser cysteamin hæmmer diegivende hunners evne til at ernære deres unger.
English: The following adverse reactions were reported during clinical trials and the French NPU programme with Cystadrops.
Danish: Følgende bivirkninger er rapporteret under kliniske forsøg og det franske NPU-program (Named Patient Use) med Cystadrops.
English: • Wash your hands carefully in order to avoid contamination by bacteria of the content in the vial.
Danish: • Vask hænderne grundigt for at undgå bakteriel forurening af flaskens indhold.
English: • Gently squeeze the dropper to release one drop of Cystadrops at a time.
Danish: • Tryk let på dråbetælleren for at få én dråbe Cystadrops ud ad gangen.
English: Superiority of Cystadrops was also demonstrated for photophobia rated by the investigator compared to the control arm (cysteamine hydrochloride 0.10%) p< 0.048 95% CI (0.23; 1.14).
Danish: Sammenlignet med kontrolarmen blev der også påvist superioritet med Cystadrops for fotofobi vurderet af investigator (cysteaminhydrochlorid 0,10 %), p<0,048; 95 % KI (0,23; 1,14).
English: Do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.
Danish: Du må ikke komme øjendråberne i øjnene, mens du har linserne i. Når du har brugt dråberne, skal du vente 15 minutter, før du må sætte kontaktlinserne i igen.
English: Cystadrops may be used in paediatric patients from 2 years of age at the same dose as in adults (see section 5.1).
Danish: Cystadrops kan bruges til børn fra 2 år ved samme dosis som til voksne (se pkt.
English: • Place the dropper bottle into the carton box.
Danish: • Læg pipetteflasken ned i kartonæsken.
English: When there is concomitant use of ocular and oral treatment with cysteamine the contribution to any systemic risk from ocular administration is considered negligible.
Danish: Ved samtidig oral og okulær behandling med cysteamin anses den okulære administration kun i ubetydelig grad at bidrage til den systemiske risiko.
English: In case of accidental ingestion, monitoring and symptomatic management of the patient should be implemented.
Danish: I tilfælde af utilsigtet indtagelse bør patienten monitoreres og behandles symptomatisk.
English: Studies in animals have shown a reduction on fertility (see section 5.3).
Danish: Dyrestudier har påvist nedsat fertilitet (se pkt.
English: • The dose may be gradually decreased (to a minimum total daily dose of 1 drop in each eye) by your doctor based on eye examinations.
Danish: • Din læge kan gradvist nedsætte din dosis (til mindst 1 dråbe i hvert øje dagligt), afhængigt af resultatet af øjenundersøgelser.