FrancophonIA/ELRC3.0 huggingface dataset:
English: The spike of the vial adapter should pierce through the vial's rubber stopper.
Danish: Adapterens spids skal gennembryde hætteglassets gummiprop.
English: Other topical ophthalmic products may be used during treatment with OXERVATE when used 15 minutes apart, with the exception of agents known to inhibit epithelial healing (e.g. corticosteroids or eye drops containing preservatives such as benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide and other quaternary ammonium derivatives) (see sections 4.2 and 4.4).
Danish: Der kan anvendes andre lokale øjenprodukter under behandlingen med OXERVATE, så længe de bruges med 15 minutters mellemrum, dog med undtagelse af stoffer, der vides at hæmme opheling af epitelet (eksempelvis korticosteroider eller øjendråber indeholdende konserveringsmiddel såsom benzalkoniumklorid, polyquaternium-1, benzododeciniumbromid, cetrimid og øvrige kvaternære ammoniumderivater) (se pkt.
English: OXERVATE 20 µg/ml eye drops cenegermin
Danish: OXERVATE 20 µg/ml øjendråber cenegermin
English: Gently push the plunger in until a single drop is dropped into the conjunctival fornix (picture 7).
Danish: Tryk forsigtigt pipettestemplet ind og dryp en enkelt dråbe i hvælvingen ind mod øjet (billede 7).
English: 7) Screw the pipette clockwise into the luer lock connector of the vial adapter.
Danish: 7) Skru pipetten med uret ind i hætteglasadapterens luer lock-lås.
English: Discard the used vial at the end of each day (even if there is still some liquid left in it), and in any case no later than 12 hours from the time you connected the vial adapter to it.
Danish: Kassér det brugte hætteglas ved dagens afslutning hver dag (også selvom der stadig er øjendråber tilbage i det), og under alle omstændigheder ikke senere end 12 timer efter det tidspunkt, du påsatte adapteren.
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 bliver klart.
English: - The other ingredients are trehalose dihydrate, mannitol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine and water for injections, hydrochloric acid and sodium hydroxide and nitrogen.
Danish: - Øvrige indholdsstoffer: trehalosedihydrat, mannitol, vandfrit dinatriumhydrogenfosfat, natriumdihydrogenfosfatdihydrat, hydroxypropylmethylcellulose, polyethylenglycol 6000, L-methionin og vand til injektionsvæske, saltsyre, natriumhydroxid og nitrogen.
English: OXERVATE 20 micrograms/ml eye drops, solution
Danish: OXERVATE 20 mikrogram/ml øjendråber, opløsning
English: OXERVATE may cause mild to moderate eye discomfort, such as eye pain, to the patient.
Danish: OXERVATE kan forårsage milde til moderate øjengener, f.eks. øjensmerter.
English: • headache.
Danish: • Hovedpine
English: Discard the used vial at the end of the day (even if there is still some liquid left in it), and in any case no later than 12 hours from the time you connected the vial adapter to it.
Danish: Kassér det brugte hætteglas ved dagens afslutning (også selvom der stadig er øjendråber tilbage i det), og under alle omstændigheder ikke senere end 12 timer efter det tidspunkt, du påsatte adapteren.
English: Water for injections
Danish: Vand til injektionsvæske Saltsyre
English: Once the vial adapter has been connected correctly, it should not be removed from the vial.
Danish: Når hætteglasadapteren er sat korrekt på, må den ikke tages af hætteglasset igen.
English: • Once it has been correctly filled, unscrew the pipette from the connector part of the vial adapter.
Danish: • Når pipetten er korrekt fyldt, skrues den ud af hætteglasadapterens tilslutningsdel.
English: The patient will receive a weekly carton containing 7 vials of OXERVATE.
Danish: Patienten får en ugekarton med 7 hætteglas med OXERVATE.
English: How to use OXERVATE
Danish: Sådan skal du bruge OXERVATE
English: Complete corneal healing rate
Danish: Komplet ophelingsgrad af cornea
English: Excipients: trehalose dihydrate, mannitol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine, water for injections, hydrochloric acid, sodium hydroxide, nitrogen.
Danish: Hjælpestoffer: trehalosedihydrat, mannitol, vandfrit dinatriumhydrogenfosfat, natriumdihydrogenfosfatdihydrat, hydroxypropylmethylcellulose, polyethylenglycol 6000, L-methionin og vand til injektionsvæske, saltsyre, natriumhydroxid, nitrogen.
English: 1 ml of OXERVATE contains 20 micrograms of cenegermin.
Danish: 1 ml OXERVATE indeholder 20 mikrogram cenegermin.
English: • Turn the vial upside-down (with the pipette still connected) and gently pull the plunger until it stops, to draw the solution into the pipette.
Danish: • Vend hætteglasset på hovedet (med pipetten påsat) og træk forsigtigt stemplet ud, indtil det stopper, så der trækkes øjendråber ind i pipetten.
English: 11) Once it has been correctly filled, unscrew the pipette from the luer lock connector of the vial adapter.
Danish: 11) Når pipetten er korrekt fyldt, skrues den ud af hætteglasadapterens luer lock-lås.
English: Cenegermin is mostly removed from the eye with the tear production and through the naso-lacrimal duct; the minor portion that is absorbed occurs mostly in the conjunctiva and peri-orbital tissue and to a minor extent through the cornea following ocular administration.
Danish: Den lille del, der absorberes, sker mest i bindehinden og det periorbitale væv, og i mindre grad gennem hornhinden efter okulær administration.
English: To ensure accurate dosing every 2 hours, the patient should be advised to set an alarm as a reminder for dosing.
Danish: Patienten skal tilrådes at sætte en alarm til som påmindelse om at tage hver dosis, så præcis dosering hver 2. time sikres.
English: • inflammation of the eyelid with itching and redness;
Danish: • Betændelse i øjenlåget med kløe og rødme
English: To control that six doses have been taken every day, the patient should be advised to use the weekly dose recording card provided with the delivery system.
Danish: Patienten skal tilrådes at bruge det ugentlige dosisregistreringskort, vedlagt administrationssystemet, for at kontrollere, at der er taget 6 doser hver dag.
English: • inflammation of the eye;
Danish: • Øjenbetændelse
English: Uncommon Corneal abscess Nervous system disorders Common
Danish: Ikke almindelig Neovaskularisering af cornea
English: This medicine should not be used in children and adolescents below 18 years of age, as there is not enough information about its use in this age group.
Danish: Lægemidlet må ikke anvendes til børn og unge under 18 år.
English: 1 ml of solution contains 20 micrograms of cenegermin.
Danish: 1 ml opløsning indeholder 20 mikrogram cenegermin.
English: Complete corneal clearing
Danish: Komplet opklaring af cornea
English: • Without removing the vial adapter from its blister pack, connect it to the vial by firmly pushing it down until it snaps into place over the neck of the vial.
Danish: • Lad hætteglasadapteren ligge i blisterpakningen og sæt den på hætteglasset ved at trykke den ned, til den klikker fast på hætteglassets hals.
English: Once a vial is opened store below 25 °C or store in a refrigerator.
Danish: Når hætteglasset er åbnet, skal det opbevares ved temperaturer under 25 °C eller i køleskab.
English: To control that six doses have been taken at the end of each treatment day, you should use the weekly dose recording card provided with the delivery system.
Danish: Du bør bruge det ugentlige dosisregistreringskort, der er vedlagt administrationssystemet, for at kontrollere ved afslutningen af hver dag under behandlingen, at du har taget 6 doser den dag.
English: To withdraw and administer each dose of OXERVATE solution, the steps below should be followed:
Danish: Følg disse trin for at trække hver dosis OXERVATE op og administrere den:
English: Use only with the vial adapters, pipettes and disinfectant wipes provided separately.
Danish: Må kun anvendes med de separat vedlagte hætteglasadaptere, pipetter og desinfektionsservietter.
English: Frequency Adverse reaction
Danish: Hyppighed Bivirkninger
English: 5) Take an individual disinfectant wipe and gently clean the surface of the valve on the luer lock connector of the vial adapter.
Danish: 5) Tag en enkelt desinfektionsserviet og rens forsigtigt ventilen på hætteglasadapterens luer locklås.
English: Gently push the pipette plunger in until a single drop is instilled into the conjunctival fornix.
Danish: Tryk forsigtigt pipettestemplet ind og dryp en enkelt dråbe i hvælvingen ind mod øjet (fornix conjunctiva).
English: OXERVATE vials
Danish: OXERVATE hætteglas
English: Study NGF0212 enrolled a total of 174 patients (mean age 61±16 years, range 18-95 years), who have been exposed to OXERVATE and vehicle without the L-methionine excipient; 156 patients were assessed independently for efficacy, comparing two different dosages of the medicinal product with 20 and 10 µg/ml cenegermin to vehicle (52 patients per arm).
Danish: NGF0212-studiet indskrev i alt 174 patienter (gennemsnitsalder 61 ± 16 år i aldersintervallet 18-95 år), der havde været eksponeret for OXERVATE eller et vehikel uden hjælpestoffet L-methionin.
English: One ml of solution contains 20 micrograms of cenegermin*.
Danish: 1 ml opløsning indeholder 20 mikrogram cenegermin*.
English: OXERVATE 20 micrograms/ml eye drops, solution cenegermin
Danish: OXERVATE 20 mikrogram/ml øjendråber, opløsning cenegermin
English: To ensure accurate dosing every 2 hours, you could set an alarm as a reminder for dosing.
Danish: Sørg for at sætte en alarm til som påmindelse om at tage hver dosis, så præcis dosering hver 2. time sikres.
English: 1) With clean freshly-washed hands, place the vial on a steady flat surface and remove the plastic flip-off cap. 2) Peel-off the back of the vial adapter blister pack.
Danish: Stil hætteglasset på en jævn flade og tag flip-off-hætten af plastik af.
English: Pull down your lower eyelid, folding between the inner eyelid and the eyeball.
Danish: Træk ned i underste øjenlåg og fold mellem inderste øjenlåg og øjeæble.
English: If the pipette is empty, keep the vial with the connected pipette upside-down, push the plunger all the way in and pull it out again.
Danish: Hvis pipetten er tom, holdes hætteglasset på hovedet med den påsatte pipette.
English: • pain in the eyelid;
Danish: • Smerter i øjenlåget
English: • eye pain.
Danish: Se pkt.
English: OXERVATE is intended to allow the healing of the cornea.
Danish: OXERVATE anvendes til heling af hornhinden.
English: 9) Turn the vial upside-down with the pipette connected and gently pull the pipette plunger outwards until it stops, to draw the solution into the pipette (ensure that the plunger has reached the stop point).
Danish: Herved trækkes opløsningen ind i pipetten (sørg for, at stemplet når stoppunktet).
English: What OXERVATE is and what it is used for What you need to know before you use OXERVATE How to use OXERVATE
Danish: Det skal du vide, før du begynder at bruge OXERVATE Sådan skal du bruge OXERVATE Bivirkninger
English: To withdraw and administer each dose of this medicine, follow the steps below:
Danish: Følg nedenstående trin for at trække lægemidlet op og indgive hver dosis.
English: If you use more OXERVATE than you should
Danish: Hvis du har brugt for meget OXERVATE
English: How to store OXERVATE Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prialt on 21 February 2005..
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prialt den 21. februar 2005.
English: The third study looked at the use of the medicine over three weeks.
Danish: Den tredje undersøgelse vedrørte brugen af lægemidlet i en periode på over tre uger.
English: The dose must not be increased more than once in any 24 hour period.
Danish: Dosis må ikke øges mere end én gang for hver 24 timer.
English: Other information about Prialt
Danish: Andre oplysninger om Prialt
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 17 January 2014.
Danish: Efter at virksomheden havde forelagt de supplerende oplysninger, det var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 17. januar 2014.
English: A risk management plan has been developed to ensure that Prialt is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Prialt anvendes så sikkert som muligt.
English: EPAR summary for the public ziconotide
Danish: EPAR - sammendrag for offentligheden ziconotid
English: This is a summary of the European public assessment report (EPAR) for Prialt.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prialt.
English: Prialt was more effective than placebo in the first two studies.
Danish: Prialt var mere effektivt end placebo i de to første undersøgelser.
English: Treatment with Prialt should only be carried out by a doctor who has experience in the intrathecal dosing of medicines.
Danish: Behandling med Prialt bør kun gives af en læge med erfaring i intratekal indgivelse af lægemidler.
English: What measures are being taken to ensure the safe and effective use of Prialt?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Prialt?
English: Prialt may need to be diluted before use, especially with the lower doses needed at the start of treatment.
Danish: Det kan være nødvendigt at fortynde Prialt, før det bruges, især ved de lavere doser, der er behov for ved behandlingens start.
English: For more information about treatment with Prialt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Prialt, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The maximum dose is 21.6 micrograms per day.
Danish: Den maksimale dosis er 21,6 mikrogram dagligt.
English: The dose should be gradually increased, preferably every two days or more, to obtain the best balance between pain relief and possible side effects.
Danish: Dosis bør gradvis øges med intervaller på to dage eller mere for at opnå den bedst mulige balance mellem smertelindring og eventuelle bivirkninger.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Prialt provides an alternative to other intrathecal painkillers, such as opioids.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Prialt er et alternativ til andre intratekale smertestillende midler såsom opioider.
English: Two of the studies were short-term, lasting five or six days: one in pain due to cancer or AIDS, and one in pain due to other causes such as nerve damage.
Danish: To af dem var korttidsundersøgelser af fem eller seks dages varighed: Den ene vedrørte smerter, som er forårsaget af kræft eller aids, og den anden vedrørte smerter, der er forårsaget af andre forhold som f.eks. nervebeskadigelser.
English: This is a score given by the patients of their pain on a scale from 0 mm (no pain) to 100 mm (maximum pain).
Danish: På skalaen tildeler patienterne deres smerter en scoreværdi fra 0 mm (ingen smerte) til 100 mm (stærkeste smerter).
English: Because the number of patients who have long-term pain that requires painkillers to be injected directly into the spine is low, the disease is considered ‘rare', and Prialt was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Danish: Da antallet af patienter med langvarige smerter, der kræver smertestillende medicin ved direkte indsprøjtning i rygmarven, er lavt, betragtes sygdommen som "sjælden", og Prialt blev udpeget som "lægemiddel til sjældne sygdomme" den 9. juli 2001.
English: Prialt was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Danish: Prialt blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet kun forelå sparsomme oplysninger som følge af sygdommens sjældenhed.
English: What is the risk associated with Prialt?
Danish: Hvilken risiko er der forbundet med Prialt?
English: The full EPAR for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Prialt findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prialt, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Prialt, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Prialt has been compared with placebo (a dummy treatment) in 589 patients with severe long-term pain in three main studies.
Danish: Prialt blev sammenlignet med virkningen af placebo (virkningsløs behandling) hos 589 patienter med svære langvarige smerter i tre hovedundersøgelser.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prialt.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Prialt skal anvendes.
English: It decided that Prialt's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det besluttede, at fordelene ved Prialt opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Prialt.
English: The starting dose of Prialt is 2.4 micrograms per day.
Danish: Startdosis af Prialt er 2,4 mikrogram dagligt.
English: The active substance in Prialt, ziconotide, is a copy of a natural substance called omega-conopeptide, which is found in the venom of a type of sea snail.
Danish: Det aktive stof i Prialt, ziconotid, er en kopi af et naturligt stof kaldet omega-conopeptid, der findes i giften fra en særlig havsnegleart.
English: Most patients need doses lower than 9.6 micrograms per day.
Danish: De fleste patienter har ikke behov for større dosis end 9,6 mikrogram dagligt.
English: The most common side effects with Prialt (seen in more than 1 patient in 10) are confusion, dizziness, nystagmus (uncontrolled eye movement), impaired memory (forgetfulness), headache, somnolence (sleepiness), blurred vision, nausea (feeling sick), vomiting, abnormal gait (difficulty walking) and asthenia (weakness).
Danish: De hyppigste bivirkninger ved Prialt (som optræder hos flere end 1 ud af 10 patienter) er omtågethed, svimmelhed, øjensitren, glemsomhed, hovedpine, søvnighed, sløret syn, kvalme, opkastning, besvær med at gå normalt og kraftesløshed.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Prialt findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Prialt is a solution for infusion that contains the active substance ziconotide.
Danish: Prialt er en opløsning til infusion, der indeholder det aktive stof ziconotid.
English: Why has Prialt been approved?
Danish: Hvorfor blev Prialt godkendt?
English: What information is still awaited for Prialt?
Danish: Hvilke oplysninger afventes der stadig for Prialt?
English: The company that makes Prialt is carrying out a study looking at the long-term use of the medicine, looking in particular at the possibility of development of tolerance to treatment (when doses of a medicine that used to be effective become less effective over time).
Danish: Virksomheden, der fremstiller Prialt, er i færd med at undersøge langtidsanvendelsen af lægemidlet, specielt muligheden for at udvikle tolerance over for behandlingen (dvs. at virkningen af en bestemt lægemiddeldosis efterhånden aftager).
English: For the full list of all side effects and restrictions with Prialt, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Prialt fremgår af indlægssedlen.
English: What is Prialt?
Danish: Hvad er Prialt?
English: Prialt is used to treat severe, long-term pain in adults who need a painkiller by intrathecal injection (injection into the space that surrounds the spinal cord and the brain).
Danish: Prialt anvendes til behandling af svære, langvarige smerter hos voksne, der har behov for smertestillende medicin ved intratekal injektion (indsprøjtning i det hulrum, der omgiver rygmarven og hjernen).
English: Prialt must not be used in patients at the same time as intrathecal chemotherapy (medicines to treat cancer that are injected into the spinal canal).
Danish: Prialt må ikke anvendes hos patienter samtidig med intratekal kemoterapi (kræftmedicin, der gives ved indsprøjtning i rygmarvskanalen).
English: In all of the studies, the main measure of effectiveness was the change in the Visual Analog Scale of Pain Intensity (VASPI).
Danish: I alle undersøgelserne blev behandlingens virkning hovedsagelig bedømt på ændringen i den visuelle analoge smerteskala (VAS).
English: By blocking the flow of calcium into the nerve cells, ziconotide interferes with the transmission of pain signals within the spine.
Danish: Ved at blokere calciumstrømmen ind i nervecellerne griber ziconotid ind i overførslen af smertesignaler i rygmarven, og dermed lindres smerterne.
English: Prialt must be given as a very slow continuous infusion through an intrathecal catheter (a tube inserted into the spinal canal) using an infusion pump capable of delivering an accurate amount of the medicine.
Danish: Prialt gives ved meget langsom, uafbrudt infusion gennem et intratekalt kateter (en slange, der er ført ind i rygmarvskanalen) ved hjælp af en infusionspumpe, der er i stand til at afgive en nøjagtig mængde af lægemidlet.
English: Ziconotide acts by blocking special pores called calcium channels on the surface of the nerve cells that transmit the pain signals.
Danish: Ziconotid virker ved, at det blokerer de særlige porer (calciumkanaler) på overfladen af de nerveceller, som overfører smertesignalerne.
English: How has Prialt been studied?
Danish: Hvordan blev Prialt undersøgt?
English: What is Prialt used for?
Danish: Hvad anvendes Prialt til?
English: In the third study, there was a trend for Prialt to be more effective than placebo, with the VASPI score changing from 81 mm before treatment to 68 mm in patients receiving Prialt and to 74 mm in patients receiving placebo.
Danish: Således aftog VAS-scoren fra 81 mm før behandlingen til 68 mm ved behandling med Prialt og til 74 mm ved behandling med placebo.
English: Before treatment, patients with cancer or AIDS pain had an average VASPI score of 74 mm, and those with other types of pain had a score of 80 mm. After treatment, the scores in patients receiving Prialt decreased to 35 and 54 mm, respectively, while scores in patients receiving placebo were 61 and 72 mm.
Danish: Før behandlingen havde patienterne med smerter som følge af kræft eller aids en gennemsnitlig VAS-score på 74 mm, og patienterne med smerter af andre årsager havde en score på 80 mm.
English: How is Prialt used?
Danish: Hvordan anvendes Prialt?
English: What benefit has Prialt shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Prialt?
English: How does Prialt work?
Danish: Hvordan virker Prialt?