FrancophonIA/ELRC3.0 huggingface dataset:
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
Danish: PegIntron 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen indeholder 50 mikrogram peginterferon alfa-2b målt på proteinbasis.
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
Danish: PegIntron 50 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder 50 mikrogram peginterferon alfa-2b målt på proteinbasis.
English: EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Danish: EU/1/00/131/003 (4 hætteglas med pulver, 4 ampuller med solvens) EU/1/00/131/004 (4 hætteglas med pulver, 4 ampuller med solvens, 4 injektionssprøjter, 8 kanyler og 4 renseservietter)
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
Danish: PegIntron 150 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder 150 mikrogram peginterferon alfa-2b målt på proteinbasis.
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
Danish: PegIntron 100 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder 100 mikrogram peginterferon alfa-2b målt på proteinbasis.
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen
Danish: PegIntron 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen PegIntron 80 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen PegIntron 100 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen PegIntron 120 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen PegIntron 150 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen
English: EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
Danish: EU/1/00/131/031 (1 pen, 1 kanyle og 2 renseservietter) EU/1/00/131/032 (4 penne, 4 kanyler og 8 renseservietter) EU/1/00/131/034 (12 penne, 12 kanyler og 24 renseservietter)
English: EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Danish: EU/1/00/131/010 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/131/027 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
English: EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Danish: EU/1/00/131/005 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/131/026 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
English: EU/1/00/131/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Danish: EU/1/00/131/013 (4 hætteglas med pulver, 4 ampuller med solvens) EU/1/00/131/014 (4 hætteglas med pulver, 4 ampuller med solvens, 4 injektionssprøjter, 8 kanyler og 4 renseservietter)
English: EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Danish: EU/1/00/131/001 (1 hætteglas med pulver, 1 ampul med solvens) EU/1/00/131/002 (1 hætteglas med pulver, 1 ampul med solvens, 1 injektionssprøjte, 2 kanyler og 1 renseserviet)
English: EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Danish: EU/1/00/131/015 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/131/028 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
English: EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Danish: EU/1/00/131/025 (6 hætteglas med pulver, 6 ampuller med solvens) EU/1/00/131/030 (12 hætteglas med pulver, 12 ampuller med solvens, 12 injektionssprøjter, 24 kanyler og 12 renseservietter)
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Danish: PegIntron 100 mikrogram pulver og solvens til injektionsvæske, opløsning Hvert hætteglas skal rekonstitueres med 0,7 ml vand til injektionsvæsker for indgift af op til 0,5 ml opløsning.
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Danish: PegIntron 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen (CLEARCLICK) tilberedes med den vedlagte solvens i tokammer-cylinderampullen (vand til injektionsvæsker) for indgift af op til 0,5 ml opløsning.
English: Ear pain
Danish: • smerte i lemmer
English: PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Danish: PegIntron 100 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen Hver fyldt pen (CLEARCLICK) tilberedes med den vedlagte solvens i tokammer-cylinderampullen (vand til injektionsvæsker) for indgift af op til 0,5 ml opløsning.
English: PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Danish: PegIntron 120 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
English: The following other side effects (not listed above) have occurred with the combination of this medicine and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART: - oral candidiasis (oral thrush), - defective metabolism of fat, - CD4 lymphocytes decreased, - appetite decreased, - back pain, - hepatitis, - limb pain, - and various laboratory blood values abnormalities.
Danish: Nedenstående andre bivirkninger (ikke nævnt ovenfor) er forekommet ved kombinationen af dette lægemiddel og ribavirin-kapsler (voksne) hos patienter med samtidig hcv/hiv infektion, der fik HAART:
English: PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Danish: PegIntron 80 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
English: - fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed, - sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching,
Danish: • sår i munden, afskalning af læberne og revner i mundvigene, udslæt, rødmende hud, kløe, eksem (betændt, rød, kløende og tør hud i nogle tilfælde med væskende læsioner), akne,
English: - changes in taste, diarrhoea, stomach upset, oral pain, - fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed, - sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching,
Danish: - øjenproblemer herunder ændringer i synet, beskadigelse af nethinden, obstruktion af nethindearterien, betændelse i synsnerven, hævelse af øjet, - hjerteinsufficiens, unormal hjerterytme, perikarditis (betændelse i hjertesækken), betændelse og nedbrydning af muskelvæv og perifere nerver, nyreproblemer, - sarkoidose (en sygdom karakteriseret ved længerevarende feber, vægttab, smertende og opsvulmede led, hudskader og hævede kirtler).
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Danish: PegIntron 50 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
English: PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Danish: PegIntron 150 mikrogram pulver og solvens til injektionsvæske, opløsning i fyldt pen peginterferon alfa-2b
English: HCV-RNA negative or ≥ 1 log decrease in viral load By week 12*** (n=915) HCV-RNA negative 508
Danish: Ved uge 12*** (n=915) hcv-RNA-negative hcv-RNA-negativ eller ≥ 2 log fald i virusbelastning
English: HVL (>600,000 IU/ml)
Danish: Baseline virusbelastning HVL (<600.000 IE/ml)
English: Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Danish: Begge aktive stoffer har været på markedet i EU som separate præparater i en årrække.
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere information fremgår af resuméet af risikostyringsplanen
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Omidria den 28. juli 2015.
English: This is a summary of the European public assessment report (EPAR) for Omidria.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Omidria.
English: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Ketorolac er et non-steroidt antiinflammatorisk lægemiddel (NSAID).
English: The full EPAR and risk management plan summary for Omidria can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Omidria findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Omidria are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Omidria er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Omidria
Danish: Andre oplysninger om Omidria
English: A risk management plan has been developed to ensure that Omidria is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Omidria anvendes så sikkert som muligt.
English: With regard to the safety of Omidria, the medicine was generally well tolerated.
Danish: Vedrørende sikkerheden af Omidria tåltes lægemidlets sædvanligvis godt.
English: Although the effect of Omidria on pain was modest, it was considered clinically important.
Danish: Virkningen af Omidria på smerter var beskeden, men blev anset for klinisk betydningsfuld.
English: What measures are being taken to ensure the safe and effective use of Omidria?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Omidria?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Omidria, 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 Omidria, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The most common side effects with Omidria (which may affect up to 1 in 10 people) are eye pain, anterior chamber inflammation (inflammation of the fluid-filled space inside the eye between the iris and the cornea), conjunctival hyperaemia (redness of the membrane that lies over the white part of the eye), photophobia (increased sensitivity of the eyes to light), corneal oedema (swelling of the transparent layer in front of the eye that covers the pupil and iris) and inflammation.
Danish: De hyppigste bivirkninger med Omidria (som forekommer hos op til 1 ud af 10 personer) er øjensmerter, inflammation af øjets forreste kammer (det væskefyldte rum mellem regnbuehinden og hornhinden), rødme af bindehinden, der dækker det hvide af øjet (konjunktival hyperæmi), øget lysfølsomhed af øjet (fotofobi), hævelse af den gennemsigtige hinde, der dækker pupillen og regnbuehinden på øjets forside (kornealt ødem) og inflammation.
English: What is Omidria and what is it used for?
Danish: Hvad er Omidria, og hvad anvendes det til?
English: These side effects are typical following lens replacement surgery, and most were mild to moderate in severity and resolved spontaneously.
Danish: Disse bivirkninger er typiske efter udskiftning af linsen, og størstedelen var lette til moderate og svandt spontant.
English: In both studies, the main measures of effectiveness were the change in diameter of the pupil by the end of the surgery, and how much eye pain patients felt soon after surgery, as indicated by the patient using a standard pain scale from 1 to 100.
Danish: I begge undersøgelser var de vigtigste mål for virkningen ændringen i pupillens diameter ved slutningen af operationen og styrken af patientens øjensmerter straks efter operationen, hvilket blev angivet af patienterne på en standard smerteskala fra 1 til 100.
English: In addition, 7% (29 out of 403) of patients receiving Omidria experienced moderate-to-severe pain compared with 14% (57 out of 403) of patients given placebo, and 25% (104 out of 403) were painfree in the early period following surgery, compared with 17% (69 out of 403) of patients receiving placebo.
Danish: Af de patienter, der fik Omidria, fik 7 % (29 ud af 403) moderate til svære smerter, sammenholdt med 14 % (57 ud af 403) af dem, der fik placebo, og 25 % af dem (104 ud af 403) var smertefri i den første tid efter operationen, sammenholdt med 17 % (69 ud af 403) af dem, der fik placebo.
English: Why is Omidria approved?
Danish: Hvorfor blev Omidria godkendt?
English: It can only be obtained with a prescription and must be given by a qualified ophthalmological surgeon (eye surgery specialist) experienced in lens replacement.
Danish: Det fås kun efter recept og skal gives af en specialist i øjenkirurgi med erfaring i linseudskiftning.
English: Omidria phenylephrine / ketorolac
Danish: Omidria phenylephrin / ketorolac
English: It works by blocking certain enzymes called cyclo-oxygenases, which produce prostaglandins, substances that are involved in pain and inflammation processes.
Danish: Det virker ved at blokere enzymer af typen cyclooxygenase, der producerer prostaglandiner, som er medvirkende til smerter og inflammatoriske processer.
English: Phenylephrine is a ‘selective alpha-1 adrenergic receptor agonist', which attaches to and activates alpha-1 adrenergic receptors that are found on smooth muscle cells, causing these muscles to contract.
Danish: Phenylephrin er et selektivt alfa-1 adrenergt receptorstimulerende middel, som bindes til glatmuskelcellernes alfa-1 adrenerge receptorer og aktiverer dem, så disse muskler trækker sig sammen.
English: It is not intended to provide practical advice on how to use Omidria.
Danish: Det er ikke en praktisk vejledning i, hvordan Omidria bør anvendes.
English: What are the risks associated with Omidria?
Danish: Hvilke risici er der forbundet med Omidria?
English: For more information about treatment with Omidria, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Omidria, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This makes lens replacement surgery easier.
Danish: Dette letter operationen til udskiftning af linsen.
English: Omidria must not be used in patients who have narrow-angle glaucoma, a serious condition of the eye in which the pressure inside the eye rises rapidly because fluid cannot drain out.
Danish: Omidria må ikke anvendes hos patienter med snævervinklet glaukom, en alvorlig øjensygdom, hvor det indvendige tryk i øjet pludselig stiger, fordi væsken ikke kan få afløb.
English: The ophthalmologist may also prescribe eye drops commonly used before and after the surgery to help prevent eye infections and pain.
Danish: Øjenlægen kan desuden udskrive øjendråber, der sædvanligvis anvendes før og efter operationen for at forebygge infektion i øjet og smerter.
English: The recommended dose is 4 ml of Omidria diluted in 500 ml of irrigation solution, to be used during the surgery to replace the lens.
Danish: Den anbefalede dosis er 4 ml Omidria fortyndet i 500 ml skyllevæske, som anvendes under operationen, hvor linsen udskiftes.
English: With respect to pain, patients treated with Omidria reported an average pain score of around 4, compared with around 9 for those given placebo.
Danish: Vedrørende smerter angav de patienter, der fik Omidria, en gennemsnitlig smertescore på omkring 4, sammenholdt med omkring 9 for dem, der fik placebo.
English: The lens is the part of the eye that focuses light passing through the pupil and allows clear vision.
Danish: Linsen er den del er øjet, der samler det lys, der kommer ind gennem pupillen, og giver et klart syn.
English: When applied to the eye, ketorolac reduces the production of prostaglandins in the eye and thereby reduces the pain and inflammation caused by eye surgery.
Danish: Når ketorolac påføres i øjet, nedsætter det øjets produktion af prostaglandiner og mindsker derved de smerter og den inflammation, der følger af operationer i øjet.
English: Both studies showed that the pupil remained dilated during surgery in patients given Omidria (+0.1 mm), while it contracted in those given placebo (-0.5 mm).
Danish: Begge undersøgelser viste, at pupillen forblev udvidet under øjenoperationen hos de patienter, der fik Omidria (+0,1 mm), men trak sig sammen hos dem, der fik placebo (-0,5 mm).
English: This is a type of surgery in which a new lens is implanted into the eye.
Danish: Ved denne type operation bliver der opereret en ny linse ind i øjet.
English: Omidria has been shown to be effective at maintaining pupil dilation and preventing pupil contraction during lens replacement surgery, which should help to make such surgery easier and safer.
Danish: Omidria er påvist at være effektivt til at opretholde udvidelse af pupillerne og forhindre sammentrækning af pupillen under udskiftning af linsen, hvilket gør operationen lettere og sikrere.
English: The incidence of side effects with Omidria was similar to that reported in patients receiving placebo.
Danish: Forekomsten af bivirkninger med Omidria svarede til forekomsten hos patienter, der fik placebo.
English: Fewer than 1 in 10 of the patients given Omidria had a pupil diameter below 6 mm (which makes surgery more difficult), whereas about 4 patients in 10 experienced this after being given placebo.
Danish: Færre end 1 ud af 10 af de patienter, der fik Omidria, fik en pupildiameter under 6 mm (som vanskeliggør operationen), hvorimod dette var tilfældet hos 4 patienter ud af de 10, der fik placebo.
English: For practical information about using Omidria, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Omidria, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Omidria, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Omidria fremgår af indlægssedlen.
English: Omidria contains the active substances phenylephrine and ketorolac.
Danish: Omidria indeholder de aktive stoffer phenylephrin og ketorolac.
English: Omidria is a medicine used in adults during lens replacement surgery in the eye to keep the pupil dilated (widened) and prevent its contraction, and to reduce eye pain after surgery.
Danish: Omidria er et lægemiddel, der anvendes hos voksne under operation til udskiftning af øjets linse for at holde pupillen udspilet og forhindre, at den trækker sig sammen, og til at mindske smerter i øjet efter operationen.
English: Omidria has been investigated in two main studies involving a total of 821 patients undergoing lens replacement surgery, in which it was compared with placebo (a dummy treatment).
Danish: Omidria er undersøgt i to hovedundersøgelser, der omfattede i alt 821 patienter, som fik foretaget operation til udskiftning af linsen.
English: How is Omidria used?
Danish: Hvordan anvendes Omidria?
English: What benefits of Omidria have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Omidria?
English: How does Omidria work?
Danish: Hvordan virker Omidria?
English: Omidria is available as a concentrate that is made up into an irrigation solution (a solution used to rinse the inside of the eye during surgery).
Danish: Omidria fås som et koncentrat, hvoraf der fremstilles en skyllevæske til indvendig skylning af øjet under operationen.
English: When applied to the eye, phenylephrine makes the muscle of the iris contract (tighten) and allows the pupil to widen.
Danish: Når phenylephrin påføres i øjet, får det regnbuehindens muskel til at trække sig sammen, så pupillen udvider sig.
English: Smoking could decrease the amount of AZILECT in the blood.
Danish: Rygning kan nedsætte mængden af AZILECT i blodet.
English: Therefore, AZILECT is not recommended for use under the age of 18.
Danish: AZILECT anbefales derfor ikke til unge under 18 år.
English: You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the unborn child are not known.
Danish: Du skal undgå at tage AZILECT, hvis du er gravid, da virkningen af AZILECT på graviditeten og det ufødte barn er ukendt.
English: There is no relevant use of AZILECT in children and adolescents.
Danish: Der er ingen relevant brug af AZILECT til børn og unge.
English: Take the next dose normally, when it is time to take it.
Danish: Tag den næste dosis på det tidspunkt, hvor De normalt tager Deres AZILECT.
English: Tyramine/rasagiline interaction
Danish: Tyramin/rasagilin-interaktion
English: AZILECT helps to increase and sustain levels of dopamine in the brain.
Danish: AZILECT er med til at øge og opretholde dopaminniveauet i hjernen.
English: Concomitant use of rasagiline with other medicinal products
Danish: Samtidig behandling med rasagilin sammen med andre lægemidler
English: This might be enhanced if you take other medicines to treat the symptoms of your Parkinson's disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking AZILECT.
Danish: Dette kan forstærkes, hvis De tager anden medicin til behandling af Deres symptomer på Parkinsons sygdom, eller hvis De tager medicin, som kan få Dem til at føle døsighed, eller hvis De drikker alkohol, mens De tager AZILECT.