FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Opatanol should not be used during breast-feeding.
Danish: Opatanol må ikke anvendes under amning.
English: Following a 10 mg oral dose in patients undergoing haemodialysis (with no urinary output), plasma olopatadine concentrations were significantly lower on the haemodialysis day than on the non-haemodialysis day suggesting olopatadine can be removed by haemodialysis.
Danish: Ved oral administration af en dose på 10 mg olopatadin til patienter i hæmodialyse (ingen urinproduktion) var plasma koncentrationer signifikant lavere på dagen for hæmodialyse end på dagen uden hæmodialyse, hvilket antyder, at olopatadin kan fjernes ved hæmodialyse.
English: Use a single drop as soon as you remember, and then go back to your regular dosing routine.
Danish: Tag den ordinerede dosis så hurtigt som muligt og fortsæt herefter med den sædvanlige dosis.
English: However, if it is almost time for your next dose, skip the missed dose before going back to your regular dosing routine.
Danish: Hvis du snart skal tage den næste dosis, så spring den glemte dosis over.
English: What you need to know before you use Opatanol
Danish: Det skal du vide, før du begynder at bruge Opatanol
English: • Don't touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Danish: • Flaskens spids bør ikke berøre øjenlåg, omgivende område eller andre overflader.
English: Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3).
Danish: De tilgængelige data fra dyrestudier viser, at olopatadin udskilles i mælk efter oral administration (se pkt.
English: Uncommon corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia
Danish: Ikke almindelig Corneaerosion, corneaepiteldefekt, corneaepitellidelse, punktformed keratitis, keratitis, cornea-pletter, flåd fra øjet, fotofobi, sløret syn, nedsat skarpsyn, blefarospasme, okulært ubehag, øjenkløe, konjunktivale follikler, konjunktivalidelser, følelse af fremmedlegeme i øjet, øget tåredannelse, øjenlågserytem, øjenlågsødem, øjenlågslidelser, okulær hyperæmi
English: Opatanol is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
Danish: Opatanol bruges til behandling af tegn og symptomer ved sæsonbetinget øjenallergi.
English: What Opatanol contains - The active substance is olopatadine.
Danish: - Aktivt stof: olopatadin.
English: Blurred, reduced, or abnormal vision, corneal disorder, eye surface inflammation with or without surface damage, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.
Danish: Sløret, nedsat eller unormalt syn, hornhindelidelse, betændelseslignende tilstand (inflammation) på øjets overflade med eller uden beskadigelse af overfladen, inflammation eller infektion i bindehinden, udflåd fra øjet, lysfølsomhed, øget tåredannelse, kløe i øjet, rødme i øjet, unormalt øjenlåg, kløe, rødme, hævelse eller skorpedannelse i øjenlåget.
English: Names and addresses of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: Only use Opatanol in both eyes if your doctor told you to. Use it for as long as your doctor told you to.
Danish: Du må kun bruge Opatanol i begge øjne, hvis du har aftalt det med din læge.
English: Respiratory, thoracic, and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Almindelige
English: Olopatadine is absorbed systemically, as are other topically administered medicinal products.
Danish: Ligesom andre topikalt administrerede lægemidler, absorberes også olopatadin systemisk.
English: You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Danish: Du skal tage kontaktlinserne ud, inden lægemidlet bruges, og vente i mindst 15 minutter, før du sætter kontaktlinserne i igen.
English: Benzalkonium is known to discolour soft contact lenses.
Danish: Benzalkoniumchlorid kan misfarve bløde kontaktlinser.
English: After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product.
Danish: Efter fjernelse af flaskens hætte og inden brug af præparatet skal forseglingsringen fjernes, hvis den sidder løst.
English: General side effects Headache, fatigue, dry nose, bad taste.
Danish: Generelle bivirkninger Hovedpine, træthed, næsetørhed, dårlig smag i munden.
English: Common nasal dryness
Danish: Nasal tørhed
English: Common eye pain, eye irritation, dry eye, abnormal sensation in eyes
Danish: Øjensmerter, øjenirritation, tørre øjne, abnorm følelse i øjnene
English: Eye swelling, corneal swelling, change in pupil size.
Danish: Hævelse i øjet, hævet hornhinde, ændring i pupilstørrelse
English: Opatanol 1 mg/mL eye drops olopatadine
Danish: Opatanol 1 mg/ml øjendråber olopatadin
English: 1 mL of solution contains 1 mg olopatadine (as hydrochloride).
Danish: 1 ml opløsning indeholder 1 mg olopatadin (som hydrochlorid).
English: Shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinus infection, skin redness and itching.
Danish: Kortåndethed, forøgelse af allergiske symptomer, hævelser i ansigtet, døsighed, generel svækkelse, kvalme, opkastninger, bihulebetændelse, rødme eller kløe i huden.
English: General side effects Abnormal or decreased sensation, dizziness, runny nose, dry skin, skin inflammation.
Danish: Generelle bivirkninger Unormal eller nedsat følesans, svimmelhed, løbende næse, tør hud, betændelseslignende tilstand i huden.
English: Eye pain, eye irritation, dry eye, abnormal eye sensation, eye discomfort.
Danish: Øjensmerter, øjenirritation, tørre øjne, abnorm følelse i øjnene, ubehag i øjnene.
English: • Bring the bottle tip close to the eye. Use the mirror if it helps.
Danish: Brug et spejl, hvis det hjælper.
English: Not known hypersensitivity, swelling face
Danish: Overfølsomhed, hævelser i ansigtet
English: Do not use Opatanol
Danish: - brug ikke Opatanol, hvis du ammer
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Opatanol Fortæl altid lægen eller på apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Opatanol 1 mg/mL eye drops, solution
Danish: Opatanol 1 mg/ml øjendråber, opløsning
English: It could infect the drops left in the bottle.
Danish: Det kan forurene øjendråberne.
English: Not known asthenia, malaise
Danish: Asteni, utilpashed
English: Benzalkonium chloride 0.1 mg/ml.
Danish: Hjælpestof, som behandleren skal være opmærksom på: benzalkoniumchlorid 0,1 mg/ml
English: Opatanol 1 mg/mL eye drops, solution olopatadine
Danish: Opatanol 1 mg/ml øjendråber, opløsning olopatadin
English: How to use Opatanol
Danish: Brug af Opatanol:
English: • You should not use OPATANOL if you are breast-feeding.
Danish: Du må ikke bruge Opatanol, hvis du ammer.
English: Use in hepatic and renal impairment
Danish: Brug ved nedsat lever- og nyrefunktion
English: For ocular use only.
Danish: Kun til okulær brug.
English: (picture 2).
Danish: Figur 2
English: Studies comparing the pharmacokinetics of 10 mg oral doses of olopatadine in young (mean age 21 years) and elderly (mean age 74 years) showed no significant differences in the plasma concentrations (AUC), protein binding or urinary excretion of unchanged parent drug and metabolites.
Danish: I et studie med 10 mg oralt dosis olopatadin blev olopatadins farmakokinetik sammenlignet hos yngre forsøgspersoner (gennemsnitsalderen: 21 år) og ældre (gennemsnitsalderen: 74 år).
English: What you need to know before you use Opatanol 3.
Danish: Det skal du vide, før du begynder at bruge Opatanol Sådan skal du bruge Opatanol Bivirkninger
English: 6 OTHER
Danish: ANDET
English: You should not use Opatanol if you are breast-feeding, ask your doctor for advice before using this medicine.
Danish: Spørg din læge til råds, inden du bruger dette lægemiddel.
English: Not known nausea, vomiting,
Danish: Kvalme, opkastning.
English: General side effects
Danish: Generelle bivirkninger
English: Excipient(s) with known effect:
Danish: Opatanol indeholder:
English: Not known corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting
Danish: Kornealt ødem, øjenødem, hævelse af øjet, konjunktivit, mydriasis, synsforstyrrelser, skorper på øjenlågsrand
English: - The other ingredients are benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydrochloric acid (E507) and/or sodium hydroxide (E524) and purified water.
Danish: 1 ml øjendråber indeholder 1mg olopatadin (som hydrochlorid) - Øvrige indholdsstoffer: benzalkoniumchlorid, natriumchlorid, dinatriumphosphat dodecahydrat,
English: This will usually be in your arm.
Danish: Det vil sædvanligvis være i armen.
English: The infusion will be given every two weeks.
Danish: Infusionen vil blive givet hver anden uge.
English: These effects have decreased with time.
Danish: Disse virkninger er svundet med tiden.
English: It is not expected to bind to proteins.
Danish: Det forventes ikke at binde til proteiner.
English: 111 20 Stockholm
Danish: 111 20 Stockholm Sverige
English: As with all protein pharmaceutical products, patients may develop antibodies to the protein.
Danish: Som med alle proteinholdige farmaceutiske produkter kan patienter udvikle antistoffer mod proteinet.
English: These results suggest the symptoms of the disease are improving or the disease is becoming stable.
Danish: Disse resultater tyder på, at sygdommens symptomer mindskes, eller at sygdommen stabiliseres.
English: The remaining 76% were antibody negative throughout.
Danish: De resterende 76% var antistof-negative hele tiden.
English: Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein.
Danish: Hver gang De bliver behandlet, vil det tage 40 minutter at indgive Replagal i en vene.
English: However some effects may be serious and may need treatment.
Danish: Imidlertid kan nogle bivirkninger være alvorlige og nødvendiggøre behandling.
English: Pharmacokinetic parameters were not significantly different between male and female patients.
Danish: Farmakokinetiske parametre var ikke signifikant forskellige for mandlige og kvindelige patienter.
English: The current medical standards for emergency treatment are to be observed.
Danish: Gældende kliniske standarder for akut behandling skal følges.
English: Studies in patients over the age of 65 have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established.
Danish: Der er ikke gennemført studier på patienter over 65 år, og der kan ikke endnu anbefales noget doseringsregime til disse patienter, da sikkerheden og virkningen endnu ikke er klarlagt.
English: Study with various dosing regimen
Danish: Studie med forskellige dosisregimer
English: Infusion of Replagal at home may be considered for patients who are tolerating their infusions well.
Danish: Infusion af Replagal i hjemmet kan overvejes for patienter, som tåler deres infusioner godt.
English: You may drive and use machines whilst on Replagal.
Danish: De kan føre motorkøretøj og betjene maskiner, medens De anvender Replagal.
English: Information is presented by system organ class and frequency (very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100).
Danish: Informationen angives efter systemorganklasse og hyppighed (meget almindelig ≥1/10; almindelig ≥1/100 til <1/10; ikke almindelig ≥1/1.000 til <1/100).
English: Twenty-five patients completed the first study and entered an extension study.
Danish: Femogtyve patienter gennemførte det første studie og indgik i et ekstensionsstudie.
English: It is not known whether Replagal crosses the placenta.
Danish: Det vides ikke, om Replagal passerer placenta.
English: The experience in children 0-6 years old is limited and therefore no dose can be recommended for this age group.
Danish: Der er kun begrænset erfaring med børn i alderen 0-6 år, og derfor kan der ikke anbefales nogen dosis for denne aldersgruppe.
English: A clear and colourless solution.
Danish: En gennemsigtig og farveløs opløsning.
English: See also section 4.4.
Danish: Se også punkt 4.4.
English: Children and adolescents may be more likely than adults to experience an infusion related reaction.
Danish: Børn og unge kan være mere tilbøjelige end voksne til at få en infusionsrelateret reaktion.
English: The pharmacokinetic properties were essentially unaffected by the dose of the enzyme.
Danish: De farmakokinetiske egenskaber var i al væsentlighed upåvirket af dosis af enzymet.
English: The occurrence of an event in a single patient is defined as uncommon in view of the number of patients treated.
Danish: Indtræden af en hændelse hos en enkelt patient defineres som usædvanlig under hensyntagen til antallet af behandlede patienter.
English: This medicine should be applied and supervised by appropriately trained personnel, who will also calculate the dose that you will be given.
Danish: Dette lægemiddel skal indgives af særligt uddannet personale, der også udregner den dosis, som De skal have.
English: Genotoxic and carcinogenic potential are not expected.
Danish: Der forventes ingen genotoksicitet eller karcinogenicitet.
English: It is not known whether Replagal is excreted in human milk.
Danish: Det er ukendt, om Replagal udskilles i human mælk.
English: You must not be given Replagal
Danish: De må ikke få Replagal
English: Agalsidase alfa is a protein.
Danish: Agalsidase alfa er et protein.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De får dette lægemiddel.
English: Based on limited data this percentage has been found to be lower (7%) in the male paediatric population.
Danish: Det er på baggrund af begrænsede data konstateret, at denne procentdel er lavere (7%) i en population af drengebørn.
English: These IgG antibodies appeared to develop following approximately 3-12 months of treatment.
Danish: Disse IgG-antistoffer syntes at udvikles efter ca. 3-12 måneders behandling.
English: The adverse reactions categorized as incidence “not known (cannot be estimated from the available data)” are derived from post-marketing spontaneous reports.
Danish: De bivirkninger, der er kategoriseret som 'ikke kendte (kan ikke estimeres ud fra forhåndenværende data)', er baseret på spontan indberetning efter markedsføring.
English: This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual.
Danish: Dette vil være ca. 14 mg eller 4 hætteglas (glasflasker) Replagal for et individ af normalstørrelse (70 kg).
English: There is a theoretical risk of decreased agalsidase alfa activity.
Danish: Der er en teoretisk risiko for nedsat agalsidase alfa-aktivitet.
English: The safety and efficacy of Replagal in children aged 0-6 years has not yet been established.
Danish: Replagals sikkerhed og virkning hos børn i alderen 0-6 år er endnu ikke klarlagt.
English: The onset of infusion related reactions has generally occurred within the first 2-4 months after initiation of treatment with Replagal although later onset (after 1 year) has been reported as well.
Danish: Infusionsrelaterede reaktioner er generelt indtrådt inden for de første 2-4 måneder efter påbegyndt behandling med Replagal, om end en senere indtræden (efter 1 år) også er indberettet.
English: In addition, oral or intravenous pre-treatment with antihistamines and/or corticosteroids, from 1 to 24 hours prior to infusion may prevent subsequent reactions in those cases where symptomatic treatment was required.
Danish: Desuden kan oral eller intravenøs forbehandling med antihistaminer og/eller kortikosteroider fra 1 til 24 timer forud for infusionen forebygge følgereaktioner i de tilfælde, hvor symptomatisk behandling var påkrævet.
English: If treatment with Replagal makes your body produce antibodies this will not stop Replagal from working and the antibodies may disappear with time.
Danish: Hvis behandlingen med Replagal får Deres krop til at danne antistoffer, vil det ikke forhindre, at Replagal virker, og antistofferne kan forsvinde med tiden.
English: 4.6 Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj og betjene maskiner
English: Replagal has no or negligible influence on the ability to drive and use machines.
Danish: Replagal påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Very common: may affect more than 1 in 10 people - general pain or discomfort.
Danish: Meget almindelige: forekommer hos flere end 1 ud af 10 behandlede personer: - generel smerte eller ubehag.
English: Do not use Replagal if you notice that there is discolouration or other foreign particles present.
Danish: Brug ikke Replagal, hvis De bemærker misfarvning eller tilstedeværelse af andre fremmede partikler.
English: It is expected that its metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis.
Danish: Det forventes, at dets metabolisering følger samme rute som andre proteiner, dvs. peptidhydrolyse.
English: The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion.
Danish: Enzymet fjernes dernæst fra cellen og omdannes til et sterilt koncentrat til opløsning til infusion.
English: Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended.
Danish: Der findes begrænsede data fra patienter i dialyse eller efter nyretransplantation; dosisjustering anbefales ikke.
English: Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids).
Danish: Deres læge kan også behandle symptomerne med andre lægemidler (antihistaminer eller kortikosteroider).
English: Idiosyncratic infusion related reactions
Danish: Idiosynkratiske infusionsrelaterede reaktioner
English: The overall incidence of SAEs by treatment group did not show any obvious effect of treatment regimen on the SAE profile of the different treatment groups.
Danish: Den samlede incidens af alvorlige bivirkninger (SAE'er) pr. behandlingsgruppe viste ingen tydelig virkning af behandlingsregimet på SAE-profilen i de forskellige behandlingsgrupper.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes straks, er opbevaringstid og -betingelser efter fortynding og inden anvendelse brugerens eget ansvar og vil normalt ikke overstige 24 timer ved 2oC til 8oC, medmindre fortyndingen er foretaget under kontrollerede og aseptiske betingelser.
English: Reduction in their hypernormal eGFRs was observed within 6 months of initiating Replagal therapy.
Danish: En reduktion i deres hypernormale eGFR'er blev observeret inden for 6 måneder efter iværksættelse af behandling med Replagal.
English: Twelve to 18 months of treatment with Replagal resulted in improvement in quality of life (QoL), as measured by validated instruments.
Danish: 12 til 18 måneders behandling med Replagal medførte en forbedring af livskvalitet (QoL) målt ved hjælp af validerede instrumenter.
English: If you have advanced renal disease, you may find that your Replagal treatment has a limited effect on your kidneys.
Danish: Hvis De har fremskreden nyresygdom, kan det være, at Replagal-behandlingen har en begrænset virkning på Deres nyrer.
English: Antibodies to the protein
Danish: Antistoffer mod proteinet
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonic/fetal development when exposed during organogenesis (see Section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditeten eller den embryonale/føtale udvikling ved eksponering under organogenesen (se pkt.
English: Once diluted, the solution should be mixed gently but not shaken.
Danish: Efter fortynding bør opløsningen blandes blidt, men uden omrystning.
English: Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin.
Danish: Fortæl det til lægen, hvis De tager medicin, der indeholder chloroquin, amiodaron, benoquin eller gentamicin.
English: Compared with placebo, treatment with Replagal also reduced accumulation of Gb3.
Danish: I sammenligning med placebo reducerede behandling med Replagal også akkumulation af Gb3.
English: Data with patients indicates that at least 0.1mg/kg is required to achieve a pharmacodynamics response.
Danish: Data fra patienter tyder på, at en dosis på mindst 0,1 mg/kg er nødvendig for at opnå et farmakodynamisk respons.
English: There is very limited data on pregnancies exposed to Replagal.
Danish: Der er meget begrænsede data fra graviditeter, hvor kvinden har været eksponeret for Replagal.
English: Elimination half-lives were 108 ± 17 minutes in males compared to 89 ± 28 minutes in females and volume of distribution was approximately 17% body weight in both sexes.
Danish: Elimineringshalveringstider var 108 ± 17 minutter hos mænd sammenlignet med 89 ± 28 minutter hos kvinder, og fordelingsvolumen var ca. 17% legemsvægt hos begge køn.
English: Very limited clinical data on pregnancies exposed to Replagal have shown no adverse effects on the mother and newborn child.
Danish: Meget begrænsede kliniske data om graviditeter, der er blevet eksponeret for Replagal, har ikke vist nogen bivirkninger på moderen og det nyfødte barn.
English: Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Danish: Lette og forbigående symptomer kræver ikke nødvendigvis medicinsk behandling eller afbrydelse af infusionen.
English: Most of the time you can still be given Replagal even if these symptoms occur.
Danish: De kan som oftest stadig kunne få Replagal, selvom De får disse symptomer.
English: Patients switched from agalsidase beta to Replagal had a safety profile consistent with that observed in other clinical experience.
Danish: Patienter, der skiftede fra agalsidase beta til Replagal, havde en sikkerhedsprofil, der stemmer overens med den, der er observeret i andre kliniske studier.
English: Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra undersøgelser af toksicitet efter gentagne doser.
English: A low titre IgG antibody response has been observed in approximately 24% of the male patients treated with Replagal.
Danish: Et lav-titret IgG-antistofsvar er observeret hos ca. 24% af mandlige patienter behandlet med Replagal.
English: About 1 out of 7 patients (frequency “very common”) may have a reaction during or following an infusion of Replagal (infusion related reaction).
Danish: Ca. 1 ud af 7 patienter (meget almindelig bivirkning) kan have en reaktion under eller efter en infusion med Replagal (infusionsrelateret reaktion).