FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000)very rare (<1/10,000) or not known (cannot be estimated from the available data).
Danish: Følgende bivirkninger blev rapporteret under kliniske studier eller i post-markedsføringsdata og er klassificeret i overensstemmelse med følgende konvention: Meget almindelig (≥1/10), almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til ≤1/100), sjælden (>1/10.000 til ≤1/1000), meget sjælden (≤1/10.000) eller ukendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not give this medicine to children under the ages of 3 years because there is no data to indicate that it is safe and work in children under 3 years.
Danish: Dette lægemiddel må ikke bruges til børn under 3 år, da der ikke dokumentation for, at det er sikkert og effektivt til børn under 3 år.
English: This exposure would result in a final dose of 0.5 mg/kg in a 10 kg infant, assuming 100% absorption.
Danish: Denne eksponering vil medføre en slutdosis på 0,5 mg/kg hos et barn på 10 kg, hvis det antages at absorptionen er 100%.
English: • If you use drops in both eyes, repeat the steps for your other eye.
Danish: • Hvis begge øjne skal behandles, gentages trinene for det andet øje.
English: Use in elderly No dosage adjustment in elderly patients is necessary.
Danish: Brug hos ældre Dosisjustering hos ældre patienter er ikke nødvendig.
English: B-2870 Puurs Belgium or
Danish: B-2870 Puurs Belgien eller
English: In vitro studies have shown that olopatadine did not inhibit metabolic reactions which involve cytochrome P-450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Danish: In vitro studier har vist, at olopatadin ikke hæmmer de metaboliske reaktioner, som involverer cytokrom P-450 isozymerne 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4.
English: These concentrations are 50-to 200-fold lower than those following well tolerated oral doses.
Danish: Disse koncentrationer er 50 til 200 gange lavere end dem der ses ved veltolererede orale doser.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med til at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Olopatadine is a potent selective antiallergic/antihistaminic agent that exerts its effects through multiple distinct mechanisms of action.
Danish: Olopatadin er et potent, selektivt antiallergikum/antihistaminikum, der udøver sin virkning via mange forskellige virkningsmekanismer.
English: In clinical studies involving 1680 patients, Opatanol was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg.
Danish: I kliniske studier med 1680 patienter blev Opatanol administreret fra 1 til 4 gange dagligt i begge øjne i op til 4 måneder som monoterapi eller som supplerende terapi til 10 mg loratadin.
English: Accidental ingestion of the entire contents of a bottle of Opatanol would deliver a maximum systemic exposure of 5 mg olopatadine.
Danish: Indtagelse ved et uheld af hele flaskens indhold af Opatanol, vil give en maksimal systemisk eksponering af 5 mg olopatadin.
English: Pull down your eyelid with a clean finger, until there is a ‘pocket' between the eyelid and your eye.
Danish: Træk dit øjenlåg ned med en finger, indtil der dannes en lomme mellem øjenlåg og dit øje.
English: Two metabolites, the mono-desmethyl and the Noxide, were detected at low concentrations in the urine.
Danish: To metabolitter, monodesmethyl og N-oxid, blev påvist i lave koncentrationer i urinen.
English: Common headache, dysgeusia
Danish: Hovedpine, dysgeusi
English: BOX OF 1 BOTTLE + BOX OF 3 BOTTLES
Danish: KARTON MED 1 FLASKE + KARTON MED 3 FLASKER
English: These results indicate that olopatadine is unlikely to result in metabolic interactions with other concomitantly administered active substances.
Danish: Disse resultater antyder, at det er usandsynligt, at olopatadin er årsag til metaboliske interaktioner med andre samtidigt administrerede aktive substanser.
English: Pharmacotherapeutic group: ophthalmologicals; decongestant and antiallergics; other antiallergics, ATC code: S01GX 09
Danish: Farmakoterapeutisk klassifikation: oftalmologika; adstringerende og antiallergiske lægemidler; andre antiallergiske lægemidler, ATC-kode: S01GX09.
English: Opatanol has no or negligible influence on the ability to drive and use machines.
Danish: Opatanol påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: No serious ophthalmic or systemic adverse reactions related to Opatanol were reported in clinical studies.
Danish: Ingen alvorlige oftalmologiske eller systemiske bivirkninger relateret til Opatanol er blevet rapporteret i kliniske studier.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionstoksicitet.
English: Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet efter systemisk administration (se afsnit 5.3).
English: It antagonises histamine (the primary mediator of allergic response in humans) and prevents histamine induced inflammatory cytokine production by human conjunctival epithelial cells.
Danish: Det antagoniserer histamin (den primære mediator ved et humant allergirespons) og forebygger histamininduceret inflammatorisk cytokinproduktion i de humane conjunktivale epitelceller.
English: Common (may affect up to 1 in 10 people) Effects in the eye:
Danish: Almindelige (kan forekomme hos op til 1 for hver 10 personer) Bivirkninger i øjet
English: Warnings and precautions Talk to your doctor or pharmacist before using Opatanol.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du bruger Opatanol.
English: If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment.
Danish: Hvis der forekommer tegn på alvorlige bivirkninger eller overfølsomhed, skal behandlingen stoppes.
English: As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Danish: Som ved enhver anden type øjendråber kan forbigående sløret syn eller andre synsforstyrrelser påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af oftalmisk olopatadin til gravide kvinder.
English: If you stop using Opatanol Do not stop using this medicine without first speaking to your doctor.
Danish: Hvis du holder op med at bruge Opatanol Du må ikke holde op med at bruge Opatanol, uden at du har talt med din læge.
English: The results indicate that a somewhat higher plasma concentration can be expected with Opatanol in this population.
Danish: Resultaterne viser, at noget højere plasmakoncentration efter administration af Opatanol, kan forventes i denne gruppe.
English: The recommended dose is one drop in the eye or eyes, twice a day, morning and evening.
Danish: Den anbefalede dosis er 1 dråbe i de(t) angrebne øje (øjne) 2 gange dagligt - morgen og aften.
English: This medicine contains 0.5 mg benzalkonium chloride in each 5 ml which is equivalent to 0.1 mg/ml.
Danish: Dette lægemiddel indeholder 0,5 mg benzalkoniumchlorid pr. 5 ml svarende til 0,1 mg/ml.
English: • If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Opatanol: - hvis du er allergisk (hypersensisitiv) over for olopatadin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The range of peak steady-state olopatadine plasma concentrations (35 to 127 ng/ml) seen in this study represents at least a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarisation.
Danish: Intervallet for peak steady-state plasmakoncentrationer for olopatadin (35 til 127 ng/ml) set i dette studie svarer til mindst 70 gange sikkerhedsmargin for topikal olopatadin med hensyn til virkning på hjertets repolarisering.
English: It does not produce a clinically significant change in pupil diameter.
Danish: Opatanol fremkalder ikke klinisk signifikant ændring i pupildiameteren.
English: If you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each medicine.
Danish: Hvis du bruger andre øjendråber eller øjensalver, skal der gå mindst 5 minutter mellem brug af hvert lægemiddel.
English: Data from in vitro studies suggest that it may act on human conjunctival mast cells to inhibit the release of pro-inflammatory mediators.
Danish: Data fra in vitro studier antyder, at olopatadin kan virke på humane conjunktivale mastceller og dermed hæmme frigivelsen af pro-inflammatoriske mediatorer.
English: If you forget to use Opatanol
Danish: Hvis du har glemt at bruge Opatanol
English: Opatanol is a medicine for treatment of allergic conditions of the eye.
Danish: Opatanol er et lægemiddel til behandling af allergiske tilstande i øjet.
English: Prolongation of the QTc interval in dogs was observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Forlængelse af QTc-intervallet er kun observeret hos hunde, som blev eksponeret med doser langt over den maximale humane eksponering, hvilket indikerer ringe klinisk relevans.
English: Opatanol should only be used as an eye drop.
Danish: Opatanol må kun anvendes som øjendråber.
English: The preservative in Opatanol, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Danish: Konserveringsmidlet i Opatanol, benzalkoniumchlorid, kan absorberes af bløde kontaktlinser og kan ændre farven af kontaktlinserne.
English: Write down the date you opened it in the space on each bottle label and box.
Danish: Skriv dato for, hvornår du har åbnet flasken på hver flaskeetiket og æsken samt på linjerne herunder.
English: Eye ointments should be administered last.
Danish: Øjensalve bør gives sidst.
English: From oral pharmacokinetic studies, the half-life of olopatadine in plasma was approximately eight to 12 hours, and elimination was predominantly through renal excretion.
Danish: Orale farmakokinetik-studier har vist, at halveringstiden i plasma var ca. 8 til 12 timer og at eliminationen fortrinsvis sker ved udskillelse gennem nyrerne.
English: You may find that your vision is blurred for a time just after you use Opatanol.
Danish: Dit syn kan blive sløret en tid efter, at du har dryppet med Opatanol.
English: Not known dyspnoea, sinusitis
Danish: Dyspnø, sinusitis
English: No interaction studies with other medicinal products have been performed.
Danish: Der er ikke udført interaktionsstudier.
English: The safety and efficacy of Opatanol in children aged under 3 years has not been established.
Danish: Opatanols sikkerhed og virkning hos børn under 3 år er ikke klarlagt.
English: Uncommon rhinitis
Danish: Ikke almindelig Rhinitis
English: Do not drive or use machines until this has worn off.
Danish: Du må ikke køre bil eller betjene maskiner, før dit syn er klart igen.
English: Olopatadine has a low order of acute toxicity in animals.
Danish: Olopatadin udviser ringe akut toksicitet hos dyr.
English: In patients with patent nasolacrimal ducts, topical ocular administration of Opatanol was suggested to reduce the nasal signs and symptoms that frequently accompany seasonal allergic conjunctivitis.
Danish: Hos patienter med patente nasolakrimale kanaler formodes topikal okulær administration af Opatanol at reducere nasale tegn og symptomer, som hyppigt ledsager sæsonbetinget allergisk conjunctivitis.
English: Olopatadine has been detected in the milk of nursing rats following oral administration.
Danish: Olopatadin er blevet påvist i mælk fra diegivende rotter efter oral administration.
English: However, systemic absorption of topically applied olopatadine is minimal with plasma concentrations ranging from below the assay quantitation limit (<0.5 ng/ml) up to 1.3 ng/ml.
Danish: Imidlertid er systemisk absorption af topikalt appliceret olopatadin minimal med plasmakoncentrationer i intervallet fra under kvantificeringsgrænsen for analysemetoden (<0,5 ng/ml) til 1,3 ng/ml.
English: Opatanol contains benzalkonium chloride which may cause eye irritation.
Danish: Opatanol indeholder benzalkoniumchlorid, som kan forårsage øjenirritation.
English: Not known dermatitis, erythema
Danish: Dermatitis, erytem
English: A 5 mg oral dose was administered twice-daily for 2.5 days to 102 young and elderly male and female healthy volunteers with no significant prolongation of QTc interval compared to placebo.
Danish: 5 mg olopatadin administreret oralt 2 gange daglig i 2,5 dage til 102 unge og gamle (mænd og kvinder) raske forsøgspersoner forlængede ikke QTc-intervallet signifikant sammenlignet med placebo.
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Danish: Hvis der forekommer sløret syn ved drypning, skal patienten vente, indtil synet bliver klart igen, før der kan føres motorkøretøj eller betjenes maskiner.
English: Shelf-life after first opening
Danish: Opbevaringstid efter første åbning
English: Since plasma concentrations following topical ocular dosing of olopatadine are 50-to 200-fold lower than after well-tolerated oral doses, dose adjustment is not expected to be necessary in the elderly or in the renally impaired population.
Danish: Da plasmakoncentrationen, efter topikal okulær dosering af olopatadin, er 50 til 200 gange lavere end efter veltolererede orale doser, forventes dosisjustering ikke at være nødvendig hos ældre personer eller personer med nedsat nyrefunktion.
English: Studies in animals have shown reduced growth of nursing pups of dams receiving systemic doses of olopatadine well in excess of the maximum level recommended for human ocular use.
Danish: Dyrestudier har vist reduceret vækst hos diende hvalpe af mødre, der havde fået systemiske doser af olopatadin, som var langt over den maksimale anbefalede dosis ved human okulær anvendelse.
English: Olopatadine in the form of eye drops (Opatanol) has not been studied in patients with renal or hepatic disease.
Danish: Olopatadin som øjendråber (Opatanol) er ikke blevet undersøgt hos patienter med lever- eller nyresygdom.
English: Olopatadine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Olopatadin frarådes under graviditet og til kvinder i den fertile alder, der ikke anvender præventionsmidler.
English: Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Danish: Der er i sjældne tilfælde rapporteret om korneal kalcifikation i forbindelse med brug af phosphatholdige øjendråber hos visse patienter med signifikant cornea-beskadigelse.
English: The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly).
Danish: Dosis er 1 dråbe Opatanol i konjunktivalsækken i de(t) pågældende øj(n)e 2 gange dagligt (8 timers interval).
English: In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Danish: I meget sjældne tilfælde har patienter med svær beskadigelse af hornhinden (det klare lag på øjets forside) udviklet slørede pletter på hornhinden pga. aflejring af kalk under behandlingen.
English: Close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Danish: Omhyggelig monitorering er nødvendig ved hyppig eller langvarig brug hos patienter med tørre øjne eller tilstande med beskadiget hornhinde.
English: Opatanol is an antiallergic/antihistaminic agent and, although administered topically, is absorbed systemically.
Danish: Opatanol er et antiallergikum/antihistaminikum som, selv ved topikal administration, kan absorberes systemisk.
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spain
Danish: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spanien
English: To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle.
Danish: For at undgå kontaminering af dråbespidsen og øjendråberne må øjenlåg, omkringliggende hudområder eller andre overflader ikke berøres med flaskens dråbespids.
English: Patients should be instructed to remove contact lenses prior to administration of the eye drop and wait at least15 minutes after instillation before re-inserting contact lenses.
Danish: Patienterne skal informeres om at tage kontaktlinserne ud inden brug af øjendråberne og vente mindst 15 minutter efter drypning, før kontaktlinserne sættes i igen.
English: No data are available in humans regarding overdose by accidental or deliberate ingestion.
Danish: Ingen humane data er tilgængelige mht. overdosering ved uheld eller forsætlig indtagelse.
English: Since olopatadine is excreted in urine primarily as unchanged active substance, impairment of renal function alters the pharmacokinetics of olopatadine with peak plasma concentrations 2.3-fold greater in patients with severe renal impairment (mean creatinine clearance of 13.0 ml/min) compared to healthy adults.
Danish: Da olopatadin primært udskilles som uændret aktiv substans i urinen, vil nedsat nyrefunktion ændre olopatadins farmakokinetik med peak plasmakoncentrationer 2,3 gange større hos patienter med svær nedsat nyrefunktion (gennemsnit keratininclearance 13,0 ml/min) sammenlignet med raske voksne.
English: Studies have not been performed to evaluate the effect of topical ocular administration of olopatadine on human fertility.
Danish: Der er ikke udført studier for at evaluere indvirkningen på human fertilitet efter okulær administration af olopatadin.
English: In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications.
Danish: I tilfælde af samtidig behandling med andre topikale øjenpræparater bør der være et interval på 510 minutter mellem de enkelte applikationer.
English: • Gently press on the base of the bottle to release one drop of Opatanol at a time.
Danish: • Tryk med pegefingeren forsigtigt i bunden af flasken, så én (1) dråbe Opatanol frigøres ad gangen.
English: Do not put in any more drops until it's time for your next regular dose.
Danish: Dryp ikke flere dråber i øjet før næste planlagte dosis.
English: Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
Danish: Øjenallergi: Visse bestanddele (allergener) som pollen, husstøv eller dyrehår kan være årsag til allergiske reaktioner, som medfører kløe, rødme og hævelse af øjet.
English: Rinse it all out with warm water.
Danish: Hvis du har brugt for meget Opatanol Skyl det ud med varmt vand.
English: Paediatric patients
Danish: Pædiatrisk population
English: Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Danish: Behandling af okulære tegn og symptomer på sæsonbetinget allergisk conjunctivitis.
English: What Opatanol looks like and contents of the pack Opatanol is a clear and colourless liquid (a solution) supplied in a pack containing either one 5 ml bottle or three 5 ml plastic bottles with screw caps.
Danish: Opatanol er en klar og farveløs væske (en opløsning), som fås i en pakning enten med en 5 ml plastflaske med skruelåg eller i en pakning med tre 5 ml plastflasker med skruelåg.
English: You should remove contact lenses that are in your eyes before using Opatanol.
Danish: Du skal tage dine kontaktlinser ud, før du bruger Opatanol.
English: Uncommon dermatitis contact, skin burning sensation, dry skin
Danish: Ikke almindelig Kontaktdermatit, brændende fornemmelse i huden, tør hud
English: Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Danish: Benzalkoniumchlorid, er beskrevet at kunne forårsage punktvis keratopati og/eller toksisk ulcerøs keratopati.
English: Benzalkonium chloride sodium chloride disodium phosphate dodecahydrate (E339) hydrochloric acid (E507) (to adjust pH) sodium hydroxide (E524) (to adjust pH) purified water
Danish: Benzalkoniumchlorid natriumchlorid dinatriumphosphatdodecahydrat (E339) saltsyre (E507) (til pH-justering) natriumhydroxid (E524) (til pH-justering) renset vand
English: Opatanol may be used in paediatric patients three years of age and older at the same dose as in adults.
Danish: Børn (3 år og ældre) kan behandles med Opatanol med samme dosis som voksne.
English: Use this much unless your doctor tells you to do differently.
Danish: Brug denne dosis, medmindre du har aftalt noget andet med din læge.
English: Opatanol contains Benzalkonium chloride
Danish: Indeholder benzalkoniumchlorid
English: However, no dosage adjustment is expected to be necessary in hepatic or renal impairment (see section 5.2).
Danish: Det forventes imidlertid, at dosisjustering ikke er nødvendig ved nedsat lever- og nyrefunktion (se pkt.
English: A renal impairment study after oral dosing of olopatadine has been performed in patients with severe renal impairment.
Danish: Et nyrefunktionsstudie efter orale administration af olopatadin er blevet udført hos patienter med alvorlig nedsat nyrefunktion.
English: • Hold the bottle, pointing down, between your thumb and middle finger.
Danish: • Hold flasken med bunden i vejret mellem tommel- og langfinger.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 for hver 100 personer) Bivirkninger i øjnene
English: Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Dose adjustment is not expected to be necessary with hepatic impairment.
Danish: Dosisjustering forventes ikke at være nødvendig ved nedsat leverfunktion.
English: 5 ml opaque low density polyethylene bottles with polypropylene screw caps (DROP-TAINER).
Danish: Opatanol leveres i en 5 ml uigennemsigtig lavdensitet-polyethylen-flaske med skruelåg af polypropylen (DROPTAINER).
English: Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric acid/sodium hydroxide and purified water.
Danish: Benzalkoniumchlorid, natriumchlorid, dinatriumphosphat dodecahydrat, saltsyre/natriumhydroxid og renset vand.
English: Effects in the eye
Danish: Til anvendelse i øjet
English: Approximately 4.5% of patients can be expected to experience adverse reactions associated with the use of Opatanol; however, only 1.6% of patients discontinued from the clinical studies due to these adverse reactions.
Danish: Det var dog kun 1,6% af patienterne, som udgik af de kliniske studier som følge af disse bivirkninger.