FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, no improvement was observed for IKERVIS compared to vehicle at Month 6 for other secondary endpoints, including ocular discomfort score, Schirmer test, use of concomitant artificial tears, investigator's global evaluation of efficacy, tear break-up time, lissamine green staining, quality of life score, and tear osmolarity.
Danish: Endvidere blev der ikke observeret nogen forbedring for IKERVIS, sammenlignet med kontrollen ved måned 6 for andre sekundære endepunkter, herunder score for ubehag i øjnene, Schirmers test, brug af samtidige kunstige tårer, investigators globale evaluering af virkning, tårernes break-up time, Lissamin grøn farvning, livskvalitetscore og i tåreosmolaritet.
English: The majority of adverse reactions reported in clinical studies with the use of IKERVIS were ocular and mild to moderate in severity.
Danish: Størstedelen af de indberettede bivirkninger i de kliniske studier af IKERVIS var okulære, og milde eller moderate i sværhedsgrad.
English: • Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Danish: • Betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af lægemidlet, som skal implementeres af medlemslandet
English: Instillation site pain was a frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials.
Danish: Smerter på inddrypningsstedet var en hyppigt indberettet lokal bivirkning forbundet med anvendelsen af IKERVIS under kliniske studier.
English: Precautions to be taken before administering the medicinal product Patients should be instructed to first wash their hands.
Danish: Patienter skal anvises i først at vaske hænderne.
English: If you use more IKERVIS than you should, rinse your eye with water.
Danish: Hvis du har brugt for meget IKERVIS, skal øjnene skylles med vand.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE UDVENDIG KARTON
English: The European Medicines Agency has waived the obligation to submit the results of studies with IKERVIS in all subsets of the paediatric population for dry eye disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med IKERVIS i alle undergrupper af den pædiatriske population med lidelsen tørre øjne (se pkt.
English: There is no relevant use of IKERVIS in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Danish: Der er ingen relevant anvendelse af IKERVIS hos børn og unge under 18 år i indikationen af behandlingen af alvorlig keratitis hos patienter med øjentørhed, som ikke er blevet bedre på trods af behandling med kunstige tårer.
English: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).
Danish: En ml emulsion indeholder 0,05 mg cetalkoniumchlorid (lidokain) (se pkt.
English: In patients with dry eye disease, a condition that may be considered to have an inflammatory immunological mechanism, following ocular administration, ciclosporin is passively absorbed into Tlymphocyte infiltrates in the cornea and conjunctiva and inactivates calcineurin phosphatase.
Danish: Hos patienter med lidelsen øjentørhed, som er en tilstand, der kan ses som havende en inflammatorisk immunologisk mekanisme, absorberes ciclosporin efter okulær administration ind i T-lymfocytinfiltraterne i cornea og conjunctiva og inaktiverer calcineurinfosfatase.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicine.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The following adverse reactions listed below were observed in clinical studies.
Danish: De følgende bivirkninger blev observeret i kliniske studier.
English: In Post SANSIKA study patients alternatively received IKERVIS treatment or no treatment depending on CFS score (patients received IKERVIS when there was a worsening of keratitis).
Danish: IKERVIS eller ingen behandling afhængig af CFS-score (patienterne fik IKERVIS, når der var en forværring af keratitis).
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA18.
Danish: Farmakoterapeutisk klassifikation: Oftalmologika, andre oftamologika, ATC-kode: S01XA18.
English: poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Danish: poloxamer 188, natriumhydroxid (til justering af pH) og vand til injektioner.
English: 5 single-dose containers.
Danish: 5 enkeltdosisbeholdere.
English: Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.
Danish: Dyreforsøg har påvist reproduktionstoksicitet efter systemisk administration af ciclosporin ved en eksponering, der betragtes tilstrækkeligt over den maksimale humane eksponering, hvilket ikke har relevans for den kliniske anvendelse af IKERVIS.
English: • Open the aluminium pouch, which contains 5 single-dose containers.
Danish: • Åbn folieposen, der indeholder fem enkeltdosisbeholdere.
English: Eye drops, emulsion.
Danish: Øjendråber, emulsion.
English: Method of administration Ocular use.
Danish: Administration Okulær anvendelse.
English: Prior to administration, the single-dose container should be gently shaken.
Danish: Før administration rystes enkeltdosisbeholderen forsigtigt.
English: Each single-dose container contains 0.3 mL eye drops, emulsion.
Danish: Hver enkeltdosisbeholder indeholder 0,3 ml øjendråber, emulsion.
English: The effect of IKERVIS has not been studied in patients with hepatic or renal impairment.
Danish: Virkningen af IKERVIS er ikke blevet undersøgt hos patienter med nedsat lever- eller nyrefunktion.
English: One pouch contains five single-dose containers.
Danish: En pose indeholder fem enkeltdosisbeholdere.
English: - The active substance is ciclosporin.
Danish: - Aktivt stof: ciclosporin.
English: Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time.
Danish: Kontaktlinser skal fjernes inden drypning med øjendråberne ved sengetid, og kan sættes i igen om morgenen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SINGLE-DOSE CONTAINER LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER MÆRKAT TIL ENKELTDOSISBEHOLDER
English: Milky white emulsion.
Danish: Mælkehvid emulsion.
English: Women of childbearing potential/contraception in females IKERVIS is not recommended in women of childbearing potential not using effective contraception.
Danish: Kvinder i den fertile alder/kontraception hos kvinder IKERVIS bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: IKERVIS contains the active ingredient, ciclosporin.
Danish: IKERVIS indeholder det aktive ingrediens ciclosporin.
English: • Twist off the cap (picture 1).
Danish: • Vrid toppen af beholderen (figur 1).
English: - The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol,
Danish: - De andre indholdsstoffer er mediumkæde-triglycerider, cetalkoniumchlorid, glycerol, tyloxapol,
English: What you need to know before you use IKERVIS Do NOT use IKERVIS
Danish: Det skal du vide, før du begynder at brugeIKERVIS Brug IKKE IKERVIS
English: It is supplied in single-dose containers made of a low-density polyethylene (LDPE).
Danish: Det leveres i enkeltdosisbeholdere, der er fremstillet af termoplast (LDPE).
English: Patients wearing contact lenses have not been studied.
Danish: Dette lægemiddel er ikke blevet undersøgt hos patienter, der anvender kontaktlinser.
English: Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies.
Danish: Oftalmiske lægemidler, der påvirker immunsystemet, herunder ciclosporin, kan påvirke patientens beskyttelse mod lokale infektioner og maligne sygdomme.
English: Uncommon Keratitis bacterial, herpes zoster ophthalmic.
Danish: Bakteriel keratitis, oftalmisk herpes zoster, herpes labialis.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter)
English: Contents of the pack and other information What IKERVIS contains
Danish: Pakningsstørrelser og yderligere oplysninger IKERVIS indeholder:
English: A small but statistically significant difference in CFS improvement was observed between the treatment groups at Month 6 in favour of IKERVIS (mean change from baseline in CFS -1.05 with IKERVIS and -0.82 with vehicle, p=0.009).
Danish: En lille, men statistisk signifikant forskel i CFS-forbedring blev observeret mellem behandlingsgrupper ved måned 6 til fordel for IKERVIS(en gennemsnitlig ændring fra baseline i CFS -1,05 med IKERVISog -0,82 med kontrollen, p=0,009).
English: IKERVIS should be administered last (see section 4.4).
Danish: IKERVIS skal administreres til sidst (se pkt.
English: months and 6 months with IKERVIS, respectively.
Danish: Der tidligere var behandlet henholdsvis 12 måneder og 6 måneder med IKERVIS.
English: • If you wear contact lenses, take them out at bedtime before using the drops; you can reinsert them when you wake up.
Danish: • Hvis du bruger kontaktlinser, skal du tage dem ud før sengetid før du bruger dråberne.
English: • Gently shake the single dose container prior to use
Danish: • Ryst forsigtigt enkeltdosisbeholderen før brug.
English: It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.
Danish: Det er blevet påvist at kunne forlænge overlevelsen af allogene transplantationer hos dyr og kan signifikant forbedre overlevelsenaftransplantatet for alle typer solide organtransplantationer hos mennesker.
English: Cases of infections have been reported uncommonly in association with the use of IKERVIS.
Danish: Der er blevet indberettet om infektioner, der ikke almindeligvis sættes i forbindelse med anvendelsen af IKERVIS.
English: Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye), eye allergy, tear disorder, eye discharge, inflammation of the iris (coloured part of the eye) or eyelid, deposits in the eye, bacterial infection or inflammation of the cornea (transparent front part of the eye), abrasion to the outer layer of the cornea, whitish patches on the cornea, cyst in the eyelid, itching in the eyelid, painful rash around the eye caused by the herpes zoster virus.
Danish: Irritation eller hævelse af bindehinden (den tynde membran, der dækker øjet foran), øjenallergi, tårelidelse, pus i øjet, betændelse af iris (den farvede del af øjet) eller øjenlåg, aflejringer i øjet, bakteriinfektion eller betændelse i hornhinden (den gennemsigtige del af øjet), ridser på det udvendige lag af hornhinden, hvide pletter på hornhinden, cyste på øjenlåget, kløe i øjenlåget, smertefuldt udslæt rundt om øjet forårsaget af virussen herpes zoster.
English: IKERVIS is supplied in 0.3 mL single-dose, low-density polyethylene (LDPE) containers presented in a sealed laminate aluminium pouch.
Danish: IKERVIS leveres i 0,3 ml enkeltdosisbeholdere af termoplast (LDPE), der igen ligger i en forseglet laminatfoliepose.
English: Excipients: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Danish: Mediumkæde-triglycerider, cetalkoniumchlorid, glycerol, tyloxapol, poloxamer 188, natriumhydroxid (til justering af pH) og vand til injektioner.
English: Any opened individual single-dose container with any remaining emulsion should be discarded immediately after use.
Danish: Anbrudte, individuelle enkeltdosisbeholdere med tilbagebleven emulsion skal bortskaffes omgående efter anvendelse.
English: Only use IKERVIS for dropping in your eye(s).
Danish: Brug kun IKERVIS til drypning af dine øjne.
English: Co-administration of Ikervis with eye drops containing corticosteroids may potentiate the effects of Ikervis on the immune system.
Danish: Samtidig administration af IKERVIS og øjendråber, der indeholder corticosteroider, kan øge effekten af IKERVIS på immunsystemet.
English: In the 12 month, double-masked, vehicle controlled, pivotal clinical trial (SANSIKA study), 246 Dry Eye Disease (DED) patients with severe keratitis (defined as a corneal fluorescein staining (CFS) score of 4 on the modified Oxford scale) were randomised to one drop of IKERVIS or vehicle daily at bedtime for 6 months.
Danish: I det 12-måneders, dobbeltblindede, kontrollerede, pivotale, kliniske studie (SANSIKA-studiet) blev 246 patienter med tørre øjne (DED), der havde svær keratitis (defineret som en score på 4ved farvning af cornea med fluorescein (CFS) på den modificerede Oxford-skala) randomiseret til én dråbe IKERVIS eller kontrollen ved sengetid i 6 måneder.
English: In the 6 month, double-masked, vehicle controlled, supportive clinical trial (SICCANOVE study), 492 DED patients with moderate to severe keratitis (defined as a CFS score of 2 to 4) were also randomised to IKERVIS or vehicle daily at bedtime for 6 months.
Danish: I det 6-måneders, dobbeltblindede, kontrollerede, roborerende, kliniske studie (SICCANOVE-studiet) blev 492 DED-patienter med moderat til svær keratitis(defineret som en CFS-score på 2 til 4) også randomiserettil IKERVIS eller kontrollen dagligt ved sengetid i 6 måneder.
English: Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).
Danish: Kombination med andre lægemidler, der påvirker immunsystemet Samtidig administration af IKERVIS med øjendråber, der indeholder kortikosteroider, kan forstærke ciclosporins virkninger på immunsystemet (se pkt.
English: Other medicines and IKERVIS
Danish: Brug af anden medicin sammen med IKERVIS
English: Patients should be advised not to instil more than one drop in the affected eye(s).
Danish: Patienten skal have at vide, at der ikke må anvendes mere end en dråbe i det/de syge øjne.
English: There is insufficient information on the effects of ciclosporin in newborns/infants.
Danish: Der foreligger utilstrækkelige data for virkningen af ciclosporin på det ammende barn.
English: The severity of keratitis, assessed using CFS, improved significantly from baseline at Month 6 with IKERVIS compared to vehicle (mean change from baseline was -1.764 with IKERVIS vs. -1.418 with vehicle, p=0.037).
Danish: Sværhedsgraden af keratitis, vurderet vha. CFS, forbedrede sig signifikant fra baseline ved måned 6 med IKERVIS sammenlignet med kontrollen (gennemsnitlig ændring fra baseline var -1,764 med IKERVIS vs. -1,418 med kontrollen,p=0,037).
English: The mean change from baseline in ocular discomfort score (assessed using a Visual Analogic Scale) was -12.82 with IKERVIS and -11.21 with vehicle (p=0.808).
Danish: Den gennemsnitlige ændring fra baseline i ubehag i øjnene (vurderet vha. en visuel, analog skala) var12,82 med IKERVIS og -11,21 med kontrollen (p=0,808).
English: EXCELVISION Rue de la Lombardière ZI la Lombardière
Danish: EXCELVISION Rue de la Lombardière ZI la Lombardière F-07100 Annonay Frankrig
English: The single-dose containers are wrapped in a sealed aluminium pouch.
Danish: Enkeltdosisbeholderne er pakket i en forseglet foliepose.
English: Package leaflet: Information for the patient IKERVIS 1 mg/mL, eye drops, emulsion ciclosporin
Danish: Indlægsseddel: Information til patienten IKERVIS 1 mg/ml øjendråber, emulsion ciclosporin
English: How to use IKERVIS
Danish: Sådan skal du bruge IKERVIS
English: How to store IKERVIS 6.
Danish: Sådan skal du bruge IKERVIS 4.
English: - if you are taking any medicines to treat glaucoma.
Danish: - hvis du bruger lægemidler til behandling af grøn stær.
English: It is used in those patients who have dry eye disease, which has not improved despite treatment with tear substitutes (artificial tears).
Danish: Det anvendes hos voksne patienter med øjentørhed, som ikke er blevet bedre på trods af behandling med kunstige tårer.
English: The mean change from baseline in the 100-point OSDI score was -13.6 with IKERVIS and -14.1 with vehicle at Month 6 (p=0.858).
Danish: Den gennemsnitlige ændring fra baseline i den 100-points OSDI-score var-13,6 med IKERVIS og14,1 med kontrollen ved måned 6 (p=0,858).
English: If you are breast feeding talk to your doctor before using this medicine.
Danish: Tal med lægen, hvis du ammer, før du bruger dette lægemiddel.
English: Effects in non-clinical studies were observed only with systemic administration or at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I prækliniske studier blev der kun iagttaget virkninger ved systemisk administration eller ved doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).
Danish: Behandling af alvorlig keratitis hos voksne patienter med øjentørhed, som ikke er blevet bedre på trods af behandling med kunstige tårer (se pkt.
English: Ocular or peri-ocular malignancies or premalignant conditions Active or suspected ocular or peri-ocular infection.
Danish: Aktive eller mistænkte okulære eller periokulære infektioner.
English: time to relapse (back to CFS grade 4) was ≤224 days and ≤175 days in patients previously treated 12
Danish: Baseret på den første kvartil (medianen kunne ikke estimeres på grund af det lille antal recidiver), var tiden til recidiv (tilbage til CF grad 4) ≤224 dage og ≤175 dage hos patienter.
English: Uncommon Instillation site reaction, instillation site discomfort, instillation site pruritus, instillation site foreign body sensation.
Danish: Reaktion på inddrypningsstedet, ubehag på inddrypningsstedet, pruritus på inddrypningsstedet, fornemmelse af fremmedlegeme på inddrypningsstedet.
English: IKERVIS 1 mg/mL eye drops, emulsion
Danish: IKERVIS 1 mg/ml øjendråber, emulsion
English: Common Instillation site irritation, instillation site erythema, instillation site lacrimation.
Danish: Almindelig Irritation på inddrypningsstedet, erytem på inddrypningsstedet, lakrimation på inddrypningsstedet.
English: Discard any opened individual single-dose container with any remaining emulsion immediately after use.
Danish: EXP Bortskaf anbrudte enkeltdosisbeholdere med eventuel overskydende emulsion umiddelbart efter brug.
English: Ciclosporin-induced inactivation of calcineurin inhibits the dephosphorylation of the transcription factor NF-AT and prevents NF-AT translocation into the nucleus, thus blocking the release of proinflammatory cytokines such as IL-2.
Danish: NF-AT-translokation i kernen, som således blokerer frigivelsen af proinflammatoriske cytokiner, såsom IL-2.
English: IKERVIS 1 mg/mL eye drops, emulsion ciclosporin
Danish: IKERVIS 1 mg/ml øjendråber, emulsion ciclosporin
English: Irritation, redness, and increase in tears when the drops are put into the eye, redness of the eyelid, watery eyes, eye redness, blurred vision.
Danish: Irritation, rødme og tåreflåd, når dråberne inddryppes i øjet, røde øjenlåg, øjne, der løber i vand, røde øjne, sløret syn.
English: Swelling of the eyelid, redness of the conjunctiva (thin membrane covering the front part of the eye), eye irritation, eye pain.
Danish: Hævelse af øjenlågene, rød bindehinde (den tynde membran, der dækker øjet foran), øjenirritation, øjensmerter.
English: Description of selected adverse reactions
Danish: Beskrivelse af valgte bivirkninger
English: 1 mL of emulsion contains 1 mg of ciclosporin.
Danish: 1 ml emulsion indeholder 1 mg ciclosporin.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Ved terapeutiske doser af ciclosporin som øjendråber er det usandsynligt, at tilstrækkelige mængder vil være til stede i human mælk Det skal besluttes, om amning skal ophøre eller behandling med IKERVIS seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Therefore, you should remove your contact lenses at bedtime before using IKERVIS; you can reinsert them when you wake up.
Danish: Derfor skal du tage kontaktlinserne ud ved sengetid, før du bruger IKERVIS.
English: One mL of emulsion contains 1 mg of ciclosporin.
Danish: En ml emulsion indeholder 1 mg ciclosporin.
English: IKERVIS is a milky white eye drops emulsion.
Danish: IKERVIS er en mælkehvid øjendråbeemulsion.
English: • Take one single-dose container from the aluminium pouch.
Danish: • Tag en enkeltdosisbeholder ud af folieposen.
English: One millilitre of IKERVIS contains 1 mg of ciclosporin.
Danish: En ml IKERVIS indeholder 1 mg ciclosporin.
English: Do not use a double dose to make up for the forgotten dose.
Danish: Du må ikke bruge en dobbeltdosis som erstatning for den glemte dosis.Dosen må ikke overskride en dråbe i det/de berørte øjne dagligt.
English: Instillation site pain.
Danish: Smerte på inddrypningsstedet.
English: • Gently squeeze one drop of the medicine onto your eye. Make sure you do not touch your eye with the tip of the single-dose container.
Danish: • Tryk forsigtigt én dråbe af lægemidlet ud i øjet.
English: Common Erythema of eyelid, lacrimation increased, ocular hyperaemia, vision blurred, eyelid oedema, conjunctival hyperaemia, eye irritation, eye pain.
Danish: Almindelig Erytem i øjenlåg, forhøjet lakrimation, okulær hyperæmi, sløret syn, øjenlågsødem, konjunktival hyperæmi, øjenirritation, øjensmerter.
English: Uncommon Conjunctival oedema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis.
Danish: Konjunktivalt ødem, lakrimal lidelse, pus i øjet, øjenpruritus, konjunktival irritation, konjunktivitis, fornemmelse af fremmedlegeme i øjnene, aflejringer i hornhinden, keratitis, blefaritis, korneal dekompensering,
English: What IKERVIS is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: What IKERVIS looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: • Risk Management Plan ( RMP)
Danish: • Risikostyringsplan (RMP)
English: This dose might be repeated if needed up to 4.8 mL.
Danish: Om nødvendigt kan denne dosis gentages op til 4,8 mL.
English: Although these biological side effects have not been reported in humans, the use of a low mechanical index is recommended.
Danish: Skønt disse biologiske bivirkninger ikke er blevet rapporteret i mennesker, anbefales det at anvende lavt mekanisk index.
English: Animal studies do not indicate harmful effects on fertility .
Danish: Dyrestudier indikerer ingen skadelige virkninger på fertiliteten.
English: Intravesical local tolerance for SonoVue was also assessed.
Danish: Intravesikal lokal tolerance for SonoVue blev også vurderet.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør præparatet bruges med det samme.
English: Technical recommendation
Danish: Teknisk anbefaling
English: Other concomitant diseases
Danish: Andre samtidige sygdomme