FrancophonIA/ELRC3.0 huggingface dataset:
English: Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not understand.
Danish: Følg disse anvisninger nøje og spørg lægen eller apotekspersonalet, hvis der er noget, du ikke forstår.
English: In both studies one third of the patients in average had Sjögren's syndrome; as for the overall population, a statistically significant improvement in CFS in favour of IKERVIS was observed in this subgroup of patients.
Danish: I begge studier havde en tredjedel af patienterne i gennemsnit Sjögrens syndrom; mht. den generelle population blev der observeret en statistisk signifikant forbedring i CFS til fordel for IKERVIS i denne undergruppe af patienter.
English: The following side effects have been reported:
Danish: Der er indberettet om følgende bivirkninger:
English: If this happens, wait until your vision clears before you drive or use machines.
Danish: Hvis det sker for dig, skal du vente, indtil synet er klar, før du fører motorkøretøj eller betjener maskiner.
English: Do not use this medicine after the expiry date which is stated on the outer carton, the aluminium pouch and on the single-dose containers after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton, aluminiumsposen og enkeltdosisbeholderne efter “EXP”.
English: Pregnancy There is no data from the use of IKERVIS in pregnant women.
Danish: Graviditet Der er ingen data fra anvendelse af IKERVIS til gravide kvinder.
English: After 12 months of treatment, values were below the low limit of detection for 56 patients and below the low limit of quantification in 19 patients.
Danish: Efter 12 måneders behandling var værdierne under den nederste detektionsgrænse for 56 patienter og under den nederste kvantificeringsgrænse hos 19 patienter.
English: Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption.
Danish: Patienter skal anvises i at anvende nasolakrimal okklusion og at lukke øjenlågene i 2 minutter efter inddrypning for at reducere systemisk absorption.
English: Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when Ikervis is used for years.
Danish: Derfor anbefales regelmæssig undersøgelse af øjet/øjnene, f.eks. mindst hver 6. måned, når IKERVIS anvendes i flere år.
English: Patients randomised to the vehicle group were switched to IKERVIS after 6 months.
Danish: Patienter randomiseret til kontrolgruppen blev skiftet til IKERVIS efter 6 måneder.
English: IKERVIS is likely to be present in breast milk in very small amounts.
Danish: IKERVIS er sandsynligvis til stede i små mængder i brystmælk.
English: Therefore, caution should be exercised when corticosteroids are administered concomitantly with Ikervis (see section 4.5).
Danish: Derfor skal der udvises forsigtighed, når der administreres corticosteroider samtidig med IKERVIS (se punkt 4.5).
English: Careful monitoring of patients with severe keratitis is recommended.
Danish: Det anbefales at monitorere patienter med alvorlig keratitis omhyggeligt.
English: Discomfort, itching or irritation in or around the eye including feeling that there is something in the eye.
Danish: Ubehag, kløe eller irritation i eller rundt om øjet, herunder en følelse af at have noget i øjet.
English: The proportion of responders in the IKERVIS group was 28.6%, compared to 23.1% in the vehicle group.
Danish: Andelen afpersoner med respons iIKERVIS-gruppen var 28,6%, sammenlignet med 23,1% i kontrolgruppen.
English: After opening of the aluminium pouches, the single-dose containers should be kept in the pouches in order to protect from light and avoid evaporation.
Danish: Efter anbrud af aluminiumsposerne, skal enkeltdosisbeholderne opbevares i poserne for at beskytte dem mod lys og for at undgå fordampning.
English: Pre-existing infections may also be aggravated (see section 4.3).
Danish: Allerede bestående infektioner kan også forværres (se pkt.
English: This study was designed to monitor the long-term efficacy and relapse rates in patients who have previously received IKERVIS.
Danish: Dette studie var udformet til at monitorere langtidsseffekten og hyppighed af recidiv hoss patienter, der tidligere har fået IKERVIS.
English: Remove contact lenses before use.
Danish: Fjern kontaktlinserne inden brug.
English: There is limited experience with IKERVIS in the treatment of patients with glaucoma.
Danish: Der er begrænset erfaring med IKERVIS i behandlingen af patienter med glaukom.
English: If you forget to use IKERVIS, continue with the next dose as planned.
Danish: Hvis du har glemt at bruge IKERVIS, skal behandlingen fortsættes med den næste dosis, som planlagt.
English: Ciclosporin belongs to a group of medicines known as immunosuppressive agents that are used to reduce inflammation.
Danish: Ciclosporin tilhører en gruppe lægemidler, der kaldes immunhæmmende midler, der anvendes til at reducere betændelse.
English: Uncommon side effects related to the eye:
Danish: Ikke almindelige bivirkninger, der relaterer til øjet:
English: Following oral administration, ciclosporin is excreted in breast milk.
Danish: Efter oral administration udskilles ciclosporin i human mælk.
English: Mechanism of action and pharmacodynamic effects Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties.
Danish: Virkningsmekanisme og farmakodynamisk virkning Ciclosporin (også kendt som ciclosporin A) er en cyklisk polypeptid-immunmodulator med immunosuppressive egenskaber.
English: - if you are allergic to ciclosporin or to any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for ciclosporin eller et af de øvrige indholdsstoffer i IKERVIS (angivet i punkt 6).
English: Patients should be advised not to drive or use machines until their vision has cleared.
Danish: Patienter skal derfor frarådes at føre motorkøretøj eller betjene maskiner, indtil deres syn er blevet klart igen.
English: At completion of the SANSIKA study (12 month study), patients were asked to enter the Post SANSIKA study.
Danish: Ved fuldførelsen af SANSIKA-studiet (12-måneders studie) blev patienterne bedt om at indgå i PostSANSIKA-studiet.
English: It is also known to up-regulate the release of anti-inflammatory cytokines.
Danish: Det vides også at opregulere frigivelsen af antiinflammatoriske cytokiner.
English: The co-primary endpoints were the change in CFS score, and the change in global score of ocular discomfort unrelated to study medication instillation, both measured at Month 6.
Danish: De ko-primære endepunkter var ændringen i CFS-score og ændringen i den globale score for ubehag i øjnene uden relation til inddrypning af forsøgsmedicin, begge målt ved måned 6.
English: In both studies, no significant improvement of symptoms was observed for IKERVIS compared to vehicle after 6 months of treatment, whether using a visual analogue scale or the OSDI.
Danish: I begge studier blev der ikke opnået nogen signifikant forbedring af symptomer for IKERVIS sammenlignet med kontrollen efter 6 måneders behandling, uanset om der blev anvendt en visuel, analog skala eller OSDI.
English: Pack sizes: 30 and 90 single-dose containers.
Danish: Pakningsstørrelser: 30 og 90 enkeltdosisbeholdere.
English: Pain when the drops are put into the eye.
Danish: Smerter, når dråberne inddryppes i øjet.
English: Patients spent more time on CFS grade 2 (Median 12.7 weeks/year) and grade 1 (Median 6.6 weeks/year) than CFS grade 3 (Median 2.4 weeks/year), CFS grades 4 and 5 (Median time 0 week/year).
Danish: Patienterne tilbragte mere tid på CFS grad 2 (median 12,7 uger/år) og grad 1 (median 6,6 uger/år) end CFS grad 3 (median 2,4 uger/år), CFS grad 4 og 5 (median tid 0 uger/år).
English: This study was an open-label, non-randomized, one-arm, 24-month study extension of the Sansika Study.
Danish: Dette studie var et iblindet, ikke-randomiseret, én arm, 24 måneder sudieforlængelse af Sansika-studiet.
English: There is no data on the effects of IKERVIS on human fertility.
Danish: Der findes ingen data om IKERVIS' virkning på human fertilitet.
English: CLINICAL PARTICULARS 4.1 Therapeutic indication
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer
English: The recommended dose is one drop in each affected eye, once daily at bedtime.
Danish: Den anbefalede dosis er én dråbe i hvert berørt øje, én gang daglig ved sengetid.
English: This may result in a decrease in systemic undesirable effects and an increase in local activity (see section 4.4).
Danish: Dette kan medføre et fald i forekomsten af systemiske bivirkninger og forøget lokal aktivitet (se pkt.
English: After the 24-month period, 61.3% of 62 patients included in the primary efficacy population did not experience a relapse based on CFS scores.
Danish: Efter 24måneders perioden oplevede 61,3 % af 62 patienter inkluderet i den primære effektpopulation ikke et ecidiv baseret på CF-scores.
English: After 6 months of ocular instillation of IKERVIS once per day, 327 patients had values below the lower limit of detection (0.050 ng/mL) and 35 patients were below the lower limit of quantification (0.100 ng/mL).
Danish: Efter 6 måneders okulær inddrypning med IKERVIS en gang daglig, havde 327 patienter værdier under den nederste detektionsgrænse (0,050 ng/ml) og 35 patienter var under den nederste kvantificeringsgrænse (0,100 ng/ml).
English: Percentage of patients who experienced a severe keratitis recurrence was 35% and 48% in patients treated 12 months and 6 months with IKERVIS respectively in the SANSIKA study.
Danish: Procentdelen af patienter, der oplevede et kraftigt recidiv af keratitis var henholdsvis 35 % og 48 % hos patienter behandlet 12 måneder og 6 måneder med IKERVIS i SANSIKA-studiet.
English: It is likely to be attributable to ciclosporin.
Danish: Det skyldes sandsynligvis ciclosporin.
English: The primary objective of the study was to assess the duration of the improvement following IKERVIS treatment discontinuation once the patient was improved with respect to the baseline of the SANSIKA study (i.e. at least 2 grade improvement on the modified Oxford scale).
Danish: Det primære formål med studiet var at vurdere varigheden af forbedringen efter seponering af behandling med IKERVIS, når først patienten var forbedret med hensyn til baseline for SANSIKAstudiet (dvs. mindst 2 grader forbedring på den modificerede Oxford-skala).
English: Studies in animals suggest that ciclosporin inhibits the development of cell-mediated reactions.
Danish: Dyrestudier antyder, at ciclosporin hæmmer udviklingen af cellemedierede reaktioner.
English: Caution should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.
Danish: Der skal udvises forsigtighed, når disse patienter behandles samtidig med IKERVIS, særligt med betablokkere, som er kendt for at reducere tåresekretionen.
English: To reduce the systemic absorption, see section 4.2.
Danish: For at reducere den systemiske absorption, se pkt.
English: • Blink a few times so that the medicine covers your eye.
Danish: • Blink et par gange, så lægemidlet spreder sig over øjet.
English: No interaction studies have been performed with IKERVIS.
Danish: Der er ikke udført interaktionsstudier med IKERVIS.
English: Seven patients had measurable values (from 0.105 to 1.27 ng/mL), all considered to be negligible values.
Danish: Syv patienter havde målbare værdier (fra 0,105 til 1,27 ng/ml), hvoraf de alle betragtes som ubetydelige.
English: What you need to know before you use IKERVIS 3.
Danish: Det skal du vide, før du begynder at bruge IKERVIS 3.
English: Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections.
Danish: Patienter, der modtager immunosuppressive behandlinger, herunder ciclosporin, har en øget risiko for udvikling af infektioner.
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 Appendix V.Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, phototoxicity and photoallergy, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, fototoksicitet og fotoallergi, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients.
Danish: IKERVIS er ikke blevet undersøgt hos patienter med okulær herpes i anamnesen og skal derfor anvendes med forsigtighed hos disse patienter.
English: Your vision may be blurred immediately after using IKERVIS eye drops.
Danish: Dit syn kan blive sløret umiddelbart efter, at du bruger IKERVIS-øjendråberne.
English: Ciclosporin appears to block the resting lymphocytes in the G0 or G1 phase of the cell cycle.
Danish: Ciclosporin blokerer tilsyneladende de hvilende lymfocytter i fase G0 eller G1 i cellecyklussen.
English: Ciclosporin has been shown to inhibit the production and/or release of pro-inflammatory cytokines, including interleukin 2 (IL-2) or T-cell growth factor (TCGF).
Danish: Ciclosporin har vist sig at hæmme produktionen og/eller frigivelsen af pro-inflammatoriske cytokiner, herunder interleukin 2 (IL-2) eller T-cellevækstfaktor.
English: Talk to your doctor if you are using eye drops containing steroids with IKERVIS as these might increase the risk of side effects.
Danish: Fortæl det til lægen, hvis du bruger øjendråber, der indeholder steroider, sammen med IKERVIS, da disse kan øge risikoen for bivirkninger.
English: IKERVIS eye drops should be used at least 15 minutes after any other eye drops are used.
Danish: IKERVIS-øjendråber må anvendes tidligst 15 minutter efter, at du har anvendt andre øjendråber.
English: This medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or use machines (see section 4.8).
Danish: Dette lægemiddel kan fremkalde midlertidigt sløret syn eller andre synsforstyrrelser, som kan påvirke evnen til at føre motorkøretøj eller betjene maskiner (se pkt.
English: Sodium hydroxide (to adjust pH) Water for injections
Danish: Natriumhydroxid (til justering af pH) Vand til injektion
English: In 374 patients from the two efficacy studies, plasma concentrations of ciclosporin were measured before administration and after 6 months (SICCANOVE study and SANSIKA study) and 12 months of treatment (SANSIKA study).
Danish: Hos 374 patienter fra to virkningsstudier blev ciclosporins plasmakoncentrationer målt før administration og efter 6 måneder (SICCANOVE-studiet og SANSIKA-studiet) og 12 måneders behandling (SANSIKA-studiet).
English: The primary endpoint was the proportion of patients achieving by Month 6 at least a twograde improvement in keratitis (CFS) and a 30% improvement in symptoms, measured with the Ocular Surface Disease Index (OSDI).
Danish: Det primære endepunkt var andelen af patienter, der ved måned 6 havde opnået mindst to graders forbedring i keratitis (CFS) og en 30% forbedring i symptomer, målt vha.Ocular Surface Disease Index (OSDI).
English: • Discard the single dose container as soon as you have used it, even if there is still some liquid left in it.
Danish: • Smid enkeltdosisbeholderen ud straks efter brug, selvom der stadig er væske tilbage i den.
English: All available evidence suggests that ciclosporin acts specifically and reversibly on lymphocytes and does not depress haematopoiesis or has any effect on the function of phagocytic cells..
Danish: Al foreliggende evidens tyder på, at ciclosporin virker specifikt og reversibelt på lymfocytter og undertrykker ikke hæmopoiesen og har ingen indvirkning på fagocytiske cellers funktion.
English: No significant changes have been observed in the other secondary endpoints (TBUT, lissamine green staining and Schirmer test, NEI-VFQ and EQ-5D) over the course of the extension study.
Danish: Der er ikke blevet observeret signifikante ændringer i de andre sekundære endepunkter (TBUT, lissamin grøn-farvning og Schirmer test, NEI-VFQ og EQ-SD) over forløbet af forlængelsesstudiet.
English: Excipient IKERVIS contains cetalkonium chloride which may cause eye irritation.
Danish: Hjælpestof IKERVIS indeholder cetalkoniumchlorid, som kan forårsage øjenirritation.
English: The most common adverse reactions were eye pain (19.2%), eye irritation (17.8%), lacrimation (6.4%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%) which were usually transitory and occurred during instillation.
Danish: De mest almindelige bivirkninger var øjensmerter (19,2 %), øjenirritation (17,8 %), lakrimation (6,4 %), okular hyperæmi (5,5 %) ogerytem i øjenlåg (1,7 %), som sædvanligvis var midlertidige og forekom ved inddrypning.
English: Three patients had values above the upper limit of quantification (5 ng/mL) however they were already taking oral ciclosporin at a stable dose, which was allowed by the studies' protocol.
Danish: Tre patienter havde værdier over kvantificeringens øverste grænse (5 ng/ml), men de tog allerede oral ciclosporin ved en stabil dosis, som var tilladt ifølge studiernes protokoller.
English: The proportion of IKERVIS-treated patients with a 3-grade improvement in CFS score at Month 6 (from 4 to 1) was 28.8%, compared to 9.6% of vehicle-treated subjects, but this was a post-hoc analysis, which limits the robustness of this outcome.
Danish: Andelen af IKERVIS-behandlede patienter med en 3graders forbedring i CFS-score ved måned 6 (fra 4 til 1) var 28,8 %, sammenlignet med 9,6 % af kontrolbehandlede forsøgspersoner, men da dette var en efterfølgende analyse, begrænser det resultatets robusthed.
English: Talk to your doctor or pharmacist before using IKERVIS - if you have previously had an eye infection by the herpes virus that might have damaged the transparent front part of the eye (cornea).
Danish: Kontakt lægen eller apotekspersonalet, før du bruger IKERVIS - hvis du tidligere har haft en øjeninfektion med herpes-virussen, der kan have beskadiget den gennemsigtige hinde foran øjet (hornhinden).
English: A topical overdose is not likely to occur after ocular administration.
Danish: Det er usandsynligt, at der vil forekomme en topisk overdosering efter okulær administration.
English: One case of severe epithelial erosion of the cornea identified as corneal decompensation by the investigator resolved without sequeleae was reported.
Danish: Der blev indberettet om et enkelt tilfælde med alvorlig corneaepitelerosion, der blev identificeret som korneal dekompensering af investigator, og blev afhjulpet uden følgevirkninger.
English: No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section
Danish: Der er ikke blevet indberettet om forringelse af fertiliteten hos dyr, der fik intravenøs ciclosporin (se pkt.
English: • The remaining single-dose containers should be kept in the aluminium pouch.
Danish: • De resterende enkeltdosisbeholdere skal opbevares i folieposen.
English: Two patients had values above the upper limit of quantification, however they were also on oral ciclosporin at a stable dose since their inclusion in the study.
Danish: To patienter havde værdier over kvantificeringens øverste grænse, men de havde allerede taget oral ciclosporin ved en stabil dosis, siden deres inklusion i studiet.
English: IKERVIS treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Danish: Behandling med IKERVIS skal påbegyndes af en oftalmolog eller sundhedspersonale, der er uddannet inden for oftamologi.
English: IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer in the front part of the eye).
Danish: IKERVIS anvendes til at behandle voksne med svær keratitis (betændelse i hornhinden, det gennemsigtige lag foran øjet).
English: IKERVIS has moderate influence on the ability to drive and use machines.
Danish: IKERVIS påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Formal pharmacokinetic studies have not been conducted in humans with IKERVIS.
Danish: Der er ikke blevet udført formelle farmakokinetiske studier hos mennesker med IKERVIS.
English: In five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year.
Danish: IKERVIS blev i fem kliniske studier, hvor 532 patienter fik IKERVIS og 398 fik IKERVIS-kontrol, administreret mindst én gang dagligt i begge øjne i op til et år.
English: Contact lenses can further damage the transparent front part of the eye (cornea).
Danish: Kontaktlinser kan beskadige den gennemsigtige hinde foran øjet (hornhinden) yderligere.
English: If you stop using IKERVIS without speaking to your doctor, the inflammation of the transparent front part of your eye (known as keratitis) will not be controlled and could lead to impaired vision.
Danish: Hvis du holder op med at tage IKERVIS uden at tale med lægen, kontrolleres betændelsen i den gennemsigtige hinde foran øjet (kendt som keratitis) ikke, og det kan føre til forringet syn.
English: • Pull down your lower eyelid (picture 2).
Danish: • Træk ned i det nederste øjenlåg (figur 2).
English: The efficacy and safety of IKERVIS were evaluated in two randomised, double-masked, vehiclecontrolled clinical studies in adult patients with dry eye disease (keratoconjunctivitis sicca) who met the International Dry Eye Workshop (DEWS) criteria.
Danish: IKERVIS' virkning og sikkerhed blev evalueret i to randomiserede, dobbeltblindede, kontrollerede kliniske studier hos voksne patienter med lidelsen tørre øjne (keratoconjunctivitis sicca), som opfylder kriterierne for workshoppen International Dry Eye Workshop (DEWS).
English: Medium-chain triglycerides Cetalkonium chloride Glycerol
Danish: Mediumkæde-triglycerider Cetalkoniumchlorid Glycerol
English: A reduction in the ocular surface inflammation assessed with Human Leukocyte Antigen-DR (HLADR) expression (an exploratory endpoint), was observed at Month 6 in favour of IKERVIS (p=0.021).
Danish: En reduktion i inflammationen i den okulære overflade vurderet med HLA-DR-udtryk (humane leukocytantigen-DR) (et eksploratorisk endepunkt) blev observeret ved måned 6 til fordel for IKERVIS (p=0,021).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP MÆRKAT TIL POSE
English: Blood concentrations of IKERVIS were measured using a specific high-pressure liquid chromatography-mass spectrometry assay.
Danish: Blodkoncentrationer af IKERVIS blev målt med en særlig analyse vha. kromatografi/massespektroskopi med væske under højtryk.
English: Measurable values not exceeding 0.206 ng/mL were measured in eight patients, values considered to be negligible.
Danish: Målbare værdier, der ikke oversteg 0,206 ng/ml, blev målt hos otte patienter.
English: 30 single-dose containers 90 single-dose containers
Danish: 30 enkeltdosisbeholdere 90 enkeltdosisbeholdere