FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapilysin is given as two injections, 30 minutes apart.
Danish: Rapilysin indgives som to injektioner med 30 minutters mellemrum.
English: Other information about Rapilysin
Danish: Andre oplysninger om Rapilysin
English: Rapilysin was also as effective as alteplase in preventing death and stroke.
Danish: Rapilysin var også lige så effektivt som alteplase til at forhindre dødsfald og slagtilfælde.
English: Rapilysin must also not be used in patients who are at risk of bleeding because of other diseases, treatment with other medicines, high blood pressure, previous bleeding or recent surgery.
Danish: Rapilysin må heller ikke anvendes til patienter, som har risiko for blødninger som følge af andre sygdomme, behandling med andre lægemidler, højt blodtryk, tidligere blødninger eller nylige kirurgiske indgreb.
English: The most common side effects with Rapilysin (seen in more than 1 patient in 10) are bleeding at the injection site, recurrent ischaemia (reduced blood supply to parts of the body) or angina (severe chest pain), hypotension (low blood pressure), heart failure or pulmonary oedema (build-up of fluid on the lungs), and reactions at the site of the injection, such as burning sensations.
Danish: De hyppigste bivirkninger ved Rapilysin (som optræder hos flere end 1 ud af 10 patienter) er blødning ved injektionsstedet tilbagevendende iskæmi (reduceret blodtilførsel til dele af kroppen) eller angina (alvorlige brystsmerter), hypotension (lavt blodtryk) hjertestop eller lungeødem (ophobning af væske i lungerne) samt reaktioner nær injektionsstedet, såsom en brændende fornemmelse.
English: Rapilysin has been compared with other medicines used to dissolve blood clots: streptokinase in 6,000 patients and alteplase in about 15,000 patients.
Danish: Rapilysin blev sammenlignet med andre lægemidler anvendt til at opløse blodkoagulering: streptokinase hos 6 000 patienter og alteplase hos omkring 15 000 patienter.
English: The CHMP decided that Rapilysin's benefits are greater than its risks for and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rapilysin opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Rapilysin.
English: Rapilysin was more effective than streptokinase in reducing the number of patients with heart failure, and it was as effective as streptokinase in preventing death.
Danish: Rapilysin var mere effektivt end streptokinase til at reducere antallet af patienter med hjertestop, og det var lige så effektivt til at forhindre dødsfald.
English: Rapilysin should be prescribed by doctors who have experience in using medicines that dissolve blood clots and who can monitor its use.
Danish: Rapilysin skal ordineres af læger, der har erfaring med at anvende lægemidler, der opløser koaguleret blod, og som kan overvåge anvendelsen.
English: Reteplase activates the production of an enzyme called plasmin, which breaks up blood clots.
Danish: Reteplase aktiverer fremstillingen af et enzym, plasmin, som opløser blodpropper.
English: Other medicines that prevent clotting (aspirin and heparin) should be given before and after the Rapilysin injection to stop clots from forming again.
Danish: Andre lægemidler, der forhindrer koagulering, såsom aspirin og heparin, bør gives før og efter Rapilysin-injektionen for at forhindre, at blodet igen koagulerer.
English: Following a heart attack, Rapilysin can help dissolve blood clots that have formed in the arteries supplying the heart muscle, thereby restoring normal blood flow to the heart.
Danish: Rapilysin kan efter et hjerteanfald hjælpe med at opløse koaguleret blod, der er dannet i de arterier, der forsyner hjertemuskelen, og dermed genoprette en normal blodtilstrømning til hjertet.
English: Rapilysin is a powder and solvent that are made up into a solution for injection.
Danish: Rapilysin er et pulver og en solvens til injektionsvæske, opløsning.
English: For the full list of all side effects reported with Rapilysin, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rapilysin fremgår af indlægssedlen.
English: What is the risk associated with Rapilysin?
Danish: Hvilke risici er der forbundet med Rapilysin?
English: Rapilysin is used within 12 hours of a suspected heart attack to help dissolve the blood clots obstructing the flow of blood to the heart muscle.
Danish: Rapilysin anvendes inden for 12 timer efter et formodet hjerteanfald til at bidrage til at opløse koaguleret blod, der forhindrer blodtilstrømningen til hjertemuskelen.
English: Why has Rapilysin been approved?
Danish: Hvorfor er Rapilysin blevet godkendt?
English: What is Rapilysin?
Danish: Hvad er Rapilysin?
English: How has Rapilysin been studied?
Danish: Hvordan blev Rapilysin undersøgt?
English: What is Rapilysin used for?
Danish: Hvad anvendes Rapilysin til?
English: What benefit has Rapilysin shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rapilysin?
English: How is Rapilysin used?
Danish: Hvordan anvendes Rapilysin?
English: How does Rapilysin work?
Danish: Hvordan virker Rapilysin?
English: • before an operation,
Danish: • før en operation,
English: A white or almost white suspension.
Danish: En hvid eller næsten hvid suspension.
English: Nebulisation should not last more than 10 to 15 minutes.
Danish: Nebuliseringen bør ikke vare længere end 10 til 15 minutter.
English: The HPA-axis function will recover within 1-2 days.
Danish: HPA-aksefunktionen vil blive genoprettet inden for 1-2 dage.
English: • You are being, or have ever been, treated for tuberculosis (TB).
Danish: • Du bliver eller nogen sinde er blevet behandlet for tuberkulose (TB).
English: In these cases no special emergency action needs to be taken.
Danish: I disse tilfælde skal ingen særlige nødforanstaltninger tages.
English: Breathe normally.
Danish: Træk vejret normalt.
English: • during admission to hospital after a serious accident,
Danish: • ved indlæggelse på et hospital efter en alvorlig ulykke,
English: • Your condition seems to be getting worse.
Danish: • Din astma lader til at blive værre.
English: The recommended initial doses are:
Danish: De anbefalede startdoser er:
English: • treatment of recurrent wheezing in children up to 5 years of age (see sections 4.2 and 4.4 paediatric population).
Danish: • behandling af tilbagevendende hos børn op til 5 år (se afsnit 4.2 og 4.4 om pædiatrisk population).
English: Do not forget to rinse the mouth, lips and the region of the face covered by the mask with water.
Danish: Glem ikke at skylle munden, læberne og det område af ansigtet, der har været dækket af masken, med vand.
English: Plasma protein binding is moderately high.
Danish: Plasmaproteinbindingen er moderat høj.
English: {See ANNEX I of referal}
Danish: {Se BILAG I af henvisning}
English: You should not increase or decrease your dose without seeking medical advice.
Danish: Du må ikke øge eller nedsætte din dosis uden at spørge en læge til råds.
English: Hepatic and renal functions remained within normal values.
Danish: Lever- og nyrefunktion forblev inden for normale værdier.
English: • You have an infection in your chest.
Danish: • Du har infektion i brystet.
English: Regular follow-up is essential to review the treatment response.
Danish: Regelmæssig opfølgning er vigtigt for at vurdere behandlingsrespons.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt 5.3).
English: Marketing Authorisation Holder: {See ANNEX I of referal} Manufacturer: Chiesi Farmaceutici S.p.A., 26/A via Palermo, 43122 Parma, Italy.
Danish: Indehaver af markedsføringstilladelsen: {Se BILAG I af henvisning} Fremstiller: Chiesi Farmaceutici S.p.A., 26/A via Palermo, 43122 Parma, Italien.
English: Adrenal suppression**
Danish: Binyresuppression**
English: * from spontaneous reporting **systemic effects of inhaled corticosteroids
Danish: * fra spontan rapportering **systemiske virkninger af inhalerede kortikosteroider
English: The remaining quantity has to be used within 12 hours after first opening.
Danish: Den resterende mængde skal anvendes inden for 12 timer efter første åbning.
English: Hoarseness is reversible and disappears after discontinuation of treatment and / or rest of the voice.
Danish: Hæshed er reversibel og forsvinder efter seponering af behandlingen og/eller hvilen af stemmen.
English: If you forget to use a dose, use it as soon as you remember.
Danish: Hvis du har glemt at bruge en dosis, skal du bruge den så snart du husker det.
English: No evidence of carcinogenicity was observed in a 95-week study in rats treated by inhalation.
Danish: Der er ikke observeret tegn på karcinogenicitet i et 95-ugers studie med rotter, behandlet med inhalation.
English: You may be told that you should not use {INVENTED NAME} again.
Danish: Du kan få at vide, at du ikke må anvende {SÆRNAVN} igen.
English: The ampoule should be opened immediately before administration.
Danish: Ampullen skal åbnes umiddelbart før administrationen.
English: Normally, a daily dose of 3200 micrograms in adults and adolescents and 1600 micrograms in children up to 11 years of age should not be exceeded.
Danish: Normalt bør en daglig dosis på 3200 mikrogram hos voksne og 1600 mikrogram hos børn på op til 11 år ikke overskrides.
English: Leave the rest in the pouch.
Danish: idet resten efterlades i posen.
English: • or if you have a chest infection or other serious illness.
Danish: • eller hvis du har infektion i brystet eller anden alvorlig sygdom.
English: Repeat this operation, until the whole content is fully re-dispersed and mixed (Figure C).
Danish: Gentag dette, indtil hele indholdet er fuldstændig fordelt igen og blandet (fig. C).
English: Do not use {INVENTED NAME} if the packaging is damaged.
Danish: {SÆRNAVN} må ikke anvendes, hvis pakningen er beskadiget.
English: Affected children and adolescents may grow more slowly than others, so it is important that they will have their height checked regularly by their doctor.
Danish: Børn og unge, som er påvirket deraf, kan vokse langsommere end andre, så det er vigtigt, at de får deres højde kontrolleret regelmæssigt af deres læge.
English: Your doctor will decide the duration of your treatment.
Danish: Lægen vil bestemme varigheden af din behandling.
English: The benefits of the corticosteroid treatment and the possible risks on the growth suppression must be carefully weighed against one another.
Danish: Fordelene ved kortikosteroidbehandling og den mulige risiko for væksthæmning bør omhyggeligt opvejes mod hinanden.
English: This should be treated immediately with a fast-acting inhaled bronchodilator.
Danish: Det bør behandles omgående med en hurtigtvirkende, inhaleret bronkodilator.
English: The dose may then be adjusted by your doctor until effective control of symptoms is reached.
Danish: Lægen kan derefter justere dosen, indtil effektiv kontrol af symptomerne opretholdes.
English: The manufacturer's instructions for use, maintenance and cleaning of the nebuliser must be followed.
Danish: Fremstillerens anvisninger for anvendelse, vedligeholdelse og rengøring af nebulisatoren skal følges.
English: It is important that your nebuliser is kept clean.
Danish: Det er vigtigt, at nebulisatoren altid holdes ren.
English: No formal pharmacokinetic drug-drug interaction studies have been conducted.
Danish: Der er ikke udført formelle farmakokinetiske interaktionsstudier.
English: Nausea, dyspepsia
Danish: Kvalme, dyspepsi
English: • tremor (involuntary trembling)
Danish: • tremor (ufrivillig rysten)
English: Some patients feel unwell for approximately 2 weeks during the withdrawal of treatment with systemic corticosteroids, even though their respiratory function remains the same or even improves.
Danish: Nogle patienter føler sig utilpas i ca. 2 uger under seponering af behandling med systemiske kortikosteroider, selvom deres åndedrætsfunktion forbliver den samme eller endda forbedres.
English: During this time your doctor will monitor the level of corticosteroids in your body regularly.
Danish: I denne periode vil din læge regelmæssigt kontrollere niveauet af steroider i din krop.
English: Although results of animal studies have shown some impaired fertility, this occurs at high doses levels.
Danish: Selvom resultater af dyreforsøg har vist nedsat fertilitet i nogen grad, forekommer dette ved høje dosisniveauer.
English: Children (up 11 years of age):
Danish: Børn (op til 11 år):
English: The two treatments were equally well tolerated (Bisca et al., 2003).
Danish: De to behandlinger blev tolereret lige godt (Bisca et al.,
English: Patients should be advised to carefully follow the manufacturer's instructions for the nebulizer device and should only use the settings recommended.
Danish: Patienter skal rådes til at følge fremstillerens brugsanvisning for nebulisatoren nøje og bør kun anvende de anbefalede indstillinger.
English: Growth retardation* (in children and adolescents), bone density decreased*
Danish: Vækstretardering* (hos børn og unge), nedsat knogletæthed*
English: These effects are much less likely to occur than with oral corticosteroids.
Danish: Det er dog mindre sandsynligt, at disse virkninger vil opstå med orale kortikosteroider.
English: Cataract**, glaucoma**
Danish: Katarakt**, glaukom**
English: In terms of safety, no change in the values of morning salivary cortisol was detected (Papi et al., 2009).
Danish: Hvad sikkerheden angår blev der ikke detekteret nogen ændring i kortisolværdierne i spyt om morgenen (Papi et al., 2009).
English: 2, 4 or 8 pouches are packed into a carton, i.e. each carton contains 10, 20 or 40 ampoules.
Danish: 2, 4 eller 8 poser er pakket i en æske, dvs. hver æske indeholder 10, 20 eller 40 enkeltdosisampuller.
English: The incidence of candidiasis seems to be related to the administered dose and treatment duration.
Danish: Incidensen af candidiasis synes at være relateret til den administrerede dosis.
English: • worsening shortness of breath, cough and wheezing (which is known as paradoxical bronchospasm).
Danish: • forværret åndenød, hoste og hvæsende vejrtrækning (som også kaldes paradoksal bronkospasme).
English: If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Your doctor may prescribe a course of antibiotics.
Danish: Din læge kan ordinere en kur med antibiotika.
English: These allergies should be symptomatically treated with antihistamines and/or topical medicinal product, including steroids for local use.
Danish: Disse allergier bør behandles symptomatisk med antihistaminer og/eller topikale lægemidler, herunder steroider til lokal brug.
English: Your doctor will try to prevent these effects by prescribing {INVENTED NAME} in the lowest effective dose.
Danish: Din læge vil forsøge at forebygge disse bivirkninger ved at ordinere {SÆRNAVN} i den lavest mulige dosis.
English: If patients find that short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
Danish: Hvis patienter finder, at behandlingen med korttidsvirkende bronkodilatorer bliver mindre effektiv, eller at de har brug for flere inhalationer end normalt, bør de søge lægehjælp.
English: If it is almost time for your next dose, do not use the missed dose, just use the next dose when it is due.
Danish: Hvis det er tæt på tidspunktet for næste dosis, må du ikke bruge den glemte dosis, men skal blot bruge næste dosis til sædvanlig tid.
English: If this occurs do not take another dose of {INVENTED NAME}.
Danish: Hvis det sker, må du ikke tage en anden dosis {SÆRNAVN}.
English: INSTRUCTIONS ON USE INFORMATION IN BRAILLE
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN INFORMATION I BRAILLESKRIFT
English: It must be recommended that patients rinse their mouth with water immediately after inhalation to reduce the frequency of oral candidiasis.
Danish: Det skal anbefales, at patienterne skyller munden med vand umiddelbart efter inhalation for at reducere hyppigheden af oral candidiasis.
English: Strips of 5 ampoules are packed in a heat sealed pouch of PET/Al/PE (Polyethylene Terephthalate/Aluminium/Polyethylene).
Danish: Strips med 5 enkeltdosisampuller er pakket i en varmeforseglet pose af PET/Al/PE (polyethylenterephtalat/aluminium/polyethylen).
English: Since glucocorticoids are excreted in breast-milk, it is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast milk.
Danish: Eftersom glukokortikoider udskilles i human mælk, er det rimeligt at antage, at beclometasondipropionat og dets metabolitter også udskilles i human mælk.
English: Besides evidence coming from long lasting use of inhaled beclometasone in the treatment of asthma and wheezing, the following data are a collection of the main supportive published data.
Danish: Udover beviser fra langvarig brug af inhaleret beclometasone i behandlingen af astma og hvæsende vejrtrækning, er de følgende data en samling af de vigtigste supporterende publicerede data.
English: • Your doctor may need to increase the dose of {INVENTED NAME} or give you a course of corticosteroid tablets, or change your treatment altogether.
Danish: • Din læge kan være nødt til at øge din {SÆRNAVN}-dosis eller give dig en kur med steroidtabletter eller ændre din behandling fuldstændigt.
English: Your doctor is likely to assess your asthma or wheezing and if necessary may start you on another course of treatment.
Danish: Din læge vil sandsynligvis vurdere din astma eller hvæsende vejrtrækning og kan om nødvendigt starte dig på et andet behandlingsforløb.
English: Psychomotor hyperactivity, sleep disorders anxiety, depression, aggressiveness, behavioural changes (predominantly in children)
Danish: Psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression, aggressivitet, adfærdsændringer (overvejende hos børn)
English: In addition, the duration of treatment of recurrent wheezing should not exceed 3 months, unless diagnosis of asthma is likely to avoid an unnecessary longterm exposure (see section 4.4).
Danish: Derudover bør behandlingen af hvæsende vejrtrækning ikke overstige 3 måneder, medmindre diagnosticering af astma er tilbøjelig til at undgå en unødvendig langvarig eksponering (se afsnit 4.4).
English: • thrush in the mouth, tongue and throat.
Danish: • trøske i mund, tunge og hals.
English: After improvement of control of asthma or wheezing, the total daily dose should be reduced to the lowest effective dose and a once daily dosing can be applied.
Danish: Efter forbedret kontrol af astma eller hvæsende vejrtrækning skal den totale daglige dosis reduceres til den laveste effektive dosis, og en dosis én gang dagligt kan foreslås.
English: In the study 40.4% and 51.7% patients in the of nebulised beclometasone dipropionate and budesonide groups respectively did not experience any major exacerbation (primary endpoint).
Danish: I studiet oplevede 40,4 % og 51,7 % af patienterne i hhv. nebuliseret beclometasondipropionat- og budesonidgrupperne ingen betydelig eksacerbation (primært endpoint).
English: Both treatments were associated with a marked reduction in night-time wheezing and in the number of days of steroid use.
Danish: Begge behandlinger var forbundet med markant mindsket hvæsende vejrtrækning om natten og et lavere antal dage med brug af steroider.
English: This leaflet was last revised in [MM/YYYY]
Danish: Denne indlægsseddel blev senest ændret [MM/ÅÅÅÅ]
English: Talk to you doctor or pharmacist before using {INVENTED NAME} if any of the following applies to you:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger {SÆRNAVN}, hvis nogen af følgende gælder for dig:
English: Your doctor may want to check the corticosteroid levels in your blood and therefore, may need to take a blood sample.
Danish: Din læge kan ønske at kontrollere steroidniveauerne i dit blod, så det kan være nødvendigt at tage en blodprøve.
English: If used concomitantly with systemic or intranasal steroids the suppressive effect on adrenal function will be additive.
Danish: Hvis lægemidlet anvendes samtidigt med systemiske eller intranasale steroider, vil den suppressive virkning på binyrefunktionen være additiv.
English: Animal studies indicate that administration of glucocorticoids during pregnancy may increase the risk for intrauterine growth retardation, adult cardiovascular and/or metabolic disease and/or neurobehavioral development.
Danish: Dyreforsøg indikerer, at administration af glukokortikoider under graviditet kan øge riikoen for intrauterin væksthæmning, voksen kardiovaskulær og/eller metabolisk lidelse og/eller udvikling af neuroadfærd.
English: Replacement of systemic steroid treatment with inhaled therapy sometimes also unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic medicinal product.
Danish: Erstatning af systemisk steroidbehandling med inhaleret behandling afslører også somme tider allergier, f.eks. allergisk rhinitis eller eksem, som det systemiske lægemiddel tidligere har kontrolleret.
English: Do not use with ultrasonic nebulisers.
Danish: Må ikke bruges med ultralydsnebulisatorer.
English: If you forget to use {INVENTED NAME}:
Danish: Hvis du har glemt at bruge {SÆRNAVN}:
English: Beclometasone dipropionate
Danish: beclometasondipropionat
English: {INVENTED NAME} must be administered by inhalation from a suitable device (jet nebuliser) according to your doctor instructions.
Danish: {SÆRNAVN} skal administreres ved inhalation fra et egnet apparat (jetnebulisator) i henhold til lægens anvisning.
English: If your child suffers from recurrent wheezing, the duration of treatment should not exceed 3 months, unless otherwise prescribed by the paediatrician.
Danish: Hvis dit barn lider af tilbagevendende hvæsende vejrtrækning, bør behandlingens varighed ikke overskride 3 måneder, medmindre andet ordineret af børnelæge.
English: Place the mask or mouth piece
Danish: Anbring masken eller mundstykket.
English: • cold sores (herpes simplex) painful blisterlike vesicles on your lips and in your mouth
Danish: • forkølelsessår (herpes simplex), smertefulde væskefyldte blærer på læberne eller i munden
English: Incorrect use of the nebuliser device could lead to incorrect dosing of the medicinal product.
Danish: Forkert brug af nebulisatoren kan føre til forkert dosering af lægemidlet.
English: {INVENTED NAME} is also indicated to treat recurrent wheezing in children up to 5 years of age.
Danish: {SÆRNAVN} er også indiceret til behandling af tilbagevendende hvæsende vejrtrækning hos børn op til 5 år.
English: Patients suffering from tuberculosis should receive tuberculostatic therapy while being treated with beclometasone propionate.
Danish: Patienter, der lider af tuberkulose, bør gives behandling mod tuberkulose, mens de behandles med beclometasondipropionat.
English: In patients with asthma, {INVENTED NAME} must be used regularly on a daily basis; the duration of treatment should be defined on the basis of symptoms.
Danish: Hos patienter med astma skal {SÆRNAVN} anvendes regelmæssigt på daglig basis; behandlingens varighed bør defineres baseret på symptomerne.
English: In addition, the time to first exacerbation was longer in children treated with nebulised beclometasone dipropionate.
Danish: Derudover var tid til første eksacerbation længere hos børn, der blev behandlet med nebuliseret beclometasondipropionat.
English: The benefits of breastfeeding are likely to outweigh any theoretical risk.
Danish: Fordelene ved amning opvejer sandsynligvis eventuelle teoretiske risici.
English: 40 ampoules
Danish: 40 ampuller