FrancophonIA/ELRC3.0 huggingface dataset:
English: bronchodilator mucolytics (a medicine that helps to dissolve the thick mucous produced in the lungs) and finally:
Danish: bronkodilatator mukolytika (medicin, som hjælper med at opløse det tykke slim, som dannes i lungerne) og til sidst:
English: As an inhaled medicine, Cayston could cause you to cough and this could lead to coughing up blood.
Danish: Da Cayston inhaleres, kan det få dig til at hoste, og dette kan føre til, at du hoster blod op.
English: The ampoule is imprinted in English only.
Danish: Ampullen har kun engelsk tekst.
English: Make sure the Altera Nebuliser Handset is on a flat, stable surface.
Danish: Sørg for, at Altera-forstøveren ligger på en plan, stabil overflade.
English: Cayston should not be reconstituted until a dose is ready to be administered.
Danish: Cayston bør ikke rekonstitueres, før en dosis er klar til at blive administreret.
English: Cayston was compared to TNS over three 28-day courses of treatment in a randomised, activecontrolled, multicenter study (GS-US-205-0110).
Danish: Cayston blev sammenlignet med TNS i løbet af tre 28-dages behandlingsforløb i et randomiseret, aktivt kontrolleret, multicenterstudie (GS-US-205-0110).
English: Following administration of aztreonam for injection, aztreonam is excreted in human milk at very low concentrations.
Danish: Efter administration af aztreonam til injektion udskilles aztreonam i human mælk i meget lave koncentrationer.
English: - Do not use the solvent or prepared Cayston if it is cloudy or if there are particles in the solution.
Danish: - Brug hverken solvensen eller klargjort Cayston, hvis væsken er uklar, eller hvis der er partikler i opløsningen.
English: Follow Step A to D in Figure 1 below to open the amber vial:
Danish: Følg trin A til D i figur 1 nedenfor for at åbne det ravfarvede hætteglas:
English: It's best to use Cayston immediately after you have made up the solution.
Danish: Det er bedst at bruge Cayston umiddelbart efter, at du har klargjort opløsningen.
English: When treatment is complete, open the medicine cap to ensure that all medicine has been used.
Danish: Når inhalationen er afsluttet, skal du åbne medicindækslet for at kontrollere, at al medicinen er brugt.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other beta-lactam antibacterials, ATC code: J01DF01
Danish: Farmakoterapeutisk klassifikation: Antibakterielle stoffer til systemisk brug, andre betalaktamantibiotika, ATC-kode: J01DF01
English: Patients received Cayston at the same frequency (2 or 3 times a day) as they took Cayston or placebo in the randomised studies.
Danish: Patienterne fik Cayston med samme hyppighed (2 eller 3 gange dagligt) som de tog Cayston eller placebo i de randomiserede studier.
English: Do not use this medicine if you notice that the package has been tampered with.
Danish: Brug ikke lægemidlet, hvis du bemærker, at pakken har været åbnet.
English: Check that your nebuliser works properly before starting your treatment with Cayston.
Danish: Kontroller, at forstøveren fungerer korrekt, før du påbegynder behandlingen med Cayston.
English: The safety and efficacy of Cayston in children younger than 6 years of age have not been established.
Danish: Caystons sikkerhed og virkning hos børn yngre end 6 år er ikke klarlagt.
English: There are no clinical data on the use of Cayston in pregnant women, therefore you should not take Cayston during pregnancy unless specifically discussed with your doctor.
Danish: Da der ikke findes kliniske data om brugen af Cayston til gravide bør du ikke bruge Cayston under graviditeten, medmindre du specifikt har drøftet det med lægen.
English: Adverse reactions specifically associated with overdose of Cayston have not been identified.
Danish: Der er ikke påvist bivirkninger, som specielt er forbundet med en overdosis af Cayston.
English: The protein binding of aztreonam in plasma is approximately 77% at clinically relevant plasma concentrations.
Danish: Plasmaproteinbindingen af aztreonam er ca. 77% ved klinisk relevante plasmakoncentrationer.
English: Be sure to completely empty the vial.
Danish: Sørg for at tømme hætteglasset helt.
English: Pyrexia was observed at a higher incidence rate in paediatric patients aged 6 to 17 years compared to adults.
Danish: Pyreksi blev observeret med en højere incidens hos pædiatriske patienter i alderen 6 til 17 år sammenlignet med voksne.
English: Patients participating in these studies could subsequently receive multiple courses of Cayston in an open-label follow-on study (CP-AI-006).
Danish: Patienterne, som deltog i disse studier, kunne derefter få flere behandlingsforløb med Cayston i et åbent opfølgningsstudie (CP-AI-006).
English: Animal and human data demonstrate low risk of cross-reactivity between aztreonam and beta-lactam antibiotics.
Danish: Data fra dyr og mennesker viser en lav risiko for krydsreaktion mellem aztreonam og beta-laktamantibiotika.
English: - if you are allergic to aztreonam or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for aztreonam eller et af de øvrige indholdsstoffer i Cayston (angivet i punkt 6).
English: Powder vial: 4 years.
Danish: Hætteglas med pulver: 4 år.
English: The vial is then gently swirled until contents have completely dissolved.
Danish: Hætteglasset svinges derefter forsigtigt rundt, indtil indholdet er opløst fuldstændigt.
English: Always take this medicine exactly as your doctor has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens anvisning.
English: - Do not use Cayston if it has been stored outside a refrigerator for more than 28 days.
Danish: - Brug ikke Cayston, hvis det har været opbevaret uden for køleskab i mere end 28 dage.
English: This pack contains one Altera Nebuliser Handset.
Danish: Denne pakning indeholder én Altera-nebulisator.
English: - Do not use Cayston if you notice that the package has been tampered with.
Danish: - Brug ikke Cayston, hvis du bemærker, at pakken har været åbnet.
English: Plasma aztreonam concentrations in paediatric patients aged 3 months to < 6 years are comparable to those observed for children > 6 years, adolescents and adults.
Danish: Aztreonamkoncentrationen i plasma hos pædiatriske patienter i alderen 3 måneder til < 6 år er sammenlignelig med de koncentrationer, der blev observeret hos børn > 6 år, unge og voksne.
English: The following side effects have been observed after the use of aztreonam for injection, but not after taking Cayston: swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, sweating, skin irritation and flaking, itchy rash, flushing, small red spots and very rarely, blistering of the skin.
Danish: Følgende bivirkninger er blevet observeret efter anvendelse af den form for aztreonam, der anvendes til injektion, men ikke efter brug af Cayston: hævelse af ansigt, læber, tunge og/eller svælg med synkeeller åndedrætsproblemer, svedtendens, hudirritation og afskalling, kløende udslæt, rødmen, små røde pletter og, meget sjældent, blærer på huden.
English: Patients with Burkholderia cepacia isolated from sputum within the previous 2 years were excluded from the clinical studies.
Danish: Patienter, der inden for de seneste 2 år havde fået påvist Burkholderia cepacia i ekspektorat, blev udelukket fra de kliniske studier.
English: Figure 3a
Danish: Figur 3a
English: Patients participating in this study in Europe who completed at least 1 course of Cayston or TNS during the randomised phase could subsequently receive up to three 28-day courses of Cayston in an open-label extension phase.
Danish: Patienter, der deltog i dette studie i Europa, og som gennemførte mindst en behandlingsserie med Cayston eller TNS i den randomiserede fase, kunne derefter få op til tre 28-dages behandlingsserier med Cayston i en åben forlængelsesfase.
English: Solvent ampoules must be separated by gently pulling them apart.
Danish: Ampullerne med solvens skal adskilles ved forsigtigt at trække dem fra hinanden.
English: Cayston was evaluated over a period of 28-days of treatment (one course) in two randomised, doubleblind, placebo-controlled, multicentre studies (CP-AI-005 and CP-AI-007).
Danish: Cayston blev vurderet over en periode på 28 dages behandling (ét behandlingsforløb) i to randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier (CP-AI-005 and CP-AI-007).
English: Press down and turn the cap clockwise as far as it will go (Figure 3b).
Danish: Tryk ned og drej dækslet med uret så langt som muligt (figur 3b).
English: Cystic fibrosis, also known as mucoviscidosis, is a life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also of the liver, pancreas, and the digestive system.
Danish: Cystisk fibrose, også kendt som mucoviscidosis, er en livstruende, arvelig sygdom, som påvirker slimkirtlerne i de indre organer, særligt i lungerne, men også i leveren, bugspytkirtlen og fordøjelsessystemet.
English: Each of the three doses should be taken by inhalation at least four hours apart, using an Altera Nebuliser Handset.
Danish: De tre doser skal inhaleres med mindst fire timers mellemrum og ved hjælp af en Altera-forstøver.
English: Pharmacokinetic studies have not been performed in patients with renal or hepatic impairment.
Danish: Der er ikke foretaget farmakokinetiske studier hos patienter med nedsat nyre- eller leverfunktion.
English: Marketing Authorisation Holder:
Danish: Indehaver af markedsføringstilladelse:
English: Class A betalactamases reported to hydrolyse aztreonam include the VEB type (primarily Southeast Asia), PER type (Turkey), and GES and IBC types (France, Greece, and S. Africa).
Danish: Klasse A betalaktamaser, som rapporteres at hydrolysere aztreonam, inkluderer VEB-typen (især Sydøstasien), PER-typen (Tyrkiet) og GES- og IBC-typen (Frankrig, Grækenland og Sydafrika).
English: Do not reconstitute more than one dose at a time.
Danish: Der må ikke rekonstitueres mere end en dosis ad gangen.
English: Do not use this medicine if it has been stored outside a refrigerator for more than 28 days.
Danish: Brug ikke lægemidlet, hvis det har været opbevaret uden for køleskab i mere end 28 dage.
English: There are no data on the use of Cayston in patients with severe hepatic impairment (ALT or AST greater than 5 times the upper limit of normal).
Danish: Der foreligger ingen data om brugen af Cayston hos patienter med svært nedsat leverfunktion (ALAT eller ASAT større end 5 gange den øvre grænse for normalområdet).
English: Squeeze out the contents completely into the vial (Figure 2).
Danish: Pres hele indholdet ned i hætteglasset (figur 2).
English: Additionally, aztreonam-treated patients had fewer hospitalisations due to respiratory events (40 versus 58, p = 0.044) and fewer respiratory events requiring the use of i.v.
Danish: Desuden havde aztreonam-behandlede patienter færre indlæggelser på grund af respiratoriske hændelser (40 versus 58, p=0,044) og færre respiratoriske hændelser, der krævede i.v.
English: CP-AI-006 was an open-label follow-on study to CP-AI-005 and CP-AI-007 evaluating the safety of repeated exposure to aztreonamand the effect on disease-related endpoints over multiple 28-day courses.
Danish: CP-AI-006 var et åbent opfølgningsstudie efter CP-AI-005 og CP-AI-007, som evaluerede sikkerheden af gentagen eksponering over for aztreonam og virkningen på sygdomsrelaterede parametre ved flere 28-dages behandlingsforløb.
English: The adverse reactions considered at least possibly related to treatment from clinical study and postmarketing experience are listed below by body system organ class and frequency.
Danish: Bivirkninger fra kliniske studier og erfaring efter markedsføring, som anses for at være i det mindste muligt relaterede til behandlingen, er opført nedenfor efter systemorganklasse og hyppighed.
English: or inhaled antipseudomonal antibiotics (84 versus 121, p = 0.004) than TNStreated patients.
Danish: eller inhalerede antibiotika mod pseudomonas (84 versus 121; p=0,004) end TNS-behandlede patienter.
English: If any of these apply to you tell your doctor before using Cayston.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til lægen, inden du begynder at bruge Cayston.
English: Data from these studies revealed minimal differences in mean plasma aztreonam concentrations between age groups in patients receiving Cayston 3 times a day.
Danish: Data fra disse studier viste minimale forskelle i den gennemsnitlige aztreonamplasmakoncentration mellem aldersgrupperne hos patienterne, der fik Cayston 3 gange dagligt.
English: If you can't leave a gap of 4 hours just skip the missed dose.
Danish: Hvis det ikke er muligt at inhalere med 4 timers mellemrum, skal du blot springe den glemte dosis over.
English: Resistance to aztreonam, other antibiotics and treatment-emergent microorganisms
Danish: Resistens over for aztreonam, andre antibiotika og mikroorganismer, som fremkommer under behandlingen
English: However, no evidence of any drug interactions with aztreonam were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, dornase alfa, pancreatic enzymes, azithromycin, tobramycin, oral steroids (less than 10 mg daily/20 mg every other day) and inhaled steroids.
Danish: Der er imidlertid ikke fundet tegn på lægemiddelinteraktioner med aztreonam i de kliniske studier, hvor behandlingen med Cayston blev ledsaget af bronkodilatatorer, dornase alfa, pancreasenzymer, azithromycin, tobramycin, orale steroider (mindre end 10 mg dagligt/20 mg hver anden dag) og inhalerede steroider.
English: Aztreonam for injection has not been formulated for inhalation, and contains arginine, a substance known to cause pulmonary inflammation.
Danish: Aztreonam til injektion er ikke formuleret til inhalation og indeholder arginin, et stof som vides at kunne forårsage pulmonal inflammation.
English: Talk to your doctor before taking Cayston: - if you are allergic to any other antibiotics (such as penicillins, cephalosporins, and/or carbapenems) - if you do not tolerate or have chest tightness from taking other inhaled medicines
Danish: Kontakt lægen, før du bruger Cayston, hvis: - du er allergisk over for andre antibiotika (som penicilliner, cefalosporiner og/eller carbapenemer) - der er anden medicin til inhalation, som du ikke tåler, eller som du får en trykkende fornemmelse i brystet af at tage
English: CP-AI-005 enrolled 246 adult (predominantly) and paediatric patients.
Danish: CP-AI-005 inkluderede 246 voksne (hovedsageligt) og børn.
English: The Kaplan-Meier estimates for this event rate at week 24 were 36% in aztreonamtreated patients and 54% in TNS-treated patients.
Danish: Kaplan-Meier-estimat for hyppigheden af denne hændelse ved uge 24 var 36% hos aztreonam-behandlede patienter og 54% hos TNS-behandlede patienter.
English: Do not try to take Cayston using any other type of nebuliser handset (including the eFlow rapid handset).
Danish: Du må ikke prøve at inhalere Cayston ved hjælp af andre typer forstøvere (herunder eFlow rapid-forstøveren).
English: Do not twist the blue cap.
Danish: Drej ikke på det blå låg.
English: There are rare reports of Class D beta-lactamases from clinical isolates of P. aeruginosa, OXA-11 (Turkey) and OXA-45 (United States) that hydrolyse aztreonam.
Danish: Der er sjældne rapporter om klasse D beta-laktamaser fra kliniske isolater af P. aeruginosa, OXA-11 (Tyrkiet) og OXA-45 (USA), som hydrolyserer aztreonam.
English: However, decreased P. aeruginosa susceptibility was not predictive of clinical efficacy of Cayston during the study.
Danish: Nedsat P. aeruginosa-følsomhed var dog ikke prædiktiv for klinisk virkning af Cayston i løbet af studiet.
English: Currently available data are described in section 5.1 but no recommendation on posology can be given.
Danish: 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Keep the handset level.
Danish: Hold forstøveren vandret.
English: Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, including P. aeruginosa.
Danish: Aztreonam har in vitro aktivitet mod gram-negative, aerobe bakterier, herunder P. aeruginosa.
English: • 28-day pack of Cayston
Danish: En 28-dages pakning med Cayston
English: An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an eFlow Control Unit of the type 178 (eFlow rapid) or type 678 (eBase Controller).
Danish: En Altera-forstøver med et Altera-aerosolapparat forbundet med en eFlow-styreenhed type 178 (eFlow rapid) eller type 678 (eBase Controller).
English: The following rare and severe adverse reactions have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.
Danish: Følgende sjældne og alvorlige bivirkninger er blevet indberettet efter parenteral anvendelse af andre lægemidler, der indeholder aztreonam: toksisk epidermal nekrolyse, anafylaksi, purpura, erythema multiforme, eksfoliativ dermatitis, urticaria, petekkier, pruritus, diaforese.
English: The use of Cayston in paediatric CF patients has been associated with haemoptysis during treatment cycles and could have aggravated underlying conditions.
Danish: Anvendelse af Cayston til pædiatriske CF-patienter er blevet forbundet med hæmoptyse i behandlingsserierne og kan have forværret underliggende forhold.
English: Intravenous aztreonam is not suitable for inhalation.
Danish: Intravenøs aztreonam er ikke egnet til inhalation.
English: Assessment of adverse reactions is based on experience in four Phase 3 clinical studies involving CF patients with chronic P. aeruginosa infection and post-marketing spontaneous reporting.
Danish: Vurdering af bivirkninger er baseret på erfaring fra fire kliniske fase 3-studier med CF-patienter med kronisk P. aeruginosa-infektion og spontane rapporter efter markedsføring.
English: But, if you cannot use the prepared dose straight away, replace the stopper in the vial and store in a refrigerator.
Danish: Hvis du ikke kan bruge den klargjorte dosis med det samme, skal du sætte proppen i hætteglasset igen og opbevare det i køleskabet.
English: Contents of the pack and other information What Cayston and the solvent contain
Danish: Pakningsstørrelser og yderligere oplysninger Cayston og solvensen indeholder:
English: Preparing your Cayston for inhalation
Danish: Klargøring af Cayston til inhalation
English: Mechanisms of resistance
Danish: Resistensmekanisme
English: The unopened vials may also be stored outside the refrigerator but below 25°C for up to 28 days.
Danish: De uåbnede hætteglas kan også opbevares uden for køleskab, men under 25 °C, i op til 28 dage.
English: In GS-US-205-0110, 268 patients with CF and chronic P. aeruginosa lung infection were randomised and received Cayston (n = 136) or TNS (n = 132).
Danish: I GS-US-205-0110 blev 268 patienter med CF og kronisk P. aeruginosa-lungeinfektion randomiseret og fik Cayston (n=136) eller TNS (n=132).
English: Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of Cayston.
Danish: Korttidsvirkende bronkodilatatorer kan tages mellem 15 minutter og 4 timer før, og langtidsvirkende bronkodilatatorer kan tages mellem 30 minutter og 12 timer før hver dosis Cayston.
English: Figure 3b
Danish: Figur 3b
English: Loss of susceptibility to aztreonam in CF patients with P. aeruginosa occurs either through selection of strains with mutations located on the chromosome or rarely through acquisition of plasmid/integron mediated genes.
Danish: Tab af følsomhed over for aztreonam hos CF-patienter med P. aeruginosa forekommer enten gennem selektion af stammer med mutationer på kromosomet eller mere sjældent gennem erhvervelse af plasmid-/integronmedierede gener.
English: In the limited subgroup of patients who received inhaled tobramycin for less than 84 days in the previous 12 months (n = 40), lung function improvements at Day 28 and across three 28-day treatment courses were numerically smaller among aztreonam-treated patients than TNS-treated patients.
Danish: I den begrænsede undergruppe af patienter, der fik inhaleret tobramycin i færre end 84 dage i løbet af de forudgående 12 måneder (n=40), var forbedringerne i lungefunktionen ved dag 28 og i løbet af tre 28-dages behandlingsforløb numerisk mindre hos aztreonam-behandlede patienter end hos TNS-behandlede patienter.
English: May be stored outside a refrigerator but below 25°C for up to 28 days.
Danish: Kan også opbevares uden for køleskab, men under 25 °C, i op til 28 dage.
English: Other medicines and Cayston
Danish: Brug af anden medicin sammen med Cayston
English: If not used immediately, the reconstituted solution must be stored at 2°C - 8°C and used within 8 hours.
Danish: Hvis den rekonstituerede opløsning ikke anvendes omgående, skal den opbevares ved 2 °C - 8 °C og anvendes inden for 8 timer.
English: If aerosol mist does not begin to flow, please refer to the Altera manual for information.
Danish: Hvis aerosoltågen ikke begynder at svæve, skal du se i Altera-manualen for at få yderligere information.
English: Do not prepare more than one dose at a time.
Danish: Der må ikke klargøres mere end én dosis ad gangen.
English: Cayston has no or negligible influence on the ability to drive or use machines.
Danish: Cayston påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Nebulised therapies, including Cayston, may be associated with bronchospasm (an acute reduction of ≥ 15% in FEV1).
Danish: Nebulisatoradministrerede behandlinger, herunder med Cayston, kan være forbundet med bronkospasme (en akut reduktion på ≥ 15% i FEV1).
English: In the Phase 3 placebo-controlled studies of Cayston, local aztreonam concentrations generally exceeded aztreonam MIC values for P. aeruginosa, regardless of the level of P. aeruginosa susceptibility.
Danish: I de placebokontrollerede fase 3-studier med Cayston oversteg de lokale aztreonamkoncentrationer generelt aztreonams MIC-værdier for P. aeruginosa uanset følsomhedsniveauet for P. aeruginosa.
English: Approximately 10% of the total inhaled aztreonamdose is excreted in the urine as unchanged drug, as compared to 60-65% following intravenous administration of aztreonam for injection.
Danish: Cirka 10% af den samlede dosis inhaleret aztreonam udskilles i urinen som ikke-metaboliseret lægemiddel sammenlignet med 60-65% efter intravenøs administration af aztreonam til injektion.
English: Step D: When the metal seal opens, continue to slowly pull on the blue cap in a counterclockwise direction until the metal seal is completely removed.
Danish: Trin D: Når metalforseglingen åbner sig, skal du fortsætte med langsomt at trække det blå låg mod uret, indtil metalforseglingen er helt fjernet.
English: Aztreonam for injection must not be used in the Altera or other nebulisers.
Danish: Aztreonam til injektion må ikke anvendes i Altera- eller andre nebulisatorer.
English: One hour following a single dose of 75 mg inhaled aztreonam (at approximately peak plasma concentration), the mean plasma level in patients with CF was 0.59 µg/ml.
Danish: En time efter en enkelt dosis på 75 mg inhaleret aztreonam (cirka ved den maksimale plasmakoncentration) var det gennemsnitlige plasmaniveau hos CF-patienter 0,59 µg/ml.
English: An association between persistent isolation of MRSA and worse clinical outcome has been reported in the literature.
Danish: En forbindelse mellem vedvarende isolering af MRSA og forværret klinisk udfald er rapporteret i litteraturen.
English: Powder should only be mixed with the solvent provided.
Danish: Pulveret må kun blandes med den medfølgende solvens.
English: The reconstituted Cayston is then poured into the Altera Nebuliser Handset and the dose administered.
Danish: Det rekonstituerede Cayston hældes i Altera-nebulisatoren og dosen administreres.
English: After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset.
Danish: Efter nogle få sekunder begynder aerosoltågen at svæve ind i Altera-forstøverens forstøverkammer.