FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in animals using parenteral administration have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier ved anvendelse af parenteral administration har påvist reproduktionstoksicitet (se pkt.
English: Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA United Kingdom
Danish: Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA Storbritannien
English: Once all the contents have been inhaled, rinse your mouth out well with water and spit out.
Danish: Når alt indholdet er inhaleret, skal du skylle din mund grundigt med vand og spytte vandet ud igen.
English: Adults and children of 6 years of age and older
Danish: Voksne og børn på 6 år eller derover
English: • The capsule shell is made of gelatin, which is harmless to humans if swallowed or inhaled.
Danish: • Kapselskallen er lavet af gelatine, som er harmløs for mennesker, hvis den synkes eller inhaleres.
English: Therefore, dose adjustment in low age groups is considered not necessary.
Danish: Det vurderes derfor, at dosisjustering i de lave aldersgrupper ikke er nødvendig.
English: If bronchospasm or coughing remain problematic, withdrawal of treatment should be considered.
Danish: Hvis bronkospasmer eller hoste fortsætter med at være et problem, bør man overveje at stoppe behandlingen.
English: It is possible while using Colobreathe that you may experience dizziness, confusion or have problems with your sight.
Danish: Det er muligt, at du, mens du bruger Colobreathe, oplever svimmelhed, forvirring eller får problemer med dit syn.
English: Based on the safety profile of colistimethate sodium, neurotoxity may occur with the possibility of dizziness, confusion or visual disturbances.
Danish: På baggrund af sikkerhedsprofilen for colistimethatnatrium kan der forekomme neurotoksicitet med mulighed for svimmelhed, forvirring eller visuelle forstyrrelser.
English: More common signs and symptoms of intravenous overdose include unsteadiness, paraesthesia and dizziness.
Danish: Mere almindelige tegn og symptomer på intravenøs overdosering indbefatter gangbesvær, paræstesi og svimmelhed.
English: Single dose intravenous studies in human pregnancy show that colistimethate sodium crosses the placenta and consequently there is potential for foetal toxicity if administered during pregnancy.
Danish: Studier med enkelt-dosis intravenøs administration til gravide kvinder viser, at colistimethatnatrium krydser placenta, og der er derfor mulighed for føtal toksicitet, hvis stoffet administreres under graviditet.
English: Weight fluctuation, decreased appetite
Danish: Vægtudsving, nedsat appetit
English: • “Patient DVD” information in “leaflet form” for those patients who do not have access to a DVD
Danish: • ”Patient-DVD”-information i ”brochure-form” for de patienter, der ikke har adgang til en DVDafspiller
English: Inhale the medicine again by repeating Steps 7 and 8 to ensure you have emptied the capsule.
Danish: Inhalér medicinen igen ved at gentage trin 7-8, så du er sikker på, at kapslen er tømt.
English: If you/your child are taking other treatments for cystic fibrosis you/your child should take them in the following order:
Danish: Hvis du/dit barn bruger andre behandlinger for cystisk fibrose, skal du eller dit barn bruge dem i den følgende rækkefølge:
English: • Inhaled bronchodilators
Danish: • Inhalations-bronkodilatorer
English: The epidemiological cut off value for colistimethate sodium for Pseudomonas aeruginosa, distinguishing the wild type population from isolates with acquired resistance traits, is 4 mg/l.
Danish: Den epidemiologiske cut off-værdi for colistimethatnatrium for Pseudomonas aeruginosa, hvor der skelnes mellem den vilde populationstype og isolater med erhvervet resistens, er 4 mg/l.
English: In embryo-fetal development studies in mice, resorptions and reduced ossification were seen, and in rats reduced fetal weights, reduced ossification and at the high dose of 10 mg colistin base per day, reduced post-natal survival.
Danish: I embryo-føtale udviklingsstudier i mus blev resorption og reduceret ossifikation observeret, og i rotter blev der observeret reduceret fostervægt, reduceret ossifikation og ved de høje doser på 10 mg colistin-base pr. dag, sås reduceret postnatal overlevelse.
English: Polymyxins are selective for Gram-negative bacteria that have a hydrophobic outer membrane.
Danish: Polymyxiner er selektive for Gram-negative bakterier, der har en hydrofobisk ydre membran.
English: You can check whether the capsule is empty by unscrewing the mouthpiece and checking the capsule.
Danish: Du kan kontrollere, om kapslen er tom ved at skrue mundstykket af og tjekke kapslen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERSTRIPS
English: Colistimethate sodium is converted to the base in vivo.
Danish: Colistimethatnatrium omdannes til den tilsvarende base in vivo.
English: You/your child should confirm the order of your treatments with your doctor.
Danish: Du/dit barn skal fastlægge rækkefølgen af behandlingerne sammen med lægen.
English: The safety and efficacy of Colobreathe in children under 6 years of age have not been established.
Danish: Colobreathes sikkerhed og virkning hos børn i alderen under 6 år er ikke klarlagt.
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Danish: Resistente bakterier er karakteriseret ved en modificering af fosfatgrupperne på lipopolysaccharidet, som bliver substitueret med ethanolamin eller aminoarabinose.
English: The use of colistimethate sodium in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Danish: Anvendelsen af colisthimetatnatrium til patienter med klinisk signifikant hæmoptysis bør kun ske eller fortsættes, dersom fordelen ved behandlingen anses at være større end risiciene for at påføre yderligere blødning.
English: A systemic absorption study showed minimal urinary excretion with less than 3% of the dose of Colobreathe excreted in the urine as colistimethate sodium and colistin.
Danish: Et studie af systemisk absorption viste en minimal udskillelse i urin, idet under 3 % af Colobreathe-dosen blev udskilt i urinen som colistimethatnatrium og colistin.
English: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Danish: Hæmoptysis er en komplikation ved cystisk fibrose og forekommer hyppigere hos voksne.
English: Pseudomonas aeruginosa is a very common bacterium that infects nearly all cystic fibrosis patients at some time during their lives.
Danish: Pseudomonas aeruginosa er en meget almindelig bakterie, som næsten alle patienter med cystisk fibrose inficeres med på et tidspunkt i deres liv.
English: The capsules must not be swallowed.
Danish: Kapslerne må ikke sluges.
English: Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Danish: Polymyxiner virker ved at skade cellemembranen og de resulterende fysiologiske effekter er dødbringende for bakterien.
English: Screw the mouthpiece firmly back into place, put the cap back on and the inhaler is ready to be used for your next dose.
Danish: Skru mundstykket stramt på plads, sæt hætten på, og inhalatoren er nu klar til at blive brugt til din næste dosis.
English: The Marketing Authorisation Holder shall agree the format and content of the healthcare professional and patient educational pack with the National Competent Authority prior to launch in the Member State.
Danish: Indehaveren af markedsføringstilladelsen skal blive enig med den nationale kompetente myndighed om formatet og indholdet af sundhedspersonale- og patientuddannelsespakken før lancering i medlemsstaten.
English: Remove a single capsule from the blister pack.
Danish: Tag én kapsel ud af blisterpakningen.
English: To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professional, with the first dose being given under medical supervision.
Danish: For at sikre at lægemidlet indgives korrekt, skal en læge eller andet sundhedspersonale vise patienten, hvordan inhalatoren anvendes, og den første dosis skal tages under supervision af lægen eller sundhedspersonalet.
English: After each inhalation of Colobreathe, the mouth should be rinsed with water.
Danish: Efter hver inhalation af Colobreathe bør munden skylles med vand.
English: An allergic reaction with Colobreathe is possible (typically serious allergic reactions may cause rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness).
Danish: Det er muligt, at der kan forekomme en allergisk reaktion, når du bruger Colobreathe (typisk kan alvorlige allergiske reaktioner forårsage udslæt, opsvulmning af ansigtet, tungen og halsen, gøre det umuligt at trække vejret på grund af forsnævring af luftvejene og bevidstløshed).
English: The number of these side-effects may reduce as you continue to use the inhaler or your doctor may prescribe a bronchodilator to use before or after taking Colobreathe.
Danish: Disse bivirkninger kan mindskes, når du fortsætter med at bruge inhalatoren, eller lægen kan ordinere en bronkodilatator, der skal bruges før eller efter brugen af Colobreathe.
English: Nephrotoxicity/neurotoxicity
Danish: Nefrotoksicitet/neurotoksicitet
English: Medication error
Danish: Medicineringsfejl
English: An embryo-fetal study in rabbits reported no effects at intravenous doses up to 80 mg/kg colistimethate sodium (32 mg colistin base/kg).
Danish: En embryo-føtal fosterundersøgelse hos rotter viste ingen effekt af intravenøse doser på op til 80 mg/kg colistimethatnatrium (32 mg colistinbase/kg).
English: In the 24-week clinical study, where Colobreathe was administered twice daily to adults and children aged 6-17, the adverse reactions identified in the paediatric population were similar to that for the overall population.
Danish: I 24-ugers undersøgelsen, hvor Colobreathe blev administreret to gange dagligt til voksne og børn i alderen 6-17 år, svarede de identificerede bivirkninger hos den pædiatriske population, til dem der sås for den samlede population.
English: • Changes in how your lungs function (found by testing)
Danish: • Ændringer af din lungefunktion (konstateres ved en test)
English: There are no or limited amount of data from the use of inhaled colistimethate sodium in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af inhaleret colistimethatnatrium til gravide kvinder.
English: Remove the cap.
Danish: Fjern hætten.
English: The estimated mean terminal half-lives for total CMS and total free colistin were 3.0 and 6.4 h, respectively.
Danish: Den estimerede gennemsnitlige terminale halveringstid for total colistimethatnatrium og total frit colistin var henholdsvis 3,0 og 6,4 timer.
English: All subjects were also required to have successfully completed a minimum of two cycles of nebulised tobramycin solution run-in prior to randomisation.
Danish: Alle forsøgspersoner blev også krævet at have vellykket fuldført mindst 2 cyklusser med indkøringsbehandling med forstøvet tobramycin-opløsning før randomisering.
English: Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity.
Danish: Der skal udvises forsigtighed ved samtidig brug af andre colistimethatnatrium-formuleringer, da der kun er begrænset erfaring hermed, og da der er risiko for kumuleret toksicitet.
English: If you/your child experience signs of an allergic reaction you should seek urgent medical attention.
Danish: Hvis du/dit barn oplever tegn på en allergisk reaktion, skal du straks søge læge.
English: Measures to increase the rate of elimination of colistimethate sodium e.g. mannitol diuresis, prolonged haemodialysis or peritoneal dialysis may be tried, but effectiveness is unknown.
Danish: Forholdsregler til at forøge hastigheden af elimineringen af colistimethatnatrium, f.eks. mannitoldiurese, forlænget hæmodialyse eller peritoneal dialyse kan forsøges, men effektiviteten er ukendt.
English: Piercing the capsule and inhaling the medicine
Danish: Gennemboring af kapslen og inhalering af medicinen
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http:/www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The Phase 3 clinical study was a randomised, open-label active comparator study comparing the efficacy of colistimethate sodium 1,662,500 IU dry powder for inhalation to tobramycin nebuliser solution for inhalation, 300 mg/5 ml, in 380 subjects with documented cystic fibrosis complicated by chronic pulmonary infection with Pseudomonas aeruginosa.
Danish: Den fase 3-kliniske undersøgelse var en randomiseret, åben, aktiv komparator-undersøgelse, der sammenlignede effekten af colistimethatnatrium 1.662.500 IE tørpulver til inhalation med tobramycinforstøvningsopløsning til inhalation 300 mg/5 mL, hos 380 forsøgspersoner med dokumenteret cystisk fibrose, som blev kompliceret af kronisk pulmonær infektion med Pseudomonas aeruginosa.
English: If this occurs, you can loosen the capsule by gently tapping the chamber of the inhaler.
Danish: Hvis dette sker, kan du løsne kapslen ved forsigtigt at banke på inhalatorens kammer.
English: Physico-chemical data suggest excretion of colistimethate sodium in human milk.
Danish: Fysisk-kemiske data indikerer, at colistimethatnatrium udskilles i human mælk.
English: There were no notable effects on fertility or general reproductive performance in male or female rats or mice.
Danish: Der var ingen bemærkelsesværdige effekter på fertiliteten eller den generelle reproduktivitet hos han- eller hunrotter eller mus.
English: Acute respiratory exacerbation
Danish: Akut respiratorisk eksacerbation
English: • Coughing up blood, wheezing, chest discomfort, asthma, productive cough (a cough which brings up mucus), infection of the lungs, lung crackles (your doctor would hear this when listening to your lungs using a stethoscope)
Danish: • Ophostning af blod, hvæsen, brystubehag, astma, produktiv hoste (en hoste som frembringer slim), lungeinfektion, knitrende lyd i lungerne (din læge vil kunne høre dette, når han/hun lytter til dine lunger med et stetoskop)
English: Colobreathe should be used with extreme caution in patients with myasthenia gravis because of potential for drug induced neuromuscular blockade.
Danish: Colobreathe bør anvendes med yderste forsigtighed hos patienter med myasthenia gravis på grund af mulighed for lægemiddelinduceret neuromuskulær blokade.
English: Rinsing may reduce the risk of developing oral fungal super-infection during treatment and may also reduce the unpleasant taste associated with colistimethate sodium.
Danish: Skylning kan reducere risikoen for at udvikle en oral super-svampeinfektion under behandlingen og kan også reducere den ubehagelige smag, som er forbundet med colistimethatnatrium.
English: Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Danish: Naturligt resistente Gram-negative bakterier, såsom Proteus mirabilis og Burkholderia cepacia, viser komplet substitution af deres lipidfosfat med etahanolamin eller aminoarabinose.
English: The expiry date refers to the last date of that month.
Danish: inden og på blister efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In the 24 week clinical study, the following adverse reactions were observed across all ages.
Danish: I den 24-uges undersøgelse er de følgende bivirkninger blevet observeret på tværs af aldersgrupper:
English: Inhalation may induce coughing or bronchospasm which may be controlled by pre-treatment with inhaled beta2 agonists.
Danish: Inhalering kan forårsage hoste eller bronkospasmer, som kan kontrolleres med forbehandling med inhalerede beta2-agonister.
English: Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin.
Danish: Colobreathe indeholder colistimethatnatrium, en type antibiotikum, der kaldes polymyxin.
English: The capsules are contained in oPA/aluminium/pvc blisters with a peelable lidding foil composed of polyester/aluminium of either 8 or 14 hard capsules in each blister.
Danish: Kapslerne er indeholdt i oPA-/aluminium/pvc-blisterpakninger med aftagelig topfolie sammensat af polyester/aluminium, der hver indeholder enten 8 eller 14 hårde kapsler.
English: Colistimethate sodium and colistin have been investigated in vitro to determine the effects on the expression of cytochrome P450 (CYP) enzymes on treating primary cultures of fresh human hepatocytes.
Danish: Colistimethatnatrium og colistin er blevet undersøgt in-vitro for at bestemme effekterne på ekspressionen af CYP-enzymer ved behandling af friske primærkulturer af humane hepatocytter.
English: These reactions usually disappear or significantly diminish with continued use and may be ameliorated by appropriate treatment with beta2agonists prior to or following dry powder colistimethate sodium inhalation.
Danish: Disse reaktioner forsvinder eller mindskes betydeligt ved kontinuerlig brug og kan bedres ved egnet behandling med beta2-agonister før eller efterfølgende inhalation af colisthimetatnatrium-tørpulver.
English: • if you/your child suffer from myasthenia gravis and are taking macrolide type antibiotics such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin.
Danish: • Hvis du eller dit barn lider af myasthenia gravis og tager antibiotika af macrolid-typen, såsom azithromycin og clarithromycin, eller fluoroquinoloner, såsom norfloxacin og ciprofloxacin.
English: • “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
Danish: • ”Læge-DVD”-information i ”brochure-form” for de læger, der ikke har adgang til en DVDafspiller
English: Tobramycin ( Mean)
Danish: Tobramycin (Middelværdi)
English: General disorders and administration site conditions
Danish: Almene sygdomme og forhold på administrationsstedet
English: It can also result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest.
Danish: Overdosering kan også foranledige neuromuskulær blokade, som kan føre til muskelsvaghed, apnø og muligt respirationsstop.
English: The Turbospin is an inspiratory flow driven dry powder inhaler made of polypropylene and stainless steel.
Danish: Turbospin er en pulverinhalator drevet af det inspiratoriske flow og fremstillet af polypropylen og rustfrit stål.
English: The most commonly reported adverse reactions as a percent of Colobreathe treated patients were: cough (55%), unpleasant taste (51%), throat irritation (34%), dyspnoea (10%) and dysphonia (10%).
Danish: De mest almindeligt rapporterede bivirkninger, som en procentdel af patienter behandlet med Colobreathe var: hoste (55 %), ubehagelig smag (51 %), halsirritation (34 %), åndenød (10 %) og dysfoni (10 %).
English: • already have a muscle condition known as myasthenia gravis or the inherited condition,
Danish: • Har en muskellidelse kendt som myasthenia gravis eller den nedarvede lidelse porfyri.
English: Cross resistance between colistimethate sodium and polymyxin B is expected.
Danish: Krydsresistens mellem colistimethatnatrium og polymyxin B vil forventes.
English: Use as directed by the physician.
Danish: Anvendes som foreskrevet af lægen.
English: As you breathe in slowly, you suck air through the body of the Turbospin inhaler into the capsule chamber.
Danish: Når du trækker vejret langsomt, suger du luft gennem Turbospin-inhalatorens krop og ind i kamret med kapslen.
English: Pyrexia, asthenia, fatigue
Danish: Pyreksi, asteni, træthed
English: Colistimethate sodium (CMS) is a cyclic polypeptide antibacterial active substance that is derived from Bacillus polymyxa var. colistinus and belongs to the polymyxin group.
Danish: Colistimethatnatrium er et cyklisk polypeptid antibakterielt aktivt stof, som stammer fra Bacillus polymyxa var. colistinus og tilhører polymyxin-gruppen.
English: Some detail about cleaning the Turbospin device.
Danish: Nogle detaljer om rengøring af Turbospin udstyret.
English: High concentrations of total free colistin (mean 23.5mg/L) and total colistimethate (mean 178mg/L) were observed in sputum at 1 hour post-dose on Day 8 following BID dosing for 7 days across all age groups.
Danish: Der blev observeret høje koncentrationer af total frit colistin (middelværdi 23,5 mg/l) og total colistimethat (middelværdi 178 mg/l) i sputum hos alle aldersgrupper 1 time efter inhalation på dag 8 efter administration to gange om dagen i 7 dage
English: The most commonly reported adverse reactions as a percent of all Colobreathe treated patients were: unpleasant taste (62%), cough (59.4%), throat irritation (43.9%), dyspnoea (16.6%) and dysphonia (10.7%).
Danish: De mest almindeligt rapporterede bivirkninger, som en procentdel af patienter behandlet med Colobreathe var: ubehagelig smag (62 %), hoste (59,4 %), halsirritation (43,9 %), åndenød (16,6 %) og dysfoni (10,7 %).
English: Tmax for total colistimethate occurred between 0.5 and 1 hour post-dose.
Danish: Tmax for total colistimethat blev nået ½-1 time efter inhalation.
English: Colistimethate sodium is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Colistimethatnatrium bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: If you do not hear the capsule spinning, the capsule may be stuck in the compartment.
Danish: Hvis du ikke kan høre kapslen snurre rundt, kan det være, at kapslen sidder fast i kamret.
English: The following instructions should be adhered to by the patient when taking Colobreathe:
Danish: Patienten skal følge nedenstående anvisninger ved inhalering af Colobreathe:
English: • Blockage in the ears
Danish: • Tilstopning af ørerne
English: Absorption of colistimethate from the gastro-intestinal tract does not occur to any appreciable extent in the normal individual.
Danish: Absorption af colistimethat fra mavetarmkanalen forekommer ikke i noget vurdérbart omfang hos normale individer.
English: When you/your child start using Colobreathe, you/your child may find they have cough, breathlessness, tightness of chest or wheezing.
Danish: Når du eller dit barn begynder at bruge Colobreathe, kan du eller dit barn få hoste, åndenød, følelse af stramhed om brystkassen eller hvæsen.
English: Removing the empty capsule from the Turbospin
Danish: Sådan fjerner du den tomme kapsel fra Turbospin
English: Contents of the pack and other information What Colobreathe contains
Danish: Pakningsstørrelser og yderligere oplysninger Colobreathe indeholder
English: When AUC 0-6 was adjusted by dose and body weight, a slightly higher AUC 0-6 /D/W for total CMS and total free colistin was observed in children.
Danish: Når AUC0-6 blev justeret for dosis og kropsvægt, sås der en lidt højere AUC0-6/D/kropsvægt for total colistimethatnatrium og total frit colistin hos børn.
English: Colistimethate is not significantly absorbed from the lung after inhalation of Colobreathe.
Danish: Colistimethat absorberes ikke i væsentligt omfang fra lungerne efter inhalation af Colobreathe.
English: If acute respiratory exacerbations develop additional intravenous or oral antibacterial agent therapy should be considered.
Danish: Hvis akut respiratorisk eksacerbation udvikles bør yderligere terapi med intravenøse eller antibakterielle midler overvejes.