FrancophonIA/ELRC3.0 huggingface dataset:
English: Following intravenous dosing, the disposition of BDP and its active metabolite, B17MP, are characterised by high plasma clearance (150 and 120 L/h respectively), with a small volume of distribution at steady state for BDP (20 L) and larger tissue distribution for its active metabolite (424 L).
Danish: Efter intravenøs dosering er fjernelsen af BDP og den aktive metabolit, B17MP, karakteriseret ved høj plasma-clearance (hhv. 150 og 120 l/t), med et lille volumen af fordeling ved steady state for BDP (20 l) og større fordeling i vævet for den aktive metabolit (424 l).
English: Then put the top on the nebuliser bowl and shake gently to mix the contents.
Danish: Sæt så toppen på nebulisatorskålen, og ryst forsigtigt for at blande indholdet.
English: A study in which the objective was to compare the efficacy and safety of nebulised beclometasone dipropionate versus fluticasone propionate suspension for nebulization was conducted in 205 adults patients aged 18-65 years with asthma randomized to a 12-week treatment period.
Danish: Et studie, hvor formålet var at sammenligne virkningen og sikkerheden af nebuliseret beclometasondipropionat kontra fluticasonpropionat som suspension til nebulisering, blev udført med 205 voksne astmapatienter i alderen 18 til 65 år, der blev randomiseret til en 12-ugers behandlingsperiode.
English: 6.6 Special precautions for disposal and other handling The ampoule should be used according to the following instructions:
Danish: 6.6 Regler for bortskaffelse og anden håndtering Enkeltdosisampullen skal anvendes i henhold til følgende instruktioner:
English: Nebulised beclometasone dipropionate was evaluated in 276 children aged 1-4 years with frequent wheezing in a randomized, double-blind, 12-week controlled trial.
Danish: Nebuliseret beclometasondipropionat blev evalueret hos 276 børn i alderen 1 til 4 år med hyppig hvæsende vejrtrækning i et randomiseret, dobbeltblindet, kontrolleret forsøg på 12 uger.
English: The use of beclometasone dipropionate nebuliser suspension in doses exceeding those recommended over a long period of time could lead to the suppression of hypothalamic-pituitary-adrenal (HPA)-axis function.
Danish: Brugen af beclometasondipropionat som suspension til nebulisering i doser, som overskrider de anbefalede, gennem længere tid, kan føre til suppression af hypothalamus-hypofyse-binyre- (HPA-) funktionen.
English: Possible systemic effects include hypothalamic-pituitary-adrenal (HPA)-axis suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Danish: Blandt mulige systemiske virkninger er suppression af hypothalamus-hypofysebinyre (HPA)-funktionen, væksthæmning hos børn og unge, nedsat mineraltæthed i knogler, katarakt og glaukom og sjældnere en række psykologiske og adfærdsmæssige påvirkninger, herunder psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression (især hos børn).
English: The systemic absorption of the main active metabolite B17MP arises from both lung deposition and oral absorption of the swallowed dose.
Danish: Den systemiske absorption af den aktive hovedmetabolit B17MP sker fra både lungedeponering og oral absorption af den slugte dosis.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Ampoule
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Ampul
English: Gently squeeze the ampoule content into the nebuliser chamber (Figure E).
Danish: Klem forsigtigt ampullens indhold ud i nebuliseringskammeret (fig. E).
English: After inhaling the prescribed dose patients should rinse their mouth with water to minimise the risk of oropharyngeal thrush (see section 4.4).
Danish: Efter inhalation af den ordinerede dosis bør patienterne skylle munden med vand for at minimere risikoen for oropharyngeal trøske (se pkt.
English: It belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in the walls of the airways (e.g. nose, lungs), and so ease breathing problems.
Danish: Det tilhører en gruppe lægemidler kaldet kortikosteroider (binyrebarkhormoner), som ofte blot kaldes steroider, som har en anti-inflammatorisk virkning, der nedsætter hævelse og irritation i luftvejenes vægge (f.eks. næse, lunger) og således afhjælper vejrtrækningsproblemer.
English: Comparable efficacy in controlling asthma was demonstrated by the two treatments at study end in terms of pulmonary function tests, asthma exacerbations, symptoms and the use of rescue salbutamol (Terzano et al., 2003).
Danish: Der blev ved studiets afslutning påvist sammenlignelig effektivitet til kontrol af astma for de to behandlinger i forhold til lungefunktionstest, eksacerbation af astma, symptomer og anvendelse af salbutamol som behovsmedicin (Terzano et al., 2003).
English: Adults and adolescents (from 12 years of age):
Danish: Voksne og unge (som er fyldt 12 år):
English: The decision to start nebulised beclometasone dipropionate for treatment of recurrent wheezing in children up to 5 years of age should be determined by the severity and frequency of wheezing episodes.
Danish: Beslutningen om at starte behandlingen af tilbagevendende hvæsende vejrtrækning med nebuliseret beclometasondipropionat hos børn op til 5 år bør bestemmes af sværhedsgraden og hyppigheden af episoder med hvæsende vejrtrækning.
English: However, if high dose inhaled beclometasone dipropionate is used it is recommended to avoid breast-feeding for 4 h after administration.
Danish: Ved høje doser inhaleret beclometasondipropionat anbefales det imidlertid at undlade amning i 4 timer efter administration.
English: However, possible effects on foetal development after high dose inhaled beclometasone dipropionate therapy could not be excluded.
Danish: Risikoen for mulig påvirkning af forsterudviklingen efter inhalation af høje doser beclometasondipropionat kan imidlertid ikke udelukkes.
English: Therefore the majority of the effect is related to B17MP systemic exposure.
Danish: Derfor er størstedelen af de systemiske kortikosteroidvirkninger relateret til den systemiske eksponering for B17MP.
English: There are strips 5 ampoules in each sealed pouch, in pack sizes of 10 ampoules (2 pouches), 20 ampoules (4 pouches) or 40 ampoules (8 pouches).
Danish: Der er strips med 5 enkeltdosisampuller i hver forseglet pose, i pakningsstørrelser med 10 enkeltdosisampuller (2 poser), 20 enkeltdosisampuller (4 poser) eller 40 enkeltdosisampuller (8 poser).
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses administered for long periods of time.
Danish: Systemiske virkninger kan opstå med inhalerede kortikosteroider, især ved høje doser ordineret i længere perioder.
English: 400 micrograms ampoule is for single use.
Danish: 400 mikrogram er til engangsbrug.
English: After inhalation, any unused suspension remaining in the nebuliser chamber must be discarded.
Danish: Efter inhalationen skal eventuelt resterende inhalationsvæske i nebuliseringskammeret kasseres.
English: Bend the ampoule backwards and forwards (Figure A).
Danish: Bøj ampullen frem og tilbage (fig. A).
English: Treatment with {INVENTED NAME} may continue at the lowest dose at which effective control of disease (asthma or wheezing) is maintained (see section 4.4).
Danish: Behandling med {SÆRNAVN} må godt fortsætte med den laveste dosis, som er tilstrækkelig til en effektiv sygdomskontrol (astma eller hvæsende vejrtrækning) (se pkt.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing, shortness of breath and cough after dosing.
Danish: Efter dosering kan der forekomme paradoksal bronkospasme med øjeblikkelig stigning i hvæsende vejrtrækning, åndenød og hoste.
English: Efficacy and safety of nebulised beclometasone dipropionate in the treatment of severe persistent asthma in infants and young children aged 6 months to 6 years, in comparison to budesonide suspension for nebulization was assessed in a multicentre, randomized, controlled open-labelled study for 14 weeks.
Danish: Effektiviteten og sikkerheden af nebuliseret beclometasondipropionat til behandling af svær, persisterende astma hos spædbørn og små børn i aldere 6 måneder til 6 år i sammenligning med budesonid som suspension til nebulisering blev vurderet i et randomiseret, kontrolleret, åbent, ublindet studie i 14 uger.
English: Beclometasone dipropionate (BDP) is a pro-drug that is hydrolysed via esterase enzymes to an active metabolite beclometasone monopropionate (B17MP) the most abundant metabolite in plasma.
Danish: Beclometasondipropionat (BDP) er et pro-drug, som hydroliseres via esterase enzymer til en aktiv metabolit beclometasonmonopropionat (B17MP), den hyppigst forekommende metabolit i plasma.
English: A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.
Danish: Der har været sjældne indberetninger af alvorlig overfølsomhedsreaktion, inklusive ødem i øje, ansigt, læber og hals (angioødem).
English: The renal excretion of BDP and its metabolites is negligible, faecal excretion is the major route of BDP elimination mainly as polar metabolites.
Danish: Den renale udskillelse af BDP og dets metabolitter er ubetydelig; den vigtigste eliminationsvej for BDP er via fæces og hovedsagelig som polære metabolitter.
English: Do not inject into a vein or use orally.
Danish: Må ikke indsprøjtes i en vene eller indtages gennem munden.
English: If you have used more {INVENTED NAME} than you should, tell your doctor as soon as possible.
Danish: Hvis du har brugt for meget {SÆRNAVN}, skal du hurtigst muligt kontakte din læge.
English: ONLY sterile sodium chloride 9 mg/ml (0.9%) solution should be used.
Danish: Der må KUN anvendes steril 9 mg/ml (0,9 %) natriumchloridopløsning.
English: *Rare
Danish: *Sjælden
English: A double-blind, double-dummy, multicentre, randomized, parallel-group study compared the efficacy and safety of nebulised beclometasone dipropionate and beclometasone dipropionate administered with metered-dose inhalation in 151 patients, aged 6-16 years, with moderate to severe asthma for 4 weeks.
Danish: Et dobbeltblindet, dobbelt-dummy, randomiseret multicenterparallelgruppestudie sammenlignede virkningen og sikkerheden af nebuliseret beclomethasondipropionat og beclometasondipropionat administreret som afmålt dosis til inhalation hos 151 patienter i alderen 6 til 16 år med moderat til svær astma i 4 uger.
English: Children (up to 11 years of age): • 400-800 micrograms twice daily which correspond to a total daily dose of 800-1600 micrograms.
Danish: Børn (op til 11 år): • 400-800 mikrogram dagligt, hvilket svarer til en total daglig mængde på 800-1600 mikrogram.
English: In this case, the content of the ampoule should be emptied into the nebuliser bowl.
Danish: I så fald bør ampullens indhold tømmes ned i nebulisatorskålen.
English: The systemic pharmacodynamic effects of beclometasone dipropionate and its active metabolite B17MP is assessed by measuring the effects on hypothalamopituitary adrenal (HPA)-axis function.
Danish: De systemiske farmakodynamiske virkninger af beclometasondipropionat og dets aktive metabolit B17MP vurderes ved at måle virkningerne på hypothalamus-hypofyse-binyre- (HPA) aksens funktion.
English: The quantity of sterile sodium chloride 9 mg/ml (0.9%) solution required should be added.
Danish: Den mængde natriumklorid 9 mg/ml (0,9 %) opløsning, der er påkrævet, bør tilsættes.
English: {INVENTED NAME} should be discontinued immediately, the patient assessed and, if necessary, alternative therapy instituted.
Danish: Brugen af {SÆRNAVN} bør seponeres omgående, og patienten bedømmes, og anden behandling påbegyndes, hvis det er nødvendigt.
English: {INVENTED NAME} is not indicated to relieve acute asthma symptoms for which an inhaled shortacting beta 2-agonists is required.
Danish: {SÆRNAVN} er ikke indiceret til at lindre akutte astmasymptomer, hvor det er nødvendigt at anvende inhalerede, korttidsvirkende beta2-agonister.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {INVENTED NAME} 400 mcg
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) {SÆRNAVN} 400 mcg
English: Tell your doctor if you are taking other corticosteroid medications as they may interact with {INVENTED NAME} and could make any side effects worsening.
Danish: Fortæl lægen, hvis du tager anden kortikosteroid medicin, som eventuelt kan interagere med {SÆRNAVN} og forstærke nogen bivirkninger.
English: Do not use {INVENTED NAME} after the expiry date which is stated on the carton, pouch and ampoule.
Danish: Brug ikke {SÆRNAVN} efter den udløbsdato, der står på æsken, posen og enkeltdosisampullen.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {INVENTED NAME} 800 mcg
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) {SÆRNAVN} 800 mcg
English: The starting dose should be prescribed by your doctor according to the frequency and severity of your disease.
Danish: Din læge vil ordinere startdosen efter sværhedsgraden af din sygdom.
English: In case of bacterial infection of the respiratory tract an adequate antibiotic co-medication may be required.
Danish: I tilfælde af en bakterieinfektion i luftvejene kan det være nødvendigt at anvende samtidig medicinering i form af et relevant antibiotikum.
English: Patients with adrenal suppression are steroid dependent and have to be treated accordingly with supplementary systemic glucocorticosteroids.
Danish: Patienter medsuppression af binyrerne er steroidafhængige, og det kan det være nødvendigt at administrere supplerende systemiske glukokortikosteroider.
English: Beclometasone dipropionate can be used during breast-feeding.
Danish: Beclometasondipropionat kan anvendes under amning.
English: Switching from corticosteroid tablets to {INVENTED NAME} Switching from corticosteroid tablets to an inhaled corticosteroid treatment might make you feel generally unwell or you might develop a rash, eczema or a runny nose and sneezing (rhinitis).
Danish: Skifter du fra steroidtabletter til inhaleret steroidbehandling, kan du føle dig generelt utilpas, eller du kan udvikle udslæt, eksem eller løbende næse og nysen (rhinitis).
English: Special care is needed in patients with viral, bacterial and fungal infections of the eye or of the mouth or respiratory tract.
Danish: Hos patienter med virus-, bakterie- eller svampeinfektioner i øjne, mund eller luftveje skal der udvises særlig forsigtighed.
English: Vigorously shake and turn the ampoule upside-down in order to make the suspension homogeneous.
Danish: Ryst ampullen kraftigt, og vend den på hovedet for at gøre suspensionen homogen.
English: No specific studies have been performed with beclometasone dipropionate with regard to the safety in human fertility.
Danish: Der er ikke udført specifikke studier af sikkerheden for human fertilitet ved anvendelse af beclometasondipropionat.
English: • If you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.
Danish: • hvis du er allergisk over for kortikosteroider eller et af de øvrige indholdsstoffer (angivet i punkt
English: {INVENTED NAME} can be diluted.
Danish: {SÆRNAVN} kan fortyndes.
English: Open the ampoule by rotating the flap as indicated by the arrow (Figure D).
Danish: Ampullen åbnes ved at dreje klappen som vist med pilen (fig. D).
English: The container closed in this way must be stored at 2-8 C (in the refrigerator) and the remaining quantity has to be used within 12 hours after first opening.
Danish: Hvis ampullen lukkes på denne måde, skal den opbevares ved 2 ◦C til 8 ◦C (i køleskab), og den resterende mængde skal anvendes inden for 12 timer efter første åbning.
English: Adverse reactions observed in clinical trials with inhaled beclometasone in the treatment of asthma and wheezing are listed in the table below according the MedDRA system organ class and frequencies: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
Danish: De bivirkninger, der er observeret i kliniske forsøg med inhaleret beclometason i behandling af astma og hvæsende vejrtrækning, er anført i nedenstående skema efter systemorganklasse og hyppighed ifølge MedDRA: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000
English: If you develop an immediate increase in wheezing, shortness of breath and cough after using {INVENTED NAME}, you should discontinued immediately {INVENTED NAME} and you should contact your doctor.
Danish: Hvis du oplever mere hvæsende vejrtrækning, åndenød og hoste umiddelbart efter brug af {SÆRNAVN}, skal du omgående anvende din hurtigtvirkende ‘reliever' inhalator.
English: Special care is necessary in patients with active or quiescent pulmonary tuberculosis and other infections.
Danish: Hos patienter med aktiv eller passiv lungetuberkulose og andre infektioner er det især nødvendigt at udvise forsigtighed.
English: Carefully squeeze out the content until the level of suspension in the ampoule reaches the graduation mark and no further.
Danish: Klem forsigtigt indholdet ud, indtil suspension i ampullen når målemærket.
English: Once half the content is used, reinsert the cap upside down by pushing it onto the container.
Danish: Når halvdelen af indholdet er klemt ud sættes hætten på igen ved at trykke den fast på ampullen, mens den vender på hovedet.
English: The active substance is beclometasone dipropionate.
Danish: Det aktive stof er beclometasondipropionat.
English: Perhaps you are more wheezy and short of breath than usual, or your nebuliser seems to be less effective.
Danish: og du har større åndenød end normalt, eller din ‘reliever' inhalator ikke virker så effektivt mere.
English: In children with recurrent wheezing, if no treatment benefit of is observed within 2-3 months, {INVENTED NAME} should be discontinued.
Danish: Hos børn med tilbagevendende hvæsende vejrtrækning skal behandling med {SÆRNAVN} ophøre, hvis der ikke observeres nogen bedring inden for 2-3 måneder.
English: What {INVENTED NAME} looks like and contents of the pack {INVENTED NAME} is a white or almost white nebuliser suspension.
Danish: Udseende og pakningsstørrelser {SÆRNAVN} er en hvid eller næsten hvid inhalationsvæske til nebulisator, suspension.
English: • 800-1600 micrograms twice daily which correspond to a total daily amount of 1600-3200 micrograms.
Danish: • 800-1600 mikrogram dagligt, hvilket svarer til en total daglig mængde på 1600-3200 mikrogram.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [to be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [udfyldes nationalt]
English: Do not use the ampoule after 3 months from the date of first opening the pouch.
Danish: Brug ikke ampullerne efter 3 måneder fra den dato, hvor posen blev åbnet første gang.
English: Comparable improvements over baseline were reported at study end for the two treatment groups in morning pulmonary expiratory flow rate (primary endpoint), clinical symptoms scores and the use of rescue salbutamol.
Danish: Der blev ved studiets afslutning indberettet sammenlignelige forbedringer siden baseline for de to behandlingsgrupper i forhold til lungefunktionstest, klinisk symptomscores og anvendelse af salbutamol som behovsmedicin.
English: The pharmacokinetics of BDP in patients with renal or hepatic impairment has not been studied; however, as BDP undergoes a very rapid metabolism via esterase enzymes present in intestinal fluids, serum, lungs and liver to originate more polar products B21MP, B17MP and BOH, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of BDP.
Danish: Da BDP dog gennemgår meget hurtig metabolisme via esterase enzymer, der findes i tarmvæsker, serum, lunger og lever for at skabe flere polære produkter B21MP, B17MP og BOH, forventes det ikke, at nedsat leverfunktion vil modificere farmakokinetikken og sikkerhedsprofilen af BDP.
English: The vial closed in this way must be stored at 2-8°C (in the refrigerator) and pour the content into the nebuliser up to the graduation mark indicated on the sides of the ampoule.
Danish: Hvis ampullen lukkes på denne måde, skal den opbevares ved 2 °C til 8 °C (i køleskab), og hæld indholdet i nebulisatoren op til målemærket på siden af ampullen.
English: The switch to {INVENTED NAME} of patients who have been treated with systemic steroids for long periods of time, or at a high dose, needs special care, since recovery from any adrenocortical suppression sustained may take a considerable time.
Danish: Der skal udvises særlig forsigtighed, hvis patienter, som er blevet behandlet med systemiske steroider i længere tid eller med en høj dosis, skiftes over til {SÆRNAVN}, da det kan tage et godt stykke tid at komme sig over en svækket binyrebarkfunktion.
English: Bone thinning and eye problems, which include clouding of the lens of the eye (cataract), increase in pressure in the eye (glaucoma) have been reported.
Danish: Der er indberettet fortynding af knogler og øjenproblemer, bl.a. uklarhed af øjets linse (grå stær eller katarakt), øget tryk i øjet (grøn stær eller glaukom).
English: The affinity of beclometasone dipropionate and its main active metabolite, beclometasone monopropionate (B17MP), for the human glucocorticoid receptor has been determined.
Danish: Affiniteten af beclometasondipropionat og dets aktive hovedmetabolit beclometasonmonopropionat (B17MP) for den humane glukokortikoidreceptor er klarlagt.
English: Pharmacotherapeutic group: Other drugs for obstructive airway diseases, inhalants; Glucocorticoids ATC code: R03 BA01.
Danish: Farmakoterapeutisk klassifikation: Andre lægemidler til obstruktive luftvejssygdomme, inhalationsmidler; glukokortikoider
English: In order to obtain a half vial, pour the content into the nebuliser up to the half dose mark indicated on the sides of the vial.
Danish: En halv ampuldosis opnås ved at hælde indholdet i nebulisatoren op til målemærket for halv dosis på siden af ampullen.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING POUCH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMLIGGENDE EMBALLAGE POSE
English: Patients should be advised to have such relief medicinal product readily available.
Danish: Patienter bør rådes til altid at have sådan 'reliever' medicin ved hånden.
English: Consideration can be given to referring the patient to paediatric pulmonologist.
Danish: Det bør overvejes, om patienten skal henvises til en børnespecialist i luftvejssygdomme.
English: In any case, beclometasone dipropionate should be administered without discontinuing the systemic treatment; after approximately one week, the latter should be gradually reduced (the size of the reduction should correspond to the maintenance dose of the systemic steroid), patient should be checked at regular intervals (in particular, adrenocortical function tests should be carried out) and dose of inhaled beclometsone dipropionate should be adjusted according to the results obtained.
Danish: I alt fald skal beclometasondipropionat administreres uden at seponere den systemiske behandling; efter ca. én uge kan sidstnævnte gradvist reduceres (reduktionens størrelse bør svare til det systemiske steroids vedligeholdelsesdosis).
English: Paradoxical bronchospasm may occur after dosing.
Danish: Der kan forekomme paradoks bronkospasme efter administration.
English: Driving and using machines {INVENTED NAME} is unlikely to affect your ability to drive and use machines.
Danish: Det er usandsynligt, at {SÆRNAVN} vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Sorbitan laurate Sodium chloride Water for injections
Danish: Sorbitanlaurat Natriumchlorid Vand til injektionsvæsker
English: 800-1,600 micrograms twice daily (total daily dose: 1600 - 3200 micrograms)
Danish: 800-1600 mikrogram to gange dagligt (total daglig dosis: 1600 - 3200 mikrogram)