natgillin/translations-raw huggingface dataset:
I en populationsfarmakokinetisk analyse af 9 kontrollerede kliniske forsøg med 350 patienter med astma i alderen 4 til 77 år (174 patienter mellem 4 og 11 år) blev der set en højere systemisk eksponering for fluticasonpropionat efter behandling med salmeterol/fluticasonpropionat-inhalationspulver 50/100 mikrogram sammenlignet med fluticasonpropionat-inhalationspulver 100 mikrogram.
In a population pharmacokinetic analysis from 9 controlled clinical trials of 350 patients with asthma aged 4 to 77 years (174 patients 4 to 11 years of age) higher fluticasone propionate systemic exposure following treatment with salmeterol/fluticasone propionate inhalation powder 50/100 compared with fluticasone propionate inhalation powder 100 was seen.
Under normale omstændigheder opnås lave plasmakoncentrationer af fluticasonpropionat efter inhalation på grund af udtalt first pass-metabolisme og høj systemisk clearance medieret af CYP3A4 i tarm og lever.
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450
Patienterne skal også informeres om at skylle munden med vand og spytte vandet ud og/eller børste tænder
Patients should also be advised to rinse their mouth with water and spit the water out, and/or brush their teeth
Der er ikke endegyldigt klinisk bevis for en forskel i risikoen for pneumoni blandt de forskellige klasser af inhalerede kortikosteroider.
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk
Hvis det sker, skal du bruge en særskilt inhalator med hurtigtvirkende anfaldsmedicin, f.eks. salbutamol, til lindring af disse symptomer.
If this happens you need to use a fast-acting ‘reliever' (‘rescue') inhaler, such as salbutamol.
Der kan opstå paradoks bronkospasme med akut forværret hvæsende vejrtrækning og åndenød efter dosering.
Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Det endokrine system Cushings syndrom, cushingoide træk, adrenal suppression, væksthæmning hos børn og unge, nedsat knoglemineraltæthed
Endocrine disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density
Der kan opstå systemiske virkninger med alle inhalerede kortikosteroider, der ordineres i længere perioder, specielt ved høje doser.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Salmeterol Multi-center Asthma Research Trial (SMART) SMART var et 28-ugers randomiseret, dobbeltblindt, placebokontrolleret studie med parallelle grupper i USA, hvor 13.176 patienter blev randomiseret til salmeterol (50 mikrogram to gange dagligt) og 13.179 patienter til placebo, i tillæg til patienternes sædvanlige astmabehandling.
SMART was a multi-centre, randomised, double blind, placebo-controlled, parallel group 28-week study in the US which randomised 13,176 patients to salmeterol (50 micrograms twice daily) and 13,179 patients to placebo in addition to the patients' usual asthma therapy.
Dødsfald under behandlingen, som blev bedømt som primært at skyldes pneumoni, var 7 for placebo, 9 for salmeterol, 13 for FP og 8 for salmeterol/fluticasonpropionat.
There was no increase in pneumonia related deaths; deaths while on treatment that were adjudicated as primarily due to pneumonia were 7 for placebo, 9 for salmeterol, 13 for FP and 8 for salmeterol/fluticasone propionate.
Samtidig behandling med ketoconazol eller andre potente CYP3A4-hæmmere bør derfor undgås, medmindre fordelene opvejer den øgede risiko for systemiske bivirkninger fra salmeterol (se pkt.
Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic undesirable effects of salmeterol treatment (see section 4.5).
Derefter skal du skylle munden med vand og spytte det ud og/eller børste tænder.
Afterwards, rinse your mouth with water and spit it out and/or brush your teeth.
Efter samtidig administration er der observeret en øget forekomst af omlagt umbilikalarterie og ufuldstændig ossifikation af nakkebenet hos rotter ved doser, der er forbundet med kendte glukokortikoid-inducerede anomalier.
Following co-administration, increased incidences of transposed umbilical artery and incomplete ossification of occipital bone were found in rats at doses associated with known glucocorticoid
Før du bruger Aerivio Spiromax første gang, skal du klargøre inhalatoren på følgende måde:
Before using your Aerivio Spiromax for the first time, you need to prepare it for use as follows:
Følgende bivirkninger er derudover blevet rapporteret hos patienter med kronisk obstruktiv lungesygdom
The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
Det gennemsnitlige antal moderate til svære eksacerbationer pr. år var signifikant reduceret med salmeterol/fluticasonpropionat (FP), sammenlignet med salmeterol, FP og placebo (gennemsnitlig hyppighed i salmeterol/fluticasonpropionat-gruppen var 0,85 sammenlignet med 0,97 i salmeterol-gruppen, 0,93 i FPgruppen og 1,13 i placebogruppen).
The mean number of moderate to severe exacerbations per year was significantly reduced with salmeterol/fluticasone propionate (FP) as compared with treatment with salmeterol, FP and placebo (mean rate in the salmeterol/fluticasone propionate group 0.85 compared with 0.97 in the salmeterol group, 0.93 in the FP group and 1.13 in the placebo).
Hav altid din inhalator med hurtigtvirkende
You should always have your fast-acting
Studierne blev udført med et tidligere godkendt præparat, tilgængeligt i tre forskellige styrker; studierne blev ikke udført med Aerivio Spiromax.
The studies described were carried out with a previously authorised product available in three different strengths; the studies were not carried out with
Dosis af det inhalerede kortikosteroid skal altid reduceres til den laveste dosis, der kan opretholde en effektiv astmakontrol.
The dose of inhaled corticosteroid should always be reduced to the lowest dose at which effective control of asthma is maintained.
Det er ikke nødvendigt at ryste inhalatoren.
You do not need to shake your inhaler.
Maksimal inspiratorisk flowhastighed gennem Spiromax-inhalationsdevice Der blev udført et randomiseret, åbent overkrydsningsstudie hos børn og unge (4-17 år) med astma, voksne (18-45 år) med astma, voksne (over 55 år) med kronisk obstruktiv lungesygdom (KOL) og raske, frivillige personer (18-45 år) for at evaluere maksimal inspiratorisk flowhastighed (peak inspiratory flow rate, PIFR) samt andre relaterede inhalationsparametre efter inhalation af placebo gennem et Spiromax-inhalationsdevice sammenlignet med inhalation gennem et allerede markedsført multidosis pulver-inhalationsdevice.
Peak Inspiratory Flow Rate through the Spiromax Device A randomised, open-label cross-over study was performed in children and adolescents with asthma (aged 417 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD) (aged older than 55 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Hvis du holder op med at bruge Aerivio Spiromax
If you stop using Aerivio Spiromax
• kronisk obstruktiv lungesygdom (KOL), for at nedsætte hyppigheden af anfald med forværring af dine
• Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms.
Pust roligt ud (pust ikke ud gennem inhalatoren).
Then breathe out gently (do not breathe out through the inhaler).
Det skal besluttes, om amning eller behandling med Aerivio Spiromax skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de
A decision must be made whether to discontinue breastfeeding or to discontinue Aerivio Spiromax therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
På basis af dyrestudier med salmeterol og fluticasonpropionat givet separat er de eneste sikkerhedsmæssige problemstillinger ved human brug virkninger forbundet med for kraftige farmakologiske virkninger.
The only safety concerns for human use derived from animal studies of salmeterol and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.
Der skal tages hensyn til den let øgede forekomst af β-agonist-relaterede bivirkninger, hvis lægen overvejer en fordobling af dosis af salmeterol/fluticasonpropionat til voksne patienter, der har behov for ekstra, kortvarig (op til 14 dage) behandling med inhaleret kortikosteroid.
The small increase in β agonist-related adverse events should be taken into account if doubling the dose of salmeterol/fluticasone propionate is considered by the physician in adult patients requiring additional shortterm (up to 14 days) inhaled corticosteroid therapy.
Patienterne bør starte behandlingen med en fastdosiskombination, der indeholder en lavere dosis kortikosteroid, hvorefter kortikorsteroiddosis trappes op, indtil der opnås astmakontrol.
Patients should commence treatment with a fixeddose combination containing a lower dose of the corticosteroid component and will then be titrated up in respect of the corticosteroid dose until control of asthma is achieved.
Det er derfor vigtigt, at patienten vurderes regelmæssigt, og at dosis af inhaleret kortikosteroid reduceres til den laveste dosis, der kan opretholde en effektiv astmakontrol.
It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is
Før indkøring seponerede personerne deres tidligere KOL-medicin undtagen hurtigtvirkende bronkodilatatorer.
Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators.
I et interaktionsstudie med intranasalt fluticasonpropionat hos raske personer øgede ritonavir (en højpotent CYP3A4-hæmmer) 100 mg to gange dagligt plasmakoncentrationen af fluticasonpropionat flere hundrede gange, hvilket resulterede i markant reducerede cortisolkoncentrationer i serum.
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg twice daily increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations.
• Fluticasonpropionat tilhører en gruppe lægemidler, der kaldes kortikosteroider (binyrebarkhormon), der nedsætter hævelse og irritation i lungerne.
• Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
EXP: Anvendes inden for 3 måneder efter, at inhalatoren er taget ud af folien.
EXP Use within 3 months of removing from foil wrapping.
Mulige systemiske virkninger omfatter Cushings syndrom, cushingoide træk, adrenal suppression, nedsat knoglemineraltæthed, katarakt og glaukom samt sjældnere en række psykiske eller adfærdsmæssige virkninger, herunder psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression (især hos børn) (se underafsnittet ”Pædiatrisk population” nedenfor for oplysninger om systemiske virkninger af inhalerede kortikosteroider hos børn og unge).
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, 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) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents).
• En nedsat mængde kalium i blodet (dit hjerteslag kan blive uregelmæssigt, du kan opleve muskelsvaghed og få kramper).
• A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle
Ved symptomer som sløret syn eller andre synsforstyrrelser bør det overvejes at henvise patienten til oftalmolog med henblik på vurdering af de mulige årsager; disse kan være grå stær, glaukom eller sjældne sygdomme såsom central serøs korioretinopati (CSCR), som er indberettet efter brug af systemiske og topikale kortikosteroider.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical
Både hæshed og forekomst af candidiasis i mund og svælg kan mindskes ved at skylle munden med vand og spytte vandet ud og/eller børste tænder efter inhalation.
Both hoarseness and the incidence of candidiasis of the mouth and throat may be relieved by rinsing the mouth with water and spitting the water out and/or brushing the teeth after using the product.
Den gennemsnitlige forbedring efter tre år for salmeterol/fluticasonpropionat i forhold til placebo var -3,1 enheder (95 % CI: -4,1 til -2,1; p<0,001); -2,2 enheder (p<0,001) sammenlignet med salmeterol og -1,2 enheder (p=0,017) sammenlignet med FP.
The average improvement over three years for salmeterol/fluticasone propionate compared with placebo was -3.1 units (95% CI: -4.1 to -2.1; p<0.001) and when compared with salmeterol was -2.2 units (p<0.001) and when compared with FP was -1.2 units (p=0.017).
Aerivio Spiromax påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene
Aerivio Spiromax has no or negligible influence on the ability to drive and use machines.
Hvis dette sker, skal du straks holde op med at bruge din Aerivio Spiromaxinhalator.
If this happens stop using your Aerivio Spiromax inhaler.
Børnene fik enten salmeterol/fluticasonpropionat (50/100 mikrogram) eller fluticasonpropionat (100 mikrogram) alene 2 gange dagligt.
Children received either salmeterol/fluticasone propionate (50/100 micrograms) or fluticasone propionate (100 micrograms) alone twice daily.
Den estimerede 3-års sandsynlighed for, at pneumoni rapporteres som en bivirkning, var 12,3 % for placebo, 13,3 % for salmeterol, 18,3 % for FP og 19,6 % for salmeterol/fluticasonpropionat (hazard ratio for salmeterol/fluticasonpropionat vs. placebo: 1,64; 95 % CI: 1,33-2,01; p<0,001).
The estimated 3-year probability of having pneumonia reported as an adverse event was 12.3% for placebo, 13.3% for salmeterol, 18.3% for FP and 19.6% for salmeterol/fluticasone propionate (hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.64, 95% CI: 1.33 to 2.01, p<0.001).
En flowhastighed på over 60 l/min er nødvendig for optimal levering af lægemiddel til lungerne via
A flow rate of greater than 60L/min is required for optimal delivery of drugs to the lungs through the multidose dry powder Spiromax inhaler.
Betablokkere kan svække virkningen af salmeterol eller have en antagonistisk virkning.
Beta adrenergic blockers may weaken or antagonise the effect of salmeterol.
Aerivio Spiromax skal anvendes med forsigtighed til patienter med svære hjerte-kar-sygdomme eller forstyrrelser i hjerterytmen samt hos patienter med diabetes mellitus, tyreotoksikose, ikke korrigeret hypokaliæmi og patienter disponeret for lav serumkalium.
Aerivio Spiromax should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
Det er ikke sandsynligt, at Aerivio Spiromax vil påvirke din evne til at føre motorkøretøj eller betjene
Aerivio Spiromax is not likely to affect your ability to drive or use machines.
Mulige systemiske virkninger omfatter Cushings syndrom, cushingoide træk, adrenal suppression, akut adrenal krise og væksthæmning og sjældnere en række forskellige psykiske eller adfærdsmæssige virkninger, herunder psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression.
Når der er opnået astmakontrol, skal behandlingen vurderes regelmæssigt, og dosis af inhaleret kortikosteroid nedtrappes hensigtsmæssigt for at opretholde sygdomskontrol.
Once control of asthma is achieved patients should be reviewed regularly and the dose of inhaled corticosteroid titrated downwards as appropriate to maintain disease control.
Angioødem (primært i ansigt og orofaryngealt ødem)
Angioedema (mainly facial and oropharyngeal
Hjælpestof, som behandleren skal være opmærksom på: Hver dosis indeholder ca. 10 milligram lactose (som monohydrat).
Each dose contains approximately 10 milligrams of lactose (as monohydrate).
I et 12-ugers forsøg med børn i alderen 4 til 11 år [n=257], der blev behandlet 2 gange dagligt med enten salmeterol/fluticasonpropionat 50/100 mikrogram eller salmeterol 50 µg + fluticasonpropionat 100 µg, oplevede begge behandlingsgrupper en 14 % stigning i den maksimale eksspiratoriske flowhastighed samt forbedringer i symptomscore og brug af salbutamol som akutmedicin.
In a 12-week trial of children aged 4 to 11 years [n=257] treated with either salmeterol/fluticasone propionate 50/100 or salmeterol 50 micrograms + fluticasone propionate 100 micrograms both twice daily, both treatment arms experienced a 14% increase in peak expiratory flow rate as well as improvements in symptom score and rescue salbutamol use.
Aerivio Spiromax indeholder salmeterol og fluticasonpropionat, der har forskellige virkningsmekanismer.
Aerivio Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Mulige systemiske bivirkninger i disse aldersgrupper omfatter Cushings syndrom, cushingoide træk, adrenal suppression og væksthæmning (se pkt.
Possible systemic effects in these age groups include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents (see section 4.4).
Læs indlægssedlen for yderligere information.
See leaflet for further information
Hvis en patient med svær KOL har fået pneumoni, skal behandlingen med Aerivio Spiromax evalueres igen.
If a patient with severe COPD has experienced pneumonia, treatment with Aerivio Spiromax should be re-evaluated.
Personerne anvendte salbutamol efter behov i alle studierne.
Subjects used salbutamol on an as-needed
FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Virkningsmekanismen for hvert af stofferne er beskrevet nedenfor.
The respective mechanisms of action of both active substances are discussed below.
Pneumoni-relaterede bivirkninger blev rapporteret hos 55 (7 %) personer i gruppen med salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt og hos 25 (3 %) i salmeterolgruppen.
Pneumonia-related events were reported for 55 (7%) subjects in the salmeterol/fluticasone propionate 50/250 micrograms twice daily group and 25 (3%) in the salmeterol group.
Den øgede forekomst af rapporterede tilfælde af pneumoni med salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt forekommer at være af samme størrelsesorden som den rapporterede forekomst efter behandling med salmeterol/fluticasonpropionat 50/500 mikrogram to gange dagligt i TORCH.
The increased incidence of reported pneumonia with salmeterol/fluticasone propionate 50/250 micrograms twice daily appears to be of similar magnitude to the incidence reported following treatment with salmeterol/fluticasone propionate 50/500 micrograms twice daily in TORCH.
Hjertearytmier (herunder supraventrikulær takykardi
Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Aerivio Spiromax 50 mikrogram/500 mikrogram inhalationspulver
Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder
*Velkontrolleret astma: op til 2 dage med symptomscore over 1 (symptomscore 1 defineret som 'symptomer i en kort periode i løbet af dagen'), anvendelse af SABA i op til 2 dage og op til 4 gange/uge, maksimalt eksspiratorisk flow om morgenen ≥ 80 % af forventet, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der medførte en ændring i behandlingen.
Pooled results across the 3 treatment levels *Well controlled asthma - less than or equal to 2 days with symptom score greater than 1 (symptom score 1 defined as ‘symptoms for one short period during the day'), SABA use on less than or equal to 2 days and less than or equal to 4 occasions/week, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma - no symptoms, no SABA use, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in
Når det er hensigtsmæssigt at titrere ned til en lavere styrke, der ikke findes for Aerivio Spiromax, er det nødvendigt at ændre til en fastdosiskombination af salmeterol og fluticasonpropionat, der indeholder en lavere dosis inhaleret kortikosteroid.
When it is appropriate to titrate down to a lower strength not available for Aerivio Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is
Hvis du ammer, skal du spørge lægen eller apotekspersonalet til råds, før du tager dette lægemiddel.
If you are breastfeeding, check with your doctor or pharmacist for advice before taking this medicine.
Dette giver en reduktion af hyppigheden af moderate til svære eksacerbationer på 25 % (95 % CI: 19-31 %; p<0,001) sammenlignet med placebo, 12 % sammenlignet med salmeterol (95 % CI: 5-19 %; p=0,002) og 9 % sammenlignet med FP (95 % CI: 1-16 %; p=0,024).
This translates to a reduction in the rate of moderate to severe exacerbations of 25% (95% CI: 19% to 31%; p<0.001) compared with placebo, 12% compared with salmeterol (95% CI: 5% to 19%, p=0.002) and 9% compared with FP (95% CI: 1% to 16%, p=0.024).
Patienterne skal rådes til altid at have deres inhalator på sig, så den kan anvendes til lindring af akutte anfald.
Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times.
I sjældne tilfælde kan Aerivio Spiromax ved høje terapeutiske doser forårsage hjertearytmi, f.eks. supraventrikulær takykardi, ekstrasystoler og atrieflimmer, og en let, forbigående reduktion i serumkalium.
Rarely, Aerivio Spiromax may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses.
Patienterne må ikke starte behandling med Aerivio Spiromax under en eksacerbation, eller hvis de har signifikant eller akut forværring.
Patients should not be initiated on Aerivio Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Hos patienter med astma eller KOL er systemisk eksponering blevet observeret i mindre grad efter inhalation af
In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been
Der kan opstå alvorlige astmarelaterede bivirkninger og eksacerbationer under behandling med Aerivio Spiromax.
Serious asthma-related adverse events and exacerbations may occur during treatment with Aerivio Spiromax.
Patienterne registrerer muligvis en smag, når de bruger Aerivio Spiromax.
Patients may notice a taste when using Aerivio Spiromax due to the lactose excipient.