natgillin/translations-raw huggingface dataset:
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.
SMART je bila 28-tedenska multicentična, randomizirana, dvojno slepa, s placebom nadzorovana študija s paralelnimi skupinami v ZDA, v kateri je bilo 13.176 bolnikov randomiziranih za salmeterol (50 mikrogramov dvakrat na dan) in 13.179 bolnikov za placebo, poleg običajnega zdravljenja, ki so ga bolniki uporabljali za astmo.
When the numbers become red in the window, you should see your doctor and get a
Ko v okencu vidite rdeča števila, obiščite zdravnika, da si priskrbite nov inhalator.
If Aerivio Spiromax therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered.
Če je treba zdravljenje z zdravilom Aerivio Spiromax prekiniti zaradi prevelikega odmerjanja agonista β v zdravilu, morate pretehtati ustrezno nadomestno terapijo s steroidom.
Clinically significant effects were not seen on blood pressure, heart rate, blood glucose and blood potassium levels.
Klinično pomembnih učinkov na krvni tlak, srčni utrip, glukozo v krvi in raven kalija v krvi niso opazili.
Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo (see section 5.1).
Podatki iz obsežnega kliničnega preskušanja (Multicentrično raziskovalno preskušanje zdravljenja astme s salmeterolom - SMART (Salmeterol Multi-Center Asthma Research Trial)) kažejo, da je pri bolnikih afroameriškega porekla tveganje hudih z dihali povezanih dogodkov ali celo smrti pri uporabi salmeterola v primerjavi s placebom večje (glejte poglavje 5.1).
The impact of optimal training (i.e. breathing in forcefully upon inhalation) in dry powder inhaler inhalation technique on inhalation speed and volume was assessed in these subject groups, together with assessment of potential differences in inhalation outputs according to the devices used.
V skupini oseb je bil ocenjen vpliv optimalnega usposabljanja (tj. silovit vdih ob inhalaciji) pri inhalacijski tehniki z inhalatorjem s suhim praškom na hitrost in volumen, skupaj z oceno možnih izstopnih razlik pri inhalaciji glede na različne pripomočke.
These effects are much less likely to occur than with oral corticosteroids.
Verjetnost, da se bodo ti učinki pojavili, je veliko manjša kot med uporabo peroralnih kortikosteroidov.
Tell your doctor if you notice any of the following symptoms while taking Aerivio Spiromax as they could be symptoms of a lung infection: fever or chills; increased mucus production, changes in mucus colour; increased cough or increased breathing difficulties.
Zdravniku povejte, če med uporabo zdravila Aerivio Spiromax opazite kar koli od naslednjega, saj so lahko to simptomi okužbe pljuč: zvišano telesno temperaturo ali mrzlico; obilnejše nastajanje sluzi, spremenjeno barvo sluzi; močnejši
During the study, patients were permitted usual COPD therapy with the exception of other inhaled corticosteroids, long-acting bronchodilators and long-term systemic corticosteroids.
V času študije je bilo bolnikom dovoljeno uporabljati običajna zdravila za zdravljenje KOPB, z izjemo drugih inhalacijskih kortikosteroidov, dolgodelujočih bronhodilatatorjev in sistemskih kortikosteroidov za kronično uporabo.
Patients with severe lactose intolerance should use this medicine with caution and those with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki s hudo intoleranco za laktozo morajo to zdravilo uporabljati previdno, bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze pa ne smejo jemati tega zdravila.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Odmerek je treba postopno titrirati do najmanjšega odmerka, ki še zagotavlja učinkovit nadzor simptomov bolezni.
The extent of the adrenal impairment may require specialist advice before elective procedures.
Zaradi izrazitosti adrenalne prizadetosti utegne biti pred elektivnimi postopki potreben
A moderate amount of data on pregnant women (between 300 to 1000 pregnancy outcomes) indicates no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate.
Manjše število podatkov o uporabi salmeterola in flutikazonpropionata pri nosečnicah (med 300 in 1.000 izpostavljenih nosečnosti) ne kaže na njuno malformacijsko ali feto/neonatalno toksičnost.
You may also have dizziness, a headache, muscle weakness and aching joints.
Morda boste imeli tudi omotico, glavobol, šibkost mišic in boleče sklepe.
The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE) , and polypropylene (PP).
Deli inhalatorja, ki so v stiku z zdravilom/sluznico, so iz akrilonitril butadien stirena (ABS), polietilena (PE) in polipropilena (PP).
• Xanthine medicines such as aminophylline and theophylline.
• Ksantinska zdravila, kot sta aminofilin in teofilin.
Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to
Salmeterol je selektiven, dolgodelujoč (12 ur) agonist adrenergičnih receptorjev β2; ima dolgo stransko verigo, ki se veže na ekso-mesto receptorja.
Side panel: For use in adults 18 years of age and older only.
Stranski del: Samo za uporabo pri odraslih, starih 18 let in več.
Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Za inhalirani flutikazonpropionat informacij o tem medsebojnem delovanju ni, a pričakovati je mogoče izrazito povečanje koncentracije flutikazonpropionata v plazmi.
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.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Aerivio Spiromax, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The data presented below refer to a lower dose of the fixed-dose combination containing these two actives, a dose and strength which is not available for Aerivio Spiromax.
Podatki, predstavljeni v nadaljevanju, se nanašajo na manjši odmerek fiksne kombinacije odmerka, ki vsebuje ti dve zdravilni učinkovini; odmerek in jakost, v kateri zdravilo Aerivio Spiromax ni na voljo.
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
Če se pri bolniku pojavijo simptomi, kot so zamegljen vid ali druge motnje vida, ga je potrebno upoštevati za napotitev k oftalmologu zaradi ovrednotenja možnih vzrokov, ki lahko vključujejo katarakto, glavkom ali redke bolezni, kot je centralna serozna horioretinopatija, o katerih so poročali po sistemski in topični uporabi
• Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually harmless and get
• občutek drhtenja (tremor) in hiter ali nereden srčni utrip (palpitacije) - ti neželeni učinki so običajno neškodljivi in se med nadaljevanjem zdravljenja zmanjšajo;
• A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle
• znižanje ravni kalija v krvi (srčni utrip lahko postane neenakomeren, mišična oslabelost, krči).
There is also an increased risk of systemic undesirable effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5).
Tveganje za sistemske neželene učinke je večje tudi med uporabo kombinacije flutikazonpropionata in drugih močnih zaviralcev CYP3A (glejte poglavje 4.5).
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk
Ni dokončnih kliničnih dokazov, da se stopnja tveganja za pljučnico znotraj skupine inhalacijskih
When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose.
Po stabilizaciji je treba zdravljenje nadaljevati s priporočenim odmerkom inhalacijskega kortikosteroida.
• Do not use this medicine after the expiry date which is stated on the carton and the label of your inhaler after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki inhalatorja, poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index
Med dejavniki tveganja za pljučnico pri bolnikih s KOPB so trenutno kajenje, višja starost, nizek indeks telesne mase (ITM) in huda KOPB.
• Depression or aggression (although these effects are more likely to occur in children when prescribed this combination of drugs but in a lower strength).
• depresija ali agresija (čeprav je bolj verjetno, da se bodo ti učinki pojavili pri otrocih, ki se jim predpiše ta kombinacija zdravil v manjši jakosti);
EXP Use within 3 months of removing from foil wrapping.
EXP Uporabite v 3 mesecih od odstranitve ovoja iz folije.
If you forget to use Aerivio Spiromax Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Aerivio Spiromax Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway.
Paradoksni bronhospazem se odziva na hitrodelujoči bronhodilatator in ga je treba zdraviti takoj.
Keep the mouthpiece closed all the time unless you are about to use your inhaler.
Ustnik naj bo vedno zaprt, razen če nameravate inhalator uporabiti.
• Bruising and fractures.
• modrice in zlomi;
• Behavioural changes, such as being unusually active and irritable (although these effects occur mainly in children when prescribed this combination of drugs but in a lower strength).
• vedenjske spremembe, kot je neobičajna aktivnost in razdražljivost (čeprav se ti učinki običajno pojavijo pri otrocih, ki se jim predpiše ta kombinacija zdravil v manjši jakosti);
Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Pogostnost motnje srčnega ritma (vključno s supraventrikularno tahikardijo in ekstrasistolami)
All patients
Posebne skupine bolnikov
Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Ogroženi so lahko tudi bolniki, ki so v preteklosti potrebovali velike odmerke nujnega zdravljenja s kortikosteroidi.
Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators.
Pred uvajanjem so osebe prenehale uporabljati prejšnja zdravila proti KOPB, razen kratkodelujočih bronhodilatatorjev.
It should not be used for the treatment of patients with mild or moderate asthma or for the initiation of treatment for patients with severe asthma unless the requirement for such a high dose of the corticosteroid together with a long-acting β2 agonist has been established previously.
Ne sme se ga uporabljati za zdravljenje bolnikov z blago ali zmerno astmo ali za uvedbo zdravljenja pri bolnikih s hudo astmo, razen če je bilo predhodno ugotovljeno, da je tako velik odmerek kortikosteroida skupaj z
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Aerivio Spiromax.
Bolnikom je treba naročiti, naj z zdravljenjem nadaljujejo, vendar naj se posvetujejo z zdravnikom, če simptomi astme niso pod nadzorom ali če se po uvedbi zdravila Aerivio Spiromax poslabšajo.
For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by
Tudi pri bolnikih s KOPB je opustitev zdravljenja lahko povezana s simptomatsko dekompenzacijo in mora zato potekati pod zdravniškim nadzorom.
A double blind, randomised, parallel group study in 318 patients with persistent asthma aged ≥18 years evaluated the safety and tolerability of administering two inhalations twice daily (double dose) of salmeterol/fluticasone propionate for two weeks.
V dvojno slepi, randomizirani študiji z vzporednimi skupinami pri 318 bolnikih s perzistentno astmo, starih ≥ 18 let, so ocenili varnost in prenašanje pri dvotedenskem dajanju dveh inhalacij (dvojni odmerek) salmeterola/flutikazonpropionata dvakrat na dan.
The mean PIFR achieved by patients with asthma or COPD with optimal training (i.e. forceful inhalation) was over 60 L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Povprečni PIFR, ki so ga z optimalnim usposabljanjem (tj. silovit vdih) dosegli bolniki z astmo ali KOPB, je bil več kot 60 l/min, kar je hitrost pretoka, s katero oba preučena pripomočka dostavita primerljivo količino zdravila v pljuča.
The trials had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 to standardize COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Preskušanji sta imeli 4-tedensko uvajalno obdobje, v katerem so vse osebe odprto prejemale salmeterol/FP 50/250 mikrogramov za standardiziranje farmakoterapije KOPB in stabiliziranje bolezni pred randomizacijo v 52-tedensko slepo obdobje prejemanja zdravila v okviru študije.
- if you are allergic (hypersensitive) to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Aerivio Spiromax: - če ste alergični (preobčutljivi) na salmeterol, flutikazonpropionat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Pojavi se lahko paradoksni bronhospazem, ki se kaže kot takojšnje povečanje piskajočega dihanja in zasoplosti po uporabi odmerka.
Patients with severe asthma and COPD were shown to be able to generate sufficient inspiratory flow rate when they breathed in forcefully through the Spiromax device to enable the delivery of the required therapeutic dose to the lungs (see also section 5.1 - last five paragraphs)
Bolniki s hudo astmo in KOPB so s silovitim vdihom skozi pripomoček Spiromax dosegli ustrezno hitrost vdišnega toka, kar je omogočilo dostavo potrebnega terapevtskega odmerka v pljuča (glejte tudi poglavje 5.1, zadnjih pet
The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Glavna pot je presnova v neaktivni presnovek karboksilne kisline s pomočjo encima CYP3A4 citokroma P450.
Not for use in children or adolescents under 18 years of age.
Ni za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Before using your Aerivio Spiromax for the first time, you need to prepare it for use as follows:
Pred prvo uporabo zdravila Aerivio Spiromax ga morate na uporabo pripraviti na naslednji način:
In a study in 158 children aged 6 to 16 years with symptomatic asthma, the combination of salmeterol/ fluticasone propionate is as efficacious as doubling the dose of fluticasone propionate in respect of symptom control and lung function.
V študiji na 158 otrocih, starih od 6 do 16 let, s simptomatsko astmo, je v smislu nadzora simptomov in pljučne funkcije kombinacija salmeterola/flutikazonpropionata enako učinkovita kot podvojitev odmerka flutikazonpropionata.
Use your fast acting ‘reliever' inhaler to help your breathing and tell your doctor straight away.
Uporabite hitrodelujoče "olajševalno" zdravilo, ki vam pomaga dihati, in o tem takoj obvestite
The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Podatki iz študije kažejo, da so lahko otroci, mladostniki in odrasli z astmo ter bolniki s KOPB, ne glede na starost in resnost osnovne bolezni, skozi pripomoček Spiromax dosegli inspiratorne hitrosti pretoka podobne tistim z večodmernimi inhalacijskimi pripomočki za suhi prašek, ki so na trgu.
If you accidentally take more doses than is recommended, talk to your doctor or pharmacist.
Če po nezgodi uporabite več odmerkov, kot je priporočeno, se posvetujte z zdravnikom ali farmacevtom.
The use of Aerivio Spiromax follows three simple steps: open, breathe and close which are outlined below.
Zdravilo Aerivio Spiromax se uporablja v treh preprostih korakih: odprite, vdihnite in zaprite, kot je
The studies described were carried out with a previously authorised product available in three different strengths; the studies were not carried out with
Opisane študije so bile izvedene s predhodno odobrenim zdravilom, ki je bilo na voljo v treh različnih jakostih; študije niso bile izvedene z zdravilom Aerivio Spiromax.
Each Aerivio Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow
En inhalator zdravila Aerivio Spiromax vsebuje 60 inhalacij in ima belo telo s polprozornim rumenim
There were no differences in safety parameters between the two treatment arms.
Med obema zdravljenima skupinama glede varnostnih parametrov ni bilo razlik.
There were no differences between the two treatment arms.
Med obema zdravljenima skupinama ni bilo razlik.
- The other ingredient is lactose monohydrate (see section 2 under ‘Aerivio Spiromax contains lactose').
- Druga sestavina zdravila je laktoza monohidrat (glejte poglavje 2 "Zdravilo Aerivio Spiromax
Aerivio Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Zdravilo Aerivio Spiromax ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 4.2).
• Beta blockers (such as atenolol, propranolol and sotalol).
• Antagonisti adrenergičnih receptorjev beta (na primer atenolol, propranolol, sotalol).
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).
Možni neželeni učinki v tej starostni skupini vključujejo Cushingov sindrom, cushingoididne značilnosti, zavrtje nadledvičnih žlez in upočasnitev rasti pri otrocih in mladostnikih (glejte poglavje 4.4).
If a patient with severe COPD has experienced pneumonia, treatment with Aerivio Spiromax should be re-evaluated.
Če je bolnik s hudo obliko KOPB zbolel za pljučnico, je treba zdravljenje z zdravilom Aerivio Spiromax ponovno oceniti.
If this happens stop using your Aerivio Spiromax inhaler.
Če se to zgodi, prenehajte uporabljati inhalator z zdravilom Aerivio Spiromax.
Just take your next dose at the usual time.
Naslednji odmerek uporabite ob
What Aerivio Spiromax is and what it is used for
Kaj je zdravilo Aerivio Spiromax in za kaj ga uporabljamo
What Aerivio Spiromax looks like and contents of the pack Aerivio Spiromax is an inhalation powder.
Izgled zdravila Aerivio Spiromax in vsebina pakiranja Zdravilo Aerivio Spiromax je prašek za inhaliranje.
Subjects were randomised 1:1 to salmeterol/FP 50/250 (total ITT n=776) or salmeterol (total ITT n=778).
Osebe so bile randomizirane v razmerju 1 : 1 v skupino s salmeterolom/FP 50/250 mikrogramov (celotna skupina z namenom zdravljenja (ITT, intent-to-treat) n = 776) ali s salmeterolom (celotna skupina ITT n = 778).
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.
Bolniki naj zdravljenje začnejo s fiksno kombinacijo odmerka, ki vsebuje manjši odmerek sestavine kortikosteroida, nato pa se odmerek kortikosteroida povečuje, dokler ni dosežen nadzor nad astmo.
As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
Bolniku je zato treba svetovati, da natančno prebere navodilo za uporabo zdravila in upošteva navedena navodila za uporabo inhalatorja.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
Višino otrok, ki se dlje časa zdravijo z inhalacijskimi kortikosteroidi, je priporočljivo redno spremljati.
The remainder of the inhaled dose of fluticasone propionate may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and presystemic metabolism, resulting in oral availability of less than 1%.
Preostanek vdihanega odmerka bolnik sicer lahko pogoltne, vendar to zaradi majhne vodotopnosti in zaradi predsistemske presnove le minimalno pripomore k sistemski izpostavljenosti, tako da je peroralna uporabnost manj kot 1 %.
Remove the Spiromax device from the mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Pripomoček Spiromax odstranite iz ust in zadržite dih 10 sekund ali
Aerivio Spiromax is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time.
Zdravilo Aerivio Spiromax ni primerno za zdravljenje astme, če je fiksna kombinacija odmerka salmeterola in flutikazonpropionata potrebna prvič.
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.
Ko je dosežen nadzor nad astmo, je treba bolnike redno pregledovati in zmanjševati odmerek inhalacijskega kortikosteroida, kot je ustrezno za ohranjanje nadzora nad boleznijo.
In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
S študijami toksičnega vpliva na sposobnost razmnoževanja pri živalih je bilo dokazano, da lahko kortikosteroidi povzročijo pojav malformacij (razcepljeno nebo, malformacije skeleta).
The excipient lactose may contain small amounts of milk proteins which may cause allergic reactions in those with severe hypersensitivity or allergy
Pomožna snov laktoza lahko vsebuje majhne količine mlečnih beljakovin, ki lahko povzročijo alergijske reakcije pri bolnikih s hudo preobčutljivostjo ali alergijo na mlečne beljakovine.
Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:
Zdravilo Aerivio Spiromax je indicirano za redno zdravljenje bolnikov s hudo astmo, pri katerih je primerna uporaba kombiniranega zdravila (inhalacijskega kortikosteroida in dolgodelujočega agonista
There are no data available from clinical trials on overdose with Aerivio Spiromax, however data on overdose with both active substances are given below:
Podatkov o prevelikem odmerjanju zdravila Aerivio Spiromax iz kliničnih preskušanj ni; podatki o prevelikem odmerjanju z obema zdravilnima učinkovinama so navedeni spodaj:
Studies have shown that salmeterol and fluticasone propionate and their metabolites, are excreted into the
Študije so pokazale, da se salmeterol in flutikazonpropionat ter njuni presnovki izločajo v mleko pri