natgillin/translations-raw huggingface dataset:
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).
Salmeterol Multi-Center Asthma Research Trial - SMART) pokazali su da su afroamerički bolesnici bili pod povećanim rizikom od ozbiljnih događaja vezanih uz dišni sustav ili smrti kada su primjenjivali salmeterol u usporedbi s placebom (vidjeti dio 5.1).
If you have been told by your doctor that you have an intolerance or allergy to lactose, other sugars, or milk, contact your doctor before taking this medicinal product.
Ako Vam je liječnik rekao da ne podnosite ili ste alergični na laktozu, druge šećere ili mlijeko, savjetujte se s liječnikom prije uzimanja ovog lijeka.
The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE) , and polypropylene (PP).
Dijelovi inhalatora koji dolaze u dodir s lijekom/sluznicama izrađeni su od akrilonitril butadien stirena (ABS), polietilena (PE) i polipropilena (PP).
Concomitant use of other β adrenergic-containing medicinal products can have a potentially additive effect.
Istodobna primjena drugih lijekova koji sadrže β adrenergičke blokatore može imati potencijalno aditivni
Patients should be given a strength of salmeterol/fluticasone propionate inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease.
Bolesnicima treba dati onu jačinu salmeterol/flutikazonpropionat inhalatora koja sadrži odgovarajuću dozu flutikazonpropionata s obzirom na težinu njihove bolesti.
• Uneven or irregular heart beat or an extra heart beat (arrhythmias).
• neujednačeni otkucaji ili nepravilni otkucaji srca ili dodatni otkucaji srca (aritmija).
Chronic Obstructive Pulmonary Disease (COPD)
Kronična opstruktivna plućna bolest (KOPB)
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
Ako bolesnik ima simptome kao što su zamućen vid ili neke druge poremećaje vida, treba razmotriti potrebu da ga se uputi oftalmologu radi procjene mogućih uzroka, koji mogu uključivati kataraktu, glaukom ili rijetke bolesti kao što je centralna serozna korioretinopatija (CSCR) koja je zabilježena nakon sustavne i topikalne uporabe
Close: Breathe out gently and close the mouthpiece cover.
Zatvaranje: Polako izdahnite i zatvorite poklopcem nastavak za usta.
What Aerivio Spiromax looks like and contents of the pack Aerivio Spiromax is an inhalation powder.
Kako Aerivio Spiromax izgleda i sadržaj pakiranja Aerivio Spiromax je prašak inhalata.
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Teva Operations Poland Sp. z.o.o.
INHALER
INHALATOR
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.
Ograničeni podaci u trudnica (između 300-1000 trudnoća) ukazuju da salmeterol i flutikazonpropionat ne uzrokuju malformacije ili da nemaju feto/neonatalni toksični učinak.
The percentage of patients who died within 3 years due to COPD-related causes was 6.0% for placebo, 6.1% for salmeterol, 6.9% for FP and 4.7% for salmeterol/fluticasone propionate.
Postotak bolesnika koji su umrli unutar 3 godine od uzroka povezanih s KOPB-om iznosio je 6,0% za placebo, 6,1% za salmeterol, 6,9% za FP i 4,7% za salmeterol/flutikazonpropionat.
Aerivio Spiromax contains two medicines, salmeterol and fluticasone propionate:
Aerivio Spiromax sadrži dva lijeka, salmeterol i flutikazonpropionat:
Aerivio Spiromax is not available on the market at strengths lower than 50/500 microgram.
Aerivio Spiromax nije dostupan na tržištu u dozama manjima od 50/500 mikrograma.
During the study, patients were permitted usual COPD therapy with the exception of other inhaled corticosteroids, long-acting bronchodilators and long-term systemic corticosteroids.
Tijekom ispitivanja, bolesnici su smjeli uzmati uobičajenu terapiju za KOPB izuzimajući druge inhalacijske kortikosteoride, dugodjelujuće bronhodilatatore i dugotrajne terapije sistemskim kortikosteroidima.
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.
U ispitivanju u 158 djece u dobi od 6 do 16 godina sa simptomatskom astmom, kombinacija salmeterola/ flutikazonpropionata jednako je učinkovita s obzirom na kontrolu simptoma i plućnu funkciju kao i udvostručenje doze flutikazonpropionata.
Animal studies have shown reproductive toxicity after administration of β2 adrenoreceptor agonists and glucocorticosteroids (see section
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost nakon primjene agonista β2 adrenoreceptora i glukokortikosteroida (vidjeti dio 5.3).
In addition, if you suddenly stop taking Aerivio Spiromax or reduce your dose of Aerivio Spiromax this may (very rarely) cause you to have problems with your adrenal glands (adrenal insufficiency) which sometimes causes side effects.
Uz to, ako naglo prestanete uzimati Aerivio Spiromax ili smanjite dozu Aerivio Spiromaxa, to može (vrlo rijetko) prouzročiti probleme s nadbubrežnim žlijezdama (insuficijenciju nadbubrežnih žlijezda), što ponekad
You may notice a taste when you take your inhalation.
Možete osjetiti nekakav okus nakon udaha.
• Use within 3 months of removing from the foil wrapping.
• Upotrijebiti unutar 3 mjeseca od uklanjanja omota od folije.
Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.
Flutikazonpropionat koji se daje inhalacijom u preporučenim dozama ima glukokortikoidno protuupalno djelovanje unutar pluća, što dovodi do smanjenja simptoma i egzacerbacija astme, uz manje nuspojava nego kad se kortikosteroidi primjenjuju sistemski.
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Place the mouthpiece between your teeth.
4. Postavite nastavak za usta između zubiju.
Patients may notice a taste when using Aerivio Spiromax due to the lactose excipient.
Bolesnici mogu osjetiti nekakav okus nakon uporabe Aerivio Spiromaxa, zbog pomoćne tvari laktoze.
Subjects were randomised 1:1 to salmeterol/FP 50/250 (total ITT n=776) or salmeterol (total ITT n=778).
Ispitanici su bili randomizirani u omjeru 1:1 u skupine koje su primale salmeterol/FP 50/250 (ukupni ITT n=776) ili salmeterol (ukupni ITT n=778).
Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
Dugotrajno liječenje bolesnika visokim dozama inhalacijskih kortikosteroida može dovesti do supresije nadbubrežnih žlijezda i akutne adrenalne krize.
Key findings from SMART by inhaled steroid use at baseline: secondary endpoints Number of secondary endpoint
Ključni nalazi u ispitivanju SMART prema primjeni inhalacijskog steroida na početku: sekundarni ishodi Broj događaja sekundarnog ishoda/ broj
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.
Dvostruko slijepim, randomiziranim ispitivanjem u usporednim skupinama u 318 bolesnika s perzistentnom astmom u dobi od ≥18 godina procijenjivala se sigurnost i podnošljivost primjene dvije inhalacije dvaput dnevno (dvostruka doza) salmeterola/flutikazonpropionata tijekom dva tjedna.
Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index
Rizični čimbenici za pneumoniju u bolesnika s KOPB-om uključuju aktivno pušenje, stariju dob, niski indeks tjelesne mase (ITM) i teški KOPB.
Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators.
Prije uvodnog razdoblja, ispitanici su prekinuli primjenjivati prethodne lijekove za KOPB osim kratkodjelujućih bronhodilatatora.
There were no differences between the two treatment arms.
Nije bilo razlike između te dvije terapijske skupine.
Afterwards, rinse your mouth with water and spit it out and/or brush your teeth.
Nakon toga isperite usta vodom i ispljunite je i/ili operite zube.
This can increase your risk of side effects with Aerivio Spiromax, including irregular heartbeats, or may make
To može povisiti rizik od nuspojava kod primjene Aerivio Spiromaxa, uključujući nepravilan rad srca, ili pogoršati
• Xanthine medicines such as aminophylline and theophylline.
• ksantinske lijekove, kao što su aminofilin i teofilin.
Your doctor has prescribed this medicine for the treatment of either • Severe asthma, to help prevent attacks of breathlessness and wheeziness,
Liječnik Vam je propisao ovaj lijek za liječenje: • teške astme, gdje pomaže spriječiti napadaje nedostatka zraka i piskanja pri disanju,
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 bilo multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje na usporednim skupinama u trajanju od 28 tjedana u Sjedinjenim Američkim Državama u kojem je randomizirano 13 176 bolesnika na salmeterol (50 mikrograma dvaput dnevno) i 13 179 bolesnika na placebo uz uobičajenu terapiju astme koju su bolesnici uzimali.
You may also have dizziness, a headache, muscle weakness and aching joints.
Također možete osjećati omaglicu, glavobolju, slabost mišića i bol u zglobovima.
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.
Malo povećanje nuspojava povezanih s β-agonistom treba uzeti u obzir ako liječnik razmatra udvostručavanje doze salmeterola/flutikazonpropionata u odraslih bolesnika kojima je potrebna dodatna kratkotrajna (do 14 dana) terapija inhalacijskim kortikosteroidom.
Co-treatment with other potent CYP3A inhibitors, such as itraconazole, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic undesirable effects.
Očekuje se da će i istodobno liječenje drugim jakim inhibitorima CYP3A, kao što je itrakonazol, i umjerenim inhibitorima CYP3A, kao što je eritromicin, povećati sistemsku izloženost flutikazonpropionatu i rizik od sistemskih nuspojava.
The pharmacological effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Zabilježeni su farmakološki učinci liječenja β2-agonistima, kao što su tremor, palpitacije i glavobolja, ali oni su obično prolazni i smanjuju se s redovitom terapijom.
Aerivio Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Aerivio Spiromax nije indiciran za primjenu u djece i adolescenata mlađih od 18 godina (vidjeti dio 4.2).
Key findings from SMART: primary endpoint Patient group
Ključni nalazi u ispitivanju SMART: primarni ishod
There were no differences in safety parameters between the two treatment arms.
Nije bilo razlike u parametrima sigurnosti primjene između te dvije terapijske skupine.
Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
manje često rijetko nepoznato srčane aritmije (uključujući supraventrikularnu tahikardiju i ekstrasistole).
The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
Koristi terapije inhalacijskim flutikazonpropionatom trebale bi svesti potrebu za peroralnim kortikosteroidima na najmanju moguću mjeru, ali bolesnici koji se prebacuju s peroralnih steroida i dalje mogu prilično dugo biti pod rizikom od smanjene adrenalne rezerve.
If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be
Ako imate šećernu bolest, može biti potrebno češće praćenje šećera u krvi i moguće prilagodba
Route of administration: Inhalation use
Put primjene: za primjenu inhalacijom
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).
Stoga treba izbjegavati istodobno liječenje ketokonazolom ili drugim jakim inhibitorima CYP3A4 osim ako su koristi veće od potencijalno povećanog rizika od sistemskih nuspojava liječenja salmeterolom (vidjeti dio 4.5).
Do not breathe through your inhaler.
Nemojte disati kroz inhalator.
There is no incidence of additional adverse events following concurrent administration of the two active substances.
Nema pojave dodatnih nuspojava nakon istovremene primjene te dvije djelatne tvari.
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:
Aerivio Spiromax je indiciran za redovito liječenje bolesnika s teškom astmom kod kojih je primjereno primijeniti kombinirani lijek (inhalacijski kortikosteroid i dugodjelujući β2-agonist):
Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Aerivio Spiromax je indiciran za simptomatsko liječenje bolesnika s KOPB-om, s FEV1 <60% predviđene normale (prije primjene bronhodilatatora) i s ponavljajućim egzacerbacijama u anamnezi, koji imaju značajne simptome unatoč redovitoj terapiji bronhodilatatorom.
Aerivio Spiromax should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.
Aerivio Spiromax treba primjenjivati s oprezom u bolesnika s aktivnom ili latentnom tuberkulozom i gljivičnim, virusnim ili drugim infekcijama dišnih putova.
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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 smije se primjenjivati za liječenje bolesnika s blagom ili umjerenom astmom ili za započinjanje liječenja bolesnika s teškom astmom, osim ako prethodno nije ustanovljeno da je potrebna tako visoka doza kortikosteroida zajedno s
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).
Mogući sistemski učinci u tim dobnim skupinama uključuju Cushingov sindrom, kušingoidni izgled, supresiju nadbubrežnih žlijezda i usporen rast u djece i adolescenata (vidjeti dio 4.4).
• 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).
• promjene u ponašanju, kao što je neobično pojačana aktivnost ili razdražljivost (iako se ovi učinici uglavnom javljaju u djece kad im se propisuje ova kombinacija lijekova premda u nižoj dozi)
The Salmeterol Multi-center Asthma Research Trial (SMART)
Multicentrično kliničko istraživanje salmeterola kod astme (The Salmeterol Multi-center Asthma Research
It is very important that you take your Aerivio Spiromax every day as directed.
Jako je važno da uzimate Aerivio Spiromax svaki dan prema uputama.
*Well controlled asthma was achieved more rapidly with salmeterol/fluticasone propionate than with ICS alone.
*Dobro kontrolirana astma postigla se brže sa salmeterolom/flutikazonpropionatom nego samo inhalacijskim kortikosteroidom.
If your doctor feels that you need a lower dose than is available from your Aerivio Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your Aerivio Spiromax but with a lower dose of the corticosteroid.
Ako liječnik smatra da trebate nižu dozu od one koja je dostupna iz Aerivio Spiromaxa, liječnik Vam može propisati drugi inhalator koji sadrži iste djelatne tvari kao i Aerivio Spiromax ali nižu dozu kortikosteroida.
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.
U analizi populacijske farmakokinetike iz 9 kontroliranih kliničkih ispitivanja u 350 bolesnika s astmom u dobi od 4 do 77 godina (174 bolesnika u dobi od 4 do 11 godina) bila je opažena veća sistemska izloženost flutikazonpropionatu nakon liječenja praškom inhalata salmeterola/flutikazonpropionata 50/100 u usporedbi s praškom inhalata flutikazonpropionata.
Aerivio Spiromax has no or negligible influence on the ability to drive and use machines.
Aerivio Spiromax ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
There is a linear increase in systemic exposure with increasing inhaled dose.
Sistemska izloženost linearno se povećava s povećanjem udahnute doze.
If you are not getting enough medicine into your lungs, it will not help your
Ako ne dobivate dovoljno lijeka u pluća, neće Vam pomoći s astmom ili KOPB-om onako kako bi
- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.
- bolesnici u kojih je bolest već dobro kontrolirana primjenom visokih doza inhalacijskih kortikosteroida i dugodjelujućeg β2-agonista.
Close the mouthpiece cover.
Zatvorite poklopac nastavaka za usta.
Side panel: For use in adults 18 years of age and older only.
Bočna strana: Samo za primjenu u odraslih u dobi od 18 godina i starijih.
• The mouthpiece will still ‘click' even when your inhaler is empty.
• Iz nastavka za usta će se začuti škljocaj čak i kad je inhalator prazan.
In cases of both acute and chronic fluticasone propionate overdose Aerivio Spiromax therapy should be continued at a suitable dose for symptom control.
U slučajevima i akutnog i kroničnog predoziranja flutikazonpropionatom potrebno je nastaviti terapiju Aerivio Spiromaxom u prikladnoj dozi za kontrolu simptoma.
Potentially serious hypokalaemia may result from β2 agonist therapy.
Posljedica terapije β2-agonistima može biti potencijalno ozbiljna hipokalemija.
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.
Srednja vrijednost postignutog PIFR-a u bolesnika s astmom ili KOPB-om koji su bili optimalno podučeni (tj. snažni udah) iznosila je više od 60 l/min, što je brzina protoka pri kojoj se zna da oba ispitivana inhalatora ispostavljaju usporedive količine lijeka u pluća.
• Aching, swollen joints and muscle pain.
• bolni, otečeni zglobovi i bol u mišićima
Consideration should be given to increasing corticosteroid
Potrebno je razmotriti mogućnost pojačanja kortikosteroidne terapije.
If you are breastfeeding, check with your doctor or pharmacist for advice before taking this medicine.
Ako dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
FOIL
FOLIJA
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.
Bolesnici trebaju započeti liječenje fiksnom kombinacijom koja sadrži nižu dozu kortikosteroidne komponente, a zatim im se doza kortikosteroida postupno povećava sve dok se ne postigne kontrola astme.
Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen whilst using
Bolesnicima crnačkog afričkog ili afrokaripskog podrijetla stoga treba savjetovati da nastave s liječenjem, ali da potraže liječnički savjet ako simptomi astme ostanu nekontrolirani ili se pogoršaju dok primjenjuju Aerivio Spiromax.
The primary endpoint was reduction in all-cause mortality at 3 years for salmeterol/fluticasone
Primarni ishod bio je smanjenje smrtnosti svih uzroka nakon 3 godine za salmeterol/flutikazonpropionat naspram placeba.
The marketing authorisation holder shall submit the first periodic safety update report for this product within
Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
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).
Brzina vršnog inspiracijskog protoka kroz inhalator Spiromax Randomizirano, otvoreno ukriženo (engl. cross-over) ispitivanje bilo je provedeno u djece i adolescenata s astmom (u dobi od 4 do 17 godina), odraslih s astmom (u dobi od 18 do 45 godina), odraslih s kroničnom opstruktivnom plućnom bolešću (KOPB) (starijih od 55 godina) i zdravih dobrovoljaca (u dobi od 18 do 45 godina) radi procjene brzine vršnog inspiratornog protoka (PIFR) i drugih povezanih inhalacijskih parametara nakon inhalacije iz inhalatora Spiromax (koji je sadržavao placebo) u usporedbi s inhalacijom iz multidoznog inhalatora sa suhim praškom već dostupnog na tržištu (koji je sadržavao placebo).
Respiratory tract infections
Infekcije dišnih putova
Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a
Povećana potreba za primjenom lijeka za brzo ublažavanje simptoma (kratkodjelujućih bronhodilatatora) ili smanjeni odgovor na lijek za brzo ublažavanje simptoma ukazuju na slabljenje kontrole astme i bolesnike
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
Nakon istovremene primjene, povećana incidencija transpozicije umbilikalne arterije i nepotpune osifikacije okcipitalne kosti pronađena je u štakora pri dozama povezanima s poznatim abnormalnostima koje izazivaju glukokortikoidi.
Keep the mouthpiece cover closed and use within 3 months of removing from foil wrapping.
Poklopac nastavka za usta držati zatvorenim i uporabiti unutar 3 mjeseca nakon uklanjanja omota od folije.