FrancophonIA/ELRC3.0 huggingface dataset:
English: All randomised patients who took at least one dose of double-blind study medication during the short-term double-blind period.
Croatian: Svi randomizirani ispitanici koji su tijekom kratkoročnog dvostruko slijepog razdoblja uzeli barem jednu dozu ispitivanog lijeka u dvostruko slijepom ispitivanju Srednja vrijednost najmanjih kvadrata prilagođena za početnu vrijednost p-vrijednost < 0,0001 naspram placeba Nije procijenjena statistička značajnost zbog postupka sekvencijalnog testiranja za sekundarne mjere ishoda
English: Furthermore, two 12-week, placebo-controlled studies were conducted in patients with inadequately controlled type 2 diabetes and hypertension.
Croatian: Osamdeset i jedan posto (81%) ispitanika imalo je indeks tjelesne mase (ITM)  27. Nadalje, dva 12-tjedna, placebom kontrolirana ispitivanja su provedena kod bolesnika s nedovoljno dobro reguliranom šećernom bolešću tipa 2 i hipertenzijom.
English: Change from baseline Difference from placebo 95% CI
Croatian: Promjena od početne vrijednosti Razlika u odnosu na placebo b
English: Gastrointestinal disorders
Croatian: Laboratorijske pretrage mokraće
English: Date of first authorisation: 19th November 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 19. studeni 2014.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek usklađeni su s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim naknadnim izmjenama objavljenim na europskom internetskom portalu za lijekove.
English: • It is important to use Vylaer Spiromax every day, even if you have no asthma or COPD symptoms at the time.
Croatian: • Bitno je primjenjivati Vylaer Spiromax svakodnevno, čak i ako trenutno nemate simptome astme ili KOPB-a.
English: Vylaer Spiromax should be used correctly in order to achieve effective treatment.
Croatian: Vylaer Spiromax se mora koristiti pravilno kako bi se postiglo učinkovito liječenje.
English: The use of Vylaer Spiromax follows three simple steps: open, breathe and close which are outlined below.
Croatian: Uporaba lijeka Vylaer Spiromax slijedi tri jednostavna koraka: otvorite, udahnite i zatvorite kako je navedeno u nastavku.
English: • If you are using Vylaer Spiromax for asthma, your doctor will want to regularly check your symptoms.
Croatian: • Ako primjenjujete Vylaer Spiromax za astmu, Vaš liječnik će tražiti redovitu kontrolu vaših simptoma.
English: What Vylaer Spiromax is and what it is used for
Croatian: Što je Vylaer Spiromax i za što se koristi
English: Contents of the pack and other information What Vylaer Spiromax contains
Croatian: Sadržaj pakiranja i druge informacije Što Vylaer Spiromax sadrži
English: Vylaer Spiromax can also be used to treat the symptoms of severe COPD in adults.
Croatian: Vylaer Spiromax također se može koristiti za liječenje simptoma teškog KOPB-a u odraslih.
English: The dosage of Vylaer Spiromax is individual and should be adjusted to the severity of the disease.
Croatian: Doziranje lijeka Vylaer Spiromax je individualno i mora se prilagoditi težini bolesti.
English: A separate rapidacting bronchodilator should be considered for such prophylactic use .
Croatian: Mora se razmotriti korištenje zasebnog brzodjelujućeg bronhodilatatora kod takve profilaktičke uporabe.
English: Talk to your doctor, pharmacist or nurse before taking Vylaer Spiromax if
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Vylaer Spiromax ako:
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Croatian: Norton (Waterford) Limited T/A Teva Pharmaceuticals Irska Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska Teva Operations Sp. z o.o., Ul.
English: The most common symptoms that may occur after if you use more Vylaer Spiromax than you should are trembling, headache or a rapid heartbeat.
Croatian: Najčešći simptomi koji se mogu pojaviti, ako koristite veću količinu lijeka Vylaer Spiromax nego biste trebali, su drhtanje, glavobolja ili brzi otkucaji srca.
English: The prophylactic use of Vylaer Spiromax , e.g. before exercise, has not been studied.
Croatian: Profilaktična uporaba lijeka Vylaer Spiromax, npr. prije vježbanja, nije ispitana.
English: Vylaer Spiromax is an inhalation powder.
Croatian: Vylaer Spiromax je prašak inhalata.
English: What Vylaer Spiromax looks like and contents of the pack
Croatian: Kako Vylaer Spiromax izgleda i sadržaj pakiranja
English: Vylaer Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Croatian: Vylaer Spiromax sadrži dvije različite djelatne tvari: budezonid i formoterolfumarat dihidrat.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Vylaer Spiromax contains lactose')
Croatian: - Drugi sastojak je laktoza hidrat (pogledajte dio 2 pod „Vylaer Spiromax sadrži laktozu”)
English: Packs of 1 and 3 inhalers.
Croatian: Pakiranja s 1 i 3 inhalatora.
English: What you need to know before you use Vylaer Spiromax Do not use Vylaer Spiromax if:
Croatian: Što morate znati prije nego počnete primjenjivati Vylaer Spiromax Nemojte primjenjivati Vylaer Spiromax ako:
English: Do not use Vylaer Spiromax to treat these asthma symptoms.
Croatian: Nemojte koristiti Vylaer Spiromax za liječenje tih simptoma astme.
English: Vylaer Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Croatian: Vylaer Spiromax sadrži formoterol i budezonid koji imaju različite mehanizme djelovanja i pokazuju aditivne učinke u smislu smanjenja egzacerbacija astme.
English: If patients find the treatment ineffective, or exceed the highest recommended dose of Vylaer Spiromax , medical attention must be sought (see section 4.2).
Croatian: Ako bolesnici smatraju liječenje neučinkovitim ili prekorače najvišu preporučenu dozu lijeka Vylaer Spiromax, moraju zatražiti liječničku pomoć (vidjeti dio 4.2).
English: If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Vylaer Spiromax.
Croatian: Ako ste uzimali tablete steroida za astmu ili KOPB, Vaš liječnik može smanjiti broj tableta koje uzimate nakon što počnete koristiti Vylaer Spiromax.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking Vylaer Spiromax - do NOT use this medicine unless your doctor tells you to.
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete Vylaer SpiromaxNEMOJTE koristiti ovaj lijek ako Vam to ne odredi vaš liječnik.
English: Vylaer Spiromax is not intended for the initial management of asthma.
Croatian: Vylaer Spiromax nije namijenjen za početno zbrinjavanje astme.
English: Vylaer Spiromax has no or negligible influence on the ability to drive and use machines.
Croatian: Vylaer Spiromax ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If these effects occur, they are usually mild and usually disappear as you continue to use Vylaer Spiromax.
Croatian: Ako se ti učinci pojave, obično su blagi i nestanu kad nastavite s primjenom lijeka Vylaer Spiromax.
English: Vylaer Spiromax is not likely to affect your ability to drive or to use tools or machines.
Croatian: Vylaer Spiromax vjerojatno neće utjecati na Vašu sposobnost upravljanja vozilima, alatima ili strojevima.
English: If you use more Vylaer Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
Croatian: Ako primijenite više lijeka Vylaer Spiromax nego što biste trebali, obratite se za savjet svojem liječniku, ljekarniku ili medicinskoj sestri.
English: Before using your Vylaer Spiromax for the first time, you need to prepare it for use as follows:
Croatian: Prije prve primjene inhalatora Vylaer Spiromax, trebate ga pripremiti za primjenu na sljedeći način:
English: Mild irritation in the throat, coughing, hoarseness Bronchospasm
Croatian: Blaga iritacija grla, kašalj, promuklost Bronhospazam
English: If Vylaer Spiromax therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
Croatian: Ako se terapiju lijekom Vylaer Spiromax mora prekinuti zbog predoziranja komponentom formoterola u lijeku, mora se razmotriti primjena odgovarajuće terapije inhalacijskim kortikosteroidom.
English: Patients should be reminded to take their Vylaer Spiromax maintenance dose as prescribed, even when asymptomatic.
Croatian: Bolesnike se mora podsjetiti da svoju dozu održavanja lijekom Vylaer Spiromax uzimaju kao što je propisano, čak i kad nemaju simptoma.
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Croatian: Dijelovi inhalera kod kojih dolazi do dodira lijeka sa sluznicom napravljeni su od akrilonitril butadien stirena (ABS), polietilena (PE) i polipropilena (PP).
English: Vylaer Spiromax contains lactose
Croatian: Vylaer Spiromax sadrži laktozu
English: The effects include: - changes in bone mineral density (thinning of the bones) - cataract (clouding of the lens in the eye) - glaucoma (increased pressure in the eye) - a slowing of the rate of growth of children and adolescents - an effect on the adrenal gland (a small gland next to the kidney)
Croatian: Ti učinci uključuju: - promjene mineralne gustoće kostiju (stanjivanje kostiju) - očnu mrenu (zamućenje očne leće) - glaukom (povišen očni tlak) - usporavanje brzine rasta u djece i adolescenata - učinak na nadbubrežnu žlijezdu (malu žlijezdu smještenu neposredno pokraj bubrega).
English: In pharmacokinetic studies with and without a charcoal blockage, Vylaer Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Croatian: U farmakokinetičkim ispitivanjima sa i bez blokade aktivnim ugljenom, Vylaer Spiromax procijenjen je usporedbom sa drugim odobrenim inhalacijskim lijekom koji sadrži kombinaciju fiksne doze istih djelatnih tvari, budezonida i formoterola, te se pokazalo kako je jednak i u smislu sistemske izloženosti (sigurnost) i odlaganja u plućima (učinkovitost).
English: You should speak to your doctor if you are concerned as to whether you should continue to use Vylaer Spiromax.
Croatian: Trebate razgovarati sa svojim liječnikom ako Vas brine trebate li nastaviti s uzimanjem inhalatora Vylaer Spiromax.
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using Vylaer Spiromax due to the lactose excipient.
Croatian: Bolesnicima se također mora savjetovati da nakon inhalacije isperu usta vodom (vidjeti dio 4.4) Bolesnik kod primjene lijeka Vylaer Spiromax može osjetiti okus zbog pomoćne tvari, laktoze.
English: In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively).
Croatian: U trogodišnjem kliničkom ispitivanju budezonida u liječenju KOPB-a, stvaranje modrica na koži i pneumonija pojavljivali su se s učestalošću od 10%, odnosno 6% u usporedbi s placebo skupinom gdje su se javljale s učestalošću od 4%, odnosno 3% (p< 0,001 odnosno p< 0,01).
English: Pack sizes of 1 or 3 inhalers.
Croatian: Pakiranja sadrže 1 ili 3 inhalatora.
English: Vylaer Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Croatian: Vylaer Spiromax od 320 mikrograma/9 mikrograma treba koristiti samo kao terapiju održavanja.
English: Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia is increased.
Croatian: Poseban se oprez preporučuje u nestabilnoj astmi gdje varira uporaba bronhodilatatora za hitno simptomatsko liječenje u akutnoj teškoj astmi jer postojeći rizik može povećati hipoksija i u drugim stanjima kad je veća vjerojatnost nastanka hipokalemije.
English: If your doctor feels that you need a lower dose than is available from your Vylaer Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your Vylaer Spiromax but with a lower dose of the corticosteroid.
Croatian: Ako Vaš liječnik smatra da trebate nižu dozu od one koja je dostupna iz Vašeg inhalatora Vylaer Spiromax, liječnik Vam može propisati zamjenski inhalator koji sadrži iste djelatne tvari kao Vaš Vylaer Spiromax, no s nižom dozom kortikosteroida.
English: Tell your doctor if you have any of the following while taking Vylaer Spiromax they could be symptoms of a lung infection:
Croatian: Obavijestite svog liječnika ako se pri primjeni lijeka Vylaer Spiromax pojavi bilo koja od sljedećih nuspojava - može se raditi o simptomima infekcije pluća:
English: Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of 80 micrograms /4.5 micrograms/inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
Croatian: Provedena su dva pedijatrijska ispitivanja u trajanju od 12 tjedana u kojima je 265 djece u dobi od 6 do 11 godina bilo liječeno dozom održavanja budezonida/formoterola (2 inhalacije od 80 mikrograma/4,5 mikrograma po inhalaciji dva puta dnevno) i kratkodjelujućim ß2 adrenoreceptorskim agonistom po potrebi.
English: Vylaer Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Croatian: Vylaer Spiromax se mora trenutno prekinuti, bolesnika se mora procijeniti , te po potrebi, treba mu uvesti drugu terapiju (vidjeti dio 4.4).
English: Teva Operations Poland Sp. z o.o.
Croatian: Teva Operations Poland Sp. z.o.o. Ul. Mogilska 80
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Vylaer Spiromax .
Croatian: Bolesnike treba savjetovati da nastave liječenje, ali da zatraže savjet liječnika ako simptomi astme ostanu nekontrolirani ili se pogoršaju nakon početka primjene lijeka Vylaer Spiromax.
English: If you use more Vylaer Spiromax than you should
Croatian: Ako primijenite više lijeka Vylaer Spiromax nego što biste trebali
English: Since Vylaer Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Croatian: Budući da Vylaer Spiromax sadrži i budezonid i formoterol, može se pojaviti isti obrazac nuspojava koji je primijećen za te dvije tvari.
English: Candida infections in the oropharynx, pneumonia (in COPD patients)
Croatian: Kandidijaza orofarinksa, Pneumonija (u bolesnika s KOPB-om)
English: 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 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.
Croatian: Podaci iz ispitivanja upućuju da neovisno o dobi i težini postojeće bolesti, djeca, adolescenti i odrasli s astmom kao i bolesnici s KOPB-om su mogli postići brzine inspiratornog protoka kroz inhalator Spiromax
English: Each Vylaer Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Croatian: Svaki inhalator Vylaer Spiromax sadrži 120 inhalacija i ima bijelo tijelo s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
English: When used for asthma, your doctor will prescribe Vylaer Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Croatian: Kada se koristi za astmu, liječnik će Vam propisati Vylaer Spiromax zajedno sa zasebnim „inhalatorom za brzo ublažavanje simptoma“ poput salbutamola.
English: Each Vylaer Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Croatian: Svaki inhalator Vylaer Spiromax sadrži 60 inhalacija i ima bijelo tijelo s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
English: A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPDaged >50 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).
Croatian: Randomizirano, otvoreno ispitivanje s placebom provedeno je na djeci i adolescentima s astmom (u dobi od 6-17 godina), odraslima s astmom (u dobi od 18- 45 godina), odraslima s kroničnom opstruktivnom plućnom bolesti (KOPB - u dobi > 50 godina) i zdravim dobrovoljcima (u dobi od 1845 godina) za procjenu brzine vršnog inspiratornog protoka (eng. peak inspiratory flow rate, PIFR) i drugih povezanih inhalacijskih parametara nakon inhalacije iz inhalatora Spiromax (koji sadrži placebo), u usporedbi s inhalacijom iz već na tržištu dostupnog inhalatora s više doza suhog praška (koji sadrži placebo).
English: Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Croatian: Vylaer Spiromax je indiciran u redovitom liječenju astme kad je primjereno kombinirano liječenje (inhalacijskim kortikosteroidom i dugodjelujućim agonistima ß2-adrenergičkih receptora):
English: Other medicines and Vylaer Spiromax
Croatian: Drugi lijekovi i Vylaer Spiromax
English: 3 inhalers each containing 60 doses.
Croatian: 3 inhalatora, svaki sadrži 60 doza.
English: Vylaer Spiromax is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Croatian: Vylaer Spiromax nije indiciran u djece i adolescenata u dobi manjoj od 18 godina starosti (vidjeti dio
English: To treat your asthma your doctor will prescribe two asthma inhalers: Vylaer Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Croatian: Za liječenje astme liječnik će Vam propisati dva inhalatora za astmu: Vylaer Spiromax i zasebni „inhalator za brzo ublažavanje simptoma” poput salbutamola.
English: Vylaer Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Croatian: Vylaer Spiromax nije odgovarajuće liječenje za odraslog bolesnika koji ima samo blagi oblik astme i koji nije zadovoljavajuće kontroliran inhalacijskim kortikosteroidom i ″prema potrebi″ inhalacijskim ß2-adrenoreceptorskim agonistima kratkog djelovanja.
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with Vylaer Spiromax .
Croatian: Ozbiljne nuspojave povezane s astmom i egzacerbacije mogu se pojaviti tijekom liječenja lijekom Vylaer Spiromax.
English: If the patient experiences paradoxical bronchopasm Vylaer Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Croatian: Ako bolesnik osjeti paradoksalni bronhospazam, Vylaer Spiromax se mora trenutno prekinuti, bolesnika se mora pregledati,te po potrebi, treba uvesti zamjensku terapiju.
English: Inhalation powder
Croatian: Prašak inhalata
English: • Use Vylaer Spiromax every day.
Croatian: • Svakodnevno koristite Vylaer Spiromax.
English: • If you get pregnant while using Vylaer Spiromax, do NOT stop using Vylaer Spiromax but talk to your doctor immediately.
Croatian: • Ako zatrudnite tijekom uzimanja lijeka Vylaer Spiromax, NEMOJTE prestati s primjenom lijeka Vylaer Spiromax, ali se odmah javite svojem liječniku.
English: Vylaer Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Croatian: Vylaer Spiromax uzima se kao redovita terapija održavanja s posebnim inhalatorom koji sadrži brzodjelujući bronhodilatator za hitno simptomatsko liječenje.
English: Patients should not be initiated on Vylaer Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Croatian: Bolesnici ne smiju započinjati liječenje lijekom Vylaer Spiromax tijekom egzacerbacije, niti tijekom značajnog ili akutnog pogoršanja astme.
English: Swensweg 5, 2031GA Haarlem The Netherlands
Croatian: Swensweg 5, 2031GA Haarlem Nizozemska
English: Do not use Vylaer Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Croatian: Nemojte koristiti Vylaer Spiromax 320/9 mikrograma kao „inhalator za brzo ublažavanje simptoma“.
English: The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations.
Croatian: Najčešće nuspojave su farmakološki predvidive nuspojave terapije ß2adrenoreceptorskim agonistima, kao što su tremor i palpitacije.
English: If any of the following happen to you, stop using Vylaer Spiromax and talk to your doctor immediately:
Croatian: Ako vam se dogodi išta od navedenog, prekinite s primjenom lijeka Vylaer Spiromax i odmah se javite liječniku:
English: Do not use Vylaer Spiromax just before exercise to stop asthma symptoms from occurring, use your separate ‘reliever inhaler'.
Croatian: Nemojte primjenjivati Vylaer Spiromax neposredno prije tjelovježbe kako biste spriječili pojavu simptoma astme, primijenite zasebni „inhalator za brzo ublažavanje simptoma”.
English: 3 inhalers each containing 120 doses.
Croatian: 3 inhalatora, svaki sadrži 120 doza.
English: Use your Vylaer Spiromax every day.
Croatian: Svakodnevno koristite Vylaer Spiromax.
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Vylaer Spiromax.
Croatian: Kad su simptomi astme dobro kontrolirani, Vaš liječnik će možda smatrati da je prikladno postupno smanjivati dozu lijeka Vylaer Spiromax.
English: If you feel you are getting breathless or wheezy while using Vylaer Spiromax, you should continue to use Vylaer Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.
Croatian: Ako osjećate da Vam nedostaje zraka ili da Vam zviždi u plućima tijekom primjene inhalatora Vylaer Spiromax, trebate nastaviti s primjenom inhalatora Vylaer Spiromax, no ipak se što prije javite svojem liječniku jer će Vam možda biti potrebno dodatno liječenje.
English: Preparing your new Vylaer Spiromax
Croatian: Priprema Vašeg novog inhalatora Vylaer Spiromax
English: If you stop using Vylaer Spiromax
Croatian: Ako prestanete primjenjivati Vylaer Spiromax
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Croatian: Agresivnost, psihomotorna hiperaktivnost, anksioznost, poremećaji spavanja Depresija, promjene ponašanja (uglavnom u djece)