natgillin/translations-raw huggingface dataset:
Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
Ispitivanjima na životinjama također je utvrđen utjecaj prekomjerne prenatalne razine glukokortikosteroida na povećane rizike intrauterinog zastoja u rastu, kardiovaskularne bolesti u odrasloj dobi i trajnih promjena gustoće glukokortikoidnih receptora, pretvorbe neurotransmitera i ponašanje pri izloženosti dozama ispod teratogenog raspona doza.
• Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine).
• lijekove pod nazivom inhibitori monoaminooksidaze (poput fenelzina, furazolidona i prokardazina).
In animal studies glucocorticosteroids have been shown to induce malformations (see section 5.3).
U ispitivanjima na životinjama, pokazalo se da glukokortikosteroidi izazivaju malformacije (vidjeti dio 5.3).
Hypokalaemia
Hipokalemija
During pregnancy, a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should only be used when the benefits outweigh the potential risks.
Za vrijeme trudnoće, terapiju kombinacijom budezonida i formoterolfumarat dihidrata u fiksnoj dozi smije se samo koristiti ako koristi premašuju potencijalne rizike.
Budesonide/Formoterol Teva Pharma B.V. is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Budezonid/Formoterol Teva Pharma B.V. nije indiciran u djece i adolescenata u dobi manjoj od 18 godina starosti (vidjeti dio 4.2).
• Xanthine medicines (such as theophylline or aminophylline).
• ksantinske lijekove (poput teofilina ili aminofilina).
In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations).
U životinjskim reprodukcijskim ispitivanjima pokazalo se da kortikosteroidi poput budezonida izazivaju malformacije (rascjep nepca, malformacije kostura).
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.
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.
The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose 3 mg) on average six-fold.
Potentan inhibitor CYP3A4, ketokonazol, 200 mg jednom dnevno, je povisio plazmatske razine istodobno oralno primijenjenog budezonida (jednokratna doza od 3 mg) za prosječno šest puta.
In animal studies formoterol has caused adverse reactions in reproduction studies at very high systemic exposure levels (see section 5.3).
U reproduktivnim ispitivanjima na životinjama, formoterol je pri vrlo visokim razinama sistemske izloženosti uzrokovao nuspojave (vidjeti dio 5.3).
Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours.
Formoterol ima visok sistemski klirens (oko 1,4 l/min) a poluvrijeme eliminacije prosječno iznosi 17 sati.
If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva Pharma B.V.
Ako se ti učinci pojave, obično su blagi i nestanu kad nastavite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V.
The benefits of inhaled budesonide therapy would normally 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 budezonidom obično bi trebale svesti na najmanju moguću mjeru potrebu za uzimanjem oralnih steroida, ali bolesnici koji prelaze s terapije oralnim steroidima mogu značajnije vrijeme biti izloženi riziku narušene adrenalne rezerve.
Uncommon: may affect up to 1 in 100 people
Manje često: mogu se javiti kod do 1 na 100 osoba
Caution should be observed when treating patients with prolongation of the QTc-interval.
Nužan je oprez u liječenju bolesnika s produljenim QTc-intervalom.
• Fast heartbeat.
• Brzi otkucaji srca.
Budesonide/Formoterol Teva Pharma B.V. is not intended for the initial management of asthma.
Budezonid/Formoterol Teva Pharma B.V. nije namijenjen za početno zbrinjavanje astme.
Open the mouthpiece cover by folding it down until one loud click is heard.
Otvorite poklopac nastavka za usta zakretanjem prema dolje dok se ne začuje glasan škljocaj.
• Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
Vaše disanje ili se noću često budite zbog nedostatka zraka ili zviždanja u plućima.
• Low levels of potassium in your blood.
• Snižene razine kalija u krvi.
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 Budesonide/Formoterol Teva Pharma B.V. due to the lactose excipient.
Bolesnicima se također mora savjetovati da nakon inhalacije isperu usta vodom (vidjeti dio 4.4) Bolesnik kod primjene lijeka Budezonid/Formoterol Teva Pharma B.V. može osjetiti okus zbog pomoćne tvari , laktoze.
Inhalation use.
Za primjenu inhalacijom.
Budesonide/formoterol maintenance therapy
Terapija održavanja budezonidom/formoterolom
A fixed-dose combination of budesonide and formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Kombinaciju fiksne doze budezonida i formoterolfumarat dihidrata mora se primjenjivati s oprezom bolesnicima s tirotoksikozom, feokromocitomom, šećernom bolešću, neliječenom hipokalemijom, hipertrofičnom opstruktivnom kardiomiopatijom, idiopatskom subvalvularnom stenozom aortne, teškom hipertenzijom, aneurizmom ili drugim teškim kardiovaskularnim poremećajima, kao što su ishemijska srčana bolest, tahiaritmije ili teško srčano zatajenje.
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax.
Ne pokušavajte rastavljati inhalator, ukloniti ili zakretati poklopac nastavka za usta, on je pričvršćen za inhalator i ne smije se skidati.
Teva Operations Poland Sp. z o.o.
Teva Operations Sp. z o.o., Ul.
Formoterol is a selective β2 adrenoceptor agonist that when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Formoterol je selektivni β2-adrenoreceptorski agonist koji kad se inhalira uzrokuje brzu i dugotrajnu relaksaciju glatkih mišića bronha u bolesnika s reverzibilnom opstrukcijom dišnih puteva.
It is recommended that serum potassium levels are monitored during these circumstances.
U tim stanjima preporučuje se pratiti razine kalija u serumu.
This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
To pomaže u sprječavanju pojavljivanja simptoma astme poput nedostatka zraka i zviždanja u plućima.
Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.
Potentni inhibitori CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, pozakonazol, klaritromicin, telitromicin, nefazodon i inhibitori HIV proteaze) vjerojatno će značajno povisiti razine budezonida u
An overdose of formoterol would likely lead to effects that are typical for β2 adrenoceptor agonists: tremor, headache, palpitations.
Predoziranje formoterolom vjerojatno bi uzrokovalo učinke tipične za agoniste β2-adrenoreceptora: tremor, glavobolju, palpitacije.
Budesonide/Formoterol Teva Pharma B.V. is not likely to affect your ability to drive or to use tools or machines.
Budezonid/Formoterol Teva Pharma B.V. vjerojatno neće utjecati na Vašu sposobnost upravljanja vozilima, alatima ili strojevima.
If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to a budesonide/formoterol fumarate fixed-dose combination therapy.
Ukoliko postoji ikakav razlog za pretpostavku da je funkcija nadbubrežne žlijezde narušena prethodnom terapijom sistemskim steroidima, mora se obratiti pozornost kod prebacivanja bolesnika na kombiniranu terapiju fiksnom dozom budezonida/formoterolfumarata.
The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma 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.
Podaci iz ispitivanja upućuju da neovisno o dobi i težini postojeće bolesti, djeca, adolescenti i odrasli s astmom su mogli postići brzine inspiratornog protoka kroz inhalator Spiromax slične onima postignutim kroz na tržištu dostupan inhalator koji sadrži više doza suhog praška.
Nervous system disorders Common
Poremećaji živčanog sustava
These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Ti učinci pojavljuju se vrlo rijetko i mnogo je manja vjerojatnost njihove pojave kod uzimanja udahnutih kortikosteroida nego kod uzimanja tableta kortikosteroida.
The exposure of budesonide and formoterol may be increased in patients with liver disease.
Izloženost budezonida i formoterola može se povećati u bolesnika s bolešću jetre.
Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Liječenje agonistima ß2 adrenoreceptora može rezultirati povećanjem razina inzulina, slobodnih masnih kiselina, glicerola i ketonskih tijela u krvi.
• Check the dose indicator to see that there are 60 inhalations in the inhaler.
• provjerite indikator doze kako biste se uvjerili da inhalator sadrži 60 inhalacija.
Taste disturbances
Poremećaji okusa
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE INHALATOR
Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations.
Budezonid je glukokortikosteroid koji inhaliran ima protuupalno djelovanje u dišnim putevima ovisno o dozi, što rezultira ublažavanjem simptoma i smanjenjem egzacerbacija astme.
Only negligible amounts of unchanged budesonide have been detected in the urine.
U mokraći su otkrivene samo zanemarive količine neizmijenjenog budezonida.
• you have problems with your thyroid or adrenal glands.
• imate tegobe sa štitnjačom ili nadbubrežnom žlijezdom.
Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler.
Udahnite: Stavite nastavak za usta između zubi tako da usnama obuhvatite nastavak za usta, nemojte zubima gristi nastavak za usta inhalatora.
To minimise the risk of oropharyngeal candida infection, the patient should be instructed to rinse their mouth out with water after inhaling the dose.
Za smanjenje rizika od orofaringealne kandidijaze, bolesnika se mora uputiti da ispere usta vodom nakon inhaliranja doze.
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60
• Indikator doze upućuje Vas koliko doza (inhalacija) je još preostalo u Vašem inhalatoru, počevši od 60 inhalacija kad je pun.
Adults (18 years and older): 1-2 inhalations twice daily.
Odrasli (s 18 godina i više): 1-2 inhalacije dvaput dnevno.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 doses
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
Nije primijećeno povećanje incidencije nuspojava nakon istodobne primjene ta dva sastojka.
Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Mogilska 80, 31-546 Krakow, Poljska
You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema).
Možda ćete imati simptome poput začepljenog nosa ili curenja iz nosa, slabosti ili bolova u zglobovima ili mišićima i osip (ekcem).
Each inhaler contains 60 doses and is foil-wrapped.
Jedan inhalator sadrži 60 doza i omotan je folijom.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler', then seek medical advice.
Ako se javi zviždanje u plućima ili Vam nedostaje zraka ili se pojave drugi simptomi napadaja astme, primijenite 'inhalator za brzo ublažavanje simptoma', a zatim zatražite liječnički savjet.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for long periods.
Sistemski učinci inhalacijskih kortikosteroida mogu se pojaviti, posebice pri visokim dozama propisanim za duga razdoblja.
• Do not shake your inhaler before use.
• nemojte tresti inhalator prije primjene.
If Budesonide/Formoterol Teva Pharma B.V. 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.
Ako se terapiju lijekom Budezonid/Formoterol Teva Pharma B.V. mora prekinuti zbog predoziranja komponentom formoterola u lijeku, mora se razmotriti primjena odgovarajuće terapije inhalacijskim kortikosteroidom.
Children and adolescents This medicine should not be used in children or adolescents under the age of 18 years.
Ovaj lijek ne smiju koristiti djeca ili adolescenti mlađi od 18 godina.
The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Dozu inhalacijskih kortikosteroida i potrebu za inhalacijskim kortikosteroidima mora se ponovno procijeniti u bolesnika s aktivnom ili latentnom tuberkulozom pluća, gljivičnim i virusnim infekcijama dišnih puteva.
Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.
Mora se uzeti u obzir razmotriti potencijalne učinke na gustoću kostiju, poglavito u bolesnika koji primaju visoke doze kroz dulje vrijeme, a istodobno imaju čimbenike rizika za osteoporozu.
• Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time.
• Inhalirani kortikosteroidi mogu utjecati na normalno stvaranje steroidnih hormona u Vašem tijelu,
- The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva Pharma B.V. contains lactose')
- Drugi sastojak je laktoza hidrat (pogledajte dio 2 pod „Budezonid/Formoterol Teva Pharma B.V. sadrži laktozu”)
The fixed-dose combination of budesonide and formoterol, and the corresponding monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide and formoterol, respectively.
Pokazalo se da su kombinacija fiksne doze budezonida i formoterola i odgovarajuće monokomponente bioekvivalentni obzirom na sistemsku izloženost budezonidu, odnosno formoterolu.
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120
• Indikator doze upućuje Vas koliko doza (inhalacija) je još preostalo u Vašem inhalatoru, počevši od 120 inhalacija kad je pun.
Paradoxical bronchopasm responds to a rapidacting inhaled bronchodilator and should be treated straightaway.
Paradoksalni bronhospazam odgovara na brzodjelujući inhalacijski bronhodilatator, te ga se mora odmah liječiti.
Do not stop using your inhaler without telling your doctor first.
Nemojte prekinuti s primjenom vašeg inhalatora bez prethodnog javljanja liječniku.
If you use more Budesonide/Formoterol Teva Pharma B.V. than you should It is important that you take your dose as advised by your doctor.
Ako primijenite više lijeka Budezonid/Formoterol Teva Pharma B.V. nego što biste trebali Važno je da svoju dozu uzimate prema naputku Vašeg liječnika.
Adverse reactions, which have been associated with budesonide or formoterol, are given below and listed by system organ class and frequency.
Nuspojave koje se povezuju s budezonidom ili formoterolom navedene su u nastavku i razvrstane prema klasifikaciji organskih sustava i učestalosti.
Concomitant treatment of β2 adrenoceptor agonists with medicinal products which can induce hypokalaemia or potentiate a hypokalaemic effect, e.g. xanthine-derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β2 adrenoceptor agonist.
Istodobno liječenje ß2-adrenoreceptorskim agonistima i lijekovima koji mogu uzrokovati hipokalemiju ili pojačati hipokalemijski učinak, npr. derivatima ksantina, steroidima i diureticima, može doprinijeti mogućem hipokalemijskom učinku ß2-adrenoreceptorskih agonista.
If you use more Budesonide/Formoterol Teva Pharma B.V. than you should, contact your doctor, pharmacist or nurse for advice.
Ako primijenite više lijeka Budezonid/Formoterol Teva Pharma B.V. nego što biste trebali, obratite se za savjet svojem liječniku, ljekarniku ili medicinskoj sestri.
Keep the mouthpiece cover closed and use within 6 months of removing from foil wrapping.
Poklopac nastavka za usta držite zatvorenom i upotrijebite unutar 6 mjeseci nakon vađenja iz folije.
If your doctor feels that you need a lower dose than is available from your Budesonide/Formoterol Teva Pharma B.V., your doctor may prescribe an alternative inhaler containing the same active substances as your Budesonide/Formoterol Teva Pharma B.V. but with a lower dose of the corticosteroid.
Ako Vaš liječnik smatra da trebate nižu dozu od one koja je dostupna iz Vašeg inhalatora Budezonid/Formoterol Teva Pharma B.V., liječnik Vam može propisati zamjenski inhalator koji sadrži iste djelatne tvari kao Vaš Budezonid/Formoterol Teva Pharma B.V., no s nižom dozom kortikosteroida.
Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section 4.4).
Budezonid/Formoterol Teva Pharma B.V. se mora trenutno prekinuti, bolesnika se mora procijeniti, te po potrebi, treba mu uvesti drugu terapiju (vidjeti dio 4.4).
• Check the dose indicator to see that there are 120 inhalations in the inhaler.
• provjerite indikator doze kako biste se uvjerili da inhalator sadrži 120 inhalacija.
Adults (18 years and older): 1 inhalation twice daily.
Odrasli (s 18 godina i više): 1 inhalacija dvaput dnevno.
During transfer from oral therapy to a budesonide/formoterol fumarate fixed-dose combination therapy, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Za vrijeme prijelaza s oralne terapije na kombiniranu terapiju fiksnom dozom budezonid/ formoterolfumarata, doći će do općenito sniženog sistemskog djelovanja steroida, što može rezultirati pojavom simptoma alergije ili artritisa, poput rinitisa, ekcema i bolova u mišićima i zglobovima.
You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva Pharma B.V.
Trebate razgovarati sa svojim liječnikom ako Vas brine trebate li nastaviti s uzimanjem inhalatora Budezonid/Formoterol Teva Pharma B.V.
Palpitations
Palpitacije
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), 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).
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) i zdravim dobrovoljcima (u dobi od 18-45 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
• Use within 6 months of removing from the foil wrapping.
• Upotrijebite unutar 6 mjeseci nakon vađenja iz folije.
Patients should be advised to have their rescue inhaler available at all times.
Bolesnicima se mora savjetovati da uvijek imaju kod sebe inhalator za hitno simptomatsko liječenje dostupan u svako doba.
Budesonide
Budezonid
Inhalation powder.
Prašak inhalata.
Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Svaki inhalator Budezonid/Formoterol Teva Pharma B.V. sadrži 60 inhalacija i ima bijelo tijelo s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
Preporučuje se postupno smanjivanje doze pri prekidu liječenja.
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog i vezivnog tkiva
These effects are much less likely to occur than with oral corticosteroids.
Mnogo je manja vjerojatnost pojave tih učinaka nego uz oralne kortikosteroide.
Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see section 4.8).
zastoj u rastu djece i adolescenata, smanjenje mineralne gustoće kostiju, kataraktu i glaukom, i rjeđe niz psiholoških učinaka ili učinaka na ponašanje uključujući psihomotornu hiperaktivnost, poremećaje spavanja, anksioznost, depresiju ili agresivnost (pogotovo u djece) (vidjeti dio 4.8).
The pharmacokinetics of budesonide or formoterol in children and patients with renal failure are unknown.
Farmakokinetika budezonida ili formoterola u djece i bolesnika sa zatajenjem bubrega nije poznata.
• you have a lung infection.
• imate infekciju pluća.
Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Svaki inhalator Budezonid/Formoterol Teva Pharma B.V. sadrži 120 inhalacija i ima bijelo tijelo s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
Talk to your doctor,pharmacist or nurse before taking Budesonide/Formoterol Teva Pharma B.V. if
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Budezonid/Formoterol Teva Pharma B.V. ako:
MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/950/001
• Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).
• lijekove za liječenje ubrzanih ili neravnomjernih otkucaja srca (poput kinidina, dizopiramida i prokainamida).
Always keep your ‘reliever inhaler' with you and use it to relieve sudden attacks of breathlessness and wheezing.
Uvijek imajte pri ruci „inhalator za brzo ublažavanje simptoma” i primjenjujte ga za ublažavanje iznenadnih napadaja nedostatka zraka i zviždanja u plućima.