natgillin/translations-raw huggingface dataset:
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Hipokalemija može povećati sklonost aritmijama u bolesnika koji se liječe glikozidima digitalisa.
Chronic obstructive pulmonary disease (COPD)
Kronična opstruktivna plućna bolest (KOPB)
In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the prescriber, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
U uobičajenoj praksi kad se kontrola simptoma postiže doziranjem dvaput dnevno s nižom jačinom lijeka, titracija na nižu učinkovitu dozu može uključiti doziranje jedanput dnevno, radije nego liječenje samim inhalacijskim kortikosteroidom , kada je po mišljenju liječnika koji propisuje lijek, za održavanje kontrole bolesti potreban bronhodilatator dugog djelovanja.
A fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should therefore not be given together with β adrenergic blockers (including eye drops) unless there are compelling reasons.
Terapija kombinacijom fiksne doze budezonida i formoterolfumarat dihidrata se stoga ne smije davati zajedno s betaadrenergičkim blokatorima (uključujući kapi za oči) osim ako za to ne postoje jako uvjerljivi razlozi.
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full.
• Indikator doze upućuje Vas koliko doza (inhalacija) je još preostalo u Vašem inhalatoru, počevši od 120 inhalacija kad je pun.
This dose will be securely held inside the inhaler for when the next inhalation is due.
Ta će se doza zadržati na sigurnom unutar inhalatora za primjenu u
To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Za liječenje astme liječnik će Vam propisati dva inhalatora za astmu: Budezonid/Formoterol Teva i zasebni „inhalator za brzo ublažavanje simptoma” poput salbutamola.
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).
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% u (p<0,001 odnosno p<0,01).
Pneumonia in patients with COPD
Pneumonija u bolesnika s KOPB-om
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.
Budesonide/Formoterol Teva can also be used to treat the symptoms of severe COPD in adults.
Teva također se može koristiti za liječenje simptoma teškog KOPB-a u odraslih.
In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva 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).
U farmakokinetičkim ispitivanjima sa i bez blokade aktivnim ugljenom, Budezonid/Formoterol Teva 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).
• Fever or chills
• vrućica ili zimica
Budesonide/Formoterol Teva is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Teva nije indiciran u djece i adolescenata u dobi manjoj od 18 godina starosti (vidjeti dio 4.2).
Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.
Simptomi uključuju nedostatak zraka, kašalj, nelagodu u prsima i iskašljavanje sluzi.
• If you get pregnant while using Budesonide/Formoterol Teva, do NOT stop using Budesonide/Formoterol Teva but talk to your doctor immediately.
• Ako zatrudnite tijekom uzimanja lijeka Budezonid/Formoterol Teva, NEMOJTE prestati s primjenom lijeka Budezonid/Formoterol Teva, ali se odmah javite svojem liječniku.
• It is important to use Budesonide/Formoterol Teva every day, even if you have no asthma or COPD symptoms at the time.
Teva svakodnevno, čak i ako trenutno nemate simptome astme ili KOPB-a.
Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Jedna doza sadrži oko 10 miligrama laktoze (u obliku hidrata).
1 inhalation (actuation), twice a day.
1 inhalacija (potisak), dvaput dnevno.
Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
U izoliranim slučajevima prijavljeni simptomi su tahikardija, hiperglikemija, hipokalemija, produljeni QTc-interval, aritmija, mučnina i povraćanje.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Budesonide/Formoterol Teva .
Bolesnike treba savjetovati da nastave liječenje, ali da zatraže savjet liječnika ako simptomi astme ostanu nekontrolirani ili se pogoršaju nakon početka primjene lijeka Budezonid/Formoterol Teva.
Inhalation powder 1 inhaler containing 60 doses.
Prašak inhalata 1 inhalator sa 60 doza.
Musculoskeletal and connective tissue disorders
Poremećaji mišićnokoštanog i vezivnog tkiva
COPD Recommended doses:
KOPB Preporučene doze:
If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Ako je nekom bolesniku nužna drukčija kombinacija doza u odnosu na one dostupne u kombiniranom inhalatoru, moraju mu se propisati odgovarajuće doze β2 adrenoceptorskih agonista i/ili kortikosteroida u pojedinačnim inhalatorima.
Budesonide/Formoterol Teva contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Teva sadrži formoterol i budezonid koji imaju različite mehanizme djelovanja i pokazuju aditivne učinke u smislu smanjenja egzacerbacija astme.
Other medicines and Budesonide/Formoterol Teva
Drugi lijekovi i Budezonid/Formoterol Teva
Inhalation powder 1 inhaler containing 120 doses.
Prašak inhalata 1 inhalator sa 120 doza.
If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Ako bolesnik osjeti paradoksalni bronhospazam, Budezonid/Formoterol Teva se mora trenutno prekinuti, bolesnika se mora pregledati,te po potrebi, treba uvesti zamjensku terapiju.
The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
. Dijelovi inhalera kod kojih dolazi do dodira lijeka sa sluznicom napravljeni su od akrilonitril butadien stirena (ABS), polietilena (PE) i polipropilena (PP).
Candida infections in the oropharynx, pneumonia (in COPD patients)
Kandidijaza orofarinksa, pneumonija (u bolesnika s KOPB-om)
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).
Mogući sistemski učinci uključuju Cushingov sindrom, Cushingoidna obilježja, adrenalnu supresiju, 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).
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 plazmi pa se istodobna primjena mora izbjegavati.
Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.
Vaš liječnik može Vam propisati i drugi bronhodilatirajući lijek, primjerice antikolinergik (poput tiotropija ili ipratropij bromida) za liječenje KOPB.
If your doctor feels that you need a lower dose than is available from your Budesonide/Formoterol Teva, your doctor may prescribe an alternative inhaler containing the same active substances as your Budesonide/Formoterol Teva 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, liječnik Vam može propisati zamjenski inhalator koji sadrži iste djelatne tvari kao Vaš Budezonid/Formoterol Teva, no s nižom dozom kortikosteroida.
Other possible side effects: Common: may affect up to 1 in 10 people
Ostale moguće nuspojave: Često: mogu se javiti kod do 1 na 10 osoba
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 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
The mean number of days on oral corticosteroids/patient during the 12 months was slightly reduced in the budesonide/formoterol group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo and formoterol groups, respectively).
Srednja vrijednost broja dana liječenja oralnim kortikosteroidima/bolesniku tijekom 12 mjeseci blago je smanjena u skupini liječenoj kombinacijom budezonida/formoterola (7-8 dana/bolesniku/godišnje u usporedbi s 11-12 i 9-12 dana u skupinama s placebom, odnosno formoterolom).
Serious asthma-related adverse reactions and exacerbations may occur during treatment with Budesonide/Formoterol Teva.
Ozbiljne nuspojave povezane s astmom i egzacerbacije mogu se pojaviti tijekom liječenja lijekom Budezonid/Formoterol Teva.
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 potencijalne učinke na gustoću kostiju, poglavito u bolesnika koji primaju visoke doze kroz dulje vrijeme, a istodobno imaju čimbenike rizika za osteoporozu.
Use your Budesonide/Formoterol Teva every day.
Svakodnevno koristite Budezonid/Formoterol Teva.
- The active substances are budesonide and formoterol fumarate dihydrate.
- Djelatne tvari su budezonid i formoterolfumarat dihidrat.
• 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 Budesonide/Formoterol Teva - do NOT use this medicine unless your doctor tells you to.
• Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinsku sestru za savjet prije nego uzmete Budezonid/Formoterol Teva - NEMOJTE koristiti ovaj lijek ako Vam to ne odredi vaš liječnik.
• 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 Budesonide/Formoterol Teva - do NOT use this medicine unless your doctor tells you to.
• 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 Budezonid/Formoterol Teva - NEMOJTE koristiti ovaj lijek ako Vam to ne odredi vaš liječnik.
In two 12-month studies, the effect on lung function and the rate of exacerbation (defined as courses of oral steroids and/or course of antibiotics and/or hospitalisations) in patients with severe COPD was evaluated.
U dva ispitivanja u trajanju od 12 mjeseci, kod bolesnika s teškom KOPB, procijenjen je učinak na plućnu funkciju i stopu egzacerbacije (definirana kao liječenje peroralnim steroidima i/ili liječenja antibioticima i/ili hospitalizacije).
Talk to your doctor,pharmacist or nurse before taking Budesonide/Formoterol Teva if
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Budezonid/Formoterol
Mild irritation in the throat, coughing, hoarseness Bronchospasm
Blaga iritacija grla, kašalj, promuklost
If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva, you should continue to use Budesonide/Formoterol Teva but go to see your doctor as soon as possible, as you may need additional treatment.
Ako osjećate da Vam nedostaje zraka ili da Vam zviždi u plućima tijekom primjene inhalatora Budezonid/Formoterol Teva, trebate nastaviti s primjenom inhalatora Budezonid/Formoterol Teva, no ipak se što prije javite svojem liječniku jer će Vam možda biti potrebno dodatno liječenje.
Budesonide/Formoterol Teva should be used correctly in order to achieve effective treatment.
Teva se mora koristiti pravilno kako bi se postiglo učinkovito liječenje.
What you need to know before you use Budesonide/Formoterol Teva Do not use Budesonide/Formoterol Teva if:
Što morate znati prije nego počnete primjenjivati Budezonid/Formoterol Teva Nemojte primjenjivati Budezonid/Formoterol
Budesonide/Formoterol Teva 160 mcg/4.5 mcg
Teva 160 mcg/4,5 mcg
Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section 4.4).
Teva se mora trenutno prekinuti, bolesnika se mora procijeniti , te po potrebi, treba mu uvesti drugu terapiju (vidjeti dio 4.4).
Budesonide/Formoterol Teva contains two different active substances: budesonide and formoterol fumarate dihydrate.
Teva sadrži dvije različite djelatne tvari: budezonid i formoterolfumarat dihidrat.
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 osipa (ekcem).
Contents of the pack and other information What Budesonide/Formoterol Teva contains
Sadržaj pakiranja i druge informacije Što Budezonid/Formoterol
The dosage of Budesonide/Formoterol Teva is individual and should be adjusted to the severity of the disease.
Teva je individualno i mora se prilagoditi težini bolesti.
Budesonide/Formoterol Teva is not likely to affect your ability to drive or to use tools or machines.
Teva vjerojatno neće utjecati na Vašu sposobnost upravljanja vozilima, alatima ili strojevima.
Budesonide/Formoterol Teva 320 micrograms/9 micrograms should be used as maintenance therapy only.
Teva od 320 mikrograma/9 mikrograma treba koristiti samo kao terapiju održavanja.
If any of the following happen to you, stop using Budesonide/Formoterol Teva and talk to your doctor immediately:
Ako vam se dogodi išta od navedenog, prekinite s primjenom lijeka Budezonid/Formoterol Teva i odmah se javite liječniku:
Budesonide/Formoterol Teva has no or negligible influence on the ability to drive and use machines.
Teva ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Preparing your new Budesonide/Formoterol Teva
Priprema Vašeg novog inhalatora Budezonid/Formoterol Teva
If you stop using Budesonide/Formoterol Teva
Ako prestanete primjenjivati Budezonid/Formoterol Teva
The use of Budesonide/Formoterol Teva follows three simple steps: open, breathe and close which are outlined below.
Teva slijedi tri jednostavna koraka: otvorite, udahnite i zatvorite kako je navedeno u nastavku.
Asthma Budesonide/formoterol maintenance therapy
Astma Terapija održavanja budezonidom/formoterolom
• Use Budesonide/Formoterol Teva every day.
• Svakodnevno koristite Budezonid/Formoterol Teva.
If you forget to use Budesonide/Formoterol Teva
Ako ste zaboravili primijeniti Budezonid/Formoterol Teva
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem,The Netherlands
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Nizozemska
Budesonide/Formoterol Teva pharmacokinetic profile
Farmakokinetički profil lijeka Budezonid/Formoterol Teva
Budesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Teva je indiciran u redovitom liječenju astme kad je primjereno kombinirano liječenje (inhalacijskim kortikosteroidom i dugodjelujućim agonistima ß2-adrenergičkih receptora):
If either of these symptoms occur, stop using Budesonide/Formoterol Teva straightaway and use your ‘reliever inhaler'.
Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Budezonid/Formoterol Teva i primijenite svoj „inhalator za brzo ublažavanje simptoma“.
Since Budesonide/Formoterol Teva contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Teva sadrži i budezonid i formoterol, može se pojaviti isti obrazac nuspojava koji je primijećen za te dvije tvari.
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva.
Kad su simptomi astme dobro kontrolirani, Vaš liječnik će možda smatrati da je prikladno postupno smanjivati dozu lijeka Budezonid/Formoterol Teva.
• Increased mucus production, change in mucus colour
• pojačano lučenje sluzi, promjena boje sluzi
COPD
KOPB
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).
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
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.
Mogući sistemski učinci uključuju Cushingov sindrom, Cushingoidna obilježja, adrenalnu supresiju, zastoj u rastu djece i adolescenata, smanjenje mineralne gustoće kosti, kataraktu i glaukom.
Patients should not be initiated on Budesonide/Formoterol Teva during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Teva tijekom egzacerbacije, niti tijekom značajnog ili akutnog pogoršanja astme.
How to use Budesonide/Formoterol Teva
Kako primjenjivati Budezonid/Formoterol Teva
If Budesonide/Formoterol Teva 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.
Teva mora prekinuti zbog predoziranja komponentom formoterola u lijeku, mora se razmotriti primjena odgovarajuće terapije inhalacijskim kortikosteroidom.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari laktoza hidrat
Budesonide/Formoterol Teva 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.
Teva 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.
Candida infection in the oropharynx is due to active substance deposition.
Kandidijaza orofarinksa uzrokovana je odlaganjem djelatne tvari.
Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
1. Držite svoj inhalator s poluprozirnim poklopcem nastavka za usta u boji crvenog vina prema dolje.
The safety and efficacy of Budesonide/Formoterol Teva in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Sigurnost i djelotvornost lijeka Budezonid/Formoterol Teva u djece stare 12 godina i mlađe, te u adolescenata, od 13 do 17 godina nisu još ustanovljene.
When it is appropriate to titrate down to a lower strength than is available for Budesonide/Formoterol Teva, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Kad je primjereno titriranje doze na nižu jačinu od one koja je dostupna u inhalatoru Budezonid/Formoterol Teva, potrebna je promjena na drugi kombinirani lijek s fiksnom dozom budezonida i formoterol fumarata, koji sadrži nižu dozu inhalacijskog kortikosteroida.
Very rare side effects: may affect up to 1 in 10,000 people
Vrlo rijetke nuspojave: mogu se javiti kod do 1 na 10 000 osoba
How to store Budesonide/Formoterol Teva
Kako čuvati Budezonid/Formoterol Teva
An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
U bolesnika s KOPB-om koji su primali inhalacijske kortikosteroide zabilježeno je povećanje incidencije pneumonije, uključujući pneumoniju koja je zahtijevala bolničko liječenje.
• Pneumonia (infection to the lung) in COPD patients.
• Upala pluća (infekcija pluća) u bolesnika s KOPB-om (česta nuspojava)
Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder
Budezonid/Formoterol Teva 320 mikrograma/9 mikrograma prašak inhalata
The inhaler is white with a semi-transparent wine red mouthpiece cover.
Inhalator je bijele boje s poluprozirnim poklopcem nastavka za usta koji je boje crvenog vina.
If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using Budesonide/Formoterol Teva .
Ako se bilo što od gore navedenog odnosi na Vas ili niste sigurni, prije uporabe lijeka Budezonid/Formoterol
How to store Budesonide/Formoterol Teva (page 21) 6.
Kako čuvati Budezonid/Formoterol Teva (stranica 21) Sadržaj pakiranja i druge informacije (stranica 22)
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.
Norton (Waterford) Limited T/A Teva Pharmaceuticals Irska Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska
Rare side effects: may affect up to 1 in 1,000 people
Rijetke nuspojave: mogu se javiti kod do 1 na 1000 osoba
• If you are using Budesonide/Formoterol Teva for asthma, your doctor will want to regularly check your symptoms.
Teva za astmu, Vaš liječnik će tražiti redovitu kontrolu vaših simptoma.
EXP Use the product within 6 months of removing from foil wrapping.
Rok valjanosti Lijek upotrijebite u roku od 6 mjeseci nakon vađenja iz folije.