natgillin/translations-raw huggingface dataset:
Budesonide/Formoterol Teva Pharma B.V. has no or negligible influence on the ability to drive and use machines.
Budezonid/Formoterol Teva Pharma B.V. ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Before using your Budesonide/Formoterol Teva Pharma B.V. for the first time, you need to prepare it for use as follows:
Prije prve primjene inhalatora Budezonid/Formoterol Teva Pharma B.V., trebate ga pripremiti za primjenu na sljedeći način:
What Budesonide/Formoterol Teva Pharma B.V. looks like and contents of the pack Budesonide/Formoterol Teva Pharma B.V. is an inhalation powder.
Kako Budezonid/Formoterol Teva Pharma B.V. izgleda i sadržaj pakiranja Budezonid/Formoterol Teva Pharma B.V. je prašak inhalata.
Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms should be used as maintenance therapy only.
Budezonid/Formoterol Teva Pharma B.V. od 320 mikrograma/9 mikrograma treba koristiti samo kao terapiju održavanja.
If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva Pharma B.V.
Ako ste uzimali tablete steroida za astmu, Vaš liječnik može smanjiti broj tableta koje uzimate nakon što počnete koristiti Budezonid/Formoterol Teva Pharma B.V.
If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Ako bolesnik osjeti paradoksalni bronhospazam, Budezonid/Formoterol Teva Pharma B.V. se mora trenutno prekinuti, bolesnika se mora pregledati, te po potrebi, treba uvesti zamjensku terapiju.
Patients with renal or hepatic impairment
Bolesnici s oštećenjem bubrega ili jetre
To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Za liječenje astme liječnik će Vam propisati dva inhalatora za astmu: Budezonid/Formoterol Teva Pharma B.V. i zasebni „inhalator za brzo ublažavanje simptoma” poput salbutamola.
Some patients may require up to a maximum of 2 inhalations twice daily.
Nekim bolesnicima može biti potrebno do najviše 2 inhalacije dvaput dnevno.
In two 12-week studies the effect on lung function of budesonide/formoterol was equal to that of the free combination of budesonide and formoterol, and exceeded that of budesonide alone.
U dva ispitivanja u trajanju od 12 tjedana učinak kombinacije budezonida/formoterola na funkciju pluća bio je istovjetan onom slobodne kombinacije budezonida i formoterola, te se pokazao većim od učinka samog budezonida.
Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
Bolesnike se mora savjetovati da uvijek imaju kod sebe zasebni brzodjelujući bronhodilatator za hitno simptomatsko liječenje u svakom trenutku.
Use the product within 6 months of removing from foil wrapping.
Lijek upotrijebite u roku od 6 mjeseci nakon vađenja iz folije.
Your doctor may increase this to 4 inhalations, twice a day.
Vaš liječnik može povećati dozu na 4 inhalacije, dvaput dnevno.
Some patients may require up to a maximum of 4 inhalations twice daily.
Nekim bolesnicima može biti potrebno do najviše 4 inhalacije dvaput dnevno.
• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness.
Rijetke nuspojave: mogu se javiti kod do 1 na 1 000 osoba • Oticanje lica, posebice oko usta (jezik i/ili grlo i/ili otežano gutanje) ili koprivnjača u kombinaciji s otežanim disanjem (angioedem) i/ili iznenadni osjećaj nesvjestice.
Patients should not be initiated on Budesonide/Formoterol Teva Pharma B.V. during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Bolesnici ne smiju započinjati liječenje lijekom Budezonid/Formoterol Teva Pharma B.V. tijekom egzacerbacije, niti tijekom značajnog ili akutnog pogoršanja astme.
Since Budesonide/Formoterol Teva Pharma B.V. contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Budući da Budezonid/Formoterol Teva Pharma B.V. sadrži i budezonid i formoterol, može se pojaviti isti obrazac nuspojava koji je primijećen za te dvije tvari.
Each inhaler contains 120 doses and is foil-wrapped.
Jedan inhalator sadrži 120 doza i omotan je folijom.
The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations.
Najčešće nuspojave su farmakološki predvidive nuspojave terapije ß2-adrenoreceptorskim agonistima, kao što su tremor i palpitacije.
Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Agresivnost, psihomotorna hiperaktivnost,
MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/950/002
or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
ili -u bolesnika u kojih astma već zadovoljavajuće kontrolirana primjenom i inhalacijskih kortikosteroida i dugodjelujućim agonistima ß2-adrenergičkih receptora.
To treat your asthma your doctor will prescribe Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Za liječenje astme, liječnik će Vam propisati Budezonid/Formoterol Teva Pharma B.V. zajedno sa zasebnim „inhalatorom za brzo ublažavanje simptoma“ poput salbutamola.
Your doctor may increase this to 2 inhalations, twice a day.
Vaš liječnik može povećati dozu na 2 inhalacije, dvaput dnevno.
• If you get pregnant while using Budesonide/Formoterol Teva Pharma B.V., do NOT stop using Budesonide/Formoterol Teva Pharma B.V. but talk to your doctor immediately.
• Ako zatrudnite tijekom uzimanja lijeka Budezonid/Formoterol Teva Pharma B.V., NEMOJTE prestati s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V., ali se odmah javite svojem liječniku.
INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V.320 mcg/9 mcg
16. PODACI NA BRAILLEOVOM PISMU Budezonid/Formoterol Teva Pharma B.V. 320 mcg/9 mcg
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)
Ti učinci uključuju: - promjene mineralne gustoće kostiju (stanjivanje kostiju) - očnu mrenu (zamućenje očne leće) - glaukom (povišen očni tlak)
2 years.
6.3 Rok valjanosti 2 godine
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Sistemski učinci mogu se pojaviti kod primjene svakog inhalacijskog kortikosteroida, posebice kad su propisane visoke doze kroz dulja razdoblja.
What Budesonide/Formoterol Teva Pharma B.V. contains - The active substances are budesonide and formoterol fumarate dihydrate.
Što Budezonid/Formoterol Teva Pharma B.V. sadrži - Djelatne tvari su budezonid i formoterolfumarat dihidrat.
• Thrush (a fungal infection) in the mouth.
• Kandidijaza (gljivična infekcija) usne šupljine.
Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
Držite svoj inhalator s poluprozirnim poklopcem nastavka za usta u boji crvenog vina prema dolje.
When it is appropriate to titrate down to a lower strength than is available for Budesonide/Formoterol Teva Pharma B.V., 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 Pharma B.V., potrebna je promjena na drugi kombinirani lijek s fiksnom dozom budezonida i formoterol fumarata, koji sadrži nižu dozu inhalacijskog kortikosteroida.
If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler' to relieve these symptoms.
Ako tijekom tjelovježbe dobijete simptome astme, primijenite zasebni „inhalator za brzo ublažavanje simptoma” kako biste ublažili simptome.
There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.
Nema dostupnih podataka o primjeni kombiniranog lijeka s fiksnom dozom budezonida i formoterol fumarat dihidrata u bolesnika s oštećenom jetrom ili bubrezima.
INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V. 160 mcg/4.5 mcg
16. PODACI NA BRAILLEOVOM PISMU Budezonid/Formoterol Teva Pharma B.V. 160 mcg/4,5 mcg
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• fenotiazinske lijekove (poput klorpromazina i proklorperazina).
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,
• lijekove za liječenje infekcija (poput ketokonazola, itrakonazola, vorikonazola, pozakonazola,
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva Pharma B.V.
Kad su simptomi astme dobro kontrolirani, Vaš liječnik će možda smatrati da je prikladno postupno smanjivati dozu lijeka Budezonid/Formoterol Teva Pharma B.V.
If any of the following happen to you, stop using Budesonide/Formoterol Teva Pharma B.V. and talk to your doctor immediately:
Ako vam se dogodi išta od navedenog, prekinite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V. i odmah se javite liječniku:
Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing.
Nakon doziranja može doći do paradoksalnog bronhospazma s trenutnim pojačanjem zviždanja u plućima i nedostatkom zraka.
Use of your ‘reliever inhaler' should not exceed 8 inhalations (puffs) in any 24 hours and you should not use your ‘reliever inhaler' more often than every 4 hours.
“Inhalator za brzo ublažavanje simptoma” ne smije se koristiti za više od 8 inhalacija (potisaka)
These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
Mnogo je manja vjerojatnost pojave tih učinaka uz inhalacijsko liječenje nego pri peroralnom uzimanju kortikosteroida.
The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. 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 Pharma B.V. u djece stare 12 godina i mlađe, te u adolescenata od 13 do 17 godina, nisu još ustanovljene.
In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. 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).
Pharma B.V. 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).
Budesonide/Formoterol Teva Pharma B.V. 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 shortacting β2 adrenoreceptor agonists.
Budezonid/Formoterol Teva Pharma B.V. 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.
What you need to know before you use Budesonide/Formoterol Teva Pharma B.V.
Što morate znati prije nego počnete primjenjivati Budezonid/Formoterol Teva Pharma B.V.
Immune system disorders Rare
Poremećaji imunološkog sustava
You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Nemojte primjenjivati Budezonid/Formoterol Teva Pharma B.V. ako: ste alergični na budezonid, formoterolfumarat dihidrat, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Do not use Budesonide/Formoterol Teva Pharma B.V. to treat these asthma symptoms.
Teva Pharma B.V. za liječenje tih simptoma astme.
Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
hiperglikemija, hipokalemija, produljeni QTc-interval, aritmija, mučnina i povraćanje.
No information regarding the effect of a budesonide/formoterol fumarate dihydrate fixed-dose combination at higher doses is available.
Nema dostupnih informacija o učinku viših doza kombinirane terapije fiksnom dozom budezonida/formoterolfumarat dihidrata.
• Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
Vrlo rijetke nuspojave: mogu se javiti kod do 1 na 10 000 osoba • Iznenadno akutno zviždanje u plućima i/ili nedostatak zraka neposredno nakon primjene inhalatora (također se naziva 'paradoksalni bronhospazam').
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol Teva Pharma B.V.
Nakon što se postigne kontrola simptoma astme, može se razmotriti postupno smanjenje doze lijeka Budezonid/Formoterol Teva Pharma B.V.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE FOLIJA
Budesonide/Formoterol Teva Pharma B.V. is taken as regular maintenance treatment with a separate rapidacting bronchodilator reliever inhaler.
Budezonid/Formoterol Teva Pharma B.V. uzima se kao redovita terapija održavanja s posebnim inhalatorom koji sadrži brzodjelujući bronhodilatator za hitno simptomatsko liječenje.
Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Srčane aritmije, npr. fibrilacija atrija,
OTHER
O
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
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht,The Netherlands 12.
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
Keep the mouthpiece cover closed after removal of the foil wrap.
Poklopac nastavka za usta držite zatvorenim nakon skidanja folije.
Do not use Budesonide/Formoterol Teva Pharma B.V. 320/9 micrograms as a ‘reliever inhaler'.
Nemojte koristiti Budezonid/Formoterol Teva Pharma B.V. 320/9 mikrograma kao „inhalator za brzo ublažavanje simptoma“.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE
Budesonide has a high systemic clearance (approximately 1.2 L/min) and the plasma elimination half-life after i.v.
Budezonid ima visok sistemski klirens (oko 1,2 l/min), a poluvrijeme eliminacije iz plazme nakon i.v. doziranja prosječno iznosi 4 sata.
• 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 Pharma B.V. - 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 Pharma B.V.
Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
Visoke doze ß2-adrenoreceptorskih agonista mogu izazvati potencijalno ozbiljnu hipokalemiju.
Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Budezonid/Formoterol Teva Pharma B.V. je indiciran u redovitom liječenju astme kad je primjereno kombinirano liječenje (inhalacijskim kortikosteroidom i dugodjelujućim agonistima ß2-adrenergičkih receptora): -u bolesnika u kojih astma nije zadovoljavajuće kontrolirana inhalacijskim kortikosteroidima i „prema potrebi“ inhalacijskim kratkodjelujućim agonistima ß2-adrenergičkih receptora.
What Budesonide/Formoterol Teva Pharma B.V. is and what it is used for (page 3) 2.
Što se nalazi u ovoj uputi: Što je Budezonid/Formoterol Teva Pharma B.V. i za što se koristi (stranica 3)
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.
adrenalnu supresiju, zastoj u rastu djece i adolescenata, smanjenje mineralne gustoće kosti, kataraktu i glaukom.
If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your ‘reliever inhaler'.
Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V. i primijenite svoj „inhalator za brzo ublažavanje simptoma“.
Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Bočna strana: Svaka primijenjena doza sadrži 320 mikrograma budezonida i 9 mikrograma formoterol fumarat dihidrata.
THE SIGHT AND REACH OF CHILDREN
Djeca i adolescenti
Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht Nizozemska
Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Bočna strana: Svaka primijenjena doza sadrži 160 mikrograma budezonida i 4,5 mikrograma formoterolfumarat dihidrata.
• Medicines for thyroid problems (such as levothyroxine).
• lijekove za liječenje tegoba sa štitnjačom (poput levotiroksina).
Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Budesonide/Formoterol Teva Pharma B.V. remains optimal.
Bolesnike mora redovito procijenjivati liječnik koji im propisuje lijekove/pružatelj zdravstvene skrbi kako bi doza inhalatora Budezonid/Formoterol Teva Pharma B.V. ostala optimalna.
• Use Budesonide/Formoterol Teva Pharma B.V. every day.
• Svakodnevno koristite Budezonid/Formoterol Teva Pharma B.V.
Budesonide/Formoterol Teva Pharma B.V. contains two different active substances: budesonide and formoterol fumarate dihydrate.
Što je Budezonid/Formoterol Teva Pharma B.V. i za što se koristi Budezonid/Formoterol Teva Pharma B.V. sadrži dvije različite djelatne tvari: budezonid i formoterolfumarat dihidrat.
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 Pharma B.V.
Ako se bilo što od gore navedenog odnosi na Vas ili niste sigurni, prije uporabe lijeka Budezonid/Formoterol Teva Pharma B.V. razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
If you forget to use Budesonide/Formoterol Teva Pharma B.V.
Ako ste zaboravili primijeniti Budezonid/Formoterol Teva Pharma B.V.
If you stop using Budesonide/Formoterol Teva Pharma B.V.
Ako prestanete primjenjivati Budezonid/Formoterol Teva Pharma B.V.
Preparing your new Budesonide/Formoterol Teva Pharma B.V.
Priprema Vašeg novog inhalatora Budezonid/Formoterol Teva Pharma B.V.
METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA
The inhaler is white with a semi-transparent wine red mouthpiece cover.
Inhalator je bijele boje s poluprozirnim poklopac nastavka za usta koji je boje crvenog vina.
Use your Budesonide/Formoterol Teva Pharma B.V. every day.
Svakodnevno koristite Budezonid/Formoterol Teva Pharma B.V.
Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Prednja strana: Ova primijenjena doza odgovara odmjerenoj dozi od 400 mikrograma budezonida i 12 mikrograma formoterolfumarat dihidrata.
Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Prednja strana: Ova primijenjena doza odgovara odmjerenoj dozi od 200 mikrograma budezonida i 6 mikrograma formoterolfumarat dihidrata.
Oral infections
Infekcije usta
This is not likely to be relevant for humans given recommended doses.
Kod čovjeka pri preporučenim dozama taj učinak vjerojatno nije relevantan.
Close your lips around the mouthpiece.
Nastavak za usta obavijte usnama.
Using Budesonide/Formoterol Teva Pharma B.V. and a separate ‘reliever inhaler'
Primjena lijeka Budezonid/Formoterol Teva Pharma B.V. i zasebnog 'inhalatora za brzo ublažavanje simptoma'
Tel: +39 028 917 981
Teva Italia S.r.l. Tel: +39 028 917 981
Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Jedna doza sadrži oko 10 miligrama laktoze (u obliku hidrata).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate.
6.1 Popis pomoćnih tvari laktoza hidrat 6.2 Inkompatibilnosti
Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Stoga se u razdobljima stresa, poput teških infekcija ili elektivnih kirurških zahvata, mora razmotriti uvođenje dodatnog sistemskog kortikosteroida.
White inhaler with a semi-transparent wine red mouthpiece cover.
Bijeli inhalator s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva Pharma B.V. than you should are trembling, headache or a rapid heartbeat.
Teva Pharma B.V. nego biste trebali, su drhtanje, glavobolja ili brzi otkucaji srca.
Marketing Authorisation Holder Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands
Nositelj odobrenja za stavljanje gotovog lijeka u promet Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska.
• Mild sore throat, coughing and a hoarse voice.
• Blaga grlobolja, kašalj i promuklost.
Candida infection in the oropharynx is due to active substance deposition.
Opis odabranih nuspojava Kandidijaza orofarinksa uzrokovana je odlaganjem djelatne tvari.
Budesonide/Formoterol Teva Pharma B.V.is indicated in adults 18 years of age and older only.
Budezonid/Formoterol Teva Pharma B.V. indiciran je samo u odraslih u dobi od 18 godina i više.
If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your 'reliever inhaler' Contact your doctor immediately as you may need to have your treatment changed.
Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V. i primijenite svoj “inhalator za brzo ublažavanje simptoma“.
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.
Budezonid/Formoterol Teva Pharma B.V. indiciran je samo u odraslih u dobi od 18 godina i starijih.
Budesonide/Formoterol Teva Pharma B.V.is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Budezonid/Formoterol Teva Pharma B.V. nije indiciran za primjenu u djece, u dobi od 12 godina i mlađe, niti za adolescente u dobi od 13 do 17 godina.
How to store Budesonide/Formoterol Teva Pharma B.V.
Kako čuvati Budezonid/Formoterol Teva Pharma B.V.
Mogilska 80
4.8 Nuspojave
How to use Budesonide/Formoterol Teva Pharma B.V.
Kako primjenjivati Budezonid/Formoterol Teva Pharma B.V.
Dizziness
Nuspojava