FrancophonIA/ELRC3.0 huggingface dataset:
English: Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
Slovenian: Držite inhalator pokonci, tako da je polprozorni vinsko rdeči pokrovček ustnika spodaj.
English: • Do not store above 25oC.
Slovenian: • Shranjujte pri temperaturi do 25 °C.
English: 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.
Slovenian: V dveh 12-tedenskih študijah so ugotovili, da je učinkovitost budezonida/formoterola pri izboljšanju pljučne funkcije enaka učinkovitosti proste kombinacije budezonida in formoterola in da presega učinkovitost samega budezonida v monoterapiji.
English: 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.
Slovenian: Če vaš zdravnik meni, da potrebujete manjši odmerek, kot je na voljo pri vašem zdravilu Budezonid/formoterol Teva Pharma B.V., vam lahko predpiše drug inhalator, ki vsebuje isti zdravilni učinkovini, kot vaše zdravilo Budezonid/formoterol Teva Pharma B.V., a z nižjim odmerkom kortikosteroida.
English: Your doctor may increase this to 2 inhalations, twice a day.
Slovenian: Zdravnik vam lahko poveča odmerek na 2 vdiha dvakrat na dan.
English: The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations.
Slovenian: Najpogostejši neželeni učinki so farmakološko pričakovani neželeni učinki zdravljenja z agonisti adrenergičnih receptorjev β2, kot so tremor in palpitacije.
English: Rare side effects: may affect up to 1 in 1,000 people
Slovenian: Redki neželeni učinki: pojavijo se lahko pri največ 1 od 1.000 bolnikov
English: Adults (18 years and older): 1-2 inhalations twice daily.
Slovenian: Priporočeni odmerki: Odrasli (18 let in več): 1-2 vdiha dvakrat na dan.
English: 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.
Slovenian: Če kar koli od naštetega velja za vas, ali če niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite zdravilo Budezonid/formoterol Teva Pharma B.V..
English: 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.
Slovenian: Če bolnik potrebuje odmerke kombiniranega zdravila v jakostih, ki jih ni na voljo v kombiniranem inhalatorju, mu predpišite ustrezne odmerke agonistov adrenergičnih receptorjev β2 ali kortikosteroidov iz ločenih inhalatorjev.
English: Paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.
Slovenian: Paradoksni bronhospazem se pojavlja zelo redko in prizadene manj kot 1 bolnika od 10.000.
English: 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..
Slovenian: Če za zdravljenje astme jemljete steroide v obliki tablet, vam bo zdravnik morda zmanjšal število tablet, ki jih jemljete, ko boste začeli uporabljati zdravilo Budezonid/formoterol Teva Pharma B.V..
English: The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Slovenian: Uporabi se lahko le najmanjši še učinkovit odmerek budezonida, ki je potreben za ohranjanje ustreznega nadzora simptomov bolezni.
English: or - in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
Slovenian: ali - pri bolnikih, pri katerih bolezen že ustrezno nadzorujemo tako z inhalacijskimi kortikosteroidi kot z dolgodelujočimi agonisti adrenergičnih receptorjev β2.
English: • Low levels of potassium in your blood.
Slovenian: • nizka koncentracija kalija v krvi,
English: 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.
Slovenian: Možni sistemski učinki vključujejo Cushingov sindrom, Cushingoidne značilnosti, supresijo nadledvične žleze, upočasnitev rasti pri otrocih in mladostnikih, zmanjšanje kostne mineralne gostote, katarakto in glavkom.
English: 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.
Slovenian: Če obstaja kakršen koli razlog za sum na motnjo delovanja nadledvične žleze zaradi prejšnje sistemskega zdravljenja s steroidi, je pri prehodu na zdravljenje s fiksno kombinacijo budezonida/formoterolijevega fumarata potrebna previdnost.
English: Each inhaler contains 60 doses and is foil-wrapped.
Slovenian: En inhalator vsebuje 60 odmerkov in je ovit v folijo.
English: Children and adolescents This medicine should not be used in children or adolescents under the age of 18 years.
Slovenian: Otroci in mladostniki Otroci in mladostniki, mlajši od 18 let, tega zdravila ne smejo uporabljati.
English: Your doctor may increase this to 4 inhalations, twice a day.
Slovenian: Zdravnik vam lahko poveča odmerek na 4 vdihe dvakrat na dan.
English: 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.
Slovenian: Podatki iz študije kažejo, da so otroci, mladostniki in odrasli z astmo neodvisno od starosti in resnosti osnovne bolezni dosegli primerljive stopnje vdišnega toka z inhalatorjem Spiromax in drugim inhalatorjem s suhim praškom v večkratnem odmerku na trgu.
English: Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.
Slovenian: Simptomi in znaki, ki se lahko pojavijo pri akutni adrenalni krizi, so včasih nejasni, lahko pa vključujejo anoreksijo, bolečine v trebuhu, izgubo telesne teže,
English: These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Slovenian: Ti učinki so med uporabo inhalacijskih kortikosteroidov mnogo manj verjetni kot med uporabo kortikosteroidov v obliki tablet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Front panel: Not for use in children and adolescents.
Slovenian: Sprednja ploskev: Ni za uporabo pri otrocih in mladostnikih.
English: If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler' to relieve these symptoms.
Slovenian: Če se med telesno dejavnostjo pojavijo simptomi astme, uporabite ločeni »inhalator z olajševalcem«
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Slovenian: Bolezni imunskega sistema redki takojšnje in zapoznele preobčutljivostne reakcije npr. eksantem, urtikarija, pruritus, dermatitis,
English: Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing.
Slovenian: Med zdravljenjem se lahko pojavi paradoksni bronhospazem, ki ga prepoznamo po okrepitvi piskanja v pljučih in težkega dihanja,takoj po vdihu zdravila.
English: The inhaler is white with a semi-transparent wine red mouthpiece cover.
Slovenian: Inhalator je bel s polprozornim vinsko rdečim pokrovčkom ustnika.
English: Paradoxical bronchospasm
Slovenian: (imenovano tudi »paradoksni bronhospazem«).
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Slovenian: Pri uporabi vseh inhalacijskih kortikosteroidov se lahko pojavijo sistemski učinki, še posebno, če so bili predpisani visoki odmerki za dlje časa.
English: • Medicines for thyroid problems (such as levothyroxine).
Slovenian: • zdravila proti težavam s ščitnico (npr. levotiroksin).
English: • Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Slovenian: • fenotiazinska zdravila (npr. klorpromazin in proklorperazin).
English: You may need to take other medicines if you develop allergic or arthritic symptoms.
Slovenian: Če se pojavijo simptomi alergije ali artritisa, boste morda morali jemati še druga zdravila.
English: Each inhaler contains 120 doses and is foil-wrapped.
Slovenian: En inhalator vsebuje 120 odmerkov in je ovit v folijo.
English: Mild irritation in the throat, coughing, hoarseness
Slovenian: • blago vnetje žrela, kašelj in hripavost,
English: Keep the mouthpiece cover closed and use within 6 months of removing from foil wrapping.
Slovenian: Po odstranitvi ovoja iz folije naj bo pokrovček ustnika zaprt, zdravilo pa porabite v 6 mesecih po odstranitvi ovoja iz folije.
English: Use the product within 6 months of removing from foil wrapping.
Slovenian: EXP Izdelek je treba porabiti v 6 mesecih po odstranitvi ovoja iz folije.
English: You may notice a taste when you take your inhalation.
Slovenian: Ko vdihnete odmerek zdravila, boste morda zaznali okus.
English: Keep the mouthpiece cover closed after removal of the foil wrap.
Slovenian: Pokrovček ustnika naj bo po odstranitvi ovoja iz folije zaprt.
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)
Slovenian: - katarakta (motnost očesne leče), - glavkom (zvišan tlak v očesu), - upočasnjena rast pri otrocih in mladostnikih, - vpliv na nadledvično žlezo (majhna žleza nad ledvico).
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Ko dosežemo ustrezen nadzor simptomov astme, je treba razmisliti o postopnem zmanjšanju odmerka zdravila Budezonid/formoterol Teva Pharma B.V..
English: Immune system disorders Rare
Slovenian: Bolezni endokrinega sistema zelo redki
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Slovenian: Srčne bolezni palpitacije tahikardija srčne aritmije, npr. atrijska fibrilacija,
English: Contents of the pack and other information
Slovenian: in vsebina pakiranja
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Pharmacokinetic parameters for the respective substances were comparable after the administration of budesonide and formoterol as monoproducts or as the fixed-dose combination.
Slovenian: Farmakokinetični parametri učinkovin po uporabi budezonida in formoterola v obliki zdravil z eno samo učinkovino so bili podobni tistim po uporabi kombinacije fiksnih odmerkov.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120
Slovenian: • Kazalnik odmerkov kaže, koliko odmerkov (inhalacij) je še v inhalatorju.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni modrice
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva Pharma B.V. contains lactose')
Slovenian: - Pomožna snov je laktoza monohidrat (glejte poglavje 2 pod »Zdravilo Budezonid/formoterol Teva Pharma B.V.
English: 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:
Slovenian: je indicirano za redno zdravljenje astme v primerih, ko je primerna kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči agonist adrenergičnih receptorjev β2):
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Slovenian: Psihiatrične motnje občasni agresija, psihomotorična hiperaktivnost,
English: Then breathe out gently (do not breathe out through the inhaler).
Slovenian: Potem rahlo izdihnite (ne izdihnite skozi inhalator).
English: Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Slovenian: Pri bolnikih, ki jemljejo glikozide digitalisa, lahko hipokaliemija poveča nagnjenost bolnika k aritmiji.
English: Budesonide/Formoterol Teva Pharma B.V. is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Slovenian: ni indicirano pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 4.2).
English: Peak Inspiratory Flow Rate through the Spiromax Device
Slovenian: Najvišja stopnja vdišnega toka z inhalatorjem Spiromax
English: To minimise the risk of oropharyngeal candida infection, the patient should be instructed to rinse their mouth out with water after inhaling the dose.
Slovenian: Tveganje za ta neželeni učinek lahko zmanjšate, če bolniku naročite, naj si po vsakem odmerku spere usta z vodo.
English: In spite of this, a small increase in cortisol suppression was seen after administration of fixed-dose combination compared to the monoproducts.
Slovenian: Kljub temu so po uporabi kombinacije budezonida in formoterola v fiksnem odmerku opažali blago okrepitev supresije izločanja kortizola v primerjavi z izdelki, ki vsebujejo le po eno učinkovino.
English: It is recommended that serum potassium levels are monitored during these circumstances.
Slovenian: da v teh primerih redno spremljate serumsko koncentracijo kalija.
English: If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your ‘reliever inhaler'.
Slovenian: Če se pojavi kateri od teh simptomov, takoj nehajte uporabljati inhalator Budezonid/formoterol Teva Pharma B.V.
English: Some patients may require up to a maximum of 2 inhalations twice daily.
Slovenian: Pri nekaterih bolnikih bosta morda potrebna največ 2
English: Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Slovenian: En odmerek vsebuje približno 10 miligramov laktoze (v obliki monohidrata).
English: Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).
Slovenian: Med obdobji stresa (npr. če imate okužbo v prsnem košu ali pred operacijo) vam bo zdravnik morda poleg vašega običajnega zdravljenja predpisal še steroide v tabletah.
English: There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Slovenian: Pri tistih bolnikih, ki sočasno dobijo anestetik iz skupine halogeniranih ogljikovodikov, je večja nevarnost pojava aritmij.
English: Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Slovenian: Zato je treba razmisliti o dodatni uporabi sistemskih kortikosteroidov v obdobjih stresa,
English: Patients should be advised to have their rescue inhaler available at all times.
Slovenian: Bolnikom svetujte, naj imajo inhalator z olajševalemc vedno pri roki.
English: • Nausea (feeling sick).
Slovenian: • občutek siljenja na bruhanje (navzea),
English: Breathe in forcefully and deeply through the mouthpiece.
Slovenian: Nato vdihnite skozi ustnik tako globoko in močno, kot morete.
English: 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.
Slovenian: Močni zaviralci CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, posakonazol, klaritromicin,
English: 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.
Slovenian: Ne poskušajte razstaviti inhalatorja ter odstraniti ali zasukati pokrovčka ustnika.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht,The Netherlands 12.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
English: Lactose contains small amounts of milk protein which may cause allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: 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).
Slovenian: tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
English: Some patients may require up to a maximum of 4 inhalations twice daily.
Slovenian: Pri nekaterih bolnikih bodo morda potrebni največ 4
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms should be used as maintenance therapy only.
Slovenian: 320 mikrogramov/9,0 mikrogramov je treba uporabljati le kot vzdrževalno zdravljenje.
English: Hyperglycaemia
Slovenian: OVOJNINAH FOLIJA
English: What you need to know before you use Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Budezonid/formoterol Teva Pharma
English: 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).
Slovenian: takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja (glejte poglavje 4.4).
English: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands.
Slovenian: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska Izdelovalec
English: /inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
Slovenian: 80 mikrogramov/4,5 mikrogramov/vdih, dvakrat na dan) in kratkodelujoči agonist adrenergičnih receptorjev β2 po potrebi.
English: Teva Pharmaceuticals Europe B.V. Swensweg 5
Slovenian: Teva Pharmaceuticals Europe B.V.
English: Advising the patient to rinse the mouth out with water after each dose will minimise the risk.
Slovenian: bolniku naročite, naj si po vsakem vzdrževalnem odmerku spere usta z vodo.
English: Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Slovenian: Stranska ploskev: En dovedeni odmerek vsebuje 160 mikrogramov budezonida in 4,5 mikrogramov formoterolijevega fumarata dihidrata.
English: If you stop using Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Če ste prenehali uporabljati zdravilo Budezonid/formoterol Teva Pharma B.V.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: If you forget to use Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Če ste pozabili uporabiti zdravilo Budezonid/formoterol Teva Pharma B.V.
English: If you get any side effects, talk to your doctor,pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Slovenian: En dovedeni odmerek (odmerek, ki pride iz ustnika Spiromax) vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
English: This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
Slovenian: To je enakovredno odmerjenemu odmerku 400 mikrogramov budezonida in 12 mikrogramov formoterolijevega fumarata dihidrata.
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 Budesonide/Formoterol Teva Pharma B.V. - do NOT use this medicine unless your doctor tells you to.
Slovenian: Nosečnost, dojenje in plodnost • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete zdravilo Budezonid/formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. contains two different active substances: budesonide and formoterol fumarate dihydrate.
Slovenian: vsebuje dve različni zdravilni učinkovini: budezonid in formoterolijev fumarat dihidrat.
English: Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Slovenian: Sprednja ploskev: Ta dovedeni odmerek je enakovreden odmerjenemu odmerku 200 mikrogramov budezonida in 6 mikrogramov formoterolijevega fumarata dihidrata.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Slovenian: se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Budesonide/Formoterol Teva Pharma B.V. is taken as regular maintenance treatment with a separate rapidacting bronchodilator reliever inhaler.
Slovenian: Budezonid/formoterol Teva Pharma B.V.V takem primeru profilaktične uporabe je treba razmisliti o uporabi hitrodelujočega bronhodilatatorja.
English: Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Slovenian: Stranska ploskev: En dovedeni odmerek vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
English: Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Slovenian: Sprednja ploskev: ta dovedeni odmerek je enakovreden odmerjenemu odmerku 400 mikrogramov budezonida in 12 mikrogramov formoterolijevega fumarata dihidrata.
English: Manufacturer:
Slovenian: Začetek:
English: This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
Slovenian: To je enakovredno odmerjenemu odmerku 200 mikrogramov budezonida in 6 mikrogramov formoterolijevega fumarata dihidrata.