natgillin/translations-raw huggingface dataset:
In Study 734, symptoms and reliever use were reduced and lung function improved, compared with both comparator treatments.
V študiji 734 so bili simptomi in uporaba olajševalca zmanjšani, pljučna funkcija pa izboljšana, v primerjavi z obema primerjalnima zdravljenjema.
1 inhalation in the morning and 1 inhalation in the evening or
1 vdih zjutraj in 1 vdih zvečer ali
In the 5 studies combined, patients receiving budesonide/formoterol maintenance and reliever therapy used, on average, no reliever inhalations on 57% of treatment days.
Ob upoštevanju rezultatov vseh petih študij bolniki, ki so prejemali vzdrževalno zdravljenje z budezonidom/formoterolom, v povprečju niso potrebovali olajševalca 57 % dni zdravljenja.
A total daily dose of more than 8 inhalations is not normally needed.
Celotni dnevni odmerek, večji od 8 vdihov, običajno ni potreben.
The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP).
Stični deli inhalatorja med zdravilom in sluznico so izdelani iz akrilnitril-butadien-stirena (ABS), polietilena (PE) in polipropilena (PP).
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 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Adults (18 years and older):
Odrasli (18 let in več):
Pack sizes of 1, 2 or 3 inhalers.
Na voljo je v pakiranjih z 1, 2 ali 3 inhalatorji.
• 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 BiResp Spiromax - do NOT use this medicine unless your doctor tells you to.
• 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 BiResp Spiromax zdravila NE uporabljajte, če vam tega izrecno ne naroči zdravnik.
Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je opredeljena kot sledi: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The prophylactic use of BiResp Spiromax, e.g. before exercise, has not been studied.
Profilaktična uporaba zdravila BiResp Spiromax, na primer pred telesnim naporom, ni bila preučena.
Patients were required to be symptomatic despite use of inhaled glucocorticosteroids.
Vključeni so bili samo bolniki, ki so imeli simptome, kljub uporabi inhalacijskih kortikosteroidov.
COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.
KOPB je dolgotrajna (kronična) bolezen dihalnih poti v pljučih, ki jo pogosto povzroči kajenje.
• If you are using BiResp Spiromax for asthma, your doctor will want to regularly check your symptoms.
• Če zdravilo BiResp Spiromax uporabljate za astmo, vas bo zdravnik redno nadziral glede simptomov.
• changes in bone mineral density (thinning of the bones)
• spremembe mineralne gostote kosti (tanjšanje kosti),
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Zdravnik vam je to zdravilo predpisal za zdravljenje astme ali kronične obstruktivne pljučne bolezni
BiResp Spiromax can also be used to treat the symptoms of severe COPD in adults.
Zdravilo BiResp Spiromax se lahko uporablja tudi za zdravljenje simptomov hude KOPB pri odraslih.
BiResp Spiromax has no or negligible influence on the ability to drive and use machines.
Zdravilo BiResp Spiromax nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Use the label on the inhaler to write down the date you open the foil pouch.
Uporabite nalepko na inhalatorju in zabeležite datum odprtja vrečke iz folije.
For such, a separate rapid-acting bronchodilator should be considered.
V takih primerih je treba razmisliti o uporabi hitrodelujočega bronhodilatatorja.
• Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
• nenadno, nepričakovano in akutno piskajoče dihanje in/ali težko dihanje nemudoma po uporabi inhalatorja (imenovano tudi »paradoksni bronhospazem«).
The amount of BiResp Spiromax to use and when to use it depends on how it has been prescribed for you.
Količina zdravila BiResp Spiromax, ki jo morate uporabiti, in čas, ko morate zdravilo uporabiti, sta odvisna od tega, kako vam je zdravnik predpisal zdravilo.
The specific properties of budesonide and formoterol allow the combination to be used either as maintenance and reliever therapy, or as maintenance treatment of asthma.
Posebne lastnosti budezonida in formoterola omogočajo, da se kombinacija teh dveh učinkovin uporablja za vzdrževalno in olajševalno zdravljenje ali pa samo za vzdrževalno zdravljenje astme.
There is no data available on the potential effect of budesonide on fertility.
Podatkov o možnih učinkih budezonida na plodnost ni.
• An increase in the amount of sugar (glucose) in your blood, when you have a blood test
• zvišan sladkor (glukoza) v krvi, kar pokaže krvni test,
• Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidine and the chemotherapy medicine procarbazine).
• antidepresive, kot so zaviralci monoamin oksidaze in zdravila s podobnimi lastnostmi (kot sta antibiotik furazolidon in kemoterapevtik prokarbazin).
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
Sočasno zdravljenje s kinidinom, dizopiramidom, prokainamidom, fenotiazini, antihistaminiki (terfenadin) in tricikličnimi antidepresivi lahko podaljša interval QTc in poveča nevarnost za pojav ventrikularnih aritmij.
• The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers.
• Kazalnik odmerkov na zadnji strani pripomočka kaže število preostalih inhalacij kot soda števila.
If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use BiResp Spiromax.
Če za zdravljenje astme ali KOPB jemljete steroide v obliki tablet, vam bo zdravnik morda zmanjšal število tablet, ki jih jemljete, ko boste začeli uporabljati zdravilo BiResp Spiromax.
• glaucoma (increased pressure in the eye)
• glavkom (zvišan tlak v očesu),
80 micrograms/4.5 micrograms/inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
80 mikrogramov/4,5 mikrogramov/vdih, dvakrat na dan) in kratkodelujoči agonist adrenergičnih receptorjev β2 po potrebi.
What you need to know before you use BiResp Spiromax Do not use BiResp Spiromax if:
Kaj morate vedeti, preden boste uporabili zdravilo BiResp Spiromax Ne uporabljajte zdravila BiResp Spiromax:
Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Simptomatsko zdravljenje bolnikov s KOPB s forsiranim ekspiratornim volumnom v prvi sekundi (FEV1) < 70 % predvidene normalne vrednosti (po bronhodilatatorju) in s ponavljajočimi se poslabšanji v anamnezi, pri katerih se kljub zdravljenju z dolgodelujočimi bronhodilatatorji pojavljajo znatni simptomi.
• Oxytocin which is given to pregnant women to induce labour.
• oksitocin, ki se daje nosečnicam za indukcijo poroda.
If you are doing exercise and you get asthma symptoms, use BiResp Spiromax as described here.
Če se med telesno dejavnostjo pojavijo simptomi astme, uporabite zdravilo BiResp Spiromax, kot je opisano tukaj.
When it is appropriate to titrate down to a lower strength than is available for BiResp Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Kadar je primerno titrirati zdravilo na nižji odmerek, kot je na voljo pri zdravilu BiResp Spiromax, je potreben prehod na alternativno fiksno kombinacijo budezonida in formoterolijevega fumarata, ki vsebuje nižje odmerke inhalacijskega kortikosteroida.
If you feel you are getting breathless or wheezy while using BiResp Spiromax, you should continue to use BiResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.
Če se vam med zdravljenjem z zdravilom BiResp Spiromax zdi, da dihanje postaja težje ali piskajoče, zdravilo uporabljajte še naprej, vendar pa čim prej obiščite zdravnika, saj boste morda potrebovali dodatno zdravljenje.
However, your doctor may allow you to take up to 12 inhalations a day for a limited period.
Vendar vam zdravnik lahko za krajše obdobje dovoli narediti do 12 vdihov na dan.
If BiResp Spiromax therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
Če je bilo treba zdravljenje z zdravilom BiResp Spiromax prekiniti zaradi prevelikega odmerka formoterola, ki je sestavina zdravila, je treba poskrbeti za ustrezno zdravljenje z inhalacijskim kortikosteroidom.
The safety and efficacy of BiResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Varnost in učinkovitost zdravila BiResp Spiromax pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
For BiResp Spiromax there are two treatment approaches:
Z zdravilom BiResp Spiromax sta možna dva različna načina zdravljenja:
BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Zdravilo BiResp Spiromax vsebuje dve različni zdravilni učinkovini: budezonid in formoterolijev fumarat dihidrat.
Patients should not be initiated on BiResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Bolnikom se ne sme uvesti zdravila BiResp Spiromax med poslabšanjem astme ali v obdobju pomembnega oziroma akutnega poslabšanja simptomov astme.
• an effect on the adrenal gland (a small gland next to the kidney).
• vpliv na nadledvično žlezo (majhna žleza nad ledvico).
If your doctor feels that you need a lower dose than is available from your BiResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax but with a lower dose of the corticosteroid.
Če vaš zdravnik meni, da potrebujete manjši odmerek, kot je na voljo pri vašem zdravilu BiResp Spiromax, vam lahko predpiše drug inhalator, ki vsebuje isti zdravilni učinkovini, kot vaše zdravilo BiResp Spiromax, a z nižjim odmerkom kortikosteroida.
BiResp Spiromax is not likely to affect your ability to drive or to use tools or machines.
Ni verjetno, da bi zdravilo BiResp Spiromax vplivalo na sposobnost vožnje, uporabe orodij in upravljanja s stroji.
Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening.
Odrasli (18 let in več): priporočen vzdrževalni odmerek je 2 vdiha na dan, bodisi 1 vdih zjutraj in 1 vdih zvečer ali pa 2 vdiha zjutraj oziroma 2 vdiha zvečer.
If any of the following happen to you, stop using BiResp Spiromax and talk to your doctor immediately:
Če se pri vas pojavi kaj od naslednjega, prenehajte uporabljati zdravilo BiResp Spiromax in se nemudoma posvetujte z zdravnikom:
If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using BiResp Spiromax.
Če kar koli od naštetega velja za vas, ali če niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite zdravilo BiResp Spiromax.
What BiResp Spiromax is and what it is used for
Kaj je zdravilo BiResp Spiromax in za kaj ga uporabljamo
The mean PIFR achieved by patients with asthma or COPD was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Povprečna PIFR), ki so jo dosegli bolniki z astmo ali KOPB, jepresegala 60 l/min, pri tej stopnji obe preiskovani napravi v pljuča dovedeta primerljivi količini zdravila.
There are no clinical study data on BiResp Spiromax available in COPD patients with a pre-bronchodilator FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal (see section 5.1)
Podatkov iz kliničnih študij za zdravilo BiResp Spiromax pri bolnikih s KOPD, ki imajo > 50 % predvidenega normalnega FEV1 pred bronhodilatatorjem in < 70 % predvidenega normalnega FEV1 po bronhodilatatorju, ni na voljo (glejte poglavje 5.1).
Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of
Izvedeni sta bili dve 12-tedenski pediatrični študiji, v katerih je 265 otrok, starih od 6 do 11 let, uporabljalo vzdrževalni odmerek budezonida/formoterola (2 vdiha po
If you use more BiResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
Če ste uporabili večji odmerek zdravila BiResp Spiromax, kot bi smeli, se za nasvet obrnite na zdravnika, farmacevta ali medicinsko sestro.
BiResp Spiromax is an inhalation powder.
Zdravilo BiResp Spiromax je prašek za inhaliranje.
Contents of the pack and other information What BiResp Spiromax contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo BiResp Spiromax
If you use more BiResp Spiromax than you should
Če ste uporabili večji odmerek zdravila BiResp Spiromax, kot bi smeli
This medicinal product is not recommended for use in children and adolescents under the age of 18 years.
Uporabe zdravila se ne priporoča pri otrocih in mladostnikih, mlajših od 18 let.
• Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procinamide and terfanadine).
• zdravila proti hitremu ali neenakomernemu bitju srca (npr. kinidin, dizopiramid, prokainamid in terfenadin).
Linearity/non-linearity Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.
Linearnost/nelinearnost Sistemska izpostavljenost za budezonid in formoterol linearno korelira z uporabljenim odmerkom.
Do not use BiResp Spiromax to treat these asthma symptoms.
Ne uporabljate zdravila BiResp Spiromax za odpravljanje teh simptomov astme.
The reliever inhalations of BiResp Spiromax should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise.
Zdravilo BiResp Spiromax kot olajševalec se uporablja v primerih, ko se pojavijo simptomi, ne pa redno v profilaktične namene, na primer pred telesnim naporom.
Always keep your BiResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing.
Inhalator BiResp Spiromax imejte vedno pri sebi in ga uporabite za lajšanje nenadnih napadov zasoplosti in piskajočega dihanja.
For some patients a maintenance dose of 2 inhalations twice daily may be appropriate.
Za nekatere bolnike je primeren vzdrževalni odmerek 2 vdiha dvakrat dnevno.
BiResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Zdravilo BiResp Spiromax 320 mikrogramov/9,0 mikrogramov je treba uporabljati le kot vzdrževalno zdravljenje.
Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
Bolniki, ki uporabljajo več kot 8 vdihov dnevno, morajo obiskati zdravnika.
Candida infections in the oropharynx, pneumonia (in COPD patients)
Pogosti okužbe s kandido v ustnih in žrelu, pljučnica (pri bolnikih s KOPB)
Use your BiResp Spiromax every day.
Zdravilo BiResp Spiromax uporabljajte vsak dan.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of BiResp Spiromax.
Ko dosežemo ustrezen nadzor simptomov astme, je treba razmisliti o postopnem zmanjšanju odmerka zdravila BiResp Spiromax.
Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).
Študije vpliva formoterola na sposobnost razmnoževanja pri živalih so pokazale nekoliko zmanjšano plodnost pri podganjih samcih pri veliki sistemski izpostavljenosti (glejte poglavje 5.3).
Each BiResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
En inhalator BiResp Spiromax vsebuje 120 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim ustnikom.
• If you get pregnant while using BiResp Spiromax, do NOT stop using BiResp Spiromax but talk to your doctor immediately.
• Če med zdravljenjem z zdravilom BiResp Spiromax zanosite, zdravila BiResp Spiromax NE nehajte uporabljati, se pa takoj posvetujte z zdravnikom.
BiResp Spiromax can be prescribed for asthma in two different ways.
Zdravnik lahko predpiše zdravilo BiResp Spiromax za zdravljenje astme na dva različna načina.
Also use BiResp Spiromax as a ‘reliever inhaler' to treat asthma symptoms when they occur.
Zdravilo BiResp Spiromax uporabite tudi kot »inhalator z olajševalcem« za odpravljanje simptomov astme, ko se pojavijo.
The spaces between the even numbers represent the odd number of remaining inhalations.
Razmaki med sodimi števili predstavljajo liha števila preostalih inhalacij.
Variations in blood pressure
• spremembe krvnega tlaka,
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.
Kombinacijo budezonida in formoterolijevega fumarata dihidrata v fiksnih odmerkih predpisujte previdno pri bolnikih s tirotoksikozo, feokromocitomom, sladkorno boleznijo, nezdravljeno hipokaliemijo, hipertrofično obstruktivno kardiomiopatijo, idiopatsko subvalvularno aortno stenozo,
• Use BiResp Spiromax when you need to take extra inhalations or puffs to relieve asthma symptoms andto make it easier to breathe again.
• Poleg tega uporabljajte inhalator BiResp Spiromax tudi v primerih, ko potrebujete dodatne odmerke ali vpihe za lajšanje simptomov astme in za lažje dihanje.
The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Te kombinacije se je treba izogibati, razen kadar koristi odtehtajo povečano tveganje za sistemske neželene učinke kortikosteroidov.
Taste disturbances
Motnje vida
• Disturbance of the heart's electrical system which does not cause symptoms (prolongation of the QTc interval).
• bolečina ali tiščanje v prsih (angina pektoris), • motnje električnega sistema srca, ki ne povzročajo simptomov (podaljšanje intervala QTc),
• Use BiResp Spiromax every day.
• Inhalator BiResp Spiromax uporabljajte vsak dan.
BiResp Spiromax maintenance therapy: BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Zdravilo BiResp Spiromax za vzdrževalno zdravljenje: Zdravilo BiResp Spiromax se uporablja za redno vzdrževalno zdravljenje, kot olajševalec pa se ločeno uporablja inhalator s hitrodelujočim bronhodilatatorjem.
However, do not use BiResp Spiromax just before exercise to stop asthma symptoms from happening.
Ne uporabljajte pa zdravila BiResp Spiromax neposredno pred telesno dejavnostjo, da bi preprečili pojav simptomov astme.
You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
če ste alergični na budezonid, formoterolijev fumarat dihidrat, ali katero koli sestavino tega zdravila
Mild irritation in the throat, coughing, hoarseness
Pogosti blago draženje grla, kašljanje, hripavost
• If you get asthma symptoms such as sudden attacks of breathlessness and wheezing, take 1 inhalation and wait a few minutes.
• Ob pojavu simptomov astme, kot so nenadni napadi zasoplosti in piskajočega dihanja, naredite
a) You may be prescribed two asthma inhalers: BiResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
a) Lahko vam predpišejo inhalator BiResp Spiromax skupaj z ločenim »inhalatorjem z olajševalcem«, npr. salbutamolom.
A lower strength of BiResp Spiromax is available for the maintenance and reliever therapy regimen.
Nižje jakosti zdravila BiResp Spiromax so na voljo kot vzdrževalno in olajševalno zdravljenje.
Infections and infestations Common
Infekcijske in parazitske bolezni
Other medicines and BiResp Spiromax
Druga zdravila in zdravilo BiResp Spiromax
BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Zdravilo BiResp Spiromax je indicirano za redno zdravljenje astme v primerih, ko je primerna kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči agonist adrenergičnih receptorjev β2):
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of BiResp Spiromax.
Ko so simptomi astme dobro obvladani, bo vaš zdravnik morda predlagal, da odmerek zdravila BiResp Spiromax postopoma zmanjšate.
When used for asthma, your doctor will prescribe BiResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Za zdravljenje astme vam bo zdravnik predpisal inhalator BiResp Spiromax skupaj z ločenim inhalatorjem z olajševalcem, npr. salbutamolom.
• Blurred vision.
• zamegljen vid.
Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.
Simptomi slabšega delovanja nadledvične žleze so lahko utrujenost, šibkost, težave z želodcem, vključno z navzeo, bruhanjem, bolečino in drisko, potemnitev kože in hujšanje.
A total of 12076 asthma patients were included in 5 double-blind clinical studies (4447 were randomised to budesonide/formoterol maintenance and reliever therapy) for 6 or 12 months.
V pet dvojno-slepih kliničnih študij, ki so trajale od 6 do 12 mesecev, so vključili 12.076 bolnikov z astmo (4447 od teh je bilo randomiziranih v skupino z vzdrževalnim in olajševalnim zdravljenjem z budezonidom/formoterolom).
Patients take a daily maintenance dose of BiResp Spiromax and in addition take BiResp Spiromax as needed in response to symptoms.
Bolniki redno jemljejo dnevni vzdrževalni odmerek zdravila BiResp Spiromax, ob pojavu simptomov pa po potrebi dodatne odmerke zdravila BiResp Spiromax.
Since BiResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Ker zdravilo BiResp Spiromax vsebuje tako budezonid kot formoterol, lahko pri bolnikih pričakujemo enak vzorec neželenih učinkov, kot so jih opažali pri posameznih učinkovinah.
In patients using potent CYP3A4 inhibitors, a fixed-dose combination of budesonide and formoterol fumarate dihydrate maintenance and reliever therapy is not recommended.
Pri bolnikih, ki jemljejo močne zaviralce CYP3A4, kombinacija budezonida in formoterolijevega fumarata dihidrata v fiksnih odmerkih kot vzdrževalno in olajševalno zdravljenje ni priporočeno.