natgillin/translations-raw huggingface dataset:
Hold your breath for 10 seconds or as long as you comfortably can.
Zadržite dih za 10 sekund ali za toliko časa, kot lahko, ne da bi vam bilo ob tem neudobno.
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
• če se vam začne zjutraj pojavljati občutek stiskanja v prsnem košu ali če takšno stiskanje traja dalj časa kot po navadi.
Volume of distribution is about 4 L/kg for formoterol and 3 L/kg for budesonide.
Volumen porazdelitve je približno 4 l/kg za formoterol in 3 l/kg za budezonid.
After opening the foil wrap: 6 months.
Po odprtju ovoja iz folije: 6 mesecev .
When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving.
Po zmanjšanju števila tablet steroida se boste morda na splošno slabo počutili, čeprav se bodo simptomi v prsnem košu morda že izboljšali.
Contact your doctor immediately if:
Nemudoma se posvetujte z zdravnikom:
In children 6-16 years of age the lung deposition falls in the same range as in adults for the same given dose.
Pri otrocih, starih od 6 do 16 let, raven odlaganja v pljučih pri istem danem odmerku dosega enak razpon kot pri odraslih.
• The mouthpiece will still ‘click' even when your Spiromax is empty.
• Ustnik bo še vedno »klikal«, tudi ko bo inhalator Spiromax že prazen.
The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed.
Skrbno je treba pretehtati koristi kortikosteroidov in možna tveganja upočasnitve rasti.
• you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
• če imate visok krvni tlak ali ste kdaj imeli težave s srcem (vključno z neenakomernim bitjem srca, zelo hitrim srčnim utripom, zožitvijo arterij ali srčnim popuščanjem).
It is impossible to accidentally take extra medicine or a double dose in one inhalation.
Ni mogoče, da bi prejeli preveč zdravila ali pa dvojni odmerek v eni inhalaciji.
• Budesonide belongs to a group of medicines called ‘corticosteroids' also known as ‘steroids'.
• Budezonid spada v skupino zdravil, imenovanih »kortikosteroidi«, ki so poznani tudi kot
A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.
Pri odmerku 90 mikrogramov, ki so ga dajali bolnikom z akutno bronhialno obstrukcijo v času treh ur, se niso pojavili nobeni pomisleki glede varnosti zdravila.
When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone.
Če je dolgoročni nadzor nad simptomi mogoče vzdrževati z najnižjim priporočenim odmerkom, lahko naslednji korak vključuje test samega kortikosteroida za inhalacijo.
Do not breathe out through your inhaler.
Ne izdihnite skozi inhalator.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
C. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height.
Omejeni podatki iz dolgotrajnih študij nakazujejo, da večina otrok in mladostnikov, zdravljenih z inhalacijskim budezonidom, doseže ciljno telesno višino v odrasli dobi.
If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests.
Če steroide v obliki tablet jemljete že dolgo, vas bo zdravnik morda redno napotil na preiskave krvi.
There was no sign of attenuation of the anti-asthmatic effect over time.
Ni bilo nobenih znakov upadanja antiastmatične učinkovitosti zdravila s časom.
Your doctor has prescribed this medicine to treat asthma.
Zdravnik vam je to zdravilo predpisal za zdravljenje astme.
• Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
• če težje dihate ali se ponoči pogosto zbudite zaradi zasoplosti in piskajočega dihanja.
The excipient lactose contains small amounts of milk proteins which may cause allergic reactions.
Pomožna snov laktoza vsebuje majhne količine mlečnih beljakovin, ki lahko povzročijo alergijske reakcije.
Date of latest renewal:
Datum prve pridobitve: Datum zadnjega podaljšanja:
It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
Deluje tako, da zmanjšuje in preprečuje otekanje in vnetje v pljučih ter vam pomaga olajšati dihanje.
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 Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poljska.
If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.
Po potrebi lahko ustnik inhalatorja Spiromax po uporabi obrišete s suho krpico ali robčkom.
This helps to prevent asthma symptoms from occurring.
To pomaga preprečiti, da bi se pojavili simptomi astme.
As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
Zato je treba bolnikom svetovati, naj natančno preberejo in upoštevajo navodila za uporabo, ki so priložena zdravilu.
This will help to open the airways and help you to breathe more easily.
Tako vam odpre dihalne poti in pomaga olajšati dihanje.
Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided (see section 4.5).
Sočasnemu zdravljenju z itrakonazolom in ritonavirjem ali drugim močnim zaviralcem CYP3A4 se je treba izogibati (glejte poglavje 4.5).
Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma.
Zdravnik vam bo pomagal nadzorovati astmo in bo prilagodil odmerek tega zdravila na najmanjši odmerek, ki omogoča nadzor astme.
Breathe out gently (as far as is comfortable).
Rahlo izdihnite (izdihnite tako globoko, kolikor lahko, ne da bi bilo neprijetno).
Treatment with supplementary systematic steroids or inhaled budesonide should not be stopped abruptly.
Zdravljenja z dopolnilnimi sistemskimi steroidi ali inhalacijskim budezonidom ne smemo nenadno prekiniti.
Formoterol is inactivated via conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are seen mainly as inactivated conjugates).
Formoterol se deaktivira s konjugacijo (nastajajo aktivni O-demetilirani in deformilirani presnovki, a so predvsem v obliki neaktivnih konjugatov).
Remove your inhaler from your mouth.
Vzemite inhalator iz ust.
If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately.
Če je kateri od teh simptomov moteč ali če se pojavijo simptomi, kot so glavobol, utrujenost, občutek siljenja na bruhanje (navzea) ali bruhanje, se morate nemudoma posvetovati z zdravnikom.
Each pack contains 1 inhaler.
Eno pakiranje vsebuje 1 inhalator.
In rats, small amounts of formoterol have been detected in maternal milk.
Pri podganah so našli majhne količine formoterola v mleku samic.
In addition consideration should be given to referring the patient to a paediatric respiratory specialist.
Treba je razmisliti tudi o napotitvi bolnika k specialistu pediatru pulmologu.
No data on fertility are available.
Podatki o plodnosti niso na voljo.
• Diuretics, also known as ‘water tablets' (such as furosemide).
• diuretike, imenujemo jih tudi »tablete za odvajanje vode« (npr. furosemid).
• Thrush (a fungal infection) in the mouth.
• kandidoza (glivična okužba) v ustih.
Possible side effects (page 18)
Možni neželeni učinki (stran 18)
This dose will be securely held inside the inhaler for when the next inhalation is due.
Ta odmerek bo varno shranjen v inhalatorju, dokler ne bo čas za vdih naslednjega odmerka.
The systemic bioavailability is about 61% of the delivered dose.
Sistemska biološka uporabnost je približno 61 % dovedenega odmerka.
• Headache.
• glavobol.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'.
• Formoterolijev fumarat dihidrat spada v skupino zdravil, imenovanih »dolgodelujoči agonisti adrenergičnih receptorjev β2 ali »bronhodilatatorji«.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics and other drugs for obstructive airway diseases.
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, adrenergiki in druge učinkovine za obstruktivne pljučne bolezni.
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 (navedeno v poglavju 6).
When ketoconazole was administered 12 hours after budesonide the concentration was on average increased only three-fold showing that separation of the administration times can reduce the increase in plasma levels.
Ko so ketokonazol dajali 12 ur po budezonidu, se je koncentracija v povprečju povečala le za trikrat, kar dokazuje, da lahko večji razmak med časoma dajanja zmanjša dvig plazemskih koncentracij.
In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2 sympathomimetics.
Poleg tega lahko L-dopa, L-tiroksin, oksitocin in alkohol zmanjšajo toleranco miokarda za β2 simpatikomimetike.
6.4 Special precautions for storage Do not store above 25°C.
6.4 Posebna navodila za shranjevanje Shranjujte pri temperaturi do 25 °C.
• Other bronchodilators (such as salbutamol).
• druge bronhodilatatorje (npr. salbutamol).
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornih za sproščanje serije
The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Inhalator je izdelan iz akrilnitril butadien-stirena (ABS), polietilen tereftalata (PT) in polipropilena (PP).
Possible side effects (page 16)
Možni neželeni učinki (stran 16)
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.
Uporaba vašega »inhalatorja z olajševalcem« ne sme preseči 8 vdihov v katerih koli 24 urah; »inhalatorja z olajševalcem« ne smete uporabiti pogosteje kot na vsake 4 ure.
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder
FARMACEVTSKA OBLIKA IN VSEBINA prašek za inhaliranje
• If you open and close the mouthpiece without taking an inhalation, the dose indicator will still register it as a count.
• Če odprete in zaprete ustnik, ne da bi vdihnili inhalacijo zdravila, bo kazalnik odmerkov to zabeležil kot dovedeno inhalacijo.
• An increase in the amount of sugar (glucose) in your blood.
• zvišan sladkor (glukoza) v krvi,
Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow rate for Spiromax to deliver the therapeutic dose (see section 5.1).
Dokazali so, da bolniki z zmerno in hudo obliko astme zmorejo ustvariti zadosten vdišni zračni tok, s katerim inhalator Spiromax dovede terapevtski odmerek (glejte poglavje 5.1).
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Povečana uporaba ločenega hitrodelujočega bronhodilatatorja kaže na poslabšanje osnovne bolezni in pomeni, da je treba zdravljenje astme ponovno ovrednotiti.
• Medicines called ‘HIV protease inhibitors' (such as ritonavir) to treat HIV infection.
• zdravila, imenovana »zaviralci proteaz HIV« (kakršno je npr. ritonavir), za zdravljenje okužbe z virusom HIV.
The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Potrebo po zdravljenju in odmerek inhalacijskega kortikosteroida je treba ponovno oceniti pri bolnikih z aktivno ali neaktivno pljučno tuberkulozo, glivičnimi in virusnimi okužbami dihalnih poti.
Close your lips around the mouthpiece.
Stisnite ustnice okrog ustnika.
Hypersensitivity to the active substances or the excipient listed in section 6.1.
Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
Contents of the pack and other information (page 22)
(stran 21) Vsebina pakiranja in dodatne informacije (stran 22)
The systemic bioavailability is approximately 49% of the delivered dose.
Sistemska biološka uporabnost je približno 49 % dovedenega odmerka.
Data from an embryo-fetal development study in the rat, showed no evidence of any additional effect from the combination.
Podatki iz študije reprodukcijske toksičnosti pri podganah niso pokazali nobenih dodatnih učinkov kombinacije.
Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours.
Formoterol ima velik sistemski očistek (približno 1,4 l/min) njegova povprečna končna razpolovna doba izločanja pa je 17 ur.
Use the label on the inhaler to write down the opening date of the foil pouch.
Uporabite nalepko na inhalatorju in zabeležite datum odprtja vrečke iz folije.
Oral infections
Peroralne okužbe
The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and 16-alfa-hydroxyprednisolone, is less than 1% of that of budesonide.
Kortikosteroidna aktivnost poglavitnih presnovkov, tj. 6-β-hidroksi-budezonida in 16-alfa-hidroksi-prednizolona, je manjša od 1 % kortikosteroidne aktivnosti budezonida.
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.
Treba je razmisliti o možnih učinkih na kostno gostoto, še posebej pri bolnikih, ki prejemajo večje odmerke za daljša obdobja in imajo sočasne dejavnike tveganja za osteoporozo.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate.
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat
• Changes in your blood pressure.
• spremembe krvnega tlaka,
It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
Priporočamo, da ob prekinitvi zdravljenja odmerek zmanjšujete postopoma in zdravljenja ne prekinete nenadoma.
Close the mouthpiece cover.
Zaprite pokrovček ustnika.
If it is nearly time for your next dose just take your next dose at the usual time.
Če je čas za naslednji odmerek že zelo blizu, počakajte in ob predvideni uri vzemite naslednji odmerek.
Paradoxical bronchopasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway (see section 4.8).
Paradoksni bronhospazem se odziva na hitrodelujoči inhalacijski bronhodilatator in ga moramo zdraviti takoj (glejte poglavje 4.8).
If this is not possible the time interval between administration of the inhibitor and budesonide should be as long as possible (see section 4.4).
Če to ni mogoče, pazite, da bo časovni razmik med uporabo zaviralca in budezonida kolikor je mogoče dolg (glejte poglavje 4.4).
• Medicines for allergies or antihistamines (such as terfenadine).
• zdravila proti alergijam ali antihistaminiki, (kot je npr. Terfenadin).
Take care not to block the air vents.
Pazite, da ne zamašite oddušnikov.
Additional blood glucose controls should be considered in diabetic patients.
Pri bolnikih s sladkorno boleznijo je treba razmisliti o dodatnih kontrolnih meritvah glukoze v krvi.
• Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
• nenadno akutno piskajoče in/ali težko dihanje nemudoma po uporabi inhalatorja (imenovano tudi »paradoksni bronhospazem«).
It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax and not to block the air vents when they are preparing the “Breathe” step.
Pomembno je tudi, da bolnikom svetujete, naj inhalatorja pred uporabo ne stresajo, naj ne izdihnejo skozi inhalator Spiromax in naj ne zamašijo oddušnikov med pripravo koraka »Vdihnite«.
The exact mechanism responsible for the antiinflammatory effect of glucocorticosteroids is unknown.
Natančen mehanizem protivnetnega delovanja kortikosteroidov ni znan.
Contents of the pack and other information (page 19)
(stran 19) Vsebina pakiranja in dodatne informacije (stran 19)
Your doctor may need to change your treatment in order to reduce your symptoms of asthma (breathlessness, wheezing and cough) and improve your asthma control and make your breathing easier.
Zdravnik bo morda moral spremeniti vaše zdravljenje, da bi zmanjšal vaše simptome astme (zasoplost, piskanje v pljučih in kašelj) in izboljšal kontolo vaše astme ter olajšal vaše dihanje.
β2 adrenoreceptor agonists
Agonisti adrenergičnih receptorjev β2
If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid to the lowest dose at which effective control of asthma is maintained, if possible.
V primeru upočasnitve rasti je treba ponovno ovrednotiti zdravljenje z namenom zmanjšanja odmerka inhalacijskih kortikosteroidov na najmanjši odmerek, pri katerem je ohranjen učinkovit nadzor nad simptomi astme, če je to mogoče.
• Keep the mouthpiece closed all the time unless you are about to use your inhaler.
• Ustnik mora biti ves čas zaprt, razen kadar nameravate uporabiti inhalator.
Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure and implantation losses as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Študije razmnoževanja živali z uporabo formoterola so pokazale nekoliko zmanjšano plodnost podganjih samcev pri veliki sistemski izpostavljenosti ter izgube implantatov, pa tudi zmanjšano zgodnje postnatalno preživetje in manjšo maso mladičev ob kotitvi pri stopnjah sistemske izpostavljenosti, ki so bile znatno višje od tiste, dosežene ob klinični uporabi zdravila.
If you are regularly using up to 8 inhalations a day or you need to increase the amount of ‘reliever inhaler' you require, you should see your doctor as soon as possible.
Če redno uporabljate do 8 inhalacij na dan ali morate povečati odmerek »inhalatorja z olajševalcem«, ki ga potrebujete, obiščite zdravnika.
However, these animal experimental results do not seem to be relevant in humans.
Kaže pa, da ti eksperimentalni podatki, dobljeni na živalih, ne veljajo tudi za človeka.
• Do not shake your inhaler before use.
• Inhalatorja pred uporabo ne stresajte.
Close: Breathe out gently and close the mouthpiece cover.
Zaprite: Rahlo izdihnite in zaprite pokrovček ustnika.
Place the mouthpiece between your teeth.
Ustnik nežno namestite med zobe.
Plasma protein binding is approximately 50% for formoterol and 90% for budesonide.
Vezava formoterola na plazemske beljakovine je približno 50 %, vezava budezonida pa 90 %.
After inhalation, 8% to 13% of the delivered dose of formoterol is excreted unmetabolised in the urine.
Po inhalaciji se 8 % do 13 % prejetega odmerka formoterola izloči s sečem v nespremenjeni obliki.
The toxicity observed in animal studies with budesonide and formoterol, given in combination or separately, were effects associated with exaggerated pharmacological activity.
Toksični učinki, ki so jih ugotavljali v študijah uporabe budezonida in formoterola (danih v kombinaciji ali ločeno) pri živalih, so bili vezani na pretirano farmakološko aktivnost zdravila.
Inhaled budesonide has less severe adverse reactions than systemic corticosteroids.
Inhalirani budezonid ima manj hudih neželenih učinkov kot sistemski kortikosteroidi.
Formoterol is a selective β2 adrenoceptor agonist that when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Formoterol je selektiven agonist adrenergičnih receptorjev β2 , ki povzroči hitro in dolgodelujočo relaksacijo gladkega mišičja bronhijev pri bolnikih z reverzibilno obstrukcijo dihalnih poti.
In both studies, lung function was improved and the treatment was well tolerated compared to the corresponding dose of budesonide alone.
Pljučna funkcija se je izboljšala v obeh študijah, bolniki pa so dobro prenašali zdravljenje, v primerjavi z odgovarjajočim odmerkom budezonida v monoterapiji.
Rinse your mouth with water after every dose, and spit it out.
Po vsakem odmerku si usta splaknite z vodo in jo izpljunite.
Very few patients had PIFRs below 40L/min; when PIFRs were less than 40L/min there appeared to be no clustering by age or disease severity.
Pri zelo malo bolnikih je bila najvišja stopnja PIFR nižja od 40 l/min; v teh primerih ni kazalo, da bi bilo to povezano s starostjo ali resnostjo bolezni.
The specific properties of budesonide and formoterol allow the combination to be used as maintenance treatment of asthma.
Posebne lastnosti budezonida in formoterola omogočajo, da se kombinacija teh dveh učinkovin uporablja za vzdrževalno zdravljenje astme.
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.
Ko v običajni praksi dosežemo ustrezen nadzor simptomov z odmerjanjem nižje jakosti zdravila dvakrat na dan, lahko titracijo do manjšega še učinkovitega odmerka opravimo tudi z zmanjšanjem pogostnosti odmerjanja na enkrat na dan, če je po mnenju zdravnika predpisovalca za nadzor bolezni potreben dolgodelujoči bronhodilatator in ne zdravljenje samo z inhalacijskim kortikosteroidom.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/950/001
• Medicines for Parkinson's disease (such as levodopa).
• zdravila proti Parkinsonovi bolezni (npr. levodopa).
When to start using a new Spiromax
Kdaj začeti uporabljati nov inhalator Spiromax
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1 inhaler.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Vsebuje 1 inhalator.
It is not known whether formoterol passes into human breast milk.
Ni znano, ali se formoterol izloča v materino mleko.
Budesonide is excreted in breast milk.
Budezonid se izloča v materino mleko.
How to take an inhalation Every time you need to take an inhalation, follow the instructions below.
Vsakokrat, ko morate vdihniti zdravilo, upoštevajte spodnja navodila.
Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide.
Podatki, zbrani pri približno 2000 nosečnicah, ki so bile izpostavljene inhalacijskemu budezonidu, niso pokazali povečanega tveganja za pojav teratogenih učinkov pri uporabi inhalacijskega budezonida.
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.
Zdravljenja s kombinacijo budezonida in formoterolijevega fumarata dihidrata v fiksnih odmerkih torej ne bi smeli predpisovati skupaj z antagonisti adrenergičnih receptorjev β (vključno s kapljicami za oko), če za to ni tehtnih razlogov.
The exposure of budesonide and formoterol may be increased in patients with liver disease.
Izpostavljenost budezonidu in formoterolu je lahko povečana pri bolnikih z jetrnimi boleznimi.
Each dose contains approximately 5 milligrams of lactose (as monohydrate).
En odmerek vsebuje približno 5 miligramov laktoze (v obliki monohidrata).