FrancophonIA/ELRC3.0 huggingface dataset:
English: if you have problems with your heart, including reduced heart rate, or if the results of an electrocardiogram (ECG) have shown that you have an abnormality of the electrical activity of your heart known as “prolonged QT interval”.
Slovenian: Pred začetkom jemanja zdravila Zykadia se posvetujte z zdravnikom ali farmacevtom: če imate težave z jetri, če imate težave s pljuči ali dihanjem, če imate težave s srcem, vključno z upočasnjenim srčnim utripom, ali če je vaš elektrokardiogram (EKG) pokazal nepravilnost električne aktivnosti srca, ki jo imenujemo "podaljšanje intervala QT", če imate sladkorno bolezen (zvišano raven sladkorja v krvi), če imate težave s trebušno slinavko, če trenutno jemljete steroide.
English: Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Slovenian: Bolnike s pljučnimi simptomi, ki lahko pomenijo intersticijsko pljučno bolezen oziroma pnevmonitis, je treba spremljati in pri njih izključiti druge možne vzroke za razvoj intersticijske pljučne bolezni oziroma pnevmonitisa (glejte poglavji 4.2 in 4.4).
English: Hepatobiliary disorders Abnormal liver function tests h
Slovenian: Bolezni jeter, žolčnika in žolčevodov patološke vrednosti testov jetrne funkcije h pogosti hepatotoksičnost i pogosti
English: Tumour responses (based on BIRC) Objective response rate (95% CI) Duration of response Number of responders Median, months d
Slovenian: a vrednost p b tumorski odzivi (po presoji odbora BIRC) objektivna stopnja odziva (95-odstotni IZ) 39,1 % (30,2, 48,7) trajanje odziva število bolnikov z odzivom mediana, meseci d
English: Titanium dioxide (E171) Macrogol
Slovenian: Filmska obloga hipromeloza titanov dioksid (E171) makrogol smukec indigotin aluminijev lak (E132)
English: Ammonium hydroxide 28%
Slovenian: a eksaktni binomski 95-odstotni interval zaupanja
English: Heart rate less than 60 beats per minutes (bpm)
Slovenian: a srčna frekvenca manj kot 60 utripov na minuto b če se težave ponovijo, je treba zdravilo dokončno ukiniti
English: Hazard Ratio = 0.55
Slovenian: verjetnost (%) za odsotnost dogodka razmerje ogroženosti = 0,55
English: Based on in vitro data, ceritinib also inhibits CYP2A6 and CYP2E1 at clinically relevant concentrations.
Slovenian: Po podatkih in vitro ceritinib v klinično ustreznih koncentracijah zavira tudi CYP2A6 in CYP2E1, zato bi ceritinib lahko zvišal plazemske koncentracije sočasno uporabljanih zdravil, ki se presnavljajo predvsem s tema encimoma.
English: Concurrent elevations of ALT or AST greater than 3× ULN and total bilirubin greater than 2× ULN without elevated alkaline phosphatase have been observed in less than 1% of patients in clinical studies with ceritinib.
Slovenian: V kliničnih študijah s ceritinibom so pri manj kot 1 % bolnikov opažali sočasno zvišanje vrednosti alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST), ki je presegalo 3-kratnik zgornje meje normalnih vrednosti (ZMN) in zvišanje vrednosti celokupnega bilirubina, ki je presegalo 2-kratnik ZMN, brez sočasnega zvišanja vrednosti alkalne fosfataze.
English: medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital).
Slovenian: Naslednja zdravila lahko zmanjšajo učinkovitost zdravila Zykadia: šentjanževka, zdravilo rastlinskega izvora za zdravljenje depresije; zdravila za preprečevanje epileptičnih napadov (antiepileptiki, kot so fenitoin, karbamazepin in fenobarbital); zdravila za zdravljenje tuberkuloze (npr. rifampicin, rifabutin).
English: Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices (e.g. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin,
Slovenian: Izogibati se je treba sočasnemu odmerjanju ceritiniba s substrati, ki se presnavljajo predvsem s CYP3A oziroma so substrati CYP3A z ugotovljenim nizkim terapevtskim indeksom (kot so alfuzosin, amiodaron, cisaprid, ciklosporin, dihidroergotamin, ergotamin, fentanil, pimozid, kvetiapin, kinidin, lovastatin, simvastatin, sildenafil, midazolam, triazolam, takrolimus, alfentanil in sirolimus) in namesto njih, če je mogoče, uporabljati druge učinkovine, ki so manj občutljive na zaviranje CYP3A4.
English: Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products transported by these proteins.
Slovenian: Na osnovi podatkov in vitro ocenjujejo, da ceritinib v klinično ustreznih koncentracijah zavira intestinalni P-gp in BCRP, zato bi ceritinib lahko zvišal plazemsko koncentracijo sočasno uporabljanih zdravil, ki jih prenašata ta dva proteina.
English: QTc prolongation has been observed in patients treated with ceritinib.
Slovenian: Pri bolnikih, ki so prejemali ceritinib, so opažali podaljšanje intervala QTc.
English: In the event of life-threatening bradycardia Zykadia should be permanently discontinued if no contributing concomitant medicinal product is identified; however, if associated with a concomitant medicinal product known to cause bradycardia or hypotension, Zykadia should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Slovenian: V primeru življenjsko nevarne bradikardije je treba zdravljenje z zdravilom Zykadia dokončno ukiniti, če bolnik ne jemlje sočasno nobenega od zdravil, ki bi lahko prispevala k razvoju bradikardije.
English: Ceritinib AUCinf values were approximately 39% and 64% higher (Cmax approximately 42% and 58% higher) in healthy subjects when a single 750 mg ceritinib dose (tablet) was administered with a low fat meal (containing approximately 330 kcalories and 9 grams of fat) and a high fat meal (containing approximately 1000 kcalories and 58 grams of fat), respectively, as compared with the fasted state.
Slovenian: Pri zdravih osebah se je pri zaužitju enkratnega odmerka 750 mg ceritiniba (tablet) skupaj z obrokom z nizko vsebnostjo maščob (ki je vseboval približno 330 kilokalorij in 9 gramov maščob) AUCinf povečala za približno 39 %, Cmax pa se je zvišala za približno 42 % v primerjavi z odmerjanjem zdravila na tešče.
English: Ceritinib AUCinf values were approximately 58% and 73% higher (Cmax approximately 43% and 41% higher) in healthy subjects when a single 500 mg ceritinib dose was administered with a low fat meal (containing approximately 330 kcalories and 9 grams of fat) and a high fat meal (containing approximately 1000 kcalories and 58 grams of fat), respectively, as compared with the fasted state.
Slovenian: Pri zdravih osebah se je pri zaužitju enkratnega odmerka 500 mg ceritiniba skupaj z obrokom z nizko vsebnostjo maščob (ki je vseboval približno 330 kilokalorij in 9 gramov maščob) AUCinf povečala za približno 58 %, Cmax pa se je zvišala za približno 43 % v primerjavi z odmerjanjem zdravila na tešče.
English: Cellulose, microcrystalline Hydroxypropylcellulose, low-substituted Sodium starch glycolate (type A) Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi Vsebina kapsule celuloza, mikrokristalna hidroksipropilceluloza, malo substituirana natrijev karboksimetilškrob (vrsta A) magnezijev stearat silicijev dioksid, koloidni, brezvodni
English: Increases to grade 3 or 4 ALT elevations were observed in 25% of patients.
Slovenian: Pri 25 % bolnikov so opažali zvišanje vrednosti alanin-aminotransferaze stopnje 3 ali 4.
English: The primary route of excretion of ceritinib and its metabolites is in the faeces.
Slovenian: Ceritinib in njegovi presnovki se večinoma izločajo z blatom.
English: 53.7% of the study population was Caucasian, 42.0% Asian, 1.6% Black and 2.6% other races The majority of patients had adenocarcinoma (96.5%) and had either never smoked or were former smokers (92.0%).
Slovenian: 53,7 % študijske populacije je bilo belcev, 42,0 % je bilo pripadnikov rumene rase, 1,6 % pripadnikov črne rase in 2,6 % pripadnikov drugih ras.
English: Cellulose, microcrystalline Hydroxypropylcellulose, low-substituted Povidone
Slovenian: 6.1 Seznam pomožnih snovi Jedro tablete celuloza, mikrokristalna hidroksipropilceluloza, malo substituirana povidon natrijev karmelozat, premreženi magnezijev stearat silicijev dioksid, koloidni, brezvodni
English: How much to take The recommended dose is 450 mg (three tablets) taken once daily with food, although your doctor could modify this recommendation if needed.
Slovenian: Priporočeni odmerek je 450 mg (tri tablete) enkrat na dan skupaj s hrano.
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, reinitiate Zykadia at the previous dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Slovenian: Če je taka bradikardija povezana s sočasno uporabo zdravila, za katerega je znano, da povzroča bradikardijo ali hipotenzijo, je treba odmerjanje zdravila Zykadia prekiniti začasno do prenehanja simptomov bradikardije oziroma zvišanja srčne frekvence na 60 utripov na minuto ali več.
English: Based on the stratified Cox proportional hazards analysis.
Slovenian: a na osnovi analize stratificiranih podatkov s Coxovim modelom proporcionalnih tveganj b na osnovi stratificiranega log-rank testa c analiza celokupnega preživetja ni bila prilagojena na učinek zamenjave zdravila d ocena s pomočjo Kaplan-Meierjeve metode
English: The presence was assumed.
Slovenian: Prisotnost je bila predpostavljena.
English: The CVMP Opinion was adopted on 14 February 2007 and the subsequent Commission Decision on 22 May 2007.
Slovenian: Mnenje CVMP je bilo sprejeto 14. februarja 2007, s tem povezana odločba Komisije pa 22. maja 2007.
English: In December 2005, a Mutual Recognition Procedure (MRP) started with Spain acting as Reference Member State and ten Concerned Member States.
Slovenian: Decembra 2005 se je pričel postopek medsebojnega priznavanja s Španijo kot referenčno državo članico ter desetimi zadevnimi državami članicami.
English: These are all references provided with the original submission.
Slovenian: Vse te reference so bile predložene s prvotno vlogo.
English: London, June 2008 EMEA/532206/2007- Rev.1
Slovenian: London, junij 2008 EMEA/532206/2007- Rev.1
English: Annex I of Directive 2001/82/EC as amended by directive 2004/28/EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Slovenian: V Prilogi I Direktive 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/EC, je navedeno, da so postmarketinške izkušnje z drugimi zdravili, ki vsebujejo enake sestavine, posebnega pomena, zato morajo predlagatelji temu nameniti posebno pozornost.
English: Therefore, the recommendation is to remove this pathogen from the indications.
Slovenian: Posledično je priporočeno, da se ta patogen izloči iz indikacij.
English: The applicant provided a justification for submission of this application on a “well-established use” basis.
Slovenian: Predlagatelj je svojo vlogo utemeljil na podlago „dobro uveljavljene uporabe“.
English: Germany considered that the product could represent a potential serious risk to animal health on the grounds that the efficacy had not been sufficiently substantiated.
Slovenian: Nemčija je menila, da bi lahko zdravilo predstavljalo možno resno tveganje za zdravje živali, saj učinkovitost ni bila zadostno utemeljena.
English: Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Slovenian: Zato je CVMP menil, da so zgoraj navedena poročila ustrezen dokaz za varnost in učinkovitost doksiciklina na splošno, pa tudi specifičnega končnega pripravka, ki se trži v Španiji.
English: Germany could not agree to the granting a marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Slovenian: Nemčija se ni strinjala z odobritvijo dovoljenja za promet, zato je bila zadeva napotena na Ukslajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v veterinarski medicini (CMD(v)) in nato na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: EMEA/532206/2007- Rev.1
Slovenian: EMEA/532206/2007- Rev.1-SL
English: The applicant submitted a scientific report on Porcine Respiratory Disease Complex (PRDC).
Slovenian: Predlagatelj je predložil znanstveno poročilo o kompleksu prašičjih bolezni dihal (PRDC).
English: The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Doxyprex 100 mg premix.
Slovenian: CVMP je med svojim zasedanjem 21. in 22. junija 2006 pričel napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Doxyprex 100 mg Premix.
English: The CVMP recommended the granting of the marketing authorisation to Doxyprex 100 mg/g Premix for medicated feeding stuff for pigs for the following indication because a positive benefit/risk analysis has been demonstrated and no potential serious risk has been identified.
Slovenian: CVMP je priporočil odobritev dovoljenja za promet z zdravilom Doxyprex 100 mg/g Premix za predmešanico za pripravo zdravilne krmne mešanice za prašiče za naslednjo indikacijo, ker je bilo v analizi ugotovljeno pozitivno razmerje med koristmi in tveganji, hkrati pa ni bilo dokazano nobeno možno resno tveganje.
English: Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/kg once daily for 5 days are stated as having been authorised since 1985.
Slovenian: Navedel je, da so v EU predmešanice na podlagi doksiciklina za prašiče v priporočljivih odmerkih 10 mg/kg enkrat dnevno do 5 dni odobrene od leta 1985.
English: The applicant justifies that the presence of M. hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
Slovenian: Prijavitelj utemeljuje, da prisotnosti M. hyopneumoniae niso določevali z bakteriološkimi metodami, ker je bilo v času študije ta organizem težko osamiti.
English: However, the CVMP considered that the fact that no post treatment bacteriological samples were taken mean that bacteriological cure cannot be assumed or claimed.
Slovenian: Vendar pa je CVMP menil, da glede na dejstvo, da po zdravljenju bakteriološki vzorci niso bili odvzeti, bakteriološke ozdravitve ni mogoče predpostavljati ali navajati.
English: Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg bags containing 100 mg/g doxycycline base as hyclate.
Slovenian: Zdravilo Doxyprex 100 mg je na voljo v 5 kg, 20 kg in 25 kg vrečah in vsebuje 100 mg/g doksiciklina v obliki hiklata.
English: A benefit-risk analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
Slovenian: Analize koristi in tveganj ni bilo mogoče izvesti zaradi pomanjkanja osrednjih dokazov o klinični učinkovitosti za indikacijo bakterija M. hyopneumoniae.
English: The Marketing Authorisation Holder (MAH) was requested to substantiate the efficacy of the product.
Slovenian: Od imetnika dovoljenja za promet z zdravilom je bilo zahtevano, da utemelji učinkovitost zdravila.
English: In the pivotal clinical trial, the presence of P. multocida and B. bronchiseptica was clearly demonstrated in sick pigs, however, no post treatment sampling was done to show bacteriological cure.
Slovenian: V glavnem kliničnem preskušanju je bila prisotnost P. multocida in B. bronchiseptica pri prašičih jasno dokazana, vendar pa ni bilo izvedeno vzorčenje po končanem zdravljenju, ki bi lahko dokazalo bakteriološko ozdravitev.
English: The product is authorised with the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Slovenian: Zdravilo je odobreno za zdravljenje bolezni dihal pri prašičih, ki jo povzročajo Pasteurella multocida, Bordetella bronchiseptica in Mycoplasma hyopneumoniae.
English: The applicant provided evidence of efficacy of the active substance, doxycycline, against M. hyopneumoniae in pigs from published literature and from MIC studies.
Slovenian: Predlagatelj je predložil dokaze o učinkovitosti zdravilne učinkovine doksiciklin proti bakteriji M. hyopneumoniae pri prašičih iz objavljene literature in študij MIK.
English: “For the treatment and prevention of porcine respiratory disease, caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.”
Slovenian: „Za zdravljenje in preprečevanje bolezni dihal pri prašičih, ki jo povzročata na doksiciklin občutljivi bakteriji Pasteurella multocida in Bordetella bronchiseptica, če je bila bolezen diagnosticirana v čredi.“
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOXYPREX 100mg PREMIX
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI (CVMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4) ZA ZDRAVILO DOXYPREX 100 mg PREMIX
English: 1 pre-filled syringe with needle guard
Slovenian: 1 napolnjena injekcijska brizga s ščitnikom igle
English: 1 pre-filled syringe pre-filled syringe (glass) with needle guard
Slovenian: 1 napolnjena injekcijska brizga napolnjena injekcijska brizga (steklena) s ščitnikom igle
English: Pack size pre-filled syringe (glass)
Slovenian: Velikost pakiranja napolnjena injekcijska brizga (steklena)
English: • you regularly drink alcohol.
Slovenian: • redno pijete alkohol.
English: Mogilska 80 Str. 31-546 Kraków Poland
Slovenian: Mogilska 80 Str. 31-546 Kraków Poljska
English: Some medicines may increase the effects of DuoResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Slovenian: Nekatera zdravila lahko povečajo učinek zdravila DuoResp Spiromax in zdravnik vas bo morda želel skrbno spremljati, če jemljeta ta zdravila (vključno z nekaterimi zdravili za HIV: ritonavirjem,
English: • It is important to use DuoResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
Slovenian: • Pomembno je, da zdravilo DuoResp Spiromax uporabite vsak dan, tudi če trenutno nimate simptomov astme ali KOPB.
English: The use of DuoResp Spiromax follows three steps: open, breathe and close which are outlined below.
Slovenian: Uporaba zdravila DuoResp Spiromax zajema tri korake: odprite, vdihnite in zaprite, ki so opisani spodaj.
English: If these effects occur, they are usually mild and usually disappear as you continue to use DuoResp Spiromax.
Slovenian: Če se ti učinki pojavijo, so po navadi blagi in po navadi izginejo med nadaljevanjem zdravljenja z zdravilom DuoResp Spiromax.
English: If patients find the treatment ineffective, or exceed the highest recommended dose of DuoResp Spiromax, medical attention must be sought (see section 4.2).
Slovenian: Če bolnik ugotavlja, da je zdravljenje neučinkovito, ali če preseže največji priporočeni odmerek zdravila DuoResp Spiromax, mora poiskati zdravniško pomoč (glejte poglavje 4.2).
English: 3 years.
Slovenian: 6-krat.
English: The dosage of DuoResp Spiromax is individual and should be adjusted to the severity of the disease.
Slovenian: Odmerjanje zdravila DuoResp Spiromax je individualno in ga je treba prilagoditi stopnji resnosti bolezni.
English: DuoResp Spiromax should be used correctly in order to achieve effective treatment.
Slovenian: Zdravilo DuoResp Spiromax je treba uporabljati pravilno, da bo doseženo učinkovito zdravljenje.
English: • An increase in the amount of sugar (glucose) in your blood, when you have a blood test.
Slovenian: • zvišan sladkor (glukoza) v krvi, kar pokaže krvni test,
English: - The other ingredient is lactose monohydrate (see section 2 under ‘DuoResp Spiromax contains lactose')
Slovenian: - Pomožna snov je laktoza monohidrat (glejte poglavje 2 pod »Zdravilo DuoResp Spiromax vsebuje laktozo«).
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 DuoResp Spiromax - do NOT use this medicine unless your doctor tells you to.
Slovenian: • 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 DuoResp Spiromax zdravila NE uporabljajte, če vam tega izrecno ne naroči zdravnik.
English: The prophylactic use of DuoResp Spiromax, e.g. before exercise, has not been studied.
Slovenian: Profilaktična uporaba zdravila DuoResp Spiromax, na primer pred telesnim naporom, ni bila preučena.
English: • If you are using DuoResp Spiromax for asthma, your doctor will want to regularly check your symptoms.
Slovenian: • Če zdravilo DuoResp Spiromax uporabljate za astmo, vas bo zdravnik redno nadziral glede simptomov.
English: • Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath).
Slovenian: • bronhospazem (krči mišic dihalnih poti, ki povzročijo piskajoče in težko dihanje).
English: DuoResp Spiromax has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo DuoResp Spiromax nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: If you feel you are getting breathless or wheezy while using DuoResp Spiromax, you should continue to use DuoResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment.
Slovenian: Če se vam med zdravljenjem z zdravilom DuoResp Spiromax zdi, da dihanje postaja težje ali piskajoče, zdravilo uporabljajte še naprej, vendar pa čim prej obiščite zdravnika, saj boste morda potrebovali dodatno zdravljenje.
English: 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 DuoResp Spiromax.
Slovenian: 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 DuoResp Spiromax.
English: The amount of DuoResp Spiromax to use and when to use it depends on how it has been prescribed for you.
Slovenian: Količina zdravila DuoResp Spiromax, ki jo morate uporabiti, in čas, ko morate zdravilo uporabiti, sta odvisna od tega, kako vam je zdravnik predpisal zdravilo.
English: The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose 3 mg) on average six-fold.
Slovenian: Močni zaviralec CYP3A4 ketokonazol je v odmerku 200 mg enkrat na dan povečal plazemsko koncentracijo sočasno uporabljanega peroralnega budezonida (enkratni odmerek 3 mg) v povprečju za
English: If you are doing exercise and you get asthma symptoms, use DuoResp Spiromax as described here.
Slovenian: Če se med telesno dejavnostjo pojavijo simptomi astme, uporabite zdravilo DuoResp Spiromax, kot je opisano tukaj.
English: When it is appropriate to titrate down to a lower strength than is available for DuoResp Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Slovenian: Kadar je primerno titrirati zdravilo na nižji odmerek, kot je na voljo pri zdravilu DuoResp Spiromax, je potreben prehod na alternativno fiksno kombinacijo budezonida in formoterolijevega fumarata, ki vsebuje nižje odmerke inhalacijskega kortikosteroida.
English: If any of the following happen to you, stop using DuoResp Spiromax and talk to your doctor immediately:
Slovenian: Če se pri vas pojavi kaj od naslednjega, prenehajte uporabljati zdravilo DuoResp Spiromax in se nemudoma posvetujte z zdravnikom: