natgillin/translations-raw huggingface dataset:
Patients should be advised to have their medicinal product to be used for relief in an acute asthma attack available at all times.
Bolesnicima se mora savjetovati da uz sebe uvijek imaju lijek za olakšavanje simptoma u slučaju napada akutne astme.
Patients should not be initiated on Salmeterol/Fluticasone Pharos during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Bolesnici ne smiju početi uzimati Salmeterol/Fluticasone Pharos tijekom egzacerbacije ili ako imaju znatno pogoršanje ili astmu koja se akutno pogoršava.
Serious asthma-related adverse events and exacerbations may occur during treatment with Salmeterol/Fluticasone Pharos.
Tijekom liječenja sa Salmeterol/Fluticasone Pharosom mogu se javiti ozbiljni štetni događaji povezani s astmom i egzacerbacijom.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Salmeterol/Fluticasone Pharos.
Bolesnicima se mora savjetovati da nastave liječenje, ali i da traže savjet liječnika ako simptomi astme nisu pod kontrolom ili ako se pogoršaju nakon početka uzimanja lijeka Salmeterol/Fluticasone Pharos.
Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should undergo urgent medical assessment.
Iznenadno i progresivno pogoršanje u kontroli astme potencijalno je stanje opasno po život i bolesnik mora proći hitan liječnički pregled.
The patient should also be medically reviewed where the current dosage of Salmeterol/Fluticasone Pharos has failed to give adequate control of asthma.
Bolesnik se također treba pregledati ako trenutačno doziranje lijeka Salmeterol/Fluticasone Pharos nije dovelo do odgovarajuće kontrole astme.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Salmeterol/Fluticasone Pharos.
Kad simptomi budu pod kontrolom, u obzir dolazi postupno smanjivanje doze lijeka Salmeterol/Fluticasone Pharos.
The lowest effective dose of Salmeterol/Fluticasone Pharos should be used (see section 4.2).
U tu se svrhu koristi najniža učinkovita doza lijeka Salmeterol/Fluticasone Pharos (vidi odlomak 4.2.).
For patients with asthma or COPD, consideration should be given to additional corticosteroid therapies.
Za bolesnike s astmom ili KOPB-om u obzir treba uzeti dodatno liječenje kortikosteroidima.
Treatment with Salmeterol/Fluticasone Pharos should not be stopped abruptly in patients with asthma due to risk of exacerbation.
Liječenje s Salmeterol/Fluticasone Pharosom ne smije biti naglo prekinuto u bolesnika s astmom zbog rizika od egzacerbacije.
For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician.
Za bolesnike s KOPB-om prekid liječenja može biti povezan s simptomatskom dekompenzacijom i liječnik ga mora nadzirati.
As with all inhaled medication containing corticosteroids, Salmeterol/Fluticasone Pharos should be administered with caution in patients with pulmonary tuberculosis.
Kao i sa svim inhalacijskim lijekovima koji sadrže kortikosteroide, Salmeterol/Fluticasone Pharos se mora oprezno primjenjivati u bolesnika s tuberkulozom pluća.
Rarely, salmeterol and fluticasone propionate may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses.
Salmeterol i flutikazon priopionat rijetko mogu uzrokovati srčane aritmije, npr. supraventrikularnu tahikardiju, ekstrasistole i fibrilaciju atrija te umjereno prolazno smanjenje serumskog kalija pri visokim terapijskim dozama.
Therefore Salmeterol/Fluticasone Pharos should be used with caution in patients with severe cardiovascular disorders, heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
Stoga se lijek Salmeterol/Fluticasone Pharos mora oprezno upotrebljavati u bolesnika s teškim kardiovaskularnim poremećajima, poremećajima srčanog ritma, diabetesom mellitusom, tireotoksikozom, nekorigiranom hipokalemijom ili unbolesnika koji su skloni niskim razinama kalija u serumu.
There have been very rare reports of increases in blood glucose levels (see section 4.8) and this should be considered when prescribing to patients with a history of diabetes mellitus.
Postoje rijetka izvješća o povećanim razinama glukoze u krvi (vidi odlomak 4.8.), što se mora uzeti u obzir prilikom propisivanja lijekova bolesnicima s diabetesom mellitusom u anamnezi.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.
Kao i s drugom inhalacijskom terapijom, mogu se javiti paradoksalni bronhospazmi s iznenadnim pojačanjem sipnje nakon doziranja.
Salmeterol/Fluticasone Pharos should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Odmah treba prestati uzimati lijek Salmeterol/Fluticasone Pharos, bolesnik se mora pregledati i, ako je to potrebno, treba uspostaviti alternativno liječenje.
Salmeterol/Fluticasone Pharos contains lactose.
Salmeterol/Fluticasone Pharos sadržava laktozu.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim bolestima, kao što su netolerancija galaktoze, Lappova deficijencija laktaze ili malapsorpcija glukoze-galaktoze, ne smiju uzimati ovaj lijek.
Care should be taken when transferring patients to Salmeterol/Fluticasone Pharos therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
Treba biti oprezan prilikom promjene terapije bolesnicima na lijek Salmeterol/Fluticasone Pharos, osobito kad postoji sumnja na oštećenje funkcije nadbubrežne žlijezde uslijed prethodnog liječenja sustavnim steroidima.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Sustavni se učinci mogu javiti s bilo kojim inhalacijskim kortikosteroidima, osobito pri visokim dozama koje su propisane tijekom dužeg vremenskog razdoblja.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Mogući sustavni učinci uključuju Cushingov sindrom, Cushingoidne značajke, adrenalnu supresiju, usporavanje rasta u djece i adolescenata, smanjenje mineralne gustoće kostiju, katarakta, glaukom i, rjeđe, raspon psiholoških i bihevioralnih učinaka koji uključuju psihomotornu hiperaktivnost, poremećaje spavanja, anksioznost, depresiju ili agresiju (osobito u djece).
It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
Stoga je važno da se bolesnici redovito pregledavaju i da doza inhaliranog kortikosteroida bude smanjena na najnižu dozu pri kojoj se održava učinkovita kontrola astme.
Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures.
Simptomi koji se javljaju tipično su nejasni i mogu uključivati anoreksiju, bol u želucu, gubitak težine, pospanost, glavobolju, mučninu, povraćanje, hipotenziju, suženu svijest, hipoglikemiju i napadaje.
Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Tijekom stresnih razdoblja ili elektivnih zahvata može doći u obzir dodatno pokrivanje sustavnim kortikosteroidima.
The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
Prednosti liječenja inhalacijskim flutikazon propionatom trebaju smanjiti potrebu za oralnim steroidima, no bolesnici koji prelaze s oralnih steroida mogu i dalje imati rizik od oštećenja adrenalne rezerve tijekom dužeg vremenskog razdoblja.
Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Bolesnici kojima je ranije bila potrebno liječenje visokim dozama kortikosteroida također su rizični.
This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
Treba računati na mogućnost preostalih oštećenja u hitnim slučajevima i elektivnim situacijama koje vjerojatno uzrokuju stres te se mora uzeti u obzir prikladno liječenje kortikosteroidima.
The extent of the adrenal impairment may require specialist advice before elective procedures.
Raspon adrenalnih oštećenja može zahtijevati savjet stručnjaka prije elektivnih zahvata.
There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5).
Postoji i povećani rizik od sustavnih nuspojava prilikom kombiniranja flutikazon propionata s drugim snažnim inhibitorima CYP3A (vidi odlomak 4.5.).
There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in the TORCH study in patients with COPD receiving salmeterol/ fluticasone propionate compared with placebo (see section 4.8 and 5.1).
Povećao se broj prijava infekcija donjeg respiratornog trakta (osobito pneumonija i bronhitisa) u TORCH ispitivanju u bolesnika s KOPB-om koji primaju salmeterol/flutikazon pripionat u usporedbi s placebom (vidi odlomak 4.8. i 5.1.).
In TORCH, older patients, patients with a lower body mass index (<;25kg/m2) and patients with very severe disease (FEV1<;30% predicted) were at greatest risk of developing pneumonia regardless of treatment.
U TORCH-u, stariji bolesnici, bolesnici s nižim indeksom tjelesne težine (<; 25kg/m2) i bolesnici s vrlo teškom bolešću (FEV<; 30% predviđenog) imali su veći rizik od razvijanja pneumonije neovisno o liječenju.
Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD as the clinical features of such infections and exacerbation frequently overlap.
Liječnici moraju biti na oprezu radi mogućeg razvoja pneumonije i drugih infekcija donjeg respiratornog trakta kod bolesnika s KOPB-om jer se klinički simptomi takvih infekcija i egzacerbacija često preklapaju.
If a patient with severe COPD has experienced pneumonia the treatment with salmeterol/ fluticasone propionate should be re-evaluated.
Ako su bolesnici s teškim KOPB-om imali pneumoniju, mora se ponovo procijeniti liječenje salmeterol/flutikazon propionatom.
Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo (see section 5.1).
Podaci velikog kliničkog ispitivanja (Multicentrično ispitivanje salmeterola u astmi, engl. SMART, the Salmeterol Multi-Center Asthma Research Trial) pokazuju da su bolesnici koji su afroamerikanci imali povećani rizik od teških štetnih događaja povezanih s disanjem ili od smrti tijekom uporabe salmeterola u usporedbi s placebom (vidi odlomak 5.1.).
It is not known if this was due to pharmacogenetic or other factors.
Nije poznato jesu li uzrok tome farmakogenetski ili drugi čimbenici.
Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remained uncontrolled or worsen whilst using salmeterol/ fluticasone propionate.
Stoga, bolesnici crnačkog afričkog ili afrokaripskog podrijetla moraju nastaviti liječenje, ali potražiti savjet liječnika ako simptomi astme nisu pod kontrolom ili se pogoršaju tijekom uzimanja salmeterol/flutikazon propionata.
Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment (see section 4.5).
Stoga, treba izbjegavati istovremeno liječenje ketokonazolom ili drugim snažnim inhibitorom CYP3A4 osim ako prednosti premašuju potencijalni povećani rizik od sustavnih nuspojava liječenja salmeterolom (vidi odlomak 4.5.).
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver.
U normalnim okolnostima, nakon doziranja inhalacijom postižu se niske koncentracije flutikazon propionata u plazmi uslijed opsežnog metaboliziranja prilikom prvog prolaza i visokog sustavnog klirensa koji posreduje citokrom P450 3A4 u crijevu i jetri.
Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
Stoga, nisu vjerojatne klinički značajne interakcije lijekova posredovane flutikazon propionatom.
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations.
U ispitivanju interakcija na zdravim ispitanicima s intranazalnim flutikazon propionatom, ritonavir (visoko potentan inhibitor citokroma P450 3A4) 100 mg b.i.b. povećao je koncentracije flutikazon propionata u plazmi nekoliko stotina puta, što je dovelo do značajnog pada koncentracije kortizola u serumu.
Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Informacije o ovim interakcijama manjkave su za inhalacijski flutikazon propionat, no očekuje se značajni porast razina flutikazon propionata u plazmi.
Cases of Cushing's syndrome and adrenal suppression have been reported.
Prijavljeni su slučajevi Cushingovog sindroma i adrenalne supresije.
In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.
U malom ispitivanju na zdravim dobrovoljcima, ketokonazol, nešto slabiji inhibitor CYP3A, povećao je izloženost flutikazon propionatu za 15% nakon jedne inhalacije.
Caution is recommended and long-term treatment with such drugs should if possible be avoided.
Preporučuje se oprez i treba izbjegavati dugoročno liječenje takvim lijekovima.
Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 mcg inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4-fold Cmax and 15-fold AUC).
Istovremena uporaba ketokonazola (400 mg oralno jednom dnevno) i salmeterola (50 mikrograma inhalacijski dva puta dnevno) u 15 zdravih dobrovoljaca kroz 7 dana dovela je do značajnog povećanja izloženosti plazmatskom salmeterolu (1,4 puta Cmax i 15 puta PIK).
This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see Section 4.4).
To može dovesti do povećane incidencije drugih sustavnih nuspojava liječenja salmeterolom (npr. produženje QTc intervala i palpitacije) u usporedbi sa samostalnim liječenjem salmeterolom ili ketokonazolom (vidi odlomak 4.4.).
Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.
Istovremena uporaba s ketokonazolom nije povećala vrijeme eliminacijskog poluživota salmeterola ili nakupljanje salmeterola s ponavljanim doziranjem.
Co-administration of erythromycin (500mg orally three times a day) and salmeterol (50mcg inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC).
Istovremena uporaba eritromicina (500 mg oralno tri puta dnevno) i salmeterola (50 mikrograma inhalacijski dva puta dnevno) u 15 zdravih dobrovoljaca kroz 6 dana dovela je do malog, ali ne i statistički značajnog povećanja izloženosti salmeterolu (1,4 puta Cmax i 1,2 puta PIK).
4.6 Fertility, pregnancy and lactation
4.6. Plodnost, trudnoća i dojenje
However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility.
No, ispitivanja na životinjama pokazala su da salmeterol i flutikazon nemaju utjecaj na plodnost.
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate.
Umjerena količina podataka o trudnicama (između 300 - 1000 ishoda trudnoće) ne pokazuje malformacijsku ili feto/neonatalnu toksičnost salmeterola i flutikazon propionata.
Animal studies have shown reproductive toxicity after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see section 5.3).
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost nakon primjene agonista beta-2-adrenoreceptora i glukokortikoida (vidi odlomak 5.3.).
Administration of Salmeterol/Fluticasone Pharos to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Davanje lijeka Salmeterol/Fluticasone Pharos trudnicama dolazi u obzir ako je očekivana prednost za majku veća od svih mogućih rizika za fetus.
Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats.
Ispitivanja su pokazala da se salmeterol i flutikazon te njihovi metaboliti izlučuju u mlijeko štakora.
A decision must be made whether to discontinue breast-feeding or to discontinue Salmeterol/Fluticasone Pharos therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Mora se odlučiti hoće li se prekinuti dojenje ili prestati uzimati Salmeterol/Fluticasone Pharos, uzimajući u obzir prednosti dojenja za dijete i prednosti liječenja za majku.
4.7 Effects on ability to drive and use machines
4.7. Utjecaj na sposobnost upravljanja vozilima i strojevima
4.8 Undesirable effects
4.8. Nuspojave
As Salmeterol/Fluticasone Pharos contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected.
S obzirom na to da Salmeterol/Fluticasone Pharos sadrži salmeterol i flutikazon propionat, može se očekivati tip i težina štetnih reakcija koje su povezane sa svakom od sastavnica.
Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency.
U nastavku su navedeni štetni događaji koji su povezani sa salmeterol/flutikazon propionatom, popisani po razredu prema organskim sustavima i učestalosti:
Frequencies are defined as: very common (≥1/10), common (≥1/100 and <;1/10), uncommon (≥1/1000 and <;1/100), rare (≥1/10,000 to <;1/1000), and very rare (<;1/10,000) including isolated reports.
Učestalosti su određene kao: vrlo česte (>; 1/10), česte (≥ 1/100 i <; 1/10), manje česte (≥ 1/1000 i <; 1/100), rijetke (≥ 1/10,000 do <; 1/1000) i vrlo rijetke (<; 1/10,000), uključujući izolirana izvješća.
Very common, common and uncommon events were derived from clinical trial data.
Vrlo česti, česti i manje česti događaji dobiveni su iz podataka kliničkih ispitivanja.
Very rare events were derived from post-marketing spontaneous data.
Vrlo rijetki događaji izvedeni su iz podataka spontano dobivenih nakon stavljanja lijeka na tržište.
System Organ Class
Razred organskog sustava
Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions including anaphylactic shock
Angioedem (uglavnom lica i orofarinksa), respiratorni simptomi (dispneja i/ili bronhospazam), anafilaktičke reakcije, uključujući anafilaktički šok
Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density
Cushingov sindrom, Cushingoidni simptomi, adrenalna supresija, usporavanje rasta u djece i adolescenata, smanjena mineralna gustoća kostiju
Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression and behavioural changes, (predominantly in children)
Psihomotorna hiperaktivnost, poremećaji spavanja, anksioznost, depresija, agresija i promjene ponašanja (uglavnom u djece)
3Reported over 3 years in a COPD study
3Prijavljene tijekom 3 godine ispitivanja KOPB-a
4See section 4.4
4Vidi odlomak 4.4.
The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Prijavljene su farmakološke nuspojave liječenja beta-2-agonistima, kao što su tremor, palpitacije i glavobolja, no uglavnom su prolazne i smanjuju se redovnom terapijom.
Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients.
Zbog djelatne tvari flutikazon propionata, u nekih se bolesnika mogu javiti promuklost i kandidijaza usta i grla.
Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product.
I promuklost i incidencija kandidijaze mogu se smanjiti grgljanjem vode nakon uporabe lijeka.
Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Salmeterol/Fluticasone Pharos.
Simptomatska kandidijaza može se liječiti topikalnim antifungalnim liječenjem uz daljnju uporabu lijeka Salmeterol/Fluticasone Pharos.
Pneumonia was reported in studies of patients with COPD (see section 5.1).
Pneumonija je prijavljena u ispitivanjima bolesnika s KOPB-om (vidi odlomak 5.1.).
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 (see section 4.4).
Mogući sustavni učinci uključuju Cushingov sindrom, Cushingoidne simptome, adrenalnu supresiju, usporavanje rasta u djece i adolescenata, smanjenje mineralne gustoće kostiju, kataraktu i glaukom (vidi odlomak 4.4.).
There have been very rare reports of hyperglycaemia (see section 4.4).
Postoje rijetki izvještaji o hiperglikemiji (vidi odlomak 4.4.).
As with other inhalation therapy, paradoxical bronchospasm may occur (see section 4.4).
Kao i s drugom inhalacijskom terapijom, mogu se javiti paradoksalni bronhospazmi (vidi odlomak 4.4.).
4.9 Overdose
4.9. Predoziranje
There are no data available from clinical trials on overdose with salmeterol/ fluticasone propionate however data on overdose with both drugs are given below:
Ne postoje dostupni podaci iz kliničkih ispitivanja o predoziranju salmeterol/flutikazon propionatom, no u nastavku su navedeni podaci o predoziranju s oba lijeka:
The preferred antidotes are cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
Preferirani antidoti su kardioselektivni beta-blokatori koji se moraju oprezno koristiti u bolesnika s brohnospazmom u anamnezi.
If Salmeterol/Fluticasone Pharos therapy has to be withdrawn due to overdose of the beta agonist component of the drug, provision of appropriate replacement steroid therapy should be considered.
Ako se mora prekinuti liječenje Salmeterol/Fluticasone Pharosom uslijed predoziranja beta-agonistočkom sastavnicom lijeka, u obzir se mora uzeti davanje prikladnog zamjenskog liječenja steroidima.
Acute:
Akutno:
Refer to section 4.4: risk of adrenal suppression:
Pogledati odlomak 4.4.: rizici adrenalne supresije: