natgillin/translations-raw huggingface dataset:
Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively). 
Terapija je prekidana uglavnom zbog mučnine (1,3% u skupini koja je uzimala placebo i 2,2
Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): 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); not known (cannot be estimated from the available data). 
faze bili barem moguće povezani s liječenjem stroncijevim ranelatom, navedene su niže i prema učestalosti razvrstane su na sljedeći način (učestalost u odnosu na placebo): vrlo često (>1/10); često (>1/100, <1/10); manje često (>1/1000, <1/100); rijetko (>1/10 000, <1/1000); vrlo rijetko (<1/10 000); nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
The following adverse reactions have been reported during clinical studies and/or post marketing use with Strontium ranelate. 
Sljedeće nuspojave zabilježene su u kliničkim ispitivanjima i/ili nakon stavljanja stroncijevog ranelata u promet.
How to take protelos 
Kako uzimati PROTELOS
If PROTELOS is used inadvertently during pregnancy, treatment must be stopped. 
PROTELOS nehotice u trudnoći, liječenje se mora obustaviti.
- If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS. 
- Uzimate li lijekove koji sadržavaju kalcij, PROTELOS smijete uzeti tek nakon što prođu najmanje dva sata od uzimanja tih lijekova.
However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists 
No osteoporoza povećava sklonost prijelomima kostiju (frakturama), osobito prijelomima kralješnice, kukova i zapešća
Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population). 
SOTI i TROPOS, sudjelovalo je 1556 bolesnica starijih od 80 godina pri uključivanju u ispitivanju
As a precautionary measure, PROTELOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics. 
PROTELOS-a mora se obustaviti za vrijeme liječenja peroralnim tetraciklinskim ili kinolonskim antibioticima.
This is especially common in women after the menopause Many people with osteoporosis have no symptoms and you may not even know that you have it. 
Mnoge osobe s osteoporozom nemaju nikakvih simptoma, tako da možda ni ne znaju da imaju osteoporozu.
• PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking. 
o Bolesnika sa značajnim čimbenicima rizika za nastanak kardiovaskularnih događaja kao što su hipertenzija, hiperlipidemija, diabetes mellitus ili pušenje.
EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets 
EU/1/04/288/004 56 vrećica EU/1/04/288/005 84 vrećica(3 pakiranja od 28 vrećica) EU/1/04/288/006 100 vrećica
Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal antifracture phase III studies carried-out inpostmenopausal women, was observed. 
Tijekom 12 mjeseci uočeno je statistički značajno povećanje BMD-a lumbalne kralježnice, glavnog kriterija djelotvornost (E (SE)=5,32% (0,75); 95%CI [3,86; 6,79]; p=0,001), je održano tijekom 12
Talk to your doctor or pharmacist before taking PROTELOS: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes, 
- ako imate rizik za srčanu bolest, što uključuje visoki krvni tlak, visoku razinu kolesterola,
In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min. 
U ispitivanjima III. faze klirens kreatinina u 85 % ispitanika bio je između 30 i 70 ml/min, a u njih 6 % bio je manji od 30
Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 
Uzimanjem stroncijeva ranelata s kalcijem ili s hranom smanjuje se bioraspoloživost stroncija za oko 60-70 % u usporedbi s primjenom 3 sata nakon jela.
- If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS. 
- Uzimate li antacide (lijekovi protiv žgaravice), smijete ih uzeti tek nakon što prođu najmanje dva sata od uzimanja PROTELOS-a.
The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study. 
Liječenje osteoporoze u poslijemenopauzi: Program ispitivanja PROTELOS-a u sprječavanju prijeloma sastojao se od dvaju placebom kontroliranih ispitivanja III. faze: ispitivanje SOTI i ispitivanje TROPOS.
In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study. 
U ispitivanjima III. faze, kojima je dokazana djelotvornost PROTELOS -a u sprječavanju prijeloma, izmjerena BMD povećavala se pri uzimanju PROTELOS -a u odnosu na početnu vrijednost za oko 4 % godišnje u slabinskim kralješcima i oko 2 % godišnje u vratu bedrene kosti te se do kraja istraživanja, nakon 3 godine, ovisno o istraživanju, povećala za ukupno 13 % do
The outcome of DRESS is favorable in most cases upon discontinuation of PROTELOS and after initiation of corticosteroid therapy when necessary. 
DRESS-a povoljan nakon prestanka primjene PROTELOS-a i nakon uvođenja liječenja kortikosteroidima kada je neophodno.
Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of PROTELOS, compared with placebo. 
Health perception score) ljestvicom SF-36 također je pokazala koristi PROTELOS-a u odnosu na placebo.
If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately. 
Ukoliko su prisutni simptomi ili znakovi SJS ili TEN (npr. progresivni kožni osip s mjehurićima ili mukoznim lezijama) ili DRESS (npr. osip, vrućica, eozinofilija i sustavni simptomi (npr. adenopatija, hepatitis, intersticijska nefropatija, intersticijska bolest pluća) treba odmah prekinuti primjenu
- if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6). 
- ako ste preosjetljivi (alergični) na stroncijev ranelat ili na bilo koji drugi sastojak PROTELOS
In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo). 
Združena analiza podataka iz ispitivanja SOTI i TROPOS u bolesnica starijih od 80 godina pri uključivanju u ispitivanje, pokazala je da je PROTELOS tijekom 3 godine smanjio relativni rizik od novih prijeloma kralješnice za 32 % (pojavnost prijeloma 19,1 % u skupini koja je uzimala stroncijev ranelat naspram 26,5 % u skupini koja je uzimala placebo).
Each sachet contains 2 g of strontium ranelate. 
Jedna vrećica sadrži 2 g stroncijeva ranelata.
PROTELOS 2 g granules for oral suspension Strontium ranelate 
PROTELOS 2 g granule za oralnu suspenziju stroncijev ranelat
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you develop a rash or these skin symptoms, stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine. 
Ukoliko ste razvili osip ili gore nabrojane kožne simptome prestanite uzimati PROTELOS, hitno zatražite savjet liječnika i recite mu da uzimate ovaj lijek.
Musculo-skeletal fraction > 3 times the upper limit of the normal range. 
Iskustvo nakon stavljanja lijeka u promet b Porast vrijednosti mišićno-koštane frakcije > 3 puta iznad gornje granice normalnog raspona.
In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment) 
Zbirni podaci iz placebom kontroliranih kliničkih ispitivanja na bolesnicama s postmenopauzalnom osteoporozom, bolesnice liječene stroncijevim ranelatom (N=3803, 11 270 bolesnik-godina liječenja)
Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing, shortness of breath and cough). 
(kao npr. vrijed u ustima ili upala desni), bol u kostima, mišićima i/ili u zglobovima, mišični grčevi, gubitak kose, smanjena proizvodnja krvnih stanica u koštanoj srži, svrbež, koprivnjača, pojava mjehurića, angioedem (oticanje lica, jezika ili grla, poteškoće u gutanju ili disanju), otekline na rukama ili nogama, malaksalost, osjećaj smetenosti, bronhijalna hiperreaktivnost (simptomi uključuju piskanje, nedostatak zraka i kašalj).
You should stop taking PROTELOS if you have to take oral tetracyclines or quinolones (two types of antibiotics). 
Ako morate uzimati kroz usta tetracikline ili kinolone (dvije vrste antibiotika), morate prestati uzimati
In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo). 
lumbalne kralješnice i/ili vrata bedrene kosti na početku ispitivanja bila u rasponu osteopenije, bez prisutnosti prijeloma, no s najmanje jednim dodatnim čimbenikom rizika za prijelom (N = 176), pokazala je da je PROTELOS tijekom 3 godine smanjio rizik od prvog prijeloma kralješnice za 72 % (incidencija prijeloma kralješnice 3,6 % u skupini koja je uzimala stroncijev ranelat naspram 12,0 % u skupini koja je uzimala placebo).
Physico-chemical data suggest excretion of Strontium ranelate in human milk.. PROTELOS should not be used during breast-feeding. 
Fizikalno-kemijski podaci ukazuju da se stroncijev ranelat izlučuje u majčino mlijeko.
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2). 
Stroncijev se ranelat ne preporučuje bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina manji od 30 ml/min) (vidjeti dijelove 4.4 i 5.2).
INFORMATION IN BRAILLE PROTELOS 2 g 
16. PODACI NA BRAILLEOVOM PISMU PROTELOS
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in PROTELOS treated patients compared to placebo (see section 4.8). 
Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnica s osteoporozom u postmenopauzi primjećen je značajan porast infarkta miokarda kod bolesnica liječenih PROTELOS
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS. 
(Stevens-Johnson-ov sindrom, toksična epidermalna nekroliza i teške reakcije preosjetljivosti (DRESS)).
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in PROTELOS treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]). 
om u usporedbi s placebom (1,7% u usporedbi s 1,1 %), s relativnim rizikom od 1,6 (95% CI = [1,07 ;
PROTELOS is a non-hormonal medicine used to treat severe osteoporosis: - in postmenopausal women, - in men, at high risk of fracture, for whom other alternative treatments are not possible. 
- u žena u poslijemenopauzi - u muškaraca s visokim rizikom za nastanak prijeloma, kod kojih drugo liječenje nije moguće.
Excipient 
Dispepsija
PROTELOS 2 g granules for oral suspension 
NAZIV LIJEKA PROTELOS 2 g granule za oralnu suspenziju
NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate 
Uputa o lijeku: Informacija za bolesnika PROTELOS 2 g granule za oralnu suspenziju stroncijev ranelat
PROTELOS is for oral use. 
Način primjene Za peroralnu primjenu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate. 
Jedna vrećica sadržava 2 g stroncijeva ranelata.
Treatment of postmenopausal osteoporosis: 
Mehanizam djelovanja Stroncijev ranelat in vitro:
s r.o. 
PROTELOS-om.
Symptoms 
Mučnina
Children and adolescents Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years. 
Djeca i adolescenti Hirobriz Breezhaler se ne smije davati djeci ili adolescentima mlađim od 18 godina.
Hirobriz Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks. 
Hirobriz Breezhaler se može koristiti tijekom trudnoće samo ako je očekivana korist veća od mogućih rizika.
Hirobriz Breezhaler should be administered at the same time of the day each day. 
Hirobriz Breezhaler treba primjenjivati svakog dana u isto vrijeme.
Do not use Hirobriz Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6). 
Nemojte primjenjivati Hirobriz Breezhaler - ako ste alergični na indakaterol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Hirobriz Breezhaler (i.e. medicines such as salmeterol and formoterol). 
Posebno Vas molimo da obavijestite svog liječnika ako uzimate: lijekove za probleme s disanjem koji su slični Hirobriz Breezhaleru (tj. lijekovi kao što su salmeterol i formoterol).
If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Hirobriz Breezhaler should be discontinued immediately and alternative therapy instituted. 
Ako znakovi koji se pojave ukazuju na alergijsku reakciju (osobito poteškoće u disanju ili gutanju, oticanje jezika, usana i lica, urtikarija, osip na koži), primjenu Hirobriz Breezhaler treba odmah prekinuti i uvesti alternativnu terapiju.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hirobriz Breezhaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Hirobriz Breezhaler uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
COPD is a long-term disease and you should use Hirobriz Breezhaler every day and not only when you have breathing problems or other symptoms of COPD. 
KOPB je dugotrajna bolest i trebate primijeniti Hirobriz Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
Please read the following instructions carefully to learn how to use and care for your Hirobriz Breezhaler inhaler. 
Molimo Vas da pažljivo pročitate upute u nastavku kako biste naučili primjenjivati i brinuti se o svom Hirobriz Breezhaler inhalatoru.
You should not use Hirobriz Breezhaler unless your doctor tells you so. 
Nemojte koristiti Hirobriz Breezhaler osim ako Vam to nije rekao liječnik.
During treatment with Hirobriz Breezhaler, Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. 
Tijekom liječenja Hirobriz Breezhalerom, prestanite primjenjivati lijeka i odmah se obratite svom liječniku ako osjetite stezanje grudnog koša, kašljanje, piskanje ili kratkoću daha odmah nakon primjene lijeka.
The 24-hour bronchodilator effect of Hirobriz Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis). 
Bronhodilatacijski 24-satni učinak Hirobriz Breezhalera bio je zadržan od prve doze kroz jednogodišnje razdoblje liječenja bez dokaza gubitka djelotvornosti (tahifilaksija).
The mean of the maximum changes in blood glucose were similar between Hirobriz Breezhaler and placebo. 
Srednja vrijednost najvećih promjena glukoze u krvi bila je slična za Hirobriz Breezhaler i placebo.
During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Hirobriz Breezhaler at the recommended doses than on placebo. 
Tijekom ispitivanja, klinički značajne promjene glukoze u krvi u pravilu su bile češće za 1-2% pri primjeni Hirobriz Breezhalera u preporučenim dozama nego pri primjeni placeba.
As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Hirobriz Breezhaler treatment and those patients who received placebo or treatment with tiotropium. 
Kao što je pokazano u 605 bolesnika s KOPB-om u dvostruko slijepom, placebo kontroliranom ispitivanju faze III u trajanju od 26 tjedana, nije bilo klinički značajne razlike u razvoju aritmičkih događaja praćenih tijekom 24 sata, na početku i do 3 puta tijekom razdoblja liječenja od 26 tjedana, između bolesnika koji bili liječeni preporučenim dozama Hirobriz Breezhalera i onih koji su primali placebo ili bili liječeni tiotropijem.
If you have questions about how long to continue your treatment with Hirobriz Breezhaler, talk to your doctor or pharmacist. 
Ako imate pitanja o tome koliko dugo trebate provoditi liječenje Hirobriz Breezhalerom, obratite se svom liječniku ili ljekarniku.
As with other inhalation therapy, administration of Hirobriz Breezhaler may result in paradoxical bronchospasm that may be life-threatening. 
Kao i kod drugih inhalacijskih terapija, primjena Hirobriz Breezhalera može dovesti do paradoksalnog bronhospazma koji može ugroziti život.
Therefore, long-acting beta2-adrenergic agonists such as Hirobriz Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval. 
Stoga, dugodjelujuće beta2adrenergičke agoniste kao što je Hirobriz Breezhaler treba oprezno koristiti u bolesnika s poznatim ili suspektnim produljenjem QT intervala ili u onih koji se liječe lijekom koji utječe na QT interval.
At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of recommended doses. 
Pri dozi od 600 mikrograma jedanput na dan, sigurnosni profil Hirobriz Breezhalera u cjelini je bio sličan onom pri preporučenim dozama.
The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6). 
Kapsule se moraju primjenjivati samo uz pomoć Hirobriz Breezhaler inhalatora (vidjeti dio 6.6).
If you use more Hirobriz Breezhaler than you should If you have inhaled too much Hirobriz Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. 
Ako ste udahnuli previše Hirobriz Breezhalera ili ako je netko drugi koristio Vaše kapsule, morate odmah obavijestiti svog liječniku ili otići u najbližu jedinicu hitne pomoći.
Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler. 
Istodobna primjena drugih simpatomimetičkih lijekova (samih ili u kombiniranom liječenju) može potencirati nuspojave Hirobriz Breezhalera.
Hirobriz Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory capacity during exercise and at rest, compared to placebo. 
Dokazano je da Hirobriz Breezhaler smanjuje plućnu hiperinflaciju, što dovodi do povećanog kapaciteta udisanja tijekom vježbe i u mirovanju, u usporedbi s placebom.
Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists. 
Hirobriz Breezhaler ne treba koristiti zajedno s drugim dugodjelujućim beta2-adrenergičkim agonistima ili lijekovima koji sadrže dugodjelujuće beta2-adrenergičke agoniste.
In addition, patients treated with Hirobriz Breezhaler required significantly less rescue medication, had more days when no rescue medication was needed compared to placebo and had a significantly improved percentage of days with no daytime symptoms. 
Osim toga, bolesnici liječeni Hirobriz Breezhalerom trebali su značajno manje lijekova za hitno ublažavanje simptoma, imali su više dana bez lijekova za hitno ublažavanje simptoma u usporedbi s placebom te su imali značajno povećanje postotka dana bez dnevnih simptoma.
Systemic exposures (AUC) in rats and mice at the no-observed adverse effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with Hirobriz Breezhaler once a day at a dose of 300 microgram. 
Sistemska izloženost (AUC) na razinama na kojima nisu bile zapažene nuspojave u ovim je ispitivanjima u štakora i miševa bila najmanje 7, odnosno 49 puta veća od one u ljudi liječenih Hirobriz Breezhalerom jedanput na dan u dozi od 300 mikrograma.
Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Hirobriz Breezhaler at recommended therapeutic doses (see section 5.1). 
Klinički važni učinci produljenja QTc-intervala nisu bili zapaženi u ispitivanjima Hirobriz Breezhalera u preporučenim terapijskim dozama (vidjeti dio 5.1).
The European Medicines Agency has waived the obligation to submit the results of studies with Hirobriz Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Hirobriz Breezhalera u svim podskupinama pedijatrijske populacije s kroničnom opstruktivnom plućnom bolešću (KOPB) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Hirobriz Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma. 
Hirobriz Breezhaler je dugodjelujući beta2-adrenergički agonist koji je indiciran samo za KOPB i ne treba se koristiti u astmi jer nema podataka o ishodima pri dugotrajnoj primjeni u astmi.
Paediatric population There is no relevant use of Hirobriz Breezhaler in the paediatric population (under 18 years). 
Nema relevantne primjene Hirobriz Breezhaler u pedijatrijskoj populaciji (mlađih od 18 godina).