natgillin/translations-raw huggingface dataset:
EU/1/04/288/006 
EU/1/04/288/006 100 vrečk
If you take too many sachets of PROTELOS, tell your doctor or pharmacist. 
Če ste vzeli večji odmerek zdravila PROTELOS, kot bi smeli Če ste vzeli preveč vrečk zdravila PROTELOS, obvestite svojega zdravnika ali farmacevta.
PROTELOS 2 g granules for oral suspension Strontium ranelate 
PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. 
Sindrom DRESS se v začetku pojavi v obliki gripi podobnih simptomov in izpuščaja na obrazu, nato v obliki razširjenega izpuščaja z visoko telesno temperaturo, zvišanih vrednosti jetrnih encimov,
Pregnancy and breast-feeding: 
Nosečnost in dojenje
An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤3 SD (manufacturer's range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i.e. 40% of the TROPOS study population)]. 
Analizo a posteriori so izvedli tudi pri podskupini bolnic iz študije TROPOS, ki so bile zlasti medicinsko zanimive in imele veliko tveganje za zlome [opredeljeno kot MKG vratu stegnenice vrednost T ≤ -3 SD (izdelovalčev razpon je ustrezal -2,4 SD po merilih NHANES III - National
It is recommended that you take PROTELOS at bedtime, preferably at least 2 hours after dinner. 
Priporočeni odmerek je ena vrečka po 2 g na dan. Priporočljivo je, da PROTELOS jemljete pred spanjem, najbolje vsaj 2 uri po večerji.
Stevens-Johnson syndrome and toxic epidermal necrolysis appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Stevens-Johnsonov sindrom in toksična epidermalna nekroliza se sprva pojavita v obliki rdečkastih,
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. 
Če na koži opazite izpuščaj ali opisane simptome, prenehajte z jemanjem zdravila PROTELOS in nemudoma poiščite zdravniško pomoč ter zdravniku povejte, da jemljete to zdravilo.
Psychiatric disorders Frequency unknown:a Confusional state Insomnia Nervous system disorders Common: Headache Disturbances in consciousness Memory loss Uncommon: Seizures Frequency unknown:a Paraesthesia Dizziness Vertigo Cardiac disorders Commond: Myocardial infarction Vascular disorders Common: Venous thromboembolism (VTE) Respiratory, thoracic and mediastinal disorders Frequency unknown:a Bronchial hyperreactivity Gastrointestinal disorders Common: Nausea Diarrhoea Loose stools Frequency unknown:a Vomiting 
Bolezni dihal, prsnega koša in mediastinalnega prostora Neznana pogostnost:a hiperaktivnost bronhijev Bolezni prebavil Pogosti: slabost diareja mehko blato Neznana pogostnost:a bruhanje bolečine v trebuhu razdraženje ustne sluznice (stomatitis in/ali razjede v ustih) gastroezofagealni refluks dispepsija zaprtje flatulenca suha usta
- in postmenopausal women, 
Zlasti pogosto se to dogaja pri ženskah v obdobju po menopavzi.
Physico-chemical data suggest excretion of Strontium ranelate in human milk.. PROTELOS should not be used during breast-feeding. 
Fizikalnokemijski podatki nakazujejo izločanje stroncijevega ranelata v materino mleko.
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). 
Za bolnike z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 70 ml/min) odmerka ni treba prilagajati (glejte poglavje 5.2).
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]). 
PROTELOS v primerjavi s placebom (1,7 % v primerjavi z 1,1 %), in relativnim tveganjem 1,6 (95% IZ = [1,07 ; 2,38].
- if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6). 
Kaj morate vedeti, preden boste vzeli zdravilo PROTELOS Ne jemljite zdravila PROTELOS: - če ste alergični na stroncijev ranelat ali katero koli sestavino tega zdravila (navedeno v poglavju
However, it is recommended to drink the suspension immediately after preparation (see section 3) Do not throw away any medicines via wastewater or household waste. 
Vseeno je suspenzijo priporočljivo popiti takoj po pripravi (glejte 3. poglavje).
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). 
pokazala, da je PROTELOS v 3-letnem zdravljenju zmanjšal relativno tveganje za pojav novih zlomov vretenc za 32 % (ob stroncijevem ranelatu je bila pojavnost 19,1 % v primerjavi s 26,5 % ob placebu).
Aspartame (E951) 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi aspartam (E951).
Abdominal pain Oral mucosal irritation (stomatitis and/or mouth ulceration) Gastrooesophageal reflux Dyspepsia Constipation Flatulence Dry mouth Hepatobiliary disorders Frequency unknown:a Serum transaminase increased (in association with hypersensitivity skin reactions) Hepatitis Skin and subcutaneous tissue disorders Common: Dermatitis Eczema Rare: DRESS (see section 4.4) Very rare: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysisc (see section 4.4) Frequency unknown:a Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema) Alopecia Musculoskeletal and connective tissue disorders Frequency unknown:a Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity) General disorders and administration site conditions Frequency unknown:a Peripheral oedema Pyrexia (in association with hypersensitivity skin reactions) Malaise Blood and Lymphatic disorders Frequency unknown:a Bone marrow failure Eosinophilia (in association with hypersensitivity skin reactions) Lymphadenopathy (in association with hypersensitivity skin reactions) Investigations Common: Blood Creatine phosphokinase (CPK) increasedb a 
Redki: sindrom DRESS (glejte poglavje 4.4) Zelo redki: hude neželene kožne reakcije (SCARs - severe cutaneous adverse reactions): Stevens-Johnsonov sindrom in toksična epidermalna nekrolizac (glejte poglavje 4.4) Neznana pogostnost:a preobčutljivostne kožne reakcije (izpuščaj, srbenje, koprivnica,
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). 
toda z vsaj enim dodatnim dejavnikom tveganja zanje (n = 176), je skupna analiza a posteriori pokazala, da je PROTELOS zmanjšal tveganje prvega zloma vretenc za 72 % v 3 letih (pojavnost zlomov vretenc 3,6 % ob stroncijevem ranelatu v primerjavi z 12,0 % ob placebu).
In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2). 
zdravilo PROTELOS ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje 5.2).
In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies. 
Poleg zdravljenja s stroncijevim ranelatom po 2 g na dan ali placebom so bolnice ves čas obeh študij jemale prilagojene pripravke kalcija in vitamina D. V 3-letnem zdravljenju v študiji SOTI je PROTELOS zmanjšal relativno tveganje novih zlomov vretenc za 41 % (preglednica 1).
Cardiac ischaemic events 
Pogosti: dermatitis ekcem
NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate 
Navodilo za uporabo PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat
• Risk Management Plan (RMP) 
venske trombembolije (VTE)
Uncommon: Seizures. 
Neznana pogostnost:
Hirobriz Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks. 
Uporaba zdravila Hirobriz Breezhaler je v času nosečnosti upravičena le v primeru, da pričakovane koristi presegajo možna tveganja.
Do not use Hirobriz Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Hirobriz Breezhaler - če ste alergični na indakaterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
An increase in the daily dose of Hirobriz Breezhaler beyond the maximum dose of 300 microgram is not appropriate. 
Zviševanje dnevnega odmerka zdravila Hirobriz Breezhaler preko najvišjega odmerka 300 mikrogramov ni primerno.
Hirobriz Breezhaler capsules must always be stored in the blister, and only removed immediately before use. 
Kapsule Hirobriz Breezhaler je treba vedno shranjevati v pretisnem omotu in jih iz njega vzeti šele tik pred uporabo.
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. 
Če ste uporabili večji odmerek zdravila Hirobriz Breezhaler, kot bi smeli Če ste vdihnili preveč zdravila Hirobriz Breezhaler ali če kdo drug uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno medicinsko pomoč.
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). 
Še posebno pomembno je, da zdravniku poveste, če: zaradi težav z dihanjem uporabljate zdravila, ki so podobna zdravilu Hirobriz Breezhaler (na primer zdravila, kot sta salmeterol in formoterol).
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). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Hirobriz Breezhaler za vse podskupine pediatrične populacije pri kronični obstruktivni pljučni bolezni (KOPB) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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 dolgotrajna bolezen in zdravilo Hirobriz Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
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). 
24-urni brohodilatatorni učinek zdravila Hirobriz Breezhaler se je ohranjal od prvega odmerka skozi celotno enoletno obdobje zdravljenja brez znakov zmanjševanja učinkovitosti (tahifilaksije).
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. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Hirobriz Breezhaler, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Hirobriz Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose. 
Povečanje izpostavljenosti zaradi interakcij ni zaskrbljujoče, in sicer zaradi izkušenj glede varnosti pri uporabi zdravila Hirobriz Breezhaler v kliničnih študijah s trajanjem do enega leta v odmerkih, ki so dosegali tudi dvakratni priporočeni terapevtski odmerek.
Hirobriz Breezhaler should be administered at the same time of the day each day. 
Zdravilo Hirobriz Breezhaler je treba jemati vsak dan ob istem času.
Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler. 
Sočasna uporaba drugih simpatikomimetičnih zdravil (samih ali v sklopu kombinacije zdravil) lahko okrepi neželene učinke zdravila Hirobriz Breezhaler.
If you have questions about how long to continue your treatment with Hirobriz Breezhaler, talk to your doctor or pharmacist. 
Če vas zanima, kako dolgo je treba nadaljevati z uporabo zdravila Hirobriz Breezhaler, se pogovorite s svojim zdravnikom ali farmacevtom.
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. 
Poleg tega so bolniki, ki so uporabljali zdravilo Hirobriz Breezhaler, potrebovali bistveno manj nadomestnih zdravil in v primerjavi s tistimi, ki so uporabljali placebo, preživeli so več dni, ko niso potrebovali hitrih olajševalcev, pri njih se je bistveno povečal delež dni, ko preko dneva niso imeli simptomov.
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. 
V kliničnih študijah so bile klinično opazne spremembe v koncentraciji glukoze v krvi večinoma za 1-2 % bolj pogoste pri bolnikih, ki so jemali zdravilo Hirobriz Breezhaler v priporočenih odmerkih, kot pri tistih, ki so jemali placebo.
You should not use Hirobriz Breezhaler unless your doctor tells you so. 
Zdravila Hirobriz Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6). 
Kapsule so namenjene samo uporabi z inhalatorjem Hirobriz Breezhaler (glejte poglavje 6.6).
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. 
Če pride do znakov, ki kažejo na alergijsko reakcijo (zlasti oteženega dihanja ali požiranja, otekanja jezika, ustnic in obraza, urtikarije ali izpuščaja), je treba zdravljenje z zdravilom Hirobriz Breezhaler takoj ukiniti in uvesti drugo zdravilo.
The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Hirobriz Breezhaler inhaler. 
Priporočeni odmerek je inhalacija vsebine ene 150-mikrogramske kapsule enkrat na dan z uporabo inhalatorja Hirobriz Breezhaler.
Children and adolescents Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years. 
Otroci in mladostniki Otroci in mladostniki, ki so stari manj kot 18 let, ne smejo prejemati zdravila Hirobriz Breezhaler.
As with other inhalation therapy, administration of Hirobriz Breezhaler may result in paradoxical bronchospasm that may be life-threatening. 
Tako kot uporaba drugih inhalacijskih zdravil lahko uporaba zdravila Hirobriz Breezhaler povzroči paradoksni bronhospazem, ki je lahko življenjsko nevaren.
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. 
V teh študijah je bila raven sistemske izpostavljenosti (AUC) brez pomembnih neželenih učinkov pri miših najmanj 7-krat višja, pri podganah pa najmanj 49-krat višja od izpostavljenosti pri ljudeh, ki prejemajo zdravilo Hirobriz Breezhaler v odmerku 300 mikrogramov enkrat na dan.
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. 
Zdravilo Hirobriz Breezhaler je dolgodelujoči agonist adrenergičnih receptorjev beta-2, ki je indiciran samo za zdravljenje KOPB in se ne sme uporabljati pri astmi, saj ni nobenih podatkov o dolgoročnih rezultatih pri zdravljenju astme.
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. 
Kot se je pokazalo pri 605 bolnikih s KOPB v 26-tedenski, dvojno slepi, s placebom kontrolirani študiji faze III, med bolniki, ki so prejemali priporočene odmerka zdravila Hirobriz Breezhaler, in tistimi, ki so prejemali placebo ali zdravljenje s tiotropijem, ni prišlo do klinično pomembnih razlik glede razvoja aritmičnih dogodkov, ki so jih spremljali 24 ur ob izhodišču, nato pa še do 3-krat v 26tedenskem obdobju zdravljenja.
If paradoxical bronchospasm occurs Hirobriz Breezhaler should be discontinued immediately and alternative therapy substituted. 
Če pride do paradoksnega bronhospazma, je treba takoj prenehati z jemanjem zdravila Hirobriz Breezhaler in ga nadomestiti z drugačnim zdravljenjem.
Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists. 
Zdravila Hirobriz Breezhaler se ne sme uporabljati v povezavi z drugimi dolgodelujočimi agonisti adrenergičnih receptorjev beta-2 oziroma z zdravili, ki vsebujejo dolgodelujoče agoniste adrenergičnih receptorjev beta-2.
The mean of the maximum changes in blood glucose were similar between Hirobriz Breezhaler and placebo. 
Povprečji največjih sprememb v koncentraciji glukoze v krvi sta bili podobni pri uporabi zdravila Hirobriz Breezhaler in pri uporabi placeba.
Your Hirobriz Breezhaler pack: Each Hirobriz Breezhaler pack contains: one Hirobriz Breezhaler inhaler one or more blister containing Hirobriz Breezhaler capsules to be used in the inhaler. 
Pakiranje zdravila Hirobriz Breezhaler: Vsako pakiranje zdravila Hirobriz Breezhaler vsebuje: en inhalator Hirobriz Breezhaler en ali več pretisnih omotov s kapsulami Hirobriz Breezhaler, ki jih vstavljate v inhalator.
What Hirobriz Breezhaler is and what it is used for What you need to know before you use Hirobriz Breezhaler How to use Hirobriz Breezhaler Possible side effects 
Kaj je zdravilo Hirobriz Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Hirobriz Breezhaler Kako uporabljati zdravilo Hirobriz Breezhaler Možni neželeni učinki
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. 
Iz navedenih razlogov je pri uporabi dolgodelujočih agonistov adrenergičnih receptorjev beta-2 , kot je zdravilo Hirobriz Breezhaler, pri bolnikih z ugotovljenim ali domnevnim podaljšanjem intervala QT in pri tistih, ki prejemajo zdravila z vplivom na interval QT, potrebna previdnost.
Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with Hirobriz Breezhaler. 
Čeprav indakaterol ni vplival na splošno sposobnost za razmnoževanje v študiji plodnosti pri podganah, so v študiji obdobja pred razvojem in po zaključenem razvoju pri podganah opažali zmanjšano število nosečnosti v generaciji F1 pri izpostavljenosti zdravilu, ki je bila 14-krat večja kot pri ljudeh, ki prejemajo zdravilo Hirobriz Breezhaler.
The inhalation of the content of one 300 microgram capsule once a day, using the Hirobriz Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD. 
Pokazalo se je, da inhalacija vsebine ene 300-mikrogramske kapsule enkrat na dan z uporabo inhalatorja Hirobriz Breezhaler še dodatno klinično koristi pri zadihanosti zlasti bolnikom s hudo KOPB.
Upon initiation of treatment with Hirobriz Breezhaler plasma glucose should be monitored more closely in diabetic patients. 
Pri sladkornih bolnikih je treba po začetku zdravljenja z zdravilom Hirobriz Breezhaler še bolj natančno spremljati koncentracije glukoze v plazmi.
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. 
Med zdravljenjem z zdravilom Hirobriz Breezhaler Takoj prenehajte uporabljati zdravilo in obvestite zdravnika, če vas začne takoj po uporabi zdravila stiskati v prsih, če začnete kašljati, če vam v pljučih piska ali vam zmanjkuje sape.
Please read the following instructions carefully to learn how to use and care for your Hirobriz Breezhaler inhaler. 
Skrbno preberite naslednja navodila, da boste znali uporabljati inhalator Hirobriz Breezhaler in skrbeti zanj.
The Hirobriz Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD. 
V klinični program faze III v razvoju zdravila Hirobriz Breezhaler so bili vključeni bolniki s klinično diagnozo zmerne do hude KOPB.
What you need to know before you use Hirobriz Breezhaler 
Kaj morate vedeti, preden boste uporabili zdravilo Hirobriz Breezhaler
At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of recommended doses. 
Pri uporabi odmerka 600 mg enkrat na dan so bile varnostne lastnosti zdravila Hirobriz Breezhaler večinoma podobne kot pri uporabi priporočenih odmerkov.
Hirobriz Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies. 
Zdravilo Hirobriz Breezhaler je v odmerkih 150 in 300 mikrogramov na dan v več kliničnih farmakodinamičnih študijah in študijah učinkovitosti dosledno dosegalo klinično pomembno izboljšanje pljučne funkcije znotraj 24 ur (kar so merili z forsiranim ekspiracijskim volumnom v prvi sekundi, FEV1).
Paediatric population There is no relevant use of Hirobriz Breezhaler in the paediatric population (under 18 years). 
Zdravilo Hirobriz Breezhaler ni namenjeno za uporabo pri pediatrični populaciji (starost pod 18 let).
How long to continue your treatment with Hirobriz Breezhaler Keep using your treatment with Hirobriz Breezhaler for as long as your doctor tells you. 
Kako dolgo je treba nadaljevati z uporabo zdravila Hirobriz Breezhaler Zdravljenje z zdravilom Hirobriz Breezhaler nadaljujte tako dolgo, kot vam naroči zdravnik.
Hirobriz Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory capacity during exercise and at rest, compared to placebo. 
Pokazalo se je, da zdravilo Hirobriz Breezhaler v primerjavi s placebom zmanjša hiperinflacijo pljuč, kar poveča inspiracijsko kapaciteto med naporom in v mirovanju.