FrancophonIA/ELRC3.0 huggingface dataset:
English: PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Estonian: PROTELOS sisaldab fenüülalaniini, mis võib olla kahjulik fenüülketonuuriat põdevatele patsientidele.
English: 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.
Estonian: PROTELOS'e kasulikkust võrreldes platseeboga näitasid nii elukvaliteedi hindamine QUALIOST eriskaalaga, kui ka elukvaliteedi tajumise näitajad SF-36 küsimustikku üldskaalal.
English: If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
Estonian: PROTELOS'e sisaldab aspartaami: Kui teil on fenüülketonuuria (harvaesinev pärilik ainevahetushäire), rääkige oma arstiga sellest enne ravimi kasutamist.
English: Renal impairment
Estonian: Segasusseisund Unetus
English: PROTELOS 2 g granules for oral suspension Strontium ranelate
Estonian: PROTELOS 2 g - suukaudse suspensiooni graanulid Strontsiumranelaat
English: 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.
Estonian: Paljudel osteoporoosi põdevatel inimestel sümptomid puuduvad ja te ei tarvitse teadagi, et teie luud on hõrenenud.
English: 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).
Estonian: Raske neerukahjustusega patsientidele strontsiumranelaati ei soovitata (kreatiniini kliirens alla 30 ml/min) (vt lõik 4.4 ja 5.2).
English: PROTELOS 2 g granules for oral suspension
Estonian: PROTELOS 2 g suukaudse suspensiooni graanulid
English: 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
Estonian: Seedetrakti häired Sage: Iiveldus Diarröa Vedel iste Sagedus teadmata:a Oksendamine Kõhuvalu Suu limaskesta ärritus (stomatiit ja/või suuhaavandid) Gastroösofageaalne refluks Düspepsia Kõhukinnisus Kõhugaasid Suukuivus Maksa ja sapiteede häired Sagedus teadmata:a Seerumi transaminaaside tõus (seotud naha ülitundlikkusreaktsioonidega) Hepatiit Naha ja nahaaluskoe kahjustused Sage: Dermatiit Ekseem Harv: DRESS (vt lõik 4.4) Väga harv: Rasked kutaansed kõrvaltoimed (SCARs): Stevens-Johnson´i sündroom ja toksiline epidermaalne nekrolüüsc (vt lõik 4.4).
English: 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.
Estonian: Siiski on soovitatav suspensioon ära juua koheselt pärast valmistamist (vt lõik 3).
English: How to take protelos
Estonian: Kuidas Protelos´t kasutada
English: If you take too many sachets of PROTELOS, tell your doctor or pharmacist.
Estonian: Kui te kasutate PROTELOS't rohkem kui ette nähtud Kui te võtate liiga palju PROTELOS'e kotikesi, pöörduge arsti või apteekri poole.
English: Tel: +46 (8) 52 25 08 00 United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
Estonian: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
English: UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28
Estonian: UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28 Luxembourg/Luxemburg S.A. Servier Benelux N.V.
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
Estonian: PROTELOS'e kasutamisega seoses on teatatud eluohtlike nahareaktsioonide tekkest (StevensJohnsoni sündroom, toksiline epidermaalne nekrolüüs ja rasked ülitundlikkusreaktsioonid (DRESS)).
English: Adverse Reaction
Estonian: Teadvusehäired
English: Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of PROTELOS.
Estonian: PROTELOS'e kasutamisega seoses on teatatud eluohtlike nahareaktsioonide tekkest (StevensiJohnsoni sündroom, toksiline epidermaalne nekrolüüs, eosinofiiliaga nahalööve ja süsteemsed sümptomid (DRESS)).
English: NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate
Estonian: RAVIMPREPARAADI NIMETUS PROTELOS 2 g, graanulid peroraalse suspensiooni valmistamiseks.
English: Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Estonian: Kreatiinfosfokinaasi (CPK) tõus veresb a Turustamisjärgsed kogemused b Luu- ja lihaskonna fraktsioon >3-kordne tõus normi ülemisest piirist.
English: Тел.
Estonian: Peroraalne.
English: Magyarország Servier Hungaria Kft. Tel: +36 1 238 7799
Estonian: Tel: +36 1 238 7799
English: 3 hours after a meal.
Estonian: - 3 aastat.
English: In Asian countries: reported as rare d
Estonian: Psühhiaatrilised häired Sagedus teadmata:a
English: 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.
Estonian: Kui teil on tekkinud Stevensi-Johnsoni sündroom, epidermaalne nekrolüüs või DRESS seoses PROTELOS´e kasutamisega, ei tohi teil enam PROTELOS-ravi alustada.
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk.. PROTELOS should not be used during breast-feeding.
Estonian: Füsiko-keemilised andmed viitavad, et strontsiumranelaat eritub rinnapiima.
English: Hirobriz Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Estonian: Hirobriz Breezhaler'it tohib raseduse ajal kasutada ainult siis, kui loodetav kasu ületab võimalikud riskid.
English: Hirobriz Breezhaler should be administered at the same time of the day each day.
Estonian: Hirobriz Breezhaler'it tuleb kasutada iga päev samal ajal.
English: Children and adolescents Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years.
Estonian: Lapsed ja noorukid Hirobriz Breezhaler'it ei tohi kasutada lastel või alla 18 aasta vanustel noorukitel.
English: Do not use Hirobriz Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Estonian: Ärge kasutage Hirobriz Breezhaler'it - kui olete indakaterooli või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: 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.
Estonian: KOK on pikaajaline haigus ja te peate kasutama Hirobriz Breezhaler'it iga päev ja mitte ainult siis, kui esinevad hingamisraskused või muud KOKi sümptomid.
English: Please read the following instructions carefully to learn how to use and care for your Hirobriz Breezhaler inhaler.
Estonian: Palun lugege järgnevaid juhiseid tähelepanelikult, et teada saada, kuidas Hirobriz Breezhaler inhalaatorit kasutada ja hooldada.
English: If you have questions about how long to continue your treatment with Hirobriz Breezhaler, talk to your doctor or pharmacist.
Estonian: Kui teil on küsimusi selle kohta, kui kaua tuleb ravi Hirobriz Breezhaler'iga jätkata, rääkige oma arsti või apteekriga.
English: 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.
Estonian: Kui te kasutate Hirobriz Breezhaler'it rohkem kui ette nähtud Kui te olete sisse hinganud liiga palju Hirobriz Breezhaler'it või kui keegi teine kasutab teie kapsleid, teavitage sellest otsekohe oma arsti või pöörduge lähima haigla erakorralise meditsiini osakonda.
English: 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.
Estonian: Lisaks vajasid Hirobriz Breezhaler'iga ravitud patsiendid oluliselt vähem hooravimit, neil oli platseeboga võrreldes rohkem hooravimi vajaduseta päevi ja neil oli oluliselt suurenenud päevade osakaal, mil puudusid päeva ajal esinevad sümptomid.
English: 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.
Estonian: Kui ilmnevad allergilisele reaktsioonile viitavad sümptomid (täpsemalt hingamis- või neelamisraskused, keele, huulte ja näo turse, urtikaaria, nahalööve), tuleks Hirobriz Breezhaler'i kasutamine koheselt lõpetada ja alustada alternatiivset ravi.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler.
Estonian: Sümpatomimeetilise toimega teiste ravimpreparaatide samaaegsel manustamisel (üksinda või osana kombinatsioonravist) võivad tugevneda Hirobriz Breezhaler'i kõrvaltoimed.
English: 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.
Estonian: Süsteemse ekspositsiooni (AUC) väärtused rottidel ja hiirtel, mis ei põhjustanud kõrvaltoimete teket nendes uuringutes, olid vastavalt vähemalt 7 ja 49 korda suuremad kui inimestel, kes said ravi Hirobriz Breezhaler'iga üks kord päevas annuses 300 mikrogrammi.
English: As with other inhalation therapy, administration of Hirobriz Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Estonian: Nagu igasuguse inhaleeritava ravi puhul, võib Hirobriz Breezhaler'i manustamisel tekkida paradoksaalne bronhospasm, mis võib olla eluohtlik.
English: Hirobriz Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Estonian: Hirobriz Breezhaler kapsleid tuleb alati hoida blistris ja eemaldada need blistrist alles vahetult enne kasutamist.
English: The mean of the maximum changes in blood glucose were similar between Hirobriz Breezhaler and placebo.
Estonian: Vere glükoosisisalduse maksimaalsete muutuste keskmine oli sarnane Hirobriz Breezhaler'i ja platseebo puhul.
English: 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.
Estonian: Koostoimetest tingitud ekspositsiooni suurenemise ulatus ei tõstata ohutusalaseid küsimusi, kuna Hirobriz Breezhaler'i kasutamine kliinilistes uuringutes kuni ühe aasta vältel maksimaalsest soovitatavast terapeutilisest annusest kuni kaks korda suuremates annustes oli ohutu.
English: 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.
Estonian: Hirobriz Breezhaler, mida manustati üks kord päevas annustes 150 ja 300 mikrogrammi, viis järjekindlalt kopsufunktsiooni kliiniliselt olulise paranemiseni (mida mõõdeti forsseeritud ekspiratoorse mahu järgi ühes sekundis, FEV1) 24 tunni jooksul mitmetes kliinilistes farmakodünaamika ja efektiivsuse uuringutes.
English: 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.
Estonian: Hirobriz Breezhaler on pikatoimeline beeta-2-adrenomimeetikum, mis on näidustatud ainult KOKi raviks ja seda ei tohi kasutada astma raviks, sest puuduvad andmed pikaajalise kasutamise kohta astma korral.
English: Hirobriz Breezhaler has no or negligible influence on the ability to drive and use machines.
Estonian: Hirobriz Breezhaler ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: How to store Hirobriz Breezhaler Contents of the pack and other information
Estonian: Kuidas Hirobriz Breezhaler'it säilitada Pakendi sisu ja muu teave
English: 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.
Estonian: Nagu demonstreeriti 605 KOKihaige osalusega 26-nädalases, topeltpimedas, platseeboga kontrollitud III faasi uuringus, puudus kliiniliselt oluline erinevus arütmiate tekke osas 24 tunni jooksul, uuringu alguses ja kuni kolmel korral 26-nädalase raviperioodi jooksul Hirobriz Breezhaler'i soovitatud annustega ravi saanud ja platseebot või tiotroopiumravi saanud patsientide vahel.
English: In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder.
Estonian: Sellest pakendist leiate inhalaatori ja kapslid (blistrites), mis sisaldavad ravimit inhaleeritava pulbrina.
English: If paradoxical bronchospasm occurs Hirobriz Breezhaler should be discontinued immediately and alternative therapy substituted.
Estonian: Paradoksaalse bronhospasmi tekkimisel tuleb Hirobriz Breezhaler'i kasutamine otsekohe lõpetada ja alustada alternatiivset ravi.
English: 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).
Estonian: Euroopa Ravimiamet ei kohusta esitama Hirobriz Breezhaler'iga läbi viidud uuringute tulemusei laste kõikide alarühmade kohta kroonilise obstruktiivse kopsuhaiguse (KOK) korral (teave lastel kasutamise kohta: vt lõik 4.2).
English: 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.
Estonian: Kuigi indakaterool ei mõjutanud üldist reproduktsioonivõimet rottidel läbi viidud fertiilsusuuringutes, täheldati Hirobriz Breezhaler'iga ravitud rottidel sünnieelse ja-järgse arengu uuringus F1 põlvkonna rottidel tiinete järeltulijate arvu langust 14 korda kõrgema ekspositsiooniga kui inimestel.
English: Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Estonian: Hirobriz Breezhaler'it ei tohi kasutada koos teiste pikatoimeliste beeta-2-adrenomimeetikumidega või ravimitega, mis sisaldavad pikatoimelisi beeta-2-adrenomimeetikume.
English: Hirobriz Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Estonian: Hirobriz Breezhaler'i kasutamist ei ole uuritud halvasti kontrollitud diabeediga patsientidel.
English: 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
Estonian: Mis ravim on Hirobriz Breezhaler ja milleks seda kasutatakse Mida on vaja teada enne Hirobriz Breezhaler'i kasutamist Kuidas Hirobriz Breezhaler'it kasutada Võimalikud kõrvaltoimed
English: 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).
Estonian: Hirobriz Breezhaler'i 24-tunnine bronhe lõõgastav toime püsis esimesest annusest kuni üheaastase raviperioodi lõpuni, ilma et oleks ilmnenud toime kadumist (tahhüfülaksia).
English: 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.
Estonian: Ühe 300-mikrogrammise kapsli sisu inhaleerimisel üks kord päevas Hirobriz Breezhaler inhalaatorist on saadud täiendavat kliinilist kasu hingelduse leevendamisel, eriti raske KOKiga patsientidel.
English: What Hirobriz Breezhaler looks like and content of the pack In this pack, you will find an inhaler, together with capsules in blister.
Estonian: Kuidas Hirobriz Breezhaler välja näeb ja pakendi sisu Sellest pakendist leiate inhalaatori ja kapslid blistrites.
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2adrenergic agonists.
Estonian: Kuigi Hirobriz Breezhaler'i soovitatavate annuste manustamise järgselt ei täheldata tavaliselt kliiniliselt olulist toimet kardiovaskulaarsüsteemile, tuleb indakaterooli sarnaselt teiste beeta-2-adrenomimeetikumidega kasutada ettevaatlikult patsientidel, kellel esinevad kardiovaskulaarsed haigused (koronaartõbi, äge müokardiinfarkt, südame rütmihäired, hüpertensioon), krambiseisundid või türeotoksikoos, ning samuti patsientidel, kes on ebatavaliselt tundlikud beeta-2-adrenomimeetikumide suhtes.
English: The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6).
Estonian: Kapslite manustamiseks tohib kasutada ainult Hirobriz Breezhaler inhalaatorit (vt lõik 6.6).
English: Upon initiation of treatment with Hirobriz Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Estonian: Hirobriz Breezhaler'iga ravi alustamise järgselt tuleb diabeetikutel hoolikamalt jälgida plasma glükoosisisaldust.
English: At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of recommended doses.
Estonian: 600 mikrogrammi üks kord päevas annuse korral oli Hirobriz Breezhaler'i ohutusprofiil üldiselt sarnane soovitatud annuste puhul täheldatuga.
English: 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.
Estonian: Hirobriz Breezhaler'i pakend: Igas Hirobriz Breezhaler'i pakendis sisaldub: üks Hirobriz Breezhaler inhalaator, üks või mitu inhalaatoris kasutatavaid Hirobriz Breezhaler kapsleid sisaldavat blistrit.
English: Hirobriz Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory capacity during exercise and at rest, compared to placebo.
Estonian: Hirobriz Breezhaler vähendas kopsude hüperinflatsiooni, mille tulemusena suurenes inspiratoorne kapatsiteet vastavalt koormusel ja puhkeolekus võrreldes platseeboga.
English: 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.
Estonian: Rinnaga toitmise katkestamine või ravi katkestamine/jätkamine, tuleb otsustada arvestades imetamise kasu lapsele ja ravi kasu naisele.
English: In the event of deterioration of COPD during treatment with Hirobriz Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken.
Estonian: Kui ravi ajal Hirobriz Breezhaler'iga tekib KOKi süvenemine, tuleb patsiendi seisundit ja KOKi raviskeemi uuesti hinnata.
English: 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.
Estonian: Seega tuleb pikatoimelisi beeta-2-adrenomimeetikume kasutada ettevaatusega patsientidel, kellel esineb või kahtlustatakse QT-intervalli pikenemist või kes kasutavad QT-intervalli mõjutavaid ravimpreparaate.
English: How long to continue your treatment with Hirobriz Breezhaler Keep using your treatment with Hirobriz Breezhaler for as long as your doctor tells you.
Estonian: Kui kaua tuleb jätkata ravi Hirobriz Breezhaler'iga Jätkake ravi Hirobriz Breezhaler'iga senikaua, kui arst soovitab.
English: At the recommended doses, the adverse reaction profile of Hirobriz Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Estonian: Soovitatud annuste puhul näitab Hirobriz Breezhaler'i kõrvaltoimete profiil KOKihaigetel kliiniliselt ebaolulisi süsteemseid toimeid seoses beeta-2-adrenergilise stimulatsiooniga.
English: Hirobriz Breezhaler contains lactose
Estonian: Hirobriz Breezhaler sisaldab laktoosi
English: The Hirobriz Breezhaler inhaler provided with each new prescription should be used.
Estonian: Kasutada tuleb iga uue retseptiga ette nähtud Hirobriz Breezhaler inhalaatorit.
English: The Hirobriz Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Estonian: Hirobriz Breezhaler'i III faasi kliinilises arendusprogrammis osalesid patsiendid, kelle kliiniliseks diagnoosiks oli keskmise raskusega või raske KOK.
English: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Hirobriz Breezhaler inhaler.
Estonian: Soovitatavaks annuseks on ühe 150-mikrogrammise kapsli sisu inhalatsioon üks kord päevas Hirobriz Breezhaler inhalaatorist.
English: Immediate hypersensitivity reactions have been reported after administration of Hirobriz Breezhaler.
Estonian: On teatatud kohestest ülitundlikkusreaktsioonidest pärast Hirobriz Breezhaler'i manustamist.
English: Other medicines and Hirobriz Breezhaler
Estonian: Muud ravimid ja Hirobriz Breezhaler
English: 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.
Estonian: Kliinilistes uuringutes esines Hirobriz Breezhaler'i soovitatavate annuste kasutamisel veresuhkru taseme kliiniliselt väljendunud muutusi üldiselt sagedamini (1...2% võrra) kui platseebo puhul.
English: Paediatric population There is no relevant use of Hirobriz Breezhaler in the paediatric population (under 18 years).
Estonian: Puudub Hirobriz Breezhaler'i asjakohane kasutus lastel (vanuses alla 18 aasta).