FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people) serious lung infection (pneumonia), infections of the upper respiratory tract, inflammation of the eye (conjunctivitis) increase of eosinophils (type of white blood cells) allergic reaction, reactions related to the infusion of the medicine decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes dehydration inflammation of the liver inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), dizziness inflammation of the eye which causes redness or pain, blurred vision rapid heart beat high blood pressure (hypertension) inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), blood clots, fluid around the lungs, cough mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy, bumpy rash)
Estonian: Sageli esinevad kõrvaltoimed (võib esineda kuni ühel patsiendil kümnest) tõsine kopsupõletik (pneumoonia), ülemiste hingamisteede infektsioonid, silmapõletik (konjunktiviit); eosinofiilide (teatud tüüpi valgete vereliblede) arvu suurenemine; allergiline reaktsioon, ravimi infusiooniga seotud reaktsioonid; neerupealiste (neerude peal paiknevad näärmed) hormoonide vähenenud eritumine, ajupõhimikul paikneva hüpofüüsi vaegtalitlus (hüpopituitarism) või põletik (hüpofüsiit), kilpnäärme turse, suhkurtõbi; vedelikupuudus; maksapõletik; närvipõletik (mis põhjustab tuimust, nõrkust, kihelust või põletavat valu kätes või jalgades), pearinglus; silmapõletik, mis põhjustab valu ja punetust, hägus nägemine; kiire südame löögisagedus; kõrge vererõhk (hüpertensioon); kopsupõletik (pneumoniit, mida iseloomustab köhimine ja hingamisraskus), verehüübed, vedelik kopsude ümber, köha;
English: 90 minutes administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab 3 mg/kg as monotherapy every 2 weeks.
Estonian: Kombinatsioonravi rühma patsiendid said nivolumabi 1 mg/kg 60 minuti jooksul ja ipilimumabi 3 mg/kg 90 minuti jooksul, manustatuna veenisiseselt iga 3 nädala järel esimese 4 annuse puhul, millele järgnes nivolumabi monoteraapia annuses 3 mg/kg iga 2 nädala järel.
English: Rare (may affect up to 1 in 1,000 people) inflammatory disease of blood vessels (most commonly head arteries) inflammation of the anus and the rectal wall (marked by bloody stools and a frequent urge to defecate) skin disease characterized by dry red patches covered with scales (psoriasis) inflammation and redness of the skin (erythema multiforme) a type of severe skin reaction characterized by rash accompanied by one or more of the following features: fever, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidneys or lungs (a reaction called DRESS).
Estonian: Harv (võib esineda kuni ühel patsiendil tuhandest) veresoonte (kõige sagedamini oimuarterite) põletikuline haigus; päraku ja pärasooleseinapõletik (mille märgiks on verine väljaheide ja sage roojamisvajadus); nahahaigus, millele on iseloomulikud kuivad punased laigud, mida katavad nahalaastud (psoriaas); nahapõletik ja punetus (multiformne erüteem).
English: Histiocytosis haematophagic has been reported in relation to ipilimumab therapy.
Estonian: Ipilimumabi raviga seoses on teatatud hematofaagilise histiotsütoosi esinemisest.
English: changes in mental health, depression, lowered sex drive severe and possibly fatal inflammation of the nerves causing pain, weakness or paralysis in the extremities (Guillain-Barré syndrome), fainting, inflammation of the nerves within the brain, excessive accumulation of fluid in the brain,difficulty in coordinating movements (ataxia), shaking, brief involuntary muscle contraction, difficulty in speaking inflammation of the eye (conjunctivitis), bleeding in the eye, inflammation of the coloured part of the eye, reduced vision, a foreign body sensation in the eyes, swollen runny eyes, swelling of the eye, inflammation of the eyelids irregular or abnormal heart beat inflammation of the blood vessels, disease of the blood vessels, restriction in the blood supply to the extremities, low blood pressure when standing up extreme difficulty in breathing, fluid accumulation in the lungs, inflammation of the lungs, hay fever bowel perforation, inflammation of the membrane of the stomach wall, inflammation of the small intestine, inflammation of the bowel or the pancreas (pancreatitis), peptic ulcer, mouth ulcers and cold sores (stomatitis), inflammation of the food pipe, blockage of the intestines liver failure, inflammation of the liver, enlarged liver, yellowing of the skin or eyes (jaundice) severe and possibly fatal peeling of the skin (toxic epidermal necrolysis) inflammation of the muscles causing pain or stiffness in the hip and shoulder, painful joints (arthralgia) swelling of the thyroid gland, inflammation of the kidney, or the central nervous system multi organ inflammation inflammation of skeletal muscles muscle weakness kidney function failure, kidney disease absence of menstrual periods multi organ dysfunction, reaction related to infusion of the medicine change in hair colour
Estonian: veresoonte põletik, veresoonte haigus, jäsemete verevarustuse vähenemine, madal vererõhk püsti seistes; tõsised hingamisraskused, vedeliku kogunemine kopsudesse, kopsupõletik, heinapalavik; soolte perforatsioon, peritoniit, peensoole põletik, soole või pankrease põletik (pankreatiit), maohaavand, suuhaavandid ja külmavillid (stomatiit), söögitoru põletik, soolte ummistus; maksapuudulikkus, maksapõletik, maksa suurenemine, naha või silmade kollasus (ikterus); raske ja võimalik, et eluohtlik naha koorumine (epidermise toksiline nekrolüüs); lihaste põletik, mis põhjustab valu ja jäikust puusa- ja õlaliigestes, liigesevalu (artralgia); kilpnäärme turse, neerupõletik või kesknärvisüsteemipõletik; mitme organi põletik; skeletilihaste põletik; lihasnõrkus; neerupuudulikus, neeruhaigus; menstruatsiooni ärajäämine; mitme organi talitlushäired, ravimi manustamisega seotud reaktsioon; juuste värvuse muutus.
English: Withhold dose(s)
Estonian: TOIMEAINE(TE) SISALDUS
English: For symptomatic hyperthyroidism, ipilimumab in combination with nivolumab should be withheld and antithyroid medication should be initiated as needed.
Estonian: Sümptomaatilise hüpotüreoosi korral tuleb ravi ipilimumabi ja nivolumabiga katkestada ning alustada vajadusel ravi kilpnäärme talitlust pärssiva preparaadiga.
English: (In clinical trials, methylprednisolone 2 mg/kg/day has been used).
Estonian: ja kohe rakendada süsteemset suureannuselist intravenoosset kortikosteroidravi (kliinilistes uuringutes on kasutatud 2 mg/kg metüülprednisolooni ööpäevas).
English: Ipilimumab was administered every 3 weeks for 4 doses and then every 12 weeks thereafter in the absence of dose limiting toxicity (DLT) and disease progression.
Estonian: Annust limiteeriva toksilisuse ja haiguse progressiooni puudumisel manustati ipilimumabi 4 annust iga 3 nädala tagant ja seejärel iga 12 nädala tagant.
English: The safety and efficacy of ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg for the treatment of advanced/metastatic RCC was evaluated in a phase 3, randomised, open-label study (CA209214).
Estonian: Randomiseeritud III faasi avatud uuringus (CA209214) hinnati 1 mg/kg ipilimumabi ja 3 mg/kg nivolumabi kombinatsioonravi ohutust ja efektiivsust kaugelearenenud/metastaatilise neerurakkkartsinoomi korral.
English: For Grade 4 diarrhoea or colitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Estonian: Neljanda raskusastme kõhulahtisuse või koliidi korral tuleb ravi ipilimumabi ja nivolumabiga alaliselt lõpetada ning alustada kortikosteroidide manustamist annusega 1 kuni 2 mg/kg metüülprednisolooni ekvivalenti ööpäevas.
English: Patients should receive the entire induction regimen (4 doses) as tolerated, regardless of the appearance of new lesions or growth of existing lesions.
Estonian: Sõltumata uute kollete tekkimisest või olemasolevate kollete kasvamisest tuleb patsientidele talutavuse korral manustada kõik induktsioonirežiimi annused (4 annust).
English: ipilimumab in combination with nivolumab must be permanently discontinued for severe (Grade 3) or lifethreatening (Grade 4) adrenal insufficiency.
Estonian: Raske (3. raskusastme) või eluohtliku (4. raskusastme) neerupealiste puudulikkuse korral tuleb ravi ipilimumabi ja nivolumabiga alaliselt lõpetada.
English: When to permanently discontinue YERVOY as monotherapy
Estonian: Millal tuleb YERVOY monoteraapia annus vahele jätta
English: Respiratory, thoracic and mediastinal disorders Common dyspnea, cough
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Sage düspnoe, köha
English: In clinical trials, rapid tapering (over periods < 1 month) resulted in recurrence of diarrhoea or colitis in some patients.
Estonian: Kliinilistes uuringutes põhjustas annuse kiire vähendamine (vähem kui 1 kuu jooksul)
English: Keep this leaflet.
Estonian: Mitte hoida sügavkülmas.
English: Ipilimumab has been shown to be present at very low levels in milk from cynomolgus monkeys treated during pregnancy.
Estonian: Tiinuse ajal ravitud makaakidel on leitud rinnapiimas väga väheses koguses ipilimumabi.
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus
Estonian: Naha ja nahaaluskoe kahjustused Väga sage löövee, sügelus löövee, sügelus
English: Talk to your doctor if you are not sure.
Estonian: Kui te ei ole selles kindel, pidage nõu oma arstiga.
English: Uncommon metabolic acidosis
Estonian: Harv temporaalarteriitd
English: Infusion reaction
Estonian: Ülitundlikkus/infusiooniga seotud reaktsioon
English: Uncommon uveitis
Estonian: Harv proktiitd
English: Severe diarrhoea or colitis has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Estonian: Ipilimumabi ja nivolumabi kombinatsioonravi ajal on täheldatud rasket kõhulahtisust või koliiti (vt lõik 4.8).
English: Common dermatitis, erythema, vitiligo, urticaria, eczemad, alopecia, night sweats, dry skin Uncommon toxic epidermal necrolysisb,c, leukocytoclastic vasculitis, skin exfoliation, hair colour changesd
Estonian: Aeg-ajalt toksiline epidermaalnekrolüüsa,b, leukotsütoklastiline vaskuliit, naha eksfoliatsioon, juuste värvuse muutusd
English: Ipilimumab in combination with nivolumab must be permanently discontinued for life-threatening diabetes.
Estonian: Eluohtliku diabeedi korral peab ravi ipilimumabi ja nivolumabiga alaliselt lõpetama.
English: For Grade 2 diarrhoea or colitis, ipilimumab in combination with nivolumab should be withheld.
Estonian: Teise raskusastme kõhulahtisuse või koliidi korral tuleb ipilimumabi ja nivolumabi manustamine ajutiselt katkestada.
English: Ipilimumab therapy was discontinued for adverse reactions in 10% of patients.
Estonian: Kõrvaltoimete tõttu lõpetati ravi ipilimumabiga 10% patsientidest.
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired
English: Nervous system disorders Very common headache Common peripheral neuropathy, dizziness headache, peripheral neuropathy, dizziness
Estonian: Sage perifeerne sensoorne neuropaatia, pearinglus, peavalu, letargia
English: Rare serous retinal detachment serous retinal detachment
Estonian: Harv seroosne võrkkesta irdumine seroosne võrkkesta irdumine
English: Further data on the long-term safety of the medicine will be collected post-marketing.
Estonian: Ravimi pikaajalise ohutuse lisateavet kogutakse turustamisjärgselt.
English: What measures are being taken to ensure the safe and effective use of Nuceiva?
Estonian: Mis meetmed võetakse, et tagada Nuceiva ohutu ja efektiivne kasutamine?
English: Further information on Nuceiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nuceiva.
Estonian: Lisateave Nuceiva kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/nuceiva.
English: Other information about Nuceiva
Estonian: Muu teave Nuceiva kohta
English: The European Medicines Agency decided that Nuceiva's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Nuceiva kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: If no side effects are experienced during the initial treatment, the injections can be repeated after at least 3 months.
Estonian: Kui esmase ravikuuri ajal ei ilmne kõrvalnähte, võib vähemalt 3 kuu pärast süste korrata.
English: As for all medicines, data on the use of Nuceiva are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Nuceiva kasutamise kohta pidevat järelevalvet.
English: What is Nuceiva and what is it used for?
Estonian: Mis on Nuceiva ja milleks seda kasutatakse?
English: Why is Nuceiva authorised in the EU?
Estonian: Miks Nuceiva ELis heaks kiideti?
English: Side effects reported with Nuceiva are carefully evaluated and any necessary action taken to protect patients.
Estonian: Nuceiva kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Nuceiva (botulinum toxin type A) EMA/249428/2019
Estonian: Nuceiva (A-tüüpi botulismitoksiin) EMA/249428/2019
English: Thirty days after treatment, 87% (205 out of 235) of adults who received Nuceiva had either mild or no vertical lines between the eyebrows, compared with 83% (202 out of 244) of patients who received another medicine containing botulinum toxin type A and 4% (2 out of 48) of patients who were given placebo.
Estonian: 30 päeva pärast ravi olid kerged kulmudevahelised vertikaalkortsud või puudusid vertikaalkortsud 87%-l (205 patsienti 235st) Nuceivat, 83%-l (202 patsienti 244st) A-tüüpi botulismitoksiini sisaldavat muud ravimit ja 4%-l (2 patsienti 48st) platseebot saanud täiskasvanud patsientidest.
English: The medicine is injected in 5 different places above and between the eyebrows.
Estonian: Ravimit süstitakse 5 eri kohta kulmude kohal ja vahel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuceiva have been included in the summary of product characteristics and the package leaflet.
Estonian: Nuceiva ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Serious side effects include drooping eyelids, immune responses (when the body's defence system produces antibodies against the botulinum toxin which stop the medicine from working), spread of the toxin to other parts of the body (which may lead to muscle weakness, difficulty breathing or swallowing, and constipation), development or worsening of disorders affecting the muscles and nerves, and hypersensitivity (allergic) reactions.
Estonian: Rasked kõrvalnähud on muu hulgas silmalaugude allavaje, immuunvastus (organismi immuunsüsteem toodab botulismitoksiini vastu antikehi, mis takistavad ravimi toimet), toksiini levimine organismis mujale (võib põhjustada lihasnõrkust, hingamis- või neelamisraskusi ja kõhukinnisust), lihas- ja närvikahjustuste teke või süvenemine ning ülitundlikkus (allergiareaktsioonid).
English: The effectiveness of treatment was measured using a standard 4-point scale, called glabellar line scale (GLS), where 0 = no lines, 1 = mild, 2 =moderate and 3 = severe.
Estonian: Ravi efektiivsust mõõdeti standardsel 4-punktilisel glabellaarkortsude skaalal (GLS), mille kohaselt 0 = kortse ei ole, 1 = kerged, 2 = mõõdukad ja 3 = sügavad kortsud.
English: The most common side effects with Nuceiva (which may affect up to 1 in 10 people) include headache and drooping eyelids.
Estonian: Nuceiva kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on peavalu ja silmalaugude allavaje.
English: For more information about using Nuceiva, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Nuceiva kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: The side effects seen with Nuceiva are as expected from this type of medicine and do not raise any major concerns.
Estonian: Nuceiva kõrvalnähud on seda tüüpi ravimi eeldatavad kõrvalnähud ega põhjusta olulisi probleeme.
English: It is used in adults less than 65 years of age who have moderate to severe facial lines and in whom those lines are having a significant psychological impact.
Estonian: Seda kasutatakse mõõdukate kuni sügavate näokortsudega alla 65-aastastel täiskasvanutel, kellele avaldavad kortsud olulist psühholoogilist mõju.
English: What are the risks associated with Nuceiva?
Estonian: Mis riskid Nuceivaga kaasnevad?
English: Nuceiva must not be used in people with diseases affecting the muscles, such as myasthenia gravis or Eaton-Lambert syndrome, and those who have an infection or inflammation at the planned site of injection.
Estonian: Nuceivat ei tohi kasutada patsiendid, kellel on lihashaigus, näiteks raske müasteenia või LambertiEatoni sündroom, või kellel on kavandatud süstekohas infektsioon või põletik.
English: For the full list of side effects of Nuceiva, see the package leaflet.
Estonian: Nuceiva kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The active substance in Nuceiva, botulinum toxin type A, is produced by the bacterium Clostridium botulinum.
Estonian: Nuceiva toimeainet A-tüübi botulismitoksiini toodab bakter Clostridium botulinum.
English: Nuceiva is a medicine used to temporarily improve the appearance of vertical frown lines between the eyebrows.
Estonian: Nuceiva on ravim, mida kasutatakse kulmudevaheliste vertikaalkortsude välimuse ajutiseks parandamiseks.
English: How does Nuceiva work?
Estonian: Kuidas Nuceiva toimib?
English: In the study, Nuceiva was compared with another medicine containing botulinum toxin type A and placebo (a dummy treatment).
Estonian: Selles uuringus võrreldi Nuceivat muu ravimiga, mis sisaldas A-tüüpi botulismitoksiini, ja platseeboga (näiv ravim).
English: An overview of Nuceiva and why it is authorised in the EU
Estonian: Ülevaade ravimist Nuceiva ja ELis müügiloa väljastamise põhjendus
English: How is Nuceiva used?
Estonian: Kuidas Nuceivat kasutatakse?
English: What benefits of Nuceiva have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Nuceiva kasulikkus?
English: The medicine can only be obtained with a prescription and must be given by a doctor with expertise in the treatment of vertical lines between the eyebrows and the use of the required equipment.
Estonian: Nuceiva on retseptiravim ja seda tohib määrata kulmudevaheliste vertikaalkortsude ravis ja vajalike seadmete kasutamises kogenud arst.
English: Nuceiva (botulinum toxin type A)
Estonian: Nuceiva (A-tüüpi botulismitoksiin)
English: Nuceiva is at least as effective as another medicine containing botulinum toxin type A and more effective than placebo in adults with moderate to severe vertical lines between the eyebrows.
Estonian: Nuceiva on mõõdukate kuni sügavate kulmudevaheliste vertikaalkortsudega täiskasvanutel vähemalt sama efektiivne kui muu A-tüüpi botulismitoksiini sisaldav ravim ja efektiivsem kui platseebo.
English: Nuceiva is given by injection into the muscles in the forehead whose contractions cause the vertical lines between the eyebrows.
Estonian: Nuceivat süstitakse otsmikulihastesse, mille kokkutõmbed põhjustavad kulmudevahelisi vertikaalkortse.
English: Nuceiva contains the active substance botulinum toxin type A.
Estonian: Nuceiva sisaldab toimeainena A-tüüpi botulismitoksiini.
English: When Nuceiva is injected directly into the muscles above and between the eyebrows, it causes the muscles to relax, helping to make the vertical lines less noticeable.
Estonian: Nuceiva süstimine otse kulmude kohal ja vahel olevatesse lihastesse lõdvestab lihaseid, vähendades vertikaalkortsude märgatavust.
English: Nuceiva has been shown to make the vertical lines between the eyebrows less noticeable in a main study involving 540 adults with moderate or severe vertical lines that affected their mood or caused symptoms of anxiety or depression.
Estonian: Põhiuuringus, milles osales 540 täiskasvanut, kellel olid mõõdukad kuni sügavad vertikaalkortsud, mis mõjutasid nende tuju või põhjustasid ärevust või depressiooni, vähendas Nuceiva kulmudevaheliste vertikaalkortsude märgatavust.
English: The toxin reduces the release of acetylcholine, a chemical messenger that causes muscle contraction.
Estonian: Toksiini toimel vabaneb vähem atsetüülkoliini, st virgatsainet, mis põhjustab lihaste kokkutõmbumist.
English: Invented name Strength Pharmaceutical form Route of administration Immediate Packaging
Estonian: Manustamistee Sisepakendi iseloomustus
English: EMA/CHMP/472738/2013 EMEA/H/C/002679
Estonian: EMA/472738/2013 EMEA/H/C/002679
English: This summary was last updated in 09/2013.
Estonian: Kokkuvõtte viimane uuendus: 09-2013.
English: The full EPAR for Ultibro Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ultibro Breezhaleri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ultibro Breezhaler on 19 September 2013.
Estonian: Euroopa Komisjon andis Ultibro Breezhaleri müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. septembril 2013.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend the use for reducing exacerbations.
Estonian: Komitee järeldas siiski, et ravimi toime ägenemiste sageduse vähenemisel oli liiga vähene, et soovitada seda ägenemiste vähendamiseks.
English: A risk management plan has been developed to ensure that Ultibro Breezhaler is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Ultibro Breezhaleri võimalikult ohutu kasutamine.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ultibro Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Ultibro Breezhaleri kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What measures are being taken to ensure the safe and effective use of Ultibro Breezhaler?
Estonian: Mis meetmed võetakse, et tagada Ultibro Breezhaleri ohutu ja efektiivne kasutamine?
English: Ultibro Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Estonian: Ultibro Breezhaler on ravim, mis sisaldab kaht toimeainet - indakaterooli (85 mikrogrammi) ja glükopürrooniumi (43 mikrogrammi).
English: The most common side effects with Ultibro Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Estonian: Ultibro Breezhaleri kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on ülemiste hingamisteede nakkused (külmetused).
English: In both studies, the main measure of effectiveness was how Ultibro Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja see, kuidas Ultibro Breezhaler parandas patsientide forsseeritud ekspiratoorset mahtu (FEV1, suurim õhukogus, mida inimene suudab 1 s jooksul välja hingata) pärast 26-nädalast ravi.