FrancophonIA/ELRC3.0 huggingface dataset:
English: Musculoskeletal and connective tissue disorders Common arthralgia, myalgia, musculoskeletal painf, muscle spasms Uncommon polymyalgia rheumatica, myositisd, arthritis, muscular weaknessd Rare polymyositisd Renal and urinary disorders Uncommon renal failureb, glomerulonephritisc, autoimmune nephritisd, renal tubular acidosis, haematuriad
Slovenian: Bolezni sečil Občasni odpoved ledvicb, glomerulonefritisc, avtoimunski nefritisd, renalna tubularna acidoza, hematurijad
English: Ipilimumab in combination with nivolumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Slovenian: Če se kateri koli resni imunsko pogojeni neželeni učinek ponovi, ali pojavi kateri koli resni imunsko pogojeni neželeni učinek, ki ogrozi življenje, je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti.
English: Ipilimumab is associated with serious immune-related neurological adverse reactions.
Slovenian: Uporaba ipilimumaba je povezana s pojavom resnih imunsko pogojenih neželenih učinkov na živčevje.
English: Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.
Slovenian: Po koncu infundiranja infuzijski sistem splaknite z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopino glukoze za injiciranje.
English: The co-primary outcome measures were progression-free survival and OS. ORR and the duration of response were also assessed.
Slovenian: Ovrednotili so tudi delež objektivnega odziva in trajanje odziva.
English: For Grade 3 or 4 transaminase or total bilirubin elevation, 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.
Slovenian: V primeru zvišanja vrednosti aminotransferaz ali skupnega bilirubina stopnje 3 ali 4 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: Grade 3 diarrhoea or colitis observed with ipilimumab in combination with nivolumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru driske ali kolitisa stopnje 3 pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom je treba zdravljenje trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: mg/kg group experienced a Grade 1 and Grade 3 on-study endocrine irAR of hyperglycemia.
Slovenian: Pri dveh bolnikih v skupini z odmerkom 10 mg/kg so med študijo poročali o endokrinem imunsko pogojenem neželenem učinku (hiperglikemija) stopnje 1 in stopnje 3.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg, the incidence of hypersensitivity/infusion reactions was 3.8% (17/448); all were Grade 1 or 2 in severity.
Slovenian: Pri bolnikih, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg je pojavnost preobčutljivostnih/infuzijskih reakcij znašala 3,8 % (17/448).
English: Grade 2 adrenal insufficiency Grade 3 diabetes
Slovenian: Diabetes stopnje 3
English: The following side effects have been reported with ipilimumab in combination with nivolumab:
Slovenian: Pri uporabi ipilimumaba v kombinaciji z nivolumabom so poročali o naslednjih neželenih učinkih:
English: The YERVOY infusion is compatible with:
Slovenian: Raztopina zdravila YERVOY za infundiranje je kompatibilna: z infuzijskimi sistemi iz PVC.
English: Myasthenia gravis-like symptoms have also been reported in < 1% of patients who received higher doses of ipilimumab in clinical trials.
Slovenian: Pri manj kot 1 % bolnikov, ki so v kliničnih preskušanjih ipilimumab prejemali v višjih odmerkih, so poročali tudi o pojavu simptomov, podobnih miasteniji gravis.
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.
Slovenian: V primeru driske ali kolitisa stopnje 4 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Slovenian: Priporočene prilagoditve zdravljenja z zdravilom YERVOY v kombinaciji z nivolumabom ali druge faze zdravljenja (nivolumab v monoterapiji) po kombiniranem zdravljenju Stevens Johnsonov sindrom (SJS) ali toksična epidermalna nekroliza (TEN)
English: ipilimumab in combination with nivolumab must be permanently discontinued for severe (Grade 3) or lifethreatening (Grade 4) adrenal insufficiency.
Slovenian: V primeru hude (stopnja 3) ali življenje ogrožajoče (stopnja 4) insuficience nadledvičnih žlez je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti.
English: Upon improvement, ipilimumab in combination with nivolumab may be resumed after corticosteroid taper, if needed.
Slovenian: Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida, če je bilo takšno zdravljenje potrebno, se zdravljenje z ipilimumabom v kombinaciji z nivolumabom lahko nadaljuje.
English: Hazard ratioa 99.1% CI p-valueb,h Median (95% CI) Confirmed objective response (BICR)
Slovenian: Celokupno preživetje Dogodki Razmerje ogroženostia 99,8% IZ p-vrednostb, c Mediana (95% IZ)
English: Severe nephritis and renal dysfunction have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Slovenian: Pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom so poročali o hudem nefritisu in okvari delovanja ledvic (glejte poglavje 4.8).
English: Additional adverse reactions not listed in Table 4 have been reported in patients who received other doses (either < or > 3 mg/kg) of ipilimumab in clinical trials of melanoma.
Slovenian: Pri bolnikih, ki so ipilimumab v kliničnih preskušanjih pri melanomu prejemali v drugih odmerkih (bodisi manjših bodisi večjih od 3 mg/kg), so poročali še o dodatnih neželenih učinkih, ki v preglednici 4 niso navedeni.
English: These include:
Slovenian: Zdravilo lahko povzroči:
English: 90 minutes administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab 3 mg/kg as monotherapy every 2 weeks.
Slovenian: Bolniki v skupini s kombiniranim zdravljenjem so pri prvih 4 odmerkih nivolumab prejemali v odmerku 1 mg/kg v obliki 60 minutne intravenske infuzije, ipilimumab pa v odmerku 3 mg/kg v obliki 90 minutne intravenske infuzije vsake 3 tedne, nato pa je sledilo zdravljenje z nivolumabom v odmerku 3 mg/kg v monoterapiji vsaka 2 tedna.
English: Ipilimumab in combination with nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Slovenian: Dokler bolnik prejema imunosupresivne odmerke kortikosteroidov ali drugih zdravil za zaviranje imunske odzivnosti, se zdravljenje ipilimumabom v kombinaciji z nivolumabom ne sme nadaljevati.
English: Not known pericardial disordersj Vascular disorders Common hypertension hypertension
Slovenian: Žilne bolezni Pogosti hipertenzija hipertenzija
English: When to withhold dose of YERVOY as monotherapy Withhold YERVOY dosea in patients with the following immune-related adverse reactions.
Slovenian: Pri bolnikih z naslednjimi imunsko pogojenimi neželenimi učinki je treba odmereka zdravila YERVOY zadržati.
English: Each vial contains 50 mg ipilimumab.
Slovenian: Ena viala vsebuje 50 mg ipilimumaba.
English: You will be given an infusion over a period of 30 minutes every 3 weeks for the first 4 doses (combination phase).
Slovenian: Pri zdravljenju napredovalega raka ledvic z zdravilom YERVOY v kombinaciji z nivolumabom boste pri prvih 4 odmerkih (faza kombiniranega zdravljenja) infuzijo, ki bo trajala 30 minut, prejemali vsake 3 tedne.
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) diarrhoea or colitis (see section 4.2), and systemic high-dose intravenous corticosteroid therapy should be initiated immediately.
Slovenian: Pri bolnikih s hudo drisko (stopnja 3 ali 4) ali kolitisom je treba zdravljenje z ipilimumabom trajno ukiniti (glejte poglavje 4.2) in nemudoma uvesti sistemsko zdravljenje z visokimi odmerki intravenskih kortikosteroidov (v kliničnih preskušanjih so uporabili metilprednizolon v odmerku 2 mg/kg/dan).
English: The improvement in OS was similar between ipilimumab with nivolumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
Slovenian: Pri bolnikih z visoko ekspresijo PD-L1 tumorja (PD-L1 ≥ 1%) je bilo izboljšanje celokupnega preživetja pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom podobno kot pri zdravljenju z nivolumabom v monoterapiji.
English: Ipilimumab in combination with nivolumab should be discontinued for life-threatening or recurrent severe cardiac and pulmonary adverse reactions (see section 4.2).
Slovenian: V primeru pojava življenje ogrožajočih ali ponovitve hudih neželenih učinkov za srce in pljuča je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom ukiniti (glejte poglavje 4.2).
English: When to permanently discontinue YERVOY as monotherapy
Slovenian: Preglednica 3A Kdaj trajno ukiniti zdravljenje z zdravilom YERVOY v monoterapiji
English: 1-year OS (%) (95% CI) BORR (%) (95% CI) SD (n/N)a
Slovenian: 1-letno celokupno preživetje (%) (95 % IZ)
English: NR (32.72, NR)
Slovenian: ND (32,72; ND)
English: CR+PR+SD) was 75% (6/8 patients) and 0%, respectively.
Slovenian: Delež nadzorovane bolezni (opredeljena kot popoln odziv + delni odziv + stabilna bolezen) je bil v skupini, ki je prejemala ipilimumab kot monoterapijo 75 % (6/8 bolnikov), v skupini, ki je prejemala samo gp100 pa 0 %.
English: Nivolumab 3 mg/kg over 30 minutes
Slovenian: Faza zdravljenja v monoterapiji nivolumab 3 mg/kg v obliki 30-minutne i.v.
English: Immune-related adverse reaction leading to permanent discontinuation Pneumonitis
Slovenian: Imunsko pogojeni neželeni učinki na živčevje
English: Further data on the long-term safety of the medicine will be collected post-marketing.
Slovenian: Več podatkov o dolgoročni varnosti zdravila bodo zbrali v obdobju trženja.
English: If no side effects are experienced during the initial treatment, the injections can be repeated after at least 3 months.
Slovenian: Če se med začetnim zdravljenjem ne pojavijo neželeni učinki, se lahko injekcije ponovijo po preteku najmanj treh mesecev.
English: Further information on Nuceiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nuceiva.
Slovenian: Nadaljnje informacije o zdravilu Nuceiva so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/nuceiva.
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.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Nuceiva večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Nuceiva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nuceiva?
English: Other information about Nuceiva
Slovenian: Druge informacije o zdravilu Nuceiva
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.
Slovenian: Uporablja se pri odraslih, mlajših od 65 let, ki imajo zmerno do močno izražene obrazne gube in pri katerih imajo te gube pomemben psihološki vpliv.
English: The medicine is injected in 5 different places above and between the eyebrows.
Slovenian: Zdravilo se injicira na pet različnih mest nad in med obrvmi.
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.
Slovenian: Trideset dni po začetku zdravljenja je imelo 87 % (205 od 235) odraslih, ki so prejemali zdravilo Nuceiva, rahlo izražene gube ali pa so bili brez gub med obrvmi, v primerjavi s 83 % (202 od 244) bolnikov, ki so prejemali drugo zdravilo z botulinskim toksinom tipa A, in 4 % (2 od 48) bolnikov, ki so prejemali placebo.
English: As for all medicines, data on the use of Nuceiva are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nuceiva stalno spremljajo.
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.
Slovenian: Resni neželeni učinki vključujejo povešenje očesnih vek, imunski odziv (kadar obrambni sistem telesa tvori protitelesa proti botulinskemu toksinu, zaradi česar preneha zdravilo delovati), razširitev toksina na druge dele telesa (kar lahko povzroči oslabelost mišic, oteženo dihanje ali požiranje ter zaprtje), razvoj ali poslabšanje obolenj, ki prizadenejo mišice in živce, ter preobčutljivostne (alergijske) reakcije.
English: Nuceiva (botulinum toxin type A) EMA/249428/2019
Slovenian: Nuceiva (botulinski toksin tipa A) EMA/249428/2019
English: For more information about using Nuceiva, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Nuceiva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Nuceiva are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Nuceiva, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The side effects seen with Nuceiva are as expected from this type of medicine and do not raise any major concerns.
Slovenian: Neželeni učinki, opaženi pri zdravilu Nuceiva, so takšni, kot jih je mogoče pričakovati pri tej vrsti zdravila, in ne vzbujajo pomembnih pomislekov.
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.
Slovenian: Zdravilo Nuceiva se ne sme uporabljati pri ljudeh z boleznimi, ki prizadenejo mišice, kot sta miastenija gravis ali Lambert-Eatonov sindrom, ter tistih, ki imajo okužbo ali vnetje na načrtovanem mestu injiciranja.
English: An overview of Nuceiva and why it is authorised in the EU
Slovenian: Pregled zdravila Nuceiva in zakaj je odobreno v EU
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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nuceiva upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What benefits of Nuceiva have been shown in studies?
Slovenian: Kakšne koristi zdravila Nuceiva so se pokazale v študijah?
English: Why is Nuceiva authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Nuceiva odobreno v EU?
English: What is Nuceiva and what is it used for?
Slovenian: Kaj je zdravilo Nuceiva in za kaj se uporablja?
English: The toxin reduces the release of acetylcholine, a chemical messenger that causes muscle contraction.
Slovenian: Toksin zmanjša sproščanje acetilholina, tj. kemijskega prenašalca, ki povzroča krčenje mišic.
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.
Slovenian: Učinkovitost zdravljenja so merili s pomočjo standardne štiristopenjske lestvice za glabelarne gube (GLS): 0 = brez gub, 1 = blaga izraženost, 2 =zmerna izraženost in 3 = močna izraženost.
English: The most common side effects with Nuceiva (which may affect up to 1 in 10 people) include headache and drooping eyelids.
Slovenian: Najpogostejša neželena učinka zdravila Nuceiva (ki se lahko pojavita pri največ 1 bolniku od 10) sta glavobol in povešenje očesnih vek.
English: What are the risks associated with Nuceiva?
Slovenian: Kakšna tveganja so povezana z zdravilom Nuceiva?
English: Nuceiva (botulinum toxin type A)
Slovenian: Nuceiva (botulinski toksin tipa A)
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.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, injicira pa ga lahko le zdravnik, ki ima izkušnje z zdravljenjem navpičnih gub med obrvmi in uporabo potrebne opreme.
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.
Slovenian: Zdravilo Nuiceva je vsaj tako učinkovito kot drugo zdravilo, ki vsebuje botulinski toksin tipa A, in učinkovitejše od placeba pri odraslih z zmerno do močno izraženimi navpičnimi obraznimi gubami med obrvmi.
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.
Slovenian: Kadar se zdravilo Nuceiva injicira neposredno v mišice nad in med obrvmi, povzroči, da se mišice sprostijo, s čimer postanejo navpične obrazne gube manj vidne.
English: In the study, Nuceiva was compared with another medicine containing botulinum toxin type A and placebo (a dummy treatment).
Slovenian: V tej študiji so zdravilo Nuceiva primerjali z drugim zdravilom, ki je vsebovalo botulinski toksin tipa A in placebo (zdravilo brez učinkovine).
English: For the full list of side effects of Nuceiva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Nuceiva glejte navodilo za uporabo.
English: Nuceiva is a medicine used to temporarily improve the appearance of vertical frown lines between the eyebrows.
Slovenian: Nuiceva je zdravilo, ki se uporablja za začasno izboljšanje videza navpičnih gub med obrvmi.
English: How does Nuceiva work?
Slovenian: Kako zdravilo Nuceiva deluje?
English: How is Nuceiva used?
Slovenian: Kako se zdravilo Nuceiva uporablja?
English: Nuceiva is given by injection into the muscles in the forehead whose contractions cause the vertical lines between the eyebrows.
Slovenian: Zdravilo Nuceiva se daje z injiciranjem v mišice čela, katerih krčenje povzroča navpične gube med obrvmi.
English: The active substance in Nuceiva, botulinum toxin type A, is produced by the bacterium Clostridium botulinum.
Slovenian: Učinkovino v zdravilu Nuceiva, botulinski toksin vrste B, proizvaja bakterija Clostridium botulinum.
English: Nuceiva contains the active substance botulinum toxin type A.
Slovenian: Zdravilo Nuceiva vsebuje učinkovino botulinski toksin tipa A.
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.
Slovenian: V glavni študiji, v katero je vključenih 540 odraslih z zmerno ali močno izraženimi navpičnimi gubami, ki so vplivale na njihovo razpoloženje ali so povzročale simptome anksioznosti ali depresivnosti, je bilo dokazano, da postanejo zaradi zdravila Nuceiva navpične gube med obrvmi manj opazne.
English: Strength Pharmaceutical Form Route of Administration
Slovenian: zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: Invented name Strength Pharmaceutical form Route of administration Immediate Packaging
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
English: EMA/CHMP/472738/2013 EMEA/H/C/002679
Slovenian: EMA/472738/2013 EMEA/H/C/002679
English: This summary was last updated in 09/2013.
Slovenian: Povzetek je bil nazadnje posodobljen 09-2013.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend the use for reducing exacerbations.
Slovenian: Vendar je odbor CHMP menil, da so njegovi učinki na zmanjšanje deleža poslabšanj preslabi, da bi ga priporočil za to indikacijo.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ultibro Breezhaler je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ultibro Breezhaler večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ultibro Breezhaler on 19 September 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ultibro Breezhaler, veljavno po vsej Evropski uniji, odobrila 19. septembra 2013.
English: This is a summary of the European public assessment report (EPAR) for Ultibro Breezhaler.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ultibro Breezhaler.
English: Ultibro Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Slovenian: Zdravilo Ultibro Breezhaler so proučevali v dveh glavnih študijah, v kateri je bilo skupaj vključeno 2 667 bolnikov s KOPB.
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.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti bolnikovo izboljšanje forsiranega ekspiracijskega volumna (FEV1 - največje količine zraka, ki jo oseba lahko izdihne v eni sekundi) po 26 tednih zdravljenja.
English: Ultibro Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Slovenian: Ultibro Breezhaler je zdravilo, ki vsebuje dve zdravilni učinkovini, indakaterol (85 mikrogramov) in glikopironij (43 mikrogramov).
English: The most common side effects with Ultibro Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Slovenian: Najpogostejši neželeni učinki zdravila Ultibro Breezhaler (ki prizadenejo več kot 1 osebo od 10) so okužbe zgornjih dihal (prehladi).
English: What measures are being taken to ensure the safe and effective use of Ultibro Breezhaler?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ultibro Breezhaler?
English: It is taken at the same time each day using the Ultibro Breezhaler device.
Slovenian: Jemlje se vsak dan ob istem času z uporabo inhalatorja Ultibro Breezhaler.
English: In patients with severely reduced kidney function Ultibro Breezhaler should only be used after a careful benefit-risk assessment.
Slovenian: Pri bolnikih s hudo poslabšanim ledvičnim delovanjem se sme zdravilo Ultibro Breezhaler uporabiti samo po skrbni oceni razmerja med tveganji in koristmi.