FrancophonIA/ELRC3.0 huggingface dataset:
English: The infusion should be given once every four weeks, for as long as the patient is considered to benefit, and doctors should re-assess at least once a year whether treatment should be continued.
Slovenian: Infuzijo je treba dati enkrat na štiri tedne, dokler ima bolnik od tega korist, zdravnik pa naj o nadaljevanju zdravljenja presodi vsaj enkrat letno.
English: Anaphylactic (severe allergic) reactions may affect less than 1 person in 100.
Slovenian: Anafilaktične (hude alergijske) reakcije se lahko pojavijo pri manj kot 1 bolniku od 100.
English: Overall the medicine was well tolerated, and appropriate measures to monitor and manage risks have been put in place.
Slovenian: V celoti gledano so bolniki zdravilo dobro prenašali, poleg tega so bili uvedeni ustrezni ukrepi za spremljanje in obvladovanje tveganj.
English: Cinqaero EMA/450050/2016
Slovenian: Cinqaero EMA/450050/2016x
English: What measures are being taken to ensure the safe and effective use of Cinqaero?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cinqaero?
English: The full EPAR for Cinqaero 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 Cinqaero je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Flare-ups were seen in 32% of patients (151 out of 477) given Cinqaero compared with 50% (237 out of 476) of those given placebo.
Slovenian: Poslabšanja so bila opažena pri 32 % (151 od 477) bolnikov, ki so prejemali zdravilo Cinqaero, in pri 50 % (237 od 476) bolnikov, ki so prejemali placebo.
English: This is a summary of the European public assessment report (EPAR) for Cinqaero.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cinqaero.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cinqaero'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) pri agenciji je zaključil, da so koristi zdravila Cinqaero večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Cinqaero
Slovenian: Druge informacije o zdravilu Cinqaero
English: This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.
Slovenian: S tem pomaga zmanjšati vnetje, kar zmanjša število napadov astme in izboljša simptome.
English: What are the risks associated with Cinqaero?
Slovenian: Kakšna tveganja so povezana z zdravilom Cinqaero?
English: It is not intended to provide practical advice on how to use Cinqaero.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinqaero have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cinqaero upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The most common side effect with Cinqaero (which may affect about 2 people in 100) is an increase in levels of the enzyme creatine phosphokinase in the blood (a measure of possible damage to muscles).
Slovenian: Najpogostejši neželeni učinek zdravila Cinqaero (ki se lahko pojavi pri približno 2 bolnikih od 100) je zvečanje vrednosti encima kreatin-fosfokinaze v krvi (merilo možne poškodbe mišic).
English: What benefits of Cinqaero have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cinqaero izkazalo v študijah?
English: What is Cinqaero and what is it used for?
Slovenian: Kaj je zdravilo Cinqaero in za kaj se uporablja?
English: For more information about treatment with Cinqaero, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cinqaero preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Cinqaero approved?
Slovenian: Zakaj je bilo zdravilo Cinqaero odobreno?
English: The main measure of effectiveness was based on the number of flare-ups (exacerbations) of asthma during treatment.
Slovenian: Glavno merilo učinkovitosti je temeljilo na številu poslabšanj astme pri zdravljenju.
English: For practical information about using Cinqaero, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cinqaero naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects and restrictions with Cinqaero, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cinqaero glejte navodilo za uporabo.
English: The benefits of Cinqaero have been shown in two main studies involving 953 patients with eosinophilic asthma that was not well controlled by inhaled corticosteroids and other asthma medication used for the prevention of the disease.
Slovenian: Koristi zdravila Cinqaero so bile dokazane v dveh glavnih študijah, ki sta vključevali 953 bolnikov z eozinofilno astmo, ki ni bila urejena z inhalacijskimi kortikosteroidi in drugim zdravilom za preprečevanje astme.
English: It is used as an additional treatment in adults with severe asthma that is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Slovenian: Uporablja se kot dodatno zdravljenje pri odraslih s hudo astmo, ki ni ustrezno urejena s kombinacijo visokih odmerkov inhalacijskih kortikosteroidov in drugega zdravila za preprečevanje astme.
English: It is available as a concentrate for making a solution for infusion (drip) into a vein.
Slovenian: Zdravilo je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Cinqaero is an asthma medicine that is used to treat adults with a particular type of asthma called eosinophilic asthma.
Slovenian: Cinqaero je zdravilo za astmo, ki se uporablja za zdravljenje odraslih s posebno vrsto astme, imenovano eozinofilna astma.
English: The reduction in flare-ups and improvement in lung function seen with Cinqaero were considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of asthma.
Slovenian: Zmanjšanje poslabšanj astme in izboljšanje pljučne funkcije pri jemanju zdravila Cinqaero sta bila ovrednotena kot klinično pomembna, zlasti za bolnike, pri katerih astme ni mogoče zadovoljivo urediti z visokimi odmerki inhalacijskih kortikosteroidov in drugim zdravilom za preprečevanje astme.
English: By attaching to interleukin-5 and blocking its activity, Cinquaero reduces the number of eosinophils in the blood and lungs.
Slovenian: Z vezavo na interlevkin-5 in blokiranjem njegovega delovanja zdravilo Cinqaero zmanjša
English: The medicine contains the active substance reslizumab.
Slovenian: Zdravilo Cinqaero vsebuje zdravilno učinkovino reslizumab.
English: Cinqaero can only be obtained with a prescription and should be prescribed by doctors with experience in the treatment of eosinophilic asthma.
Slovenian: Predpisovanje in izdaja zdravila Cinqaero je le na recept, zdravilo pa mora predpisati zdravnik, ki ima izkušnje z zdravljenjem eozinofilne astme.
English: How does Cinqaero work?
Slovenian: Kako zdravilo Cinqaero deluje?
English: Additionally there was evidence of an improvement in lung function and asthma symptoms, and a decrease in number of eosinophils in the blood in patients given Cinqaero.
Slovenian: Poleg tega je pri bolnikih, zdravljenih z zdravilom Cinqaero, prišlo do izboljšanja pljučne funkcije in simptomov astme ter zmanjšanja števila eozinofilcev v krvi.
English: The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which
Slovenian: Zdravilna učinkovina v zdravilu Cinqaero, reslizumab, je monoklonsko protitelo, zasnovano za vezavo na interlevkin-5, tj. snov, ki stimulira rast in aktivnost eozinofilcev.
English: How is Cinqaero used?
Slovenian: Kako se zdravilo Cinqaero uporablja?
English: Cinqaero was compared with placebo (a dummy infusion), both given every 4 weeks for a year.
Slovenian: Zdravilo Cinqaero so primerjali s placebom (infuzijo brez zdravilne učinkovine).
English: An appropriate positive control was used.
Slovenian: Uporabljena je bila primerna pozitivna kontrola.
English: The response was submitted to the EMEA on 23 March 2006.
Slovenian: Odgovor je bil 23. marca 2006 posredovan EMEA.
English: The result of the test was negative.
Slovenian: Rezultat analize je bil negativen.
English: The reason for this was that the United Kingdom national competent authority, Veterinary Medicines Directorate (VMD) considered that this medicinal product could present a potential serious risk to public health on the following grounds:
Slovenian: Pristojni nacionalni organ Združenega kraljestva, Direktorat za veterinarska zdravila (VMD), je bil namreč mnenja, da lahko to zdravilo predstavlja potencialno veliko tveganje za javno zdravje, in sicer na podlagi:
English: The product is indicated to treat respiratory diseases in horses caused by Streptococcus equi subsp.
Slovenian: Izdelek je namenjen zdravljenju bolezni dihal pri konjih, ki jih povzroča Streptococcus equi subsp.
English: One positive result on chromosome aberration was reported.
Slovenian: Poročali so o enem pozitivnem rezultatu kromosomske aberacije.
English: Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Slovenian: Skladno s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena, je bila zadeva napotena na CVMP.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Slovenian: DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVIL, ŽIVALSKE VRSTE, NAČINI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Therefore it can be concluded that the effect seen in vitro is not of biological relevance.
Slovenian: Tako je mogoče zaključiti, da učinek, viden in vitro, ni biološko pomemben.
English: Therefore, the Committee considered that no further mutagenicity study is required for the assessment of the substance.
Slovenian: Zato je Odbor mnenja, da za oceno snovi dodatne raziskave mutagenosti niso potrebne.
English: zooepidemicus and severe bacterial infections with a high risk of septicaemia in foals in which Escherichia coli is involved.
Slovenian: zooepidemicus, in hudih bakterijskih okužb z visokim tveganjem septikemije pri žrebcih, kjer je vpletena tudi Escherichia coli.
English: Taking into account the intrinsic values and limitations of the tests and that only one out of eleven studies has shown positive results, it is concluded that there are no concerns that 2,3-cyclohexenopyridine may present a potential serious risk to public health.
Slovenian: Ob upoštevanju intrinzičnih vrednosti in omejitev analiz in da je le ena od enajstih analiz dala pozitivne rezultate, se zaključi, da ni nevarnosti, da bi 2,3cikloheksenopiridin predstavljal potencialno resno tveganje za javno zdravje.
English: The Reference Member State for the Mutual Recognition Procedure regarding Cobactan IV 4.5%, Germany, notified the EMEA on 2 March 2006 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding the product.
Slovenian: Referenčna država članica za postopek medsebojnega priznavanja zdravila Cobactan IV 4,5 %, Nemčija, je 2. marca 2006 obvestila EMEA, da Koordinacijska skupina za medsebojno priznavanje in decentralizirane postopke - veterina (CMD(v)) ni sklenila dogovora o izdelku.
English: In conclusion, the CVMP agrees that it was sufficiently demonstrated that 2,3-cyclohexenopyridine has no clastogenic potential in vivo, and that further studies are not warranted.
Slovenian: CVMP se na koncu strinja, da je bilo zadovoljivo dokazano, da 2,3-cikloheksenopiridin nima klastogenega potenciala in vivo in da nadaljnje raziskave niso upravičene.
English: Cobactan IV 4.5%, presented as a powder and solvent for solution for injection, contains 45 mg/ml cefquinome (as sulphate).
Slovenian: Zdravilo Cobactan IV 4,5 % v obliki praška in vehikla za raztopino za injiciranje vsebuje 45 mg/ml cefkvinoma (kot sulfat).
English: The CVMP during its meeting of 14-16 March 2006 initiated a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Cobactan IV 4.5% containing cefquinome.
Slovenian: CVMP je na zasedanju 14.-16. marca 2006 sprožil postopek v skladu s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Cobactan IV 4,5 %, ki vsebuje cefkvinom.
English: Cobactan Powder and solvent for solution for injection
Slovenian: Cobactan Prašek in vehikel za raztopino za injiciranje
English: The highest dose corresponded to the maximum tolerated in a dose range finding assay and also caused clear symptoms of toxicity but no lethality in all animals of the main study.
Slovenian: Najvišji odmerek je ustrezal največji vrednosti, ki je še sprejemljiva v analizi iskanja razpona odmerka, in je pri vseh živalih glavne raziskave povzročil jasne simptome toksičnosti, vendar ne smrtnosti.
English: The positive finding in vitro was further investigated in an in vivo micronucleus test.
Slovenian: Pozitiven izid in vitro je bil nadaljnje raziskan z in vivo analizo mikronukleusa.
English: Given (1) the high proliferation rate of bone marrow tissue, (2) the intravenous route of administration, and (3) the high doses employed, it is highly unlikely that a second in vivo test in another tissue would give a positive result.
Slovenian: Glede na (1) hitro proliferacijo celic kostnega mozga, (2) intravensko odmerjanje zdravila, in (3) velike odmerke, je zelo malo verjetno, da bi druga in vivo analiza v drugem tkivu dal pozitiven rezultat.
English: Genotoxicity testing was carried out at the impurity concentration of 1% with cefquinome (8 tests) and in addition 3 tests have been carried out with 2,3-cyclohexenopyridine alone.
Slovenian: Opravljena je bilo genotoksična analiza cefkvinoma pri 1 % koncentraciji nečistoče (8 analiz), poleg tega so bile opravljene še 3 analize z 2,3-cikloheksenopiridinom samim.
English: Despite the fact that there have also been negative results in two in vivo micronucleus assays, the positive in vitro results are not negated, as both in vivo studies involved the assessment of effects in bone marrow cells.
Slovenian: Kljub temu, da so bili rezultati v dveh in vivo analizah mikronukleusa negativni, pozitivni in vitro rezultati niso izničeni, saj sta obe in vivo raziskavi vključevali oceno vpliva na celice kostnega mozga.
English: The questions identified related to the concerns raised regarding the potential mutagenicity of 2,3cyclohexenopyridine, the starting material and impurity of cefquinome and were submitted to the Marketing Authorisation Holder on 16 March 2006.
Slovenian: Vprašanja o zaskrbljenosti glede potencialne mutagenosti 2,3-cikloheksenopiridina, o vhodni snovi in nečistosti cefkvinoma, so bila 16. marca 2006 predložena imetniku dovoljenja za promet z zdravilom.
English: 2.1 Considerations of the safety concerns regarding the starting material 2,3-cyclohexenopyridine
Slovenian: 2.1 Obravnava varnostnih vidikov pri vhodni snovi 2,3-cikloheksenopiridin
English: Also, the 4 in vivo genotoxicity tests performed with cefquinome at low and high concentrations of 2,3-cyclohexenopyridine were negative.
Slovenian: Poleg tega so bile 4 in vivo analize genotoksičnosti, opravljene s cefkvinomom pri nizkih in visokih koncentracijah 2,3-cikloheksenopiridina, negativne.
English: The specifications of the active ingredient cefquinome sulphate sterile used in the manufacturing of Cobactan IV 4.5% and the specifications at release and at end of shelf-life for the powder of the finished product Cobactan IV 4.5% were provided.
Slovenian: Podane so bile specifikacije aktivne sestavine sterilnega cefkvinom sulfata, uporabljenega v izdelavi zdravila Cobactan IV 4,5 %, in specifikacije praška končnega izdelka Cobactan IV 4,5 % ob začetku veljavnosti in ob poteku roka uporabe.
English: The clastogenic potential in vitro was not demonstrated in vivo.
Slovenian: Klastogeni potencial in vitro ni bil dokazan in vivo.
English: In Chinese hamster lung fibroblasts in vitro, 2,3-cyclohexenopyridine induced structural chromosomal aberrations at 600-700 µg/ml in a dose-dependent manner when including metabolic activation in the method.
Slovenian: V fibroblastih pljuč kitajskega hrčka je 2,3-cikloheksenopiridin in vitro sprožil strukturne kromosomske aberacije pri 600-700 µg/ml na način, odvisen od odmerka, ko je bila v metodi zajeta metabolna aktivacija.
English: Specifications for cefquinome sulfate report a 2,3- cyclohexenopyridine content of <1%.
Slovenian: Specifikacije za cefkvinom sulfat poročajo o vsebnosti 2,3cikloheksenopiridina <1 %.
English: In vivo results are most relevant for human exposure, as these results “overrule” the results from in vitro tests.
Slovenian: Rezultati in vivo so najpomembnejši za izpostavljenost ljudi, saj ti rezultati „preglasijo“ rezultate analiz in vitro.
English: As the in vivo results are most relevant for human exposure, these results “overrule” the results from the in vitro tests.
Slovenian: Ker so rezultati in vivo najpomembnejši za izpostavljenost ljudi, ti rezultati „preglasijo“ rezultate in vitro analiz.
English: The CVMP concluded that the clastogenic potential in vitro was not demonstrated in vivo.
Slovenian: CVMP je zaključil, da klastogeni potencial in vitro ni bil dokazan in vivo.
English: The maximum cefquinome concentrations measured in plasma of treated target animals (e.g. 2 µg/ml after a dose of 1 mg/kg bw) compared with the 2,3-cyclohexenopyridine concentrations expected (e.g. 1% of this impurity in cefquinome leading to 0.02 µg 2,3-cyclohexenopyridine/ml plasma) demonstrates that the concentrations of several hundred µg/ml in the positive in vitro test by far exceed the concentrations relevant in vivo.
Slovenian: V plazmi ciljnih zdravljenih živali izmerjene maksimalne koncentracije cefkvinoma (npr. 2 µg/ml po odmerku 1 mg/kg tt) v primerjavi s pričakovano koncentracijo 2,3-cikloheksenopiridina (npr. 1 % te nečistoče v cefkvinomu pomeni 0,02 µg 2,3-cikloheksenopiridina/ml plazme) kažejo na to, da koncentracije več sto µg/ml v pozitivni in vitro analizi krepko presežejo koncentracije, pomembne in vivo.
English: In the direct method, 2,3-cyclohexenopyridine induced slight structural chromosomal aberrations at 350 µg/ml with 24 and 48 h treatments.
Slovenian: Pri direktni metodi je 2,3-cikloheksenopiridin pri 24- in 48-urnem zdravljenju povzročil majhne strukturne kromosomske aberacije pri 350 µg/ml.
English: • For the starting material 2,3 cyclohexenopyridine, which also occurs as an impurity in the active substance, cefquinome a positive in vitro mutagenicity assay has been reported.
Slovenian: • Za vhodno snov 2,3 cikloheksenopiridin, ki se prav tako pojavlja kot nečistoča v zdravilni učinkovini cefkvinom, je bila ugotovljena pozitivna in vitro analiza mutagenosti.
English: 2.3 Data concerning the mutagenicity and carcinogenicity of cefquinome and its starter material 2,3-cyclohexenopyridine.
Slovenian: 2.3 Podatki o mutagenosti in karcinogenosti cefkvinoma in njegovi vhodni snovi 2,3cikloheksenopiridin.
English: Out of the 11 genotoxicity studies available for 2,3-cyclohexenopyridine, either conducted with cefquinome containing the impurity 2,3-cyclohexenopyridine or with 2,3-cyclohexenopyridine on its own one test (chromosome aberration in vitro) resulted in a positive response and only at a high 2,3cyclohexenopyridine concentration whereas the subsequent mammalian in vivo micronucleus test resulted in a negative response.
Slovenian: Od 11 raziskav genotoksičnosti za 2,3-cikloheksenopiridin, opravljenih bodisi s cefkvinomom, ki vsebuje nečistočo 2,3-cikloheksenopiridin, bodisi z 2,3-cikloheksenopiridinom, je ena analiza (kromosomska aberacija in vitro) dala pozitiven rezultat in samo pri visokih koncentracijah 2,3cikloheksenopiridina, medtem ko je kasnejša sesalčja in vivo analiza mikronukleusa dala negativni odgovor.
English: 2.2 Data regarding the specification of cefquinome, in particular in relation the impurity 2,3-cyclohexenopyridine.
Slovenian: 2.2 Podatki o specifikaciji cefkvinoma, še posebej o nečistoči 2,3-cikloheksenopiridin.
English: The specific findings of a clastogenic potential of 2,3- cyclohexenopyridine in one in vitro test at high concentrations was not confirmed to be present at the highest intravenous dose tested (2000 mg/kg bw) in the in vivo micronucleus test.
Slovenian: Specifični izsledki klastogenega potenciala 2,3- cikloheksenopiridina v eni in vitro analizi pri visokih koncentracijah v in vivo analizi mikronukleusa pri najvišjem analiziranem intravenskem odmerku (2000 mg/kg tt) niso bili zasledeni.
English: In this study 2,3-cyclohexenopyridine was administered in 0.9% NaCl twice intravenously at an interval of 24 h at doses of 7.5, 25, and 75 mg/kg bw to male and female mice.
Slovenian: V tej raziskavi so mišjim samcem in samicam v intervalu 24 ur v dveh intravenskih odmerkih odmerili po 7,5, 25 in 75 mg/kg 2,3-cikloheksenopiridina v 0,9 % NaCl.
English: The specifications at release and at end of shelf-life reports of contents of 2,3- cyclohexenopyridine of <1% and <1.5%, respectively.
Slovenian: Specifikacije ob začetku veljavnosti poročajo o vsebnosti 2,3cikloheksenopiridina <1 %, ob poteku roka uporabe pa o vsebnosti <1,5 %.
English: It is considered that a negative result in a second in vivo study using a different tissue is required before the concerns about this impurity are allayed.
Slovenian: Za ublažitev zaskrbljenosti glede nečistoče je potreben negativni rezultat v drugi in vivo raziskavi na drugem tkivu.
English: pipettes
Slovenian: Ciljna živalska vrsta
English: - if you have heart problems or high blood pressure
Slovenian: - če imate težave s srcem ali visok krvni tlak,
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
Slovenian: Datum prve odobritve: 08.05.2014 Datum zadnjega podaljšanja: 11. januar 2019
English: It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor.
Slovenian: Zelo pomembno je, da zdravilo LAVENTAIR ELLIPTA uporabljate vsak dan, kot vam je naročil zdravnik.
English: Elderly patients No dose adjustment is required in patients over 65 years.
Slovenian: Starejši bolniki Bolnikom, starejšim od 65 let, odmerka ni treba prilagoditi.
English: LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Slovenian: Zdravilo LAVENTAIR ELLIPTA je treba uporabljati vsak dan ob istem času, za ohranjanje bronhodilatacije.
English: The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose') and magnesium stearate.
Slovenian: Drugi sestavini zdravila sta laktoza monohidrat (glejte poglavje 2 "Zdravilo LAVENTAIR ELLIPTA vsebuje laktozo") in magnezijev stearat.
English: Talk to your doctor before using this medicine: - if you have asthma (Don't use LAVENTAIR ELLIPTA to treat asthma)
Slovenian: Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom: - če imate astmo (zdravila LAVENTAIR ELLIPTA ne uporabljajte za zdravljenje astme),
English: If you forget to use LAVENTAIR ELLIPTA Don't inhale an extra dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo LAVENTAIR ELLIPTA Ne vdihnite dodatnega odmerka, da bi nadomestili pozabljenega.