natgillin/translations-raw huggingface dataset:
The medicine contains the active substance reslizumab.
Zdravilo Cinqaero vsebuje zdravilno učinkovino reslizumab.
Cinqaero can only be obtained with a prescription and should be prescribed by doctors with experience in the treatment of eosinophilic asthma.
Predpisovanje in izdaja zdravila Cinqaero je le na recept, zdravilo pa mora predpisati zdravnik, ki ima izkušnje z zdravljenjem eozinofilne astme.
How does Cinqaero work?
Kako zdravilo Cinqaero deluje?
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.
Poleg tega je pri bolnikih, zdravljenih z zdravilom Cinqaero, prišlo do izboljšanja pljučne funkcije in simptomov astme ter zmanjšanja števila eozinofilcev v krvi.
The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which
Zdravilna učinkovina v zdravilu Cinqaero, reslizumab, je monoklonsko protitelo, zasnovano za vezavo na interlevkin-5, tj. snov, ki stimulira rast in aktivnost eozinofilcev.
How is Cinqaero used?
Kako se zdravilo Cinqaero uporablja?
Cinqaero was compared with placebo (a dummy infusion), both given every 4 weeks for a year.
Zdravilo Cinqaero so primerjali s placebom (infuzijo brez zdravilne učinkovine).
An appropriate positive control was used.
Uporabljena je bila primerna pozitivna kontrola.
The response was submitted to the EMEA on 23 March 2006.
Odgovor je bil 23. marca 2006 posredovan EMEA.
The result of the test was negative.
Rezultat analize je bil negativen.
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:
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:
The product is indicated to treat respiratory diseases in horses caused by Streptococcus equi subsp.
Izdelek je namenjen zdravljenju bolezni dihal pri konjih, ki jih povzroča Streptococcus equi subsp.
One positive result on chromosome aberration was reported.
Poročali so o enem pozitivnem rezultatu kromosomske aberacije.
Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Skladno s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena, je bila zadeva napotena na CVMP.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVIL, ŽIVALSKE VRSTE, NAČINI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Therefore it can be concluded that the effect seen in vitro is not of biological relevance.
Tako je mogoče zaključiti, da učinek, viden in vitro, ni biološko pomemben.
Therefore, the Committee considered that no further mutagenicity study is required for the assessment of the substance.
Zato je Odbor mnenja, da za oceno snovi dodatne raziskave mutagenosti niso potrebne.
zooepidemicus and severe bacterial infections with a high risk of septicaemia in foals in which Escherichia coli is involved.
zooepidemicus, in hudih bakterijskih okužb z visokim tveganjem septikemije pri žrebcih, kjer je vpletena tudi Escherichia coli.
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.
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.
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.
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.
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.
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.
Cobactan IV 4.5%, presented as a powder and solvent for solution for injection, contains 45 mg/ml cefquinome (as sulphate).
Zdravilo Cobactan IV 4,5 % v obliki praška in vehikla za raztopino za injiciranje vsebuje 45 mg/ml cefkvinoma (kot sulfat).
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.
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.
Cobactan Powder and solvent for solution for injection
Cobactan Prašek in vehikel za raztopino za injiciranje
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.
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.
The positive finding in vitro was further investigated in an in vivo micronucleus test.
Pozitiven izid in vitro je bil nadaljnje raziskan z in vivo analizo mikronukleusa.
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.
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.
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.
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.
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.
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.
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.
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.
2.1 Considerations of the safety concerns regarding the starting material 2,3-cyclohexenopyridine
2.1 Obravnava varnostnih vidikov pri vhodni snovi 2,3-cikloheksenopiridin
Also, the 4 in vivo genotoxicity tests performed with cefquinome at low and high concentrations of 2,3-cyclohexenopyridine were negative.
Poleg tega so bile 4 in vivo analize genotoksičnosti, opravljene s cefkvinomom pri nizkih in visokih koncentracijah 2,3-cikloheksenopiridina, negativne.
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.
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.
The clastogenic potential in vitro was not demonstrated in vivo.
Klastogeni potencial in vitro ni bil dokazan in vivo.
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.
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.
Specifications for cefquinome sulfate report a 2,3- cyclohexenopyridine content of <1%.
Specifikacije za cefkvinom sulfat poročajo o vsebnosti 2,3cikloheksenopiridina <1 %.
In vivo results are most relevant for human exposure, as these results “overrule” the results from in vitro tests.
Rezultati in vivo so najpomembnejši za izpostavljenost ljudi, saj ti rezultati „preglasijo“ rezultate analiz in vitro.
As the in vivo results are most relevant for human exposure, these results “overrule” the results from the in vitro tests.
Ker so rezultati in vivo najpomembnejši za izpostavljenost ljudi, ti rezultati „preglasijo“ rezultate in vitro analiz.
The CVMP concluded that the clastogenic potential in vitro was not demonstrated in vivo.
CVMP je zaključil, da klastogeni potencial in vitro ni bil dokazan in vivo.
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.
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.
In the direct method, 2,3-cyclohexenopyridine induced slight structural chromosomal aberrations at 350 µg/ml with 24 and 48 h treatments.
Pri direktni metodi je 2,3-cikloheksenopiridin pri 24- in 48-urnem zdravljenju povzročil majhne strukturne kromosomske aberacije pri 350 µg/ml.
• 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.
• 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.
2.3 Data concerning the mutagenicity and carcinogenicity of cefquinome and its starter material 2,3-cyclohexenopyridine.
2.3 Podatki o mutagenosti in karcinogenosti cefkvinoma in njegovi vhodni snovi 2,3cikloheksenopiridin.
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.
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.
2.2 Data regarding the specification of cefquinome, in particular in relation the impurity 2,3-cyclohexenopyridine.
2.2 Podatki o specifikaciji cefkvinoma, še posebej o nečistoči 2,3-cikloheksenopiridin.
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.
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.
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.
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.
The specifications at release and at end of shelf-life reports of contents of 2,3- cyclohexenopyridine of <1% and <1.5%, respectively.
Specifikacije ob začetku veljavnosti poročajo o vsebnosti 2,3cikloheksenopiridina <1 %, ob poteku roka uporabe pa o vsebnosti <1,5 %.
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.
Za ublažitev zaskrbljenosti glede nečistoče je potreben negativni rezultat v drugi in vivo raziskavi na drugem tkivu.
pipettes
Ciljna živalska vrsta
- if you have heart problems or high blood pressure
- če imate težave s srcem ali visok krvni tlak,
Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
Datum prve odobritve: 08.05.2014 Datum zadnjega podaljšanja: 11. januar 2019
It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor.
Zelo pomembno je, da zdravilo LAVENTAIR ELLIPTA uporabljate vsak dan, kot vam je naročil zdravnik.
Elderly patients No dose adjustment is required in patients over 65 years.
Starejši bolniki Bolnikom, starejšim od 65 let, odmerka ni treba prilagoditi.
LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Zdravilo LAVENTAIR ELLIPTA je treba uporabljati vsak dan ob istem času, za ohranjanje bronhodilatacije.
The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose') and magnesium stearate.
Drugi sestavini zdravila sta laktoza monohidrat (glejte poglavje 2 "Zdravilo LAVENTAIR ELLIPTA vsebuje laktozo") in magnezijev stearat.
Talk to your doctor before using this medicine: - if you have asthma (Don't use LAVENTAIR ELLIPTA to treat asthma)
Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom: - če imate astmo (zdravila LAVENTAIR ELLIPTA ne uporabljajte za zdravljenje astme),
If you forget to use LAVENTAIR ELLIPTA Don't inhale an extra dose to make up for a forgotten dose.
Če ste pozabili uporabiti zdravilo LAVENTAIR ELLIPTA Ne vdihnite dodatnega odmerka, da bi nadomestili pozabljenega.
Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare.
Takojšnje težko dihanje po uporabi zdravila LAVENTAIR ELLIPTA je redko.
You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Morda boste pri sebi opazili hitrejši srčni utrip od običajnega, tresavica, motnje vida, suha usta ali glavobol.
It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk.
Ni znano, ali lahko sestavine zdravila LAVENTAIR ELLIPTA prehajajo v materino mleko.
If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.
Če imate po jemanju zdravila LAVENTAIR ELLIPTA katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika.
EU/1/14/899/001 1 inhaler of 7 doses EU/1/14/899/002 1 inhaler of 30 doses
EU/1/14/899/001 1 inhalator s 7 odmerki EU/1/14/899/002 1 inhalator s 30 odmerki
Don't use LAVENTAIR ELLIPTA if you already use these medicines.
Ne uporabite zdravila LAVENTAIR ELLIPTA, če ste že vzeli katero od teh zdravil.
Plasma clearance following intravenous administration was 151 litres/hour.
Umeklidinij Plazemski očistek po intravenski uporabi je bil 151 litrov/uro.
DL12 8DT
DL12 8DT Velika Britanija
- ketoconazole or itraconazole, to treat fungal infections - clarithromycin or telithromycin, to treat bacterial infections - ritonavir, to treat HIV infection - medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) - other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
- ketokonazol ali itrakonazol za zdravljenje glivičnih okužb, - klaritromicin ali telitromicin za zdravljenje bakterijskih okužb, - ritonavir za zdravljenje okužbe z virusom HIV, - zdravila, ki znižajo kalij v krvi, npr. nekateri diuretiki (zdravila za odvajanje vode) ali zdravila, ki se uporabljajo za zdravljenje astme (npr. metilksantin ali steroidi),
It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.
Ni verjetno, da bi zdravilo LAVENTAIR ELLIPTA vplivalo na vašo sposobnost upravljanja vozil in strojev.
Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Laventair Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Opazovalna kohortna raziskava za določitev incidence in primerjalne varnosti za izbrane kardiovaskularne in cerebrovaskularne dogodke pri bolnikih s KOPB z zdravilom Laventair Ellipta v primerjavi s tiotropijem (raziskava 201038), po porotokolu, ki ga je potrdil PRAC.
In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with LAVENTAIR ELLIPTA and tiotropium; 49% and 54% for LAVENTAIR ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
V drugih dveh študijah z aktivno primerjalno učinkovino je podoben delež bolnikov dosegel vsaj MCID z zdravilom LAVENTAIR ELLIPTA kot s tiotropijem: 49 % oz. 54 % z zdravilom LAVENTAIR ELLIPTA 55/22 mikrogramov in 52 % oz. 55 % s tiotropijem.
Atrial fibrillation Supraventricular tachycardia Rhythm idioventricular Tachycardia
Srčne bolezni atrijska fibrilacija supraventrikularna tahikardija idioventrikularni ritem tahikardija občasni občasni občasni občasni
LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Zdravilo LAVENTAIR ELLIPTA je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za olajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Varnostne značilnosti zdravila LAVENTAIR ELLIPTA temeljijo na izkušnjah z varnostjo kombinacije umeklidinij/vilanterol in s posameznima sestavinama iz programa kliničnega razvoja, ki je zajel 6.855
In the second study, the treatment difference in EET between LAVENTAIR ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
V drugi študiji je bila razlika EET med zdravilom LAVENTAIR ELLIPTA 55/22 mikrogramov in placebom 21,9 sekunde (p = 0,234) v 12. tednu.
What you need to know before you use LAVENTAIR ELLIPTA 3.
Kaj morate vedeti, preden boste uporabili zdravilo LAVENTAIR ELLIPTA 3.
What you need to know before you use LAVENTAIR ELLIPTA Do not use LAVENTAIR ELLIPTA:
Kaj morate vedeti, preden boste uporabili zdravilo LAVENTAIR ELLIPTA Ne uporabljajte zdravila LAVENTAIR ELLIPTA:
If you use more LAVENTAIR ELLIPTA than you should
Če ste uporabili večji odmerek zdravila LAVENTAIR ELLIPTA, kot bi smeli
LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Zdravilo LAVENTAIR ELLIPTA vsebuje dve učinkovini, umeklidinijev bromid in vilanterol.
LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Zdravilo LAVENTAIR ELLIPTA je zmanjšalo uporabo rešilnega zdravila s salbutamolom tekom 1.-24. tedna v primerjavi s placebom in umeklidinijem (glejte preglednico 1) ter je doseglo zvišanje deleža dni glede na izhodišče , ko ni bilo treba uporabiti rešilnega zdravila (v povprečju 11,1 %), v primerjavi z znižanjem deleža glede na izhodišče pri placebu (v povprečju 0,9 %).
Eye problems during treatment with LAVENTAIR ELLIPTA
Težave z očmi med zdravljenjem z zdravilom LAVENTAIR ELLIPTA
- if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
- če imate povečano prostato, težave pri odvajanju urina ali zaporo v mehurju, - če imate epilepsijo,
LAVENTAIR ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Zdravilo LAVENTAIR ELLIPTA je v vseh treh študijah doseglo tudi večje zvišanje deleža dni glede na izhodišče, ko rešilno zdravilo ni bilo potrebno (povprečje v razponu od 17,6 % do 21,5 %), v primerjavi s tiotropijem (povprečje v razponu od
These include: - medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems
- zaviralci adrenergičnih receptorjev beta (kot je propranolol); uporabljajo se za zdravljenje visokega krvnega tlaka ali drugih težav s srcem,
There is no relevant use of LAVENTAIR ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Zdravilo LAVENTAIR ELLIPTA za indikacijo KOPB v pediatrični populaciji (mlajši od 18 let) nima relevantne uporabe.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
(≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000)
To use LAVENTAIR ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
uporabite tako, da ga s pomočjo inhalatorja ELLIPTA skozi usta vdihnete v pljuča.
The use of LAVENTAIR ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution.
Uporaba zdravila LAVENTAIR ELLIPTA ni raziskana pri bolnikih s hudo okvaro jeter, zato ga je pri takšnih bolnikih treba uporabljati previdno.
What LAVENTAIR ELLIPTA is and what it is used for 2.
Kaj je zdravilo LAVENTAIR ELLIPTA in za kaj ga uporabljamo 2.
LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Zdravilo LAVENTAIR ELLIPTA se uporablja za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
The “Discard by” date is 6 weeks from the date of opening the tray.
Datum “Zavrzite do” je 6 tednov od datuma odprtja embalaže.
Step-by-step instructions
Navodila za uporabo po korakih