natgillin/translations-raw huggingface dataset:
Based on Predicted Environmental Concentrations (PEC) for surface water PECsw of 0.0026 µg doramectin/l surface water (run-off scenario) and PECsw of 0.5225 µg doramectin/l surface water (direct excretion) an acute risk for Daphnia was identified in Tier A for both exposure scenarios with PEC/PNEC risk quotients (RQ) of 26 and 5225, respectively.
Na osnovi predvidenih koncentracij v okolju (PKO) za površinske vode PKOpovršinske vode 0,0026 µg doramektina/l površinske vode (scenarij odtekanja) oziroma PKOpovršinske vode 0,5225 µg doramektina/l površinske vode (neposredno izločanje) je bilo ugotovljeno akutno tveganje za organizem Daphnia na stopnji A pri obeh scenarijih izpostavljenosti s količnikoma tveganja (RQ) 26 za prvi scenarij oziroma 5225 za drugi scenarij.
Overall summary of the scientific evaluation of Prontax 5 mg/ml pour-on solution for cattle and associated names
Splošni povzetek znanstvenega vrednotenja zdravila Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezanih imen
• On the basis of environmental risk assessment data submitted with the application it was considered that in order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation risk mitigation measures should be applied; the CVMP concluded that the objections raised by the Netherlands and France should not prevent the granting of a marketing authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names (see annex I) as the overall benefit-risk balance for the product is positive subject to the recommended changes in the product information set out in annex III.
prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem uporabiti ukrepe za zmanjševanje tveganja; je CVMP zaključil, da ugovori Nizozemske in Francije ne smejo preprečiti odobritve dovoljenja za promet z zdravilom Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezanimi imeni (glejte prilogo I), saj je celokupno razmerje med tveganji in koristmi za zdravilo, ob upoštevanju priporočenih sprememb informacij o zdravilu, ki so navedene v prilogi III, pozitivno.
The product is intended for the treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Zdravilo je namenjeno za zdravljenje infestacij z želodčno-črevesnimi glistami, pljučnimi črvi, očesnimi črvi, ličinkami zolja, sesajočimi ušmi, garjami in muhami Haematobia irritans pri govedu.
Elanco Animal Health, Eli Lilly and Company Limited and the name of the reference product in
Ireland na družbe Elanco Animal Health, Eli Lilly in Company Limited, ime referenčnega zdravila na Irskem pa je bilo spremenjeno v Zearl 5 mg/ml, raztopina za kožni poliv za govedo.
Denmark Pfizer Limited Veterinary Medical Research &
Nizozemska Pfizer Limited Veterinary Medical Research &
Prontax 5 mg/ml pour-on solution for cattle and associated names is a clear, colourless pour-on solution containing doramectin.
Zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezana imena je bistra, brezbarvna raztopina za kožni poliv, ki vsebuje doramektin.
The reference product for this generic application was Dectomax 5 mg/ml pour-on solution for cattle.
Referenčno zdravilo pri tej generični vlogi je bilo zdravilo Dectomax 5 mg/ml, raztopina za kožni poliv za govedo.
Prontax 5 mg/ml pour-on solution for cattle contains doramectin as active ingredient.
Zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, vsebuje zdravilno učinkovino doramektin.
Dectomax 5 mg/ml pour-on solution for cattle was transferred from Pfizer Healthcare Ireland to
Dectomax 5 mg/ml, raztopina za kožni poliv za govedo, preneseno z družbe Pfizer Healthcare
Add the following text in the relevant sections of the product information:
Naslednje besedilo je treba vključiti v oddelek 5.3 povzetka glavnih značilnosti zdravila (okoljski podatki):
In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended: The following text is proposed in section 4.5 of the SPC(special precautions for use): Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
Za obravnavo opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem, se priporočajo naslednji ukrepi za zmanjševanje tveganja:
The first time you use Temybric Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Ko prvič uporabite zdravilo Temybric Ellipta, vam ni treba preverjati, ali inhalator deluje pravilno; inhalator vsebuje predhodno odmerjene odmerke in je pripravljen za takojšnjo uporabo.
Don't use Temybric Ellipta if you already use these medicines.
Ne uporabljajte zdravila Temybric Ellipta, če že uporabljate ta zdravila.
Administration of Temybric Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Uporaba zdravila Temybric Ellipta pri nosečnicah pride v poštev le, če pričakovana korist za mater upravičuje morebitno tveganje za plod.
Temybric Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Zdravilo Temybric Ellipta morate uporabljati vsak dan in ne samo, kadar imate težave z dihanjem ali druge simptome KOPB.
A decision must be made whether to discontinue breast-feeding or to discontinue Temybric Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Temybric Ellipta, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Temybric Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Zdravila Temybric Ellipta se ne sme uporabljati pri bolnikih z astmo, ker v tej populaciji bolnikov ni raziskano.
Patients should not stop therapy with Temybric Ellipta without physician supervision since symptoms may recur after discontinuation.
Bolniki ne smejo končati zdravljenja z zdravilom Temybric Ellipta brez zdravniškega nadzora, ker se lahko simptomi po prenehanju zdravljenja ponovijo.
There are no clinical data to support the use of Temybric Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Ni kliničnih podatkov, ki bi potrjevali uporabo zdravila Temybric Ellipta za zdravljenje akutnega bronhospazma ali akutnega poslabšanja KOPB (tj. za rešilno zdravljenje).
The most frequently reported adverse reactions with Temybric Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Najpogosteje zabeleženi neželeni učinki med uporabo zdravila Temybric Ellipta so bili nazofaringitis (7 %), glavobol (5 %) in okužba zgornjih dihal (2 %).
The other ingredients are lactose monohydrate (see section 2 under ‘Temybric Ellipta contains lactose') and magnesium stearate.
Pomožni snovi sta laktoza monohidrat (glejte poglavje 2 pod naslovom "Zdravilo Temybric Ellipta vsebuje laktozo") in magnezijev stearat.
Tabulated summary of adverse reactions The safety profile of Temybric Ellipta is based on three phase III clinical studies.
Povzetek neželenih učinkov v preglednici Ugotovljene varnostne značilnosti zdravila Temybric Ellipta temeljijo na treh kliničnih študijah III. faze.
The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day.
Priporočeni in največji odmerek je ena inhalacija zdravila Temybric Ellipta 92/55/22 mikrogramov enkrat na dan, vsak dan ob istem času.
The fluticasone furoate/vilanterol component of Temybric Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Sestavini flutikazonfuroat/vilanterol zdravila Temybric Ellipta so ocenili pri bolnikih z vsemi stopnjami okvare jeter (Child-Pugh A, B in C).
Caution should be exercised when Temybric Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Previdnost je potrebna, če se zdravilo Temybric Ellipta uporablja z drugimi zdravili, ki lahko prav tako povzročijo hipokaliemijo (glejte poglavje 4.5).
Temybric Ellipta is for inhalation use only.
Zdravilo Temybric Ellipta je namenjeno samo za inhalacijsko uporabo.
This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs.
Zdravilo Temybric Ellipta sprosti te mišice v pljučih, zmanjša oteklost in draženje v malih dihalnih poteh ter olajša vstopanje zraka v pljuča in njegovo izstopanje iz pljuč.
The efficacy of Temybric Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Učinkovitost zdravila Temybric Ellipta (92/55/22 mikrogramov) enkrat na dan so ovrednotili na bolnikih s klinično diagnozo KOPB v dveh z zdravilno učinkovino kontroliranih študijah in v eni študiji neinferiornosti.
Once the tray is opened Temybric Ellipta is ready to use.
Ko je embalaža odprta, je zdravilo Temybric Ellipta pripravljeno za uporabo.
Pneumonia which required hospitalisation occurred in 1% of patients receiving Temybric Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Pljučnica, ki je zahtevala sprejem v bolnišnico, se je v obdobju do 24 tednov pojavila pri 1 % prejemnikov zdravila Temybric Ellipta in pri < 1 % prejemnikov kombinacije budezonid/formoterol.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Temybric Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma z ozkim zakotjem; naročiti jim je treba, da morajo v primeru takšnih znakov ali simptomov nemudoma prenehati uporabljati zdravilo Temybric Ellipta in se posvetovati z zdravnikom.
Upon initiation of treatment with Temybric Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Po uvedbi zdravljenja z zdravilom Temybric Ellipta je treba sladkornim bolnikom natančneje kontrolirati glukozo v plazmi.
If you use more Temybric Ellipta than you should
Če ste uporabili večji odmerek zdravila Temybric Ellipta, kot bi smeli
Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Temybric Ellipta.
Če jemljete katero od teh zdravil, vas bo zdravnik morda natančno nadzoroval, kajti ta zdravila lahko povečajo neželene učinke zdravila Temybric Ellipta.
Treatment difference (95% CI) Comparison with BUD/FOR
Razlika med zdravljenji (95% IZ) Primerjava zdravila Temybric s FF/VI
Patients with moderate to severe hepatic impairment receiving Temybric Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Bolnike z zmerno do hudo okvaro jeter, ki prejemajo zdravilo Temybric Ellipta, je treba nadzorovati glede sistemskih neželenih učinkov, povezanih s kortikosteroidi (glejte poglavje 5.2).
It is very important that you use Temybric Ellipta every day, as instructed by your doctor.
Zdravilo Temybric Ellipta uporabljajte redno Zelo pomembno je, da zdravilo Temybric Ellipta uporabljate vsak dan, kot vam je naročil zdravnik.
What Temybric Ellipta is and what it is used for 2.
Kaj je zdravilo Temybric Ellipta in za kaj ga uporabljamo 2.
In FULFIL, Temybric Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
V študiji FULFIL je zdravilo Temybric Ellipta izboljšalo dnevne simptome KOPB, ocenjene z E-RS: celotna ocena KOPB, v primerjavi z BUD/FOR (zmanjšanje izhodiščne vrednosti za ≥ 2 enoti).
The incidence of pneumonia with Temybric Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Pojavnost pljučnice z zdravilom Temybric Ellipta je primerljiva tisti, ki so jo opažali v skupini s kombinacijo flutikazonfuroat/vilanterol (FF/VI) 100/25 kliničnih študij FF/VI pri KOPB.
There is no relevant use of Temybric Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
V pediatrični populaciji (mlajši od 18 let) zdravilo Temybric Ellipta nima relevantne uporabe za indikacijo KOPB.
Temybric Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Zdravilo Temybric Ellipta je treba uporabljati previdno pri bolnikih s konvulzivnimi motnjami ali tirotoksikozo in pri bolnikih, ki so nenavadno odzivni na agoniste adrenergičnih receptorjev beta2.
In the event of deterioration of COPD during treatment with Temybric Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Če se KOPB med zdravljenjem z zdravilom Temybric Ellipta poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
4.1 Terapevtske indikacije Zdravilo Temybric Ellipta je indicirano za vzdrževalno zdravljenje odraslih bolnikov z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), ki niso zadostno zdravljeni s kombinacijo inhalacijskega kortikosteroida in dolgodelujočega agonista adrenergičnih receptorjev β2 ali s kombinacijo dolgodelujočega agonista adrenergičnih receptorjev β2 in dolgodelujočega antagonista muskarinskih receptorjev (za učinke na obvladanje simptomov in preprečevanje poslabšanj glejte poglavje 5.1).
What you need to know before you use Temybric Ellipta 3.
Kaj morate vedeti, preden boste uporabili zdravilo Temybric Ellipta 3.
Temybric Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Zdravila Temybric Ellipta se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
In Study 200812, Temybric Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
V študiji 200812 je bilo zdravilo Temybric Ellipta neinferiorno v primerjavi s sočasno uporabljeno kombinacijo dveh inhalatorjev FF/VI+UMEC, kar zadeva izboljšanje najnižjega FEV1 od izhodišča do 24. tedna.
Therefore, Temybric Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Zato je treba zdravilo Temybric Ellipta previdno uporabljati pri bolnikih, ki imajo kakšno nestabilno ali življenjsko ogrožujočo kardiovaskularno bolezen.
Treatment with Temybric Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Zdravljenje z zdravilom Temybric Ellipta je značilno zmanjšalo letni delež hudih poslabšanj za 34 % v primerjavi z UMEC/VI (95 % IZ: 22, 44; p < 0,001).
FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Temybric Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Študija FULFIL (CTT116853) je bila 24 tednov trajajoča študija (N = 1810) s podaljšanjem do 52 tednov v podskupini preiskovancev (n = 430), v kateri so primerjali zdravilo Temybric Ellipta (92/55/22 mikrogramov) s kombinacijo budezonid/formoterol 400/12 mikrogramov (BUD/FOR) dvakrat na dan.
In IMPACT, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
V študiji IMPACT je zdravilo Temybric Ellipta značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila (dogodki na dan) v vsakem 4-tedenskem obdobju kot FF/VI in UMEC/VI.
Your Temybric Ellipta inhaler carton contains
Škatla vašega inhalatorja Temybric Ellipta vsebuje
In IMPACT, Temybric Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
V študiji IMPACT je zdravilo Temybric Ellipta značilno izboljšalo (p < 0,001) pljučno funkcijo v primerjavi s kombinacijo FF/VI in UMEC/VI v obdobju 52 tednov (glejte Preglednico 2).
INFORMATION IN BRAILLE temybric ellipta
PODATKI V BRAILLOVI PISAVI temybric ellipta
Temybric Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Zdravilo Temybric Ellipta je treba uporabljati previdno pri bolnikih s pljučno tuberkulozo in pri bolnikih s kroničnimi ali nezdravljenimi okužbami.
Temybric Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Zdravilo Temybric Ellipta vsebuje tri zdravilne učinkovine: flutikazonfuroat, umeklidinij in vilanterol.
What you need to know before you use Temybric Ellipta
Kaj morate vedeti, preden boste uporabili zdravilo Temybric Ellipta
Other medicines and Temybric Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
In IMPACT, treatment with Temybric Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
V študiji IMPACT je zdravljenje z zdravilom Temybric Ellipta zmanjšalo letni delež hudih poslabšanj (tj. poslabšanj, ki so zahtevala sprejem v bolnišnico ali so se končala s smrtnim izidom) za 13 % v primerjavi s FF/VI (95 % IZ: -1, 24; p = 0,064).
Eye problems during treatment with Temybric Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Temybric Ellipta:
Težave z očmi med zdravljenjem z zdravilom Temybric Ellipta Če se vam med zdravljenjem z zdravilom Temybric Ellipta pojavijo bolečine ali nelagodje v očesu, prehodno zamegljen vid, odsevi okrog stvari ali obarvane slike ter pordele oči:
In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Temybric Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
predvidenega, standardni odklon (SD) 13 %), od katerih jih je 65 % imelo zmerno/hudo poslabšanje KOPB v letu pred vstopom v študijo (študija CTT116853), so do 24. tedna ugotovili večjo pojavnost pljučnic med prejemniki zdravila Temybric Ellipta (20 bolnikov, 2 %) kot med prejemniki kombinacije budezonid/formoterol (7 bolnikov, < 1 %).
Talk to your doctor before using Temybric Ellipta - if you have asthma (Don't use Temybric Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Pred začetkom uporabe zdravila Temybric Ellipta se posvetujte z zdravnikom: - če imate astmo (zdravila Temybric Ellipta ne uporabljajte za zdravljenje astme), - če imate težave s srcem ali visok krvni tlak, - če imate težave z jetri, - če imate pljučno tuberkulozo (TB) ali kakšne dolgotrajne ali nezdravljene okužbe,
Temybric Ellipta contains lactose
Zdravilo Temybric Ellipta vsebuje laktozo
In FULFIL, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
V študiji FULFIL je zdravilo Temybric Ellipta med 1. in 24. tednom značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila kot BUD/FOR (razlika med zdravljenjema: -0,2 dogodka na dan; 95 % IZ: -0,3,
Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Temybric Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
ki so prejemali zdravilo Temybric Ellipta, pri 5 od 4134 bolnikov (1,7 na 1000 bolnik-let), ki so prejemali kombinacijo flutikazonfuroat/vilanterol in pri 5 od 2070 bolnikov (2,9 na 1000 bolnik-let), ki so prejemali kombinacijo umeklidinij/vilanterol.
In IMPACT, Temybric Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
V študiji IMPACT je zdravilo Temybric Ellipta podaljšalo čas do prvega zmernega ali hudega poslabšanja in značilno zmanjšalo (p < 0,001) tveganje za zmerno ali hudo poslabšanje, merjeno s časom do prvega poslabšanja, tako v primerjavi s FF/VI (14,8 %; 95 % IZ: 9,3, 19,9) kot z UMEC/VI (16,0 %; 95% IZ: 9,4, 22,1).
If you are breast-feeding, you must check with your doctor before you use Temybric Ellipta.
Če dojite, se morate pred uporabo zdravila Temybric Ellipta posvetovati z zdravnikom.
Co-administration of Temybric Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Druge dolgodelujoče antimuskarinske učinkovine in dolgodelujoči agonisti adrenergičnih receptorjev beta2 Sočasna uporaba zdravila Temybric Ellipta z drugimi dolgodelujočimi muskarinskimi antagonisti ali dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ni raziskana in ni priporočljiva, ker lahko poveča neželene učinke (glejte poglavji 4.8 in 4.9).
Temybric Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Za kaj uporabljamo zdravilo Temybric Ellipta Zdravilo Temybric Ellipta uporabljamo za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1378/001
In FULFIL, Temybric Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
V študiji FULFIL je zdravilo Temybric Ellipta značilno zmanjšalo tveganje za zmerno ali hudo poslabšanje v primerjavi z BUD/FOR v 24 tednih (33 %; 95 % IZ: 12, 48; p = 0,004).
In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Temybric
V podskupini 430 bolnikov, zdravljenih do 52 tednov, je bila pojavnost pljučnic tako v skupini z zdravilom Temybric Ellipta kot v skupini s kombinacijo budezonid/formoterol enaka in je znašala 2 %.