FrancophonIA/ELRC3.0 huggingface dataset:
English: An ERA was performed by the applicant in accordance with the VICH guidelines for Phase I and Phase II assessment adopted by the CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) as well as the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH Guidelines GL6 and GL38 (CVMP/ERA/418282/2005-corr).
Slovenian: Oceno tveganja za okolje je predlagatelj izvedel v skladu s smernicami VICH za oceno faze I in faze II, ki jih je sprejel CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final), in smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicam VICH GL6 in GL38 (CVMP/ERA/418282/2005-corr).
English: Doramectin is an antipatasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Slovenian: Doramektin je antiparazitik, izoliran pri fermentaciji izbranih sevov, ki izvirajo iz talnega organizma Streptomyces avermitilis.
English: The supplementary data provided did not allow ruling out a medium to longterm risk to dung insects.
Slovenian: Na podlagi predloženih dodatnih podatkov ni bilo mogoče izključiti srednje- do dolgoročnega tveganja za insekte, prisotne v gnoju.
English: As the risk for Daphnia could not be ruled out by PEC refinements Tier B assessment should be performed according VICH Guideline 38 be performed for which a Daphnia magna reproduction study is required.
Slovenian: Ker tveganja za organizem Daphnia z izboljšanjem PKO ni bilo mogoče izključiti, bi bilo treba izvesti ocenjevanje tveganja stopnje B v skladu s smernico VICH 38, za katero je potrebna študija vpliva na sposobnost razmnoževanja Daphnia magna.
English: Therefore, risk mitigation measures are considered necessary, as specified in the product information.
Slovenian: Iz tega razloga je bilo ocenjeno, da so nujni ukrepi za zmanjševanje tveganja, kot so navedeni v informacijah o zdravilu.
English: The concentration of total doramectin residues excreted in cattle faeces peaked at 21 days after administration (270 µg/kg) and declined thereafter, accounting for 52 µg/kg at 35 days and 3.9 µg/kg at 56 days.
Slovenian: Koncentracija celotnih ostankov doramektina, izločenih z blatom goveda, je dosegla najvišjo vrednost 21. dan po dajanju zdravila (270 µg/kg) ter se nato zmanjševala in 35. dan znašala 52 µg/kg, 56. dan pa 3,9 µg/kg.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, karence, imetnikov dovoljenja za promet v državah članicah.
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Prontax 5 mg/ml pour-on solution for cattle.
Slovenian: CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki so jih je izrazile zadevne države članice, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo.
English: In terms of environmental safety, in addition to the fact that the current data package does not allow to rule out bioaccumulation of doramectin, a risk to the aquatic compartment has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung out when the product is used in accordance with the recommended posology.
Slovenian: V zvezi z varnostjo za okolje je bilo poleg dejstva, da na osnovi trenutnega nabora podatkov ni mogoče izključiti biološkega kopičenja doramektina, na osnovi razpoložljivih podatkov o toksičnosti ugotovljeno tveganje za vodno okolje (akutna toksičnost za Daphnia magna) ter tveganje za organizme, prisotne v gnoju, ki so pri uporabi zdravila v skladu s priporočenim načinom odmerjanja izpostavljeni gnoju, ki vsebuje ostanke.
English: The potential serious risks regarding the environment identified by France and the Netherlands are risks to dung fauna and Daphnia in accordance with the proposed instructions for use and a risk identified by the Netherlands due to the bioaccumulation potential linked to the determination of the log KOW by using a test method, which was not considered appropriate for the active ingredient.
Slovenian: Možna resna tveganja za okolje, ki sta jih izpostavili Francija in Nizozemska, so tveganja za organizme, prisotne v gnoju, in organizem Daphnia glede na predlagano navodilo za uporabo ter tveganje, ki ga je izpostavila Nizozemska, glede možnosti biološkega kopičenja v povezavi z določitvijo log KOW s testno metodo, ki je bila ocenjena za neustrezno za to zdravilno učinkovino.
English: The product is applied topically along the mid-line of the back in a narrow strip between the withers and tailhead.
Slovenian: Zdravilo nanašamo topikalno po sredini hrbta v ozkem pasu od pleč do korena repa.
English: Further PEC refinement considering that peak excretion of total residues occurred on day 21 after administration and accounted for 2.3% of the administered dose, as well as based on sediment partitioning lead to a PECsw-refined-direct of 0.00037 µg/l, resulting in a RQ for Daphnia (3.7) still higher than 1.
Slovenian: Nadaljnje izboljšanje PKO ob upoštevanju, da je bilo izločanje celotnih ostankov največje 21. dan po dajanju zdravila in je ustrezalo 2,3 % uporabljenega odmerka, ter na podlagi porazdelitve sedimenta je privedlo do izboljšane PKOpovršinske vode za neposredno izločanje 0,00037 µg/l, kar pomeni, da je količnik tveganja za organizem Daphnia (3,7) še vedno večji od 1.
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 5 mg/ml pour-on solution for cattle.
Slovenian: Predlagatelj družba Pfizer Limited je predložil vlogo za decentralizirani postopek za zdravilo Dectomax 5 mg/ml, raztopina za kožni poliv za govedo.
English: The benefit-risk evaluation is deemed to be positive provided that the recommended risk mitigation measures are added to the product literature regarding risk to aquatic organisms and dung fauna.
Slovenian: Ocena razmerja med tveganji in koristmi velja za pozitivno pod pogojem, da se v dokumentacijo izdelka vključijo priporočeni ukrepi za zmanjševanje tveganja v zvezi s tveganjem za vodne organizme in organizme, prisotne v gnoju.
English: Based on the Predicted No Effect Concentrations (PNECs) derived from the LC50 of 1.34 µg/kg soil for horn flies (Haematobia irritans) and the NOEC of 4.0 µg/kg soil for dung beetles (Ontophagus gazelle) the resulting risk quotients for both species were high (20149 and 675, respectively, based on the amount of total residues in dung at day 21 after administration), indicating a high acute risk to dung insects in Tier A. Consequently a Tier B assessment should be performed.
Slovenian: Na osnovi predvidenih koncentracij brez učinka (PKBU), izpeljanih iz vrednosti LC50 1,34 µg/kg prsti za muho Haematobia irritans, in koncentracije brez opaznega učinka (KBOU) 4,0 µg/kg prsti za govnača (Ontophagus gazelle) sta bila izračunana količnika tveganja (RQ) za obe vrsti visoka (20149 za Haematobia irritans oziroma 675 za Ontophagus gazelle, na osnovi celotnih ostankov v gnoju 21. dan po dajanju zdravila), kar kaže na visoko akutno tveganje za insekte, prisotne v gnoju, na stopnji A. Posledično bi bilo treba izvesti oceno stopnje B. Vendar pa je znano, da usklajena navodila za izvedbo ocenjevanja tveganja v stopnji B za insekte, prisotne v gnoju, trenutno niso na voljo.
English: The outcome of the ERA indicates that RQ are higher than 1 in the Tier A assessment in two cases, namely daphnids (following direct excretion scenario) and dung fauna.
Slovenian: Izid ocene tveganja za okolje kaže, da je količnik tveganja pri ocenjevanju v stopnji A večji od 1 v dveh primerih, in sicer pri dafnidih (pri scenariju neposrednega izločanja) in pri organizmih, prisotnih v gnoju.
English: The referral for Prontax 5 mg/ml pour on solution for cattle relates to the potential serious risks raised by France and the Netherlands regarding the environmental risk assessment (ERA).
Slovenian: Napotitveni postopek za zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, se nanaša na možno resno tveganje v zvezi z oceno tveganja za okolje, na katero sta opozorili Francija in Nizozemska.
English: Sweden (Applicant) Pfizer Limited Veterinary Medical Research &
Slovenian: Švedska (Applicant) Pfizer Limited Veterinary Medical Research &
English: A Phase II, Tier A assessment was required.
Slovenian: Potrebno je bilo ocenjevanje stopnje A faze II.
English: 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.
Slovenian: 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.
English: Overall summary of the scientific evaluation of Prontax 5 mg/ml pour-on solution for cattle and associated names
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezanih imen
English: • 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.
Slovenian: 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.
English: The product is intended for the treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Slovenian: 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.
English: Elanco Animal Health, Eli Lilly and Company Limited and the name of the reference product in
Slovenian: 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.
English: Denmark Pfizer Limited Veterinary Medical Research &
Slovenian: Nizozemska Pfizer Limited Veterinary Medical Research &
English: Prontax 5 mg/ml pour-on solution for cattle and associated names is a clear, colourless pour-on solution containing doramectin.
Slovenian: Zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, in povezana imena je bistra, brezbarvna raztopina za kožni poliv, ki vsebuje doramektin.
English: The reference product for this generic application was Dectomax 5 mg/ml pour-on solution for cattle.
Slovenian: Referenčno zdravilo pri tej generični vlogi je bilo zdravilo Dectomax 5 mg/ml, raztopina za kožni poliv za govedo.
English: Prontax 5 mg/ml pour-on solution for cattle contains doramectin as active ingredient.
Slovenian: Zdravilo Prontax 5 mg/ml, raztopina za kožni poliv za govedo, vsebuje zdravilno učinkovino doramektin.
English: Dectomax 5 mg/ml pour-on solution for cattle was transferred from Pfizer Healthcare Ireland to
Slovenian: Dectomax 5 mg/ml, raztopina za kožni poliv za govedo, preneseno z družbe Pfizer Healthcare
English: Add the following text in the relevant sections of the product information:
Slovenian: Naslednje besedilo je treba vključiti v oddelek 5.3 povzetka glavnih značilnosti zdravila (okoljski podatki):
English: Slovenia
Slovenian: Latvija
English: 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.
Slovenian: 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:
English: 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.
Slovenian: 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.
English: Don't use Temybric Ellipta if you already use these medicines.
Slovenian: Ne uporabljajte zdravila Temybric Ellipta, če že uporabljate ta zdravila.
English: 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.
Slovenian: Uporaba zdravila Temybric Ellipta pri nosečnicah pride v poštev le, če pričakovana korist za mater upravičuje morebitno tveganje za plod.
English: Temybric Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Slovenian: Zdravilo Temybric Ellipta morate uporabljati vsak dan in ne samo, kadar imate težave z dihanjem ali druge simptome KOPB.
English: 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.
Slovenian: 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.
English: Temybric Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Slovenian: Zdravila Temybric Ellipta se ne sme uporabljati pri bolnikih z astmo, ker v tej populaciji bolnikov ni raziskano.
English: Patients should not stop therapy with Temybric Ellipta without physician supervision since symptoms may recur after discontinuation.
Slovenian: Bolniki ne smejo končati zdravljenja z zdravilom Temybric Ellipta brez zdravniškega nadzora, ker se lahko simptomi po prenehanju zdravljenja ponovijo.
English: 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).
Slovenian: Ni kliničnih podatkov, ki bi potrjevali uporabo zdravila Temybric Ellipta za zdravljenje akutnega bronhospazma ali akutnega poslabšanja KOPB (tj. za rešilno zdravljenje).
English: The most frequently reported adverse reactions with Temybric Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Slovenian: Najpogosteje zabeleženi neželeni učinki med uporabo zdravila Temybric Ellipta so bili nazofaringitis (7 %), glavobol (5 %) in okužba zgornjih dihal (2 %).
English: The other ingredients are lactose monohydrate (see section 2 under ‘Temybric Ellipta contains lactose') and magnesium stearate.
Slovenian: Pomožni snovi sta laktoza monohidrat (glejte poglavje 2 pod naslovom "Zdravilo Temybric Ellipta vsebuje laktozo") in magnezijev stearat.
English: Tabulated summary of adverse reactions The safety profile of Temybric Ellipta is based on three phase III clinical studies.
Slovenian: Povzetek neželenih učinkov v preglednici Ugotovljene varnostne značilnosti zdravila Temybric Ellipta temeljijo na treh kliničnih študijah III. faze.
English: The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day.
Slovenian: Priporočeni in največji odmerek je ena inhalacija zdravila Temybric Ellipta 92/55/22 mikrogramov enkrat na dan, vsak dan ob istem času.
English: The fluticasone furoate/vilanterol component of Temybric Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Slovenian: Sestavini flutikazonfuroat/vilanterol zdravila Temybric Ellipta so ocenili pri bolnikih z vsemi stopnjami okvare jeter (Child-Pugh A, B in C).
English: 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).
Slovenian: Previdnost je potrebna, če se zdravilo Temybric Ellipta uporablja z drugimi zdravili, ki lahko prav tako povzročijo hipokaliemijo (glejte poglavje 4.5).
English: Temybric Ellipta is for inhalation use only.
Slovenian: Zdravilo Temybric Ellipta je namenjeno samo za inhalacijsko uporabo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Once the tray is opened Temybric Ellipta is ready to use.
Slovenian: Ko je embalaža odprta, je zdravilo Temybric Ellipta pripravljeno za uporabo.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Temybric Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Upon initiation of treatment with Temybric Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Slovenian: Po uvedbi zdravljenja z zdravilom Temybric Ellipta je treba sladkornim bolnikom natančneje kontrolirati glukozo v plazmi.
English: If you use more Temybric Ellipta than you should
Slovenian: Če ste uporabili večji odmerek zdravila Temybric Ellipta, kot bi smeli
English: 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.
Slovenian: Če jemljete katero od teh zdravil, vas bo zdravnik morda natančno nadzoroval, kajti ta zdravila lahko povečajo neželene učinke zdravila Temybric Ellipta.
English: Treatment difference (95% CI) Comparison with BUD/FOR
Slovenian: Razlika med zdravljenji (95% IZ) Primerjava zdravila Temybric s FF/VI
English: Patients with moderate to severe hepatic impairment receiving Temybric Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Slovenian: 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).
English: It is very important that you use Temybric Ellipta every day, as instructed by your doctor.
Slovenian: Zdravilo Temybric Ellipta uporabljajte redno Zelo pomembno je, da zdravilo Temybric Ellipta uporabljate vsak dan, kot vam je naročil zdravnik.
English: What Temybric Ellipta is and what it is used for 2.
Slovenian: Kaj je zdravilo Temybric Ellipta in za kaj ga uporabljamo 2.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: There is no relevant use of Temybric Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Slovenian: V pediatrični populaciji (mlajši od 18 let) zdravilo Temybric Ellipta nima relevantne uporabe za indikacijo KOPB.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Če se KOPB med zdravljenjem z zdravilom Temybric Ellipta poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
English: 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).
Slovenian: 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).
English: What you need to know before you use Temybric Ellipta 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Temybric Ellipta 3.