FrancophonIA/ELRC3.0 huggingface dataset:
English: The parent drug accounted for 79% of the total radioactive faecal residue.
Estonian: Muutumatul kujul moodustas doramektiin väljaheites 79% ravimijääkide koguradioaktiivsusest.
English: Package leaflet:
Estonian: Pakendi Infoleht:
English: The supplementary data provided did not allow ruling out a medium to longterm risk to dung insects.
Estonian: Taotleja esitatud täiendavate andmete alusel ei olnud võimalik välistada keskpikka või pikaaegset ohtu sõnniku putukatele.
English: Two Concerned Member States (the Netherlands and France) considered that the authorisation of Dectomax 5 mg/ml pour-on solution for cattle may present a potential serious risk to the environment.
Estonian: Kaks asjaomast liikmesriiki (Madalmaad ja Prantsusmaa) leidsid, et veterinaarravimi Dectomax 5 mg/ml kriipsulahus veistele müügiloa andmine võib kujutada endast tõsist ohtu keskkonnale.
English: As no harmonised guidance on how to conduct Tier B assessment studies for dung insects is currently available, risk mitigation measures to reduce exposure are considered to overcome the identified risk.
Estonian: Et käesoleval ajal puuduvad ühtlustatud juhised selle kohta kuidas läbi viia B-astme hindamise uuringuid sõnnikus pesitsevatel putukatel, siis on kindlakstehtud riski vähendamiseks vaja kasutusele võtta riskivähendamise meetmed, et vähendada ravimijääkide ekspositsiooni.
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
Estonian: Riski vee ökosüsteemidele ja sõnnikufaunale saab vähendada, vältides doramektiini (ja samasse anthelmintikumide klassi kuuluvate preparaatide) liiga sagedast ja korduvat kasutamist veistel.
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.
Estonian: Väljaheitega eritatud dorametiini ravimijääkide üldkontsentratsioon oli veistel suurim 21. päeval pärast manustamist (270 µg/kg) ja hakkas seejärel vähenema, olles 35. päeval 52 µg/kg ja 56. päeval 3,9 µg/kg.
English: For the dung fauna, the results of the Tier A assessment showed a very high RQ indicating an unacceptable acute risk.
Estonian: Mis puudutab sõnniku faunat, siis näitas A-astme hindamine väga kõrget riskikordajat, mis viitab vastuvõetamatult suurele akuutsele ohule.
English: Therefore, risk mitigation measures are considered necessary, as specified in the product information.
Estonian: Seetõttu on ravimi kasutamisel vajalikud vastavad riskivähendamise meetmed, mis on toodud tooteinfos.
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.
Estonian: Inimravimite komiteel paluti esitada arvamus asjaomaste liikmesriikide poolt tõstatatud probleemide kohta ning võtta vastu otsus veterinaarravimi Prontax 5 mg/ml kriipsulahus veistele kasulikkuse ja riski tasakaalu kohta.
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.
Estonian: • koos taotlusega esitatud keskkonnariskide hindamise andmete alusel on vajalik kasutusele võtta riskivähendamise meetmed, et vähendada kindlakstehtud ohte veeorganismidele ja sõnniku faunale ning arvestada ka ebaselgust ravimi võimaliku bioakumulatsiooni osas, otsustas veterinaarravimite komitee, et Madalmaade ja Prantsusmaa poolt tõstatud vastuväited ei ole takistuseks müügiloa andmisele veterinaarravimi Prontax 5 mg/ml kriipsulahus veistele ja sarnaste nimetuste (vt I lisa) turustamiseks, sest ravimi üldine kasulikkuse ja riski tasakaal on positiivne, kui tooteinfosse viiakse sisse III lisas toodud soovitatavad muudatused.
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.
Estonian: Et arvutusliku keskkonnas esineva kontsentratsiooni kohandamisega ei ole võimalik välistada ohtu vesikirpudele, tuleb VICH juhise 38 alusel läbi viia B-astme hindamine, milleks on vaja teha Daphnia magna reproduktsiooniuuring.
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.
Estonian: Keskkonnaohutuse osas on asjaolu kõrval, et antud andmete pakett ei võimalda välistada doramektiini bioakumulatsiooni võimalust olemasolevate toksilisuse andmete alusel (akuutne toksilisus Daphnia magna suhtes), kindlaks tehtud veel risk veeorganismidele ja sõnniku faunale, kui see puutub kokku doramektiini ravimijääke sisaldava väljaheitega, ka ravimi kasutamisel soovitatava annustamisskeemi järgi.
English: After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, the RQ remains above 1 for Daphnia.
Estonian: Pärast PECsw väärtuse kohandamist veterinaarravimite komitee juhises CVMP/ERA/418282/2005 soovitatud FOCUSe mudeli järgi oli riskikordaja vesikirpude suhtes endiselt suurem kui 1.
English: Labelling:
Estonian: Pakendi Märgistus:
English: The following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Estonian: Detsentraliseeritud menetluse ja inimravimite komitee poolt algatatud esildismenetluse ajal tehti esialgsesse taotlusse kaks järgmist muudatust, mida on oluline siinjuures märkida:
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).
Estonian: Veterinaarravimi Prontax 5 mg/ml kriipsulahus veistele esildismenetlus algatati põhjusel, et Prantsusmaa ja Madalmaad tõstatasid küsimuse võimalikest tõsistest riskidest, mis tulenesid keskkonnariski hindamisest.
English: Overall summary of the scientific evaluation of Prontax 5 mg/ml pour-on solution for cattle and associated names
Estonian: Prontax 5 mg/ml veiste kriipsulahuse ja sarnaste nimetuste teadusliku hindamise üldkokkuvõte
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.
Estonian: Pinnavee arvutuslike keskkonnas esinevate kontsentratsioonide (PECsw) alusel 0,0006 g doramektiini liitris pinnavees (läbi pinnase filtreerumise stsenaarium, nn run-off stsenaarium) ja 0,5225 g doramektiini liitris pinnavees (otsese pinnavette eritumise stsenaarium) leiti uuringus mõlema riskistsenaariumi korral A-astme akuutne risk vesikirpudele PEC/PNEC riskikordajatega vastavalt 26 ja 5225.
English: Prontax 5 mg/ml pour-on solution for cattle and associated names is a clear, colourless pour-on solution containing doramectin.
Estonian: Prontax 5 mg/ml kriipsulahus veistele ja sarnased nimetused on selge ning värvitu kriipsulahus, mis sisaldab toimeainena doramektiini.
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 5 mg/ml pour-on solution for cattle.
Estonian: Ravimifirma Pfizer Limited esitas detsentraliseeritud menetluse vahendusel müügiloa taotluse veterinaarravimi Dectomax 5 mg/ml kriipsulahus veistele turustamiseks.
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.
Estonian: Arvutuslike mittetoimivate kontsentratsioonide (PNECs) alusel, mis saadi LC50 kontsentratsioonist mullas verdimevate kärbeste Haematobia irritans suhtes (1,34 µg/kg) ja täheldatavat toimet mitteavaldavast kontsentratsioonist mullas sõnnikumardikate (Ontophagus gazelle) suhtes (4,0 µg/kg), olid sellest tulenevad riskikordajad mõlema liigi puhul kõrged (üldiste ravimijääkide alusel sõnnikus 21. päeval pärast manustamist vastavalt 20 149 ja 675).
English: Prontax 5 mg/ml pour-on solution for cattle contains doramectin as active ingredient.
Estonian: Prontax 5 mg/ml kriipsulahus veistele sisaldab toimeainena doramektiini.
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.
Estonian: Keskkonnariski hindamine veistel näitas, et riskikordajad olid A-astme hindamisel kahel juhul suuremad kui 1: vesikirpudel (otsese pinnavette sattumise stsenaarium) ja sõnniku faunas.
English: Doramectin is an antipatasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Estonian: Doramektiin on parasiidivastane aine, mida saadakse mullabakterite Streptomyces avermitilis teatud tüvede fermentatsiooni teel.
English: Summary of Product Characteristics
Estonian: Ravimi Omaduste Kokkuvõte
English: The Netherlands
Estonian: Madalmaade tõstatatud
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Estonian: Nii ivermektiinil kui ka doramektiinil on lai parasiidivastane toimespekter, mis kutsub nematoodidel ja parasitaarsetel artropoodidel esile ühesuguse paralüüsi.
English: INN/Strength Animal species
Estonian: Nimetus Ravimvorm INN/Tugevus Loomaliigid Manustamisviis Soovitatav doos
English: The reference product for this generic application was Dectomax 5 mg/ml pour-on solution for cattle.
Estonian: Võrdlusravimid olid antud geneerilise taotluse korral Dectomax 5 mg/ml kriipsulahus veistele.
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.
Estonian: Järeldused kasulikkuse ja riski tasakaalu kohta Kasulikkuse ja riski tasakaal on positiivne, kui veterinaarravimi tooteinfole lisatakse soovitatavad riskivähendamise meetmed ohtude vähendamiseks veeorganismidele ja sõnniku faunale.
English: Denmark Pfizer Limited Veterinary Medical Research &
Estonian: Hispaania Pfizer Limited Veterinary
English: The product is indicated for treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Estonian: Doramektiin on näidustatud seedetrakti ümarusside, kopsuusside, silmausside, kiinide, verdimevate ja hammustavate täide, sügelislestade ning verdimevate kärbeste Haematobia irritans raviks ja tõrjeks veistel.
English: Conclusions on the benefit-risk balance
Estonian: Kasulikkuse ja riski tasakaalu hindamine
English: Sweden (Applicant) Pfizer Limited Veterinary Medical Research &
Estonian: Sloveenia Pfizer Limited Veterinary
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.
Estonian: 2,3% manustatud annusest, ning teiselt poolt seda, et settimise jaotumine viib PECsw-kohandatudotsesele kontsentratsioonile 0,00037 µg/l, on riskikordaja vesikirpude jaoks siiski suurem kui 1 (3,7).
English: The product is applied topically along the mid-line of the back in a narrow strip between the withers and tailhead.
Estonian: Veterinaarravimit manustatakse lokaalselt peene joonena loomade selja keskjoonele alates turjast kuni saba alguskohani.
English: Elanco Animal Health, Eli Lilly and Company Limited and the name of the reference product in
Estonian: Iirimaal ravimifirmalt Pfizer Healthcare Ireland üle ravimifirmale Elanco Animal Health, Eli Lilly
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.
Estonian: Võimalikud tõsised keskkonnariskid, millele juhtisid tähelepanu Prantsusmaa ja Madalmaad, olid seotud ravimi kasutusjuhistest tulenevate riskidega sõnniku faunale ja vesikirpudele.
English: In general terms, as for the benefits, that except for the risks identified in particular by the referral (ERA) all other risks are expected to be the same as for the reference product and have not been discussed in any detail by CVMP.
Estonian: Kui mitte arvestada käesoleva esildismenetluse käigus kindlakstehtud riske (keskkonnariski hindamine ja keeluaja pikkus veistel), on üldiselt kõik riskid nagu kasudki samad, mida võib oodata ka võrdlusravimi kasutamisel.
English: Dectomax 5 mg/ml Pour-On Solution for Cattle
Estonian: • esildismenetluse ajal anti võrdlusravimi Dectomax 5 mg/ml kriipsulahus veistele müügiluba
English: Ireland was changed to Zearl 5 mg/ml pour-on solution for cattle.
Estonian: & Company Limited, ning võrdlusravimi nimetuseks Iirimaal sai Zearl 5 mg/ml kriipsulahus veistele.
English: The following text should be included in section 5.3 of the SPC (environmental properties): Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Estonian: Doramektiinil, nagu ka teisel makrotsüklilistel laktoonidel, on potentsiaal kahjulikult mõjutada mittesihtorganisme.
English: A Phase II, Tier A assessment was required.
Estonian: Seetõttu tuleb läbi viia ka B-astme hindamine.
English: 5 mg/ml pour-on solution for cattle to Prontax 5 mg/ml pour-on solution for cattle1.
Estonian: • detsentraliseeritud menetluse ajal muudeti väljapakutud ravimi nimetus Dectomax 5 mg/ml kriipsulahus veistele nimetuseks Prontax 5 mg/ml kriipsulahus veistele;1
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.
Estonian: Selleks, et vähendada doramektiini kindakstehtud riski veeorganismidele ja sõnniku faunale ning ebaselgust seoses võimaliku bioakumulatsiooniga, on soovitatav võtta järgmised riskivähendamise meetmed.
English: Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Vahetu pakend Pakendi suurus
English: Don't use Temybric Ellipta if you already use these medicines.
Estonian: Ärge kasutage Temybric Ellipta't, kui te juba kasutate nimetatud ravimeid.
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.
Estonian: Temybric Ellipta esmakordsel kasutamisel ei ole vaja kontrollida, kas inhalaator töötab korralikult; see sisaldab mõõdetud annuseid ja on kohe kasutamiseks valmis.
English: It is very important that you use Temybric Ellipta every day, as instructed by your doctor.
Estonian: Väga tähtis on Temybric Ellipta't kasutada iga päev vastavalt arstilt saadud juhistele.
English: Comparison Temybric vs. FF/VI
Estonian: Temybric vs. FF/VI võrdlus
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.
Estonian: Temybric Ellipta manustamist rasedatele tuleb kaaluda vaid juhul, kui oodatav kasu emale kaalub üles võimalikud ohud lootele.
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.
Estonian: Tuleb teha otsus, kas lõpetada rinnaga toitmine või ravi Temybric Ellipta'ga, arvestades imetamise kasu lapsele ja ravi kasu naisele.
English: The most frequently reported adverse reactions with Temybric Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Estonian: Temybric Ellipta kasutamisel kõige sagedamini kirjeldatud kõrvaltoimed olid nasofarüngiit (7%), peavalu (5%) ja ülemiste hingamisteede infektsioon (2%).
English: The other ingredients are lactose monohydrate (see section 2 under ‘Temybric Ellipta contains lactose') and magnesium stearate.
Estonian: Teised koostisosad on laktoosmonohüdraat (vt lõik 2 „Temybric Ellipta sisaldab laktoosi“) ja magneesiumstearaat.
English: Temybric Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Estonian: Temybric Ellipta't tuleb kasutada iga päev ning mitte ainult hingamisprobleemide või muude KOKi sümptomite esinemise korral.
English: Patients should not stop therapy with Temybric Ellipta without physician supervision since symptoms may recur after discontinuation.
Estonian: Patsiendid ei tohi lõpetada ravi Temybric Ellipta'ga ilma arsti järelevalveta, sest pärast ravi lõpetamist võivad sümptomid uuesti tekkida.
English: One fatal case of pneumonia was reported in a patient who received Temybric Ellipta.
Estonian: Ühte surmaga lõppenud pneumoonia juhtu kirjeldati patsiendil, kes sai Temybric Ellipta't.
English: Temybric Ellipta (N = 4,151
Estonian: Temybric (N = 4151)
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).
Estonian: Ettevaatlik peab olema Temybric Ellipta kasutamisel koos teiste ravimitega, mis võivad samuti põhjustada hüpokaleemiat (vt lõik 4.5).
English: The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day.
Estonian: Soovitatav ja maksimaalne annus on üks Temybric Ellipta 92/55/22 mikrogrammi inhalatsioon üks kord ööpäevas, iga päev samal kellaajal.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Temybric Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Estonian: Haiglaravi vajanud pneumoonia tekkis kuni 24 nädala jooksul 1%-l Temybric Ellipta't saanud ja  1%-l budesoniidi/formoterooli saanud patsientidest.
English: Tabulated summary of adverse reactions The safety profile of Temybric Ellipta is based on three phase III clinical studies.
Estonian: Kõrvaltoimete kokkuvõte tabelina Temybric Ellipta ohutusprofiil põhineb kolme III faasi kliinilise uuringu ohutusandmetel.
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.
Estonian: Patsiente tuleb teavitada ägeda suletud nurga glaukoomi nähtudest ja sümptomitest ning juhendada, et nimetatud nähtude ja sümptomite tekkimisel tuleb Temybric Ellipta kasutamine otsekohe lõpetada ja ühendust võtta arstiga.
English: Temybric Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Estonian: Temybric Ellipta't ei tohi kasutada astmahaigetel, sest nendel patsientidel ei ole ravimi kasutamist uuritud.
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).
Estonian: Puuduvad kliinilised andmed, mis toetaksid Temybric Ellipta kasutamist ägedate bronhospasmi episoodide või KOKi ägenemise raviks (st hooravina).
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).
Estonian: Temybric Ellipta on näidustatud mõõduka kuni raske kroonilise obstruktiivse kopsuhaiguse säilitusraviks täiskasvanutele, kes ei ole saavutanud piisavat ravivastust inhaleeritava kortikosteroidi ja pikatoimelise beeta2-agonisti kombinatsiooni või pikatoimelise beeta2-agonisti ja pikatoimelise muskariiniretseptorite antagonisti kombinatsiooniga (toime sümptomite kontrollile ja ägenemiste ennetamisele vt lõik 5.1).
English: Temybric Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Estonian: Temybric Ellipta't kasutatakse kroonilise obstruktiivse kopsuhaiguse (KOK) raviks täiskasvanutel.
English: Temybric Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Estonian: Temybric Ellipta parandas oluliselt (p < 0,001) kopsufunktsiooni (määratletuna minimaalse FEV1 muutuse järgi uuringu algusest 24. nädalani) (vt tabel 1); paranemine püsis 52. nädalani ravi jätkanud patsientide alarühmas.
English: There is no relevant use of Temybric Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Estonian: Puudub Temybric Ellipta asjakohane kasutus lastel (vanuses alla 18 aasta) KOKi näidustusel.
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.
Estonian: Pneumoonia esinemissagedus Temybric Ellipta kasutamisel on võrreldav sellega, mida täheldati KOKi flutikasoonfuroaadi/vilanterooli (FF/VI) kliiniliste uuringute FF/VI 100/25 rühmas.
English: Once the tray is opened Temybric Ellipta is ready to use.
Estonian: Pärast aluse avamist on Temybric Ellipta valmis kasutamiseks.
English: If you are breast-feeding, you must check with your doctor before you use Temybric Ellipta.
Estonian: Kui te toidate last rinnaga, peate enne Temybric Ellipta kasutamist nõu pidama oma arstiga.
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).
Estonian: Temybric Ellipta flutikasoonfuroaadi/vilanterooli komponenti on hinnatud erineva raskusega maksakahjustuse korral (Child-Pugh A, B või C).
English: 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).
Estonian: Temybric Ellipta kasutamist koos teiste pikatoimeliste muskariiniretseptorite antagonistide või pikatoimeliste beeta2-agonistidega ei ole uuritud ning see ei ole soovitatav, sest võib potentseerida kõrvaltoimeid (vt lõigud 4.8 ja 4.9).