FrancophonIA/ELRC3.0 huggingface dataset:
English: As expected from the mode of action of the active substance, safety data shows that a mild and transient rise in somatic cell counts in individual cows may be seen.
Slovenian: Kot je pričakovano iz načina delovanja zdravilne učinkovine, varnostni podatki kažejo, da se pri posameznih kravah lahko blago in prehodno poveča število somatskih celic (Somatic Cell Count, SCC).
English: No information is available on the safety and efficacy of the concurrent use of this product with vaccines.
Slovenian: Ni podatkov o varnosti in učinkovitosti pri sočasni uporabi tega zdravila in cepiv.
English: The product increases the number of circulating neutrophils.
Slovenian: Zdravilo zvišuje število nevtrofilcev v obtoku.
English: It has also been proved that it enhances myeloperoxidase hydrogen peroxide halide mediated microbiocidal capabilities of neutrophils.
Slovenian: Dokazano je bilo tudi, da zdravilo izboljšuje mikrobiocidne zmožnosti nevtrofilcev, ki so odvisne od mieloperokidaznega halogenida vodikovega peroksida.
English: Do not mix with any other veterinary medicinal products.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: Imrestor 15 mg injection pegbovigrastim
Slovenian: Imrestor 15 mg injekcija pegbovigrastim
English: As an aid in a herd management programme, to reduce the risk of clinical mastitis in periparturient dairy cows and heifers during the 30 days following calving.
Slovenian: Kot pomoč pri programu upravljanja črede za zmanjševanje tveganja za klinični mastitis pri kravah molznicah in telicah v peripartalnem obdobju brejosti in še 30 dni po telitvi.
English: bG-CSF presents additional functions beyond its action on neutrophils and these may be direct or indirect functions on other cells/receptors and cytokine pathways.
Slovenian: Poleg delovanja na nevtrofilce ima faktor, ki spodbuja nastajanje kolonij granulocitov (bG-CSF), tudi dodatne funkcije, in sicer neposredno ali posredno delovanje na druge celice/receptorje in poti citokinov.
English: Store in original packaging.
Slovenian: Shranjujte v originalni ovojnini.
English: Pharmacotherapeutic group: Colony stimulating factors.
Slovenian: FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: faktorji, ki spodbujajo nastajanje kolonij.
English: The immunoregulatory activities of granulocyte colony stimulating factor concerns notably cells of the neutrophilic granulocyte lineage which bear cell surface receptors for the protein.
Slovenian: Imunoregulatorne aktivnosti faktorja, ki spodbuja nastajanje kolonij granulocitov, se večinoma nanašajo na celice nevtrofilne granulocitne linije, ki nosijo celične površinske receptorje za protein.
English: PACKAGE SIZE 10 pre-filled syringes 50 pre-filled syringes 100 pre-filled syringes
Slovenian: VELIKOST PAKIRANJA 10 napolnjenih injekcijskih brizg 50 napolnjenih injekcijskih brizg 100 napolnjenih injekcijskih brizg
English: Evidence from similar active substances in humans suggests that accidental administration of more than the authorised dose could result in adverse reactions, which are related to the activity of pegbovigrastim.
Slovenian: Dokazi, zbrani za podobne zdravilne učinkovine pri ljudeh, nakazujejo, da nenamerna uporaba odmerka, večjega od predpisanega, lahko povzroči neželene učinke, ki so povezani z aktivnostjo pegbovigrastima.
English: There is no information about the pharmacokinetics of pegbovigrastim in cattle.
Slovenian: Ni podatkov o farmakokinetiki pegbovigrastima pri govedu.
English: Manufacturer for the batch release: Elanco Speke Operations Fleming Road
Slovenian: Proizvajalec, odgovoren za sproščanje serij: Elanco Speke Operations Fleming Road
English: Pregnancy and lactation: Can be used in pregnancy and lactation
Slovenian: Brejost in laktacija: Lahko se uporablja v obdobju brejosti in laktacije.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
English: Cattle (dairy cows and heifers).
Slovenian: Govedo (krave molznice in telice).
English: Seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Takoj se posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Concurrent administration of substances which alter immune function (e.g. corticosteroids or non steroidal anti-inflammatory drugs) may reduce the efficacy of the product.
Slovenian: Sočasna uporaba snovi, ki spreminjajo delovanje imunskega sistema (npr. kortikosteroidi ali nesteroidna protivnetna zdravila), lahko zmanjša uspešnost zdravljenja.
English: No information is available with regard to a possible immune reaction towards the product or towards the endogenous molecule (bG-CSF) after repeated use of the product in cows.
Slovenian: Ni podatkov o morebitni imunski reakciji na zdravilo ali na endogeno molekulo (faktor, ki spodbuja nastajanje kolonij govejih granulocitov, bG-CSF) po ponavljajoči se uporabi zdravila pri kravah.
English: Meat and offal: zero days.
Slovenian: Meso in organi: nič dni.
English: STATEMENT OF ACTIVE SUBSTANCES Each 2.7 ml pre-filled syringe contains 15 mg pegbovigrastim.
Slovenian: Vsaka 2,7 ml napolnjena injekcijska brizga vsebuje 15 mg pegbovigrastima.
English: The content of a second pre-filled syringe is to be injected subcutaneously within 24 hours after calving.
Slovenian: Vsebino druge napolnjene injekcijske brizge injicirajte subkutano v 24 urah po telitvi.
English: Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 - 0.35).
Slovenian: Imrestor (delež preprečitve) 0,25 (s 95 % intervalom zaupanja 0,14-0,35).
English: CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Slovenian: KONTRAINDIKACIJE Ne uporabite v primerih preobčutljivosti na učinkovino ali na katero koli pomožno snov.
English: Subcutaneous administration.
Slovenian: Subkutana uporaba.
English: Only for subcutaneous administration.
Slovenian: Samo za subkutano uporabo.
English: 50 syringes.
Slovenian: 50 injekcijskih brizg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cartons of 10, 50 or 100 syringes
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonske škatle z 10, 50 ali 100 injekcijskimi brizgami
English: PHARMACEUTICAL FORM Solution for injection
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje.
English: 100 syringes.
Slovenian: 100 injekcijskih brizg
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) The product is a clear, colourless to pale yellow solution for injection containing 15 mg pegbovigrastim (pegylated bovine colony stimulating factor) in a pre-filled syringe.
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN Zdravilo je bistra brezbarvna do bledorumena raztopina za injiciranje v napolnjeni injekcijski brizgi, ki vsebuje 15 mg pegbovigrastima (pegiliranega faktorja, ki spodbuja nastajanje kolonij govejih granulocitov).
English: Only clear solutions without particles should be used.
Slovenian: Uporabite samo raztopino, ki je bistra in brez trdih delcev.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Slovenian: Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben, ali pa ne spadajo v področje Uredbe
English: A single syringe delivers a dose of 20-40 µg/kg pegbovigrastim for most cows depending on bodyweight: e.g. a dose of 21 µg/kg bodyweight for a 700 kg cow or 33 µg/kg bodyweight for a 450 kg heifer.
Slovenian: Količina aktivne učinkovine je odvisna od telesne mase živali: npr. krava, težka 700 kg, prejme odmerek 21 µg/kg telesne mase, telica, težka 450 kg, pa 33 µg/kg telesne mase.
English: In the clinical studies, non-typical anaphylactoid reactions were uncommonly observed.
Slovenian: V kliničnih študijah so bile netipične anafilaktoidne reakcije ugotovljene občasno.
English: During the clinical field studies, non typical anaphylactoid type reactions were uncommonly observed.
Slovenian: Med kliničnimi terenskimi študijami so bile netipične anafilaktoidne reakcije ugotovljene občasno.
English: The cows presented with swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation.
Slovenian: Pri kravah so se pojavile reakcije, kot so oteklost sluznic (zlasti sluznice vulve in vek), kožne reakcije, zvišana frekvenca dihanja in slinjenje.
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions) (see also section 4.10).
Slovenian: V eni študiji varnosti zdravila pri kravah pasme jersey je bil varnostni prag tega zdravila 1,5-krat večji od največjega priporočenega odmerka (trikrat je bil uporabljen prevelik odmerek 60 µg/kg) (glejte tudi poglavje 4.10).
English: The solution should be visually inspected prior to use.
Slovenian: Pred uporabo opravite vizualni pregled raztopine.
English: Biological/ Immunomodulat or
Slovenian: Biološka/imu nomodulatorn a zdravila
English: In one safety study in Jersey cows, at overdose of 60 µg/kg, administered on three occasions (1.5x the highest recommended dose), abomasal ulcers were observed.
Slovenian: V eni študiji varnosti zdravila pri kravah pasme jersey, pri katerih je bil trikrat uporabljen prevelik odmerek 60 µg/kg (1,5-kratnik največjega priporočenega odmerka), so opazili ulkuse siriščnika.
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions).
Slovenian: V eni študiji varnosti zdravila pri kravah pasme jersey je bil varnostni prag tega zdravila 1,5-krat večji od največjega priporočenega odmerka (trikrat je bil uporabljen prevelik odmerek 60 µg/kg).
English: The syringes are packed into cardboard boxes as follows;
Slovenian: Injekcijske brizge so pakirane v kartonske škatle, kot je navedeno spodaj: 10 injekcijskih brizg
English: Personal protective equipment consisting of gloves when handling broken or damaged syringes.
Slovenian: Pri rokovanju z zlomljenimi ali poškodovanimi injekcijskimi brizgami nosite osebno zaščitno opremo, ki sestoji iz rokavic.
English: Pegbovigrastim (Pegylated bovine Granulocyte Colony Stimulating Factor [PEG bG-CSF]) 15 mg For the full list of excipients, see section 6.1.
Slovenian: pegbovigrastim (pegilirani faktor, ki spodbuja nastajanje kolonij govejih granulocitov [PEG bG-CSF]) 15 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Imrestor 15 mg raztopina za injiciranje za govedo
English: Pegylated bovine granulocyte colony stimulating factor
Slovenian: Pegilirani faktor, ki spodbuja nastajanje kolonij govejih granulocitov
English: Pegbovigrastim is a modified form of the naturally occurring immunoregulatory cytokine, bovine granulocyte colony stimulating factor (bG-CSF).
Slovenian: Pegbovigrastim je faktor, ki spodbuja nastajanje kolonij govejih granulocitov (bG-CSF), in je spremenjena oblika imunoregulatorja citokina, ki je naravno prisoten pri govedu.
English: Name and address of the manufacturers responsible for batch release
Slovenian: SPROŠČANJE SERIJ Ime in naslov proizvajalcev zdravila, odgovornih za sproščanje serij
English: Citric acid monohydrate.
Slovenian: 6.1 Seznam pomožnih snovi citronska kislina monohidrat argininijev klorid arginin voda za injekcije
English: Concurrent use of such products should be avoided.
Slovenian: Izogibajte se sočasni uporabi teh zdravil.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Imrestor 15 mg solution for injection for cattle pegbovigrastim
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Imrestor 15 mg raztopina za injiciranje za govedo pegbovigrastim
English: If you notice any serious effects or other effects not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri) Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: 4.7 Use during pregnancy and lactation
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti in laktacije.
English: PACKAGE LEAFLET Imrestor 15 mg solution for injection for cattle
Slovenian: NAVODILO ZA UPORABO Imrestor 15 mg raztopina za injiciranje za govedo
English: Or
Slovenian: RAZLIČNA
English: Keep out of sight and reach of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom.
English: 6.1 List of excipients
Slovenian: 4.3 Kontraindikacije
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA
English: Arginine.
Slovenian: Rp-Vet.
English: Arginine hydrochloride.
Slovenian: Bistra brezbarvna do bledorumena raztopina.
English: Further information on Revinty Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Revinty Ellipta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It works on various types of immune cells, blocking the release of substances involved in inflammation.
Slovenian: Deluje na različne vrste imunskih celic, ki zavirajo sproščanje snovi, ki sodelujejo pri vnetju.
English: The European Medicines Agency concluded that Revinty Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Revinty Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Revinty Ellipta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Revinty Ellipta?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revinty Ellipta have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Revinty Ellipta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Revinty Ellipta (fluticasone furoate / vilanterol)
Slovenian: Revinty Ellipta (flutikazonfuroat/vilanterol)
English: This medicine is the same as Relvar Ellipta, which is already authorised in the EU.
Slovenian: To zdravilo je enako zdravilu Relvar Ellipta, ki je že odobreno v EU.
English: Revinty Ellipta received a marketing authorisation valid throughout the EU on 2 May 2014.
Slovenian: Za zdravilo Revinty Ellipta je bilo 2. maja 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: As for all medicines, data on the use of Revinty Ellipta are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Revinty Ellipta stalno spremljajo.
English: Side effects reported with Revinty Ellipta are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Revinty Ellipta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Revinty Ellipta, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Revinty Ellipta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Slovenian: Zdravilo Revinty Ellipta je na voljo v obliki inhalatorja v dveh jakostih (92/22 mikrogramov in 184/22 mikrogramov).
English: The most common side effects with Revinty Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Slovenian: Najpogostejša neželena učinka zdravila Revinty Ellipta (ki se lahko pojavita pri več kot 1 od 10 bolnikov) sta glavobol in nazofaringitis (vnetje nosu in žrela).
English: The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent').
Slovenian: Podjetje, ki proizvaja zdravilo Relvar Ellipta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Revinty Ellipta („uporaba dokumentacije s soglasjem“).
English: Other information about Revinty Ellipta
Slovenian: Druge informacije o zdravilu Revinty Ellipta
English: More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma.
Slovenian: Resnejši neželeni učinki vključujejo pljučnico in zlome (opaženi pri največ 1 od 10 bolnikov), o katerih so pogosteje poročali pri bolnikih s KOPB kot pri bolnikih z astmo.
English: Why is Revinty Ellipta authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Revinty Ellipta odobreno v EU?
English: Revinty Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Slovenian: Revinty Ellipta je inhalator za zdravljenje astme in kronične obstruktivne pljučne bolezni (KOPB).
English: It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Slovenian: Pripoji se na receptorje beta2 v dihalih in povzroči, da se mišice dihal sprostijo in razširijo, kar bolniku olajša dihanje.
English: Regarding its safety, the most frequent side effects reported with Revinty Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
Slovenian: V zvezi z varnostjo so bili najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Revinty Ellipta, podobni tistim, ki so jih opazili pri drugih načinih zdravljenja KOPB in astme; pri bolnikih s KOPB so opazili povečano pojavnost pljučnice.
English: What benefits of Revinty Ellipta have been shown in studies?
Slovenian: Kakšne koristi zdravila Revinty Ellipta so se pokazale v študijah?
English: A fourth study in 1,522 patients showed that Revinty Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
Slovenian: V četrti študiji pri 1 522 bolnikih so dokazali, da je zdravilo Revinty Ellipta enako učinkovito kot drugo zdravilo, ki vsebuje kortikosteroid (flutikazonpropionat) in dolgodelujoči agonist adrenergičnih receptorjev beta2 (salmeterol).
English: What is Revinty Ellipta and what is it used for?
Slovenian: Kaj je zdravilo Revinty Ellipta in za kaj se uporablja?
English: An overview of Revinty Ellipta and why it is authorised in the EU
Slovenian: Pregled zdravila Revinty Ellipta in zakaj je odobreno v EU
English: These patients were already well controlled with the comparator medicine and Revinty Ellipta treatment was able to maintain their FEV1.
Slovenian: Bolezen pri teh bolnikih je že bila dobro obvladana s primerjalnim zdravilom in pri zdravljenju z zdravilom Revinty Ellipta se je vrednost FEV1 ohranila.
English: In a third study, fewer patients taking Revinty Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
Slovenian: V tretji študiji je imelo manj bolnikov, ki so jemali zdravilo Revinty Ellipta z jakostjo 92/22 mikrogramov, po enem letu zdravljenja vsaj eno resno poslabšanje bolezni v primerjavi z bolniki, ki so jemali samo flutikazonfuroat (13 % v primerjavi s 16 %).
English: What are the risks associated with Revinty Ellipta?
Slovenian: Kakšna tveganja so povezana z zdravilom Revinty Ellipta?
English: Revinty Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Slovenian: Zdravilo Revinty Ellipta vsebuje dve učinkovini, ki različno delujeta za izboljšanje dihanja pri bolnikih z astmo in KOPB.
English: In two further studies, Revinty Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone
Slovenian: V dveh drugih študijah je zdravilo Revinty Ellipta zmanjšalo število poslabšanj bolezni za od 13 do 34 % več kot samostojno zdravljenje z vilanterolom.
English: Revinty Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Slovenian: Zdravilo Revinty Ellipta z jakostjo 184/22 mikrogramov je prav tako povečalo FEV1 za 193 ml v primerjavi s flutikazonfuroatom in za 210 ml v primerjavi z drugim inhalatorjem, ki vsebuje flutikazonpropionat.
English: The first study showed that Revinty Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Revinty Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
Slovenian: V prvi študiji so dokazali, da je zdravilo Revinty Ellipta z jakostjo 92/22 mikrogramov povečalo povprečno vrednost FEV1 za 115 ml več kot placebo, v drugi študiji pa, da je zdravilo Revinty Ellipta z jakostjo 184/22 mikrogramov povečalo povprečno vrednost FEV1 za 131 ml več kot placebo.
English: Three studies in over 3,200 patients showed that Revinty Ellipta improves breathing and reduces flareups in patients with persistent asthma.
Slovenian: Tri študije pri več kot 3 200 bolnikih so pokazale, da zdravilo Revinty Ellipta izboljša dihanje in zmanjša število poslabšanj pri bolnikih s trajno astmo.
English: Four studies in over 5,500 patients showed that Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with COPD.
Slovenian: Štiri študije pri več kot 5 500 bolnikih so pokazale, da zdravilo Revinty Ellipta izboljša dihanje in zmanjša število poslabšanj simptomov pri bolnikih s KOPB.
English: Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD.
Slovenian: Zdravilo Revinty Ellipta izboljša dihanje in zmanjša število poslabšanj simptomov pri bolnikih z astmo in KOPB.
English: In two of the studies, Revinty Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
Slovenian: V dveh študijah je zdravilo Revinty Ellipta z jakostjo 92/22 mikrogramov povečalo volumen zraka, ki ga bolnik lahko izdihne v eni sekundi (FEV1), za 36 ml v primerjavi s samim flutikazonfuroatom in za 172 ml v primerjavi s placebom (zdravilom brez učinkovine).
English: • whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting
Slovenian: • katerih simptomi niso obvladani z inhalacijskim kortikosteroidom in inhalacijskim kratkodelujočim agonistom adrenergičnih receptorjev beta2;