FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Pheburane, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Pheburane kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Pheburane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Pheburanega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Pheburane is a ‘hybrid medicine'.
Estonian: Pheburane on hübriidravim.
English: These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver.
Estonian: Nende patsientide organism ei suuda vabaneda jääklämmastikust, sest neil puuduvad teatud maksaensüümid.
English: EPAR summary for the public
Estonian: Kokkuvõte üldsusele naatriumfenüülbutüraat
English: Pheburane is a medicine that contains the active substance sodium phenylbutyrate.
Estonian: Pheburane on ravim, mis sisaldab toimeainena naatriumfenüülbutüraati.
English: The daily dose of Pheburane should be divided into equal amounts and given with each meal.
Estonian: Pheburane ööpäevane annus jagatakse võrdseteks osadeks ja manustatakse söögiaegadel.
English: Studies in patients have been limited to tests to determine that Pheburane is bioequivalent to the reference medicine, Ammonaps.
Estonian: Uuringud piirdusid katsetega, milles näidati Pheburane bioekvivalentsust võrdlusravimiga Ammonaps.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Pheburane has been shown to have comparable quality and to be bioequivalent to Ammonaps.
Estonian: Inimravimite komitee järeldas, et on tõendatud Pheburane võrdväärne kvaliteet ja bioekvivalentsus ravimiga Ammonaps.
English: Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys.
Estonian: Fenüülatsetaat ühineb lämmastikku sisaldava aminohappe glutamiiniga, tekitades aine, mis väljub organismist neerude kaudu.
English: What are the benefits and risks of Pheburane?
Estonian: Milles seisneb Pheburane kasulikkus ja mis riskid ravimiga kaasnevad?
English: The reference medicine for Pheburane is Ammonaps.
Estonian: Pheburane võrdlusravim on Ammonaps.
English: In the body, waste nitrogen is in the form of ammonia, which is toxic when it accumulates, especially for the brain.
Estonian: Jääklämmastik on organismis ammoniaagi kujul, mis on selle kogunemisel eriti mürgine ajule.
English: Eating protein brings nitrogen into the body, which is then transformed into ammonia.
Estonian: Valkude söömisel saab organism lämmastikku, mis muundatakse ammoniaagiks.
English: How is Pheburane used?
Estonian: Kuidas Pheburanet kasutatakse?
English: It is used to treat patients who have urea cycle disorders.
Estonian: Pheburanet kasutatakse patsientidel, kellel on uureatsükli häire.
English: How has Pheburane been studied?
Estonian: Kuidas Pheburanet uuriti?
English: How does Pheburane work?
Estonian: Kuidas Pheburane toimib?
English: The active substance in Pheburane, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Estonian: Pheburane toimeaine naatriumfenüülbutüraat muundub organismis fenüülatsetaadiks.
English: It can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Estonian: Pheburane on retseptiravim ja ravi Pheburanega tohib alustada üksnes uureatsükli häirete ravis kogenud arsti järelevalve all.
English: Strength
Estonian: Tugevus
English: (Invented) name
Estonian: (Väljamõeldud) nimetus
English: EU Number
Estonian: Müügiloa nr Euroopa Liidus
English: Pharmaceutical Form
Estonian: Ravimvorm Manustamistee Sisepakendi iseloomustus
English: The PRAC adopted a recommendation on 17 March 2016 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Estonian: Ravimiohutuse riskihindamise komitee võttis 17. märtsil 2016 vastu soovituse, mida inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 107k kohaselt.
English: Since the results of the TORCH study were published in 2007, a number of large meta-analyses of pooled data have been conducted.
Estonian: Alates uuringu TORCH tulemuste avaldamisest 2007. aastal on tehtud mitu suuri koondandmete metaanalüüsi.
English: It was considered that this should be reflected in the product information.
Estonian: Otsustati, et see tuleb lisada ravimiteabesse.
English: Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015].
Estonian: Ägenemised ja kaasuvad haigused suurendavad konkreetsel patsiendil haiguse üldist raskust (Global Initiative for Obstructive Lung Disease (GOLD), 2015).
English: The therapeutic effect of inhaled corticosteroids is considered to be the result of suppression of airway inflammation, but the airway effects of ICS in COPD are complex and the mechanism of action is not completely understood (Finney et al., 2014, Jen et al., 2012).
Estonian: Inhaleeritavate kortikosteroidide ravitoime arvatakse tulenevat hingamisteede põletiku supressioonist, kuid inhaleeritavate kortikosteroidide toimed hingamisteedele on KOK-i korral keerukad ning toimemehhanism ei ole täielikult teada (Finney et al., 2014, Jen et al., 2012).
English: On 27 April 2015 the European Commission therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of ICS containing medicinal products indicated in the treatment of COPD and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Estonian: Sel põhjusel algatas Euroopa Komisjon 27. aprillil 2015 ravimiohutuse järelevalve andmete põhjal direktiivi (EÜ) nr 2001/83/EÜ artikli 31 kohase menetluse ja palus ravimiohutuse riskihindamise komiteel hinnata nimetatud probleemide mõju KOK-i ravis näidustatud inhaleeritavaid kortikosteroide sisaldavate ravimite kasulikkuse ja riski tasakaalule ning soovitada, kas asjakohased müügiload tuleb säilitada, muuta, peatada või tühistada.
English: Chronic obstructive pulmonary disease (COPD) is characterised by persistent, usually progressive, airflow limitation associated with an enhanced inflammatory response in the airways and the lungs.
Estonian: Kroonilist obstruktiivset kopsuhaigust (KOK) iseloomustab püsiv ja tavaliselt progresseeruv õhuvoolu piiratus ning tugevnenud põletikureaktsioon hingamisteedes ja kopsudes.
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Estonian: Olles tutvunud ravimiohutuse riskihindamise komitee soovitusega, nõustus inimravimite komitee üldjärelduste ja soovituse alustega.
English: ICS-containing products authorised across the EU for the treatment of COPD includes the active substances beclomethasone, fluticasone propionate, fluticasone furoate, budesonide and flunisolide.
Estonian: Euroopa Liidus KOK-i raviks heaks kiidetud inhaleeritavaid kortikosteroide sisaldavad ravimid sisaldavad toimeainena beklometasooni, flutikasoonpropionaati, flutikasoonfuroaati, budesoniidi ja flunisoliidi.
English: No clinical trials directly examined the risk of pneumonia with ICSs head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available, mainly between budesonide and fluticasone.
Estonian: Üheski kliinilises uuringus ei käsitletud otseselt kopsupõletiku riski seost inhaleeritavate kortikosteroididega ning olemas on ainult metaanalüüsides / süstemaatilistel ülevaadetel või vaatlusuuringutes tehtud kaudsed võrdlused, põhiliselt budesoniidi ja flutikasooni vahel.
English: All these products are restricted to ‘prescription only' status.
Estonian: Kõik need ravimid on retseptiravimid.
English: It is considered mechanistically plausible that a higher dose of corticosteroid could cause a greater degree of immunosuppression in the lung and lead to a higher risk of pneumonia, but this has not been demonstrated conclusively across all studies.
Estonian: Mehhanismi poolest on võimalik, et kortikosteroidi suurem annus võib tekitada kopsudes tugevama immunosupressiooni ja see võib suurendada kopsupõletiku tekkeriski, kuid seda ei ole kõikides uuringutes veenvalt tõestatud.
English: Grounds for PRAC recommendation
Estonian: Ravimiohutuse riskihindamise komitee soovituse alused
English: A signal of increased risk of pneumonia in COPD patients with ICS-containing treatments was first identified in the TORCH study (Calverley et al., 2007) a large clinical study of three years treatment duration comparing the fluticasone propionate/salmeterol combination with its component parts and placebo in COPD patients.
Estonian: Esimene signaal kopsupõletiku tekkimise riski suurenemisest inhaleeritavaid kortikosteroide sisaldavaid ravimeid kasutavatel patsientidel saadi uuringus TORCH (Calverley et al., 2007), mis oli suur kolmeaastase ravi kliiniline uuring, milles võrreldi flutikasoonpropionaadi/salmeterooli kombinatsioonravi selle eraldi komponentide ja platseebo kasutamisega KOK-iga patsientidel.
English: Although a number of common criticisms can be levelled at the studies included in these meta-analyses, including difficulties with the accurate identification of pneumonia (particularly pre-TORCH studies), variations in participant populations and comparators, differential withdrawal rates, and trials not specifically powered to detect pneumonia, a consistent association between ICS use and increased risk of pneumonia in COPD patients was seen across the meta-analyses.
Estonian: Kuigi nende metaanalüüsidega hõlmatud uuringuid võib mitme aspekti poolest ühiselt kritiseerida, sealhulgas probleemide poolest kopsupõletiku täpsel tuvastamisel (eelkõige uuringutes enne uuringut TORCH), osalejapopulatsioonide ja võrdlusravimite varieerumise, katkestamise eri sageduse ja mitte konkreetselt kopsupõletiku avastamisele suunatud uuringute kasutamise poolest, leiti kõigis metaanalüüsides inhaleeritavate kortikosteroidide kasutamise ja kopsupõletiku tekkeriski järjekindel seos KOK-iga patsientidel.
English: • The PRAC considered that some evidence of an increased risk of pneumonia with increasing steroid dose exists, although this has not been demonstrated conclusively across all studies;
Estonian: • Komitee leidis, et on tõendeid kopsupõletiku suurema tekkeriski kohta suurema steroidiannuse korral, kuigi seda ei ole kõikides uuringutes veenvalt tõestatud.
English: However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015).
Estonian: Mõne ravijuhise kohaselt on inhaleeritavad kortikosteroidid siiski teatudpatsiendirühmadele tähtis ravivõimalus (GOLD report, 2015).
English: Results from older meta-analyses and from observational studies were also variable, with some suggesting an increased risk of pneumonia with fluticasone compared to budesonide and others finding no difference.
Estonian: Ka varasemate metaanalüüside ja vaatlusuuringute tulemused varieerusid - mõnes järeldati, et kopsupõletiku risk oli flutikasooni korral suurem kui budesoniidi korral, ja teistes erinevusi ei leitud.
English: Overall the evidence from observational studies was in agreement with the randomised clinical trials (RCT) findings and it was therefore considered that the evidence continues to support the conclusion that treatment with ICS increases the risk of pneumonia in COPD patients.
Estonian: Kokkuvõttes olid vaatlusuuringutest saadud tõendid kooskõlas randomiseeritud kliiniliste uuringute tulemustega ning seepärast leiti, et tõendid toetavad ikka järeldust, et ravi inhaleeritavate kortikosteroididega suurendab KOK-iga patsientidel kopsupõletiku tekkeriski.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease (COPD);
Estonian: • Ravimiohutuse riskihindamise komitee arutas direktiivi 2001/83/EÜ artikli 31 kohast esildist, mis käsitles kroonilise obstruktiivse kopsuhaiguse (KOK) raviks näidustatud inhaleeritavaid kortikosteroide sisaldavate ravimite ravimiohutuse järelevalve andmeid.
English: Further, it was recognised that there are difficulties associated with the differential diagnosis of pneumonia or an exacerbation of COPD.
Estonian: Peale selle võeti teadmiseks, et on probleeme kopsupõletiku ja KOK-i ägenemise diferentsiaaldiagnostikaga.
English: Overall, due to the variability in the clinical data and multiple uncertainties with study methodologies, there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among inhaled corticosteroid products.
Estonian: Kliiniliste andmete varieerumist ja uuringumetoodikate määramatusi üldiselt arvestades puuduvad veenvad kliinilised tõendid, et inhaleeritavate kortikosteroidide rühmas esineks riskisuuruse erinevusi.
English: Symptoms of COPD include dyspnoea, chronic cough and chronic sputum production.
Estonian: KOK-i sümptomid on näiteks düspnoe, krooniline köha ja krooniline rögaeritus.
English: Inhaled corticosteroid (ICS) medicinal products are widely used in the treatment of COPD, as a monocomponent or in combination with a long-acting beta2 adrenergic agonist (LABA).
Estonian: Laialdaselt kasutatakse KOK-i raviks inhaleeritavaid kortikosteroide kas ainsa ravimina või kombinatsioonis pika toimeajaga β2-adrenergilise agonistiga.
English: Episodes of acute worsening of these symptoms (exacerbations) often occur.
Estonian: Sageli ägevnevad need sümptomid episoodiselt.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for ICS-containing medicinal products indicated in the treatment of COPD.
Estonian: Seetõttu soovitab komitee muuta KOK-i raviks näidustatud inhaleeritavaid kortikosteroide sisaldavate ravimite müügilubade tingimusi.
English: The PRAC therefore concluded that pneumonia (in COPD patients) should be added as a common adverse drug reaction in the product information of all ICS-containing products and that for products with an existing Risk Management Plan, “increased risk of pneumonia in COPD patients” should be considered an Important Identified Risk.
Estonian: Ravimiohutuse riskihindamise komitee järeldas seega, et kopsupõletik (KOK-iga patsientidel) tuleb lisada sageda kõrvaltoimena kõikide inhaleeritavaid kortikosteroide sisaldavate ravimite ravimiteabesse ning kui on olemas ravimi riskijuhtimiskava, tuleb sellesse lisada „kopsupõletiku riski suurenemine KOK-iga patsientidel“ kui tähtis tuvastatud risk.
English: Since then other products containing ICS have been subject to review and it was considered that data on the risk of pneumonia with these products in the COPD population should be reviewed all together, so that the risk of pneumonia in this patient population could be further characterised.
Estonian: Alates sellest ajast on läbi vaadatud ka teiste inhaleeritavaid kortikosteroide sisaldavate ravimide andmed ning leiti, et on vaja läbi vaadata nende ravimite kasutamisega KOK-iga patsientidel üldiselt kaasnev kopsupõletiku risk, et saaks iseloomustada kopsupõletiku tekkeriski sellel patsiendirühmal.
English: Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients.
Estonian: KOK-i raviks määratavate muude ravimirühmade võimalike toimete kohta on andmeid vähe ja seepärast ei saanud teha järeldusi samaaegsete ravimite mõju kohta kopsupõletiku tekkeriskile KOK-iga patsientidel.
English: Some evidence suggests an increased risk of pneumonia with increasing steroid dose.
Estonian: On tõendeid, et suurema steroidiannuse korral võib kopsupõletiku risk olla suurem.
English: In conclusion, the PRAC considered that the benefit-risk balance of ICS-containing products remained favourable, provided the proposed changes to the product information are implemented.
Estonian: Kokkuvõttes leidis ravimiohutuse riskihindamiskomitee, et inhaleeritavaid kortikosteroide sisaldavate ravimite kasulikkuse ja riski tasakaal on endiselt soodne, kui ravimiteabesse tehakse kavandatud muudatused.
English: To mitigate the risk of pneumonia, the PRAC considered that a warning should be included in the product information for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Estonian: Kopsupõletiku riski leevendamiseks leidis ravimiohutuse riskihindamise komitee, et ravimiteabesse on vaja lisada tervishoiuspetsialistidele ja patsientidele hoiatus jälgida KOK-iga patsiente hoolikalt kopsupõletiku võimaliku kujunemise suhtes, arvestades kopsupõletiku sümptomite kattumist KOK-i ägenemise sümptomitega.
English: • The PRAC also concluded that there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS-containing products;
Estonian: • Komitee järeldas ka, et puuduvad veenvad kliinilised tõendid, et selle riski suurus oleks inhaleeritavaid kortikosteroide sisaldavate ravimite rühma eri ravimitel erinev.
English: Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class.
Estonian: Esitatud andmete põhjal võib hinnata, et inhaleeritavate kortikosteroidide rühma ravimeid kasutab kümneid miljoneid patsiente.
English: • The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Estonian: • Ravimiohutuse riskihindamise komitee oli arvamusel, et kõikide inhaleerivaid kortikosteroide sisaldavate ravimite ravimiteabesse on vaja lisada kopsupõletiku suurenenud tekkerisk ning lisada hoiatus tervishoiuspetsialistidele ja patsientidele, et tuleb hoolikalt jälgida KOK-iga patsiente kopsupõletiku võimaliku kujunemise suhtes, arvestades kopsupõletiku sümptomite kattumist KOK-i ägenemise sümptomitega.
English: • The PRAC reviewed the data submitted by the marketing authorisation holders in relation to the increased risk of pneumonia in patients with COPD in association with ICS-containing medicinal products;
Estonian: • Komitee vaatas läbi müügiloa hoidjate esitatud andmed kopsupõletiku riski suurenemise kohta KOK-iga patsientidel seoses inhaleeritavaid kortikosteroide sisaldavate ravimitega.
English: • The PRAC concluded that the evidence provided supports a causal association between the use of ICS-containing products and an increased risk of pneumonia in COPD patients;
Estonian: • Komitee järeldas, et esitatud tõendid toetavad inhaleeritavaid kortikosteroide sisaldavate ravimite kasutamise põhjuslikku seost kopsupõletiku suurema tekkeriskiga KOK-iga patsientidel.
English: It was acknowledged that any risk of pneumonia with ICS should be considered in context, as pneumonia is an intrinsic comorbidity to COPD with certain predisposing factors making some COPD patients more susceptible to this risk than others.
Estonian: Võeti teadmiseks, et kopsupõletiku tekkeriski inhaleeritavate kortikosteroidide kasutamisel tuleb käsitleda konkreetseid asjaolusid arvestades, sest kopsupõletik on teatavate eelsoodumuste korral KOK-iga olemuslikult kaasuv haigus, mistõttu osa KOK-iga patsiente on sellele riskile teistest vastuvõtlikumad.
English: In view of the above, the Committee considers that the benefit-risk balance of ICS-containing medicinal products remains favourable in the treatment of COPD subject to the agreed amendments to the product information.
Estonian: Nendel põhjustel leiab ravimiohutuse riskihindamise komitee, et inhaleeritavaid kortikosteroide sisaldavate ravimite kasulikkuse ja riski tasakaal KOK-i ravis on endiselt soodne, kui ravimiteabesse tehakse kavandatud muudatused.
English: CHMP opinion
Estonian: Inimravimite komitee arvamus
English: Finally, the PRAC considered the ICS dose-response effect or the influence of LABA and other concomitant medications on the risk of pneumonia in COPD patients.
Estonian: Ravimiohutuse riskihindamise komitee käsitles ka inhaleeritavate kortikosteroidide annuse ja toime seost ning β2-adrenergilise agonisti ja teiste samaaegsete ravimite mõju kopsupõletiku tekkeriskile KOK-iga patsientidel.
English: It can also prevent death due to panleucopenia.
Estonian: Samuti võib see aidata ära hoida panleukopeeniast põhjustatud surma.
English: The studies included young and adult cats of various breeds, but not young kittens.
Estonian: Uuringutesse kaasati eri tõugu noored ja täiskasvanud kassid, kuid mitte väikeseid kassipoegi.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every three years.
Estonian: Kass tuleb revaktsineerida kõigi komponentide vastu ühe aasta möödumisel esimesest vaktsineerimiskuurist ja seejärel iga kolme aasta tagant.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP on 23 February 2005.
Estonian: Euroopa Komisjon andis vaktsiini Purevax RCP müügiloa, mis kehtib kogu Euroopa Liidus, 23. veebruaril 2005.
English: The antibodies will help to protect against the diseases caused by these viruses.
Estonian: Antikehad aitavad kaitsta haiguste eest, mida need viirused põhjustavad.
English: If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age.
Estonian: Kui kassipojal on suur emalt üsasiseselt ja piimaga saadud antikehade sisaldus, tuleb esmane vaktsineerimine edasi lükata 12 nädala vanuseni.
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Estonian: • inaktiveeritud (hävitatud) kalitsiviroosi antigeenid (tüved FCV 431 ja G1),
English: When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Estonian: Nende viirustega hiljem elu jooksul kokku puutudes kass ei nakatu või on nakkus oluliselt kergem.
English: It also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination.
Estonian: Kalitsiviroosi korral aitab see ka vähendada viiruse eritumist ühe aasta vältel pärast vaktsineerimist.
English: The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Estonian: Esimene süst tuleb teha vähemalt 8-nädalastele kassipoegadele ja teine süst 3-4 nädalat hiljem.
English: Information on the prescription status of this product may be found on the label/outer package.
Estonian: Teave selle kohta, kas toode on retseptivaktsiin, on esitatud etiketil/välispakendil.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign' and makes antibodies against them.
Estonian: Kui kassile antakse vaktsiini, peab looma immuunsüsteem nõrgestatud või hävitatud viirusi võõraks ja tekitab nende vastu antikehi.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP exceed the risks for the approved indications and recommended that Purevax RCP be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et heakskiidetud näidustustel on vaktsiini Purevax RCP kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini Purevax RCP müügiloa.