FrancophonIA/ELRC3.0 huggingface dataset:
English: Formulation differences may make a difference to how the active substance is absorbed from the injection site, and also, therefore, the overall residues depletion pattern.
Estonian: Koostise erinevused võivad mõjutada seda, kuidas toimeaine süstekohast imendub, ja seega ka kogu ravimijääkide kadumise mustrit.
English: The CVMP considered whether it would be necessary to restrict the volume of injection, to mitigate any uncertainties around the effect of formulation differences at the injection sites.
Estonian: Veterinaarravimite komitee kaalus, kas süstemahtu on vaja vähendada, et leevendada koostise erinevustega seotud mõju määramatusi süstekohas.
English: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link less sensitive, at 500 µg/kg.
Estonian: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link kontrollrühmaga, mis koosnes ühest ravimata loomast.
English: Quality, target animal safety, user safety, environmental risk and parasitic resistance for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Estonian: Selles esildismenetluses ei hinnatud asjaomaste veterinaarravimite kvaliteeti, ohutust sihtloomadele, kasutajaohutust, keskkonnariski ega parasiitide resistentsust.
English: It was also shown that, in general, the higher the volume of injection, the slower the rate of absorption from the injection site.
Estonian: Samuti tõendati üldiselt, et mida suurem on süstemaht, seda aeglasem on imendumiskiirus süstekohast.
English: Data were provided, based on the pharmacokinetics of closantel, that demonstrated that the formulation differences, and thereby the potential differences in the rates of absorption from the injection site, would not affect the overall elimination from the edible tissues, other than from the injection site itself.
Estonian: Klosanteeli farmakokineetika põhjal esitatud andmed tõendasid, et ravimi koostise erinevused ja sellest tulenevalt ka võimalikud imendumiskiiruse erinevused süstekohas ei mõjuta üldist eliminatsiooni söödavatest kudedest, välja arvatud süstekohast endast.
English: As a result, a withdrawal period of 107 days was determined, using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Estonian: Tulemusena määrati „alternatiivse meetodi“ abil 107-päevane keeluaeg, mis on kooskõlas veterinaarravimite komitee (CVMP) keeluaegade ühtlustamise suunisega (EMEA/CVMP/036/95)1.
English: In terms of sensitivity, the limit of quantification in Study 1 was determined as 150 µg/kg in muscle, whereas the limit of quantification in Study 2 was
Estonian: Tundlikkuse osas määrati 1. uuringus kvantifitseerimise piiriks lihases 150 µg/kg, samas 2. uuringus oli kvantifitseerimise piir vähem tundlik (500 μg/kg).
English: There were no residues depletion data provided for the last two products mentioned.
Estonian: Viimasena mainitud kahe ravimi kohta ei esitatud ravimijääkide kadumise andmed.
English: the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Estonian: veterinaarravimite komitee soovitas muuta lammastele subkutaanselt kasutatava süstelahustena turustatava 50 mg/ml klosanteeli (ainsa toimeainena) sisaldavate veterinaarravimite (vt I lisa) müügilube, et muuta ravimi omaduste kokkuvõtteid, märgistust ja pakendi infolehti kooskõlas ravimiteabes soovitatud muudatustega, mis on esitatud III lisas.
English: The available data demonstrate that the liver is the withdrawal period determining tissue and that the rate of elimination from edible tissues would not be influenced by the rate of absorption from the injection site and thereby impacted by product formulation.
Estonian: Olemasolevad andmed tõendavad, et maks on keeluaega määrav kude ja et elimineerimiskiirust söödavatest kudedest ei mõjuta süstimiskoha imendumiskiirus ega seega ka ravimi koostis.
English: However, based on the data assessed during this procedure, it is possible to make a recommendation to have a 107-day withdrawal period for sheep (meat and offal) for the concerned products containing 50 mg closantel per ml (as a single active substance) presented as a solution for injection for subcutaneous use in sheep.
Estonian: Selle menetluse käigus hinnatud andmete põhjal on siiski võimalik soovitada kasutada lammastel (liha ja rups) keeluaega 107 päeva asjaomaste ravimite puhul, mis sisaldavad ainsa toimeainena 50 mg/ml klosanteeli ja mida turustatakse süstelahusena, mida manustatakse lammastele subkutaanselt.
English: A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Estonian: WT1.4 tarkvaraga tehtud ravimijääkide kadumise andmete statistilise hindamise põhjal määrati 41-päevane keeluaeg.
English: The concentration of closantel residues in the core injection site samples were below the MRL at 29 days after administration.
Estonian: Klosanteeli jääkide kontsentratsioon keskse süstekoha proovides oli 29 päeva pärast manustamist alla jääkide piirnormi.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case due to the weights of the animals used and the mg/kg, rather than mg/animal, dosing regimen, when compared to the recommended weights of animals in VICH GL 482.
Estonian: • Kuigi valitseb mõningane ebakindlus selle suhtes, kuidas ravimi koostise erinevused mõjutaksid süstekohtadest jääkide kadumise kiirust, peeti 1. uuringus kasutatud süstemahte mõistlikuks halvima stsenaariumi korral kasutatud loomade kehamassi ja annustusskeemi mg/kg (pigem kui mg/loom) tõttu, kui seda võrreldi suunises VICH GL 48 soovitatud loomade kehamassiga2.
English: The study was conducted in 2009, with 30 treated animals (5 mixed-sex groups of six animals) and a control group consisting of one untreated animal.
Estonian: Uuring tehti 2009. aastal 30 ravitud loomaga (5 rühma 6 eri soost loomaga) ja
English: Residue depletion in sheep meat and offal
Estonian: Ravimijääkide kadumine lammaste lihast ja rupsist
English: Another product has propylene glycol as the main vehicle, and includes no water for injections.
Estonian: Teises ravimis on peamine vehiikul propüleenglükool ja see ei sisalda süstevett.
English: It has been shown that, in general, the higher the viscosity of the product, the slower the rate of absorption from the injection site.
Estonian: Üldiselt on tõendatud, mida suurem on ravimi viskoossus, seda aeglasem on imendumiskiirus süstekohast.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Endoex Solucion Injectable', a product containing 50 mg closantel per ml.
Estonian: Esitati hea laboritava nõuetele vastav lammaste ravimijääkide kadumise uuring, mis tehti veterinaarravimiga „Endoex Solucion Injectable“, mis sisaldab klosanteeli 50 mg/ml.
English: The Committee considered that, due to the slow and limited metabolism of closantel, the high protein binding and retention in plasma, and the long elimination time from tissues, the differences seen in the product formulations, which may lead to different rates of absorption from the injection site, should not influence the final rate of elimination from the edible tissues, other than at the injection site itself.
Estonian: Komitee leidis, et klosanteeli aeglase ja piiratud metabolismi, valguga tugeva seondumise ja plasmas püsimise ning pika kudedest elimineerimise aja tõttu on ravimite koostistes täheldatud erinevusi, mis
English: It was considered that the presence of glycerol formal in one product would have less of an effect than propylene glycol on the overall viscosity of the product, when compared to that of water.
Estonian: Leiti, et ühes ravimis oleks glütseroolformaali sisaldusel viskoossusele väiksem mõju kui propüleenglükoolil, võrreldes veega.
English: The CVMP was requested to review all available residue depletion data for the veterinary medicinal products containing 50 mg closantel per ml (as a single active substance), presented as a solution for injection for subcutaneous use in sheep and recommend withdrawal periods for meat and offal derived from treated sheep.
Estonian: Veterinaarravimite komiteel paluti läbi vaadata kõik kättesaadavad andmed jääkide kadumise kohta veterinaarravimite puhul, mis sisaldavad ainsa toimeainena klosanteeli 50 mg/ml ja mida kasutatakse subkutaanse süstelahusena lammastel, ja soovitada ravitud lammastelt saadud liha ja rupsi keeluajad.
English: Residues at the injection site were below the MRL for muscle at 61 days post administration.
Estonian: Ravimijäägid süstekohas olid alla jääkide piirnormi lihastes 61. päeval pärast manustamist.
English: It has been noted that there are different approved withdrawal periods for sheep (meat and offal) for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solution for injection for subcutaneous use in sheep across the EU, i.e., between 28 days and 107 days.
Estonian: On täheldatud, et lammaste (liha ja rups) puhul on ainsa toimeainena klosanteeli 50 mg/ml sisaldavatel veterinaarravimitel, mida kasutatakse lammastel subkutaanse süstelahusena kogu ELis, erinevad heakskiidetud keeluajad, st 28 päeva ja 107 päeva vahel.
English: • The tissue-specific withdrawal period determined from Study 1 for liver was 28 days longer than that for injection sites, which leaves a suitably long time for any additional injection site residues to deplete before the 107-day withdrawal period is complete.
Estonian: • 1. uuringus maksa puhul määratud koespetsiifiline keeluaeg oli 28 päeva pikem kui süstekohtade puhul, mis jätab enne 107-päevase keeluaja lõppu piisavalt aega mis tahes täiendavate ravimijääkide kadumiseks süstekohast.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Flukiver 5%', a product containing 50 mg closantel per ml.
Estonian: Esitati hea laboritava nõuetele vastav ravimijääkide kadumise uuring lammastel, mis tehti veterinaarravimiga „Flukiver 5%“, mis sisaldab 50 mg/ml klosanteeli.
English: Consideration has been given to the absolute amounts injected at the subcutaneous injection site.
Estonian: Vaadeldi subkutaansesse süstekohta süstitud absoluutseid koguseid.
English: The product was administered via subcutaneous injection to sheep at the single recommended dose of 5 mg closantel per kg body weight.
Estonian: Ravimit manustati subkutaanse süstena lammastele ühekordses soovitatavas annuses 5 mg klosanteeli kehamassi kg kohta.
English: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep sheep sheep: subcutaneous
Estonian: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep lambad lambad: subkutaanne
English: Overall summary of the scientific evaluation of veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I)
Estonian: Lammastel süstelahusena subkutaanseks kasutamiseks ettenähtud veterinaarravimite (vt I lisa), mis sisaldavad 50 mg/ml klosanteeli (ainsa toimeainena), teadusliku hindamise üldkokkuvõte
English: Animal species
Estonian: Ravimvorm Loomal iigid
English: The different quantities included may lead to the products having different viscosities, resulting in different rates of absorption of closantel from the injection site; however, this parameter is not considered to affect the elimination rate from the edible tissues, other than at the injection site itself.
Estonian: Ravimites sisalduvad eri kogused võivad põhjustada erinevat viskoossust, tulemusena on klosanteeli imendumiskiirus süstekohas erinevad.
English: Sheep:
Estonian: Lambad
English: powder: 15 mg 1 vial
Estonian: Pulber: 15 mg
English: 15 mg Powder for solution for infusion
Estonian: 15 mg Infusioonilahuse pulber Intravenoosne
English: The marketing authorisation was renewed on 11-2006.
Estonian: Müügiluba uuendati 11-2006.
English: Another study has also looked at the use of Protopy for up to 4 years in about 800 patients.
Estonian: Veel ühes uuringus vaadeldi Protopyu salvi kasutamist kuni 4 aasta jooksul ligikaudu 800 patsiendil.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Protopy to Astellas Pharma GmbH on 28 February 2002.
Estonian: Euroopa Komisjon väljastas Protopyu müügiloa, mis on kehtiv kogu Euroopa Liidu territooriumil, ettevõttele Astellas Pharma GmbH 28. veebruaril 2002.
English: Generally, improvement is seen within one week of starting treatment, and if there is no improvement after 2 weeks, the doctor needs to look at more treatment options.
Estonian: Paranemine ilmneb üldiselt ühe nädala jooksul pärast ravi alustamist ning kui kahenädalase ravi järel ei ole paranemist ilmnenud, peab arst kaaluma muid ravivõimalusi.
English: In the longer study, Protopy could be used repeatedly without losing its effectiveness.
Estonian: Pikemas uuringus võis Protopyut kasutada korduvalt, ilma et selle efektiivsus oleks vähenenud.
English: Treatment should be started as twice a day for up to three weeks.
Estonian: Ravi tuleb alustada kahe korraga päevas kuni kolme nädala jooksul.
English: Other information about Protopy:
Estonian: Muu teave Protopyu kohta:
English: Protopy is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ingredient tacrolimus.
Estonian: Protopy on valge kuni kergelt kollakas salv, mis sisaldab 0,1% või 0,03% toimeainet takroliimust.
English: If possible, patients should use less frequent applications, or the lower strength as their condition improves.
Estonian: Võimaluse korral tuleks patsientidel püüda manustamissagedust vähendada või kasutada seisundi paranedes nõrgema kontsentratsiooniga salvi.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROTOPY EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE PROTOPY Kokkuvõte üldsusele
English: Protopy should not be used continuously.
Estonian: Protopy ei ole ette nähtud pidevaks kasutamiseks.
English: The safety and effectiveness of Protopy has been studied in more than 13,500 patients treated with tacrolimus ointment in clinical trials.
Estonian: Protopyu ohutust ja efektiivsust on uuritud rohkem 13 500 patsiendil, keda kliinilistes uuringutes raviti takroliimuse salviga.
English: Each affected area is treated with Protopy until the skin is clear and then treatment should be stopped.
Estonian: Iga haigestunud piirkonda tuleb ravida salviga, kuni nahk on puhas, ning seejärel ravi lõpetada.
English: In adults, treatment should be started with Protopy 0.1% twice a day and treatment should be continued until the skin is clear.
Estonian: Täiskasvanutel tuleb ravi alustada 0,1% Protopyu salviga kaks korda päevas ja jätkata, kuni nahk on puhas.
English: Tacrolimus has been used since the mid-1990's to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Estonian: Takroliimust on kasutatud alates 1990-ndate aastate keskpaigast siirdatud elunditega patsientidel siiriku hülgamise ennetamiseks (kui immuunsüsteem ründab siirdatud elundit).
English: Afterwards, application should be reduced to once a day until the skin is clear.
Estonian: Edasi tuleks määrimise sagedust vähendada ühe korrani päevas, kuni nahk on puhas.
English: The exact way that Protopy works in atopic dermatitis is not yet fully understood.
Estonian: Protopyu toimemehhanism atoopilise dermatiidi puhul ei ole veel täielikult teada.
English: The six main clinical studies involved 1,202 adults (over the age of 16) and 1,535 children (aged 2 to 16 years of age), and Protopy was compared either with placebo (a dummy treatment, the ointment base) or with a topical corticosteroid often used for eczema (hydrocortisone butyrate in adults, hydrocortisone acetate in children).
Estonian: Kuues kliinilises põhiuuringus osales 1202 täiskasvanut (üle 16-aastased) ja 1535 last (2-16-aastased) ning Protopyut võrreldi kas platseeboga (näiv ravim, salvipõhi) või toopilise kortikosteroidiga, mida kasutatakse sageli ekseemi ravimiseks (täiskasvanutel hüdrokortisoonbutüraat, lastel hüdrokortisoonatsetaat).
English: They recommended that Protopy be given marketing authorisation.
Estonian: Komitee soovitas anda Protopyule müügiloa.
English: This summary was last updated in 09-2007
Estonian: Kokkuvõtet on viimati uuendatud 2006. aasta mais.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite inimtervishoius kasutatavate ravimite komitee soovituste aluse kohta lisateavet, lugege palun teaduslikku arutelu (samuti Euroopa avaliku hindamisaruande osa).
English: Protopy should not be used in children under 2 years of age.
Estonian: Alla 2-aastastel lastel ei tohi Protopyut kasutada.
English: Protopy should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Estonian: Protopyu salvi võib välja kirjutada üksnes arst, kellel on atoopilise dermatiidi diagnoosimise ja ravi kogemus.
English: What is Protopy?
Estonian: Mis on Protopy?
English: In children, only the lowest strength Protopy 0.03% should be used.
Estonian: Lastel tuleb kasutada ainult nõrgema kontsentratsiooniga Protopyut (0,03%).
English: The most common side effects (seen in more than 1 patient in 10) are burning sensation and itching at the application site.
Estonian: Kõige sagedasemad kõrvaltoimed (mida esines rohkem kui ühel patsiendil kümnest) on põletustunne ja kihelus manustamiskohal.
English: Tacrolimus calms down the immune system, and this helps relieve the skin inflammation and the itch.
Estonian: Takroliimus rahustab immuunsüsteemi, mis aitab nahapõletikku ja kihelust leevendada.
English: Protopy was significantly more effective than either of the 2 hydrocortisone preparations at producing improvements in the modified Eczema Area and Severity Index, although it also produced more burning than hydrocortisone.
Estonian: Protopy oli ekseemi ulatuse ja raskuse modifitseeritud indeksi parandamisel oluliselt efektiivsem kui kumbki kahest hüdrokortisoonipreparaadist, kuigi põhjustas ka hüdrokortisoonist rohkem põletustunnet.
English: The main measure of effectiveness was the improvement in the eczema seen at the end of the study (3 or 12 weeks) using a scoring system (the modified Eczema Area and Severity Index) that looks at all the symptoms of atopic dermatitis.
Estonian: Efektiivsust mõõdeti põhiliselt ekseemi paranemisega uuringu lõpuks (3-12 nädala pärast), kasutades punktisüsteemi (ekseemi ulatuse ja raskuse modifitseeritud indeks), mis hõlmab kõiki atoopilise dermatiidi sümptomeid.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Protopy's benefits are greater than its risks for the treatment of moderate to severe atopic dermatitis in adults and children over the age of 2 who are not adequately responsive to or are intolerant of conventional therapies.
Estonian: Inimtervishoius kasutatavate ravimite komitee leidis, et Protopyu kasulikkus ületab sellega seotud riske mõõduka kuni raske atoopilise dermatiidi ravimisel täiskasvanutel ja lastel alates 2. eluaastast, kes ei reageeri piisavalt konventsionaalsetele ravimitele või ei talu neid.
English: Why has Protopy been approved?
Estonian: Miks Protopy heaks kiideti?
English: Protopy should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of the other ingredients.
Estonian: Protopyut ei tohi kasutada patsiendid, kellel võib esineda ülitundlikkust (allergiat) takroliimuse või ravimi mõne teise koostisaine suhtes.
English: Tacrolimus, the active substance in Protopy, is an immunomodulator, this means that it works on the immune system (the body's natural defences).
Estonian: Protopyu toimeaine takroliimus on immunomodulaator, mis tähendab, et see mõjutab immuunsüsteemi (keha looduslikku kaitsemehhanismi).
English: A link to Protopy has not been shown.
Estonian: Seost Protopyuga ei ole tõendatud.
English: The lower strength of Protopy (0.03%) may also be used for this condition in children (2 years of age and above) who do not respond well to, or do not tolerate usual treatments.
Estonian: Nõrgema kontsentratsiooniga Protopyut (0,03%) võib kasutada selle haiguse ravimiseks ka lastel (alates 2. eluaastast), kes ei reageeri piisavalt tavalistele ravimitele või ei talu neid.
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Estonian: Atoopilise dermatiidi puhul põhjustab nahapõletikku (kihelust, punetust, kuivust) naha immuunsüsteemi ülemäärane reageerimine.
English: However, doctors must ensure that the medicine is used appropriately.
Estonian: Arstid peavad siiski olema sellest teadlikud ja tagama ravimi õige kasutamise ja patsiendi jälgimise ravi ajal.
English: What is the risk associated with Protopy?
Estonian: Millised on Protopyuga seostatavad riskid?
English: Doctors must be aware that a very small number of patients using the medicine have developed cancer (skin cancer, lymphoma).
Estonian: Väga vähestel patsientidel on tekkinud ravimi kasutamise ajal vähk (nahavähk, lümfoom).
English: Protopy is used for the treatment of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin- atopic means that is linked to an allergy) in adults who do not respond well or do not tolerate usual treatments.
Estonian: Protopyut kasutatakse mõõduka kuni raske atoopilise dermatiidi (ekseem, kihelev ja punetav nahalööve - atoopiline tähendab, et see on seotud allergiaga) raviks täiskasvanutel, kes ei reageeri piisavalt tavalistele ravimitele või ei talu neid.
English: For the full list of all the side effects reported with Protopy, please see the Package Leaflet.
Estonian: Protopyu kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: The ointment should be applied as a thin layer to affected areas of the skin.
Estonian: Salvi tuleb määrida õhukese kihina haigestunud nahapiirkondadele.
English: What benefit has Protopy shown during the studies?
Estonian: Milles seisneb uuringute põhjal Protopyu kasulikkus?
English: How does Protopy work?
Estonian: Kuidas Protopy toimib?
English: How has Protopy been studied?
Estonian: Kuidas Protopyut uuriti?
English: What is Protopy used for?
Estonian: Milleks Protopyut kasutatakse?
English: How is Protopy used?
Estonian: Kuidas Protopyut kasutatakse?
English: The full EPAR for Protopy is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Protopyu kohta leiate siit.
English: Such reactions may be life-threatening.
Estonian: Need reaktsioonid võivad olla eluohtlikud.
English: Less than 10
Estonian: Vähem kui 10
English: Children or adolescents
Estonian: Lapsed või noorukid
English: This is because it is not known if the medicine is safe to use in these age groups.
Estonian: Põhjuseks on, et selle ravimi ohutus kasutamiseks neis vanuserühmades ei ole teada.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 20. november 2018
English: The final volume is approximately 21.3 ml.
Estonian: Lõplik maht on ligikaudu 21,3 ml.
English: Meropenem alone is not known to interact with active transport systems.
Estonian: Meropeneemil endal ei ole teadaolevalt koostoimeid aktiivsete transpordisüsteemidega.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1334/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/18/1334/001
English: Every 12 hours
Estonian: Iga 12 tunni järel