FrancophonIA/ELRC3.0 huggingface dataset:
English: • In horses, the proposed indications are for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders and for the relief of pain associated with equine colic.
Estonian: • Soovitatud näidustused hobustel on põletiku ja valu leevendamine nii ägedate kui ka krooniliste luu- ja lihaskonna häirete korral ning hobuste voolmetega seotud valu leevendamine.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Estonian: Ravimi omaduste kokkuvõtte ja pakendi infolehe vastavate lõikude parandused
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the bioequivalence of Melosolute 40 mg/ml solution for injection with the reference product, Metacam 20 mg/ml solution for injection for the target species pigs, or provided other satisfactory justification to extrapolate the data of the reference product.
Estonian: Direktiivi 2001/82/EÜ artikli 33 lõike 4 kohane esildis tehti seetõttu, et taotleja ei olnud sihtloomaliigi sigade korral rahuldavalt tõendanud ravimi Melosolute 40 mg/ml solution for injection bioekvivalentsust võrdlusravimiga Metacam 20 mg/ml solution for injection ega esitanud muid rahuldavaid põhjendusi võrdlusravimi andmete ekstrapoleerimiseks.
English: The proposed indications in cattle, pigs and horses for Melosolute 40 mg/ml are identical to the approved indications for the reference product, Metacam 20 mg/ml solution for injection for cattle, pigs and horses.
Estonian: Ravimi Melosolute 40 mg/ml soovitatud näidustused kasutamiseks veistel, sigadel ja hobustel on samasugused nagu võrdlusravimi Metacam 20 mg/ml solution for injection for cattle, pigs and horses heakskiidetud näidustused.
English: This is a generic ‘hybrid' application in which the applicant is extrapolating pre-clinical and clinical data from the reference product Metacam 20 mg/ml.
Estonian: Tegu on hübriidtaotlusega, milles taotleja ekstrapoleerib võrdlusravimi Metacam 20 mg/ml prekliinilisi ja kliinilisi andmeid.
English: Any increase in the rate/extent of absorption has not been quantified for Melosolute 40 mg/ml in a comparative pharmacokinetic study with the reference product and it could have implications in terms of target animal safety.
Estonian: Imendumise kiiruse/ulatuse suurenemist ei ole võrdlusravimiga võrdlevas farmakokineetilises uuringus Melosolute 40 mg/ml jaoks kvantifitseeritud ja see võib mõjutada sihtloomade ohutust.
English: The applicant has submitted a residue depletion study conducted with Melosolute 40 mg/ml as evidence of the comparative pharmacokinetic profile between their product and Metacam 20 mg/ml.
Estonian: Taotleja on esitanud ravimi Melosolute 40 mg/ml kohta tehtud ravimijääkide vähenemise uuringu, et tõendada oma ravimi ja Metacam 20 mg/ml farmakokineetilise profiili võrreldavust.
English: The Committee considered whether the bioequivalence of the test product with the reference product in the target species pigs had been proven, based on the available data.
Estonian: Veterinaarravimite komitee kaalus olemasolevate andmete alusel, kas uuritava ravimi bioekvivalentsus võrdlusravimiga on sihtloomaliigi sigade kohta tõendatud.
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam 40 mg/ml.
Estonian: Ravim Melosolute 40 mg/ml solution for injection for cattle, pigs and horses sisaldab meloksikaami 40 mg/ml.
English: It should be noted that for cattle and horses, the applicant is exempt from providing an in vivo bioequivalence study under waiver 7.1.a of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)1 (Bioequivalence GL).
Estonian: Tuleb märkida, et veterinaarravimite komitee veterinaarravimite bioekvivalentsuse uuringute läbiviimise juhiste (EMA/CVMP/016/00-Rev.2)1 vabastussätte 7.1 punkti a kohaselt (bioekvivalentsuse juhised) on taotleja vabastatud veiste ja hobuste in vivo bioekvivalentsuse uuringu esitamisest.
English: For this generic ‘hybrid' application, the benefits are extrapolated from the safety and efficacy data for the reference product, Metacam 20 mg/ml.
Estonian: Käesoleva hübriidtaotluse jaoks ekstrapoleeritakse kasulikkus võrdlusravimi Metacam 20 mg/ml ohutus- ja efektiivsusandmetest.
English: In order to address the concerns raised by the referral, the applicant presented a justification for the omission of a bioequivalence study for Melosolute 40 mg/ml solution for injection and the reference product, Metacam 20 mg/ml solution for injection.
Estonian: Esildises tõstatatud probleemide lahendamiseks esitas taotleja põhjenduse ravimi Melosolute 40 mg/ml solution for injection ja võrdlusravimi Metacam 20 mg/ml solution for injection bioekvivalentsuse uuringu väljajätmiseks.
English: In the absence of such a study, the residues depletion data provide no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and consequently the identification of its impact on clinical safety and efficacy is not possible.
Estonian: Sellise uuringu puudumisel ei anna ravimijääkide vähenemise andmed kindlaid tõendeid, mis võimaldaksid kvantifitseerida meloksikaami imendumise kiiruse ja ulatuse erinevusi Melosolute 40 mg/ml ja Metacam 20 mg/ml vahel.
English: • The pharmaceutical similarity of Melosolute 40 mg/ml and Metacam 20 mg/ml formulations.
Estonian: • Melosolute 40 mg/ml ja Metacam 20 mg/ml ravimvormide farmatseutiline sarnasus.
English: • Residues studies would suffice as a substitute for bioequivalence, considering that as the meloxicam residues in liver and muscle were comparable at the 4 hour sampling point and as the withdrawal times for Melosolute 40 mg/ml and Metacam 20 mg/ml are the same, the pharmacokinetic parameters will be comparable.
Estonian: • Ravimijääkide uuringud on piisavad bioekvivalentsuse asendajad, arvestades, et meloksikaami jäägid maksas ja lihases olid võrreldavad 4 tunni proovide võtmise hetkel, ning et Melosolute
English: The applicant should have provided a blood-level comparative pharmacokinetic study between Melosolute 40 mg/ml and the reference product.
Estonian: Taotleja oleks pidanud esitama Melosolute 40 mg/ml ja võrdlusravimi verenäitajate võrdleva farmakokineetilise uuringu.
English: Melosolute 40 mg/ml solution for injection is administered intramuscularly in pigs, whereas in cattle and horses it is administered intravenously.
Estonian: Ravimit Melosolute 40 mg/ml solution for injection manustatakse sigadele intramuskulaarselt, samas veistele ja hobustele manustatakse seda intravenoosselt.
English: Potential serious risks were identified during the decentralised procedure by Ireland and the United Kingdom as they considered the bioequivalence of Melosolute 40 mg/ml solution for injection with the reference product, Metacam 20 mg/ml solution for injection had not been sufficiently demonstrated for the target species pigs, and no other satisfactory data had been provided to enable extrapolation of safety and efficacy data from the reference product for this species.
Estonian: Nad leidsid, et ravimi Melosolute 40 mg/ml solution for injection bioekvivalentsust võrdlusravimiga Metacam 20 mg/ml solution for injection ei olnud sihtloomaliigi sigade kohta piisavalt tõendatud ning muid rahuldavaid andmeid, mis oleksid võimaldanud ekstrapoleerida võrdlusravimi ohutus- ja efektiivsusandmeid sellele loomaliigile, ei esitatud.
English: Therefore the CVMP recommends the refusal of the granting of the marketing authorisation for Melosolute 40 mg/ml solution for injection for the target species pigs.
Estonian: Seetõttu soovitab veterinaarravimite komitee keelduda sihtloomaliigile sead ette nähtud ravimi Melosolute 40 mg/ml, süstelahus, müügiloa andmisest.
English: However, for pigs, where the product is administered intramuscularly, the applicant has not provided sufficient evidence of the relative rate and extent of absorption, to allow extrapolation of the data from the reference product.
Estonian: Siiski ei ole taotleja esitanud võrdlusravimi andmete ekstrapoleerimist võimaldavaid piisavaid tõendeid ravimi imendumise suhtelise kiiruse ja ulatuse kohta sigadel, kellele ravimit manustatakse intramuskulaarselt.
English: Bioequivalence between the test product and the originator
Estonian: Uuritava ja originaalravimi bioekvivalentsus
English: In order to do this, the applicant must establish a link between the test and reference products and as the product is systemically active, the assumptions behind the concept of bioequivalence would allow this.
Estonian: Et ravim on süsteemselt aktiivne, on see bioekvivalentsuse kontseptsiooni eelduste kohaselt lubatud.
English: The applicant submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses.
Estonian: Taotleja esitas ravimi Melosolute 40 mg/ml solution for injection for cattle, pigs and horses taotluse detsentraliseeritud menetluseks.
English: Meloxicam appeared to be more rapidly absorbed from the 40 mg/ml compared to the 20 mg/ml injection site, as suggested from the residue depletion data at the first (4 hours) sampling time-point, where the injection site levels were lower and kidney levels higher for the 40 mg/ml formulation.
Estonian: Koeproovide võtmise ajastus ja väike sagedus ei võimalda koejääkide kontsentratsioone kasutada plasmasisalduse asendajana, mis võimaldaks prognoosida vere Cmax-i ja AUC-d. Meloksikaam näis kiiremini imenduvat 40 mg/ml süstekohast võrreldes 20 mg/ml süstekohaga, millele viitasid jääkide vähenemise andmed esimesel (4 tundi) proovide võtmise ajahetkel, kus 40 mg/ml ravimvormi korral oli toimeainesisaldus süstekohas väiksem ja neerudes suurem.
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam as active ingredient.
Estonian: Ravim Melosolute 40 mg/ml solution for injection for cattle, pigs and horses sisaldab toimeainena meloksikaami.
English: The CVMP acknowledged the similarity of the formulations of the Melosolute 40 mg/ml and Metacam 20 mg/ml in terms of their excipients.
Estonian: Veterinaarravimite komitee nõustus Melosolute 40 mg/ml ja Metacam 20 mg/ml abiainete sarnasusega.
English: • the residues depletion data provided no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and therefore to quantify its impact on clinical safety and efficacy; the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs.
Estonian: Sellest tulenevalt ei ole võimalik ka tuvastada mõju kliinilisele ohutusele ja efektiivsusele; taotluse toetuseks esitatud üksikandmed sihtloomaliigi sigade kohta ei vasta direktiivi 2001/82/EÜ artiklile 13 ega rahulda müügiloa saamise kriteeriume seoses nimetatud sihtloomaliigi ohutuse ja efektiivsusega.
English: Metacam 5 mg/ml formulation.
Estonian: Seda pidas veterinaarravimite komitee varem Metacam 5 mg/ml ravimvormi korral aktsepteeritavaks.
English: Make sure it is fixed well in place.
Estonian: Veenduge, et see on kindlalt paigas.
English: - At the request of the European Medicines Agency;
Estonian: • Euroopa Ravimiameti nõudel;
English: After first opening: 5 months
Estonian: Pärast esmakordset avamist: 5 kuud.
English: * Statistically significant (p-value)
Estonian: * Statistiliselt oluline (p-väärtus)
English: - The medicine may be taken with or without food.
Estonian: - Ravimit võib võtta koos toiduga või ilma.
English: Children less than 4 years
Estonian: Alla 4 aasta vanused lapsed
English: Belgium (name and address only for outer carton, logo on carton and etiquette)
Estonian: Belgia (nimi ja aadress ainult välispakendile, logo karbile ja etiketile)
English: More details are provided below the table.
Estonian: Täiendavad üksikasjad on esitatud tabeli all.
English: Instructions for use for patients or carers:
Estonian: Kasutamisjuhend patsientidele või hooldajatele:
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for brivaracetam.
Estonian: Selle riski mehhanism on teadmata ning olemasolevad andmed ei välista võimalikku suuremat riski brivaratsetaami puhul.
English: Treatment of an overdose should include general supportive measures.
Estonian: Üleannustamise ravi peab hõlmama üldtoetavaid meetmeid.
English: The three metabolites are not pharmacologically active.
Estonian: Kolm metaboliiti ei ole farmakoloogiliselt aktiivsed.
English: The terminal plasma half-life (t1/2) is approximately 9 hours.
Estonian: Terminaalne plasma poolväärtusaeg (t1/2) on ligikaudu 9 tundi.
English: No safety risks were observed.
Estonian: Ohutusega seotud riske ei täheldatud.
English: Although data are limited, the efficacy was comparable to younger subjects.
Estonian: Kuigi andmeid on piiratud hulgal, oli efektiivsus võrreldav noorematel isikutel täheldatuga.
English: Not Applicable.
Estonian: Ei kohaldata.
English: In such cases, it should be used straight after dilution.
Estonian: Sellistel juhtudel tuleb seda manustada vahetult pärast lahjendamist.
English: Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Estonian: Antud hetkel teadaolevad andmed on esitatud lõikudes 4.8, 5.1 ja 5.2, aga soovitusi annustamise kohta ei ole võimalik anda.
English: - These effects are more likely at the start of the treatment or after a dose increase.
Estonian: - Need toimed tekivad suurema tõenäosusega ravi alguses või pärast annuse suurendamist.
English: - Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
Estonian: - Hoidke pudelit tagurpidi ühes käes ja kasutage teist kätt suusüstla täitmiseks.
English: Learning and memory function were not affected.
Estonian: Õppimine ega mälufunktsioon ei olnud mõjutatud.
English: Excipients which may cause intolerance
Estonian: Abiained, mis võivad põhjustada talumatust
English: If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated.
Estonian: Kui naine soovib rasestuda, tuleb brivaratsetaami kasutamist hoolikalt uuesti hinnata.
English: Juvenile animals studies
Estonian: Uuringud noorte loomadega
English: Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters.
Estonian: Kuigi selle valgu täpne roll ei ole veel välja selgitatud, on näidatud, et see moduleerib neurotransmitterite eksotsütoosi.
English: Do not stop treatment without talking to your doctor first.
Estonian: Ärge lõpetage ravi kõigepealt arstiga nõu pidamata.
English: Formal interaction studies have only been performed in adults.
Estonian: Koostoimete uuringud on läbi viidud ainult täiskasvanutel.
English: You do not need to remove the adaptor after use.
Estonian: Pärast kasutamist ei ole vaja adapterit eemaldada.
English: You may feel dizzy and sleepy.
Estonian: Võite tunda pearinglust ja unisust.
English: The renal clearance of these non active metabolites was decreased 10-fold.
Estonian: Nende mitteaktiivsete metaboliitide renaalne kliirens vähenes 10 korda.
English: Your doctor may then decide to adjust your dose to find the best dose for you.
Estonian: Teie arst võib hiljem otsustada annust kohandada, et leida teile parim annus.
English: - Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
Estonian: - Ärge juhtige autot, sõitke jalgrattaga ega töötage tööriistade või masinatega enne, kui olete teadlik, kuidas ravim teile mõjub.
English: The number of patients with other ethnic background was limited.
Estonian: Muu etnilise kuuluvusega patsientide arv oli piiratud.
English: Percent reduction over placebo (%)
Estonian: Protsentuaalne vähenemine võrreldes platseeboga (%)
English: The risk of clinically relevant CYP3A4 interactions is considered to be low.
Estonian: Risk kliiniliselt olulisteks CYP3A4 koostoimeteks arvatakse olevat madal.
English: No additional safety or tolerability concerns were observed.
Estonian: Täiendavaid ohutuse või talutavusega seotud probleeme ei täheldatud.
English: Administered in 2 equally divided doses
Estonian: Manustatuna 2 võrdselt jagatud annusena
English: Other medicines and Briviact
Estonian: Muud ravimid ja Briviact
English: - Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
Estonian: - Sulgege pudel plastmassist keeratava korgiga (te ei pea adapterit eemaldama).
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23
Estonian: Farmakoterapeutiline rühm: epilepsiavastased ained, teised epilepsiavastased ained, ATC-kood: N03AX23
English: Seek advice immediately from your doctor if you are pregnant or are planning to become pregnant.
Estonian: Võtke otsekohe ühendust oma arstiga, kui te olete rase või kavatsete rasestuda.
English: Opening date (Only for outer carton)
Estonian: Avamiskuupäev (Ainult välispakendi jaoks)
English: All studies had an 8-week baseline period followed by a 12-week treatment period with no uptitration.
Estonian: Kõikides uuringutes oli 8-nädalane ravieelne periood, millele järgnes 12-nädalane raviperiood ilma annuse järk-järgulise suurendamiseta.
English: - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Estonian: • kui muudetakse riskijuhtimissüsteemi, eriti kui saadakse uut teavet, mis võib oluliselt mõjutada riski/kasu suhet, või kui saavutatakse oluline (ravimiohutuse või riski minimeerimise) eesmärk.
English: Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose.
Estonian: Unisust ja väsimust (8,2%) kirjeldati suurema esinemissagedusega annuse suurendamise ajal.
English: No additional safety or tolerability concern was observed (see section 5.1).
Estonian: Täiendavaid ohutuse või talutavuse probleeme ei täheldatud (vt lõik 5.1).
English: These partial seizures can spread and extend to larger areas on both sides of the brain - this is called a ‘secondary generalisation'.
Estonian: Partsiaalsed hood võivad levida ja mõjutada suuremaid alasid mõlemas ajupoolkeras - seda nimetatakse „sekundaarseks generalisatsiooniks“.
English: Plasma concentrations were shown to be dose-proportional in all age groups.
Estonian: Plasmakontsentratsioonid olid kõigis vanuserühmades proportsionaalsed annusega.
English: Any unused solution should be discarded (see section 3).
Estonian: Kasutamata lahus tuleb minema visata (vt lõik 3).
English: Patients with more than a 25 % increase in POS are shown at left as “worse”.
Estonian: Patsiendid, kellel tekkis partsiaalsete hoogude esinemissageduse enam kui 25% suurenemine, on näidatud vasakul „halvem“ all.
English: More than 95 % of the dose, including metabolites, is excreted in the urine within 72 hours after intake.
Estonian: Üle 95% annusest (sh metaboliidid) eritub uriiniga 72 tunni jooksul pärast manustamist.
English: Discontinuation of anti-epileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Estonian: Epilepsiavastase ravi katkestamine võib põhjustada haiguse ägenemist, mis võib olla kahjulik nii emale kui ka lootele.
English: If you have any of these thoughts at any time, contact your doctor immediately.
Estonian: Kui teil tekivad mis tahes ajal sellist laadi mõtted, võtke otsekohe ühendust oma arstiga.
English: As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Estonian: Ettevaatusabinõuna ei tohi brivaratsetaami raseduse ajal kasutada, välja arvatud juhul, kui see on kliiniliselt vajalik (kui ravist saadav kasu emale ületab selgelt võimalikku riski lootele).
English: Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the long-term open-label extension studies.
Estonian: Kõigi uuringute lõikes kaasati 81,7% randomiseeritud uuringud läbinud patsientidest pikaajalistesse avatud jätku-uuringutesse.
English: The efficacy outcomes are summarized in Table 2.
Estonian: Tabelis 2 on toodud efektiivsustulemuste kokkuvõte.
English: The safety profile in elderly patients appears to be similar to that observed in younger adult patients.
Estonian: Eakatel patsientidel täheldatud ohutusprofiil tundub olevat sarnane noorematel täiskasvanud patsientidel täheldatuga.
English: 1,558 patients received study drug of which 1,099 received brivaracetam.
Estonian: Uuringuravimit said 1558 patsienti, nendest 1099 brivaratsetaami.
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated.
Estonian: Ravi saanud populatsioonis on väärarengute esinemissageduse suurenemist täheldatud polüteraapia korral, samas ei ole välja selgitatud, mil määral on vastutavad ravi ja/või olemasolev haigus.
English: Pharmacokinetics is dose-proportional from 10 to at least 600 mg.
Estonian: Farmakokineetika on proportsionaalne annusega alates 10 mg-st kuni vähemalt 600 mg-ni.
English: - Wash the oral syringe with water only (figure 13).
Estonian: - Peske suusüstalt ainult veega (joonis 13).
English: Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.
Estonian: Patsiente tuleb juhendada, et nad ei juhiks autot ega töötaks muude potentsiaalselt ohtlike masinatega enne, kui nad teavad, kuidas mõjutab brivaratsetaam selliste tegevuste sooritamise võimet.
English: Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms.
Estonian: Individuaalse tundlikkuse võimaliku erinevuse tõttu võib mõnedel patsientidel tekkida unisus, pearinglus või muud kesknärvisüsteemiga (KNS) seotud sümptomid.
English: The dose per intake for each patient should be calculated using the following formula:
Estonian: Iga patsiendi ühekordne annus tuleb arvutada järgmise valemiga:
English: - 1.16 milligrams sodium per millilitre.
Estonian: - 1,16 milligrammi naatriumi milliliitri kohta.
English: - sorbitol (a type of sugar).
Estonian: - sorbitooli (teatud tüüpi suhkur).
English: Patients had a mean duration of epilepsy of approximately 23 years.
Estonian: Patsientide epilepsia kestuse mediaan oli ligikaudu 23 aastat.
English: Risk related to epilepsy and antiepileptic medicinal products in general For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Estonian: Epilepsia ja epilepsiavastaste ravimitega seotud risk üldiselt Kõikide epilepsiavastaste ravimite puhul on tõestatud, et epilepsia ravi saavate naiste järglastel on väärarengute esinemissagedus 2...3 korda suurem esinemissagedusest üldpopulatsioonis, mis on ligikaudu 3%.
English: The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was estimated to be 0.57 mg/L.
Estonian: EC50 (brivaratsetaami plasmakontsentratsioon, mis vastab 50%-le maksimaalsest toimest) oli hinnanguliselt 0,57 mg/l.
English: * Based on physician assessment of need for seizure control.
Estonian: * Vastavalt arsti hinnangule krambivastase ravi vajalikkuse kohta.
English: Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days Study
Estonian: Tabel 2: Põhilised efektiivsuse tulemused 28 päeva kohta esinenud partsiaalsete hoogude esinemissageduse osas