FrancophonIA/ELRC3.0 huggingface dataset:
English: For longer term treatment, once a clinical response has been observed (after ≥ 4 days), the dose of the product can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Estonian: Pikemaajaliseks raviks pärast kliinilise ravivastuse tekkimist (≥ 4 päeva pärast) võib ravimi annust korrigeerida madalaima efektiivse individuaalse annuseni, võttes arvesse krooniliste lihas-skeleti kahjustustega seotud valu ja põletiku astme võimalikku muutumist ajas.
English: Use during pregnancy and lactation: See section "Contraindications".
Estonian: Tiinus ja laktatsioon: Vt lõiku "Vastunäidustused".
English: Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water.
Estonian: Vältida ravimi vahetut kokkupuutumist nahaga, juhuslikul ravimi sattumisel nahale pesta kohe käed seebi ja veega.
English: EU/2/12/138/001 6 ml/10 ml vial EU/2/12/138/002 11 ml/20 ml vial EU/2/12/138/003 33 ml/50 ml vial EU/2/12/138/004 3 ml/10 ml vial EU/2/12/138/005 3 ml/20 ml vial EU/2/12/138/006 8 ml/50 ml vial
Estonian: EU/2/12/138/001 6 ml/10 ml klaasviaalis EU/2/12/138/002 11 ml/20 ml klaasviaalis EU/2/12/138/003 33 ml/50 ml klaasviaalis EU/2/12/138/004 3 ml/10 ml klaasviaalis EU/2/12/138/005 3 ml/20 ml klaasviaalis EU/2/12/138/006 8 ml/50 ml klaasviaalis
English: To prime the pump depress at least 10 times prior to first use or until a fine spray appears.
Estonian: Pumba eeltäitmiseks vajutada seda enne esmakordset kasutamist vähemalt 10 korda kuni peene pihustuse tekkimiseni.
English: When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Estonian: Ravimi kasutamisel soovitatud annustamisskeemi kohaselt saavutatakse meloksikaami stabiilsed kontsentratsioonid vereplasmas teisel ravipäeval.
English: Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Estonian: Meloksikaam sisaldub valdavalt plasmas ning oluline osa sellest eritub ka sapiga, kuid uriin sisaldab ainult lähteaine jälgi.
English: Shake gently before use.
Estonian: Enne kasutamist ettevaatlikult loksutada.
English: Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Estonian: Mitte kasutada loomadel, kellel on seedehäireid, näiteks ärritus ja verejooks, maksa-, südame- või neerufunktsiooni kahjustus ja hemorraagilised häired.
English: In case of pump failure, wipe nozzle and then re-prime the pump as described above.
Estonian: Pumba tõrke korral pühkige otsikut ja eeltäitke pump, nagu eespool kirjeldatud.
English: * For the initial treatment of a single dose of 0.2 mg meloxicam/kg body weight, the above maintenance doses should be doubled.
Estonian: * Esmaseks raviks ühekordse annusega 0,2 mg meloksikaami kehamassi 1 kg kohta tuleb eeltoodud säilitavad annused kahekordistada.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - väga sage (ühe ravikuuri jooksul ilmnes(id) kõrvaltoime(d) rohkem kui 1-l loomal 10 looma hulgast) - sage (rohkem kui 1-l, kuid vähem kui 10 loomal 100-st) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st) - harv (rohkem kui 1-l, kuid vähem kui 10 loomal 10,000-st) - väga harv (vähem kui 1-l loomal 10,000-st, kaasaarvatud harva esinevad üksikjuhud).
English: Manufacturer for the batch release: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS
Estonian: Partii väljastamise eest vastutav tootja: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, HOLLAND
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Estonian: Meloksikaam on oksikaamide klassi kuuluv mittesteroidne põletikuvastane ravim, mille toime seisneb prostaglandiinide sünteesi inhibeerimises, millega avaldatakse põletikuvastast, valuvaigistavat, antieksudatiivset ja palavikuvastast toimet.
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Estonian: Zoetis Belgium SA, Rue Laid Burniat, 1 1348 Louvain-la-Neuve BELGIA
English: To administer RevitaCAM, the dog's top lip should be grasped and gently pulled away exposing the gums.
Estonian: RevitaCAMi manustamiseks võtke koera ülahuulest kinni ja tõmmake see ettevaatlikult igemetest eemale, et paljastada igemed.
English: Wash hands after administration of the product.
Estonian: Pärast ravimi manustamist peske käed.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Estonian: MÄRGE “AINULT VETERINAARSEKS KASUTAMISEKS“
English: RevitaCAM must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Estonian: RevitaCAMi ei ole lubatud manustada koos teiste mittesteroidsete põletikuvastaste ravimite või glükokortikosteroididega.
English: Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Estonian: Kui kliinilist paranemist ei täheldata, tuleb ravi hiljemalt 10 päeva pärast katkestada.
English: Marketing authorisation holder: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Estonian: Müügiloa hoidja: Zoetis Belgium SA, Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIA
English: Immediately after administration of the spray use a moist paper towel or tissue to clean the tip of the pump.
Estonian: Kohe pärast sprei manustamist puhastage pumba ots niiske paberkäteräti või -salvrätiga.
English: Insert pump into vial
Estonian: Sisestage pump viaal
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Estonian: Mitte kasutada, kui esineb ülitundlikkust toimeaine või ravimi ükskõik millise abiaine suhtes.
English: Ethyl alcohol Polycarbophil Boric acid Potassium chloride Hydrochloric acid Sodium hydroxide Water, purified
Estonian: 6.1 Abiainete loetelu etüülalkohol polükarbofiil boorhape kaaliumkloriid vesinikkloriidhape naatriumhüdroksiid puhastatud vesi
English: Store the vial in an upright position.
Estonian: Hoida viaal püstiasendis.
English: EXP {month/year} Shelf-life of opened vial: 6 months
Estonian: Kõlblik kuni: {kuu/aasta} Avatud viaali kõlblikkusaeg: 6 kuud
English: Meloxicam 5mg/ml
Estonian: Meloksikaam 5 mg/ml
English: People with known hypersensitivity to Non Steriodal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Estonian: Inimesed, kes on mittesteroidsete põletikuvastaste ravimite suhtes ülitundlikud, peaksid kokkupuudet veterinaarravimiga vältima.
English: Excipients: Ethyl alcohol 150 mg
Estonian: Abiained: etüülalkohol 150 mg
English: Wipe pump with tissue to prevent clogging
Estonian: Pühkige pumpa salvrätiga ummistuse vältimiseks
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Estonian: Põletiku ja valu leevendamine ägedate ja krooniliste lihas-skeleti kahjustuste korral.
English: Oromucosal spray Yellow colloidal dispersion
Estonian: Kollane kolloidne dispersioon.
English: 10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Not all pack sizes may be marketed.
Estonian: 10 ml klaasviaal, mis sisaldab kas 3 ml või 6 ml - 50 µl pumbaga 20 ml klaasviaal, mis sisaldab kas 3 ml või 11 ml - 100 µl pumbaga 50 ml klaasviaal, mis sisaldab kas 8 ml või 33 ml - 215 µl pumbaga Kõik pakendi suurused ei pruugi olla müügil.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet Code:
Estonian: Farmakoterapeutiline rühm: põletikuvastased ja reumaravimid, mittesteroidsed ravimid (oksikaamid) ATCvet kood: QM01AC06
English: Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Estonian: Esmaseks raviks esimesel päeval on ühekordne annus 0,2 mg meloksikaami kehamassi 1 kg kohta.
English: 10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Care should be taken to select the correct size vial depending on the bodyweight of the dog.
Estonian: 10 ml klaasviaalis, mis sisaldab kas 3 ml või 6 ml - 50 µl pumbaga 20 ml klaasviaalis, mis sisaldab kas 3 ml või 11 ml - 100 µl pumbaga 50 ml klaasviaalis, mis sisaldab kas 8 ml või 33 ml - 215 µl pumbaga Olenevalt koera kehamassist tuleb hoolikalt valida õige suurusega viaal.
English: Typical adverse drug reactions of Non Sterioidal Anit-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Estonian: Vahetevahel on esinenud mittesteroidsete põletikuvastaste ravimite tüüpilisi kõrvaltoimeid, nt isutus, oksendamine, diarröa, peitveri väljaheites, apaatia ja neerupuudulikkus.
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Estonian: Põletiku ja valu leevendamine koertel ägedate ja krooniliste lihas-skeleti kahjustuste korral.
English: Medicines should not be disposed of via wastewater or household waste but in accordance with local requirements.
Estonian: Kasutamata jäänud ravimeid ega jäätmematerjali ei tohi ära visata kanalisatsiooni kaudu ega koos majapidamisprügiga.
English: Treatment is to be continued once daily by oromucosal administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table).
Estonian: Ravi tuleb jätkata üks kord päevas oromukosaalse manustamisega (24-tunniste intervallidega) säilitavas annuses 0,1 mg meloksikaami kehamassi 1 kg kohta (vt annustamistabelit).
English: Treatment should be continued once daily by application of the spray to the oral mucosa (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table).
Estonian: Ravi tuleb jätkata üks kord päevas sprei manustamisega suu limaskestale (24-tunniste intervallidega) säilitavas annuses 0,1 mg meloksikaami kehamassi 1 kg kohta (vt annustamistabelit).
English: Body weight range (kg)
Estonian: Kehamass (kg)
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Estonian: A. RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA
English: PACKAGE LEAFLET FOR: RevitaCAM 5mg/ml oromucosal spray for Dogs
Estonian: PAKENDI INFOLEHT RevitaCAM 5 mg/ml suuõõnesprei koertele
English: EXP {month/year}> Shelf-life of opened vial: 6 months Once broached, use by …
Estonian: Avatud viaali kõlblikkusaeg: 6 kuud Pärast pakendi avamist kasutada kuni:
English: Allow the pump to fully reflate before administering consecutive sprays.
Estonian: Enne järgmiste pihustuste manustamist laske pumbal uuesti täielikult täituda.
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Estonian: Manustatud annus ja kontsentratsioon vereplasmas on terapeutilises annusevahemikus lineaarses sõltuvuses.
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs Meloxicam
Estonian: RevitaCAM 5 mg/ml, suuõõnesprei koertele Meloksikaam
English: Prime pump by spraying into tissue
Estonian: Eeltäitke pump salvrätikusse pihustamisega
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs
Estonian: RevitaCAM 5 mg/ml, suuõõnesprei koertele
English: Do not use in pregnant or lactating animals.
Estonian: Tiinuse või laktatsiooni ajal mitte kasutada.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Pärast ravimi manustamist peske käed.
English: Oromucosal Spray
Estonian: Suuõõnesprei.
English: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS
Estonian: 4817 ZJ Breda HOLLAND
English: Oromucosal use
Estonian: Meloksikaami
English: 30 x 1 tablets (unit dose)
Estonian: 30 x 1 tabletti (üksikannus)
English: 90 (3 x 30) tablets (multipack)
Estonian: Pakendi suurus tabletti (mitmikpakend)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Estonian: Tugevus Ravivorm Manustamistee Sisepakend
English: It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93').
Estonian: See sisaldab hobuste gripi inaktiveeritud (hävitatud) tervikviiruse kaht tüve (A/equine-2/South Africa/4/03 ja A/equine-2/Newmarket/2/93).
English: The swelling is expected to decrease within two days.
Estonian: Paistetus peaks kahe päeva jooksul alanema.
English: In very rare cases fever may occur for one day, and up to three days in exceptional circumstances.
Estonian: Väga harvadel juhtudel võib ühe ööpäeva jooksul esineda palavik, mis väga erandlikes tingimustes võib kesta kuni kolm ööpäeva.
English: The effectiveness of the current formulation of the vaccine has been assessed in additional laboratory studies.
Estonian: Praeguse vaktsiini efektiivsust on hinnatud ka täiendavates laboriuuringutes.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza on 8 July 2005.
Estonian: Euroopa Komisjon andis Equilis Prequenza müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. juulil 2005.
English: Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
Estonian: Hobuste gripp on väga nakkav haigus, mis on hobustel väga sage, kuid põhjustab surmajuhtumeid harva.
English: This should be followed by a third vaccination five months later, and afterwards by yearly revaccinations.
Estonian: Sellele peab järgnema kolmas vaktsineerimine 5 kuud hiljem ja seejärel revaktsineerimine üks kord aastas.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided led to the recommendations on the conditions of use.
Estonian: Selles selgitatakse, kuidas veterinaarravimite komitee hinnangu alusel, mis tugineb esitatud dokumentidele, koostati ravimi kasutustingimuste soovitused.
English: The main measure of effectiveness was the production of protective levels of antibodies against the influenza components.
Estonian: Efektiivsuse põhinäitaja oli gripivastaste antikehade kaitsva taseme tekkimine.
English: This summary was last updated in February 2013.
Estonian: Kokkuvõtte viimane uuendus: 02-2013.
English: The antibodies will then help to protect against the disease caused by these strains of the equine influenza virus.
Estonian: Antikehad aitavad kaitsta haiguse eest, mida põhjustavad need hobuste gripiviiruse tüved.
English: Horses developed protection two weeks after primary vaccination.
Estonian: Hobustel tekkis kaitsetase kaks nädalat pärast esmast vaktsineerimist.
English: The duration of protection was five months after primary vaccination and 12 months after the first revaccination.
Estonian: Esmase vaktsineerimise järgne kaitse kestis 5 kuud ja esimese revaktsineerimise järgne kaitse 12 kuud.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption or before the milk can be used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha või piima toiduks tarvitada.
English: When a horse is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against them.
Estonian: Kui hobusele manustatakse vaktsiini, peab immuunsüsteem viirust võõraks ja tekitab selle vastu antikehi.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza exceed the risks for the approved indications and recommended that Equilis Prequenza be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et heakskiidetud näidustusel on Equilis Prequenza kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: These equine influenza viruses have been inactivated so that they can no longer cause disease.
Estonian: Hobuste gripi viirused on inaktiveeritud, st nad ei põhjusta haigust.
English: The current formulation of Equine Prequenza has been shown to produce similar results to those shown in the initial studies.
Estonian: Tõendati, et Equilis Prequenza praegune koostis tekitab algsete uuringute tulemustega samalaadse tulemuse.
English: The effectiveness of Equilis Prequenza was initially studied in several trials under laboratory and field conditions.
Estonian: Equilis Prequenza efektiivsust uuriti algselt mitmes uuringus nii labori- kui ka välitingimustes.
English: Equilis Prequenza contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Estonian: Equilis Prequenza sisaldab gripi inaktiveeritud tervikviiruse tüvesid, mille vastu vaktsiin on näidustatud.
English: Equilis Prequenza is a vaccine for use in horses.
Estonian: Equilis Prequenza on hobustel kasutatav vaktsiin.
English: Horses should receive a primary vaccination, consisting of two injections given four weeks apart.
Estonian: Hobustele tuleb teha esmane vaktsineerimine: kaks süsti, mis manustatakse 4-nädalase intervalliga.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Estonian: Vaktsiin sisaldab ravivastuse tugevdamiseks ka adjuvanti.
English: The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, i.e. which did not receive the vaccine.
Estonian: Uuringutes võrreldi ka kliinilisi nähte ja viiruse eritumist vaktsineeritud ja kontrollrühma loomadel (vaktsineerimata loomad).
English: The safety of the initial formulation of Equilis Prequenza was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Estonian: Vaktsiini Equilis Prequenza esialgse koostise ohutust uuriti mitmes uuringus labori- ja välitingimustes suurel hulgal vähemalt 2-kuustel hobustel.
English: Vaccines work by ‘teaching' the immune system how to defend itself against diseases.
Estonian: Vaktsiinid n-ö õpetavad immuunsüsteemi (organismi looduslikke kaitsemehhanisme) kaitsma organismi haiguse eest.
English: The initial studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age.
Estonian: Uuringud näitasid, et Equilis Prequenza on efektiivne hobuste gripi vastane vaktsiin, mis vähendab kliinilisi nähte ja nakatumisejärgset viiruse eritumist vähemalt 6-kuustel hobustel.
English: The withdrawal period for Equilis Prequenza for meat and milk is zero days.
Estonian: Vaktsiini Equilis Prequenza keeluaeg liha ja piima korral on 0 päeva.
English: The vaccine is given as an injection into a muscle.
Estonian: Vaktsiini manustatakse lihasesisese süstina.
English: The viruses included in the current formulation of Equilis Prequenza are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs.
Estonian: Vaktsiinis Equilis Prequenza sisalduvaid viirusi kasvatatakse imetajarakkudes erinevalt algsest vaktsiinist, mille viiruseid kasvatati kanamunades.
English: What is Equilis Prequenza?
Estonian: Mis on Equilis Prequenza?
English: Other information about Equilis Prequenza:
Estonian: Muu teave Equilis Prequenza kohta
English: A hard or soft swelling may occur at the injection site.
Estonian: Süstekohal võib esineda tugev või nõrk paistetus.
English: Most of the studies used Equilis Prequenza Te, a vaccine which protects against tetanus as well as the strains of equine influenza included in Equilis Prequenza.
Estonian: Enamikus uuringutes kasutati vaktsiini Equilis Prequenza Te, mis kaitseb nii teetanuse kui ka vaktsiinis Equilis Prequenza sisalduvate hobuste gripi tüvede vastu.
English: Equilis Prequenza is used to vaccinate horses from six months of age against equine influenza.
Estonian: Equilis Prequenzat kasutatakse vähemalt 6 kuu vanuste hobuste vaktsineerimiseks hobuste gripi vastu.
English: The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Estonian: Vaktsiin vähendab hobuste gripi nähte ja infektsioonijärgset viiruse eritumist.
English: Pain at the injection site can occur rarely.
Estonian: Harva esineb süstepiirkonna valulikkust.
English: Why has Equilis Prequenza been approved?
Estonian: Miks vaktsiin Equilis Prequenza heaks kiideti?
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Estonian: Kui immuunsüsteem puutub nende viirusetüvedega kokku hiljem uuesti, tekivad antikehad kiiremini.
English: What is the risk associated with Equilis Prequenza?
Estonian: Mis riskid vaktsiiniga Equilis Prequenza kaasnevad?
English: How does Equilis Prequenza work?
Estonian: Kuidas Equilis Prequenza toimib?
English: How has Equilis Prequenza been studied?
Estonian: Kuidas Equilis Prequenzat uuriti?
English: The vaccine is available as a suspension for injection.
Estonian: Vaktsiini turustatakse süstesuspensioonina.
English: What benefit has Equilis Prequenza shown during the studies?
Estonian: Milles seisneb uuringute põhjal Equilis Prequenza kasulikkus?
English: Equine influenza vaccine
Estonian: Equilis Prequenza hobuste gripi vaktsiin
English: Although a possible effect in these conditions was observed, several shortcomings were identified.
Estonian: Kuigi täheldati võimalikku mõju neile seisunditele, ilmnesid mitmed puudused.
English: 5 April 2016 EMA/152385/2016
Estonian: 5. aprill 2016 EMA/543474/2016
English: This means that, although there is insufficient evidence from clinical studies, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Estonian: See tähendab, et kuigi puuduvad kliinilistest uuringutest saadud piisavad tõendid, on tõenäoline, et need taimsed ravimid on efektiivsed, ja on tõendeid, et neid on sel viisil ohutult kasutatud vähemalt 30 aastat (sh vähemalt 15 aastat Euroopa Liidus).
English: 1 Dry extract (DER 3-7.4:1), extraction solvent: ethanol 40-70% (V/V).
Estonian: 1 Kuivekstrakt (DER 3-7,4:1), ekstrakti lahusti: etanool 40-70 mahu-%.
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian root medicines.
Estonian: Lahtiste haavade, nahaprobleemide, kõrge palaviku, raskete infektsioonide ning raskete südame- ja vereringeprobleemidega patsiendid ei tohi võtta vanni, kuhu on lisatud palderjanijuurt sisaldavaid ravimeid.
English: Results showed improvements in the time it takes to fall asleep and sleep quality.
Estonian: Tulemused näitasid uinumiseks kulunud aja vähenemist ja unekvaliteedi paranemist.
English: DER or drug extract ratio is the ratio between the amount of herbal substance used and the quantity of extract obtained.
Estonian: DER ehk ravimiekstrakti suhe on kasutatud taimse aine ja saadud ekstrakti koguse vaheline suhe.