FrancophonIA/ELRC3.0 huggingface dataset:
English: • There is no alternative manufacturing site registered in the marketing authorisation for SoliCol D3 and the CHMP noted that no batches of SoliCol D3 are currently available on the EU market;
Estonian: Inimravimite komitee märkis, et Solicol D3 partiisid ei turustata praegu ELi turul.
English: • In view of the nature of the disease and the fact that alternatives are not available in all Member States;the CHMP considers Ammonaps critical to public health; The CHMP, as a consequence, considers that the benefit-risk balance of Ammonaps remains favourable for critical use and therefore recommends that the marketing authorisations be varied and subject to the condition that the marketing authorisation holder for Ammonaps provides evidence by 30 June 2017 that the manufacturing process complies with the requirements of Commission Directive
Estonian: Seetõttu on inimravimite komitee arvamusel, et Ammonapsi kasulikkuse ja riski suhe on jätkuvalt soodne ravimi kasutamiseks kriitilistes situatsioonides, ja soovitab seetõttu müügiluba muuta ning lisada sellesse tingimuse, et Ammonapsi müügiloa hoidja peab 30. juuniks 2017 tõendama, et tootmisprotsess vastab nõuetele, mis on esitatud komisjoni direktiivis 2003/94/EÜ, milles sätestatakse hea tootmistava põhimõtted ja suunised vastavalt direktiivi 2001/83/EÜ artiklis 8 lõikes 3 kehtestatule.
English: The tablets are given twice a day with or without food and usually 2 - 3 months is sufficient to control the condition although some dogs may need longer treatment.
Estonian: Tablette antakse kaks korda ööpäevas koos toiduga või ilma ja tavaliselt piisab seisundi kontrollimiseks 2-3 kuust, kuigi mõnel koeral võib olla vaja pikemat ravi.
English: The full EPAR for Clomicalm can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Clomicalmi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This summary was last updated in April 2016.
Estonian: Kokkuvõtte viimane uuendus: 04-2016.
English: Clomicalm is available as tablets (5, 20 and 80 mg) and can only be obtained with a prescription.
Estonian: Clomicalmi turustatakse tablettidena (5, 20 ja 80 mg) ja see on retseptiravim.
English: Vomiting may be reduced by giving the tablets with a small quantity of food.
Estonian: Oksendamist aitab vähendada tablettide andmine koos väikese hulga toiduga.
English: It works by increasing the levels of certain neurotransmitters, serotonin and noradrenaline, in the central nervous system.
Estonian: Selle toime seisneb teatud neurotransmitterite serotoniini ja noradrenaliini sisalduse suurendamises kesknärvisüsteemis.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clomicalm on 1 April 1998.
Estonian: Euroopa Komisjon andis Clomicalmi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 1. aprillil
English: Clomipramine is an antidepressant.
Estonian: Klomipramiin on antidepressant.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clomicalm's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Clomicalmi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Since low levels of these neurotransmitters can be linked to depression and anxiety, increasing them can help the dogs feel calmer so improving the behavioural signs in dogs with separation related problems.
Estonian: Et neurotransmitterite väike sisaldus võib olla seotud depressiooni ja ärevusega, võib nende sisalduse suurendamine aidata koertel rahuneda ja leevendada seeläbi eraldamisega seotud käitumisprobleeme.
English: Clomicalm must not be used in dogs with a known hypersensitivity to clomipramine and related medicines (known as tricyclic antidepressants).
Estonian: Clomicalmi ei tohi kasutada koertel, kes on teadaolevalt ülitundlikud klomipramiini ja seotud ravimite (tritsükliliste antidepressantide) suhtes.
English: A neurotransmitter is a substance that relays signals from a nerve cell to another cell.
Estonian: Neurotransmitter on aine, mis vahendab närvirakkudevahelisi signaale.
English: Clomicalm is a veterinary medicine used as an aid in the treatment of dogs with behavioural problems when separated from their owners, their home or other dogs.
Estonian: Clomicalm on veterinaarravim, mida kasutatakse nende koerte ravi soodustamiseks, kellel on omanikest, kodust või teistest koertest eraldamisel käitumisprobleemid.
English: What is Clomicalm and what is it used for?
Estonian: Mis on Clomicalm ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Clomicalm.
Estonian: Hindamisaruandes ei anta Clomicalmi kasutamise praktilisi nõuandeid.
English: Liver effects have been reported particularly in dogs with existing liver problems.
Estonian: Teatatud on mõjust maksale, eelkõige koertel, kellel on maksaprobleemid.
English: If a child accidentally swallows the medicine, this could cause serious reactions.
Estonian: Lapsel võivad ravimi juhusliku neelamise korral tekkida rasked reaktsioonid.
English: This is a summary of the European public assessment report (EPAR) for Clomicalm.
Estonian: See on ravimi Clomicalm Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Clomicalm approved?
Estonian: Miks Clomicalm heaks kiideti?
English: Clomicalm clomipramine hydrochloride
Estonian: Clomicalm klomipramiinvesinikkloriid
English: Other information about Clomicalm:
Estonian: Muu teave Clomicalmi kohta
English: It contains the active substance clomipramine hydrochloride.
Estonian: Ravim sisaldab toimeainena klomipramiinvesinikkloriidi.
English: What are the risks associated with Clomicalm?
Estonian: Mis riskid Clomicalmiga kaasnevad?
English: For practical information about using Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Clomicalmi kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (lack of energy) or an elevation in liver enzymes which is reversible when treatment is stopped.
Estonian: Väga harva võib Clomicalm põhjustada oksendamist, isutust, loidust või maksaensüümide aktiivsuse tõusu.
English: Such problems may include destruction of property and inappropriate defaecation and urination in the home. Clomicalm should only be given in combination with behavioural therapy.
Estonian: Need probleemid võivad olla näiteks vara lõhkumine või sobimatu roojamine või urineerimine siseruumides.
English: How does Clomicalm work?
Estonian: Kuidas Clomicalm toimib?
English: How is Clomicalm used?
Estonian: Kuidas Clomicalmi kasutatakse?
English: to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
Estonian: USAs ja Euroopas läbiviidud väliuuringud näitasid, et Clomicalm oli efektiivne koos käitumisteraapiaga kasutamisel, vähendades käitumisprobleeme eraldamisest tuleneva ärevusega koertel, ning efektiivsem kui üksnes käitumisteraapia paljude ärevusest tingitud käitumisprobleemide, näiteks suure omanikku kiindumuse korral.
English: What benefits of Clomicalm have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Clomicalmi kasulikkus?
English: These local reactions gradually reduce and disappear without need for treatment
Estonian: Need paiksed reaktsioonid aegamisi vähenevad ja kaovad ilma ravita.
English: Very common: nodules or swelling (< 2 cm) can be observed in the injection site, which may last 24 hours.
Estonian: Väga sage: süstekohal võib täheldada mügaraid või turseid (< 2 cm), mis võivad püsida 24 tundi.
English: This slight temperature increase resolves spontaneously without treatment by day 5 post-vaccination.
Estonian: See vähene kehatemperatuuri tõus taandub iseenesest 5. vaktsineerimisjärgseks päevaks.
English: Laboratory studies in doe rabbits in the last third of gestation have not produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Estonian: Tiinuse viimases kolmandikus olevate emaste küülikute laboriuuringud pole andnud mingeid tõendeid teratogeensetest, fetotoksilistest ja maternotoksilistest mõjudest.
English: Revaccination: 9 months after vaccination.
Estonian: Uus vaktsineerimine: 9 kuud pärast eelmist vaktsineerimist.
English: Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination.
Estonian: Väga sage: kahe või kolme päeva möödumisel vaktsineerimisest võib tekkida mööduv kehatemperatuuri tõus veidi üle 40 ºC.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP..
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud etiketil pärast EXP. Kõlblikkusaeg pärast vahetu pakendi esmast avamist: Kasutada koheselt
English: -very common (more than 1 in 10 animals treated displaying adverse reaction (s)) -common (more than 1 but less than 10 animals in 100 animals treated) -uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -rare (more than 1 but less than 10 animals in 10,000 animals treated) -very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - Väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - Sage (rohkem kui 1-l, kuid vähem kui 10 loomal 100-st ravitud loomast) - Aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - Harv (rohkem kui 1-l, kuid vähem kui 10 loomal 10,000-st ravitud loomast) - Väga harv (vähem kui 1-l loomal 10,000-st ravitud loomast, kaasaarvatud üksikjuhud).
English: Duration of immunity: 9 months demonstrated by challenge
Estonian: Immuunsuse kestus: nakkuskatses demonstreeritud 9 kuud.
English: ERAVAC Emulsion for injection for rabbits
Estonian: ERAVAC Süsteemulsioon küülikutele
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Estonian: Küülikute hemorraagilise haiguse viiruse 2. tüüp (RHDV2), tüvi V-1037……≥ 70% cELISA40* (*) ≥ 70% vaktsineeritud küülikutest on cELISA antikeha tiitrid 40 või suuremad.
English: Pregnancy
Estonian: Sobimatus
English: Thiomersal: ………………..0.05 mg Whitish emulsion.
Estonian: Tiomersaal: ………………0,05 mg
English: Thiomersal…………0.05 mg For the full list of excipients, see section 6.1.
Estonian: Abiainete täielik loetelu on esitatud punktis 6.1.
English: Inactivated RHDV2, strain V-1037: ……… ≥70% cELISA40*
Estonian: Inaktiveeritud RHDV2, tüvi V-1037 ≥ 70% cELISA40 ≥ 70% vaktsineeritud küülikutest on cELISA antikeha tiitrid 40 või suuremad.
English: 5 April 2016 EMA/154066/2016
Estonian: 5. aprill 2016 EMA/154066/2016
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian essential oil medicines.
Estonian: Lahtiste haavade, nahaprobleemide, kõrge palaviku, raskete infektsioonide ning raskete südame- ja vereringeprobleemidega patsiendid ei tohi võtta vanni, kuhu on lisatud palderjaniõli sisaldavaid ravimeid.
English: If symptoms continue during the use of the medicine, a doctor or a healthcare practitioner should be consulted.
Estonian: Kui sümptomid ravimi kasutamise ajal püsivad, tuleb pöörduda arsti või tervishoiutöötaja poole.
English: Valerian essential oil medicines should be used only in adults and adolescents over the age of 12 years.
Estonian: Palderjaniõli sisaldavaid ravimeid tohivad kasutada üksnes täiskasvanud ja vähemalt 12 aasta vanused noorukid.
English: Valerian essential oil EMA/154066/2016
Estonian: Palderjaniõli EMA/154066/2016
English: The HMPC noted the lack of clinical studies with valerian essential oil medicines, but took into account the well documented use of this herbal medicine.
Estonian: Taimsete ravimite komitee märkis, et puuduvad palderjaniõli käsitlevad kliinilised uuringud, kuid arvestas selle taimse ravimi hästi dokumenteeritud kasutust.
English: Further information on the risks associated with these valerian essential oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave palderjaniõli sisaldavate ravimitega kaasnevate riskide, sh nende ohutu kasutamise ettevaatusabinõude kohta on taimse aine monograafias Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Valerian essential oil is obtained by directing steam through the underground parts of the plant.
Estonian: Palderjaniõli saadakse, juhtides auru läbi taime maa-aluste osade.
English: Further information on the HMPC assessment of valerian essential oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave palderjaniõli sisaldavate ravimite hindamise kohta, sh komitee kokkuvõtte üksikasjalik kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instructions on how to take valerian essential oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Üksikasjalik teave, kuidas võtta palderjaniõli sisaldavaid ravimeid ja kes neid tohib kasutada, on ravimi pakendi infolehel.
English: Other information about valerian essential oil medicines
Estonian: Muu teave palderjaniõli sisaldavate ravimite kohta
English: Any applications for the licensing of medicines containing valerian essential oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Palderjaniõli sisaldavate ravimite müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimsete ravimite müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslikke järeldusi.
English: The HMPC conclusions on the use of these valerian essential oil medicines for the relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Estonian: Taimsete ravimite komitee järeldused nende palderjaniõli sisaldavate ravimite kasutamise kohta vaimse stressi kergete sümptomite leevendamiseks ja une parandamiseks põhinevad nende traditsioonilisel kasutusel.
English: Valerian essential oil may also be found in combination with other herbal substances in some herbal medicines.
Estonian: Mõnes taimses ravimis võib esineda palderjaniõli ka kombinatsioonis teiste taimsete ainetega.
English: Valerian essential oil is the common name for the essential oil extracted from the underground parts of the plant Valeriana officinalis L.
Estonian: Palderjaniõli on taime Valeriana officinalis L. maa-alustest osadest saadud õli üldnimetus.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian essential oil.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad palderjaniõli sisaldavate taimsete ravimite müügilubade taotlusi.
English: What evidence supports the use of valerian essential oil medicines?
Estonian: Mis tõendid toetavad palderjaniõli sisaldavate ravimite kasutamist?
English: The HMPC concluded that, on the basis of its long-standing use, valerian essential oil can be used for relief of mild symptoms of mental stress and to aid sleep.
Estonian: Taimsete ravimite komitee järeldas, et lähtudes pikaajalisest kasutamisest tohib palderjaniõli kasutada vaimse stressi kergete sümptomite leevendamiseks ja une parandamiseks.
English: Herbal medicines containing valerian essential oil are usually available in liquid forms to be taken by mouth or used as bath additives.
Estonian: Palderjaniõli sisaldavaid taimseid ravimeid turustatakse tavaliselt vedelate suukaudsete valmististena või vannilisandina.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian essential oil.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb palderjaniõli meditsiinilisi kasutusviise.
English: Information on the use and licensing of valerian essential oil medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab palderjaniõli sisaldavate ravimite kasutamise ja müügilubade teavet asjakohastelt riiklikelt ravimiametitelt.
English: This summary is not intended to provide practical advice on how to use medicines containing valerian essential oil.
Estonian: Kokkuvõttes ei anta palderjaniõli sisaldavate ravimite kasutamise praktilisi nõuandeid.
English: For more information about treatment with valerian essential oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate palderjaniõli sisaldavate ravimitega toimuva ravi kohta lisateavet, lugege palun ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What are the risks associated with valerian essential oil medicines?
Estonian: Mis riskid palderjaniõli sisaldavate ravimitega kaasnevad?
English: What are the HMPC conclusions on its medicinal uses?
Estonian: Mis on taimsete ravimite komitee järeldused palderjaniõli meditsiiniliste kasutusalade kohta?
English: How are valerian essential oil medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus palderjaniõli sisaldavate ravimite müügiluba?
English: For practical information about using valerian essential oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate palderjaniõli sisaldavate ravimite kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What is valerian essential oil?
Estonian: Mis on palderjaniõli?
English: Side effects have been reported with valerian essential oil medicines.
Estonian: Palderjaniõli sisaldavate ravimite kasutamisel on teatatud kõrvalnähtudest.
English: 28 x 1 tablets (calendar pack)
Estonian: 28 x 1 tabletti (kalenderpakend)
English: Onivyde received a marketing authorisation valid throughout the EU on 14 October 2016.
Estonian: Onivyde on saanud müügiloa, mis kehtib kogu ELis, 14. oktoobril 2016.
English: What measures are being taken to ensure the safe and effective use of Onivyde?
Estonian: Mis meetmed võetakse, et tagada Onivyde ohutu ja efektiivne kasutamine?
English: This summary was last updated in 01-2019.
Estonian: Kokkuvõtte viimane uuendus: 01.2019.
English: Onivyde (irinotecan)
Estonian: Onivyde (irinotekaan)
English: The European Medicines Agency decided that Onivyde's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Onivyde kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Onivyde are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Onivyde kasutamise kohta pidevat järelevalvet.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu311933.
Estonian: Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/medicines/human/orphandesignations/eu311933.
English: Onivyde (irinotecan) EMA/947/2019
Estonian: Onivyde (irinotekaan) EMA/947/2019
English: Other information about Onivyde
Estonian: Muu teave Onivyde kohta
English: What is Onivyde and what is it used for?
Estonian: Mis on Onivyde ja milleks seda kasutatakse?
English: Further information on Onivyde can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Onivyde.
Estonian: Lisateave Onivyde kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Onivyde.
English: In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer.
Estonian: Euroopas on irinotekaan olnud kolorektaalvähi raviks heaks kiidetud juba aastaid.
English: The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby decreasing the rate at which irinotecan is removed from the body and allowing it to act for longer.
Estonian: Liposoomid eeldatavasti akumuleeruvad kasvajas ja vabastavad ravimit aeglaselt pika aja jooksul, vähendades irinotekaani organismist eemaldumise kiirust ja võimaldades ravimil kauem toimida.
English: It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells.
Estonian: See blokeerib ensüümi topoisomeraas I, mis osaleb raku DNA kopeerimisel, mida on vaja uute rakkude loomiseks.
English: Side effects reported with Onivyde are carefully evaluated and any necessary action taken to protect patients.
Estonian: Onivyde kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Metastatic means that the cancer has spread to other parts of the body.
Estonian: Metastaatiline (siiretega) tähendab, et vähk on levinud organismis ka mujale.
English: For more information about using Onivyde, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Onivyde kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onivyde have been included in the summary of product characteristics and the package leaflet.
Estonian: Onivyde ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women.
Estonian: Onivydet ei tohi manustada patsientidele, kellel on varem esinenud raske ülitundlikkusreaktsioon (allergiline reaktsioon) irinotekaani suhtes, ega imetavatele naistele.
English: Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.
Estonian: Onivyde on retseptiravim ja ravi tohib määrata ja manustada üksnes vähiravimite kasutamises kogenud arst.
English: The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects.
Estonian: Arst tohib annust kohandada patsientidel, kellel tekivad rasked kõrvalnähud ja kellel on kõrvalnähtude riski suurendavad teatud geneetilised omadused.
English: The recommended dose is 70 mg per square metre of body surface given every 2 weeks together with 5-fluorouracil and leucovorin.
Estonian: Soovitatav annus on 70 mg kehapindala ruutmeetri kohta, manustatuna iga 2 nädala järel koos 5-fluorouratsiili ja leukovoriiniga.
English: What are the risks associated with Onivyde?
Estonian: Mis riskid Onivydega kaasnevad?