FrancophonIA/ELRC3.0 huggingface dataset:
English: - The Committee, as a consequence, concluded that a warning to reflect that suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
Estonian: - eeltoodule tuginedes otsustas komitee, et estsitalopraami, fluoksetiini, fluvoksamiini, mianseriini, minatsipraani, mirtasapiini, paroksetiini, reboksetiini, sertraliini, tsitalopraami ja venflafaksiini sisaldavate preparaatide ravimi omaduste kokkuvõtetesse ning pakendi infolehtedesse tuleb lisada hoiatus, mis näitaks, et kliinilistes katsetes esines antidepressantidega ravitud lastel ja noorukitel platseebogrupiga võrreldes rohkem suitsiidikäitumist (enesetapukatseid ja suitsiidimõtteid) ja vaenulikkust (peamiselt vägivaldsust, vastanduvat käitumist ja viha);
English: 1/SNRIs products particularly as regards their use in the paediatric population: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine, and mirtazapine.
Estonian: 2-de kohta käivaid siseriiklikele pädevatele organisatsioonidele kättesaadavate kliiniliste uuringute andmeid põhiliselt nende preparaatide pediaatrilise kasutuse seisukohast lähtuvalt: fluoksetiin, fluvoksamiin, sertraliin, paroksetiin, tsitalopraam, estsitalopraam, atomoksetiin, venlafaksiin, mianseriin, milnatsipraan, reboksetiin ja mirtasapiin.
English: ATOMOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad ATOMOKSETIINI sisaldavad ravimid
English: Luxembourg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany
Estonian: Luksemburg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany
English: Belgium RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
Estonian: Rue St, Lambert 141 1200 BRUXELLES, Belgium
English: Netherlands Katwijk Farma B.V. Postbus 408
Estonian: Katwijk Farma B.V.
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Estonian: HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
English: Belgium MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
Estonian: MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
English: COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain
Estonian: Hispaania COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain
English: CZECH REPUBLIC
Estonian: Tšehhi
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
Estonian: KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
English: Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Estonian: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
Estonian: KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
English: Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Estonian: Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
English: IV.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PACKAGE LEAFLET FOR FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Estonian: IV.1 FLUOKSETIINI, FLUVOKSAMIINI, SERTRALIINI, PAROKSETIINI, TSITALOPRAAMI, ESTSITALOPRAAMI, VENLAFAKSIINI, MIANSERIINI, MILNATSIPRAANI, REBOKSETIINI JA MIRTASAPIINI PAKENDI INFOLEHTEDE ASJAKOHASTESSE LÕIKUDESSE LISATAVAD PARANDUSED
English: Netherlands Niche Generics Ltd. 1 The Cam Centre
Estonian: Niche Generics Ltd.
English: Luxembourg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany
Estonian: Luksemburg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany
English: Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Estonian: H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
English: Alfred E Tiefenbacher (GmbH & Co. KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
Estonian: KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 Overijse
Estonian: Brusselsesteenweg 288 3090 Overijse
English: Oral lyophilisate
Estonian: Peroraalne lüofilisaat
English: Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France
Estonian: Prantsusmaa Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France
English: VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad VENLAFAKSIINI sisaldavad ravimid
English: FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad FLUOKSETIINI sisaldavad ravimid
English: MERCK GENERICOS, S.L , CTRA.N-152,Km 19 - Pol. MERCK 08100 Mollet del Valles, Spain
Estonian: Hispaania MERCK GENERICOS, S.L , CTRA.N-152,Km 19 - Pol. MERCK 08100 Mollet del Valles, Spain
English: DOBUPAL RETARD 75 mg hard Capsules
Estonian: DOBUPAL RETARD 75 mg
English: Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Estonian: Ühendkuningriik Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
English: Tablets
Estonian: Kihisev tablett
English: Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France
Estonian: Prantsusmaa Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France
English: Belgium AKTUAPHARMA N.V. Ambachtenlaan 13, 3001 Heverlee, Belgium
Estonian: Ambachtenlaan 13, 3001 Heverlee, Belgium
English: Hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with [Invented Name] compared to those treated with placebo.
Estonian: Kliinilistes katsetes esines [ravimi nimetus, osastavas käändes] saanud lastel ja noorukitel platseebogrupiga võrreldes rohkem vaenulikku käitumist (peamiselt vägivaldsust, vastanduvat käitumist ja viha) ja emotsionaalset labiilsust.
English: Film-coateds tablet
Estonian: Õhukese polümeerkilega kaetud tabletts
English: Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Estonian: Ühendkuningriik Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
English: SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad SERTRALIINI sisaldavad ravimid
English: Belgium EUROGENERICS N.V. Heizel Esplanade B 22 1020 Brussel
Estonian: Heizel Esplanade B 22 1020 Brussel
English: Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Estonian: Ühendkuningriik Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
English: Oral solution, single dose Oral use
Estonian: Peroraalne lahus, üksik annus
English: Prolonged release capsule Oral use
Estonian: Toimeainet prolongeeritult vabastav pehmekapsel
English: Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
Estonian: Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
English: Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
Estonian: Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
English: RIMAFAR, S.L., Pol. Ind. Malpica Calle C, Nº 4, 50016 Zaragoza, Spain
Estonian: Hispaania RIMAFAR, S.L., Pol. Ind. Malpica Calle C, Nº 4, 50016 Zaragoza, Spain
English: Belgium TEVA PHARMA BELGIUM N.V. Laarstraat 16, 2610 WILRIJK, Belgium
Estonian: Laarstraat 16, 2610 WILRIJK, Belgium
English: Denmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
Estonian: Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
English: BEXAL FARMACEUTICA, S.A Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain
Estonian: Hispaania BEXAL FARMACEUTICA, S.A Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 OVERIJSE, Belgium
Estonian: Brusselsesteenweg 288 3090 OVERIJSE, Belgium
English: Cipramil 40 mg/ml, drops oral drops, solution Oral use
Estonian: Cipramil 40 mg/ml, drops
English: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
Estonian: Ühendkuningriik Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
English: ALFRED E. TIEFENBACHER (GMBH & CO. KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany
Estonian: KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany
English: Merk Generiques 34 rue Saint Romain 69359 Lyon cedex 08 France
Estonian: Prantsusmaa Merk Generiques 34 rue Saint Romain 69359 Lyon cedex 08
English: Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
Estonian: Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
English: FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad FLUVOKSAMIINI sisaldavad ravimid
English: Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08 France
Estonian: Prantsusmaa Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08
English: Denmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
Estonian: Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
English: ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad TSITALOPRAAMI sisaldavad ravimid
English: Luxembourg EUROGENERICS N.V. Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
Estonian: Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
English: Modified-release capsule, hard Oral use
Estonian: Toimeainet modifitseeritult vabastav kõvakapsel
English: Lithuania Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21
Estonian: Eli Lilly Holdings Limited, Kingsclere Road, Basing Stoke, Hampshire, RG21 6XA, United Kingdom
English: G Gam
Estonian: KG)
English: Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Estonian: H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
English: Eli Lilly and Company Ltd. Kingsclere Road, Basingstocke RG216XA Hampshire, UK
Estonian: Kingsclere Road, Basingstocke RG216XA Hampshire, UK
English: SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013 Barcelona, Spain
Estonian: Hispaania SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013
English: Denmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
Estonian: Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
English: Netherlands GlaxoSmithKline B.V. Postbus 780
Estonian: GlaxoSmithKline B.V.
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
Estonian: D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Estonian: D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
English: Prolonged releasecapsule, hard Oral use
Estonian: Toimeainet prolongeeritult vabastav kõvakapsel
English: Alfred E. Tiefenbacher GmbH & Co. KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
Estonian: KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
English: Netherlands GenRx B.V. Postbus 75
Estonian: GenRx B.V.
English: Meat and offal: cattle: 22 days.
Estonian: Veis: 22 päeva
English: Subcutaneous use Vial (glass) 500 ml
Estonian: 100 mg/ml Süstelahus Veis
English: Target species
Estonian: Subkutaanne manustamine
English: E-mail info@ema.europa.eu Website www.ema.europa.eu
Estonian: E-mail info@ema.europa.eu Websie www.ea.europa.eu
English: This summary was last updated on 14/03/2011.
Estonian: Kokkuvõtte viimane uuendus: 14/03/2011.
English: These reactions resolve spontaneously within two days to two weeks.
Estonian: Need reaktsioonid mööduvad iseenesest 2 päeva kuni 2 nädala jooksul.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011.
Estonian: Euroopa Komisjon andis CaniLeishi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Virbac S.A. 14/03/2011.
English: The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended.
Estonian: Juba infektsiooni saanud koerte vaktsineerimise efektiivsust ei uuritud ja seetõttu ei saa seda soovitada.
English: The first injection can be given from six months of age, the second injection is given three weeks later and the third three weeks from the second one.
Estonian: Esimene süst tehakse alates 6 kuu vanusest, teine 3 nädalat pärast esimest ja kolmas 3 nädalat pärast teist süsti.
English: The vaccine was generally well tolerated as shown by the absence of major adverse reactions.
Estonian: Vaktsiini taluti üldiselt hästi, mida näitab peamiste kõrvalnähtude puudumine.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Estonian: Kui soovite vaktsineeritava looma haigusseisundi või vaktsineerimise kohta rohkem teavet, pöörduge oma loomaarsti poole.
English: Afterward a single ‘booster' should be given every year to maintain the vaccine's effect.
Estonian: Hiljem tuleb teha kord aastas kordusvaktsineerimine (1 süst), et säilitada vaktsiini toime.
English: In case of accidental self-injection, the advice of a doctor should be sought immediately.
Estonian: Juhusliku enesesüstimise korral tuleb pöörduda otsekohe arsti poole.
English: CaniLeish is a vaccine.
Estonian: CaniLeish on vaktsiin.
English: It contains Leishmania infantum excreted secreted proteins (ESP).
Estonian: See sisaldab parasiidi Leishmania infantum ekskreteeritud sekreteeritud valke (ESP).
English: What is CaniLeish?
Estonian: Mis on CaniLeish?
English: The risk of vaccine-induced infection can be excluded since the vaccine does not contain parasites.
Estonian: Vaktsiini tõttu nakatumine on välistatud, sest vaktsiin ei sisalda parasiite.
English: The safety of the vaccine was studied in two main laboratory safety studies carried out in leishmania-free dogs (overdose and single and repeated administration) and one field trial.
Estonian: Vaktsiini ohutust uuriti kahes leišmanioosita koerte laboratoorses ohutuse põhiuuringus (üleannustamine, ühekordne ja korduv manustamine) ning ühes väliuuringus.
English: In dogs developing leishmaniosis (active infection or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Estonian: Koertel, kellel tekkis leišmanioos (aktiivne infektsioon või haigus) vaatamata vaktsineerimisele, ei andnud täiendav vaktsiini süstimine kasulikku toimet.
English: After injection, some dogs can have moderate and temporary local reactions, such as swelling, nodule (hardening), pain on palpation or erythema (reddening).
Estonian: Pärast süstimist võivad mõnel koeral tekkida mõõdukad ja ajutised paiksed reaktsioonid, näiteks tursed, kühmud, valu palpeerimisel või erüteem (punetus).
English: Other temporary signs commonly seen following vaccination can also occur such as hyperthermia (raised body temperature), apathy (lack of vitality) and digestive disorders lasting one to six days.
Estonian: Ilmneda võivad ka teised, sageli pärast vaktsineerimist täheldatavad ajutised nähud, näiteks hüpertermia (kõrgenenud kehatemperatuur), apaatia (loidus) ja seedesüsteemi häired, mis kestavad 1-6 päeva.
English: Why has CaniLeish been approved?
Estonian: Miks CaniLeish heaks kiideti?
English: A number of laboratory trials where dogs were submitted to experimental infection were also presented.
Estonian: Esitati ka mitme sellise laboriuuringu tulemusi, kus koeri nakatati tehistingimustes.
English: What is the risk associated with CaniLeish?
Estonian: Mis riskid CaniLeishiga kaasnevad?
English: Canine vaccine against Leishmania infantum adjuvanted
Estonian: Koerte vaktsiin parasiidi Leishmania infantum vastu, adjuveeritud
English: CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth.
Estonian: CaniLeish on vaktsiin, mis sisaldab mitut valku, mida eraldab parasiit Leishmania infantum kasvamise ajal.
English: After vaccination transient antibodies against leishmania detected by immunofluorescence antibody test (IFAT) may appear but do not reflect an active infection.
Estonian: Pärast vaktsineerimist võivad antikehade immunofluorestsentstestil (IFAT) ajutiselt ilmneda Leishmania vastased antikehad, mis ei viita aga aktiivsele nakkusele.
English: Other information about CaniLeish:
Estonian: Muu teave CaniLeishi kohta
English: The parasite is transmitted from an infected dog to a non-infected dog by the bites of sand flies.
Estonian: Parasiit levib nakatunud koeralt nakkuseta koertele kõrbesääste pistete kaudu.
English: It is available as a powder and solvent that is made up into suspension for injection.
Estonian: Seda turustatakse pulbri ja lahustina, millest valmistatakse süstesuspensioon.
English: In the future, if the animals are exposed to Leishmania infantum parasite, the immune system will be able to respond more quickly.
Estonian: Kui loomad puutuvad hiljem parasiidiga Leishmania infantum kokku uuesti, tekivad antikehad kiiremini.
English: CaniLeish contains an ‘adjuvant' (a highly purified fraction of Quillaja saponaria) to enhance the immune response.
Estonian: CaniLeish sisaldab parema immuunvastuse saamiseks ka adjuvanti (tšiili seebikoorepuust (Quillaja saponaria) pärinevat ülipuhastatud ainet).
English: Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment.
Estonian: Aeg-ajalt võib tekkida allergilisi reaktsioone, mille korral tuleb anda sobivat sümptomaatilist ravi.
English: CaniLeish is to be used only in ‘leishmania-negative' dogs.
Estonian: CaniLeishi tohib kasutada ainult leišmanioosita koertel.
English: The studies showed that the vaccine is safe for both leishmania-negative and leishmania-infected dogs.
Estonian: Uuringud näitasid, et vaktsiin on ohutu nii leišmanioosita kui ka leišmanioosiga koertel.
English: When CaniLeish is given to dogs the immune system recognises the proteins as ‘foreign' and make defences against it.
Estonian: Kui koertele manustatakse CaniLeishi, peab immuunsüsteem vaktsiinis sisalduvaid valke võõraks ja tekitab selle vastu antikehi.
English: The vaccine is given to dogs as three injections, three weeks apart, under the skin.
Estonian: Vaktsiini manustatakse koerale 3 nahaaluse süstina 3-nädalaste vahedega.
English: The detection of Leishmania infection using a rapid diagnostic test is recommended before vaccination.
Estonian: Enne vaktsineerimist soovitatakse kontrollida Leishmania infektsiooni puudumist kiirdiagnostilise testi abil.
English: The benefit of the vaccination was assessed in zones with a high risk of infection where it has been shown in leishmania free dogs to decrease the risk of developing an active infection and a symptomatic disease after contact with the parasite.
Estonian: Vaktsineerimise kasulikkust hinnati suure nakatumisriskiga piirkondades, kus selgus, et vaktsineerimine vähendab leišmanioosita koertel pärast parasiidiga kokkupuudet aktiivse infektsiooni ja sümptomaatilise haiguse tekkimise riski.
English: How does CaniLeish work?
Estonian: Kuidas CaniLeish toimib?
English: How has CaniLeish been studied?
Estonian: Kuidas CaniLeishi uuriti?
English: CaniLeish is used to vaccinate dogs from six months of age to reduce the risk of developing an active infection and clinical disease after contact with Leishmania infantum.
Estonian: CaniLeishi kasutatakse vähemalt 6-kuuste koerte vaktsineerimiseks, et vähendada aktiivse infektsiooni ning kliiniliste tunnuste tekke riski pärast kokkupuudet parasiidiga Leishmania infantum.
English: Dogs that have been infected may show no signs of infection, but some do (fever, hair and weight loss, skin sores) and in the latter case the outcome of active infection can be fatal.
Estonian: Nakatunud koertel võivad nakkuse sümptomid (palavik, karvade väljalangemine, kaalulangus, nahahaavandid) puududa või esineda.
English: Leishmania infantum is a parasite that causes leishmaniosis.
Estonian: Leishmania infantum on Vahemere riikides levinud parasiit, mis põhjustab haigust leišmanioosi.
English: What is CaniLeish used for?
Estonian: Milleks CaniLeishi kasutatakse?
English: What benefit has CaniLeish shown during the studies?
Estonian: Milles seisneb uuringute põhjal CaniLeishi kasulikkus?
English: The CVMP concluded that the benefits of CaniLeish outweigh the risks for the active immunisation of leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum and recommended that CaniLeish be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et CaniLeishi kasulikkus on suurem kui kaasnevad riskid, kui seda kasutatakse vähemalt 6 kuu vanuste leišmanioosita koerte aktiivseks immuniseerimiseks, et vähendada aktiivse infektsiooni ning haiguse kliiniliste tunnuste ilmnemist kokkupuutel parasiidiga Leishmania infantum.
English: Infected dogs play a central role in the accidental transmission of parasites to humans.
Estonian: Nakatunud koertelt võivad parasiidid juhuslikult levida ka inimestele.
English: The number of dogs developing an active infection and a symptomatic disease was significantly reduced in the vaccinated group.
Estonian: Vaktsineeritud koerte hulgas oli oluliselt vähem koeri, kellel tekkis aktiivne infektsioon ja sümptomaatiline haigus.
English: The efficacy of the vaccine was studied in one main field trial that lasted for two years involving vaccinated and control dogs submitted to natural exposure to infection in zones where there is a high risk of infection.
Estonian: Uuringus osalesid vaktsineeritud ja kontrollrühma koerad, kes puutusid kokku suure infektsiooniriskiga piirkondades loomulikult esineva parasiidiga.
English: Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.
Estonian: Kui piirkonnas parasiiti Leishmania infantum ei esine või esineb vähe, peab veterinaar hindama vaktsineerimise kasulikkuse ja riski suhet.
English: The company presented data from three main studies involving over 3,000 patients.
Estonian: Ettevõte esitas andmed kolmest põhiuuringust, milles osales enam kui 3000 patsienti.
English: What is Plivensia?
Estonian: Mis on Plivensia?
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab) EMA/727596/2017
Estonian: Müügiloa taotluse tagasivõtmise teave: Plivensia (sirukumab) EMA/727596/2017
English: It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Estonian: Seda kavatseti turustada süstelahusena eeltäidetud pensüstaldes ja süstaldes (50 mg).
English: How does Plivensia work?
Estonian: Kuidas Plivensia toimib?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et arvestades täiendavate kliiniliste andmete vajadust ja asjaolu, et saadaval on teisi interleukiin-6 toimet blokeerivaid ravimeid, soovib ta oma ravimiarendustegevuses keskenduda teistele programmidele.