natgillin/translations-raw huggingface dataset:
Telmisartan Teva Pharma 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Telmisartan Teva Pharma 40 mg tabletid on valged kuni valkjad ovaalse kujuga tabletid; tableti ühele küljele on märgitud number „93“.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Ravimid, mis võivad suurendada kaaliumi taset veres, nt kaaliumi sisaldavad soolaasendajad, kaaliumi säästvad diureetikumid (teatud „vett väljutavad tabletid“), AKE inhibiitorid, angiotensiin II retseptorite antagonistid, MSPVA-d (mittesteroidsed põletikuvastased ravimid,
Each tablet contains 20 mg telmisartan
Üks tablett sisaldab 20 mg telmisartaani
Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Pakendi infoleht: teave kasutajale Telmisartan Teva Pharma 20 mg tabletid
Telmisartan Teva Pharma 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Telmisartan Teva Pharma 20 mg tabletid on valged kuni valkjad ovaalse kujuga tabletid; tableti ühele küljele on märgitud number „93“.
Symptomatic hypotension, especially after the first dose of Telmisartan Teva Pharma, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Patsientidel, kes saavad tugevat diureetilist ravi, on piiratud soolasisaldusega dieedil, kellel on kõhulahtisus või oksendamine, mille tagajärjel on välja kujunenud vedeliku- ja/või naatriumipuudus, võib Telmisartan Teva Pharma kasutamisel, eriti pärast esimest annust esineda sümptomaatiline hüpotensioon.
If you get any side effects, takl to your doctor or pharmacist.
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Sepsis* (sageli nimetatakse “veremürgistuseks”, mis on kogu organismi põletikulise reaktsiooniga kulgev raske infektsioon ja mis võib lõppeda surmaga), teatavate vere valgeliblede arvu tõus (eosinofiilia), vereliistakute vähesus (trombotsütopeenia), raske allergiline reaktsioon (anafülaktiline reaktsioon), allergiline reaktsioon (nt lööve, sügelus, hingamisraskus, kähisev hingamine, näo turse või madal vererõhk), madal veresuhkru kontsentratsioon (suhkruhaigetel), ärevuse tunne, unisus, nägemishäire, kiire südame löögisagedus (tahhükardia), suukuivus, mao häired, maitsetundlikkuse häired (düsgeusia), maksafunktsiooni kahjustus** (Jaapani patsientidel võib suurema tõenäosusega esineda see kõrvaltoime), naha ja limaskestade kiire tursumine, mis võib lõppeda surmaga (angioödeem võib samuti lõppeda surmaga), ekseem (naha häire), naha punetus, nõgestõbi (urtikaaria), raskekujuline ravimlööve, liigesevalu (artralgia), jäsemevalu, kõõlusvalu, gripitaoline haigus, hemoglobiini (verevalgu) taseme langus, kusihappe taseme tõus veres, maksaensüümide aktiivsuse tõus või kreatiinfosfokinaasi sisalduse tõus veres.
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets 28 tablets
14x1 tabletti 28x1 tabletti 30x1 tabletti 40x1 tabletti 56x1 tabletti 60x1 tabletti 84x1 tabletti 90x1 tabletti 98x1 tabletti 100x1 tabletti 30 tabletti 28 tabletti
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
14x1 tabletti 28x1 tabletti 30x1 tabletti 40x1 tabletti 56x1 tabletti 60x1 tabletti 84x1 tabletti 90x1 tabletti 98x1 tabletti 100x1 tabletti 28 tabletti
Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Üks Telmisartan Teva Pharma tablett sisaldab 40 mg telmisartaani.
Telmisartan Teva Pharma 40 mg tablets
Telmisartan Teva Pharma 40 mg tabletid
Telmisartan Teva Pharma 40 mg tablets telmisartan
Telmisartan Teva Pharma 40 mg tabletid telmisartanum
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters.
Pakendi suurused 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablett lahtikooritavates perforeeritud blistrites.
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters.
Pakendi suurused 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablett perforeeritud blistrites.
Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Üks Telmisartan Teva Pharma tablett sisaldab 20 mg telmisartaani.
Back pain (e.g. sciatica), muscle spasms, myalgia
Seljavalu (nt ishias), lihaskrambid, lihasvalu
Telmisartan Teva Pharma 20 mg tablets
Telmisartan Teva Pharma 20 mg tabletid
Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Üks Telmisartan Teva Pharma tablett sisaldab 80 mg telmisartaani.
Telmisartan Teva Pharma 20 mg tablets telmisartan
Telmisartan Teva Pharma 20 mg tabletid telmisartanum
Telmisartan Teva Pharma 80 mg tablets
Telmisartan Teva Pharma 80 mg tabletid
Telmisartan Teva Pharma 80 mg tablets telmisartan
Telmisartan Teva Pharma 80 mg tabletid telmisartanum
EU/1/11/719/041 14x1 tablets EU/1/11/719/042 28x1 tablets EU/1/11/719/043 30x1 tablets EU/1/11/719/044 40x1 tablets EU/1/11/719/045 56x1 tablets EU/1/11/719/046 60x1 tablets EU/1/11/719/047 84x1 tablets EU/1/11/719/048 90x1 tablets EU/1/11/719/049 98x1 tablets EU/1/11/719/050 100x1 tablets
EU/1/11/719/041 14x1 tabletti EU/1/11/719/042 28x1 tabletti EU/1/11/719/043 30x1 tabletti EU/1/11/719/044 40x1 tabletti EU/1/11/719/045 56x1 tabletti EU/1/11/719/046 60x1 tabletti EU/1/11/719/047 84x1 tabletti EU/1/11/719/048 90x1 tabletti EU/1/11/719/049 98x1 tabletti EU/1/11/719/050 100x1 tabletti
EU/1/11/719/001 14x1 tablets EU/1/11/719/002 28x1 tablets EU/1/11/719/003 30x1 tablets EU/1/11/719/004 40x1 tablets EU/1/11/719/005 56x1 tablets EU/1/11/719/006 60x1 tablets EU/1/11/719/007 84x1 tablets EU/1/11/719/008 90x1 tablets EU/1/11/719/009 98x1 tablets EU/1/11/719/010 100x1 tablets
EU/1/11/719/001 14x1 tabletti EU/1/11/719/002 28x1 tabletti EU/1/11/719/003 30x1 tabletti EU/1/11/719/004 40x1 tabletti EU/1/11/719/005 56x1 tabletti EU/1/11/719/006 60x1 tabletti EU/1/11/719/007 84x1 tabletti EU/1/11/719/008 90x1 tabletti EU/1/11/719/009 98x1 tabletti EU/1/11/719/010 100x1 tabletti
EU/1/11/719/021 14x1 tablets EU/1/11/719/022 28x1 tablets EU/1/11/719/023 30x1 tablets EU/1/11/719/024 40x1 tablets EU/1/11/719/025 56x1 tablets EU/1/11/719/026 60x1 tablets EU/1/11/719/027 84x1 tablets EU/1/11/719/028 90x1 tablets EU/1/11/719/029 98x1 tablets EU/1/11/719/030 100x1 tablets
EU/1/11/719/021 14x1 tabletti EU/1/11/719/022 28x1 tabletti EU/1/11/719/023 30x1 tabletti EU/1/11/719/024 40x1 tabletti EU/1/11/719/025 56x1 tabletti EU/1/11/719/026 60x1 tabletti EU/1/11/719/027 84x1 tabletti EU/1/11/719/028 90x1 tabletti EU/1/11/719/029 98x1 tabletti EU/1/11/719/030 100x1 tabletti
EU/1/11/719/031 14x1 tablets EU/1/11/719/032 28x1 tablets EU/1/11/719/033 30x1 tablets EU/1/11/719/034 40x1 tablets EU/1/11/719/035 56x1 tablets EU/1/11/719/036 60x1 tablets EU/1/11/719/037 84x1 tablets EU/1/11/719/038 90x1 tablets EU/1/11/719/039 98x1 tablets EU/1/11/719/040 100x1 tablets EU/1/11/719/061 30 tablets EU/1/11/719/064 28 tablets
EU/1/11/719/031 14x1 tabletti EU/1/11/719/032 28x1 tabletti EU/1/11/719/033 30x1 tabletti EU/1/11/719/034 40x1 tabletti EU/1/11/719/035 56x1 tabletti EU/1/11/719/036 60x1 tabletti EU/1/11/719/037 84x1 tabletti EU/1/11/719/038 90x1 tabletti EU/1/11/719/039 98x1 tabletti EU/1/11/719/040 100x1 tabletti EU/1/11/719/061 30 tabletti EU/1/11/719/064 28 tabletti
EU/1/11/719/051 14x1 tablets EU/1/11/719/052 28x1 tablets EU/1/11/719/053 30x1 tablets EU/1/11/719/054 40x1 tablets EU/1/11/719/055 56x1 tablets EU/1/11/719/056 60x1 tablets EU/1/11/719/057 84x1 tablets EU/1/11/719/058 90x1 tablets EU/1/11/719/059 98x1 tablets EU/1/11/719/060 100x1 tablets EU/1/11/719/062 30 tablets EU/1/11/719/065 28 tablets
EU/1/11/719/051 14x1 tabletti EU/1/11/719/052 28x1 tabletti EU/1/11/719/053 30x1 tabletti EU/1/11/719/054 40x1 tabletti EU/1/11/719/055 56x1 tabletti EU/1/11/719/056 60x1 tabletti EU/1/11/719/057 84x1 tabletti EU/1/11/719/058 90x1 tabletti EU/1/11/719/059 98x1 tabletti EU/1/11/719/060 100x1 tabletti EU/1/11/719/062 30 tabletti EU/1/11/719/065 28 tabletti
EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
EU/1/11/719/011 14x1 tabletti EU/1/11/719/012 28x1 tabletti EU/1/11/719/013 30x1 tabletti EU/1/11/719/014 40x1 tabletti EU/1/11/719/015 56x1 tabletti EU/1/11/719/016 60x1 tabletti EU/1/11/719/017 84x1 tabletti EU/1/11/719/018 90x1 tabletti EU/1/11/719/019 98x1 tabletti EU/1/11/719/020 100x1 tabletti EU/1/11/719/063 28 tabletti
Telmisartan Teva Pharma should be used only with caution in patients with mild to moderate hepatic impairment.
Kerge kuni mõõduka maksakahjustusega patsientidel tuleb Telmisartan Teva Pharma't kasutada ettevaatusega.
EU/1/11/719/035 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/036 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/037 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/038 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/039 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/040 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/061 Carton of 30 tablets in aluminium-aluminium blister EU/1/11/719/064 Carton of 28 tablets in aluminium-aluminium blister
Telmisartan Teva Pharma 20 mg tabletid EU/1/11/719/001 Karbid 14x1 tabletiga lahti kooritavates perforeeritud üheannuselistes alumiinium-alumiinium blistrites EU/1/11/719/002 Karbid 28x1 tabletiga lahti kooritavates perforeeritud üheannuselistes alumiinium-alumiinium blistrites EU/1/11/719/003 Karbid 30x1 tabletiga lahti kooritavates perforeeritud üheannuselistes alumiinium-alumiinium blistrites EU/1/11/719/004 Karbid 40x1 tabletiga lahti kooritavates perforeeritud üheannuselistes alumiinium-alumiinium blistrites
Hypotension2, orthostatic hypotension
Aordi- ja mitraalklapi stenoos, obstruktiivne hüpertroofiline kardiomüopaatia
For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Vastastikuse tunnustamise menetluses oli Ungari viiteliikmesriik ning asjaomased liikmesriigid olid Austria, Belgia, Bulgaaria, Eesti, Horvaatia, Iirimaa, Island, Itaalia, Kreeka, Küpros, Leedu, Läti, Madalmaad, Poola, Portugal, Rootsi, Rumeenia, Saksamaa, Slovakkia, Sloveenia, Soome, Tšehhi Vabariik ja Ühendkuningriik.
Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Nimelt on p-väärtus väiksem kui 0,0001, mis tähendab, et valepositiivse seose tõenäosus on alla 0,01%.
Efficacy of the vaccine under practical conditions of use
Vaktsiini efektiivsus praktilise kasutamise tingimustes
ATCvet code: QI09AB07
ATCvet kood: QI09AB07
17455 ALIMOS Greece
17455 ALIMOS Kreeka
Viale Colleoni 15, 20864 Agrate Brianza (MB)
Viale Colleoni 15, 20864 Agrate Brianza (MB) Itaalia
40472 Düsseldorf Germany
40472 Düsseldorf Saksamaa
Furthermore, it was confirmed that standardisation of variables was applied.
Kinnitati ka seda, et muutujad olid standardiseeritud.
Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Iga serotüübi kohta esitati üksikasjalik statistika, et toetada kahe asjakohase mõõteväärtuse vahelise positiivse seose ulatust.
Monograph 1360.
monograafia 1360 kriteeriumidele.
Duration of immunity
Immuunsuse kestus
All the strains express also ApxII.
Kõik tüved ekspresseerivad ka ApxII.
The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims.
Müügiloa hoidja esitatud viimase 15 aasta müüginumbreid ei peetud väite toetamiseks piisavaks.
040185 Bucharest Romania
040185 Bucharest Rumeenia
The main difference was that the vaccine batch used in these studies had a higher antigen content than the minimum one proposed for the EU market.
Peamine erinevus oli see, et nimetatud uuringutes kasutatud vaktsiinipartii antigeenisisaldus oli suurem kui Euroopa Liidu turu jaoks väljapakutud miinimumsisaldus.
Monograph 04/2013:1360, Porcine Actinobacillosis Vaccines (inactivated)).
monograafiasse 04/2013:1360, Porcine Actinobacillosis Vaccines (inaktiveeritud)).
List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Veterinaarravimite nimetuste, ravimvormide, tugevuste, loomaliikide, manustamisteede, müügiloa hoidjate nimekiri liikmesriikides
Okrzei 1A,
Tiendweg 8 c,
Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Samuti peeti küsitavaks lõpptoote koostist, kas antigeenisisalduse või lisakoostisosade poolest.
Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Esildismenetluses ei hinnatud kvaliteeti ega ohutust, sest viiteliikmesriik ei tõstatanud neid küsimusi.
IMMUNOLOGICAL PROPERTIES
IMMUNOLOOOGILISED OMADUSED
It is also considered that the indication is acceptable taking account of the intended use of the vaccine and the existing data from the laboratory studies.
Näidustus loetakse vastuvõetavaks, võttes arvesse vaktsiini kavandatud kasutust ja olemasolevaid laboriuuringute andmeid.
Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Peale selle peeti perioodilistest ohutusaruannetest kogutud teavet ainult toetavaks ja see ei põhjendanud väiteid piisavalt.
Add the following text in the relevant sections of the product information:
Lisada järgnev tekst ravimiinfo asjakohastele lõikudele.
831 53 Bratislava Slovakia
831 53 Bratislava Slovakkia
Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Et Itaalia tõstatatud probleemid jäid lahendamata, ei jõudnud asjaomased liikmesriigid Coglapixi efektiivsuse suhtes kokkuleppele ja seetõttu tehti 24. oktoobril 2014 veterinaarravimite komiteele direktiivi 2001/82/EÜ artikli 33 lõike 4 kohane esildis.
Monograph 04/2013:1360.
monograafia 04/2013:1360 kriteeriume.
Elemag 26, vh.b, Et.1, Apt .1
Elemag 26, vh.b, Et.1, Apt .1 Sofia -1113
Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Eeldatavasti kasvavad tervemad vaktsineeritud sead paremini, kuigi välitingimustes ei ole seda näidatud.
The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Müügiloa hoidja Ceva-Phylaxia Veterinary Biologicals Co. Ltd. esitas Ungari poolt direktiivi 2001/82/EÜ artikli 32 kohaselt antud müügiloa vastastikuse tunnustamise taotluse.
Efficacy was demonstrated under laboratory but not under field conditions.
Tõhusus on tõestatud laboritingimustes, kuid mitte välitingimustes.
Major issues concerning the complex nature of A. pleuropneumaniae infections, and compliance with the requirements of European Pharmacopoeia was also addressed.
Samuti käsitleti olulisi küsimusi seoses A. pleuropneumoniae infektsioonide keeruka olemusega ja Euroopa farmakopöa nõuete täitmisega.
Rua Doutor António Loureiro Borges 9/9A - 9°A, Miraflores, 1495131 Algès Portugal
9/9A - 9°A, Miraflores, 1495131 Algès Portugal
During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Vastastikuse tunnustamise menetluse ajal leidis asjaomane liikmesriik Itaalia, et Coglapix võib põhjustada tõsist riski loomatervisele.
Six additional laboratory studies were also provided, but these studies were carried out for the marketing authorisation of Coglapix in a country outside the EU and in some elements did not meet the criteria of Ph. Eur.
Lisaks esitati kuue täiendava laboriuuringu andmed, kuid need uuringud viidi läbi Coglapixi müügiloa taotlemiseks väljaspool Euroopa Liitu ning need ei vastanud täielikult Ph. Eur.
Bulgaria Ceva Animal Health Bulgaria ul.
Ceva Animal Health Bulgaria ul.
INDICATION(s)
NÄIDUSTUS(ED)
Special attention was given to the use of a combined analysis using a limited number of animals for sample size and the use of global clinical scores as measure of the primary efficacy parameter.
Erilist tähelepanu pöörati kombineeritud analüüsi kasutamisele, kus valimisse kuulus piiratud arv loomi, ja globaalsete kliiniliste tulemusnäitajate kasutamisele efektiivsuse põhiparameetri mõõtmisel.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Kehtiv ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht on lõplikud versioonid järgnevate muudatustega, milleni jõuti koordinatsioonirühma protseduuril,:
In particular, Italy considered that (i) the correlation between the reduction of lung lesions and the reduction of clinical signs has not been adequately demonstrated; (ii) the benefit of the vaccine under practical conditions of use (i.e. reduction of lung lesions and clinical signs resulting in reduced weight losses in vaccinated animals) has not been demonstrated and (iii) inconsistent results were obtained from duration of immunity studies.
Nimelt oli Itaalia arvamusel, et i) kopsukahjustuste vähenemise ja kliiniliste nähtude vähenemise vaheline seos ei ole piisavalt tõendatud; ii) vaktsiini kasulikkus praktilise kasutamise tingimustes (s.t kopsukahjustuste ja kliiniliste nähtude vähenemine, mistõttu väheneb vaktsineeritud loomade kaalulangus) ei ole tõendatud ning iii) immuunsusuuringute tulemused ei ole järjekindlad.
The CVMP was asked to consider the available data supporting the efficacy of Coglapix and conclude whether the veterinary medicinal product may present a potential serious risk to the animal health.
Veterinaarravimite komiteel paluti läbi vaadata Coglapixi efektiivsust toetavad olemasolevad andmed ja teha järeldus, kas kõnealune veterinaarravim võib põhjustada tõsist riski loomatervisele.
The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Vaktsineerimisskeem näeb ette 2 annust, mis manustatakse loomadele alates 7. elunädalast kolmenädalase vahega.
These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Probleemid jäid lahendamata, mistõttu otsustati algatada veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühmas direktiivi 2001/82/EÜ artikli 33 lõike 1 kohane esildismenetlus.
These batches had been tested according to the requirements when the product was first authorised in Hungary.
Kõnealuseid partiisid oli nõuetekohaselt kontrollitud, kui anti ravimi esimene müügiluba Ungaris.
Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
Tüvi NT3 kuulub serotüüpi 1, ekspresseerides ApxI, samas kui tüved SzII, PO ja B4 kuuluvad serotüüpi 2, ekspresseerides ApxIII.
Onset of immunity: 21 days following second vaccination Duration of immunity: 16 weeks following second vaccination
Immuunsuse tekkimine: 21 päeva pärast teist vaktsineerimist Immuunsuse kestus: 16 nädalat pärast teist vaktsineerimist
When assessing the results of efficacy studies an additional point for concern was raised in relation to the consistency of the vaccine batches used for these trials.
Efektiivsusuuringute tulemuste hindamisel tõstatati veel üks probleem seoses nendes uuringutes kasutatud vaktsiinipartiide järjepidevusega.
Correlation between the reduction of lung lesions and the reduction of clinical signs
Kopsukahjustuste vähenemise ja kliiniliste nähtude vähenemise seos
Unit 3, Anglo Office Park, White Lion Road Amersham, Bucks HP7 9FB
Unit 3, Anglo Office Park, White Lion
The MAH was requested to confirm, in writing, that the statistical analysis was performed using the results of relevant studies and to provide assurance the data-analysis method used was adequate and submit, if possible, a meta-analysis of all the results obtained from the different studies.
Müügiloa hoidjal paluti kirjalikult kinnitada, et statistilises analüüsis kasutati asjakohaste uuringute tulemusi, tagada, et kasutatud andmeanalüüsi meetod oli adekvaatne, ning esitada võimaluse korral kõigi erinevate uuringute tulemuste metaanalüüs.
Field trials have not corroborated the results obtained under laboratory conditions and there were concerns regarding the benefit of the vaccine under practical conditions of use.
Väliuuringud ei toeta laboritingimustes saadud tulemusi ja küsimusi tekitas vaktsiini kasulikkus praktilise kasutamise tingimustes.
The total quantity is 20 x 109 inactivated germs per dose.
Kogus kokku on 20 × 109 inaktiveeritud pisikut ühe annuse kohta.
To demonstrate the immunogenicity of the vaccine, six laboratory efficacy studies were conducted to an acceptable standard and design to establish the onset and duration of immunity and meet the criteria of the Ph. Eur.
Vaktsiini immunogeensuse tõendamiseks viidi läbi kuus vastuvõetava taseme ja ülesehitusega efektiivsuse laboriuuringut, et teha selgeks immuunsuse teke ja kestus ning täita Ph. Eur.
The CVMP concluded that the concerns expressed by Italy should not prevent the granting of marketing authorisations for Coglapix and recommended amendments in the relevant sections of the Summary of Product Characteristics and package leaflet (see Annex III).
Veterinaarravimite komitee järeldas, et Itaalia tõstatatud probleemid ei tohiks takistada Coglapixi müügilubade andmist, ning soovitas muuta ravimi omaduste kokkuvõtte ja pakendi infolehe asjakohaseid lõike (vt III lisa).