natgillin/translations-raw huggingface dataset:
Therefore, the justification of the recommended treatment dose of a single injection of 40 mg florfenicol and 2.2 mg flunixin per kg bw for the treatment of BRD associated with M. bovis is based on the clinical data.
Seetõttu põhineb M. bovis'ega seostatava veiste respiratoorhaiguse korral soovitatava raviannuse (üks süste 40 mg florfenikooli ja 2,2 mg fluniksiini kehamassi kg kohta) põhjendus kliinilistel andmetel.
From the data currently available, no particular risk of increase of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
Praegu olemasolevate andmete kohaselt ei eeldata olulist ohtu, et Resflori kasutamisel M. bovis'e antimikroobne tundlikkus florfenikooli suhtes märgatavalt suureneb.
The study confirmed the superiority of Resflor to placebo (saline) for the treatment of M. bovis-induced bovine respiratory disease (BRD).
Uuring kinnitas platseeboga võrreldes Resflori paremust M. bovis'e põhjustatud veiste respiratoorhaiguse ravis.
CVMP guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010)
CVMP guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120834.pdf ravi saanud rühmas (84%) oli sama suur kui üldpopulatsioonis (83,5% Resflori rühmas ja 79,4% florfenikooli ainuravimi rühmas).
Lithuania Intervet International B.V. Wim de Koerverstraat 35
Wim de Koerverstraat 35
No particular risk of decrease of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
Resflori kasutamisest ei ole oodata ohtu, et M. bovis'e antimikroobne tundlikkus florfenikooli suhtes märgatavalt väheneb.
Luxembourg Intervet International B.V. Wim de Koerverstraat 35
Luksemburg Intervet International B.V.
Another positive control group treated with a florfenicol monoproduct was used, however it should be noted that this product is not approved for the treatment of respiratory infections caused by M. bovis.
Teist, positiivset kontrollrühma raviti ainult florfenikooli sisaldava ravimiga.
- The Committee considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Protopic
- inimtervishoius kasutatavate ravimite komitee kaalus vastavalt määruse (EÜ) nr 726/2004 artiklile 20 menetlust Protopic'i kohta;
• A statement that Protopic should not be used in children under 2 years.
• märge selle kohta, et Protopic'it ei tohi kasutada alla 2-aastastel lastel.
Protopic is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Protopic on dermatoloogiline ravim, mis sisaldab kaltsineuriini inhibiitorit takroliimust kontsentratsioonis 0,1% ja 0,03%.
• Protopic should not be used in immunocompromised adults or children.
• Protopic'it ei tohi kasutada immunosupressiooniga täiskasvanutel ega lastel;
• The treatment should be intermittent and not continuous.
• ravi peab toimuma tsüklitena ning ei tohi olla pidev;
• The treatment with Protopic should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
• ravi Protopic'iga tohib alustada vaid arst, kellel on kogemus atoopilise dermatiidi diagnoosimises ja ravis;
Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Protopic is not used in this age group.
Seetõttu nõudis komitee, et müügiloa hoidja võtaks vajalikke meetmeid selle tagamiseks, et Protopic'it nimetatud vanuserühmas ei kasutataks.
The CHMP also expressed concerns about the degree of use of Protopic in children under the age of 2 (not approved) when the immune system is still developing.
Samas väljendas inimtervishoius kasutatavate ravimite komitee muret seoses Protopic'i kasutamise määraga kuni 2-aastastel lastel (ei ole heaks kiidetud), kelle immuunsüsteem alles areneb.
The CHMP has recommended the amendment to the terms of the Marketing Authorisation for Protopic for which the revised Summary of Product Characteristics and Package Leaflet are set out respectively in annexes I and IIIB.
soovitab inimtervishoius kasutatavate ravimite komitee teha Protopic'i müügiloa tingimustesse muudatus, mille kohta läbivaadatud ravimi omaduste kokkuvõte ja pakendi infoleht on sätestatud vastavalt lisades I ja IIIB.
- The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma) have been reported in patients treated with Protopic.
- komitee nõustus, et on teateid pahaloomulistest protsessidest (sealhulgas nahavähk ja lümfoom) patsientidel, keda raviti Protopic'iga.
On 21 April 2005 the European Commission in view of the potential risk of malignancies requested the Opinion of the CHMP on the benefit/risk profile of Protopic.
21. aprillil 2005. aastal palus Euroopa Komisjon inimtervishoius kasutatavate ravimite komiteelt arvamust Protopic'i kasu-/riskiprofiili kohta seoses võimalike pahaloomuliste protsessidega.
• A statement to highlight that tacrolimus should not be applied to lesions, which are considered to be potentially malignant or pre-malignant.
• tuleb rõhutada seda, et takroliimust ei tohi kanda kahjustustele, mis võivad olla maliigsed või premaliigsed;
After reviewing the available data the CHMP concluded that the balance of risks and benefits for Protopic is considered favourable.
Pärast olemasolevate andmete ülevaatamist järeldas inimtervishoius kasutatavate ravimite komitee, et Protopic'i riski ja kasu suhe on soodus.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
EMEA POOLT ESITATUD TEADUSLIKUD JÄRELDUSED NING RAVIMI OMADUSTE KOKKUVÕTTE JA PAKENDI INFOLEHE MUUTMISE ALUSED
- The Committee, as a consequence, concluded that the following information should be included in the Summary of Product Characteristics and relevant sections of the Package Leaflet of Protopic:
- kokkuvõtteks leidis komitee, et Protopic'i ravimi omaduste kokkuvõttesse ja pakendi infolehele tuleb lisada järgmine teave:
In view of the available data (including pre-clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopic cannot be ruled out and therefore further data are needed to ensure an acceptable long-term safety profile.
kliinilisi ja epdemioloogilisi), leidis inimtervishoius kasutatavate ravimite komitee, et nende juhtude võimalikku seost Protopic'iga ei saa välistada ning vastuvõetava pikaajalise ohutusprofiili tagamiseks on seetõttu vaja täiendavaid andmeid;
In order to address the safety concerns in relation to the cases of malignancies the CHMP concluded that warnings reflecting the cases of malignancies and the need for monitoring of patients treated with Protopic should be included in the product information.
Ohutusnõuete käsitlemiseks seoses pahaloomuliste haiguste tekkejuhtudega leidis inimtervishoius kasutatavate ravimite komitee, et ravimi infolehte tuleb lisada hoiatused pahaloomuliste haiguste tekke kohta ning rõhutada vajadust jälgida patsiente, kes saavad Protopic'i ravi.
In addition, the CHMP concluded that further data are required to better elicit the long-term safety of Protopic in respect of its association with malignancies.
Lisaks sellele leidis inimtervishoius kasutatavate ravimite komitee, et järelduste tegemiseks Protopic'i pikaajalise kasutamise ohutuse kohta eelkõige seoses pahaloomuliste protsessidega on vaja täiendavaid uuringuid.
Protopic 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopic 0.03% is indicated for the treatment of moderate to severe AD in adults or children (2 years of age and above) who failed to respond adequately to conventional therapies.
Protopic 0,03% on näidustatud mõõduka kuni raske AD raviks täiskasvanutel või lastel (alates teisest eluaastast), kes piisavalt ei allu ravile tavapäraste ravimitega.
Case reports of malignancies (including skin cancer, cutaneous T-Cell lymphoma (CTCL), NonHodking lymphoma (NHL) and systemic malignancies) have been received during the clinical development and post-marketing experience in association with the use of Protopic.
Protopic'i kliinilise väljatöötamise ajal ja müügiloa väljastamise järel on esinenud teateid halvaloomulistest protsessidest seoses ravimi kasutamisega (sh nahavähk, naha T-rakuline lümfoom (CTCL), mitte-Hodgkini lümfoom (NHL) ja süsteemsed pahaloomulised protsessid).
In order to reduce the likelihood of mis-diagnosis and in order to better ensure the appropriate use of the medicinal product, the CHMP emphasised that the product information should reflect that the initial diagnosis and initial prescription should be undertaken by physicians with experience in the treatment of AD. Additionally, the CHMP concluded that Protopic should not be used in immunocompromised adults or children and that Protopic should not be applied to lesions that are considered to be potentially malignant or pre-malignant and that lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Lisaks järeldas inimtervishoius kasutatavate ravimite komitee, et Protopic'it ei tohi kasutada immunosupressiooniga täiskasvanutel ega lastel, samuti ei tohi Protopic'it kanda kahjustustele, mis võivad olla pahaloomulised või premaliigsed ning ravi alustamisel olemasolevat lümfadenopaatiat tuleb uurida ja jälgida.