natgillin/translations-raw huggingface dataset:
The two experimental studies and the retrospective analyses on field trials show that the recommended dose and duration of treatment of Resflor is adequate for the treatment of BRD associated with M. bovis.
Obe eksperimentalni študiji in retrospektivne analize terenskih preskušanj kažejo, da sta priporočeni odmerek in trajanje zdravljenja, določena za zdravilo Resflor, primerna za zdravljenje bolezni dihal pri govedu, povezanih z bakterijo M. bovis.
The two experimental studies and the retrospective analyses on field trials show that the dose and duration of treatment of Resflor is adequate for the treatment of BRD associated with M. bovis.
Obe eksperimentalni študiji in retrospektivne analize terenskih preskušanj kažejo, da sta odmerek in trajanje zdravljenja, določena za zdravilo Resflor, primerna za zdravljenje bolezni dihal pri govedu, povezanih z bakterijo M. bovis.
By the end of the study (Day 18), 61 of 87 cases (70.1%) were successfully treated with florfenicol compared to 68 out of 89 cases (76.4%) treated with tulathromycin.
Odziv zvišane telesne temperature na zdravljenje s tulatromicinom ali florfenikolom je bil klinično podoben, s statistično značilnimi razlikami v korist florfenikola na 2. in 3. dan. Do zaključka študije (18. dan) so s florfenikolom uspešno ozdravili 61 od 87 primerov (70,1 %), s tulatromicinom pa 68 od 89 primerov (76,4 %).
From the data currently available, no particular risk of increase of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
Na podlagi trenutno razpoložljivih podatkov ob uporabi zdravila Resflor ni pričakovati posebnega tveganja za povečanje občutljivosti bakterije M. bovis za florfenikol.
the CVMP concluded that the overall benefit-risk balance is positive and recommended the granting of the variation to the terms of the marketing authorisation for Resflor solution injectable (see annex I)
je CHMP zaključil, da je splošno razmerje med tveganji in koristmi pozitivno, in priporočil odobritev spremembe pogojev dovoljenja za promet z zdravilom Resflor raztopina za injiciranje (glejte Prilogo I), katerega veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kakor je navedeno v Prilogi III.
No particular risk of decrease of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
Ob uporabi zdravila Resflor ni pričakovati posebnega tveganja za zmanjšanje občutljivosti bakterije M. bovis za florfenikol.
Lithuania Intervet International B.V. Wim de Koerverstraat 35
Slovenija Intervet International B.V.
Route of administration
Quinta da Fonte
Belgium Intervet International B.V. Wim de Koerverstraat 35
Madžarska Intervet International B.V.
- The Committee considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Protopic
- je Odbor obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravilo Protopic.
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.
CHMP je tudi izrazil zaskrbljenost v zvezi s stopnjo uporabe zdravila Protopic pri otrocih, starih manj kot dve leti (uporaba ni odobrena), pri katerih se imunski sistem šele razvija.
Protopic is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Protopic je dermatološko zdravilo, ki vsebuje takrolimus, zaviralec kalcineurina, v koncentraciji 0,1 % in 0,03 %.
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 0,1 % je namenjen zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih, ki se na konvencionalne terapije ne odzovejo ustrezno ali jih ne prenesejo, Protopic 0,03 % pa je namenjen zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih ali otrocih (starih 2 leti ali več), ki se na konvencionalne terapije ne odzovejo ustrezno.
• The treatment with Protopic should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
• Zdravljenje z zdravilom Protopic sme uvesti le zdravnik, ki ima izkušnje z diagnostiko in z zdravljenjem atopičnega dermatititsa.
After reviewing the available data the CHMP concluded that the balance of risks and benefits for Protopic is considered favourable.
Po pregledu razpoložljivih podatkov je CHMP sklenil, da je razmerje med tveganji in koristmi za zdravilo Protopic mogoče oceniti kot ugodno.
• A statement that Protopic should not be used in children under 2 years.
• Navedbo, da zdravila Protopic ni dovoljeno uporabljati pri otrocih, starih manj kot 2 leti.
• Protopic should not be used in immunocompromised adults or children.
• Zdravila Protopic se ne sme uporabljati pri odraslih ali otrocih z oslabljenim imunskim sistemom.
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.
Iz tega razloga je CHMP zahteval, da imetnik dovoljenja za promet z zdravilom sprejme ustrezne ukrepe, da bi tako zagotovil, da se zdravilo Protopic v tej starostni skupini ne uporablja.
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.
Poleg tega je CHPM sklenil, da so potrebni nadaljnji podatki za boljšo oceno dolgoročne varnosti uporabe zdravila Protopic glede na njegovo povezavo z malignimi obolenji.
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.
Za upoštevanje varnostnih pomislekov v zvezi s primeri malignih obolenj je CHMP zaključil, da je treba v informacije o zdravilu vključiti opozorila, ki bodo odražala primere malignih obolenj ter potrebo po spremljanju bolnikov, zdravljenih z zdravilom Protopic.
• A warning to advise that any lymphadenopathy present prior to initiation of therapy should be investigated and kept under assessment.
• Opozorilni nasvet, da je potrebno raziskati in nadzorovati limfoadenopatije, prisotne pred začetkom zdravljenja.
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.
Dne 21. aprila 2005 je Evropska komisija zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP) za mnenje o razmerju med koristmi in tveganji za zdravilo Protopic z vidika potencialnega tveganja za maligna obolenja.
- 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:
- je Odbor posledično sklenil, da je potrebno v Povzetek glavnih značilnosti zdravila in ustrezne razdelke Navodil za uporabo za zdravilo Protopic vključiti naslednje informacije:
- The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma) have been reported in patients treated with Protopic.
- je Odbor vzel na znanje, da so pri bolnikih, zdravljenih z zdravilom Protopic, poročali o primerih malignih obolenj (vključujočih kožni rak in limfom).
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.
V okviru kliničnega razvoja in postmarketinških izkušenj, povezanih z uporabo zdravila Protopic, so poročali o posameznih primerih malignih obolenj (vključujočih kožni rak, kožni limfom celic T (CTCL, Cutaneous T-Cell Lymphoma), ne-Hodgkinov limfom (NHL) in sistemska maligna obolenja).
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.
zaključil, da potencialne povezave z uporabo zdravila Protopic ni mogoče izključiti in da je zaradi tega potrebno zbrati dodatne podatke, ki bi zagotovili sprejemljiv dolgoročni varnostni profil.
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.
Da bi zmanjšali verjetnost napačno postavljenih diagnoz in v večji meri zagotovili ustrezno uporabo zdravila, je CHMP poudaril, da morajo informacije o zdravilu odražati zahtevo po tem, da začetno diagnozo postavi in zdravilo uvede zdravnik z izkušnjami pri zdravljenju atopičnega dermatitisa.
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.
Revidiran Povzetek glavnih značilnosti zdravila je na voljo v Dodatku I, revidirana Navodila za uporabo pa v Dodatku IIIB.