FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
Polish: A administração do medicamento veterinário não conforme as instruções dadas no RCMV pode aumentar a prevalência de bactérias e fungos resistentes à gentamicina e ao miconazol, respectivamente, podendo ainda diminuir a eficácia do tratamento com aminoglicósidos e agentes anti-fúngicos azol, devido ao potencial de resistência cruzada.
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Polish: Não administrar em caso de hipersensibilidade às substâncias activas ou a qualquer dos excipientes, aos corticosteróides, a outros agentes anti-fúngicos azol e a outros aminoglicósidos.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY ANDUSE
Polish: CONDIÇÕES OU RESTRIÇÕES DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO RELATIVAMENTE AO FORNECIMENTO OU UTILIZAÇÃO
English: Special precautions for use in animals
Polish: Precauções especiais para utilização em animais
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Polish: ADVERTÊNCIAS ESPECIAIS, SE NECESSÁRIO Antes de utilizar, leia o folheto informativo.
English: • Introduce the atraumatic cannula in the ear canal.
Polish: • Introduzir a cânula atraumática no canal auditivo.
English: CLINICAL PARTICULARS
Polish: INFORMAÇÕES CLÍNICAS
English: ADVICE ON CORRECT ADMINISTRATION
Polish: INSTRUÇÕES COM VISTA A UMA UTILIZAÇÃO CORRECTA
English: METHOD AND ROUTE(S) OF ADMINISTRATION For auricular use only.
Polish: MODO E VIA DE ADMINISTRAÇÃO Apenas para administração auricular.
English: Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Polish: Tratamento de otite externa aguda e exacerbação aguda de otite externa recorrente, associada a bactérias sensíveis à gentamicina e fungos sensíveis ao miconazol, especialmente Malassezia pachydermatis.
English: This dose is adequately delivered by one pump activation.
Polish: Esta dose é fornecida adequadamente, premindo uma vez o aplicador.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Polish: MENÇÃO “EXCLUSIVAMENTE PARA USO VETERINÁRIO” E CONDIÇÕES OU RESTRIÇÕES RELATIVAS AO FORNECIMENTO E À UTILIZAÇÃO, se for caso disso
English: Introduce the atraumatic canula in the ear canal.
Polish: Introduzir a cânula atraumática no canal auditivo.
English: PHARMACEUTICAL FORM Ear drops, suspension.
Polish: FORMA FARMACÊUTICA Gotas auriculares suspensão.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/11/2008.
Polish: DATA DA PRIMEIRA AUTORIZAÇÃO/RENOVAÇÃO DA AUTORIZAÇÃO
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Polish: CONTEÚDO EM PESO, VOLUME OU NÚMERO DE DOSES
English: Gentamicin as sulphate
Polish: Sulfato de Gentamicina
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Polish: MERCADO RELATIVAMENTE AO FORNECIMENTO OU UTILIZAÇÃO Medicamento veterinário sujeito a receita médico veterinária.
English: PHARMACEUTICAL PARTICULARS
Polish: INFORMAÇÕES FARMACÊUTICAS
English: WITHDRAWAL PERIOD(S) SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Polish: INTERVALO DE SEGURANÇA ADVERTÊNCIAS ESPECIAIS, SE NECESSÁRIO Antes de utilizar, leia o folheto informativo.
English: 5.2 Pharmacokinetic particulars
Polish: 5.2 Propriedades farmacocinéticas
English: [Multi-dose container:] Shake the bottle thoroughly before first administration and prime the pump by pressing it.
Polish: Antes da primeira administração, agitar bem o frasco e premir o aplicador.
English: Gentamicin resistant bacteria isolated from the field between 2008 and 2010 in canine otitis before treatment (determined according to CLSI guideline breakpoint ≥ 8 for all isolates except for Staphylococci ≥ 16 μg/ml) were low: 4.7%, 2.9% and 12.5% for Staphylococcus spp., Pseudomonas and Proteus spp.
Polish: Bacterias resistentes á Gentamicina ,isoladas em oites caninas entre 2008 e 2010 antes do tratamento (determinado de acordo coma as linhas de orientação CLSI, ponto de rotura ≥ 8 para todos os isolados.
English: SPECIAL STORAGE PRECAUTIONS
Polish: PRECAUÇÕES ESPECIAIS DE CONSERVAÇÃO
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTI-DOSE CONTAINER
Polish: INDICAÇÕES MÍNIMAS A INCLUIR EM PEQUENAS UNIDADES DE ACONDICIONAMENTO PRIMÁRIO
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 5, 10, 50, 100 or 200 PIPETTES
Polish: INDICAÇÕES A INCLUIR NO ACONDICIONAMENTO SECUNDÁRIO CAIXA DE CARTÃO COM 5,10,50,100 E 200 PIPETAS
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs
Polish: NOME DO MEDICAMENTO VETERINÁRIO Easotic gotas auriculares suspensão para cães
English: See also “Special precautions for use in animals”.
Polish: Ver “ Precauções especiasi para uso em animais
English: MARKETING AUTHORISATION HOLDER
Polish: NÚMERO DE REGISTO DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO
English: Easotic ear drops, suspension for dogs
Polish: Easotic gotas auriculares suspensão para cães.
English: Hydrocortisone aceponate
Polish: Hidrocortisona aceponato-Miconazol- Gentamicina
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC
Polish: TITULAR DA AUTORIZAÇÃO DE INTRODUÇÃO NO MERCADO VIRBAC S.A.
English: Tel: 32 (0) 16 38 72 60
Polish: B-3001 Leuven Tel: 32 (0) 16 38 72 60
English: 1ère avenue 2065 m LID 06516 Carros
Polish: 1ère avenue 2065 m LID 06516 Carros France
English: B. PACKAGE LEAFLET
Polish: B. FOLHETO INFORMATIVO
English: France VIRBAC 13ème rue - L.I.D - BP 27 06517 Carros Hrvatska VIRBAC
Polish: France VIRBAC 13ème rue - L.I.D - BP 27 F-06517 Carros HrvatskaVIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
English: Shelf life after first opening the multi-dose container: 10 days.
Polish: Prazo de validade após a primeira abertura do acondicionamento primário: 10 dias.
English: To be supplied only on veterinary prescription.
Polish: Exclusivamente para uso veterinário - Medicamento veterinário sujeito a receita médico-veterinária.
English: Single-dose container:
Polish: Embalagem mono-dose :
English: Tel.: 0033/4.92.08.73.00 Fax: 0033/4.92.08.73.48 E-mail: dar@virbac.fr
Polish: 0033/4.92.08.73.48 E-mail.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PIPETTE NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic
Polish: INDICAÇÕES MÍNIMAS A INCLUIR EM PEQUENAS UNIDADES DE ACONDICIONAMENTO PRIMÁRIO PIPETA
English: Miconazole as nitrate
Polish: Nitrato de Miconazol
English: Read the package leaflet before use.
Polish: Antes de utilizar, leia o folheto informativo.
English: Tel: + 372 6 709 006 E-mail: zoovet@zoovet.ee
Polish: E-mail: zoovet@zoovet.ee
English: One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
Polish: Um ml contém 1.11 mg de aceponato de hidrocortisona, 15.1 mg de nitrato de miconazol e 1,505 IU de sulfato de gentamicina.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
Polish: PRECAUÇÕES ESPECIAIS DE ELIMINAÇÃO DO MEDICAMENTO NÃO
English: STATEMENT OF THE MRLs
Polish: NÚMERO DO LOTE
English: EXPIRY DATE EXP {month/year} Once opened use within 10 days.
Polish: Depois da primeira abertura da embalagem, administrar no prazo de 10 dias.
English: 4.1 Target species
Polish: 4.1 Espécie(s)-alvo
English: Pharmacotherapeutic group: Otologicals, corticosteroids and antiinfectives in combination.
Polish: Grupo farmacoterapêutico: Otorrino - corticosteróides e anti-infecciosos combinados Código ATCvet: QS02CA03
English: PACKAGE LEAFLET : Easotic ear drops, suspension for dogs
Polish: FOLHETO INFORMATIVO Easotic suspensão de gotas auriculares para cães
English: SPECIAL WARNING(S)
Polish: ADVERTÊNCIAS ESPECIAIS
English: Do not use if the eardrum is perforated.
Polish: Não administrar se a membrana do tímpano estiver perfurada.
English: Suomi/Finland VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Polish: Suomi/Finland VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: ROUTE(S) OF ADMINISTRATION (Reference is made to the drawing in section 1)
Polish: VIA(S) DE ADMINISTRAÇÃO
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Hydrocortisone aceponate 1.11 mg/ml, Miconazole as nitrate 15.1 mg/ml, Gentamicin as sulphate 1,505 IU/ml.
Polish: COMPOSIÇÃO QUANTITATIVA DA(S) SUBSTÂNCIA(S) ACTIVA(S) Aceponato de Hidrocortisona 1.11 mg/ml Nitrato de Miconazol
English: STATEMENT OF ACTIVE SUBSTANCES Hydrocortisone aceponate 1.11 mg/ml, Miconazole as nitrate 15.1 mg/ml, Gentamicin as sulphate 1,505 IU/ml.
Polish: DESCRIÇÃO DAS SUBSTÂNCIAS ACTIVAS Aceponato de Hidrocortisona 1.11 mg/ml Nitrato de Miconazol
English: Magyarország VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Polish: Magyarország VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: Ísland VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Polish: Ísland VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: 2 pre-filled pens + 2 alcohol wipes
Polish: 2 wkłady dozownika i 2 waciki nasączone alkoholem
English: 2 dose-dispenser cartridges + 2 alcohol wipes
Polish: 2 wstrzykiwacze automatyczne i 2 gaziki nasączone alkoholem
English: London, 24 January 2008 Doc.
Polish: Londyn, dnia 24 stycznia 2008 r. Nr ref. dok.
English: The company that applied for authorisation is Wyeth Europa Ltd.
Polish: Firmą ubiegającą się o przyznanie pozwolenia na dopuszczenie do obrotu jest Wyeth Europa Ltd.
English: Ref. EMEA/37537/2008
Polish: EMEA/186660/2008
English: What is Mylotarg?
Polish: Co to jest Mylotarg?
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 24 January 2008.
Polish: Po rozważeniu podstaw wniosku o ponowne rozpatrzenie opinii, CHMP ponownie rozpatrzył wstępną opinię i w dniu 24 stycznia 2008 r. potwierdził odmowę przyznania pozwolenia na dopuszczenia do obrotu.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for MYLOTARG
Polish: PYTANIA I ODPOWIEDZI DOTYCZĄCE ZALECENIA ODMOWY PRZYZNANIA POZWOLENIA NA DOPUSZCZENIE DO OBROTU dotyczące preparatu MYLOTARG
English: International non-proprietary name (INN): gemtuzumab ozogamicin
Polish: Nieopatentowana nazwa międzynarodowa: gemtuzumab ozogamicyny
English: In all three studies, the main measure of effectiveness was the proportion of patients who achieved ‘complete remission' after a seven-month course of treatment.
Polish: We wszystkich trzech badaniach głównym kryterium oceny skuteczności był odsetek pacjentów, u których wystąpiła „pełna remisja” po siedmiomiesięcznym kursie leczenia.
English: These included severe and long-lasting bone marrow suppression causing low levels of white blood cells and platelets, liver problems, and side effects related to the infusion, such as chills, fever and low blood pressure.
Polish: Należy do nich ciężka i długotrwała supresja szpiku, powodująca spadek liczby leukocytów i płytek krwi, problemy dotyczące wątroby oraz działania niepożądane związane z wlewem dożylnym, takie jak dreszcze, gorączka i spadek ciśnienia tętniczego.
English: On 20 September 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia.
Polish: W dniu 20 września 2007 r. Komitet ds. Produktów Leczniczych Stosowanych u Ludzi (CHMP) wydał negatywną opinię, zalecając odmowę przyznania pozwolenia na dopuszczenie do obrotu produktu leczniczego Mylotarg 5 mg proszek do sporządzania roztworu do wlewów dożylnych, przeznaczonego do leczenia ostrej białaczki szpikowej.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mylotarg?
Polish: Jakie są skutki odmowy dla pacjentów uczestniczących w badaniach klinicznych lub w „programach współczucia” z użyciem preparatu Mylotarg?
English: The company informed the CHMP that patients currently included in compassionate use programmes will continue to receive Mylotarg until they have finished their course of treatment.
Polish: Firma poinformowała CHMP, że pacjenci obecnie uczestniczący w „programach współczucia” będą nadal otrzymywać preparat Mylotarg do czasu zakończenia przebiegu leczenia.
English: Complete remission is when the leukaemia cells can no longer be detected in the blood and are at very low levels in the bone marrow.
Polish: Pełna remisja oznacza, że komórek białaczkowych nie wykrywa się już we krwi, a w szpiku kostnym występują one w bardzo małej liczbie.
English: The CHMP was concerned that the studies of Mylotarg had not shown a benefit of the medicine, because of the way they were designed.
Polish: CHMP wyraził obawę, że badania preparatu Mylotarg nie wykazały korzyści ze stosowania leku ze względu na sposób, w jaki zostały one zaprojektowane.
English: However, it was difficult to compare the effectiveness of Mylotarg and other treatments used for this disease, in terms of how long remission would last, how long it would take until the disease got worse, or what the medicines' effects would be on survival.
Polish: Trudno było jednak porównać skuteczność preparatu Mylotarg i innych metod leczenia stosowanych w tej chorobie pod względem czasu utrzymywania się remisji, czasu do nasilenia się choroby lub wpływu leku na przeżywalność.
English: When the antibody attaches to CD33, the cells absorb the antibody, as well as the cytotoxic substance that it is attached to.
Polish: Gdy przeciwciało przyłącza się do CD33, komórka wchłania to przeciwciało wraz z przyłączoną do niego substancją cytotoksyczną.
English: The calicheamicin then breaks up the leukaemia cells' DNA, eventually killing the cells.
Polish: Następnie kalicheamicyna niszczy DNA komórek białaczkowych, co ostatecznie prowadzi do ich zniszczenia.
English: The company also stated that it will continue to supply Mylotarg for use in existing, ongoing clinical trials.
Polish: Firma poinformowała także, że będzie nadal dostarczać preparat Mylotarg dla celów trwających badań klinicznych.
English: Mylotarg was to be used to treat patients whose disease had come back after one previous course of treatment, and who were not suitable for other types of intensive chemotherapy such as highdose cytarabine (another anticancer medicine).
Polish: Preparat Mylotarg miał być stosowany w leczeniu pacjentów, u których wystąpił nawrót choroby po wcześniejszym kursie leczenia oraz którzy nie kwalifikowali się do innych typów intensywnej chemioterapii, takich jak cytarabina (inny lek przeciwnowotworowy) w wysokich dawkach.
English: A small proportion of the patients whose disease had come back after one previous course of treatment achieved complete remission.
Polish: Pełna remisja wystąpiła u niewielkiego odsetka pacjentów, u których wystąpił nawrót choroby po jednym wcześniejszym kursie leczenia.
English: The effects of Mylotarg were studied in three main studies involving a total of 277 patients with CD33-positive acute myeloid leukaemia, whose disease had come back after one previous course of treatment.
Polish: Działania preparatu Mylotarg oceniano w trzech głównych badaniach z udziałem łącznie 277 pacjentów z CD33-dodatnią ostrą białaczką szpikową, u których wystąpił nawrót choroby po wcześniejszym kursie leczenia.
English: At that point in time, the CHMP was of the opinion that there was insufficient evidence to establish the effectiveness of Mylotarg in the treatment of acute myeloid leukaemia, and therefore that the medicine's benefits did not outweigh its risks.
Polish: CHMP uważał wówczas, że nie były dostępne wystarczające dowody na skuteczność preparatu Mylotarg w leczeniu ostrej białaczki szpikowej i dlatego korzyści ze stosowania tego leku nie przewyższały związanego z tym ryzyka.
English: Mylotarg was not compared to any other treatment in any of the studies.
Polish: W żadnym z badań preparatu Mylotarg nie porównywano z jakimkolwiek innym leczeniem.
English: Inside the cells, the cytotoxic substance, which is called calicheamicin, is released.
Polish: Wewnątrz komórki uwalniana jest substancja cytotoksyczna o nazwie kalicheamicyna.
English: The effects of Mylotarg were first tested in experimental models before being studied in humans.
Polish: Zanim przeprowadzono badania na ludziach, działanie preparatu Mylotarg zbadano najpierw w modelach eksperymentalnych.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Polish: Przeciwciało monoklonalne to przeciwciało (typ białka), które zostało zaprojektowane w taki sposób, aby rozpoznawało określone struktury (zwane antygenami) występujące na określonych komórkach organizmu oraz wiązało się z tymi strukturami.
English: Hence, the CHMP recommended that Mylotarg be refused marketing authorisation.
Polish: W związku z tym CHMP zalecił odmowę przyznania pozwolenia na dopuszczenie preparatu Mylotarg do obrotu.
English: The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic (cell-killing) substance that is linked to a monoclonal antibody.
Polish: Składnik czynny preparatu Mylotarg, gemtuzumab ozogamicyny, jest substancją cytotoksyczną (zabijającą komórki), która jest połączona z przeciwciałem monoklonalnym.
English: The monoclonal antibody part of the active substance (gemtuzumab) has been designed to bind to CD33, an antigen which is found on the surface of acute myeloid leukaemia cells in about 80% of patients.
Polish: Część substancji czynnej będąca przeciwciałem monoklonalnym (gemtuzumab) została zaprojektowana w taki sposób, aby wiązała się z CD33 - antygenem występującym na powierzchni komórek ostrej białaczki szpikowej u około 80% pacjentów.
English: Mylotarg was expected to be used to treat acute myeloid leukaemia, a type of cancer of the white blood cells.
Polish: Preparat Mylotarg miał być stosowany w leczeniu ostrej białaczki szpikowej - typu nowotworu krwinek białych.
English: Mylotarg was designated as an orphan medicinal product on 18 October 2000 for acute myeloid leukaemia.
Polish: W dniu 18 października 2000 r. preparat Mylotarg został oznaczony jako sierocy produkt leczniczy do leczenia ostrej białaczki szpikowej.
English: What was Mylotarg expected to be used for?
Polish: W jakim celu miał być stosowany preparat Mylotarg?
English: It was to be used in patients who were ‘CD33-positive', meaning that their cancerous white blood cells had a protein called CD33 on their surface.
Polish: Lek ten miał być stosowany u pacjentów z dodatnimi wynikami badań w kierunku receptorów CD33, co oznacza, że na powierzchni zmienionych nowotworowo krwinek białych występuje białko określane jako CD33.
English: How is Mylotarg expected to work?
Polish: Jakie jest oczekiwane działanie preparatu Mylotarg?
English: Mylotarg is a powder that is made up into a solution for infusion (drip into a vein).
Polish: Preparat Mylotarg ma postać proszku, z którego przygotowuje się roztwór do wlewu dożylnego (kroplówki).
English: It contains the active substance gemtuzumab ozogamicin.
Polish: Składnikiem czynnym tego preparatu jest gemtuzumab ozogamicyny.
English: The Committee noted that there were side effects associated with Mylotarg.
Polish: Komitet zauważył, że stosowanie preparatu Mylotarg jest związane z działaniami niepożądanymi.
English: All patients should be assessed at least once every two years.
Polish: Pacjenci powinni być poddawani ocenie co najmniej raz na 2 lata.
English: As for all medicines, data on the use of Rebif are continuously monitored.
Polish: Tak jak w przypadku wszystkich leków, dane o stosowaniu leku Rebif są stale monitorowane.
English: A 22-microgram dose is recommended for patients who cannot tolerate the higher dose.
Polish: Dawka 22 mikrogramów jest zalecana u pacjentów, którzy nie tolerują wyżej dawki.
English: Some effect on progression of disability could be seen, but only in the patients who had relapses in the two years before the start of the study.
Polish: Zaobserwowano pewien wpływ na postęp niepełnosprawności, lecz tylko u pacjentów, u których doszło do nawrotów w ciągu dwóch lat przed rozpoczęciem badania.
English: The European Medicines Agency decided that Rebif's benefits are greater than its risks and it can be authorised for use in the EU.
Polish: Europejska Agencja Leków (EMA) uznała, że korzyści płynące ze stosowania leku Rebif przewyższają ryzyko i może on być dopuszczony do obrotu w UE.
English: What is Rebif and what is it used for?
Polish: Czym jest lek Rebif i w jakim celu się go stosuje
English: Other information about Rebif
Polish: Inne informacje dotyczące leku Rebif
English: The probability of developing MS over 24 months was 62.5% for patients given Rebif three times a week and 75.5% for patients given Rebif once a week compared with 85.8% for patients given placebo.
Polish: Prawdopodobieństwo rozwoju stwardnienia rozsianego w ciągu 24 miesięcy wynosiło 62,5% w przypadku pacjentów, którym podawano Rebif trzy razy w tygodniu i 75,5% u pacjentów, którym podawano raz w tygodniu w porównaniu z 85,8% w przypadku pacjentów, którym podawano placebo.
English: Side effects reported with Rebif are carefully evaluated and any necessary action taken to protect patients.
Polish: Zgłaszane działania niepożądane leku Rebif są starannie oceniane i podejmowane są wszystkie czynności konieczne do ochrony pacjentów.
English: When first starting treatment with Rebif, the dose should be slowly increased from a starting dose of 8.8 micrograms three times a week to avoid side effects.
Polish: Na początku leczenia dawkę należy powoli zwiększać od początkowej dawki 8,8 mikrogramów podawanych trzy razy na tydzień, w celu uniknięcia działań niepożądanych.
English: Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Polish: Pacjenci otrzymywali albo Rebif (22 lub 44 mikrogramy) lub placebo (leczenie pozorowane) przez dwa lata.
English: Rebif must not be used in patients who have severe depression or have thoughts of suicide.
Polish: Leku Rebif nie wolno stosować u pacjentów z ciężką depresją lub myślami samobójczymi.
English: Rebif (44 micrograms given once or three times a week) has also been compared with placebo in 515 patients who had experienced a single attack of demyelination.
Polish: Rebif (w dawce 44 mikrogramów podawanych raz lub trzy razy w tygodniu) porównywano również z placebo u 515 pacjentów z przebytym pojedynczym rzutem choroby demielinizacyjnej.
English: Further information on Rebif can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rebif.
Polish: Lek Rebif otrzymał pozwolenie na dopuszczenie do obrotu, ważne w całej UE od dnia 4 maja 1998 r. Dalsze informacje na temat leku Rebif znajdują się na stronie internetowej Agencji pod adresem: ema.europa.eu/medicines/human/EPAR/rebif.
English: The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Polish: Zalecana dawka leku Rebif wynosi 44 mikrogramy podawane trzy raz na tydzień we wstrzyknięciu podskórnym.