União Europeia - português - EMA (European Medicines Agency)

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - imunológicos para suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. outro contribuidor chave para a mancha de javali, skatole, também pode ser reduzido como um efeito indireto. os comportamentos agressivos e sexuais (de montagem) também são reduzidos. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).

União Europeia - português - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimicóticos para uso sistêmico - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 e 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 e 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 e 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 e 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 e 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 e 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 e 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- aspergilose invasiva em pacientes com a doença de que é refratária a anfotericina b e itraconazol ou em pacientes que são intolerantes a esses medicamentos;- fusariosis em pacientes com a doença de que é refratária a anfotericina b ou em pacientes que são intolerantes a anfotericina b;- chromoblastomycosis e mycetoma em pacientes com doença refratária ao itraconazol ou em pacientes que são intolerantes itraconazol;- coccidioidomicose em pacientes com a doença de que é refratária a anfotericina b, itraconazol ou fluconazol ou em pacientes que são intolerantes a esses medicamentos;- candidíase orofaríngea: como terapia de primeira linha em pacientes que têm doenças graves ou são imunocomprometidos, nos quais a resposta a terapia tópica é esperado para ser pobre. refractoriness é definido como a progressão da infecção ou insuficiência melhorar, depois de um mínimo de 7 dias antes de doses terapêuticas eficazes de terapia antifungal. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - recombinante vírus da estomatite vesicular (strain indiana), com exclusão do envelope glicoprotéico, substituído com o zaire ebolavirus (strain kikwit 1995), a glicoproteína de superfície - febre hemorrágica Ébola - vacinas - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus. o uso de ervebo deve estar em conformidade com as recomendações oficiais.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimicóticos para uso sistêmico - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - daptomicina - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibacterianos para uso sistémico, - cubicin é indicado para o tratamento das seguintes infecções. adultos e pediátricos (de 1 a 17 anos de idade) pacientes com complicadas da pele e dos tecidos moles infecções (icptm). pacientes adultos com lado direito endocardite infecciosa (rie), devido à staphylococcus aureus. recomenda-se que a decisão de usar esta deve levar em conta a antibacteriano suscetibilidade do organismo e deve ser baseado em pareceres de peritos. adultos e pediátricos (de 1 a 17 anos de idade) pacientes com staphylococcus aureus bacteriemia (sab). em adultos, o uso em bacteriemia deve ser associado com o bruno ou com icptm, enquanto que em pacientes pediátricos, o uso em bacteriemia deve ser associado com icptm. daptomicina é ativa contra bactérias gram-positivas apenas. em infecções mistas, onde gram-negativas e/ou de certos tipos de bactérias anaeróbicas são suspeitos, cubicin deve ser co-administrado com adequada agente antibacteriano(s). deve ser tido em consideração a orientação oficial sobre o uso apropriado de agentes antibacterianos..

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatite b, antígeno de superfície recombinante - hepatitis b; immunization - vacinas - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. o risco específicos de categorias para ser imunizadas devem ser determinados com base nas recomendações oficiais. pode ser esperado que a hepatite d, também serão prevenidas pela imunização com hbvaxpro como a hepatite d (causada pelo agente delta) não ocorre na ausência de hepatite b infecção. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. o risco específicos de categorias para ser imunizadas devem ser determinados com base nas recomendações oficiais. pode ser esperado que a hepatite d, também serão prevenidas pela imunização com hbvaxpro como a hepatite d (causada pelo agente delta) não ocorre na ausência de hepatite b infecção. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. pode ser esperado que a hepatite d, também serão prevenidas pela imunização com hbvaxpro como a hepatite d (causada pelo agente delta) não ocorre na ausência de infecção por hepatite b.

União Europeia - português - EMA (European Medicines Agency)

bayer animal health gmbh - imidacloprido, moxidectin - produtos antiparasitário, inseticidas e repelentes - dogs; cats; ferrets - dogsfor cães que sofrem ou correm o risco de, misto de infecções parasitárias:o tratamento e a prevenção de infestação de pulgas (ctenocephalides felis),o tratamento de morder piolhos (trichodectes canis),o tratamento de orelha a infestação dos ácaros (otodectes cynotis), sarcoptic mange (causada pelo sarcoptes scabiei var. canis), demodicosis (causada pelo demodex canis),a prevenção da dirofilariose doença (l3 e l4 larvas da dirofilaria immitis),o tratamento de circulação de microfilárias (dirofilaria immitis),o tratamento de tegumento cutâneo dirofilariosis (adulto fases de dirofilaria repens)a prevenção cutânea dirofilariosis (l3 larvas da dirofilaria repens),a redução da circulação de microfilárias (dirofilaria repens),a prevenção de angiostrongylosis (l4 larvas e adultos imaturos de angiostrongylus vasorum),o tratamento de angiostrongylus vasorum e crenosoma vulpis,a prevenção de spirocercosis (spirocerca lupi),o tratamento de eucoleus (syn. capillaria) boehmi (adultos),o tratamento do olho verme thelazia callipaeda (adultos),o tratamento de infecções por nematóides gastrointestinais (l4 larvas, imaturos e adultos de toxocara canis, ancylostoma caninum e uncinaria stenocephala, os adultos de toxascaris leonina) e trichuris vulpis). o produto pode ser usado como parte de uma estratégia de tratamento para dermatite de alergia a pulga (fad). catsfor gatos que sofrem ou correm o risco de, misto de infecções parasitárias:o tratamento e a prevenção de infestação de pulgas (ctenocephalides felis),o tratamento de orelha a infestação dos ácaros (otodectes cynotis),o tratamento de notoedric mange (notoedres cati),o tratamento da lungworm eucoleus aerophilus (syn. capillaria aerophila) (adultos),a prevenção de lungworm doença (l3/l4 larvas de aelurostrongylus abstrusus),o tratamento da lungworm aelurostrongylus abstrusus (adultos),o tratamento do olho verme thelazia callipaeda (adultos),a prevenção da dirofilariose doença (l3 e l4 larvas da dirofilaria immitis),o tratamento de infecções por nematóides gastrointestinais (l4 larvas, imaturos e adultos de toxocara cati e ancylostoma tubaeforme). o produto pode ser usado como parte de uma estratégia de tratamento para dermatite de alergia a pulga (fad). ferretsfor furões que sofrem ou correm o risco de, misto de infecções parasitárias:o tratamento e a prevenção de infestação de pulgas (ctenocephalides felis),a prevenção da dirofilariose doença (l3 e l4 larvas da dirofilaria immitis).

União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetes mellitus, tipo 2 - drogas usadas em diabetes - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 e 5.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - agentes antineoplásicos - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacientes com egfr ou alk positivo tumor mutações também deve ter recebido a terapia direcionada antes de receber keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

União Europeia - português - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningite, meningococo - vacinas - nimenrix é indicado para a imunização ativa de indivíduos de até 6 semanas contra doenças meningocócicas invasivas causadas por neisseria meningitidis grupo a, c, w-135 e y.