Kiovig União Europeia - português - EMA (European Medicines Agency)

kiovig

takeda manufacturing austria ag - imunoglobulina normal humana (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - imune soros e imunoglobulinas, - a terapêutica de substituição em adultos, e as crianças e adolescentes (0-18 anos) em:síndromes de imunodeficiências primárias com deficiência na produção de anticorpos;hypogammaglobulinaemia e recorrentes infecções bacterianas em pacientes com leucemia linfocítica crônica, em quem profilático de antibióticos falharam;hypogammaglobulinaemia e recorrentes infecções bacterianas no planalto-fase-de vários doentes que não responderam à vacinação pneumocócica;hypogammaglobulinaemia em pacientes após hematopoiéticas alogênico-transplante de células-tronco (hsct);congênita, aids e infecções bacterianas recorrentes. imunomodulação em adultos, e as crianças e adolescentes (0-18 anos) em:primário trombocitopenia imune (pti), em pacientes com alto risco de sangramento ou antes de uma cirurgia para corrigir a contagem de plaquetas;síndrome de guillain barré;doença de kawasaki;multifocal motor de neuropatia (mmn).

Clopidogrel Acino União Europeia - português - EMA (European Medicines Agency)

clopidogrel acino

acino ag - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - agentes antitrombóticos - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , , , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease, non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa), st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy, patients suffering from acute coronary syndrome. , ,.

Rivastigmine Hexal União Europeia - português - EMA (European Medicines Agency)

rivastigmine hexal

hexal ag  - rivastigmina - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - tratamento sintomático da demência de alzheimer leve a moderadamente grave. tratamento sintomático de leve a moderadamente grave demência em pacientes com a doença de parkinson idiopática.

Xarelto União Europeia - português - EMA (European Medicines Agency)

xarelto

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - agentes antitrombóticos - xarelto, co-administrada com ácido acetilsalicílico (asa) sozinho ou com asa mais clopidogrel ou ticlopidina, é indicada para a prevenção de eventos aterotrombóticos em pacientes adultos, após uma síndrome coronária aguda (sca), com elevação de biomarcadores cardíacos. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. prevenção de tromboembolismo venoso (vte) em pacientes adultos submetidos à cirurgia eletiva de substituição de quadril ou joelho. tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Pandemic Influenza Vaccine H5N1 Baxter AG União Europeia - português - EMA (European Medicines Agency)

pandemic influenza vaccine h5n1 baxter ag

resilience biomanufacturing ireland limited - vacina contra a gripe (todo virião, inativado) contendo antigénio de: a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vacinas - prophylaxis da gripe em uma situação de pandemia oficialmente declarada. a vacina contra a gripe pandémica deve ser utilizada de acordo com a orientação oficial.

Oyavas União Europeia - português - EMA (European Medicines Agency)

oyavas

stada arzneimittel ag - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - agentes antineoplásicos - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. para mais informações sobre o status do receptor do fator de crescimento epidérmico humano (her2), consulte a seção 5. oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with oyavas in combination with capecitabine. para mais informações sobre o status her2, consulte a seção 5. oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Airexar Spiromax União Europeia - português - EMA (European Medicines Agency)

airexar spiromax

teva b.v. - salmeterol, fluticasone propionate - pulmonary disease, chronic obstructive; asthma - medicamentos para obstrutiva, doenças das vias respiratórias, - airexar spiromax é indicado para uso em adultos com mais de 18 anos. asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist. doença pulmonar obstrutiva crônica (dpoc)airexar spiromax é indicado para o tratamento sintomático dos pacientes com dpoc com vef1.

Episalvan União Europeia - português - EMA (European Medicines Agency)

episalvan

amryt ag - betulae cortex - wounds and injuries; wound healing - preparados para tratamento de feridas e úlceras - tratamento de feridas de espessura parcial em adultos. veja as seções 4. 4 e 5. 1 na informação do produto em relação ao tipo de feridas estudadas.

Iblias União Europeia - português - EMA (European Medicines Agency)

iblias

bayer ag - octocog alfa - hemofilia a - anti-hemorrágicos - tratamento e profilaxia do sangramento em pacientes com hemofilia a (deficiência congênita de fator viii). iblias pode ser usado para todos os grupos de idade.

Movymia União Europeia - português - EMA (European Medicines Agency)

movymia

stada arzneimittel ag - teriparatida - osteoporose - homeostase de cálcio - movymia está indicada em adultos. tratamento da osteoporose em mulheres pós-menopáusicas e em homens com risco aumentado de fratura. nas mulheres pós-menopáusicas, foi demonstrada uma redução significativa na incidência de fraturas vertebrais e não vertebrais, mas não nas fraturas do quadril. tratamento da osteoporose associada com sustentado sistêmica do glicocorticóide terapia em mulheres e homens em aumento do risco de fratura.