domingo, 25 de setembro de 2011
Problemas com o blog
Estamos tendo problemas de postar comentários no nosso blog e não sabemos como resolver; se alguém puder ajudar, agradecemos. O blog não pode ficar estático. Para aqueles a quem não pudemos responder, por favor, entre em contato através do email abranghe@gmail.com
quinta-feira, 15 de setembro de 2011
segunda-feira, 5 de setembro de 2011
Aprovação de Firazyr pelo FDA
Firazyr foi aprovado pelo FDA, em 25 de agosto de 2011, para tratar crises agudas de Angioedema Hereditário
http://www.prnewswire.com/news-releases/fda-approves-firazyr-to-treat-acute-attacks-of-hereditary-angioedema-128386823.html
FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
Download image SILVER SPRING, Md., Aug. 25, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have HAE.
People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death. Swelling of the digestive tract may cause abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation.
"Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.
The safety and efficacy of Firazyr was demonstrated in three controlled clinical trials, with open-label extension periods, in which 225 patients received 1,076 doses of 30 mg Firazyr. The median time for patients treated with Firazyr to report onset of symptom relief was two hours compared with almost 20 hours with placebo.
Firazyr is the third drug approved in the United States to treat HAE attacks. In October 2009 the FDA approved Berinert to treat facial and abdominal attacks of HAE, and Kalbitor was approved in December 2009 to treat acute attacks of HAE in patients ages 16 years and older.
The FDA approved Firazyr with patient counseling information that includes injection instructions. The most common side effects reported by those using Firazyr were injection site reactions, fever, increased liver enzymes, dizziness, and rash.
Firazyr is marketed by Shire Human Genetic Therapies Inc. of Cambridge, Mass.
For more information:
Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
http://www.prnewswire.com/news-releases/fda-approves-firazyr-to-treat-acute-attacks-of-hereditary-angioedema-128386823.html
FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
Download image SILVER SPRING, Md., Aug. 25, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have HAE.
People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death. Swelling of the digestive tract may cause abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation.
"Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.
The safety and efficacy of Firazyr was demonstrated in three controlled clinical trials, with open-label extension periods, in which 225 patients received 1,076 doses of 30 mg Firazyr. The median time for patients treated with Firazyr to report onset of symptom relief was two hours compared with almost 20 hours with placebo.
Firazyr is the third drug approved in the United States to treat HAE attacks. In October 2009 the FDA approved Berinert to treat facial and abdominal attacks of HAE, and Kalbitor was approved in December 2009 to treat acute attacks of HAE in patients ages 16 years and older.
The FDA approved Firazyr with patient counseling information that includes injection instructions. The most common side effects reported by those using Firazyr were injection site reactions, fever, increased liver enzymes, dizziness, and rash.
Firazyr is marketed by Shire Human Genetic Therapies Inc. of Cambridge, Mass.
For more information:
Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Angioedema Hereditário - Hospital Edmundo Vasconcelos
O Complexo Hospitalar Edmundo Vasconcelos é o primeiro hospital particular do Brasil a disponibilizar o novo tratamento para crises agudas de Angioedema Hereditário (AEH), doença genética rara que causa inchaço em várias partes do corpo, principalmente no intestino e trato respiratório. Assista o vídeo com o dra. Yara Mello e saiba mais sobre a doença e o novo tratamento.
31 de agosto de 2011.
31 de agosto de 2011.
Assinar:
Postagens (Atom)