What is valsartan?
Valsartan has also long been used to cooperate with other countries.
This makes pressure and pumps blood throughout the body. By lightening the work of the heart, will make the blood vessels of the brain, heart, and kidneys.
Withdrawal of products in 22 countries
Novartis as the first company to develop drugs such as Sandral and valsartan / tablet HCT film coated for "not meet Sandoz high quality standards."
Pharmacies in the UK have been told to collect valsartan drugs made by Dexcel Pharma Ltd and Accord Healthcare.
The recall caused approximately 2,300 bets sent to Germany, Norway, Finland, Sweden, Hungary, Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Croatia, Greece, Canada, Bosnia and Herzegovina, Bahrain, and Malta.
Novartis Agency and FDA
Novartis spokesman Eric Althoff said that products sold in the United States are no longer by this waste. Sandy Walsh, public relations officer for the Food and Drug Administration said that the agency is visible and there is no comment at the moment.
According to him, the FDA is committed to providing information to the public in a timely manner. In general, the FDA does not comment on third-party announcements, but is a resource to improve understanding of specific issues and help the FDA's mission to promote public health.
Valsartan products proved to be harmful impurities
Problems encountered during the purchase of valsartan active pharmaceutical goods (API / active inggridient pharmaceuticals) derived from external suppliers contain impurities. European Drug Agency of Medicines, Zhejiang Huahai Pharmaceuticals in Linhai, China. The FDA says impurities are "results in the manufacturing process."
The impurity is N-Nitrosodimethylamine (NDMA), an organic chemical present in a potent carcinogen family. These chemicals have been used to make fuels, softeners and lubricants, liquid launchers, among other products. It is also reliable and can not be used to produce pesticides, rubber tire manufacture or fish processing.
"The amount available in the API is much lower than the usual cumulative and external external endogen production of NDMA," Althoff wrote in an email quoted from the CNN website (6/7/2018).
"There is no certainty about how much this contaminant could potentially increase the risk of cancer in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk in patients taking Sandoz Valsartan and Sandoz Valsartan HCT film coated tablets. "
NDMA Faq
Q: A: What does NDMA stand for? NDMA stands for "N-nitrosodimethylamine".
Q: A: How to abbreviate "N-nitrosodimethylamine"? "N-nitrosodimethylamine" can be abbreviated as NDMA.
Q: A: What is the meaning of NDMA abbreviation? The meaning of NDMA abbreviation is "N-nitrosodimethylamine".
Q: A: What is NDMA abbreviation? One of the definitions of NDMA is "N-nitrosodimethylamine".
Q: A: What does NDMA mean? NDMA as abbreviation means "N-nitrosodimethylamine".
Q: A: What is shorthand of N-nitrosodimethylamine? The most common shorthand of "N-nitrosodimethylamine" is NDMA.
Valsartan has also long been used to cooperate with other countries.
Withdrawal of products in 22 countries
Novartis as the first company to develop drugs such as Sandral and valsartan / tablet HCT film coated for "not meet Sandoz high quality standards."
Pharmacies in the UK have been told to collect valsartan drugs made by Dexcel Pharma Ltd and Accord Healthcare.
The recall caused approximately 2,300 bets sent to Germany, Norway, Finland, Sweden, Hungary, Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Croatia, Greece, Canada, Bosnia and Herzegovina, Bahrain, and Malta.
Novartis Agency and FDA
Novartis spokesman Eric Althoff said that products sold in the United States are no longer by this waste. Sandy Walsh, public relations officer for the Food and Drug Administration said that the agency is visible and there is no comment at the moment.
According to him, the FDA is committed to providing information to the public in a timely manner. In general, the FDA does not comment on third-party announcements, but is a resource to improve understanding of specific issues and help the FDA's mission to promote public health.
Valsartan products proved to be harmful impurities
Problems encountered during the purchase of valsartan active pharmaceutical goods (API / active inggridient pharmaceuticals) derived from external suppliers contain impurities. European Drug Agency of Medicines, Zhejiang Huahai Pharmaceuticals in Linhai, China. The FDA says impurities are "results in the manufacturing process."
The impurity is N-Nitrosodimethylamine (NDMA), an organic chemical present in a potent carcinogen family. These chemicals have been used to make fuels, softeners and lubricants, liquid launchers, among other products. It is also reliable and can not be used to produce pesticides, rubber tire manufacture or fish processing.
NDMA impurities cause cancer
Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidneys, and respiratory tract. It also includes humans in certain quantities. High levels of exposure can cause liver damage and is a possible human carcinogen, according to the US Department of Health and Human Services."The amount available in the API is much lower than the usual cumulative and external external endogen production of NDMA," Althoff wrote in an email quoted from the CNN website (6/7/2018).
"There is no certainty about how much this contaminant could potentially increase the risk of cancer in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk in patients taking Sandoz Valsartan and Sandoz Valsartan HCT film coated tablets. "
NDMA Faq
Q: A: What does NDMA stand for? NDMA stands for "N-nitrosodimethylamine".
Q: A: How to abbreviate "N-nitrosodimethylamine"? "N-nitrosodimethylamine" can be abbreviated as NDMA.
Q: A: What is the meaning of NDMA abbreviation? The meaning of NDMA abbreviation is "N-nitrosodimethylamine".
Q: A: What is NDMA abbreviation? One of the definitions of NDMA is "N-nitrosodimethylamine".
Q: A: What does NDMA mean? NDMA as abbreviation means "N-nitrosodimethylamine".
Q: A: What is shorthand of N-nitrosodimethylamine? The most common shorthand of "N-nitrosodimethylamine" is NDMA.
Valsartan, What is NDMA?
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