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Alfasigma
Alfasigma USA, Inc. (''formerly'' Pamlab) is an American medical food company, and a division of Alfasigma Group, of Bologna, Italy. Alfasigma's base of operations is located in Covington, Louisiana. History The company entered the pharmaceutical industry in 1957, initially introducing prescription cough/cold products. In 1987, Pamlab was purchased by Samuel and Judith Camp. In early 2013, Pamlab was purchased by Nestlé Health Science. In December 2016, Pamlab was purchased by Alfasigma Group of Bologna, Italy. Legal actions Alfasigma USA, Inc. was sued by ExeGi Pharma LLC and the Italian inventor of probiotic VSL#3, Claudio De Simone, for making false advertising claims and ownership rights to VSL#3. According to court documents: "Defendant VSL Inc., and its licensees Alfasigma and Leadiant, having lost the right to sell the De Simone Formulation, decided to manufacture, market, and sell a different, inferior formulation (the “Fraudulent Formulation”) without conducti ...
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Alfasigma Group
Alfasigma USA, Inc. (''formerly'' Pamlab) is an American medical food company, and a division of Alfasigma Group, of Bologna, Italy. Alfasigma's base of operations is located in Covington, Louisiana. History The company entered the pharmaceutical industry in 1957, initially introducing prescription cough/cold products. In 1987, Pamlab was purchased by Samuel and Judith Camp. In early 2013, Pamlab was purchased by Nestlé Health Science. In December 2016, Pamlab was purchased by Alfasigma Group of Bologna, Italy. Legal actions Alfasigma USA, Inc. was sued by ExeGi Pharma LLC and the Italian inventor of probiotic VSL#3, Claudio De Simone, for making false advertising claims and ownership rights to VSL#3. According to court documents: "Defendant VSL Inc., and its licensees Alfasigma and Leadiant, having lost the right to sell the De Simone Formulation, decided to manufacture, market, and sell a different, inferior formulation (the “Fraudulent Formulation”) without conduct ...
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Cerefolin NAC
Cerefolin is a prescription medication made by Pamlab that contains 5.635 mg of folate as L-methylfolate, 1 mg of vitamin B12 as methylcobalamin, 50 mg of vitamin B2 as riboflavin, and 5 mg of vitamin B6 as pyridoxine. It is approved by the U.S. Food and Drug Administration for the treatment or prevention of vitamin deficiencies. "Cerefolin NAC" contains L-methylfolate (as Metafolin) 5.6 mg, methylcobalamin 2 mg, N-acetylcysteine 600 mg. Risks Cerefolin is a potentially harmful drug. Adverse effects can include diarrhea, Hand-foot syndrome Chemotherapy-induced acral erythema, also known as palmar-plantar erythrodysesthesia or hand-foot syndrome is reddening, swelling, numbness and desquamation (skin sloughing or peeling) on palms of the hands and soles of the feet (and, occasionally ..., Rashes, Renal stones, Constipation, headaches, flushing, and swelling. References Vitamins Combination drugs {{gastrointestinal-drug-stub ...
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Cerefolin
Cerefolin is a prescription medication made by Pamlab that contains 5.635 mg of folate as L-methylfolate, 1 mg of vitamin B12 as methylcobalamin, 50 mg of vitamin B2 as riboflavin, and 5 mg of vitamin B6 as pyridoxine. It is approved by the U.S. Food and Drug Administration for the treatment or prevention of vitamin deficiencies. "Cerefolin NAC" contains L-methylfolate (as Metafolin) 5.6 mg, methylcobalamin 2 mg, N-acetylcysteine 600 mg. Risks Cerefolin is a potentially harmful drug. Adverse effects can include diarrhea, Hand-foot syndrome Chemotherapy-induced acral erythema, also known as palmar-plantar erythrodysesthesia or hand-foot syndrome is reddening, swelling, numbness and desquamation (skin sloughing or peeling) on palms of the hands and soles of the feet (and, occasionally ..., Rashes, Renal stones, Constipation, headaches, flushing, and swelling. References Vitamins Combination drugs {{gastrointestinal-drug-stub ...
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Metanx
Metanx is a prescription medical food made by Alfasigma that contains L-methylfolate (as Metafolin, a calcium salt of vitamin B9), methylcobalamin (vitamin B12) and pyridoxal 5'-phosphate (vitamin B6). It is a vitamin B supplement. Metanx is indicated for the dietary management of peripheral neuropathy (i.e. DPN). Ingredients Metanx contains the following active ingredients (per capsule): * Folate * L-methylfolate (Metafolin): 3 mg * Pyridoxal 5'-phosphate: 35 mg * Methylcobalamin: 2 mg (Google Books) Indication and usage Metanx is used for treating: * Painful diabetic neuropathy, (Google Books) * Diabetic foot ulcers, * Endothelial dysfunction associated with diabetic peripheral neuropathy, * Hyperhomocysteinemia Hyperhomocysteinemia is a medical condition characterized by an abnormally high level of homocysteine in the blood, conventionally described as above 15 μmol/L. As a consequence of the biochemical reactions in which homocysteine is involved .... Referen ...
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Medical Food
Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States they were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015. Definition Medical foods, called "food for special medical purposes" in Europe, are distinct from the broader category of foods for special dietary use, from traditional foods that bear a health claim, and from dietary supplements. In order to be considered a medical food the product must, at a minimum: * be a food for oral ingestion or tube feeding (nasogastric tube) * be labeled for the dietary management of a specific medical disorder, disease or condit ...
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Food Manufacturers Of The United States
Food is any substance consumed by an organism for nutritional support. Food is usually of plant, animal, or fungal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism and assimilated by the organism's cells to provide energy, maintain life, or stimulate growth. Different species of animals have different feeding behaviours that satisfy the needs of their unique metabolisms, often evolved to fill a specific ecological niche within specific geographical contexts. Omnivorous humans are highly adaptable and have adapted to obtain food in many different ecosystems. The majority of the food energy required is supplied by the industrial food industry, which produces food with intensive agriculture and distributes it through complex food processing and food distribution systems. This system of conventional agriculture relies heavily on fossil fuels, which means that the food and agricultural ...
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Nestlé Brands
Nestlé S.A. (; ; ) is a Switzerland, Swiss multinational food and drink processing conglomerate corporation headquartered in Vevey, Vaud, Switzerland. It is the largest publicly held food company in the world, measured by revenue and other metrics, since 2014."Nestlé's Brabeck: We have a "huge advantage" over big pharma in creating medical foods"
, ''CNN Money'', 1 April 2011
It ranked No. 64 on the Fortune Global 500, ''Fortune'' Global 500 in 2017 and No. 33 in the 2016 edition of the ''Forbes'' Global 2000 list of largest public companies. Nestlé's products include baby food (some including human milk oligosaccharides), medical food, bottled water, breakfast cereals, coffee and tea, confectionery, ...
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Medical Food
Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States they were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015. Definition Medical foods, called "food for special medical purposes" in Europe, are distinct from the broader category of foods for special dietary use, from traditional foods that bear a health claim, and from dietary supplements. In order to be considered a medical food the product must, at a minimum: * be a food for oral ingestion or tube feeding (nasogastric tube) * be labeled for the dietary management of a specific medical disorder, disease or condit ...
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Deplin
Levomefolic acid (INN, also known as L-5-MTHF, L-methylfolate and L-5-methyltetrahydrofolate and (6''S'')-5-methyltetrahydrofolate, and (6''S'')-5-MTHF) is the primary biologically active form of folate used at the cellular level for DNA reproduction, the cysteine cycle and the regulation of homocysteine. It is also the form found in circulation and transported across membranes into tissues and across the blood–brain barrier. In the cell, L-methylfolate is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon unit for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. The un-methylated form, folic acid (vitamin B9), is a synthetic form of folate, and must undergo enzymatic reduction by dihydrofolate reductase (DHFR) to become biologically active. It is synthesized in the absorptive cells of the small intestine from polyglutamylated dietary folate. It is a methylated derivative o ...
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Major Depressive Disorder
Major depressive disorder (MDD), also known as clinical depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Introduced by a group of US clinicians in the mid-1970s, the term was adopted by the American Psychiatric Association for this symptom cluster under mood disorders in the 1980 version of the ''Diagnostic and Statistical Manual of Mental Disorders'' (DSM-III), and has become widely used since. The diagnosis of major depressive disorder is based on the person's reported experiences, behavior reported by relatives or friends, and a mental status examination. There is no laboratory test for the disorder, but testing may be done to rule out physical conditions that can cause similar symptoms. The most common time of onset is in a person's 20s, with females affected about twice as often as males. The course of the disorder varies widely, from one epis ...
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VSL(3)
Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut microbiota. Probiotics are considered GRAS, generally safe to consume, but may cause bacteria-Host (biology), host interactions and unwanted side effects in rare cases. There is some evidence that probiotics are beneficial for some conditions, but there is little evidence for many of the health benefits claimed for them. The first discovered probiotic was a certain strain of bacillus in Bulgarian yoghurt, called ''Lactobacillus bulgaricus''. The discovery was made in 1905 by Bulgarian physician and microbiologist Stamen Grigorov. The modern-day theory is generally attributed to Russian Nobel prize, Nobel laureate Élie Metchnikoff, who postulated around 1907 that yoghurt-consuming Bulgarian peasants lived longer. A growing probiotics market has led to the need for stricter requirements for evidence based medicine, scientific substan ...
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High-risk Pregnancy
A high-risk pregnancy is one where the mother or the fetus has an increased risk of adverse outcomes compared to uncomplicated pregnancies. No concrete guidelines currently exist for distinguishing “high-risk” pregnancies from “low-risk” pregnancies, however there are certain studied conditions that have been shown to put the mother or fetus at a higher risk of poor outcomes. These conditions can be classified into three main categories: health problems in the mother that occur before she becomes pregnant, health problems in the mother that occur during pregnancy, and certain health conditions with the fetus. In 2012, the CDC estimated that there were approximately 65,000 pregnancies deemed "high-risk" in the United States. Causes Mother-related factors Pregnancies could be considered high risk if the mother has certain pre-existing health conditions. These include: * Age ** Older age - Pregnancies in women over the age of 35 are considered " advanced age". First-time p ...
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