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  • Professor, Department of Clinical Pharmacy, West Virginia University School of Pharmacy
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Regenerathrough electrostatic interactions with polyacrylate coated tive adsorber systems consist of column pairs, which are polyacrlyamide beads; sequentially regenerated during a treatment session, and may 5. The situation is heterogeneous clinical syndrome of rapidly progressive glomerulonephritis in Asian countries. These include: Overall, there is only a weak correlation of the underlying etiology with descriptive histologic patterns as detected by 1. Although electron microscopy to detect deposits of immunoglobudue care has been used in the preparation of this doculins, complement, or immune complexes. Extent of membranoproliferative including but not limited to, warranties as to the informapatterns, crescents. The cellularity, composed of a variable mixture of cells), fibrous cresinformation contained herein is not intended to supplant cents, segmental fibrinoid necrosis, interstitial fibrosis, or tubular the clinical judgment of qualified medical professionals. The pathogenesis is thought to be disseminated multifocal inflammation and patchy demyelination associated with transient autoimmune response against myelin oligodendrocyte glycoprotein or other autoantigens. The prognosis is favorable, with complete recovery within weeks or months in ~55-95% of cases while mortality is rare. Due to the postulated immune-mediated pathogenesis, treatment is based on immunomodulatory agents. Corticosteroids are considered effective because of their anti-inflammatory and immunomodulatory effects with additional beneficial effect on cerebral edema. The principal outcome of interest for therapeutic apheresis is acute response to treatment, rather than long-term effects on attack frequency. Factors associated with improvement were male gender, preserved reflexes and early initiation of treatment. In most studies, clinical response was noticeable within days, usually after 2-3 exchanges. Acute disseminated encephalomyelitis: current controversies in diagnosis and outcome. Blood seminated encephalomyelitis, plasmapheresis, therapeutic plasma exchange for Purif. Plasma exchange for acute attacks of were searched for additional cases and trials. A case report of plasmapheresis in patients with neurologic diseases: retrospective multicenter study. Acute disseminated encephalomyelitis in children: discordant neurologic and neuroimaging abnormalmyelitis. Acute disseminated encephalomypatients with neurologic disorders: review of 63 cases. Weakness or sensory impairment progresses over a period of 12 hours to 28 days before nadir is reached and may involve respiratory and oropharyngeal muscles in severe cases. Autonomic dysfunction can cause variability in blood pressure and heart rate resulting in life threatening complications. Spontaneous recovery may occur; however, neurologic complications persist in up to 20% of patients, with half severely disabled at 1 year. Guillain-Barre syndrome is usually preceded by infection or other immune stimulation that induces an aberrant autoimmune response targeting peripheral nerves and their spinal roots. However, how the immune response is shifted towards unwanted autoreactivity is still not well understood. Current management/treatment Since spontaneous recovery is anticipated in most patients, supportive care is the mainstay of treatment in ambulatory patients. Severely affected patients may require intensive care, mechanical ventilation, and assistance through paralysis and necessary rehabilitation over several months toa year or more. Other therapeutic modalities studied include cerebrospinal fluid filtration, double filtration plasmapheresis, and drug targeting of complement activation. Technical notes Since autonomic dysfunction may be present, affected patients may be more susceptible to intravascular volume shifts during apheresis treatments and should be monitored carefully. Tryptophan-immobilized columndence-based guideline update: Plasmapheresis in neurologic disorders: based immunoadsorption as the choice method for plasmapheresis in report of the Therapeutics and Technology Assessment Subcommittee Guillain-Barre syndrome.

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Febrile mucocutaneous syndromes (erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis) have been associated with penicillin and with sulfonamides. For the rare patient allergic to both penicillins and sulfonamides, erythromycin is recommended. Other macrolides, such as azithromycin or clarithromycin, also should be acceptable; they have less risk of gastrointestinal tract intolerance but increased costs. Some experts recommend secondary prophylaxis for these patients during the observation period. However, use of oral antiseptic solutions and maintenance of optimal oral health remain important components of an overall health care program. Invasive disease in infants is categorized on the basis of chronologic age at onset. Late, late-onset disease occurs beyond 89 days of age, usually in very preterm infants requiring prolonged hospitalization. Pilus-like structures are important virulence factors and potential vaccine candidates. Associated with implementation of widespread maternal intrapartum antimicrobial prophylaxis, the incidence of early-onset disease has decreased by approximately 80% to an estimated 0. The case-fatality ratio in term infants ranges from 1% to 3% but is higher in preterm neonates (20% for early-onset disease and 5% for late-onset disease). A low or an undectable maternal concentration of type-specifc serum antibody to capsular polysaccharide of the infecting strain also is a predisposing factor. Other risk factors are intrauterine fetal monitoring and maternal age younger than 20 years. Black race is an independent risk factor for both early-onset and late-onset disease. Although the incidence of earlyonset disease has declined in all racial groups since the 1900s, rates consistently have been higher among black infants (0. The period of communicability is unknown but can extend throughout the duration of colonization or disease. Infants can remain colonized for several months after birth and after treatment for systemic infection. For ampicillin, the recommended dosage for infants with meningitis 7 days of age or younger is 200 to 300 mg/kg per day, intravenously, in 3 divided doses; the recommended dosage for infants older than 7 days of age is 300 mg/kg per day, intravenously, in 4 divided doses. Additional lumbar punctures and diagnostic imaging studies are indicated if response to therapy is in doubt, neurologic abnormalities persist, or focal neurologic defcits occur. For infants with uncomplicated meningitis, 14 days of treatment is satisfactory, but longer periods of treatment may be necessary for infants with prolonged or complicated courses. Septic arthritis or osteomyelitis requires treatment for 3 to 4 weeks; endocarditis or ventriculitis requires treatment for at least 4 weeks. Intrapartum chemoprophylaxis should be given to all pregnant women identifed as carriers of group B streptococci. Colonization during a previous pregnancy is not an indication for intrapartum chemoprophylaxis. Such treatment is not effective in eliminating carriage of group B streptococci or preventing neonatal disease. Women expected to undergo cesarean deliveries should undergo routine culture screening, because onset of labor or rupture of membranes can occur before the planned cesarean delivery, and in this circumstance, intrapartum antimicrobial prophylaxis is recommended. An alternative drug is intravenous ampicillin (2 g initially, then 1 g every 4 hours until delivery). If clindamycin susceptibility testing has not been performed, intravenous vancomycin (1 g every 12 hours) should be administered. Antimicrobial therapy is appropriate only for infants with clinically suspected systemic infection. The recommendations are intended to help clinicians promptly detect and treat cases of earlyonset infections. All other maternal antimicrobial agents or durations before delivery are considered inadequate for purposes of neonatal management. Routine cultures to determine whether infants are colonized with group B streptococci are not recommended.


  • Hing Torack Dowston syndrome
  • Double fingernail of fifth finger
  • Vascular helix of umbilical cord
  • Chromosome 2, monosomy 2q24
  • Deafness vitiligo achalasia
  • Ptosis strabismus ectopic pupils
  • Gorlin Chaudhry Moss syndrome
  • Hypogonadism hypogonadotropic due to mutations in GR hormone
  • Paraplegia
  • Glioblastoma multiforme

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Accurate and rapid diagnosis may be more diffcult in children because of their inability to describe symptoms. In addition, adults on whom children depend for their health and safety may become ill or require quarantine during a bioterrorism event. Public health assessment and prioritization of potential biological terrorism agents. Bioterrorism Agents and Categories Category A Category A agents are high-priority agents that include organisms that pose a risk to national security because they: 1. Result in high mortality rates and have the potential for major public health impact; 3. Viral hemorrhagic fever (floviruses [eg, Ebola, Marburg] and arenaviruses [eg, Lassa, Machupo]) Category B Category B agents are second highest priority agents and include agents that: 1. Food safety threats (eg, Salmonella species, Escherichia coli O157:H7, Shigella species) 4. Viral encephalitis (alphavirus [eg, Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis]) 12. Water safety threats (eg, Vibrio cholerae, Cryptosporidium parvum) Category C Category C agents are third highest priority agents, which include emerging pathogens that could be engineered for mass dissemination because of: 1. Category C agents include emerging infectious diseases, such as Nipah virus and hantavirus. Children also may be at risk of unique adverse effects 1 from preventive and therapeutic agents that are recommended for treating exposure to agents of bioterrorism. Further, availability of appropriate pediatric formulations of medical countermeasures may be limited. Parents, pediatricians, and other adults should be cognizant of the psychological responses of children to a disaster or terrorist incident to reduce the possibility of long-term psychological morbidity. Some bio terrorism agents can cause typical distinctive signs and symptoms and incubation periods and require unique diagnostic tests, isolation, and recommended treatment and prophylaxis. Agents are discussed in Section 3 under specifc pathogens, and extensive information and advice are available elsewhere. Psychosocial implications of disaster or terrorism on children: a guide for the pediatrician. When clinicians suspect that illness is caused by an act of bioterrorism, they should contact their local public health authority immediately so that appropriate infection-control measures and outbreak investigations can begin. Public health authorities should be contacted before obtaining and submitting patient specimens for identifcation of suspected agents of bioterrorism. Blood Safety: Reducing the Risk of Transfusion-Transmitted Infections In the United States, risk of transmission of screened infectious agents through transfusion of blood components (Red Blood Cells, Platelets, and Plasma) and plasma derivatives (clotting factor concentrates, immune globulins, and protein-containing plasma volume expanders) is extremely low. Continued vigilance is crucial, however, because of risk from newly identifed or emerging infections as well as lack of a uniform nationwide system for transfusion reaction surveillance. This chapter reviews blood and plasma collection procedures in the United States, factors that have contributed to enhancing the safety of the blood supply, some of the known and emerging infectious agents and related blood safety concerns, and approaches to decreasing the risk of transfusion-transmitted infections. Platelets and, less commonly, Red Blood Cells and Plasma can be collected through apheresis, in which blood passes through a machine that separates blood components and returns uncollected components to the donor. Plasma for transfusion or further manufacturing into plasma derivatives can be prepared from Whole Blood or collected by apheresis. Most Plasma in the United States is obtained from paid donors at specialized collection centers. Plasma derivatives are prepared by pooling plasma from many donors and subjecting the plasma to a fractionation process that separates the desired proteins, including immune globulin and clotting factors. From an infectious disease standpoint, plasma derivatives differ from blood components in several ways. For economic and therapeutic reasons, plasma from thousands of donors is pooled, and therefore, recipients of plasma derivatives have vastly greater donor exposure than do blood component recipients.

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Dietary Interactions There is evidence that manganese may interact with certain other nutrients and dietary substances (see Table 2). In limited studies on induced manganese depletion in humans, subjects developed scaly dermatitis and hypocholesterolemia. Iron Iron status may affect Low ferritin concentrations are associated with manganese absorption: low increased manganese absorption, thereby having a serum ferritin concentration gender effect on manganese bioavailability (because may increase manganese women tend to have lower ferritin concentrations absorption. Phytate Phytate may decrease In a study of infant formula, the soy-based formula manganese absorption. The totality of evidence in animals and humans supports a causal association between elevated blood manganese concentrations and neurotoxicity. Special Considerations Individuals susceptible to adverse effects: People with chronic liver disease may be distinctly susceptible to the adverse effects of excess manganese intake, probably because elimination of manganese in bile is impaired. Also, manganese in drinking water and supplements may be more bioavailable than food manganese. Therefore, individuals who take manganese supplements, particularly those who already consume large amounts of manganese from diets high in plant products, should take extra caution. In limited studies on induced manganese depletion in humans, subjects developed scaly dermatitis and hypocholesterolemia. Neurotoxicity of orally ingested manganese at relatively low doses is more controversial, but evidence suggests that elevated blood manganese levels and neurotoxicity are possible. The requireM ments for molybdenum are based on controlled balance studies with specific amounts of molybdenum consumed. These enzymes are involved in catabolism of sulfur amino acids and heterocylic compounds such as purines and pyrimidines. A clear molybdenum deficiency syndrome that produces physiological signs of molybdenum restriction has not been achieved in animals, despite major reduction in the activity of these molybdoenzymes. Rather, the essential nature of molybdenum is based on a genetic defect that prevents sulfite oxidase synthesis. Because sulfite is not oxidized to sulfate, severe neurological damage leading to early death occurs with this inborn error of metabolism. Absorption, Metabolism, Storage, and Excretion the absorption of molybdenum is highly efficient over a wide range of intakes, which suggests that the mechanism of action is a passive (nonmediated) diffusion process. However, the exact mechanism and location within the gastrointestinal tract of molybdenum absorption have not been studied. Excretion is primarily through the urine and is directly related to dietary intake. When molybdenum intake is low, about 60 percent of ingested molybdenum is excreted in the urine, but when molybdenum intake is high, more than 90 percent is excreted in the urine. Although related to dietary intake, urinary molybdenum alone does not reflect status. Information on dietary intake of molybdenum is limited because of lack of a simple and reliable analytical method for determining molybdenum in foods. In addition, studies have identified levels of dietary molybdenum intake that appear to be associated with no harm. More soluble forms of molybdenum have greater toxicity than insoluble or less soluble forms. National surveys do not provide percentile data on the dietary intake of molybdenum. Because there was no information from national surveys on percentile distribution of molybdenum intakes, the risk of adverse effects could not be characterized. Bioavailability Little is known about the bioavailability of molybdenum, except that it has been demonstrated to be less efficiently absorbed from soy than from other food sources (as is the case with other minerals). It is unlikely that molybdenum in other commonly consumed foods would be less available than the molybdenum in soy. The utilization of absorbed molybdenum appears to be similar regardless of food source.

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Explanation: this standard requires that one or more samples of individual cryopreserved cellular therapy products be available in case further testing of the product is required. Samples from products that have been cryopreserved must be stored under conditions that allow the sample to represent the product. The method by which cellular therapy product samples are cryopreserved is determined by the Processing Facility Director. It should be acknowledged that methods for cryopreservation of a small aliquot versus the product may not be considered to produce identical results, regardless of whether they are frozen at the same time in the same controlled-rate freezer or separately using different procedures. However, the availability of a sample of the product to be administered has potential value for quality control and/or investigative purposes. Routine tests performed on aliquots for quality control purposes should be determined by the director. For some cryopreserved cellular therapy products, storage of additional samples is not possible due to low volume and/or low cellular content of the final product. In such situations, a cell-free sample that represents final steps of the processing shall be stored so repeat evaluation of microbial contamination, if needed, can be performed. For example, the negative fraction from cell-enrichment processing may substitute for the supernatant from the final product wash in preparation for freezing. The most appropriate step during the processing to collect such a sample shall be determined by the Processing Facility Director. Evidence: the inspector should request an inventory log for samples of cryopreserved cellular therapy products that are, or have been, stored. It is also recommended, but not required, to store the samples(s) minimally 10 years after the final disposition (administration, transfer, or discard) of the cellular therapy product or until the patient expires. While there may be scientific value in maintaining product samples longer, it is appreciated that cryopreservation storage space may be at a premium. Explanation: Product stability and establishment of product expiration depend on processing and storage methods. The validation of new cellular therapy products, or the validation of changes in processing or cryopreservation, require stability testing program be established and maintained. There must be a stability program in place that evaluates cellular therapy products each year with predefined criteria, but is not prescriptive in terms of the number of products, which products are tested in a given year, or other details. For cellular therapy products in early phase trials, the stability program should be in place but may not have mature data available. The stability program for all cellular therapy products should assess characteristics that affect the safety and efficacy of the product including sterility, container and label integrity, and as other characteristics as defined by the program. Processing Facilities are encouraged to discontinue any use of research-grade reagents and adopt single platform technology and diagnostic kits that include a viability marker. Explanation: the Processing Facility must establish a process to assure that cellular therapy products are stored in a manner that maintains their integrity and potency and that assures that products are not released prematurely before all release criteria have been met. Standard D2 requires that defined areas for storage be established and that these areas be controlled to prevent the possibility of mix-ups, contamination, or cross-contamination. Storage often occurs prior to processing, either within the Processing Facility or at the Collection Facility as well as after processing is complete. Storage temperature and duration shall be defined by the storing facility and shall include conditions for non-cryopreserved, cryopreserved, and thawed cellular therapy products. Products that have been processed and are awaiting the results of release testing. For liquid products, including thawed products, temperature ranges, storage duration, and product expiration date and time must be established to safeguard adequate viability and to decrease the risk of contamination. Processing procedures should specify the temperatures at which products are handled and processed prior to storage. Likewise, transport and shipping temperature both from the Collection Facility to the Processing Facility, and at distribution from the Processing Facility, must be defined.


  • You have sudden bleeding into the skin for no apparent reason
  • Damage to the brain from an injury
  • Have the teeth been abnormally colored since they grew in, or did they change color over time?
  • Unconscious
  • Sneezing
  • Blood culture
  • Long pregnancy or labor

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During attacks, there often is loss of appetite, stomach and intestinal problems, fever, and decreased urine output. The body cannot handle all the purines and other acids in the meat, and so these products settle in the body. Gout typically attacks the smaller joints of the feet and hands, especially the big toe. Uric acid salts crystallize in the joint, and produce swelling, redness, and a sensation of heat and extreme pain. However, weight reduction must be done gradually, so as not to stir up more urates and temporarily increase the number of gout attacks. In contrast, a high-fat diet decreases excretion and may bring on a gout attack (even though they may be unsaturated fats). If canned cherries are used, only use water-packed ones; most have too much sugar and additives. Here are foods high in purines: liver, brains, kidneys, heart, anchovies, sardines, meat extract, fish roes, herring, consomme, mussels, and sweet breads. But it causes nausea, vomiting, diarrhea, cramping, hair loss, anemia, liver damage, and decreased leukocytes and platelets. During these few years of your earthly probation, you can choose to stand resolutely for God. It most often occurs in shoulder joint and less often in the hip joint, in the elbows, or feet. Overstimulation of the bursa causes the synovial membrane to produce excess fluid. Injury to the area is a common cause, but chilling of the area during the day, especially at night can also lead to it. Bursitis can also be caused by chronic overuse, calcium deposits in the bursa wall, reactions to certain foods or airborne allergies. In some instances, suddenly working tight muscles can do it; it is called a stretched muscle. Athletes and older people are most likely to get bursitis, but it can happen to anyone at any age. Tendonitis causes a sharp pain during movement, and is most likely to be caused to over-reaching for something. Hot castor oil packs are useful (see "Arthritis" for information on how to prepare them). So many poisons have accumulated in the body from wrong eating, overwork, and stress that the immune system attacks the tissues lining the joints. A lack of minerals (especially calcium, magnesium, and silicon) can strengthen the problem. Possible headache, toothaches, dizziness, pain and ringing in the ears, and pressure behind the eyes When eating or yawning, there is a clicking, grinding, and popping noise, and perhaps pain. This causes the bones of the temporomandibular joint to rub against one another instead of gliding smoothly past each other. If the tooth repair or replacements have not been done properly, this can be a factor in causing the problem. Some people develop the habit of clenching their teeth together during the day and/or at night. An injury, poor dental work, osteoarthritis, bad posture, repeated or hard blows to the jaw or chin, whiplash, gum chewing, thumb sucking, chewing on only one side of the mouth, or holding the phone between the shoulder and jaw. But it is estimated that 90% of all cases respond well to simple, inexpensive, treatments. The antibodies and antitoxins of this system recognize these foreign bodies and send white blood cells to attack them. With his immune system weakened, a person is less able to withstand Epstein Barr virus, candidiasis, food allergies, arthritis, multiple sclerosis, cancer, etc.

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The breath may also contain volatile metabolites when large amounts of selenium are being excreted. Although some studies indicate a potential anticancer effect of selenium, the data were inadequate to set dietary selenium requirements based on this potential effect. Food animals in the United States and Canada usually have controlled diets to which selenium is added, and thus, the amounts found in muscle meats, milk, and eggs are more consistent than for plant-based foods. Dietary intake of selenium in the United States and Canada varies by geographical origin, based on the selenium content of the soil and meat content of the diet. This variation is buffered by a large food-distribution system, in which the extensive transport of food throughout North America prevents decreased intakes in people living in low-selenium areas. Although the food distribution systems in the United States and Canada ensure a mix of plantand animalbased foods originating from a broad range of soil selenium conditions, local foods. The content of selenium in plants depends on the availability of the element in the soil where the plant was grown. Unlike plants, animals require selenium, and so meat and seafood are reliable dietary sources of selenium. Therefore, the lowest selenium intakes are in populations that eat vegetarian diets comprising plants grown in low-selenium areas. Bioavailability Most dietary selenium is highly bioavailable, although its bioavailability from fortified foods and supplements is lower than for naturally occurring dietary forms of selenium. Inorganic selenium can cause toxicity at tissue levels of selenium that are much lower than those seen with similar intakes of dietary selenium as selenomethionine. Department of Agriculture has identified them and proscribed their use for raising animals for food. No evidence of selenosis has been found in these areas of high selenium content, even in the subjects consuming the most selenium. The cation sodium and the anion chloride are S normally found in most foods together as sodium chloride (salt). For this reason, this publication presents data on the requirements for and the effects of sodium and chloride together. In the United States, sodium chloride accounts for about 90 percent of total sodium intake in the United States. Most of the sodium chloride found in the typical diet is added to food during processing. Examples of high-sodium processed foods include luncheon meats and hot dogs, canned vegetables, processed cheese, potato chips, Worcestershire sauce, and soy sauce. Overall, there is little evidence of any adverse effect of low dietary sodium intake on serum or plasma sodium concentrations in healthy people. Likewise, chloride deficiency is rarely seen because most foods that contain sodium also provide chloride. The primary adverse effect related to increased sodium chloride intake is elevated blood pressure, which is directly related to cardiovascular disease and end-stage renal disease. Chloride, in association with sodium, is the primary osmotically active anion in the extracellular fluid. In addition, chloride, in the form of hydrochloric acid, is an important component of gastric juice. Absorption, Metabolism, Storage, and Excretion Sodium and chloride ions are typically consumed as sodium chloride. About 98 percent of ingested sodium chloride is absorbed, mainly in the small intestine. Absorbed sodium and chloride remain in the extracellular compartments, which include the plasma, interstitial fluid, and plasma water. As long as sweating is not excessive, most of this sodium chloride is excreted in the urine.

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If you cannot sleep in the middle of the night, pray and thank God for your blessings. Go outside and breathe deeply of the good night air, then go back to bed and to sleep. Other symptoms include sluggishness, lethargy, delusions, indecisiveness, dizziness, constipation, hemorrhoids, skin eruptions, and migraines. It affects one-third to one-half of all American women between the ages of 20 and 50. About 5% are incapacitated by it, and about a third report symptoms severe enough to interfere with their daily life. The liver regulates hormonal balance, by selectively filtering out of the blood and excreting unwanted excess hormones. Part of the hormonal imbalance problem is that there is too much estrogen in the body and not enough progesterone. This affects the circulation and impedes oxygen and nutrient flow to the brain and female organs. It is thought that they increase the production of serotonin, a brain chemical which counteracts depression. Search out the offending foods and stop eating them (see "Allergies" and "Pulse Test"). This increases oxygen intake, which in turn aids in nutrient absorption and elimination of toxins. Rub the cream into the skin on the chest, inner arms, thighs, and abdomen just after ovulation. Vitamin E is an antioxidant and helps prevent inflammatory reactions to dietary fats. Women whose general health and resistance are good are less likely to have menstrual problems. There are two types of dysmenorrhea (painful menstruation): Primary dysmenorrhea usually does not occur until several years after menstruation begins. The pain begins a few hours before or at the onset of bleeding, may last from a few hours to 1-2 days, and is generally worst the first day. Secondary dysmenorrhea may start 2-3 days before onset, with pain in the abdomen, small of back, and on down the legs. It is a more constant pain, but includes sharp cramps, and continues throughout the period. This type is often linked to a pelvic disorder (inflammation, uterine malposition, endometriosis, tumors, etc. Iron-rich sources include blackstrap molasses (best single source), apricots, and raisins. In one study, eight patients were freed of the problem when all foods they were allergic to were eliminated (see "Allergies" and "Pulse Test"). Stress or the birth control pill can seriously affect the adrenals (which produce 20% of the total estrogen used by the body). It is important that we cooperate with God by accepting Christ as our Saviour and, by faith in Him, obeying the Ten Commandments. In chronic ovarian congestion, apply the stomach compress during the night; daily give a Revulsive Sitz Bath or Hot Pelvic Pack and the very hot vaginal irrigation, 115 -120 F. In cases of deficient development, as in infantile uterus or nerve spasm of0 0 the uterine vessels, employ the Revulsive Sitz Bath, alternate genito-urinary douche, tonic sitz bath, pelvic and general massage. Surgical measures are often required for permanent relief, but a surprisingly large number of cases are resolvable without surgery; hence water therapies should be perseveringly tried before resorting to surgical procedures. There tends to be a hormone starvation at that time, since menopause usually results from a decreased production of the female sex hormones. The lessened supply of estrogen increases the possibility of cardiovascular disease, vaginal atrophy, and osteoporosis. It is popular to take estrogen supplements, to prevent or postpone menopausal symptoms.

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The plan should reflect differences between specific program needs and general hospital needs, and complement the hospital plan. Arrangements must be made so that these documents are available in the event that the computer system goes down. Staff should have periodic training and review of alternate systems so they will be competent in the use of these systems should the need arise. Evidence: the inspector should review policies and forms to be used in case the electronic record keeping system is unavailable. The inspector should determine if cellular therapy products can be produced to the same standard of quality even if the electronic records are not available. Example(s): Examples include malfunctioning electronic records systems, drug shortages, power outages, equipment failures, supply shortages, etc. In the example of failed electronic record systems, a Processing Facility may create hard copies of reports from the system that are periodically produced to be used as a manual record. When calculations are utilized, there should be documentation of staff competency in performing these calculations manually in the event that the electronic system is unavailable. Even if supplies, reagents, and equipment are qualified, the manner in which they are used must also be qualified to prevent product mix-ups, contamination, or cross-contamination. Explanation: A plan for qualification must be reviewed and approved prior to performing a qualification. The qualification plan should be reviewed after the qualification to determine if all acceptance criteria were met. Suppliers of laboratory services, such as the Flow Cytometry Laboratory or the Microbiology Laboratory that provides product testing, must also be qualified. Qualification procedures should include instructions for requalification and under which circumstances qualification is required. Suppliers with pre-existing service agreements preceding the implementation of this standard can be qualified as meeting expectations by a retrospective review of the quality of service provided. Equipment qualification is performed to establish that equipment and ancillary systems are capable of consistently operating within established limits and tolerances. Verification is the confirmation of the accuracy of something or that specified requirements have been fulfilled. Validation should confirm acceptable endpoints can be achieved while maintaining purity, potency and safety of the cellular therapy product. Examples of acceptable endpoints may include nucleated cell recovery, viability, sterility, and red cell reduction. The introduction of a piece of equipment such as a controlled rate freezer of the same model as already present in the facility would generally require a verification study, whereas the introduction of a different model or a model from a different manufacture would require a more extensive validation study. Validation of the labeling process should demonstrate completeness and correctness of each data point, as well as the accuracy of data as shown by traceability and trackability of the product from donor to recipient or final disposition. When this is not possible, a validation study must be performed using mock products with known values to document that the reagent or supply meets acceptable endpoints and does not cause harm to the product (purity, potency and safety) or the recipient of the product. Examples of acceptable endpoints may include but are not limited to nucleated cell recovery, viability, sterility, and red cell reduction. The inspector should note that studies are properly designed, objectively collect the required data, that outcome and intended actions are summarized, and that both the finalized plan and report are reviewed and approved by the Processing Facility Director and Quality Manager. Example(s): A change of reagents used for processing, such as cryopreservation, would need to be validated to verify cellular therapy product nucleated cell recovery, viability, sterility and potency are maintained at acceptable limits. The potential for adverse reactions and comparison of times to engraftment should also be examined. Another example of a change that would need to be validated is a change to a different method of red cell reduction.

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No participation certifcates, non-voting equity securities (Genussscheine), or proft-sharing A table with additional information on changes in the certifcates have been issued. Currency fuctuations have an infuence on the representation of the relative performance of Novartis vs. Corporate governanCe Novartis Annual Report 2017 | 87 our shares and our shareholders Key Novartis share data 2017 2016 2015 Issued shares 2 616 844 820 2 627 114 820 2 676 993 000 Treasury shares1 299 388 321 253 055 807 303 098 183 outstanding shares at December 31 2 317 456 499 2 374 059 013 2 373 894 817 Weighted average number of shares outstanding 2 345 783 843 2 378 474 555 2 402 806 352 1 Approximately 131 million treasury shares (2016: 135 million; 2015: 137 million) are held in Novartis entities that restrict their availability for use. Novartis shares can only be voted if they are registered with voting rights in In addition, the law provides for a qualifed majority for the Novartis Share Register by the third business day other resolutions, such as a merger or spin-of. Such requests must be made in writing by providing a discretionary proxy to an uninstructed at least 45 days before the meeting, specify the agenda independent designee. The General Meeting passes resolutions and elections Other rights associated with a registered Novartis with the absolute majority of the votes represented at the share may only be exercised by the shareholder, its legal meeting. However, under article 18 of the Articles of Incorrepresentative, another shareholder with the right to vote, poration ( The Articles of Incorporation provide that no shareNo restrictions on trading of shares holder shall be registered with the right to vote for more No restrictions are imposed on the transferability of than 2% of the registered share capital. The registration of shareholders in the upon request, grant an exemption from this restriction. The record date serves only to determine the right Oslo, which as of December 31, 2017, was not registered to vote at a General Meeting. Furthermore, an exemption, but as of December 31, 2017, was not regemployment contracts with Executive Committee memistered in the Novartis Share Register. Corporate governanCe Novartis Annual Report 2017 | 91 our shares and our shareholders General com pensation provisions the short-term compensation relates. In particuas fnancial, innovation, shareholder return and/or other lar, non-executive members of the Board shall receive metrics). Achievements are generally measured based no company contributions to any pension plan, no peron a period of not less than three years. Fixed promoted Executive Committee members, Novartis may compensation is comprised of the base salary and may pay out compensation, in a total amount up to 40% of the include other elements and benefts such as contributotal maximum aggregate amount last approved for the tions to pension plans. Variable compensation may be Executive Committee per compensation period, to newly structured into short-term and long-term compensation appointed or promoted Executive Committee members. Short-term variable compensation elements For detailed information on the compensation of the Board shall be governed by performance metrics that take and the Executive Committee, see articles 29-35 of the into account the performance of Novartis and/or parts Articles of Incorporation ( Achievements are gencompany-overview/corporate-governance) and the Comerally measured based on the one-year period to which pensation Report, beginning on page 118. Fudge audit and Compliance Compensation governance, nominat ion research & risk Committee Committee Committee and Corporate responsDevelopment ibilities Committee Committee E. Under special circumstances, shareholders may grant an exemption from this rule and re-elect a Board members, the Chairman, and Compensation ComBoard member for additional terms of ofce. There is no mittee members are elected annually and individually as mandatory term limit for Board members, enabling the a matter of law by the shareholders at the General Meetcompany to beneft from the insight and knowledge that ing. Board members whose term of ofce has expired are long-serving Board members have developed about the immediately eligible for re-election. The average tenure of Board members is six years, with two-thirds of Board members having a tenure of less than six years. Board diversity Profle of individual Board m em bers Board members should have the following personal the diversity of a Board is critical to its efectiveness. The committees enable the Board to work ground and expertise; business and other experience in an efcient and efective manner, ensuring a thorough relevant to the business of Novartis; the ability and willreview and discussion of issues, while giving the Board ingness to commit adequate time and efort to Board and more time for deliberation and decision-making.