Safety profiles

Pha.rma.ceutica.1 Purity. A safety profile of a generic dmg can differ from that of the brand-name product because different impurities may be present in each of the dmgs (154). Impurities can arise out of the manufacturing processes and may be responsible for adverse interactions that can occur. Eor example, serious adverse reactions (LyeU syndrome) were observed upon the use of isoxicam in 1985. These seemed to have resulted from trace elements of a manufacturing by-product that was within the manufacturing quaUty control specifications. 

Although anti-TNFa agents are well tolerated and have a good overall safety profile, pitfalls to the use of these drugs apparent with increasing clinical experience include infective complications and, in particular, reactivation of tuberculosis. To date, no statistically significant increased rate of tumour occurrence over that expected has been noted although cases of lymphoma have rarely been reported in patients treated with TNFa blockade. 

The applications of a-sulfo fatty acid esters are widely spread as for other surfactants. They can be used in detergents, cleansers, and cosmetic products as well as in the building industry and for the production of synthetic materials and agrochemicals. The main properties for these applications are surface activity, wetting ability, hard water stability, lime soap dispersion power, and good human and environmental safety profiles. 

In summary, studies involving more than 4,000 patients provided consistent evidence of a beneficial effect of acamprosate in relapse prevention. On the basis of the drug s efficacy (as demonstrated by at least a doubling of the total abstinence rate in three European studies, two of which were of 12 months duration) and a good safety profile, the FDA approved the medica-... 

General precautions for each medication that has been used for smoking cessation are listed in the sections describing each medication. All FDA-approved first-line medications for smoking cessation have a relatively good safety profile. Consensus opinions on the safety of the various medications for persons with cardiovascular disease, other medical conditions, and pregnancy are beyond the scope of this chapter but can be found elsewhere (Society for Research on Nicotine and Tobacco 2003). 

An established safety profile in patients with skin types i-Vi... 

Excellent safety profile Can be used in all skin types... 

L-acetyl carnitine, a compound with a known safety profile, has shown symptomatic benefits (Scarpini et al. 1997 Hart et al. 2004 Herzmann et al. 2005 Oslo et al. 2006) and improvements in epidermal nerve fiber density (Hart et al. 2004) in HIV patients with ATN. A short term randomized, double-blind, placebo-controlled... 

The multiple effects of UFH on the coagulation cascade may increase its potential to cause hemorrhage." Anticoagulants with more specific sites of action may confer a better safety profile. Two such anticoagulants are low-molecular-weight heparin (LMWH) and heparinoids. 

Many clinical studies have been performed on human subjects to assess the effect of soy isoflavones on chronic disease risk factors with no ill-effects (see Section 10.4). The safety profile of isoflavones is, however, difficult to establish because of the limited sample sizes and short periods of investigation of such studies. At present the upper tested limits are ... 

Shallow innovation can appear to be an attractive strategy. Particularly where a specific ingredient is a cause for concern, finding a substitute looks like the quickest and most cost-effective solution. Organisations like the Environmental Protection Agency in the US have collated tables of known substitutes for materials where the environmental or health and safety profile have caused concern. This approach is particularly used for solvents, and has been quite effective. ... 

All the compoimds showed a good safety profile until the highest dose [17]. There was no sedation, convulsions and tremors upon inspection, no ulceration and no hemorrhagic spots were observed. 

HRT, but they are less efficacious than hormonal therapies. Alternative treatments should be chosen based on the efficacy and safety profile of the treatment and the patient s past medical history and current medications. 

Black cohosh has been one of the most studied herbal remedies for vasomotor symptoms, and it has not demonstrated a substantial benefit over placebo. The mechanism of action, safety profile, drug-drug interactions, and adverse effects of black cohosh remain unknown. In non-placebo-controlled trials conducted for 6 months or less, black cohosh demonstrated a small reduction in vasomotor symptoms. It has not been shown to be effective for vasomotor symptoms in women with breast cancer.33 There have been case reports of hepatotoxicity with the use of black cohosh.36 Caution should be exercised when considering the use of this product, especially in patients with liver dysfunction. 

Methotrexate is the disease-modifying antirheumatic drug of choice because of its documented efficacy and safety profile when monitored appropriately. 

Aspirin has not been demonstrated to be more effective than acetaminophen, and because its safety profile may be inferior it is not recommended for treatment of acute musculoskeletal pain. 

The ocular hypotensive lipids in typical ophthalmology practice are considered first-line alternatives to topical P-blockers because of their superior efficacy and safety profiles. Many clinicians may choose to use the ocular hypotensive lipids as first-line agents, especially in patients that have an initial requirement to lower IOP by more than 25%, or in patients that have relative or absolute contraindications to topical P-blockers. However, latanoprost is currently the only ocular hypotensive lipid drug that has a Food and Drug Administration (FDA) indication for first-line therapy. Bimatoprost and travoprost are indicated by the FDA for patients who are intolerant of other IOP-lowering therapy or insufficiently responsive to another IOP-lowering medication.10,38... 

These qualities make cromolyn an option for patients with multiple comorbidities and concomitant medications. Cromolyn is an alternative for patients in whom antihistamines are too sedating and impair work and school performance. Additionally, cromolyn helps to prevent AR when taken prior to exposure, such as visiting a home with a pet.18 Due to its excellent safety profile, cromolyn is a first-line agent in children with AR.11,12... 

Azelastine nasal spray is indicated for children 5 years of age and older and is considered an alternative to intranasal corticosteroids in patients with persistent severe symptoms. Intranasal cromolyn, another commonly used agent in children, is indicated in patients 2 years of age and older and has an acceptable safety profile. However, limited efficacy and multiple daily administrations limit its use to mild and early rhinitis or for prophylaxis of a known imminent exposure. 

Other natural and nature identical preservatives with similar safety profile without the drawbacks of strong smell, strong colour, and short shelf life need to be developed to meet the consumer s needs. These would than gain the acceptance of the major multinational companies scientists and marketers, which would help to reduce overall allergy experienced from personal care products, and would enhance our lives and the standing of this industry. 

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