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TABLE 4. SIGNIFICANT LABELING CHANGES OR "DEAR HEALTH PROFESSIONAL LETTERS" RELATED TO SAFETY Generic Name Brand Name Company ; Atropine AtroPen King Pharmaceuticals Cefotetan Cefotan AstraZeneca Fludarabine Fludara Berlex Laboratories Warning Web Site, for example, avodart liver.
Exclusively amongst themselves to further any purpose authorized by statute or charter, or an employee in the executive or legislative branch of state government or a quasi-public agency, whether in the classified or unclassified service and full or part-time, and only in such person's capacity as a state or quasi-public agency employee. "Prospective state contractor" means a person, business entity or nonprofit organization that i ; submits a response to a state contract solicitation by the state, a state agency or a quasi-public agency, or a proposal in response to a request for proposals by the state, a state agency or a quasi-public agency, until the contract has been entered into, or ii ; holds a valid prequalification certificate issued by the Commissioner of Administrative Services under section 4a100. "Prospective state contractor" does not include a municipality or any other political subdivision of the state, including any entities or associations duly created by the municipality or political subdivision exclusively amongst themselves to further any purpose authorized by statute or charter, or an employee in the executive or legislative branch of state government or a quasi-public agency, whether in the classified or unclassified service and full or parttime, and only in such person's capacity as a state or quasi-public agency employee. "Principal of a state contractor or prospective state contractor" means i ; any individual who is a member of the board of directors of, or has an ownership interest of five per cent or more in, a state contractor or prospective state contractor, which is a business entity, except for an individual who is a member of the board of directors of a nonprofit organization, ii ; an individual who is employed by a state contractor or prospective state contractor, which is a business entity, as president, treasurer or executive vice president, iii ; an individual who is the chief executive officer of a state contractor or prospective state contractor, which is not a business entity, or if a state contractor or prospective state contractor has no such officer, then the officer who duly possesses comparable powers and duties, iv ; an officer or an employee of any state contractor or prospective state contractor who has managerial or discretionary responsibilities with respect to a state contract, v ; the spouse or a dependent child who is eighteen years of age or older of an individual described in this subparagraph, or vi ; a political committee established or controlled by an individual described in this subparagraph or the business entity or nonprofit organization that is the state contractor or prospective state contractor. "State contract" means an agreement or contract with the state or any state agency or any quasi-public agency, let through a procurement process or otherwise, having a value of fifty thousand dollars or more, or a combination or series of such agreements or contracts having a value of one hundred thousand dollars or more in a calendar year, for i ; the rendition of services, ii ; the furnishing of any goods, material, supplies, equipment or any items of any kind, iii ; the construction, alteration or repair of any public building or public work, iv ; the acquisition, sale or lease of any land or building, v ; a licensing arrangement, or vi ; a grant, loan or loan guarantee. "State contract" does not include any agreement or contract with the state, any state agency or any quasi-public agency that is exclusively federally funded, an education loan or a loan to an individual for other than commercial purposes. "State contract solicitation" means a request by a state agency or quasi-public agency, in whatever form issued, including, but not limited to, an invitation to bid, request for proposals, request for information or request for quotes, inviting bids, quotes or other types of submittals, through a competitive procurement process or another process authorized by law waiving competitive procurement. "Managerial or discretionary responsibilities with respect to a state contract" means having direct, extensive and substantive responsibilities with respect to the negotiation of the state contract and not peripheral, clerical or ministerial responsibilities. "Dependent child" means a child residing in an individual's household who may legally be claimed as a dependent on the federal income tax of such individual. "Solicit" means A ; requesting that a contribution be made, B ; participating in any fund-raising activities for a candidate committee, exploratory committee, political committee or party committee, including, but not limited to, forwarding tickets to potential contributors, receiving contributions for transmission to any such committee or bundling contributions, C ; serving as chairperson, treasurer or deputy treasurer of any such committee, or D ; establishing a political committee for the sole purpose of soliciting or receiving contributions for any committee. Solicit does not include: i ; making a contribution that is otherwise permitted by Chapter 155 of the Connecticut General Statutes; ii ; informing any person of a position taken by a candidate for public office or a public official, iii ; notifying the person of any activities of, or contact information for, any candidate for public office; or iv ; serving as a member in any party committee or as an officer of such committee that is not otherwise prohibited in this section.
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DRUG NAME PA QLL $$$$ ATROVENT QLL $$$$ FLOVENT HFA QLL $$$$$ COMBIVENT QLL $$$$$ EPIPEN QLL $$$$$ EPIPEN JR. QLL $$$$$ PULMICORT QLL $$$$$ TILADE QLL !!!!! ADVAIR DISKUS QLL !!!!! DUONEB QLL !!!!! INTAL QLL !!!!! SPIRIVA QLL 15.1.4 LEUKOTRIENE MODIFIERS $$$$$ ACCOLATE PAR !!!!! SINGULAIR PAR 15.2.1 ANTIHISTAMINES $ cyproheptadine hcl $ promethazine hcl $$$$ ALLEGRA PAR, QLL $$$$ CLARINEX PAR, QLL $$$$ ZYRTEC PAR, QLL 15.2.3 ANTIHISTAMINE DECONGESTANT COMBINATIONS $ promethazine vc $$$ SEMPREX-D PAR $$$ ZYRTEC-D PAR, QLL PAR, QLL $$$$ ALLEGRA-D $$$$ CLARINEX-D PAR, QLL $$$$ RYNATAN PAR 15.3 ANTITUSSIVE AND EXPECTORANT DRUGS $ benzonatate $ guaifenesin w codeine $ guaifenex pse $ hydrocodone w guaifenesin $ promethazine vc w codeine $ promethazine w codeine $ promethazine w dm $$$$ TUSSIONEX 16.1.1 ANTICHOLINERGIC ANTISPASMODICS $ oxybutynin chloride $$$ ENABLEX $$$ SANCTURA $$$ VESICARE $$$$ DETROL, -LA $$$$ DITROPAN XL $$$$ OXYTROL 16.1.3 URINARY ANESTHETICS $ phenazopyridine hcl 16.1.4 OTHER GENITOURINARY PRODUCTS $$ UROXATRAL $$$ FLOMAX $$$ LEVITRA $$$$ AVODART $$$$ CIALIS $$$$ PROSCAR $$$$ VIAGRA and dutasteride.
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Changes identifi ed in OA cartilage i nclude cartilage thinni ng, micro-fibrillation, and the disruption of the cartilage bone interfac e. In s ome cases , cartilage breakdown was identified prior to cartilage thinning using PS-OCT demonstrati ng differences in the rate of optic al rotation meas ured both off A-scans and fast fourier transfor m FFT ; . Si milar obser vati ons were noted when comparing healthy versus diseas ed tendons and ligaments. In addition, abs orption and dispersion OCT spectrosc opy has yi elded information on water content, which is also relevant to OA. Conclusion: This study demonstrates that OCT i maging provides an exc ellent model for the sequential monitoring of OA. The high resolution and polarization s ensiti vity of OCT allows the early detection of surfac e fibrillations, changes i n cartilage thickness , and changes in the bone-cartilage interfac e, providing a val uabl e tool for the testing of therapeutics. In conclusion, OCT represents a pr omising new technolog y for assessing early s ubtle OA and ziagen.
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Despite the high risk associated with SciClone's product pipeline, the company is distinct from most early-stage pharmaceutical companies due to its established revenue stream from international sales of Zadaxin. Unlike other companies that trade exclusively on technology value, SciClone does have revenue-generating assets. Applying a 3-4x multiple to "normalized" Zadaxin revenue of $22.5 million implies a $70 million - $90 million value for this asset, excluding the pending opportunities in HCV and HBV. We also note that the company currently has over $60 million in cash on hand, enough to fund operations through the completion of the ongoing phase III HCV trials in the U.S. As a result, nearly half of the current market cap is represented by current Zadaxin sales and the company's cash position, which suggests a reasonable risk adjusted value for the U.S. hepatitis C market opportunity.
M. WHSER Department of Psychiatry, Sheba Medical Center, Tel Hashomer 52621, Israel and precose.
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A PIM Glossary has been published but the table below provides additional definitions of terms used in the present document. Term Application Number Baseline Definition Unique identifier of a running application, composed of the core number, the marker of the procedure type, and a sequence number. The baseline is the last submission inline with a positive CHMP opinion or with a positive EC decision. There is one baseline per product. Each new baseline automatically supersedes the previous one. Applicant decision to stop the marketing of a product, or a portion of a product The conversion is a process that transforms a PIM submission from a DES version to another one. The core number is the application number for the initial marketing authorisation for that product. For human products under centralised procedure, it consists of 4 parts: EMEA, H for Human ; , C for Centralised ; and a number. The marker is one or more characters that identify a procedure type. "Merge" is the process by which a part of the Product Information coming from one submission is combined with the Product Information of another submission. The intention of the "merge process" is to become a new set of documents that contain all the relevant information of both submissions. In certain cases this "merge process" can be automated in other cases human intervention is needed to combine the Product Information of the two submissions. The migration is a process that transforms product information from paper RTF or Ms Word ; to PIM XML ; . The linguistic merge is a business process that compiles translations in different languages of the same English texts, into a single PIM file. The reference is the term used to identify that texts of a submission utilise texts that have been approved in the context of another application. Temporary decision to cancel the marketing authorisation of a product or a portion of a product Definitive decision to cancel the marketing authorisation of a product or a portion of a product and salbutamol.
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Bagnall A-M, Jones L, Richardson G, Duffy S, Riemsma R. Effectiveness and cost-effectiveness of acute hospital-based spinal cord injuries services: systematic review. Health Technol Assess 2003; 7 19.
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This pilot and feasibility study examined a data collection tool in a pediatric population with symptoms of irritable bowel syndrome IBS ; . IBS, a functional gastrointestinal disorder, was a particularly appropriate focus for the study because the absence of biological indicators for IBS means that measures of treatment outcome must rely exclusively on patients' reports of their symptoms Drossman, 1994 ; . Recent studies have demonstrated that symptoms associated with IBS affect a significant number of children and adolescents Hyams et al., 1996; Walker, Guite, Duke, Barnard, & Greene, 1998 ; . New drugs for the treatment of IBS have been evaluated in adults e.g., Camilleri et al., 1999 ; but have not yet been tested in children. Neither the assessment questions nor the data collection tools in the adult outcome studies are appropriate for children and calciferol.
The principles of the Canada Health Act began as simple conditions attached to federal funding for medicare. Over time, they became much more than that. Today, they represent both the values underlying the health care system and the conditions that governments attach to funding a national system of public health care. The principles have stood the test of time and continue to reflect the values of Canadians." -- Roy J. Romanow, Q.C. November, 2002 ; What is the Canada Health Act? The Canada Health Act is Canada's federal health insurance legislation. The Act sets out the primary objective of Canadian health care policy: ".to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers." The Canada Health Act establishes criteria and conditions related to insured health care services and extended health care services that the provinces and territories must meet in order to receive the full federal cash contribution under the Canada Health and Social Transfer CHST ; . The aim of the Canada Health Act is to ensure that all eligible residents of Canada have reasonable access to medically necessary insured services on a prepaid basis, without direct charges at the point of service for such services. Key Definitions under the CHA There are two types of services defined in the Canada Health Act. Insured health care services are medically necessary hospital, physician and surgical-dental services provided to insured persons. Insured hospital services are defined under the Canada Health Act and include medically necessary in- and outpatient services such as standard or public ward accommodation; nursing services; diagnostic procedures such as blood tests and x-rays; drugs administered in hospital; and the use of operating rooms, case rooms and anaesthetic facilities. Insured physician services are defined under the Act as "medically required services rendered by medical practitioners." Medically required physician services are generally determined by physicians in conjunction with their provincial and territorial health insurance plans. Insured surgical-dental services are services provided by a dentist in a hospital, where a hospital setting is required to properly perform the procedure. Extended health care services as defined in the Canada Health Act are certain aspects of long-term residential care nursing home intermediate care and adult residential care services ; , and the health aspects of home care and ambulatory care services.
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Experimental Animals Our experiments were conducted in accordance with the National Institutes of Health guidelines for the care and use of experimental animals. Male 3-mo-old Swiss-Webster mice were fed lab chow diets supplemented with 2% creatine, or 0.005% rofecoxib or their combination for 1 wk before MPTP administration. Standard unsupplemented lab chow diet served as a control. We examined 12 mice in each group for neurochemistry and 10 mice in each group for histology. MPTP 20 mg kg, 5 mL kg, intraperitoneally ; was administered four times at 2-h intervals to the mice. The animals were killed 1 wk after MPTP treatment, and both striata were rapidly dissected on a chilled glass plate and frozen at 70C. The samples were subsequently thawed in 0.4 mL of chilled 0.1 M perchloric acid and sonicated. Aliquots were taken for protein quantification using a spectrophotometric assay. Other aliquots were centrifuged, and dopamine, 3, 4-dihydroxyphenylacetic acid DOPAC ; and homovanillic acid HVA ; were measured in the supernatants by high performance Journal of Molecular Neuroscience, for example, avodart buy.
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