Nexium esomeprazole magnesium, manufactured by AstraZeneca AB ; Nimotop nimodipine, manufactured by Bayer Corporation ; Nolvadex tamoxifen citrate, manufactured by Astra Zeneca ; Couflox ofloxacin ophthalmic solution, manufactured by Allergan ; Orfadin nitisinone, manufactured by Apoteket AB ; Ortho-Novum norethindrone ethinyl estradiol, manufactured by Ortho-McNeil Pharmaceutical ; Ovidrel choriogonadotropin alfa for injection, manufactured by Serono S.A. ; OxyContin oxycodone HCl controlled-release, manufactured by Purdue Pharma L.P. ; Pegasys peginterferon alfa-2a, manufactured by Hoffman-La Roche Inc. ; PEG-Intron TM peginterferon alfa-2b, manufactured by Schering Corporation ; Prilosec omeprazole, manufactured by Merck & Co., Inc., and distributed by AstraZeneca LP ; Prinivil lisinopril, manufactured by Merck & Co., Inc.
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Represented 15%, 12% and 9% of total Company sales in 2000, 1999 and 1998, respectively. The period of new chemical entity exclusivity in the United States for Alphagan R ; ophthalmic solution extends for five years from the date of approval. Allergan sells Alphagan R ; ophthalmic solution in 69 countries worldwide. Allergan filed two new drug applications "NDAs" ; with the FDA in 2000 for glaucoma products. In the third quarter of 2000, Allergan filed an NDA in the U.S. and in the fourth quarter of 2000 filed a Marketing Authorization Application "MAA" ; in Europe for Lumigan TM ; , a topical treatment for elevated intraocular pressure in patients with glaucoma or ocular hypertension. The FDA approved Lumigan TM ; in March 2001 for the reduction of elevated intraocular pressure "IOP" ; in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP lowering medications or insufficiently responsive failed to achieve target IOP determined after multiple measurements over time ; to another IOP-lowering medication. The second NDA was for Alphagan R ; P, a reformulation containing brimonodine, the active ingredient in Alphagan R ; ophthalmic solution, preserved with Purite R ; . The FDA also approved Alphagan R ; P in March 2001 for the lowering of IOP in patients with open-angle glaucoma and ocular hypertension. Alphagan R ; P ophthalmic solution lowers IOP by reducing aqueous humor production and increasing uveoscleral outflow, while data suggests that Lumigan TM ; ophthalmic solution lowers IOP by increasing the outflow of aqueous humor through trabecular meshwork and uveoscleral routes. The Company intends to launch both products in 2001. The Company also markets Betagan R ; ophthalmic solution, a topical beta blocker used in the treatment of glaucoma, and Propine R ; ophthalmic solution, which is used alone or in combination with other drugs when initial drug therapy for glaucoma becomes inadequate. Patent protection for both products expired in the United States in 1991 and they both face generic competition from several companies including Bausch & Lomb and Alcon Laboratories, Inc. a division of Nestle ; . In addition, the Company markets its own generic version of these two products. INFLAMMATION Allergan's leading ophthalmic anti-inflammatory product is Acular R ; 1 ; ophthalmic solution. It is indicated for the relief of itch associated with seasonal allergic conjunctivitis and for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Acular R ; PF was the first unit-dose, preservative-free topical nonsteroidal anti 1 ; Acular R ; is a registered trademark of and is licensed from its developer Syntex U.S.A. ; Inc. 2 inflammatory drug NSAID ; in the United States, and is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery. Pred Forte R ; and FML R ; Liquifilm R ; ophthalmic suspensions are Allergan's products in the ocular corticosteroid inflammation market. INFECTION Allergan's major products in the anti-infective market are Ocufloxx R ; Oflox R ; Exocin R ; ophthalmic solution, a fluroquinolone which treats bacterial conjunctivitis and corneal ulcers, Blephamide R ; ophthalmic suspension, a topical anti-inflammatory and anti-infective, and Polytrim R ; ophthalmic solution, a synthetic antimicrobial which treats surface ocular bacterial infections. Blephamide R ; , Pred Forte R ; and Polytrim R ; ophthalmic solutions no longer have patent protection and face generic competition. McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, is Allergan's marketing partner for Ocutlox R ; ophthalmic solution in the U.S. pediatric and selected general practitioner markets. ALLERGY Allergan launched Alocril R ; ophthalmic solution in early 2000. Alocril R ; is indicated for the treatment of itch associated with allergic conjunctivitis. The allergy market, is by its nature, a seasonal market, peaking during the Spring months. OCULAR SURFACE DISEASE In addition to its eye care pharmaceuticals, Allergan markets a variety of artificial tear products for various needs, under a range of brand names worldwide, led by the Refresh R ; brand. In the United States, the Refresh R ; brand includes Refresh Plus R ; , Refresh Tears R ; , and Refresh P.M. R ; Allergan also markets Celluvisc R ; in the United States for severe dry eye. Other Allergan brands marketed around the world include the, Liquifilm Tears R ; and Lacri-Lube R ; S.O.P. R ; products as well as Lerin R ; , a decongestant. Allergan has filed an NDA and an MAA for Restasis TM ; , a prescription ophthalmic emulsion product for the treatment of chronic dry.
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In the case of the first or second regimen, when virus is wild type or harbours few resistance mutations, maintaining an undetectable viral load is an achievable goal of therapy; in this setting, treatment failure is best defined as inability to achieve a viral load below assay detection limits 50 copies mL ; or as any sustained return of the viral load to above the target value 400 copies mL ; . With increasing rounds of treatment failure, the level and spectrum of virus resistance may increase, and it may be and oxybutynin.
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You can ask Customer Service for a list of similar drugs that are covered by PARTNERS .When you receive the list, show it to your doctor and ask him or her to prescribe a similar drug that is covered by PARTNERS . You can ask PARTNERS to make an exception and cover your drug. See below for information about how to request an exception. How do I request an exception to the PARTNERS Formulary? You can ask us to cover your drug even if it is not on our formulary and prednisolone, for example, quinolone.
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You show signs of keratconus corneal disease ; You have a tendency to form scars You are taking one or more of the following medications: o Accutane isotretinoin ; o Cordarone amiodarone hydrochloride ; HOW LASIK CORRECTS YOUR VISION LASIK stands for laser in-situ keratomileusis. The LASIK procedure combines two sophisticated techniques of surgery to correct nearsightedness. The first technique uses an automated microsurgical instrument, the microkeratome, to create a protective flap of corneal tissue that covers the area to be sculpted by the laser. This protective flap allows for an early recovery of vision and reduces discomfort after surgery. This technique, called keratomileusis, has been performed by surgeons around the world for approximately thirty years and has been refined for use in the LASIK procedure. The second technique uses a computer-controlled excimer laser a cold, invisible, ultraviolet laser to reshape the cornea by removing extremely small amounts of tissue in a prescribed shape. During LASIK, the microtome creates a protective flap of corneal tissue, which is folded back. The excimer laser is then used to reshape the bed of the flap, which is then replaced into position. No sutures are needed. Depending upon the appearance of the corneal epithelium at the end of the procedure, the surgeon may elect to place a thin contact lens, which will remain in position the first day following surgery. The laser sculpting causes curvature of the cornea to flatten, reducing or eliminating myopia. Astigmatism may be treated with the laser or by making small incisions in the cornea with a diamond knife. THE LASIK SURGICAL EXPERIENCE WARNING FOR PATIENTS WITH DRUG ALLERGIES The following medications may be used during LASIK, either as eye drops or orally. If you have an allergy to any of the following drugs, notify the Eye Clinic staff before your treatment so that alternative medication can be selected: Proparacaine Demerol Ocuflix Mydriacyl Phenergan Tobramycin Phenylephrine Acular Fluromethalone.
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Perfusion CT to identify patients for delayed treatment, and the first clinical trials using this imaging modality for patient selection are only just beginning. The current concerns with perfusion CT are clearly surmountable and it is likely that it will be used widely in future neuroprotection trials, along with DWI PWI. Another approach to Phase IIB trial design is to use Bayesian methodology and decision theory to assign a greater percentage of patients to doses more likely to demonstrate benefit. Such an approach was utilized in the ASTIN Acute Stroke Therapy by Inhibition of Neutrophils ; trial of a polymorphonuclear leucocyte inhibitor [53]. In this study, the knowledge base was continually updated based on the actual outcomes of patients at different dose assignments in the trial, and assignment of patients was modified in response to this accruing information to assign more patients to more informative treatment arms. A clinical outcome measure, the Scandinavian Stroke Scale, was used to assess outcome and 16 different dose arms were included in the study. In the ASTIN trial, a stopping rule continuously ascertained if a particular dose had a 10% chance of success futility ; or a 90% chance of success. The trial ultimately did not show that any of the doses evaluated demonstrated a successful treatment effect, but the value of the trial is apparent as it showed that adaptive design trials can be performed with neuroprotective drugs. Refining the outcome measure used in adaptive design trial should be considered for future trials, such as using an MRI-based endpoint or a clinical endpoint adapted to baseline severity. A neuroprotective drug demonstrating a reasonable treatment effect in an imaging-based or adaptive design-based clinical endpoint Phase IIB trial should then advance to a pivotal Phase III trial with a clinical endpoint. Until the recently presented SAINT StrokeAcute Ischaemic NXY Treatment ; -I trial of the free radical scavenger NXY-059, the endpoints employed in all previous neuroprotective acute stroke therapy trials were dichotomous or trichotomous [29]. A typical approach was to define success as a statistically significant increase in the percentage of patients who achieved an mRS modified Rankin Scale ; score of 01 or the active treatment group as compared with the placebo group. Such an approach did show a statistically significant treatment effect in the NINDS National Institute of Neurological Disorders and Stroke ; trial of rt-PA when dichotomized outcomes on the mRS, Barthel and NIHSS National Institutes of Health Stroke Scale ; were evaluated [29]. A robust treatment effect was observed in all three of these dichotomized outcome measures, driven by the 50% of patients in the trial in whom treatment was started within 90 min of stroke onset. Defining successful treatment as an mRS of 01, Barthel Index of 95100 and or an NIHSS of 01 essentially means that the patient has little or no functional, activity of daily living or neurological deficit, i.e. a `cure' [54]. This may have been appropriate for rt-PA initiated within 3 h after stroke onset but it may not be the optimal way to evaluate more subtle but meaningful treatment effects likely to be engendered by neuroprotective agents or even delayed.
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9. Blier P. Pharmacology of rapid-onset antidepressant treatment strategies. J Clin Psychiatry 62 Suppl 15: 12-17, 2001, for example, fluoroquinolone.
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Found it necessary to purchase the webbing and supply it to Delco as governmentfurnished material GFM ; in order to "optimize contract delivery." AR, Tab 10, Source Selection Decision Document, at 5. Based on this information, the agency concluded that Delco's "minimal edge" in ABVS delivery scores was "more than offset by 1 ; the positive recommendation . for Weckworth; 2 ; Delco's current delinquencies on the same item; and 3 ; Delco's production delays for this same item on a previous contract which required intervention in the form of Government Furnished Material . AR, Tab 10, Source Selection Decision Document, at 9. Since the firms were rated the same for quality performance and Weckworth's price was lower, the agency made award to Weckworth. Upon learning of the award, Delco filed an agency-level protest. That protest was denied, and Delco then filed this protest with our Office. Delco argues that the evaluation of its delivery performance was unreasonable because the recent late deliveries that led to the downgrading of its proposal were due, not to its own actions, but to late deliveries by its webbing supplier. Delco asserts that it had expressed its concerns to the agency about its webbing supplier, and that the agency therefore knew that Delco was not to blame for the late deliveries. Delco also asserts that the agency improperly considered allegedly incorrect information from its supplier that Delco had credit problems and a poor 2 payment history. The evaluation of past performance is a matter within the discretion of the contracting agency that our Office will review to ensure that it was reasonable and consistent with the stated evaluation criteria. NLX Corp., B-288785, B-288785.2, Dec. 7, 2001, CPD 198 at 7. An agency's past performance evaluation may be based on a reasonable perception of inadequate prior performance, regardless of whether the contractor disputes the agency's interpretation of the underlying facts. Ready Transp., Inc., B-285283.3, B-285283.4, May 8, 2001, CPD 90 at 5. The evaluation here was reasonable. First, while the record shows that the agency indeed was aware that Delco held its supplier responsible for the late deliveries, the agency had no information--and the record contains none--definitively showing that Delco's position regarding the cause of the delinquencies was the correct one. Rather, the agency was aware that the delivery problems may be due to other problems Delco was having; the agency states--without purporting to adjudicate any In its protest, Delco also argued that the agency improperly evaluated its quality performance because it failed to consider Delco's extensive experience in manufacturing large quantities of cargo nets. The agency responded to this argument in its report, and since Delco did not rebut the agency's position in its comments on the report, we consider this issue abandoned. Westinghouse Gov't and Envtl. Servs. Co., Inc., B-280928 et al., Dec. 4, 1998, 99-1 CPD 3 at 7 n.6 and eldepryl.
Objective: Increased plasma levels of inflammatory cyokines are reported in patients with several psychiatric disorders. We investigated whether these phenomena are specific to some disorders. Method: Plasma levels of Interleukin-1beta IL-1 b ; , IL-6, IL-18, TNF-alpha, and IFN-gamma were measured by ELISA in non-medicated 9 patients with depressive disorder, 5 with anxiety, 4 with adjustment, and 15 normal controls. Results: The level of IL-18 in each patient group mean 366 pg ml ; was significantly higher than that in control mean 211 pg ml ; , but other cyokines were undetectable in our assay system 20pg ml ; . There was no significant difference in the level of IL-18 among each patient group. Conclusion: Increase of IL-18 plasma level in the patient group is presumed due to a certain kind of non-specific stress reaction. However, sensitive elevation of IL-18 might have significance in mental health studies. References: Z. Kronfol et al 2000 ; : Cyokines and the Brain: Implications for Clinical Psychiatry, J Psychiatry, 157, 683-694 U.H. Frommberger et al 1997 ; : Interleukin-6 IL-6 ; Plasma Levels in Depression between the Acute State and After remission, Eur Arch Psychiatry Clin Neurosci, 247, 228-233.
Colado MI, O'Shea E, Green AR: Acute and long-term effects of MDMA on cerebral dopamine biochemistry and function. Psychopharmacology Berl ; 2004, 173: 249-263. This is another very good review focusing on the effects of MDMA on the DA system. 5. 6. Simantov R: Multiple molecular and neuropharmacological effects of MDMA Ecstasy ; . Life Sci 2004, 74: 803-814. Mayerhofer A, Kovar KA, Schmidt WJ: Changes in serotonin, dopamine and noradrenaline levels in striatum and nucleus and feldene and ocuflox, because side affects.
Emergency contraception use and the evaluation of barrier contraceptives. New challenges for study design, implementation, and analysis Contraception 1998 Dec; 58 6 ; : 379-86 Dominik R, Trussell J, Dorflinger L Family Health International FHI ; , Research Triangle Park, North Carolina27513, USA. rdominik fhi The availability of emergency contraception EC ; introduces new complexities to barrier contraceptive evaluation. Researchers must determine whether the primary objective of interest is to measure the effectiveness of the barrier plus EC back-up or the effectiveness of the barrier alone. Barrier contraceptive effectiveness study protocols must specify what study volunteers will be told about EC, under what conditions EC will be dispensed, what information about EC use will be collected, and how EC use will be addressed during data analysis. REVIEW, TUTORIAL.
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In the initiation and maintenance of cardiac hypertrophy Cooper et al., 1985 ; , then a reduction of hemodynamic challenge may cause obvious but reversible alterations in cardiac hypertrophy, hyperfunction, and dysfunction Cooper and Tomanek, 1982; Thompson et al., 1984 ; . This study demonstrated that relief of aortic constriction after a period of constriction actually reversed hemodynamic changes, including HR, SV, CO, Rp, aortic impedance, and compliance. However, some cardiac function including fo, Wo, Wo Wt, Pb and Pf, were still abnormal even after constriction ended. A hypertrophied heart with depleted ventricular NE and EPI concentration still remained lower than normal even 4 weeks after aortic constriction in group C ended. The depletion of NE and EPI in the left ventricle was also noted in rats which received vasodilators during aortic constriction. Therefore, we suggest that a reduction in afterload due to either mechanical or pharmacologic action can keep a hypertrophied heart from deteriorating, but that already present compensatory changes in the myocardium are irreversible. The persistence of cardiac hypertrophy, combined with ventricular catecholamine depletion, implies the occurrence of cardiac decompensation and heart failure. Constriction of the aortic lumen above the renal arteries reduces the renal blood flow and elicits a prompt reaction in the renin-angiotensin system Yagi et al., 1968; Symbas et al., 1983; Morgan and Baker, 1991; Kromer and Riegger, 1985; Salgado and Salgado, 1989; Baker et al., 1990; Sadoshima and Izumo, 1993 ; . Moreover, it also causes an increase in plasma catecholamines and the renin concentration in systemic circulation Gelman et al., 1990; Symbas et al., 1983; Normann et al., 1983 ; . However, the complexity of neurohumoral response for vasopression and or hypertrophic role on the myocardium still remains controversial Morgan and Baker, 1991; Salgado et al., 1994; Sen et al., 1974, 1977, 1981; Sen and Tarazi, 1983.
We acknowledge the participation of the following investigators: J. Aloia, M.D. Mineola, NY A. Bankhurst, M.D. Albuquerque, NM D. Baylink, M.D. Loma Linda, CA R. Beyerlein, M.D. Eugene, OR M. B. Block, M.D. Phoenix, AZ M. A. Bolognese, M.D. Gaithersburg, MD S. L. Bonnick, M.D. Denton, TX D. Brecher, M.D. Palm Harbor, FL W. Brown, M.D. Pittsburgh, PA C. H. Chesnut, M.D. Seattle, WA L. M. Cohen, M.D. Sarasota, FL S. Corson, M.D. Philadelphia, PA M. Davidson, M.D. Chicago, IL M. Drehobl, M.D. San Diego, CA B. L. Drinkwater, Ph.D. Seattle, WA F. E. Dunlap, M.D. Tuscon, AZ R. D. Emkey, M.D. West Reading, PA E. Evans, M.D. Seattle, WA R. Freeman, M.D. Bronx, NY S. A. Funk, M.D. Atlanta, GA J. C. Gallagher, M.D. Omaha, NE R. Gottesfeld, M.D. Denver, CO M. Greenwald, M.D. Palm Springs, CA M. Heuer, M.D. Gainesville, FL B. Kessel, M.D. Boston, MA R. A. Khairi, M.D. Indianapolis, IN M. Kleerekoper, M.D. Detroit, MI M. Layton, M.D. Olympia, WA R. Levitt, M.D. Laurel, MD S. E. Lipton, M.D. Philadelphia, PA J. Lucas, M.D. Fort Lauderdale, FL M. McClung, M.D. Portland, OR M. T. McDermott, M.D. Austin, TX N. H. E. Mezitis, M.D. New York, NY D. Mishell, M.D. Los Angeles, CA L. Nachtigall, M.D. New York, NY L. Olansky, M.D. Oklahoma City, OK C. Rosen, M.D. Bangor, ME P. J. Sulak, M.D. Temple, TX S. L. Schwartz, M.D. San Antonio, TX L. L. Shane, M.D. White Plains, NY S. L. Silverman, M.D. Beverly Hills, CA R. Stoltz, M.D. Evansville, IN T. Stovall, M.D. WinstonSalem, NC S. Swanson, M.D. Lincoln, NE M. Vranian, M.D. Richmond, VA R. L. Young, M.D. Houston, TX ; . Received March 7, 2001. Accepted June 6, 2001. Address all correspondence and requests for reprints to: J. Christopher Gallagher, M.D., Creighton University Medical Center, St. Joseph's Hospital, 601 North 30th Street, Suite 6712, Omaha, Nebraska 68131. E-mail: jcg creighton . This study was supported by a grant from Organon Inc. West Orange, NJ.
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Single dose was 100 mg for fasted healthy subjects, and 200 mg for fed subjects.6 For a single 100 mg dose, the area under the plasma concentration-time curve AUC ; was 4.87 1.41 mg.h L, whereas the 12-hour AUC for multiple doses of 50 mg every 12 hours was 3.07 0.38 mg.h L.7 Age, sex and ethnicity did not appear to affect the pharmacokinetic parameters of the drug in healthy volunteers. 8 It was moderately protein-bound 71% to 87% ; , and had a large volume of distribution 7.2 8.6 L kg ; suggesting extensive, for example, phlebitis.
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