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09107sgp04
09107sgp04

... It was found that this resulted in some cardiovascular interactions at high doses. In rats, mild atria myocarditis(心肌炎)and focal coronary arteritis(動脈炎) were transient effects that resolved with regular dosing. In dogs, heart rate increases were greater after co-administration than after salmeterol ...
Codeine Therapy in the Context of Cytochrome P450 2D6
Codeine Therapy in the Context of Cytochrome P450 2D6

... to variations in the CYP2D6 gene independent of drug metabolism and response. Although there are some isolated reports of CYP2D6 genetic effects on phenotypes other than in relation to drug response,4,5 these findings have not been consistently reproduced in other studies. Other considerations Modif ...
EVALUATION OF ANTI-INFLAMMATORY ACTIVITY OF ALCOHOLIC EXTRACT OF LEAVES OF
EVALUATION OF ANTI-INFLAMMATORY ACTIVITY OF ALCOHOLIC EXTRACT OF LEAVES OF

SERETIDE ACCUHALER/DISKUS™
SERETIDE ACCUHALER/DISKUS™

... Well controlled asthma; less than or equal to 2 days with symptom score greater than 1 (symptom score 1 defined as ‘symptoms for one short period during the day’), SABA use on less than or equal to 2 days and less than or equal to 4 occasions/week, greater than or equal to 80% predicted morning peak ...
Pharmacogenomics of Tamoxifen Therapy Review
Pharmacogenomics of Tamoxifen Therapy Review

... As compared with the parent drug, both metabolites have an approximately 100-fold greater affinity for the estrogen receptor and the ability to inhibit cell proliferation. The polymorphic CYP2D6 is the key enzyme in this biotransformation, and recent mechanistic, pharmacologic, and clinical evidence ...
(venlafaxine hydrochloride) (Extended-Release Capsules) EFFEXOR XR
(venlafaxine hydrochloride) (Extended-Release Capsules) EFFEXOR XR

...  Do not take an MAOI within 7 days of stopping EFFEXOR XR unless directed to do so by your physician.  Do not start EFFEXOR XR if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. People who take EFFEXOR XR close in time to an MAOI may have serious or even ...
Radius Health, Inc. - Nasdaq`s INTEL Solutions
Radius Health, Inc. - Nasdaq`s INTEL Solutions

... such holder to a partner of such holder, or a retired partner of such holder who retires after the date hereof, or the estate of any such partner or retired partner if, with respect to such Transfer by a partnership, (i) such Transfer is made in accordance with the partnership agreement of such par ...
Hyperforin as a natural antidepressant: an overview
Hyperforin as a natural antidepressant: an overview

... Hyperforin exhibits significant antidepressant activity.1 Biochemical research demonstrates that hyperforin - like many prescription antidepressants - inhibits the reuptake of the neurotransmitters norepinephrine, serotonin, and dopamine.2 All three of these compounds are naturally found in the brai ...
Phenylpropanolamine There are four optical isomers of
Phenylpropanolamine There are four optical isomers of

... for the Tenth Circuit in Denver upheld the FDA's final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the United States.[5] Ephedrine is, however, still legal in many applications outside of dietary supplements. However, purc ...
Neurologic Effects of Caffeine - Health301Co
Neurologic Effects of Caffeine - Health301Co

... Quinlan et al from the United Kingdom randomized subjects after overnight caffeine abstention. In the first study (n=17), the caffeine level was manipulated by preparing tea and coffee at different strengths (equivalent of 1-2 cups). Caffeine levels were 37.5 mg and 75 mg in tea and 75 mg and 150 mg ...
Resveratrol
Resveratrol

... While some complementary and alternative techniques have been studied scientifically, high-quality data regarding safety, effectiveness, and mechanism of action are limited or controversial for most therapies. Whenever possible, it is recommended that practitioners be licensed by a recognized profes ...
The GCC Data Requirements for Human Drugs Submission Content
The GCC Data Requirements for Human Drugs Submission Content

...  For a drug product with multiple strengths: one complete “3.2.P” section should be provided with the information for the different strengths provided within the subsections. One complete copy of the dossier should be provided for each strength.  For a drug product with multiple container closure ...
11146002
11146002

... extensively bound to plasma protein. Prednisolone is excreted in the urine as free and conjugated metabolites, together with an appreciable amount of unchanged Prednisolone. Prednisolone crosses the placenta and small amounts are excreted in breast milk. The biological half-life of Prednisolone last ...
ADHD: CT Studies
ADHD: CT Studies

... • amphetamines increase risk of sudden cardiac death with structural cardiac abnormalities and other serious heart problems, esp. Adderall • Starting with long acting formulation is better ...
Increased risk of atherothrombotic events associated with
Increased risk of atherothrombotic events associated with

... Recent reports have indicated a lack of platelet inhibitory activity by clopidogrel (clopidogrel resistance) in some patients.5–8 The drug interaction of clopidogrel with CYP3A inhibitors has been suggested as a mechanism of this resistance.9–11 Clopidogrel is a prodrug that needs to be metabolized ...
Supersensitive Kappa Opioid Receptors Promotes Ethanol
Supersensitive Kappa Opioid Receptors Promotes Ethanol

... Representative signals were analyzed before drug application to determine dopamine release per electrical stimulation (μM) and uptake (Vmax, μM/sec). Representative traces after drug application were similarly analyzed. The effects of U50,488 on dopamine release across the concentration response cur ...
Ion channel regulators for the treatment of cystic fibrosis
Ion channel regulators for the treatment of cystic fibrosis

... a Phase  II trial, during which patients were exposed to increasing drug doses for 14 days. An additional group of patients was exposed to 150, 250  mg or placebo during 28  days. The improvement in sweat chloride seen was remarkable: several patients normalized their sweat chloride throughout the t ...
PSAPVII_Book4_ Pediatrics.indb
PSAPVII_Book4_ Pediatrics.indb

... concluded that more than 70% of all drugs listed in the Physicians’ Desk Reference were not labeled for use in pediatric patients. Around that time, a regulatory approach to correct the lack of pediatric drug studies and information available was devised. In 1994, the FDA had requested that spons ...
Drug Coverage Criteria - Med
Drug Coverage Criteria - Med

... Restriction Criteria: Bextra will be available without prior authorization if the following are appropriate: 1. The recipient is over age 60; 2. With a diagnosis code of osteoarthritis or degenerative joint disease (Diagnosis code 715.90 or rheumatoid arthritis (Diagnosis code 714.0); and 3. The rec ...
Dear Sir/Madam - University of Michigan College of Pharmacy
Dear Sir/Madam - University of Michigan College of Pharmacy

...  Vesicare and Sanctura for the Treatment of Overactive Bladder. The major goal of this project is to compare several therapies for the treatment for of bothersome urge urinary incontinence in women. PI: Cathy Spino, Consultant: Rose Feng (5% effort).  Development of an anti-norovirus Inhibitor (NI ...
A clickable analogue of ketamine retains NMDA receptor activity
A clickable analogue of ketamine retains NMDA receptor activity

... norketamine could act intracellularly to produce some behavioral effects. To explore the viability of this latter hypothesis, we examined intracellular accumulation of novel visualizable analogues of ketamine/ norketamine. We introduced an alkyne “click” handle into norketamine (alkyne-norketamine, ...
Medical treatment with phototherapy
Medical treatment with phototherapy

... of the skin is a type of therapy without any photo-sensitizing agent. It is the oldest form of treatment, and it is based on the experience with the favorable effects of sunlight on the general appearance of the skin. Numerous investigations show(6,7) that phototherapy with UVB is just as effective ...
High dose intravenous immunoglobulin treatment: Mechanisms of
High dose intravenous immunoglobulin treatment: Mechanisms of

... significantly different from each other with respect to chemical structure, antibody content, subclass distribution, and electrophoretic profile. When commercial products are compared for antibody activity to various bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and ...
EFSA provisional statement on a request form the European
EFSA provisional statement on a request form the European

... Data on the toxicity of cyanuric acid are scarce (Canelli, 1974; Hammond et al., 1986; US-EPA, 2007). Cyanuric acid has a very low acute toxicity in rats (LD50 >5000 mg/kg b.w.). The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has assessed sodium dichloroisocyanurate which is rapidly an ...
Treatment of Pulmonary Arterial Hypertension
Treatment of Pulmonary Arterial Hypertension

... and inhibits the growth of smooth-muscle cells.43 In the control group, the survival rate was 58 perIn addition, it is a powerful inhibitor of platelet ag- cent at one year, 43 percent at two years, 33 pergregation.42,44 Intravenous prostacyclin (epopros- cent at three years, and 28 percent at five ...
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Bilastine



Bilastine (trade name Bilaxten) is a second generation antihistamine drug for the treatment of allergic rhinoconjunctivitis and urticaria (hives).It exerts its effect as a selective histamine H1 receptor antagonist, and has a effectiveness similar to cetirizine, fexofenadine and desloratadine. It was developed in Spain by FAES Farma.Bilastine is approved in the European Union for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria, but it is not approved by the U.S. Food and Drug Administration for any use in the United States. Bilastine meets the current European Academy of Allergy and Clinical Immunology (EAACI) and Allergic Rhinitis and its Impact of Asthma (ARIA) criteria for medication used in the treatment of allergic rhinitis.Bilastine has been effective in the treatment of ocular symptoms and diseases of allergies, including rhinoconjuctivitis. Additionally, bilastine has been shown to improve quality of life, and all nasal and ocular symptoms related to allergic rhinitis.
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