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Keppra® (levetiracetam)
Keppra® (levetiracetam)

... impaired renal function. A pharmacokinetic study in 16 elderly subjects (age 61-88 years) showed a decrease in clearance by about 40% with oral administration of both single dose and 10 days of multiple twice-daily dosing. This decrease is most likely due to the expected decrease in renal function i ...
Oral NSAIDs – An Update
Oral NSAIDs – An Update

... to possible CV risks, GI side effects and serious skin reactions. At this time, they concluded that the overall benefit-risk balance of these medicines was positive, but a small increased CV risk could not be excluded. As the data were limited, the CHMP suggested that the European commission fund in ...
COMPARATIVE BIOAVAILABILITY OF TWO LISINOPRIL
COMPARATIVE BIOAVAILABILITY OF TWO LISINOPRIL

... physical examination, hematological and urinary laboratory tests. Subjects did not take any other medications for at least 1 week prior to and throughout the study. Each subject fasted overnight before the experiment. Tablets were swallowed with 150 mL water. A light, normal lunch consisting of chee ...
FORMULATION AND EVALUATION OF ORODISPERSIBLE FILM OF SILDENAFILCITRATE Research Article
FORMULATION AND EVALUATION OF ORODISPERSIBLE FILM OF SILDENAFILCITRATE Research Article

... In such cases, bioavailability is significantly greater than that observed from conventional tablet dosage form[10, 11]. Hence, orally disintegrating systems may be anticipated to result in achievement of the required peak plasma concentration rapidly for drugs stable in the gastric pH. Oral films a ...
AusPAR: Efmoroctocog alfa (rhu) - Therapeutic Goods Administration
AusPAR: Efmoroctocog alfa (rhu) - Therapeutic Goods Administration

... Cell banking processes are satisfactory. All viral and prion safety issues have been addressed for the fermentation and purification processes. Physical and chemical properties The majority of rFVIIIFc is cleaved intracellularly. The non-cleaved single chain form, referred to as single chain rFVIIIF ...
Beyond the ABCs - Information for Professionals: Amphetamines
Beyond the ABCs - Information for Professionals: Amphetamines

... intravenous use becomes more and more attractive. Intravenous injection will produce greater effects for the same dose of drug and the effects occur much more rapidly (within minutes). An intense rush is more likely to occur when the drug is taken intravenously. Users can develop a very high degree ...
Eltroxin - Medsafe
Eltroxin - Medsafe

... not have been dispensed the new formulation until the end of 2007 or even early 2008. GlaxoSmithkline (GSK) made the decision to change the formulation. This was not due to a request from Medsafe or PHARMAC. The new formulation contains an identical active ingredient (thyroxine also known as levothy ...
PRODUCT MONOGRAPH ANAFRANIL - Sunovion Pharmaceuticals
PRODUCT MONOGRAPH ANAFRANIL - Sunovion Pharmaceuticals

... which are responsible for certain side effects. It also has weak antihistamine and antiserotonin properties, lowers the convulsive threshold, potentiates the effect of norepinephrine and other drugs acting on the central nervous system, has a quinidine-like effect on the heart and may impair cardiac ...
DRUG NAME: Sorafenib
DRUG NAME: Sorafenib

... Sorafenib inhibits glucuronidation by the UGT1A1 and UGT1A9 pathways. Systemic exposure to substrates of UGT1A1 and UGT1A9 may be increased when co-administered with sorafenib. Caution is recommended when administering sorafenib together with compounds that are metabolized/eliminated predominantly b ...
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS)
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS)

... by cross-linking to form clusters that are more readily ingested by phagocytic cells. The effect of MESI has indicated that immunostimulation achieved through humoral immunity. MESI was evaluated for in vivo immunomodulatory acitivity with antigen-antibody titer response i.e. haemagglutination titer ...
GATE 2009 Pharmaceutical Sciences Question Paper
GATE 2009 Pharmaceutical Sciences Question Paper

... (A) Polypeptide cytokines important in the inflammatory cascade (B) Prostaglandins that account for gastrointestinal disorders (C) Enkephalins which are specific for asthma (D) Dipeptides which have antimicrobial properties ...
Imodium Liquid, 2 mg/ 15 ml oral solution PL 15513/0182
Imodium Liquid, 2 mg/ 15 ml oral solution PL 15513/0182

... are well defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. PRECLINICAL No new preclinical data were submitted and none are required f ...
Injection Preparation and Administration
Injection Preparation and Administration

... Needle gauge for an intramuscular injection is generally a 21 gauge (green hub) needle. The gauge of the needle refers to the size of the lumen (bore), not the length of the needle. It is recommended that a blunt fill needle is used for drawing up change to a 21 gauge for the actual injection. Needl ...
FORMULATION AND EVALUATION OF LOSARTAN POTASSIUM SUSTAINED RELEASE TABLETS  Research Article
FORMULATION AND EVALUATION OF LOSARTAN POTASSIUM SUSTAINED RELEASE TABLETS Research Article

... Losartan potassium is a potent antihypertensive drug which is a highly specific Angiotensin II Type/AT 1 receptor antagonist. It is readily absorbed from the gastro intestinal tract, having oral bioavailability 33% and plasma elimination half life from 1.5 to 2.5 hours. The present study is an attem ...
5F-APINACA (5F-AKB-48) Review Report
5F-APINACA (5F-AKB-48) Review Report

... Studies on abuse and dependence potential of 5F-APINACA have not been performed, but users reported a rapidly developing dependence (tolerance, compulsive re-dosing, craving). A variety of withdrawal symptoms have been reported, such as chest pains and pressure, tachycardia and palpitations, ongoing ...
Development of BT1718, a novel Bicycle Drug Conjugate for the
Development of BT1718, a novel Bicycle Drug Conjugate for the

... tumor aggressiveness and invasiveness, NSCLC (94) ...
Focus on Lisdexamfetamine: A Review of its use in Child and
Focus on Lisdexamfetamine: A Review of its use in Child and

... duration of up to 13 hours. Administration of lisdexamfetamine via nasal or intravenous routes did not result in significant elevation of drug liking scores in known stimulant abusers, suggesting low potential for abuse. Lisdexamfetamine has been available in the United States since 2007, but was on ...
Votrient - Novartis Pharmaceuticals Corporation
Votrient - Novartis Pharmaceuticals Corporation

... fraction (LVEF) and congestive heart failure have occurred. In the overall safety population for RCC (N=586), cardiac dysfunction was observed in 0.6% (4/586) of patients without routine on-study LVEF monitoring. In a randomized RCC trial of VOTRIENT compared with sunitinib, myocardial dysfunction w ...
Cultivation of this plant and production of medicinal plant material is
Cultivation of this plant and production of medicinal plant material is

... A * Datura stramonium B Passiflora incarnata C Chelidonium majus D Hyoscyamus niger E Vinca minor At identification of poisonous raw material the fact, that such medicinal plants as Atropa belladonna, Hyoscyamus niger, Datura stramonium have a common microscopic diagnostic feature is taken into con ...
(PSD) November 2015 PBAC Meeting
(PSD) November 2015 PBAC Meeting

... The Australian Pain Society (APS), on the other hand, considered that there was a clinical need for additional strengths of oxycodone + naloxone at both the low and higher doses. The APS argued that the varied oxycodone + naloxone strengths would provide for greater flexibility in up- and down-titra ...
Full Prescribing Information
Full Prescribing Information

... "" Use the lowest dose necessary to obtain adequate cardiac visualization and individualize the weight-based dose depending on multiple factors, including, patient weight, imaging equipment and acquisition type used to perform the procedure. For example, 3D imaging acquisition may require doses at t ...
Antiobesity
Antiobesity

... than sibutramine or orlistat, and they were often used for longer than approved by the FDA. Despite the risk of adverse effects and the FDA recommendation for only short term use, data suggest phentermine has been widely prescribed for weight loss in the United States, often for durations longer tha ...
MDMA produces stimulant-like conditioned locomotor activity* I
MDMA produces stimulant-like conditioned locomotor activity* I

... sessions. The time course of the unconditioned locomotion produced by MDMA is shown for days I (A) and 5 (B) of the drug conditioning trials. Conditioned locomotion is measured on day 6 following saline injection {C). Ten minute means+SEM arc plotted. *P<0.05 exhibit it more elevated and stable leve ...
Stability testing protocols according to ICH guideline
Stability testing protocols according to ICH guideline

... generated as a function of time and storage conditions (e.g., temperature and relative humidity [RH]). Stability testing provides evidence that the quality of a drug substance or drug product under the influence of various environmental factors changes with time (2). Although the storage conditions ...
The  clinical  efficacy  of  inhaled ... ) in  the  treatment  of  asthma ®
The clinical efficacy of inhaled ... ) in the treatment of asthma ®

... group of patients (Group 4) who did not have optimal control of asthma using inhaled corticosteroids, as compared to Group 5 and also to patients maintained on bronchodilator treatment alone. The difference between Groups 4 and 5 did not appear to be dependent upon dose of inhaled corticosteroids. G ...
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