The Australian Clinical Trial Handbook
... Declaration of Helsinki. This document was first developed post-WWII as a result of the revelations of the Nuremberg trials, to ensure that human subjects involved in clinical research would, in future, forever have their rights, safety and well-being placed above all other priorities in clinical re ...
... Declaration of Helsinki. This document was first developed post-WWII as a result of the revelations of the Nuremberg trials, to ensure that human subjects involved in clinical research would, in future, forever have their rights, safety and well-being placed above all other priorities in clinical re ...
Antiviral drugs for cytomegalovirus diseases
... In the heart transplant study, patients were given study drug for 28 days post-transplant. The incidence of CMV illness at post-transplant day 120 was assessed, with the results stratified based on the recipient’s serostatus. For seropositive recipients, significantly fewer patients given GCV had CM ...
... In the heart transplant study, patients were given study drug for 28 days post-transplant. The incidence of CMV illness at post-transplant day 120 was assessed, with the results stratified based on the recipient’s serostatus. For seropositive recipients, significantly fewer patients given GCV had CM ...
as terbinafine base
... occur in patients treated with terbinafine tablets should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with terbinafine tablets. Carcinogenesis and Mutagenesis An increase in liver tumours was observed in male rats ...
... occur in patients treated with terbinafine tablets should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with terbinafine tablets. Carcinogenesis and Mutagenesis An increase in liver tumours was observed in male rats ...
Prescribing Information
... Corticosteroids have been shown to impair fertility in animal studies. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnant and Nursing Woman Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregna ...
... Corticosteroids have been shown to impair fertility in animal studies. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnant and Nursing Woman Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregna ...
Moxy® drug-coated balloon: a novel device for the treatment of
... novo femoropopliteal stenosis. Treatment with another DCB (paclitaxelcoated at 3 µg/mm2, hydrophilic carrier) resulted in significantly lower late loss at six months33 and lower TLR rates at two years follow-up34. Further evidence of DCB efficacy is being investigated in the LEVANT I multicentre, si ...
... novo femoropopliteal stenosis. Treatment with another DCB (paclitaxelcoated at 3 µg/mm2, hydrophilic carrier) resulted in significantly lower late loss at six months33 and lower TLR rates at two years follow-up34. Further evidence of DCB efficacy is being investigated in the LEVANT I multicentre, si ...
A randomized, double-blind, placebo
... nerve typically in the third intermetatarsal space. The pain can be severe and especially problematic with walking. Treatment options are limited and surgery may lead to permanent numbness in the toes. Capsaicin, the pungent ingredient of hot peppers, produces analgesia by inducing retraction of noc ...
... nerve typically in the third intermetatarsal space. The pain can be severe and especially problematic with walking. Treatment options are limited and surgery may lead to permanent numbness in the toes. Capsaicin, the pungent ingredient of hot peppers, produces analgesia by inducing retraction of noc ...
PREZISTA® - Janssen
... dose ritonavir is 30% lower, compared to intake with food. Therefore, PREZISTA tablets should be taken with ritonavir and with food. The type of food does not affect exposure to darunavir. Distribution Darunavir is approximately 95% bound to plasma protein. Darunavir binds primarily to plasma alpha- ...
... dose ritonavir is 30% lower, compared to intake with food. Therefore, PREZISTA tablets should be taken with ritonavir and with food. The type of food does not affect exposure to darunavir. Distribution Darunavir is approximately 95% bound to plasma protein. Darunavir binds primarily to plasma alpha- ...
DOXYCYCLINE CAPSULES, USP
... growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic ...
... growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic ...
Morphine Sulphate Data sheet May 14
... with morphine-induced postural hypotension particularly in elderly or debilitated patients. The dosage should be adjusted according to individual needs but, because of reduced clearance, dosage may be lower in patients over 50 years of age. Nausea and Vomiting: Nausea and vomiting are common after s ...
... with morphine-induced postural hypotension particularly in elderly or debilitated patients. The dosage should be adjusted according to individual needs but, because of reduced clearance, dosage may be lower in patients over 50 years of age. Nausea and Vomiting: Nausea and vomiting are common after s ...
Slide 1 - The Immunology Report
... 26. Oh C, Huh J, Lee J, et al. Multicenter randomized clinical investigation for the safety and efficacy of Advagraf (extended-release tacrolimus) vs Prograf (twice-daily tacrolimus) in de novo Korean adult kidney recipients [abstract]. Am J Transplant. 2013;13(suppl 5):317. 27. Andrés A, Gonzalez E ...
... 26. Oh C, Huh J, Lee J, et al. Multicenter randomized clinical investigation for the safety and efficacy of Advagraf (extended-release tacrolimus) vs Prograf (twice-daily tacrolimus) in de novo Korean adult kidney recipients [abstract]. Am J Transplant. 2013;13(suppl 5):317. 27. Andrés A, Gonzalez E ...
Clinical Implications of Dihydropyrimidine
... toxicities, which are thought to be secondary to 5-FU catabolites, may be eliminated by using a DIF drug such as UFT. Several articles within this supplement provide evidence of the efficacy and tolerable toxicity of UFT. Page 2 of 5 ...
... toxicities, which are thought to be secondary to 5-FU catabolites, may be eliminated by using a DIF drug such as UFT. Several articles within this supplement provide evidence of the efficacy and tolerable toxicity of UFT. Page 2 of 5 ...
(PSD) March 2015 PBAC Meeting
... The price proposed for the new strengths was based on pricing derivation advised by the Pharmaceutical Benefits Pricing Authority manual, where if the new strength is double that of an existing strength it should be priced at one and two-thirds of the existing strength. In line with this methodology ...
... The price proposed for the new strengths was based on pricing derivation advised by the Pharmaceutical Benefits Pricing Authority manual, where if the new strength is double that of an existing strength it should be priced at one and two-thirds of the existing strength. In line with this methodology ...
U.S. Prescribing Information
... Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifoc ...
... Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifoc ...
Reyataz label - HIV Drug Resistance Database
... REYATAZ (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks durat ...
... REYATAZ (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks durat ...
20110503_Manuscript - international journal of advances in
... from more than 1,000 centres in about 40 countries. The study drug was apixaban 5 mg BD and warfarin 2 mg was used as a control for the reduction of stroke in atrial fibrillation. The primary efficacy outcome is the time to first occurrence of stroke or systemic embolism and the primary safety endpo ...
... from more than 1,000 centres in about 40 countries. The study drug was apixaban 5 mg BD and warfarin 2 mg was used as a control for the reduction of stroke in atrial fibrillation. The primary efficacy outcome is the time to first occurrence of stroke or systemic embolism and the primary safety endpo ...
Steps to better asthma care
... • Patients should be offered an ICS inhaler if they use their ßagonist inhaler more than three times per week or have had an exacerbation in the past two years • It is generally considered that combination inhalers aid compliance and also have the advantage of guaranteeing that any long-acting β2-ag ...
... • Patients should be offered an ICS inhaler if they use their ßagonist inhaler more than three times per week or have had an exacerbation in the past two years • It is generally considered that combination inhalers aid compliance and also have the advantage of guaranteeing that any long-acting β2-ag ...
Pharmacological Therapies for Obesity Lee M. Kaplan, MD, PhD
... Goals of pharmacological therapy Available pharmacological treatments for obesity can be effective adjuncts to diet- and exercise-based behavioral therapies, typically increasing the amount of weight loss by 4% to 6% (eg, from a weight loss of 4% to a weight loss of 8%) over 1 to 2 years [3]. In all ...
... Goals of pharmacological therapy Available pharmacological treatments for obesity can be effective adjuncts to diet- and exercise-based behavioral therapies, typically increasing the amount of weight loss by 4% to 6% (eg, from a weight loss of 4% to a weight loss of 8%) over 1 to 2 years [3]. In all ...
The Effects of Using Color Foods of Children on Immunity Properties
... show no significant increase in serum AST when compared control group. Also, the level of AST was significant increase in group administration of ketchup potato chips at concentration 30% reached to 11.2%. A significant increase in serum ALT and AST may be attributed those change in liver function t ...
... show no significant increase in serum AST when compared control group. Also, the level of AST was significant increase in group administration of ketchup potato chips at concentration 30% reached to 11.2%. A significant increase in serum ALT and AST may be attributed those change in liver function t ...
Tricyclic Antidepressants
... • Results in rapid fluid shifts causing significant haemodynamic effects (hypoxia and hypotension) – may not be tolerated in patients with severe poisoning ...
... • Results in rapid fluid shifts causing significant haemodynamic effects (hypoxia and hypotension) – may not be tolerated in patients with severe poisoning ...
Australian public assessment for everolimus
... everolimus does not generally result in tumour regression and it is not effective against all human breast carcinomas tested in vitro. In vitro studies in aromatase expressing breast cancer cell lines (MCF7/Aro) showed increased anti proliferation activity for the everolimus/letrozole combination co ...
... everolimus does not generally result in tumour regression and it is not effective against all human breast carcinomas tested in vitro. In vitro studies in aromatase expressing breast cancer cell lines (MCF7/Aro) showed increased anti proliferation activity for the everolimus/letrozole combination co ...
Fentanyl Data Sheet Oct 13
... narcotics, alcohol and general anaesthetics, will have additive or potentiating effects with fentanyl. When patients have received such medicines, the dose of fentanyl required will be less than usual. Likewise, following the administration of fentanyl the dose of other CNS depressant medicines shou ...
... narcotics, alcohol and general anaesthetics, will have additive or potentiating effects with fentanyl. When patients have received such medicines, the dose of fentanyl required will be less than usual. Likewise, following the administration of fentanyl the dose of other CNS depressant medicines shou ...
Potential Ocular Side Effects of Select Systemic Drugs
... This Poster is brought to you for free and open access by the College of Optometry at CommonKnowledge. It has been accepted for inclusion in Faculty Scholarship (COO) by an authorized administrator of CommonKnowledge. For more information, please contact [email protected]. ...
... This Poster is brought to you for free and open access by the College of Optometry at CommonKnowledge. It has been accepted for inclusion in Faculty Scholarship (COO) by an authorized administrator of CommonKnowledge. For more information, please contact [email protected]. ...
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.