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Product Information for sofosbuvir
... Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorp ...
... Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorp ...
LITHIUM CARBONATE Extended-Release
... Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fail ...
... Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fail ...
Sacubitril / Valsartan salt complex
... aldosterone. ACE inhibitors block the deleterious effects of angiotensin II and, usually combined with a diuretic, they have formed the basis of treatment for many years. Additional complementary therapies include beta-blockers and aldosterone antagonists (MRAs). ACEIs are recommended as first-line ...
... aldosterone. ACE inhibitors block the deleterious effects of angiotensin II and, usually combined with a diuretic, they have formed the basis of treatment for many years. Additional complementary therapies include beta-blockers and aldosterone antagonists (MRAs). ACEIs are recommended as first-line ...
PRODUCT MONOGRAPH Cipralex Escitalopram Oxalate
... In animal reproduction studies, escitalopram has been shown to have adverse effects on embryo/fetal and postnatal development, when administered at doses greater than human therapeutic doses. (see TOXICOLOGY, Reproduction Toxicity). There are no adequate and well-controlled studies in pregnant women ...
... In animal reproduction studies, escitalopram has been shown to have adverse effects on embryo/fetal and postnatal development, when administered at doses greater than human therapeutic doses. (see TOXICOLOGY, Reproduction Toxicity). There are no adequate and well-controlled studies in pregnant women ...
Saccharomyces boulardii
... (metronidazole or vancomycin) for an average of 16 days in addition to S. boulardii one gram daily for 28 days (with overlap of antibiotic and S. boulardii for eight days).20 Individuals who had a history of recurrent C. difficile infections were given high-dose vancomycin (two grams daily) and S. b ...
... (metronidazole or vancomycin) for an average of 16 days in addition to S. boulardii one gram daily for 28 days (with overlap of antibiotic and S. boulardii for eight days).20 Individuals who had a history of recurrent C. difficile infections were given high-dose vancomycin (two grams daily) and S. b ...
PROPECIA
... PSA ≤3.0 ng/mL. Men received either PROSCAR® (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer wa ...
... PSA ≤3.0 ng/mL. Men received either PROSCAR® (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer wa ...
Public Assessment Report Mutual Recognition Procedure
... hypotension can occur in patients without prior risk, especially when high doses are prescribed. Therefore patients who receive high doses should be followed up for arrhythmia’s and hypotension Great care is necessary if nortriptyline is administered to hyperthyroid patients or to those receiving th ...
... hypotension can occur in patients without prior risk, especially when high doses are prescribed. Therefore patients who receive high doses should be followed up for arrhythmia’s and hypotension Great care is necessary if nortriptyline is administered to hyperthyroid patients or to those receiving th ...
Product Monograph
... Lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) levels in patients with primary hypercholesterolemia (Type IIa)† or combined (mixed) hyperlipidemia (Type IIb)† when the response to diet and other nonpharmacological measures alone has been inadequate. ZOCOR® (5-80 mg ...
... Lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) levels in patients with primary hypercholesterolemia (Type IIa)† or combined (mixed) hyperlipidemia (Type IIb)† when the response to diet and other nonpharmacological measures alone has been inadequate. ZOCOR® (5-80 mg ...
Risk Management Plan Rasagiline tablets
... indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline. Coadministration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%. Coadministration of rasagiline and theophylline (a substrate of CYP1A2) did ...
... indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline. Coadministration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%. Coadministration of rasagiline and theophylline (a substrate of CYP1A2) did ...
Version 7
... the chance of central undesirable effects, which may occur because of high maximum concentrations of buspirone. Increased dosages should be considered carefully and only after 4-5 days experience with the prior dosage. Elderly Patients Current data do not support a change in dosage regimen based on ...
... the chance of central undesirable effects, which may occur because of high maximum concentrations of buspirone. Increased dosages should be considered carefully and only after 4-5 days experience with the prior dosage. Elderly Patients Current data do not support a change in dosage regimen based on ...
PRODUCT MONOGRAPH ACCUTANE™ ROCHE isotretinoin
... isotretinoin is highly lipophilic, the passage of the drug in human milk is very likely. Because of the potential for adverse effects, women should not breast-feed if they are receiving ACCUTANE (see CONTRAINDICATIONS). Pediatrics: The long term safety of ACCUTANE, in prepubertal children (< 12 year ...
... isotretinoin is highly lipophilic, the passage of the drug in human milk is very likely. Because of the potential for adverse effects, women should not breast-feed if they are receiving ACCUTANE (see CONTRAINDICATIONS). Pediatrics: The long term safety of ACCUTANE, in prepubertal children (< 12 year ...
Therapeutic Guidelines in Systemic Fungal Infections
... Preface to the Third Edition An even greater understanding of the benefits and limitations of old and new antifungal agents is reflected in this edition of Therapeutic Guidelines in Systemic Fungal Infections. Each table has been revised to present antifungal treatment as it is used today, taking in ...
... Preface to the Third Edition An even greater understanding of the benefits and limitations of old and new antifungal agents is reflected in this edition of Therapeutic Guidelines in Systemic Fungal Infections. Each table has been revised to present antifungal treatment as it is used today, taking in ...
WELLBUTRIN® (bupropion hydrochloride) Tablets
... Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and ...
... Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and ...
LACTULOSE 3.3G/5ML ORAL SOLUTION PL 10321/0002 UKPAR
... of the physiological mode of action of Lactulose Liquid Ph. Eur it may take up to 48 hours before effects are obtained. In addition there is a carry-over effect which may enable the patient to reduce the effective dose gradually over a period of time. ...
... of the physiological mode of action of Lactulose Liquid Ph. Eur it may take up to 48 hours before effects are obtained. In addition there is a carry-over effect which may enable the patient to reduce the effective dose gradually over a period of time. ...
PRODUCT MONOGRAPH CYPROTERONE Cyproterone Acetate
... Infertility is usual, and there may be azoospermia after 8 weeks of therapy, which is associated with atrophy of seminiferous tubules. Follow-up examinations on discontinuation of therapy have shown these changes to be reversible. Spermatogenesis usually reverts to its previous level about 3 - 5 mon ...
... Infertility is usual, and there may be azoospermia after 8 weeks of therapy, which is associated with atrophy of seminiferous tubules. Follow-up examinations on discontinuation of therapy have shown these changes to be reversible. Spermatogenesis usually reverts to its previous level about 3 - 5 mon ...
Macrolides and ketolides: azithromycin, clarithromycin, telithromycin * Jerry M. Zuckerman, MD
... The macrolides and ketolides are lipophilic and are extensively distributed in body fluids and tissues. Mean tissue concentrations are 2- to 20-fold greater than serum concentrations for clarithromycin and are 10- to 100fold greater than serum concentrations for azithromycin [14,26]. Tissue concentra ...
... The macrolides and ketolides are lipophilic and are extensively distributed in body fluids and tissues. Mean tissue concentrations are 2- to 20-fold greater than serum concentrations for clarithromycin and are 10- to 100fold greater than serum concentrations for azithromycin [14,26]. Tissue concentra ...
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... addition, there is a considerable mismatch between clinical and electrographic diagnosis of neonatal seizure (11). Neonates can make jerky movements that may be misinterpreted as seizures and may rece ...
... addition, there is a considerable mismatch between clinical and electrographic diagnosis of neonatal seizure (11). Neonates can make jerky movements that may be misinterpreted as seizures and may rece ...
KLOR-CON® M (Potassium Chloride Extended - Upsher
... dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal ...
... dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal ...
Herpes Simplex Epithelial Keratitis and Proposed Treatments
... higher acyclovir dosage is most likely due to absorption of a higher drug concentration into corneal tissue. There may also be the added benefit of increased reduction of viral load in the ciliary ganglion and associated nerves, even if the corneal epithelium is not severely affected.16 Topical anti ...
... higher acyclovir dosage is most likely due to absorption of a higher drug concentration into corneal tissue. There may also be the added benefit of increased reduction of viral load in the ciliary ganglion and associated nerves, even if the corneal epithelium is not severely affected.16 Topical anti ...
Clinical Pharmacokinetics Of
... concentrations can be obtained at almost any time relative to the phenobarbital dose. As a matter of consistency, how ever, trough concentration are generally recommend and if phenobarbital is being adminisered by the intravenous route, care should be taken to sample at least one hour after the end ...
... concentrations can be obtained at almost any time relative to the phenobarbital dose. As a matter of consistency, how ever, trough concentration are generally recommend and if phenobarbital is being adminisered by the intravenous route, care should be taken to sample at least one hour after the end ...
MS_Word ~ 341 KB
... UK study states that only a minority of CD and UC sufferers are hospital inpatients but they account for approximately half the direct medical costs of IBD treatment. Drug costs contribute less than a quarter of the ...
... UK study states that only a minority of CD and UC sufferers are hospital inpatients but they account for approximately half the direct medical costs of IBD treatment. Drug costs contribute less than a quarter of the ...
Corneal Collagen Cross-Linking
... and results from 1 trial have reported that these benefits are maintained at 2 to 3 years. From these RCTs, one can conclude that CXL reduces, and in some cases, reverses the corneal steepening that leads to a reduction in visual acuity in the short term. Greater uncertainty exists regarding the lon ...
... and results from 1 trial have reported that these benefits are maintained at 2 to 3 years. From these RCTs, one can conclude that CXL reduces, and in some cases, reverses the corneal steepening that leads to a reduction in visual acuity in the short term. Greater uncertainty exists regarding the lon ...
November 2015 – Positive Recommendations (Word 80KB)
... (Minor Submission) AFLIBERCEPT 40 mg/mL solution for intravitreal injection. The injection volume is 50µL (equivalent to 2mg aflibercept) / Single-use vial or prefilled syringe / 1 single-use vial in a carton or pre-filled syringe in a blister pack. Eylea® ...
... (Minor Submission) AFLIBERCEPT 40 mg/mL solution for intravitreal injection. The injection volume is 50µL (equivalent to 2mg aflibercept) / Single-use vial or prefilled syringe / 1 single-use vial in a carton or pre-filled syringe in a blister pack. Eylea® ...
Report on the Deliberation Results April 27, 2012 Evaluation and
... 2 diabetes mellitus has been demonstrated and its safety is acceptable in view of its observed benefits. Safety information on hypoglycemia, gastrointestinal disorder, pancreatitis, hepatic impairment, etc., as well as the safety and efficacy in patients with renal impairment, patients with hepatic ...
... 2 diabetes mellitus has been demonstrated and its safety is acceptable in view of its observed benefits. Safety information on hypoglycemia, gastrointestinal disorder, pancreatitis, hepatic impairment, etc., as well as the safety and efficacy in patients with renal impairment, patients with hepatic ...
Ofloxacin
Ofloxacin is a synthetic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone.Ofloxacin was first patented in 1982 (European Patent Daiichi) and received approval from the U.S. Food and Drug Administration (FDA) on December 28, 1990. Ofloxacin is sold under a wide variety of brand names as well as generic drug equivalents, for oral and intravenous administration. Ofloxacin is also available for topical use, as eye drops and ear drops (marketed as Ocuflox and Floxin Otic respectively in the United States and marketed as Optiflox, eylox respectively in Jordan and Saudi Arabia).Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin.Ofloxacin has been associated with adverse drug reactions, such as tendon damage (including spontaneous tendon ruptures) and peripheral neuropathy (which may be irreversible); tendon damage may manifest long after therapy had been completed, and, in severe cases, may result in lifelong disabilities.