diclofenac - Endo Pharmaceuticals
... ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID t ...
... ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID t ...
Cardizem LA
... dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance. Pharmacokinetics and Metabolism Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous adminis ...
... dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance. Pharmacokinetics and Metabolism Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous adminis ...
Flagystatin (metronidazole, nystatin)
... Metronidazole is bactericidal against anaerobic bacteria; it exerts trichomonacidal activity and is also active against Giardia lamblia and Entamoeba histolytica. Its exact mechanism of action has not been entirely determined as yet. It has been proposed that an intermediate in the reduction of metr ...
... Metronidazole is bactericidal against anaerobic bacteria; it exerts trichomonacidal activity and is also active against Giardia lamblia and Entamoeba histolytica. Its exact mechanism of action has not been entirely determined as yet. It has been proposed that an intermediate in the reduction of metr ...
Part I: Summary of Product Information
... should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection. If the other medicinal products used in combination with Gratisovir are permanently discontinued, Gratisovir should also be discontinued. Treatment-experienced patients with genotype 1,4,5 a ...
... should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection. If the other medicinal products used in combination with Gratisovir are permanently discontinued, Gratisovir should also be discontinued. Treatment-experienced patients with genotype 1,4,5 a ...
Treatment in Acute MI
... Maximal ADP-induced platelet aggregation 4 hours after administration of a 300-, 600-, and 900- mg loading dose An increase of the clopidogrel loading dose from 600 to 900 mg does not result in further suppression of platelet aggregation caused by a failed increase in plasma concentration of the dr ...
... Maximal ADP-induced platelet aggregation 4 hours after administration of a 300-, 600-, and 900- mg loading dose An increase of the clopidogrel loading dose from 600 to 900 mg does not result in further suppression of platelet aggregation caused by a failed increase in plasma concentration of the dr ...
LM - Prevalite Powder - Upsher
... In a large, placebo-controlled, multi-clinic study, LRC-CPPT1, hypercholesterolemic subjects treated with cholestyramine resin had mean reduction in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the sev ...
... In a large, placebo-controlled, multi-clinic study, LRC-CPPT1, hypercholesterolemic subjects treated with cholestyramine resin had mean reduction in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the sev ...
a reanalysis of the collaborative ocular melanoma study medium
... recalculated doses to originally reported doses (⫾1 SD) and the range (for the central 95% of the data points) of ratios for each plaque size and structure of interest combination. These ratios ranged from 79% to 93%, with the mean change reflecting primarily the 10% reduction due to attenuation by ...
... recalculated doses to originally reported doses (⫾1 SD) and the range (for the central 95% of the data points) of ratios for each plaque size and structure of interest combination. These ratios ranged from 79% to 93%, with the mean change reflecting primarily the 10% reduction due to attenuation by ...
Guidelines for the prescribing and administration of `when required
... Although ‘PRN’ prescribing is a valuable and useful intervention, (particularly in those with acute, fluctuating conditions) it is open to misuse if it is used unnecessarily or inappropriately, increasing the risk of patients being given above the BNF maximum licensed dose, in addition to a total cu ...
... Although ‘PRN’ prescribing is a valuable and useful intervention, (particularly in those with acute, fluctuating conditions) it is open to misuse if it is used unnecessarily or inappropriately, increasing the risk of patients being given above the BNF maximum licensed dose, in addition to a total cu ...
Paresthesia (including formication) (postmarketing AE), reformating
... The mean elimination half-life is 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children aged 6 to 12 years compared to that in adults (t1/2 is 10 hours for d-amphetamine and 13 hours for l-amphetamine in adults, and 9 hours and 11 hours, respectively, for children). Chi ...
... The mean elimination half-life is 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children aged 6 to 12 years compared to that in adults (t1/2 is 10 hours for d-amphetamine and 13 hours for l-amphetamine in adults, and 9 hours and 11 hours, respectively, for children). Chi ...
Felbamate (PDF, 63KB, File is accessible)
... Hepatitis, severe; hepatic failure, acute (sometimes fatal) (see section 4.4) Rash, Hypersensitivity reactions (including Stevens-Johnson syndrome, bullous eruption, toxic epidermal necrolysis) (see section 4.4) Crystalluria ...
... Hepatitis, severe; hepatic failure, acute (sometimes fatal) (see section 4.4) Rash, Hypersensitivity reactions (including Stevens-Johnson syndrome, bullous eruption, toxic epidermal necrolysis) (see section 4.4) Crystalluria ...
prescribing information
... intramuscular dose on a mg/m2 basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg daily for 10 days (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). Although, there are no adequate and wellcontrolled studies in pre ...
... intramuscular dose on a mg/m2 basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg daily for 10 days (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). Although, there are no adequate and wellcontrolled studies in pre ...
CO-DIOVAN - GuildLink
... The main objective for the extension studies 11E and 31E was to obtain long term tolerability, safety and efficacy data in adult patients with hypertension treated with valsartan and hydrochlorothiazide. Patients whose blood pressure was inadequately controlled in the extension phase of these studi ...
... The main objective for the extension studies 11E and 31E was to obtain long term tolerability, safety and efficacy data in adult patients with hypertension treated with valsartan and hydrochlorothiazide. Patients whose blood pressure was inadequately controlled in the extension phase of these studi ...
ZYTIGA - Medsafe
... The major enzymes involved in the metabolism of abiraterone are CYP3A4 for phase I (oxidative) metabolites, the sulfotransferase (SULT) isozyme SULT2A1, and UDP-glucuronosyl transferase (UGT) UGT1A4. No studies have been conducted to determine if drugs that induce or inhibit these enzymes affect the ...
... The major enzymes involved in the metabolism of abiraterone are CYP3A4 for phase I (oxidative) metabolites, the sulfotransferase (SULT) isozyme SULT2A1, and UDP-glucuronosyl transferase (UGT) UGT1A4. No studies have been conducted to determine if drugs that induce or inhibit these enzymes affect the ...
CN Palsy Update - Alberta Association of Optometrists
... Acute, unilateral facial paralysis can occur from damage to the facial nerve secondary to infcctiolr, inflafiunation, compression, or trauma. T]rc diagnosis of Bell's palsy is reserved for those cases in which the precipitating event cannot be identified (i.e, idiopathic CN 7 palsy) ...
... Acute, unilateral facial paralysis can occur from damage to the facial nerve secondary to infcctiolr, inflafiunation, compression, or trauma. T]rc diagnosis of Bell's palsy is reserved for those cases in which the precipitating event cannot be identified (i.e, idiopathic CN 7 palsy) ...
3 0 M a r c h 1 6 ,
... open to the public for observation and participation. Anyone wishing to make an oral presentation should notify the contact person listed above 8s soon as possible before the meeting. The request should state the amount of time desired, the capacity in which the person will appear. and 8 brief outli ...
... open to the public for observation and participation. Anyone wishing to make an oral presentation should notify the contact person listed above 8s soon as possible before the meeting. The request should state the amount of time desired, the capacity in which the person will appear. and 8 brief outli ...
HƯỚNG DẪN VỀ DƯỢC PHẨM INCIVEK
... ribavirin may cause birth defects and fetal death, telaprevir in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. (4, 5.3, 8.1, 17.2) Co-administration with drugs that: are highly dependent on CYP3A for clearance an ...
... ribavirin may cause birth defects and fetal death, telaprevir in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. (4, 5.3, 8.1, 17.2) Co-administration with drugs that: are highly dependent on CYP3A for clearance an ...
... to that of placebo. In controlled pediatric clinical trials, the incidence of treatment-related headache, sedation and nervousness, which were rarely reported events, was similar to that of placebo. CONTRAINDICATIONS: LORATADINE (CLARITIN*) products are contraindicated in patients who have shown hyp ...
update on antiplatelet therapy in the treatment and prevention
... A randomized, double-blind placebo controlled trial of 15,603 patients (79% ) with established CVD and 21% with multiple risk factors designed to test whether clopidogrel should be continued beyond 1 year in addition to aspirin. All patients received daily aspirin(75-162mg) and were randomized to da ...
... A randomized, double-blind placebo controlled trial of 15,603 patients (79% ) with established CVD and 21% with multiple risk factors designed to test whether clopidogrel should be continued beyond 1 year in addition to aspirin. All patients received daily aspirin(75-162mg) and were randomized to da ...
Word 68KB
... The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing of nivolumab for the treatment of locally advanced or metastatic, squamous or non-squamous, non-small cell lung cancer (NSCLC) in patients who meet certain conditions. The PBAC considere ...
... The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing of nivolumab for the treatment of locally advanced or metastatic, squamous or non-squamous, non-small cell lung cancer (NSCLC) in patients who meet certain conditions. The PBAC considere ...
Epclusa - Gilead
... EPCLUSA with ribavirin, 6 subjects and 4 subjects were assessed to have Child-Pugh A and Child-Pugh C cirrhosis, respectively [see Clinical Studies (14.3)]. The most common adverse reactions (adverse events assessed as causally related by the investigator, all grades with frequency of 10% or greate ...
... EPCLUSA with ribavirin, 6 subjects and 4 subjects were assessed to have Child-Pugh A and Child-Pugh C cirrhosis, respectively [see Clinical Studies (14.3)]. The most common adverse reactions (adverse events assessed as causally related by the investigator, all grades with frequency of 10% or greate ...
Xyrem - Annexes - European Commission
... Common: blood pressure increased In some patients, cataplexy may return at a higher frequency on cessation of sodium oxybate therapy, however this may be due to the normal variability of the disease. Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at thera ...
... Common: blood pressure increased In some patients, cataplexy may return at a higher frequency on cessation of sodium oxybate therapy, however this may be due to the normal variability of the disease. Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at thera ...
amikai
... trial design, regulatory and business strategies, plans and objectives of management, growth opportunities for existing and proposed products, financial projections and estimates and their underlying assumptions, and statements regarding future performance. Forward-looking statements are generally i ...
... trial design, regulatory and business strategies, plans and objectives of management, growth opportunities for existing and proposed products, financial projections and estimates and their underlying assumptions, and statements regarding future performance. Forward-looking statements are generally i ...
VIOXX® - Merck.com
... presence of a saturable route of metabolism (i.e., non-linear elimination). The effective half-life (based on steady-state levels) was approximately 17 hours. Special Populations Gender The pharmacokinetics of rofecoxib are comparable in men and women. Geriatric After a single dose of 25 mg VIOXX in ...
... presence of a saturable route of metabolism (i.e., non-linear elimination). The effective half-life (based on steady-state levels) was approximately 17 hours. Special Populations Gender The pharmacokinetics of rofecoxib are comparable in men and women. Geriatric After a single dose of 25 mg VIOXX in ...
Constipation - Australian Medicines Handbook
... approximately 8.1 mmol (186 mg) sodium per sachet; Movicol-Half® and Movicol Junior® sachets contain approximately half this); consider impact of sodium intake in certain patients (eg those with heart failure). ...
... approximately 8.1 mmol (186 mg) sodium per sachet; Movicol-Half® and Movicol Junior® sachets contain approximately half this); consider impact of sodium intake in certain patients (eg those with heart failure). ...
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.