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Hepatic in Medical Technology

Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting

... cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, ... elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal ...

New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure

... reactions that have occurred in adults. hepatic Impairment Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since ... of fluid and electrolyte balance may precipitate hepatic coma. Hypersensitivity Reaction ...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

... of the olmesartan medoxomil component. hepatic Impairment Since amlodipine is extensively ... is 56 hours in patients with severely impaired hepatic function, caution should be exercised when administering AZOR to patients with severe hepatic impairment. Laboratory Tests There was a ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... bleeding, Child-Pugh class C, grade 2 or higher hepatic encephalopathy, ascites requiring therapeutic ... significant reduction in clinical events of hepatic decompensation on protocol-defined secondary ... of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; ... treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than ... C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; ... treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than ... C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha ...

Dr. James F. Pingpank to Present at Leading Regional Therapies Conference

... company testing its proprietary Percutaneous hepatic Perfusion ("PHP(TM)") System for the treatment of ... of High-dose Melphalan (MEL) Administered via hepatic Arterial Infusion for Patients with Unresectable hepatic Metastases from ...

Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia

... taking dose. Use caution in patients with hepatic impairment. ECGs should be obtained to monitor ... CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days ... abnormality Serum bilirubin and hepatic transaminases The use of Tasigna may result ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... dose should be used for patients with severe hepatic impairment. Patients with moderate renal ... taking dose. Use with caution in patients with hepatic impairment. ECGs should be obtained to monitor ... CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days ...

FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

... clinical symptoms of liver injury or evidence for hepatic decompensation. Reinitiating treatment with ... when administering PROMACTA to patients with hepatic disease. Use a lower starting dose of PROMACTA in patients with moderate to severe hepatic disease and monitor closely. Bone ...

Journal of Clinical Oncology Publishes Leukine(R) Study Demonstrating Positive Survival Outcomes in Patients with High-Risk Melanoma

... cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, ... elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or ...

Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanoma Patients

... cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, ... elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or ...

CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI

... receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used ... count (ANC) cardiac, and up to 3.6% of hepatic transplant patients receiving CellCept 3 g ... of renal, in 1.7% of cardiac, and in 5.4% of hepatic transplant patients treated with CellCept 3 g ...

Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function

... receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used ... up to 2.8% of cardiac, and up to 3.6% of hepatic transplant patients receiving CellCept 3 g ... of renal, in 1.7% of cardiac, and in 5.4% of hepatic transplant patients treated with CellCept 3 g ...

Strength and Innovation of Novartis Oncology Products and Pipeline With Potential to Improve Patient Treatment Demonstrated by More Than 170 Abstracts at ASCO Annual Meeting

... taking dose. Use with caution in patients with hepatic impairment. ECGs should be obtained to monitor ... CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days ... Liver function abnormality Serum bilirubin and hepatic transaminases: Tasigna may result in elevations ...

New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENICAR HCT(R)

... adverse reactions that have occurred in adults. hepatic Impairment Thiazides should be used with ... of fluid and electrolyte balance may precipitate hepatic coma. Hypersensitivity Reaction ... (creatinine clearance < 40 mL/min), or in hepatic dysfunction. In patients with possible depletion ...

Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune(R) (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients

... VIRAMUNE. Any patient can experience hepatic events; however, female gender and higher CD4+ ... cells/mm3 unless the benefit outweighs the risk. hepatic events are often associated with rash. ... Patients should be intensively monitored for hepatic and skin reactions for the first 18 weeks of ...

Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders

... aimed at developing new therapies for hepatic disease." About GT4P GT4P is composed of a ... caution when administering to patients with hepatic or renal insufficiency. AMMONUL(R) may cause ... Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta ...

Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA

... B or C co-infection or patients with mild hepatic impairment. -- Liver function tests should be ... for reports of: -- Clinical hepatitis and hepatic decompensation including some fatalities. ... with reports of clinical hepatitis and hepatic decompensation, including some fatalities. Extra ...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

... Doses to Subjects with Mild or Moderate Chronic hepatic Insufficiency" Cethromycin at 300 mg once daily for seven days was well tolerated by subjects with hepatic impairment and subjects with normal hepatic function. The results suggest that no dose ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... blood chemistry tests to evaluate renal and hepatic function. Dose adjustments to pemetrexed and/or ... See also Warnings and Special Precautions. hepatic impairment: Patients with hepatic impairment, such as bilirubin >1.5-times the ...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

... Doses to Subjects with Mild or Moderate Chronic hepatic Insufficiency" Cethromycin at 300 mg once daily for seven days was well tolerated by subjects with hepatic impairment and subjects with normal hepatic function. The results suggest that no dose ...

New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile

... seen with analysis of adverse events. Shifts in hepatic and renal laboratory values during treatment with ... Isolated cases of clinically significant hepatic dysfunction, hepatitis, worsening hepatic failure, renal dysfunction, acute renal failure, ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... taking Afinitor. Afinitor should not be used in patients with severe hepatic impairment. Afinitor may cause fetal harm in pregnant women. The most ... decrease in the recommended dose should be used for patients with severe hepatic impairment. Some GIST patients (5%) were reported to have severe ...

New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal

... NUCYNTA(TM) is not recommended in patients with severe renal or hepatic impairment. NUCYNTA(TM) should be used with caution in patients with moderate hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA(TM) ...

Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders

... retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or ... ongoing research and development of HPN-100 for urea cycle disorders, hepatic encephalopathy, and other forms of hyperammonemia. Hyperion is ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... alpha or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in ... dyspnea, pulmonary infiltrates, pneumonia, interstitial pneumonitis, hepatic failure, increases in serum creatinine in patients with renal ...

Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders

... ongoing research and development of HPN-100 for urea cycle disorders, hepatic encephalopathy, and other forms of hyperammonemia. About BUPHENYL(R) ... retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... alpha or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in ... dyspnea, pulmonary infiltrates, pneumonia, interstitial pneumonitis, hepatic failure, increases in serum creatinine in patients with renal ...

FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain

... caution in patients with pancreatic or biliary tract disease, and moderate hepatic impairment. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with ...

New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients

... to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in ... patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in ...

GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition

... our medicine is very important to us. On a continual basis, an external hepatic Safety Board reviews any adverse event report received by GSK of liver ... as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for AVANDIA. Patients being treated with AVANDIA or other ...

Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults

... have an increased risk for liver function abnormalities, including severe hepatic adverse events. Post-marketing cases of liver injury, including some ... are no pharmacokinetic or safety data available in patients with severe hepatic impairment. PREZISTA should be used during pregnancy only if the ...

New Study Shows BENICAR(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering

... and possibly other adverse reactions that have occurred in adults. hepatic Impairment Thiazides should be used with caution in patients with ... since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hypersensitivity Reaction Hypersensitivity reactions to ...

Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited

... levels for the Phase III clinical trial of the Company's Percutaneous hepatic Perfusion (PHP) technology for inoperable cancers in the liver. Enrollment ... an unprecedented rate of response in this patient group, the median hepatic progression free survival was reported to be 39 months. The presentation ...

PEGASYS(R)/COPEGUS(R) Show Benefit in Hard-to-Treat Latino Population with Hepatitis C

... to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in ... patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in ...

Azor(TM) Reduces Blood Pressure in Difficult to Treat Special Populations

... be expected with AZOR because of the olmesartan medoxomil component. hepatic Impairment Since amlodipine is extensively metabolized by the liver and ... should be exercised when administering AZOR to patients with severe hepatic impairment. Laboratory Tests There was a greater decrease in ...

Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)

... proposed by the Company has a primary endpoint of a two-stage drop in hepatic encephalopathy and its secondary endpoints include several survival based endpoints. The Company is refining its position that a two-stage drop in hepatic encephalopathy is clinically meaningful and an appropriate primary ...

Roche responds to announcement of 'IDEAL' hepatitis C trial results

... to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in ... patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in ...

Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)

... to Vidaza or mannitol and in patients with advanced malignant hepatic tumors. In clinical studies, the most commonly occurring adverse ... Vidaza is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. In addition, ...
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