Concomitant in Medical Technology

Video: Partnership Unites UCB with Consumer Product Innovator OXO(R)

... who developed these infections were taking concomitant immunosuppressants such as methotrexate or ... taking CIMZIA 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract ...

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

... Drug interactions The concomitant use of QT prolonging drugs and strong inhibitors ... affect serum concentration of Tasigna. concomitant strong CYP3A4 inhibitors The concomitant use of strong CYP3A4 inhibitors should be avoided ...

CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors

... in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia ... pneumonia is required for all patients receiving concomitant TEMODAR and radiotherapy for the 42-day regimen. ... adverse events in clinical studies in the concomitant Phase (Radiotherapy + TEMODAR) and the ...

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

... of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following ... closely. Drug interactions The concomitant use of QT prolonging drugs and strong inhibitors ... affect serum concentration of Tasigna. concomitant strong CYP3A4 inhibitors ...

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

... be monitored closely. Drug interactions: Avoid concomitant use of QT prolonging drugs and strong inhibitors ... they may affect serum concentration of Tasigna. concomitant strong CYP3A4 inhibitors The concomitant use of strong CYP3A4 inhibitors should be ...

Clinical Trial Data on the Safety and Efficacy of Concomitant Formoterol Fumarate/ Tiotropium Treatment for COPD

... IIIb clinical study presented at CHEST 2007 on concomitant use of Perforomist(TM) Inhalation Solution with ... College of Chest Physicians (ACCP), demonstrate concomitant use of nebulized formoterol fumarate and ... Chicago. Poster # 251: Safety and Efficacy of concomitant Treatment with Nebulized Formoterol and ...

Data from Three Clinical Trials for Perforomist(TM) Inhalation Solution to be Presented at CHEST 2007 on October 24, 2007

... fumarate and safety/ efficacy of concomitant use with tiotropium for ... presents results from a Phase IIIb study of the concomitant use of Perforomist(TM) Inhalation Solution with ... Study" Poster # 238 -- "Safety and Efficacy of concomitant Treatment with Nebulized Formoterol and ...

Schering-Plough Announces Results of the Early ACS Trial

... After a study amendment, bivalirudin and fondaparinux were allowed as concomitant baseline antithrombotic therapies. If early clopidogrel was used, the ... if bleeding cannot be controlled with pressure, infusion of INTEGRILIN and concomitant heparin should be stopped immediately; because INTEGRILIN inhibits ...

Continuous Treatment With Abbott's HUMIRA(R) Achieves Superior Long-Term Efficacy for Psoriasis Patients Compared to Interrupting Treatment

... HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease ... T-cell lymphomas with HUMIRA have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for Crohn's disease. ...

Sanofi Aventis: People With Type 2 Diabetes Treated With LANTUS(R) and APIDRA(R) Achieved Greater Reductions in A1C Than Those Treated With Pre-mixed Insulin

... at 0, 3, 6 and 9 months included A1C, hypoglycemia, insulin dose, concomitant medications, and therapy change. Medication costs were estimated using ... treatment therapy. Additional study findings showed that mean number of concomitant oral diabetes agents were 0.86 versus 1.14 (d=-0.28, p=0.041). Total ...

Concomitant Use of Nebulized Formoterol Fumarate and Tiotropium Provides Significant Improvement in Dyspnea, COPD Symptoms and Rescue Medication Use over Tiotropium Alone

... Conference of the American Thoracic Society (ATS) demonstrate that concomitant therapy with Perforomist(TM) Inhalation Solution (formoterol fumarate ... team for their careful investigation into the clinical benefits of concomitant therapy of Perforomist and tiotropium. At DEY, we are committed to ...

U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older

... RA therapy, such as anakinra. Important Safety Information for ORENCIA concomitant use with TNF antagonists: Concurrent therapy with ORENCIA and a biologic ... not recommended. In controlled clinical trials, adult patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63 ...

ATS Medical Announces Initial Clinical Results of Stand-Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line

... standard Maze lesion set in both open chest and closed chest procedures. concomitant Treatment -- The most common surgical ablation procedure today is the concomitant procedure in which an ablation is performed in conjunction with other ...

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

... agents; most of these patients had pre-existing cardiovascular risk. concomitant use of live attenuated vaccines is not recommended. Interactions concomitant administration of nephrotoxic drugs and substances that are also tubularly ...

Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain

... were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms. In addition, ... and skilled in the use of Schedule II opioids to treat cancer pain. The concomitant use of FENTORA with strong and moderate cytochrome P450 3A4 inhibitors may ...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

... hypercholesterolemia or combined dyslipidemia. About half of the patients had hypertension, 5 percent had diabetes and about 80 percent were taking concomitant medications. A 60-week, open-label extension to this core study was conducted to assess the long-term safety of pitavastatin at the recommended ...

Cardiogenesis Announces Presentation of its PHOENIX(R) Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) Annual Meeting

... by conventional methods. Eight patients treated with the PHOENIX System completed 1 year follow up: Seven patients had concomitant coronary bypass grafting, one patient stand alone therapy. There was no operative or hospital mortality. One year survival was 100%. ...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... studies demonstrating potential anti-tumor and angiogenesis inhibition effects of XERECEPT(R). "The ability to reduce the use of steroids and concomitant reduction in adverse side effects in the treatment of patients with brain tumors is an important goal," said Lawrence Recht, MD, Professor of ...

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

... or peripheral blood (10 percent), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious or anaphylactic ...

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

... upon rechallenge. Several postmarketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction. Consider potential toxicities-specifically liver, ...

Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults

... demonstrated efficacy and tolerability when combined with a broad range of existing AEDs, and also provided efficacy regardless of the number of concomitant AEDs. Vimpat was also studied with several commonly used medications, including digoxin, metformin, omeprazole, and an oral contraceptive (containing ...

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

... The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including NUCYNTA(TM), particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs). ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may ...

U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold

... or OP RESUS to proceed in the foreseeable future. The company expects the NMRC to seek FDA approval for a clinical trial of Hemopure with a concomitant drug to address vasoactivity, which occurs with the use of Hemopure alone. The NMRC and the FDA are in discussions concerning such a trial, and the ...

AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

... with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, and digoxin). concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs ...

VentiRx Pharmaceuticals Initiates Phase I Clinical Trial of VTX-1463, a Novel TLR8 Agonist for the Treatment of Allergic Rhinitis

... rhinitis. In preclinical animal studies, this compound has been shown experimentally to dramatically reduce allergic responses without requiring the concomitant administration of allergen. As such, it represents a potential prophylactic and/or therapeutic solution for allergic diseases, regardless of the ...

Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)

... initial dose. In addition, noticeable relief of BPH symptoms was realized in just three to four days, with the majority of patients, including men on concomitant cardiovascular medications, achieving at least a three-point improvement in IPSS score, regardless of age or severity of symptoms. RAPAFLO(TM) is ...

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

... splenectomised and non-splenectomised groups when treated with Nplate. Additionally, patients treated with Nplate were able to reduce or discontinue concomitant medications such as corticosteroids which are often not well tolerated. Nplate patients also used far less "emergency" medications such as IVIG and ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... stable doses of levodopa, who had motor fluctuations with >1.5 hours of "OFF" time(1) during the day. Additionally, patients may have received concomitant treatment with stable doses of a dopamine agonist and/or an anti-cholinergic drug. After a four-week levodopa dosage stabilization phase, study ...

Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile

... studies demonstrated the life-saving potential of ABthrax (raxibacumab). The results showed that a single dose of raxibacumab, administered without concomitant antibiotics, improved survival rates by up to 64 percent when administered after animals were symptomatic for anthrax disease as a result of ...

Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma

... (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or ...

Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients

... (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or ...

Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients

... (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or ...

Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures

... measures compared with placebo in study 1, but not in study 2. Carisbamate 200 mg/day did not differ from placebo in either study. In both studies, concomitant use of enzyme-inducing AEDs lowered plasma levels of carisbamate by up to 44% (40% in study 1 and 44% in study 2). As a result, there were greater ...

Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion

... and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy. ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure. ...

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

... counts between 50,000 to 400,000/microliters during a six- month treatment period, thereby reducing patients' bleeding symptoms and their need for concomitant and rescue ITP treatments. These data were presented at the 50th Annual Meeting of the American Society of Hematology (ASH), December 6-9, 2008, in ...

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

... The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including tapentadol, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs). ...

Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union

... splenectomised and non-splenectomised groups when treated with Nplate. Additionally, patients treated with Nplate were able to reduce or discontinue concomitant ITP and emergency medications which are often not well tolerated or whose effects are transient (i.e. corticosteroids, IVIG, Win-Rho Anti-D therapy). ...

CHMP Recommends Approval of New Indication for Enbrel(R) as Treatment for Severe Psoriasis in Paediatric Patients

... . Accessed October 2008 4. Mrowietz, U et al. The importance of disease associations and concomitant therapy for the long-term management of Psoriasis patients Arch Dermatol Res (2006) 5. Paller, AS et al. Etanercept treatment for ...

Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting

... thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion. -- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy. -- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome ...