Data from FDA - Curated by EPG Health - Last updated 27 July 2017
Indication(s)
Learning Zones
An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.
Acute and Advanced Heart Failure
What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...
+ 3 more
Allergic Rhinitis
Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.
+ 4 more
Anticoagulation Therapy for Stroke Prevention
Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.
Atopic Dermatitis
The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.
Biosimilars Knowledge Centre
What are biologics and how do they differ from small molecule medicines? Discover more about their development, as well as the manufacturing and regulatory processes in the Biosimilars in Oncology Knowledge Centre.
CDK 4/6 inhibitors in metastatic breast cancer
The CDK 4/6 Inhibitors in Metastatic Breast Cancer Learning Zone provides insights and information for metastatic breast cancer (mBC) and CDK 4/6 signalling. This includes the burden and pathophysiology of the disease, the role of CDK 4/6 in cell proliferation and an overview of the CDK 4/6 inhibitors that have been approved for the management of mBC.
Cardiovascular Metabolism Knowledge Centre
The Cardiovascular Metabolism Knowledge Centre is an information hub providing expert insight into the management of hypertension and type 2 diabetes. This Knowledge Centre contains a wealth of scientific video content offering insights and opinion from some of the leading experts in the field.
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Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults (GWPCARE3)
The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).
Added 4 days ago
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults (GWPCARE4)
To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).
Added 4 days ago
Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With...
Added 14 days ago
A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes
This study is a Phase 2 randomized, crossover study comparing ORMD-0801 given QD versus TID in subjects with T1D. Subjects with T1D will have a screening visit (Visit 1) during which they will be required to review and sign the informed consent form.
Added 14 days ago
A Study With NLY01 in Subjects With Type 2 Diabetes
This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.
Added 14 days ago
Over 50 Years of Fibrinogen Concentrate.
March 2013 represented the 50th anniversary of the first license granted for a fibrinogen concentrate. In this review, we look at the history of bleeding management that led to the development of fibrinogen concentrate...
Added 1 hour ago
Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial.
Background: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed size.
Added 1 hour ago
Impact of intraoperative factor concentrates on blood product transfusions during orthotopic liver transplantation.
Background: Major bleeding in orthotopic liver transplantation is associated with significant morbidity and mortality. Limited literature exists regarding comparative effectiveness of prothrombin complex concentrate and fibrinogen...
Added 4 hours ago
Analysis of the venous thromboembolic risk associated with severe postpartum haemorrhage in the NOHA First cohort
Severe postpartum haemorrhages (PPH) are responsible for maternal morbidity/mortality. Their complex management sometimes requires haemostatic supplementation, and therapeutic trials on fibrinogen or activated factor VII...
Added 5 hours ago
Fibrinogen replacement therapy for congenital fibrinogen deficiency.
This review of published studies was conducted to derive data on patients with congenital fibrinogen deficiency (CFD), including dosing of fibrinogen replacement therapy, outcome, and adverse events, either temporally related...
Added 5 hours ago
Cannabis-based medicinal products
This guideline covers prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy.
Added 5 days ago
Familial hypercholesterolaemia: identifification and management
This guideline covers identifying and managing familial hypercholesterolaemia (FH), a specific type of high cholesterol that runs in the family, in children, young people and adults. It aims to help identify people at increased risk of...
Added 5 days ago
Abortion care
This guideline covers care for women of any age (including girls and young women under 18) who request an abortion. It aims to improve the organisation of services and make them easier for women to access.
Added 5 days ago
ERS guidelines on the diagnosis and treatment of chronic cough in adults and children.
These guidelines incorporate the recent advances in chronic cough pathophysiology, diagnosis and treatment. The concept of cough hypersensitivity has allowed an umbrella term that explains the exquisite sensitivity of patients to external stimuli
Added 2 months ago
Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline.
Background: This document provides clinical recommendations for the diagnosis of idiopathic pulmonary fibrosis (IPF). It represents a collaborative effort between the American Thoracic Society, European Respiratory Society...
Added 2 months ago
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Category | Value |
---|---|
Agency product number | QI7G114Y98 |
Orphan designation | No |
Product NDC | 35356-569 |
Date Last Revised | 15-11-2011 |
Type | HUMAN PRESCRIPTION DRUG |
List of excipients | INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE |
Marketing authorisation holder | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |