1) DRAP is warning the public and healthcare providers about the risk of fatal irregular heart rhythms with the antibiotic azithromycin.
2) A study found an increased risk of cardiovascular death among patients treated with a 5-day course of azithromycin compared to other antibiotics or no drug.
3) DRAP is requiring label changes and updates for azithromycin to describe this risk of QT interval prolongation and potential fatal heart rhythm abnormalities.
Case Study- FDA WITHDRAWL OF IBS-C DRUG ZELNORM DUE TO CARDIOVASCULAR RISKSSandhya Ganapathiraju
The Zelnorm manufactured by Novartis was the first FDA-approved drug for the treatment of IBS-C , which had additional use in the treatment of functional dyspepsia and gastroparesis.
However as there were reported cases on cardiovascular risks on its usage, FDA effectively stopped the marketing of the drug in the U.S. market and finally putting a ban on the product. But eventually it was permitted for restricted use in emergency situations in U.S.
This was followed by withdrawl from Canada market by Health Canada and in India by Ministry of Health also.
Etodolac Capsules USP 300mg/400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Etodolac Dosage & Rx Info | Etodolac Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Etodolac-Drug Information –Taj Pharma, Etodolac dose Taj pharmaceuticals Etodolac interactions, Taj Pharmaceutical Etodolac contraindications, Etodolac price, Etodolac Taj Pharma Etodolac SmPC-Taj Pharma Stay connected to all updated on Etodolac Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
This ppt highlights about scientific basis of drug therapy described with four processes involved in the choice of appropriate drug therapy with examples.... helps to make rational choice of drugs with systematic steps as like that of making diagnosis.
Case Study- FDA WITHDRAWL OF IBS-C DRUG ZELNORM DUE TO CARDIOVASCULAR RISKSSandhya Ganapathiraju
The Zelnorm manufactured by Novartis was the first FDA-approved drug for the treatment of IBS-C , which had additional use in the treatment of functional dyspepsia and gastroparesis.
However as there were reported cases on cardiovascular risks on its usage, FDA effectively stopped the marketing of the drug in the U.S. market and finally putting a ban on the product. But eventually it was permitted for restricted use in emergency situations in U.S.
This was followed by withdrawl from Canada market by Health Canada and in India by Ministry of Health also.
Etodolac Capsules USP 300mg/400mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Etodolac Dosage & Rx Info | Etodolac Uses, Side Effects Vecuronium bromide: Indications, Side Effects, Warnings, Etodolac-Drug Information –Taj Pharma, Etodolac dose Taj pharmaceuticals Etodolac interactions, Taj Pharmaceutical Etodolac contraindications, Etodolac price, Etodolac Taj Pharma Etodolac SmPC-Taj Pharma Stay connected to all updated on Etodolac Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
This ppt highlights about scientific basis of drug therapy described with four processes involved in the choice of appropriate drug therapy with examples.... helps to make rational choice of drugs with systematic steps as like that of making diagnosis.
Exemestane Tablets USP 25mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Exemestane Dosage & Rx Info | Exemestane Uses, Side Effects Exemestane: Indications, Side Effects, Warnings, Exemestane -Drug Information –Taj Pharma, Exemestane dose Taj pharmaceuticals Exemestane interactions, Taj Pharmaceutical Exemestane contraindications, Exemestane price, Exemestane Taj Pharma Exemestane SmPC-Taj Pharma Stay connected to all updated on Exemestane Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Voriconazole for Injection Taj Pharma SmPCTajPharmaQC
Voriconazole for Injection 200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Voriconazole Dosage & Rx Info | Voriconazole Uses, Side Effects Voriconazole: Indications, Side Effects, Warnings, Voriconazole -Drug Information –Taj Pharma, Voriconazole dose Taj pharmaceuticals Voriconazole interactions, Taj Pharmaceutical Voriconazole contraindications, Voriconazole price, Voriconazole Taj Pharma Voriconazole SmPC-Taj Pharma Stay connected to all updated on Voriconazole Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
International Journal of Clinical Pharmacology & Toxicology (IJCPT) ISSN:2167-910X is an Open Access journal and a peer-reviewed journal. Clinical Pharmacology & Toxicology is the all-encompassing and becoming an increasingly important discipline for the identification of disease targets and drug designing with their toxicological effects and means to eradicate diseases.
International Journal of Clinical Pharmacology & Toxicology (IJCPT) ISSN:2167-910X is an Open Access journal, which aims to develop coherent means to modify drug therapy, with respect to the patient's genotype, and to ensure maximum efficiency with minimal contrary effects.
Exemestane Tablets USP 25mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Exemestane Dosage & Rx Info | Exemestane Uses, Side Effects Exemestane: Indications, Side Effects, Warnings, Exemestane -Drug Information –Taj Pharma, Exemestane dose Taj pharmaceuticals Exemestane interactions, Taj Pharmaceutical Exemestane contraindications, Exemestane price, Exemestane Taj Pharma Exemestane SmPC-Taj Pharma Stay connected to all updated on Exemestane Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SMPC.
Voriconazole for Injection Taj Pharma SmPCTajPharmaQC
Voriconazole for Injection 200mg Taj Pharma: Uses, Side Effects, Interactions, Pictures, Warnings, Voriconazole Dosage & Rx Info | Voriconazole Uses, Side Effects Voriconazole: Indications, Side Effects, Warnings, Voriconazole -Drug Information –Taj Pharma, Voriconazole dose Taj pharmaceuticals Voriconazole interactions, Taj Pharmaceutical Voriconazole contraindications, Voriconazole price, Voriconazole Taj Pharma Voriconazole SmPC-Taj Pharma Stay connected to all updated on Voriconazole Taj Pharmaceuticals Mumbai. Patient Information Leaflets, SmPC.
International Journal of Clinical Pharmacology & Toxicology (IJCPT) ISSN:2167-910X is an Open Access journal and a peer-reviewed journal. Clinical Pharmacology & Toxicology is the all-encompassing and becoming an increasingly important discipline for the identification of disease targets and drug designing with their toxicological effects and means to eradicate diseases.
International Journal of Clinical Pharmacology & Toxicology (IJCPT) ISSN:2167-910X is an Open Access journal, which aims to develop coherent means to modify drug therapy, with respect to the patient's genotype, and to ensure maximum efficiency with minimal contrary effects.
"Session ID: BUD17-503
Session Name: The HPE Machine and Gen-Z - BUD17-503
Speaker:
Grant Likely
Track:
★ Session Summary ★
With the exponential rise in quantity of data to manage, the modern data centre is increasingly limited by the capacity of individual machines. Since storage and compute demand more capacity than can be provided by a single machine, we distribute both over large clusters and use the network to transfer data between where it is stored and where it is processed. Moving all that data around uses deep storage stacks which incur a significant performance impact. If we could somehow flatten the storage stack and provide applications with direct access to data, then we could improve performance by orders of magnitude.
Hewlett Packard Enterprise recently demonstrated that we can do exactly with their research project, ""The Machine"". Instead of moving data around with a network, The Machine uses multi terabytes of persistent memory and a next generation fabric-attached memory interconnect to provide a single pool of storage which can be accessed by any processor in the cluster. It shows that we can provide applications with immediate load/store access to huge data sets in a model called Memory-Driven Computing.
Proof in hand, now it is time to bring Memory-Defined Computing to the data centre. Gen-Z is an open systems interconnect designed to provide memory semantic access to data and devices via direct attached, switched or fabric topologies. HPE has joined the Gen-Z consortium and is using the knowledge gained with The Machine to help shape Gen-Z to set the stage for true Memory-Driven Computing. With putting memory at the centre, this enables us to overcome the limitations of today's computing systems and power innovations.
This session will cover two topics. It will start with a status update on The Machine and an overview of how it works. Then we'll shift into an introduction of Gen-Z, and how it can reshape the architecture of computing in the years to come.
---------------------------------------------------
★ Resources ★
Event Page: http://connect.linaro.org/resource/bud17/bud17-503/
Presentation:
Video: https://youtu.be/1BVtChDQVyQ
---------------------------------------------------
★ Event Details ★
Linaro Connect Budapest 2017 (BUD17)
6-10 March 2017
Corinthia Hotel, Budapest,
Erzsébet krt. 43-49,
1073 Hungary
---------------------------------------------------
Keyword: HPE, Gen-Z
http://www.linaro.org
http://connect.linaro.org
---------------------------------------------------
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IBM Connections 6 will be release on March 28th. XCC is going to work with IBM Connections 6 Classic without any modifications! Full XCC reature compatibility with iBM Connections 6 from day 1. Have a look at first screenshots including an outlook of what will come soon.
Synthetic Drugs/Hormones - Boon or Bane- Concept of Dooshivisha and Gara VishaIJARIIT
21st century is the world full of synthetics and everyone are living in the influence of synthetic substances. Altered life
styles, food habits and irregular sleep pattern had resulted not only Non communicable disease but also resulting in reduced
immunity and is risking the person more for infections. Pharma Industry has grown as big as hierarchy in recent centauries
and introduces new chemical molecules quoting as capable for treating diabetes, hypertension etc. But bitter truth is prolonged
usage these medications itself has adverse effect on liver and kidneys causes hepatotoxicity and nephrotoxicity or organs
specific toxicity.
Drug Interactions of Dipyridamole (Antiplatelt - Adenosine reuptake inhibitor)Naina Mohamed, PhD
Dipyridamole is used as an Antiplatelet drug by inhibiting the reuptake of adenosine. Dipyridamole can interact with many drugs including ADP blockers (Clopidogrel, Prasugrel, Ticlopidine, Ticagrelor, etc), Glycoprotein IIB/IIIA inhibitors (Abciximab, Tirofiban, etc.), Fibrinolytics (Reteplase, Tenecteplase, Streptokinase, etc.), Adenosine, Treprostinil, Sulfinpyrazone, Regadenoson, Distigmine and Ginkgo.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Clinically Important Drug Interactions of FibrinolyticsNaina Mohamed, PhD
• It is Contraindicated to use Fibrinolytics and Defibrotide concomitantly.
• Drugs increasing the risk of Fibrinolytics associated Bleeding include…
o Anticoagulants (Warfarin, Heparin, Enoxaparin, Dabigatran, etc)
o Antiplatelet agents (Aspirin, Clopidogrel, etc)
o Pentosan Polysulfate Sodium
• Herbs increasing the risk of Fibrinolytics associated Bleeding include…
o Fenugreek
o Garlic
o Ginkgo
o Evening Primrose Oil
o Clove Oil
o Anise
o Turmeric (Curcumin)
o Licorice
o Asafetida
o Capsicum (Capsaicin)
o Celery
o Kava
o Cat's claw
o Medowsweet
o Feverfew
o Tan-shen
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
The Team Member and Guest Experience - Lead and Take Care of your restaurant team. They are the people closest to and delivering Hospitality to your paying Guests!
Make the call, and we can assist you.
408-784-7371
Foodservice Consulting + Design
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
Oprah Winfrey: A Leader in Media, Philanthropy, and Empowerment | CIO Women M...CIOWomenMagazine
This person is none other than Oprah Winfrey, a highly influential figure whose impact extends beyond television. This article will delve into the remarkable life and lasting legacy of Oprah. Her story serves as a reminder of the importance of perseverance, compassion, and firm determination.
Artificial intelligence (AI) offers new opportunities to radically reinvent the way we do business. This study explores how CEOs and top decision makers around the world are responding to the transformative potential of AI.
1. PTPS-DSA-02-2013
Drug Safety Alert
Azithromycin
(Risk of fatal irregular heart rhythm)
Ref: US-FDA
Roohi Bano Obaid, Deputy Director,
Drugs Regulatory Authority of Pakistan
For Policy, Training and Pharmacy Services
September 2013
2. Roohi Bano Obaid, Deputy Director, DRAP, September 09th 2013 Page 2 of 6
AZITHROMYCIN
AZITHROMYCIN
DRAP requires label changes to warn of risk for potentially fatal heart rhythm
from antibacterial Azithromycin.
DRAP is warning the public (Patients and Health Care Providers) that Azithromycin (all brands
registered in Pakistan) can cause abnormal changes in the electrical activity of the heart that may
lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this
condition include those with known risk factors such as existing QT interval prolongation, low
blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs
used to treat abnormal heart rhythms, or arrhythmias. This public announcement is a result of
US-FDA review of a study by medical researchers as well as another study by a manufacturer of
the drug that assessed the potential for Azithromycin to cause abnormal changes in the electrical
activity of the heart.
Hence, DRAP requires from manufacturers of azithromycin that the Drug Labels (and all other
literature designed to promote the drug) of Azithromycin, an antibacterial drug be strengthened
and updated to better describe the risk of QT interval prolongation and torsades de pointes, a
specific, rare (potentially fatal) heart rhythm abnormality. Information must also be added
regarding the results of a clinical QT study which showed that Azithromycin can prolong the
QTc interval. (see Data Summary)
Health care professionals should consider the risk of fatal heart rhythms with azithromycin
when considering treatment options for patients who are already at risk for cardiovascular
events (see Additional Information for Health Care Professionals below). US-FDA notes
that the potential risk of QT prolongation with azithromycin should be placed in
appropriate context when choosing an antibacterial drug: Alternative drugs in the
macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for
QT prolongation or other significant side effects that should be considered when choosing
an antibacterial drug.
3. Roohi Bano Obaid, Deputy Director, DRAP, September 09th 2013 Page 3 of 6
AZITHROMYCIN
Report of US-FDA: On May 17, 2012, FDA referred about a New England Journal of
Medicine (NEJM) study that compared the risks of cardiovascular death in patients treated with
the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin and levofloxacin or no
antibacterial drug.A
The study reported an increase in cardiovascular deaths, and in the risk
of death from any cause, in persons treated with a 5-day course of azithromycin compared
to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular
death associated with levofloxacin treatment were similar to those associated with azithromycin
treatment. Azithromycin was the only macrolide examined in the published study; the study did
not address other macrolide antibacterial drugs, such as clarithromycin (Biaxin) and
erythromycin, regarding the potential for cardiovascular death.
In 2011, approximately 40.3 million individuals in the U.S. received an outpatient prescription
for the macrolide azithromycin.B
In 2011, US-FDA reviewed macrolide drug labeling
information related to QT interval prolongation and TdP. The WARNINGS AND
PRECAUTIONS section of the drug label of azithromycin extended release for oral suspension
was revised in March 2012 to include new information regarding risk for QT interval
prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also
contain information about QT interval prolongation in the WARNINGS section. US-FDA is in
the process of updating risk information in the drug labels for additional macrolide antibacterial
drugs.
DRAP will continue to update health care professionals and the public with any relevant
information that becomes available about azithromycin and the risk of abnormal heart rhythms.
FACTS ON AZITHROMYCIN
Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been
associated with cardiovascular effects; specifically, prolongation of the QT interval. Prolongation
of the QT interval can lead to torsades de pointes (TdP), an abnormal heart rhythm, which can be
fatal.
Azithromycin is marketed under the various brand names registered in the name of different
companies in Pakistan.
4. Roohi Bano Obaid, Deputy Director, DRAP, September 09th 2013 Page 4 of 6
AZITHROMYCIN
Approved indications for azithromycin include:
• Acute bacterial exacerbations of chronic obstructive pulmonary disease
• Acute bacterial sinusitis
• Community-acquired pneumonia
• Pharyngitis/tonsillitis
• Uncomplicated skin and skin structure infections
• Urethritis and cervicitis
• Genital ulcer disease
Additional Information for Patients
• Do not stop taking azithromycin without talking to your Doctor / Pharmacist (Health
Care Provider).
• Discuss any questions or concerns about azithromycin or other antibacterial drugs with
your Doctor / Pharmacist (Health Care Provider).
• Seek immediate care if you experience an irregular heartbeat, shortness of breath,
dizziness, or fainting while taking azithromycin.
• Report any side effects you experience to your Doctor / Pharmacist (Health Care
Provider) and DRAP.
• Carefully read the updated information that comes with your azithromycin/ macrolide
class drugs prescription.
Additional Information for Doctor / Pharmacist (Health Care Provider)
• Doctor / Pharmacist (Health Care Provider) should consider the risk of torsades de
pointes and fatal arrhythmia when considering treatment options with azithromycin or
alternative antibacterial drugs. Groups at higher risk include:
5. Roohi Bano Obaid, Deputy Director, DRAP, September 09th 2013 Page 5 of 6
AZITHROMYCIN
Patients with known prolongation of the QT interval, a history of torsades de
pointes, congenital long QT syndrome, brady-arrhythmias, or uncompensated
heart failure
Patients on drugs known to prolong the QT interval
Patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia
or hypomagnesemia, clinically significant bradycardia, and in patients receiving
Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol)
antiarrhythmic agents.
• Elderly patients and patients with cardiac disease may be more susceptible to the effects
of arrhythmogenic drugs on the QT interval.
• The potential risk of QT prolongation should be placed in appropriate context when
choosing an antibacterial drug: Alternative drugs in the macrolide or fluoroquinolone
drug classes also have the potential for QT prolongation or other significant side effects
that should be considered when choosing an antibacterial drug.
• Make sure patients know to contact you if they experience an irregular heartbeat,
shortness of breath, dizziness, or fainting while taking azithromycin.
• If the patient develops such symptoms, the azithromycin should be stopped and an
alternative antibacterial drug should be used, unless the benefit of continued treatment
with azithromycin outweighs the risk.
• Make sure your patients receive the updated information with every prescription.
• Report adverse events involving azithromycin to DRAP.
Data Summary
The study published in NEJM suggested a higher risk of cardiovascular deaths and deaths from
any cause in persons treated with a 5-day course of azithromycin compared to persons treated
with amoxicillin, ciprofloxacin, or no drug.A
6. Roohi Bano Obaid, Deputy Director, DRAP, September 09th 2013 Page 6 of 6
AZITHROMYCIN
The study has important limitations. First, patients were not randomized to the antibacterial
drugs studied, so patients who received different drugs might have differed in ways that could
have biased the results. Second, the study only examined antibacterial drugs used in an outpatient
setting, so it is likely that few patients were being treated for severe or life-threatening infections.
Third, cardiovascular deaths were determined using death certificates rather than full medical
records. Fourth, there were also some limitations to the statistical methods used.
On balance, however, the study was methodologically sound and supports the validity of the
overall finding. The estimated excess risk of cardiovascular death compared with amoxicillin
varied considerably with the patients’ baseline cardiovascular risk, from roughly 1 in 111,000
among healthier patients to 1 in 4,100 among high-risk patients. The duration of the elevated risk
of all-cause mortality and of cardiovascular death corresponded to the duration of azithromycin
therapy. The increase in total deaths was due to cardiovascular deaths and not due to an increase
in deaths from other causes. The excess risk of cardiovascular death, especially of sudden death,
is consistent with arrhythmias from drug-related QT prolongation.
Leading Regulatory Agency evaluated the results of a clinical QT study of the manufacturer
assessing the effects of azithromycin on the QT interval in adults, which indicates the
prolongation of QTc interval associated with azithromycin. Information regarding the results of
the QT study has been added to the azithromycin drug label in parent country of drug origin.
References:
A. Ray WA, Murray KT, Hall K, et al. Azithromycin and the risk of cardiovascular death. N
Engl J Med 2012;366:1881-1890.http://www.nejm.org/doi/full/10.1056/NEJMoa1003833
B. Source: IMS Health Vector One National Total Patient Tracker.
C. US-FDA