The potential threats that can cause harm to your computer

Fact is that about 3/4ths of the American population are connected to the Internet. This shows how much technology dependant this society is turning into. With over millions of people browsing the Internet every day, every hour, the chances for potential security threats have increased if not doubled. Even a single unsuspecting tap of the key board or click of the mouse may result in a severe loss. Worms and viruses written by cyber criminals of the present days are highly dangerous as they are capable of stealing your personal data and misusing them. It is necessary to keep you computer safe and protected at all times. Failing to install a security tool will not only cause harm to your computer but may cause damage to the other computers connected in your network.
Before choosing an Internet security tool however, having some knowledge about the different types of viruses and worms will help you keep your computer safe.

Unlawful cracking groups and computer hacklers write and develop harmful viruses every other day. You wouldn?t want to choose a software that is not upgraded enough to detect and tackle the kinds of viruses every day. The thing with these threats is that once a computer gets affected with a virus, then there is no stopping it from spreading to the rest of the world in a limited period of time. While some computer viruses and related worms are capable of monitoring your computer?s activities by a third party, some other viruses and bugs are intentionally created to cause damage to your computers.
These computer bugs and viruses will shut down your system and you may end up losing all your important data. In all honesty, I don?t think there?s a purpose for which these malicious albeit pointless attacks on the Internet exist. These viruses were probably created by bored adolescents who didn?t have something better to do. That being said let?s take a look at the types of prevalent programs that can cause harm to your computer:
Adware: These are probably the least harmful softwares developed and need not actually be considered as viruses. Adwares are those pop-up ad windows you see when you visit questionable websites. These ads are usually flash and may sometimes contain keyloggers that are capable of recording your key strokes and sending them across to the hacker.
Spyware: Spyware include softwares such as rootkits, keyloggers etc. These are used to retrieve ransom content or what is known as software designed to harvest profit. Unlike computer viruses and worms that were generally written for pranks or experiments, spyware are the actual kind of software that one needs to be wary of. Spyware are capable of tracking you computer?s activities, record the information and send it away to the third party hacker.
Viruses and worms: These may not actually cause harm to your computer in terms of misusing the data stored there. As told before, computer viruses and worms were probably initiated as experiments or as pranks. Although both viruses and worms usually carry a payload that can trigger malicious actions that harm your computer, there is a certain distinction that separates the two. Viruses need some kind of intervention to spread whereas worms once infected on the system spread automatically.
The above given types of software all come under the broad category of malware. Although there are certain anti-virus softwares to protect your computer from the evils of the Internet, not all of these come equipped with the latest tools to keep your computer protected from all kinds of malware. Also, with quality Internet security tools the price is always almost too high. Therefore it is better to subscribe to an Internet connection such as the one from Charter Communications that provide reliable security packages at reasonable prices.

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University of Texas apologizes for ?pubic affairs? commencement typo

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roofing contractors, roofing in surrey - Roofing Contractors Known ...

Hire Williams Roofing if looking for a quality workmanship based commercial roofing contractor in Surrey, BC.

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Surrey, BC: For roof installation, reroofing, roof maintenance and other related services, Williams Roofing has been gaining attention of different sectors for quality workmanship, modern equipment and client's comfort factors in Surrey and nearby areas of BC.

Roofing is required in commercial as well as residential areas and is needed to be done with great care and attention. And when we talk about quality and professional services, it can only be expected from an experienced roofing expert.

As far as Williams Roofing is concerned, the company is leading in the industry for its competitive features of quality workmanship, cost-effectiveness, thorough support and much more. The firm is known to be serving different sectors of Surrey with having 30 years of experience.

How the firm has reached to a recognized service and success level? The firm gives credit to its,

Quality workmanship

For any service provider, quality workmanship matters a lot to deal different roofing challenges. And the quality workmanship is comprised of a team of professional, skilled and experienced workers in different departments.

Practical skills & related knowledge

Other than excellence in roofing, the roofing team is also required to remain updated with advanced practical skills and related knowledge to handle different situations lie under the repair, installation and maintenance of roofs.

Work commitment & professionalism

The company is known to deal different roofing projects with deep care and attention. They work with dedication, certain work commitments and with professionalism to complete the roofing projects on time committed with the clients.

Williams Roofing is also a professional roofing contractor that deals all size of roofing projects as per the demand and budget of the clients. If you want to know more about the services of the company, you can access the website.

About the Submitter
Williams Roofing is a commercial roofing contractor located in Surrey, BC. The roofing contractors is specialized in drainage services as well.

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Study: Twitter Sentiment Mirrored Facebook?s Stock Price Today

Facebook's IPO was obviously the single most discussed topic on Twitter today. The good folks over at social media data platform DataSift monitored what Twitter users were saying about the IPO throughout the day and came up with some interesting conclusions. Turns out, the ups and downs of how Twitter's users felt about the stock pretty much mirrored the price of Facebook's stock as the day progressed.

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Be Careful in the Sun ? Avoid Skin Cancer : Myrtle Beach Golf ? On ...

Home > Articles > Be Careful in the Sun ? Avoid Skin Cancer

Posted on May 18, 2012 ?
Filed under Articles

The American Academy of Dermatology, the medical association helping to lead the fight against skin cancer, has a new :60 second public service ad on the airwaves. It features a group of middle-aged men on the links, trying as they might to avoid hazards like sand traps, trees and, yes, geese ? and failing. [See it here, on YouTube]

The goal of the ad is simple: to remind golfers ? men in particular ? that a bright, sunny day on the course may be increasing their risk of developing skin cancer. After all, men ages 50 and older are at the highest risk from this disease. And consider these other facts provided by the AAD:

• When outside in the sun, fewer than one-third of men (29 percent) surveyed by the Academy say they ?always? protect their skin, compared with women;
• A significantly larger percentage of men (39 percent) than women (28 percent) agreed that they prefer to enjoy sunshine and not worry about what they should do to protect their skin;
• Less than half of men (46 percent) indicated they knew how to examine their skin for signs of skin cancer compared with a majority (59 percent) of women.

On the golf course, we might be more concerned with making par or hitting that birdie. But when you realize how long it takes to play 18 holes, and the fact that you and your foursome are likely spending those hours on a broad swath of green with very little shade, protection from the sun becomes even more important, whether you?re an amateur or pro golfer.

So here are some simple tips you can use before heading out onto the course. Don?t worry, they don?t involve staying in the golf cart all day:

• Use sunscreen. Specifically, sunscreens that offer broad-spectrum protection ? that is, against UVA and UVB rays ? and that offer an SPF of 30 or higher. Apply it before getting out on the course; Dr. Susan Taylor of the AAD recommends that you use a shotglass worth of sunscreen and that you re-apply every two hours or so. (And surely there?s room in that duffel bag of yours for an extra bottle of sunscreen.)
• Consider wearing sun-protective clothing. Sure, a baseball cap is probably part of your regular golf attire. But try wearing apparel that is also UV-resistant. And remember that clothing alone is not always enough to protect you from the harmful effects of the sun ? be sure to use sunscreen as well.
• If you see a spot, say something. Chances are you?ve been golfing with your buddies for a while. So you know if something?s not quite right. And we?re not just talking about your buddy?s golf game: if you see a suspicious-looking spot on their skin, whether it?s on the back of their necks, their arm, their wrists or anywhere else, point it out and suggest they get it checked. ?Unlike other types of cancer that can?t be seen by the naked eye, skin cancer shows obvious signs on the surface of the skin that can be easily detected by properly examining it,? says the AAD president, Dr. Dan Siegel.

Head over to www.spotskincancer.org for more helpful tips and resources such as a free skin cancer screening locator. Because more than 3.5 million skin cancer cases affecting two million Americans are diagnosed each year ? and helping reduce your risks should be par for the course.

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Hearth and Home: Guidelines to Marriage and Family | CSREES ...

May 18, 2012 admin Self Advancement,

No wonder that over and over again, Scripture tells us that God hates pride (Prov 6:16-17, Prov 8:13) and He will not leave it unpunished (Isaiah 2:11-17.) God?s Word teaches us that ?Pride goes before destruction, and a haughty spirit before a fall? (Prov 16:18.)? This is a frightening reality, because, if we are honest, pride is always present in our hearts and homes, even if we are often oblivious to its presence. ?

How do we detect pride? What are the characteristics of prideful people?

Prideful people tend to be self-righteous, thinking more highly of themselves than they should. They are often oblivious to their own failures and shortcomings and have difficulty admitting their own sin. Because of this, prideful people tend to think that they don?t really need God. If we are a ?good person? all on our own, then we feel no need to come to Jesus Christ in repentance and faith. Why confess our sin and prayerfully seek God?s grace and mercy to help in our times of need, if we are ?okay? all on our own? If we find ourselves thinking very little of our own sin and need, then we are likely a prideful person.

Prideful people also tend to possess a critical spirit where others are concerned. They are exceptionally good at pointing out the faults of others. In large part, this is because a prideful person feels superior and is confident that they are doing everything ?the right way.? Therefore, they tend to look down upon those who disagree with them or who fall short of their standard.? If we find ourselves constantly criticizing others, then pride is likely running rampant in our own hearts.

Prideful people are often self-protective and self-serving. They selfishly guard the use of their time, talents and treasures and will insist on receiving what they feel they deserve. They tend to demand their own rights and refuse to let any wrong go unpunished. They are defensive when questioned and typically make excuses and blame others when confronted about their own sin and failures. They often have a very hard time saying, ?I was wrong? and asking for forgiveness. If this describes us, then we need to beware of the fall which pride will sooner or later bring about in our lives.

Prideful people tend to be self-conscious. They are overly concerned about what other people think of them. They tend to be fixated on success, self-advancement and recognition. They want to be noticed by others and, when people don?t notice them, they can easily become sullen and depressed and feel like they are being slighted.? This also manifests itself in jealousy when others are recognized and appreciated. If we spend an excessive amount of time pondering what others think of us, then pride is no doubt lurking beneath the surface of our lives.

Think about how prevalent pride is in our homes.? Think about how often we see families fall apart as a result of pride. Pride leads us to think only of ourselves. It leads us think we deserve to have things our own way, even at the expense of others. The self-serving attitude produced by pride destroys any possibility of truly loving relationships. It pushes away those who would encourage us and counsel us toward greater relational health. It causes us to rely on ourselves rather than to seek God, who is the only One who can truly correct the problems in ourselves and in our homes. Pride, if left unchecked, leads to personal and family destruction! And none of us are immune. The sooner we recognize the danger of pride in our hearts and homes, then the sooner we can begin combating this sinful tendency within ourselves and our families.

I believe the words of John RW Stott ring true, both in our personal lives and in our homes, ?At every stage of our Christian development and in every sphere of our Christian discipleship, pride is the greatest enemy and humility our greatest friend.?? If we want to have healthy, God-honoring families, then we must prayerfully consider how prevalent pride is in our homes and we must strive to root out pride in our own hearts. We must plead with God to revive within our homes a spirit of humility which leads us to confess our pride, trusting that God will forgive us and remove this sinful tendency from our midst (I Jn 1:9.)? Remember, ?Pride goes before destruction, and a haughty spirit before a fall? (Prov 16:18.) May God Himself protect us from the danger of pride in our homes!

Pastor Dan can be reached at (928) 537-7555 or at pastordan@calvaryshowlow.org.

Self Advancement

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Phase 3 Data Show NUCYNTA? ER ... - Business Review Europe

RARITAN, N.J., May 17, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. today announced the results of an investigational Phase 3 study suggesting NUCYNTA? ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN). Results of the study were presented at the 31st Annual Scientific Meeting of the American Pain Society being held May 16-19 in Honolulu, Hawaii.

Diabetes affects nearly 26 million people in the United States(1)? and its prevalence is expected to grow significantly during the coming decades(2). Over time, people with diabetes can develop a type of nerve damage called neuropathy. Approximately 60 to 70 percent of people with diabetes have some form of neuropathy(3). The most common type is diabetic peripheral neuropathy, which causes pain or loss of feeling in the toes, feet, legs, hands, and arms.

The study found, among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with tapentadol ER, those who continued on an optimized dose of tapentadol ER (100-250 mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo(4). Treatment-emergent adverse events reported in 10 percent or more of tapentadol ER-treated patients during the double-blind maintenance period included nausea (21.1 percent) and vomiting (12.7 percent)(4).

"Painful DPN is a common and burdensome complication of diabetes, and controlling pain in people with DPN can be challenging," said Aaron I. Vinik, M.D., Ph.D., FCP, MACP, Director of Research and Neuroendocrine Unit at Strelitz Diabetes Center for Endocrine and Metabolic Disorders at Eastern Virginia Medical School, and lead investigator of the study. "These data suggest tapentadol ER provides a significant reduction in chronic pain in adult patients with DPN."

The findings of this study are consistent with those of another Janssen-sponsored study published early last year, which found tapentadol ER to be effective versus placebo for relieving moderate to severe chronic pain associated with diabetic peripheral neuropathy.

"We are pleased the Phase 3 data presented today showed tapentadol ER was effective at providing pain management for patients with chronic, moderate to severe pain associated with DPN," said Christine Rauschkolb, M.D., Ph.D., Vice President and Head of Integrated Operations, Janssen Research & Development, LLC and one of the study's authors. "Janssen has a long history of helping physicians provide responsible treatment for patients to relieve their acute and chronic pain. We are committed to developing new pain management options for the millions of Americans who have painful DPN."

About the Study

This Phase 3 clinical trial was a randomized-withdrawal, placebo-controlled study.? It enrolled adult patients who had moderate to severe, chronic painful DPN for six months or more and a history of analgesic use for painful DPN for three months or more. This trial had three phases: an open-label phase, which included a 3-week titration period during which the individually optimized tapentadol ER dose (100-250 mg two times per day) was determined for each patient; a 12-week, double-blind maintenance phase, during which patients with a one-point or greater reduction in pain intensity from beginning to end of titration were randomized either to continue taking tapentadol ER (at their optimal dose) or to receive placebo; and a follow-up period with a clinic visit at four days and a telephone interview at 10 to 14 days after discontinuation of study drug.

The primary efficacy endpoint of the study was the mean change in average pain intensity from baseline (point of randomization) to the last week of the 12-week, double-blind maintenance phase, as determined by an 11-point pain rating scale or numerical rating scale (NRS; 0='no pain,' 10='pain as bad as you can imagine'). Safety assessments were performed on the open-label and double-blind safety populations (all patients who received greater than or equal to 1 dose of open-label and double-blind treatment, respectively). Treatment-emergent adverse events (TEAEs), defined as any AEs (new or worse in intensity) that occurred after the first intake of study drug during the open-label or double-blind phase, were monitored throughout the study.

In the open-label titration period, 459 patients received one or more doses of tapentadol ER and were included in the open-label safety population. At the start of the 3-week, open-label phase, the majority of patients (87.1 percent) reported severe pain (6 or more on the 11-point NRS) with a mean pain intensity of 7.3. By the end of the open-label phase, the mean pain intensity was reduced to 3.6. Treatment-emergent adverse events (TEAEs) experienced by 10 percent or more of patients during the open-label phase were nausea (24.4 percent), dizziness (17), constipation (11.8) and somnolence (10.7).

A total of 358 patients completed the open-label titration period; 318 were randomized and received one or more dose of study medication (n=152 for placebo, 166 for tapentadol ER).

Following randomization, during the double-blind treatment phase to week 12, pain increased in the placebo group (as demonstrated by the mean change in pain intensity of 1.3), while in the tapentadol ER group, efficacy was maintained, as indicated by the mean change in pain intensity of 0.28. The least-squares mean difference between the tapentadol ER and placebo groups in the change in average pain intensity was -0.95 on the 11-point NRS favoring tapentadol ER (95 percent CI, -1.42 to -0.49; p<0.001, tapentadol ER vs. placebo)(4).

For more details about the study design, please visit www.clinicaltrials.gov (NCT01041859).

Janssen Research & Development, LLC? and Grunenthal GmbH, conducted this study, which Janssen Research & Development, LLC has included as part of its Supplemental New Drug Application (sNDA) submitted on October 28, 2011 to the U.S. Food and Drug Administration (FDA) for tapentadol ER tablets for the management of neuropathic pain associated with DPN in patients 18 years of age or older. The FDA currently is reviewing this supplemental application.

About Tapentadol and NUCYNTA^? ER

Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

NUCYNTA^? ER (tapentadol) extended-release tablets are an oral analgesic available by prescription only and indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. NUCYNTA^? ER is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

Outside the United States, tapentadol is marketed by Janssen Inc. in Canada; Gr?nenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA^?) in various countries in Europe.

IMPORTANT SAFETY INFORMATION FOR NUCYNTA^? ER (tapentadol) extended-release tablets

WARNING: POTENTIAL FOR ABUSE, PROPER PATIENT SELECTION, AND LIMITATIONS OF USE

Potential for Abuse

NUCYNTA^? ER contains tapentadol, a mu-opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.

NUCYNTA^? ER can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when prescribing or dispensing NUCYNTA^? ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Proper Patient Selection

NUCYNTA^? ER is an extended-release formulation of tapentadol indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

NUCYNTA^? ER is not intended for use as an as-needed analgesic.

NUCYNTA^? ER is not intended for the management of acute or postoperative pain.

NUCYNTA^? ER tablets are to be swallowed whole and are not to be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or crushed NUCYNTA^? ER tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol.

Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol. Co-ingestion of alcohol with NUCYNTA^? ER may result in a potentially fatal overdose of tapentadol.

CONTRADICTIONS

• NUCYNTA^? ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment.
• NUCYNTA^? ER is contraindicated in any patient who has or is suspected of having a paralytic ileus.
• NUCYNTA^? ER is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have taken them within the last 14 days due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.
• NUCYNTA^? ER is contraindicated in patients with a known hypersensitivity to the active substance, tapentadol, or any component of the product. Angioedema has been reported in association with use of tapentadol.

WARNINGS & PRECAUTIONS

• NUCYNTA^? ER tablets are to be swallowed whole and are not to be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, crushed, or dissolved NUCYNTA^? ER tablets leads to the rapid release and absorption of a potentially fatal dose of tapentadol.?
• NUCYNTA^? ER tablets must be kept in a secure place out of the reach of children. Accidental consumption of NUCYNTA^? ER, especially in children, can result in a fatal overdose of tapentadol.
• Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
• Use NUCYNTA^? ER with caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve, such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA^? ER may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non?mu-opioid agonist analgesics should be considered, and NUCYNTA^? ER should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.
• Patients receiving other opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, centrally acting muscle relaxants, or other CNS depressants (including alcohol) concomitantly with NUCYNTA^? ER may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma, or death may result if these drugs are taken in combination with NUCYNTA^? ER. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.
• Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA^? ER should not be used in patients who may be susceptible to the effects of raised cerebrospinal fluid pressure, such as those with evidence of head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA^? ER should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.
• Tapentadol is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty.
• Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
• NUCYNTA^? ER can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA^? ER in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addiction, since use of mu-opioid agonist analgesic products carries the risk of addiction even under appropriate medical use.
• Drug abusers may attempt to abuse NUCYNTA^? ER by crushing, chewing, snorting, or injecting the product. These practices may result in the uncontrolled delivery of NUCYNTA^? ER and pose a significant risk to the abuser that could result in overdose and death.
• NUCYNTA^? ER may cause severe hypotension. Patients at higher risk of hypotension include those with hypovolemia or those taking concurrent products that compromise vasomotor tone (eg, phenothiazines, general anesthetics).
• Patients should be cautioned that NUCYNTA^? ER may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected, especially at the beginning of treatment, at any change of dosage, as well as in combination with alcohol or tranquilizers.
• NUCYNTA^? ER may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause CNS depression, because respiratory depression, hypotension, hypertension, and profound sedation, coma, or death may result.
• NUCYNTA^? ER has not been evaluated in patients with a predisposition to a seizure disorder, and such patients were excluded from clinical studies. As with other opioids, NUCYNTA^? ER should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.
• Cases of life-threatening serotonin syndrome have been reported with the concurrent use of tapentadol and serotonergic drugs. Serotonergic drugs comprise selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, drugs that affect the serotonergic neurotransmitter system (eg, mirtazapine, trazodone, and tramadol), and drugs that impair metabolism of serotonin (including MAOIs). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination) and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea), and can be fatal.
• Withdrawal symptoms may occur if NUCYNTA^? ER is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA^? ER.
• A study with the immediate-release formulation of tapentadol in subjects with hepatic impairment showed higher serum concentrations of tapentadol than in those with normal hepatic function. Tapentadol should be used with caution in patients with moderate hepatic impairment.
• NUCYNTA^? ER has not been studied in patients with severe hepatic impairment, and use in this population is not recommended.
• Like other drugs with mu-opioid agonist activity, NUCYNTA^? ER may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
• NUCYNTA^? ER should be used with caution in the following conditions: adrenocortical insufficiency (eg, Addison's disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.
• Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA^? ER in pregnant women. NUCYNTA^? ER should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus.

ADVERSE REACTIONS

• The most common (greater than equal to 10%) adverse reactions were nausea, constipation, headache, dizziness, and somnolence.

About Janssen Pharmaceuticals, Inc. and Janssen Research and Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop and bring innovative products, services and solutions to people throughout the world.

Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas. Innovative therapies Janssen Pharmaceuticals, Inc. offers currently include ACIPHEX^? (rabeprazole sodium), DORIBAX^? (doripenem for injection), ELMIRON^? (pentosan polysulfate sodium), NUCYNTA^? (tapentadol), NUCYNTA^? ER (tapentadol) extended-release tablets and XARELTO^? (rivaroxaban) tablets. The full prescribing information for NUCYNTA^? ER, including boxed warnings, is available here; the full prescribing information for XARELTO^?, including boxed warnings, is available here.

For more information on Janssen Pharmaceuticals, Inc., visit us at www.janssenpharmaceuticalsinc.com?or follow us on Twitter at www.twitter.com/JanssenUS.

For more information on Janssen Research & Development, LLC, visit us at http://www.janssenrnd.com/.

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* Dr. Vinik was compensated for his work as a clinical investigator in the clinical trials for NUCYNTA^? ER.

1.??? Centers for Disease Control and Prevention. 2011 Diabetes Fact Sheet: Diagnosed and undiagnosed diabetes in the United States, all ages, 2010. http://www.cdc.gov/diabetes/pubs/estimates11.htm#1.

2.??? International Diabetes Federation.? 2009 Diabetes Fact Sheet.? http://www.idf.org/diabetesatlas/diabetes.? Updated August 2009.

3.??? National Diabetes Information Clearinghouse. Diabetic Neuropathies: The Nerve Damage of Diabetes. http://diabetes.niddk.nih.gov/dm/pubs/neuropathies/index.aspx#peripheralneuropathy. Updated February 2009.

4.??? Vinik A., et al. Efficacy and Tolerability of Tapentadol Extended Release (ER) in Patients With Chronic, Painful Diabetic Peripheral Neuropathy (DPN): Results of a Phase 3, Randomized-Withdrawal, Placebo-Controlled Study. Abstract.

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SOURCE Janssen Pharmaceuticals, Inc.

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