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Privacy

At Mallinckrodt (a Covidien company), we understand that protecting your privacy is important and that your health information is particularly sensitive. We only collect personally identifiable information about you if you choose to give it to us. Please review this Privacy Statement to learn more about how Mallinckrodt collects, uses, shares and protects information online.

Mallinckrodt shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, and we also may share personally identifiable data with our company's affiliates. However, we do not share any of your personally identifiable information with third parties for their own marketing use.


INFORMATION COLLECTED


Information You Give Us

At our Web sites, we only collect your personally identifiable information (such as your name, address, telephone number or e-mail address) when you choose to submit it to us. For example, you may choose to register to receive additional product information or information about a disease state that interests you.

In some cases, we also remove personal identifiers from data and maintain it in aggregate form. We may combine this data with other information to produce anonymous, aggregated statistical information helpful to us in improving our products and services.

Automatically Collected Information

We automatically receive certain types of information whenever you interact with us on our Web sites and in some e-mails we may send each other. Automatic technologies we use may include, for example, Web server logs and IP addresses, cookies and Web beacons.

Web Server Logs and IP Addresses

An IP address is a number assigned to your computer whenever you access the Internet. All computer identification on the Internet is conducted with IP addresses, which allow computers and servers to recognize and communicate with each other. Mallinckrodt collects IP addresses to conduct system administration and report aggregate information to affiliates, business partners and/or vendors to conduct site analysis and Web site performance review.

Cookies

A cookie is a piece of information that is placed on your computer when you access certain Web sites. The cookie uniquely identifies your browser to the server. Cookies allow us to store information on the server to help make the Web experience better for you and to conduct site analysis and Web site performance review. Most Web browsers are set up to accept cookies, although you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

Web Beacons

On certain Web pages or e-mails, Mallinckrodt may utilize a common Internet technology called a "Web beacon" (also known as an "action tag" or "clear GIF technology.") Web beacons help analyze the effectiveness of Web sites by measuring, for example, the number of visitors to a site or how many visitors clicked on key elements of a site. Web beacons, cookies and other tracking technologies do not automatically obtain personally identifiable information about you. Only if you voluntarily submit personally identifiable information, such as by registering or sending e-mails, can these automatic tracking technologies be used to provide further information about your use of the Web sites and/or interactive e-mails to improve their usefulness to you.

YOUR CHOICES

You have several choices regarding your use of our Web sites. Mallinckrodt may require you to provide certain personally identifiable information in order for you to receive additional product information or information about a disease state. You could decide not to submit any personally identifiable information at all by not entering it into any forms or data fields on our sites and not using any available personalized services. Certain sites may ask for your permission for certain uses of your information and you can agree to or decline those uses. If you opt-in for particular services or communications, such as an e-newsletter, then you may be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, then we will work to remove your information promptly, although we may require additional information before we can process your request.

As described above, if you wish to prevent cookies from tracking you anonymously as you navigate our sites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

USE OF DATA

Mallinckrodt and/or the companies we hire to perform services on our behalf will use any personally identifiable information you choose to give us to comply with your requests or as otherwise disclosed to you in this Statement or on the Web page where you submit your information to us. We may refer to this information to better understand your needs and how we can improve our products and services.

We use aggregated (non-personally identifiable) information to help us understand trends and customer needs. For example, we may analyze the gender or age of visitors to Web sites about a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others.

DATA SHARING AND TRANSFER

General

Mallinckrodt shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, such as providing customer services, sending marketing communications about our products, services and offers, and doing technological maintenance. We also may share personally identifiable data with our company's affiliates.

We may also disclose personally identifiable information for these purposes:

  • In connection with the sale, assignment or other transfer of the business of the Web site to which the data relates;
  • To respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders, or government regulations; or
  • Where needed for corporate audits or to investigate or respond to a complaint or security threat.

No Third-Party Direct Marketing Use

Mallinckrodt will not sell or otherwise transfer the personally identifiable information you provide to us at our Web sites to any third parties for their own direct marketing use.

E-mail a Friend or Colleague

On some Mallinckrodt Web sites, you can choose to send a link or a message to a friend or colleague referring them to a Mallinckrodt Web site. E-mail addresses you may provide for a friend will be used to send your friend information on your behalf and will not be collected or used by Mallinckrodt or other third parties for additional purposes.

LINKS TO OTHER SITES

Our sites contain links to a number of Web sites that may offer useful information to our visitors. This Privacy Statement does not apply to those sites, and we recommend communicating to them directly for information on their privacy policies.

MISCELLANEOUS

Privacy Statement for Children

Our Web sites are not intended or designed to attract children under the age of 13. We do not collect any personally identifiable information from anyone we know to be under the age of 18.

Additional Information on Web Sites

If a Web site has particular provisions relating to privacy that differ from those stated here, then those provisions will be disclosed to you on the page on which personally identifiable information is collected.

Note to Users of Business or Professional Web Sites

If you have a business or professional relationship with Mallinckrodt, then we may use information you submit on our Web sites, including sites intended specifically for business and professional users, to fulfill your requests and develop our business relationship with you and the entities you represent. We also may share such information with third parties acting on our behalf.

Updates to Privacy Statement

From time to time, Mallinckrodt may revise this Privacy Statement. Any such changes to this Privacy Statement will be promptly communicated on this page. Continued use of our sites after receiving notice of a change in our Privacy Statement indicates your consent to the use of newly submitted information in accordance with the amended Mallinckrodt Privacy Statement. The effective date of this Privacy Statement is March 26, 2010.

HOW TO CONTACT US

If you have any questions about the Mallinckrodt Privacy Statement or the information practices of our Web sites, then you may contact us as follows:

Covidien
675 McDonnell Blvd.
Building 10-3-S
Hazelwood, MO 63042
Attention: Stuart Kim, J.D., Legal Department

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

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INDICATION

EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII) is indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

IMPORTANT RISK INFORMATION

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing EXALGO. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving EXALGO for signs of misuse, abuse, and addiction during treatment.

Life-threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of EXALGO, even when the drug has been used as recommended and not misused or abused. EXALGO is for use in opioid tolerant patients only. Proper dosing and titration are essential and EXALGO should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of EXALGO or following a dose increase. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of hydromorphone.

Accidental Exposure

Accidental ingestion of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.

  • EXALGO is contraindicated in:
    • - Opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant.
    • - Patients with significant respiratory depression
    • - Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
    • - Patients with known or suspected paralytic ileus
    • - Patients who have had surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or have "blind loops" of the gastrointestinal tract or gastrointestinal obstruction
    • - Patients with hypersensitivity (e.g., anaphylaxis) to hydromorphone or sulfite-containing medications
  • EXALGO is indicated for opioid tolerant patients only. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.
  • EXALGO is not intended for use as an as-needed analgesic and is not indicated for the management of acute or postoperative pain. It is contraindicated in patients who need management of mild pain or pain not expected to persist.
  • Avoid concurrent use of alcohol and EXALGO. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. EXALGO may impair the ability to drive a car or operate machinery.
  • Not intended in patients who have received MAO inhibitors within 14 days of starting EXALGO.
  • Use with caution and in reduced doses in older or debilitated patients, as well as patients with renal or hepatic insufficiency, Addison's disease, delirium tremens, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, toxic psychosis. May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings. Consider use of an alternate analgesic in patients with severe renal impairment.
  • Respiratory depression, which occurs more frequently in elderly or debilitated patients, is the chief hazard with EXALGO.
  • Serious adverse events could also include hypotensive effects, GI effects, cardiac arrest from overdose and precipitation of withdrawal. Most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation (31%), nausea (28%), vomiting, somnolence, headache, asthenia and dizziness.
  • Use EXALGO with extreme caution in patients susceptible to intracranial effects of CO2 retention.
  • Do not abruptly discontinue EXALGO.

Please see Full Prescribing Information, including boxed warning and Additional Important Risk Information.

IMPORTANT RISK INFORMATION

WARNING:ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

EXALGO® contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid agonists,
legal or illicit. Click here for more Important Risk Information, including full boxed warning