Privacy Policy

(Effective as of October 22, 2013)

We are committed to protecting the privacy of visitors to our website. It is our intention to balance our legitimate business interests in collecting and using information received from and about you with your reasonable expectations of privacy. This Privacy Policy sets forth our practices regarding the collection, use and disclosure of information that you may provide through this site, or in e-mail or other electronic communication between you and this site. This Privacy Policy does not apply to information collected by us offline or through any other means, including on any other website operated by us or any other third party, nor does it apply to information collected by any third party, including through any application or content (including advertising) that may link to or be accessible from this site.

By accessing or submitting information through our website, you agree to this Privacy Policy without limitation or qualification. This Privacy Policy should be read in conjunction with the Terms of Use that are available separately on this website.

Information We Collect

We may collect anonymous information about the use of this website, such as the number of visitors, the length and time of their visits, the pages they view, their internet connection type and IP address, the web browsers, operating system and equipment they use, and other similar information. This information may be collected through the use of cookies or other tracking technology. Such anonymous data may be used by us and disclosed by us to third parties to improve this website and to better understand the needs of our users.

We only collect certain personally identifiable information, including your name, address, email address, phone and fax number, and occupational information when voluntarily provided by you. Personal information you submit to us is used by our affiliates, business partners and us either to provide you with information you have specifically requested or to aid us in better serving our users.

Children Under the Age of 13

This site is not directed to children and we do not knowingly solicit information from any child under the age of 13. If you are under 13, please do not provide us with any personal information.

How Your Personally Identifiable Information is Used

We may use your personal information to provide you with information or services that you have specifically requested or to fulfill any other purpose for which you provide it. We may also use it t o communicate with you about topics in which you may be interested, to provide new information regarding our business, to notify you about changes to our website, for any other purpose we describe when you provide personal information or in any other manner with your consent.

Disclosure of Your Information

We do not intend to otherwise share your identifiable personal information with others without your permission except under the following circumstances:

We may remove personal identifiers from the personal information you provide to us and maintain it in aggregate form. We may combine such de-identified information with other information to provide anonymous, aggregated statistical information for use by us, our business partners or our service providers to improve our products and services. We may disclose aggregated information about our users without restriction.

Security

While we take reasonable measures to protect the information collected through our website, we do not currently encrypt your personally identifiable information. Please be aware that any data transmitted over the internet may be at risk and we cannot guarantee that our website will be free from illegal tampering or “hacking.”

Third Party Privacy Policies

As a resource to you, this site may include links to third party websites. Our Privacy Policy does not apply to such websites, and you should contact them directly for information regarding their privacy policies.

Modifications to Privacy Policy

At any time, we reserve the right to add to, modify or remove portions of our Privacy Policy. The effective date of our Privacy Policy will be included at the beginning of the Privacy Policy, and will serve as a notice to users of this website of when changes have been implemented to the Privacy Policy. Please check back to this page from time to time to determine if any revisions have been made. Your continued use of this website after any revisions have been made will indicate your acknowledgement of such changes and agreement to be bound by the terms and conditions of such changes.

Your California Privacy Rights

California Civil Code Section § 1798.83 permits user s of our website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please see “How to Contact Us about this Privacy Policy.”

How to Contact Us about this Privacy Policy

If you have any questions regarding this Privacy Policy, would like to obtain a copy of or make changes to the personal information collected from you, or would like to have your personal information removed from our database, correspondence may be sent to:

Mallinckrodt Hospital Products Inc.
675 McDonnell Blvd.
Hazelwood, MO 63042
Phone: 314.654.2000
Fax: 858.436.1401

Use of this website constitutes your acceptance of our Privacy Policy.


INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with:
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

SCROLL DOWN FOR ADDITIONAL IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

Tap for additional Important Risk Information

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with:
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.