TERMS OF USE

BEFORE ACCESSING THIS SITE, PLEASE READ THE FOLLOWING TERMS OF USE CAREFULLY AS THEY GOVERN YOUR USE OF THIS SITE. IF YOU DO NOT AGREE WITH THESE TERMS OF USE, YOU ARE NOT GRANTED PERMISSION BY MALLINCKRODT TO ACCESS OR OTHERWISE USE THIS SITE.

By accessing, viewing, or using this Site, you indicate that you understand and intend these Terms of Use to be the legal equivalent of a signed, written contract and equally binding, and that you accept such Terms of Use and agree to be legally bound by them. Please note that Mallinckrodt reserves the right to change these Terms of Use. Your continued use of this Site following such modifications will be conclusively deemed acceptance of any changes to these Terms of Use.

License Grant
This Agreement provides you with a personal, revocable, non-exclusive, non-transferable license to use this Site conditioned on your continued compliance with the Terms of Use of this Agreement. You may print and download materials and information on this Site solely for personal and non-commercial use, provided that all hard copies contain all copyright and other applicable notices contained in such materials and information. If you violate any of these Terms of Use, your permission to use this Site and any materials it contains automatically and immediately terminates and you must immediately destroy any copies you have made of any materials from this Site. As a further condition of use of this Site, you warrant to Mallinckrodt that you will not use this Site for any purpose that is unlawful or otherwise prohibited by these Terms of Use.

1. Terms of Use Applies. You should assume that everything you see or read on this Internet Website (“Site”) may not be used except as provided in these Terms of Use or in the text on the Site, without the written permission of Mallinckrodt LLC, or its affiliates (“Mallinckrodt”).

2. Feedback. Mallinckrodt welcomes your feedback and suggestions about how to improve this Site. Any ideas, suggestions, information, know-how, material, or other content (collectively, "content") received through this Site, however, shall be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, non-exclusive right and license for Mallinckrodt to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display (in whole or part), or act on such content without additional approval or consideration, in any form, media, or technology now known or later developed for the full term of any rights that may exist in such content.

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ATTENTION: LINKING TO MALLINCKRODT’S SITE INDICATES THAT YOU ACCEPT MALLINCKRODT’S TERMS OF USE AND LEGAL RESTRICTIONS AND THAT YOU WILL ABIDE BY THE GUIDELINES BELOW. IF YOU DO NOT ACCEPT THESE TERMS AND AGREE TO ABIDE BY THESE GUIDELINES, DO NOT LINK TO THIS WEB SITE.

If you link to Mallinckrodt's site, you agree that you:

7. Revision of Terms of Use. Mallinckrodt may at any time revise these Terms of Use by updating this posting. You are bound by any such revisions and should therefore periodically visit this page to review the current Terms of Use to which you are bound

8. Additional Prohibited Uses. You may use this Site only for lawful purposes and in accordance with these Terms of Use. In addition to the other prohibitions set forth in these Terms of Use, You agree not to use this Site in the following ways:

9. Disclaimers & Limitations.
The information provided by this Site is not intended nor is implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health care provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

This Site may contain information on worldwide products and services, not all of which are available in every location. A reference to a product or service on this Site does not imply that such product or service is or will be available in your location. The products referred to on this Site may be subject to different regulatory requirements depending on the country of use. Consequently, visitors may be notified that certain sections of this Site are intended only for certain kinds of expert users or only for audiences in certain countries. You should not construe anything on this Site as a promotion or advertisement for any product or for the use of any product that is not authorized by the laws and regulations of your country of residence.

Mallinckrodt, the owner of this Site, will use reasonable efforts to include up-to-date and accurate information in this Site, but makes no representations, warranties, or assurances as to the accuracy, currency, or completeness of the information provided. Mallinckrodt shall not be liable for any damages or injury resulting from your access to, or inability to access, this Internet site, or from your reliance on any information provided at this Internet site. This limitation on damages means that you agree that Mallinckrodt shall not be liable for any loss, costs, expense, loss of anticipated profits, direct damages, indirect damages, consequential damages, punitive damages, special damages, or other damages or liability of any nature whatsoever whether based on contract, tort or any other theories of liability.

This Site may provide links or references to other sites but the owners of this site have no responsibility for the content of such other sites and shall not be liable for any damages or injury arising from that content. Any links to other sites are provided as merely a convenience to the users of this Site.

Your use of this Site is at your own risk. Neither Mallinckrodt, any of its agencies, nor any other party involved in creating, producing, or delivering the Site will be liable for any direct, incidental, consequential, indirect, or punitive damages arising out of your access to, or use of, the Site. Without limiting the foregoing, everything on the Site is provided to you "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT. Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you.

Mallinckrodt also assumes no responsibility, and shall not be liable for, any damages to, or viruses that may infect, your computer equipment or other property on account of your access to, use of, browsing in the Site, or your downloading of any materials, data, text, images, video, or audio from the Site.

Although Mallinckrodt may from time to time monitor or review emails, discussions, postings, transmissions, and the like on the Site, Mallinckrodt is under no obligation to do so and assumes no responsibility or liability arising from the content of any such locations nor for any error, defamation, libel, slander, omission, falsehood, obscenity, pornography, profanity, danger, or inaccuracy contained in any information within such locations on the Site. You are prohibited from posting or transmitting any unlawful, threatening, libelous, defamatory, obscene, scandalous, inflammatory, pornographic, or profane material or any material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or otherwise violate any law. Mallinckrodt will fully cooperate with any law enforcement authorities or court order requesting or directing Mallinckrodt to disclose the identity of anyone posting any such information or materials.

10. Intellectual Property Information.
Mallinckrodt, the “M” brand mark, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. In addition, all trademarks, trade names, logos, taglines, service marks, trade dress, designs and products (collectively the “Trademarks”) displayed on this Site, whether marked or unmarked, are U.S. and internationally registered and/or unregistered Trademarks of a Mallinckrodt company or their respective owner.

Nothing contained on the Site should be construed as granting, by implication, estoppel, or otherwise, any license or right to use any Trademarks displayed on the Site without the written permission of Mallinckrodt or such third party that may own the Trademarks displayed on the Site. Your use of the Trademarks displayed on the Site, or any other content on the Site, except as provided in these Legal Statements, is strictly prohibited. You are also advised that Mallinckrodt will strictly and aggressively enforce its intellectual property rights to the fullest extent of the law, including the seeking of criminal prosecution.

The materials of this Site are protected by Copyright and Trademark Laws of the U.S. and other countries and are owned by, or licensed to Mallinckrodt. All content of this Site is owned or controlled by Mallinckrodt. You may download content only for your personal use for non-commercial purposes but no modification or further reproduction of the content is permitted. The contents of the Site, including any images, text, executable code, and layout design may not be distributed, reproduced, publicly displayed, downloaded, modified, reused, re-posted, or otherwise used except as provided herein without the express prior written permission of the Mallinckrodt Legal Department.

Mallinckrodt neither warrants nor represents that your use of materials displayed on the Site will not infringe rights of third parties not owned by or affiliated with Mallinckrodt.

Mallinckrodt maintains this Site for your personal information, education, and communication. Please feel free to browse the Site. You may download material displayed on the Site for personal, noncommercial use only provided you also retain all copyright and other proprietary notices contained on the materials. You may not, for any reason, distribute, modify, duplicate, transmit, reuse, re-post, or use the content of the Site for public or commercial purposes, including the text, images, audio, and video without Mallinckrodt's prior written permission.

All rights reserved. All materials are provided for noncommercial personal use only.

In the event You believe that your intellectual property is being used on the Site in a way that constitutes copyright infringement, please provide us with the following information (as required by Section 512(c)(3) of the Digital Millennium Copyright Act):

— A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.
— Identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works at a single online site are covered by a single notification, a representative list of such works at that site.
— Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit the service provider to locate the material.
— Information reasonably sufficient to permit the service provider to contact the complaining party, such as an address, telephone number, and, if available, an electronic mail address at which the complaining party may be contacted.
— A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law.
— A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

The information specified above must be sent using the following contact information:

Mallinckrodt
675 McDonnell Blvd.
Hazelwood, MO 63042 USA
Attention: Legal Department – Online Infringement

Please note that Section 512(f) of the Digital Millennium Copyright Act may impose liability for damages on any person who knowingly sends meritless notices of infringement. Please do not make false claims.

Any information or correspondence that you provide to us may be shared with third parties, including the person who provided us with the allegedly infringing material.

11. Securities Information. Mallinckrodt is not providing investment advice through this Site. The material on this Site should not be regarded as an offer to sell, or a solicitation of an offer to buy, any of our securities. If you decide to use any material available on this Site in assessing whether to buy or sell our securities, please be aware that the material on this Site reflects past performance and historical information only and that such performance and information is not necessarily an indication of future performance.

You hereby acknowledge understand and agree that statements included on this Site that are not a description of historical facts may be forward-looking statements. You hereby acknowledge understand and agree that you will not rely on these forward-looking statements, and that you will not change your position as a result of these forward looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Mallinckrodt that any of Mallinckrodt’s plans will be achieved. Actual results may differ materially from those set forth on this Site due to the risks and uncertainties inherent Mallinckrodt’s business. For information about the risks and uncertainties that Mallinckrodt faces and a discussion of Mallinckrodt’s financial statements and footnotes, see the periodic public filings Mallinckrodt makes with the Securities and Exchange Commission and other regulatory agencies. All forward-looking statements are qualified in their entirety by this cautionary statement and Mallinckrodt undertakes no obligation to revise or update this Site to reflect events or circumstances after information is posted on this Site, even if new information becomes available to Mallinckrodt in the future.

12. Law and jurisdiction. These Terms of Use will be governed by and construed in accordance with Nevada law without regard to its conflicts of law provisions, and any disputes relating to these terms and conditions will be subject to the exclusive jurisdiction of the federal and state courts sitting in Clark County, Nevada. To the fullest extent permitted by law, the Parties voluntarily, knowledgeably, intentionally, and irrevocably waive all rights to trial by jury in any action, proceeding or counterclaim.


INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY 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

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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Click for chapters

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY 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 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, 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. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • 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. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

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 SAFETY INFORMATION

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY 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 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, 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. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • 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. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

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.

Tap for additional Important Risk Information

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY 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 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, 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. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • 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. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

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.