The THERAKOSTM CELLEXTM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.
THERAKOSTM Photopheresis is contraindicated in:
Warnings and Precautions
THERAKOSTM Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure. Safety in children has not been established.
Please refer to the THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings and precautions.
Methoxsalen is contraindicated in:
Warnings and Precautions
Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.
Please refer to the THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.
Mallinckrodt and its affiliates and brands collect, use, and share personal information.
If you are a Healthcare Professional (“HCP”), for additional information about how we collect, use, and share your personal information, please click here.
The primary data controller is Mallinckrodt Pharmaceuticals Ireland Limited, with registered offices at College Business & Technology Park, Cruiserath,
Blanchardstown, Dublin 15, Ireland.
If you have any questions, comments, or complaints concerning our data privacy or data protection practices, please contact us at email@example.com or call us at 800-822-2075.
Types of Data We Collect
Personal Information means any information relating to an identified or identifiable natural person (“Data Subject”). An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, mental, economic, cultural or social identity of that natural person. The following provides examples of the types of data that we collect from you and how we use the information.
In addition to the information that we collect from you directly, we may also receive information about you from other sources, including third parties, business partners, our affiliates, or publicly available sources.
Sharing Of Personal Information
In addition to the specific situations discussed elsewhere in this Policy, we may disclose personal information in close relation to the purposes specified above to trusted third parties, collectively referred to as “Recipients.”
How We Protect Personal Information
No method of transmission over the internet, or method of electronic storage, is fully secure. While Mallinckrodt implements appropriate technical and organizational
security measures to protect your personal information from unauthorized access, use, or disclosure, due to the public nature of the internet,
we cannot guarantee the security of your personal information. In the event that we are required by law to inform you of any unauthorized access to your personal information,
we will notify you electronically, in writing, or by telephone, if permitted to do so by law.
Some of our websites permit you to create an account. When you do, you will be prompted to create a password. You are responsible for maintaining the confidentiality of your password, and you are responsible for any access to or use of your account by someone else that has obtained your password, whether or not such access or use has been authorized by you. You should notify us of any unauthorized use of your password or account.
Cookies and Other Web Devices
Each website can send its own cookie to your web browser if your browser’s preferences allow it. Cookie settings can be controlled in your internet browser to automatically reject some forms of cookies. If you do not allow cookies, some features and functionality of our site may not operate as expected.
Mallinckrodt may use Adobe Flash technology (including Flash Local Stored Objects “Flash LSOs”) that allow Mallinckrodt to, among other things, serve you with more tailored information, facilitate your ongoing access to and use of the Site, and collect and store information about your use of the Site. Some
of our websites or emails also use pixel tags, web beacons, clear GIFs, or other similar technologies to measure the success of marketing campaigns, and compile statistics about usage and response rates, and other purposes.
Mallinckrodt may use other web devices to track website usage and views. If you have questions or concerns about our cookie or web device usage, please contact us at firstname.lastname@example.org or call 800-822-2075.
Your EU Privacy Rights
Pursuant to EU General Data Protection Regulation (GDPR), below is additional specific information which relates to the processing of personal information of Data Subjects who are in the EU. Mallinckrodt has put in place a data protection governance structure to ensure the data privacy rights and freedoms of Data Subjects are protected.
California Consumer Privacy Act Rights
Subject to legal limitations, if you are a resident of California, you may have the right to make the following choices regarding your personal information:
Note that, as required by law, we will require you to prove your identity. We may verify your identity by telephone call or email. Depending on your request, we will ask for information such as your name, your physical address, or the name of our clinical trial in which you participated. We may also ask you to provide a signed declaration confirming your identity. Following a request, we will use reasonable efforts to supply, correct or delete personal information about you in our files.
In some circumstances, you may designate an authorized agent to submit requests to exercise certain privacy rights on your behalf. We will require verification that you provided the authorized agent permission to make a request on your behalf. You must provide us with a copy of the signed permission you have given to the authorized agent to submit the request on your behalf and verify your own identity directly with us. If you are an authorized agent submitting a request on behalf of an individual you must attach a copy of the following information to the request:
If we do not receive both pieces of information, the request will be denied.
Requests to exercise your rights must be sent to email@example.com or made via telephone by calling 800-822-2075.
Other Important Information
The following additional information relates to our privacy practices:
Last Updated: July 2020
Effective: January 2018
California Information Sharing Disclosure
California Civil Code Sections 1798.115(c), 1798.130(a)(5)(c), 1798.130(c), and 1798.140 indicate that organizations should disclose whether the following categories of personal information are collected, transferred for “valuable consideration,” or transferred for an organization’s “business purpose” (as those terms are defined under California law). We do not “sell” your personal information. The table below indicates the categories of personal information we collect and transfer in a variety of contexts. Please note that because this list is comprehensive, it may refer to types of information that we collect and share about people other than yourself. For example, while we transfer credit card or debit card numbers for our business purposes in order to process payments for orders placed with us, we do not collect or transfer credit card or debit card numbers of individuals that submit questions through our website’s “contact us” page.