1. Site Use
2. Not Medical Advice
(a) THIS SITE DOES NOT PROVIDE MEDICAL ADVICE. The Site and its Content (as defined below) are for general informational purposes only and are not intended to be a replacement or substitute for the standard practices, professional judgment, skill and expertise of a health professional, or for professional medical advice, diagnosis, or treatment. You should consult an appropriate medical or other professional adviser as to the application of any particular technique, practice or information referred to on the Site or in the Content to your particular circumstances. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking medical advice as a result of the Site or Content. IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL YOUR DOCTOR OR 911 IMMEDIATELY.
You understand and acknowledge that many factors unknown to Concordia may affect the application of any statement, comment or information that is made available through the Site or the Content to your particular circumstances. It is your sole responsibility to obtain health care for yourself, and Concordia does not assume, and actively disclaims, responsibility for how the information provided on this Site may be used, including as the basis for care, and Concordia assumes no, and actively disclaims, all responsibility whatsoever with respect to the usage of such information, which information is provided with no representations, warranties, or conditions, whether express or implied.
(b) Communication with the Concordia and its partners, licensors, agents, content providers, service providers, employees, officers, directors or representatives (“Representatives”) as provided by the Site or Content (as defined herein) is for general informational purposes only and is not intended to provide a means to communicate professional medical advice, diagnosis, or treatment. Concordia is not a medical provider and cannot give you medical advice or provide any information concerning the diagnosis or treatment of any health condition. Concordia and its Representatives are under no obligation to respond to these communications.
(c) Other than with respect to a general endorsement of the Concordia products on this Site, which endorsement again is not specific to your particular circumstances, Concordia does not recommend or endorse any specific products, tests, physicians, procedures, opinions, or other information that may be referred to on or in the Site or Content. Reliance on (i) any information provided by Concordia or its Representatives, (ii) the Site, or (iii) the Content is solely at your own risk.
3. Age Requirement
4. Site Content Ownership
This Site and the content including but not limited to the layout, color schemes, URL’s, photos, drawings, images, catalogs, advertisement, videos and sound and all intellectual property rights included in or associated with the Site, including, but not limited to patents, copyrights, trademarks, service marks, logos and trade secrets (collectively “Content”) are either owned by Concordia or owned by others and licensed to us. All right, title and interest in and to the Site and such Content remains with us or our licensors, as applicable.
5. Limited Right to Use Site Materials
6. Rights of Others
Concordia respects the intellectual property rights of others. If you believe that your work has been infringed by means of an improper posting of it on the Site, then please see Section 13, below.
7. Limitations on Linking and Framing
You are free to establish a hypertext link to our Site so long as the link does not state or imply any sponsorship, endorsement, affiliation or other connection of your website, product or service by Concordia. However, you may not, without our prior written permission, frame or inline link or deep link any of the content of our Site, or incorporate into another website or other service any of our material, Content or intellectual property.
8. Linking and Third Party Content
The Site may contain links to third party websites not under our control or operation. Concordia or users may provide any such links only as a convenience; Concordia does not endorse and is not responsible for or have control over the contents of any linked site or any link contained in a linked site. The Site may contain news, advertisements, content and information published by various third party providers. Use of any such third party content may be conditioned upon such third party’s terms and conditions: you are solely responsible for identifying and complying with those terms and conditions. You are also solely responsible for protecting yourself, your device, and your systems from worms, viruses, Trojan horses and any other harmful content.
9. Additional Terms and Conditions
Additional terms and/or conditions (e.g. Concordia standard terms and conditions) may apply to specific areas of the Site or Site functionality, and you agree to abide by such other terms and conditions.
10. Laws and Regulations
You acknowledge and agree that Concordia, regardless of the device or form factor chosen, is not responsible for your software or browser compatibility and functionality, hardware, and/or network connections with the Site, or for your resulting access to, availability of, use of, and timing, receipt and accuracy of information transmitted to or received from the Site and/or its features.
13. Procedure for Alleging Copyright Infringement Under Digital Millennium Copyright Act
Concordia will respond to alleged copyright violations in the United States in accordance with the Digital Millennium Copyright Act (“DMCA”). The applicable Concordia privacy statement does not protect information that Concordia may provide to third parties at its discretion or as required by DMCA through copies of notices referenced below.
A. If you are a copyright owner or an agent thereof and believe that any third party content on the Site (“Third Party Content”) infringes upon your copyrights, you may submit a written notification pursuant to DMCA by providing Concordia with the following:
1) A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed;
2) 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;
3) Identification of the Third Party Content 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 Concordia to locate the material;
4) Information reasonably sufficient to permit Concordia to contact you, such as an address, telephone number, and, if available, an electronic mail address;
5) A statement that you have a good faith belief that use of the Third Party Content in the manner complained of is not authorized by the copyright owner, its agent, or the law; and
6) A statement that the information in the notification is accurate, and under penalty of perjury, that you are authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.
B. Counter-Notification. If you believe that your Third Party Content that was removed (or to which access was disabled) is not infringing, or that you have the authorization from the copyright owner, the copyright owner’s agent, or pursuant to the law, to post and use the material in your Third Party Content, you may send a Counter-Notification containing the following information to Concordia at the address set forth below:
1) Your physical or electronic signature;
2) Identification of the Third Party Content that has been removed or to which access has been disabled and the location at which the Third Party Content appeared before it was removed or disabled;
3) A statement that you have a good faith belief that the Third Party Content was removed or disabled as a result of mistake or a misidentification of the Third Party Content; and
4) Your name, address, telephone number, and e-mail address, a statement that you consent to the jurisdiction of the Federal court in New York City, New York, USA, and a statement that you will accept service of process from the person who provided notification of the alleged infringement.
5) If a Counter-Notification is received by Concordia, Concordia may send a copy of the Counter-Notification to the original complaining party informing that person that Concordia may replace the removed Third Party Content or cease disabling it in 10 business days. Unless the copyright owner files an action seeking a court order against the Third Party Content provider, member or user, the removed Third Party Content may be replaced, or access to it restored, in 10 to 14 business days or more after receipt of the Counter-Notification, at Concordia’s sole discretion.
6) You acknowledge that if you fail to comply with all of the requirements of this Section 13, your DMCA notice may not be valid.
7) Concordia will only respond to DMCA Notices that it receives by mail or e-mail at the addresses below:
By Mail: Concordia Laboratories Inc.
St. Michael, Barbados BB11005
By E-Mail: firstname.lastname@example.org
It is often difficult to determine if your copyright has been infringed. Concordia may elect to not respond to DMCA Notices that do not substantially comply with all of the foregoing requirements, and Concordia may elect to remove allegedly infringing material that comes to its attention via notices that do not substantially comply with the DMCA.
Please note that the DMCA provides that any person who knowingly materially misrepresents that material or activity is infringing may be subject to liability.
We may send the information that you provide in your notice to the person who provided the allegedly infringing work. That person may elect to send us a DMCA Counter-Notification.
Without limiting Concordia’s other rights, Concordia may, in appropriate circumstances, terminate a repeat infringer’s access to the Site and any other website owned or operated by Concordia.
You should also be aware that we may forward the DMCA Counter-Notification to the party who sent us the DMCA Copyright Infringement Notice.
14. No Unsolicited Ideas and Materials Accepted; No Confidential Relationship With Concordia.
Concordia employs individuals to develop new ideas. As a result, Concordia does not accept any unsolicited submissions, ideas or materials for products or services, or even improvements to products or services (“Unsolicited Ideas and Materials”). Do not send to Concordia, in any form and by any means, any Unsolicited Ideas and Materials. Should you do so, you grant us, and anyone authorized by us, a royalty-free, perpetual, irrevocable, non-exclusive, unrestricted, worldwide, transferable, assignable and sub licensable license to use, copy, modify, transmit, sell, exploit, create derivative works from, distribute, and/or publicly perform or display such Unsolicited Ideas and Materials, in whole or in part, in any manner or medium (whether now known or hereafter developed), for any purpose that we choose, and waive all moral rights in such Unsolicited Ideas and Materials. The foregoing grant includes the right to exploit any proprietary rights in such Unsolicited Ideas and Materials, including, but not limited to, rights under copyright, trademark, trade secret or patent laws that exist in any relevant jurisdiction. Also, in connection with the exercise of these rights, you grant us, and anyone authorized by us, the right, but not the obligation, to identify you as the author of any of your Unsolicited Ideas and Materials by name or e-mail address, as we deem appropriate. Concordia has no obligation of any kind with respect to such Unsolicited Ideas and Materials and is free to reproduce, use, disclose and distribute any portion of the Unsolicited Ideas and Materials, including any ideas or information contained in the Unsolicited Ideas and Materials for any purpose whatsoever. You understand that the technical processing and transmission of the Site, including content submitted by you including the Unsolicited Ideas and Materials, may involve transmissions over various networks, and may involve changes to the content to conform and adapt it to technical requirements of connecting networks or devices. You will not receive any compensation, and may not receive any acknowledgement, of any kind for the use of any Unsolicited Ideas and Materials.
Your relationship with Concordia is not a confidential, fiduciary, or other type of special relationship and your Unsolicited Ideas and Materials (and anything else submitted by you) will be treated as non-confidential and non-proprietary information, regardless of whether you mark them “confidential”, “proprietary”, or the like. Concordia will not assume any responsibility, obligation, or liability for the receipt or non-receipt of any of the foregoing or for the loss or destruction of any of the foregoing. Therefore, your decision to submit any Unsolicited Ideas and Materials to Concordia does not place Concordia in a position that is any different from the position held by members of the general public with regard to your Unsolicited Ideas and Materials.
Concordia’s receipt of your Unsolicited Ideas and Materials is not an admission by Concordia of their novelty, priority, or originality, and neither such receipt nor the licence granted above impairs Concordia’s right to contest existing or future intellectual property rights relating to your Unsolicited Ideas and Materials.
15. Disclaimer of Warranties
CONCORDIA PROVIDES THE SITE AND ALL INFORMATION, CONTENT, MATERIALS, PRODUCTS (INCLUDING SOFTWARE) AND SERVICES INCLUDED ON OR OTHERWISE MADE AVAILABLE TO YOU THROUGH THE SITE ON AN “AS IS” AND “AS AVAILABLE” BASIS, UNLESS OTHERWISE SPECIFIED IN WRITING. YOU EXPRESSLY AGREE THAT YOUR USE OF THE SITE IS AT YOUR SOLE RISK, UNLESS OTHERWISE SPECIFIED IN WRITING. CONCORDIA MAKES NO, AND ACTIVELY DISCLAIMS, ALL REPRESENTATIONS, WARRANTIES AND COVENANTS OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF NON-INFRINGEMENT, FITNESS FOR A PARTICULAR PURPOSE, OR MERCHANTABILITY, REGARDING YOUR USE OF THE SITE OR ANY INFORMATION, CONTENT, SERVICES OR PRODUCTS PROVIDED OR MADE AVAILABLE HEREIN OR THE AVAILABILITY OF THE SITE ITSELF OR THE ACCURACY OF ANY INFORMATION, CONTENT, OR RESULTS OBTAINED THROUGH YOUR USE OF THE SITE. WITHOUT INTENDING TO BE EXHAUSTIVE, AS PART OF THIS DISCLAIMER, CONCORDIA DOES NOT WARRANT THAT THE SITE OR ANY PORTIONS THEREOF WILL OPERATE UNINTERRUPTED OR ERROR-FREE, AND GIVES NOTICE THAT IT IS POSSIBLE THAT THE SITE OR ONE OR MORE PORTIONS THEREOF OR FEATURES OR SERVICES AVAILABLE THROUGH THE SITE MAY BE OR BECOME INACCESSIBLE, UNAVAILABLE, OR INOPERABLE FROM TIME TO TIME OR PERMANENTLY.
THE HEALTH INFORMATION CONTAINED HEREIN IS PROVIDED FOR EDUCATIONAL PURPOSES ONLY AND IS NOT INTENDED TO REPLACE DISCUSSIONS WITH YOUR DOCTOR.
16. Limitation of Liability
CONCORDIA SHALL NOT BE LIABLE TO YOU, AND YOU SHALL BE SOLELY RESPONSIBLE, FOR THE SELECTION, USE, AND SUITABILITY OF THE SITE AND THE INFORMATION, CONTENT, PRODUCTS, SERVICES AND EXPERIENCES PROVIDED VIA THE SITE. CONCORDIA SHALL NOT BE LIABLE TO YOU FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL OR ANY OTHER DAMAGES IN CONNECTION WITH YOUR USE OF THE SITE, OR PURCHASE OR USE OF ANY SERVICES, OR EXPERIENCES VIA THE SITE, INCLUDING, BUT NOT LIMITED TO, LOSS OF OR DAMAGE TO DATA, LOSS OF OR DAMAGE TO INFORMATION, PERSONAL INJURY OR PROPERTY DAMAGE, OR LOSS OF PROFITS OR REVENUE, HOWEVER CAUSED, WHETHER BASED ON CONTRACT, TORT, WARRANTY, OR OTHER LEGAL THEORY, EVEN IF CONCORDIA HAS BEEN INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES AND/OR SUCH DAMAGES COULD HAVE BEEN REASONABLY FORESEEN BY CONCORDIA. REGARDLESS OF WHETHER ANY REMEDY SET FORTH HEREIN FAILS OF ITS ESSENTIAL PURPOSE OR OTHERWISE, CONCORDIA’S TOTAL LIABILITY, REGARDLESS OF THE FORM OF ACTION, SHALL NOT EXCEED $50.
17. Exclusions and Limitations
SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF CERTAIN WARRANTIES OR THE LIMITATION OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. ACCORDINGLY, SOME OF THE LIMITATIONS IN THE SECTION ABOVE MAY NOT APPLY TO YOU.
18. Governing Law and Jurisdiction
C. By offering this Site and any information, products or other content through the Site, Concordia does not purport to distribute to you or any person, or solicit you or any person to use, the Site or such information, products or other content in jurisdictions where providing such is prohibited by law.
D. You agree to comply with all local rules regarding online conduct and acceptable materials. Specifically, you agree to comply with all applicable laws regarding the transmission of technical or other data exported from the United States or the country in which you reside.
G. The product information provided in this Site is intended for residents of the United States only.
I. Concordia may immediately suspend or terminate availability of the Site and Content (and any elements and features of them) for any reason, in Concordia’s sole discretion, and without notice or liability.
IMPORTANT SAFETY INFORMATION AND INDICATION
Who should not take PHOTOFRIN? Do not take PHOTOFRIN?
- If you have a rare disorder with a blood component called porphyria
- If you have an abnormal connection (fistula) between the esophagus and airways leading to the lungs
- If you have a tumor extending into a major blood vessel
- If you have life-threatening breathing failure due to an obstructing airway tumor that requires emergency treatment
- If you have enlarged veins in the stomach or esophagus or large ulcers in the esophagus
What should I tell my healthcare provider before taking PHOTOFRIN?
Before taking PHOTOFRIN, tell your healthcare provider about all your medical conditions, including if you are:
- Taking other medicines that are activated by light
- Taking other medicines during your photodynamic treatment with PHOTOFRIN
- If you are pregnant or are a nursing mother
What is the most important information I should know about PHOTOFRIN?
- Sensitivity or allergic reaction to light can be expected; eye sensitivity is possible. This reaction is called phototoxicity, which has a sunburn-like effect and may be severe. All patients receiving PHOTOFRIN will be sensitive to light and must take precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor light for at least 30 days, but it may be required for more than 90 days. The phototoxicity with PHOTOFRIN is unique since it is activated, not only by UV light, but also by light visible to your eyes that is usually safe for humans. Phototoxicity reactions with PHOTOFRIN can occur following the first exposure to direct sunlight or intense indoor light from within a few minutes to up to several hours after exposure; resulting skin damage can persist. After PHOTOFRIN administration, when outside wear protective clothing and dark sunglasses which let less than 4% white light through.
- An abnormal connection (fistula) can occur if an esophageal tumor is eroding into the main airway leading to the lungs or into one of its branches
- Holes can develop through the wall of the organs in your digestive system where photodynamic therapy was applied (esophagus, stomach, small intestine, large bowel, rectum, gallbladder)
- Bleeding can occur if you have enlarged veins in your esophagus
- Some patients with treated lung cancer lesions are at high risk for coughing up life-threatening amounts of blood
- If you are being treated for pre-cancerous cells (high-grade dysplasia) in Barrett’s esophagus, biopsy of your esophagus will be performed every 3 months and checked by your doctor until 4 consecutive biopsies are negative for high-grade dysplasia
- If you require radiotherapy after treatment with PHOTOFRIN, the radiotherapy should not be started until 2-4 weeks after your PHOTOFRIN treatment
- You may experience chest pain or breathing difficulty. Notify your doctor if you experience chest pain or any other side effects after treatment with PHOTOFRIN. Your doctor may prescribe medication to help reduce the pain.
- Photodynamic therapy for advanced lung cancer may block the main lung airway, leading to life-threatening difficulty breathing
- Narrowing of the esophagus occurs frequently after treatment of pre-cancerous cells (high-grade dysplasia) in Barrett’s esophagus
- If you have liver or kidney problems you may be need to take extra precautions regarding sensitivity to light and for a longer time period
- Blockage of blood vessels from pieces of a blood clot can happen after treatment with PHOTOFRIN
What are the possible side effects of PHOTOFRIN?
- For esophageal cancer (treatment of the esophagus): anemia, accumulation of fluid in the lungs, fever, constipation, nausea, chest pain, general pain, stomach pain, difficulty breathing, sensitivity or allergic reaction to light, pneumonia (infection of the lung), vomiting, difficulty sleeping, back pain, inflammation of the throat.
- For obstructing endobronchial cancer (when cancer blocks the lungs airways): difficulty breathing, sensitivity or allergic reaction to light, coughing with or without small amounts of blood, fever, coughing, pneumonia (infection of the lungs)
- For superficial endobronchial tumors (when cancer slightly invades surrounding tissues): fluid leaking out of blood vessels nearby tissue, sensitivity or allergic reaction to light, blockage lung airways, swelling of tissue due to large fluid volume, narrowing of the main airway leading to lungs
- High-grade dysplasia (pre-cancerous cells) in Barrett’s Esophagus (treatment of the esophagus): sensitivity or allergic reaction to light, narrowing of the esophagus, vomiting, chest pain, nausea, fever, constipation, difficulty or pain when swallowing, abdominal pain, accumulation of fluid in the lungs, dehydration.
These are not all the possible side effects of PHOTOFRIN. For more information call your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Concordia Laboratories Inc. at 1-866-248-2039.
IndicationPHOTOFRIN is used for:
- Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy
- Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated
- Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC
High-Grade Dysplasia in Barrett's Esophagus
- Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy
PHOTOFRIN®, Pinnacle Biologics™ and the logo of Pinnacle Biologics™ are trademarks of Pinnacle Biologics, Inc. See more.
The PHOTOFRIN® trademark is owned by Concordia Laboratories Inc.
PHOTOFRIN® is manufactured for Concordia Laboratories Inc. and distributed in the United States by Pinnacle Biologics Inc. See more.