Privacy Statement
Grifols Therapeutics Inc. is aware that the security of your private information from the use of our website is an important concern. We take the protection of your personal data very seriously. Therefore we would like you to know what data we maintain and what data we discard. With this privacy statement, we would like to inform you about our security measures.Collection of Data
You can use our website without disclosing your personal data. You are not required to provide personal information as a condition of using our site, except as may be necessary to provide you a product or service at your request. When you use our website, we store data on our servers for various security purposes. This data may include the name of your Internet service provider, the website that you used to link to our site, the websites that you visit from our site, and your IP-Address. This data could possibly lead to your identification, but we do not use it to do so. We do use the data from time to time for statistical purposes but maintain the anonymity of each individual user so that the person cannot be identified. In cases when personal data is provided to others to provide you products or services you have requested, or for other purposes you have authorized, we rely on technical and organizational means to assure that applicable data security regulations are followed.
Collection and Processing of Personal Data
We collect personal data only when you provide it to us, through registration, completion of forms or emails, as part of an order for products or services, inquiries, or requests about materials being ordered and similar situations in which you have chosen to provide the information to us.
The database and its contents remain at our company or with our authorized agents and stay with data processors or servers acting on our behalf and responsible to us. Your personal data will not be passed on by us or by our agents for use by third parties in any form whatsoever, unless we have obtained your consent or are legally required to do so.
We will retain control of and responsibility for the use of any personal data you disclose to us. Some of this data may be stored or processed at computers located in other jurisdictions, such as the United States, whose data protection laws may differ from the jurisdiction in which you live. In such cases, we will ensure that appropriate protections are in place to require the data processor in that country to maintain protections on the data that are equivalent to those that apply in the country in which you live.
Purposes of Use
The data we collect will only be used for the purpose of supplying you with the requested products or services or for other purposes for which you have given your consent, except where otherwise provided by law.
Right of Access and Correction
You have the right to review and amend any personal data stored in our system if you believe it may be out of date or incorrect. Just send an email to the address given in the imprint or contact the Website Administrator at the address below.
Right of Cancellation
You have the right at any time to withdraw your consent to the use of your personal data in the future. Again, just send an email to the address given in the imprint or contact the Website Administrator at the address below.
Data Retention
We only retain personal data for as long as is necessary for us to render a service you have requested or to which you have given your consent, except where otherwise provided by law (eg, in connection with pending litigation).
Use of Cookies
In some websites, so-called Cookies are used in order for us to improve the efficiency of your individual use of the website. Cookies are identifiers that our server could send to your computer in order to identify the computer being used for the duration of the session. Most browsers are set up to accept these Cookies automatically. In addition, you can deactivate the storing of Cookies or adjust your browser to inform you before the Cookie is stored on your computer. If Cookies are going to be saved to your computer not only for the duration of a session, with automatic subsequent deletion, but for the long term, we will provide you notice of this fact when the relevant Cookies are set.
Security
Grifols uses technical and organizational security precautions to protect your data from manipulation, loss, destruction, or access by unauthorized persons. Any personal data that is provided to Grifols by you will be encrypted in transit to prevent its possible misuse by third parties. Our security procedures are continuously revised based on new technological developments.
Children
In light of the importance of protecting children’s privacy, we do not collect, process, or use on our website any information relating to an individual whom we know to be under 13 years old without the prior, verifiable consent of his or her legal representative. Such legal representative has the right, upon request, to view the information provided by the child and/or to require that it be deleted.
Contacts
Please contact the Grifols Website Administrator with any problems, questions, or suggestions that you may have. The constant development of the Internet requires occasional adjustments to our privacy statement. We retain the right to make changes when necessary.
Email: Grifols Website Administrator
HIPAA Agreement
The Health Insurance Portability and Accountability Act of 1996, and its regulations (collectively “HIPAA”), and the Health Information Technology for Economic and Clinical Health Act, and its regulations (collectively “HITECH”), contain provisions (collectively, provisions of either HIPAA or HITECH, “HIPAA Provisions”) requiring certain entities (“Covered Entities”) to meet certain standards for the privacy and security of certain information (“Protected Health Information” or “PHI”). Under the HIPAA Provisions, Centric Health Resources (“Centric”) is a Covered Entity. As such, Centric is required to maintain the privacy and security of PHI in accordance with the HIPAA Provisions. We follow a Notice of Privacy Practices with respect to such PHI.
You have chosen to receive information and/or participate in the Gamunex Connexions Program. We follow the Notice of Privacy Practices with respect to information provided through the Site/Program for our use and disclosure of PHI. Information you provide in any public areas of the Site/Program and areas open to other members of the Site/Program is information that is used and disclosed by you, not information that is used or disclosed by Centric, and, thus, it is not subject to the Notice of Privacy Practices. By signing below, you are acknowledging that you understand that the Notice of Privacy Practices has this limited applicability to your participation in the Site/Program and that you will not attempt to hold Centric responsible for your uses and disclosures of your own PHI through the public areas and areas open to other members of the Site/Program.
Further, information entered in the Site/Program may be de-identified by us in accordance with the HIPAA Provisions. Such de-identified information is no longer considered PHI and is not subject to the HIPAA Provisions. Information entered in the Site/Program may also be used to create a limited data set in accordance with the HIPAA Provisions. A limited data set is PHI that has had many of the identifiers that make the information individually identifiable removed, but still contains a few data points that keep it from being considered de-identified under the HIPAA Provisions. We will only use or disclose a limited data set for purposes of research, public health, or health care operations. Any disclosures of a limited data set will be subject to a data use agreement.
Contacting Centric - If you have any questions about this HIPAA Agreement please contact:
Centric Health Resources
Attn: Chief Operating Officer
17877 Chesterfield Airport Rd.
Chesterfield, MO 63005
866-849-4481
mhefley@centrichealthresources.com
Important Safety Information for GAMUNEX-C
GAMUNEX-C, Immune Globulin Injection (Human), 10% Caprylate/ Chromatography Purified, is approved to treat primary humoral immunodeficiency disease (PI). If you have PI, you may take GAMUNEX-C under the skin (subcutaneously) or in a vein (intravenously.) GAMUNEX-C is also approved to treat other patients with idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP), but they may only take it intravenously. You may only take GAMUNEX-C by subcutaneous injection if you have PI.
If you take GAMUNEX-C or a similar Immune Globulin (Human) product intravenously, you could experience serious kidney disease and death. You may have symptoms of decreased urination, sudden weight gain, swelling in your legs (edema), or shortness of breath. You are more likely to develop serious kidney disease if you already have a kidney problem, have Type II diabetes (diabetes mellitus), or are older than 65. You are more likely to develop serious kidney disease if you are dehydrated, have blood poisoning (sepsis), have high protein content in your blood, or if you are receiving other medicines that are harmful to your kidneys. Tell your healthcare professional immediately if your medical history is similar to what we describe here, and especially if you start having any of these symptoms while taking GAMUNEX-C.
You are more likely to develop serious kidney disease if you take an Immune Globulin product that contains sugar (sucrose). GAMUNEX-C does not contain sugar. If your situation makes you more likely to experience serious kidney disease, you should take GAMUNEX-C at the lowest concentration available and the slowest infusion rate that is practical.
Do not take GAMUNEX-C if you have an allergy to Immune Globulin. Tell your healthcare professional if you have had a serious reaction to other medicines that contain Immune Globulin. Also tell your healthcare professional if you have Immunoglobulin A (IgA) deficiency.
You may not take GAMUNEX-C subcutaneously if you have CIDP or ITP. If you have ITP and take GAMUNEX-C subcutaneously, you could experience a very serious and life-threatening black and blue wound (hematoma, which is a large pocket of blood within a tissue).
You could possibly experience high protein content in your blood, thickening of your blood (increased serum viscosity), and low levels of sodium in the blood due to Immune Globulin.
You could possibly experience serious and life-threatening blood clots (thromboembolism) due to Immune Globulin. You might have symptoms of chest pain, shortness of breath, leg pain, or swelling of the legs or feet. You would be more likely to experience a blood clot if you have a history of hardening of the arteries (atherosclerosis), stroke, heart attack, or heart failure (low volume of blood pumped by the heart). You may also be more likely to get a blood clot if you are older than 65, if you have a blood clotting disorder, if you are inactive for long periods of time (such as long bed rest for an infirmity), or if you have thickening of your blood.
You could experience other serious and life-threatening problems due to Immune Globulin. You could get a lung problem called TRALI (transfusion-related acute lung Injury), or have fluid on the lungs (pulmonary edema) that is not the result of heart failure. You could get a blood problem called hemolytic anemia (common symptoms include increased heart rate, fatigue, yellow skin or eyes, and dark colored urine). You could get aseptic meningitis, a type of brain inflammation with symptoms of severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
We do not recommend higher doses, such as 1g/kg for 1-2 days, if you have a condition of higher than normal body fluid volumes or where increasing the body fluid volume may be a concern.
Because GAMUNEX-C is made from human blood, we must warn you that you could get a virus disease, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.After you take GAMUNEX-C, you will have a rise in your blood antibody level which could cause some blood antibody tests to give false results.
The most common side effects in a clinical study with PI patients who got subcutaneous injections of GAMUNEX-C were redness, swelling and itching at the infusion site, and headache, fatigue, pain (including pain in the back, joints arms, and legs) and fever. In clinical studies with PI patients who got GAMUNEX-C intravenously, the most common side effects were headache, cough, nausea, inflammation of the throat (which is the most common cause of sore throat), and redness, swelling and itching at the injection site. In a clinical study with CIDP patients who got GAMUNEX-C intravenously, the most common side effects were headache, fever, chills, high blood pressure, rash, nausea, physical weakness, and loss of strength. In clinical trials with ITP patients who got GAMUNEX-C intravenously, the most common side effects were headache, vomiting, fever, nausea, back pain, and rash.
The most serious side effects in clinical studies were a blood clot to the lung (pulmonary embolism) in one patient with a history of this condition (CIDP), a flare-up of an existing type of anemia (autoimmune pure red cell aplasia) in one patient (PI), and heart inflammation (myocarditis) in one patient (ITP).
Please see full Prescribing Information for Gamunex-C.
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.
Copyright © 2012. Grifols Therapeutics Inc., a subsidiary of Grifols Inc. All rights reserved.