Effective Date: April, 12, 2017
Your privacy is important to us. To better protect that privacy, Grifols USA, LLC ("Grifols") provides this notice to explain our online information practices and the choices you can make about the way your information is collected and used. This Privacy Notice applies only to the use and collection of data collected by this website or application, and does not apply to any other data collected by Grifols or its affiliates, online or offline. This website or application and its contents are designed to comply with U.S. laws and regulations and is intended for U.S. residents 18 years of age and older.
As used in this Privacy Notice, "we," "our," or "us" includes Grifols, and its related companies and affiliates, as well as any third-party vendors we hire to assist in the administration of the website or application. These vendors are required to maintain the confidentiality of the user information to which they become privy in accordance with the terms of this Privacy Notice and to otherwise abide by the terms of this Privacy Notice.
Collection, Use and Sharing of Your Information
We collect two basic types of information – personally-identifiable information and non- personally-identifiable information – and we may use personal and anonymous information to create a third type of information, aggregated statistical information. You can visit our website and find out about Grifols' products and services without giving us any personally-identifiable information about you. When you visit our website or application, we do not collect any personally identifiable information without your consent. We collect and store information from you that you voluntarily choose to give us or enter on our website or application, including but not limited to "personally-identifiable information" such as your name, address, e-mail address, health information, etc. If you do not want Grifols to collect your personally-identifiable information, please do not provide it to us.
We may combine your personally-identifiable information provided by you with personally-identifiable information provided in other online or offline records held by us, and/or with records provided by third parties. We may also combine your personally-identifiable information with different types of non-personally-identifiable information discussed in this policy.
Our primary purpose in collecting and processing such information is to provide you with services that you request or to personalize product or service information for you. We may also use your personally-identifiable information to provide you with additional information about our products and services, to provide you with advertising based on your activity on our websites and applications and third-party websites and applications, to optimize or improve our products, services and operations, to detect, investigate and prevent activities that may violate our policies or be illegal, or for technical support, troubleshooting or account administration purposes. We may also share your personally-identifiable information with our agents, contractors, or business partners in order that they may perform services for us.
We may also collect and use non-personally-identifiable information from website visitors, which includes information that does not directly or indirectly identify, and cannot reasonably be used to identify, an individual visitor. This can be technical information, such as your device type or internet browser version, or it can be demographic information, such as your age, gender or interests. Non-personally-identifiable information does NOT identify you personally.
We will share your personally-identifiable information with third parties only in the ways that are described in this Privacy Notice. We do not sell your personal information to third parties.
We do conduct research or analysis on users' demographics, interests and behaviors based upon information provided to us during use of our website and application and we may combine your information with information collected from other individuals to produce anonymous, aggregated statistical information. Aggregated data does not include personally-identifiable information. We use this demographic information, such as the percentage of visitors within certain age brackets, to improve the content of our website or application. We also may share this anonymous, aggregated information, which does not include personally-identifiable information, with third parties.
Public and Social Media Forums
From time to time, we display personal testimonials on our website or application in addition to other endorsements. With your consent we may post your testimonial along with your name. If you wish to update or delete your testimonial, you can contact us at email@example.com.
While the information you provide will be retained for a commercially reasonable time by Grifols for administrative, liability, and archival purposes, your personally-identifiable information is not shared with a third party, other than (i) as required by law, (ii) to protect and defend the rights of Grifols, the website or application, or the users of the website or application, (iii) as incident to a corporate sale, merger, reorganization, dissolution, bankruptcy, or similar event, (iv) under circumstances we believe reasonably necessary to protect the personal safety of the public or users of Grifols products and services, the website, or the application, or (v) as is otherwise described in this Privacy Notice.
We may collect your personal or professional contact information on this website or application to provide you product or service information or other requested information or services. If you wish to subscribe to a newsletter(s) or request other product or service information, we will use your name and e-mail address to send such information to you. Out of respect for your privacy, you may choose to stop receiving our newsletter or marketing e-mails by following the unsubscribe instructions included in these e-mails.
On some Grifols websites, if you choose to use our referral function to tell a friend about our website or application, we will ask you for your friend's name and e-mail address as well as your information. The form automatically sends your friend a one-time e-mail inviting him or her to visit the website or application. We will only collect and use this information to send this invitation.
We may provide you the opportunity to participate in surveys on our website or application. If you participate, we will request certain personally-identifiable information from you. Participation in these surveys is completely voluntary and you therefore have a choice whether or not to disclose this information. The requested information typically includes contact information (such as name and e-mail address) and demographic and/or health information (such as zip code and health condition information).
Social Media Features
Our website or application may include social media features, such as the Facebook Like button and widgets, such as the Share This button or interactive mini-programs that run on our website or application. These features may collect your IP address, which page you are visiting on our website or application, and may set a cookie to enable the feature to function properly. Social media features and widgets are either hosted by a third party or hosted directly on our website or application. Your interactions with these features are governed by the Privacy Notice of the company providing it.
Security and Use of Information
To prevent unauthorized access to the website or application or any portion thereof, maintain data accuracy, and ensure the correct use of information, we use appropriate technical, administrative, and physical safeguards to protect the information we collect. Unfortunately, no organization can guarantee the absolute security of information, especially information transmitted over the internet, we cannot guarantee the security of the personally-identifiable information you transmit to our websites or applications. Any transmission is at your own risk.
Special Note Regarding Website Use By Children
Grifols does not knowingly collect or solicit personal information from anyone under the age of 13. This website and application are not intended or designed to attract children. If you are under 13, please do not send any personal information about yourself to Grifols. If you believe that we might have any information from or about a child under 13, please contact us at firstname.lastname@example.org and we will delete such information.
Links to Other Websites
As a resource to our visitors, Grifols may provide links to other websites. Please be aware that these other websites are not covered under Grifols' Privacy Notice. We suggest that when linking to another website, you always read that website's privacy notice before volunteering any personally-identifiable information.
Some services on this website or application may make use of location-based data. If you allow these services, we may collect information about the Wi-Fi routers closest to you or the cell IDs of the towers closest to you. We may use this information to provide the requested location based service or to provide you content, including advertising, based upon your location, not to identify you. Although Grifols may use or collect geo-location data, we are not capable of assisting in an emergency.
"Refer-A-Friend" or "Forward-to-a-Friend" Functionality
We may offer you opportunities to request that we send content from our website or application or otherwise reach out to friends or family members that you believe may be interested in learning more about our products or services. If you choose to make such a referral, which is voluntary, we may ask you for your name and contact information as well as contact information for the individual or individuals that you refer, such as their name, e-mail address and/or phone number. When we contact your friend, we may identify you as the party that made the referral.
Cookies, Online Tracking and IP Addresses
We may collect information through technology, such as cookies, Flash cookies and Web beacons (also known as "clear gifs," "web bugs" or "pixel tags"), including when you visit our website or application or use our applications on third-party websites or platforms. (See additional information below). You can choose to have your device warn you each time a cookie is being sent, or you can choose to turn off all cookies. Cookie management tools provided by your browser will not remove Flash cookies. Web beacons are used to allow us to count users who have visited certain pages of the website and to help determine the effectiveness of promotional or advertising campaigns. Web beacons can tell the sender whether and when the e-mail has been opened. In contrast to cookies, which are stored on a user's computer hard drive, web beacons are embedded invisibly on web pages.
Grifols may also work with third party advertising or personalization partners that use tracking pixels or cookies to help us display personalized content and appropriate advertising during your visits to this website or other websites. Cookies placed by our third party partners may also assist us with measuring the performance of our advertising campaigns.
Do Not Track (DNT) is a preference you can set in your web browser to let the websites you visit know that you do not want to be tracked. You can disable or enable this setting by visiting the preferences or settings menu of your web browser. This website does not respond to do not track (DNT) signals.
An IP address is a unique identifying number that is automatically assigned to a device connected to the internet. Depending on the nature of your internet connection, the IP address may change each time you connect or may always be the same number. We reserve the right to log IP addresses for system administration, security, statistical analysis, demographic analysis of website use, and other such functions.
For additional information on personalized or interest-based advertising, you may visit the Digital Advertising Alliance (DAA) website: www.aboutads.info. On this website, you may also be able to opt-out from receiving interest-based advertising from some online publishing companies providing this service (see www.aboutads.info/choices).
Changes to this Privacy Notice
Grifols may, from time to time in its sole discretion, change or modify this Privacy Notice to accommodate new technologies, industry practices, regulatory requirements or for other purposes. Any changes or modifications will be effective upon posting of the revisions on the website or application. At any given time, your access and use of the website or application and provision of information is governed by the Privacy Notice then in effect. Grifols may post changes or modifications to referenced policies and guidelines without your approval, and may determine whether and when any such changes apply to you. Your continued use of the website or application following Grifols' posting of any changes or modifications will constitute your acceptance of such changes or modifications. Should you not wish to be bound by the modified Privacy Notice, you may not use or access the website or application. We will provide notice to you if these changes are material and, where required by applicable law, we will obtain your consent.
Comments, suggestions, or other communications sent by you to us are deemed to be non-confidential. We have no obligations of any kind in relation to such comments, suggestions, or communications and are free to use or distribute them in any way, including in relation to the administration, update, or improvement of the website or application, without compensation to the author, sender, or any other party.
By using the website or application, you signify your assent to this Privacy Notice. Should you have any questions or concerns regarding this Privacy Notice you may contact us at:
Grifols USA, LLC
Attn: General Counsel
79 T.W. Alexander Drive
4101 Research Commons
Research Triangle Park, NC 27709
Notice to California Residents – Your California Privacy Rights
Under California law, a California resident with whom Grifols has an established relationship has the right to request certain information with respect to the types of personally identifiable-information Grifols has shared with third parties for its direct marketing purposes, and the identities of those third parties, within the immediately preceding calendar year, subject to certain exceptions. All requests for such information must be in writing and sent to:
Grifols USA, LLC
Attn: General Counsel
79 T.W. Alexander Drive
4101 Research Commons
Research Triangle Park, NC 27709
GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.
GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment.
Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C.
There have been reports of aseptic meningitis, hemolytic anemia, and noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) in patients administered with IVIG, including GAMUNEX-C.
The high-dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.
Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation.
Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis.
If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation.
If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient's serum.
After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.
In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia (in ITP).
The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).
Please see accompanying full Prescribing Information for GAMUNEX-C.
Terms to know
IG=immune globulin, CIDP=chronic inflammatory demyelinating polyneuropathy, PIDD=primary immunodeficiency disease, ITP=idiopathic thrombocytopenic purpura, Sub Q=subcutaneous, IV=intravenous, ICE=10% caprylate-chromatography purified immune globulin intravenous (IGIV-C) CIDP efficacy.