Privacy Notice

Effective Date: April, 12, 2017

Introduction

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

You should also be aware that any communication you submit or that may be posted to any publicly-viewable interactive feature such as a blog, community forum or testimonial page is a public communication and may be viewed by the general public. Therefore, you acknowledge and agree that you do not expect privacy or confidentiality of the content you submit to such services over our websites or applications, whether or not it includes personally-identifiable information. If you display personally-identifiable information in any communication submitted to such services or features, other individuals may collect and use your personally-identifiable information. We are not responsible for, nor can we guarantee the protection of, any personally-identifiable information you disclose in a communication submitted to such services or features for posting or contained in an e-mail or other communication submitted to us for such posting, and thus, you acknowledge that if you disclose personally-identifiable information in any such material, you do so at your own risk. Posting included on social media platforms are governed by the social media site's own privacy policy.

Testimonials

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 us.privacypolicy@grifols.com.

Data Retention

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.

Communications

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.

Surveys

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 us.privacypolicy@grifols.com 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.

Location Services

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

Cookies are text files that are stored on a user's computer or device by the website or application. Cookies typically contain user-related information such as preferences, status, settings, etc. The purpose of most cookies is to make use of the internet, website or application easier and quicker. Most browsers allow the user to choose settings that allow the use of cookies, that provide notice to the user when cookies are being stored, and/or that refuse all cookies.

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.

Grifols uses certain analytical services, including but not limited to Google Analytics, a service by Google, Inc. ("Google"), to analyze non-personally-identifiable information to learn about how visitors interact with this website or application to help us improve user experiences. Google Analytics uses cookies to analyze use patterns and may collect information about your use of this website or application, including your IP address. In addition, Grifols may also use AdWords and DoubleClick, which are online advertising display services by Google that also make use of use cookies. To access Google's privacy policy please visit: www.google.com/policies/privacy/. If you would like to opt-out of having your data used by Google Analytics please visit: https://tools.google.com/dlpage/gaoptout/

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.

Feedback

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

Indication and Usage

HYPERRAB® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies.

Limitations of Use 

Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.

For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.

Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.

Important Safety Information

For infiltration and intramuscular use only.

Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available for treatment of acute allergic symptoms, should they occur.

HYPERRAB is made from human blood and 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.

The most common adverse reactions in >5% of subjects during clinical trials were injection-site pain, headache, injection-site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain.

Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.

Other antibodies in the HYPERRAB preparation may interfere with the response to live vaccines such as measles, mumps, polio, or rubella. Defer immunization with live vaccines for 4 months after HYPERRAB administration.  

Please see full Prescribing Information for HYPERRAB.

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.


HyperTET® S/D (tetanus immune globulin [human]) is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain.

HyperTET S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HyperTET S/D should be given only if the expected benefits outweigh the risks.

Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare. In the course of routine injections of large numbers of persons with immunoglobulin, there have been a few isolated occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock after injection. Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after tetanus immune globulin (human) administration.

HyperTET S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Please see full Prescribing Information for HyperTET S/D.

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.


HyperRHO® S/D Mini-Dose (RhO[D] immune globulin [human]) is recommended to prevent the isoimmunization of RhO(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks' gestation provided the following criteria are met:

  1. The mother must be RhO(D) negative and must not already be sensitized to the RhO(D) antigen.
  2. The father is not known to be RhO(D) negative.
  3. Gestation is not more than 12 weeks at termination.

HyperRHO S/D Mini-Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

NEVER ADMINISTER HYPERRHO S/D MINI-DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE OF UP TO 12 WEEKS' GESTATION. NEVER ADMINISTER TO THE NEONATE.

HyperRHO S/D Mini-Dose should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations.

The attending physician who wishes to administer HyperRHO S/D Mini-Dose to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.

Other antibodies in the HyperRHO S/D Mini-Dose preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after HyperRHO S/D Mini-Dose administration.

Animal reproduction studies have not been conducted with HyperRHO S/D Mini-Dose. It is also not known whether HyperRHO S/D Mini-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRHO S/D Mini-Dose is not indicated for use during pregnancy and it should be administered only postabortion or postmiscarriage.

Safety and effectiveness in the pediatric population have not been established.

Reactions to HyperRHO S/D Mini-Dose are infrequent in RhO(D) negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human globulin is extremely rare, it has occurred.

Please see full Prescribing Information for HyperRHO S/D Mini-Dose.

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.


HyperRHO® S/D Full Dose (RhO[D] immune globulin [human]) is indicated for prevention of Rh hemolytic disease of the newborn (HDN) and the prevention of isoimmunization in RhO(D) negative individuals who have been transfused with RhO(D) positive red blood cells.

HyperRHO S/D Full Dose is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Never administer HyperRHO S/D Full Dose intravenously. Inject only intramuscularly. Never administer to the neonate.

RhO(D) immune globulin (human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive DU test result. If there is any doubt about the mother's Rh type, she should be given RhO(D) immune globulin (human). A screening test to detect fetal red blood cells may be helpful in such cases.

If more than 15 mL of D-positive red blood cells are present in the mother's circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.

Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after RhO(D) immune globulin (human) administration.

HyperRHO S/D Full Dose should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted.

Reactions to RhO(D) immune globulin (human) are infrequent in RhO(D)-negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immunoglobulin is extremely rare, it has occurred.

Elevated bilirubin levels have been reported in some individuals receiving multiple doses of RhO(D) immune globulin (human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.

Please see full Prescribing Information for HyperRHO S/D Full Dose.

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.


HyperHEP B® S/D (hepatitis B immune globulin [human]) is indicated for postexposure prophylaxis in the following situations: acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to an HBsAg-positive person, and household exposure to persons with acute HBV infection.

HyperHEP B S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Epinephrine should be available.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, hepatitis B immune globulin (human) should be given only if the expected benefits outweigh the risks.

Local pain and tenderness at the injection site, urticaria, and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immunoglobulin preparations. Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after hepatitis B immune globulin (human) administration.

HyperHEP B S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Please see full Prescribing Information for HyperHEP B S/D.

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.


INDICATIONS AND USAGE

GAMASTAN (immune globulin [human]) is indicated for prophylaxis following exposure to hepatitis A infection, prevention or modification of measles in susceptible persons exposed fewer than 6 days previously, modification of varicella, and modification of rubella in exposed women who will not consider a therapeutic abortion.

Limitations of Use

GAMASTAN is not indicated for routine prophylaxis or treatment of viral hepapitis type B, rubella, poliomyelitis, mumps, or varicella.

IMPORTANT SAFETY INFORMATION

Thrombosis may occur with immune globulin products, including GAMASTAN. 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, do not exceed the recommended dose of GAMASTAN. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

GAMASTAN is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human) and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Administer GAMASTAN cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Have epinephrine available for treatment of acute allergic symptoms, should they occur.

Inject intramuscularly only. Do not administer GAMASTAN intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]). Do not inject into a blood vessel.

GAMASTAN 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.

The most common adverse reaction reported for GAMASTAN S/D during post-approval use was fatigue.

Antibodies in GAMASTAN may interfere with the response to live virus vaccines such as measles, mumps, polio, rubella, and varicella. Defer live vaccine administration for up to 6 months after GAMASTAN administration.

Please see full Prescribing Information for GAMASTAN.

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.