Privacy Policy

Kedrion Biopharma Inc. ("Kedrion Biopharma") understands that the security of your private information is important and we take the protection of personal data that you provide on our websites (“Website”) and through other means very seriously. This privacy policy (“Privacy Policy”) describes how we collect, manage, use, protect and disclose the information that you may provide via our Website. By visiting our Website, or by registering as a user of the on-line services that we provide, you agree to the terms of this Privacy Policy and to our Terms of Use as they may be amended from time to time. Kedrion Biopharma (“we”, “us”, “our”) means our entire company, including our United States affiliates, subsidiaries and related companies.

Our site may contain links to third party websites that are not owned or controlled by Kedrion Biopharma. This Privacy Policy only applies to information collected by Kedrion Biopharma, and does not apply to any information collected by any third party. Accordingly, we recommend that you read the applicable third party privacy policies and terms for more information.

Collection and Use of Personal Information
You can use our Website without disclosing your personal data. You are not required to provide personal information as a condition of using our Website, except as may be necessary to provide you with information, products or services at your request. If you request information, products, or services from our Website, or ask us to resolve complaints or concerns, we may require certain information necessary to fulfill your request (e.g., your name, contact information, and other identifying information). Personal information that you provide may be used by Kedrion Biopharma to provide you with information, such as educational and marketing information about our products. We may use your information for market research and other marketing purposes, and for the purposes specified in this Privacy Policy. Please do not submit any personal information if you do not want it to be collected.

We collect personal information only when you provide it to us, through registration, completion of forms or e-mails, 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. If you choose not to provide any requested personal information, you may be unable to access certain areas of the Website, such as password protected areas. We will retain control of and responsibility for the use of any personal information you disclose to us.

Disclosure of Personal Information
Kedrion Biopharma does not sell or rent your personal information to unauthorized third parties. We may retain third party vendors to assist us to perform services on your behalf. Such third party vendors may be provided with access to your personal information to perform their obligations but for no other purpose. We may share your personal information with a company in connection with the sale or transfer of one of our product lines, business units or affiliates to that company. Such company will be required to use and protect your personal information consistent with this Privacy Policy. Kedrion Biopharma reserves the right to disclose your personal information to respond to duly authorized information requests from governmental authorities or when otherwise required by law.

Right of Access, Correction and Cancellation/Opt-Out
You have the right to review, correct, amend, change and delete your preferences, your personal information stored in our system, or withdraw your consent to the use of your personal data in the future. You also have the right to opt-out of our communications and discontinue receiving educational and/or promotional information at any time. Please contact our Legal Department at the address below.

Use of Cookies
Cookies are used in order for us to improve the efficiency of your individual use of the Website. Cookies are small text file identifiers that are sent to your web browser and stored on your computer’s hard drive. Cookies allow the Website to remember your computer on return visits. This is particularly important for websites that require you to sign in as it speeds up your access. We may use both session cookies that are deleted when you close your web browser and persistent cookies that may be used by the Website on subsequent visits. When you use our Website, we automatically receive the name of your internet service provider, the website that you used prior to our Website, the websites that you visit from our Website and your Internet protocol address. This information is not linked to personally identifiable information.

Most web browsers are set up to accept cookies automatically but you can change the web browser’s settings to refuse new cookies, disable existing ones or let you know before new cookies are stored on your computer. However, if you refuse or disable cookies, some of the Website’s functionality may be lost. We may also include web beacons (also known as web bug, pixel tag or clear GIFs) on our Website or e-mails. Web beacons help us monitor the effectiveness of the Website by measuring the activity of the Website or how many users clicked on any elements of the Website. Web beacons do not automatically obtain personal information from you but can tell us when you have opened your email or visited the Website. If you want to delete any cookies or web beacons that are already on your computer or stop cookies or web beacons being stored on your computer in the future, see the “Help” section of your web browser. For additional information about deleting or controlling cookies or web beacons, see www.aboutcookies.org.

Security
Kedrion Biopharma uses reasonable technical and organizational security precautions to protect your personal information from manipulation, loss, destruction or access by unauthorized persons. Any personal data that is provided to Kedrion Biopharma 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. Due to the nature of Internet communications, we cannot guarantee that such communications are 100% secure or error-free and disclaim that the information you provide us will remain free from theft, loss, or unauthorized access or use by third parties, despite our best efforts. You are responsible for maintaining the privacy of your own passwords and other special access numbers you might use to access the Website.

Children
Children under the age of 13 are not the intended audience for the Website. In light of the importance of protecting children’s privacy, we do not knowingly collect personal information from this age group without prior parental or legal guardian consent.

Updates to Privacy Policy
We reserve the right to modify our Privacy Policy at any time so please review the Privacy Policy each time you access the Website. Material changes will be indicated on the revised Privacy Policy. Any changes will be effective immediately as of the updated revision date indicated below.

Contact Us
Please contact us with any problems, questions or suggestions regarding our Privacy Policy at USLegal@Kedrion.com or Kedrion Biopharma Inc., 400 Kelby Street, Fort Lee, NJ 07024, Attn: Legal Department.

Last updated: November 22, 2016

 

APPROVED USES
RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg), is a prescription medicine given by intramuscular injection that is used to prevent Rh immunization, a condition in which an individual with Rh-negative blood develops antibodies after exposure to Rh-positive blood. MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) is a lower dose of Rho(D) immune globulin that is used in certain clinical situations. 

If the father or baby is not conclusively shown to be Rh-negative, RhoGAM should be given to a Rh-negative mother in the following clinical situations to prevent Rh immunization:

  • After delivery of a Rh-positive baby.
  • Routine prevention of Rh immunization at 26 to 28 weeks of pregnancy.
  • Maternal or fetal bleeding during pregnancy from certain conditions.
  • Actual or threatened pregnancy loss at any stage. MICRhoGAM should be used in Rh-negative women who experience pregnancy loss at or up to 12 weeks of pregnancy.
  • Ectopic pregnancy (pregnancy in which the fertilized egg implants outside the uterus).

RhoGAM or MICRhoGAM may also be used to prevent Rh immunization in Rh-negative patients after the incompatible transfusion of Rh-positive blood or blood products. 

IMPORTANT SAFETY INFORMATION
RhoGAM or MICRhoGAM should NOT be used if you are Rh-positive.
Be sure to tell your healthcare provider about all your medical conditions, including:

  • If you have known severe allergic reactions or a severe response to human immune globulin.
  • If you have experienced a serious reaction to other medicines that contain immune globulin.
  • If you have an immunoglobulin A (IgA) deficiency. RhoGAM and MICRhoGAM contain a small quantity of IgA and there is a potential risk of an allergic reaction in IgA-deficient individuals. Ask your healthcare provider if you are not sure.
  • Your recent history of vaccinations. Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immune globulin products, like RhoGAM or MICRhoGAM. The antibodies in RhoGAM and MICRhoGAM may prevent the vaccine from working. Before you get a vaccine, tell your healthcare provider that you have received RhoGAM or MICRhoGAM.

RhoGAM and MICRhoGAM are made from human blood and therefore, carry a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.

Reactions to RhoGAM or MICRhoGAM that affect the entire body are extremely rare. However allergic responses to RhoGAM or MICRhoGAM may occur. You should be observed for at least 20 minutes after administration for early signs of an allergic reaction.  Signs and symptoms of an allergic reaction include itchy rash (hives), tightness of the chest, wheezing, low blood pressure and anaphylaxis (which may also include throat or tongue swelling, shortness of breath, vomiting, hives and/or lightheadedness).

The most common side effects of RhoGAM and MICRhoGAM are swelling, hardening, redness, and mild pain at the site of the injection.  A small number of patients have noted a slight fever.

Your healthcare provider should provide you with a completed Patient Identification Card for you to retain and present to other healthcare providers.

You are encouraged to report adverse events of prescription drugs to the FDA.
Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088.

Click here for the RhoGAM Full Prescribing Information

This site is intended for residents of the US only.

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