Terms of Use

Kedrion Biopharma Inc. ("Kedrion Biopharma") operates certain websites (“Website”) for personal information and education purposes. By visiting our Website, or by registering as a user of the on-line services that we provide, you agree to these Terms of Use and to our Privacy Policy as they may be amended from time to time. If you do not agree to the Terms of Use, do not enter the Website. Kedrion Biopharma (“we”, “us”, “our”) means our entire company, including our United States affiliates, subsidiaries and related companies.

Use of Website and Intellectual Property
All documents, text, graphics, photos, interactive features, presentations, materials, or such other informational materials in all forms on this Website (“Website Information”) are the property of Kedrion Biopharma unless otherwise indicated. You may view, print or download one copy of Website Information (except for third party materials identified as such) solely for your personal, informational, non-commercial use, provided you keep all copyright and other proprietary notices intact. You may not otherwise, in whole or in part, copy, reproduce, modify, republish, upload, post, transmit or distribute in any form, or create any derivative work based on such Website Information, without Kedrion Biopharma’s prior written permission. No links to our Website may be included in a third party website without our prior written permission.

All product names, whether or not appearing with the trademark symbol, are trademarks of Kedrion Biopharma unless otherwise indicated. Except as expressly permitted herein, the use of these trademarks or any Website Materials is expressly prohibited and may be in violation of copyright, trademark and other similar laws. The entire contents of this Website are subject to copyright protection. No license or other right under any patent or trademark of Kedrion Biopharma or any third party or to Website Information is granted to you.

Subject to our Privacy Policy, you agree that any material or information you submit through or to the Website will not be deemed confidential or proprietary and permit us to use, disclose, copy, modify, adapt or otherwise publicly display all or any of such material for any purpose whatsoever without restriction. You represent and warrant that you will not submit any material to the Website unless you have the unrestricted right to submit or authorize Kedrion Biopharma to use such material, and shall indemnify Kedrion Biopharma and hold it harmless against any claim of infringement arising out of such material. We reserve the right, in our discretion, to remove or delete any material you submit through or to the Website without notice to you.

Third Party Websites
Our Website may contain links to third party websites that are not owned, affiliated or operated by Kedrion Biopharma. These links are provided for your information only. We have no control over any third party website and do not endorse, sponsor or recommend your use of such website. We are not responsible for the content of third party websites and shall not be liable for any damages or injury arising from your use of such websites. Accordingly, we recommend that you read the applicable third party terms and privacy policies for more information.

Disclaimer and Limitations of Liability
THE WEBSITE INFORMATION IS PROVIDED “AS-IS” AND WITHOUT ANY WARRANTY WHATSOEVER, EITHER EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, TITLE, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. KEDRION BIOPHARMA MAKES NO REPRESENTATIONS AS TO THE AVAILABILITY, ACCURACY OR COMPLETENESS OF THIS WEBSITE OR THAT THIS WEBSITE OR SERVER IS FREE OF VIRUSES OR MALICIOUS CODE. IN NO EVENT WILL KEDRION BIOPHARMA AND ITS OFFICERS, DIRECTORS, EMPLOYEES AND AGENTS BE LIABLE TO YOU FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THIS WEBSITE INCLUDING, WITHOUT LIMITATION, LOSS OF REVENUES OR PROFITS (WHETHER IN CONTRACT OR TORT), EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Indemnity
You agree to defend, indemnify and hold harmless Kedrion Biopharma and its officers, directors, employees, and agents, from any and all liability and claims for damages and costs or injury (including attorney’s and expert’s fees) caused by, or resulting from, your use of and access to the Website, violation of these Terms of Use, any third party’s intellectual property rights and/or your negligent acts, willful misconduct or omissions.

Medical Information
This Website may contain medical information. Such information is provided for informational purposes only and is not intended to be a substitute for informed medical advice provided by a doctor or other qualified health care professional. You should consult with a qualified doctor or other health care professional for medical advice or information related to any information on this Website before taking any action.

Privacy
We take the protection of personal information that you provide on our Websites and through other means very seriously. Please refer to Kedrion Biopharma's Privacy Policy.

General
This Website and its contents are intended to comply with the laws and regulations in the United States and intended for use only by United States residents. These Terms of Use shall be governed by, construed and enforced in accordance with the laws of the State of New York, without respect to its conflict of laws principles. Exclusive venue for any disputes arising under these Terms of Use shall be in New York City, New York. Kedrion Biopharma reserves the right to modify or delete any part of the Website at any time and without notice to you. Kedrion Biopharma reserves the right to terminate your access to the Website, in its sole discretion, for any violation of the Terms of Use and to remove or take down any content posted on the Website in violation, or suspected to be in violation, of the Terms of Use.

Updates to Terms of Use
We reserve the right to modify our Terms of Use at any time so please review the Terms of Use each time you access the Website. Material changes will be indicated on the revised Terms of Use. 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 Terms of Use 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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