Treating With HyperRHO S/D1
HyperRHO S/D is an immune globulin with a high level of preformed antibodies against rhesus (Rh)-positive blood cells.
The injection of an RHO(D) immune globulin provides a passive immunity for rapid immune protection and an acute response in high-risk situations.
HyperRHO S/D destroys any Rh-positive blood cells that may have entered the mother's bloodstream and prevents the mother's immune system from producing Rh-positive antibodies, thus protecting the baby from developing hemolytic disease.
- 4-step virus removal and inactivation process
- The only RhO(D) immune globulin product with US Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions
- Mercury (thimerosal) and latex free1,3
- BD UltraSafe Plus™ passive needle guard* to protect against needlestick injury
- Grifols only uses plasma from qualified donors
- Each unit of plasma is extensively tested and subjected to careful controls to protect its quality through a multiphase production process
- PediGri® provides additional information related to the quality and safety of Grifols plasma derivatives and can be accessed at www.pedigri.grifols.com
Provide Immediate and Effective Protection With HyperRHO S/D1-3
Each single-dose syringe of HyperRHO S/D contains sufficient anti-RhO(D) to effectively suppress the immunizing potential of 15 mL of Rh-positive red blood cells.
Antepartum and postpartum administration of a single dose of HyperRHO S/D to susceptible Rh-negative women reduces the incidence of Rh isoimmunization to less than 0.1%.
HyperRHO S/D destroys Rh-positive cells in the mother's body, prevents the mother's immune system from producing Rh-positive antibodies, and protects the baby from contracting HDN.
Dosing consistent with the American College of Obstetricians and Gynecologists (ACOG) practice guidelines
Low-volume, fully assembled, prefilled syringes
HyperRHO® S/D Full Dose (RhO[D] immune globulin [human]) is indicated for the prevention of Rh 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 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:
- The mother must be RhO(D) negative and must not already be sensitized to the RhO(D) antigen.
- The father is not known to be RhO(D) negative.
- Gestation is not more than 12 weeks at termination.
How Does HyperRHO S/D Full Dose Prevent HDN?1
A clinical study of 1579 women to assess the protection against sensitization to the Rh antigen found that 6 months after delivery, the efficacy of HyperRHO S/D was4:
- 99.5% in women with an ABO-compatible pregnancy
- 100% in other women
The administration of HyperRHO S/D within 72 hours of a full-term delivery of an Rh-positive infant by an Rh-negative mother reduces the rate of Rh sensitization from 12%-13% to 1%-2%.1
Safety Is a Priority
For over 40 years, produced with an unwavering commitment to safety, HyperRHO S/D has been a reliable treatment choice for Rh-negative pregnant women.
The HyperRHO S/D manufacturing process is designed to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the Creutzfeldt-Jakob disease (CJD) and variant CJD agents.
HyperRHO S/D 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.
Traceability and Transparency of Information5
Grifols' manufacturing process has a comprehensive computer system called PediGri® that ensures full traceability from every donation.
- Each plasma unit is coded and computer-traced from the start of the process until the units are transformed into a final product
- Users can access the donation number and the viral screening conducted at the origin of the donation with the product lot number
- Specific information is also available, including the total number of plasma units, the total volume of plasma, the certificate of analysis showing the plasma origin viral screening, and biochemical characteristics of the final product
- Users can access the applicable product SPC/package insert for their country