About Grifols
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. The company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries.
A pioneer in the plasma industry, Grifols develops innovative plasma-derived medicines and other biopharmaceutical solutions that treat patients with chronic, rare, and, at times, life-threatening conditions.
Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases.
Grifols has the largest network of donation centers in the world, with more than 390 across North America, Europe, Africa and the Middle East, and China.
As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. The company provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. In addition, Grifols supplies tools, information, and services that enable hospitals, pharmacies, and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership.
For more information, please visit www.grifols.com
Important Safety Information for GamaSTAN® (immune globulin [human])
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.