Known hypersensitivity to rabbit proteins or to any of the excipients
Intravenous infusion
May include leucopenia, thrombocytopenia, infusion reactions, infections
L04AA03
Colourless to pale yellow solution
Prescription only
30021500
Dr. Reddy's Laboratories
GRAFALON INJ Product Specifications
Shelf life of 24 months
GRAFALON
Rabbit immunoglobulin against human T-lymphocytes
Germany
Administered under strict medical supervision in a hospital setting
Dosage as per physicians direction; typically infused intravenously
1 vial per box
Store between 2C-8C. Do not freeze.
Prevention and treatment of acute rejection in organ transplantation
Anti-human T lymphocyte immunoglobulin (rabbit) 20mg/ml
Prevention and treatment of steroid-resistant acute rejection after solid organ transplantation
Glass vial
One vial contains 5 ml (100 mg)
Immunosuppressant
Liquid
Injection
Adults
Biological/Immunosuppressive agent
Known hypersensitivity to rabbit proteins or to any of the excipients
Intravenous infusion
May include leucopenia, thrombocytopenia, infusion reactions, infections
L04AA03
Colourless to pale yellow solution
Prescription only
30021500
Dr. Reddy's Laboratories
GRAFALON INJ Trade Information
Cash on Delivery (COD), Cash Advance (CA), Cash in Advance (CID)
1000 Number Per Week
2 Days
No
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
All India
Product Description
Active Ingredient: Human rabbit anti-T cell immunoglobulin, also known as anti-human T-lymphocyte globulin (ATLG).
Mechanism of Action: It works by targeting and suppressing specific white blood cells, primarily T lymphocytes, which are responsible for identifying and attacking the transplanted cells or tissues as "foreign".
Formulation: It is a concentrate for solution for infusion and must be diluted in 0.9% sodium chloride solution before intravenous administration. It is not for direct injection and should be administered over a period of at least 4 hours under strict medical supervision in a hospital setting.
Storage: Vials should be stored in a refrigerator (2C - 8C or 36F - 46F) and kept in the outer carton to protect from light.
Key Uses
Grafalon is primarily used in combination with other immunosuppressive medicines for the following indications:
Prevention of organ transplant rejection: To help the body accept solid organs such as kidneys.
Treatment of acute organ transplant rejection: For rejection episodes that have not responded well to standard corticosteroid treatment.
Prevention or treatment of severe Graft-versus-Host Disease (GvHD): A serious complication following bone marrow or stem cell transplants where the donor's immune cells attack the recipient's body.
Treatment of Aplastic Anemia: A blood disorder where the bone marrow doesn't produce enough healthy blood cells.
Mechanism of Action
GRAFALON functions as an immunosuppressive agent by targeting and depleting human T lymphocytes. This action aids in reducing immune responses that lead to organ rejection, thereby increasing the success rate of transplantation procedures.
Indications and Clinical Use
This medication is recommended for the prevention and treatment of steroid-resistant acute rejection in adult patients who have undergone solid organ transplantation. Administration of GRAFALON is strictly as per the physician's direction, usually as a controlled intravenous infusion.
Safety and Storage Guidelines
GRAFALON must be stored at 2C-8C and protected from freezing. Safety protocols require its administration in a hospital, supervised by healthcare professionals due to potential adverse reactions including leucopenia, thrombocytopenia, and infusion-related effects.
FAQ's of GRAFALON INJ:
Q: How is GRAFALON INJ administered?
A: GRAFALON INJ is given as an intravenous infusion in a hospital setting under the supervision of trained healthcare professionals.
Q: What is the primary benefit of using GRAFALON INJ in organ transplantation?
A: GRAFALON helps prevent and treat acute rejection in transplant patients, especially in cases where steroid-based therapies have failed, by reducing the activity of immune T cells.
Q: When should GRAFALON INJ not be used?
A: GRAFALON should not be administered to individuals with known hypersensitivity to rabbit proteins or any of its excipients.
Q: What are the potential side effects of GRAFALON INJ?
A: Possible adverse effects include leucopenia, thrombocytopenia, infusion reactions, and an increased risk of infections. Monitoring by medical staff during administration is essential.
Q: Where should GRAFALON INJ be stored?
A: GRAFALON INJ should be stored refrigerated between 2C-8C, and must not be frozen to preserve its efficacy.
Q: What is the process for receiving GRAFALON INJ?
A: The process involves prescription by a specialist, hospital admission for supervised intravenous infusion, and careful monitoring for adverse effects during and after administration.
Q: Who is GRAFALON INJ suitable for?
A: This medication is intended for adult patients who are undergoing solid organ transplantation and require prevention or treatment of steroid-resistant acute rejection.
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