Description

Anti-D (Rho) Immunoglobulin Injection

Healthy Inc is a specialized global supplier and exporter of critical plasma-derived biologicals and life-saving immunoglobulins. We provide high-purity Anti-D (Rho) Immunoglobulin Injection (150 mcg / 300 mcg), manufactured in WHO–GMP certified sterile biological facilities. This “Maternal Shield” is a mandatory export to maternity hospitals, hematology units, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive prophylaxis against Hemolytic Disease of the Newborn (HDN) and a specialized treatment for Immune Thrombocytopenic Purpura (ITP).

Product Overview

This formulation contains Rho(D) Immune Globulin, a highly purified preparation of immunoglobulin G (IgG) antibodies derived from human plasma containing high titers of antibodies against the Rh(D) antigen.

The “Alloimmunization Preventer” Specialist:

• Mechanism (Macrophage Clearance): During childbirth, miscarriage, or trauma, Rh-positive fetal red blood cells (RBCs) can enter the circulation of an Rh-negative mother. The maternal immune system treats these as foreign and produces permanent anti-D antibodies, which will cross the placenta in future pregnancies and destroy the next baby’s red blood cells. Administering Anti-D IgG rapidly coats and neutralizes any fetal Rh-positive RBCs in the mother’s bloodstream. These coated cells are then destroyed by the mother’s reticuloendothelial system (spleen/liver) before her immune system can recognize them and mount a permanent immune response.
• Future Pregnancy Protection: It is the global standard of care to prevent Hemolytic Disease of the Fetus and Newborn (HDFN), ensuring the viability of subsequent pregnancies for Rh-negative women.
• ITP Treatment (Fc-Receptor Blockade): In Rh-positive patients with ITP, IV Anti-D coats the patient’s own red blood cells. The spleen’s macrophages become “busy” clearing these coated red blood cells, which prevents them from destroying the patient’s platelets, leading to a rapid rise in platelet counts.

Product Composition & Strength

We supply this product as a Sterile, Ready-to-Use Liquid Solution or Lyophilized Powder in pre-filled syringes (PFS) or glass vials.

*Pack Sizes: Single Pre-Filled Syringe (PFS) or Single Vial.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Dual Viral Inactivation: Because it is derived from human plasma, extreme safety measures are mandatory. Our manufacturing utilizes rigorous multi-step viral clearance protocols, including Solvent/Detergent (S/D) treatment and Nanofiltration, ensuring complete eradication of enveloped (HIV, HBV, HCV) and non-enveloped viruses.
• Chromatographic Purification: Advanced ion-exchange chromatography guarantees an ultra-pure IgG profile, minimizing the presence of IgA and mitigating the risk of anaphylactic reactions in IgA-deficient patients.

Therapeutic Indications (Human Use)

Indicated for the prevention of Rh isoimmunization and treatment of ITP:

• Routine Antenatal Prophylaxis: Administered at 28–30 weeks of gestation to an Rh-negative mother.
• Postpartum Prophylaxis: Administered within 72 hours of delivering an Rh-positive baby.
• Obstetric Complications: Post-abortion, ectopic pregnancy, amniocentesis, or abdominal trauma in an Rh-negative woman.
• Incompatible Transfusion: Emergency administration following transfusion of Rh-positive blood to an Rh-negative individual.
• Immune Thrombocytopenic Purpura (ITP): Used in Rh-positive, non-splenectomized patients to raise platelet counts.

Dosage & Administration

Recommended Dosage (Strictly as per Obstetrician/Hematologist):

• Route: Intramuscular (IM) ONLY for most standard pregnancy formulations. (Some specific formulations are designed for IV use; verify the label).
• CRITICAL WARNING: NEVER INJECT THE NEONATE (BABY). This drug is exclusively for the mother.
• Postpartum: 300 mcg (1500 IU) IM within 72 hours of delivery. (If a massive fetomaternal hemorrhage is suspected, a Kleihauer-Betke test must determine if additional doses are required).
• ITP Dosage: Administered Intravenously (IV formulation required) at 50 mcg/kg body weight.

Safety Warnings (CRITICAL):

• Contraindications: DO NOT administer to an Rh-negative woman who is already alloimmunized to the Rh(D) antigen (meaning she already has natural anti-D antibodies). It is also contraindicated in Rh-positive individuals (except when treating ITP).
• Anaphylaxis / IgA Deficiency: Patients with severe IgA deficiency may develop antibodies to IgA and suffer anaphylactic shock upon administration.
• Live Vaccines: Immunoglobulins can interfere with the immune response to live virus vaccines (Measles, Mumps, Rubella, Varicella). Postpone live vaccines for at least 3 months after receiving Anti-D.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Biologicals and Immunoglobulins, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.