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Description

Important Safety Information

RhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) and MICRhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) are indicated for the prevention of Rh immunization, including during and after pregnancy and other obstetrical conditions or incompatible transfusion of Rh-positive blood.

RhoGAM and MICRhoGAM are made from human plasma. Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent.

RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration.

RhoGAM and MICRhoGAM contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Hypersensitivity reactions include hives, generalized urticaria, and tightness of the chest, wheezing, hypotension and anaphylaxis. Patients who receive RhoGAM and MICRhoGAM for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.

Features

• RhoGAM comes in a pre-filled, ready-to-use syringe that eliminates the need for preparation steps
• Syringe provided
• Safety Shield designed to offer protection from needle sticks by completely encompassing the needle once engaged
• Administration right out of the refrigerator - there are no temperature restrictions
• No light protection required
• Non-returnable

Specification

• Volume: 1mL fill volume
• Range: 0.5- to 1.2-mL range
• Syringe Size: 2 Gauge, 1 ¼" Needle
• Prefilled syringe contains: 300 μg (1500 IU) of Rho(D) Immune Globulin (Human)