RH-D抗体球蛋白说明书.pdfVIP

Rh (D) Immune Globulin (Human) o RhoGAM ® Ultra-Filtered PLUS (300 µg) (1500 IU) MICRhoGAM® Ultra-Filtered PLUS (50 µg) (250 IU) Rx Only For Intramuscular Injection Only Prefilled syringes, preservative-free (thimerosal free), latex-free delivery system HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) and MICRhoGAM Ultra-Filtered PLUS (MICRhoGAM) safely and effectively. See full prescribing information for RhoGAM and MICRhoGAM. • Rho(D) Immune Globulin (Human) RhoGAM® Ultra-Filtered PLUS (300 µg) (1500 IU) Initial U.S. Approval: 1968 • Rho(D) Immune Globulin (Human) MICRhoGAM® Ultra-Filtered PLUS (50 µg) (250 IU) Initial U.S. Approval: 1979 INDICATIONS AND USAGE For use in preventing Rh immunization. • Pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby are conclusively Rh-negative, e.g. delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy. (1.1) • Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (1.2) DOSAGE AND ADMINISTRATION For intramuscular use only, do not administer intravenously. Pregnancy and other obstetrical conditions (2.1) RhoGAM (300 µg) (1500 IU) • Postpartum – if the newborn is Rh-positive. Administer within 72 hours of delivery. • Antepartum – • Prophylaxis at 26 – 28 weeks gestation. • At or beyond thirteen weeks gestation: administer within 72 hours when suspected or proven exposure to Rh-positive red blood cells occurs resulting from invasive procedures, abdominal trauma or obstetrical manipulation