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RH-D抗体球蛋白说明书.docx

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RH-D抗体球蛋白说明书.docx

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文档介绍:Rho(D) Immune Globulin (Human)
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 . Approval: 1968
Rho(D) Immune Globulin (Human)
MICRhoGAM® Ultra-Filtered PLUS (50 µg) (250 IU) Initial . 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, . 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. ()
Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products ()
DOSAGE AND ADMINISTRATION
For intramuscular use only, do not administer intravenously.
Pregnancy and other obstetrical conditions ()
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, ectopic pregnancy, pregnancy termination or threatened termination.
Administer every 12 weeks starting from first injection