Rx Item-Rhogam Uf+ 1500 Unit Syringe 5 By J O M Pharma

RHOGAM ULTRA-FILTERED PLUS- human rho(d) immune globulin injection, solution
MICRHOGAM ULTRA-FILTERED PLUS- human rho(d) immune globulin injection, solution
Kedrion Melville, Inc.

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1 INDICATIONS AND USAGE

1.1. Pregnancy and other obstetrical conditions


For administration to Rh-negative women not previously sensitized to the Rho (D) factor, 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
Antepartum prophylaxis at 26 to 28 weeks gestation
Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
Actual or threatened pregnancy loss at any stage of gestation
Ectopic pregnancy
1.2. Transfusion of Rh-incompatible blood or blood products
Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates)
2 DOSAGE AND ADMINISTRATION

For intramuscular use only. Do not inject RhoGAM Ultra-Filtered PLUS (RhoGAM) or MICRhoGAM Ultra-Filtered PLUS (MICRhoGAM) intravenously. In the case of postpartum use, the product is intended for maternal administration. Do not inject the newborn infant. Inject the entire contents of the syringe(s). For single use only. (See WARNINGS AND PRECAUTIONS)

RhoGAM or MICRhoGAM should be administered within 72 hours of delivery or known or suspected exposure to Rh-positive red blood cells. There is little information concerning the effectiveness of Rho (D) Immune Globulin (Human) when given beyond this 72 hour period. In one study, Rho (D) Immune Globulin (Human) provided protection against Rh immunization in about 50% of subjects when given 13 days after exposure to Rh-positive red blood cells.1 Administer every 12 weeks starting from first injection to maintain a level of passively acquired anti-D. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for fetal-maternal hemorrhage should be performed to determine if exposure to > 15 mL of red blood cells has occurred.2

RX ITEM-Rhogam Uf+ 1500 Unit Syringe 5 B
NDC 00562-7805-05 UPC/GTIN No.3-05627-80505-3 Mfg.Part No.780505

Rhogam Uf+ 1500 Unit Syringe 5 By J O M
BRAND: RHOGAM NDC: 00562-7805-05,562780505 UPC: 3-05627-80505-3,305627805053 J/O/M Pharma Services

RHO(D) IMMUNE GLOBULIN IN
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