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Rh O (D Immune Globulin Systemic)


VA CLASSIFICATION
Primary: IM402
Primary: BL900

Commonly used brand name(s): Gamulin Rh; HypRho-D Full Dose; HypRho-D Mini-Dose; MICRhoGAM; Mini-Gamulin Rh; RhoGAM; WinRho SD; WinRho SDF.

Other commonly used names are
anti-D gammaglobulin ; anti-D (Rh o) immunoglobulin ; anti-Rh immunoglobulin ; anti-Rh o(D) ; D(Rh o) immune globulin ; RhD immune globulin ; Rh immune globulin ; Rh-IG ; and Rh o(D) immune human globulin . {11} {12} {13} {17}
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Immunizing agent (passive); —

platelet count stimulator (systemic)—

Indications

Accepted

Sensitization of Rh o(D)–negative females to Rh o(D)–positive blood (prophylaxis) or
Rh hemolytic disease of the newborn (prophylaxis)—Rh o(D) immune globulin is indicated in Rh o(D)–negative females of child-bearing age or younger who have not been previously sensitized to the Rh o(D) erythrocyte factor and who may be exposed to the factor during one or more of the following events: the birth of an Rh o(D)–positive infant; incomplete pregnancy terminating in the delivery of an Rh o(D)–positive fetus (e.g., spontaneous or induced abortion or ruptured tubal pregnancy); amniocentesis, abdominal trauma during pregnancy, or transplacental hemorrhage, while carrying an Rh o(D)–positive fetus; or transfusion involving mismatched Rh o(D)–positive blood. Treating these females prophylactically prevents sensitization to the Rh o(D) erythrocyte factor, which in turn prevents Rh hemolytic disease (erythroblastosis fetalis) in Rh o(D)–positive neonates. See Mechanism of action/Effect. {01} {02} {03} {04} {05} {06} {07} {08} {16} {17} {19} {20}

Thrombocytopenic purpura, immune (treatment)— Rh o(D) immune globulin intravenous is indicated for the treatment of immune thrombocytopenic purpura (ITP) in non-splenectomized, Rh o(D) positive   • children with chronic or acute ITP
   • adults with chronic ITP, or
   • children and adults with ITP secondary to HIV infection
in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage. {21}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    A sterile, nonpyrogenic solution of immune globulin that contains antibody to the erythrocyte factor Rh o(D). The solution is prepared from large pools of human blood plasma {01} {02} {03} {05} {10}

Mechanism of action/Effect:

By providing passive Rh o(D) antibody, Rh o(D) immune globulin suppresses the immune response to Rh o(D)–positive blood in nonsensitized Rh o(D)–negative females. This prevents sensitization to the Rh o(D) erythrocyte factor and the subsequent formation of active Rh o(D) antibody. This in turn prevents the occurrence of Rh hemolytic disease (erythroblastosis fetalis) in Rh o(D)–positive neonates, which results from in utero exposure to maternal Rh o(D) antibody. {01} {02} {03} {05}

Rh o(D) immune globulin has been shown to increase platelet counts in non-splenectomized Rh o(D) positive patients with immune thrombocytopenic purpura. The mechanism of action is not fully understood, but it is thought to be due to the formation of anti-Rh o(D) (anti-D)-coated RBC complexes resulting in Fc receptor blockade, thus sparing antibody-coated platelets. {21}


Protective effect

Administration of Rh o(D) immune globulin (full dose) within 72 hours of a delivery of a full-term Rh o(D)–positive infant by an Rh o(D)–negative mother reduces the incidence of Rh immunization from the usual 12 or 13% to 1 or 2%. The 1 or 2% treatment failures are thought to be due to immunization that occurred during the latter part of pregnancy. Studies have shown that 2 doses, the first given at 28 weeks gestation and the second given following delivery, can reduce treatment failures to 0.l%. {01} {02} {03} {05}

Studies have shown that administration of Rh o(D) immune globulin (mini-dose) within 3 hours following termination of pregnancy prior to 13 weeks of gestation in Rh o(D)–negative females who have not been previously sensitized to the Rh o(D) factor was 100% effective in preventing Rh immunization. {02} {04}


Time to response

Platelet counts usually rise within 1 to 2 days.{21}


Duration of protective effect

The half-life of Rh o(D) immune globulin is 23 to 26 days. {01} {07}

Peak platelet counts are seen 7 to 14 days after initiation of therapy. The average duration of response is approximately 30 days. {21}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other human immune globulin products may be sensitive to Rh o(D) immune globulin also. {01} {02} {03}

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies have not been done in pregnant women. However, use of Rh o(D) immune globulin (full dose) during the third trimester has not produced evidence of hemolysis in the infant.

Studies have not been done in animals.

FDA Pregnancy Category C. {01} {03} {05} {07}

Breast-feeding

Problems in humans have not been documented.

Pediatrics

No information is available on the relationship of age to the effects of Rh o(D) immune globulin in pediatric patients. Safety and efficacy have not been established.


Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Live virus vaccines    (antibodies contained in Rh o(D) immune globulin may interfere with the body"s immune response to certain live virus vaccines; live virus vaccines, such as measles, mumps, and rubella, should be administered at least 3 months after administration of Rh o(D) immune globulin {01} {02} {07})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Antibody screening test, maternal    (passively acquired anti-Rh o(D) may be detected in maternal serum if antibody screening tests are performed subsequent to administration of Rh o(D) immune globulin antepartum or postpartum {01} {03} {05} {07})


Direct antiglobulin test, neonate    (infants born to women administered Rh o(D) immune globulin antepartum may have a weakly positive direct antiglobulin test result at birth {01} {03} {05} {07})

With physiology/laboratory test values
Bilirubin, serum    (concentrations may be elevated in persons receiving multiple doses of Rh o(D) immune globulin, e.g., following a mismatched transfusion involving Rh o(D)–positive blood. The elevation is believed to be due to a relatively rapid rate of foreign red cell destruction {01} {03} {07})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Immunoglobulin A (IgA) deficiencies, selective, in patients who have known antibody to IgA    (small amounts of IgA may be present in Rh o(D) immune globulin and may cause a severe allergic reaction in patients with antibody to IgA {01} {02} {07} {08})


Sensitivity to Rh o(D) immune globulin
Sensitivity to thimerosal    (the Rh o(D) immune globulin available in the U.S. and Canada may contain thimerosal {01} {02} {03} {04} {05} {06} {07})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Rh o(D) positive patients with immune thrombocytopenic purpura (ITP) should be monitored for signs and symptoms of intravascular hemolysis (IVH), clinically compromising anemia, and renal insufficiency. {21}


Side/Adverse Effects

Note: Severe systemic adverse effects to Rh o(D) immune globulin are rare. {01} {02} {04} {07}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Anemia (pale skin; troubled breathing, exertional; unusual bleeding or bruising ; unusual tiredness or weakness)
    
intravascular hemolysis
    
renal insufficiency (Lower back pain; decreased frequency /amount of urine; bloody urine; increased thirst; loss of appetite; nausea ; vomiting; unusual tiredness or weakness ; swelling of face, fingers, lower legs; weight gain; troubled breathing; increased blood pressure)
{21}


Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Fever
    
soreness at the place of injection {01} {02} {03} {04} {05} {07}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Rh o(D) Immune Globulin (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to Rh o(D) immune globulin, other human immune globulins, or thimerosal
Other medical problems, especially immunoglobulin A (IgA) deficiencies

Proper use of this medication

» Proper dosing


General Dosing Information
Rh o(D) immune globulin is not for use in neonates. {01} {02} {03} {04} {05} {06} {07} {08}

Rh o(D) immune globulin should be administered only to Rh o(D)–negative females. {01} {02} {03} {04} {05} {06} {07} {08} However, if there is doubt about the mother"s Rh type, she should be given Rh o(D) immune globulin. Doubt may arise when a large fetomaternal hemorrhage occurring late in pregnancy or during delivery infuses enough fetal red blood cells into the maternal circulation to cause a weak mixed field positive D u test result. {01} {05} {07}

Although Rh o(D) immune globulin is not effective in Rh o(D)–negative females who have been already sensitized to the Rh o(D) erythrocyte factor, administration to these females does not increase the risk of adverse effects. {01} {03} {07}

When Rh typing of the fetus or newborn infant is not possible, the fetus or newborn infant should be assumed to be Rh o(D)–positive, unless the father can be determined to be Rh o(D)–negative. {01} {07}

Since 1 full dose of Rh o(D) immune globulin available in the U.S. contains Rh o(D) antibody sufficient to suppress the immunizing potential of approximately 15 mL of Rh o(D)–positive packed red blood cells or 30 mL of Rh o(D)–positive whole blood, the amount of Rh o(D)–positive blood present in the mother"s circulation should be carefully determined, since more than 1 dose of Rh o(D) immune globulin may be required. A fetal red blood cell count can be performed on the maternal blood to determine the dosage of Rh o(D) immune globulin required. {01} {05} {14} {15} {18}

For all except one indication, at least 1 full dose of Rh o(D) immune globulin is indicated. If a pregnancy is terminated prior to 13 weeks of gestation, the patient may be administered a mini-dose (approximately 1/6 of the full dose) of Rh o(D) immune globulin instead of a full dose, since it is estimated that the total volume of red blood cells in a fetus at 12 weeks of gestation is less than 2.5 mL. For a pregnancy that is terminated at or beyond 13 weeks of gestation, the patient should receive at least 1 full dose of Rh o(D) immune globulin. {01} {02}

Rh o(D) immune globulin should be administered to the Rh o(D)–negative female within 72 hours after the incompatible event involving Rh o(D)–positive blood. If the event is a mismatched transfusion involving Rh o(D)–positive blood, Rh o(D) immune globulin should be administered within 72 hours, but preferably as soon as possible. {01} If the event is a pregnancy terminated prior to 13 weeks of gestation, and the mini-dose of Rh o(D) immune globulin will be given, the mini-dose should be administered within 72 hours, but preferably within 3 hours. {02} {04}

To maintain protection throughout pregnancy once Rh o(D) immune globulin is administered, the level of passively acquired anti-Rh o(D) should not be allowed to fall below the level required to prevent an immune response to Rh o(D)–positive blood. Additional doses of Rh o(D) immune globulin should be administered during pregnancy at approximately 12-week intervals following the first dose. In all cases, the postpartum dose of Rh o(D) immune globulin should be administered, unless the previous dose was within 3 weeks of delivery and any fetomaternal hemorrhage that occurs during delivery produces less than 15 mL of red blood cells. For example, if an incompatible event involving Rh o(D)–positive blood requires administration of Rh o(D) immune globulin at 13 to 18 weeks of gestation, an additional dose should be administered at 26 to 28 weeks of gestation, followed by the postpartum dose within 72 hours of delivery. If the first dose is administered at 26 to 28 weeks of gestation, the postpartum dose is still required. {01} {03} {05} {07}

Rh o(D) immune globulin should be administered by intramuscular injection when used as an immunizing agent. When used to treat ITP, Rh o(D) immune globulin must be administered by intravenous administration. {21}{01} One Canadian product is indicated for either intravenous or intramuscular use. {08}


Parenteral Dosage Forms

RH O(D) IMMUNE GLOBULIN (HUMAN) (FOR INJECTION)

Usual adult and adolescent dose
Immunizing agent (passive)
Intramuscular, into the deltoid muscle or the anterolateral aspect of the thigh, or intravenous: a sufficient amount of Rh o(D) antibody to suppress the immunizing potential of the amount of Rh o(D)–positive blood calculated or estimated to be present in the female's circulation because of pregnancy or transfusion. {08}

Thrombocytopenic purpura, immune (treatment)
Initial dosing: intravenous, into a suitable vein over 3 to 5 minutes: 50 micrograms/kilogram (mcg/kg) (250 IU/kg) body weight given as a single injection. The initial dose may be administered in 2 divided doses given on separate days.

Note: If the patient as a hemoglobin level than 10g/dL, a reduced dose of 25 to 40 mcg/kg (125 to 200 IU/kg) should be given to minimize the risk of increasing the severity of anemia.

Subsequent dosing: intravenous: 25 to 60 mcg/kg (125 to 300 IU/kg) body weight.   • If patient responded to initial dose with a satisfactory increase in platelet count:   —Maintenance therapy: dosing 25 to 60 mcg/kg based on platelet and Hgb levels.

   • If patient did not respond to initial dose, administer a subsequent dose based on Hgb:   —If Hgb between 8 and 10 g/dL, redose between 25 to 40 mcg/kg (125 to 200 IU/kg).
   —If Hgb > 10 g/dL, redose between 50 to 60 mcg/kg (250 to 300 IU/kg).
   —If Hgb < 8 g/dL, use with caution.


{21}

Usual pediatric dose
Immunizing agent (passive)
Intramuscular, into the deltoid muscle or the anterolateral aspect of the thigh, or intravenous: a sufficient amount of Rh o(D) antibody to suppress the immunizing potential of the amount of Rh o(D)–positive blood calculated or estimated to be present in the female's circulation because of transfusion. {08} {20}

Thrombocytopenic purpura, immune (treatment)
See usual adult and adolescent dose.


Note: See General Dosing Information for the parameters for administering Rh o(D) immune globulin.
If the patient requires administration of more than 1 vial/syringe of Rh o(D) immune globulin, the contents of the vials/syringes may be administered at different sites at the same time or at intervals over time, provided that the entire dose is administered with 72 hours of the event. {01} {03} {05} {07}


Size(s) usually available:
U.S.—


120 micrograms (600 IU) (Rx) [WinRho SDF ( contains no preservatives)]


300 micrograms (1500 IU): sufficient Rh o(D) antibody to suppress the immunizing potential of approximately 17 mL of Rh o(D)–positive packed red blood cells (Rx) [WinRho SDF{21} (contains no preservatives)]


1000 micrograms (5000 IU) (Rx) [WinRho SDF (contains no preservatives )]

Note: In the past, a full dose of Rh o(D) Immune Globulin (Human) has traditionally been referred to as a “300 mcg dose”. Potency and dosing recommendations are now expressed in IU by comparison to WHO anti-Rh o(D) standard. The conversion of mcg to IU is 1 mcg = 5 IU. {21}


Canada—


Sufficient Rh o(D) antibody to suppress the immunizing potential of approximately 6 mL of Rh o(D)–positive packed red blood cells or 12 mL of Rh o(D)–positive whole blood (Rx) [WinRho SD{08} (contains no preservatives)]


Full dose: Sufficient Rh o(D) antibody to suppress the immunizing potential of approximately 15 mL of Rh o(D)–positive packed red blood cells or 30 mL of Rh o(D)–positive whole blood (Rx) [WinRho SD{08} (contains no preservatives)]

Note: Each full dose of Rh o(D) immune globulin contains at least as much anti-Rh o(D) as is contained in 1 mL of the U.S. Reference Rh o(D) immune globulin. A full dose of Rh o(D) immune globulin has traditionally been referred to as a "300 mcg" dose; however, this is not the actual anti-Rh o(D) content of the product. Studies have shown that the U.S. Reference contains 820 International Units (IU) of anti-Rh o (D) per mL, which is thought to be equivalent to 164 mcg per mL. {01} {02} {03} {04} {05} {06} {07}


Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Protect from freezing. {08}

Preparation of dosage form:
A suitable syringe and needle should be used to withdraw the diluent. 1.25 mL of diluent should be used for an intramuscular injection or 2.5 mL of diluent should be used for an intravenous injection. The diluent should be injected slowly into the vial containing the freeze-dried pellet so that the liquid is directed onto the inside glass wall of the vial. The pellet should be wet by gently tilting and inverting the vial. Frothing should be avoided. While the vial is held upright, it should be gently swirled until the pellet is dissolved. This should take less than 10 minutes. {08}

Stability:
The reconstituted solution may be stored at room temperature for up to 4 hours. It should be discarded if it is not used within 12 hours. {08}{21}

The solution should not be used if it is discolored or contains particulate matter. {08}

Auxiliary labeling:
   • Do not freeze the powder, diluent, or the reconstituted solution. {08}
   • Use the reconstituted solution within 12 hours. {08}{21}


RH O(D) IMMUNE GLOBULIN (HUMAN) (INJECTION) USP

Usual adult and adolescent dose
Immunizing agent (passive)
Intramuscular, into the deltoid muscle or the anterolateral aspect of the thigh: a sufficient amount of Rh o(D) antibody to suppress the immunizing potential of the amount of Rh o(D)–positive blood calculated or estimated to be present in the female's circulation because of pregnancy or transfusion. {01} {02} {03} {04} {05} {06} {07}


Usual pediatric dose
Immunizing agent (passive)
Intramuscular, into the deltoid muscle or the anterolateral aspect of the thigh: a sufficient amount of Rh o(D) antibody to suppress the immunizing potential of the amount of Rh o(D)–positive blood calculated or estimated to be present in the female's circulation because of transfusion. {01} {02} {03} {04} {05} {06} {07} {20}


Note: See General Dosing Information for the parameters for administering Rh o(D) immune globulin.
If the patient requires administration of more than 1 vial/syringe of Rh o(D) immune globulin, the contents of the vials/syringes may be administered at different sites at the same time or at intervals over time, provided that the entire dose is administered with 72 hours of the event. {01} {03} {05} {07}


Strength(s) usually available
U.S.—


Mini-dose: Sufficient Rh o(D) antibody to suppress the immunizing potential of approximately 2.5 mL of Rh o(D)–positive packed red blood cells or 5 mL of Rh o(D)–positive whole blood (Rx) [HypRho-D Mini-Dose (thimerosal){02}] [MICRhoGAM (thimerosal){04}] [Mini-Gamulin Rh (thimerosal){06}]


Full dose: Sufficient Rh o(D) antibody to suppress the immunizing potential of approximately 15 mL of Rh o(D)–positive packed red blood cells or 30 mL of Rh o(D)–positive whole blood (Rx) [Gamulin Rh ( thimerosal){05}] [HypRho-D Full Dose (thimerosal){01}] [RhoGAM ( thimerosal){03}]

Canada—


Full dose: Sufficient Rh o(D) antibody to suppress the immunizing potential of approximately 15 mL of Rh o(D)–positive packed red blood cells or 30 mL of Rh o(D)–positive whole blood (Rx) [HypRho-D Full Dose ( thimerosal)]{07}

Note: Each full dose of Rh o(D) immune globulin contains at least as much anti-Rh o(D) as contained in 1 mL of the U.S. Reference Rh o(D) immune globulin. A full dose of Rh o(D) immune globulin has traditionally been referred to as a "300 mcg" dose; however, this is not the actual anti-Rh o (D) content of the product. Studies have shown that the U.S. Reference contains 820 International Units (IU) of anti-Rh o (D) per mL, which is thought to be equivalent to 164 mcg per mL. {01} {02} {03} {04} {05} {06} {07}
Each mini-dose of Rh o(D) immune globulin contains not less than one-sixth of the amount of anti-Rh o(D) that is contained in 1 mL of the U.S. Reference Rh o(D) immune globulin. {02} {04} {06}


Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Protect from freezing. {01} {02} {03} {04} {05} {06} {07} {10}

Stability:
The solution should be discarded if it has been frozen. {01} {02} {03} {04} {05} The solution should not be used if it is discolored or contains particulate matter. {01} {02} {03} {04} {05}

Auxiliary labeling:
   • Store in refrigerator. {01} {02} {03} {04} {05}
   • Do not freeze. {01} {02} {03} {04} {05}
   • Discard if solution has been frozen. {01} {02} {03} {04} {05}



Developed: 08/31/1994
Revised: 1/31/2000



References
  1. HypRho-D Full Dose package insert (Cutter—US), Rev 10/90, Rec 5/93.
  1. HypRho-D Mini-Dose package insert (Cutter—US), Rev 9/90, Rec 5/93.
  1. RhoGAM (Ortho Diagnostic). In: PDR Physicians" desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 1663.
  1. MICRhoGAM (Ortho Diagnostic). In: PDR Physicians" desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 1662.
  1. Gamulin Rh package insert (Armour—US), Rev 10/90, Rec 8/93.
  1. Mini-Gamulin Rh (Armour). In: PDR Physicians" desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 529.
  1. HypRho-D Full Dose (Miles). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 577.
  1. WinRho SD (Rh Pharmaceuticals). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 1446.
  1. Centers for Disease Control and Prevention. General Recommendations on Immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994 Jan 28; 43(RR-1): 15.
  1. The United States pharmacopeia. The national formulary. USP 22nd revision (January 1, 1990). NF 17th ed (January 1, 1990). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1990: 606.
  1. Fleeger CA, editor. USAN 1994. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1993: 576.
  1. Rules and Regulations. Fed Regist 1985 Jan 29 Tue: 50(19): 4129.
  1. Centers for Disease Control and Prevention. Lack of transmission of human immunodeficiency virus through Rho(D) immune globulin (human). MMWR 1987 Nov 13; 36(44): 728-9.
  1. Patton WN, Nicholson GS, Sawers AH, et al. Assessment of fetal-maternal haemorrhage in mothers with hereditary persistence of fetal haemoglobin. J Clin Pathol 1990 Sep; 43(9): 728-31.
  1. Feldman N, Skoll A, Sibai B. The incidence of significant fetomaternal hemorrhage in patients undergoing cesarean section. Am J Obstet Gynecol 1990 Sep; 163(3): 855-8.
  1. Tovey LA. ABC of transfusion. Haemolytic disease of the newborn and its prevention. BMJ 1990 Feb 3; 300(6720): 313-6.
  1. Heim MU, Bock M, Kolb HJ, et al. Intravenous anti-D gammaglobulin for the prevention of rhesus isoimmunization caused by platelet transfusions in patients with malignant diseases. Vox Sang 1992; 62(3): 165-8.
  1. Bayliss KM, Kueck BD, Johnson ST, et al. Detecting fetomaternal hemorrhage: a comparison of five methods. Transfusion 1991 May; 31(4): 303-7.
  1. Duerbeck NB, Seeds JW. Rhesus immunization in pregnancy: a review. Obstet Gynecol Surv 1993 Dec; 48(12): 801-10.
  1. Reviewers" consensus on monograph revision of 6/24/94.
  1. Product Information: WinRho SDF™, Rho (D) Immune Globulin Intravenous (Human). Nabi, Boca Raton, FL, (PI revised 12/99), reviewed 1/2000.
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