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Winrho Sdf Generic Name & Formulations
Legal Class
Rx
General Description
Rho(D) immune globulin intravenous human 600IU (120mcg), 1500IU (300mcg), 2500IU (500mcg), 5000IU (1000mcg), 15000IU (3000mcg); per vial; lyophilized pwd or soln; for IV or IM inj after reconstitution; preservative-free.
How Supplied
Single-dose vials (pwd) 600IU, 1500IU, 5000IU—1 (w. diluent); Single-dose vials (soln) 600IU, 1500IU, 2500IU, 5000IU, 15000IU—1
Manufacturer
Winrho Sdf Indications
Indications
Treatment of non-splenectomized, Rho(D)-positive children with acute immune thrombocytopenic purpura (ITP); adults and children with chronic ITP and ITP secondary to HIV infection; in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage.
Winrho Sdf Dosage and Administration
Adults and Children
Give by IV inj only. Confirm Rho(D)-positive prior to treatment. Initially: 250 IU/kg as single dose or 2 divided doses on separate days; if Hgb <10g/dL, reduce to 125–200 IU/kg. Maintenance: 125–300 IU/kg; Hbg >10g/dL: 250–300 IU/kg; Hgb 8–10g/dL: 125–200 IU/kg; Hgb <8g/dL: use with caution. Base frequency and dose on clinical response.
Winrho Sdf Contraindications
Contraindications
IgA deficiency. Allergy to blood products. Treatment of immune globulin deficiency syndromes.
Winrho Sdf Boxed Warnings
Boxed Warning
Intravascular hemolysis in immune thrombocytopenic purpura (ITP). (Warning does not apply to Rho(D)-negative patients in suppression of Rh isoimmunization).
Winrho Sdf Warnings/Precautions
Warnings/Precautions
Not for use in Rho(D)-negative or splenectomized patients; monitor for intravascular hemolysis, anemia, renal insufficiency; hemoglobin <10g/dL decrease dose, if <8g/dL use extreme caution. Pregnancy (Cat.C).
Winrho Sdf Pharmacokinetics
See Literature
Winrho Sdf Interactions
Interactions
Do not give live vaccines within 3 months.
Winrho Sdf Adverse Reactions
Adverse Reactions
Headache, chills, fever, local or infusion reactions; see full labeling.
Winrho Sdf Clinical Trials
See Literature
Winrho Sdf Note
Notes
Report all infections suspected to be transmitted by WinRho SDF to (800) 423-2090.
Winrho Sdf Patient Counseling
See Literature
Winrho Sdf Generic Name & Formulations
Legal Class
Rx
General Description
Rho(D) immune globulin intravenous human 600IU (120mcg), 1500IU (300mcg), 2500IU (500mcg), 5000IU (1000mcg), 15000IU (3000mcg); per vial; lyophilized pwd or soln; for IV or IM inj after reconstitution; preservative-free.
How Supplied
Single-dose vials (pwd) 600IU, 1500IU, 5000IU—1 (w. diluent); Single-dose vials (soln) 600IU, 1500IU, 2500IU, 5000IU, 15000IU—1
Manufacturer
Winrho Sdf Indications
Indications
Suppression of Rh isoimmunization in nonsensitized Rho(D)-negative women in appropriate obstetrical conditions, unless the fetus or father is known to be Rho(D)-negative. Suppression of Rh isoimmunization in Rho(D)-negative females after accidental transfusion of Rho(D)-positive blood products.
Winrho Sdf Dosage and Administration
Adult
Pregnancy: 1500IU at 28 weeks gestation; if given early in pregnancy, repeat every 12 weeks. Post-delivery: 600IU as soon as possible (preferably within 72 hrs, up to 28 days) of an Rh incompatible delivery. Amniocentesis or other manipulation late in pregnancy (after 34 weeks gestation), abortion: 600IU as soon as possible (within 72 hrs). Chorionic villus sampling, amniocentesis (before 34 weeks gestation), threatened abortion: 1500IU as soon as possible, repeat every 12 weeks during pregnancy. Transfusion: IV route: 3000IU (600micrograms) every 8 hours; or IM route: 6000IU (1200micrograms) every 12 hours; for both: total dose based on exposure (see full labeling); give within 72 hours.
Children
See full labeling. Do not give to infant for maternal Rh incompatability.
Winrho Sdf Contraindications
Contraindications
Rho(D)-positive patients. IgA deficiency. Allergy to blood products. Treatment of immune globulin deficiency syndromes.
Winrho Sdf Boxed Warnings
Boxed Warning
Intravascular hemolysis in immune thrombocytopenic purpura (ITP). (Warning does not apply to Rho(D)-negative patients in suppression of Rh isoimmunization).
Winrho Sdf Warnings/Precautions
Warnings/Precautions
Rho(D)-negative patients who are Rh immunized. Thrombocytopenia. Pregnancy (Cat.C).
Winrho Sdf Pharmacokinetics
See Literature
Winrho Sdf Interactions
Interactions
Do not give live vaccines within 3 months.
Winrho Sdf Adverse Reactions
Adverse Reactions
Local or infusion reactions, fever; see full labeling.
Winrho Sdf Clinical Trials
See Literature
Winrho Sdf Note
Notes
Report all infections suspected to be transmitted by WinRho SDF to (800) 423-2090.
Winrho Sdf Patient Counseling
See Literature
