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WinRho® SDF
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Manufacturer: Cangene |
| Generic
Name: Immune Globulin;
Rho(D) Immune Globulin |
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Indications:
Treatment of ITP WinRho SDF® must be administered via the intravenous route when used in
clinical situations requiring an increase in platelet count to prevent excessive
hemorrhage in the treatment of non-splenectomized, Rho(D) positive:
- children with chronic or acute ITP,
- adults with chronic ITP, or
- children and adults with ITP secondary to HIV infection
Pregnancy and Other Obstetric Conditions WinRho® SDF may be administered by either intramuscular injection
or intravenously. WinRho® SDF is indicated for the suppression of Rh
isoimmunization in non-sensitized, Rho(D) negative (D-negative) women
within 72 hours after spontaneous or induced abortions, amniocentesis,
chorionic villus sampling, ruptured tubal pregnancy, abdominal trauma or
transplacental hemorrhage or in the normal course of pregnancy unless the
blood type of the fetus or father is known to be Rho(D) negative. In the
case of maternal bleeding due to threatened abortion, WinRho® SDF should
be administered as soon as possible. Suppression of Rh isoimmunization
reduces the likelihood of hemolytic disease in an Rho(D) positive fetus in
present and future pregnancies. WinRho® SDF should not be administered
to infants born to Rh incompatible mothers.
The criteria for an Rh-incompatible pregnancy requiring administration of
WinRho® SDF at 28 weeks gestation and within 72 hours after delivery in an
Rho(D) negative mother are:
- the mother is carrying a child whose father is either Rho(D)
positive or Rho(D) unknown,
- the baby is either Rho(D) positive or Rho(D) unknown, and
- the mother must not be previously sensitized to the Rho(D)
factor.
Transfusion WinRho® SDF, Rho(D) Immune Globulin Intravenous (Human), is
recommended for the suppression of Rh isoimmunization in Rho(D)
negative female children and female adults in their childbearing years
transfused with Rho(D) positive RBCs or blood components containing
Rho(D) positive RBCs. Treatment should be initiated within 72 hours
of exposure. Treatment should be given (without preceding exchange
transfusion) only if the transfused Rho(D) positive blood represents less
than 20% of the total circulating red cells. A 1,500 IU (300 μg) dose will
suppress the immunizing potential of approximately 17 mL of Rho(D)
positive RBCs.
WinRho® SDF, Rho(D) Immune Globulin Intravenous (Human), is not
indicated for use as immunoglobulin replacement therapy for immune
globulin deficiency syndromes. It should not be used for the treatment
of ITP in Rho(D) negative or splenectomized individuals; efficacy in these
patients has not been demonstrated. |
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Available Sizes |
Size |
NDC Numbers |
PI |
MSDS |
| WinRho® |
300 mcg |
53270-3300-01 |
PI |
MSDS |
| WinRho®
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1000 mcg |
53270-3500-01 |
PI |
MSDS |
| WinRho®
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500 mcg |
53270-3100-01 |
PI |
MSDS |
| WinRho®® |
3000 mcg |
53270-3000.01 |
PI |
MSDS |
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| Clinical Data:
For any questions or for
further information regarding WinRho® SDF, Immune Globulin;
Rho(D) Immune Globulin, clinical pharmacology, additional indications and
usages, contraindications,
warnings, precautions, adverse
reactions, dosage,
administration and/or storage
of this product, please
contact
BDI Pharma or call
1-800-948-9834. |
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