HyperRHO S/D Full Dose

HyperRHO S/D Full Dose

anti-d immunoglobulins

Manufacturer:

Grifols

Distributor:

Grifols Asia Pacific
Concise Prescribing Info
Contents
Rho(D) Ig (human)
Indications/Uses
Prevention of Rh hemolytic disease of the newborn, & of isoimmunization in Rho(D) negative individuals transfused w/ Rho(D) positive RBC or RBC-containing blood components.
Dosage/Direction for Use
IM Pregnancy & other obstetric conditions Postpartum prophylaxis: 1 syringe w/in 72 hr of delivery. Suspected fetomaternal hemorrhage (>30 mL of whole blood or 15 mL RBC): Perform fetal red cell count by an approved laboratory technique (eg, modified Kleihauer-Betke acid elution stain technique) to determine the required Ig dosage. Divide the RBC vol of the calculated fetomaternal hemorrhage by 15 mL to obtain the number of syringe or administration. If >15 mL RBC is suspected or if the dose calculation results in a fraction, administer the next higher whole number of syringe (eg, if 1.4, give 2 syringe). Antenatal prophylaxis: 1 full dose syringe administered at approx 28 wk gestation. Follow w/ another full dose, preferably w/in 72 hr following delivery, if the infant is Rh positive. Following threatened abortion at any stage of gestation w/ continuation of pregnancy; following miscarriage, abortion, or termination of ectopic pregnancy ≥13 wk gestation; following amniocentesis at either 15-18 wk gestation or during 3rd trimester or following abdominal trauma in 2nd or 3rd trimester: 1 full dose. Suspected fetomaternal hemorrhage in excess of 15 mL RBC: Perform fetal red cell count by an approved laboratory technique (eg, modified Kleihauer-Betke acid elution stain technique) to determine the required Ig dosage. Divide the RBC vol of the calculated fetomaternal hemorrhage by 15 mL to obtain the number of syringe or administration. If >15 mL RBC is suspected or if the dose calculation results in a fraction, administer the next higher whole number of syringe (eg, if 1.4, give 2 syringe). Abdominal trauma, amniocentesis, or other AR requiring administration of HyperRHO S/D at 13-18 wk gestation: Give another full dose at 26-28 wk. Any case (if the baby is Rh positive): Give w/in 72 hr after delivery. May withheld postpartum dose if delivery occurs w/in 3 wk after last dose unless there is fetomaternal hemorrhage in excess of 15 mL RBC. Transfusion of Rho(D) positive red cells to Rho(D) negative recipient Multiply the vol of Rh positive whole blood administered by the hematocrit of the donor unit giving the vol of RBC transfused. Divide RBC vol by 15 mL which provides the number of syringes to be administered. If the dose calculation results in a fraction, administer the next higher whole number of syringe (eg, if 1.4, give 2 syringe). Administer preferably as soon as possible or w/in 72 hr after incompatible transfusion.
Special Precautions
Do not administer IV. Patients w/ a history of prior systemic allergic reactions following administration of human Ig prep. Increased potential for developing Ab to IgA, & anaphylactic reactions to subsequent administration of IgA-containing blood products in patients w/ isolated IgA deficiency. Epinephrine should be available for treatment of acute anaphylactic reactions. May contain infectious agents eg, viruses, & theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. May encounter bleeding complications in patients w/ thrombocytopenia or other bleeding disorders. A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive Du test result. Give human Rho(D) Ig if there is any doubt about the mother's Rh type. Pregnancy. Do not administer to neonates. Childn.
Adverse Reactions
Slight soreness at the inj site, & temp elevation. Potentially elevated bilirubin levels.
Drug Interactions
Other Ab in human Rho(D) Ig prep may interfere w/ the response to live vaccines eg, measles, mumps, polio or rubella; do not give immunization w/ live vaccines w/in 3 mth after human Rho(D) Ig administration. Potential weakly positive direct antiglobulin test at birth w/ babies born of women given Rho(D) Ig (human) antepartum. May detect passively acquired anti-Rho(D) in maternal serum if Ab screening tests are performed subsequent to ante- or postpartum Rho(D) Ig (human) administration.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB01 - anti-D (rh) immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
HyperRHO S/D Full Dose inj ≥1,500 IU
Packing/Price
1's
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