药物信息为Rhophylac Rh0 (D) Immune Globulin Intravenous (Human) 1500 IU (300 mcg) For Intravenous or Intramuscular InjectionInitial U.S. Approval: 2004 (CSL Behring AG): DOSAGE AND ADMINISTRATION
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DESCRIPTION
- REFERENCES
- HOW SUPPLIED, STORAGE AND HANDLING
- 外部链接相关的Rhophylac Rh0 (D) Immune Globulin Intravenous (Human) 1500 IU (300 mcg) For Intravenous or Intramuscular InjectionInitial U.S. Approval: 2004 (CSL Behring AG)
As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac®.
2.1 Preparation and Handling
Bring Rhophylac® to room temperature before use.
Rhophylac® is a clear or slightly opalescent, colorless to pale yellow solution. Rhophylac® should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Do not use solution that has been frozen.
Rhophylac® is for single use only. Dispose of any unused product or waste material in accordance with local requirements.
2.2 Suppression of Rh Isoimmunization
Rhophylac® should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac® in divided doses at different sites.
Table 1 provides dosing guidelines based on the condition being treated.
Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization Indication Timing of Administration DoseA 1500 IU (300 mcg) dose of Rhophylac®will suppress the immunizing potential of ≥15 mL of Rh0(D)-positive RBCs.1 (Administer by Intravenous or Intramuscular Injection) IU, international units; mcg, micrograms. Rh-incompatible pregnancy - Routine antepartum prophylaxis
At Week 28-30 of gestation 1500 IU (300 mcg) - Postpartum prophylaxis(required only if the newborn is Rh0(D)-positive)
Within 72 hours of birth 1500 IU (300 mcg) The dose of Rhophylac® must be increased if the patient is exposed to >15 mL of Rh0(D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage. - Obstetric complications(e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage)
Within 72 hours of complication 1500 IU (300 mcg) - Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)
Within 72 hours of procedure 1500 IU (300 mcg) - Excessive fetomaternal hemorrhage(>15 mL)
Within 72 hours of complication 1500 IU (300 mcg) plus: - 100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantifiedor
- An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified
Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg) per 2 mL transfused blood or per 1 mL erythrocyte concentrate 2.3 ITP
For treatment of ITP, Rhophylac® must be administered by the intravenous route.
A 250 IU (50 mcg) per kg body weight dose of Rhophylac® is recommended for patients with ITP. The following formula can be used to calculate the amount of Rhophylac® to administer:
- Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = # of syringes
- Rhophylac® should be administered at a rate of 2 mL per 15 to 60 seconds.
- Drug Information Provided by National Library of Medicine (NLM).
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