Rh o (D) Immune Globulin Intravenous (Human) (Rh o (D) IGIV)--WinRho SDF™--is a sterile, freeze-dried gamma globulin (IgG) fraction containing antibodies to the Rh o (D) antigen (D antigen). WinRho SDF™ is prepared from human plasma by an anion-exchange column chromatography method. 1-3 The manufacturing process includes a solvent detergent treatment step (using tri-n-butyl phosphate and Triton X-100) that is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. 4 WinRho SDF™ is filtered using a Planova 35 nm Virus Filter which has been validated to be effective in the removal of some nonlipid enveloped viruses. 5-6 These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and nonenveloped viruses, respectively.
The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard. A 300 µg (1,500 International Unit [IU]*) vial contains sufficient anti-Rh o (D) to effectively suppress the immunizing potential of approximately 17 mL of Rh o (D) (D-positive) red blood cells (RBCs). This product contains approximately 5 µg/mL IgA per 120 µg (600 IU) vial.
The product is stabilized with 0.1 M glycine, 0.04 M sodium chloride, and 0.01% polysorbate 80. It contains no preservative.
Treatment of ITP
For use in the treatment of immune thrombocytopenic purpura (ITP), WinRho SDF™ must be administered intravenously.
Suppression of RH Isoimmunization
For use in the suppression of Rh isoimmunization, SDF™ may be administered either intramuscularly or intravenously.
Treatment of ITP
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), has been shown to increase platelet counts in non-splenectomized, Rh o (D) positive patients with ITP. Platelet counts usually rise within one to two days and peak within seven to 14 days after initiation of therapy. The duration of response is variable; however, the average duration is approximately 30 days. The mechanism of action is not completely understood, but 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. 7-8
Suppression of Rh Isoimmunization
WinRho SDF™ is used to suppress the immune response of non-sensitized Rh o (D) negative individuals following exposure to Rh o (D) positive RBCs by fetomaternal hemorrhage during delivery of an Rh o (D) positive infant, abortion (spontaneous or induced), amniocentesis, abdominal trauma, or mismatched transfusion. 9-11 The mechanism of action is not completely understood.
WinRho SDF™, when administered within 72 hours of a full-term delivery of an Rh o (D) positive infant by an Rh o (D) negative mother, will reduce the incidence of Rh isoimmunization from 12-13% to 1-2%. The 1-2% is, for the most part, due to isoimmunization during the last trimester of pregnancy. When treatment is given both antenatally at 28 weeks gestation and postpartum, the Rh immunization rate drops to about 0.1%. 12-15
When 120 µg (600 IU) of Rh o (D) IGIV is administered to pregnant women, passive anti-Rh o (D) antibodies are not detectable in the circulation for more than six weeks and therefore a dose of 300 µg (1,500 IU) should be used for antenatal administration.
In a clinical study with Rh o (D) negative volunteers (nine males and one female), Rh o (D) positive red cells were completely cleared from the circulation within eight hours of intravenous administration of Rh o (D) IGIV. There was no indication of Rh isoimmunization of these subjects at six months after the clearance of the Rh o (D) positive red cells.
In a clinical study involving Rh o (D) negative volunteers, two subjects received 120 µg (600 IU) Rh o (D) IGIV by intravenous (IV) administration and two subjects received this dose by intramuscular (IM) administration. Peak levels (36 to 48 ng/mL) were reached within two hours of IV administration and peak levels (18 to 19 ng/mL) were reached at five to 10 days after IM administration. The calculated areas under the curve were the same for both routes of administration. The t 1/2 for anti-Rh o (D) was about 24 days following IV administration and about 30 days following IM administration.
Treatment of ITP
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), is recommended for the treatment of non-splenectomized, Rh o (D) positive
in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage. The safety and efficacy of WinRho have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients.
Suppression of Rh Isoimmunization
WinRho SDF™ is recommended 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 Rh o (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 Rh o (D) positive fetus in present and future pregnancies.
The criteria for an Rh-incompatible pregnancy requiring administration of WinRho SDF™ at 28 weeks gestation and within 72 hours after delivery are:
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), is recommended for the suppression of Rh isoimmunization in Rh o (D) negative female children and female adults in their childbearing years transfused with Rh o (D) positive RBCs or blood components containing Rh o (D) positive RBCs. Treatment should be initiated within 72 hours of exposure. Treatment should be given (without preceding exchange transfusion) only if the transfused Rh o (D) positive blood represents less than 20% of the total circulating red cells. A 300 µg (1,500 IU) dose will suppress the immunizing potential of approximately 17 mL of Rh o (D) positive RBCs.
Treatment of ITP
Efficacy was documented in four subgroups of patients with ITP:
In an open-label, single arm, multicenter study, 24 non-splenectomized, Rh o (D) positive children with ITP of greater than six months duration were treated initially with 50 µg/kg (250 IU/kg) Rh o (D) Immune Globulin Intravenous (Human) (25 µg/kg (125 IU/kg) on days 1 and 2, with subsequent doses ranging from 25 to 55 µg/kg (125 to 275 IU/kg)). Response was defined as a platelet increase to at least 50,000/mm 3 and a doubling of the baseline. Nineteen of 24 patients responded for an overall response rate of 79%, and overall mean peak platelet count of 229,400/mm 3 (range 43,300 to 456,000), and a mean duration of response of 36.5 days (range 6 to 84). 16-17
A multicenter, randomized, controlled trial comparing Rh o (D) IGIV to high dose and low dose Immune Globulin Intravenous (Human) and prednisone was conducted in 146 non-splenectomized, Rh o (D) positive children with acute ITP and platelet counts less than 20,000/mm 3 . Of 38 patients receiving Rh o (D) IGIV (25 µg/kg (125 IU/kg) on days 1 and 2), 32 patients (84%) responded (platelet count >/= 50,000 mm 3 ) with a mean peak platelet count of 319,500/mm 3 (range 61,000 to 892,000), with no statistically significant differences compared to other treatment arms. The mean times to achieving >/= 20,000/mm 3 or >/= 50,000/mm 3 platelets for patients receiving Rho(D) IGIV were 1.9 and 2.8 days, respectively. When comparing the different therapies for time to platelet count >/= 20,000/mm 3 or >/= 50,000/mm 3 , no statistically significant differences among treatment groups were detected, with a range of 1.3 to 1.9 days and 2.0 to 3.2 days, respectively. 18-19
Twenty-four non-splenectomized, Rh o (D) positive adults with ITP of greater than six months duration and platelet counts < 30,000/mm 3 or requiring therapy were enrolled in a single-arm, open-label trial and treated with 20 to 75 µg/kg (100 to 375 IU/kg) Rh o (D) IGIV (mean dose 46.2 µg/kg (231 IU/kg)). Twenty-one of 24 patients responded (increase >/= 20,000/mm 3 ) during the first two courses of therapy for an overall response rate of 88% with a mean peak platelet count of 92,300/mm 3 (range 8,000 to 229,000). 20-21
Eleven children and 52 adults, who were non-splenectomized and Rh o (D) positive, with all Walter Reed classes of HIV infection and ITP, with initial platelet counts of </= 30,000/mm 3 or requiring therapy, were treated with 20 to 75 µg/kg (100 to 375 IU/kg) Rh o (D) IGIV in an open label trial. Rh o (D) IGIV was administered for an average of 7.3 courses (range 1 to 57) over a mean period of 407 days (range 6 to 1,952). Fifty-seven of 63 patients responded (increase >/= 20,000/mm 3 ) during the first six courses of therapy for an overall response rate of 90%. The overall mean change in platelet count for six courses was 60,900/mm 3 (range -2,000 to 565,000), and the mean peak platelet count was 81,700/mm 3 (range 16,000 to 593,000). 21-23
Suppression of Rh Isoimmunization
The pivotal study 24 supporting this indication was conducted in 1,186 non-sensitized, Rh o (D) negative pregnant women in cases in which the blood types of the fathers were either Rh o (D) positive or unknown. Rh o (D) IGIV was administered according to one of three regimens: 1) 93 women received 120 µg (600 IU) at 28 weeks; 2) 131 women received 240 µg (1200 IU) each at 28 and 34 weeks; 3) 962 women received 240 µg (1200 IU) at 28 weeks. All women received a postnatal administration of 120 µg (600 IU) if the newborn was found to be Rh o (D) positive. Of 1,186 women who received antenatal Rh o (D) IGIV, 806 were given Rh o (D) IGIV postnatally following the delivery of an Rh o (D) positive infant, of which 325 women underwent testing at six months after delivery for evidence of Rh isoimmunization. Of these 325 women, 23 would have been expected to display signs of Rh isoimmunization; however, none was observed (p < 0.001 in a Chi-square test of significance of difference between observed and expected isoimmunization in the absence of Rh o (D) IGIV).
Treatment of ITP and Suppression of Rh Isoimmunization
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), or any other Immune Globulin (Human).WinRho SDF™ contains trace amounts of IgA (approximately 5 µg/mL per 120 µg [600 IU] vial). Individuals who are deficient in IgA may have the potential for developing IgA antibodies and have anaphylactic reactions. The physician must weigh the potential benefit of treatment withWinRho SDF™ against the potential for hypersensitivity reactions.
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. The WinRho SDF™ manufacturing process includes a solvent detergent treatment step (using tri-n-butyl phosphate and Triton X-100) that is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV.WinRho SDF™ is filtered using a Planova 35 nm Virus Filter that is effective in reducing the level of some non-lipid enveloped viruses such as hepatitis A. These two processes are designed to increase product safety by reducing the risk of transmission of lipid enveloped and non-lipid enveloped viruses, respectively. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to the distributor, Nabi® at 1-800-4WINRHO (1-800-494-6746). The physician should discuss the risks and benefits of this product with the patient.
Treatment of ITP
WinRho SDF™ must be administered via the intravenous route for the treatment of ITP as its efficacy has not been established by the intramuscular or subcutaneous routes.
WinRho SDF™ should not be administered to Rh o (D) negative or splenectomized individuals as its efficacy in these patients has not been demonstrated.
Suppression of Rh Isoimmunization
For the suppression of Rh isoimmunization in the mother, do not administer to the infant.
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), should not be administered as immunoglobulin replacement therapy for immune globulin deficiency syndromes.
Treatment of ITP
Following administration of WinRho SDF™, Rh o (D) positive ITP patients should be monitored for signs and/or symptoms of intravascular hemolysis (IVH), clinically compromising anemia, and renal insufficiency.
If patients are to be transfused, Rho(D) negative red blood cells (PRBCs) should be used so as not to exacerbate ongoing IVH. Platelet products may contain up to 5.0 mL of RBCs, thus caution should likewise be exercised if platelets from Rh o (D) positive donors are transfused.
If the patient has a lower than normal hemoglobin level (less than 10 g/dL), a reduced dose of 25 to 40 µg/kg (125 to 200 IU/kg) should be given to minimize the risk of increasing the severity of anemia in the patient. WinRho SDF™ must be used with extreme caution in patients with a hemoglobin level that is less than 8 g/dL due to the risk of increasing the severity of the anemia (See DOSAGE AND ADMINISTRATION, Treatment of ITP ).
Suppression of Rh Isoimmunization
WinRho SDF™ should not be administered to Rh o (D) negative individuals who are Rh immunized as evidenced by an indirect antiglobulin (Coombs') test revealing the presence of anti-Rh o (D) (anti-D) antibody.
A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive D u test result. Such an individual should be assessed for a large fetomaternal hemorrhage and the dose ofWinRho SDF™ adjusted accordingly. WinRho SDF™ should be administered if there is any doubt about the mother' blood type.
In addition to anti-D, WinRho SDF™ contains trace amounts of anti-A, anti-B, anti-C and anti-E antibodies.
Treatment of ITP
Passively acquired anti-A, anti-B, anti-C, and anti-E blood group antibodies may be detectable in direct and indirect antiglobulin (Coombs') tests obtained followingWinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), administration. Interpretation of direct and indirect antiglobulin tests must be made in the context of the patient' underlying clinical condition and supporting laboratory data.
Suppression of Rh Isoimmunization
The presence of passively administered anti-Rh o (D) in maternal or fetal blood can lead to a positive direct antiglobulin (Coombs') test. If there is an uncertainty about the mother' Rh group or immune status, WinRho SDF™ should be administered to the mother.
Treatment of ITP and Suppression of Rh Isoimmunization
Administration of WinRho SDF™ concomitantly with other drugs has not been evaluated. Other antibodies contained in WinRho SDF™ may interfere with the response to live virus vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after WinRho SDF™ administration.
Refer to Dosage and Administration section for information on drug compatibility.
Treatment of ITP and Suppression of Rh Isoimmunization
Animal reproduction studies have not been conducted with WinRho SDF™. It is not known whether WinRho SDF™ can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. WinRho SDF™ should be given to a pregnant woman only if clearly needed.
Treatment of ITP
In clinical trials of subjects (n=161) with childhood acute ITP, adults and children with chronic ITP, and adults and children with ITP secondary to HIV, 60/848 (7%) of infusions were associated with at least one adverse event that was considered to be related to the study medication. The most common adverse events were headache (19 infusions; 2%), chills (14 infusions; <2%), and fever (nine infusions; 1%). All are expected adverse events associated with infusions of immunoglobulins.
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), is administered to Rh o (D) positive patients with ITP. Therefore, side effects related to the destruction of Rh o (D) positive red blood cells, most notably a decreased hemoglobin, can be expected. In four clinical trials of patients treated with the recommended initial intravenous dose of 50 µg/kg (250 IU/kg), the mean maximum decrease in hemoglobin was 1.70 g/dL (range: +0.40 to -6.1 g/dL). At a reduced dose, ranging from 25 to 40 µg/kg (125 to 200 IU/kg), the mean maximum decrease in hemoglobin was 0.81 g/dL (range: +0.65 to -1.9 g/dL). Only 5/137 (3.7%) of patients had a maximum decrease in hemoglobin of greater than 4 g/dL (range 4.2 to 6.1 g/dL).
In most cases, the RBC destruction is believed to occur in the spleen. However, signs and symptoms consistent with IVH, including back pain, shaking chills, and/or hemoglobinuria, have been reported, occurring within 4 hours of WinRho administration. IVH-related complications that have been reported include death (four cases reported between May 1996 and April 1999), acute onset or exacerbation of anemia, and acute onset or exacerbation of renal insufficiency. One patient died from complications secondary to IVH-induced exacerbation of anemia after administration of WinRho for treatment of ITP. Although the primary cause of death in the other three ITP patients treated with WinRho was related to underlying disease, the extent to which IVH-related clinical complications exacerbated their conditions and contributed to their deaths in unknown.
The mean maximum decrease in hemoglobin in patients who were not transfused with PRBCs was 3.7 g/dL (range: 0.0-7.6 g/dL). Transfusions for treatment-associated anemia were administered within hours to days of the onset of IVH and consisted of between 1-6 units of PRBCs. Acute renal insufficiency was noted within 2 to 48 hours of the onset of IVH. The mean maximum increase in serum creatinine was 3.5 mg/dL (range: 0.8-10.3 mg/dL) and occurred within 2-9 days. The renal insufficiency in all surviving patients resolved with medical management, including dialysis, within 4-23 days.
The etiology of IVH following WinRho administration is unknown. No known risk factors associated with this adverse event have yet been identified from among those examined, which included age, gender, pre-treatment renal function, pretreatment hemoglobin, concomitantly administered PRBCs, or WinRho dose.
Suppression of Rh Isoimmunization
Adverse reactions to Rh o (D) Immune Globulin Intravenous (Human) are infrequent in Rh o (D) negative individuals. In the clinical trial 24 of 1,186 Rh o (D) negative pregnant women, no adverse events were attributed to Rh o (D) IGIV. Discomfort and slight swelling at the site of injection and slight elevation in temperature have been reported in a small number of cases. A post-marketing survey conducted since the Canadian licensure of Rh o (D) IGIV in 1980 for this indication included data obtained from 31,059 injections (25,068 for routine Rh prophylaxis and 5,991 following abortions, amniocentesis, chorionic villus sampling and antepartum hemorrhage). There were 9,905 Rh o (D) negative women who delivered Rh o (D) positive infants, almost all of whom had received antenatal as well as postnatal prophylaxis. Of the patients followed in this survey, there were 26 reported treatment failures that resulted in the development of Rh o (D) antibodies. There were no adverse experiences related to Rh o (D) IGIV reported in this survey.
General Adverse Reactions
In addition to the adverse reactions described above, the following have been reported infrequently in clinical trials and/or postmarketing experience, in patients treated for ITP or the suppression of Rh isoimmunization, and are thought to be temporally associated with WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), use: asthenia, abdominal or back pain, hypotension, pallor, diarrhea, increased LDH, arthralgia, myalgia, dizziness, hyperkinesia, somnolence, vasodilation, pruritus, rash, and sweating.
As is the case with all drugs of this nature, there is a remote chance of an idiosyncratic or anaphylactic reaction with WinRho SDF™ in individuals with hypersensitivity to blood products.
Treatment of ITP and Suppression of Rh Isoimmunization
There are no reports of known overdoses in patients being treated for Rh isoimmunization or ITP. In clinical studies with nonpregnant Rh o (D) positive patients with ITP (n=141) treated with 120 to 6,500 µg (600 to 32,500 IU) of Rh o (D) IGIV, there were no signs or symptoms that warranted medical intervention. However, these same doses were associated with a mild, transient hemolytic anemia.
Treatment of ITP and Suppression of Rh Isoimmunization
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), should be reconstituted only with the accompanying vial of 0.9% Sodium Chloride Injection. It should not be administered concurrently with other products.
Aseptically reconstitute the product shortly before use with 2.5 mL of 0.9% Sodium Chloride Injection for 120 µg (600 IU) and 300 µg (1,500 IU) and 8.5 mL of 0.9% Sodium Chloride Injection for 1,000 µg (5,000 IU) (see the next table). Inject the diluent slowly onto the inside wall of the vial and gently swirl until dissolved. Do not shake .
Aseptically reconstitute the product shortly before use with 1.25 mL of 0.9% Sodium Chloride Injection for 120 µg (600 IU) and 300 µg (1,500 IU) and 8.5 mL of 0.9% Sodium Chloride Injection for 1,000 µg (5,000 IU) (see the next table). Inject the diluent slowly onto the inside wall of the vial and gently swirl until dissolved. Do not shake .
|
||||||||||||||||||||
Parenteral products such as WinRho SDF™ should be inspected for particulate matter and discoloration prior to administration. Use the product within 12 hours of reconstitution. Discard any unused portion.
Infuse the entire dose into a suitable vein over three to five minutes. WinRho SDF™ should be administered separately from other drugs.
Administer into the deltoid muscle of the upper arm or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, the gluteal region should not be used as a routine injection site. If the gluteal region is used, use only the upper, outer quadrant.
Treatment of ITP
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), must be given by intravenous administration for the treatment of ITP.
Initial Dosing: After confirming that the patient is Rh o (D) positive, an initial dose of 50 µg/kg (250 IU/kg) body weight, given as a single injection, is recommended for the treatment of ITP. The initial dose may be administered in two divided doses given on separate days, if desired. If the patient has a hemoglobin level that is less than 10 g/dL, a reduced dose of 25 to 40 µg/kg (125 to 200 IU/kg) should be given to minimize the risk of increasing the severity of anemia in the patient. All patients should be monitored to determine clinical response by assessing platelet counts, red cell counts, hemoglobin, and reticulocyte levels (See PRECAUTIONS, Treatment of ITP ).
Subsequent Dosing: If subsequent therapy is required to elevate platelet counts, an intravenous dose of 25 to 60 µg/kg (125 to 300 IU/kg) body weight of WinRho SDF™ is recommended. The frequency and dose used in maintenance therapy should be determined by the patient' clinical response by assessing platelet counts, red cell counts, hemoglobin, and reticulocyte levels.
If patient responded to initial dose with a satisfactory increase in platelets:
Dosing (25-60 µg/kg (125-300 IU/kg)) individualized based on platelet and Hgb levels.
If patient did not respond to initial dose, administer a subsequent dose based on Hgb:
If Hgb between 8-10 g/dL, redose between 25-40 µg/kg (125-200 IU/kg).
If Hgb >10 g/dL, redose between 50-60 µg/kg (250-300 IU/kg).
If Hgb <8 g/dL, use with caution.
The following equations are provided to determine the dosage and number of vials needed for the treatment of ITP:
Suppression of Rh Isoimmunization
WinRho SDF™ may be given by intravenous or intramuscular administration for the suppression of Rh isoimmunization.
The same dosage, as described below, is to be administered by either the intramuscular or intravenous routes.
A 300 µg (1,500 IU) dose of WinRho SDF™ should be administered at 28 weeks gestation. If WinRho SDF™ is administered early in the pregnancy, it is recommended that WinRho SDF™ be administered at 12-week intervals in order to maintain an adequate level of passively acquired anti-Rh.
A 120 µg (600 IU) dose should be administered as soon as possible after delivery of a confirmed Rh o (D) positive baby and normally no later than 72 hours after delivery. In the event that the Rh status of the baby is not known at 72 hours, WinRho SDF™ should be administered to the mother at 72 hours after delivery. If more than 72 hours have elapsed, WinRho SDF™ should not be withheld, but administered as soon as possible up to 28 days after delivery.
The same dosage, as described below, is to be administered by either the intramuscular or intravenous routes.
A 120 µg (600 IU) dose of WinRho SDF™ should be administered immediately after abortion, amniocentesis (after 34 weeks gestation) or any other manipulation late in pregnancy (after 34 weeks gestation) associated with increased risk of Rh isoimmunization. Administration should take place within 72 hours after the event.
A 300 µg (1,500 IU) dose of WinRho SDF™ should be administered immediately after amniocentesis before 34 weeks gestation or after chorionic villus sampling. This dose should be repeated every 12 weeks while the woman is pregnant. In the case of threatened abortion, WinRho SDF™ should be administered as soon as possible.
|
||||||||||||||||
WinRho SDF™ should be administered within 72 hours after exposure for treatment of incompatible blood transfusions or massive fetal hemorrhage.
|
|||||||||||
Administer 600 µg (3,000 IU) every 8 hours via the intravenous route, until the total dose, calculated from the above table, is administered.
Administer 1,200 µg (6,000 IU) every 12 hours via the intramuscular route, until the total dose, calculated from the above table, is administered.
WinRho SDF™, Rh o (D) Immune Globulin Intravenous (Human), is available in packages containing:
|
NDC Number
|
Contents
|
|
60492-0021-1
|
|
|
60492-0023-1
|
|
|
60492-0024-1
|
Store at 2 to 8°C (35 to 46°F). Do not freeze. Do not use after expiration date.
If the reconstituted product is not used immediately, store it at room temperature for no longer than 12 hours. Do not freeze the reconstituted product. Discard the product if not administered within 12 hours.
Rx Only
Manufactured by:
Cangene Corporation
Winnipeg, Canada R3T 5Y3
U.S. License No. 1201
Distributed by:
Nabi®
Boca Raton, FL 33487
To report adverse events contact Nabi® at 1-800-327-7106
Date of Revision: 1/20/2000
Part No. 07.0205.05
|
|