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Uses
Octagam 10% is indicated in Chronic Immune Thrombocytopenic Purpura to rapidly raise platelet counts to control or prevent bleeding in adults.
History
There is currently no drug history available for this drug.
Other Information
Immune Globulin Intravenous (Human), Octagam 10%, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously.
This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. On average, the product contains 106 µg/mL of IgA and even lower amounts of IgM.
The sodium content of the final solution is not more than 30 mmol/L and the pH is between 4.5 and 5.0. The osmolality is 310 - 380 mosmol/kg.
The manufacturing process for Octagam 10% isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 10% contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%.
Octagam 10% contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (90 mg/mL), but no preservatives or sucrose.
All units of human plasma used in the manufacture of Octagam 10% are provided by FDA-approved blood establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative).
The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 10% manufacturing process shows significant viral reduction in in vitro studies (Table 4). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment.
Table 4: In vitro reduction factor during Octagam 10% manufacturing
*not calculated for global LRF
HIV-1: Human Immunodeficiency Virus - 1
PRV: Pseudorabies Virus
SBV: Sindbis Virus
MEV: Mouse Encephalomyelitis Virus
PPV: Porcine Parvovirus
Sources
Octisalate Manufacturers
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Julep Nail Parlor
Octisalate | Octapharma Usa Inc
For intravenous use only.
2.1 DosageAdminister Octagam 10% at a total dose of 2 g/kg, divided into two doses of 1 g/kg (10mL/kg) given on two consecutive days.
2.2 Preparation and handling Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if Octagam 10% is turbid and/or if discoloration is observed. Do not mix Octagam 10% with other medicinal products or administer simultaneously with other intravenous preparation in the same infusion set. Do not mix Octagam 10% with immune globulin intravenous (IGIV) products from other manufacturers. Do not freeze Octagam 10%. Do not use solutions that have been frozen. Octagam 10% contains no preservative. Octagam 10% bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles. The content of Octagam 10% bottles may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling. Do not use after expiration date. Do not dilute Octagam 10%. The infusion line may be flushed before and after administration of Octagam 10% with either normal saline or 5% dextrose in water. 2.3 Administration Administer Octagam 10%, which is to be at room temperature, only by the intravenous route. Octagam 10% is not supplied with an infusion set. If an in-line filter is used the pore size should be 0.2 – 200 microns. Do not use a needle of larger than 16 gauge to prevent the possibility of coring. Insert needle only once, within the stopper area delineated (by the raised ring for penetration). Penetrate the stopper perpendicular to its plane and within the ring.For rate of administration, see Table 1.
Table 1
Rate of Administration mg/kg/min (mg/kg/hour) mL/kg/minfirst 30 min
1 (60)
0.01
next 30 min, if above is tolerated
2 (120)
0.02
next 30 min, if above is tolerated
4 (240)
0.04
next 30 min, if above is tolerated
8 (480)
0.08
Maximum
≤ 12 (≤720)
≤0.12
Monitor the patient carefully throughout the infusion. Certain adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly. Once the symptoms subside, the infusion may then be resumed at a lower rate. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thromboembolic events, administer Octagam 10% at the minimum infusion rate practicable, not to exceed 3.3 mg/kg/min (0.03 mL/kg/min). Discontinue Octagam 10% if renal function deteriorates. -
Julep Nail Parlor
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