Octisalate

Octisalate

Octisalate Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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


Image File


*not calculated for global LRF


HIV-1: Human Immunodeficiency Virus - 1

PRV: Pseudorabies Virus

SBV: Sindbis Virus

MEV: Mouse Encephalomyelitis Virus

PPV: Porcine Parvovirus



Octisalate Manufacturers


  • Julep Nail Parlor
    Octisalate, Avobenzone, Homosalate, Octocrylene Spf30 (Julep Solace Oil-free Sunscreen Broad Spectrum) Lotion [Julep Nail Parlor]
  • Julep Nail Parlor
    Octisalate, Avobenzone, Homosalate, Octocrylene Spf30 (Julep Time Machine) Kit [Julep Nail Parlor]

Login To Your Free Account