GAMMAGARD LIQUID Immune Globulin Intravenous (Human), 10% is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma.1,2 The Fc and Fab functions are maintained in GAMMAGARD LIQUID. Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID (immune globulin intravenous human 10%) contains 100 mg/mL protein. At least 98% of the protein is gammaglobulin, the average immunoglobulin A (IgA) concentration is 37µg/mL, and immunoglobulin M is present in trace amounts. GAMMAGARD LIQUID (immune globulin intravenous human 10%) contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent, and there are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1. The osmolality is 240-300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg).3

Tetanus Immune Globulin (Human) — BayTet® (tetanus immune globulin human solvent/detergent treated 250 units) treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per container.

Rhophylac® (immune globulin intravenous human solution) is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh0(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard.

HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent- treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion- exchange column chromatography manufacturing method9,10. HepaGam B (hepatitis b immune globulin human) is formulated as a 5% (50 mg/mL) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 mL and 5 mL single dose vials. The product appears as a clear to opalescent liquid. It contains no preservatives and is intended for single use. HepaGam B (hepatitis b immune globulin human) may be administered intravenously or intramuscularly dependent upon indication [see INDICATIONS]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1 and HCV and found to be negative. An investigational NAT for HBV was performed on all Source Plasma used, and found to be negative; however, the significance of a negative result has not been established. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 104 IU of B19 DNA per mL.

Hepatitis B Immune Globulin (Human) — HyperHEP B™ S/D treated with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperHEP B S/D is prepared by cold ethanol fractionation from the plasma of donors with high titers of antibody to the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperHEP B S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperHEP B S/D is then incubated in the final container for 21–28 days at 20–27°C. Each vial contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitisB immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220international units (IU) per mL.

Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (GAMUNEX) is a ready-to-use sterile solution of human immune globulin protein for intravenous administration. GAMUNEX (immune globulin intravenous human 10%) consists of 9%–11% protein in 0.16–0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. GAMUNEX (immune globulin intravenous human 10%) contains trace levels of fragments, IgA (average 0.046 mg/mL), and IgM. The distribution of IgG subclasses is similar to that found in normal serum. GAMUNEX (immune globulin intravenous human 10%) doses of 1 g/kg correspond to a glycine dose of 0.15 g/kg. While toxic effects of glycine administration have been reported [12], the doses and rates of administration were 3 – 4 fold greater than those for GAMUNEX (immune globulin intravenous human 10%) . In another study it was demonstrated that intravenous bolus doses of 0.44 g/kg glycine were not associated with serious adverse effects [13] Caprylate is a saturated medium-chain (C8) fatty acid of plant origin. Medium chain fatty acids are considered to be essentially non-toxic. Human subjects receiving medium chain fatty acids parenterally have tolerated doses of 3.0 to 9.0 g/kg/day for periods of several months without adverse effects [14]. Residual caprylate concentrations in the final container are no more than 0.216 g/L (1.3 mmol/L).The measured buffer capacity is 35 mEq/L and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). The pH of GAMUNEX (immune globulin intravenous human 10%) is 4.0 – 4.5. GAMUNEX (immune globulin intravenous human 10%) contains no preservative and is latex-free.

Immune Globulin (Human) — BayGam™ (immune globulin) treated with solvent/detergent is a sterile solution of immune globulin for intramuscular administration; it contains no preservative. BayGam is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn fraction II. The fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltra-tion. BayGam (immune globulin) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayGam (immune globulin) is then incubated in the final container for 21–28 days at 20–27°C.

Rabies Immune Globulin (Human) USP, Imogam® Rabies – HT (rabies immune globulin human) , is a sterile solution of antirabies immunoglobulin (10-18% protein) for intramuscular administration. It is prepared by cold alcohol fractionation from pooled venous plasma of individuals immunized with Rabies Vaccine prepared from human diploid cells (HDCV). The product is stabilized with 0. 3 M glycine. The globulin solution has a pH of 6. 8 ?± 0. 4 adjusted with sodium hydroxide or hydrochloric acid. No preservatives are added. Imogam® Rabies – HT (rabies immune globulin human) is a colorless to light opalescent liquid.

Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured from large pools of human plasma by cold alcohol fractionation and is not chemically altered or enzymatically degraded.

Rabies Immune Globulin (Human) — BayRab® (rabies immune globulin human solvent/detergent treated) treated with solvent/detergent is a sterile solution of antirabies immune globulin for intramuscular administration; it contains no preservative. BayRab (rabies immune globulin human solvent/detergent treated) is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solu-tion is adjusted to a final concentration of 0.3% tri-n-butyl phosphate ( TNBP) and 0.2% sodium cholate. After the addition of solvent ( TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayRab (rabies immune globulin human solvent/detergent treated) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayRab (rabies immune globulin human solvent/detergent treated) is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody.