Botulinum Antitoxin A B E, Biomed Warsaw (1 vial contains 5,000 IUs of A-type aurantium botulinum toxin, 5,000 IU B-type botulinum toxin antitoxin, 1000 IU of E.B. Antiboxic.)
Cytotect Biotest, Biotest Pharma (1 ml of solution contains 100 mg of human plasma protein, including ≥95% of IgG (approximately 62% IgG1, about 34% IgG2, about 0.5% IgG3, about 3.5% IgG4), ≤5 mg of IgA and 50 U of antibodies against the cytomegalovirus. )
Endobulin S / D, Baxter (1 ml solution (after dissolving the powder) contains 51 mg of human protein, including at least 95% of immunoglobulin G.)
Flebogamma DIF, Instituto Grifols (50 mg / ml solution: 1 ml of solution contains 50 mg of normal human immunoglobulin (including at least 97% IgG). Distribution of IgG subclasses: IgG1 - 66.6%, IgG2 - 28.5%, IgG3 - 2.7%, IgG4 - 2.2%. The maximum IgA content is 50μg / ml. 1 ml of solution contains 50 mg of D-sorbitol.A solution of 100 mg / ml: 1 ml of solution contains 100 mg of normal human immunoglobulin (including at least 97% IgG). Distribution of IgG subclasses: IgG1 - 66.6%, IgG2 - 27.9%, IgG3 - 3.0%, IgG4 - 2.5%. The maximum IgA content is 100 μg / ml. 1 ml of solution contains 50 mg of D-sorbitol.)
Gammagard S / D, Baxter (1 vial contains 5g of normal human immunoglobulin (IVIg), including at least 90% of immunoglobulin G (IgG) Distribution of IgG subclasses: IgG1 ≥ 56.9%, IgG2≥ 16.0%, IgG3≥ 3.3%, IgG4 ≥ 0.3% Maximum IgA content: not more than 3μg / ml in 5% solution The 5% formulation contains 21.7 mg glucose per dose and approximately 0.85 mg / ml sodium.)
Gammanorm, Octapharma (1 ml of solution contains 165 mg of human plasma protein (purity: at least 95% of IgG) Distribution of IgG subclasses: IgG1 - 59%, IgG2 - 36%, IgG3 - 4.9%, IgG4 - 0.5%. IgA is 0.082 mg / ml, the preparation contains 4.35 mmol (or 100 mg) of sodium per dose (40 ml).)
Hepatect CP, Biotest Pharma (1 ml of solution contains 50 mg of human plasma protein, including ≥96% IgG (approximately 59% IgG1, about 35% IgG2, about 3% IgG3, about 3% IgG4), ≤ 2000 μg IgA and 50 IU. anti-HBs antibodies. )
Histaglobulina, Biomed Lublin (1 vial contains 12 mg of human normal immunoglobulin (IgG) and 0.15 μg of histamine dihydrochloride.)
Hizentra, CSL Behring (1 ml of solution contains 200 mg of human plasma protein (purity: at least 98% of IgG) Approximate distribution of IgG1 subclasses: IgG1 - 62-74%, IgG2 - 22-34%, IgG3 - 2-5%, IgG4 - 1- 3% Maximum IgA content is 0.050 mg / ml.)
Ig Vena, Kedrion (1 ml contains 50 mg of normal human immunoglobulin (including at least 95% of immunoglobulin G) Distribution of IgG subclasses (average values): IgG1 - 62.1%, IgG2 - 34.8% IgG3 - 2.5% IgG4 - 0 , 6% The maximum content of IgA is 50 μg / ml The preparation contains maltose (100 mg / ml) The preparation contains 3 mmol / l (69 mg) sodium.)
Intraglobin® F, Biotest Pharma (1 ml of solution contains 50 mg of human plasma protein, including ≥95% of IgG (approximately 62% IgG1, about 34% IgG2, about 0.5% IgG3, about 3.5% IgG4) and ≤2.5 mg of IgA. )
Intratect, Biotest Pharma (50 mg / ml solution:: 1 ml of solution contains 50 mg of normal human immunoglobulin, including not less than 96% IgG (57% IgG1, 37% IgG2, 3% IgG3, 3% IgG4); the maximum IgA content is 900 μg / ml.A solution of 100 mg / ml: 1 ml of solution contains 100 mg of normal human immunoglobulin, including not less than 96% IgG (57% IgG1.37% IgG2, 3% IgG3, 3% IgG4); the maximum IgA content is 1.8 mg / ml.)
Kiovig, Baxter (1 ml contains 100 mg of human normal immunoglobulin (IVIg) (corresponds to the content of human protein, at least 98% of which is IgG).)
Nanogy 5%, Biomed Lublin (1 ml contains 50 mg of human normal immunoglobulin (with a purity not less than 95% IgG.) Distribution of IgG subclasses (mean values): IgG1 - 61%, IgG2 - 33%, IgG3 - 2.5%, IgG4 - 2%. The maximum IgA content is 22 μg / ml.)
Octagam, Octapharma
Octagam 10%, Octapharma (1 ml of solution contains 50 mg or 100 mg of human normal immunoglobulin (including at least 95% of IgG). Distribution of IgG: IgG subclasses1 - about 60%, IgG2 - approx. 32%, IgG3 - about 7%, IgG4 - about 1%. The maximum IgA content is not more than 0.4 mg.)
Partobulin-Inject, Baxter (1 auto-syringe contains 250 μg (1250 IU) in 1 ml 95% pure human anti-Rh globule concentrate0(D)).
Pentaglobin, Biotest Pharma (1 ml of solution contains 50 mg of human plasma protein, including ≥ 95% of immunoglobulin: 38 mg of IgG (including approximately 63% of IgG)1, about 26% IgG2, about 4% IgG3, about 7% IgG4), 6 mg IgM and 6 mg IgA. )
Privigen, CSL Behring (1 ml contains 100 mg of human normal immunoglobulin (at least 98% is IgG). Distribution of IgG subclasses (approximate values): IgG1 - 67.8%, IgG2 - 28.7%, IgG3 - 2.3%, IgG4 - 1 , 2% The maximum IgA content is 0.025 mg / ml.)
Rhophylac, CSL Behring (1 pre-filled syringe contains 300 μg (1500 IU) of human anti-D immunoglobulin. The product contains up to 30 mg / ml human plasma proteins, including 10 mg / ml albumin as a stabilizer of the solution. At least 95% of other plasma proteins are immunoglobulins IgG class, contains no more than 5 μg / ml IgA class immunoglobulin.)
Sandoglobulin-P, Imed Poland (1 vial contains 6 g powder containing human plasma protein, including at least 96% IgG. Distribution of IgG subclasses: IgG1 - 57.7%, IgG2 - 35.1%, IgG3 - 3.1%, IgG4 - 4.1 The IgA content is not more than 40 mg / g of protein.)
Subcuvia, Baxter Polska (1 vial (5 ml or 10 ml) contains 800 mg or 1600 mg of human protein (including at least 95% of immunoglobulin) respectively.)
Tetabulin S / D, Baxter Polska (1 dose (1 ml) of solution for injection contains 250 IU of human immunoglobulin against tetanus, human protein 100 mg-170 mg, including at least 90% of immunoglobulin G.)
Vivaglobin, CSL Behring (1 ml of solution contains 160 mg of human normal immunoglobulin, including at least 95% of immunoglobulin G. The preparation contains sodium.)
Zutectra, Biotest Pharma (1 pre-filled syringe (1 ml) contains 500 IU human hepatitis B virus. Human protein 150 mg / ml, at least 96% of which is IgG, with antibody content to hepatitis B surface antigen (HBs) 500 IU / ml. Distribution of IgG subclasses: 59% IgG1, 35% IgG2, 3% IgG3, 3% IgG4. The maximum content of IgA is 6000 μg / ml.)
(C)
