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| Last update | 2009-11 | 2010-02 | 2010-02 | 2007-02 | 2009-11 | ||||||
| Company | CSL-Behring | CSL-Behring | Octapharma | Octapharma | Octapharma | ||||||
| Name of product | Privigen | Sandoglobulin (lyo) | Octagam 5% | Gammanorm | Octagam 10% infusionnilahus 100 mg/ml | ||||||
| Available for Hospital therapy | Registered | Registered | Yes | Yes | Yes | ||||||
| Available for Home therapy | No | - | Depends on legal situation, may be used at home in general | Yes | Depends on legal situation, may be used at home in general | ||||||
| IVIG, SCIG or IMIG | IVIG | IVIG | IVIG | SCIG | IVIG | ||||||
| Patient´s age | Adults and children | Adults and children | Children and adults | Children and adults | Children and adults | ||||||
| Présentation | Liquid | Lyophilisat | Liquid | Liquid | Liquid | ||||||
| Concentration % | 10% | 3%, 6%, 9%, 12% | 5% | 16.5 % | 10% | ||||||
| Content of IgG | ≥ 98% | ≥ 96% | ≥ 95% | ≥ 95% | ≥ 95% | ||||||
| IgG1 | 67.80% | 60.7% | 62,2% ± 2,2 | 59% | ca. 60% | ||||||
| IgG2 | 28.70% | 31.9% | 31,1% ± 2,3 | 36% | ca. 32% | ||||||
| IgG3 | 2.30% | 3.8% | 6,1% ± 1,6 | 4.5% | ca. 7% | ||||||
| IgG4 | 1.20% | 3.6% | 1,2 % ± 0,2 | 0.5% | ca. 1% | ||||||
| Content of IgA | ≤ 0,025 mg/ml | 1.2g/L (typical value) | ≤ 0.2 mg/mL | max. 0,0825 mg/ml | ≤ 0.4mg/mL | ||||||
| Glucose, Maltose,… | L-proline (amino acid) | Sucrose | Maltose 10% | Glycine | Maltose 10% | ||||||
| Average dosage for PID | Starting
dose: 0.4–0.8 g/kg bw Thereafter: 0.2–0.8 g/kg bw |
0.2-0.8g/kg bodyweight | 0.4 g/kg b.w. | 0.1 g/kg | 0.4 - 0.8 g/kg b.w. | ||||||
| Max. Speed of infusion | Human
normal immunoglobulin should be infused intravenously. The initial infusion
rate is 0.3 ml/kg bw/hr. If well tolerated, the rate of administration may
gradually be increased to 4.8 ml/kg bw/hr. In PID patients who have tolerated the infusion rate of 4.8ml/kg bw/hr well, the rate may be further increased gradually to 7.2 ml/kg bw/hr. |
About 2.5ml/min | 5 ml/kg/hour | 40 ml/hour using two pumps simultaneously | 7.2 mL/kg/hour | ||||||
| Intervals of infusion for PID | Every two to four weeks to obtain IgG trough levels of at least 4–6 g/l | Usually every 2-4 weeks | every 3 to 4 weeks | weekly (flexible) | every 3 to 4 weeks | ||||||
| Preserving | • 2 years • Do
not store above 25 °C. • Do not freeze. • Keep the vial in the outer carton in order to protect from light. |
3 years ≤25°C | Between 2- 25°C | 2 years between 2 and 8 °C - 1 month under 25°C | 2 years between 2 and 8 °C - 3 months under 25°C | ||||||
| Time for reconstitution | None | A few minutes | none | none | none | ||||||
| Packaging* | Pack
sizes: 1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml), 3 vials (10 g/100 ml, 20 g/200 ml). Not all pack sizes may be marketed. |
1g, 3g, 6g, 12g | 1g, 2.5g, 5g, 10g | 10 ml (packs of 1, 10 or 20) | 20,50,100,200 ml | ||||||
| * May be different from country to country | |||||||||||