| CYPRUS | |||||||||
| Last update | 2008-11 | 2009-11 | 2008-11 | 2010-02 | |||||
| Company | Bio-Products Laboratory | CSL-Behring | CSL-Behring | Octapharma | |||||
| Name of product | Vigam | Privigen | Vivaglobin | Octagam 5% | |||||
| Available for Hospital therapy | Yes | Registered | Yes | Yes | |||||
| Available for Home therapy | - | No | Yes | Depends on legal situation, may be used at home in general | |||||
| IVIG, SCIG or IMIG | IVIG | IVIG | SCIG | IVIG | |||||
| Patient´s age | Adults and pediatrics | Adults and children | Adults and children | Children and adults | |||||
| Présentation | Liquid | Liquid | Liquid | Liquid | |||||
| Concentration % | 5% | 10% | 16% | 5% | |||||
| Content of IgG | 95% | ≥ 98% | IgG monomers & dimers 97-97% • IgG polymers 3-5% | ≥ 95% | |||||
| IgG1 | 65 | 67.80% | 61% | 62,2% ± 2,2 | |||||
| IgG2 | 29 | 28.70% | 28% | 31,1% ± 2,3 | |||||
| IgG3 | 6 | 2.30% | 5% | 6,1% ± 1,6 | |||||
| IgG4 | 1 | 1.20% | 6% | 1,2 % ± 0,2 | |||||
| Content of IgA | < 0.02% w/w | ≤ 0,025 mg/ml | max. 1.7 g/L | ≤ 0.2 mg/mL | |||||
| Glucose, Maltose,… | Sucrose | L-proline (amino acid) | Glycine | Maltose 10% | |||||
| Average dosage for PID | Dependant on age and weight of patient | 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. | |||||
| Max. Speed of infusion | 3 ml/minute | 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 22ml/hour | 5 ml/kg/hour | |||||
| Intervals of infusion for PID | Every 2-4 weeks to obtain IgG trough level of at least 4-6 g/L | Every two to four weeks to obtain IgG trough levels of at least 4–6 g/l | usually weekly | every 3 to 4 weeks | |||||
| Preserving | Vigam® Liquid should be stored in the dark in its carton, between 2° and 8°C. DO NOT FREEZE. A short period up to 3 months at 25°C is possible within the shelf-life period. | • 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 | Below 25°C | |||||
| Time for reconstitution | N/A | None | none | none | |||||
| Packaging* | 2,5g, 5g | 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, 2.5g, 5g, 10g | ||||||
| * May be different from country to country |