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Last update  2008-04 2008-04 2008-04 2008-04 2008-11 2008-11 2010-02 2010-02 2010-02 2008-04 2008-04 2010-02 2009-11 2008-04
Company Baxter Baxter Baxter Biotest Pharma GmbH Bio Products Laboratory Bio Products Laboratory CSL-Behring CSL-Behring CSL-Behring Grifols Octapharma Octapharma Octapharma Talecris
Name of product KIOVIG SUBCUVIA Gammagard S/D Intratect®  Vigam® Subgam® Sandoglobulin (lyo) Privigen Vivaglobin Flebogamma Gammanorm Octagam 5% Octagam 10% Gamunex 10%
Available for Hospital therapy Yes Yes Yes Yes Yes Yes Registered Registered Registered Yes Yes Yes Yes The products are distributed on a named patient basis.
Available for Home therapy May vary in different countries due to different licensing situations. Yes May vary in different countries due to different licensing situations. No Yes Yes - No Yes   Yes Depends on legal situation,  may be used at home in general Depends on legal situation,  may be used at home in general  
IVIG, SCIG or IMIG IVIG SCIG IVIG IVIG IVIG SCIG IVIG IVIG SCIG IVIG SCIG IVIG IVIG  
Patient´s age All ages Adults and juveniles at the age of ≥ 12 years All ages unlimited Adults and paediatrics Adults and paediatrics Adults and children Adults and children Adults and children   Children and adults Children and adults Children and adults  
Présentation Liquid Liquid Lyophilised Powder ready-to-use solution Liquid Liquid Lyophilisat Liquid Liquid Liquid Liquid Liquid Liquid  
Concentration % 10% 16% 5% or 10%  5% solution 5% 16% 3%, 6%, 9%, 12% 10% 16% 5% 16.5 % 5% 0.1  
Content of IgG ≥ 98% ≥ 90% ≥ 90% ≥ 95% 95% 95%   ≥ 96% ≥ 98% IgG monomers & dimers 97-97%  •   IgG polymers 3-5%   ≥ 99% ≥ 95% ≥ 95% ≥ 95%  
IgG1 56.9% 45-75% 63% 57% 64 64 60.7% 67.8% 61% 70.3% 59% 62,2% ± 2,2 ca. 60%  
IgG2 26.6% 20-45% 21.80% 37% 29 29 31.9% 28.7% 28% 24.7% 36% 31,1% ± 2,3 ca. 32%  
IgG3 3.4% 3-10% 5.40% 3% 6 6 3.8% 2.3% 5% 3.1% 4.5% 6,1% ± 1,6 ca. 7%  
IgG4 1.7% 2-8% 0.20% 3% 1 1 3.6% 1.2% 6% 2% 0.5% 1,2 % ± 0,2 ca. 1%  
Content of IgA ≤ 0.14 mg/ml ≤ 4.8 mg/ml ≤ 3 µg/ml max. 2 mg/ml < 0.02% w/w < 0.02% w/w 1.2g/L (typical value) ≤ 0,025 mg/ml 0.39-1.17 g/l <0,05 mg/ml max. 0,0825 mg/ml ≤ 0.2 mg/mL ≤ 0.4mg/mL  
Glucose, Maltose,… Glycine Glycine Glucose glycine 300 mmol/l Sucrose Glycine Sucrose  L-proline (natural amino acid) - Contains no sugar Glycine   Glycine Maltose 10% Maltose 10%  
Average dosage for PID The dosage regimen should achieve a trough level of 4-6 g/l. The dose and dosage regimen may need to be individualised depending on pharmacokinetic and clinical response (Also see European core SPC).  The dosage should be adjusted to maintain an approximate level of at least 4-6 g/l of circulating IgG.  • The dose and dosage regimen may need to be individualised depending on pharmacokinetic and clinical response The dosage regimen should achieve a trough level of 4-6 g/l.  The dose and dosage regimen may need to be individualised depending on pharmacokinetic and clinical response (Also see European core SPC). initial 0.4 - 0.8 g/kg, followed by 0.2 -0.8 g/kg 0.2-0.8g/kg bodyweight 0.2-0.8g/kg bodyweight 0.2-0.8g/kg bodyweight 0.2-0.8g/kg bodyweight 0.2-0.8g/kg bodyweight   0.1 g/kg 0.4 g/kg b.w.  0.4 - 0.8 g/kg b.w.  
Max. Speed of infusion Human normal immunoglobulin should be infused at an initial rate of 0.5 ml/kg BW/hr for 30 minutes. If well tolerated, the rate of administration may be gradually increased to a maximum of 6 ml/kg BW/hr. Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr. It is recommended to use an initial administration speed of 10 ml/h/pump. The infusion speed can be enhanced for 1 ml/h/pump every subsequent infusion. The recommended maximum speed is 20 ml/h/pump. More than 1 pump can be used simultaneously. Gammagard S/D should be infused at an initial rate of 0.5 ml/kg BW/hour. If well tolerated, the rate of administration may gradually be increased to a maximum of 4 ml/kg BW/hour. Patients who tolerate Gammagard S/D 5% solutions at 4 ml/kg BW/hour can be infused with the 10% concentration starting at 0.5 ml/kg BW/hour. If no adverse events occur, the rate can be increased gradually up to a maximum rate of 8 ml/kg BW/hour. 1.9 ml/kg per hour 3 mL/minute 20 mL/hour About 2.5ml/min 4.8 ml/kg bw/hr - If well tolerated Up to 7.2 ml/kg bw/hr. About 22ml/hour   40 ml/hour using two pumps simultaneously 5 ml/kg/hour 7.2 mL/kg/hour  
Intervals of infusion for PID See European core SPC After the loading dose, maintenance doses at repeated intervals to reach a cumulative monthly dose of 0.4-0.8 g/kg See European core SPC dependent on the individual serum IgG level between 2 and 4 weeks Every 2-4 weeks to obtain IgG trough level of at least 4-6 g/L Maintenance doses are administered at repeated interval (usually weekly) to reach monthly cumulative dose of the order of 0.4 – 0.8 g/kg Usually every 2-4 weeks Usually every 2-4 weeks usually weekly   weekly (flexible) every 3 to 4 weeks every 3 to 4 weeks  
Preserving • Store in a refrigerator (2°C - 8°C)   •  KIOVIG may be stored at room temperature (not more than 25°C) for up to 9 months.   Once stored at room temperature KIOVIG must not be returned to the refrigerator and must be discarded, if not used by the end of the 9-month period.  •  Do not store above 25°C  •  Do not freeze  •  Keep the container in the outer carton in order to protect from light • Store in a refrigerator (2°C - 8°C)  •  The packaged product may be kept at room temperature (up to 25°C) for up to 6 weeks. In this case, the product expires at the end of the 6 weeks period.  •  Do not freeze  •  Keep the vial in the carton to protect from light. • Do not store above 25°C.  •  Do not freeze, the solvent vial might break.  •  Keep vial in the outer carton to protect from light.    storage at room temperature (max. 25 0C) shelf-life: 2 years 2 years 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 in the dark in its carton, between 2°C and 8°C.  DO NOT FREEZE.  Storage for up to one week (within the overall shelf-life) at ambient temperatures (25°C) is possible within the shelf-life period. 3 years ≤25°C • 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 Between +2ºC and +25ºC. Do not freeze. Discard after expiration date. 2 years between 2 and 8 °C - 1 month under 25°C Between 2- 25°C 2 years between 2 and 8 °C - 3 months under 25°C  
Time for reconstitution N/A N/A General information not available.    N/A N/A A few minutes none none none none none none  
Packaging* Pack sizes of 1 vial of 1 g/10 ml, 2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml and 20 g/200 ml Pack sizes of 1 x 5 ml, 20 x 5 ml, 1 x 10 ml, and 20 x 10 ml. Pack sizes of 0.5g, 2.5g, 5g, and 10g of lyophilized Gammagard S/D per vial, with appropriate volume of water for injections. Each pack also contains devices for reconstitution and administration. containers with 20, 50, 100 or 200 ml 2.5g, 5g, 10g 250mg, 750mg, 1500mg 1g, 3g, 6g, 12g 2g, 5g, 10g, 20g 3g, 10g, 20g   10 ml (packs of 1, 10 or 20)  1g, 2.5g, 5g, 10g  20,50,100,200 ml  
* May be different from country to country