AUSTRIA
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Last update 2008-04 2008-04 2008-04 2008-04 2010-02 2010-02 2008-04 2008-04 2010-02 2009-11  
Company Baxter Baxter Baxter Biotest Pharma GmbH CSL-Behring CSL-Behring Kedrion Octapharma Octapharma Octapharma
Name of product KIOVIG SUBCUVIA Gammagard S/D Intratect®   Privigen Vivaglobin IG VENA Gammanorm Octagam 5% Octagam 100 mg/ml Infusionslösung
Available for Hospital therapy Yes Yes Yes Yes Registered Registered Yes Yes Yes Yes
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 No Yes None 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 SCIG IVIG IVIG
Patient´s age All ages Adults and juveniles at the age of ≥ 12 years All ages All ages Adults and children Adults and children Adults & Children Children and adults Children and adults Children and adults
Présentation Liquid Liquid Lyophilised Powder ready-to-use solution Liquid Liquid Liquid Liquid Liquid Liquid
Concentration % 10% 16% 5% or 10%  5% solution 10% 16% 5% 16.5 % 5% 10%
Content of IgG  ≥ 98% ≥ 90% ≥ 90% ≥ 95% ≥ 98% IgG monomers & dimers 97-97%  •   IgG polymers 3-5% 95% ≥ 95% ≥ 95% ≥ 95%
IgG1 56.9% 45-75% 63% 57% 67.8% 61% 24,3  -  37,2  mg 59% 62,2% ± 2,2 ca. 60%
IgG2 26.6% 20-45% 21.80% 37% 28.7% 28% 12,4  -  22,1  mg 36% 31,1% ± 2,3 ca. 32%
IgG3 3.4% 3-10% 5.40% 3% 2.3% 5% 0,9  -   1,5  mg 4.5% 6,1% ± 1,6 ca. 7%
IgG4 1.7% 2-8% 0.20% 3% 1.2% 6% 0,1  -   0,5  mg 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 ≤ 0,025 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   L-proline (natural amino acid) - Contains no sugar Glycine Maltose 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). 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). 0.2-0.8g/kg bodyweight 0.2-0.8g/kg bodyweight 0,4 - 0,8 g/kg 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. Intract should be infused intravenoulsy at an initial rate of not more than 1.4 ml/kg/hour for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 1.9ml/kg /hour  for the remainder of the infusion.  4.8 ml/kg bw/hr
If well tolerated Up to 7.2 ml/kg bw/hr.		 About 22ml/hour 40 drops/minute 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 See European core SPC. Dependent on the individual serum IgG level between 2 and 4 weeks Usually every 2-4 weeks usually weekly 21-28 days 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 • Do not store above 25 °C.
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.		 3 years +2C°< T <+8C° 2 years between 2 and 8 °C - 1 month under 25°C Below 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 None none Ready for use 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 2g, 5g, 10g, 20g 3g, 10g, 20g 1g/ 20 ml ; 2,5 g/ 50 ml ;  5 g/ 100 ml ; 10 g/ 200 ml 10 ml (packs of 1, 10 or 20)  1g, 2.5g, 5g, 10g  20,50,100,200 ml
* Not all pack sizes may be marketed in all countries.