Belgium
Last update	2008-04	2008-04	2008-04	2008-11	2010-02	2010-02	2010-02	2010-02	2009-11
Company	Baxter	Baxter	Biotest Pharma GmbH	Sanquin	CSL-Behring	CSL-Behring	CSL-Behring	Octapharma	Octapharma
Name of product	SUBCUVIA	Gammagard S/D	Intraglobin® F	Multigam	Privigen	Sandoglobulin (lyo)	Vivaglobin	Octagam 5%	Octagam 10%
Available for Hospital therapy	Yes	Yes	Yes	Yes	Registered	Registered	Registered	Yes	Yes
Available for Home therapy	Yes	May vary in different countries due to different licensing situations.	not available for home therapy	-	No	-	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	SCIG	IVIG	IVIG	IVIG	IVIG	IVIG	SCIG	IVIG	IVIG
Patient´s age	Adults and juveniles at the age of ≥ 12 years	All ages	unlimited	No restrictions	Adults and children	Adults and children	Adults and children	Children and adults	Children and adults
Présentation	Liquid	Lyophilised Powder	ready-to-use solution	20, 50, 100, 200 ml	Liquid	Lyophilisat	Liquid	Liquid	Liquid
Concentration %	16%	5% or 10%	5% solution	5%	10%	3%, 6%, 9%, 12%	16%	5%	10%
Content of IgG	≥ 90%	≥ 90%	≥ 95%	≥ 95%	≥ 98%	≥ 96%	IgG monomers & dimers 97-97%  •   IgG polymers 3-5%	≥ 95%	≥ 95%
IgG1	45-75%	63%	62%	59%	67.8%	60.7%	61%	62,2% ± 2,2	ca. 60%
IgG2	20-45%	21.80%	34%	36%	28.7%	31.9%	28%	31,1% ± 2,3	ca. 32%
IgG3	3-10%	5.40%	0.5%	3%	2.3%	3.8%	5%	6,1% ± 1,6	ca. 7%
IgG4	2-8%	0.20%	3.5%	2%	1.2%	3.6%	6%	1,2 % ± 0,2	ca. 1%
Content of IgA	≤ 4.8 mg/ml	≤ 3 µg/ml	≤ 2.5 mg/ml	≤ 2,5 mg/ml	≤ 0,025 mg/ml	1.2g/L (typical value)	0.39-1.17 g/l	≤ 0.2 mg/mL	≤ 0.4mg/mL
Glucose, Maltose,…	Glycine	Glucose	glucose 25 mg	Glycine	L-proline (natural amino acid) - Contains no sugar	Sucrose	Glycine	Maltose 10%	Maltose 10%
Average dosage for PID	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	Dosis : 0,1 – 0,4 g/kg every 4 weeks. If IgG level stays low you can rise the dosis to 0,8 g/kg or lower the interval to 2 or 3 weeks	0.2-0.8g/kg bodyweight	0.2-0.8g/kg bodyweight	0.2-0.8g/kg bodyweight	0.4 g/kg b.w.	0.4 - 0.8 g/kg b.w.
Max. Speed of infusion	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.	2.2 mg/ml per hour	50 drops per min	4.8 ml/kg bw/hr If well tolerated Up to 7.2 ml/kg bw/hr.	About 2.5ml/min	About 22ml/hour	5 ml/kg/hour	7.2 mL/kg/hour
Intervals of infusion for PID	After the loading dose, maintenance doses at repeated intervals to reach a cumulative monthly dose of 0.4-0.8 g/kg	Every 2 to 4 weeks for a residual rate from 4 to 6 g/l	dependent on the individual serum IgG level between 2 and 4 weeks	For first time users : For first time users : 15 min : 10 drops/min - In case of good tolerance : 10 – 50 drops/min.	Usually every 2-4 weeks	Usually every 2-4 weeks	usually weekly	every 3 to 4 weeks	every 3 to 4 weeks
Preserving	• 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 in refrigerator (+2 to +8 0C) - shelf-life: 2 years	no	• 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	3 years	Between 2- 25°C	2 years between 2 and 8 °C - 3 months under 25°C
Time for reconstitution	N/A	General information not available.	none	no	None	A few minutes	none	none	none
Packaging*	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	1g, 3g, 6g, 12g	3g, 10g, 20g	1g, 2.5g, 5g, 10g	20,50,100,200 ml
* May be different from country to country