ITALY
Last update	2008-04	2008-04	2008-04	2008-04	2010-02	2010-02	2010-02	2008-04	2008-04	2010-02
Company	Baxter	Baxter	Baxter	Biotest Pharma GmbH	CSL-Behring	CSL-Behring	CSL-Behring	Grifols	Kedrion	Octapharma
Name of product	Gammagard S/D	KIOVIG	SUBCUVIA	Intraglobin® F	Privigen	Sandoglobulin (lyo)	Vivaglobin	Flebogamma	IG VENA	Octagam 5%
Available for Hospital therapy	Yes	Yes	Yes	Yes	Registered	Registered	Registered	Yes	Yes	Yes
Available for Home therapy	May vary in different countries due to different licensing situations.	May vary in different countries due to different licensing situations.	Yes	not available for home therapy	No	-	Yes		None	Depends on legal situation,  may be used at home in general
IVIG, SCIG or IMIG	IVIG	IVIG	SCIG	IVIG	IVIG	IVIG	SCIG	IVIG	IVIG	IVIG
Patient´s age	All ages	All ages	Adults and juveniles at the age of ≥ 12 years	unlimited	Adults and children	Adults and children	Adults and children		Adults & Children	Children and adults
Présentation	Lyophilised Powder	Liquid	Liquid	ready-to-use solution	Liquid	Lyophilisat	Liquid	Liquid	Liquid	Liquid
Concentration %	5% or 10%	10%	16%	5% solution	10%	3%, 6%, 9%, 12%	16%	5%	5%	5%
Content of IgG	≥ 90%	≥ 98%	≥ 90%	≥ 95%	≥ 98%	≥ 96%	IgG monomers & dimers 97-97%  •   IgG polymers 3-5%	≥ 99%	95%	≥ 95%
IgG1	63%	56.9%	45-75%	62%	67.8%	60.7%	61%	70.3%	24,3  -  37,2  mg	62,2% ± 2,2
IgG2	21.80%	26.6%	20-45%	34%	28.7%	31.9%	28%	24.7%	12,4  -  22,1  mg	31,1% ± 2,3
IgG3	5.40%	3.4%	3-10%	0.5%	2.3%	3.8%	5%	3.1%	0,9  -   1,5  mg	6,1% ± 1,6
IgG4	0.20%	1.7%	2-8%	3.5%	1.2%	3.6%	6%	2%	0,1  -   0,5  mg	1,2 % ± 0,2
Content of IgA	≤ 3 µg/ml	≤ 0.14 mg/ml	≤ 4.8 mg/ml	≤ 2.5 mg/ml	≤ 0,025 mg/ml	1.2g/L (typical value)	0.39-1.17 g/l	<0,05 mg/ml	< 0,05 mg/ml	≤ 0.2 mg/mL
Glucose, Maltose,…	Glucose	Glycine	Glycine	glucose 25 mg	L-proline (natural amino acid) - Contains no sugar	Sucrose	Glycine		Maltose	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 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	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		0,4 - 0,8 g/kg	0.4 g/kg b.w.
Max. Speed of infusion	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.	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.	2.2 mg/ml per hour	4.8 ml/kg bw/hr If well tolerated Up to 7.2 ml/kg bw/hr.	About 2.5ml/min	About 22ml/hour		40 drops/minute	5 ml/kg/hour
Intervals of infusion for PID	See European core SPC	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	dependent on the individual serum IgG level between 2 and 4 weeks	Usually every 2-4 weeks	Usually every 2-4 weeks	usually weekly		21-28 days	every 3 to 4 weeks
Preserving	• Do not store above 25°C.  •  Do not freeze, the solvent vial might break.  •  Keep vial in the outer carton to protect from light.	• 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.	storage in refrigerator (+2 to +8 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 ≤25°C	3 years	Between +2ºC and +25ºC. Do not freeze. Discard after expiration date.	+2C°< T <+8C°	Between 2- 25°C
Time for reconstitution	General information not available.	N/A	N/A		None	A few minutes	none	none	Ready for use	none
Packaging*	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.	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.	containers with 20, 50, 100 or 200 ml	2g, 5g, 10g, 20g	1g, 3g, 6g, 12g	3g, 10g, 20g		1g/ 20 ml ; 2,5 g/ 50 ml ;  5 g/ 100 ml ; 10 g/ 200 ml	1g, 2.5g, 5g, 10g
* May be different from country to country