FRANCE
Last update	2009-05	2009-05	2009-05	2010-02	2010-02	2010-02	2009-05	2009-05	2010-02	2009-11
Company	Baxter	Baxter	Baxter	CSL-Behring	CSL-Behring	CSL-Behring	LFB	Octapharma	Octapharma	Octapharma
Name of product	KIOVIG	SUBCUVIA	Gammagard S/D	Sandoglobulin (lyo)	Privigen	Vivaglobin	TEGELINE	Gammanorm	Octagam 5%	Octagam 10%
Available for Hospital therapy	Yes	Yes	Yes	Registered	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	Yes	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	SCIG	IVIG	IVIG
Patient´s age	All ages	Adults and juveniles at the age of ≥ 12 years	All ages	Adults and children	Adults and children	Adults and children	None	Children and adults	Children and adults	Children and adults
Présentation	Liquid	Liquid	Lyophilised Powder	Lyophilisat	Liquid	Liquid	Lyoph.	Liquid	Liquid	Liquid
Concentration %	10%	16%	5% or 10%	3%, 6%, 9%, 12%	10%	16%	5%	16.5 %	5%	10%
Content of IgG	≥ 98%	≥ 90%	≥ 90%	≥ 96%	≥ 98%	IgG monomers & dimers 97-97%  •   IgG polymers 3-5%	> 97%	≥ 95%	≥ 95%	≥ 95%
IgG1	56.9%	45-75%	63%	60.7%	67.8%	61%	58.80%	59%	62,2% ± 2,2	ca. 60%
IgG2	26.6%	20-45%	21.80%	31.9%	28.7%	28%	34.10%	36%	31,1% ± 2,3	ca. 32%
IgG3	3.4%	3-10%	5.40%	3.8%	2.3%	5%	5.40%	4.5%	6,1% ± 1,6	ca. 7%
IgG4	1.7%	2-8%	0.20%	3.6%	1.2%	6%	1.70%	0.5%	1,2 % ± 0,2	ca. 1%
Content of IgA	≤ 0.14 mg/ml	≤ 4.8 mg/ml	≤ 3 µg/ml	1.2g/L (typical value)	≤ 0,025 mg/ml	0.39-1.17 g/l	17 mg/ g of proteins	max. 0,0825 mg/ml	≤ 0.2 mg/mL	≤ 0.4mg/mL
Glucose, Maltose,…	Glycine	Glycine	Glucose	Sucrose	L-proline (natural amino acid) - Contains no sugar	Glycine	Saccharose : 2 g/g of proteins	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).	0.2-0.8g/kg bodyweight	0.2-0.8g/kg bodyweight	0.2-0.8g/kg bodyweight	0.4 to 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.	About 2.5ml/min	4.8 ml/kg bw/hr If well tolerated Up to 7.2 ml/kg bw/hr.	About 22ml/hour	4  mL / kg / h	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	Usually every 2-4 weeks	Usually every 2-4 weeks	usually weekly	Every 2 to 4 weeks	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.	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	< 25 ° C	2 years between 2 and 8 °C - 1 month under 25°C	Between 2- 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.	A few minutes	None	none	< 30 min.	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.	1g, 3g, 6g, 12g	2g, 5g, 10g, 20g	3g, 10g, 20g	0,5 g - 2,5 g - 5 g - 10 g	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
No information from the firm