MALTA
Last update	2007-05	2007-05	2010-02	2007-05
Company	Bio-Products Laboratory	Biotest Pharma GmbH	CSL-Behring	Kedrion
Name of product	Vigam	Intraglobin® F	Privigen	IG VENA
Available for Hospital therapy	Yes	Yes	Registered	Yes
Available for Home therapy	-	not available for home therapy	No	None
IVIG, SCIG or IMIG	IVIG	IVIG	IVIG	IVIG
Patient´s age	Adults and pediatrics	unlimited	Adults and children	Adults & Children
Présentation	Liquid	ready-to-use solution	Liquid	Liquid
Concentration %	5%	5% solution	10%	5%
Content of IgG	95%	≥ 95%	≥ 98%	95%
IgG1	65	62%	67.8%	24,3  -  37,2  mg
IgG2	29	34%	28.7%	12,4  -  22,1  mg
IgG3	6	0.5%	2.3%	0,9  -   1,5  mg
IgG4	1	3.5%	1.2%	0,1  -   0,5  mg
Content of IgA	< 0.02% w/w	≤ 2.5 mg/ml	≤ 0,025 mg/ml	< 0,05 mg/ml
Glucose, Maltose,…	Sucrose	glucose 25 mg	L-proline (natural amino acid) - Contains no sugar	Maltose
Average dosage for PID	Dependant on age and weight of patient	initial 0.4 - 0.8 g/kg, followed by 0.2 -0.8 g/kg	0.2-0.8g/kg bodyweight	0,4 - 0,8 g/kg
Max. Speed of infusion	3 ml/minute	2.2 mg/ml per hour	4.8 ml/kg bw/hr If well tolerated Up to 7.2 ml/kg bw/hr.	40 drops/minute
Intervals of infusion for PID	Every 2-4 weeks to obtain IgG trough level of at least 4-6 g/L	dependent on the individual serum IgG level between 2 and 4 weeks	Usually every 2-4 weeks	21-28 days
Preserving	Vigam® Liquid should be stored 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.	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.	+2C°< T <+8C°
Time for reconstitution	N/A		None	Ready for use
Packaging*		containers with 20, 50, 100 or 200 ml	2g, 5g, 10g, 20g	1g/ 20 ml ; 2,5 g/ 50 ml ;  5 g/ 100 ml ; 10 g/ 200 ml
* May be different from country to country