ROMANIA
Last update	2010-02	2007-02	2010-02	2009-11
Company	CSL-Behring	Kedrion	Octapharma	Octapharma
Name of product	Privigen	IG VENA	Octagam 5%	Octagam 10%
Available for Hospital therapy	Registered	Yes	Yes	Yes
Available for Home therapy	No	None	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	IVIG	IVIG	IVIG
Patient´s age	Adults and children	Adults & Children	Children and adults	Children and adults
Présentation	Liquid	Liquid	Liquid	Liquid
Concentration %	10%	5%	5%	0.1
Content of IgG	≥ 98%	95%	≥ 95%	≥ 95%
IgG1	67.8%	24,3  -  37,2  mg	62,2% ± 2,2	ca. 60%
IgG2	28.7%	12,4  -  22,1  mg	31,1% ± 2,3	ca. 32%
IgG3	2.3%	0,9  -   1,5  mg	6,1% ± 1,6	ca. 7%
IgG4	1.2%	0,1  -   0,5  mg	1,2 % ± 0,2	ca. 1%
Content of IgA	≤ 0,025 mg/ml	< 0,05 mg/ml	≤ 0.2 mg/mL	≤ 0.4mg/mL
Glucose, Maltose,…	L-proline (natural amino acid) - Contains no sugar	Maltose	Maltose 10%	Maltose 10%
Average dosage for PID	0.2-0.8g/kg bodyweight	0,4 - 0,8 g/kg	0.4 g/kg b.w.	0.4 - 0.8 g/kg b.w.
Max. Speed of infusion	4.8 ml/kg bw/hr If well tolerated Up to 7.2 ml/kg bw/hr.	40 drops/minute	5 ml/kg/hour	7.2 mL/kg/hour
Intervals of infusion for PID	Usually every 2-4 weeks	21-28 days	every 3 to 4 weeks	every 3 to 4 weeks
Preserving	• 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°	Between 2- 25°C	2 years between 2 and 8 °C - 3 months under 25°C
Time for reconstitution	None	Ready for use	none	none
Packaging*	2g, 5g, 10g, 20g	1g/ 20 ml ; 2,5 g/ 50 ml ;  5 g/ 100 ml ; 10 g/ 200 ml	1g, 2.5g, 5g, 10g	20,50,100,200 ml
* May be different from country to country