BULGARIA
Last update	2007-02	2010-02	2009-11
Company	Biotest Pharma GmbH	CSL-Behring	Octapharma
Name of product	Intraglobin® F	Privigen	Octagam 10%
Available for Hospital therapy	Yes	Registered	Yes
Available for Home therapy	not available for home therapy	No	Depends on legal situation,  may be used at home in general
IVIG, SCIG or IMIG	IVIG	IVIG	IVIG
Patient´s age	unlimited	Adults and children	Children and adults
Présentation	ready-to-use solution	Liquid	Liquid
Concentration %	5% solution	10%	10%
Content of IgG	≥ 95%	≥ 98%	≥ 95%
IgG1	62%	67.8%	ca. 60%
IgG2	34%	28.7%	ca. 32%
IgG3	0.5%	2.3%	ca. 7%
IgG4	3.5%	1.2%	ca. 1%
Content of IgA	≤ 2.5 mg/ml	≤ 0,025 mg/ml	≤ 0.4mg/mL
Glucose, Maltose,…	glucose 25 mg	L-proline (natural amino acid) - Contains no sugar	Maltose 10%
Average dosage for PID	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 b.w.
Max. Speed of infusion	2.2 mg/ml per hour	4.8 ml/kg bw/hr If well tolerated Up to 7.2 ml/kg bw/hr.	7.2 mL/kg/hour
Intervals of infusion for PID	dependent on the individual serum IgG level between 2 and 4 weeks	Usually every 2-4 weeks	every 3 to 4 weeks
Preserving	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.	2 years between 2 and 8 °C - 3 months under 25°C
Time for reconstitution		None	none
Packaging*	containers with 20, 50, 100 or 200 ml	2g, 5g, 10g, 20g	20,50,100,200 ml
* May be different from country to country