| EL
SALVADOR |
|
|
|
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|
| Last
update |
2010-02 |
2007-05 |
2010-02 |
|
| Company |
CSL-Behring |
Grifols |
Octapharma |
|
| Name of
product |
Sandoglobulin
(lyo) |
Flebogamma |
Octagam
5% |
|
| Available
for Hospital therapy |
Registered |
Yes |
Yes |
|
| Available
for Home therapy |
- |
|
Depends on
legal situation, may be used at home
in general |
|
| IVIG,
SCIG or IMIG |
IVIG |
IVIG |
IVIG |
|
| Patient´s
age |
Adults and
children |
|
Children and
adults |
|
| Présentation |
Lyophilisat |
Liquid |
Liquid |
|
| Concentration
% |
3%, 6%, 9%, 12% |
5% |
5% |
|
| Content
of IgG |
≥ 96% |
≥ 99% |
≥ 95% |
|
| IgG1 |
60.7% |
70.3% |
62,2% ± 2,2 |
|
| IgG2 |
31.9% |
24.7% |
31,1% ± 2,3 |
|
| IgG3 |
3.8% |
3.1% |
6,1% ± 1,6 |
|
| IgG4 |
3.6% |
2% |
1,2 % ± 0,2 |
|
| Content
of IgA |
1.2g/L (typical
value) |
<0,05 mg/ml |
≤ 0.2
mg/mL |
|
| Glucose,
Maltose,… |
Sucrose |
|
Maltose 10% |
|
| Average
dosage for PID |
0.2-0.8g/kg
bodyweight |
|
0.4 g/kg b.w. |
|
| Max.
Speed of infusion |
About
2.5ml/min |
|
3 ml/kg/hour |
|
| Intervals
of infusion for PID |
Usually every
2-4 weeks |
|
every 3 to 4
weeks |
|
| Preserving |
3 years
≤25°C |
Between +2ºC
and +25ºC. Do not freeze. Discard after expiration date. |
Below 25°C |
|
| Time for
reconstitution |
A few minutes |
none |
none |
|
| Packaging* |
1g, 3g, 6g, 12g |
|
1g, 2.5g, 5g,
10g |
|
| * May be different from country to country |
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